[Senate Hearing 111-881]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-881

   VA DISABILITY COMPENSATION: PRESUMPTIVE DISABILITY DECISION-MAKING

=======================================================================

                                HEARING

                               BEFORE THE

                     COMMITTEE ON VETERANS' AFFAIRS
                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 23, 2010

                               __________

       Printed for the use of the Committee on Veterans' Affairs








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                     COMMITTEE ON VETERANS' AFFAIRS

                   Daniel K. Akaka, Hawaii, Chairman
John D. Rockefeller IV, West         Richard Burr, North Carolina, 
    Virginia                             Ranking Member
Patty Murray, Washington             Lindsey O. Graham, South Carolina
Bernard Sanders, (I) Vermont         Johnny Isakson, Georgia
Sherrod Brown, Ohio                  Roger F. Wicker, Mississippi
Jim Webb, Virginia                   Mike Johanns, Nebraska
Jon Tester, Montana                  Scott P. Brown, Massachusetts
Mark Begich, Alaska
Roland W. Burris, Illinois
Arlen Specter, Pennsylvania
                    William E. Brew, Staff Director
                 Lupe Wissel, Republican Staff Director











                            C O N T E N T S

                              ----------                              

                           September 23, 2010
                                SENATORS

                                                                   Page
Akaka, Hon. Daniel K., Chairman, U.S. Senator from Hawaii........     1
Isakson, Hon. Johnny, U.S. Senator from Georgia..................     2
Rockefeller, Hon. John D., IV, U.S. Senator from West Virginia...     3
Johanns, Hon. Mike, U.S. Senator from Nebraska...................     4
Murray, Hon. Patty, U.S. Senator from Washington.................     5
Brown, Hon. Scott, U.S. Senator from Massachusetts...............     6
Sanders, Hon. Bernard, U.S. Senator from Vermont.................     7
Brown, Hon. Sherrod, U.S. Senator from Ohio......................     9
Webb, Hon. Jim, U.S. Senator from Virginia.......................    10
Tester, Hon. Jon, U.S. Senator from Montana......................    12
Burris, Hon. Roland W., U.S. Senator from Illinois...............    13
Begich, Hon. Mark, U.S. Senator from Alaska......................    14

                               WITNESSES

Shinseki, Hon. Eric K., Secretary of U.S. Department of Veterans 
  Affairs; accompanied by Robert L. Jesse, MD, Ph.D., Principal 
  Deputy Under Secretary for Health; Victoria Cassano, MD, MPH, 
  FACPM, Director, Radiation and Physical Exposures Service; 
  Thomas J. Pamperin, Associate Deputy Under Secretary for Policy 
  and Program Management; and John H. Thompson, Deputy General 
  Counsel........................................................    16
    Prepared statement...........................................    19
    Response to pre-hearing questions submitted by Hon. Jim Webb.    23
    Response to post-hearing questions submitted by:
      Hon. Daniel K. Akaka.......................................    25
      Hon. Jim Webb..............................................    35
    Response to request arising during the hearing by Hon. Jim 
      Webb.......................................................    44
Principi, Hon. Anthony J., Former Secretary, U.S. Department of 
  Veterans Affairs...............................................    49
    Prepared statement...........................................    52
    Response to pre-hearing questions submitted by Hon. Jim Webb.    54
    Response to post-hearing questions submitted by Hon. Daniel 
      K. Akaka...................................................    56
Samet, Jonathan M., MD, MS, Chair, Committee on Evaluation of the 
  Presumptive Disability Decision-Making Process for Veterans, 
  Institute of Medicine of the National Academies................    61
    Prepared statement...........................................    62
        Attachment...............................................    67
    Response to pre-hearing questions submitted by Hon. Jim Webb.    88
    Response to post-hearing questions submitted by Hon. Daniel 
      K. Akaka...................................................    93
Bild, Diane, MD, MPH, Associate Director, Prevention and 
  Population Sciences Program, National Heart, Lung, and Blood 
  Institute, National Institutes of Health.......................    99
    Prepared statement...........................................   100
    Response to pre-hearing questions submitted by Hon. Daniel K. 
      Akaka......................................................   101
    Response to post-hearing questions submitted by Hon. Daniel 
      K. Akaka...................................................   105
Birnbaum, Linda, Ph.D., DABT, ATS, Director, National Institute 
  of Environmental Health Sciences, National Institutes of 
  Health, and Director, National Toxicology Program, U.S. 
  Department of Health and Human Services........................   107
    Prepared statement...........................................   108
    Response to pre-hearing questions submitted by Hon. Daniel K. 
      Akaka......................................................   110

                                APPENDIX

Reserve Officers Association of the United States and Reserve 
  Enlisted Association of the United States; prepared statement..   119
    Figure 1.....................................................   123
    Attachment 1.................................................   124

 
   VA DISABILITY COMPENSATION: PRESUMPTIVE DISABILITY DECISION-MAKING

                              ----------                              


                      THURSDAY, SEPTEMBER 23, 2010

                                       U.S. Senate,
                            Committee on Veterans' Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:30 a.m., in 
room G50, Dirksen Senate Office Building, Hon. Daniel K. Akaka, 
Chairman of the Committee, presiding.
    Present: Senators Akaka, Rockefeller, Murray, Brown of 
Ohio, Webb, Tester, Begich, Burris, Sanders, Isakson, Johanns, 
and Brown of Massachusetts.

     OPENING STATEMENT OF HON. DANIEL K. AKAKA, CHAIRMAN, 
                    U.S. SENATOR FROM HAWAII

    Chairman Akaka. This hearing of the U.S. Senate Committee 
on Veterans' Affairs will come to order.
    Welcome and aloha to today's hearing on the VA Presumptive 
Disability Decision-Making Process.
    Today much of our focus will be on Vietnam veterans and 
Agent Orange. However, this discussion also extends the 
presumptions from the first Gulf War. We are just beginning to 
hear about exposures to potential toxins connected to the wars 
in Iraq and Afghanistan. This Committee is also addressing 
exposures at military installations. This is why it is so 
important that the presumptions created are appropriate and 
transparent for past and future wars.
    One issue we will look at this morning is the VA 
Secretary's role in creating presumptions under the Agent 
Orange Act. The Secretary is called on to determine, on the 
basis of sound medical and scientific evidence, whether there 
is a positive association between exposure for all herbicides 
and occurrence of a disease. The law sets up a balancing test 
between exposure and disease. A positive association exists 
when the evidence or an association is equal to or greater than 
evidence against association.
    In making the determination, the Secretary has to take into 
account reports from IOM and all other sound medical and 
scientific information. As we look at the recent Agent Orange 
decision, we must be satisfied that all scientific evidence was 
made available to the Secretary and we must understand how it 
was weighed and considered. For my part, I must be satisfied 
that the law enacted almost 20 years ago now, is working today.
    While it is clear that there are real and substantial costs 
associated with this new presumption, that is not the 
motivation for this hearing or for our larger work of 
evaluating the process put in place pursuant to the Agent 
Orange Act. We made a promise to care for and compensate 
veterans for service-connected injuries. I will never stop 
fighting for veterans, especially when the issue is directly 
related to the consequences of service.
    Keeping our promise to veterans will cause us to look 
closely at the current presumption process. We must be sure the 
process gives VA appropriate authority to consider all relevant 
factors in order to determine whether a service-connected 
presumption is warranted. I hope that our witnesses will shed 
some light on these issues. The current Secretary and a former 
Secretary will testify about their experiences with presumptive 
decisionmaking, and experts from the scientific community will 
testify on dioxin and what science exists for determining an 
association between Agent Orange and heart disease and other 
diseases common to aging.
    I thank our witnesses for being here today and helping us 
in this effort. I look forward to your testimony.
    At this time I would like to call on our Ranking Member, 
Senator Isakson, for his opening statement.

               STATEMENT OF HON. JOHNNY ISAKSON, 
                   U.S. SENATOR FROM GEORGIA

    Senator Isakson. Thank you very much, Mr. Chairman. I want 
to welcome all our panelists, in particular Secretary Shinseki 
and former Secretary Principi. Thank you for your time today.
    I also want to apologize. I am in charge of the floor from 
10:30 to 12:30 in a debate and will have to leave, but Senator 
Johanns will take my place as ranking member, and I thank him 
for that.
    Mr. Chairman, unfortunately many military personnel and 
their families have been put at risk over the years by 
dangerous exposure where they are living, working, or serving 
our Nation. Last year this Committee held a hearing to discuss 
some of those exposures, including the contaminated drinking 
water at Camp LeJeune and smoke from burn pits in Afghanistan 
and Iraq.
    Today we will hear about defoliants with toxic contaminants 
that were widely used in Vietnam to destroy jungles, kill 
crops, and clear perimeters. For all who have been put at risk 
by these and other exposures, it is extremely important to have 
a process in place to identify how their health may be affected 
and make sure they receive, in a fair, hassle-free, and timely 
manner the benefits and services they need and they deserve.
    As we will discuss today presumptions can play a critical 
role in that process. Those presumptions can relieve individual 
veterans of the burden of providing scientifically the 
potential health effects of dangerous exposures. This in turn 
can create a quicker, easier path to benefits and services.
    But the current framework for creating presumptions may 
have flaws. In fact, the Institute of Medicine recommended a 
whole new approach, one that is more transparent, allows 
stakeholders greater input, and proactively identifies 
exposures and conditions that may warrant presumptions.
    Given the profound impact the presumptions can have, I hope 
to have a productive session today about the current process 
where improvements may be needed, and more importantly, how any 
changes would impact our Nation's veterans and their families.
    On top of that, I am interested in learning the extent to 
which medical treatment is being emphasized for those who may 
have been exposed. Take, for example, coronary heart disease, 
which we will hear today, may be very common among Vietnam 
veterans. Treating the risk factors associated with the disease 
has proven effective in keeping folks healthy.
    VA's overreaching goal is to restore the capability of 
disabled veterans to the greatest extent possible. That goal 
cannot be achieved if we only focus on a disability process and 
neglect treatment and prevention.
    Mr. Chairman, I am grateful for the opportunity to 
participate today, and I thank again all our panelists for 
being here.
    Chairman Akaka. Thank you very much Senator Isakson. 
Senator Rockefeller.

           STATEMENT OF HON. JOHN D. ROCKEFELLER IV, 
                U.S. SENATOR FROM WEST VIRGINIA

    Senator Rockefeller. Thank you, Mr. Chairman. I appreciate 
your commitment to oversight, I welcome our panelists, and I 
apologize that I also have to leave because we are having a 
hearing in the Commerce Committee which I need to chair about 
making sure that full spectrum is available exclusively for our 
public defenders. You know, fire, police, EMS, EMT, all the 
rest of them right now do not have enough. Some wireless 
companies want to get it for themselves. I say that we have to 
give it to those people who are our first responders. But I 
apologize for that.
    First, I want to say I am very proud to be a co-sponsor of 
the 1991 Agent Orange Law and I still am. That law directed the 
Secretary of the Department of Veterans Affairs to rely on the 
Institute of Medicine Studies and other science to determine 
presumptive coverage based on exposure to Agent Orange. The 
standard is a positive association. And if the majority of the 
evidence makes such an association, the Secretary shall provide 
the coverage.
    I have met extensively with the Secretary, who I greatly 
respect, and I believe he followed the standard set by the law. 
I believe that some will suggest that a new standard of 
causation, rather than positive association, is more 
appropriate. I do not have to agree with that, partly because I 
come from a coal **State where we have something called black 
lung. And I know perfectly well, having been in West Virginia 
for 46 years, that if you worked underground for 10 years, by 
definition you have black lung. By definition. But the 
presumption does not give you that diagnosis as a result. Very 
few of our miners in southwestern Virginia and West Virginia 
are getting the black lung medical care that they deserve and 
they die horrible deaths.
    So, I am concerned that the standard is very inadequate. I 
am more concerned that sick veterans not be left out. Let me be 
clear. I believe the underlying unspoken issue here today that 
some will talk about and some may not want to is cost. People 
are going to say in muted ways, it costs too much. We cannot 
afford to do that. So it comes down to what are the spending 
priorities for our country? The Vietnam War cost $740 billion, 
and caring for the veterans drafted to fight that war is a 
fraction of that $740 billion. We did not question then. We do 
not question now.
    Some will face enormous deficits; some say we are going to 
face enormous deficits, and of course that is the case. I will 
not get into that. They are correct. But when we are talking 
about deficits, we also have to present the full picture. I was 
here when people claimed that we had such surpluses that we had 
to cut taxes, including those for the very wealthy.
    The Bush tax cuts enacted in 2001-2003, converted our 
national surplus into enormous deficits. I did not vote for 
that but people did and it passed and everybody said OK. The 
tax cuts expire at the end of this year; hence, the moral 
choice facing the Veterans' Affairs Committee and the U.S. 
Congress.
    There is debate about extending these tax cuts. If we do 
not extend the tax cuts to the wealthiest 2 percent, we will 
save $700 billion in revenues over the next 10 years. Frankly, 
that is so much more than enough to take care of what it is the 
Secretary is required under law to do and needs to do and wants 
to do. I have never believed tax cuts for the wealthiest among 
us is fiscally responsible. I also do not think it stimulates 
the economy. I believe that is proven fact; others will 
disagree.
    But even more than that, if given the choice between tax 
cuts for the rich and paying for care for our veterans, we on 
this Committee have a fairly clear choice about priorities, 
which will test who we are morally. I think the choice is 
clear; we spend it on veterans. We must serve our veterans. We 
have the resources and the ability to fulfill our obligations 
to care for them and we have to do that. We owe them that. 
Thank you, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Rockefeller. 
Senator Johanns.

                STATEMENT BY HON. MIKE JOHANNS, 
                    U.S. SENATOR FROM NEVADA

    Senator Johanns. Mr. Chairman, thank you very, very much. I 
intend to be quite brief today but I do have a few thoughts I 
want to offer.
    First and foremost, I want to say thank you to the 
Chairman. I appreciate him holding this hearing. I might add, 
Mr. Chairman, I have appreciated being on this Committee. For 
me it is an honor to serve on a Senate Committee that focuses 
on the needs of the veterans. I just cannot tell you how much I 
have appreciated serving with the Chairman and our Ranking 
Member while trying to figure out really tough issues which 
help the families that are impacted here.
    Sometimes the impacts are very direct, as you know, Mr. 
Secretary. We can identify somebody who has been physically 
injured in war who maybe have lost a limb or whatever. You 
could look at that and come to grips with what their disability 
is or try to help them come to grips with that. Sometimes it is 
much more indirect than that. But there are unintended 
consequences that we as a Committee and as a Congress have to 
deal with. That is just the reality of this situation.
    I would classify Agent Orange in that category. Millions 
and millions of gallons of Agent Orange were used to conduct a 
war. I suspect at the time those who made that decision thought 
they were making the right choice for a variety of reasons, but 
we have seen the consequences of its use are just horrendous.
    Now, Mr. Secretary, I have been somewhat in your position 
as a former cabinet member, and I remember the hearings when I 
would get called up for some discussion of some action I was 
taking and I thought I was discharging the responsibility given 
to me by Congress, only to be caught in a debate.
    I would imagine today you might not have thought that you 
would get in a debate over the 2001-2003 tax cuts. The reality 
of that though, I might add, is that the largest revenue in our 
Nation's history occurred in 2007 when they were fully in 
effect. You can grow the base. But let me stop there because 
quite honestly what I want to focus on is what you have done.
    I think you have looked at this in every way we have asked 
you to. I think you dug deep. You did the analysis that we 
expected you would do. As Chairman Rockefeller points out, once 
you get to that conclusion your discussion ends. Once you reach 
the point where there is evidence that leads you to that, then 
you shall provide the benefits. It is not something where you 
say, well, I cannot do that.
    So, I think as we go through this hearing we have got to 
focus on that and the responsibility we gave you in your 
attempt to discharge that responsibility.
    I will offer this final thought. I come from the State of 
Nebraska where as Governor for 6 years I did not have the 
option of borrowing money. Our State does not owe any money. 
Why? Because our constitution prohibited borrowing; so I could 
never balance the budget by borrowing money. There were not 
many choices available to me.
    Now, some might argue that is not a good way of doing 
things. I would argue that what it forced us to do is to make 
important decisions about priorities. I think this is what this 
hearing is about. For me, our veterans are a priority. We put 
them in harm's way; we asked them to risk their lives and 
oftentimes they give their lives. I just think in the end we 
have got to protect them from the direct and unintended 
consequences of those decisions.
    I come here today with an attitude of wanting to dig deep, 
I want to understand what you saw; I want to feel the 
justification that you felt. At the end if that is there, we 
stand here with our veterans. So Secretary Shinseki, thank you 
so much for your being here, for your work in this area. I know 
you are trying to get to a decent and honorable result for the 
veterans. Thanks. Thank you, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Johanns.
    Senator Murray.

                STATEMENT BY HON. PATTY MURRAY, 
                  U.S. SENATOR FROM WASHINGTON

    Senator Murray. Thank you very much, Mr. Chairman, for 
holding this hearing.
    You know, as everybody on this Committee knows, while the 
costs of war are never able to be predicted, it is always 
higher than we ever imagined. It includes lives that are lost, 
billions in funding to keep our troops safe and investments 
that are made in faraway lands. It always, always includes the 
many years of care seen and unforeseen that our veterans will 
need. It includes what is often expensive but absolutely 
sacred. And that is a promise we made to our veterans: that we 
will care for them when they return.
    Mr. Chairman, the veterans that have come forward with 
these new presumptive diseases are among those that we made 
that promise to. This is a promise I remember well when I 
interned at the Seattle VA medical center while I was in 
college during the Vietnam War. We made this promise decades 
ago without the thought of budget deficits or Agent Orange 
exposure or politics. We made it because their sacrifice 
warranted it, but for years now they have had to fight to see 
it fulfilled. They have had to fight the VA, they have had to 
fight with doctors, and they have had to fight with Members of 
Congress. That is unacceptable.
    I understand the need to tighten our fiscal belt, but we 
cannot do it at the expense of squeezing our veterans. Mr. 
Chairman, as you know, in the aftermath of widespread Agent 
Orange exposure in Vietnam, the Department of Defense did not 
offer early intervention, track servicemembers who were 
exposed, or create a registry for affected veterans. Then as 
veterans became sick, they had to fight to have their diseases 
recognized by the VA.
    Ultimately, the unacceptable challenges faced by veterans 
exposed to Agent Orange led Congress to pass the Agent Orange 
Act of 1991. That legislation established a presumptive process 
to lower the burden of proof for veterans in determining 
whether a disability or illness is service-connected. Make no 
mistake; I believe that veterans who have sacrificed so much 
deserve the benefit of the doubt. That is why it appears to me 
that the Secretary made the best decision possible given the 
limitations on the findings and the limitations of his role 
under that law. Given the lack of tracking data on who was 
exposed and to what extent, I know we must provide for our 
veterans if an association can be made.
    With all that being said, this Committee does need to know 
how this process works and how it can be improved. Going 
forward there is no question we need to make a better effort to 
identify exposures that could lead to illnesses and diseases, 
and the Pentagon and VA need to work together to make sure that 
we care for these individuals.
    DOD must provide treatment immediately after the exposure. 
I believe DOD and VA should work to create a registry to track 
the servicemembers and veterans and their levels of exposure, 
so that over time we have a better understanding of how these 
exposures impact veterans.
    So, Mr. Chairman, I thank you for this hearing and I look 
forward to the testimony from our witnesses.
    Chairman Akaka. Thank you very much, Senator Murray.
    Senator Brown of Massachusetts.

                STATEMENT OF HON. SCOTT BROWN, 
                U.S. SENATOR FROM MASSACHUSETTS

    Senator Brown of Massachusetts. Thank you, Mr. Chairman. 
Congratulations again on that nice award you received the other 
night. It is well deserved.
    Mr. Secretary, thank you for your leadership and devoted 
service to our Nation's veterans. We had an opportunity to 
speak in my office about some of the issues we are discussing 
today. I enjoyed that meeting very much and I appreciate you 
taking--making the effort to reach out and talk to me. 
Unfortunately, I will be bouncing back and forth as well due to 
some other issues that I am working on as well.
    As you all know, we have a solemn duty and moral obligation 
to our veterans. I have been fortunate enough to serve for 
almost 31 years now, and am still serving in the Army National 
Guard where I have witnessed firsthand the sacrifices made by 
the men and women who have decided to volunteer and serve, 
often at a great expense not only to them but their families. 
Making good on our promise to repay those sacrifices is one 
that will never change.
    The Veterans Administration and Institute of Medicine have 
a steep climb here but I, along with my colleagues, want to 
work with you every step of the way. At the same time, the 
process of creating presumptive conditions for deserving 
veterans is one that should be examined closely with all the 
facts.
    There exist certain realities beyond the Institute of 
Medicine, findings that are in my view a very critical 
component of the VA's decisionmaking process to assess 
presumptive treatment. Nonetheless, the key stakeholders 
involved in the process are highly qualified, and I am 
interested in learning more about the VA process and about 
determining what conditions are referred to the Institute for 
study and how the VA reviews the Institute of Medicine report 
to make presumptive determinations.
    I would ask that this group of distinguished stakeholders 
continue to review current policies and decisionmaking 
processes for determining presumptive conditions and implement 
efficiencies where possible.
    So, Mr. Chairman, I want to thank you again for all your 
work on this and other issues. And although I have some 
concerns, I think there is an opportunity to improve the 
process to ensure we provide our veterans with the necessary 
compensation they deserve while also taking into consideration 
the financial obligations of these decisions. As you and others 
should know, you are more than welcomed to provide any and all 
information to bring me up to speed being the new person here 
to give me the tools and resources I need to make better 
decisions.
    So thank you, Mr. Chairman.
    Senator Akaka. Thank you very much, Senator Brown from 
Massachusetts.
    Senator Sanders.

             STATEMENT FROM HON. BERNARD SANDERS, 
                   U.S. SENATOR FROM VERMONT

    Senator Sanders. Thank you, Mr. Chairman. I want to thank 
Secretary Shinseki and the other witnesses for their 
participation in today's very important hearing. I also want to 
applaud Secretary Shinseki not only on this issue but on a 
number of issues; stepping up to the plate and his bold 
leadership in terms of addressing some very long-standing 
problems facing the veterans' community.
    Today I want to express my support for his decision based 
on existing law. That is the main point to be made today based 
on existing law: to add three new presumptive medical 
conditions as service-connected for Vietnam Veterans. I just 
want to say to my colleagues what I know they already know, 
that what we are talking about today is the ongoing cost of 
war. This is what war is about. War is more than bullets and 
guns and airplanes. War is about making sure that we take care 
of the last veteran who served in that war and we do that 
person justice. If we do not want to do that, do not send them 
off to war. But if you make that decision, that is the moral 
responsibility that we have, which I think is what we are 
talking about today.
    We have witnessed over and over again wartime decisions 
that were tools of war but had an adverse impact on the health 
of the very young men and women this Nation has placed in 
harm's way. I think we are all familiar with that. We all 
remember the rather shameful experience that took place after 
World War II when many of our soldiers were exposed to atomic 
radiation, yet the DOD and other officials were saying, what 
are you talking about. Yes, you are coming down with cancer. Do 
not blame us. We had nothing to do with it.
    Well, obviously history has proved that very, very wrong. I 
think all of us know the shameful history of Agent Orange. We 
know that it was the service organizations themselves that had 
to step up to the plate and sue their own government to say our 
people are getting sick. No, no, no. It is not us. And we have 
made real progress since then. But that is something we should 
never, ever forget. Men and women who put their lives on the 
line should not have to sue their own government for the 
benefits that they are entitled to and that they earned.
    The Agent Orange Act of 1991, which is the fundamental 
topic of this hearing, enabled the VA to begin treating and 
compensating the veterans exposed in Vietnam because of 
positive association.
    Mr. Chairman, it has been my experience in dealing with 
veterans, especially those with serious medical conditions, 
that all they really want is timely access to quality health 
care. When this Nation needed these young men and women to go 
into harm's way, they went. However, when those same veterans 
came back knocking on the doors of DOD or VA medical centers 
seeking health care, they too often found themselves turned 
away or denied health care because of rules and regulations 
that would rather split hairs than provide health care.
    I was in the House for many years on the Government 
Operations Committee, and I will never forget as long as I live 
the hearings that Chris Shays, who was then chairman of the 
committee, and I held on Gulf War illness. We had veterans 
coming in whose bodies were falling apart and we had the VA at 
that time saying you are not sick. You are not sick. It was a 
very distressing experience.
    The debate--this debate is about a presumption 
decisionmaking process rather than meeting the health care 
needs of veterans. It is about presumption decisionmaking. 
Agent Orange was a kick the can down the road issue which is 
too common inside the beltway but does not make a bit of sense 
to the men and women who truly believe VA is their health care 
system, which I hope all of them do believe.
    Secretary Shinseki, you have been placed in a very, very 
difficult position. In a sense I think we owe you an apology 
and your predecessors an apology as to: on one hand give you 
the authority and responsibility to make this decision; and 
then perhaps turn around only to question and second guess your 
decisionmaking process. I am confident that you labored over 
this decision and sought wise counsel. I know that you did. The 
presumption process dates back long before Agent Orange and has 
repeatedly accomplished one objective that I think we can all 
agree on--truly demonstrated the thanks of a grateful nation by 
aggressively addressing health care needs and if necessary, 
providing veterans with their earned benefits.
    My colleagues: on the issue of cost, none of us are willing 
to put a price tag on good health. If cost is a concern, then 
cost should be discussed before sending servicemembers into 
harm's way.
    Clearly, this is about the ongoing cost of war. The cost of 
our efforts in Iraq and Afghanistan will be paid by not only 
this generation but generations to come. Personally, I believe 
no veteran should ever, ever be denied timely access to the VA 
health care system, especially if they truly believe their 
medical condition was due to their service in the Armed Forces. 
How can we call these brave servicemembers heroes in one breath 
and question their integrity and intentions when they come to 
the VA for assistance.
    I would ask my colleagues how many Vietnam veterans do you 
think this Nation failed due to inaction between 1975 and 1991? 
I am afraid there are many, many thousands of them.
    So Mr. Chairman, I just want to congratulate you for your 
efforts; and Secretary Shinseki, I hope we can proceed in 
addressing this issue.
    Chairman Akaka. Thank you very much, Senator Sanders.
    Senator Brown of Ohio.

               STATEMENT OF HON. SHERROD BROWN, 
                     U.S. SENATOR FROM OHIO

    Senator Brown of Ohio. I thank you, Mr. Chairman. And 
aloha. Thanks also to General Shinseki for your many years of 
service prior to the Secretary's job at the VA and especially 
what you are doing now.
    We know it has been 40 years since the last use of the 
dioxin Agent Orange in Vietnam. It has been a long, sad 40-year 
history for our servicemembers who have suffered because of 
exposure to Agent Orange. For decades, as other have said, 
veterans suffered from the effects of Agent Orange, but also 
were plagued by foot-dragging in Congress, at the VA, and at 
the Department of Defense. They and their families encountered 
bureaucratic mazes, ignorance, and indifference that are 
frankly a national disgrace.
    Clearly complicated science is involved in determining 
presumption of illness due to Agent Orange. Exposures, close 
reconstructions, and ever-changing technological developments 
have made determining straight-line presumptions very 
difficult. Waiting for a causal link after 40 years is just 
another way of telling veterans no. Complexity is not an excuse 
for years of inaction. It is not an excuse for veterans nor 
their families like the widow from Pike County, Ohio, who for 
more than a year tried to get dependency and indemnity 
compensation. Her husband who served in Vietnam died 5 years 
ago from ischemic heart disease. Her claim was originally 
denied. The appeal was held up, as are all the appeals in 
claims for that condition, because the regulations had not been 
approved. The widow of a Vietnam veteran wrote to me, ``My late 
husband did not hesitate to go to Vietnam when he got his 
orders. He was gone and I waited for a year for him to come 
home. When my husband came home he was never the same and his 
life was cut short by the aftereffects of Agent Orange.''
    I recently had a long discussion with Secretary Shinseki 
about the most recent presumptive editions, one of which would 
help this widow. I am convinced he made the right decision in 
adding these diseases to the presumptive list. I understand we 
are talking about billions of dollars, but the cost of caring 
for the veteran is a non-negotiable cost of war, as Senator 
Sanders said. If it is a question of choosing between tax cuts 
for the wealthiest Americans and spending money on our 
veterans, the clear moral answer is you take care of veterans 
first. Utilizing an eligibility system that can take years to 
produce an answer overlooks the fact that there are lives at 
stake; lives of men and women who served their country because 
we asked them to.
    Under the Chairman's leadership, this Committee has been 
working on a host of exposure issues. Together we are trying to 
find the right balance between evidence in level of exposure 
and causation. Agent Orange was sprayed during the Vietnam War. 
Our troops--and I would add many citizens still today of 
Vietnam--suffered and are suffering still. This is beyond 
scientific doubt. This is about where do we draw the line. How 
did VA get to the decision to add three new presumptions? What 
lessons does this provide for us as we talk about Agent Orange 
and other current and future exposures? It is not easy. There 
are legitimate questions about the process of determining new 
presumptions, but I believe the Secretary of the Veterans 
Administration is correct.
    For more than 40 years, Vietnam veterans have waited. That 
is simply too long. We must work together to correct this 
injustice. Thank you, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Brown.
    Senator Webb.

                  STATEMENT OF HON. JIM WEBB, 
                   U.S. SENATOR FROM VIRGINIA

    Senator Webb. Thank you, Mr. Chairman and General Shinseki. 
Welcome. Also, I would like to welcome and thank Secretary 
Principi, who is going to testify later, for a great job as a 
counsel on this Committee and then later served as Secretary of 
the Department of Veterans Affairs.
    I would like to thank you, Mr. Chairman, for holding this 
hearing. We sometimes have an uncomfortable duty to ask the 
hard questions, and given the questions that have come about as 
a result of the decision that has been made, we really need to 
have this hearing so people can understand the process that was 
put into place.
    I would like to first of all say that I have pretty 
extensive experience with this issue, beginning as a Marine 
rifle platoon and company commander in one of the more war-torn 
areas of Vietnam. For those of you who are veterans in the 
audience, the Arizona Valley, An Hoa Basin, Khe Sanh Mountains, 
Go Noi Island. Very ravaged places with very devastated 
villages and populations.
    I also had the privilege of serving as committee counsel on 
the House Veterans' Affairs Committee for 4 years, 1977 to 
1981. On that committee during that period, we had a number of 
hearings about Agent Orange. I counseled several of them. I 
believe four, in my recollection, as we were attempting to come 
to grips with how to examine where Agent Orange was used, who 
actually was exposed. Then, what conditions might have resulted 
from this exposure, and what we should do about it as a 
government, as the stewards of the people who served, and as 
the stewards of our country at large.
    Those issues have never been clearly and fully resolved. So 
what we are looking at today--if I could ask Juliet Beyler, 
also a former Marine by the way, one of my staff members, to 
put that chart up. Here is what we have to look at. We have a 
duty up here on this Committee to examine these issues.
    First, the implementation of the law. This regards the 
Secretary's decision. I have no question that the Secretary's 
decision was within the ambit of the law. But we may want to 
ask ourselves whether this is the right way for these decisions 
to be made in the future with issues of this magnitude. I want 
to say very clearly, this is not simply a cost item. For me, as 
someone who has worked on veterans' issues my entire adult 
life, this is not a cost item at all. This is an issue about 
the credibility of our programs. I think Secretary Principi 
pointed this out in his statement very eloquently, though I do 
not want to get ahead of his testimony.
    It is also about the accuracy of the scientific process as 
it pertains to Agent Orange and service in Vietnam. We have 
struggled with this now for more than 30 years--how we 
intersect scientific analysis with actual service inside 
Vietnam. It is about the use of presumptions. The reason I put 
the chart up and the reason I asked for this chart to be shared 
with my fellow senators here is that we really need to think 
about what was in the minds of the lawmakers when this law was 
originally passed. So, if you look at the first three items 
here--chlorachne, soft tissue sarcoma, and non-Hodgkin's 
lymphoma--those were the three conditions that actually were 
written into the 1991 law.
    We asked the VA to give us the number of people who were 
receiving disability benefits as a result of those conditions 
today and they come up with a total of a little more than 5,000 
people. The law then began, in accordance with scientific 
evidence, to be examined in a broader context--in the context 
of dual presumptions. Presumptions are a major part of what we 
are going to look at today.
    First, that everyone in Vietnam presumptively was exposed 
to Agent Orange. We could not break it down so we said every 
single person who served in Vietnam was exposed to Agent 
Orange. Second, we have said that any Vietnam veteran who ends 
up with a systemic disease based on this process that was 
written into law, has, as a result, a service-connected 
condition with respect to Agent Orange. If you look at the last 
three items on this chart, you see what has happened in terms 
of the number of people receiving compensation.
    So we have dual presumptions, both based on very broad 
categorizations that we are having to struggle with, not only 
now, and most importantly not only now, but in the future, as 
we examine a whole host of issues of exposure, which were 
mentioned earlier in testimony.
    So this hearing is vitally important for us to examine 
where we are now and where we need to go in the future. Mr. 
Chairman, I thank you again for having had the courage to hold 
this hearing and I very much appreciate Secretary Shinseki's 
appearance and the people we are going to see on the second 
panel.
    Chairman Akaka. Thank you very much, Senator Webb.
    Senator Tester.

                STATEMENT FROM HON. JON TESTER, 
                   U.S. SENATOR FROM MONTANA

    Senator Tester. I, too, want to thank you, Mr. Chairman, 
for holding this hearing. This is a topic that is not an easy 
one for anybody here. I also want to commend Senator Webb for 
asking some very tough questions about Agent Orange exposure 
and about exposure issues generally.
    I also want to thank you, Secretary Shinseki for coming 
here today to talk about the steps that the VA has taken to do 
right by Vietnam veterans who were exposed to Agent Orange and 
now are suffering the consequences.
    I do not think anyone here expects the rules expanding 
presumptive eligibility for Agent Orange veterans that the VA 
issued earlier to be changed. The rules are in place; the 
funding is in place. We are not going backwards, and I do not 
think we should. But I have been to a few Democratic Policy 
Committee meetings chaired by Senator Dorgan on things like 
burn pits in Iraq. We have heard Senator Burr's passionate 
pleas for help for the Camp LeJeune veterans. We obviously 
still need to sort out whether the VA or the DOD needs to pay 
for those exposure claims. However, the bottom-line is there 
are going to be many, many more concerns raised about exposure 
to toxins and toxic substances in the years to come.
    In the case of granting presumptive eligibility for 
Parkinson's and ischemic heart disease, we need to be sure that 
exposure compensation is based on sound science and the right 
interpretation of the 1991 Agent Orange law. I am not a doctor. 
I am not a lawyer. But I believe that the one most basic 
responsibility of our government and this Committee in 
particular is to care for the veterans' for the injuries that 
they have suffered in the defense of this country. That 
includes services members who are exposed to toxic substances 
and who become ill as a result of it. At the same time, we also 
want to be sure that in this budget environment we are certain 
that we are careful stewards of the taxpayer dollars.
    I look forward to hearing more about the Department's 
decisionmaking process and balancing the conclusions reached by 
the several different studies on Agent Orange exposure. It is 
not going to be easy which is why I am so very happy we are 
having this hearing.
    I want to thank you again, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Tester.
    Senator Burris.

              STATEMENT OF HON. ROLAND W. BURRIS, 
                   U.S. SENATOR FROM ILLINOIS

    Senator Burris. Thank you, Mr. Chairman. I would like to 
certainly thank you, Mr. Chairman, for holding this very 
important hearing. I would also like to extend my warm welcome 
to Secretary Shinseki and the other distinguished members of 
the panel. I also want to mention that I am glad to see on the 
second panel that there will be two witnesses from the great 
University of Illinois. So if I am not here you certainly will 
understand that your senator recognized you.
    I am also pleased that all of you have come here to give us 
your assessment of the current and possible--on the possible 
future presumptive disability decisionmaking process. So your 
experience and expertise should prove to be invaluable in 
providing information on this important topic.
    I know I have witnessed several situations in regard to our 
Vietnam veterans. I remember being at the parade in Chicago 
when they were finally welcomed home. That was a very, very 
heart-wrenching, moving situation to see General Wes Moreland 
stand on that platform and watch those veterans come up and 
give their respect to the general. There was not a dry eye on 
the reviewing stand. Now we know that some of those have come 
home with no type of parade, no type of motorcade, no type of 
flags flying. They were not really given what they deserve. So, 
I am just hoping and praying that we do not do something that 
is going to cause continued misery for these men and women who 
gave all and were fortunate enough to come back. If they are 
suffering from some disease, as the Secretary has determined 
under law that there is presumptive support for, then we should 
find a way to make sure that those individuals are given the 
best care that we can possibly give them. They have suffered 
enough and do not need to be going through the wringer.
    I agree with Senator Sanders, who indicated that the cost 
of war is costly. It is more than guns and planes and bullets 
and tanks. It is the aftermath of those who donned the uniform 
and dared to go out and face bullets and all the other trials, 
tribulations, and hardships to defend this country. So it is 
certainly my belief that we must take care of the veterans, and 
I would not--I am sorry the Secretary had to come and go 
through this type of review but I guess that is our job. It is 
oversight. If it costs us additional funds then there is no 
price that we can put on what we can do if those veterans 
suffer from those chemicals that were sprayed throughout that 
country. We do not even know what the outcome is for those 
individuals who are in war, and we certainly cannot use 
finances and budget shortfalls and other excuses to not support 
our veterans. So I am anxious to hear the Secretary's testimony 
and the other witnesses. Rest assured that we are going to be 
in the process of taking care of veterans who have taken care 
of us.
    I have told everyone who donned a service uniform, the only 
way America is and can be great--the land of the free--is 
because those individuals were awfully brave. There is no 
reason for us, Mr. Chairman, to give any more agony to those 
people who are finally coming into the VA system. Some of them 
stayed away. They are finally coming back in because they are 
now really in desperate need, illness is upon them, and they 
need our help. Let us not abandon those men and women. I look 
forward to the testimony. Thank you, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Burris.
    Senator Begich.

                STATEMENT OF HON. MARK BEGICH, 
                    U.S. SENATOR FROM ALASKA

    Senator Begich. Thank you, Mr. Chairman, and thank you for 
holding this hearing. Secretary Shinseki, thank you for the 
meeting we had briefly to talk about some of the issues. I 
appreciate that. I apologize, Mr. Chairman. I have to go to a 
Commerce Committee. When I saw Chairman Rockefeller here I 
thought I had more time but then he left, so I have to go where 
he is in a few minutes.
    First, I want to echo some of the prior comments. One of 
the challenges we have as we engage in conflict, maybe they be 
small or large, is we fail collectively--Democrats, 
Republicans, former administrations, current administrations--
we fail to really outline what the total cost will be. It is 
not just fighting the war; it is what happens after. What we 
have in front of us is one of those issues that was not 
calculated from a monetary point of when we fight wars and what 
we do.
    Next, I want to say I support what you have done. You know, 
I have served in legislative bodies on the city council for 10 
years when I was in Anchorage and I served in the executive 
branch as mayor for 5 years. There are times when you have to 
make decisions based on a policy set by the legislative body, 
which this body did. They set a policy. You did the work; 
actually, your predecessors did the work. Years went by; here 
we are. You have made a decision. I can tell you in Alaska I 
hear from many Vietnam veterans about the issue of Agent Orange 
and the work and trouble involved, the paperwork they have to 
go through just to prove what their ailment is and what caused 
it.
    We can argue over, you know, certain quantities of 
individuals, but for the simple reason we called them up to 
serve our country in a war, we have an obligation to provide 
them with the benefits they have earned and they deserve.
    I am not a doctor. I am not here to tell you what the 
science is. That is what you do. That is why you are the 
Secretary of the Veterans Affairs office. You were able to 
reach out over the last several months, and in this case many 
years of work, to determine what is the right approach to deal 
with Agent Orange. My issue is going to be longer term. We had 
the Gulf War. Then we have Iraq and Afghanistan. More than 
likely we have some other issues that we are not fully 
addressing that we are going to have to deal with the full cost 
of those. We have to recognize that we are going to have a bill 
due that is more significant than we can ever imagine from 
these conflicts that we have been engaged in. So, that is the 
cost of going to war.
    After our discussion and my review of the efforts you have 
made, I am not going to sit here and try to second guess 
doctors and scientists and others that have gone through this. 
You had an obligation to follow the law. You did. I will tell 
you many Vietnam veterans in my State are appreciative of the 
steps you have taken for the illnesses that they have and how 
they can be covered, as well as the disability components.
    So again, I want to just thank you for the work you have 
done. We can argue, and we will. Oversight is good. That is 
part of the process of the Committee. You have a better 
understanding. But I hope the oversight leads us to 
understanding what the next issues are going to be--the next 
generation of veterans and the costs that are going to be 
associated with it, which I know will be staggering. We think 
this is an increasing cost in the sense of what it will be, but 
all you have to do is look at the wars we are engaged in today. 
There are going to be staggering costs that we cannot even 
measure today.
    So again, I just want to reiterate my review that, at least 
from my perspective, I think the steps you have taken are 
positive steps for our Vietnam veterans. I think the process 
you went through, at least from my review, was tedious, in-
depth, and came to a resolution that we have heard for so many 
years. I have only been here less than 2 years but I can tell 
you it took no longer than a few months serving in this office 
for people to find out I served on this Committee. They were 
very quick to tell me and talk about this issue very 
aggressively. So, again, thank you for being here today. Now 
you finally get to say a few words.
    I will end there and say, Mr. Chairman, thank you very much 
for the opportunity.
    Chairman Akaka. Thank you very much, Senator Begich. I want 
to thank the Members of this Committee for their opening 
statements.
    I want to welcome our lead witness, Secretary Eric K. 
Shinseki. Secretary Shinseki is accompanied by Dr. Robert 
Jesse, who is the Principal Deputy Under Secretary for Health; 
Dr. Victoria Cassano, the Director of the Radiation and 
Physical Exposure Service. The Secretary is also accompanied by 
Thomas J. Pamperin, Associate Deputy Under Secretary for Policy 
and Program Management; and Jack Thompson, the Deputy General 
Counsel.
    Secretary Shinseki, I want to again thank you very much for 
joining us today to give your perspective on the Department's 
presumptive disability and decisionmaking process. We are 
looking forward to understanding the process better after this 
hearing and deal with it legislatively to try to improve it for 
the future.
    So, I look forward to your testimony, Mr. Secretary. Your 
prepared statements will, of course, appear in the record of 
the Committee. Please proceed.

