[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
          CONTINUING ETHICS AND MANAGEMENT CONCERNS AT NIH AND THE 

                  PUBLIC HEALTH SERVICE COMMISSIONED CORPS


                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                OF THE 

                       COMMITTEE ON ENERGY AND 

                               COMMERCE

                       HOUSE OF REPRESENTATIVES 


                     ONE HUNDRED NINTH CONGRESS

                           SECOND SESSION


                         SEPTEMBER 13, 2006

                         Serial No. 109-136

Printed for the use of the Committee on Energy and Commerce

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                   COMMITTEE ON ENERGY AND COMMERCE
JOE BARTON, Texas, Chairman
RALPH M. HALL, Texas
MICHAEL BILIRAKIS, Florida
  VICE CHAIRMAN
FRED UPTON, Michigan
CLIFF STEARNS, Florida
PAUL E. GILLMOR, Ohio
NATHAN DEAL, Georgia
ED WHITFIELD, Kentucky
CHARLIE NORWOOD, Georgia
BARBARA CUBIN, Wyoming
JOHN SHIMKUS, Illinois
HEATHER WILSON, New Mexico
JOHN B. SHADEGG, Arizona
CHARLES W. "CHIP" PICKERING,  Mississippi 
  Vice Chairman
VITO FOSSELLA, New York
ROY BLUNT, Missouri 
STEVE BUYER, Indiana
GEORGE RADANOVICH, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
C.L. "BUTCH" OTTER, Idaho
SUE MYRICK, North Carolina
John Sullivan, OKLAHOMA
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
JOHN D. DINGELL, Michigan
  RANKING MEMBER
HENRY A. WAXMAN, California
EDWARD J. MARKEY, Massachusetts
RICK BOUCHER, Virginia
EDOLPHUS TOWNS, New York
FRANK PALLONE, JR., New Jersey
SHERROD BROWN, Ohio
BART GORDON, Tennessee
BOBBY L. RUSH, Illinois
ANNA G. ESHOO, California
BART STUPAK, Michigan
ELIOT L. ENGEL, New York
ALBERT R. WYNN, Maryland
GENE GREEN, Texas
TED STRICKLAND, Ohio
DIANA DEGETTE, Colorado
LOIS CAPPS, California
MIKE DOYLE, Pennsylvania
TOM ALLEN, Maine
JIM DAVIS, Florida
JAN SCHAKOWSKY, Illinois
HILDA L. SOLIS, California
CHARLES A. GONZALEZ, Texas
JAY INSLEE, Washington
TAMMY BALDWIN, Wisconsin
MIKE ROSS, Arkansas


BUD ALBRIGHT, Staff Director
DAVID CAVICKE, General Counsel
REID P. F. STUNTZ, Minority Staff Director and Chief Counsel


           SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
ED WHITFIELD, Kentucky, Chairman
CLIFF STEARNS, Florida
CHARLES W. "CHIP" PICKERING,  Mississippi 
CHARLES F. BASS, New Hampshire
GREG WALDEN, Oregon
MIKE FERGUSON, New Jersey
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
JOE BARTON, Texas
  (EX OFFICIO)
BART STUPAK, Michigan
  RANKING MEMBER
DIANA DEGETTE, Colorado
JAN SCHAKOWSKY, Illinois
JAY INSLEE, Washington
TAMMY BALDWIN, Wisconsin
HENRY A. WAXMAN, California
JOHN D. DINGELL, Michigan
  (EX OFFICIO)


CONTENTS


Page
Testimony of:

Agwunobi, Hon. John, Assistant Secretary of Health, U.S. Department 
of Health and Human Services 	

319
Kingston, Dr. Raynard, Deputy Director, National Institutes of 
Health, U.S. Department of Health and Human Services	

327

CONTINUING ETHICS AND MANAGEMENT CONCERNS AT NIH AND THE PUBLIC 
HEALTH SERVICE COMMISSIONED CORPS 


WEDNESDAY, SEPTEMBER 13, 2006

HOUSE OF REPRESENTATIVES,
COMMITTEE ON ENERGY AND COMMERCE,
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,
Washington, DC.


	The subcommittee met, pursuant to notice, at 1:03 p.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Ed Whitfield 
(Chairman) presiding.
	Members present:  Representatives Whitfield, Burgess, 
Blackburn, Barton (ex officio), Stupak, and Dingell (ex officio). 
	Staff present:  Mark Paoletta, Chief Counsel for Oversight 
and Investigations; Alan Slobodin, Deputy Chief Counsel for 
Oversight and Investigations; Mike Abraham, Legislative Clerk; Ryan 
Ambrose, Legislative Clerk; Matthew Johnson, Legislative Clerk; 
Christa Carpenter, Counsel; David Nelson, Minority Investigator 
/Economist; and Jonathan Brater, Minority Staff Assistant. 
	MR. WHITFIELD.  I call the hearing to order this afternoon, 
and today's subject is continuing ethics and management concerns at 
NIH and the Public Health Service Commissioned Corps. 
	This hearing builds on our previous oversight hearings in 
2004 on NIH ethics and hearings in 2006 on NIH's handling of human 
tissue samples.  In the last 2 years, NIH has been faced with 
unprecedented ethics concerns.  Based largely on information provided 
by the committee, NIH conducted its own investigations and found 52 
 individuals in violation of ethics rules.  The full results of 
these investigations have been submitted to the committee and now 
we consider whether NIH and the Corps have vigorously enforced the 
rules. 
	Two of the most serious cases involve Dr. Trey Sunderland of 
the National Institute of Mental Health and Dr. Thomas Walsh of the 
National Cancer Institute, both of whom happen to be officers in the 
Corps.  In both of these cases, we are troubled about whether NIH 
and the Corps has acted appropriately.  In the case of 
Dr. Sunderland, we had questions about why NIMH continued to deal 
with Dr. Sunderland in a business-as-usual way while he was under 
investigation and his retirement from NIH was on hold.  In 2005, it 
was determined that Dr. Sunderland had engaged in undisclosed, 
unreported, and unapproved consulting for activities in which he 
was paid over $700,000 and that some of his consulting conflicted 
with his government job.  In November 2005, Dr. Thomas Insel, the 
Director of the National Institute of Mental Health, proposed to 
the Corps that Dr. Sunderland be considered for termination but 
except for not receiving a $12,000 bonus.   Dr. Sunderland has 
continued to enjoy privileges that belong to the dedicated NIH 
scientists and Corps officers who faithfully followed the rules. 
	Did NIMH take steps to prevent Dr. Sunderland from 
representing them and going on taxpayer-funded trips?  No.  In 
one case, Dr. Sunderland took a taxpayer-funded trip costing over 
$3,000 to a scientific association meeting in Hawaii in December 
2005 only a few weeks after Dr. Insel had proposed that 
Dr. Sunderland be terminated from the Corps.  Was Dr. Sunderland 
as a Commissioned Corps officer deployed to help on Hurricane 
Katrina or Rita relief?  No, but NIMH did clear him to go to 
Geneva, Switzerland, in September for a couple of days at taxpayer 
expense.  Were steps taken even after Dr. Sunderland took the Fifth 
Amendment at the June subcommittee hearing?  No.  Was he denied the 
ability to engage in paid activities outside his employment?  
No.  Did they even take away his title of Branch Chief even 
after Dr. Sunderland's branch was in effect closed?  No.  After 
integrity questions were raised, did NIMH take steps to restrict 
Dr. Sunderland's access to confidential data?  No. 
	Dr. Insel told us at the June 14 hearing that his hands 
were tied to take any action on Dr. Sunderland because 
Dr. Sunderland was a Commissioned Corps officer, but after the 
committee staff raised questions about why NIMH continued to approve 
trips and activities for Dr. Sunderland, Dr. Insel did in August 
2006 finally restrict Dr. Sunderland from traveling to represent 
NIMH. 
	Dr. Walsh also presents another serious case.  Over a 5-year 
period, Dr. Walsh engaged in unreported and unapproved consulting 
with 25 companies taking more than $100,000 in payments.  The NIH 
ethics panel determined in the one activity it has reviewed 
involving Dr. Walsh that there were conflict-of-interest 
violations.  Although the Corps received a proposal for 
Dr. Walsh's termination at the beginning of this year, the Corps 
chose not to act on the Walsh matter.  Given the paramount interest 
in protecting the integrity of the Corps and NIH, we must ask the 
question, why didn't the Corps act on the Walsh case?  Instead of 
being proactive, it appears that the Corps and the NIH seemed 
passive really on this issue, taking the minimum steps to enforce 
the rules that are the foundation of maintaining public trust.  We 
know that public trust is vitally important, and in our previous 
hearings on this subject, that has been emphasized. 
	We recognize that NIH has taken needed steps to improve the 
ethics program, but more action is needed.  The NIH system is one 
of multiple silos of information holding financial records, outside 
activity forms, recusals and waivers, leave records, technology 
transfer agreements, and human subject protection records.  
However, these silos are not yet connected to each other to 
provide an informed review. 
	Through these hearings, we expect the Corps and NIH to 
improve their systems to prevent these violations, detect them 
better when they occur, and to act decisively and appropriately.  
We look forward to the testimony of all the witnesses today, and 
I will certainly be introducing you all after Mr. Stupak and other 
members have made their opening statements.  At this time I 
recognize the Ranking Minority Member, Mr. Stupak, for his opening 
statement. 
	[The prepared statement of Hon. Ed Whitfield follows:] 

