[Senate Hearing 111-881]
[From the U.S. Government Publishing Office]
S. Hrg. 111-881
VA DISABILITY COMPENSATION: PRESUMPTIVE DISABILITY DECISION-MAKING
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HEARING
BEFORE THE
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 23, 2010
__________
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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
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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
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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