STATEMENT OF HON. ERIC K. SHINSEKI, SECRETARY, U.S. DEPARTMENT 
  OF VETERANS AFFAIRS; ACCOMPANIED BY ROBERT L. JESSE, M.D., 
 Ph.D., PRINCIPAL DEPUTY UNDER SECRETARY FOR HEALTH; VICTORIA 
  CASSANO, M.D., M.P.H., F.A.C.P.M., DIRECTOR, RADIATION AND 
   PHYSICAL EXPOSURES SERVICE; THOMAS J. PAMPERIN, ASSOCIATE 
 DEPUTY UNDER SECRETARY FOR POLICY AND PROGRAM MANAGEMENT; AND 
            JOHN H. THOMPSON, DEPUTY GENERAL COUNSEL

    Secretary Shinseki. Chairman Akaka, Senator Isakson who has 
departed, and other distinguished Members of the Committee, 
thank you for the invitation to appear here today to discuss my 
decision to establish presumptions of service connection for 
three new diseases in accordance with the Agent Orange Act of 
1991. Some of what I say will be somewhat repetitive of all the 
opening comments provided by Members of the Committee. And Mr. 
Chairman, thank you for including my written statement for the 
record.
    I appreciate the generosity of time shared by Members of 
this Committee prior to testimony. I also want to acknowledge 
the representatives of our veterans' service organizations who 
are in attendance today. Their insights are important and have 
been helpful to me.
    Mr. Chairman, you have already introduced the members of 
the panel. Let me make sure that I position who they are. On 
the far left is Tom Pamperin, who is the Associate Deputy Under 
Secretary for Policy and Program Management of the Veterans 
Benefits Administration.
    As you indicated, to my immediate left is Jack Thompson, 
our Deputy General Counsel. To my immediate right is Dr. Bob 
Jesse, Principal Deputy Under Secretary for Health in the 
Veterans Health Administration. And to the far right, Dr. 
Victoria Cassano, from our Office of Public Health and 
Environmental Hazards.
    Congress established many significant presumptions for 
service connection since creating them as part of the veterans' 
benefit system in 1921 following World War I. The Department of 
Veterans Affairs has also used its statutory authority to 
establish fact-based presumptions of service connection in 
several notable cases. Congress passed the Agent Orange Act of 
1991, which prescribed a more focused and proactive policy for 
addressing veterans' concerns. The Act is explicit both in the 
information the Secretary must consider and the standard the 
Secretary must apply in the determinations. The Act directs VA 
to establish a presumption for any disease where the evidence 
shows a ``positive association'' between herbicide exposure and 
the development of disease in humans. By law, a positive 
association exists whenever the credible evidence for an 
association is equal to or outweighs the credible evidence 
against an association.
    The Act further specifies that in determining whether a 
positive association exists, VA must consider a biannual report 
by the Institute of Medicine that evaluates the evidence 
regarding the health effects of exposure to herbicides and all 
other sound medical and scientific evidence available to VA. 
Once the IOM report is released, the law allows VA only 60 days 
to determine whether new presumptions are warranted. VA is 
mindful of its duty to faithfully execute the requirements of 
the Agent Orange Act and to ensure that its determinations are 
made in a manner consistent with the standards Congress 
established. Each report from the IOM is reviewed by a working 
group of VA employees with medical, legal, and program 
expertise, and by a task force of senior VA leaders. The 
Secretary benefits from the advice and analyses of these groups 
and others in VA. But the Secretary is responsible for 
determining whether the evidence regarding any diseases 
satisfies the statutory standard.
    In July 2009, VA received the most recent IOM report known 
as Update 2008. The most significant changes from the 2006 IOM 
report are: the findings of sufficient evidence of a positive 
association between herbicide exposure and chronic b-cell 
leukemias; and of limited suggestive evidence of an association 
between herbicide exposure and Parkinson's disease and ischemic 
heart disease. After reviewing the IOM's analyses and relevant 
scientific studies and then consulting with medical and legal 
experts in VA, I determined that the evidence concerning b-cell 
leukemias, Parkinson's disease, and ischemic heart disease met 
the positive association standard of the Agent Orange Act. 
Accordingly, VA proposed regulations to establish presumptions 
of service connection for those diseases.
    The evidence regarding hypertension, which was placed in 
the limited suggestive category in 2006, was less compelling in 
my view and still did not meet--did not establish a positive 
association. I believe that these decisions in all four cases 
were consistent within the law. In conducting my review and 
making my decision under the Agent Orange Act, I was aware of 
the prevalence of ischemic heart disease within the general 
population and the fact that it is associated with a number of 
factors other than herbicide exposure. I carefully considered 
whether and to what extent those factors may be considered in 
applying the statutory standard. My determination that there is 
a positive association between herbicide exposure and ischemic 
heart disease was based solely upon the evaluation of the 
scientific and medical evidence according to the statutory 
standard prescribed by the Agent Orange Act.
    The IOM's 2008 report identified nine studies that were 
rigorously conducted, some containing reliable measures of 
exposure that permitted evaluation of dose response 
relationships which are particularly compelling in determining 
whether or not an association exists. Of the nine primary 
studies, six showed strong statistically significant 
associations between herbicide exposure and ischemic heart 
disease. Five of the studies detected a dose response 
relationship. The studies with the best dose information all 
showed increased risk at the highest categories of exposure. 
Additionally, there is sound medical evidence of a biological 
mechanism of disease causation. I took particular note that all 
nine studies had controlled for age. Age is the primary 
determinant of ischemic heart disease. It is the one 
determinant that cannot be moderated.
    Some of the studies showed the association persisting after 
adjustment for numerous other potentially confounding factors. 
The IOM study further noted that although some of the studies 
did not adequately control for certain risk factors, those risk 
factors were unlikely to explain the significant increased 
risks detected.
    The VA's review brought to my attention an additional 
recent study which was particularly helpful, useful because it 
analyzed numerous prior studies and concluded that those with 
the best data and comparisons were consistent in finding a 
significant dose relationship between dioxin exposure and 
increased risk of ischemic heart disease. In my judgment, 
taking into account the number of statistically significant 
findings, the strong evidence of dose response relationship, 
and the extent to which the studies control for risk factors 
including age, the evidence for an association between 
herbicide exposure and ischemic heart disease more than 
satisfies the positive association standard of the Agent Orange 
Act.
    The statute therefore directed that I establish a 
presumption of service connection without regard to the 
projected costs or the existence of independent risk factors. 
My determination regarding ischemic heart disease, Parkinson's 
disease, and b-cell leukemias was not made lightly. It was made 
in accordance with the legal responsibilities assigned to me in 
the Agent Orange Act and my duty as Secretary of Veterans 
Affairs to faithfully execute the letter and the purpose of 
that statute. No other course of action would have met the 
intent of the law.
    Veterans and their families have waited decades while the 
sciences incrementally revealed more about the impact of Agent 
Orange on Vietnam veterans. Not only did our actions follow the 
statute, but I believe our actions on Agent Orange will be 
viewed as an indicator of our seriousness and commitment in 
addressing veterans' needs, not only for Vietnam veterans but 
for veterans of every generation.
    Presumptions will continue to be an important part of the 
veterans' benefit system for the foreseeable future. They are 
powerful tools for promoting efficiency, fairness, and justice. 
These features of presumptions are particularly significant for 
the efforts of VA and Congress to ensure the fair and 
expeditious adjudication of benefits claims at a time when 
claims are increasing in number, scope, and complexity.
    The most important lesson I have learned from this process 
is the one that Senator Murray and others pointed out, and that 
is we must track the exposures of our servicemembers to toxic 
chemicals and environments earlier. Such tracking does not get 
easier or less complicated as time passes. Early registration 
and surveillance of those exposed enables better treatment and 
rehabilitation and allows us to make proactive decisions in 
mitigating future exposures. Early tracking, intervention, 
treatment, rehabilitation, equals better health for America's 
veterans. We must do better and we will.
    Mr. Chairman, thank you again for this opportunity to 
appear before this Committee, and thank you for your continued 
unwavering support of our veterans. I look forward to your 
questions.
    [The prepared statement of Secretary Shinseki follows:]
        Prepared Statement of Hon. Eric K. Shinseki, Secretary, 
                  U.S. Department of Veterans Affairs
    Chairman Akaka, Ranking Member Burr, Distinguished Members of the 
Committee, I am pleased to be here today to discuss the role of 
presumptions of service connection in claims for Veterans' benefits 
and, in particular, to discuss presumptions established pursuant to the 
Agent Orange Act of 1991.
    Presumptions of service connection have been an important part of 
the Veterans benefits system since Congress established presumptions 
for tuberculosis and neuropsychiatric diseases following World War I. 
Over this period, Congress has established many significant 
presumptions, including those for diseases of former prisoners of war, 
diseases associated with ionizing radiation, and undiagnosed illnesses 
and chronic multisymptom illnesses in Gulf War Veterans. The Department 
of Veterans Affairs (VA) also plays a vital role in this process. VA's 
statutory authority to issue regulations governing benefit claims 
includes the ability to establish fact-based presumptions of service 
connection. VA has exercised this authority judiciously to establish 
several significant presumptions to complement and supplement those 
created by Congress, including presumptions relating to mustard gas 
exposure and the presumption of service connection for amyotrophic 
lateral sclerosis (ALS) in Veterans of all periods of service.
    The Agent Orange Act of 1991 created an innovative process for 
establishing presumptions of service connection, one that combines the 
efforts of Congress and VA, while delineating their respective roles in 
the process. Under this act, VA is responsible for determining which 
diseases will be accorded a presumption of service connection, but its 
determination is guided by evidentiary criteria and decisional 
standards prescribed by Congress. Specifically, VA is charged with 
evaluating medical and scientific evidence and analyses from the 
National Academy of Sciences and other sources in order to determine 
whether such evidence satisfies the ``positive association'' standard 
defined in the Agent Orange Act.
    VA takes seriously its responsibilities under the Agent Orange Act. 
I know that concerns have been expressed regarding the potential impact 
of my determination under this statute to establish presumptions of 
service connection for ischemic heart disease, Parkinson's disease, and 
chronic b-cell leukemias. I can assure you that my determination was 
made upon careful consideration of the scientific and medical evidence 
and the governing legal standards, was informed by consultation with 
medical and legal experts in VA, and reflects the best efforts of all 
within VA to carry out the requirements of the Agent Orange Act. I 
welcome this opportunity to explain the determinations VA has made in 
applying the Agent Orange Act and to discuss the important issue of how 
best to utilize presumptions to ensure that Veterans are properly 
compensated for their disabilities related to herbicide exposure or 
other factors.
    Presumptions in the adjudication process eliminate the need to 
obtain certain evidence and decide complex issues. They permit VA to 
accept as established certain facts that would otherwise have to be the 
subject of extensive development and evidentiary analysis. They also 
assist Veterans in establishing service connection in cases where the 
slow development of disability makes direct proof of service connection 
difficult. For example, there is a longstanding statutory presumption 
that a Veteran who develops multiple sclerosis to a compensable degree 
within seven years after leaving service will be presumed to have 
incurred the disease in service. Congress established that presumption 
based on scientific evidence that it may take up to seven years from 
the date of onset for multiple sclerosis to progress to the point of a 
diagnosable disability. Like most presumptions of service connection, 
this presumption serves a number of important functions. First, it 
relieves claimants of the burden of submitting medical evidence 
directly linking the onset of their condition to service, a burden that 
would be difficult to meet where the condition manifests at a time 
remote from service and the relevant medical principles may not be 
widely known. Second, it ensures that similar claims are given similar 
treatment. Third, it enables VA to process claims more quickly by 
relying upon medical principles that need not be independently 
established in each case. Fourth, it helps Veterans, who may not have 
been otherwise eligible, to obtain prompt medical assistance for their 
service-connected conditions .
    Finally, presumptions are used to implement policy when scientific 
certainty cannot be achieved in a timeframe necessary to address 
Veterans healthcare issues. This is an important aspect of the 
presumption process in a benefits system designed to meet the needs of 
our Veterans.
    It has long been known that dioxin, a contaminant of Agent Orange, 
is a potent carcinogen. As our troops returned from Vietnam, many 
expressed concerns that the health problems they were experiencing had 
been caused by their exposure to Agent Orange. However, they found it 
difficult to establish service connection, because the evidence at that 
time did not clearly link Agent Orange to any specific illness other 
than a skin condition, chlorachne. In a 1984 report, Congress noted 
that, although VA had granted service connection based on herbicide 
exposure in more than 1400 cases, fewer than one hundred grants were 
for conditions other than chlorachne or similar skin conditions. 
Consequently, some Veterans grew to feel that VA was not giving serious 
consideration to their legitimate concerns regarding the harmful 
exposures incurred in their service.
    In 1984, Congress enacted the Dioxin and Radiation Exposure 
Compensation Standards Act in an effort to improve this process. The 
statute included findings that there was scientific uncertainty 
regarding the health effects of dioxin exposure and that claims based 
on such exposure present uniquely challenging issues of proof. The 
statute directed VA to establish standards and guidelines for deciding 
those claims and to identify the diseases that VA would recognize as 
being associated with herbicide exposure. It also established an 
advisory committee to review available research and make 
recommendations to VA. The statute did not prescribe specific criteria 
to govern VA's decisions, but included a more general statement of the 
statute's purpose. As passed by the House, the bill's stated purpose 
was to provide benefits for diseases that ``may be attributable'' to 
Agent Orange exposure ``notwithstanding that there is insufficient 
medical evidence to conclude that such diseases are service-
connected.'' As enacted, however, the statute's stated purpose was to 
provide benefits for diseases ``that are connected, based on sound 
scientific and medical evidence,'' to Agent Orange exposure. To 
implement the statute, VA issued a regulation providing that chlorachne 
was the only disease shown by sound scientific and medical evidence to 
be associated with Agent Orange exposure and was thus the only disease 
VA would presume to be service-connected.
    In 1991, Congress enacted the Agent Orange Act of 1991, which 
prescribed a more focused and proactive policy for addressing these 
Veterans' concerns. The Act directed VA to seek to contract with the 
National Academy of Sciences, a respected independent expert scientific 
body, to evaluate the evidence regarding the health effects of exposure 
to herbicides. Under that requirement, VA receives reports every two 
years from the National Academy's Institute of Medicine (IOM). The act 
further directed VA to establish presumptions of service connection for 
any disease discussed in the IOM's reports for which the evidence 
showed a ``positive association'' between herbicide exposure and the 
development of the disease in humans. The statute specifies that a 
``positive association'' exists whenever the Secretary determines that 
the credible evidence for an association is equal to or outweighs the 
credible evidence against an association. The language and legislative 
history of this act made clear that it did not require evidence of a 
causal association, but only credible evidence that herbicide exposure 
was statistically associated with increased incurrence of the disease. 
The Act further specified that, in determining whether a positive 
association exists, VA must consider the IOM's report and any other 
sound scientific and medical evidence available to VA.
    The Agent Orange Act was a compromise between the desire for 
scientific certainty and the need to address the legitimate health 
concerns of Veterans exposed to herbicides in service. By establishing 
an evidentiary threshold lower than certainty and lower than actual 
causation, Congress required that presumptions will be established when 
there is sound scientific evidence, though not conclusive, establishing 
a positive association between a disease and herbicide exposure. Based 
on the numerous reports received from IOM since 1991, VA has 
established presumptions of service connection for 12 categories of 
disease associated with herbicide exposure. While there is always room 
to review decisions with respect to specific diseases, there is no 
question that the actions of Congress and VA related to the Agent 
Orange Act demonstrate the Government's commitment to provide Vietnam 
Veterans with treatment and compensation for the health effects of 
herbicide exposure.
    In view of this history, VA is mindful of its duty to faithfully 
execute the requirements of the Agent Orange Act and to ensure that its 
determinations are made in a manner consistent with the standards 
Congress has established. Each report from the IOM is reviewed by a 
working group of VA employees with medical, legal, and program 
expertise, and by a task force of senior VA leaders. I benefit from the 
advice and analyses of these groups and others in VA; but as Secretary, 
I am responsible for determining whether the evidence regarding any 
disease satisfies the statutory standard.
    In July 2009, VA received the most recent IOM report, known as 
``Update 2008.'' The most significant findings in this report are the 
findings of ``sufficient'' evidence of a positive association between 
herbicide exposure and chronic b-cell leukemias and of ``limited/
suggestive'' evidence of an association between herbicide exposure and 
Parkinson's disease, ischemic heart disease, and hypertension. After 
reviewing the IOM's analyses and relevant scientific studies, and 
consulting with medical and legal experts in VA, I determined that the 
evidence concerning b-cell leukemias, Parkinson's disease, and ischemic 
heart disease met the ``positive association'' standard of the Agent 
Orange Act. Accordingly, VA proposed regulations to establish 
presumptions of service connection for those diseases. The evidence 
regarding hypertension was less compelling and, in my view, did not 
establish a positive association under the statute.
    I would like to address the concerns that have been expressed 
regarding my determination with respect to ischemic heart disease. 
These concerns relate to the economic impact of the presumption, due to 
the high prevalence rate of ischemic heart disease, and the fact that 
ischemic heart disease is associated with a number of factors other 
than herbicide exposure, including age, smoking, serum cholesterol, 
body mass index, and diabetes. In conducting its review under the Agent 
Orange Act, VA was cognizant of the prevalence of ischemic heart 
disease and its known risk factors, and we carefully considered whether 
and to what extent those factors may be considered in applying the 
statutory standard.
    VA's Office of General Counsel has advised that the Agent Orange 
Act does not permit me to weigh the potential economic impact of my 
decision to establish a presumption under that statute. The statute 
requires that I establish a presumption if the ``positive association'' 
standard is met, and it provides that the standard will be met if the 
credible scientific and medical evidence for an association is equal to 
or outweighs the credible scientific evidence against an association. 
Additionally, the statute does not permit VA to exclude a disease from 
consideration on the basis that it is a common disease. Rather, it 
directs VA to determine whether a positive association exists for each 
disease discussed in the IOM reports it receives. VA's Office of 
General Counsel advised me that consideration of the prevalence of 
ischemic heart disease and the potential economic impact of a 
presumption would violate the clear requirements of the Agent Orange 
Act. Accordingly, those factors did not enter into my decision under 
the positive association standard.
    The impact of other known causes and risk factors for ischemic 
heart disease is relevant in interpreting the results of scientific 
studies concerning that disease. In determining whether a study 
provides evidence for an association between herbicide exposure and a 
particular disease, IOM routinely evaluates the extent to which the 
study controlled for other known risk factors for that disease in order 
to minimize or rule out the possibility that an increased prevalence in 
the study population may be due to factors other than herbicide 
exposure. By considering this factor, IOM is able to draw conclusions 
regarding how strongly the evidence shows that an association between 
herbicide exposure and a disease exists, independent of other known 
risk factors. In reviewing the IOM reports, VA also takes this factor 
into account in determining whether, and to what extent, a study 
provides evidence for an association between herbicide exposure and the 
disease independent of other risk factors. Studies that do not 
adequately control for other risk factors are generally less reliable 
than those that do.
    After taking these considerations into account, if VA determines 
that the evidence demonstrates a positive association between herbicide 
exposure and a specific disease, then VA has no discretion under the 
Agent Orange Act to decline to establish a presumption solely on the 
basis that the disease is independently associated with other known 
risk factors. Rather, the Act requires that VA establish a presumption 
and provides that the presumption may be rebutted in individual cases 
if the evidence shows that the Veteran's disease was due to a factor 
other than herbicide exposure.
    For these reasons, my determination that there is a positive 
association between herbicide exposure and ischemic heart disease was 
based solely upon evaluation of the scientific and medical evidence and 
application of the statutory standard prescribed by the Agent Orange 
Act. The IOM's Update 2008 report identified nine studies that were 
considered to be highly informative with respect to this disease. Those 
studies were rigorously conducted and contained reliable measures of 
exposure that permitted evaluation of dose-response relationships, 
which are particularly helpful in determining whether an association 
exists. Of the nine primary studies, six showed strong and 
statistically significant associations between herbicide exposure and 
ischemic heart disease. Several of the studies detected a dose-response 
relationship and the studies with the best dose information all showed 
increased risk in the highest categories of exposure. IOM noted that 
most of the studies had controlled for age, which is the primary risk 
factor for ischemic heart disease. Some of the studies showed the 
association persisting after adjustment for numerous other potentially 
confounding factors. IOM further noted that, although some of the 
studies did not adequately control for certain risk factors, those risk 
factors were unlikely to explain the significant increased risks 
detected in the studies. VA identified an additional recent study by 
Humblet and Birnbaum, 2008, which analyzed numerous prior studies and 
concluded that the studies with the best exposure data and comparisons 
were consistent in finding an association between dioxin exposure and 
increased risk of ischemic heart disease.
    In my judgment, taking into account the number of statistically 
significant findings, the strong evidence of dose-response 
relationship, and the extent to which the studies controlled for risk 
factors including age, the evidence for an association between 
herbicide exposure and ischemic heart disease satisfies the ``positive 
association'' standard of the Agent Orange Act. The statute therefore 
directed that I establish a presumption of service connection, without 
regard to other independent risk factors.
    My determinations regarding ischemic heart disease, Parkinson's 
disease, and b-cell leukemias were not made lightly. They were made in 
accordance with the responsibilities entrusted to me in the Agent 
Orange Act and my duty as Secretary of Veterans Affairs to faithfully 
execute the letter and the purpose of that statute.
    A significant portion of the costs associated with the new 
presumptions is the result of a series of Federal court decisions in 
the Nehmer class-action litigation. In that case, the United States 
Court of Appeals for the Ninth Circuit has held that, each time VA 
establishes a new presumption under the Agent Orange Act, it must make 
retroactive payments based on claims filed as early as 1985. This 
ruling overrides statutes expressly prohibiting retroactive payments 
based on such new presumptions, and it thus substantially increases the 
costs associated with presumptions under the Agent Orange Act. Under 
the Nehmer decisions, this requirement for retroactive payment will 
continue to apply to any future presumptions established before the 
Agent Orange Act's 2015 sunset date or any later date that may be 
established by future extensions of the act.
    The presumptions established by Congress and VA have been 
invaluable in addressing the challenges of claims involving unique 
circumstances, such as prisoner-of-war captivity and toxic exposures, 
and claims involving devastating diseases such as amyotrophic lateral 
sclerosis (ALS). Based on reports from IOM regarding Gulf War Veterans' 
health, VA recently proposed to establish presumptions for nine 
infectious diseases endemic to the Gulf War theater, and we are 
preparing to revise the existing presumption for medically unexplained 
chronic multisymptom illnesses to clarify that functional 
gastrointestinal disorders are covered by that presumption. 
Presumptions will continue to be an important part of the Veterans' 
benefits system for the foreseeable future. I look forward to working 
with Congress to ensure that the process for establishing presumptions 
of service connection is one that properly meets the needs of our 
Veterans and our Nation.
    This concludes my statement, Mr. Chairman. I would be happy to 
entertain any questions you or the other Members of the Committee may 
have.
                                 ______
                                 
    Response to Pre-Hearing Questions Submitted by Hon. Jim Webb to 
   Hon. Eric Shinseki, Secretary, U.S. Department of Veterans Affairs
    Question 1. With regard to the decision to create a presumption for 
ischemic heart disease, you stated in your June 29 response to me that 
the VA ``Task Force reviewed and summarized the IOM Report material to 
facilitate [your] decision.'' Please describe the recommendations that 
the VA Task Force and any other working group provided to you with 
regard to establishing a presumption for ischemic heart disease. Did 
either VHA or VBA leadership express any concerns with regard to 
establishing a presumption for ischemic heart disease?
    Response. In an effort to expeditiously address the IOM Report in 
accordance with applicable statutory deadlines, a VA Task Force, which 
included VHA and VBA leadership, received the report of a staff level 
work group's comprehensive review of the IOM Report, and provided me 
with a summary of the IOM Report's findings, and offered perspectives 
for my review. The pre-decisional material developed as part of the 
intradepartmental deliberation process helped frame my perspective on 
the scientific evidence regarding the association between herbicide 
exposure and ischemic heart disease. Given the pre-decisional nature of 
the Task Force input as well as to avoid second-guessing those who 
participated in this review, I prefer to avoid details on this topic.
    I would note the Task Force was encouraged to be candid and 
thorough in their work. I benefited from their advice and analysis as I 
made my decision. I can tell you that with respect to ischemic heart 
disease, the vast majority of VA medical professionals who analyzed the 
IOM Report and advised me agreed that the ``positive association'' 
standard in the law had been met.

    Question 2. Please identify and describe the credible evidence 
against the association between dioxin and ischemic heart disease that 
the Task Force reviewed in considering this presumption. Did the Task 
Force review the evidence for and against the association provided in 
the Institute of Medicine's Agent Orange Update 2006? Did the Task 
Force review the Environmental Protection Agency's Dioxin Reassessment 
as part of its work?
    Response. In IOM Update 2008, the Committee revisited all of the 
studies that were reviewed in Update 2006. It expressed the fact that 
the 2006 committee could not reach consensus on the weight of the 
various studies and therefore deferred decisions on elevating ischemic 
heart disease to the Limited/Suggestive Evidence category. All of the 
credible evidence, both for and against a positive association from the 
2006 report, was also available in the 2008 report.
    The studies reviewed by the 2006 Committee were: Kang 2006; AFHS 
2005; Vena 1998; Flesch-Janys 1995; Hooiveld 1998; and Steeland 1999. 
The IOM's synthesis of these studies in 2006 reads as follows: 
``Members of the Committee were divided in their judgments as to 
whether the evidence related to ischemic heart disease and exposure to 
the compounds of interest were adequately informative to advance this 
health outcome from the inadequate or insufficient category to the 
limited or suggestive evidence category.'' In the 2008 Update, the 
credible evidence of these studies was presented in its entirety. 
Additionally, in light of the inability of the 2006 Update committee to 
reach consensus on the information, more confidence was given to 
studies that had been more rigorously conducted, focused on the 
chemicals of concern, compared Vietnam Veterans to non-deployed era 
Veterans and had reliable measures of the important dose response 
relationships. This approach was combined with two studies published 
subsequent to the 2006 Report (HA 2007 and Consonni 2008) which 
provided the 2008 Committee with enough credible evidence to elevate 
ischemic heart disease to the level of Limited/Suggestive Evidence of 
association. Additionally, the Task Force reviewed the study by 
Humblet, Birnbaum, et al., 2008. The Task Force did not review the 
Environmental Protection Agency's Dioxin Reassessment as part of its 
work, because it did not address ischemic heart disease, but addressed 
primarily the effect of low-dose exposures present in the general 
environment to which many ordinary citizens are exposed.

    Question 3. You stated in your June 29 response to me that ``it is 
important to note that most of the scientific studies on which the IOM 
assessment relied controlled for other known or suspected risk 
factors.'' With the exception of the age risk factor, what other major 
risk factors for ischemic heart disease were controlled for in the 
mortality studies relied upon by VA?
    Response. Of the nine studies given greatest weight by the IOM 
Committee, five were mortality-based studies. Risk factors that were 
controlled for included duration of exposure, gender, age, and 
socioeconomic status. In addition, several of the studies used an 
internal comparison group to eliminate the healthy worker effect and 
other confounders. The chart below delineates by study which risk 
factors were controlled for and which used an internal comparison.


------------------------------------------------------------------------
                         Internal Comparison?
                        (Controls for healthy     Confounders controlled
   Mortality Study     worker effect and other             for:
                             confounders)
------------------------------------------------------------------------
Hooiveld (1998);      YES                        age, timing of exposure
 Dutch Herbicide
 factory workers
------------------------------------------------------------------------
Flesch-Janys (1995);  YES                        socioeconomic status,
  FRG herbicide                                   gender, Healthy Worker
 factory workers                                  Effect  (workers in a
                                                  different industry)
------------------------------------------------------------------------
Steenland (1999);     YES                        adjusted for age
 NIOSH Cohort Study
------------------------------------------------------------------------
Consonni (2008);      N/A  Environmental Study   age, gender, exposure
 Seveso Italy--                                   period
 mortality after 25
 years
------------------------------------------------------------------------
Vena (1998);  IARC    YES                        gender, age, duration
 Cohort of phenoxy                                of exposure
 herbicide workers
------------------------------------------------------------------------


    Question 4. In your view, is the current presumptive disability 
decisionmaking process established by the Agent Orange Act of 1991 the 
most efficient process for making presumption determinations? Is this 
process the appropriate mechanism to address gaps in exposure and 
association for diseases common to aging or other highly prevalent risk 
factors?
    Response. The 1991 Act was a solution to address the lack of 
progress in addressing the concerns of the potential health effects of 
herbicide exposure. This was a controversy that had defied resolution 
for over 20 years. The resulting law created a process that replaced a 
causality standard with the more attainable standard of ``positive 
association.'' This standard, while in no means perfect, has resulted 
in more Vietnam veterans obtaining health care as a result of herbicide 
exposure. I am not aware of alternative approaches that address the 
current scientific uncertainty, regarding how we treat our Nation's 
Veterans with environmental hazard exposure resulting from service to 
their country.

    Question 5. What specific guidance has VA adopted from IOM's 2008 
report titled ``Improving the Presumptive Disability Decision-Making 
Process for Veterans?'' What is your view on that IOM committee's 
recommendation to develop and publish a formal process for considering 
disability presumptions that is uniform and transparent and clearly 
sets forth all evidence considered and the reasons for the decisions 
made?
    Response. The 2008 IOM report titled ``Improving the Presumptive 
Disability Decision-Making Process for Veterans'' contained the 
following recommendation:

        The Committee suggests the following six principles as a 
        foundation for its proposed framework: (1) stakeholder 
        inclusiveness; (2) evidence-based decisions; (3) transparent 
        process; (4) flexibility; (5) consistency; and (6) using 
        causation, not just association, as the basis for 
        decisionmaking. Flexibility and consistency are not 
        contradictory constructs here. Flexibility refers to the 
        ability to be adaptable through time in evaluating scientific 
        evidence, and consistency refers to being consistent in the 
        process of evaluating evidence and making consistent decisions 
        based on a comparable level of certainty based on the 
        scientific evidence.

Pages 18-19.

    This IOM report was commissioned by the Veterans Disability 
Benefits Commission rather than by VA. Some of these recommendations 
already are part of VA's regulatory process. However, the ultimate 
recommendation to use causation as a basis for decisionmaking, rather 
than positive association, is contrary to the law enacted by Congress 
and was not endorsed by the Commission (which stated at page 157 of its 
report that it was ``concerned over the use of causal effect rather 
than association as the criteria [sic] for decision and encourages 
further exploration''). The law requires that the Secretary determine 
whether there is a positive association between exposure to a herbicide 
agent and the occurrence of a disease in humans. It also provides that 
an association ``shall be considered to be positive [ ] if the credible 
evidence for the association is equal to or outweighs the credible 
evidence against the association.''
    VA is mindful of its duty to faithfully execute the requirements of 
the Agent Orange Act and to ensure that its determinations are made in 
a manner consistent with the standards Congress established. By 
establishing an evidentiary threshold lower than certainty and actual 
causation, Congress ensured that presumptions would be established when 
there is sound evidence, although not conclusive, establishing a 
positive association between a disease and herbicide exposure. The 
positive association standard is evidence-based.
    VA's process for establishing service-connection presumptions by 
regulation is uniform and transparent. Once the Secretary makes a 
positive association determination based upon evaluation of the IOM 
report and all other available sound medical and scientific information 
and analysis, Congress is informed and VA initiates the Federal 
rulemaking process. VA publishes a proposed rule in the Federal 
Register explaining the medical and scientific bases for the 
determination and invites public comments. In this particular case, VA 
received over 600 public comments on its proposed rule during the 30 
day comment period. By comparison, VA seldom receives more than a dozen 
public comments on most proposed rules. VA responded to all of the 
comments and published a final rule establishing the new presumptions. 
As required by law, VA will also publish a notice in the Federal 
Register explaining why other diseases were not determined to have met 
the positive association standard.
    The short timelines prescribed in the statute for making the 
positive association determination and publishing the required proposed 
rule, final rule, and public notice in the Federal Register generally 
preclude stakeholder involvement prior to the public comment period. As 
you know, VA has proposed legislation to establish more realistic 
timeframes for these steps. If VA's proposal were enacted, and 
additional time were made available, the Department would be better 
able to accommodate the IOM recommendation for greater ``stakeholder 
inclusiveness.'' This might be accomplished in various ways, including 
publication of Advance Notice of Proposed Rulemaking (ANPRM), which is 
a regulatory vehicle for obtaining additional information from 
interested parties, prior to the actual proposal of agency rules.
                                 ______
                                 
Response to Post-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
 Hon. Eric K. Shinseki, Secretary, U.S. Department of Veterans Affairs
    Question 1. VA's response to a pre-hearing question on evidence 
utilized in making the presumption decision on ischemic heart disease 
(IHD) listed studies discussed in the IOM Update 2006 that were 
suggestive of an association between dioxin exposure and IHD as having 
been presented in the IOM Update 2008. I recognize that those studies 
were important in VA's decisionmaking, but the response did not mention 
studies discussed in the IOM Update 2006 that provided evidence against 
an association between dioxin exposure and IHD.

    Question 1a. Was evidence against the association included in VA's 
decisionmaking process? If so, how was it weighed against the evidence 
suggestive of an association? If not, was there a reason for not 
including it?
    Response. IOM Update 2008 reviewed all of the materials from IOM 
Update 2006 as well as any new materials relevant to the issue of 
herbicide exposure and disease. In its decisionmaking process, VA used 
all of the studies the IOM considered both relevant and statistically 
valid. A study's outcome with regard to the association between 
exposure to Agent Orange and development of IHD was not considered 
during selection. The selected epidemiologic studies demonstrated a 
positive association that was statistically significant, an association 
that was positive but could not reach statistically significance, or 
failed to show a positive association. Evidence against an association 
would have included studies that showed a statistically significant 
negative association. There were no studies that demonstrated a 
negative association.

    Question 1b. Were there any other sources that VA relied upon to 
examine the strength of the evidence against the association since 
discussion of such evidence was not included in the IOM Update 2008?
    Response. The Working Group searched for all peer review literature 
on Agent Orange published since the IOM report. No studies were found 
that demonstrated a negative association between exposure to Agent 
Orange and IHD. Similarly the IOM Update 2008 found no studies that 
showed a negative association between Agent Orange exposure and IHD.

    Question 2. EPA examined the rigor of three of the studies--
Steenland, et al; Flesch-Janys, et al; and Consonni, et al--relied upon 
by IOM Update 2008 to support the association between dioxin exposure 
and IHD. During the decisionmaking process, did anyone from the Working 
Group or the Task Force note that the EPA had determined that those 
studies were not suitable for examining an association due to 
inadequate exposure data and uncontrolled risk factors preventing 
reliable dose-response measurements?
    Response. The Working Group reviewed the EPA's Reassessment but did 
not use it in their deliberations. The Working Group found the findings 
not valid pertaining to determining an association. It is significant 
to note that the EPA could not have considered the Consonni study 
referenced by the IOM Update 2008 because the study was published after 
the 2003 EPA review. Regarding the Steenland study, EPA stated: 
``Steenland et al. (1999) found mortality from ischemic heart disease 
moderately increased with increasing exposure score, with an SMR 
[(standard mortality ratio)] = 93 in the lowest septile to an SMR = 123 
for workers in the highest septile (P test for trend = 
0.14).'' This is a very positive statement regarding a dose--response 
relationship. We could not identify in the 2003 EPA assessment where it 
is stated that either the Flesch-Janys or Steenland studies were not 
suitable for examining an association. There is a difference between a 
statistical association and a dose-response relationship. Studies can 
show both or either one independent of the other. The fact that there 
is no dose-response relationship demonstrated does not nullify a 
statistically significant relative risk or odds ratio.

    Question 3. In response to a pre-hearing question, VA indicated 
that the IOM Update 2008 reviewed two additional studies--Consonni and 
the Ha, et al., study--that provided enough credible evidence to 
elevate IHD to the level of a limited/suggestive association.
    I understand that the IOM Update 2008 describes the Consonni study 
as not showing a dose-response pattern to support an association, and 
that Dr. Linda Birnbaum, a reviewer of the IOM Update 2008, describes 
in correspondence with the Veterans' Affairs Committee the Ha study as 
having ``little relevance to the role of dioxin-like chemicals in the 
development of IHD or CVC.''
    Did the Working Group or Task Force note either or both of these 
caveats about the two studies?
    Response. Not all studies contribute the same information in regard 
to determining a positive association. The Consonni study did show a 
statistically significant positive association between exposure and 
disease. The dose-estimate was based on distance from the explosion. 
Earlier studies on this cohort did show a dose-response relationship in 
that the mortality for IHD was highest in the most exposed group (Zone 
1--closest to the explosion) therefore those that had the highest 
exposure by this estimate had already died from ischemic heart disease 
and were therefore removed from the populations at risk. This is 
hypothesized as the reason that those in the zone farthest away from 
the explosion and with lower exposure now have a higher mortality from 
IHD.
    We agree that the Ha study provides less useful information than 
the other studies. The working group's perspective of the Ha study, 
which provided less compelling but certainly supportive evidence, is 
discussed in the response to question 4 below. This study was included 
in our review as it had met the IOM criteria for inclusion.

    Question 4. VA's June 29th letter provided a list of the five most 
reliable studies that informed VA's decision to establish the IHD 
presumption. This list did not include the Ha study. However, VA's 
response to pre-hearing questions noted that the Ha study was one of 
the two new studies providing enough credible evidence to elevate IHD 
to the level of a limited/suggestive association. To what extent did VA 
rely on the Ha study while establishing the IHD presumption?
    Response. The list provided in the June 29th letter included the 
five mortality studies requested in the pre-hearing questions. The Ha 
study was not one of the six studies IOM determined to have a strong 
statistical association (what is stated above as the most reliable), so 
its contribution was limited by both IOM and the VA working group. 
Despite its limits, the Ha study did provide valuable information to 
the decisionmaking process in that it showed a statistically 
significant finding in women though not in men. This study also 
controlled well for risk factors including body mass index (BMI), 
smoking, family history, cholesterol and socio-economic status.

    Question 5. The six studies referenced on page 630 of the IOM 
Update 2008 as showing ``strong and statistically significant 
associations with ischemic heart disease'' did not include either the 
Consonni or Ha studies. Did either the Working Group or Task Force note 
this during the decisionmaking process?
    Response. Yes, the working group paid great attention to which 
studies showed statistically significant associations.
    The Consonni study was included in these six studies. The three 
studies that were not included were Ha, Calvert and the Air Force 
Health Study (Ranch Hand). However, IOM also made the following 
statement: ``Because of small numbers, the studies that did not report 
statistically significant associations, did not rule out modest 
increases in ischemic heart disease risk in those with the strongest 
evidence of exposure'' (p. 630). These studies, in the IOM committee's 
conclusions, added weight to the credible evidence for an association.

    Question 6. Dr. Birnbaum stated in correspondence with the 
Veterans' Affairs Committee that the Ha study did not correctly apply 
the toxic equivalency methodology for examining dioxin-like chemicals 
and did not measure TCDD specifically.
    Response. TCDD is the most toxic of all dioxins and dioxin-like 
compounds. If studies show that IHD is related to exposure to less 
toxic dioxins and dioxin-like compounds than TCDD, this would 
strengthen the association between TCDD and IHD.

    Question 6a. Did either the Working Group or the Task Force provide 
an independent review of the Ha study to determine the extent to which 
it provides credible evidence to elevate the level of association?
    Response. The Working Group reviewed and assessed the strength of 
each study the IOM indicated was important in their decision. The VA 
Working Group also reviewed each study for its rigor and contribution 
to the credible evidence of association. The Working Group review 
included the Ha study because it provided additional useful 
information. The Ha study showed a statistically significant finding in 
women though not in men. This study also controlled for risk factors 
including body mass index (BMI), smoking, family history, cholesterol 
and socio-economic status. While the limits of the Ha study were 
recognized, the study was also found to contain valid and valuable 
information that contributed to the total body of information that led 
to the presumption decision.

    Question 7. In response to pre-hearing questions, VA noted that the 
IOM 2008 Update lists among its most important study selection criteria 
those studies that examined the exposure risk of Vietnam veterans 
compared with non-deployed Vietnam-era veterans.
    Only two of the nine studies discussed by the IOM Update 2008 
Committee examined Vietnam veterans, and one of the two was not 
identified by IOM as one of the six strongest studies that supported 
its determination.
    Did either the Working Group or the Task Force discuss the extent 
to which IOM's determination of a suggestive/limited association, based 
largely on studies examining non-veteran populations with known levels 
of exposure, can be extrapolated to a veteran population with unknown 
levels of exposure?
    Response. There are measured levels of dioxin in Vietnam Veteran 
populations such as in the Ranch Hand and Army Chemical Corps studies. 
Using data from other exposed populations strengthens the argument for 
similar health effects found in Vietnam Veterans. Chemical toxicants do 
not affect different populations in grossly different ways except in 
cases of rare genetic susceptibility or protection. The 
pathophysiologic mechanisms by which TCDD causes cell damage and 
subsequent disease are basic and apply to human populations in general. 
Accordingly, the IOM and the VA Working Group and Task Force considered 
studies of non-Veteran populations relevant in assessing the risks in 
Veteran populations. This is consistent with the statutory standard in 
the Agent Orange Act requiring the Secretary to determine whether 
herbicide exposure is associated with health effects in humans 
generally, rather than only in Veteran populations.

    Question 8. I understand that EPA's Dioxin Reassessment (available 
at http://www.epa.gov/ncea/pdfs/dioxin/nas-review) addresses IHD 
specifically, and the health effects of low-to-high dose exposures of 
many of the same populations examined in the studies relied upon by IOM 
Update 2008 [see Part II, Chapter 7B (pp. 60-66) of the EPA Dioxin 
Reassessment (2003)].
    Dr. Linda Birnbaum cites this EPA source as the most reliable and 
comprehensive source for current data on the health risks of dioxin 
exposure.
     Did the Working Group or the Task Force provide 
information on the EPA reassessment during the decisionmaking process?
    Response. We did not use the EPA risk assessment for a number of 
reasons. While it did discuss ischemic heart disease, that was not the 
major focus of the EPA reassessment. Also, the EPA study was completed 
in 2003 and many of the studies were older and superseded by more 
recent studies that were reviewed in the IOM report. Dr. Birnbaum also 
stated that: ``In addition, the Institute of Medicine's report, 
entitled Veterans and Agent Orange: Update 2008, also provides a 
comprehensive and reliable source for the most current data on the 
health risks of dioxin exposure.''