PREPARED STATEMENT OF THE HON. ED WHITFIELD, CHAIRMAN, SUBCOMMITTEE 
ON OVERSIGHT AND INVESTIGATIONS 

	Today the Subcommittee examines continuing ethics and 
management concerns at the National Institutes of Health (NIH) and 
the Public Health Service Commissioned Corps.  This hearing builds 
on our previous oversight hearings in 2004 on NIH ethics and hearings 
in 2006 on NIH's handling of human tissue samples. 
	In the last two years, NIH has been faced with an 
unprecedented ethics mess.  Based largely on information provided 
by the Committee, the NIH conducted its own investigations and found 
52 individuals in violation of ethics rules.  The full results of 
these investigations have been submitted to the Committee and now we 
consider whether NIH and the Corps have vigorously enforced the 
rules. 
	Two of the most serious cases involve Dr. Trey Sunderland 
of the National Institute of Mental Health (NIMH) and Dr. Thomas 
Walsh of the National Cancer Institute (NCI), both of whom happen 
to be officers in the Corps.  In both of these cases we are troubled 
about whether the NIH and the Corps acted appropriately.  
	In the case of Dr. Sunderland, we have questions about why 
NIMH continued to deal with Dr. Sunderland in a "business as 
usual" way while he was under investigation and his retirement from 
NIH was on hold.  In 2005 NIH had determined that Dr. Sunderland had 
engaged in undisclosed, unreported, and unapproved consulting for 
activities in which he was paid over $700,000, and that some of 
consulting conflicted with his government job.   In November 2005, 
Dr. Thomas Insel, the Director of the National Institute of Mental 
Health, proposed to the Corps that Dr. Sunderland be considered 
for termination. 
	But except for not getting a $12,000 bonus, Dr. Sunderland 
has continued to enjoy privileges that belong to the dedicated NIH 
scientists and Corps officers who faithfully followed the rules.  
Did NIMH take steps to prevent Dr. Sunderland from representing 
the NIMH and going on taxpayer-funded trips?  No.  In one case, 
Dr. Sunderland took a taxpayer-funded trip costing over $3000 to 
a scientific association meeting in Hawaii in December 2005, only 
a few weeks after Dr. Insel had proposed Dr. Sunderland's 
termination to the Corps.  Was Dr. Sunderland as a commissioned 
corps officer deployed to help on Hurricane Katrina or Rita relief?  
No, but NIMH did clear him to go to Geneva, Switzerland in September 
for a couple of days at taxpayer expense.  Did NIMH take such steps 
even after Dr. Sunderland took the Fifth Amendment at the June 
Subcommittee hearing?  No. Did NIMH deny Dr. Sunderland the ability 
to engage in paid outside activities?  No. Did NIMH even take away 
Dr. Sunderland's title of branch chief even after Dr. Sunderland's 
Branch was in effect closed?  No.  After integrity questions were 
raised, did NIMH take steps to restrict Dr. Sunderland's access to 
confidential data?  No.  
	Dr. Insel told us at the June 14th hearing that his hands 
 were tied to take any action on Dr. Sunderland because 
Dr. Sunderland was a Commissioned Corps officer.  But after the 
Committee staff raised questions about why NIMH continued to approve 
trips and activities for Dr. Sunderland, Dr. Insel in August 2006 
finally restricted Dr. Sunderland from traveling to represent NIMH 
and from no longer getting approval for certain outside activities, 
and reassigned him to the extramural branch.	
	Dr. Walsh presents another serious case.   Over a five-year 
period, Dr. Walsh engaged in unreported and unapproved consulting 
with 25 companies, taking more than $100,000 in payments.  The NIH 
Ethics Panel determined in the one activity it has reviewed 
involving Dr. Walsh that there were conflict of interest violations. 
 Although the Corps received a proposal for Dr. Walsh's termination 
at the beginning of this year, the Corps chose not to act on the 
Walsh matter.  Given the paramount interest in protecting the 
integrity of the Corps and the NIH, why didn't the Corps act on the 
Walsh case? 
	Instead of being proactive, both the Corps and the NIH seem 
passive, taking the minimal steps to enforce the rules that are the 
foundation of maintaining public trust.  I do recognize that NIH has 
taken needed steps to improve its ethics program, but more action is 
needed.  The NIH system is one of multiple silos of information 
holding financial reports, outside activity forms, recusals and 
waivers, leave records, technology transfer agreements, and human 
subject protection records, but these silos are not yet connected 
to each other to provide an informed review.  Through these hearings, 
we aim to get the Corps and the NIH to improve their systems to 
prevent violations, detect them better when they occur, and to act
 decisively and appropriately. 
	I thank the witnesses and look forward to their testimony.  
I thank the Minority side for its work in this investigation.  I now 
recognize my friend, the Ranking Member of the Subcommittee, Bart 
Stupak, for his opening statement. 

	MR. STUPAK.  Thank you, Mr. Chairman. 
	This hearing is a result of a 4-year investigation by the 
Oversight and Investigations Subcommittee.  Four years after this 
subcommittee pointed out conflict-of-interest problems at the 
National Institute of Health, this agency still does not have any 
safeguards to prevent the types of abuse as we previously 
discovered.  The National Institute of Health spends $29 billion 
of taxpayers' money on biomedical research.  It operates with wide 
latitude to focus our resources on most promising lines of research 
and yet the National Institute of Health cannot rid itself of 
conflict of interest. 
	Today three institutions will be singled out for their 
failure to prevent conflicts of interest.  First and foremost is 
the Office of Inspector General, an office that has not been called 
to appear before us today, and I do not know why not.  They should 
be here.  Three years ago this subcommittee identified over 100 
National Institutes of Health employees that had not reported income 
from drug and biotech companies.  At that point the Office of 
Inspector General should have been the first agency to investigate 
files, interview the possible violators and their supervisors, 
peers and subordinates.  The Inspector General should have 
immediately and aggressively obtained all pertinent information 
in the possession of the drug companies regarding the alleged 
payments.  Instead, the Office of Inspector General did nothing.  
Simply put, the Office of Inspector General failed to fulfill its 
statutory responsibility.  Instead, the office delegated whatever 
investigations might be done to the NIH itself. 
	Then we have the Public Health Service Corps represented 
today by Assistant Secretary for Health since there is no Surgeon 
General at this time.  The Public Health Service, also referred to 
as Commissioned Corps, is organized along paramilitary lines and 
enlistment is open to certain professionals at the National 
Institutes of Health and in the Department of Health and Human 
Services.  The Public Health Service Corps is an organization that 
accepts no responsibility for the performance of its employees at 
the NIH including the ethical behavior of its officers, but is 
charged with administering all discipline in excess of 14 days, 
suspension.  Last fall the National Institutes of Health informed 
the Public Health Service that two of its employees would be 
terminated if they were civilians and they had not been employed 
correctly by the NIH but yet to date the Commissioned Corps has 
taken no action.  This arrangement leaves the National Institutes 
of Health in a compromised position, having limited ability to 
discipline its researchers.  Furthermore, it is unclear what, if 
any, advantage the National Institutes of Health gains from having 
employees that have joined the Public Health Service and are 
technically assigned or detailed to their jobs by the Public Health 
Service.  The overriding rationale is that the medical doctors and 
other doctors of the Public Health Service are on duty 24/7 and 
may be assigned anywhere anytime to handle public health crisis.  
In fact, a number of the Commissioned Corps medical doctors were 
assigned to assist with the public health disasters in the wake of 
Hurricanes Katrina and Rita.  Curiously, though, Dr. Trey 
Sunderland, who had lost his lab and was awaiting disciplinary 
action, was not sent to the Gulf Coast.  Instead, Dr. Sunderland, 
a public service officer who asserted his Fifth Amendment rights 
rather than explain his conduct to this subcommittee, was permitted 
to attend a conference in Switzerland while New Orleans was 
underwater.  I expect our witnesses today to explain this curious 
pampering of Dr. Sunderland in this instance. 
	Finally, like in previous hearings, the National Institutes 
of Health and particularly the National Institute of Mental Health 
have much explaining to do.  Specifically, I and others want to 
understand if the work that Dr. Sunderland performed for the last 
2 decades at the taxpayers' expense was as a matter of science 
worth the millions of dollars that taxpayers invested or an 
opportunity for personal financial gain and professional boasting.  
Dr. Sunderland's studies included Alzheimer's patients and their 
families from which blood and spinal fluid samples were taken over 
time with the goal of trying to identify biomarkers that would 
predict the early onset of this terrible disease.  We know, for 
example, that Pfizer and other drug companies consider these 
samples and related patient histories invaluable and paid 
Dr. Sunderland for turning over these public samples.  We know 
that senior officials at the National Institutes of Health bent 
over backwards to allow Dr. Sunderland to continue this research 
in New York despite their knowledge of serious ethical and 
possible criminal charges pending against Dr. Sunderland.  This 
subcommittee suspects that Dr. Sunderland assumed this New York 
research while on the National Institutes of Health payroll without 
formal authorization.  Is this another example of ethical lapse and 
failure to assert accountability over Dr. Sunderland? 
	What I cannot understand is why the National Institutes of 
Health, what is their plan to do with Dr. Sunderland's very expensive 
and possible value Alzheimer's study.  We are told that the National 
Institute of Mental Health will not continue to fund it, and both the 
Institute on Aging and the Institute on Neurological Disorders and 
Stroke have no interest in pursuing this research.  Why is that?  
If this research was important enough to spend millions of dollars 
a year for over a decade and if no one has developed biomarkers that 
predict the onset of Alzheimer's, and if there seems to be a 
consensus that early detection is critical in understanding and 
delaying the progression of this disease, then why is the National 
Institutes of Health going to abandon these patients and the hope 
for a cure?  Does this mean any time a National Institutes of 
Health researcher is caught with his or her hand in the cookie 
jar that research in their field is terminated?  Why wasn't the 
study reassigned 2 years ago when it was discovered that 
Dr. Sunderland was ethically compromised?  What is the National 
Institutes of Health's responsibility to study early onset of 
Alzheimer's?  Why has Dr. Sunderland not been removed from the 
National Institutes of Health projects despite the allegations?  
The National Institutes of Health, the Public Health Service, 
and the Inspector General have much to explain. 
	I hope for some honest accountability today.  If the 
National Institutes of Health cannot discipline Dr. Sunderland 
and if the Public Health Service is tardy in taking action and 
the Office of Inspector General failed to investigate, then the 
question must be asked, is anyone accountable?  Who has the 
responsibility to hold individuals accountable, or is the NIH 
simply broken down, cannot fulfill its mission for the American 
people in a responsible, ethical, and professional manner. 
	With that, Mr. Chairman, I yield back. 
	MR. WHITFIELD.  Thank you, Mr. Stupak.  At this time, 
Mrs. Blackburn, you are recognized for 5 minutes. 
	MRS. BLACKBURN.  Thank you, Mr. Chairman.  In the interest 
of time and knowing that we are going to have a vote, I will submit 
my statement, and just to welcome our witnesses.  We hope that we 
will have the opportunity to have a dialog with you and to get 
some information.  This is a tremendous concern to us.  What has 
been perceived as arrogance by some of our agencies and avoidance 
of dealing with ethical and management issues is of concern to us 
and we hear about it from our constituents.  So we look forward to 
a frank discussion.  Thank you. 
	MR. WHITFIELD.  Thank you, Mrs. Blackburn.  I am going to 
ask unanimous consent to introduce the binder, our document 
binder, into the record.  Without objection, so ordered. 
	[The information follows:] 