    Question 9. In response to pre-hearing questions, VA seemed to 
suggest that a source examining the effect of low-dose exposures 
present in the general population would not be relevant to an 
examination of dioxin exposures experienced by Vietnam veterans. What 
evidence is available to VA that demonstrates the dioxin exposure level 
experienced by a majority of Vietnam veterans?
    Response. In both the Ranch Hand study and the Army Chemical Corps 
studies, the levels of dioxin in the general population are considered 
the ``background'' levels to which levels in Vietnam Veterans were 
compared. In those Vietnam Veterans in which TCDD levels were measured, 
the levels in those who had increased relative risks had levels much 
higher than these ``background'' levels.

    Question 10. VA's response to a pre-hearing question on the IOM 
Update 2008 committee's five most reliable mortality studies provided a 
list of risk factors that these studies took into account. However, 
none of the additional risk factors listed in VA's response are 
associated with developing IHD.
     How did the Working Group and the Task Force describe the 
strength of this evidence?
    Response. The five studies listed in response to the pre-hearing 
questions were the five mortality studies that were utilized in the 
deliberative process. This information was in response to a question 
asked specifically about mortality studies. Because they are based on 
death certificates, mortality studies do not contain information 
regarding confounders other than age (the primary determinant of 
development of IHD) and gender. This is a limitation of all mortality 
studies, not just those related to Agent Orange.

    Question 11. In the March 25, 2010, proposed rule, VA assumed a 60 
percent disability rating for IHD based on the assumption that the 
level of disability of Vietnam veterans with IHD ``would mirror the 
degree of disability for the current Vietnam veteran population on VA's 
rolls.'' Please clarify whether VA selected the mean, mode, or median 
value of the degree of disability of the current Vietnam veteran 
population for the proposed cost estimate of the IHD presumption, along 
with the basis for this choice.
    Response. The 60 percent disability rating for Vietnam era Veterans 
with IHD that VA selected was the mean evaluation (rounded up) based on 
data available when the initial cost estimate was prepared for the 
proposed rulemaking in November 2009. VA elected to use the mean 
evaluation based on program judgment. As noted in the response to the 
next question, when the costing was revised for the final rulemaking, 
more complete data was available.

    Question 12. VA's August 31, 2010, final rule cost analysis 
included a modified assumption of a 50 percent degree of disability for 
IHD, as opposed to the 60 percent degree of disability assumed in the 
March 25, 2010 proposed rule. How does this assumed degree of 
disability relate to the ratings for Vietnam veterans currently 
service-connected for an IHD-specific disability?
    Response. The modified assumption of a 50 percent degree of 
disability for IHD was based on actual data for 54,576 known in-country 
Vietnam Veterans with service-connected IHD (diagnostic codes 7005, 
7006, 7017, 7018, 7019, 7020). Of the 54,574 Veterans, 1,514 were rated 
at 0 percent and were excluded from the analysis because a minimum of a 
10 percent rating is required for a presumptive condition. Of the 
remaining 53,062 Veterans, the mean degree of disability was 49 
percent.

    Question 13. The cost analysis for the August 31, 2010, final rule 
contained a modified assumption that 60 percent of new IHD enrollees 
will be designated as Priority Group 1 veterans and 40 percent will be 
designated as Priority Group 2 veterans, as opposed to the designation 
contained in the March 25, 2010, proposed rule, which assumed a 
designation of Priority Group 1 patient, aged 45-64, for all new IHD 
enrollees. Please provide an explanation of this difference between 
VA's assumptions in the two cost analyses.
    Response. The cost analysis for the final rule was revised based 
upon the new estimate, which reduced the projected average disability 
rating from 60% to 50%. VA reviewed the new service-connected rating 
distribution and determined that it was no longer appropriate to assign 
a single priority group for these enrollees given the substantial 
difference in annual health care costs associated with various priority 
groups ($14,608 for Priority Group 1 (PG1) versus $6,064 for Priority 
Group 2 (PG2)). We believe the revised estimate provides a better 
approximation of the health care costs that VA will incur for these 
Veterans.

    Question 14. VA's June 29th letter provided the cost information 
for IHD-specific diagnostic tests and procedures used in the estimate 
of the overall care cost of adding IHD to the list of presumptions. 
Were costs for these tests and procedures factored into the final cost 
estimate that is described as being based on the average health care 
costs of Vietnam veterans in Priority Groups 1 and 2?
    Response. VA considered the average costs for compensation 
examinations understanding that required testing is reflected in these 
costs when required. We believe this is an accurate methodology for 
estimating exam costs considering that VA can utilize previously 
performed test results (both from within VA and from private sector 
sources) to support the disability determination process. The actual 
health care costs by priority group provides an appropriate 
representation of the diagnostic testing that may be required to 
specifically support ongoing diagnosis and treatment of this Veteran 
population.

    Question 15. Dr. Jonathan Samet, Chair of the IOM Committee that 
reviewed the presumptions process, suggests that openness and 
transparency in the process are important. Allowing those outside of VA 
to better understand how this decision is made may increase their 
support for the result. Are there ways to create opportunities to 
inform the public's opinion on the advice that the Secretary receives 
and how the Secretary responds to such information, while still 
promoting a robust internal discussion at VA?
    Response. While VA believes the current process provides a great 
deal of transparency and opportunity for public input, we are also 
committed to pursuing appropriate new ways to enhance transparency for 
Veterans and the public concerning the determination of presumptions of 
service connection. Some ways VA is now working to improve transparency 
include Veterans' newsletters and information provided on VA's Web 
sites.
    While we are committed to an open and transparent process, VA has 
concluded that VA-internal discussions are also needed to maintain an 
open and candid exchange of views during the decisionmaking process. In 
addition to VA's internal discussions, there are opportunities for the 
public to participate in the process. For example, when committees of 
the IOM are engaged in their scientific reviews for VA, they routinely 
hold open meetings during which the public is invited to comment. This 
includes when VA makes its charge to each IOM Committee before they 
undertake their reviews. Also, the public has an opportunity to provide 
comment during the rulemaking process when notices are posted in the 
Federal Register. VA's responses to these comments are provided after 
careful consideration by the Department.

    Question 16. VA's written testimony noted that major risk factors 
and the prevalence of heart disease were considered during the 
decisionmaking process. How and to what extent did VA consider other 
known risk factors for developing IHD that were not taken into account 
in the studies relied upon for establishing the IHD presumption?
    Response. The relative contribution of different risk factors to 
the development of IHD was beyond the scope of the legislative mandate 
or the available studies. VA's charge under the Agent Orange Act was to 
determine if herbicide exposure was also a risk factor for IHD. The 
available evidence met the standard of association established by the 
legislation. This standard was met despite the multifactorial nature of 
IHD risk facts. With this in mind, the VA did not consider risk factors 
other than those that are most closely associated with IHD, such as 
family history, hypertension, and obesity. Other risk factors would be 
so insignificant as to render their consideration meaningless.

    Question 17. Section 1116(f) of title 38, as added by the Agent 
Orange Act, provides that a Vietnam veteran shall be presumed to have 
been exposed to an herbicide agent during service in Vietnam, ``unless 
there is affirmative evidence to establish that the veteran was not 
exposed to any such agent during that service.'' What type of evidence 
does VA regard as affirmative evidence in this context, how does VA 
determine that such evidence exists, and how many times has VA 
precluded a presumption for individual veterans on the basis of such 
affirmative evidence?
    Response. The statutory mandate at 38 U.S.C. Sec. 1116(f) provides 
for the presumption of exposure to certain herbicide agents for any 
Veteran who, ``served in the Republic of Vietnam during the period 
beginning on January 9, 1962, and ending on May 7, 1975.'' VA 
regulations at 38 CFR Sec. 3.307(a)(6)(iii) interpret the term 
``service in the Republic of Vietnam'' to include service involving, 
``duty or visitation in the Republic of Vietnam'' during the specified 
date range.
    Examples of duty in Vietnam would include service with combat or 
support units operating on the ground in Vietnam and service with 
riverine units operating on Vietnam's inland waterways. Examples of 
visitation in Vietnam would include attendance at strategic command 
meetings held in Vietnam by military personnel stationed outside the 
country, shore leave in Vietnam for Navy personnel serving aboard 
offshore vessels, and temporary aircraft landings at airfields in 
Vietnam for personnel in route to other locations.
    The presumption of herbicide exposure is broadly applied to all 
Veterans who were present in Vietnam because there generally is not 
sufficient information to correlate movement of troops, let alone 
individuals, with herbicide application in a manner sufficient to rule 
in or to rule out the possibility of such exposure. This fact makes it 
very difficult for VA to determine there is ``affirmative evidence'' 
that a Veteran was not exposed to herbicides during his or her time in 
Vietnam. Further, VA generally does not seek to develop evidence for 
the purpose of disproving a Veteran's otherwise valid claim for 
benefits. Accordingly, ``affirmative evidence'' to rebut the 
presumption of herbicide exposure generally could be found only if the 
evidence of record showed that, although the Veteran was physically 
present in the Republic of Vietnam, the circumstances of his or her 
presence were incompatible with the reasonable possibility of herbicide 
exposure. VA does not track claims that are denied based solely on 
affirmative evidence for non-exposure to herbicide agents.

    Question 18. VA's written testimony states that IOM noted in its 
Update 2008 that ``although some of the studies did not adequately 
control for certain risk factors, those risk factors were unlikely to 
explain the significant increased risks detected in the studies.'' I 
understand that IOM discussed the effects of only two uncontrolled IHD 
risk factors--BMI and smoking--and discussed them in the context of 
cardiovascular disease, as opposed to ischemic heart disease. IOM 
stated that ``confounding by smoking could not explain RRs [relative 
risks] above 1.4,'' implying that a study that does not control for 
smoking must consider that smoking is potentially responsible for an RR 
up to 1.4. I understand that IOM did not discuss effects occurring when 
several major risk factors for a disease are uncontrolled in a study, 
further complicating examination of any association between IHD and 
dioxin exposure.
    Did the Working Group or the Task Force discuss the multiple 
complicating effects of uncontrolled risk factors in efforts to weigh 
the credible evidence for and against the association?
    Response. The Working Group and Task Force discussed the impact 
(confounding effect) of risk factors extensively during its 
deliberations. Controlling for confounding is difficult to impossible 
in mortality studies (five of the nine studies were mortality studies). 
Each of the studies considered as credible by IOM has strengths and 
weaknesses. When considered together, a consistent pattern emerges that 
exposure to dioxins, such as TCDD, increases the chances of developing 
ischemic heart disease. The most persuasive evidence is found in those 
studies in which increasing levels of TCDD measured in serum are 
associated with increased risk of developing disease. These cohorts 
with measured TCDD levels, particularly in the Air Force Ranch Hand 
study, were well controlled for some important confounders and 
conclusively showed that risk for ischemic heart disease increased with 
increasing tissue levels of TCDD. Biologic plausibility demonstrated 
with animal models on a repeatable experimental basis adds additional 
important evidence that exposure to dioxins is a cause of accelerated 
atherosclerosis leading to ischemic heart disease.

    Question 19. VA's written testimony stated that ``[t]he language 
and legislative history of this act made clear that it did not require 
evidence of a causal association, but only credible evidence that 
herbicide exposure was statistically associated with increased 
incurrence of the disease. The Act further specified that, in 
determining whether a positive association exists, VA must consider the 
IOM's report and any other sound scientific and medical evidence 
available to VA.''
    Did the Working Group or the Task Force review additional health 
studies, disease registries, or other public health data containing 
reliable health information on Vietnam veterans to determine whether 
Vietnam veterans have an increased occurrence of IHD compared to the 
general population?
    Response. The Working Group and Task Force consulted a cardiologist 
and other VA subject matter experts experienced with the health effects 
associated with exposure to Agent Orange. The Work Group and Task Force 
also considered information that was published after the IOM cutoff 
date for articles. One of these articles was Dioxins and Cardiovascular 
Disease Mortality authored by Olivier Humblet, Linda Birnbaum, Eric 
Rimm, Murray A. Mittleman, and Russ Hauser and published in the 
November 2008 Environmental Health Perspectives. Recent National Health 
and Nutrition Examination Survey (NHANES) data on the prevalence of IHD 
in various age categories were also reviewed.

    Question 20. VA's written testimony noted that there is a 
possibility that decisions on presumptions for specific diseases can be 
reviewed. Have any previously established presumptions been 
subsequently reviewed by VA to determine whether scientific and medical 
evidence continues to suggest a positive association with dioxin 
exposure?
    Response. The Agent Orange Act of 1991, and the statutory 
directives at 38 U.S.C. Sec. 1116, grant the Secretary of VA discretion 
to determine whether or not there is a positive association between the 
occurrence of a disease in humans and exposure to certain herbicide 
agents. The National Academy of Sciences' Institute of Medicine (IOM) 
reports, Veterans and Agent Orange, issued every two years, are 
specified by law as an important source to be considered when making 
such determinations. The Agent Orange Act contemplates that the 
Secretary will review the evidence concerning each disease discussed in 
the IOM reports and remove presumptions that are no longer supported by 
the available medical and scientific evidence.
    This review process occurs regularly with the publication of each 
new Veterans and Agent Orange report update released by IOM. These 
reports are closely followed by VA. Each new report describes relevant 
studies done since publication of the previous report and, based on 
these, provides either a continuing confirmation of a disease's prior 
herbicide association status or changes a disease's association status. 
As a result of this process, a number of diseases, such as IHD, have 
received an upgraded association status. Through these reports, VA is 
able to monitor and review the status of diseases already presumptively 
associated with herbicide exposure and evaluate whether a disease 
should remain on, be deleted from, or be added to, the presumptive 
list. To date, reviews of these reports have provided no basis for 
removing a presumptive disease from the list.

    Question 21. Would there be value to VA pursuing the approach taken 
by the Australian Government of seeking to address scientific 
uncertainties regarding the health of Vietnam veterans by carrying out 
health studies that might identify diseases occurring at a higher 
prevalence in that population than in the general population that might 
be associated with the Vietnam experience, in general, rather than with 
a specific causative agent?
    Response. Differences in prevalence of disease between Vietnam 
Veterans and the general population can be derived through well-
designed studies that make comparisons in health outcomes and mortality 
experience between these groups. Studies of this type are important and 
VA is able to derive answers at this level of inquiry through several 
study designs. Mortality studies can be used to compare the experience 
of deployed Veterans with age and gender matched civilian populations 
or non-deployed Veteran populations. In the past year, VA has worked 
with the Centers for Disease Control and Prevention (CDC) and the 
National Center for Health Statistics to enhance the questions used in 
CDC population based studies (e.g. NHANES) of the general U.S. 
population to help identify with greater precision those survey 
participants who served in the military. This will help, over time, to 
allow comparisons between Veterans and the general population on 
national health related surveys. Additionally, VA has implemented 
rigorous studies (such as the Army Chemical Corps Study) which allow 
for comparisons between Vietnam Veterans and non-deployed Veterans. 
These types of studies have provided valuable information on health 
related issues of Vietnam Veterans over time.

    Question 22. I was encouraged by VA's emphasis on both the 
importance of tracking exposures and surveillance of those exposed. 
Such measures hold the promise of impacting the need for future 
presumptions. Please describe VA's current efforts toward this goal and 
any progress VA has made toward collecting exposure data from DOD and 
establishing surveillance programs to monitor the health of veterans 
known to have been exposed during past and current wars.
    Response. The DOD/VA Deployment Health Working Group (DHWG) is 
composed of environmental health experts from both VA and DOD who 
collaborate in establishing surveillance programs to monitor the health 
of Veterans exposed to potential toxicants. This group reports to the 
VA/DOD Health Executive Council (HEC) and has a specific mandate to 
coordinate efforts to increase health surveillance information sharing, 
track research initiatives on deployment health issues, and create 
annual joint health risk communication products.
    One example of such a program is the medical surveillance program 
for those possibly exposed to sodium dichromate in Iraq at Qarmat Ali. 
VA has already contacted Veterans known to have been at Qarmat Ali by 
phone and offered them participation in the program. Veterans, active 
duty personnel and DOD civilians will also be contacted by mail. They 
will receive specific instructions on how to enroll in the Qarmat Ali 
medical surveillance program. This program includes both initial and 
follow-up examinations. If any abnormalities are found, the Veteran 
will be referred to the proper specialty service. The intent of this 
program is to closely monitor the health of Veterans and prevent the 
development of diseases known to be caused by sodium dichromate.

    Question 23. In response to a question from Senator Sanders with 
respect to your knowledge of any health studies of individuals exposed 
to herbicides in Vietnam, you stated that ``[VA has] just restarted a 
long term study of Vietnam veterans and Agent Orange. It is a study 
that continued up until about 2000, and then for lack of emphasis, it 
lost priority. [VA has] just restarted [its] effort to begin that study 
again. It is looking at the long term effects of Agent Orange on 
Vietnam veterans.''
    I am interested in learning more about this study, and request the 
following information:

     Date study initially began
     Date study was suspended and reason(s) for suspension
     Date VA resumed study
     Data elements being collected
     Data sources
     Vietnam veteran populations being examined (e.g., specific 
units, locations, etc.)
     Number of participants in each group being examined, 
including control groups
     Characteristics of study participants, including control 
groups
     Selection methodology of study participants, including 
control groups
     Previously published or unpublished preliminary and/or 
final study results
     Public and private entities partnering with VA to carry 
out study
     Date that VA anticipates using any of the study findings
     Study costs and funding amounts and source(s)

    In addition to the above information, I request that VA provide the 
Committee with quarterly updates on the status and findings of this 
study.
    Response. This study is related to Post Traumatic Stress Disorder 
(PTSD). In 1988, the National Vietnam Veterans Readjustment Study 
(NVVRS) provided an extensive report of disabilities including PTSD in 
Vietnam Veterans. The researchers at the Research Triangle Institute 
published a book titled ``Trauma and the Vietnam War Generation: Report 
of Findings From The National Vietnam Veterans Readjustment Study'' 
(the authors are Richard A. Kulka, William E. Schlenger, John A 
Fairbanks, Richard L. Hough, B. Kathleen Jordan, Charles R. Marmar, 
Daniel S. Weiss, and David A. Grady). An unpublished report of findings 
was provided to VA in two volumes, titled ``Contractual Report of 
Findings from the National Vietnam Veterans Readjustment Study'' in 
November 1988. Volume I contains an executive summary, description of 
findings and technical appendices. Volume II contains tables of 
findings.
    In 2000, Congress required VA to use an external vendor to conduct 
a longitudinal follow-up study of NVVRS, and call it the National 
Vietnam Veterans Longitudinal Study (NVVLS). VA contracted in 2001 to 
conduct NVVLS. However, delays, escalating costs, and concerns about 
contracting practices prompted suspension of the study and a VA Office 
of Inspector General (OIG) audit in 2003.
    To address Congressional concerns and respond to increasing 
interest in understanding the long-term effects of PTSD, in 
September 2009, VA reinstituted the process to contract for the 
completion of NVVLS. The contract was awarded to Abt Associates on 
September 30, 2010, and the study began immediately. The contract 
amount is $ 6,637,089 (firm-fixed price), funded directly from the 
Office of Research and Development budget appropriations.
    Between 2011 and 2013, the awarded contractor will obtain 
Institutional Review Board (IRB) and Office of Management and Budget 
(OMB) approvals for the project and initiate the study under VA 
monitoring. By 2014, the data should be available for analysis and we 
anticipate the results will be available shortly thereafter for 
publication in a scientific journal.
    The goal is that NVVLS will result in a credible, comprehensive 
report on the long-term effects of Vietnam military service including:

    (1) What is the long-term course of PTSD in Vietnam Veterans?
    (2) What is the relationship between PTSD and other psychiatric 
disorders and physical health in Vietnam Veterans?
    (3) Are particular subgroups of Vietnam Veterans at greater risk of 
chronic, more severe problems with such psychiatric disorders, 
including later life onset of PTSD?
    (4) What services are used by Vietnam Veterans who have or have had 
PTSD, and what is the relationship between those services (VA and 
other) on the course of the PTSD?

    The new National Vietnam Veterans Longitudinal Study (NVVLS) will 
consist of the following four main phases:

     Feasibility Phase: To establish how many individuals from 
the original NVVRS cohort are available to participate in the NVVLS.
     Start Up Phase: To prepare the assessment and data 
collection materials, finalize protocol and obtain IRB approval.
     Implementation Phase: Recruit and enroll participants and 
conduct assessment by phone and by mail. A limited number of in-person 
interviews may be required to validate assessment tools and to increase 
the participation rate.
     Close Out Phase: Analyze data, prepare final reports, and 
deliver data to VA.

    There were 2,348 Veterans from original NVVRS (1988), including 
both theater and era Veterans. The contractor is tasked with trying to 
contact, obtain consent from and survey as many of the original cohort 
as possible to determine willingness and availability to participate in 
NVVLS. The entities involved in completing the study are OMB and Abt 
Associates.

                                                    Timeline:
FY 2010
  Contract Awarded                                                             September 29, 2010
  Study begins, feasibility phase                                              September 30, 2010

FY 2011
October:
  Data transfer agreement to be completed
  Kick off meeting with Abt Associates                                         October 14, 2010
April:  Feasibility phase to be completed
May:   Start-up phase begins

FY 2012
October:  Implementation phase begins

FY 2012-2013
Conduct study; monitor ongoing performance

FY 2014
Analyze data; submit final report to VA, publish results in scientific
 journal


    The Office of Research and Development does provide quarterly 
updates on the status of the NVVLS to the Committees on Veterans 
Affairs. The timeline above provides the most up to date information on 
award of the contract and projected course of action that is contained 
in the most recent quarterly report.

    Question 24. In response to a question from Senator Tester, you 
stated that a 10-year administrative cost estimate of $1.66 billion for 
the IHD presumption that was provided to you on a document at the 
hearing appeared to reflect a calculation error. I understand that the 
$1.66 billion estimate for the IHD portion of the administrative costs 
was based on a table on page 22 of VA's August 31, 2010, final rule 
cost impact analysis. Please clarify the administrative costs and 
provide the underlying basis for each line item listed in that table.
    Response. We are not certain of the origin of the $1.66 billion 
estimate to which you make reference. However, the table shown below 
expands upon the table from page 22 of VA's Impact Analysis. Please 
note that administrative costs are determined by the level of FTE, 
which is calculated based on expected workload for claims receipts. The 
total estimated 10-year administrative cost is $894 million.

      Diseases Associated With Exposure to Certain Herbicide Agents
                      Administrative Costs ($000s)
------------------------------------------------------------------------
                                     1st Year
           Cost Element             (FY 2010)      5 year      10 year
------------------------------------------------------------------------
Personal Services................       *4,554      665,621      753,904
Training.........................            -       16,856       16,856
Rent.............................            -       99,724      108,582
Supplies & Materials.............            -       15,272       15,272
                                  --------------------------------------
  Total..........................       $4,554     $797,473     $894,614
------------------------------------------------------------------------
* FTE costs in FY 2010 represented a level of effort of current FTE that
  would be used to work claims received in FY 2010. New hiring would
  begin in 2011.


    Question 25. In response to a question that I asked with respect to 
concerns that may have been raised while you were deliberating on 
establishing the IHD presumption, you noted that you sought open dialog 
and advice from several sources and that some of the information was 
more helpful than others, but that the process for creating 
presumptions is not perfect. What improvements might be made to the 
current process?
    Response. Enactment of legislation to extend VA's timeframe to 
review IOM evidence would better accommodate the comprehensive review 
that must be conducted prior to making critical policy decisions 
relating to presumption of service connection.

    Question 26. In response to a question that I asked with respect to 
any challenges faced in making the IHD determination, you indicated 
time constraints were a substantial challenge. I support your effort to 
establish a timeframe that will permit VA to conduct a thorough and 
independent review of the IOM report, all underlying studies considered 
by IOM in its review of the evidence for and against an association, as 
well as all other sound medical and scientific information available. 
What specific changes do you recommend?
    Response. In May 2010, VA submitted to Congress a draft bill, ``The 
Veterans Benefit Programs Improvement Act of 2010,'' section 103 of 
which would extend the time limits for VA's action under the Agent 
Orange Act to better accommodate the need for thorough analysis of the 
numerous complex medical and scientific issues presented in the IOM's 
reports and to permit effective coordination within the executive 
branch. Section 103 would provide that (1) within 120 days after 
receiving the IOM report, the Secretary would determine whether a 
presumption of service connection is warranted for any disease; (2) 
within 170 days from the Secretary's determination, VA would publish 
proposed rules to establish any warranted presumptions; (3) within 200 
days after the Secretary's determination, VA would publish a notice 
explaining why presumptions are not warranted for other diseases; and 
(4) within 230 days after publication of the proposed rules, VA would 
issue final rules establishing any warranted presumptions. Further, to 
minimize the impact of these extended time periods on Veterans' 
benefits, section 103 would also provide that presumptions established 
under this process would take effect retroactive to the date on which 
the Secretary's determination was required to be made (i.e. 120 days 
after receipt of the IOM report).
    Further, VA fully supports enhancement of exposure-tracking 
mechanisms within the military services so that reliable data is 
available for future scientific studies and reviews. The availability 
of this exposure data will serve as the foundation for high quality 
studies that will lead to sound presumptive decisionmaking. If this 
data, along with other scientific data, is available for review, then 
the current presumptive framework appears to be sufficient to render 
equitable decisions. VA will continue to analyze various options 
provided by IOM and other experts regarding the presumptive 
decisionmaking process.

    Question 27. Treatments for heart disease range from medications 
and lifestyle counseling up to high-tech surgeries. What steps is VHA 
taking to be prepared to absorb the increased workload that will result 
from the IHD regulation?
    Response. Informed by a national advisory workgroup of VA 
cardiologists, an algorithmic approach to confirm and /or diagnose IHD 
and assess disability has been developed. The goal of this algorithm 
was efficiency both in terms of providing the Compensation and Pension 
(C&P) data for Veterans, but also to optimally utilize VA resources. 
More specifically, the algorithm takes maximum advantage of medical 
information in the Veterans' Electronic Medical Record. This 
information would include diagnostic tests, medications, procedures and 
health care provided in outpatient visits and inpatient admissions that 
the Veterans have already had. The algorithm also suggests less 
resource-intensive methods for obtaining ratings information (e.g. 
patient interviews to assess metabolic equivalents, chest X-rays and 
EKGs to assess for cardiac enlargement and hypertrophy). When combined 
with information provided by the Veteran for care and testing outside 
of VA, the resulting data available to providers will help avoid any 
unnecessary or duplicative testing. Despite these measures, it is 
expected that Veterans will require additional testing, but this will 
largely consist of noninvasive testing such as echocardiography or 
treadmill tests. Moreover, the increase in testing requests is likely 
to rise for some period of time, but then decrease toward prior levels. 
However, there may be some facilities where capacity could be an issue, 
and these facilities may need to request additional resources from the 
Veterans Integrated Service Network (VISN) to ensure timely response to 
requests for tests. If the VISN cannot provide these resources, a 
request will be made to VA Central Office. It is our intention to 
closely monitor workload and intervene to provide additional resources 
as needed.

    Question 28. I am pleased to note that the final regulation 
corrected the draft regulation with respect to the numbers of those 
potentially affected by heart disease and the resulting cost. Are you 
satisfied that the cost estimate is now accurate?
    Response. The Final Regulation Preamble contains a discussion of a 
revised cost forecast that is discussed in detail in the Impact 
Analysis. Since, as discussed in the Preamble, cost forecasts are based 
upon data that is available at the time the forecast is prepared, we 
are confident that VA has identified the appropriate forecasted funding 
levels needed at this time.

    Question 29. I understand that VA will rely, in part, on 
examinations by non-VA health care providers in order to conduct some 
of the examinations that will be necessary to establish that a veteran 
has heart disease. Are there any concerns about either the reliability 
of these outside exams or about VA's ability to secure and utilize the 
results of those exams?
    Response. VBA's goal is to have Disability Benefit Questionnaires 
(DBQs) replace the current 67 C&P Examination worksheets. Upon 
completion of the approval process, the DBQs will be available on VA's 
internet site and accessible for use by private physicians. VBA will 
not be requesting examinations from non-VA healthcare providers. The 
use of DBQs by non-VA clinicians is merely another option available for 
Veterans to submit medical evidence in support of a claim.
    VA's DBQ Project Management Plan requires that all DBQs be made 
available to VA or non-VA clinicians of the Veteran's choosing, with 
the exception of initial evaluations of Post Traumatic Stress Disorder. 
A properly completed DBQ will reflect the clinician's examination and 
evaluation of the Veteran's disability and should provide the 
information VA needs to evaluate the claim. Accordingly, a DBQ from a 
private clinician that is sufficient for VA rating purposes may obviate 
the need for an examination conducted by VA or VA-contractor personnel.
    The use of DBQs, as opposed to C&P Examination worksheets, offers 
several advantages. First, DBQs collect only essential rating criteria 
related medical information that a Rating Veterans Service 
Representative (RVSR) would need to render benefit claim decisions. The 
expected results are more timely and standardized benefit claim 
decisions. Second, the use of the DBQs by private physicians is 
expected to reduce the number of VA exams needed, which will improve 
processing timeliness. Finally, the use of DBQs will allow for a more 
focused examination. In cases of IHD, performing an examination using a 
DBQ, as opposed to a current C&P heart examination worksheet, is 
expected to be at least 50 percent more efficient.
    In sum, DBQs provide additional medical evidence from a Veteran's 
VA or non-VA physician that RVSRs may use in rendering decisions on 
benefit claims. DBQs are not the sole piece of evidence used in 
rendering benefit claim decisions. Rather, DBQs are considered with the 
totality of other evidence contained in the Veteran's claims file. In 
cases where DBQs received are of questionable reliability or are 
otherwise insufficient for rating purposes, VBA will request a VA 
examination under the provisions of 38 CFR Sec. 3.326 and the Veterans 
Claims Assistance Act.

    Question 30. If credible evidence relating to a disease is made 
available to VA that is not in the IOM report, does VA discuss the 
credibility of such evidence with IOM prior to making a presumption 
determination?
    Response. The Agent Orange Act of 1991 and the statutory directives 
at 38 U.S.C. Sec. 1116 grant the Secretary of VA discretion to 
determine whether or not there is a positive association between the 
occurrence of a disease in humans and exposure to certain herbicide 
agents. The IOM periodic reports, Veterans and Agent Orange, play a 
significant role in making such determinations.
    By law, ``all other sound medical and scientific information and 
analyses'' that are available to the Secretary are also considered. 
However, because IOM is a reputable and reliable scientific 
organization and because its mission in this case is to review and 
evaluate all studies on the health effects of herbicide exposure, it 
would be unusual that ``credible evidence'' relating to a disease and 
herbicide exposure would be unknown to IOM or excluded from its 
reports. However, new evidence may be developed subsequent to issuance 
of an IOM report.
    In the event that such credible evidence not considered by IOM is 
made available to VA, VA is not required to discuss its credibility 
with IOM, but may seek to do so if warranted. For example, following 
receipt of IOM's Agent Orange 1998 Update (released in February 1999), 
VA asked IOM to evaluate two new studies concerning type II diabetes 
that had been released too late for consideration in the 1988 update. 
IOM provided its analysis of the new reports in October 2000, 
ultimately leading to VA's issuance of a presumption of service 
connection for type II diabetes. Accordingly, while IOM's insights may 
be helpful, its processes for formulating and providing views may 
interpose substantial delays incompatible with statutory time limits 
for VA determinations.

    Question 31. When IOM modifies the categorization of a disease 
based on newly published evidence, does VA conduct an independent 
review of such evidence or rely solely upon IOM's analysis?
    Response. VA carefully reviews all evidence considered when IOM 
modifies the categorization of a disease. VA assembles a team of 
medical and legal experts to review not only the IOM findings, but also 
the actual scientific evidence, (i.e., studies, reviews, statistics, 
etc.) which IOM considered in making its conclusions.

    Question 32. In an article in the July 2010 edition of the Agent 
Orange Review, you are quoted as saying: ``We must do better reviews of 
illnesses that may be connected to service, and we will.'' Do you have 
any specific suggestions or ideas in mind to accomplish this?
    Response. VA plans to pursue several avenues of inquiry to better 
understand what illnesses affect Veterans and to what extent these are 
related to their military service. By conducting detailed long term 
follow-up studies, we can understand specific impacts, as we are doing 
with Vietnam Veterans of the U.S. Army Chemical Corps. A study of Army 
Chemical Corps Veterans is under development. Part of the study will 
carefully review a sample of medical records to establish whether 
specific diagnoses were recorded by health care providers. In addition, 
this same group of Veterans will be asked to participate in physical 
exams to measure cardiovascular and respiratory health outcomes. 
Another approach that VA has taken, and continues to pursue, is the 
identification of a large group of Veterans known to have served in a 
conflict and a similar group of Veterans without the same deployment 
experience. The groups are surveyed to assess health and illness 
outcomes, health care utilization, and other indicators of well-being. 
A sample of 60,000 Veterans, half of whom returned from Afghanistan and 
Iraq, were enrolled in a health study that used survey methodology to 
learn about their health experience and concerns. Data collection for 
this study, The National Study of a New Generation of U.S. Veterans, 
was recently completed and preliminary results are expected in 2011. VA 
has also partnered with the CDC to collect information through broad 
based population surveys that will allow for better comparisons between 
the health outcomes of Veterans and general population groups.
                                 ______
                                 
 Response to Post-Hearing Questions Submitted by Hon. Jim Webb to Hon. 
    Eric K. Shinseki, Secretary, U.S. Department of Veterans Affairs
    Question 1. Secretary Shinseki, when adjusted for age, smoking, 
cholesterol, body mass index, and other major contributing factors, 
what is the increased rate of ischemic heart disease (IHD) in Vietnam 
veterans when compared to the general population?
    Response. Currently, there are no studies in the literature that 
compare estimates of the prevalence of IHD among Vietnam Veterans to 
the general population. The studies cited by the Institute of Medicine 
(IOM) reflect the evidence of a statistical association of IHD and 
Agent Orange and support the presumption for ischemic heart disease. 
The study designs demonstrate limited or suggestive increased risk 
associated with Agent Orange. These studies neither provide, nor rely 
on, other risk factors in the population impact of disease. They do not 
allow for comparisons to other risk factors in the general population.
    Question 2. Secretary Shinseki, in response to pre-hearing 
questions you stated that the positive association standard is not 
perfect, but that it has resulted in more Vietnam veterans obtaining 
health care as a result of herbicide exposure. Understanding that 
health care benefits yielded by the presumption process are important, 
and that 30 percent of service-connected veterans rely on DVA health 
care, the question arises regarding levels of disability compensation 
for systemic illnesses whose onset is affected by other factors and 
typically occurs with a latency period of thirty to forty years. Please 
provide the Committee your view on the issue of how best to determine 
the level of such compensation, separate from the issue of access to 
medical care.
    Response. Under the provisions of title 38, U.S.C. Sec. 1155, 
disability compensation is to be based on the average impairment in 
earning capacity due to injury or disease incurred in or aggravated by 
active military service. VA maintains a Schedule for Rating 
Disabilities consisting of disabilities in 15 body systems with 
associated levels of severity from zero to 100 percent that represent 
the average impairment in earning capacity for any listed condition.
    There is no basis in law for compensating Veterans for disabilities 
in a bifurcated system that would be based on relative risk for 
developing any particular disease. Such a system, if able to be 
developed, would be fraught with inconsistency and add substantial time 
to the already lengthy claims process.

    Question 3. Secretary Shinseki, in correspondence with the Senate 
Committee on Veterans Affairs (SVAC), Dr. Mary Paxton, Study Director, 
Institute of Medicine (IOM) Update 2008 said that the three additional 
studies (Ha, et al.; Consonni, et al.; and Calvert, et al.) included in 
the 2008 report ``did not show strong and statistically significant 
associations with IHD'' and, in fact, provided weaker evidence than the 
six studies relied upon and determined as inadequate evidence by the 
IOM Update 2006 Committee. Given the weak nature of these new studies, 
did the Department ask the Update 2008 Committee specifically how and 
why it reached a different determination on the strength of the 
association between herbicides and IHD than the Update 2006 Committee?
    Response. There were two, not three, additional studies: Ha and 
Consonni. Calvert was published in 1998 and also was considered by the 
2006 committee. The Calvert and Ha studies, while not providing a 
statistically significant association, still had results and 
conclusions that supported the determination of a positive association 
when taken into consideration with all of the other studies. This 
includes a very substantial body of toxicologic literature which 
elucidated the pathophysiologic mechanism by which 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD) damages arteries and leads to 
ischemic heart disease.
    The three studies referred to by Dr. Paxton (see quote below) were 
the Air Force Health Study (AFHS), Calvert and Ha.

        ``* * * The three studies having individual measurements of 
        serum dioxin levels that did not show ``strong and 
        statistically significant associations with ischemic heart 
        disease'' were AFHS (2005), Calvert et al. (2008 [should be 
        1998]), and Ha et al. (2007).''

    Except for the Ha study, which VA agrees provides only supporting 
evidence, the other two studies referred to by Dr. Paxton were reviewed 
by the 2006 committee. (The quote above incorrectly states the date of 
publication for the Calvert study. It was 1998, rather than 2008).
    IOM gives the explanation for why a different decision was made by 
the 2008 committee on pages 628-630 of the published report. VA 
referenced this explanation in testimony before the Committee on 
September 23, 2010. VA was well aware of and understood the legitimate 
scientific reasons for a different decision:

    1. Two new epidemiologic studies (Consonni and Ha) provided 
additional evidence in support of a positive statistical association; 
and
    2. Several toxicological and animal studies since Update 2006 have 
provided clear evidence of biological plausibility and a 
pathophysiologic mechanism for the development of ischemic heart 
disease secondary to exposure to Agent Orange.

    The Committee was impressed by the fact that those studies with the 
best dose information all showed evidence for risk elevations in the 
highest exposure categories.

    Chairman Akaka. Thank you very much, Mr. Secretary. I know 
we all appreciate understanding more about your decision.
    Will you please tell me about any concerns within VA that 
were raised while you were deliberating on the issue--on your 
decision?
    Secretary Shinseki. By concerns do you mean about the 
dialog that went on inside of our process?
    Chairman Akaka. Within VA.
    Secretary Shinseki. Well, I can say, as I indicated, we had 
a work group and a task force and then there were other 
independent views I sought. I would say it was an open dialog. 
You know, people were encouraged to participate fully. So in 
that kind of an environment you are going to have give and take 
on the discussions. I listened to all of it and all of it was 
helpful. Some of it was more key in focusing my final decision. 
I would say perhaps the most robust of the debate centered on 
ischemic heart disease for much of the same discussion that has 
already prevailed. I would also say that the vast majority of 
the medical experts who engaged in that dialog with me were 
solidly in support of the positive associations. So that is as 
much as I can describe for you about the internal process.
    I will add that when I say 60 days is what the law 
stipulates, I would say it was a time-constrained process. The 
dialog was important, and I had to find a way to make sure that 
all views, including minority views, were shared. But the 60-
day time limit was a bit constraining. One of my suggestions is 
that we look at a way to expand the window that the VA has to 
do its part of this. After all, the study that is provided to 
VA is a 2-year process out of the IOM. Of all the studies they 
looked at, we receive a report about 650 pages in length. Sixty 
days is a little challenging.
    Chairman Akaka. According to responses to pre-hearing 
questions from a witness on the next panel, 80 to 90 percent of 
patients suffering from heart disease have lifestyle factors 
such as smoking, lack of exercise, and a diet high in 
cholesterol. How did this affect your decision?
    Secretary Shinseki. Well, Mr. Chairman, I do not have any 
data that would refute that. I think it is fair to say that for 
folks my age in this country, the 60-year group folks, heart 
disease of some kind is a fact of life for all. Eighty percent 
may be the right number, and I will accept that, but we are not 
talking about asymptomatic heart disease. The 80 percent of 
people who have this condition, whether it is having to control 
lipids through medication or the buildup of plaque in blood 
vessels, that 80 percent is for the most part asymptomatic.
    What we are concerned about in ischemic heart disease, the 
17 percent who are estimated to have symptomatic ischemic heart 
disease--symptomatic in the sense that there is pain associated 
with it or that in doing a routine activity like climbing a 
flight of stairs, they are exhausted and cannot do it. This is 
what we are talking about. It is this lesser subset that we are 
focused on with the ischemic presumption that we are dealing 
with.
    Chairman Akaka. Thank you. We will have 5-minute rounds of 
questions here. Let me call on Senator Johanns for your 
questions.
    Senator Johanns. Thank you, Mr. Chairman.
    Mr. Secretary, let me, if I might, go back a ways and just 
lay some groundwork here. Back when Agent Orange was so 
routinely used, how much of it was ultimately used in Vietnam?
    Secretary Shinseki. Senator, this is a great question. I 
would say our best review of the records says that 19 million 
gallons of Agent Orange was dispersed over Vietnam. I accept 
Senator Webb's description of his area. But the records show 
that Agent Orange was dispersed along the DMZ and all four 
major military regions along the tri-border areas between 
Cambodia, Laos, and Vietnam, areas in the central highlands, 
northwest of Saigon, southeast of Saigon, along those canals 
and down in the delta. So it was dispersed throughout the 
country.
    Senator Johanns. And typically how would it be dispersed?
    Secretary Shinseki. Aerosol sprayed by planes. And so 
asking a veteran to prove that he was sprayed--many of them may 
not know.
    Senator Johanns. Yeah.
    Secretary Shinseki. I mean, it is distributed by aerosol. 
And unless you happen to be there when it is sprayed, you 
probably did not know you were in the midst of it. So it was 
throughout the country.
    Senator Johanns. So if you happened to be out on patrol or 
you went into an area where that disbursement was made and 
walked through the brush and the trees and whatever else, you 
probably got soaked to the skin I would imagine.
    Secretary Shinseki. I guess if you were there when the 
spraying went on you would probably know it if you could see 
through the canopies.
    Senator Johanns. Yeah.
    Secretary Shinseki. In some areas the canopies were 200 to 
300 feet in the air and you might not see the aircraft. But I 
think if you moved through an area where it was used, very 
clearly the foliation will tell you you are in a different 
ground. But again, in those days I do not think most youngsters 
understood or realized what that meant. With the deployment of 
fires, artillery fires and bombing, you have in effect a 
landscape and sort of a moonscape. Landscape to look like the 
moonscape because it is devoid of trees and foliation. I am not 
sure youngsters could distinguish between what caused it but 
the facts show 19 million gallons. If you think of the big 
50,000 gallon tankers that pull up at Exxon to download into 
the tanks underground as being a significant fuel supply or a 
supply of liquids, we are talking 19 million gallons, which is 
significant.
    Senator Johanns. That is significant.
    Now, moving ahead to this presumption and how you will 
handle it, the last piece of your testimony in response to the 
Chairman's question raises a question or two for me. What I 
understand you to be saying, and correct me if I am wrong, is 
that if I walk in and I say, I have got some elevated 
cholesterol, how are you going to handle that versus somebody 
who says, look, I have not been able to work for a number of 
years. Walking to the bathroom I am short of breath. I have 
pain in my chest. Tell me the degrees here. Kind of walk us 
through how you are going to handle managing this presumption.
    Secretary Shinseki. That is a fair question. Clearly, 
again, we are talking about symptomatic ischemic heart disease 
which would be the latter condition you described. But in 
fairness to the first veteran who walked in, what we should be 
doing is accepting the fact that there is some signature here 
with cholesterol and at least begin the process of monitoring 
the health condition so that over time, if it does become of 
the ischemic symptomatic order, we can make decisions about 
whether and what kind of disabilities are involved. But if it 
is asymptomatic, there is no disability and until you reach a 
10 percent level of disability, we are not into that 
discussion.
    Let me just turn to the one cardiologist on the panel and 
see if there is more to be added here. Dr. Jesse?
    Dr. Jesse. Yes. Thank you, sir. A couple of comments. While 
the statement was made that 80 percent of the people will have 
risk factors, which is inherently true, roughly one-third will 
have hypertension and two-thirds will not. Almost 50 percent 
will have a total cholesterol over 200 and about one-third will 
have an LDL, bad cholesterol, beyond what is acceptable. But 
two-thirds will not. A third will be but these two-thirds will 
not. So the risk factors are important but they are not able to 
be parsed out in this presumption of Agent Orange. But what is 
important, and it comes back to comments made by several of the 
senators, is that in the treatment of those risk factors, high 
quality care is imperative. Whether a veteran was in Vietnam 
and exposed to Agent Orange or was in World War II or is in a 
current conflict, we take the mitigation of risk for cardiac 
disease very seriously. We have performance measures in place 
that are at par or better in most cases than any other health 
care system in this country for the treatment of hypertension, 
the treatment of lipids, the treatment of diabetes. Mitigating 
the risk is the best that we can do.
    We have a program called MOVE, which is focused at getting 
the veterans to increase their physical activity. So all of 
these are taken very seriously and the VA does it very well. 
Can we do better? Yes. We are trying to do even more but we 
clearly are at attention for these.
    Senator Johanns. Thank you. That is helpful. Thank you, Mr. 
Chairman.
    Chairman Akaka. Thank you very much, Senator Johanns.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman. Mr. 
Secretary, in his statement, the former Secretary Principi made 
some suggestions: to improve the Agent Orange Act of 1991, 
including some new studies in dioxin level blood testing; to 
direct the IOM to provide VA with an estimate for latency 
period for Agent Orange-related illnesses; and finally, asking 
IOM to estimate the number of Vietnam veterans who might be 
affected by an illness linked to herbicide exposure. I wanted 
to ask you what your thoughts are on those recommendations, and 
how do you think we ought to move forward from here?
    Secretary Shinseki. Let me call on Dr. Jesse to talk about 
the specific technical aspects of those recommendations and 
then let me conclude.
    Dr. Jesse. If we move to the issue of attributable risk it 
becomes very difficult to do that. In the charge of the 
Institute of Medicine, they have been since the inception of 
their engagement--it has been asked to answer that question. 
They very specifically, in each of their biannual reports, have 
said we cannot do that. If we go back to causation, which 
inherently makes sense, it is actually the wisdom of Congress 
in the 1991 Act that moved beyond making that decision. Then 
finally, in terms of trying to assign how many veterans might 
or might not be affected because of this, if you cannot do 
attributable risk and we cannot do causation, it makes that 
very difficult to do. We are back in the same position of even 
trying to define the highest exposed populations.
    Senator Murray. Mr. Secretary, how do we move forward?
    Secretary Shinseki. Dr. Cassano.
    Dr. Cassano. Senator, the question is on measuring levels 
of TCDD. Unfortunately as time goes by these levels drop. You 
have some very good determined levels from 1980 and 1987 in 
some of the studies. But at this point the residual from those 
exposures in Vietnam are now approaching the level of the 
residual exposure in the general population because TCDD was 
used in this country.
    The other important point regarding that is that we do not 
know when the damage to the cells actually occurred that 
eventually develops into clinically significant disease. It 
could have happened in the 1960s. It could have happened in the 
1970s. And the Air Force Health Study shows that in showing 
that increased disease risk correlates with 1980 and 1987 
levels.
    Senator Murray. OK. Which goes to----
    Secretary Shinseki. Let me just wrap here. There is one 
issue you asked about also which was latency.
    Senator Murray. Yes.
    Secretary Shinseki. I would just offer that there has been 
some engagement on latency in the past, and I forget the 
disease--30 years--what was it?
    Dr. Jesse. In the original presumption, pulmonary cancers 
were given a latency period of 30 years. That latency period 
was actually withdrawn by Congress. When the Institute of 
Medicine was again asked to address that they said there was no 
sound basis for it continuing. Now, some of the presumptions, 
like chlorachne would be expected to be present at the time of 
high exposure and not appear many years later. So there is 
certainly a rationale for doing that. But broadly, for ischemic 
heart disease in particular, you cannot put a time period on 
this.
    Secretary Shinseki. I just wanted to get that discussion 
out.
    Senator Murray. Good, thank you.
    Secretary Shinseki. Senator, I think this is a tough 
question. This is what we are wrestling with. I would say that 
our best opportunity to set up an outcome different than the 
one we are dealing with today is sort of what you suggest, and 
that is when an exposure occurs we ought to be looking for it, 
first of all. When an exposure occurs we ought to acknowledge 
it. It does not mean that we are into the discussion of 
disabilities. It means that we have acknowledged that an 
exposure occurred. What we want to do next is much like what 
Senator Webb described, and that is identify the units who were 
exposed, get a registry of everyone who was in that unit, begin 
a surveillance over time that will help us provide better 
treatment for veterans, and in the long run you address the 
outcome issue that has a cost associated with it.
    As I am fond of saying, you either believe in the efficacy 
of medicine or you do not. I happen to be one who believes in 
the efficacy of medicine which is, if you diagnose and treat, 
you influence the outcomes of those patients. That is what we 
in VA are very much into here, the prevention model: early 
diagnosis and treatment. And as these diseases reveal 
themselves, we treat them and then begin to modify the severity 
and the incidents. I think that in the long run will address 
the other question about cost.
    Senator Murray. Right. I think that it is something you and 
I have talked about before, too. Denial of something at the 
time never gets us to a good place later. We sort of have a 
history of that when it comes to warning this country. I think 
that--I hope that is a lesson we all learn and are thinking 
about now as we have troops overseas in Afghanistan and Iraq.
    My time is----
    Secretary Shinseki. May I follow up, Senator?
    Senator Murray. Yes, please.
    Secretary Shinseki. I guess this is the next comment. That 
is to look around and see where we have the opportunity to 
change the outcome and not have the Agent Orange example 
repeated.
    We do know about burn pits in Iraq.
    Senator Murray. Right.
    Secretary Shinseki. Operationally we have departed Iraq. 
Opportunities to figure out where and what was the exposure, 
and to which units; we are losing the opportunity to do that.
    Senator Murray. Every day.
    Secretary Shinseki. Each passing day. Qarmat Ali, same 
thing. So this is the tough part of the business: identifying 
that exposure and then being willing to do something about it 
early on.
    Senator Murray. Well, good. I want to keep working on that 
and I appreciate that. My time is up. Mr. Secretary, while I 
have you, real quickly, we have a severe problem in my State in 
a very rural area on the Olympic Peninsula with access for our 
veterans. A high number of veterans coming home live there 
miles and miles and miles from care with very jammed 
facilities, and I want to talk to you later about perhaps 
getting a full service CBOC or a Vet Center there to begin to 
deal with some of those folks who are home and have--are not 
getting the care that they need. So I will contact you.
    Secretary Shinseki. Happy to have that discussion.
    Senator Murray. Thank you.
    Chairman Akaka. Thank you very much, Senator Murray.
    Senator Sanders.
    Senator Sanders. Thank you, Mr. Chairman. This is a very 
difficult discussion because we are asking the Secretary to 
play God. I happen to think you are doing a great job but you 
are not God. None of us are.
    And the difficulty is that in the old days, before we knew 
what we knew today, everybody recognizes that if a soldier was 
wounded, lost a leg, lost an arm, there was no debate. That was 
a cost of war and that soldier gets all the care he or she 
needs plus all the benefits. The difficulty is that the world 
has changed very significantly as a result of chemical 
exposure. Let us not forget that when Agent Orange was first 
used, our friends at Dow, Monsanto, and all of those companies, 
they said this was benign; there is not a problem.
    Am I correct on that, Mr. Secretary?
    Secretary Shinseki. My recollection also.
    Senator Sanders. I am certainly sure the military would not 
have used this chemical if they thought otherwise. By the end 
of the day we used a poison and we poisoned our own people. Who 
is smart enough to know exactly what the impact--would somebody 
have come down with a heart disease or other illnesses if they 
had never been to Vietnam? The answer is of course they would 
have. On the other hand, because somebody was in Vietnam and 
exposed to Agent Orange to some degree, combine the exposure to 
genetic predisposition, for example, could that have led to one 
or another illness? Of course it could have. Who is smart 
enough to make the determination as to exactly what the balance 
is? I am not. I do not think you are. Nobody is.
    What presumption is about is to say you, soldier, put your 
life on the line. We are going to give you the benefit of the 
doubt. We are going to assume that if you come down with an 
illness that we can relate to exposure--in this case to Agent 
Orange--we are going to make the presumption that was the 
cause. Maybe it was not but that is the presumption we are 
going to make. And I think that is the right presumption.
    In terms of Agent Orange--now is not the time to go into a 
lengthy discourse on it. Our history on the subject as a 
government has not been particularly good. There has been a lot 
of denial, as I mentioned earlier, on the part of the 
government against Vietnam vets who originally came back. I was 
in Vietnam a few months ago. We were in Da Nang, which was one 
of the hotspots. To the best of my knowledge, interestingly 
enough, Mr. Chairman, I believe--and somebody correct me if I 
am wrong--that we have really not done a thorough study of the 
impact of Agent Orange on the Vietnamese people. Not 
necessarily because, you know, we are concerned about everybody 
in the world, but to learn from their exposure what it means to 
Americans.
    I do not think that was an accident. I think originally, 
especially in the years after the war, the attitude was the 
less we know, the better we will be. Because the less we know 
means that when people come forward and say I am sick because 
of exposure, we can say, well, we really do not know. But I am 
kind of curious, so the Secretary or anybody on the panel, does 
not it seem strange that the people who were most exposed--
people who were dumped on who were eating food, drinking water 
in Vietnam, in addition to our own soldiers--that we have never 
done a thorough study about the impact of Agent Orange on the 
people of Vietnam.
    Am I wrong on that or am I right about it? Does somebody 
want to comment on that?
    Secretary Shinseki. Senator, I am not familiar with studies 
on the people of Vietnam. There may have been studies. I am 
just not personally aware of them, but I will have a look at 
that and provide you with an answer. I would also say that we 
have just restarted a long-term study of Vietnam veterans and 
Agent Orange. It is a study that continued up until about the 
year 2000, and then due to lack of emphasis it was a lost 
priority. We have just restarted our efforts to begin that 
study again which is looking at the long-term effects of Agent 
Orange on Vietnam.

    [Response was not received within the Committee's timeframe 
for publication.]

    Senator Sanders. If somebody on the panel could answer my 
question. Would not one think that if we were worried about 
American soldiers and their exposure you would take a look at 
the impact of where Agent Orange was dropped on the Vietnamese 
people to learn their suffering or non-suffering. Am I missing 
something there or would that be a legitimate scientific quest?
    Dr. Jesse. I will try to answer that. Would it be a 
legitimate scientific quest? Obviously, yes. Could it be done, 
I think, is another challenge. And just as we are not able to 
precisely identify the veterans who were maximally exposed, it 
would be equally and probably more difficult to actually 
identify which of those folks in Vietnam were also----
    Senator Sanders. Actually, Doctor, I think not because our 
soldiers came and went, were dispersed. There are people who 
live in given communities and so forth. But does anybody--
alright. OK.
    That was the point I wanted to make. I think we have put 
the Secretary in a very difficult position and I think he has 
done the right thing. So I think we have got to give the 
benefit of the doubt to the people who served.
    Thank you very much, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Sanders.
    Senator Webb.
    Senator Webb. Thank you, Mr. Chairman. Mr. Secretary, I 
have three or four questions and we have a very short time 
period here. I am going to try to get them all in but they are, 
again, an attempt to clarify the decisional process and also to 
clarify for people who may be paying attention to this hearing 
what set of unknowns that we have been working on in order to 
try to bring some validity to this process.
    I looked at these nine studies that you mentioned in your 
testimony. You are correct that all of them did adjust for age 
but there was a great variance in the other control factors, 
risk factors. Only two studies actually dealt with Vietnam 
veterans. One of them as I recall was Army chemical veterans; 
another was, I assume, Ranch Hand because it was Air Force. And 
I am struck by the fact that I do not know of any extensive 
study that actually has looked at Vietnam veterans as a whole. 
What you just said a minute ago about a study that was begun 
and then interrupted in the year 2000--are you aware of any 
other studies that have examined Vietnam veterans as a whole?
    Secretary Shinseki. I am not. This is the long-term study 
of Vietnam veterans that to my understanding, sometime around 
2000 or shortly thereafter, began to lose momentum. But we 
have, in an effort to answer some of the questions you have 
raised, recently reinitiated an effort to create that long-term 
look.
    Senator Webb. Right. I appreciate that there are questions 
about the half life of dioxin in the environment, which goes to 
one of the areas that Senator Sanders was sort of hinting at 
with respect to Vietnam but also from what I am hearing in 
terms of being able to trace the dioxin or other chemicals in 
one's blood. Wouldn't there be a way to still examine, say, 
tissue damage and these sorts of things where you could 
determine exposure among a control group? Doctor?
    Dr. Cassano. Senator, it is very attractive to look at that 
type of delineation but it is not possible. There are many 
different numbers out there regarding what the half life of 
TCDD is. Actually, it is very variable from individual to 
individual. When you look at actual tissue damage there is no 
way to really say that this damage was due to TCDD and this 
damage was due to smoking, for instance. There is no way to 
tease that out. Once a cell is damaged, it is damaged.
    Senator Webb. So one of the----
    Dr. Jesse. Senator----
    Senator Webb. I take your point. I am on a very short 
period of time here. Let me suggest something else because as 
Secretary Shinseki and I were discussing in the office, when we 
were first looking at this issue back in 1978, one of the 
discussions that we were having with committee staff on the 
House side with the Army Historical Center was to take veterans 
from specific units that we know had been in areas where dioxin 
had been sprayed and do a comparable study of them as opposed 
to other Vietnam veteran groups and non-veterans groups in the 
age group. I do not know if that is what they had begun and 
interrupted in 2000 or is that something you are thinking about 
doing?
    Secretary Shinseki. Fair question. I will get more into 
this and provide you a better answer of exactly what had 
transpired in that previous study. I think you and I are in 
agreement. We need for the long term an effort to create better 
data than what we are working with today. But it does not 
change the conditions today. We have veterans who are suffering 
from these diseases, and the presumption allows us to accept 
them into our programs for treatment.
  Response to Request Arising During the Hearing by Hon. Jim Webb to 
 Hon. Eric K. Shinseki, Secretary, U.S. Department of Veterans Affairs
    VA plans to pursue several avenues of inquiry to better understand 
what illnesses affect Veterans and to what extent these are related to 
their military service. By conducting detailed long term follow-up 
studies, we can understand specific impacts, as we are doing with 
Vietnam Veterans of the U.S. Army Chemical Corps. A study of Army 
Chemical Corps Veterans is under development. Part of the study will 
carefully review a sample of medical records to establish whether 
specific diagnoses were recorded by health care providers. In addition, 
this same group of Veterans will be asked to participate in physical 
exams to measure cardiovascular and respiratory health outcomes. 
Another approach that VA has taken, and continues to pursue, is the 
identification of a large group of Veterans known to have served in a 
conflict and a similar group of Veterans without the same deployment 
experience. The groups are surveyed to assess health and illness 
outcomes, health care utilization, and other indicators of well-being. 
A sample of 60,000 Veterans, half of whom returned from Afghanistan and 
Iraq, were enrolled in a health study that used survey methodology to 
learn about their health experience and concerns. Data collection for 
this study, The National Study of a New Generation of U.S. Veterans, 
was recently completed and preliminary results are expected in 2011. VA 
has also partnered with the CDC to collect information through broad 
based population surveys that will allow for better comparisons between 
the health outcomes of Veterans and general population groups.

    Senator Webb. I understand that. In that regard, when you 
are looking at disability compensation on this issue, has there 
been any discussion about these other risk factors as a 
component of evaluating one's disability? Or do you just 
measure the overall disability of the individual despite 
smoking or all the other conditions that were mentioned?
    Secretary Shinseki. At this point, Senator, I think Dr. 
Cassano's insights are helpful. It is difficult to tease the 
level of contribution of these various confounding factors. All 
we know is from the studies presented, scientific and medical 
evidence, that TCDD attacks the vasculature of animals. That is 
the biological mechanism, and it exists in this case. So we 
know there is a contribution here. What we cannot tease out is 
to what degree that contribution is more significant than 
others. I would venture to say that----
    Senator Webb. So you are basically just taking the medical 
condition at the time and assigning a disability rating to it?
    Secretary Shinseki. Assigning a disability to the 
conditions overall.
    Senator Webb. Right, overall, rather than breaking out one 
component having been TCDD.
    Secretary Shinseki. That is correct.
    Senator Webb. I would like to get an understanding of your 
motivations moving toward your decision based on the 2008 
report in this area. The 2006 report had stated that an 
association between herbicides and ischemic heart disease was 
unwarranted. The 2008 report concluded there was limited but 
suggestive evidence. Were there new studies that came into 
effect or what was the reason that the recommendation changed?
    Secretary Shinseki. Let me call on Dr. Jesse.
    Senator Webb. OK.
    Dr. Jesse. The 2006 report was split. They could not come 
to an agreement. There were two new studies between 2006 and 
2008 that drove that preponderance of association much stronger 
to the point that the committee then agreed to elevate it to 
the suggestive category. So there was new information.
    Senator Webb. Was there new research or new evaluation of 
old research?
    Dr. Jesse. No, it was new studies.
    Senator Webb. New research?
    Dr. Cassano. The 2008 Committee, Senator, looked at all of 
the available literature that was there for 2006, as well as 
2008. There were two additional studies, Ha and Consonni that 
were published after 2006 which we looked at. In addition, most 
of the animal studies on the toxicological data that was 
available was published after--most of it was published after 
the 2006 Committee had their deliberations. So when you look at 
all of the evidence for a positive association you have these 
consistent studies. You have animal experimentation. You have a 
known biological mechanism and a dose dependent response.
    Senator Webb. So between the two studies you are saying 
that there was actually new research that had been conducted. 
It was not simply an evaluation of old material?
    Dr. Cassano. Yes, sir.
    Senator Webb. OK. One final question. The clock is beating 
me here.
    Secretary Shinseki, do you believe that this authority 
should remain with the Secretary of Veterans Affairs to make 
these decisions or do you believe that it should be given to 
the Congress in the future?
    Secretary Shinseki. The last part of the question as 
whether it should be left to Congress?
    Senator Webb. The decisional authority as it now exists in 
the statute. Is that something that you believe should remain 
with the Secretary of Veterans Affairs or should it be a 
recommendation from the Secretary of Veterans Affairs to be 
made by the Congress in the same way as say cost of living or, 
you know, weapon systems in the Pentagon or whatever.
    Secretary Shinseki. Senator, I never presume to suggest to 
Congress how to do its work. I just would reply that it says 
Congress' intent in the 1991 law, if we understand the history 
that led up to it and then see what transpired--no presumptions 
to treat Vietnam veterans up until 1991 and then following 
1991, 12 presumptions; the last three being my decision of a 
year ago to bring it to 15. If the intent of Congress was to 
move from where we were and causation was not working, and we 
needed some other mechanism, I think the will of Congress was 
met. Congress achieved what it wanted.
    Now, we can discuss how to modify that process to include 
if Congress would like to retain to itself the decision 
authority on determining whether or not a presumption is 
warranted. It will require the kind of work that I have been 
through for the past nearly a year now. But, you know, I think 
in that 1991 legislation, besides being very prescriptive on 
what Congress expected the Secretary of Veterans Affairs to do, 
unstated in that legislation is any reference to cost. As I 
have been advised by general counsel, that was not oversight. 
That was clearly the intent of Congress that the Secretary's 
decision would be based on sound medical scientific evidence.
    What I also interpret from that is that Congress reserved 
to itself the decisional authority on whether, how, and when to 
pay for that decision. So I do think there is significant 
involvement on the part of Congress and oversight. If that 
needs to be adjusted, I am more than happy to have that 
discussion as we look for a better outcome. I would also add 
this, that Congress has decided to fund these three 
determinations through the appropriations process. So I think, 
again, Congress had an opportunity to review my decision and 
decide to do its part.
    Senator Webb. Well, with respect to funding, as you know, 
if a disability is service-connected, it will be funded. This 
is the United States of America. So, whether Congress would 
fund this or not was never really a question.
    Thank you, Mr. Chairman.
    Chairman Akaka. Thank you. Thank you, Senator Webb.
    Senator Tester.
    Senator Tester. Thank you, Mr. Chairman. Secretary 
Shinseki, I also want to thank you for being in my office last 
Tuesday to help me understand the process on presumptive 
disability decisionmaking. I think you have been very 
conscientious in making some, as is apparent today, some tough 
decisions.
    I, as well as everybody else I think in this room, stand 
firmly behind veterans getting the benefits that they have 
earned and that they deserve. I also believe it is important 
that the process for determining service connections prevents 
or limits at a minimum fraudulent claims from being made.
    In the meeting that we had on Tuesday, you mentioned the 
fact that claims for ischemic heart disease are rebuttable in 
certain cases. This is--I have been broached with several 
different questions since I have been sitting here and I want 
you to walk through, if you could, the kind of latitude that 
you envision the VBA has in determining ischemic heart disease 
and its--and who is responsible for what. Let me give you an 
example.
    You got somebody who pounds a couple of packs of cigarettes 
a day and a like amount of alcohol that comes to you with a 
problem. Is that rebuttable or is it a situation where--and 
they have the heart disease--is it a situation where you just 
say they are in. You cannot----
    Secretary Shinseki. Let me take the question on in two 
pieces. Let me just ask Dr. Jesse to talk about how we 
distinguish ischemic heart disease and----
    Senator Tester. Yes.
    Secretary Shinseki [continued]. All other asymptomatic. 
Then I will turn to Mr. Pamperin to talk about the benefits 
decision.
    Senator Tester. OK.
    Dr. Jesse. Thank you, sir. Ischemic heart disease is by 
definition where the heart does not get enough oxygen to meet 
its needs. Generally, that is symptomatic. People have chest 
pain or shortness of breath or lack of exercise activity, and 
that would essentially constitute the disability. We, as 
clinicians, we confirm that that shortness of breath, say, or 
chest pain is due to ischemic heart disease from a number of 
mechanisms--stress testing, necro imaging associated with 
stress testing, and some other methodologies, and/or the 
presence of having had a heart attack or having had a diagnosis 
of stable or unstable angina--would automatically meet the 
level of testing for that. If somebody came in and said I am 
having chest pain; well, a lot of things can cause chest pain 
if they have a normal stress test, and we determine this is not 
ischemic heart disease.
    Senator Tester. But cannot overuse of tobacco and alcohol 
create ischemic heart disease?
    Dr. Jesse. Well, they do not cause ischemic heart disease. 
The risk factors, particularly when you get multiple risk 
factors, can contribute to its progress.
    Senator Tester. OK. So let us back up. So if they served in 
Vietnam and they got it, regardless of their lifestyle, it is 
an Agent Orange problem?
    Dr. Jesse. Yes. Because we cannot parse that out perfectly.
    Senator Tester. You had somebody else who wanted to 
comment?
    Mr. Pamperin. Yes, sir. With respect to a rebuttal of 
presumption, again, the claims examiners in the regional 
offices are not making a medical opinion. If there is clear 
evidence in the file of risk factors for heart disease, when 
they request the examination it is appropriate for them to ask 
the clinician in light of this risk factor, this risk factor, 
and this risk factor, is it as likely as not that the veteran's 
current disability is due to herbicide exposure? We will then 
award benefits based upon what the clinician says.
    Senator Tester. All right. Based on what Dr. Jesse just 
said though, it would be very difficult for a doctor to say it 
is not herbicide exposure. Or is there some marker within a 
test that would indicate this is herbicide exposure?
    Mr. Pamperin. I do not believe so, sir.
    Senator Tester. OK. Secretary Shinseki----
    Secretary Shinseki. Senator, just to add----
    Senator Tester. Yes?
    Secretary Shinseki. At this point of the Vietnam veteran 
age group, age 60, because of the confounding aspects of age, 
lifestyle, and the exposure, it is difficult to parse out.
    Senator Tester. Yes.
    Secretary Shinseki. But we do know from the studies, those 
nine studies I referred to and that the IOM considered rigorous 
enough for us to give weight for them, six of the studies were 
strong and statistically significant in making the tie between 
herbicide exposure and ischemic heart disease. For Vietnam 
veterans, what this means is anywhere from 1.4 to 2.8 times the 
risk of others for developing this ischemic heart disease. So, 
we have to make this connection and say that the exposure 
occurred.
    Senator Tester. I understand, General. And I understand 
this is a very difficult topic. I also understand that there 
are a number of veterans out there that have tried to get 
through the door and could not for whatever reason--not on this 
issue but others. I know you have worked on it. Your 
predecessors worked on it to make sure that veterans are 
treated fairly. I think that is the whole point here. I think 
everybody that earned a benefit should get it, they should get 
it ASAP.
    I guess the question is as we try to limit potential fraud, 
is there a rebuttal process if somebody comes in that served in 
Vietnam--and maybe everybody was exposed to Agent Orange who 
served in Vietnam; I do not know that but it appears to me that 
if they come in with ischemic heart disease and they served in 
Vietnam, they are going to get it. Is that a fair statement?
    Secretary Shinseki. That is correct, absent a rebuttable 
condition. I am told that there is one individual who recently 
made a comment that he is receiving Agent Orange benefits, yet 
he only paused in the airport in Saigon for 8 hours. I do not 
know if this is true, but it is reported. I say that when 
someone self-identifies like this, we are going to go take a 
look. And if there is rebuttable----
    Senator Tester. OK. My time is long past. Thank you, Mr. 
Chairman, and thank you, General.
    Chairman Akaka. Thank you very much for this round. Are 
there any further questions for the Secretary?
    Senator Tester. I have one. It is a real quick one if he 
can do it. I did not ask it because I ran out of time.
    Chairman Akaka. Then ask it.
    Senator Tester. It deals with administrative costs. One 
estimate says presumptive eligibility for ischemic heart 
disease would cost about $1.6 billion over the next decade. 
Implementing Type 2 diabetes was about $250 million. Do you 
agree with those estimates?
    Secretary Shinseki. Senator, I think you are referring to a 
10-year cost estimate.
    Senator Tester. Yes.
    Secretary Shinseki. I am just reading the notes on the 
sheet and the note that applies to the ischemic heart disease 
administrative cost estimate of $1.6 billion. The note reads 
that multiply the total admin costs of $1,888,574 at 31 August 
2010, by 88 percent for IHD administrative costs. I think we 
have got a calculation error here. I do not know how 88 percent 
of one million becomes one billion.
    Senator Tester. 1.6 billion.
    Secretary Shinseki. I think we----
    Senator Tester. Well, I would just say that if these 
figures are correct, as I would expect, I believe you would do 
your best to try to reduce that administrative overhead to get 
those benefits for the soldiers.
    Secretary Shinseki. Absolutely.
    Senator Tester. Thank you. Thank you, Mr. Chairman.
    Chairman Akaka. Thank you very much, Senator Tester.
    Mr. Secretary, I really appreciate your being here today 
and this panel as well. I believe there is much value added 
through transparent discourse. I will have follow-up questions 
for you that will be included in the record. I want to thank 
this panel very much for your responses. Thank you.
    Secretary Shinseki. Thank you, Mr. Chairman.
    Chairman Akaka. Now I welcome the second panel.
    Our first witness is former VA Secretary Anthony Principi, 
who served as the head of the Department from 2001 to 2005. He 
is the one who will focus on the challenges he faced with the 
presumption process and the primary factors that influenced his 
decision to establish a presumption for Type 2 diabetes. Mr. 
Principi is also a former staff director of this Committee.
    I understand Mr. Principi that you will need to leave soon 
for a flight. There may be questions that will be sent to you 
for the record.

 STATEMENT OF HON. ANTHONY J. PRINCIPI, FORMER SECRETARY, U.S. 
                 DEPARTMENT OF VETERANS AFFAIRS

    Mr. Principi. Thank you, Mr. Chairman. I certainly will try 
to stay as long as possible. I do regret I have a flight out 
west to give a speech this evening, but I certainly will stay 
as long as I can.
    Mr. Chairman, Members of the Committee, thank you for 
allowing me to submit my written testimony for the record. I am 
pleased to testify this morning on an issue of great importance 
to our Nation's veterans, their families, and to the American 
people. We know that neither individual veterans, nor the VA, 
can show that an individual veteran's post-service illness is 
or is not the result of in-service exposure to a harmful 
substance. That is why the Congress established a process for 
determining presumptive service connection and that is why I 
endorse the concept of presumptive service connection.
    In the real world, the Secretary of Veterans Affairs must 
decide, based on imperfect knowledge and substantial 
uncertainty, whether or not to presumptively service-connect a 
disease and to do so within 60 days after receiving the IOM 
report. The 1991 decision of Congress to have the Institute of 
Medicine review this scientific literature and report its 
findings casts some light into the starkness of unprovability. 
The state-of-the-art is such that decisions must still be made 
despite ambiguity and uncertainty. My decision to establish a 
presumptive service connection for Vietnam veterans with Type 2 
diabetes illustrates the point.
    While IOM's report pointed out significant uncertainties 
and possible confounding factors, other risk factors with Type 
2 diabetes, IOM's findings on the relationship of herbicide 
exposure and Type 2 diabetes reported positive associations in 
most of the morbidity studies they evaluated. These included 
the Air Force Ranch Hand study, a National Institute of 
Occupational Safety and Health of U.S. Chemical Workers, and 
studies of male and female veterans from Australia. Only the 
survey of female Australian veterans did not show a positive 
association. Five self-reported cases of diabetes were found 
when 10 were expected. However, the study of male Australian 
Vietnam veterans found 2,391 cases reported when only 1,780 
were expected.
    So at the time I believed that only one small dataset kept 
IOM from declaring a positive association instead of a limited 
or suggestive one between Type 2 diabetes and exposure to Agent 
Orange. I also considered the recommendation of my Under 
Secretary for Health, whose staff thoroughly reviewed the 
entire report and recommended a presumption. Finally, my belief 
that America's veterans earned the benefit of the doubt led me 
to decide in favor of presumptively service-connecting Type 2 
diabetes.
    I was very aware that the American people were watching my 
decision closely, both to ensure that I would treat those who 
defended our Nation fairly and to ensure that I was a good 
steward of the resources entrusted to me. This was a very, very 
difficult decision and one I labored over, and even at one 
point called in an IOM representative to see if I could get 
more definitive information and help make a better decision. 
Because I believe if the American people lose faith in the 
integrity of the VA's disability compensation system--and that 
is not just about cost--veterans and their families will most 
certainly suffer. And the surest way for that to happen is for 
the American people to believe that large numbers of veterans 
are being compensated for illnesses that may not be the result 
of their military service. I think that is the crux of the 
issue we are all grappling with, how to make the right 
decision.
    A herbicide-based presumption for a Vietnam veteran rests 
on the foundation of three degrees of possibility. First, the 
possibility that the veteran was exposed to dangerous 
herbicides; second, the possibility that such exposure leads in 
at least some cases to illness; and third, the possibility that 
the individual veteran's illness was caused by that exposure. 
Presumptions are premised on the transformation of those three 
possibilities into certainties, and that transformation has 
significant consequences for veterans and for the American 
people. It is unquestionably a very difficult question.
    I have a few suggestions I believe will reduce the 
uncertainty surrounding these decisions and improve the 
process. Senator Murray asked Senator Shinseki about them and 
he responded accordingly. The first is about new studies. 
Medicine and medical research have made tremendous strides in 
the 20 years since the Agent Orange Act of 1991 was enacted. At 
the time the 1991 Act was enacted we were dealing with rare 
diseases--non-Hodgkin's lymphoma and soft tissue sarcoma. Today 
we are dealing with diseases of ordinary life. Do new studies 
now exist or could they be commissioned that might improve our 
ability to base future presumptive service connection decisions 
on stronger scientific evidence? Perhaps we could consider 
replicating the Center for Disease Control's Vietnam Experience 
Study of the 1990s.
    Second, I would suggest that Congress or the Secretary of 
Veterans Affairs direct IOM to provide VA with an estimate of a 
latency period for the illness. That is a point after which it 
is no longer likely that the illness onset is a result of 
exposure but rather of other factors. This has been done twice 
in the past to my knowledge. Certainly, a presumptive service 
connection for peripheral, I am sure I know the name of the 
disease, has to be manifested within 1 year of exposure to 
herbicides. I believe in 1994 the Institute of Medicine 
indicated that respiratory cancer could last a couple of 
decades after exposure.
    So, for example, there are certain diseases that are 
prevalent in older people and not in younger ones. Is it a 
better policy to establish a presumptive service connection for 
veterans who develop those diseases for a period of time after 
disservice, whether that is 10 years, 20 years, or 50 years, 
depending upon what science might conclude.
    Then third, I believe that IOM should be asked to estimate 
the additional number of Vietnam veterans who might be affected 
by an illness as a result of herbicide exposure. In other 
words, if 100,000 veterans and an age cohort of Vietnam 
veterans could be expected in the normal course of life to 
develop a disease, approximately how many more veterans would 
develop that disease as a result of their exposure to 
herbicides? If the number is very small, then perhaps other 
steps can be taken to ensure that they receive proper medical 
care--all 100,000 or whatever that number might be--and to hold 
off on disability compensation until there is further evidence 
that takes it out of the limited suggestive category and puts 
it into the positive association category.
    Mr. Chairman, in conclusion I am very proud of the role I 
played in my career of service to veterans. I make no apology 
for ensuring Vietnam veterans receive the benefits they earn, 
including diabetes. They earn those benefits in response to our 
Nation's gratitude in the heat of battle during a very long, 
difficult, and unpopular war. But I am also aware that the 
American people are the source of those benefits and I believe 
all Americans are entitled to know that the veterans' benefits 
are rooted in sound science. VA's benefit system must be beyond 
reproach and decisions must be based on the best facts 
available. I hope you and the VA will consider my suggestions 
to help us make better informed decisions.
    Thank you for this opportunity to testify, Mr. Chairman and 
Members of the Committee.
    [The prepared statement of Mr. Principi follows:]
   Prepared Statement of Hon. Anthony J. Principi, Former Secretary, 
                  U.S. Department of Veterans Affairs
    Mr. Chairman and Members of the Committee, good morning. Thank you 
for this opportunity to testify on decisions to presumptively service 
connect diseases related to the use of herbicides (dioxin in Agent 
Orange) in Vietnam.
    This is not a new question. The Congress held its first hearing 
related to the possible effects of herbicide exposure in Vietnam on 
April 7 and 15, 1970--forty years ago. The most contentious issue has 
long been the criteria for providing service connections for veterans 
for health problems that might have resulted from their presumed 
exposure to herbicides.
    In 1984, the Congress provided Vietnam veterans with automatic 
disability benefits for chlorachne and porphyria cutanea tarda. 
Congress also directed VA to establish the Veterans Advisory Committee 
on Environmental Hazards, and asked VA to determine new standards for 
evaluating disability claims based on herbicide exposure.
    At the time, Mr. Chairman, I was on the staff of this Committee, 
and I was very proud to have been part of this important step forward 
for my fellow Vietnam veterans.
    When I became Deputy Secretary for Veterans Affairs in 1989, I took 
up this issue from ``the other side,'' as it were--working closely with 
this Committee to create the landmark legislation that became Public 
Law 102-4: the Agent Orange Act of 1991. The provisions of that Act 
have served our Nation well for twenty years, but I believe it is time 
to look at some of the Act's unintended consequences--and to make a few 
changes that will allow the Act to remain useful in the future.
    In Pub. L. 102-4, Congress permanently granted presumptive service 
connection for chlorachne, non-Hodgkin's lymphoma, and soft-tissue 
sarcoma: all diseases associated with exposure to dioxin in Agent 
Orange. The law also transferred the responsibility of reviewing 
scientific literature on the association between herbicide exposure and 
health outcomes suspected to be associated with that exposure from the 
Advisory Committee on Environmental Hazards to the National Academy of 
Sciences. Congress left the ultimate decision to presumptively service 
connect additional diseases in the hands of the Secretary of Veterans 
Affairs.
    In response, VA developed a policy that if a positive association 
exists between the exposure of humans to a herbicide agent and the 
occurrence of a disease in humans, the Secretary would, by regulation, 
establish a presumption of service connection for that disease.
    In theory, this is an even-handed, fair, and scientifically based 
method of making decisions on which illnesses should be presumptively 
service-connected. As a former Secretary of Veterans Affairs, however, 
I can tell you that such decisions are much more difficult than they 
would seem.
    First of all, it has always been difficult, if not impossible, to 
determine the level of exposure to herbicides, if any, experienced by 
troops in Vietnam. While some of the evidence reviewed by IOM comes 
from evaluations of Air Force and Army troops who worked with 
herbicides, most of the documentation they use is from studies of 
people who were exposed to herbicides in civilian life or in industrial 
accidents.
    It is also true that while levels of herbicide contaminants can 
still be detected in the blood of Vietnam veterans, those levels vary. 
All Americans are exposed to herbicides in their daily lives, and there 
is no way to tell where or when any individual with dioxin in his or 
her blood was exposed to the chemical
    IOM has soldiered on, however. Their biennial reports evaluate 
illnesses to determine whether an association with herbicide exposure 
exists, and whether there is a plausible biologic mechanism or other 
evidence of a causal relationship between herbicide exposure and the 
disease.
    They categorize their findings in four ways: illnesses that have 
sufficient evidence of an association with herbicide exposure; 
illnesses that have limited or suggestive evidence of an association; 
illnesses with limited or suggestive evidence of no association; and 
illnesses with inadequate or insufficient evidence to determine whether 
an association exists.
    Cases in which IOM believes sufficient evidence of an association 
exists, or in which they do not believe such evidence exists, are easy 
to decide. Where we can say for certain, with scientific evidence, that 
there is a direct link between a veteran's service and illness, it is 
clear that veterans should be service-connected for that illness. On 
battlefields, not all injuries are caused by shrapnel and bullets.
    But those illnesses in which IOM has found only limited or 
suggestive evidence of an association are much more difficult to 
decide. Today, fourteen diseases are presumed to be connected to 
exposure to herbicide use in Vietnam. Some are rare; others, like 
diabetes, prostate and lung cancer, and leukemia, are much more common.
    In making this kind of decision, we are taking degrees of 
possibility; the possibility that veterans were exposed to dangerous 
herbicides; the possibility that such exposure might lead to illness; 
and the possibility that the illness in any individual veteran was 
caused by that exposure--and turning them into certainties with 
significant consequences for veterans and the American people. It is, 
unquestionably, a difficult process.
    My decision to establish a presumptive service-connection for 
Vietnam veterans with type II diabetes illustrates this point. While 
IOM's report pointed out significant uncertainties and possible 
confounding factors, IOM's findings on the relationship of herbicide 
(dioxin) exposure and type II diabetes reported positive associations 
in most of the morbidity studies they evaluated.
    These included the Air Force's Ranch Hand study; a National 
Institute for Occupational Safety and Health study of U.S. Chemical 
Workers; and studies of male and female veterans from Australia. Only 
the survey of female Australian veterans did not show a positive 
association: 5 self-reported cases of diabetes were found while 10 were 
expected. However, the study of male Australian Vietnam veterans did 
find a statistically significant excess of self-reported diabetes 
(2,391 cases were reported when 1,780 were expected.)
    To me, this was an indication that only one data set kept IOM from 
declaring a ``positive association'' instead of a ``limited/
suggestive'' one between Type II diabetes and exposure to Agent Orange. 
In addition, I received a report from the Under Secretary for Health, 
whose staff thoroughly reviewed the entire report from a scientific 
viewpoint. The recommendation was to presumptively service connect for 
diabetes. And finally, my belief that America's veterans have earned 
the benefit of any doubt led me to decide in favor of presumptively 
service connecting type II diabetes for Vietnam veterans.
    Make no mistake: these decisions do not merely affect those who may 
or may not receive presumptive service connections and their families. 
The American people watch these decisions closely, both to ensure that 
those who have defended our Nation while in uniform are treated fairly, 
and to ensure that those who have been given the responsibility to 
administer the program are good stewards of the resources with which 
they have been entrusted. If the American people lose faith in the 
integrity of our disability benefits system, veterans and their 
families will be the ones who will suffer. The surest way for that to 
happen is for the public to be convinced that presumptive service 
connection decisions are based on anything other than sound scientific 
advice.
    Accordingly, I have three suggestions I believe will improve the 
process. First, medicine and medical research have made tremendous 
strides in the twenty years since the Agent Orange Act of 1991 was 
enacted. In those twenty years, has anyone found a better way to 
measure dioxin levels in blood for Vietnam veterans and a control 
group? Is there now a way to differentiate between those servicemembers 
who received repeated and prolonged exposure to dioxin in Vietnam and 
those whose exposure was brief or nonexistent? And are there new 
studies that now exist, or can be commissioned, that might improve our 
ability to base future presumptive service connection decisions on 
strong scientific evidence? One such study might be a replication of 
the Centers for Disease Control's Vietnam Experience Study of the 
1980s. IOM, or some other scientific organization, should look into 
these issues and report back to VA and Congress.
    Second, I would suggest that Congress, or the Secretary of Veterans 
Affairs, direct the IOM to provide VA with an estimate of a latency 
period for the illness; that is, a point after which it is no longer 
likely that the illness' onset is a result of exposure, but rather of 
other factors. For example, heart disease is prevalent in older people 
and not in younger ones. It may be that the best policy here is to 
establish a presumptive service connection for veterans who develop 
that disease for a fixed post-service period of time, but not the rest 
of their lives.
    This has already been done twice: first, presumptive service 
connection for peripheral neuropathy was limited to those cases that 
manifested themselves within one year of herbicide exposure; and 
second, IOM in 2004 decided that the effects of herbicides on 
respiratory cancer ``could last many decades.'' IOM's best estimate for 
each new disease, and perhaps a review of previous decisions, would be 
helpful for the public record and to any Secretary in his or her 
decisionmaking.
    And third, IOM should be asked to estimate the number of Vietnam 
veterans who might be affected by an illness with limited or suggestive 
linkage to herbicide exposure. In other words, if 100,000 veterans in 
the age cohort of Vietnam veterans could be expected to develop a 
disease, approximately how many more veterans will develop that disease 
as a result of exposure to herbicides. Secretaries must weigh that 
information too before making a final decision on presumptive service 
connection.
    Mr. Chairman, I am proud of the role I played during my long career 
of service in getting my fellow Vietnam veterans the benefits they have 
earned for their service and sacrifices on behalf of our Nation. The 
benefits Vietnam veterans now have were earned in the heat of battle 
during a difficult and often unpopular war. But I am also aware that 
the American public is the source of those benefits, and I believe all 
Americans are entitled to know veteran benefits are rooted in the 
reality of science and good public policy.
    I hope that you, and VA, will consider my suggestions to help us 
make better and more informed decisions of this nature in the future.