	MR. WHITFIELD.  The Chairman of the full committee, it is my 
understanding, is on his way and I am sure he will want to make an 
opening statement when he arrives, but in the meantime, I want to go 
and introduce our panel of witnesses today and I want to thank you 
for coming, and you can tell by the opening statements the concerns 
that we have and we do look forward to your testimony and answers to our questions.
	The first witness today is the Honorable John Agwunobi, who 
is the Assistant Secretary of Health at the Department of Health and 
Human Services.  We also have Dr. Raynard Kington, who is the Deputy 
Director of the National Institutes of Health.  We have 
Dr. John Niederhuber, who is the Director of the National Cancer 
Institute.  We have Dr. Thomas Insel, who is the Director of the 
National Institute of Mental Health, and then we have Mr. William 
Fitzsimmons, who is the Executive Officer at the National Institute 
of Mental Health at the National Institutes of Health.  We welcome 
all of you.  Thank you for being here. 
	As you know, this is an Oversight and Investigations 
Subcommittee hearing and we always take our testimony under oath, and 
I assume you do not have any objection to testifying under oath.  
And I would also say you are always entitled to legal counsel.  
I am assuming none of you have legal counsel here today, but if 
you do--do any of you have legal counsel?  Okay.  Well, if you 
would stand raise your right hand I will swear you in. 
	[Witnesses sworn] 
	MR. WHITFIELD.  Thank you very much.  At this time all of 
you are under oath, and what we are going to do, Mr. Agwunobi, we 
are going to allow you to give your testimony first.  Here comes the 
Chairman now.  So what we will do, before you begin your testimony, 
we will recognize Chairman Barton for any opening statement that he 
may have at this time. 
	CHAIRMAN BARTON.  Thank you, Chairman Whitfield.  I was 
downtown at a luncheon for the Boy Scouts and former Chairman Tauzin 
was the master of ceremonies, so it took a while.  I apologize to our 
witnesses. 
	I think this is a very important oversight hearing as we 
begin to move towards reauthorization of the National Institutes of 
Health.  We released a bill yesterday and we are getting great 
reviews on it, and hopefully we have a legislative hearing next week 
and go to markup very soon. 
	At our last NIH oversight hearing in June, Dr. Thomas Insel, 
the Director of the National Institute of Mental Health, told us 
that when it comes to ethics, NIH has to be better than clean.  In 
his words, it has to be Camelot.  Unfortunately, one of the 
scientists at his institute, a multiple and serious violator of 
the ethics rules in the eyes of the NIH, Dr. Trey Sunderland, still 
comes to work at NIH every day and collects his salary.  Until 
recently, Dr. Sunderland was going on taxpayer-funded trips to 
Hawaii and other locales, was making thousands of dollars in 
outside income, all with the blessings of Dr. Insel and his 
managers.  Although he proposed Dr. Sunderland's termination to 
the Commissioned Corps in November of 2005, Dr. Insel also 
recommended a $15,000 retention bonus for Dr. Sunderland in 
January of 2006.  That just doesn't make sense.  Dr. Sunderland 
continues to have access to confidential data.  Dr. Sunderland 
continues to have access to NIH staff and property.  We now know 
that Dr. Sunderland has shipped his personal effects to his future 
employer at taxpayer expense. Without any waiver or approval from 
NIH, he took tissue samples and patient-related records and used 
NIH staff to help box it and send it to the future employer in New 
York State. 
	Everybody here remembers Dr. Sunderland's visit when he 
invoked his Fifth Amendment right under the Constitution against 
self-incrimination.  That is his right, and we honor it, but we 
believe that he is the first scientist to ever take the Fifth 
Amendment rather than tell Congress what he has been doing.  He 
refused to answer questions about what he did with spinal fluid 
samples from his patients who participated in a taxpayer-funded 
study.  That seems to have made relatively little difference to 
Dr. Insel.  Before the committee staff raised questions, did 
Dr. Insel or other supervisors treat Dr. Sunderland differently 
after the hearing?  Apparently not.  Dr. Sunderland is also a 
Commissioned Corps medical officer.  Did the Corps do anything 
to uphold its high ethical standards?  There is little evidence 
to suggest that they have done so. 
	Now we have another case of an NIH scientist, Dr. Thomas 
Walsh of the National Cancer Institute, whom NIH found to be a serial 
l violator of ethics rules.  Following the same road as Dr. Insel of 
the NIMH, the director of the NCI, Dr. John Niederhuber, has 
proposed Dr. Walsh's termination, but he has done little else that 
would reflect the changed circumstance.  The Corps likewise so far 
has failed to act at the beginning of this year when it had a chance 
to do so.  That is not Camelot.  It is not even close. 
	This is really an ethical Potemkin village where a hollow 
system appears to provide the illusion of integrity, but 
transgressors never leave.  Of the over 100 individuals who were 
identified by the NIH itself several years ago as violating NIH's 
policies, not one of them, according to information I have, has 
been terminated, not one.  The vast majority have had nothing worse 
happen to them than get a reprimand and continue in their current 
jobs.  Some have voluntarily left the agency and sought employment 
in the private sector.  Only two are still under serious 
investigation so far as we can tell.  The NIH has changed its 
rules, and that is a good thing, but they don't appear to really be 
doing anything to enforce the old rules against their most serious 
transgressors.  So while NIH leaders like Dr. Insel acknowledge the 
ethics rules to the subcommittee, apparently behind closed doors at 
NIH there is a very different message that has been communicated, 
one that appears to look past or even encourage these 
transgressions.  The shenanigans involving Dr. Sunderland using 
NIH resources and NIH staff to further his post-NIH employment do 
not occur in a vacuum.  They occur in an environment of support 
where he felt comfortable enough to operate openly.  Dr. Insel 
did finally take some steps to restrict Dr. Sunderland but only 
after the committee staff raised questions and concerns. 
	I think it is time to tear down the illusions of ethics and 
build up a real information and management structure that protects 
the integrity of NIH and the Commissioned Corps.  It may also be 
time to revisit the question of whether we need a uniformed Public 
Health Service at all.  The GAO in 1996 reported that the functions 
of the Commissioned Corps are essentially civilian and could be 
performed efficiently and well by doctors and scientists without 
uniforms at much less cost to the taxpayers. 
	This is a time for serious rethinking of our ethics and 
management structure at the NIH.  There should be and must be 
evidence of real enforcement.  I think it is absurd that taxpayers 
have been footing the bill for nearly 2 years for Dr. Sunderland, 
even though he wants to leave and the NIH wants him out.  We are 
going to reauthorize hopefully the NIH and help make it a stronger 
scientific agency in the very near future.  It really does deliver 
for the American people, but NIH needs to regain the public trust. 
 This is only going to happen if there is meaningful enforcement.  
Sensible and decisive leadership on such enforcement is a 
much-needed first step and I hope that we can see the seeds of that 
at this hearing. 
	With that, Mr. Chairman, I yield back, and thank you for 
your leadership. 
	[The prepared statement of Hon. Joe Barton follows:] 

PREPARED STATEMENT OF THE HON. JOE BARTON, CHAIRMAN, COMMITTEE ON 
ENERGY AND COMMERCE 

	Thank you, Mr. Chairman, for holding this important 
oversight hearing as this Committee moves on NIH reauthorization 
legislation for the first time in over a decade. 
	At our last NIH oversight hearing in June, Dr. Thomas 
Insel, the Director of the National Institute of Mental Health, 
told us that when it comes to ethics, NIH has to be better than 
clean.  In Dr. Insel's words, "It has to be Camelot." 
	Unfortunately, one of the scientists at his institute, a 
multiple and serious violator of the ethics rules in the eyes of 
the NIH, Dr. Trey Sunderland, still comes to work at NIH and 
collects his salary.  Until recently, Dr. Sunderland was going on 
taxpayer-funded trips to Hawaii and other locales, and making 
thousands of dollars in outside income - all with the blessing of 
Dr. Insel and his managers.  Although he proposed Dr. Sunderland's 
termination to the Commissioned Corps in November 2005, Dr. Insel 
also recommended a $15,000 retention bonus for Dr. Sunderland in 
January 2006.  Dr. Sunderland continues to have access to 
confidential data.  Dr. Sunderland continues to have access to 
NIH staff and property.  We now know that Dr. Sunderland shipped 
his personal effects to his future employer at taxpayer expense.  
Without any waiver or approval from NIH, he took tissue samples 
and patient-related records, and used NIH staff to help box it and 
send it to his future employer in New York.  
	Everybody here remembers Dr. Sunderland's visit, when he 
invoked his Fifth Amendment right under the Constitution against 
self-incrimination before this Subcommittee.  This is his right and 
we honor it, but we believe he is the first NIH scientist to ever 
take the Fifth rather than tell Congress what he's been doing. He 
refused to answer questions about what he did with spinal fluid 
samples from his patients who participated in a taxpayer-funded 
study.  That seems to have made relatively little difference to 
Dr. Insel.  Before the Committee staff raised questions, did 
Dr. Insel or other supervisors treat Dr. Sunderland any differently 
after the hearing?  Apparently not. 
	Dr. Sunderland is also a Commissioned Corps medical 
officer.  Did the Corps do anything to uphold its high ethical 
standards?  There is little evidence that they did. 
	Now we have another case of an NIH scientist, Dr. Thomas 
Walsh of the National Cancer Institute, whom NIH found to be a 
serial violator of ethics rules.  Following the same road as 
Dr. Insel of the NIMH, the Director of the NCI, Dr. John 
Niederhuber, has proposed Dr. Walsh's termination but has done 
little else that would reflect the changed circumstances.  The 
Corps likewise failed to act at the beginning of this year when 
it had a chance to do so. 
	This isn't Camelot, not even close.  This is really an 
ethical Potemkin village where -a hollow system provides the 
illusion of integrity, but transgressors never leave.  The Corps 
and the NIH present an elaborate structure of rules and regulations 
on ethical standards which, when tested by reality, just doesn't 
seem to work.  
	Even worse, while NIH leaders like Dr. Insel acknowledge the 
ethics rules to the Subcommittee, behind closed doors at NIH a 
different message seems to be informally communicated  -- one that 
appears to look past or even encourage these transgressions.  The 
shenanigans involving Dr. Sunderland using NIH resources and NIH 
staff to further his post-NIH employment did not occur in a vacuum.  
They occurred in an environment of support, where he felt 
comfortable to operate openly.  Dr. Insel did finally take some 
steps to restrict Dr. Sunderland, but only after the Committee staff 
raised questions and concerns.  
	Mr. Chairman, it's time to tear down the illusion of ethics 
and build up a real information and management structure that protects 
the integrity of NIH and the Commissioned Corps.  It may also be 
time to revisit the question of whether we need a uniformed public 
health service at all.   The GAO in 1996 reported that the functions 
of the Commissioned Corps are essentially civilian and could be 
performed efficiently and well by doctors and scientists without 
uniforms, at less cost to the taxpayers. 
	This is a serious time for rethinking ethics and management. 
There must be evidence of real enforcement.  It is absurd that 
taxpayers have been footing the bill for nearly two years for 
Dr. Sunderland, even though he wants to leave and the NIH wants 
him out.  
 	We are going to reauthorize the NIH and help make it a 
stronger scientific agency that delivers for the American people.  
But NIH needs the public trust to make it happen.  That is only 
going to happen if there is meaningful enforcement.  Sensible and 
decisive leadership on such enforcement is a needed first step. 

	MR. WHITFIELD.  Thank you, Chairman Barton.  At this time 
we will recognize Mr. Agwunobi for his opening statement. 

TESTIMONY OF THE HONORABLE JOHN AGWUNOBI, ASSISTANT SECRETARY FOR 
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. RAYNARD 
KINGTON, DEPUTY DIRECTOR, NATIONAL INSTITUTES OF HEALTH, U.S. 
DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. JOHN NIEDERHUBER, 
DIRECTOR, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. THOMAS R. INSEL, 
DIRECTOR, NATIONAL INSTITUTE OF MENTAL HEALTH, NATIONAL INSTITUTES 
OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND 
WILLIAM FITZSIMMONS, EXECUTIVE OFFICER, NATIONAL INSTITUTE OF 
MENTAL HEALTH, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF 
HEALTH AND HUMAN SERVICES 

	DR. AGWUNOBI.  Thank you, Chairman Whitfield, Chairman 
Barton, and members of the subcommittee.  Thank you for inviting 
me to testify at today's hearing on management and disciplinary 
procedures of the Public Health Service Commissioned Corps. 
	My name is John Agwunobi and I am the Assistant Secretary 
for Health with the U.S. Department of Health and Human Services.  
As the Assistant Secretary for health, I serve as the Secretary's 
primary advisor on matters involving the Nation's public health and 
I oversee the U.S. Public Health Service Commissioned Corps. 
	The Corps is one of seven uniformed services of the United 
States.  It is composed of more than 6,000 active-duty health 
professionals who serve at HHS and at other Federal agencies 
including the Bureau of Prisons, the Department of Homeland 
Security, the U.S. Coast Guard, and a number of others.  The origins 
of the Corps may be traced back to the passage of an act in 1798 
that provided for the care and relief of sick and injured 
merchant seaman.  In the 1870s, the loose network of locally 
controlled hospitals was subsequently reorganized into the Marine 
Hospital Service.  This name was changed in 1912 to the Public 
Health Service because it was noted that this force of dedicated 
individuals were taking on broader and broader responsibilities in 
pursuit of the public health of our Nation. 
	As America's uniformed service of public health 
professionals, the Corps achieves its mission to protect, promote, 
and advance the health and safety of the Nation through rapid and 
effective response to the public health needs, leadership and 
excellence in public health practice, and the advancement of 
public health science.  Now, the Corps today has a specialized 
career system.  It is designed to attract, develop, and retain 
health professionals who may be assigned to Federal, State, or 
local agencies and indeed to some international agencies and 
organizations.  The Corps has grown into one of the most significant 
public health assets in the world.  In doing so, a tradition has 
evolved of a long and successful partnership with agencies where 
officers are employed.  Corps members have served honorably and 
have been at the forefront of many of the advances in public health 
over this Nation's history.  Indeed, the Commissioned Corps was 
there at the beginning, the inception of the National Institutes 
of Health.  Corps officers are expected to uphold the highest 
standards of ethical behavior both in their official roles and 
in their personal conduct.  The Corps takes seriously any 
allegations of illegal infractions or other wrongdoings that bring 
discredit and dishonor to the Corps and to the Department of Health 
and Human Services. 
	Now, I have been invited to discuss with the subcommittee 
the subject of disciplinary and administrative actions that may be 
taken against Corps officers and the requirement and procedures 
applicable to the termination of an officer's commission for 
misconduct.  Misconduct by a Corps officer includes violation of 
any HHS standards of conduct regulations or of any other Federal 
regulation, law, or official government policy.  The Corps has a 
variety of administrative and disciplinary actions that can be 
initiated to address officers who engage in misconduct.  The 
decision as to which type of action to be applied is based upon 
the nature of infraction and the status of an officer.  
Generally, lesser offenses may be dealt with by the officer's 
line supervisor in the agency of employment through letters of 
reproval or reprimand.  When a potential offense is serious 
enough for a disciplinary action that affects the officer's pay, 
rank, or employment, the matter is referred to the Corps for one 
of several possible board review processes.  These included 
temporary promotion review boards, involuntary retirement b
oards, and boards of inquiry.  A board of inquiry may be convened 
when an officer is charged by his or her supervisor with conduct 
constituting grounds for disciplinary action.  Upon a finding of 
misconduct, a board may recommend the following action:  
termination of commission, which may include loss of retirement 
benefits and a reduction in rank or grade.  All testimony before 
the board is given under oath or affirmation, and when the board 
has completed its deliberations, its recommendations are forwarded 
to me, the ASH, for final decision-making. 
	I will just conclude by saying that, sir, as you are 
aware, Secretary Leavitt is currently directing a major 
transformation of the Commissioned Corps.  It is designed in part 
to allow us an opportunity to examine all of our policies and 
administrative systems and to ensure that they are robust, 
rigorous, and efficient in their implementation.  I fully 
understand the gravity of the issues being explored by the 
subcommittee and I want to thank you again for inviting me to 
testify.  I am ready to answer questions.  I stand at your 
convenience to answer any questions you might have. 
	[The prepared statement of Hon. John Agwunobi follows:] 

PREPARED STATEMENT OF THE HON. JOHN AGWUNOBI, ASSISTANT  SECRETARY 
FOR HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Introduction 
	Chairman Whitfield and Members of the Subcommittee, thank 
you for inviting me to testify at today's hearing on management 
and disciplinary procedures of the Public Health Service 
Commissioned Corps. 
	My name is John Agwunobi, and I am the Assistant Secretary 
for Health with the U.S. Department of Health and Human Services 
(HHS). As the Assistant Secretary for Health (ASH), I serve as the 
Secretary's primary advisor on matters involving the nation's 
public health and oversee the U.S. Public Health Service (PHS) 
for the Secretary. The PHS is comprised of agency divisions of 
HHS and the Commissioned Corps, a uniformed service of more than 
6,000 active duty health professionals who serve at HHS and other 
federal agencies, including the Bureau of Prisons, the Department 
of Homeland Security, and the U.S. Coast Guard. The mission of 
the Commissioned Corps is:  "Protect, promote, and advance the 
health and safety of the Nation."   I am the highest ranking 
member of the Commissioned Corps; I am a Regular Corps officer 
and hold the rank of Admiral. 

The Public Health Service 
	The origins of the Public Health Service (PHS), one of the 
seven uniformed services of the United States, may be traced to the 
passage of an act in 1798 that provided for the care and relief of 
sick and injured merchant seamen.  In the 1870s, the loose network 
of locally controlled hospitals was reorganized into a centrally 
controlled Marine Hospital Service and the position of Supervising 
Surgeon, later becoming the Surgeon General of the United States, 
was created to administer the Service.  The first Supervising 
Surgeon, Dr. John Maynard Woodworth, adopted a military model for 
his medical staff and created a cadre of mobile, career service 
physicians who could be assigned to areas of need.  The uniformed 
services component of the Marine Hospital Service was formalized 
as the Commissioned Corps by legislation enacted by Congress in 
1889.  At first open only to physicians, over the course of the 
twentieth century, the Corps expanded to include dentists, 
dieticians, engineers, environmental health officers, health 
service officers, nurses, pharmacists, scientists, therapists, 
and veterinarians. 
	The scope of activities of the Marine Hospital Service also 
began to expand well beyond the care of merchant seamen in the 
closing decades of the nineteenth century, beginning with the 
control of infectious disease.  As immigration increased 
dramatically in the late nineteenth century, the Marine Hospital 
Service was assigned the responsibility for the medical inspection 
of arriving immigrants at sites such as Ellis Island in New York.  
Because of the broadening responsibilities of the Service, its name 
was changed in 1912 to the Public Health Service.  The Service 
continued to expand its public health activities as the Nation 
entered the twentieth century, with the Commissioned Corps leading 
the way.  As the century progressed, PHS Commissioned Corps officers 
served their country by controlling the spread of contagious 
diseases such as yellow fever and smallpox (eventually assisting in 
the eradication of this disease from the world), conducting 
important biomedical research, regulating the food and drug supply, 
providing health care to underserved populations, supplying medical 
assistance in the aftermath of disasters, and in numerous other 
ways.  
	As America's uniformed service of public health 
professionals, the Commissioned Corps achieves its mission to, 
"Protect, promote, and advance the health and safety of the 
Nation," through rapid and effective response to public health 
needs, leadership and excellence in public health practices, and 
the advancement of public health science.  The Corps today is a 
specialized career system designed to attract, develop, and retain 
health professionals who may be assigned to Federal, State or local 
agencies or international organizations.  The PHS, with the 
Commissioned Corps at its center, has grown from a small collection 
of marine hospitals to one of the most significant public health 
programs in the world.  In doing so, the tradition of a long and 
successful partnership has evolved with the agencies where officers 
are employed.  Corps members have served honorably and been at the 
forefront of many of the advances in public health over this 
nation's history. 

Disciplinary and Administrative Actions  
	I have been invited to discuss with the Subcommittee the 
subject of disciplinary and administrative actions that may be taken 
against Corps officers; and the requirements and procedures 
applicable to the termination of an officer's commission for 
misconduct. 
	Corps officers are expected to uphold the highest standards 
of ethical behavior, both in their official roles and in their 
personal conduct.  Commissioned Corps officers are on duty 24 hours 
a day, seven days a week, similar to our sister Services.  The Corps 
takes seriously allegations of illegal infractions or other 
wrongdoing that brings discredit and dishonor to the Corps and the 
Department.  We believe the Corps should strive for excellence of 
character and excellence in performance of duty, and we expect 
nothing less.  When a determination is made that an officer has 
engaged in misconduct, he/she is subject to disciplinary action. 
	As a preliminary matter, I note that Commissioned Officers 
in the PHS and the National Oceanic and Atmospheric Administration 
(NOAA) are not generally under the purview of the Uniformed Code 
of Military Justice (UCMJ).  Under the UCMJ jurisdictional statute, 
10 U.S.C ï¿½ 802, PHS and NOAA officers are subject to the UCMJ only 
when they are assigned to and serving with the armed forces.  
	If this jurisdictional prerequisite is not satisfied, cases 
of alleged misconduct involving individual Corps officers are 
solely handled in accordance with Commissioned Corps policies, as 
set forth in published Corps issuances.  If there are potential 
criminal issues involved, these must be referred to the HHS Office 
of the Inspector General (OIG), which will coordinate with the 
Department of Justice for purposes of law enforcement 
investigation and prosecution.  Non-criminal misconduct may be 
investigated by the agency operating division or by the Corps, 
depending on the situation.  
	Generally speaking, under Corps policy issuances, there are 
two broad categories of disciplinary administrative action 
available for uses in cases involving PHS Commissioned Corps 
officers:  those actions not requiring a hearing - which include 
only a Letter of Reproval and a Letter of Reprimand - and those 
actions requiring a hearing - that is, all other administrative 
disciplinary actions up to and including termination of an 
officer's commission. The nature of the hearing requirement may 
differ depending on the officer's status (probationary vs. 
non-probationary, Reserve Corps vs. Regular Corps, etc.), as I 
will more fully describe in a moment.  Moreover, involuntary 
termination of an officer's commission results in the loss of 
all benefits otherwise associated with the officer's uniformed 
services status. 
	How does the Corps define officer misconduct?  Misconduct 
by a Regular or Reserve Corps officer includes violation of the 
HHS Standards of Conduct Regulations or of any other Federal 
regulation, law, or official Government policy.  Such misconduct 
by an officer constitutes grounds for disciplinary or administrative 
action. 
	Some examples of officer misconduct include, but are not 
necessarily limited to: 
Disobedience or negligence in obeying lawful orders of an official 
superior; 
Absence from his/her assigned place of duty without authorized 
leave; 
Unauthorized use or consumption of controlled substances or alcohol 
while on duty, being under the influence of such substances or 
alcohol while on duty, or illegally possessing, transferring, or 
ingesting controlled substances at any time; 
Abusive treatment of subordinate officers, employees, patients or 
program beneficiaries, or of members of the public in their 
dealings with the Government; 
Engaging in action or behavior of a dishonorable nature which 
reflects discredit upon the officer and/or PHS; 
Submission of false information in an application for appointment 
or in any other official document; 
Failure to observe generally accepted rules of conduct and the 
specific provisions of law and Standards of Conduct regulations; 
Failure to comply with the Office of Government Ethics (OGE) 
regulations, Departmental supplemental and any other applicable 
standards of ethical conduct or regulations; 
Failure to exercise informed judgment to avoid misconduct or 
conflict of interest;
Failure to consult supervisors or the Agency or Program's Ethics 
Officer, when in doubt about any provision of regulations; or 
Conviction of a felony. 