    Thank you again for this opportunity to testify. I look forward to 
your questions.
                                 ______
                                 
 Response to Pre-Hearing Questions Submitted by Hon. Jim Webb to Hon. 
  Anthony J. Principi, Former Secretary, U.S. Department of Veterans 
                                Affairs
    Question 1. Please describe the process in place when you were 
Secretary for reviewing the scientific evidence provided by IOM and 
other sources to determine whether to establish a presumption for type 
II diabetes. How did VA translate IOM's categorization of ``limited/
suggestive'' evidence of an association into meeting the legal standard 
of a ``positive association'' standard for establishing a presumption? 
What sources, other than the specially commissioned IOM report on 
diabetes, did VA review in making its presumption determination for 
type II diabetes?
    Response. IOM's study stated that ``positive associations are 
reported in most of the (type II diabetes) morbidity studies'' they 
identified, including the Air Force's Ranch Hand study; a National 
Institute for Occupational Safety and Health study of U.S. Chemical 
Workers; and studies of male and female veterans from Australia. Only 
the survey of female Australian veterans did not show a positive 
association: 5 self-reported cases of diabetes were found while 10 were 
expected. However, the study of male Australian Vietnam veterans did 
find a statistically significant excess of self-reported diabetes 
(2,391 cases were reported when 1,780 were expected.)
    To me, this was a clear indication that only one small data set 
kept IOM from declaring a ``positive association'' instead of a 
``limited/suggestive'' one between Type II diabetes and exposure to 
Agent Orange. Still, I was concerned by the uncertain findings, and I 
met personally with an IOM representative to discuss their report 
before making a decision. I left that meeting with great uncertainty 
that IOM had developed the kind of strong scientific evidence I 
believed I needed to make a significant policy decision, as their 
recommendations were almost entirely based on literature reviews of 
those morbidity studies. However, their findings, a recommendation from 
the Under Secretary for Health, whose staff thoroughly reviewed the 
entire report from a scientific viewpoint, and my lifelong belief that 
America's veterans have earned the benefit of any doubt, led me to 
decide in favor of presumptively service connecting type II diabetes 
for Vietnam veterans.

    Question 2. Please describe the challenges that you faced and the 
primary factors that influenced your decision to establish a 
presumption for type II diabetes.
    Response. The challenges I faced in the Type II diabetes decision 
were significant, and the decision I made came only after significant 
deliberation. Before I made the decision to presumptively service-
connect type II diabetes, I called in an IOM representative to my 
office. I spoke with him at length about their work and the methodology 
behind it. I came away with the realization that I would have to make 
an extremely consequential decision with profound implications for 
individual veterans and the Nation as a whole with great uncertainty.
    Because IOM's study came very close to declaring a positive 
association between Agent Orange exposure and Type II diabetes; because 
I believe strongly that on modern battlefields, not all injuries are 
caused by bullets and shrapnel; and because I believe that veterans, 
through their honorable service to our Nation, have earned the benefit 
of any doubt, I accepted the recommendation of my Under Secretary for 
Health that type II diabetes should be presumptively service-connected.

    Question 3. Please describe any benefits you believe could be 
gained from the recommendation made by the IOM's Committee on 
Evaluation of the Presumptive Disability Decision-Making Process for 
Veterans that Congress create a formal Advisory Committee and a Science 
Review Board to advise and assist the Secretary with reviewing 
scientific research and considering conditions for presumptions.
    Response. I am not convinced that additional layers of review will 
improve the decisionmaking process. What will improve the process is 
better information. I would like to know, from IOM or some other 
scientific source, whether or not there is now a better way to measure 
dioxin levels in blood, and their source, than there was twenty years 
ago. I would also ask IOM, in any future study, to estimate a latency 
period for illnesses in which they have found a limited or suggestive 
linkage with dioxin: that is, a point after which it is no longer 
likely that the onset of the illness is a result of Agent Orange 
exposure. We might consider replicating the Centers for Disease 
Control's Vietnam Experience study of the 1980s. And finally, where IOM 
has found a limited or suggestive linkage, I would like them to 
estimate for me the number of Vietnam veterans who might have developed 
the illness as a result of their exposure, compared to the total number 
of Vietnam veterans who might be expected to develop that illness.
    With that information, it would be easier to make a decision that 
takes into account all facets of the issue, and additional levels of 
oversight would be less necessary.

    Question 4. Please describe the challenges that common diseases of 
aging or other highly prevalent risk factors generated for you in your 
attempt to make a presumption decision based on sound medical and 
scientific evidence, and whether these challenges are adequately 
addressed by the language in the Agent Orange Act of 1991.
    Response. These are significant challenges, especially as they 
relate to illnesses with limited but suggestive evidence of linkage to 
Agent Orange exposure. The decision to presumptively service connect an 
illness is a long-term decision, obligating our Nation to veterans, 
their families and descendants for many years, even centuries, to come. 
The American people watch these decisions closely, both to ensure that 
those who defended our Nation while in uniform are treated fairly, and 
to ensure that those who have been given the responsibility to 
administer the program are good stewards of the resources with which 
they have been entrusted.
    If the American people lose faith in the integrity of our 
disability system, veterans and their families will suffer. The surest 
way for that to happen is for the public to be convinced that 
presumptive service connection decisions are based on anything other 
than sound scientific advice. Based on my discussions with IOM I was 
quite concerned that I was about to make an extremely consequential 
decision with profound implication for veterans and the Nation with 
great uncertainty. The language of the 1991 Act, in my opinion, did not 
fully anticipate this problem.

    Question 5. Do you believe that the Secretary is able to determine, 
on the basis of sound medical and scientific evidence, whether a 
positive association exists between exposure to an herbicide and the 
occurrence of a disease that is common to aging or results from other 
highly prevalent risk factors?
    Response. No Secretary is able to make such a determination; 
however, the law does not ask Secretaries to determine whether or not 
positive associations exist. That is IOM's responsibility. Secretaries 
are required to act on IOM's findings to make public policy decisions 
based on those findings, and that is an appropriate division of 
responsibilities.

    Question 6. Do you believe that the presumption process is the 
appropriate mechanism to address gaps in exposure and association for 
diseases common to aging or other highly prevalent risk factors?
    Response. VA's disability compensation system is the manner in 
which Americans compensate our veterans for injuries or diseases that 
happen while on active duty, or are made worse by active military 
service. I supported the concept of presumptive service-connection 
because I believe strongly that on the modern battlefield, not all 
injuries are caused by shrapnel and bullets; and that veterans must be 
compensated for those injuries they incur while on active duty. In 
addition, the burden of providing a nexus between exposure and disease 
cannot be placed on individual veterans. Implementation of the process, 
however, has to take into account all factors relating to the veteran 
and his or her overall health, including the length of time the veteran 
is removed from active service.
    It should be noted, however, that we are taking degrees of 
possibility: the possibility that veterans were exposed to dangerous 
herbicides; the possibility that such exposure might lead to illness; 
and the possibility that the illness in any individual veteran was 
caused by that exposure--and turning them into certainties with 
significant consequences for veterans and the American people. It is, 
unquestionably, a difficult process. While I personally do not know of 
a better way to address illnesses incurred as a result of environmental 
factors, I would be open to reviewing others' suggestions.

    Question 7. In your view, what is the value of science in the 
process for evaluating the merits of a presumption for a disease that 
is common in an aging population or that is highly related to other 
prevalent risk factors? Is this a question more appropriately addressed 
by Congress or the Secretary?
    Response. The responsibility of reviewing scientific literature on 
the association between herbicide exposure in Vietnam and health 
outcomes suspected to be associated with that exposure has been in the 
hands of scientists since 1984: first the Advisory Committee on 
Environmental Hazards, and, since 1991, the National Academy of 
Sciences. The decisionmaking responsibility, however, is in the hands 
of the Secretary of Veterans Affairs. I believe this is an appropriate 
division of responsibility between scientists and Presidential 
appointees.
    However, I believe that Secretaries have a responsibility to ask 
for additional information when what scientists provide them is 
insufficient to make a sound, reasoned decision--and to override the 
recommendations of scientists without fear of criticism, especially 
when uncertainty levels are as high as they are in this issue. Science 
is an appropriate tool for political appointees, and Congress, to use 
as a public policy guide; but other factors come into play as well, and 
ultimate decisions will have to be made by those with a view of the 
entire picture, not only its scientific aspects.
                                 ______
                                 
Response to Post-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
Hon. Anthony J. Principi, Former Secretary, U.S. Department of Veterans 
                                Affairs
    Question 1. In response to a pre-hearing question on your 
establishment of the presumption for type 2 diabetes, you described 
your reliance on a study of male Australian Vietnam veterans among the 
studies examined by the IOM Update Committee as suggestive of an 
association between type 2 diabetes and dioxin exposure. You stated 
that ``[s]till, [you] were concerned by the uncertain findings, and 
[you] met personally with an IOM representative to discuss their report 
before making a decision. [You] left that meeting with great 
uncertainty that IOM had developed the kind of strong scientific 
evidence [you] believed [you] needed to make a significant policy 
decision * * *''
    I understand that this study conducted by the Australian Government 
examined the health effects of the Vietnam experience in general, 
rather than herbicide exposure.
    I admire the great effort you made to come to an informed decision. 
When you met with the representative from the IOM Committee to discuss 
your reservations about the uncertain findings, did that representative 
advise you that the Australian study upon which the IOM Committee 
relied for its determination of a suggestive association between type 2 
diabetes and dioxin exposure did not actually examine dioxin exposure, 
rather the study examined the health effects of the Vietnam experience 
in general? If not, do you believe that information would have been 
valuable for your decisionmaking?
    Response. Unfortunately, I do not remember many of the specifics of 
my meeting, and cannot say for certain whether I was informed that the 
Australian study examined the health effects of the Vietnam experience, 
not dioxin exposure. I am certain, however, that I would have found any 
information IOM could have provided me to be useful, as the entire 
purpose of my meeting was to learn more than I had already learned from 
reading their report before making my decision. I cannot say whether 
such information would have changed that decision in any way--but it 
would have been useful for me to have known more about the Australia 
study, if I did not know it at the time.

    Question 2. In your view, does IOM's reliance on the Australian 
study suggest value in examining the health effects of the Vietnam 
experience in general, in place of examining the health effects of 
herbicides used in Vietnam in the absence of sound exposure data? Do 
you believe that Vietnam cohort health studies might yield more 
reliable information about those Vietnam veterans who may be suffering 
adverse health effects from their service in Vietnam, than the current 
attempts to directly examine an association with herbicides in the 
absence of sound exposure data and controlled risk factors?
    Response. In my testimony to the Committee, I suggested that the 
Vietnam Experience Study, which was completed by the Centers for 
Disease Control in 1989, should be brought up to date in order to 
provide additional information to future decisionmakers. (The Vietnam 
Experience Study was a multidimensional assessment of the health of 
Vietnam veterans in the 1980's, compared to the health of non-Vietnam 
veterans who served in the same era.) I do not see, however, why a 
study of this data should be used in place of the current system or 
that the information it would provide would be more reliable than 
current data, as your question suggests. Instead, I think both sets of 
information would be valuable. The updated Vietnam Experience Study, in 
particular, would allow Secretaries of Veterans Affairs to better 
answer the questions I posed in my testimony about estimating latency 
periods for illnesses, and about estimating the number of veterans who 
might be affected by an illness with limited or suggestive linkage to 
herbicide exposure.

    Question 3. In response to a question from Senator Johanns with 
respect to identifying things you wish you could have had at your 
disposal to help your decisionmaking, you stated:

        ``Certainly, a more definitive recommendation from IOM. I felt 
        like I was getting conflicting data. On the one hand, honestly 
        telling me about all of the confounding factors--about diet, 
        about lifestyle, about heredity. And then on other hand, 
        pointing out that I had three studies that showed a positive 
        association, which really made it very difficult for a 
        Secretary to take all that information, absorb it, assimilate 
        it, and then come up with a decision. So I think better 
        information is needed, a more definitive recommendation from 
        the scientists, whether it's done by IOM, or a scientific 
        review board, to help the Secretary make the right decision, 
        especially as it relates to common diseases. It's a greater 
        challenge for Secretaries when you're dealing with diabetes, 
        prostate cancer--because we know if we live long enough we're 
        going to die of prostate cancer, as well as heart disease. 
        Those confounding factors really make it very, very difficult 
        for us. So I think better information would be very useful.''

    a. Would you characterize the challenge you faced when establishing 
the type 2 diabetes presumption as being how to interpret scientific 
findings that appeared credible but not entirely on point for 
addressing the unique policy matter before you?
    b. Do you envision the role of a scientific review board to extend 
beyond merely a scientific review of the evidence, but also to assist 
the Secretary with interpreting the scientific evidence within the 
context of the Secretary's policy decisionmaking, to ensure that any 
limitations of the scientific findings are given proper weight?
    c. Should such a scientific review board be independent from VA, as 
recommended by the IOM Committee that reviewed the presumptions 
process?
    Response. a. I am not certain that the problem with the scientific 
findings was that they were not entirely ``on point.'' IOM's reports 
were, and continue to be, accomplished fully in accordance with the 
expectations of Public Law 102-4 and VA policy. Rather, my problem with 
the reports were in the degrees of possibility that the reports leave 
unanswered: the possibility that veterans were exposed to dangerous 
herbicides; the possibility that such exposure might lead to illness; 
and the possibility that the illness in any individual veteran was 
caused by that exposure. Decision makers are required to turn these 
possibilities into certainties with significant consequences for 
veterans and for all Americans. In my opinion, they are required to do 
so without sufficient information.
    b. Should a scientific review board be established, I would expect 
it to do more than just review the evidence IOM presents--VA's Under 
Secretary for Health can accomplish that task and has historically done 
so. I would hope that a board would suggest to the Secretary any 
additional areas where possible evidence may be found that IOM did not 
consider, and synopsize the information to be found; that the board 
would provide its thoughts and estimates on possible latency periods 
based on any information it believes to be relevant; and that the board 
would also provide its thoughts and estimates on the number of veterans 
whose illnesses might be attributed to herbicide exposure as opposed to 
aging for the illness under review.
    c. As long as the Secretary remains the final decisionmaker, I 
would have no problem if any scientific review board that is 
established were independent from VA in its deliberative processes.

    Question 4. During the hearing, you described the uncertainties of 
the presumption process for conditions that IOM has found to have only 
limited or suggestive evidence of an association with herbicide 
exposure in the following manner:

        ``The herbicide-based presumption for a Vietnam veteran rests 
        on the foundation of three degrees of possibility:

           First, the possibility that the veteran was exposed 
        to dangerous herbicides;
           Second, the possibility that such exposure leads, in 
        at least some cases, to illness; and
           Third, the possibility that the individual veteran's 
        illness was caused by that exposure.

        Presumptions are premised on the transformation of those three 
        possibilities into certainties. And that transformation has 
        significant consequences for veterans and the American people. 
        It is an unquestionably a very difficult question.''

    You then provided the following three suggestions for improving the 
process:

           Commission studies that might differentiate between 
        servicemembers who received significant exposure to dioxin in 
        Vietnam and those whose exposure was insignificant or 
        nonexistent in order to base presumptive service connection 
        decisions on stronger scientific evidence. You suggested that 
        such studies might replicate the Centers for Disease Control's 
        Vietnam Experience Study.
           Commission IOM to provide VA with an estimate of a 
        latency period for illness; that is, a point after which it is 
        no longer likely that the illness' onset is a result of 
        exposure, but rather other factors.
           Commission IOM to estimate the number of Vietnam 
        veterans who might be affected by an illness found by IOM to 
        have only limited or suggestive evidence of an association with 
        herbicide exposure.

    a. Would a Vietnam veteran health study, such as the CDC's Vietnam 
Experience Study, address some or all of the three degrees of 
possibilities you described? Do you envision such a study or studies 
being ongoing throughout a veteran's lifetime?
    b. What role would a scientific review board play in assisting the 
Secretary and implementing the suggestions you have offered?
    Response. a. I believe a Vietnam Veterans Health study would help 
improve our ability to determine latency periods for individual 
illnesses, and to make more realistic assessments of whether an 
individual veteran's illness was caused by exposure to herbicides. 
Better knowledge of the overall health of Vietnam veterans in 
comparison to a control group, and to the study done twenty years ago 
(which used Vietnam-era veterans who had not served in Vietnam as a 
control) would give us improved information on the latency periods for 
illnesses. This would be true both for illnesses that only appear after 
many years have passed, and those that disappear with time, depending 
on whether the difference in percentages of Vietnam veterans 
contracting an illness compared to non-Vietnam veterans has increased, 
decreased, or remained the same over time.
    The percentage of any observed increases would also offer us 
additional data to help determine whether individual illnesses were 
more likely to be caused by exposure to herbicides or by aging. If the 
number of Vietnam veterans who become ill from a disease was 
significantly larger than that for those who did not serve in-country, 
we would have an indication that a significant number of veterans with 
the disease contracted it as a result of their Vietnam service. If 
there was little difference between Vietnam veterans and the control 
group, we would be much more likely to conclude that there was little, 
if any, association between the illness and Vietnam service.
    It should be understood however, that in a cohort study such as 
this, results are expressed at a 95% level of confidence. Such a study 
is likely to find false positives. Given the 95% confidence level, 
about 5% of the positive correlations should be incorrect, and 
therefore any positive correlations the study uncovers should be 
considered as a basis for further studies such as IOM's, but not as 
proof that a correlation--or the lack of a correlation--exists for any 
illness. In addition, statisticians are aware that correlation does not 
imply causation, which means that any correlations that are uncovered 
will not automatically imply that one causes the other. Other sound 
studies will therefore always be needed for a Secretary to be confident 
in his or her decisionmaking.
    Although this information will not provide decisionmakers with 
certainty, it should significantly improve a Secretary's ability to 
estimate the effects of Vietnam service on individual illnesses. I 
would envision that these studies should be repeated every ten years 
for the next two or three decades if resources are available.
    b. The scientific review board I envision would use the Vietnam 
Experience studies and any other data they think relevant to help the 
Secretary better quantify the possibilities I listed in my testimony 
for illnesses which IOM believes may be linked to herbicide exposure. 
Their review, along with IOM's original report and the review of VA's 
Under Secretary for Health, would be part of the Secretary's 
decisionmaking process and would assist Congress in their oversight 
responsibilities.

    Chairman Akaka. Thank you very much, Mr. Principi. And 
thank you for your suggestions.
    One question before you leave and then I will continue with 
the rest of the panel. Mr. Principi, you have suggested that 
the language of the Agent Orange Act did not fully anticipate 
the challenge of determining presumptions based on limited or 
suggestive evidence with respect to diabetes. Did you believe 
that it was clear under the law how you were to weigh evidence 
that was suggestive in association but where there were 
uncontrolled risk factors?
    Mr. Principi. Mr. Chairman, that was clearly the most 
difficult part of the decision I had to make, whether the 
evidence was clear. Again, I felt, based upon the fact that 
three of the four studies that I reviewed that IOM submitted to 
me showed a positive association and my Under Secretary's 
recommendation. Then, of course, balancing the evidence for and 
against and the fact that it was relatively close, I erred on 
the side of giving the benefit of the doubt to the veteran.
    But clearly, I think we need to look at the '91 Act. We 
need to make whatever changes are appropriate. Certainly, the 
60-day time limit that Secretary Shinseki also eluded to is too 
short a period of time. So it does, indeed, create certain 
difficulties for us.
    Chairman Akaka. Let me ask the other senators whether they 
have specific questions for Mr. Principi.
    Senator Johanns. I will just ask one.
    Chairman Akaka. Senator Johanns.
    Senator Johanns [continued]. That I hope will be just a 
brief question, which I think you have answered in part. 
Looking back on those days when you were going through the 
decisionmaking process, if you could identify one, two, three 
things that you wish you would have had at your disposal--
because I can see even today you agonized over this. And I 
understand why. It is a tough call. What would those one, two, 
or three things be?
    Mr. Principi. Well, certainly a more definitive 
recommendation from IOM. I felt that I was getting conflicting 
data on the one hand, honestly telling me about all of the 
confounding factors about diet, about lifestyle, about 
heredity. Then on the other hand pointing out that I had three 
studies that showed a positive association really made it very 
difficult for a secretary to take all of that information, 
absorb it, assimilate it, and then come up with a decision. So 
I think better information is needed. A more definitive 
recommendation, if you will, from the scientists, whether it is 
done by IOM or a scientific review board to help the Secretary 
make the right decision, especially as it relates to common 
diseases. I think that is where--it is a greater challenge for 
secretaries when you are dealing with the diabetes, the 
prostate cancer, because we know if we live long enough we are 
going to die of prostate cancer, as well as heart disease. 
Those confounding factors really make it very, very difficult 
for us. So I think better information would be very useful.
    Senator Johanns. Under the law that you had to work with 
there is this 60-day limit. Do you have the option as secretary 
to say, gosh, the information is so conflicting. I want to hold 
this open for a year or I want to hold it open for 6 months? Or 
do you just simply have to yes or no at the end of that period?
    Mr. Principi. Well, you certainly--good question, Senator--
we try to adhere to the law. I know veterans are very anxious 
to get a decision. You know, if you delay the decision there is 
no penalty, so to speak, but you always try to be responsive to 
the dictates of the Congress. It should clearly be longer, 
perhaps no time limit. It should be up to the secretary to make 
a decision based upon the IOM report. He may have to go back or 
she may have to go back to IOM to get further information. I 
think it should be a little more open-ended.
    Senator Johanns. That is helpful. Thank you.
    Chairman Akaka. Senator Webb.
    Senator Webb. Thank you, Mr. Chairman. I would like first 
of all to thank Secretary Principi for coming to this hearing 
and for the perspectives that he brings to this issue because 
like myself, you know, Tony, you started as a staff person 
struggling to come up with answers on this issue well before 
you became a member of the Executive Branch, and you and I both 
know how well intentioned the members were all through this 
process. We have heard some comments about the inattentiveness, 
people being inattentive to the struggles of the people who 
served in Vietnam. I never found that. It is just an incredibly 
hard issue when we have, as you said in your testimony, when we 
are putting together a series of unknowns to try to come up 
with a legislative known.
    There are two portions of your testimony that I hope 
everyone will pay attention to, particularly, those people who 
are working in the area of veterans' law. The first is when you 
said if the American people lose faith in the integrity of our 
disability benefits system, veterans and their families will be 
the ones that will suffer. There is no truer statement. We must 
maintain the integrity of our compensation system, even given 
these unknowns.
    The other thing that I would like to say is I think you 
have given three really constructive forward-looking 
recommendations here, and I, for one, am going to take those 
and see if we cannot come up with a way to better deal with 
this issue. There is nothing wrong with trying to make laws 
better. So, the recommendation that you have, given your 
experiences here and over in the VA, I think are really going 
to help us do that. I appreciate you coming today.
    Mr. Principi. Thank you, Senator Webb. Thank you, Mr. 
Chairman and Senator Johanns. I apologize again for an early 
departure, and I certainly apologize to my fellow panel 
members. I look forward to learning more about their testimony 
and hopefully working with this Committee to find a good 
solution that protects our Nation's veterans and, of course, 
preserves the integrity of the system. I think that is very, 
very important. Thank you very much, Sir.
    Chairman Akaka. Thank you very much for your presence and 
your responses. Without question it is going to be helpful to 
us as we try to improve the legislation. Thank you.
    Our next witness is Jonathan Samet, Chair of IOM's 
Committee on Evaluation of the Presumptive Disability Decision-
Making Process for Veterans. He is here today to share insights 
on what his committee has learned from evaluating the process 
that yielded the presumptions for prostate cancer and Type 2 
diabetes. I also intend to seek his views on how we might apply 
those lessons for current decisionmaking, such as a presumption 
for IHD.
    So will you please proceed with your statement?

STATEMENT OF JONATHAN M. SAMET, M.D., M.S., CHAIR, COMMITTEE ON 
   EVALUATION OF THE PRESUMPTIVE DISABILITY DECISION-MAKING 
  PROCESS FOR VETERANS, INSTITUTE OF MEDICINE OF THE NATIONAL 
                           ACADEMIES

    Dr. Samet. Thank you, Mr. Chairman, Members of the 
Committee. I am Jonathan Samet from the Keck School of Medicine 
at the University of Southern California. I am a physician and 
epidemiologist and I will note that I was in the U.S. Army from 
1971 to 1973 working as an anesthesiologist in Panama.
    I am here representing the Committee that I chair--the 
Committee on Improving the Presumptive Disability Decision-
making Process for Veterans. I note that with me is one of our 
distinguished committee members, Guy McMichael, in fact, 
formerly a counsel to this Committee.
    Our committee had two broad assignments. One was to 
describe and evaluate the model in place, to recognize diseases 
that might be subject to service connection on a presumptive 
basis. I feel that remarks up to now have probably covered the 
same ground as our report. I will focus my remarks on our 
second assignment, which was to, if appropriate, propose a 
scientific framework that would justify recognizing or not 
recognizing conditions as presumptive. Our committee produced 
an extensive report that I think covered much of both the 
theoretical and practical groundwork that would be needed to 
put a system into place and I think address some of the 
methodological complexities that you have heard about today.
    I will say that in our case studies that we carried out as 
part of the groundwork for our report, we noted some of the 
problems that have already been discussed--the lack of evidence 
on exposures, the difficulty of retrospectively identifying the 
effects of an exposure associated with service from those that 
might be sustained from lifestyle or other factors. We, in 
fact, in our report propose that there should be a more robust 
and evidence-based process for future cohorts of veterans. We, 
in our work, examined the data being collected and the 
epidemiological studies in progress and found gaps--I think 
gaps that are well known--the difficulties of assessing 
exposures and in tracking health, particularly after veterans 
leave service. Nonetheless, we thought that these gaps might be 
addressed by using our fundamental research tools of public 
health.
    We made recommendations for a new presumptive disability 
decisionmaking process that would be transparent, stakeholder 
inclusive, and evidence-based. We recommended that VA establish 
an advisory committee that would provide guidance on disability 
matters, including presumptive disability. This advisory 
committee was proposed as the clearing house for new possible 
presumptions that might be recommended by veterans, 
researchers, the government, VA, DOD, and others. Also as part 
of this process we recommended that an independent scientific 
organization be identified to perform the function of the 
science review board just as IOM does now. This independent 
group would consider the relevant evidence and analyze 
candidate presumptive conditions given to it by VA.
    We recommended a two-step process. A first step that would 
involve literature review and determination of the strength of 
evidence to assess whether a given health outcome can be 
caused; and I will note that we did recommend causation as the 
standard by a particular exposure. We recommended that strength 
of evidence be graded and that if there was a tie, meaning 
possible causation or stronger evidence, that consideration 
would then be given to a presumption.
    In the second step we recommend that this science review 
board calculate the service-attributable fraction of the 
disease if the needed data were available. That is, there would 
be an assessment of how much of the observed disease could be 
attributed to the exposure. We thought that this information 
would be important for decisionmaking and give an understanding 
of the scope of the population that would be covered by a 
presumption. We note that there would be times as evidence 
accumulated that it would be incomplete and action would need 
to be taken.
    I will say that the report does address the complexities of 
disentangling the effects of an exposure--military exposure--
from those of other factors and the need for good data. Let me 
move quickly to the report's bottom-line. I think the example 
of ischemic heart disease shows why a new approach would be of 
benefit to the veterans. We found limitations in the current 
process, one, the focus on association and not causation. In 
looking at the VA process, our committee at least did not 
understand with clarity what the internal process was and how 
the VA moves from evidence on limited suggestive association--
evidence of association to presumption. The problem of 
insufficient exposure and risk data is clear.
    Our new approach includes these two committees and a 
process that we view as evidence-based and transparent. We 
recommended that the evidence be looked at for its support of 
causation and the calculation of the service attributable 
burden of disease to provide a better indication of the 
magnitude of the support that would be given to the veterans. 
Again, the details are provided here in our report which was 
published 3 years ago.
    Thank you for the opportunity to address the Committee.
    [The prepared statement of Dr. Samet follows:]
 Prepared Statement of Jonathan M. Samet, M.D., M.S., Chair, Committee 
on Evaluation of the Presumptive Disability Decision-Making Process for 
       Veterans, Institute of Medicine of the National Academies
    Mr. Chairman and Members of the Committee: My name is Jonathan M. 
Samet. I am Professor and Chair of the Department of Preventive 
Medicine, Keck School of Medicine, University of Southern California, 
and I direct the Institute for Global Health at the University of 
Southern California.
    I have been invited to this hearing today because of my previous 
role as chairman of an Institute of Medicine (IOM) Committee which 
examined the presumptive disability decisionmaking (PDDM) process. By 
way of introduction, IOM is the health policy arm of the National 
Academy of Sciences, which was created by a Congressional charter 
signed by President Abraham Lincoln in 1863 as a private honorary 
society dedicated to the furtherance of science and its use for the 
general welfare. The IOM was chartered in 1970 to enlist distinguished 
members of the appropriate professions in the examination of policy 
matters pertaining to the health of the public. Under the terms of this 
charter, the IOM is called upon to act as an official, yet independent, 
advisor to the Federal Government in matters of science.
    The IOM, like other Academy units, is uniquely situated to provide 
assessments in areas of science, health care, and public policy. 
Studies are undertaken by distinguished panels of individuals selected 
for their expertise and experience in the topic under study. To a 
degree unmatched elsewhere, the IOM can secure the participation of 
virtually any expert whom it invites to serve. Members on IOM study 
committees serve without compensation.
    IOM has a longstanding interest in veterans' health issues and has 
conducted several studies that touch on ways to improve disability 
processing performed by the Department of Veterans Affairs.
    The study committee that I chaired produced a report titled, 
``Improving the Presumptive Disability Decision-Making Process for 
Veterans'' (hereafter the PDDM committee). This Committee complemented 
a second IOM study committee which produced a report titled ``A 21st 
Century System for Evaluating Veterans for Disability Benefits''. Both 
of these VA-funded studies were requested by the Veteran Benefits 
Disability Commission (VBDC), begun in 2006, and completed in 2007.
    I am submitting the full summary of the report of the PDDM 
committee as an attachment to my testimony. [Attachment follows.] Here, 
I will attempt to provide a brief overview. The VBDC asked the PDDM 
committee to:

     Describe and evaluate the current model used to recognize 
diseases that are subject to service connection on a presumptive basis.
     If appropriate, propose a scientific framework that would 
justify recognizing or not recognizing conditions as presumptive.

    In tackling the first task--to review the current presumptive 
decisionmaking process--the Committee reviewed statutes, received input 
from the VA, spoke with former congressional staff and reviewed the 
IOM's methodology in support of this process. I will offer a brief 
synopsis here.
    In 1921, Congress empowered the VA Administrator (now Secretary) to 
establish presumptions of service connection for veterans. Only 
Congress and the VA Secretary had the authority to establish 
presumptions. Over time, presumptions have been made to relieve 
veterans of the burden to prove that disability or illness was caused 
by a specific exposure which occurred during military service (e.g., 
Prisoners of War). Since 1921, nearly 150 health outcomes have been 
service-connected on a presumptive basis.
    The current presumptive disability decisionmaking process for 
veterans involves several steps and several organizations. The process 
involves input from many parties--Congress, VA, the National Academies, 
Veteran Service Organizations, advisory committees, and individual 
veterans. Congress has on it own authority made presumptions in the 
past. In the current model, which evolved from the Agent Orange Act, 
Congress may call on VA to assess whether a presumption is needed. The 
VA turns to the IOM for completion of a review of the scientific 
evidence and a determination as to the strength of evidence linking 
military service, or some specific element of military service, to risk 
for some health outcome. Our committee examined several decisions made 
in the past regarding presumptions, treating them as case studies in 
order to identify ``lessons learned'' of potential value for improving 
the process. In examining these case studies, our committee found 
variable approaches to synthesizing evidence on the health consequences 
of military service. The target of scientific evidence reviews had not 
been consistent and varied between causation (e.g., mustard gas and 
lewisite, Gulf War) and association alone (e.g., Agent Orange). 
Starting in 1991 the basis for the scientific review in regard to Agent 
Orange was specified in the statute (Public Law 102-4). This statute 
says, ``the Academy shall review and summarize the scientific evidence 
and assess the strength thereof, concerning the association between 
exposure to an herbicide * * * and each disease suspected to be 
associated with such exposure.'' Specifically:

    (1) whether a statistical association with herbicide exposure 
exists, taking into account the strength of the scientific evidence and 
the appropriateness of the statistical and epidemiological methods used 
to detect the association;
    (2) the increased risk of the disease among those exposed to 
herbicides during service in the Republic of Vietnam during the Vietnam 
era; and
    (3) whether there exists a plausible biological mechanism or other 
evidence of a causal relationship between herbicide exposure and the 
disease.

    This guidance from the VA has not substantively changed since the 
beginning of the Agent Orange series of studies, which are now carried 
out biannually. Each IOM committee in the Veterans Agent and Orange 
(VAO) Update series is selected as a different and new committee. Each 
committee has the prerogative to decide how it will review the 
published literature and to assign categories of strength on assessing 
association. The several IOM committees since 1991 have been quite 
consistent in their categorization schemes for strength of evidence, 
typically assigning four categories:

     Sufficient evidence of an association
     Limited/suggestive evidence of an association
     Inadequate/insufficient evidence to determine whether an 
association exists
     Limited/suggestive evidence of no association

    Once the IOM committee completes its task, it provides its report 
to the VA. The VA staff described its internal decisionmaking processes 
to our committee in a general fashion, and the Committee reviewed the 
VA's Federal Register notices and documents to gain further insights. 
However, it was unclear to our committee how the VA makes particular 
determinations once the IOM report is received and how information 
beyond the IOM's findings figure into decisionmaking by the VA, such as 
the size of the affected population of veterans and the potential costs 
of a presumption. Generally the VA staff makes recommendations to the 
Secretary and the Secretary decides whether to assign a presumption of 
service connection to any new condition. That decision is then 
documented in the Federal Register.
    Our committee determined that a more robust and evidence-based 
process could be envisioned for future cohorts of veterans. We reviewed 
the current approach to characterizing exposures of veterans to toxins 
and other stressors that might adversely affect their health. We also 
considered the scope of epidemiological research undertaken by the DOD 
and the VA. Our review found gaps in the assessment of exposures of 
military personnel and in the tracking of their health that could be 
addressed through a more systematic approach.
    We also made recommendations for a future presumptive 
decisionmaking process that would build on accumulating evidence on 
exposure and risk. We recommended that the VA establish an Advisory 
Committee to provide guidance on disability matters including 
presumptive disability (if allowed by Congress). That Advisory 
Committee would serve as a clearing house for new presumptions 
recommended by veterans, veteran service organizations (VSOs), 
veterans' families, VA, DOD, other governmental bodies, researchers, or 
the general public. We also recommended that Congress allow the VA to 
contract with an independent scientific organization to perform the 
function of a Science Review Board. This independent scientific entity 
would consider the relevant evidence and analyze candidate presumptive 
conditions given to it by the VA through VA's Advisory Committee.
    We also recommended the establishment of an independent Science 
Review Board. This Science Review Board would use a two-step process. 
In step one, the scientific literature would be reviewed to determine 
the strength of the evidence to assess whether a given health outcome 
can be caused by a given exposure. This scientific review process is 
very much like that currently followed by IOM. The Committee 
recommended that the target of the review should be to determine 
likelihood of causation and not simply the existence of statistical 
association. The Committee developed a system to grade the strength of 
the scientific evidence for causation using four levels in ascending 
order of certainty (highest at top). The upper two levels were set to 
correspond to 50% or more certainty of causation. If the strength of 
the scientific evidence reached either of these upper two levels, the 
process would move on to step two. In step two, the Science Review 
Board would calculate the service-attributable fraction of disease, if 
the required data and information were available. This second step 
assesses how much of the observed disease both in absolute and relative 
terms can be attributed to the exposure. The calculation is independent 
of the classification of the strength of evidence for causation, and 
the magnitude of the service-attributable fraction is not considered in 
categorizing evidence. Rather, the service-attributable fraction would 
be of value for decisionmaking, giving an understanding of the scope of 
the population to be covered by a presumption. In step two, the Science 
Review Board would consider the extent of exposure among veterans and 
subgroups of veterans, as well as dose-response relationships. A 
critical element in the deliberations of the Science Review Board would 
be evidence available from studies on exposures and health risks to the 
veterans. When such information is available, the board would estimate 
the service-attributable fraction and the related uncertainty. The 
purpose of step two is to convey the impact of the exposure on veterans 
as a whole for the purpose of decisionmaking and planning, but not to 
serve, inappropriately, as an estimate of probability of causation for 
individuals. Some exposures may contribute greatly to the disease 
burden of veterans, while other exposures (even with a known causal 
effect) may have a small impact overall. This additional information 
would be useful to the VA in its decisionmaking as to whether a 
presumption should be made for the veteran population in general, for 
subgroups, or not at all. In the absence of service-attributable 
fraction data, as will likely occur for many exposures over the short-
term, we assumed that the VA would consider presumptions on the basis 
of information considered in step one.
    Under this model, the VA Advisory Committee would be more 
effective, visible, and stakeholder-inclusive in establishing candidate 
conditions for presumptive determinations. In addition the Science 
Review Board would permit the VA to receive outside, independent, 
evidence-based advice that would not be perceived as politically driven 
or influenced. This model would also identify important research gaps 
to which the VA could give special emphasis to reduce uncertainty.
    I have been asked to comment on how the PDDM committee would 
evaluate the three new presumptions, ischemic heart disease (IHD), 
Parkinson's Disease (PD), and B-cell leukemias in a manner similar to 
our committee's assessment of previously established Agent Orange 
presumptions such as prostate cancer and diabetes. Our PDDM committee 
finished its work and has been inactivated, so my comments are my own 
and cannot be construed as coming from the PDDM committee or the IOM.
    Keep in mind that our PDDM committee performed our case studies 
well after the presumptions had been established whereas these three 
new presumptions have not gone into effect, so it is too soon to tell 
what experiences will result and what lessons will be learned.
    Nevertheless I will try to draw from some of the relevant 
observations we made from our prior case study analysis as they relate 
to the three new presumptions. I will start with the presumption that 
is likely to affect the most veterans, that for ischemic heart disease 
(IHD).
    The PDDM committee noted that association and not causation was the 
target for the IOM reviews on Agent Orange and remarked that causation 
would be a preferable choice. In addition our committee concluded that 
it would have been desirable to better integrate information concerning 
``plausible biologic mechanism or other evidence of a causal 
relationship'' into the interpretation of the evidence. Consideration 
of mechanistic and other biological evidence is a standard element of 
causal inference.
    Our critique was done with recognition that all of the IOM 
committees evaluating the effects of Agent Orange were operating under 
the statutory guidance, incorporating judicial rulings, that were 
passed from Congress to the VA and then from the VA to IOM. When 
evaluating any possible medical condition that might be associated with 
Agent Orange exposure, the VAO update committees were required to 
perform the three tasks delineated above.
    The PDDM report pointed out the imprecise wording included in the 
explanation of criteria for the ``limited/suggestive'' category that 
had been carried along since the first Agent Orange report. Literally 
interpreted, this implies that a single positive ``high-quality'' study 
would permanently keep a health outcome in the ``limited/suggestive'' 
category of association no matter how many negative ``high-quality'' 
studies were published later. Such a standard did not appear to be 
reasonable to our committee. It has been brought to my attention that 
VAO update committees for Update 2006 and Update 2008 have revised this 
statement to better characterize this particular category of evidence.
    Criteria for the strength of evidence can be established, but that 
evidence exits along a continuum, extending from no evidence at all to 
full certainty. An element of subjectivity always remains in 
synthesizing evidence into a particular category of strength of 
evidence. It requires ``expert scientific judgment'' to conduct these 
reviews. IOM has a very systematic process and uses acknowledged 
experts who have volunteered their time pro bono to arrive at consensus 
findings and recommendations.
    For both prostate cancer and Type II diabetes our PDDM case studies 
pointed out the difficult challenges of establishing a service 
connection for a common chronic condition when exposure data are 
unavailable and evidence of association is limited. There was no 
additional exposure data available relating to Vietnam veterans when 
considering an association with IHD.
    For prostate cancer and Type II diabetes mellitus, the PDDM 
committee was unable to judge the rationale for the VA's translation of 
IOM's VAO update committee's category of ``limited/suggestive'' 
association to a presumptive decision, considering that the 
congressionally stipulated standard requires evidence to be ``equal to 
or outweighs'' lack of such evidence. This basis for this decision on 
VA's part remains unclear. The designation of the evidence for IHD as 
limited-suggestive appears reasonable in light of the evidence 
reviewed. But, the scientific rationale for a presumptive determination 
is still unclear.
    One of the key lessons learned from the PDDM case studies and 
particularly those related to Agent Orange exposure was a need for 
high-quality data on cohorts of veterans; ideally such data would 
include more accurate assessments of exposure during service, 
evaluation of other risk factors that may have been present during 
service or have developed after service before the onset of disease, 
and longitudinal assessments for evaluation of diseases that may have 
long latency periods. IOM VAO update committees have made this same 
suggestion since 1994. Such cohort information remains an 
unquestionably desirable resource for future presumptive 
decisionmaking. It is not generally feasible to obtain accurate 
exposure data many years after the fact.
    I will make just a few comments about the other two presumptions, 
Parkinson's Disease and B-cell malignancies. The VAO committee (Update 
2008) observed that data were accumulating with regard to Parkinson's 
disease. They upgraded the evidence of association to limited/
suggestive based on several recent published studies supporting 
evidence of an association not just with herbicide exposure, but 
specifically, exposure to the phenoxyherbicides that were the intended 
components of Agent Orange.
    Regarding B-Cell leukemias, the VAO (Update 2008) determined that 
B-cell leukemia should be regarded as a form of chronic lymphocytic 
leukemia (CLL). A previous VAO committee (Update 2002) had already 
concluded that there was sufficient evidence for CLL being associated 
with herbicide exposures. Investigation of the biological nature of the 
cells progressing to B-cell leukemia confirmed that this malignancy is 
a form of CLL. CLL itself has now been classified as form of non-
Hodgkin's lymphoma, which has long been recognized as a presumptive 
illness. Consequently, the VAO committee (Update 2008) placed this in 
the ``sufficient'' association category.
    A major theme that emerged from the case reviews was the difficulty 
of disentangling the potential role of service-related factors in 
diseases that have multiple causes, particularly as disease rates rise 
with age through the actions of these causes. Additionally, there is 
the possibility that the effects of exposures in the military, e.g., 
Agent Orange, might be synergistically enhanced by other factors. There 
are multiple causes for all the presumptive conditions mentioned above. 
Beyond assessing whether these conditions are associated with exposure 
to Agent Orange and other herbicides, it would be useful to determine 
to what extent these exposures are contributing to disease burden among 
our servicemen and women. In the absence of accurate exposure data this 
estimation would be difficult for Vietnam veterans, but the PDDM 
committee concluded that future presumptive decisions would be made 
more useful if the attributable fraction of the disease burden caused 
by a military service-related exposure were determined.
    I have also been asked to comment on the degree of clarity that the 
VA has provided to various IOM committees for determining how to weigh 
conflicting evidence related to possible presumptions. I have not been 
privy to the contractual discussions that the VA has held with IOM as 
IOM convened committees to conduct scientific review on potential 
health effects of military-relevant exposures. Nevertheless, in my 
opinion, the VA understands the role of IOM as an independent advisory 
organization and it allows IOM committees to determine how to best 
search for, weigh, and synthesize the scientific evidence on health 
effects relating to military-relevant exposures. In recent years 
congressional legislation has stipulated what should be considered in 
the scientific reviews conducted for Agent Orange and Gulf War 
presumptions. The VA has ensured that this congressional guidance is 
made evident to IOM before IOM conducts its scientific reviews.
    Finally, I have been asked to provide my views on the extent to 
which the PDDM committee's recommendations were followed by the 
Secretary in his most recent presumptive decisions, especially with 
respect to ischemic heart disease. The specific basis for this decision 
is not apparent. As far I am aware, the VA is operating under the 
established statutory guidelines and procedures used in prior 
presumptive reviews. The PDDM committee proposed a model that would 
make the basis for decisionmaking fully transparent so that, for the 
future, this type of question could be answered.

    This concludes my remarks. Thank you for the opportunity to speak 
with the Committee. I will be pleased to address questions from the 
Senate Committee Members.
                               Attachment



                                 ______
                                 
    Response to Pre-Hearing Questions Submitted by Hon. Jim Webb to 
 Jonathan M. Samet, M.D., M.S., Chair, Committee on Evaluation of the 
Presumptive Disability Decision-Making Process for Veterans, Institute 
            of Medicine of the National Academy of Sciences
    Question 1. To the extent the Committee that you chaired examined 
this question, please describe the varying approaches IOM committees 
have taken since 1991 in reviewing the scientific evidence and in 
forming their opinions on the possibility that exposure to Agent Orange 
during military service contributed to causing various health 
conditions.
    Response. Across the case studies, our Presumptive Disability 
Decision-Making (PDDM) committee found variable approaches for 
synthesizing evidence on the health consequences of military service. 
The inferential target of scientific evidence reviews had not been 
consistent and varied between causation (e.g., mustard gas and 
lewisite, and the Gulf War) and association alone (e.g., Agent Orange). 
However, since 1991, as shown by the three case studies on the 
association of several health outcomes prostate cancer, type 2 
diabetes, and spina bifida in offspring) with Agent Orange exposure in 
Vietnam veterans, the IOM's Veterans and Agent Orange (VAO) committees 
were consistent in executing the congressional mandate set out in the 
Agent Orange Act of 1991 (Public Law 102-4).
    When Congress enacted the Agent Orange Act, it started a model for 
a decisionmaking process that is still in place. Congress asked VA to 
contract with an independent organization-VA contracted with IOM-to 
review the scientific evidence related to exposure to the herbicides 
used in Vietnam. Since l994,IOM's VAO committees have produced biennial 
evidence-synthesis reports for VA to use in making presumptions. These 
reports are referred to as Updates 1996, 1998, 2000, 2002, 2004, 2006, 
and most recently Update 2008. The tasks given to IOM by VA were 
directly drawn from the criteria contained in statutory language of 
Public Law 102-4: When looking at a possible health outcome of concern, 
the requirements were to determine:

    (1) whether a statistical association with herbicide exposure 
exists, taking into account the strength of the scientific evidence and 
the appropriateness of the statistical and epidemiological methods used 
to detect the association;
    (2) the increased risk of the disease among those exposed to 
herbicides during service in the Republic of Vietnam during the Vietnam 
era; and
    (3) whether there exists a plausible biological mechanism or other 
evidence of a causal relationship between herbicide exposure and the 
disease.
    Although VA has on occasion added requests about specific health 
outcomes, this general guidance has not changed since the beginning of 
the Agent Orange series of studies. Each IOM VAO committee is selected 
as a different and new committee. Each committee has the prerogative to 
decide how it will review the published literature and to assign 
categories of strength on assessing association within the constraints 
of the above statement of task. Each successive committee does have the 
precedents of prior committees as they carry out their reviews. Several 
VAO committees have been consistent in their categorization schemes for 
the strength of evidence, assigning four categories:

     Sufficient evidence of an association
     Limited/suggestive evidence of an association
     Inadequate/insufficient evidence to determine whether an 
association exists
     Limited/suggestive evidence of no association

    After a VAO committee completes its task, it provides its report to 
the VA and the VA then considers the report and other information in 
its internal decisionmaking process. The VA described its internal 
decisionmaking processes to the PDDM Committee in a general fashion and 
the Committee reviewed VA's Federal Register notices and documents for 
additional insights into these processes. However, it was unclear to 
our committee as to how VA makes a particular determination after 
receiving an IOM report; specifically, we were unable to characterize 
how VA weighs strength of evidence for association and exposure 
potential in making its presumptive decisions. Generally, the VA staff 
makes recommendations to the Secretary and the Secretary decides 
whether to assign a presumption of service connection to any newly 
categorized condition.
    Since the completion of the study by the PPDM committee, I have 
been advised that subsequent VAO Update committees have made some 
adjustments in their approach to their tasks. For example:

     In response to an observation of the PDDM committee, the 
VAO committees for Update 2006 and Update 2008 acknowledged the 
imprecise wording included in the explanation of criteria for the 
``limited/suggestive'' category that had been carried along since the 
first VAO report. Those earlier committees considered evidence in the 
category of ``limited/ suggestive'' if at least one high-quality study 
shows a positive association, but the results of other studies were 
inconsistent. This wording implies that a single positive ``high-
quality'' study would permanently keep a health outcome in the 
``limited/suggestive'' category of association no matter how many 
negative ``high-quality'' studies were subsequently published. 
Beginning with the VAO Update 2006, the designation of this category 
has been revised for clarity.
     With the improvement of methods and technology for 
assessing exposure that has occurred over the period of the VAO 
reviews, the Committees have become somewhat more selective about the 
characterizations of (possible) exposure to the five chemicals of 
interest (COI) (COIs: TCDD; 2,4-D; 2,4,5-T; cacodylic acid; and 
picloram). Recent committees have required greater exposure specificity 
for new studies under consideration.
     The VAO committees for Update 2006 and Update 2008 were 
uncomfortable with the assertion of the original VAO report that 
several outcomes should be put in the category of ``limited/suggestive 
evidence of no association'' without reliable negative findings for all 
five of the COIs and returned them to the category of ``inadequate/
insufficient'' evidence.

    Question 2. Please indicate whether the Committee that you chaired 
had any contact, and in what capacity, with IOM's VAO Update 2008 
committee in reference to its determination of ``limited/suggestive'' 
evidence for an association between dioxin and ischemic heart disease.
    Response. No, we did not have contact with this other committee. 
Our IOM committee's work was concluded long before the independent IOM 
committee that produced the Agent Orange Update 2008, which found 
ischemic heart disease to be associated with AO exposure.

    Question 3. Similar to the case study analyses that the Committee 
you chaired included in your report with reference to the presumptions 
of prostate cancer and type 2 diabetes, please provide a brief analysis 
and lessons learned with reference to the Secretary's most recent 
presumption for ischemic heart disease.
    Response. The PDDM Committee's judgments in its case studies were 
made after-the-fact. The three new potential presumptions from the VAO 
Update 2008 (ischemic heart disease (IHD), Parkinson's disease (PD), 
and hairy cell leukemia and other B-cell malignancies) have not yet 
gone into effect, so my comments will be limited accordingly.
    I will attempt to answer this question by noting aspects of the 
PDDM committee's case studies on prostate cancer and type 2 diabetes 
that appear to be applicable to the new presumption for IHD.
    Before turning to the case studies, I note that several general 
comments of the PDDM Committee are relevant to the question. First, the 
PDDM Committee commented in its report on the use of association rather 
than causation as the benchmark for its evaluations. In addition, our 
committee thought it would be preferable and more consistent with 
common practices in evidence evaluation to better integrate information 
concerning ``plausible biologic mechanism or other evidence of a causal 
relationship'' into the determination and interpretation of 
association.
    Our assessments in the case studies were conducted with the 
understanding that the IOM VAO committees evaluating the effects of 
Agent Orange operated under the statutory guidance passed from Congress 
to the VA and then from the VA to the IOM. When evaluating any possible 
medical condition that might be related to Agent Orange exposure, the 
statutory guidance below was followed by the VAO committees:

    (1) whether a statistical association with herbicide exposure 
exists, taking into account the strength of the scientific evidence and 
the appropriateness of the statistical and epidemiological methods used 
to detect the association;
    (2) the increased risk of the disease among those exposed to 
herbicides during service in the Republic of Vietnam during the Vietnam 
era; and
    (3) whether there exists a plausible biological mechanism or other 
evidence of a causal relationship between herbicide exposure and the 
disease.

    The PDDM report pointed out the imprecise wording included in the 
explanation of criteria for the ``limited/suggestive'' category that 
has been applied since the first Agent Orange report. Literally 
interpreted, this wording implies that a single positive ``high-
quality'' study would permanently keep a health outcome in the 
``limited/suggestive'' category of association, regardless of how many 
negative ``high-quality'' studies were published later. A criterion 
with such consequences was not viewed as reasonable by the PDDM 
committee.
    Criteria for the strength of evidence can be established but that 
evidence exits along a continuum. An element of subjectivity always 
remains in synthesizing evidence into a strength category. It requires 
``expert scientific judgment'' to conduct these reviews. IOM has a very 
systematic process and uses recognized experts who volunteer their time 
pro bono to arrive at consensus findings and recommendations.
    For both prostate cancer and type 2 diabetes, the PDDM case studies 
exemplified the difficult challenges of establishing a service 
connection for a common chronic disease with multiple causes under 
circumstances of not having exposure data. Additionally, the level of 
association found in the studies was low. The occurrence of both 
prostate cancer and type 2 diabetes rises with age as age-related 
causal factors come into play. Consequently, the number of persons 
affected by presumptions for prostate cancer and type 2 diabetes 
becomes very large because of the age-driven increase in background 
rates.
    For prostate cancer and type 2 diabetes, the PDDM Committee was 
unable to identify a specific rationale for VA's translation of IOM's 
Agent Orange Update committee's category of ``limited/suggestive'' 
association to a presumptive decision; the congressionally stipulated 
standard requires evidence to be ``equal to or outweighs'' lack of such 
evidence.
    The case studies of prostate cancer and diabetes highlight the 
problem of characterizing the role of Agent Orange exposure for 
diseases with multiple causes. Absent any ``signature'' feature of a 
case in which Agent Orange played a role, epidemiological evidence can 
only provide evidence as to whether it is a risk factor and as to the 
proportion of cases that it may cause. A robust body of evidence is 
needed to be able to estimate the attributable burden of disease; an 
understanding of both the risk and the magnitude of exposure is needed 
for this calculation. Consequently, the PDDM committee concluded that 
future presumptive decisionmaking would be improved if the attributable 
fraction of the disease burden caused by a military service-related 
exposure were determined.
    One of the key lessons learned from the PDDM case studies and Agent 
Orange exposure was a need for high-quality data on a cohort of 
veterans; ideally such data would include more accurate assessments of 
exposure during service, evaluation of other risk factors that may have 
been present during service or have developed after service before the 
onset of disease, and longitudinal assessments for evaluation of 
diseases that may have long latency periods. Many IOM VAO Update 
Committees have made this same suggestion since 1994. Such cohort 
information remains an unquestionably desirable resource for future 
presumptive decisionmaking. However, it is not feasible to obtain 
accurate exposure data many years after the fact.

    Question 4. Please elaborate on what the Committee you chaired saw 
as the benefits to be gained from VA developing and publishing a formal 
process for consideration of disability presumption that is uniform and 
transparent and which clearly sets forth all evidence considered and 
the reasons for the decisions made.
    Response. The PDDM Committee felt very strongly that a transparent 
process for determining presumptive disability was needed and that such 
a process would better serve all involved parties including veterans, 
VA, Congress, and the Nation as a whole. These presumptive disability 
decisions are often contentious and emotionally charged, and their 
implications may be costly. In addition, government agencies, 
deservedly or not, are not trusted by all citizens to make the best 
decisions on their behalf. Our committee's recommendations were 
intended to enhance openness and inclusiveness in the process. Greater 
transparency would lead to a higher level of confidence in the outcome 
and all affected parties would be able to see the evidence and the 
rationale that drove the decisionmaking process. Transparency is likely 
to lead to more acceptable, consistent, and equitable decisionmaking.

    Question 5. Which of the recommendations made by the Committee you 
chaired for improving the presumptive disability decisionmaking process 
could be carried out promptly by VA?
    Response. Many of our committee's recommendations would take time 
to implement including those requiring coordination, agreement, and 
joint actions with other agencies such as DOD. But some could be 
accomplished rather quickly.
    If statutorily permitted by Congress, VA could establish an 
Advisory Committee to help advise them on disability matters including 
presumptive disability. That Advisory Committee would serve as a 
clearing house for new presumptions suggested by veterans, veteran 
service organizations (VSOs), veterans' families, VA, DOD, other 
governmental bodies, researchers, or the general public.
    Also with agreement or directives from Congress, VA could contract 
with an independent scientific organization to perform the function of 
the Scientific Review Board to analyze candidate presumptive conditions 
given to it by the VA, as recommended by its Advisory Committee.
    In addition, VA could inventory research related to the health of 
veterans, including research funded by DOD and VA, and research funded 
by the National Institutes of Health and other organizations; it could 
develop a strategic plan for research on the health of veterans, 
particularly those returning from conflicts in the Gulf and 
Afghanistan; and it could establish registries of Servicemembers and 
veterans based on exposure, deployment, and disease histories.
    In my opinion, recommendations relating to the better surveillance 
and exposure data on deployed personnel (necessary for more refined 
estimation of service-attributable fraction in step two for the Science 
Review Board), will require considerably more time to be of sufficient 
scope, intensity, and specificity to accurately assign a level of 
exposure to potential toxic agents to which they may be exposed. This 
is particularly problematic for past wars such as Vietnam where 
exposure information is currently very limited and exposures cannot be 
accurately reconstructed.

    Question 6. Which, if any, of the recommendations made by the 
Committee you chaired have been adopted by VA?
    Response. I do not know specifically at this time. Our sponsors are 
not required to inform study committees about actions that they have 
taken or plan to take as a result of our studies.

    Question 7. Please elaborate on what you believe are the benefits 
from the recommendation made by the Committee you chaired that Congress 
create a formal Advisory Committee and a Science Review Board to advise 
and assist the Secretary with reviewing scientific research and 
considering conditions for presumptions. In your response, please 
indicate whether this recommendation was intended as a replacement for 
the current function of the IOM Committees in the presumptive 
disability decisionmaking process and the rationale for any such 
intention.
    Response. The design of the future presumptive decisionmaking 
process envisioned by our committee was to have two advisory groups, 
one assembled by and answering to VA and a second independent entity 
which would advise VA, but be independent of the government.
    The Advisory Committee would consider the exposures and illnesses 
that might be a basis for presumptions and recommend to the VA 
Secretary exposures and illnesses needing further consideration. It 
would also consider research needs and assist VA with strategic 
research planning.
    The Science Review Board would use a two-step process. In step one, 
published literature would be reviewed to determine the strength of the 
evidence to assess whether a given health outcome can be caused by a 
given exposure. This scientific review is very much like what IOM does 
in the current process. The Committee believes that the target here 
should be to determine likelihood of causation, and not simply 
statistical association. The Committee developed a categorization 
schema with four levels for grading the strength of the scientific 
evidence in ascending order. If the strength of the scientific evidence 
reached level two or one (50% or more likelihood of causation), the 
process would move on to step two. In step two the Science Review Board 
would attempt to estimate the service-attributable fraction of disease 
if the required data and information were available. This second step 
assesses how much of the observed disease both in absolute and relative 
terms can be attributed to the exposure. The calculation is independent 
of the classification of the strength of evidence for causation, and 
the magnitude of the service-attributable fraction is not considered in 
categorizing evidence. Rather, the service-attributable fraction would 
be of value for decisionmaking, giving an understanding of the scope of 
the population to be covered by a presumption. In step two, the Science 
Review Board would consider the extent of exposure among veterans and 
subgroups of veterans, as well as dose-response relationships. A 
critical element in the deliberations of the Science Review Board would 
be any evidence available on exposures and health of veterans. When 
such information is available, the board would estimate the service-
attributable fraction and its related uncertainty. The purpose of step 
two is to convey the impact of the exposure on veterans as a whole for 
the purpose of decisionmaking and planning, but not to serve, 
inappropriately, as an estimate of probability of causation for 
individuals. Some exposures may contribute greatly to the disease 
burden of veterans, while other exposure (even with a known causal 
effect) may have a small impact overall. This additional information 
would be useful to VA in its decisionmaking as to whether a presumption 
should be made for the veteran population in general, for subgroups, or 
not at all. In the absence of service-attributable fraction data, we 
assume the VA would consider presumptions on the information contained 
in step one.
    There are a number of potential beneficial consequences of this 
model. The VA Advisory Board would be effective, visible, and 
stakeholder-inclusive in establishing candidate conditions for 
presumptive determinations. The Scientific Review Board would give VA 
outside, independent evidence-based advice synthesizing the best 
available data that could inform the relationship between exposures and 
outcomes in veterans.
    The report does not speak to the details of the Science Review 
Board or imply that this body should replace the IOM. It is against IOM 
policy to recommend in our study reports that IOM be selected to serve 
future specific advisory roles.
    IOM committees are currently performing step one of the roles 
envisioned by the Science Review Board. If this new model were to be 
adopted, the function of the current committees would need to be 
expanded to evaluate how much of the disease burden in veterans is due 
to these presumed exposures (the service-attributable fraction).

    Question 8. Faced with the challenge of identifying a possible 
small increased risk of commonly occurring diseases absent accurate 
exposure data, how would you describe the approach that policymakers 
have adopted to minimize the possibility of denying service connection 
to a veteran whose disease may have been caused by Agent Orange?
    Response. It is clear that VA has decided to set a very high level 
of sensitivity in making its presumptive disability decisions. Let me 
explain my use of the word ``sensitivity.'' In the decisionmaking 
process there exist two possible types of errors: (1) to make a 
decision to compensate when the exposure has not caused the illness 
(false positive) and (2) to not compensate when the exposure has 
actually caused the illness (false negative). Our PDDM committee noted 
that any decision process cannot avoid considering the tradeoff between 
these two errors and that it is not possible to simultaneously maximize 
both the sensitivity (i.e., minimize the false negatives) and the 
specificity (i.e., minimize the false positives). Generally, higher 
sensitivity cannot be achieved without lower specificity. These errors 
have costs. False positive errors result in the expenditure of funds 
for cases of disease not caused by military service while false 
negative errors leave deserving veterans uncompensated. The appropriate 
balancing of these costs needs great consideration. Where that proper 
balance should be established is a social policy issue rather than a 
scientific one. What this scientific model does is allow one to place 
the fulcrum along the balance board with more precision.

    Question 9. Do you believe that the current process for creating 
presumptions is the appropriate mechanism to address gaps resulting 
from the inability to measure attributable risk of dioxin exposure for 
diseases common to aging or other highly prevalent risk factors? Can 
determinations of whether common diseases of aging are positively 
associated with dioxin exposure be resolved by science in the absence 
of accurate exposure data?
    Response. The current process does not specifically involve the 
estimation of the attributable fraction or utilization of such 
information. In the current process, there is not a role for using the 
attributable fraction. As implied by the question, the attributable 
fraction may be low for those diseases that become increasingly common 
with aging and for which there are multiple risk factors. Hence, 
presumptions that all cases are caused by Agent Orange are being 
applied to some cases caused by other factors or for which Agent Orange 
may make only a minor contribution to causation.
    To move beyond such generic presumptions, sufficiently robust 
information on exposure and risks would be needed. Because so much time 
has elapsed since U.S. troops were in Vietnam, it is very difficult to 
estimate levels of exposures to dioxin or other related chemicals with 
needed certainty. In situations where so little is known about 
exposures and risks are not estimated with great certainty, it is 
probably not possible to calculate the service-attributable fraction. 
Absent sufficiently accurate exposure information, epidemiological 
approaches are not likely to provide more certain estimates of the risk 
for diseases such as prostate cancer that occur frequently in persons 
in the age span of Vietnam Veterans at present.

    Question 10. In your opinion, do you believe that the challenges 
that diseases common to aging or other highly prevalent risk factors 
pose to the presumptive disability decisionmaking process are a 
question of science or law, and do you believe that such a question is 
most appropriately addressed by Congress or the Secretary?
    Response. I believe that the model proposed by our committee allows 
better science to inform decisions made on behalf of our veterans. Our 
committee recognized and acknowledged that final decisions often must 
weigh many other factors such as economic, social, and legal factors. 
We viewed both the current and future decisionmaking models as advisory 
in nature only, without decisionmaking authority. The decisionmakers 
need to understand the nature and limitations of the scientific 
evidence that will be available to support their decisionmaking. Final 
decisions rest with government elements accountable for such decisions.
                                 ______
                                 
Response to Post-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
Dr. Jonathan M. Samet, Chair, Committee on Evaluation of the Disability 
  Decision-Making Process for Veterans, Institute of Medicine of the 
                      National Academy of Science
    Question 1. In response to pre-hearing questions, Dr. Linda 
Birnbaum, Director of the National Institute of Environmental Health 
Sciences, described the Boehmer et al. study (the CDC Vietnam 
Experience Study) and The Third Australian Vietnam Veterans Mortality 
Study among the studies considered by IOM Update 2008 in its 
determination of an association between IHD and dioxin exposure. I 
understand that these studies examined the health effects of the 
Vietnam experience in general, rather than herbicide exposure.
     Does IOM's reliance on these studies suggest value in 
examining the health effects of the Vietnam experience in general, in 
place of examining the health effects of herbicides used in Vietnam in 
the absence of sound exposure data?
    Response. In setting the context for answering this question, I 
offer the reminder that I was not on the IOM committee that conducted 
the Veterans and Agent Orange (VAO) Update 2008. Additionally, the 
question does not refer to a topic specifically covered by our 
Presumptive Disability Decision-making (PDDM) Committee. However, our 
committee did call for studies of military personnel in general, 
including sustained follow-up to track long-term consequences of 
exposures during military service. Our committee thought that there 
were opportunities to learn much about the consequences of military 
experience by constructing prospective cohort studies of military 
personnel. By carrying out such studies prospectively, exposures could 
be assessed in real-time, so as to avoid the difficulties of 
retrospective exposure assessment. The range of exposures assessed 
could be broad, extending from chemical and physical to psychological.
    Regarding general cohort studies of veterans who served in Vietnam, 
such as the CDC Vietnam Experience Study, since individual exposures to 
Agent Orange cannot be estimated with sufficient accuracy, comparisons 
need to be made to external populations to detect unexpected disease 
occurrence. Such studies represent a useful form of surveillance but 
are insensitive to detecting modest excesses of disease, unless there 
is some link to a ``signature condition'' (for example, mesothelioma, a 
cancer caused almost exclusively by asbestos). For Agent Orange, 
chlorachne represents such a signature but most other diseases of 
concern have multiple causes. Such general studies might also provide 
leads for more focused follow-up studies.

    Question 2. Does a recognized standard exist for determining a 
threshold for concern with respect to the magnitude of an increased 
relative risk for developing a disease in a specific cohort compared to 
the general population? Does such a threshold differ depending on 
whether the concern is for purposes of prevention versus post-injury 
causal investigation?
     What would be an appropriate threshold for concern with 
respect to the magnitude of an increased relative risk for developing a 
disease associated with the Vietnam experience in general, compared to 
the general population?
    Response. There is no general standard for a specific level of 
excess relative risk that signals a value of concern. In interpreting a 
relative risk estimate, consideration needs to be given to both the 
magnitude of the increase and the extent to which the population is 
exposed to the factor of interest. A relatively ``small'' relative risk 
associated with a common exposure could lead to a substantial burden of 
disease in the exposed population. Additionally, while higher levels of 
relative risk provide greater assurance that the association is causal 
because bias becomes a less plausible explanation, the magnitude of the 
relative risk reflects underlying biological processes. For example, 
the relative risk for lung cancer in never smokers who live with 
smokers is about 1.25, compared to never smokers living with non-
smokers. An increase of this magnitude is plausible in terms of the 
exposures to secondhand smoke received by never smokers in the home. 
Some have proposed that the relative risk needs to be at least 2.0 if 
causality is to be inferred in a particular individual; this 
proposition incorrectly applies a legal standard of ``more likely than 
not'' to causal inference more generally.
    The question of whether there is a ``threshold for concern'' with 
regard to interpreting findings from studies related to the Vietnam 
experience is a complicated matter, involving not only scientific 
considerations but broader issues with regard to actions that will be 
taken based on the findings. At lower and lower relative risk values, 
the contribution of the exposure to the overall burden of becomes 
smaller and smaller. For multi-caused chronic diseases, such as 
diabetes or ischemic heart disease, a ``small'' relative risk indicates 
a correspondingly ``small'' contribution in relation to that coming 
from other factors.
    Any further response to this question would depend on the actions 
taken if a ``threshold of concern'' were reached. If a threshold were 
to be established for making a presumption, given the implications for 
veterans, a broad discussion would be needed that would move beyond 
scientific issues to broader matters related to principles by which the 
Veterans Administration and the Congress compensate veterans for the 
consequences of their service.

    Question 3. In Dr. Birnbaum's written testimony, she stated that 
``[t]he epidemiological studies that the IOM evaluated and considered 
in their recommendations for ischemic heart disease varied considerably 
in their attempts to adjust or control for all the major risk factors 
of ischemic heart disease, such as, age, smoking, high blood pressure, 
diabetes, and obesity. It should be noted that few of the studies 
attempted to control for all of these major risk factors. Also, the 
epidemiological studies have not attempted to compare the attributable 
risks of developing ischemic heart disease from dioxins to these other 
risk factors and have not reported the data in a manner that would 
allow the quantification of these comparisons. It may be possible to 
obtain some of this data and reanalyze it in order to address these 
questions. However, at present this analysis is not available.''
     I am encouraged by the possibility Dr. Birnbaum mentioned 
of calculating the amount of risk contributed by dioxin exposure and 
comparing the amount contributed by other risk factors in developing 
IHD. How might such data be obtained and analyzed in order to calculate 
the amount of risk? What would be the level of effort and cost involved 
in such an undertaking?
    Response. The PDDM Committee recommended that an independent 
Science Review Board would attempt to make such assessments of service 
attributable fraction. The report addresses the analytic techniques and 
methods used to estimate attributable risk. To calculate a service-
attributable fraction and make a comparison to the contributions of 
other factors, data would ideally be available from a cohort of 
veterans on the suite of factors of interest. The level of effort and 
costs would depend on the approach taken and the future possibilities 
of carrying out cohort studies of veterans through linkages of their 
exposure information to health data obtained from electronic medical 
records. Approaches based on intensive collection of data from 
individuals, while likely to be more informative, would be more costly; 
well established cohort studies, like the Framingham study of 
cardiovascular disease, exemplify this approach.

    Question 4. In correspondence with the Veterans' Affairs Committee, 
Dr. Birnbaum commented that ``if there is a desire to derive a [TCDD] 
blood concentration that does not increase the risk of ischemic heart 
disease, it may be best to set up an expert panel that is designed to 
specifically answer this question.''
     How would an expert panel derive such a value? What would 
be the level of effort and cost involved in such an undertaking?
    Response. I have not spoken with Dr Birnbaum about the proposal for 
using an expert panel to ``* * * derive a [TCDD] blood concentration 
that does not increase the risk of ischemic heart disease.'' Given the 
lack of relevant human data, the panel would need to rely on findings 
from animal models. However, according to VAO Update 2000, 
``establishing a correlation between the effects of TCDD in 
experimental systems and in humans, however, is particularly 
problematic because species differences in susceptibility to TCDD have 
been documented.'' Additionally, animal models may not accurately 
reflect ischemic heart disease in people. Thus, I am uncertain as to 
the evidence that would be considered by the panel.

    Question 5. In response to a question from Senator Webb with 
respect to the extent to which common risk factors for developing IHD 
may have attributed to the elevated risk observed in the studies 
reviewed by the IOM Update 2008, you explained that dioxin exposure can 
also increase the risk for developing many of the risk factors for IHD, 
further complicating the examination of whether such risk factors have 
a stronger association than dioxin exposure.
    I understand from Dr. Diane Bild's testimony that age is the 
strongest risk factor for developing IHD, and that other major risk 
factors include smoking, physical inactivity, poor diet, and family 
history of heart disease. While I have learned that the studies 
reviewed by the IOM Update 2008 controlled for the risk factor of age, 
these other risk factors were not controlled for in the mortality 
studies.
     In your view, does dioxin exposure increase the risk for 
these other IHD risk factors? Do these other risk factors increase the 
risk for developing IHD without regard to any complicating effect of 
dioxin exposure?
    Response. Prior VAO Update reports have reviewed evidence showing 
associations between herbicide exposure and risk factors for IHD, 
specifically hypertension and DM Type II, both of which are known 
causal risk factors for IHD. Consequently it would be difficult to 
determine whether dioxin exposure may increase risk for IHD directly or 
indirectly by increasing risk for these two causal factors.

    Question 6. In response to a question from Senator Webb, Dr. 
Birnbaum discussed the value of the dose-response findings in the Air 
Force Health Study (AFHS), one of the studies referenced in the IOM 
Update 2008 as suggestive of an association between IHD and dioxin 
exposure.
    The AFHS states that ``[e]xtrapolation of the serum dioxin results 
to the general population of ground troops who served in Vietnam was 
difficult because Ranch Hand and ground troop exposure situations were 
very different. Based on serum dioxin testing results obtained by the 
CDC and others, nearly all ground troops tested had current levels of 
dioxin similar to background levels. Even combat troops who served in 
herbicide-sprayed areas of Vietnam had current level similar to those 
in men who never left the United States * * *. There is little 
scientific basis for an extrapolation of these results to the larger 
population of Vietnam veterans * * *. These possibilities and a 
multitude of factors * * * suggest that existing data do not provide an 
adequate basis for extrapolation.'' [section 1.6.8 of AFHS]
     To what extent should the findings of the AFHS be 
extrapolated to the general Vietnam veteran population, in light of the 
above caveat?
    Response. The most recent AFHS (Ranch Hand) findings were reported 
by Ketchum and Michalek (2005). As summarized in Table 9-5 of the IOM 
VAO Update 2008, there was not a clear dose-response relationship of 
circulatory disease mortality with serum TCDD concentrations. A dose-
response relationship was observed in other studies composed of non-
military personnel.
    It is true that the Ranch Hand cohort was thought to be among the 
most heavily exposed military population in Vietnam. It is a common 
approach in public health to evaluate health effects in the most 
exposed group for identifying hazards.
    Whether information obtained in Ranch Handers should be 
extrapolated to the ground troops is an open question since their 
exposure levels are not known. The quotation below is relevant to the 
extrapolation question:

        ``AFRL-HE-BR-TR-2007-0070
        Air Force Health Study--Summary of Findings in the Ranch Hand 
        Group

        3.9. EXTRAPOLATION TO ARMED FORCES GROUND TROOPS
        Extrapolation of the serum dioxin results to the general 
        population of ground troops who served in Vietnam is 
        problematic because Ranch Hand and ground troop exposure 
        situations were very different from one another. Based on serum 
        dioxin testing results obtained by the CDC (7) and others (8), 
        nearly all ground troops tested had 1987 levels of dioxin 
        similar to background levels. Even combat troops who served in 
        herbicide-sprayed areas of Vietnam had 1987 dioxin levels 
        similar to those in men who never left the United States (with 
        average dioxin levels of 4.2 ppt and 4.1 ppt, respectively). 
        Little scientific basis for an extrapolation of these results 
        to the larger population of Vietnam veterans exists. The 
        possibility that a limited number of veterans could have been 
        exposed to levels of dioxin comparable to the Ranch Hand 
        veterans cannot be excluded, but because blood or adipose 
        tissue were not collected immediately after their return from 
        Vietnam, the actual exposures of these veterans cannot be 
        known. Others may have received long-term low-dose exposure. 
        These possibilities and a multitude of factors, including 
        differential elimination and exposures to other persistent 
        organic pollutants, suggest that existing data do not provide 
        an adequate basis for extrapolation.''

    Question 7. During the hearing, Former Secretary of Veterans 
Affairs Anthony Principi described the uncertainties of the presumption 
process for conditions that IOM has found to have only limited or 
suggestive evidence of an association with herbicide exposure. Mr. 
Principi provided the following three suggestions for improving the 
process:

     Commission studies that might differentiate between 
servicemembers who received significant exposure to dioxin in Vietnam 
and those whose exposure was insignificant or nonexistent in order to 
base presumptive service connection decisions on stronger scientific 
evidence. Mr. Principi suggested that such studies might replicate the 
Centers for Disease Control's Vietnam Experience Study.
     Commission IOM to provide VA with an estimate of a latency 
period for illness; that is, a point after which it is no longer likely 
that the onset of the illness is due to exposure, but instead due to 
other factors.
     Commission IOM to estimate the number of Vietnam veterans 
who might be affected by an illness found by IOM to have only limited 
or suggestive evidence of an association with herbicide exposure.

    I would appreciate your views on Mr. Principi's suggestions.
    Response. As these topics were not addressed by the PDDM Committee, 
the following responses reflect my own views and not those of the 
Institute of Medicine. With regard to Mr. Principi's first point, 
several IOM study committees have recommended the desirability and 
value of conducting longitudinal studies in military personnel to 
better understand long term health effects due to military service that 
were not evident when the servicemember left active duty. Of course, 
various such studies have been carried out on Vietnam veterans and 
further studies could be done today by enrolling surviving Vietnam 
veterans into a cohort study, making comparison to non-deployed 
Vietnam-era veterans. However, a new cohort study would be unlikely to 
be informative on the consequences of Agent Orange exposure, given the 
uncertainties associated with any attempt to estimate exposures for 
individual cohort members. Of note, a recent IOM report entitled ``The 
Utility of Proximity-based Herbicide Assessment in Epidemiology Studies 
of Vietnam Veterans'' suggested approaches to advance retrospective 
estimation of exposures using sophisticated reconstruction modeling of 
herbicide spraying operations in country.
    Regarding the second recommendation, that IOM investigate the time 
course (``latency'') of the adverse effects of herbicides, the 
requisite data are not available to the best of my knowledge. The data 
needed for this purpose would track the relative risk across the course 
of follow-up with sufficient precision to determine the temporal 
pattern of the relative risk. Whether a decline in relative risk over 
time would be anticipated from a biological perspective could be 
explored by the IOM, though the relevant evidence may be too limited to 
provide a sufficiently certain answer to the question posed by Mr. 
Principi. Certain clinical endpoints, such as selected cancers, might 
not become manifest until several decades elapsed following exposure.
    Regarding the third recommendation, IOM could make such 
calculations, drawing on available literature and estimates of the size 
of the exposed population. While such estimates could be made, they 
would be subject to various sources of uncertainty. They would provide 
an indication of the numbers of cases attributable to Agent Orange for 
these disease associations. The PDDM committee recommended that an 
independent scientific review board also estimate to what extent that 
condition might be due to specific military exposure verses other non-
military factors.

    Question 8. If Congress called for a Vietnam veteran health study, 
what would be the value of such a study for addressing uncertainties of 
the presumption process? Should such a study continue throughout a 
veteran's lifetime? Should there be multiple studies uniquely designed 
for each wartime veteran cohort? What would be the most critical 
information to be sought from such a study?
    Response. Our PDDM committee commented on the high importance and 
relevance of prospective studies among veterans. However, whether a new 
study initiated at present could prove informative is not clear. Any 
new study could not address Agent Orange directly; instead, inferences 
would have to be based on comparison of Vietnam veterans to non-
deployed veterans of the same era. Implementing an informative study 
would require substantial effort and useful results might not be 
forthcoming for a number of years. Perhaps, an assessment could be 
carried out as to the feasibility and costs of mounting a new study, 
along with an assessment of the potential for obtaining results that 
would be useful.
    The PDDM Committee's report provides an extensive discussion of the 
need for prospective cohort studies of veterans. The Committee did 
recommend that each wartime group of veterans should be separately 
studied, as each may have unique exposures and experiences. Most 
critically, exposures would be prospectively assessed so that the 
cohort studies undertaken would be informative on a broad array of 
questions, including concerns that may not have been anticipated when 
the cohort was established. The report of the PDDM Committee provides 
general guidance.

    Question 9. I understand that the IOM Committee that you chaired 
recommended the establishment of an independent Science Review Board to 
assist the Secretary in the presumptive disability decisionmaking 
process. The Committee described a two-step process through which the 
Science Review Board would function.
     How would the two-step process of the Science Review Board 
address the uncertainties in the current presumption process?
    Response. The Science Review Board (SRB) would use a two-step 
process. In step one, published literature would be reviewed to 
determine the strength of the evidence to assess whether a given health 
outcome can be caused by a given exposure. This scientific review is 
very much like the role of IOM in the current process. The PDDM 
Committee recommended, however, that the target for the review should 
be the likelihood of causation, and not simply statistical association. 
The Committee developed a categorization schema with four levels for 
grading the strength of the scientific evidence in ascending order. If 
the strength of the scientific evidence reached level two or one (50% 
or more likelihood of causation), the process would move on to step two 
in the recommended process.
    In step two, the SRB would estimate the service-attributable 
fraction of disease if the required data and information were 
available. This second step assesses how much of the observed disease, 
both in absolute and relative terms, can be attributed to the exposure. 
The calculation is independent of the classification of the strength of 
evidence for causation, and the magnitude of the service-attributable 
fraction is not considered in categorizing evidence. Rather, the 
service-attributable fraction would be of value for decisionmaking, 
giving an understanding of the scope of the population to be covered by 
a presumption.
    In step two, the SRB would consider the extent of exposure among 
veterans and subgroups of veterans, as well as dose-response 
relationships. A critical element in the deliberations of the SRB would 
be any evidence available on exposures and the health of veterans. When 
such information is available, the board would estimate the service-
attributable fraction and the related uncertainty. The purpose of step 
two is to convey the impact of the exposure on veterans as a whole for 
the purpose of decisionmaking and planning, but not to serve, 
inappropriately, as an estimate of probability of causation for 
individuals. Some exposures may contribute greatly to the disease 
burden of veterans, while other exposures (even with a known causal 
effect) may have a small impact overall. This additional information 
would be useful to VA in its decisionmaking as to whether a presumption 
should be made for the veteran population in general, for subgroups, or 
not at all. In the absence of service-attributable fraction data, we 
assume that the VA would consider presumptions based on the information 
contained in step one.
    There are a number of potential beneficial consequences of the 
proposed SRB. It would give VA outside, independent evidence-based 
advice synthesizing the best available data that could inform the 
relationship between exposures and outcomes in veterans.
    IOM committees are currently performing step one of the roles 
envisioned for the SRB. If this new model were to be adopted, the 
function of the current committees would need to be expanded to 
evaluate how much of the disease burden in veterans is due to these 
presumed exposures (the service-attributable fraction).

    Question 10. The IOM Committee that you chaired recommended 
causation, not just association, as the target for determining a 
presumption of service-connection for health conditions.
    I understand the presumptions process attempts to address two 
uncertainties relating to the relationship between dioxin exposure and 
health outcomes: the uncertainty that an exposure to an herbicide 
leads, in at least some cases, to illness and the uncertainty that an 
individual veteran's illness was caused by that exposure.
     While you stated in your testimony that the lack of 
exposure data seems to preclude a causal analysis for an individual 
veteran's illness, would a causal analysis be appropriate for purposes 
of examining whether an exposure to an herbicide leads, in at least 
some cases, to illness in the presence of reliable exposure data?
    Response. Our committee concluded that the basis for decisionmaking 
should be causation and not just association. The proposed approach 
incorporates all of the relevant evidence, both from epidemiological 
studies and from other lines of investigation. The Committee's report 
provides guidance on causal inference. A commonly accepted set of 
criteria, sometimes referred to as the Bradford Hill criteria for 
causation, include a proper temporal relationship between cause and 
effect, strength of association, a dose-response relationship, 
consistency of response, plausibility, ruling out alternative 
possibilities, proof by controlled experiment, specificity of effect, 
and coherence with existing knowledge and theory.
    In step one of the process--determining that an exposure can cause 
an effect--exposure data is needed, of course. To find an association 
and to infer causality, it is necessary to demonstrate that the 
exposure occurred before the effect (correct temporal relationship); 
that more exposure leads to greater effect in the number or severity of 
cases (dose-response); and that several different studies showed the 
same general finding (consistency). Such findings might be made in 
epidemiological analyses if exposures could be assigned to specific 
groups with sufficient accuracy, even if exposures could not be 
accurately designated for individuals.