	Typically, administrative and disciplinary cases occurring 
within the Corps involve marginal or substandard performance, 
periods of being Absent Without Leave (AWOL), and cases of minor 
misconduct.  The actual number of disciplinary cases is less than 
1 percent of the Corps' active duty strength.  In the past two 
years, there were approximately 100 disciplinary actions or pending 
actions that involved a total of 82 officers. 
	The Corps has a variety of administrative and disciplinary 
actions that can be initiated to address officers who engage in 
misconduct.  The decision as to which type of administrative or 
disciplinary action to be applied is based upon the nature of the 
infraction and the status of the officer.  Lesser offenses may result 
in a Letter of Reproval, an administrative action generally taken 
by a supervisor, which does not become part of an officer's personnel 
folder.  More serious offenses can lead to the termination of an 
officer's commission based on the recommendation of a Board of 
Inquiry or an Involuntary Termination Board.  If a determination 
is made that an officer's commission should be terminated, then the 
status of the officer determines what mechanism to be used and the 
level of due process that must be afforded to the officer in 
carrying out the action.  For example, an officer who is on 
probation during their first three years on active duty may be 
summarily terminated upon 30 days notice with an opportunity to 
provide a written statement to the Director, Office of Commissioned 
Corps Operations.  However, a Regular Corps officer or an officer 
who is eligible for retirement is afforded an opportunity to appear 
at a Board and present witnesses. 
	As a practical matter, disciplinary and administrative 
actions are enacted or recommended at the lowest level of the 
supervisory and administrative chain.  Through delegation, the HHS 
Operating and Staff Division Heads, regional offices, the Surgeon 
General and Deputy Surgeon General, or the Director, Office of 
Commissioned Corps Operations (OCCO) have the authority to issue 
a letter of reproval or a letter of reprimand and to make 
recommendations to the Commissioned Corps regarding more serious 
disciplinary actions.  
	To summarize, the disciplinary and administrative actions 
that may be taken against an officer may be grouped into two 
classifications, those actions not requiring Board review and 
recommendation and those disciplinary actions that require board 
review and recommendation.  It is important to note, however, that 
even in cases that do not require Board review, the agency to which 
the officer is assigned works in consultation with the Commissioned 
Corps in developing a reasonable plan of disciplinary action. 
	Actions not requiring board review and recommendation are 
the following:
A Letter of Reproval, which is generally issued by the officer's 
line supervisor.  The letter is retained in the officer's duty 
station personnel file and does not become part of the officer's 
official personnel folder (OPF). 
A Letter of Reprimand, which is generally issued by the line 
supervisor with the concurrence of the officer's administrative 
chain of command.  This letter becomes part of the officer's OPF 
for a period of two years. While a Letter of Reprimand is within 
the officer's OPF, he/she is not eligible for promotion, deployment, 
or to receive a PHS award. 
Suspension from Duty is an administrative action recommended by the 
line supervisor with concurrence of the administrative chain of 
command.  An officer may be placed in a non-duty with pay status 
pending resolution of disciplinary or administrative matters if 
such action is believed to be in the best interest of the 
Government. 
Summary Termination is an action where the Corps terminates an 
officer's commission without the review and recommendation of a 
board.  Such action can be taken for officers who are AWOL for 
30 or more consecutive days or those officers found guilty by a 
civil authority of one or more criminal offenses and having been 
sentenced to confinement for a period in excess of 30 days with or 
without suspension of probation.  In addition, the commission of 
a Reserve Corps officer may be terminated during the first three 
years of his/her current tour of active duty - normally for 
substandard performance or misconduct. 

	The Commissioned Corps also has disciplinary actions that 
require board review and recommendation; they are the following: 
Temporary Promotion Review Board (TPRB).  This Board is appointed 
and convened by the Surgeon General to make recommendations about 
whether an officer should retain a temporary promotion based upon 
evidence that: an officer's performance has deteriorated to an 
unsatisfactory level; an officer has engaged in misconduct; an 
officer is functioning at more than one grade below his/her 
temporary grade; an officer has failed to respond to progressive 
discipline; or an officer has failed to meet or maintain readiness 
standards, licensure requirements, and/or any other requirements 
set by the PHS Commissioned Corps.  The ASH has the authority to 
revoke the temporary promotion of Regular and Reserve Corps 
officers based on a Board recommendation. 
Involuntary Termination Board for Reserve Corps Officers (ITB).  
Except in the case of summary terminations, requests for 
involuntary termination of Reserve Corps officers are reviewed by 
an Involuntary Termination Board (ITB).  An ITB may be convened 
for misconduct, substandard performance, and/or no suitable 
assignment.  The ASH has the authority to terminate a Reserve 
Corps officer's commission without the consent of the officer 
based on the recommendation of the Board. 
Involuntary Retirement Board (IRB).  An officer may be referred 
to an IRB after 19 years of creditable service by the Director, 
OCCO, based upon the recommendation of the OPDIV/StaffDIV, Program 
Head or his/her designee to which the officer is assigned.  The 
grounds to refer an officer to an IRB include, but are not limited 
to, substandard performance, conduct issues, falsification of 
official documents, or no suitable assignment.  The IRB's findings 
and recommendations, along with all documentation, are forwarded 
to the Surgeon General for approval or disapproval.  The decision 
of the Surgeon General is based upon the IRB's findings and 
recommendations, and any other relevant information in the 
record.  A commissioned officer may be retired without the 
officer's consent following the completion of 20 years of active 
service.  
A Board of Inquiry (BOI) may be convened when an officer is charged 
by his/her superior or by any responsible person or persons with
 conduct constituting grounds for disciplinary action.  Upon a 
finding of misconduct, a BOI may recommend the following actions: 
termination of commission and/or reduction in rank/grade.  When a 
BOI recommends that an officer's commission be terminated and the 
ASH concurs, the ASH will then make a final decision as to the 
characterization of service based on the board's recommendation, 
e.g., honorable, general (under honorable conditions), or other 
than honorable. 

     To explain a little more fully, a Board of Inquiry consists of 
at least three PHS commissioned officers, who are Commander or 
Captain in rank.  A PHS representative(s), one or more PHS 
commissioned officers, is appointed to prepare the statement of 
charges and specifications against the officer and to act in the 
interest of the Government before the Board.  The hearing is 
conducted by a Presiding Officer and the proceedings are not limited 
by formal rules of evidence, but do require reasonable standards 
of competency, relevancy, and materiality.  All testimony before 
the BOI is given under oath or affirmation.  When the BOI has 
completed its deliberations, its recommendations are forwarded to 
the ASH for final decision making. 
	The officer who is being charged does have the right to 30 
days advance written notice, the opportunity to appear in person, 
with or without counsel, before the Board, and the opportunity to 
present witnesses before the BOI. 
	Particularly for the Board of Inquiry, when allegations 
brought forward against an officer include possible violations of 
the United States criminal code, the law requires the matter to be 
referred to the OIG.  In such cases, we do not conduct any further 
proceedings, including any investigations, without the prior 
express concurrence of an authorized representative of OIG.  We 
proceed only when it is determined that the Board of Inquiry will 
not pose any risk to criminal proceedings. 
	These are the disciplinary actions that can be taken by 
the Commissioned Corps in cases of misconduct by an officer.  They 
are based in the policies and procedures that currently govern our 
Service.  As you are aware, HHS Secretary Leavitt is directing a 
major transformation of the Corps.  As part of this transformation, 
we are examining our policies and administrative systems to ensure 
they are robust and rigorous.  We seek to ensure that our 
disciplinary approaches and procedures match those serious ethical 
questions that face us today and in the future.
	In conclusion, I fully understand the gravity of the issues 
being explored by the Subcommittee and want to thank you again for 
inviting me to testify.  I am ready to answer questions posed by 
the Subcommittee. 