    Question 11. When examining the link between an exposure and a 
health outcome, does a causal analysis require a higher quality of 
exposure data, as compared to an analysis examining only association? 
Are job classifications, soil samples, and residential locations valid 
indicators for examining dioxin exposure for a study cohort? To what 
degree should such indicators, as opposed to human biological samples, 
be relied upon for examining association and causation?
    Response. An analysis limited to association considers only the 
findings of epidemiological studies while a causal analysis considers 
the full range of evidence. Mechanistic evidence may give strong 
support to causation. The quality of exposure information is of 
comparable relevance and importance to assessments of either 
association or causation. In classifying exposures to dioxin, all 
relevant sources of data should be considered; each has limitations and 
attendant uncertainties. Biomarker data, when available, may be very 
useful for classifying exposure, particularly if they cover a 
biologically relevant interval for causation.

    Question 12. In response to pre-hearing questions, Dr. Bild 
explained the level of increased risk for each of the major risk 
factors for developing IHD. If a health study examines only service-
connected exposures and health status of individual veterans, without 
collecting data on lifestyle behaviors, what would be the potential 
limitations of the study's findings?
    Response. As mentioned, all factors that can contribute toward an 
effect should be measured. If the comparison groups used in these 
studies had the same level of these unmeasured factors as the exposed 
population, then the effect of these unmeasured factors would cancel 
out. However one would not know this unless these important factors 
were measured, documented, reported and properly adjusted.

    Question 13. During the hearing, I asked you if a different 
approach comparing disease levels among Vietnam veterans and the 
general population would be more likely to identify diseases that may 
be associated with Vietnam service. You stated:

    ``I would say that we have the tools to do that. It would require a 
large effort and measurement of many factors. And in the end, I think 
in the case of trying to retrospectively do this we would be left with 
an imperfect and uncertain answer.''
     Can you elaborate on your answer regarding a retrospective 
study yielding imperfect and uncertain results?
    Response. In responses to other questions, I have already addressed 
this issue. The model proposed by the PDDM Committee is to be 
implemented prospectively.

    Question 14. In response to a question from Senator Webb on 
uncontrolled risk factors in the studies cited in the IOM Update 2008, 
Dr. Diane Bild stated:

        ``Those studies [examined] the relationship of dioxin and IHD 
        mortality. They were able to adjust for age but were not 
        necessarily all able to take into account other so-called 
        confounders, such as smoking. For example, if somebody was 
        exposed to dioxin also happened to [be in a] group with a 
        higher smoking rate, the IHD could be attributable to smoking 
        rather dioxin and that would not be apparent from the study if 
        you did not have the data on smoking and were unable to adjust 
        for it in the analysis.''

     If a study is unable to control for multiple risk factors 
for IHD, such as smoking, obesity, or physical inactivity, how might 
each additional uncontrolled risk factor affect the uncertainty of the 
relative risk calculation for the association between dioxin exposure 
and IHD? How would a researcher account for such uncertainty in 
determining whether the findings of a study are reliable?
    Response. If control is not possible for other risk factors, there 
is concern for the possibility of confounding--that is, the effect of 
dioxin is incorrectly estimated because it is ``contaminated'' by the 
effects of other, uncontrolled factors. It is possible, using external 
information on the relative risk associated with the confounding 
factor, to estimate the potential magnitude of any bias. Comparability 
of findings across multiple studies, which may have differing potential 
confounding factors, weighs against confounding as the explanation for 
the association of the exposure of interest with the health outcome.

    Chairman Akaka. Thank you very much. Next, we have two 
witnesses from NIH, Dr. Diane Bild from the National Heart, 
Lung, and Blood Institute, and Dr. Linda Birnbaum, from the 
National Institute of Environmental Health Sciences. Both have 
been asked to provide insight on IHD and its major risk factors 
and to address what role science is currently capable of with 
respect to determining an association between dioxin exposure 
and IHD and other diseases common to aging.
    Will you please begin, Dr. Bild and following you will be 
Dr. Birnbaum. Dr. Bild.

  STATEMENT OF DIANE BILD, M.D., M.P.H., ASSOCIATE DIRECTOR, 
  PREVENTION AND POPULATION SCIENCES PROGRAM, NATIONAL HEART, 
    LUNG, AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH

    Dr. Bild. Mr. Chairman and Members of the Committee, thank 
you for the opportunity to appear before you on behalf of the 
Acting Director of the National Heart, Lung, and Blood 
Institute of the National Institutes of Health.
    I was asked to address our current understanding of 
ischemic heart disease, or IHD, including information on known 
risk factors and the extent of those risks for developing the 
disease, methods of diagnosis and treatment, physician 
qualifications for treating IHD, its prevalence among men over 
age 60, and the relationship between dioxin exposure and IHD.
    Atherosclerotic plaque begins to develop in humans during 
the first two decades of life in the form of ``fatty streams'' 
inside the artery walls. I brought along this diagram to help 
illustrate the process. This is meant to show an artery at 
different stages throughout life and the ``fatty streams'' that 
I referred to that begin early in life are shown here. This is 
the lumen of the artery where the blood flows.
    A good example of the evidence that this disease starts 
early in life was a landmark study published in 1953 that found 
visible evidence of coronary plaque in 77 percent of U.S. 
casualties in Korea. The average age of these young solders was 
22. This study opened our eyes to the fact that coronary 
disease or IHD starts early and generally progresses throughout 
life. For most people this plaque causes no symptoms but for 
some people later in life it may eventually rupture, blocking 
the artery as shown here, leading to chest pain or angina or 
heart attack, also known as myocardial infarction or MI. By the 
eighth decade of life, almost all Americans have some plaque in 
their arteries.
    The major causes of IHD are smoking, dyslipidemia--that is 
high LDL, ``bad cholesterol,'' or low HDL, ``good 
cholesterol''--high blood pressure, and diabetes. Sedentary 
lifestyle, poor diet, obesity, and psychosocial factors such as 
stress and depression are also believed to contribute to IHD 
and altogether these factors account for 80 to 90 percent of 
IHD.
    I mentioned several forms of IHD. I will briefly mention 
how they are diagnosed. The diagnosis of angina is usually 
based on symptoms of chest pain or shortness of breath, 
particularly upon exertion. Because these symptoms can be 
nonspecific, some testing is needed to confirm the diagnosis--
exercise testing with an electrocardiogram, echocardiogram, 
nuclear imaging, or angiography, which demonstrates the actual 
narrowing in the artery if present. The diagnosis of an acute 
MI or heart attack is made on the basis of similar symptoms but 
they are usually more severe and prolonged, plus a certain 
pattern on the electrocardiogram and elevation of cardiac 
enzymes in the blood.
    Internal medicine, family practice, and general practice 
physicians in the U.S. are all trained to recognize the typical 
symptoms of IHD and understand the need for prompt treatment in 
the acute setting. Treatment guidelines from respected 
professional organizations are readily available and widely 
promulgated. Most physicians who do not feel comfortable 
diagnosing or treating IHD will refer to a subspecialist, 
generally a cardiologist.
    I was asked to address the prevalence of IHD. In the U.S., 
17 percent of men aged 60 to 69 and 26 percent of men 70 to 79 
report having IHD. In addition, a larger proportion will have 
atherosclerotic plaque, of which they are unaware, which brings 
the total of men age 60 to 79 with symptomatic or asymptomatic 
disease to about 80 or 90 percent.
    Treatment of IHD involves aggressive modification of the 
risk factors mentioned earlier, such as blood pressure, lipids, 
with medication or lifestyle changes, daily aspirin, or more 
invasive interventions to treat specifically narrowed arteries 
with coronary bypass or angioplasty.
    Dr. Birnbaum is going to address the relationship between 
dioxin and IHD in more detail. My only comment is to say that 
although the National Academy of Sciences concluded that dioxin 
exposure does appear to be associated with IHD mortality, the 
association is modest and most of the studies could not be 
adjusted for confounders such as smoking that might have 
contributed to the risk. This has been discussed in some detail 
earlier in these proceedings. It is also impossible to 
determine in a given individual if dioxin was responsible for 
their IHD.
    Thank you again for this opportunity to provide information 
on this topic. I would be pleased to try to answer any 
questions that you have.
    [The prepared statement of Dr. Bild follows:]
Prepared Statement of Diane Bild, M.D., M.P.H., Associate Director for 
    Prevention and Population Sciences, Division of Cardiovascular 
     Sciences, National Heart, Lung, and Blood Institute, National 
   Institutes of Health, U.S. Department of Health and Human Services
    Mr. Chairman and Members of the Committee, thank you for this 
opportunity to appear before you on behalf of the Acting Director of 
the National Heart, Lung, and Blood Institute, part of the National 
Institutes of Health, an agency of the Department of Health and Human 
Services (HHS). I was asked to address current understanding of 
ischemic heart disease, or IHD, including information on known risk 
factors and the extent of those risks for developing the disease, 
methods of diagnosis and treatment, physician qualifications for 
treating IHD, its prevalence rates among males over age 60, and the 
relationship between dioxin exposure and IHD.
    Atherosclerotic plaque begins to develop in humans during the first 
two decades of life in the form of ``fatty streaks'' inside the artery 
walls. A landmark study published in 1953 found gross evidence of 
coronary plaque in 77.3% of U.S. fatalities in Korea. The average age 
of these young soldiers was 22 years. This eye-opening study taught us 
that coronary disease or IHD starts early and generally progresses 
throughout life. These findings have been repeatedly confirmed. For 
most people this plaque causes no symptoms, but for some persons later 
in life it may eventually ``rupture,'' blocking an artery and leading 
to symptoms including chest pain or angina, or heart attack (myocardial 
infarction, known as MI). By the eighth decade of life almost all 
Americans have some plaque in their arteries.
    The major causes of IHD are smoking, dyslipidemia (high low-density 
lipoprotein [LDL] cholesterol and/or low high-density lipoprotein [HDL] 
cholesterol levels), high blood pressure, and diabetes. Sedentary 
lifestyle, poor diet, obesity, and psychosocial factors such as stress 
and depression are also believed to contribute to IHD. Together these 
factors account for 80 to 90% of IHD.
    The diagnosis of angina is based on symptoms of chest pain and 
shortness of breath, particularly upon exertion. The diagnosis of acute 
MI or heart attack is made on the basis of similar but usually more 
severe symptoms, a certain pattern on an electrocardiogram, and 
elevation in cardiac enzymes measured in the blood. Diagnostic testing 
for IHD may include exercise electrocardiogram; nuclear testing with 
exercise; echocardiography with exercise; computed tomography (CT), 
including CT angiography; or conventional angiography. Stress testing 
would never be performed on someone suspected of having an acute MI.
    Primary care, internal medicine, family practice, and general 
practice physicians in the U.S. are all trained to recognize the 
typical symptoms of IHD and understand the need for prompt treatment. 
Treatment guidelines from respected sources are readily available and 
widely promulgated. Most physicians who do not feel comfortable 
instituting or changing treatment for IHD would refer to a 
subspecialist.
    In the US, 17% of men aged 60-69 and 26% of men aged 70-79 report 
having IHD. These proportions have remained stable since 1996, as 
indicated by the National Health Interview Survey of HHS's Centers for 
Disease Control and Prevention. Three of four men 60-69 years old and 
80% of men 70-79 who do not report having IHD would be expected to have 
coronary atherosclerotic plaque. Combining these estimates, 
approximately 80-90% of men aged 60-79 would be expected to have either 
symptomatic or asymptomatic IHD.
    Treatment of IHD includes aggressive treatment of the risk factors 
mentioned earlier with medication and lifestyle changes, daily aspirin, 
and more invasive interventions as indicated, including coronary artery 
bypass or angioplasty.
    Although the National Academy of Sciences recently concluded that 
dioxin exposure does appear to be associated with II-ID mortality, the 
association is modest, and most of the studies in the NAS review could 
not be adjusted for the other factors I have just described, known as 
confounders. Men in these studies who had been exposed to dioxin also 
may have had other exposures that increased their risk of IHD, such as 
smoking. It is also impossible to determine in a given individual if 
dioxin caused the IHD. The specific risk factors for disease are more 
clearly identifiable in populations than in individuals.

    Thank you again for this opportunity to provide information on this 
topic. I would be pleased to try to answer any questions you may have.
                                 ______
                                 
Response to Pre-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
 Diane Bild, M.D., MPH, Associate Director, Prevention and Population 
 Sciences Program, National Heart, Lung, and Blood Institute, National 
                          Institutes of Health
    Question 1. Please describe ischemic heart disease (IHD), including 
the difference between symptomatic and asymptomatic ischemic heart 
disease, and indicate the major causes of the disease.
    Response. Ischemic heart disease (IHD) gets its name from ischemia 
or reduction of blood flow to the heart muscle due to blockage of the 
blood supply. Other terms for IHD are coronary heart disease and 
coronary artery disease, because the coronary arteries are the ones 
that supply blood to the heart muscle. Build-up of atherosclerotic 
``plaque'' in the coronary arteries is extremely common--plaque is the 
complex mixture of cells, fibrous connective tissue, fatty material, 
and sometimes cellular debris and calcification that may eventually 
lead to clinical, symptomatic ischemic heart disease.
    Atherosclerotic plaque is believed to begin developing in humans 
during the first two decades of life in the form of ``fatty streaks'' 
inside the artery walls. Plaque develops slowly over the decades and 
may reach a point, generally during older adulthood, when it 
``ruptures,'' tightly narrows an artery, and leads to symptoms 
including angina or heart attack (myocardial infarction). By the eighth 
decade of life almost all Americans have some plaque in their arteries, 
which may be identified at autopsy or by some types of imaging. 
However, for most people this plaque causes no symptoms.
    Asymptomatic IHD may be thought of in several categories: The 
smallest category in terms of numbers in the general population are new 
myocardial infarctions (MIs) that are silent, occurring without 
symptoms or detection. One-quarter to one-third of new MIs are silent. 
In another category, roughly 2-4 percent of the general population has 
asymptomatic or silent IHD--artery blockages that could be detected by 
stress testing. Finally, a higher proportion has coronary artery 
disease that does not significantly block the arteries. The prevalence 
of both symptomatic and asymptomatic IHD is higher in older men than in 
the general population.
    The major causes of IHD are smoking, dyslipidemia (high low-density 
lipoprotein (LDL) cholesterol and/or low high-density lipoprotein (HDL) 
cholesterol), hypertension (high blood pressure), and diabetes. 
Sedentary lifestyle and poor diet also contribute, in part by causing 
obesity, which is in turn related to IHD. Psychosocial factors such as 
stress and depression are also believed to contribute to IHD. Together 
these factors account for 80-90% of IHD in the United States.

    Question 2. Approximately what percentage of the major causes of 
ischemic heart disease is explained by lifestyle factors, and to what 
extent does each major factor increase an individual's risk for 
developing IHD?
    Response. Approximately 80-90% of IHD is explained by lifestyle 
factors, either directly or indirectly. For example, a factor such as a 
high cholesterol diet is an indirect factor because it may result in a 
high LDL-cholesterol level, which in turn is a direct cause of IHD.
    A contemporary international study of 15,152 cases of acute 
myocardial infarction and 14,820 controls (called INTERHEART) provides 
a good estimate of the percentage contribution of different lifestyle 
factors in men aged 55+. In this study, smoking, low fruit and 
vegetable consumption, low levels of exercise (regular participation in 
moderate or vigorous physical activity for 4 hours or more a week), low 
alcohol consumption (<3-4 times per week), hypertension, diabetes, 
abdominal obesity, psychosocial factors (reflecting depression, stress, 
life events, and locus of control), and a high ApoB/ApoA1 ratio (which 
indicates high LDL-cholesterol and low HDL-cholesterol) accounted for 
88.3% of all cases of acute myocardial infarction.
    In this same group, the ``attributable risk'' (AR, explained below) 
for each of these factors was as follows:



------------------------------------------------------------------------
                          Factor                                 AR
------------------------------------------------------------------------
Smoking...................................................        39.0%
Lack of fruit and vegetable consumption...................        10.1%
Lack of exercise..........................................        12.5%
Low alcohol consumption...................................        10.5%
Hypertension..............................................        15.7%
Diabetes..................................................         7.8%
Abdominal obesity.........................................        18.3%
Psychosocial factors......................................        23.7%
High ApoB/ApoA1 ratio.....................................        45.3%
------------------------------------------------------------------------

    These attributable risk figures represent the proportions of 
disease in the population that might be prevented by modifying each 
factor. For example, in the overall INTERHEART population, elimination 
of smoking could eliminate 39% of the acute MI cases. It is important 
to note several caveats about these data:

    1. The amount of the contribution of each of the factors depends on 
two characteristics: the prevalence of the factor in the population and 
the strength of the causal relationship to acute MI. Thus, if smoking 
rates decline, the AR due to smoking will decline.
    2. The ARs do not add up to 100%, because there is overlap in 
behaviors. For example, people with abdominal obesity tend to have more 
diabetes than people without abdominal obesity, so eliminating both 
factors does not mean that 7.8% + 18.3% = 26.1% of disease would be 
prevented.
    3. This type of analysis conveys the risk associated with whether a 
variable is present or absent, rather than considering different levels 
of a risk factor. For example, the risk of smoking 5 cigarettes per day 
is less than the risk of smoking 20 cigarettes per day, but this 
analysis sets smoking as any tobacco use in the previous 12 months.
    4. This analysis is based on an observational study, and the 
interpretation depends on statistical modeling and knowledge of the 
impact of the risk factors on disease. In some cases (exercise, fruit 
and vegetable intake, alcohol consumption, diabetes, and abdominal 
obesity), there is no clinical trial evidence to confirm that modifying 
the factor will reduce risk to exactly this extent.
    5. This is just one study, but it is a large one, and the 
relationships between these factors and IHD are generally what have 
been found in other studies.
    6. This unique, large study used acute MI as its endpoint. It is an 
extrapolation, but not an unreasonable one, that similar relationships 
would be found for the general broader category of IHD.

    Question 3. Do most primary care, internal medicine, and general 
practice physicians possess the necessary qualifications to competently 
diagnose and treat IHD?
    Response. Primary care, internal medicine, and general practice 
physicians in the U.S. are all trained to recognize the typical 
symptoms of ischemic heart disease and understand the need for prompt 
treatment. Treatment guidelines from the American College of Cardiology 
and American Heart Association (ACC/AHA) are readily available and 
widely promulgated (e.g., Kushner, et al. 2009 Focused Updates: ACC/AHA 
Guidelines for the Management of Patients with ST-Elevation Myocardial 
Infarction. JACC 2009;54:2205-41). Most physicians who do not feel 
comfortable instituting or changing treatment would refer to a 
subspecialist, but there is significant regional and economic variation 
in subspecialty access--for example, physicians in remote or 
underserved areas assume a greater portion of subspecialty care.
    Internal Medicine physicians receive specific training in 
cardiovascular disease, and in fact it accounts for 14% of the content 
on the internal medicine certification exam, of which about one-third 
of the questions are about ischemic heart disease.
    The American Board of Family Medicine, which certifies Family 
Practitioners, includes eight modules in its examination, including 
ambulatory medicine, emergent/urgent care, and hospital medicine, all 
of which include heart disease (https://www.theabfm.org/cert/
examcontent.aspx). Cardiovascular disease accounts for 12% of the in-
training examination content (https://www.theabfm.org/residency/
ite.aspx).
    While most internists and family practitioners are capable of 
overseeing routine diagnosis and optimal medical management, they would 
not be qualified to perform coronary angiograms, read nuclear/echo/PET/
CT images, implant coronary stents, or perform coronary bypass surgery. 
For these advanced imaging tests or invasive treatments, primary care 
physicians need to refer their patients to specialists.
    According to the Bureau of Labor Statistics, in 2007, internists 
made up 20.1% of all active practicing physicians (http://www.bls.gov/
oco/ocos074.htm). Cardiology is a subspecialty of internal medicine, 
and cardiologists comprise about 3% of all physicians (Watcher RM. NEJM 
2004;350:1935-36). Family practitioners and general practitioners made 
up 12.4% of practicing physicians. Most are trained as family 
practitioners, which means that they have had 3 years of training after 
completing medical school, and often been certified by the American 
Board of Family Medicine. Few are true general practitioners who have 
had only one year of post-medical school clinical training. At least 
one year of training after medical school is required for a license to 
practice medicine.

    Question 4. Does the prevalence rate of 17.2 percent for coronary 
artery disease in males ages 60-69, as reported by the Centers for 
Disease Control, represent the prevalence rate for IHD specifically or 
the broader category of all cardiovascular diseases?
    Response. The prevalence rate as reported by the Centers for 
Disease Control and Prevention (CDC) represents IHD specifically. This 
rate was derived from men who participated in the 2008 National Health 
Interview Survey and is based on self-report, where each respondent 
answered questions about whether a doctor or other health professional 
told him that he had coronary heart disease, angina, or a heart attack. 
The self-report method is generally accepted for measuring prevalence 
and trends in the general population. It is important to recognize that 
this is an estimate of clinically apparent or symptomatic disease. 
Because such a large proportion of the adult population in the U.S. has 
clinically silent or asymptomatic IHD, it is neither practical nor 
medically necessary to identify this much larger proportion on a 
routine basis.

    Question 5. Will the prevalence rate for IHD in males ages 60-69 
increase as the average age of the group increases? If so, what is the 
expected magnitude of any such increase over a ten year period?
    Response. The estimate of IHD for those aged 70-79 years was 26.3%, 
also based on the 2008 National Health Interview Survey.
    The rates of IHD for the 60-69 and 70-79 year olds agree closely 
with those obtained from CDC's Behavioral Risk Factor Surveillance 
System, which further shows that the reported prevalence has remained 
steady in these groups since 1996. Thus, one may expect that the cohort 
of 60-69 year olds will experience the prevalence of IHD noted above 
for 70-79 year olds 10 years later.

    Question 6. Do these prevalence rates include individuals who are 
not experiencing symptoms, but could be diagnosed with IHD based on 
test results alone? What do you estimate to be the prevalence rate of 
males ages 60-69 with either symptomatic or asymptomatic IHD?
    Response. Since the prevalence rates are based on self report 
rather than diagnostic testing results, they likely represent only 
symptomatic disease. The only exception would be asymptomatic men who 
underwent some type of screening for coronary artery disease and were 
then told that they had IHD. While such screening has become 
increasingly popular, it is expensive, not routinely recommended, and 
not generally covered by insurance, and therefore unlikely to have 
affected this figure.
    In the US, three-fourths of men 60-69 years old who do not report 
having IHD would be expected to have coronary atherosclerosis or 
plaque, based on a measure of coronary calcification, a marker of 
plaque. The amount of calcification, which reflects of the amount of 
plaque, may range from very small to substantial. (See http://www.mesa-
nhlbi.org/Calcium/input.aspx)
    Therefore, approximately 80% of men aged 60-69 would be expected to 
have either symptomatic or asymptomatic IHD.

    Question 7. Is it common practice for physicians to diagnose and 
treat asymptomatic IHD? What are some of the dangers of treating 
asymptomatic IHD identified by imaging alone?
    Response. While screening for asymptomatic IHD has been widely 
marketed since the mid-1990s, the National Heart, Lung, and Blood 
Institute is not aware of survey data on its use by physicians. While 
direct-to-consumer advertising would tend to increase its use, several 
other factors are likely to discourage screening. For example, informed 
professional groups that develop consensus practice guidelines, 
including the American College of Cardiology and the American Heart 
Association, do not support general screening, although they do suggest 
it as an option in selected circumstances. Screening procedures that 
can be performed without a physician's order tend to be expensive. For 
example, one company charges $395 for a coronary calcium scan, and 
another company that specializes in ultrasound testing charges $119 for 
the basic ``stroke and vascular disease'' screening package. These 
procedures are often not covered by insurance.
    Over the past six decades, the scientific community and public 
health advocacy groups have developed guidelines for when it is 
appropriate to implement screening, however the benefits of screening 
for asymptomatic IHD have not been demonstrated. Three of the most 
commonly used IHD screening techniques include coronary artery calcium 
(CAC) detection, which uses computed tomography (CT, a type of X-ray), 
carotid artery ultrasound, and stress testing. Of these, CAC screening 
has received the most attention recently because it has several 
features that make it a potentially attractive screening tool.
    However, the dangers of treating asymptomatic IHD identified by 
imaging alone are confounded by the disadvantages of implementing 
unproven screening strategies overall. These include:

     Turning healthy people into patients, causing worry
     Reassuring people inappropriately. The tests do not 
exclude the presence of plaque, and a negative test could lead persons 
to de-emphasize proven effective preventive measures such as control of 
other risk factors which may exist.
     Subjecting people to ionizing radiation
     Identifying incidental findings that are commonly found on 
X-ray, triggering follow-up diagnostic testing and interventions, most 
of which are unnecessary
     Creating the need for more testing to further elucidate 
IHD
     Providing medication for disease that never becomes 
symptomatic
     Leading a patient to undergo potentially unnecessary 
invasive interventions, such as angioplasty or bypass surgery, if 
further testing identifies blockages
     Incurring the costs of the testing

    When it comes to the dangers of treating asymptomatic disease per 
se, it should be noted that no proven effective treatment for 
asymptomatic IHD is known, other than treating individuals with 
established risk factors, such as high blood pressure or high LDL-
cholesterol, or initiating use of aspirin therapy. In rare cases, CAC 
testing may lead to further testing that identifies severe disease of 
the left main coronary artery, and physicians are likely to proceed 
with an intervention, such as coronary artery bypass.

    Question 8. What are the most effective preventive measures for 
IHD, and to what extent does each of the measures lower an individual's 
risk for adverse outcomes associated with IHD?
    Response. The most effective preventive measures for IHD are 
smoking avoidance and cessation, lipid-lowering, blood pressure 
control, weight control, and aspirin. Proper diet and exercise may 
achieve the goals of maintaining optimal blood pressure, lipids, and 
weight, but often medications are needed to lower blood pressure and 
LDL-cholesterol. Below is a general (and rounded) indication of the 
preventive potential of each of these strategies:



------------------------------------------------------------------------
                                             Reduction in
               Intervention                      IHD         References
------------------------------------------------------------------------
Smoking cessation........................          30-60%          1, 2
Lipid lowering (statin therapy)..........             30%             3
Blood pressure control...................             20%             4
Exercise.................................             20%             5
Aspirin..................................             30%             6
------------------------------------------------------------------------

References
    1. Ockene JK, et al. The relationship of smoking cessation to 
coronary heart disease and lung cancer in the Multiple Risk Factor 
Intervention Trial (MRFIT). Am J Public Health 1990;80:954-58.
    2. Thun MJ, et al. Age and exposure-response relationships between 
cigarette smoking and premature death in Cancer Prevention Study II: In 
Changes in Cigarette-Related Disease Risks and Their Implications for 
Prevention and Control. Smoking and Tobacco Monograph No. 8, Bethesda 
(MD): U.S. Department of Health and Human Services, Public Health 
Service, National Institutes of Health, National Cancer Institute, 
1997:383-475. NIH Publication No. 97-4213. http://cancercontrol 
.cancer.gov/tcrb/monographs/8/m8_4.pdf
    3. Thavendiranathan P, et al. Primary prevention of cardiovascular 
diseases with statin therapy: A meta-analysis of randomized controlled 
trials. Arch Intern Med 1006;166:2307-13.
    4. Blood Pressure Lowering Treatment Trialists' Collaboration. 
Effects of different blood-pressure-lowering regimens on major 
cardiovascular events: Results of prospectively-designed overviews of 
randomised trials. Lancet 2003;362:1527-35.
    5. Zheng H, et al. Quantifying the dose-response of walking in 
reducing coronary heart disease risk: meta-analysis. Eur J Epidemiol 
2009;24:181-92.
    6. U.S. Preventive Services Task Force. Aspirin for the primary 
prevention of cardiovascular events: recommendation and 
rationale. Ann Intern Med 2002;136:157-60.
                                 ______
                                 
Response to Post-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
  Diane Bild, MD, MPH, Associate Director, Division of Cardiovascular 
     Sciences, National Heart, Lung, and Blood Institute, National 
                          Institutes of Health
    Question 1. In response to a question from Senator Webb about the 
extent to which common risk factors for developing IHD may have 
[contributed] to the elevated risk observed in the studies reviewed by 
the IOM Update 2008, Dr. Linda Birnbaum testified that dioxin exposure 
can also increase the risk for developing many of the risk factors for 
IHD, further complicating the examination of whether such risk factors 
have a stronger association than dioxin exposure.
    I understand from your correspondence with the Veterans' Affairs 
Committee that age is the strongest risk factor for developing IHD, and 
that other major risk factors include smoking, physical inactivity, 
poor diet, and family history of heart disease. While I have learned 
that the studies reviewed by the IOM Update 2008 controlled for the 
risk factor of age, these other risk factors were not controlled for in 
the mortality studies.
     In your view, does dioxin exposure increase the risk for 
these other IHD risk factors? Would it be correct to say that these 
other risk factors increase the risk for developing IHD without regard 
to any confounding effect of dioxin exposure?
    Response. The ischemic heart disease (IHD) risk factors with which 
dioxin has most often been found to be associated are diabetes and 
hypertension. Based on my review of expert opinion, there appears to be 
more evidence for a relationship between dioxin and diabetes than 
between dioxin and hypertension, but neither relationship is strong. 
The October 2000 Institute of Medicine (IOM) report, Veterans and Agent 
Orange: Herbicide/Dioxin Exposure and Type 2 Diabetes, found ``limited/
suggestive evidence of an association between exposure to the 
herbicides used in Vietnam or the contaminant dioxin and Type 2 
diabetes,'' but noted that ``the increased risk, if any * * * appears 
to be small [and the] known predictors of diabetes risk--family 
history, physical inactivity, and obesity--continue to greatly outweigh 
any suggested risk from wartime exposure to herbicides.'' The published 
literature on associations between dioxin exposure and hypertension is 
insufficient to draw conclusions.
    It is correct that diabetes and hypertension greatly increase the 
risk of IHD regardless of dioxin exposure.

    Question 2. In response to a question that I asked with respect to 
men aged 60-69 who have IHD but no apparent symptoms, and the 
likelihood of their developing symptomatic disease, you explained that 
``[a]therosclerosis is a progressive disease, and by middle and late 
age, particularly in men in this country, there will be some plaque, 
early forms of coronary disease, detectable through some method. It is 
a relatively small proportion in the US. About 17% of men aged 60-69 
will report having IHD; that is, they have symptoms, [such as] a heart 
attack, [or] bypass surgery, so it is clinically apparent IHD, as 
opposed to the much larger proportion who have silent or asymptomatic 
disease that may never become clinically apparent.''
    I understand that CDC's NHANES prevalence data show an increasing 
IHD prevalence rate of 17.2 percent, 26.3 percent, and 43.9 percent for 
men aged 60-69, aged 70-79, and aged 80 and over, respectively.
     Would it be correct to say that while only approximately 
17.2 percent of men aged 60-69 exhibit symptomatic IHD, an additional 
26.7 percent of asymptomatic men aged 60-69 are predicted to develop 
symptomatic IHD by their eighties?
    Response. One would actually expect approximately one-third of men 
aged 60-69 who do not have IHD to develop it within 20 years.
    While intuitive, one cannot simply subtract 17.2 percent from 43.9 
percent to conclude that an additional 26.7 percent of men aged 60-69 
would develop IHD 20 years later. Many men in their 60s will die of 
causes other than IHD before they reach their 80s; they never have a 
chance to develop symptomatic IHD. In epidemiology, we call this 
phenomenon ``competing risks.'' Also, men who are now in their 60s were 
born 20 years later than men who are in their 80s. That means they 
began life and lived it in a healthier environment and therefore enjoy 
greater longevity; in epidemiology, we call this phenomenon a ``cohort 
effect.'' The U.S. population of men aged 80-89 is only 27 percent the 
size of the population of men aged 60-69 (according to the U.S. Census 
Bureau Population Division, estimates for 2009).
    According to data from three large NHLBI cohort studies that 
included 2,615 men aged 60-69 who did not have symptomatic IHD and who 
were followed for 17-21 years, 890 (34.0 percent) developed IHD during 
that period. Of the group that developed IHD, 251 (9.6 percent of the 
original 2,615) died from IHD, 382 (14.6 percent) developed IHD but 
were still alive at the end of the follow-up period, and 257 (9.8 
percent) developed IHD but died from other causes. Note that this 
cohort had more survivors to age 80-89 than one might expect based on 
the Census data because the studies started with groups that were 
healthier than the general population (i.e., they were without IHD); 
moreover, there was no ``cohort effect''--it was all one cohort of men 
born within the same 10-year calendar period.

    Question 3. In response to pre-hearing questions, you described the 
level of increased risk for developing IHD due to each of the major 
risk factors. If a health study examines only service-connected 
exposures and health status of individual veterans, without collecting 
data on lifestyle behaviors, what would be the potential limitations of 
the study's findings?
    Response. Failure of a study to collect data on lifestyle behaviors 
and analytically control for their confounding effects may lead 
investigators to impute false associations. An example of this comes 
from the recent controversy about whether postmenopausal hormone 
therapy reduces the risk of IHD in women. Numerous observational 
studies found an apparent protective effect of hormone therapy, but 
none of them measured socioeconomic status (SES)--a variable that 
ultimately proved to be quite important. Women with higher SES (i.e., 
more education and wealth) were more likely to take hormone therapy. 
They were also less likely to smoke or be overweight and more likely to 
have access to regular medical care and to engage in healthy lifestyle 
behaviors. Eventually, the Women's Health Initiative clinical trial--in 
which women from all walks of life were randomly assigned to take or 
not take hormones--definitively showed that taking hormones does not 
reduce the risk of heart attack and, in fact, may increase the risk.

    Question 4. In response to a question from Senator Webb with 
respect to the uncontrolled risk factors in the studies relied upon by 
the IOM Update 2008, you stated:

        ``Those studies [examined] the relationship of dioxin and IHD 
        mortality. They were able to adjust for age but were not 
        necessarily all able to take into account other so-called 
        confounders, such as smoking. For example, if somebody exposed 
        to dioxin also happened to [be in a] group with a higher 
        smoking rate, the IHD could be attributable to smoking rather 
        than to dioxin and that would not be apparent from the study if 
        you did not have the data on smoking and were unable to adjust 
        for it in the analysis.''

    If a study is unable to control for multiple risk factors for IHD, 
such as smoking, obesity, or physical inactivity, how would each 
additional uncontrolled risk factor affect the uncertainty of the 
relative risk calculation for the association between dioxin exposure 
and IHD? How would a researcher account for such uncertainty in 
determining whether a study's findings are reliable?
    Response. The level of uncertainty that results from failure to 
control for a confounder is related to how closely the confounding 
factor is linked to both the exposure and the disease of interest. With 
regard to dioxin exposure in Vietnam, ideally it would be useful to 
have information on health habits, such as smoking, among men who were 
and were not exposed. If, for example, one were able to determine that 
men who were exposed to dioxin had the same levels of risk factors 
before their dioxin exposure as men who were not exposed, one could 
conclude that confounding is less likely to be responsible for the 
findings that dioxin is associated with IHD.

    Chairman Akaka. Thank you. Thank you very much. And now we 
will hear from Dr. Birnbaum. Please proceed.

STATEMENT OF LINDA BIRNBAUM, Ph.D., D.A.B.T., A.T.S., DIRECTOR, 
 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SERVICES, NATIONAL 
    INSTITUTES OF HEALTH, AND DIRECTOR, NATIONAL TOXICOLOGY 
     PROGRAM, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Ms. Birnbaum. Mr. Chairman and Mr. Webb, I am pleased to 
appear before you today to present testimony on the 
relationship between dioxin exposure and the risk of ischemic 
heart disease. I am Linda Birnbaum and I am the director of the 
National Institute of Environmental Health Sciences of the 
National Institutes of Health, an Agency of the Department of 
Health and Human Services. I am also the director of the 
National Toxicology Program, an interagency program housed at 
NIEHS whose mission is to evaluate agents of public health 
concern by developing and applying tools of modern toxicology 
and molecular biology.
    Understanding the role that environmental and occupational 
exposures play in the development of chronic diseases can be 
challenging, particularly for diseases that have significant 
risk factors in addition to the chemical exposure. Thus, the 
task of estimating the quantitative role of Agent Orange and 
dioxin exposure in the development of ischemic heart disease in 
Vietnam veterans is clouded by the contributions of other risk 
factors, such as age, smoking, family history, body mass index, 
serum lipid concentrations, and other factors.
    In 2008, my colleagues and I published a systematic review 
that evaluated the evidence of an association between dioxin 
exposure and cardiovascular disease mortality in humans. We 
found that the group of highest quality studies reported 
consistent and significant dose-related increases in ischemic 
heart disease mortality and concluded that there is an 
association between dioxin exposure and mortality from ischemic 
heart disease and cardiovascular disease.
    Similarly, the Institute of Medicine concluded in 2008 that 
there is limited or suggestive evidence of an association 
between Agent Orange or dioxin exposure and ischemic heart 
disease. The IOM based this decision on an approach that used 
all the available data from epidemiological, toxicological, and 
mechanistic studies. There are several challenges and 
limitations of the toxicological and epidemiological studies. 
In experimental animals dioxin increases the severity and the 
incidence of cardiomyopathy that is already present in aging 
rats. Similarly, in humans dioxin is not causing a unique 
cardiovascular disease but is increasing the risk of developing 
ischemic heart disease which has significant background 
incidence.
    Thus, there are a number of other risk factors that can 
also influence the development of this disease. The 
epidemiological studies that the IOM evaluated and considered 
in their recommendations varied considerably in their attempts 
to address, adjust, or control for all the major risk factors 
of ischemic heart disease, such as age and smoking, high blood 
pressure, diabetes, and obesity. It should be noted that few of 
the studies attempted to control for all of the major risk 
factors.
    Also, the epidemiological studies have not attempted to 
compare the attributable risks of developing ischemic heart 
disease from dioxins to these other risk factors and have not 
reported the data in a manner that would allow the quantization 
of these comparisons. It may be possible to obtain some of 
these data and reanalyze them in order to address these 
questions. However, at present this analysis is not available.
    The timing of exposure is another question that arises in 
evaluating risk. The window of possible exposure during service 
in Vietnam adds a level of uncertainty to the actual exposure 
estimates that are based on blood levels measured much later 
on.
    It is also unclear from the studies available to us how 
much risk remains many years after exposure. Research in 
Seveso, Italy, showed an increase in the incidence of 
cardiovascular disease among people living in the most highly 
exposed areas after the 1976 accident that resulted in 
widespread dioxin exposure. But over time this effect 
dissipated.
    In contrast, a recent study from the Australian Department 
of Veterans' Affairs of their Vietnam War veterans observed a 
pattern of increased risk for ischemic heart disease with 
increase in time. A number of review activities in this area by 
different agencies of the U.S. Government, as well as the 
National Academy of Sciences and the IOM, have generated 
comprehensive reviews of the risk of dioxin exposure.
    For instance, in 2008, EPA released a literature search 
entitled ``TCDD Dose Response Studies: Preliminary Literature 
Search Results and Request for Additional Studies'' as part of 
an ongoing update of their dioxin reassessment. This literature 
search was reviewed by an outside panel of experts to ensure 
that all appropriate studies were identified with special 
emphasis on the latest literature.
    The summary from this workshop, which was held in February 
in Ohio, was released in June 2009. In addition, the IOM's 
report entitled ``Veterans and Agent Orange: Update 2008'' also 
provides a comprehensive and reliable source for the most 
current data on the health risks of dioxin exposure.
    Thank you again for this opportunity to testify on this 
important and difficult issue. I would be happy to answer any 
questions.
    [The prepared statement of Ms. Birnbaum follows:]
    Prepared Statement of Linda Birnbaum, Ph.D., D.A.B.T., A.T.S., 
Director, National Institute of Environmental Health Sciences, National 
 Institutes of Health, and Director, National Toxicology Program U.S. 
                Department of Health and Human Services
    Mr. Chairman and distinguished Members of the Committee: I am 
pleased to appear before you today to present testimony on the 
relationship between dioxin exposure and the risk of ischemic heart 
disease. My name is Linda Birnbaum; I am the Director of the National 
Institute of Environmental Health Sciences (NIEHS), of the National 
Institutes of Health, an agency of the Department of Health and Human 
Services, and Director of the National Toxicology Program (NTP), an 
interagency program, housed at NIEHS, whose mission is to evaluate 
agents of public health concern by developing and applying tools of 
modern toxicology and molecular biology. The program maintains an 
objective, science-based approach in dealing with critical issues in 
toxicology and is committed to using the best science available to 
prioritize, design, conduct, and interpret its studies.
    Understanding the role that environmental and occupational 
exposures play in the development of chronic diseases can be 
challenging, particularly for diseases that have significant risk 
factors in addition to the chemical exposure. Thus, the task of 
estimating the quantitative role of Agent Orange and dioxin exposure in 
the development of ischemic heart disease in Vietnam Veterans is 
clouded by the contributions of other risk factors such as age, 
smoking, family history, body mass index, serum lipid concentrations, 
and other factors. In 2008, my colleagues and I published a systematic 
review that evaluated the evidence of an association between dioxin 
exposure and cardiovascular disease mortality in humans.\1\ We found 
that the studies in the highest-quality group found consistent and 
significant dose-related increases in ischemic heart disease mortality 
and concluded that there is an association between dioxin exposure and 
mortality from ischemic heart disease and cardiovascular disease.
---------------------------------------------------------------------------
    \1\ Humblet O, Birnbaum L, Rimm E, Mittleman MA, Hauser R. 2008. 
Dioxins and cardiovascular disease mortality. Environ Health Perspect 
116:1443-1448.
---------------------------------------------------------------------------
    Similarly, the Institute of Medicine (IOM) concluded in 2008 that 
there is limited or suggestive evidence of an association between Agent 
Orange or dioxin exposure and ischemic heart disease. The IOM based 
this decision on an approach that used all the available data from 
epidemiological, toxicological, and mechanistic studies. There are 
several challenges and limitations of the toxicological and 
epidemiological studies. In experimental animals, dioxin increases the 
severity and incidence of cardiomyopathy that is already present in 
aging rats. Similarly in humans, dioxin is not causing a unique 
cardiovascular disease, but increases the risk of developing ischemic 
heart disease, which has a significant background incidence. Thus there 
are a number of other risk factors that can influence the development 
of this disease. The epidemiological studies that the IOM evaluated and 
considered in their recommendations for ischemic heart disease varied 
considerably in their attempts to adjust or control for all the major 
risk factors of ischemic heart disease, such as, age, smoking, high 
blood pressure, diabetes and obesity. It should be noted that few of 
the studies attempted to control for all of these major risk factors. 
Also, the epidemiological studies have not attempted to compare the 
attributable risks of developing ischemic heart disease from dioxins to 
these other risk factors and have not reported the data in a manner 
that would allow the quantification of these comparisons. It may be 
possible to obtain some of this data and reanalyze it in order to 
address these questions. However, at present this analysis is not 
available.
    The timing of exposure is another question that arises in 
evaluating risk. The window of possible exposure during service in 
Vietnam adds a level of uncertainty to the actual exposure estimates 
that are based on blood levels measured much later on. It is also 
unclear from the studies available to us how much risk remains many 
years after exposure. At least one study, the Australian Department of 
Veterans Affairs study of Vietnam War Veterans in that country, 
observed a pattern of increased risk for ischemic heart disease with 
time.\2\ In contrast, while there was an increase in the incidence of 
cardiovascular disease in Seveso, Italy, shortly after the 1976 
accident there that resulted in widespread dioxin exposure, this effect 
dissipated over time.\3\
---------------------------------------------------------------------------
    \2\ ADVA (Australian Department of Veterans Affairs). 2005b. The 
Third Australian Vietnam Veterans Mortality Study 2005. Canberra, 
Australia: Department of Veterans' Affairs.
    \3\ Consonni D, Pesatori AC, Zocchetti C, Sindaco R, D'Oro LC, 
Rubagotti M, Bertazzi PA. 2008. Mortality in a population exposed to 
dioxin after the Seveso, Italy, accident of 1976: 25 years of follow-
up. American Journal of Epidemiology 167(7):847-858.
---------------------------------------------------------------------------
    A number of review activities in this area, by different agencies 
of the U.S. Government as well as the National Academy of Sciences 
(NAS) and the IOM, have generated comprehensive reviews of the risks of 
dioxin exposure. For instance, In 2008, the EPA released a literature 
search entitled ``2,3,7,8-Tetrachlorodibenzo-P-Dioxin (TCDD) Dose-
Response Studies: Preliminary Literature Search Results and Request for 
Additional Studies,'' as part of an ongoing update of the Dioxin 
Reassessment. This literature search was reviewed by an outside panel 
of experts at a workshop to ensure that the all appropriate studies 
were identified, with special emphasis on the latest literature. The 
summary from this workshop, held on February 18-20, 2009, in 
Cincinnati, Ohio, was released by the EPA in June 2009. In addition, 
the IOM's report entitled Veterans and Agent Orange: Update 2008 also 
provides a comprehensive and reliable source for the most current data 
on the health risks of dioxin exposure.