	MR. WHITFIELD.  Thank you, Mr. Secretary. 
	Dr. Kington, you are recognized for 5 minutes for your 
opening statement. 
	DR. KINGSTON.  Thank you, Chairman Whitfield, Ranking Member 
Stupak, and members of the subcommittee.  I am Raynard Kington.  I am 
the Principal Deputy Director of the National Institutes of Health.  
I appear at your request today to testify about enforcement of ethics 
rules at the agency. 
	The mission of NIH is to advance biomedical and behavioral 
science to promote the health of the public.  Part of achieving our 
mission requires working collaboratively with many parts of the 
private sector including colleges, universities, and research 
institutions across the country as well as private industry.  
Especially in our dealings with private industry, we always keep in 
mind the unique role we play in being guided always first by the 
requirement that we support science of the highest quality that will 
lead to improvements of health without consideration of personal 
or institutional profit.  As the biomedical research enterprise of 
this country has grown in size and complexity over recent decades, 
the need for NIH to be seen both by the public at large and the 
scientific community as an unbiased source of scientific information 
has grown as well.  We must be vigilant and adaptive in response 
to the evolution of the biomedical research enterprise so that that 
goal remains at the top of our priorities. 
	We were reminded of this responsibility in 2004 largely 
through the investigative work of this subcommittee when we learned 
that a small percentage of NIH scientists had taken undue advantage 
of or ignored Federal ethics rules that allowed them to engage in 
paid outside consulting with industry.  As a result of these cases, 
the NIH and the Department of Health and Human Services working with 
the Office of the Government Ethics completely banned any paid 
consulting by NIH employees for the pharmaceutical and biotech 
industries.  We took this action because even the suggestion of 
ethical lapses, apparent or real, in NIH programs would undermine 
public confidence in federally supported medical research and we 
could not allow this to happen. 
	In addition to these necessary ethics reforms, we 
disciplined 34 NIH intramural scientists who had violated ethics 
rules by failing to seek approval for or report consulting 
relationships with industry, failing to take annual leave while 
consulting, or consulting in areas that overlap with their official 
duties.  These actions resulted from information provided through 
the subcommittee's earlier investigation that identified 81 NIH 
scientists who had allegedly consulted with industry but had not 
reported their consulting relationships to NIH as required.  NIH 
investigated those individuals as well as 22 others either featured 
in the media or discovered when we asked our scientists to report 
any additional consulting that had not been reported to their 
supervisors.  When violations were found, NIH implemented sanctions 
ranging from oral admonishment to suspension.  In all cases where 
individual scientists failed to take leave to conduct outside 
activities, we ordered that the leave be paid back to the 
Government.  In some cases, scientists returned honoraria that 
were inappropriately received, and in two serious cases, the NIH 
recommended that the employees be terminated.  Every disciplinary 
action taken was guided by Federal personnel regulations and 
policies governing such matters which guarantee all employees access 
to due process, require the Government to consider several factors 
when recommending a particular discipline, and encourage the use 
of alternative forms of discipline. 
	The review of the 103 cases involves multiple components of 
the agency.  The NIH Office of Management Assessment, NIH's official 
liaison to the Office of the Inspector General, conducted reviews of 
all the cases, determining the facts and identifying the violations 
of our rules.  The NIH ethics office was brought in to help assess 
whether specific ethics rules had been violated, particularly in 
matters involving potential overlap between official duties and 
private consulting.  Under my direction, an expert panel of NIH 
Institute directors comprised of an objective group of Institute 
and Center directors, whose institutes did not have any cases, were 
convened to determine in each case where the employee had not 
received prior approval to engage in activity, whether the 
scientists' outside activities overlapped with official duties.  
This step was taken because determining whether activities that had 
not received prior approval would have been approvable had procedures 
been followed was one relevant piece of information to be considered 
in determining penalties.  Ten cases were referred to the Office of 
Inspector General for potential violations of criminal law.  Upon 
completion of the reviews, the Office of Human Resources used 
existing policies to recommend appropriate penalties for those found 
to have violated the rules. 
	Two of the cases remain in the aftermath of our reviews.  
They involve NIH scientists who are also members of the Public 
Health Service's Commissioned Corps.  In each of these cases, we 
concluded that violations of Federal ethics rules were so egregious 
that they would have warranted proposed dismissal had the employee 
been part of the Civil Service.  The cases were referred to the Corps 
because NIH cannot terminate the employment of Commissioned Corps 
officers.  As Admiral Agwunobi noted, only the Corps itself after 
conducting a formal board of inquiry can dismiss officers in this 
circumstance.  While these unique cases were pending before the 
Commissioned Corps and recognizing that each had not been formally 
adjudicated, NIH had to determine appropriate continuing duties for 
the scientists, each of whom remains an NIH employee. 
	It is important to note that neither the agency nor the 
Commissioned Corps anticipated at the outset that it would take as 
long as it has taken to resolve these cases.  The employees involved 
are clinical investigators with responsibilities involving hundreds 
of patients and are leading researchers in important areas of public 
health concern.  Their supervisors decided that the proper course of 
action should be determined by the needs of patients and the research 
while final decisions regarding employment were being determined.  
To the extent possible and under certain restrictions, we attempted 
to facilitate the needs of the patients and those important areas 
and research but only after it was clear that their continued 
involvement in no way harmed patients.  Indeed, there was 
considerable concern about abruptly stopping their continued 
involvement as leaders of large clinical studies.  In one of the 
studies where the employee's actions continued to raise concern 
about his case, one of our institutes took further action, 
restricting his activities pending the outcome of the Commissioned 
Corps inquiry. 
	We also continue to address issues raised in the course of 
the committee's investigation of the particular cases under 
discussion today.  First, as NIH witnesses testified at the June 14 
hearing, we are in the process of clarifying guidelines for NIH 
investigators so that they know which formal mechanisms are to be 
used to transfer human tissue samples to outside collaborators.  In 
cases involving the transfer of material derived from human 
subjects, all written agreements must be accompanied by rigorous 
checks and balances including the review and approval by senior 
leadership at the relevant institute.  Second, human subjects' 
protection oversight at the NIH requires that use of all human 
subject samples be under continuing review of an institutional 
review board or overseen by the NIH Office of Human Subject Research 
and we are strengthening the system of oversight for continued 
review.  Third, NIH is clarifying our policies regarding the 
presentation of scientific information to FDA advisory committees. 
 NIH scientists may not appear at FDA committee meetings as 
representatives of outside companies.  There may be, however, 
circumstances where it would be appropriate and beneficial to the 
public for a particular NIH scientist to appear at an FDA advisory 
committee meeting as part of his or her official duties.  NIH is 
preparing a specific policy which will describe the circumstances 
in which such appearances are permissible.  We will keep the 
subcommittee apprised of our progress as we implement these changes. 
	As a result of these investigations and reforms implemented 
by NIH, we believe that these cases are remnants of past policies.  
With new restrictions in place and a more efficient and rigorous 
ethics program underway, we are confident that the problems 
previously identified by this subcommittee are behind us. 
	Thank you for this opportunity to testify.  I would be 
pleased to answer any questions members might have.  Thank you. 
	[The prepared statement of Dr. Kington follows:] 

PREPARED STATEMENT OF DR. RAYNARD KINGSTON, DEPUTY DIRECTOR, NATIONAL 
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

	Chairman Whitfield, Ranking Member Stupak and Members of the 
Subcommittee. I am Dr. Raynard Kington, Principal Deputy Director of 
the National Institutes of Health (NIH). I appear today at your 
request to testify about the enforcement of the Agency's ethics 
rules. 
	NIH's mission is to conduct research that will lead to better 
methods of diagnosing, treating, preventing, and curing disease. The 
research that we support has resulted in improvements in detecting 
disease, better therapies, and more effective vaccines. 
	The United States leads the world in biomedical research. We 
have achieved and maintained our preeminent status by balancing a 
massive public and private sector partnership. The programs of NIH 
are supported by appropriated funds, whereas the pharmaceutical 
and biotechnology industries finance their research from revenues 
or the promise of profits.  Nevertheless, the translation of research 
from the bench to the bedside cannot occur without collaborations 
between publicly-supported researchers and industry scientists. 
While some work in government and others operate in industry 
facilities, they undergo similar training, and their methods are 
often indistinguishable. 
	Most biomedical research, whether funded by the public or 
private sector, is conducted at non-government facilities. An 
exception to that is the NIH intramural program, where research is 
conducted in federal facilities by government scientists, although 
this intramural research represents only ten percent of NIH's 
overall budget. 
	It is expected that those at NIH entrusted with Federal funds 
are faithful stewards of the public trust.  This clearly means that 
NIH-funded research must be free of bias and the influence of 
profit incentives.  To this end, NIH and the Department of Health 
and Human Services (HHS), working with the Office of Government 
Ethics, banned any paid-consulting for NIH employees with the 
pharmaceutical and biotechnology industries. 
	We took this action because even the suggestion of ethical 
lapses, apparent or real, in NIH programs would undermine public 
confidence in federally-supported medical research. We could not 
allow this to happen. 
	In addition to these ethics reforms, we disciplined 34 NIH 
intramural scientists who had violated the previous ethics rules by 
failing to seek approval for -- or even report -- consulting 
relationships with industry, by failing to take annual leave while 
consulting, or by consulting in areas that overlapped with their 
official duties. These actions were taken because information 
provided through the Subcommittee's earlier investigation had 
identified NIH scientists who consulted for industry but had not 
reported their consulting relationships to NIH.  NIH investigated 
these individuals, as well as other individuals whose cases were 
discovered when we asked our scientists to report any undisclosed 
consulting to their supervisors.  When violations were found, NIH 
implemented sanctions ranging from oral admonishments to letters of 
reprimand to suspensions.  In all cases where individual scientists 
failed to take leave to conduct outside activities, they were 
directed to pay back that leave to the government.  In many cases, 
scientists returned honoraria that were inappropriately received.  
	The review of these cases involved multiple components of 
NIH. The Office of Management Assessment (OMA), NIH's official 
liaison to the HHS Office of the Inspector General (OIG), conducted 
reviews of all the cases, determining the facts and identifying 
violations of rules. My office convened an expert panel of NIH 
Institute Directors, whose Institutes did not have any cases, to 
determine whether the scientists' outside activities overlapped with 
official duties.   The NIH ethics office gave technical advice and 
administrative support to this panel.   Ten cases were referred to 
the OIG due to potential violations of criminal law.  Upon 
completion of the reviews, the Office of Human Resources used 
existing policies to identify appropriate penalties for those found 
in violation of the rules. 
	Two of the cases identified in the internal review are still 
active. They involve NIH scientists who are also members of the 
Public Health Service Commissioned Corps (Corps).  In each of the 
cases, NIH concluded that the facts were sufficiently egregious to 
warrant referral to the Corps, which has independent authority to 
investigate the facts and the latitude to determine the most 
appropriate level of discipline for its commissioned officers 
through the Board of Inquiry process. 
	We also continue to address issues raised in the course 
of the Committee's investigation of the particular cases under 
discussion today.  First, as NIH witnesses testified at this 
Subcommittee's June 14, 2006, hearing, we are in the process of 
clarifying guidelines for NIH investigators to inform them which 
formal mechanisms are to be used to transfer human tissue samples 
to outside collaborators.  In cases involving the transfer of 
material derived from human subjects, all written agreements must 
be accompanied by rigorous checks and balances, including the 
review and approval by senior leadership at the relevant Institute.  
Second, the use of samples or data of human subjects, as HHS 
regulations prescribe, is overseen by an Institutional Review Board 
or by the NIH Office of Human Subjects of Research.  Third, NIH is 
clarifying its policies regarding the presentation of scientific 
information to Advisory Committees at the Food and Drug 
Administration (FDA).  NIH scientists may not appear at FDA Advisory 
Committee meetings as representatives of outside companies.  There 
may, however, be circumstances where it would be both appropriate 
and beneficial for a particular NIH scientist to appear at an FDA 
Advisory Committee meeting as part of his or her official duties.  
NIH is preparing a specific policy which will describe the 
circumstances in which such appearances are permissible.   We will 
keep the Subcommittee apprised of our progress as we implement these 
changes. 
	As a result of these investigations and reforms implemented 
by NIH, cases such as those being discussed today are hopefully 
remnants of past policies.  With new restrictions in place and a 
more efficient and rigorous ethics program underway, we are confident 
that the problems previously identified by this Subcommittee are 
behind us. 
	Thank you for the opportunity to testify. I will be pleased 
to answer any questions Members of the Subcommittee may have. 

	MR. WHITFIELD.  Thank you, Dr. Kington. 
	Now, it is my understanding that Dr. Niederhuber, Dr. Insel, 
and Mr. Fitzsimmons do not have any opening statement but are here 
simply to answer questions.  Is that correct? 
	DR. NIEDERHUBER.  That is correct. 
	MR. WHITFIELD.  All right.  We have three votes on the House 
floor.  We have about 4 minutes left in the first vote and then 
there will be two 5-minute votes.  So we will recess the hearing 
until we go cast these votes, and I would expect we will be back 
here before 2:00.  So you all relax and we will be back in a few 
minutes.  Thank you. 
	[Recess] 
	MR. WHITFIELD.  The hearing will reconvene, and Chairman 
Barton has another hearing that he is going to be involved in so I am 
going to recognize him for the first round of questions.  Chairman 
Barton is recognized for 10 minutes. 
	CHAIRMAN BARTON.  Thank you, Mr. Chairman, and I thank 
Ranking Member Stupak for allowing me to go out of turn. I am not 
real sure exactly who these questions should be referred to, whether 
they should be Mr. Agwunobi or Mr. Kington or Dr. Insel, so I am 
going to ask the question and then whichever person appears 
appropriate should answer it. 
	My concern, the thrust of my question is going to be, we 
have an employee, Dr. Sunderland, who has been recommended for 
termination, who offered to resign subject to certain conditions, 
and that resignation was not accepted, who testified before this 
subcommittee and took his constitutional privilege against 
self-incrimination under the Fifth Amendment and yet he is still 
on the payroll, going to work and doing things that would appear 
to be inappropriate.  Let me give you an example.  He was 
recommended for termination by Dr. Insel.  The following week was 
approved apparently for a travel request to go to Denmark.  Now, 
that was revoked after the committee staff questioned that.  All 
in all, he has apparently though been approved for travel five 
times since he was recommended that he be terminated and one of 
those was a trip to Hawaii.  In addition, he has been approved for 
somewhere between $20,000 and $95,000 in compensation and various 
expenses since his recommendation for termination.  There has yet 
to be a court of inquiry so we have an individual here who everybody 
appears to acknowledge at least appears to have repeatedly violated 
some of the ethical rules at NIH and yet he is still on active 
duty, fully funded, and the NIH is even helping to pay to move some 
of his equipment and personal belongings to New York.  Why in the 
world is that going on?  Who wants to take an attempt to answer 
that? 
	DR. AGWUNOBI.  Thank you, Mr. Chairman.  If I may, I will try 
to talk to the active-duty part of this and then I will defer to my 
NIH colleagues to speak to the NIH-specific aspects of your 
question. 
	In situations where a Commissioned Corps officer is alleged 
to have had or to have participated in serious misconduct, the rules 
and requirements of the Commissioned Corps require that that 
individual, in the situation, the facts and the premise be inquired 
into and investigated by a board of inquiry.  That board of inquiry 
makes a determination as to whether or not the facts, the evidence, 
statements from witnesses, whether or not in their minds this board 
of typically three to five Commissioned Corps officers and others, 
they make a determination as to whether or not they believe a 
recommendation needs to be made that the individual be terminated.  
Now, I would add that a similar circumstance would happen if-- 
	CHAIRMAN BARTON.  But you have not conducted that board yet. 
	DR. AGWUNOBI.  That is correct, sir. 
	CHAIRMAN BARTON.  And it is not even scheduled. 
	DR. AGWUNOBI.  Sir, the board of inquiry was actually ordered 
by the Surgeon General at the time, Richard Carmona.  This was done 
shortly after the allegation was formally brought to the Corps.  That 
board of inquiry was subsequently suspended by the Surgeon General, 
that order was suspended because of a request that we received from 
the Department of Justice.  They informed us that a criminal inquiry 
was underway and that they required us to stand down, stand to one 
side, suspend our activities so that they could pursue the criminal 
investigation. 
	CHAIRMAN BARTON.  What if that takes 15 years?  How long are 
you going to--I mean, look, I respect the Department of Justice but 
that shouldn't preclude the Commissioned Corps from doing its duty.  
You have got an individual in our service that has been accused and 
there appears to be more than adequate evidence, it is evidence 
enough that it has been recommended he be terminated, and yet he is 
going on trips to Hawaii.  We are paying to move his personal 
effects to New York. 
	DR. AGWUNOBI.  Yes, Mr. Chairman. 
	CHAIRMAN BARTON.  I do not understand that. 
	DR. AGWUNOBI.  As it relates to the board of inquiry, that 
is a process that will determine what kind of discipline needs to 
occur, and there is only one reason why that board of inquiry hasn't 
finished its work.  The only reason is because at the request of 
the Department of Justice and in pursuit of justice-- 
	CHAIRMAN BARTON.  Well, where are you going to conduct this 
court of inquiry? 
	DR. AGWUNOBI.  It is a standing policy within our 
organization, it is long adhered to within the uniformed service, 
the Commissioned Corps, and I would add-- 
	CHAIRMAN BARTON.  Why would it not be appropriate to go 
ahead and conduct the court of inquiry?  Let us assume you exonerate 
the man.  Then that helps him with the DOI and Department of 
Justice investigation.  On the other hand, let us assume that you 
convict him or find him--I don't know what the correct legal term is, 
but find that he is actually guilty of the allegations.  Then that 
would be a plus in the investigation of DOJ. 
	DR. AGWUNOBI.  My understanding-- 
	CHAIRMAN BARTON.  I don't understand why you--I can't think 
of a good analogy in the Congress that would apply but in any event, 
why in the world is he being approved for travel?  Why in the world 
is he going on travel?  Why in the world is he having the NIH staff 
help him package and send NIH materials and his personal effects to 
his next place of employment? 
	DR. KINGSTON.  Sir, let me respond initially and then 
Dr. Insel can respond as well.  The decisions regarding his 
day-to-day work assignments by practice was handled by his 
immediate supervisors at the Institute but it is important to 
remember a couple points here.  First of all, none of us, neither 
the Commissioned Corps nor the agency ever anticipated it would take 
this long to resolve the matter, and the expectation was that it 
would be resolved more quickly.  In the interim, there was a 
balancing decision made about how much he should be allowed to do 
because we did not have the authority without this board of 
inquiry to terminate him, and a decision was made-- 
	CHAIRMAN BARTON.  Why is that? 
	DR. KINGSTON.  Because those are the rules, the way the-- 
	CHAIRMAN BARTON.  The only way you can terminate an 
individual is if they have been convicted of some gross crime or 
something? 
	DR. KINGSTON.  For commissioned officers, there is the policy 
that Admiral Agwunobi just described and this is the way the 
policies are set up, that we may not terminate an officer in that 
position independently. 
	CHAIRMAN BARTON.  So as long as he can drag this out, he is 
a free agent?  He can do whatever he wants to do and the NIH 
management is just going to make sure that his pay voucher is 
there? 
	DR. KINGSTON.  We can take actions in terms of supervising 
but we can't terminate, and maybe Dr. Insel could comment on the-- 
	CHAIRMAN BARTON.  What if he just stopped coming to work?  
What if he just said the hell with it, I am not--then could you 
terminate him? 
	DR. AGWUNOBI.  Sir, our rules say that if you are away 
without leave, AWOL, for more than 30 consecutive days, that is 
reason for summary termination, even without a board.  We have 
pretty clear rules on when is an individual referred to a board and 
when can they be summarily terminated.  In that situation, that 
would apply. 
	CHAIRMAN BARTON.  What if he came one day a month, every 
25th day? 
	DR. AGWUNOBI.  Sir, if there was a-- 
	CHAIRMAN BARTON.  I mean, he is not doing--let us be a 
little bit positive. He is showing up.  Apparently he is trying to 
work, so I guess he should be commended for that, but-- 
	DR. AGWUNOBI.  Sir, in any circumstance where his supervisor 
believes that there is misconduct that requires action that could 
affect the person's commission, rank, retirement, these are all 
situations that would require us to use a board of inquiry to 
inquire into the facts, make a determination and a-- 
	CHAIRMAN BARTON.  That would be nice if you had held a board 
of inquiry.  Now, Dr. Insel, my briefing says that you recommended 
that he be terminated.  Is that correct? 
	DR. INSEL.  That is correct.  I think it was 
November 21, 2005. 
	CHAIRMAN BARTON.  Okay.  Now, do you think it is appropriate 
since you recommended his termination that he still be allowed to 
basically continue his activities as he sees fit? 
	DR. INSEL.  Well, the first point in your opening statement, 
you said that you thought it was absurd that he is still working for 
us, and I think that may have been kind.  I think this is, as I 
told you in June, well beyond the time that any of us would have 
liked to have seen this resolved, and it is not clear, as you are 
pointing out, that the end is in sight even now. 
	CHAIRMAN BARTON.  If he were not in the Commissioned Corps, 
would you have more ability to terminate him? 
	DR. INSEL.  Yes. 
	CHAIRMAN BARTON.  So the fact that he is part of the 
Commissioned Corps makes it more difficult? 
	DR. INSEL.  It takes-- 
	CHAIRMAN BARTON.  Does it make it impossible? 
	DR. INSEL.  It takes it out of my hands.  Were he in the 
Civil Service, I believe he would have been gone before the end of 
2005. 
	CHAIRMAN BARTON.  But why has he not been restricted?  I 
mean, it is bad enough that he hasn't been terminated but why hasn't 
he been restricted in his activities and prevented from having 
access to apparently all of his equipment and office materials and 
things like that? 
	DR. INSEL.  So he has been restricted in a number of ways but 
that has been iterative, and in retrospect, we should have some of 
that earlier.  Had we known this was going to take so long and had 
we known the extent of violations, some of which we are only finding 
out about how, we would have done more much earlier.  What we were 
doing throughout though was, we recognized that there was a 
difference between the outside activities which were the source of 
the violations and all of the concerns about his ethical behavior 
and his official duty activities.  Official duty had to do with what 
the studies were that he was involved with, how he behaved while he 
was at work.  We don't have here a record of him harming patients.  
We don't have here a record of an integrity, a research problem.  
This is about outside activities and those were greatly restricted 
very early on.  In terms of the official-duty piece, you asked 
before about why would he be allowed to go to a meeting.  Well, 
this was part of his job.  He represented the Institute in terms of 
work that he did. 
	CHAIRMAN BARTON.  Well, if he has been recommended for 
termination, I would think if you can't fire the man, you could at 
least put him on leave without pay, and if you can't put him on 
leave without pay, you could at least restrict him to showing up at 
the office and doing some routine work that doesn't impact the 
outside world in any way. 
	DR. INSEL.  So let us go through the options because we have 
talked about this right along.  It has been a concern about what we 
actually could do in this situation, and I must say, to some extent 
this is frontier territory.  We haven't been in this situation 
before.  Leave without pay we were told was not an option. 
	CHAIRMAN BARTON.  Why is that? 
	DR. INSEL.  I might refer that to-- 
	CHAIRMAN BARTON.  I apologize for my time expiring.  But if 
we could just finish this before I have to turn it back over. 
	DR. AGWUNOBI.  Mr. Chairman, I would just start by restating, 
there is only one reason why a board of inquiry hasn't sat and met 
on the individual that you identified and that is because the 