    Thank you for inviting me to testify. I would be happy to answer 
any questions.
                                 ______
                                 
Response to Pre-Hearing Questions Submitted by Hon. Daniel K. Akaka to 
   Linda Birnbaum, Ph.D., DABT, ATS, Director, National Institute of 
   Environmental Health Sciences, National Institutes of Health and 
 Director, National Toxicology Program, U.S. Department of Health and 
                             Human Services
    Question 1. What is the most reliable and comprehensive source for 
the most current data on the health risks of dioxin exposure?
    Response. The series of documents included in the United States 
Environmental Protection Agency's (USEPA) Dioxin Reassessment are the 
most reliable and comprehensive sources for the most current data on 
the risks of dioxin exposure. The latest full version of the 
reassessment is the draft that was sent to the National Academy of 
Sciences (NAS) for review in 2004 entitled the ``NAS External Review 
Draft of the Dioxin Assessment''. However, since the 2004 document, the 
USEPA has released several other documents as part of the reassessment. 
In 2008 the USEPA released a literature search entitled ``2,3,7,8-
Tetrachlorodibenzo-P-Dioxin (TCDD) Dose-Response Studies: Preliminary 
Literature Search Results and Request for Additional Studies'' as part 
of an update of the reassessment. This report was reviewed by an 
outside panel of experts at a workshop to ensure that the all 
appropriate studies were identified, with special emphasis on the 
latest literature. The summary (Dioxin Workshop Summary report 
containing discussions and conclusions) from this workshop held on Feb 
18-20, 2009, in Cincinnati, Ohio was released by the USEPA in 
June 2009. The most recent addition to the Dioxin Reassessment entitled 
``EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and 
Response to NAS Comments (External Review Draft)'' was released on 
May 2010. This is a response to the NAS review of the 2004 draft dioxin 
reassessment. The draft response to the NAS review provides dose 
response analysis for low dose effects of dioxins in animals and 
humans. In summary, the above-cited documents provide the most recent 
and comprehensive review of the literature evaluating the risks 
associated with dioxin exposure. In addition, the Institute of 
Medicine's report entitled Veterans and Agent Orange: Update 2008 also 
provides a comprehensive and reliable source for the most current data 
on the health risks of dioxin exposure.

    Question 2. Given the currently available data for Viet Nam 
veterans, is it possible to calculate a quantitative estimate for the 
attributable and relative risks of developing ischemic heart disease 
from exposure to dioxin for males over the age of 60? If not, please 
describe the data limitations.
    Response. Complex chronic diseases are difficult to attribute to a 
single factor due to the challenges and limitations of toxicological 
and epidemiological studies. The strength of the relationship between 
TCDD exposure and ischemic heart disease is based on epidemiological, 
toxicological and mechanistic arguments, and this strength evidence 
approach makes it difficult to quantify attributable and relative risk. 
In addition, the epidemiological studies have not attempted to address 
this issue; thus, the data is not reported in a manner that would allow 
the quantification of these comparisons. It may be possible to obtain 
some of this data and reanalyze it in order to address these questions.

    Question 3. As a reviewer of the Institute of Medicine's Agent 
Orange Update 2008, please describe which, if any, of the studies 
relied upon by the IOM committee in reaching its determination reported 
a suggestive association between dioxin and ischemic heart disease 
after controlling for all of the major risk factors of ischemic heart 
disease, such as age, smoking, high blood pressure, diabetes and 
obesity.
    Response. The epidemiological studies that the IOM evaluated and 
considered in their recommendations for ischemic heart disease varied 
considerably in their attempts to adjust or control for all the major 
risk factors of ischemic heart disease, such as age, smoking, high 
blood pressure, diabetes and obesity. Below is a list of those studies 
that considered other risk factors and which of the risk factors they 
considered:

     Kang HK, Dalager NA, Needham LL, Patterson DG, Lees PSJ, 
Yates K, Matanoski G.M. 2006. Health status of Army Chemical Corps 
Vietnam veterans who sprayed defoliant in Vietnam. American Journal of 
Industrial Medicine 49(11):875-884. Adjusted for age, race, rank, body 
mass index (BMI) and smoking. Kang et al also compared risks in 
diabetics and non-diabetics but did not adjust for high blood pressure 
or family history.
     AFHS. 2005. An Epidemiologic Investigation of Health 
Effects in Air Force Personnel Following Exposure to Herbicides. 1997 
Follow-up Examination and Results. Brooks AFB, TX: Epidemiologic 
Research Division, Armstrong Laboratory. AFRL-HE-BR-SR-2005-0003. 
Adjusted for age, rank, race, smoking and drinking history, high-
density lipoproteins (HDL), cholesterol, HDL/cholesterol ratio, uric 
acid, diabetes, BMI or percent body fat, waist-hip ratio, family 
history of heart disease.
     Boehmer TK, Flanders WD, McGeehin MA, Boyle C, Barrett DH. 
2004. Postservice mortality in Vietnam veterans: 30-year follow-up. 
Archives of Internal Medicine 164(17):1908-1916. Adjusted for age, race 
and military occupation.
     Vena J, Boffeta P, Becher H, Benn T, Bueno de Mesquita HB, 
Coggon D, Colin D, Flesch-Janys D, Green L, Kauppinen T, Littorin M, 
Lynge E, Mathews JD, Neuberger M, Pearce N, Pesatori AC, Saracci R, 
Steenland K, Kogevinas M. 1998. Exposure to dioxin and nonneoplastic 
mortality in the expanded IARC international cohort study of phenoxy 
herbicide and chlorophenol production workers and sprayers. 
Environmental Health Perspectives 106 (Supplement 2):645-653. Adjusted 
for age and timing of exposure.
     Hooiveld M, Heederik DJ, Kogevinas M, Boffetta P, Needham 
LL, Patterson DG Jr, Bueno de Mesquita HB. 1998. Second follow-up of a 
Dutch cohort occupationally exposed to phenoxy herbicides, 
chlorophenols, and contaminants. American Journal of Epidemiology 
147(9):891-901. Adjusted for age and timing of exposure.
     Calvert GM, Wall DK, Sweeney MH, Fingerhut MA. 1998. 
Evaluation of cardiovascular outcomes among US workers exposed to 
2,3,7,8-tetrachlorodibenzo-p-dioxin. Environmental Health Perspectives 
106 (Supplement 2):635-643. Adjusted for age, sex, BMI, smoking, 
drinking, diabetes, triglycerides, total cholesterol, HDL, family 
history of heart disease, chemical plant.
     Kitamura K, Kikuchi Y, Watanabe S, Waechter G, Sakurai H, 
Takada T. 2000. Health effects of chronic exposure to polychlorinated 
dibenzo-p-dioxins (PCDD), dibenzofurans (PCDF) and coplanar PCB (Co-
PCB) of municipal waste incinerator workers. Journal of Epidemiology 
10(4):262-270. Adjusted for age, BMI, smoking.
     Consonni D, Pesatori AC, Zocchetti C, Sindaco R, D'Oro LC, 
Rubagotti M, Bertazzi PA. 2008. Mortality in a population exposed to 
dioxin after the Seveso, Italy, accident in 1976: 25 years of follow-
up. American Journal of Epidemiology 167(7):847-858. Adjusted for age, 
gender, period.

    Question 4. As a reviewer of the Institute of Medicine's Agent 
Orange Update 2008, please describe which, if any, of the studies 
relied upon by the IOM committee in reaching its determination of a 
limited or suggestive association reported elevated risks for ischemic 
heart disease associated with dioxin exposure beyond 20 years after 
suspected dioxin exposure.
    Response. Ketchum and Michalek (2005) examined the relationship 
between dioxin exposure and circulatory system disease in Vietnam War 
veterans in 1999. They concluded from this study that, ``The risk of 
death attributable to circulatory system diseases continues to be 
increased, especially for enlisted ground crew, a subgroup with 
relatively high skin exposure to herbicides.'' Since this is a study of 
Vietnam War veterans, these veterans were exposed between 1961, when 
spraying started, to 1974, when the last of the US troops left Vietnam. 
The mortality study collected data up to December 31, 1999. This study 
suggests that some of these veterans were exposed for at least 20 years 
when the study was completed. However, the study does not specifically 
examine onset of the disease post exposure.
    In addition, the IOM concluded that the ADVA (2005) study of 
Australian Vietnam War veterans displayed a pattern of increased risk 
for ischemic heart disease with time. The latter time period in this 
study was 1991-2001 which would suggest increasing risk 20 years after 
the initial exposure.
    In contrast, the incidence of cardiovascular disease in Seveso 
Italy was increased by dioxin exposure shortly after the accident and 
this effect dissipated over time (Consonni et al 2008).
     ADVA (Australian Department of Veterans Affairs). 2005b. 
The Third Australian Vietnam Veterans Mortality Study 2005. Canberra, 
Australia: Department of Veterans' Affairs.
     Consonni D, Pesatori AC, Zocchetti C, Sindaco R, D'Oro LC, 
Rubagotti M, Bertazzi PA. 2008. Mortality in a population exposed to 
dioxin after the Seveso, Italy, accident in 1976: 25 years of follow-
up. American Journal of Epidemiology 167(7):847-858.
     Ketchum NS, Michalek JE. 2005. Postservice mortality of 
Air Force veterans occupationally exposed to herbicides during the 
Vietnam War: 20-year follow-up results. Military Medicine 170(5):406-
413.

    Question 5. Does the scientific evidence indicate that an 
individual who has been medically determined to have developed ischemic 
heart disease more than 20 years after suspected exposure to dioxin is 
more likely than not to have developed ischemic heart disease as a 
result of a factor other than dioxin exposure?
    Response. No epidemiological studies have directly addressed this 
issue, thus there is no direct evidence to support or refute this 
statement.

    Chairman Akaka. Thank you very much, Dr. Birnbaum.
    Dr. Samet, in response to pre-hearing questions you noted 
that the lack of exposure data for Vietnam veterans precludes a 
determination of any increased risk of disease that might be 
caused by a specific exposure. The question is would an 
alternative approach comparing disease prevalence among Vietnam 
veterans and the general population more accurately identify 
diseases that are likely to be associated with Vietnam service?
    Dr. Samet. So without going into all the complexities of 
epidemiological research, I think the comparison that one would 
like to make is the risks of ischemic heart diseases or other 
diseases in those who were in Vietnam exposed to Agent Orange 
compared to a group of similar military personnel in Vietnam 
and not exposed, then absent that you look for alternatives 
that may be suitable to varying degrees depending on how 
similar or alike Vietnam veterans are, let us say, to the 
general population or any other group. If we try to make that 
comparison, let us say for ischemic heart disease, where we 
know there are many lifestyle factors, our ability to make that 
comparison with validity really hinges on how well we can 
measure all those relevant factors in the Vietnam veterans 
group and then equally make and compare to the general 
population, in essence trying to compare like to like, except 
for the Vietnam experience.
    I would say that we have the tools to do that. It would 
require a large effort and measurement of many factors. In the 
end I think, in the case of trying to retrospectively do this, 
we would be left with an imperfect and uncertain answer. I will 
in part use your question to say that the difficulty of 
retrospect reconstruction speaks to the need to really be 
thinking prospectively for those troops who are now receiving 
exposures, how not to be in this position 20, 30, or 40 years 
from now with collection of exposure data and prospective 
follow up.
    Chairman Akaka. Thank you. Dr. Birnbaum, your responses to 
pre-hearing questions suggest that the EPA's dioxin 
reassessment is the most reliable source on the health risks 
related to dioxin. What is EPA's most recent analysis on the 
association between dioxin and IHD?
    Ms. Birnbaum. The EPA's document is still undergoing final 
review by their science advisory board. The final meeting of 
that board will be the end of next month. But in the draft that 
has been released and is available for public comment there is 
a great deal of analysis of many of the different health 
impacts and review of the literature. It is clear from the 
wealth of animal studies in multiple animal species. It is 
clear from data from mechanistic studies, both in animals and 
cells in culture, including human cells, that dioxin can cause 
heart disease as a consequence. They have not directly 
quantitated the association between dioxin and ischemic heart 
disease in people.
    There does appear to be an association with cardiovascular 
disease more broadly defined in some of the studies. I think it 
is important that we mention the Ranch Hand Study, which was 
the long-term study conducted by the Air Force, the Air Force 
Health Study, which unfortunately ended in 2006. But in that 
study, in one of the last reports from it which has been 
published since then, there was a dose-related increase in the 
Ranch Handers with the highest measurable dioxins in their 
blood as compared to other veterans who had not served in 
southeast Asia but had served at the same time window. I think 
they did not explicitly look for ischemic heart disease in that 
study, which is one issue of many in the epidemiology studies, 
which makes them difficult to compare because not all of them 
looked for the same measures of effects on the cardiovascular 
system.
    Chairman Akaka. Dr. Bild, in your response to pre-hearing 
questions, you stated that approximately 80 or 90 percent of 
IHD is explained by lifestyle factors. You have explained the 
major factors that cause the disease. What can you share about 
what role, if any, scientists believe dioxin exposure plays in 
connection with the lifestyle factors?
    Dr. Bild. Are you asking what role dioxin plays in 
connection with the lifestyle factors to produce IHD?
    Chairman Akaka. Yes.
    Dr. Bild. Well, there are decades of very good evidence 
that link the lifestyle or risk factors that I discussed 
earlier with ischemic heart disease. Dr. Birnbaum and others 
are more expert than I am on the specific relationship between 
dioxin and IHD, but in general the 80 to 90 percent figure that 
I quoted was looking at all IHD and from models estimating that 
proportion attributable to the lifestyle factors in the 
population. Theoretically, if one were able to eliminate or 
modify all those factors, one would eliminate that amount of 
disease in the population.
    Now, in order to understand how dioxin might contribute to 
that you have to know the strength of its association with IHD, 
and we know some of that from the studies that Dr. Birnbaum has 
quoted. We have to also know the extent of exposure in the 
population at risk, which is a big unknown. So if you assume 
that the proportion of people exposed was low, then that 
attributable risk becomes very low. That is not really a 
question that I can answer.
    Chairman Akaka. Thank you. Senator Webb, you have 
questions.
    Senator Webb. Thank you, Mr. Chairman. I believe Mr. Samet, 
did you have a follow-on to that? You had your hand up.
    Dr. Samet. I wanted to comment, just because I think there 
may be a misimpression that if other lifestyle--if lifestyle 
factors cause 80 or 90 percent of coronary heart disease there 
is only 10 or 20 percent left over to be caused by other 
things. That is really not correct. If, let us say, dioxin or 
any other exposure amplifies the effects of these common 
lifestyle exposures which might be the case, then that is 
important to know and understand and best addressable by 
research. So the problem, in fact, is that these diseases are 
common because these risk factors are common. Then we have on 
top of that the question of how additional Agent Orange or 
other exposures might amplify this background.
    Chairman Akaka. Dr. Birnbaum.
    Ms. Birnbaum. I would also like to add to that. There is 
lots of evidence that indicates, certainly from, again, all the 
mechanistic studies, the animal studies, and from of the 
epidemiological studies, that dioxin can contribute to all of 
these common risk factors that we talked about. So for example, 
dioxin alters the triglyceride content. Dioxin is associated or 
can be associated with Type 2 diabetes which is a risk factor. 
Dioxin can be associated with elevated blood pressure, again, 
both in animal studies and in some human studies. And we know 
that dioxin can alter the vasculature as well. So I think the 
point that Dr. Samet made that you have interacting factors 
here that all may be involved is a very important one.
    Senator Webb. Thank you. Mr. Chairman, I would like to ask 
a couple questions. First of all, thank all of you for the 
details that you provided in your written statements and the 
follow-on questions. We have gone through those. There is a 
tremendous amount of valuable material here that will be useful 
to this Committee.
    Dr. Birnbaum, on your July 15 response, on the second page 
you were referring to the Steenland and Vena studies. Basically 
it says, based solely on those studies it would appear less 
likely that incidences of ischemic heart disease that occurred 
20 years after exposure are related to dioxin exposure. Your 
point was that if the condition had been manifested before the 
20th year that it would be more likely to be dioxin-related but 
if a person was later determined to have ischemic heart disease 
or in the 30th year after their suspected dioxin exposure, the 
credible evidence or an association between dioxin exposure and 
ischemic heart disease would be outweighed by the credible 
evidence against.
    Ms. Birnbaum. I may want to eat those words a little bit 
because I do not think we really understand. Some of the things 
that dioxin can do, it can permanently alter how our body 
functions. And once you permanently change the expression, for 
example, of certain genes, you cannot reverse those changes. 
And there may be critical windows of exposure. I think when we 
think especially about our veterans, especially in Vietnam, 
many of them were young men. And the additional stress that the 
early dioxin exposure, which may have in some ways set them up 
for all the additional risk factors that would occur later on, 
I think we have to think about that.
    I think there are different studies. There is a recent 
study which clearly shows--the Australian Veterans Study--
clearly shows that risk appears to increase with time since the 
Vietnam experience; and there is actually a suggestion of that 
again from the Ranch Hand Study. But the last Ranch Hand 
analysis was terminated before we could really find out whether 
it would continue to show the same.
    Senator Webb. I recall going through the original Ranch 
Hand Studies in great detail back in the late 1970s, looking at 
the mortality rates and the incidence, particularly the liver--
conditions of the liver were prominent back then.
    I am still curious to get your comments, collectively or 
whoever would like to comment, on the reason that the 
recommendation on ischemic heart disease was changed between 
2006 and 2008. Was this actual new scientific studies or was 
this as a result of further evaluation of studies that had 
already been done?
    Ms. Birnbaum. Science continues to advance. There is always 
new information which is incremental to what was known before 
and there are new approaches to the data so that there were 
several new epidemiological studies that were published in that 
time window. There were also additional mechanistic and animal 
studies that were published in that timeframe, all which added 
to the evidence that supported the limited association between 
ischemic heart disease and exposure to dioxin.
    I think the biggest problem that we face which has been 
referred to by many of the panelists is the fact that we really 
do not--frequently do not have good measures of what exposure 
was and continues to be in the affected people.
    Senator Webb. Dr. Bild, you mentioned in your oral 
statement--I think I wrote this down right--the studies cannot 
be adjusted for risk factors and that it is impossible to know 
if dioxin was instrumental. Would you like to comment further 
on that?
    Dr. Bild. Yes. I was reiterating statements that were made 
earlier and in part the scientific review that Dr. Birnbaum's 
group published which examined a set of studies on the 
relationship between dioxin and IHD mortality which were able 
to adjust for age but were not necessarily all able to take 
into account other so-called confounders such as smoking.
    So, for example, if those exposed to dioxin also happened 
to be part of a group that had a higher smoking rate, the IHD 
could be attributable to smoking rather than dioxin. But that 
would not be apparent from the study if you did not have the 
data on smoking and were not able to adjust for it in the 
analysis.
    Senator Webb. Well, Secretary Shinseki made a comment 
toward the end of his testimony; he had actually made a similar 
comment when I met with him, though I am not sure where this 
data comes from or what exactly he meant. But he said something 
to the effect that Vietnam veterans have a three times greater 
probability of contracting ischemic heart disease. Does staff 
have a better understanding of what he said? 1.4 to 2.8?
    Dr. Jesse. Yes. 1.4 to 2.8. That is the relative risk of 
ischemic heart disease in the veteran population cited across 
the six different studies.
    Senator Webb. Based on which studies?
    Dr. Jesse. The six studies that the Institute of Medicine 
put forward. The fact that there were six, which Dr. Birnbaum 
in her meta-analysis looked at as well. So those studies, they 
ranged from 1.4 to 2.8 as increased relative risk in the 
exposed population.
    Senator Webb. Were these studies among the nine that were 
reported out?
    Dr. Jesse. Yes. Yes.
    Senator Webb. And only two of those studies even related to 
Vietnam veterans.
    Dr. Jesse. Well, the exposure--I am sorry.
    Senator Webb. None of them related to Vietnam veterans at 
large. So basically, what you are saying--what the point is so 
that I can understand it--let me say it and tell me if I am 
wrong, is that looking at the analytical data from these 
studies based on dioxin exposure or TCDD exposure, you can then 
summarize that the probability or the risk factors were 1.4 to 
2.8.
    Dr. Jesse. Yes.
    Senator Webb. We do not have actual determinant of 
information on that. Do we? We do not have a Vietnam veteran 
control group----
    Dr. Jesse. Not for being on veteran controls.
    Senator Webb. So we cannot say a Vietnam veteran is 1.4 to 
2.8 more times likely to come down with ischemic heart disease 
than a non-veteran?
    Dr. Jesse. Well, what we can say is that those exposed to 
Agent Orange--and we have a presumption that a Vietnam veteran 
was exposed--so we can say that those exposed to Agent Orange 
have a 1.4----
    Senator Webb. Well, first of all, I do not think anyone 
will, in fact would agree that all people that went to Vietnam 
were exposed to Agent Orange. Those who were presumptively 
exposed----
    Dr. Jesse. Presumptively exposed. Right.
    Senator Webb. Right?
    Dr. Jesse. Yes.
    Ms. Birnbaum. In the Air Force Health Study by Ketchum and 
Michalek, which was published in 2005, they reported that for 
the ground crew, if you compared the ground crew on the 
sprayers to all Southeast Asia veterans not including those in 
Vietnam, they had an estimated relative risk of 1.7.
    Senator Webb. Right. Well, that would----
    Ms. Birnbaum. But that was of heart disease.
    Senator Webb [continued]. Also seem to be logical and 
understandable because of the functions that they performed.
    Ms. Birnbaum. Right.
    Senator Webb. Compared to a lot of other people. Thank you, 
Mr. Chairman.
    Chairman Akaka. Thank you. We still have a second round 
here. Dr. Samet, you note that it is unclear how VA makes a 
particular determination once the IOM report is received and 
how information beyond the IOM's findings figure into VA's 
decision. What specific changes in that process do you 
recommend? And what do you see as a value of greater openness 
and transparency in that process?
    Dr. Samet. This was one of the tasks of our committee, to 
describe the VA process in place. We interacted with VA 
extensively trying to understand in general what their 
processes were, and in particular what their processes were and 
how they responded to particular findings by IOM. As we talk to 
stakeholder groups, we found I think frustration with 
understanding how VA made decisions once the IOM reported in 
terms of its predecisional internal processes. They were 
described to us in general as involving a consideration of IOM 
and additional evidence, and we understood that some burden and 
cost estimates were made. And I think the Secretary provided 
some insights into that around the IHD decision.
    We felt and proposed in our process for decisionmaking for 
improving the process, that there be full transparency. That 
would show how the scientific evidence and all the 
nonscientific considerations, particularly related to handling 
of uncertainty, would be played out. When the decision was 
made, whether for a presumption or not, it would be very clear 
what the underlying internal logic was. So we think that 
process should be transparent.
    Chairman Akaka. Thank you. Dr. Birnbaum, does IOM's 
conclusion that there is a limited or suggestive evidence of an 
association between IHD and dioxin serve as proof that Vietnam 
veterans have a higher risk for prevalence of the disease than 
the general population?
    Ms. Birnbaum. I think the science supports the conclusion 
of the IOM, that there is an association between an exposure to 
dioxins and ischemic heart disease. Whether that means that all 
veterans have an increased risk or not I cannot say.
    Chairman Akaka. Dr. Bild, in your pre-hearing questions you 
stated that approximately 80 percent of men aged 60 through 69 
could be expected to have some symptoms of IHD or have IHD but 
no apparent symptoms. Can you explain why? And how many of them 
will develop symptoms?
    Dr. Bild. Yes. Well, as I explained earlier, 
atherosclerosis is a progressive disease and by middle and late 
age, particularly in men in this country, there will be some 
plaque, early forms of coronary disease detectible through some 
method. A relatively small proportion in the U.S., about 17 
percent of men age 60 to 69, will report having IHD--that is 
they had symptoms, they had a heart attack, or they have had 
bypass surgery. This is clinically apparent IHD as opposed to 
the much larger proportion who have silent or asymptomatic 
disease that may never become clinically apparent.
    Chairman Akaka. I want to thank you very much. In closing, 
I again say thank you for your responses and for appearing here 
today. You have been very helpful in what we want to do in the 
future and for work on a process that would be legislatively 
helpful.
    As chairman, it is my responsibility to make certain that 
this Committee fulfills its obligation to conduct the oversight 
of the Department of Veterans Affairs. Issues raised at today's 
hearing affect not only Vietnam veterans but Persian Gulf, 
Iraq, and Afghanistan veterans, as well as those who were 
exposed on military installations. My hope is that we can move 
forward from today's hearing with a better understanding of how 
the current process is working and what improvements need to be 
made. I, again, thank all of you for your participation.
    This hearing is now adjourned.
    [Whereupon, at 12:19 p.m., the hearing concluded.]
                            A P P E N D I X

                              ----------                              


 Prepared Statement of the Reserve Officers Association of the United 
      States and Reserve Enlisted Association of the United States
    Mr. Chairman and Members of the Committee, the Reserve Officers 
Association (ROA) and the Reserve Enlisted Association (REA) thank the 
Committee for the opportunity to submit testimony. Many Soldiers, 
Sailors, Marines, and Airmen from both the Active and Reserve 
Components were exposed to Agent Orange and other toxic herbicides in 
Vietnam. While many ailments may appear to be that of an aging 
population, statistically the incidents of these ailments are much more 
prevalent than the general populations. In addition to those veterans 
whose illnesses have been exacerbated by exposure, there are other 
veterans who remain ineligible that suffer from ailments that are 
recognized by the Department of Veterans Affairs (VA).
    Both ROA and REA believe that blue-water sailors, and blue-sky 
airmen need to be included under the eligibility for VA treatment of 
ailments relating to exposure to toxic herbicides. The current litmus 
test of ``boots on the ground'' is inadequate when the effects of 
exposure extended beyond the boundaries of Vietnam.
    Decisions being made by this Committee will affect not only 
veterans of the Southeast Asia conflict, but also later generations, 
such as veterans who have fought in the Southwest Asia during Desert 
Storm, and the Iraq and Afghanistan contingency operations. Precedents 
will be set, for not only contemporary conflicts but for the next 
generations' wars as well.
    ROA has a resolution, number 11, that passed in 2008 (see page 7) 
that talks to ``Preserving Veteran Status and Benefits for Those Who 
Have Served in Theaters of Operations'' that originates from the lack 
of available treatment for certain Vietnam veterans.
    ROA and REA recognizes that exposures to chemicals, toxins and 
heavy metals can occur in any war and that these can be spread more 
widely by airborne drift or water-borne runoff than calculated computer 
models. It remains vitally important in any theater of contingency 
operations that individuals are recognized for their service and remain 
eligible for health benefits regardless of the manner of exposure 
whether on land, sea, or in the air. Medical treatment of serving 
members as well as veterans needs to take precedence over determining 
statistical correlations.
                               background
    As the Committee is aware, American forces sprayed millions of 
gallons of Agent Orange and other defoliants over parts of Vietnam from 
1961 to 1971. During ``Operation Ranch Hand,'' US forces sprayed about 
20 million gallons of Agent Orange and other herbicides ion southern 
and central Vietnam to deprive enemies of jungle cover.
    Veterans who served ``in country'' in Vietnam may be eligible for 
disability compensation and health care benefits for diseases that VA 
has recognized as associated with exposure to Agent Orange and other 
herbicides. These are the diseases which VA currently presumes resulted 
from exposure to herbicides like Agent Orange.

     Acute and Subacute Peripheral Neuropathy
    A nervous system condition that causes numbness, tingling, and 
motor weakness.
     AL Amyloidosis
    A rare disease caused when an abnormal protein, amyloid, enters 
tissues or organs.
     Chloracne (or Similar Acneform Disease)
    A skin condition that occurs soon after exposure to chemicals and 
looks like common forms of acne seen in teenagers.
     Chronic Lymphocytic Leukemia and Other Chronic B Cell 
Leukemias
    A type of cancer which affects white blood cells. Currently, only 
chronic lymphocytic leukemia is recognized as associated with Agent 
Orange exposure.
     Diabetes Mellitus (Type 2)
    A disease characterized by high blood sugar levels resulting from 
the body's inability to respond properly to the hormone insulin.
     Hodgkin's Disease
    A malignant lymphoma (cancer) characterized by progressive 
enlargement of the lymph nodes, liver, and spleen, and by progressive 
anemia.
     Ischemic Heart Disease
    A disease characterized by a reduced supply of blood to the heart 
that leads to chest pain.
     Multiple Myeloma
    A disorder which causes an overproduction of certain proteins from 
white blood cells.
     Non-Hodgkin's Lymphoma
    A group of cancers that affect the lymph glands and other lymphatic 
tissue.
     Parkinson's Disease
    A motor system condition with symptoms that include a trembling of 
the hands, imbalance, and loss of facial expression.
     Porphyria Cutanea Tarda
    A disorder characterized by liver dysfunction and by thinning and 
blistering of the skin in sun-exposed areas.
     Prostate Cancer
    Cancer of the prostate; one of the most common cancers among men.
     Respiratory Cancers
    Cancers of the lung, larynx, trachea, and bronchus.
     Soft Tissue Sarcoma (other than Osteosarcoma, 
Chondrosarcoma, Kaposi's sarcoma, or Mesothelioma)
    A group of different types of cancers in body tissues such as 
muscle, fat, blood and lymph vessels, and connective tissues.

    Under current law, only veterans who served in the Republic of 
Vietnam during the war are entitled to a presumption of exposure to 
Agent Orange and other toxic herbicides when seeking compensation for 
conditions linked to herbicide exposure. Excluded are sailors from 
ships who sailed in littoral waters of Vietnam and airmen who may have 
been exposed to toxins at storage and load out locations
    The ``boots on the ground'' policy was unsuccessfully challenged in 
Haas vs. Nicholson. In January 2009, the Supreme Court let stand an 
earlier court ruling that requires a veteran to have served on land or 
on the inland waterways of Vietnam in order to be presumed exposed to 
Agent Orange.
    ROA and REA thank the Committee for earlier letters sent by the 
Chairman to expand the presumption, and the associations believe that 
there is justification to introduce legislation that will extend 
eligibility to those who were exposed to toxic herbicides outside of 
Vietnam.
Blue Water Exposure
    In addition to the Navy's reverie ``brown water'' missions in 
Vietnam, the U.S. Navy controlled the coastal waters off of Vietnam, 
provided power projection along the shore, and provided logistic 
support both afloat and ashore by having a sizable portion of its fleet 
in Vietnam waters. This blue water Navy supplemented the Republic of 
Vietnam navy to deny access along the coastal waterways for 
infiltration of men and supplies from the North.
    One tactic used by the Navy was to use shipboard guns as artillery 
along the coast to support military operations, and destroy military 
targets. Working from four corps areas, a destroyer (and cruiser) 
gunline of U.S. and Australian ships furnished shore bombardment and 
naval gunfire support. Located between one to two miles off the coast, 
they accurately fired 5 inch shells at a rate of 40 rounds per minute 
on targets at ranges beyond 14 nautical miles inland. This bombardment 
would go 24 hours a day, with ships firing thousands of rounds. These 
ships were close enough ashore that during the war, twenty-nine gunline 
ships were hit by enemy shore artillery.
    Operation Sea Dragon provided coast destroyer and cruiser patrols 
that searched for water borne logistic craft head to the South. 
Destroyers and frigates also gave search and rescue support along the 
coast for downed pilots.
    Navy supplies ships cruised along the coast resupplying these 
littoral vessels allowing them to stay on station.
    Many blue water ships were exposed to herbicide runoff from Vietnam 
river basins. With 13 large river systems, Vietnam is considered to 
have a complex and dense river network with most of the large river 
systems linked. The Mekong River, alone, splits into nine arms, with 
all flowing down and emptying into the sea. Agent Orange is insoluble. 
It was carried whole into the swamps, down creeks into the rivers and 
down the rivers into the South China Sea.
    It can also be noted in Figure One (see page 6) that herbicides 
were heavily sprayed along the coast. The Navy ships stationed off the 
coast were adrift in an herbicide soup, with runoff continuing to occur 
even after spraying ended in 1971. Even today, certain areas off the 
Vietnam coast are off limits to fishing, remaining as toxic hot spots.
    Aboard Navy ships, potable water is produced by evaporative 
distillation of seawater. In distillation plants on ships seawater was 
usually fed into an evaporator where the water was boiled by a 
combination of heating and reduced pressure (vacuum). The vapor was 
condensed in the condenser from where it was pumped into the feed 
tanks.
    As a result insoluble agents remained in the potable water. An 
Australian study focused on the evaporative distillation process that 
was used to produce potable water by Navy ships from surrounding 
estuarine waters. It was entitled Co-Distillation of Agent Orange and 
other Persistent Organic Pollutants in Evaporative Water Distillation, 
and found that ``the main contaminant in Agent Orange was found at 
about 85 percent of the quantity observed in the control samples and 
co-distilled to a greater extent than any other PCDD/F investigated 
here.'' Sailors were being exposed to herbicides through their drinking 
water.
    A question needs to be asked as to what happened to the remaining 
15 percent? As kitchen chemistry demonstrates to anyone who cooks, an 
agent in the water when it is boiled migrates to the sides of a 
container. Boil insoluble salt in a coffeepot, soon that insoluble salt 
coats the inside of the coffeepot. Through the distilling process, 
Agent Orange continued to percolate within the evaporators even after 
external exposure ceased because it coated the system. Every additional 
load of seawater taken into a Navy ship and then boiled added to the 
concentration of Agent Orange on the inside of the evaporators and 
condensers--continuing to contaminate potable water used on the ship.
    The Australian study was motivated by an Australian Veterans 
Administration report noted that veterans of the Royal Australian Navy 
(RAN) experienced higher mortality than other Australian Vietnam 
Veterans. Australia's largest naval commitment to the Vietnam War was 
the provision of destroyers, on rotation, to serve on the gunline, 
along side American ships--delivering naval gunfire support for allied 
ground forces.
Blue Sky Airmen Exposure
    In 1996, Dr. Michael Gough, the chairman of the Federal panel 
charged with investigating the potential health impacts of Agent Orange 
use, ``[The Centers for Disease Control and Prevention] found that 
while the Air Force's Operation Ranch Hand sprayed 90 percent of the 
Agent Orange used in Vietnam, there is no difference in the health of 
the Ranch Hands, the only veterans known to have been exposed, and that 
of other veterans who served in Southeast Asia at the same time and 
flew the same kinds of airplanes but were not exposed to Agent 
Orange.''
    Yet, the Air Force studies of the Operation Ranch Hand personnel 
showed that the exception was an increased mortality rate for 
circulatory diseases seen in enlisted ground crew personnel, a group at 
higher risk for skin exposure to herbicides. In 2005, an AFHS update 
reviewing 20 years of Epidemiologic data on mortality rates reported a 
small, but significant, increase in all cause death rates for Ranch 
Hand veterans.
    Research has determined that there was significant use of 
herbicides on the fenced in perimeters of military bases in Thailand 
intended to eliminate vegetation and ground cover for base security 
purposes. Security policemen, security patrol dog handlers, members of 
a security police squadron, or others that served near the air base 
perimeter during the Vietnam Era were exposed to toxins.
    A U.S. Court of Appeals for Veterans' ruling in 2005, concluded 
that an air force veteran contracted a disease as a result of his 
exposure to Agent Orange while stationed on Guam in the late 1960s. 
During the Vietnam War era, Guam was used as storage facility for Agent 
Orange.
    Johnston Island is less than 2 miles long and less than a half mile 
wide. Approximately 113,400 kg of Agent Orange accidentally spilled in 
1972 during redrumming after the Air Force brought approximately 5.18 
million liters of unused Agent Orange from Vietnam to Johnston Island. 
In addition, 49,000 gallons per year of Agent Orange are estimated to 
have leaked from drums at the Johnston Island storage site.
    The above examples are but a few cases where airmen were exposed to 
Agent Orange and other herbicides. During the Vietnam War, there is 
reported use of herbicides in Thailand, Okinawa, Guam, Philippines, and 
many other locations on the Pacific rim, mainly at Air Force bases. 
Additionally the Department of Defense has published a list of 
locations even in the U.S.s where these toxins were used.
    Congress needs to continue to explore cases where the health of 
veterans has been compromised by Agent Orange and other toxic 
herbicides.
                               conclusion
    The majority of studies have focused on morbidity and mortality of 
Vietnam veterans. Studies on Agent Orange are historically burdened by 
the lack of reliable exposure data. For veterans who have been exposed 
to Agent Orange and other toxic herbicides, the burden of proof is 
placed on the veteran to demonstrate a causal link between ailments and 
exposure.
    Thousands of Sailors served providing gunfire support aboard 
destroyers along the coast and on Yankee Station aircraft carriers 
providing air cover and bomb support over Vietnam. Navy veterans who 
were awarded the Vietnam Service Medal as a result of service in the 
waters offshore Vietnam (blue water vets) should be entitled to the 
same presumption of exposure to Agent Orange as veterans who set ``foot 
on land'' in Vietnam or did duty in brown water missions. As a result, 
many Navy veterans who served offshore and their survivors were granted 
disability or DIC benefits based on an Agent Orange-related disease.
    Also overlooked are Air Force Airmen who were exposed to herbicides 
stored at staging airbases, and storage sites outside of Vietnam and in 
the airspace above. Many of these same bases used herbicides to control 
vegetation along the perimeters of the bases and airfields for security 
reasons. Numerous mechanics, supply clerks, and air patrolman are 
suffering the same diseases as a result of exposure to the herbicide 
Agent Orange, and deserve Veteran health care, and disability benefits 
for their ailments, or care for survivors.

    The Reserve Officers Association and the Reserve Enlisted 
Association representing over 63 thousand members support expanding the 
presumptive coverage by the Department of Veterans Affairs.

    Please see the following pages for Figure One: Spray Patterns of 
Herbicides in Vietnam, and Attachment One: ROA Resolution 08-11, 
``Preserving Veteran Status and Benefits for Those Who Have Served in 
Theaters of Operations.''
          Figure 1.--Spray Patterns of Herbicides in Vietnam.



                 Attachment One.--ROA Resolution 08-11.
         preserving veteran status and benefits for those who 
                 have served in theaters of operations.
                            resolution 08-11
    WHEREAS, the Department of Veterans Affairs (VA) has proposed to 
amend its adjudication regulations regarding the definition of service 
in the Republic of Vietnam in regard to exposure to Agent Orange;
    WHEREAS, the current definition of service in Vietnam includes 
service in the waters offshore and service in other locations if 
``conditions of service involved duty or visitation in the Republic of 
Vietnam''; and
    WHEREAS, the VA wishes the definition ``to include only service on 
land and on inland waterways'' of the Republic of Vietnam; and WHEREAS, 
thousands of Sailors served providing gunfire support aboard destroyers 
along the coast and on Yankee Station aircraft carriers providing air 
cover and bomb support over Vietnam; and
    WHEREAS, thousands of Airmen stationed in Thailand, prepared 
aircraft and flew missions over Vietnam; and
    WHEREAS, Marines and Soldiers fought in Laos and crossed into 
Cambodia; and
    WHEREAS, distinguishing types of service in an theater of 
operations is a bad precedent, when ``boots-on-the-ground'' veterans 
are differentiated from all other Armed Forces participants, especially 
when this Nation is currently at war; and
    WHEREAS, exposures to chemicals, toxins and heavy metals can be 
spread more widely by airborne drift or water-borne runoff than 
calculated patterns;
    NOW THEREFORE BE IT RESOLVED, that the Reserve Officers Association 
of the United States, chartered by the Congress, urge the Congress, the 
Department of Defense and the Department of Veterans Affairs, to retain 
current definitions of service in any theater of operations ensuring 
that individuals are recognized for their service and remain eligible 
for health benefits regardless of manner of exposure whether on land, 
sea, or in the air.

Time Sensitive--submitted by ROA Headquarters Staff
Adopted by the ROA National Convention, June 28, 2008

      

                                  
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