Department of Justice has asked us to hold while they conduct a 
criminal investigation.  Leave without pay is a disciplinary 
intervention.  It would require that this individual go before a 
board of inquiry and that that board of inquiry determine what 
the intervention needed to be before it could be recommended.  That 
process would have occurred once again if it weren't for the fact 
that the Department of Justice is conducting an ongoing criminal 
investigation and has asked us to hold-- 
	CHAIRMAN BARTON.  Well, I predict, if you don't do the board 
of inquiry, the Department of Justice will take at least another 2 
years, and he is still going to be on the payroll.  If you hang your 
hat on waiting for the Department of Justice, and I am not down on 
the Department of Justice but, they do not operate on the same 
timetable.  You have got somebody that has been recommended for 
termination.  Since then he has gone on at least one trip to Hawaii 
and yet you are still sitting here telling us you don't even have a 
time for it.  You don't even have a time for it.  I mean, I 
understand due process and I respect the rights of the accused to 
have the ability to face their peers and all this but that doesn't 
mean they can hide under bureaucracy for years and years and years, 
and that is what is happening.  Now, the Department of Justice can 
request that you do something, but that does not prevent you from 
doing your duty and your duty is not to let this individual continue 
to operate apparently without any penalty for what appears to be 
serious violations of the ethical rules of the NIH. 
	Mr. Chairman, I have abused the privilege.  I apologize for 
that, and I yield back. 
	MR. WHITFIELD.  At this time I recognize Mr. Stupak of 
Michigan for 10 minutes. 
	MR. STUPAK.  Thank you, Mr. Chairman.  Dr. Insel, let me 
just follow up where the Chairman left off.  If he is an employee 
of NIH but really a Corps employee, why not just send him back to 
the Corps and not even have him at NIH anymore?  Doesn't it really 
cause the other people at NIH who are trying to do their jobs, 
doesn't it look sort of odd to them to have this person who is 
under this cloud of suspicion for so long who you recommended for 
termination to still be there doing functions?  Why not just send 
him back?  You can send him back, can't you? 
	DR. INSEL.  Well, that is a good question and one that I am 
not sure I have the full answer for.  We have looked at a lot of 
options and there have been meetings with senior NIH management 
and-- 
	MR. STUPAK.  Well, can't you send him back? 
	DR. INSEL.  So since he is effectively detailed to us, the 
question had been raised about-- 
	MR. STUPAK.  Well, is there an end date of this detail?  Does 
he have to be there for so many years?  Isn't it really at your 
discretion? 
	DR. INSEL.  No, I think it is at the Corps' discretion as to 
where the detail takes place as far as-- 
	MR. STUPAK.  So as director of NIH, you don't have any say 
on who gets detailed to you? 
	DR. INSEL.  Well, not when someone has been there for a 
while.  I can ask my colleagues to the right.  I actually don't 
know that there has been an instance of changing the detail in this 
kind of a case but-- 
	DR. KINGSTON.  That was--we had lengthy discussions with the 
various specialists in actions we could take and in numerous 
discussions, that was never raised as something that we were allowed 
to do. 
	MR. STUPAK.  Okay.  I am raising it now.  Can you send him 
back? 
	DR. KINGSTON.  Well, we would have to ask the authorities to 
see whether we could. 
	MR. STUPAK.  I mean, I find it rather appalling.  You are 
sitting there saying he is going to these meetings representing NIH 
under this dark cloud that everybody knows about.  What the heck 
kind of signal does that send everybody else?  I mean, I would think 
someone would go out and take the bull by the horns and do something 
here.  It has been 4 years since we brought this your attention.  
Four years.  We are still going round and round.  He represents the 
NIH, is under a cloud of suspicion.  He has got criminal 
investigations going on.  Gentlemen, someone has got to accept 
some responsibility and do something here. 
	DR. AGWUNOBI.  Sir, the particular case that you described, 
it is my understanding it was first referred to the Commissioned 
Corps in December of 2005 for action.  We have been in dialog with 
the leadership of NIH since then as partners--
	MR. STUPAK.  Eleven months, haven't been able to make a 
decision. 
	DR. AGWUNOBI.  Well, actually a decision was made within 60 
days.  A decision was made to hold a board of inquiry.  We-- 
	MR. STUPAK.  But my question was, why not just send him back 
to the Corps? 
	DR. AGWUNOBI.  As I say, sir, the conversation, the 
partnership between us and the agency decided that the best approach 
to handling this circumstance was a board of inquiry.  Once again, 
the only reason why that board of inquiry-- 
	MR. STUPAK.  Right.  I understand.  Okay.  I don't want to 
use up my whole time going over--how about Mr. Walsh?  There is no 
board of inquiry on him, is there? 
	DR. AGWUNOBI.  I believe there is.  A board of inquiry has 
been ordered. 
	MR. STUPAK.  As of like a couple days ago you just started 
it? 
	DR. AGWUNOBI.  Within the last week, sir. 
	MR. STUPAK.  Yeah, so he sat in limbo for 9 months from 
January of 2005 until September 7, so for 9 months he wasn't under a 
board of inquiry once again and he is not a Corps person, right? 
	DR. AGWUNOBI.  No-- 
	MR. STUPAK.  Oh, he is? 
	DR. AGWUNOBI.  Yes, sir. 
	MR. STUPAK.  So why was no decision made on him then, 
Mr. Walsh? 
	DR. AGWUNOBI.  A decision was made when the board of inquiry 
was ordered for Dr. Sunderland that we would hold the board of 
inquiry for Walsh upon completion of the board for Sunderland. 
	MR. STUPAK.  So he sat for 9 months not knowing whether or 
not there would be one? 
	DR. AGWUNOBI.  A board of inquiry hasn't sat on him yet, 
sir. 
	MR. STUPAK.  Okay.  Mr. Kington, if I may--Dr. Kington.  Go 
to Exhibit #3 because I was looking at this spreadsheet produced by 
the Office of Management Assessment and it is entitled Results of 
103 Individuals' Reviews by NIH Human Capital Group, Exhibit #3.  
Some of these findings and subsequent actions are simply astounding. 
 An investigator named J. Gade, if I am saying that right, was found 
to have received almost half a million dollars, $500,000 without 
prior approval and was given a 45-day suspension.  So Mr. Gade is 
an investigator.  How much money would he make a day? 
	DR. KINGSTON.  Actually, I am not--I don't know what his 
salary is. 
	MR. STUPAK.  Well, with a 45-day suspension, that comes out 
to $11,000 per day.  Did he have to pay back the half-million 
dollars? 
	DR. KINGSTON.  I am not aware that he returned the payments. 
	MR. STUPAK.  So therefore if I am making maybe $1,000 a day 
and I am sure that is more than generous of what he makes, I am 
$10,000 ahead because I don't have to pay anything back, so where 
is the deterrent in this kind of activity? 
	DR. KINGSTON.  First of all, it was unprecedented for us to 
suspend without pay an NIH scientist.  No one in the entire 
administration of the agency had ever had a case even remotely close 
to suspending an employee for 9 weeks of pay, especially for a 
senior scientist, so it was a significant penalty and all of--every 
step of the way, every step of the way we obeyed Federal personnel 
rules and regulations that-- 
	MR. STUPAK.  Come on.  You can't tell me Federal rules say 
you can accept improper $500,000-- 
	DR. KINGSTON.  You are right, and-- 
	MR. STUPAK.  --and you can keep your job, you get a 45-day 
suspension, you don't have to pay it back and everybody is happy. 
	DR. KINGSTON.  This was a significant penalty.  We-- 
	MR. STUPAK.  Forty-five days?  Come on.  This is a 
half-million dollars. 
	DR. KINGSTON.  Nine weeks of leave without pay, it is 
unprecedented for an NIH scientist to have received-- 
	MR. STUPAK.  So then what does it take for an NIH person to 
be terminated?  If a half a million dollars won't do it, what does 
it take? 
	DR. INSEL.  Can I add to that? 
	MR. STUPAK.  Sure. 
	DR. INSEL.  I think the answer to your question is conflict. 
 This was a case in which it was determined as far as I can 
understand, and Dr. Kington can give you more information about 
this, but there was no inherent conflict of interest.  All the 
activities, though they were highly paid, were considered to have 
been approvable, but they were not disclosed. 
	MR. STUPAK.  So if it would have been approved, he could 
have kept the half-million dollars? 
	DR. INSEL.  Had they been approved, had they been disclosed, 
we wouldn't be talking about this. 
	MR. STUPAK.  Do you have scientists who receive half a 
million dollars in outside activities that is approved? 
	DR. INSEL.  In 2006, that is no longer possible, but-- 
	MR. STUPAK.  No, back then, before this, 2005-- 
	DR. INSEL.  Not even in 2005. 
	MR. STUPAK.  Okay.  Explain this one to me.  How about 
Steven Katz, director of NIAMS, received about $275,000 but no 
action was taken because the employee, and I quote now from Title 
III, "remedied the violation."  What does that mean?  How do you 
remedy a violation? 
	DR. KINGSTON.  First of all, let me respond.  These reviews 
were handled centrally by the NIH Office of Management Assessment. 
 We followed standard GAO rules and regulations and it was 
determined-- 
	MR. STUPAK.  Excuse me, Doctor.  I only have a limited 
time. 
	DR. KINGSTON.  It was determined that-- 
	MR. STUPAK.  So what does "remedied the violation" mean? 
	DR. KINGSTON.  It was determined that it was not a 
significant violation, and I was intentionally, as were all of the 
senior leadership, kept away from specifics because we might be 
appeal officials later on and if we had been involved-- 
	MR. STUPAK.  That is fine, but just--
	DR. KINGSTON.  --it would have been prejudice. 
	MR. STUPAK.  Well, what does "remedied the violation," what 
does it mean?  He paid it back? 
	DR. KINGSTON.  There was some type of compensation and that 
it was determined that it was not severe enough to warrant any type 
of significant intervention, and that was true.  That case was 
reviewed at length, and Dr. Katz was not found to have-- 
	MR. STUPAK.  Well, there are others here, between $40,000 
and $60,000, and you have things like oral admonishment. 
	DR. KINGSTON.  There were a number of factors taken into 
consideration.  Those factors are guided by law, and we-- 
	MR. STUPAK.  You know, every one of us Members up here, I 
bet you, receive at least once a year a letter in the mail and there 
is always a dollar bill stapled at the top of it and it is like I 
am paying you a dollar to answer my letter.  Okay.  We send the 
dollar back.  You know what would happen if any one of us took a 
dollar for answering a piece of mail?  We would all be out the door.  
And why?  Because of ethics and integrity and no blemish on it.  
You are blemishing the Corps.  You are blemishing the NIH.  And 
these are just, oh, give him an oral admonishment.  That doesn't 
fly. 
	DR. KINGSTON.  There is a system that determines the factors 
that are taken into consideration for any type of penalty.  Every 
step of the way we assure that any action that we took fit within 
the Federal rules and regulations about what penalties were taken 
and every step of the way we followed Federal rules and regulations 
and laws that determine what factors are considered when taking 
disciplinary action against an employee. 
	MR. STUPAK.  I will bet you there is no Federal rule or 
regulation that says half a million dollars, you get 45 days off, 
$275-- 
	DR. KINGSTON.  That is correct, because the rules are more 
complex than that. 
	MR. STUPAK.  And it is your interpretation and it is your 
application of those rules and regulations? 
	DR. KINGSTON.  We believe that we applied those rules 
rigorously and consistently across the cases and consistent with how 
any other disciplinary action was-- 
	MR. STUPAK.  Consistent with what?  What did you review it 
with?  You said you never had these problems before.  So where is 
your consistency?  Where is your parallel?  How did you make that 
determination? 
	DR. KINGSTON.  That is a fair question. 
	MR. STUPAK.  What is your baseline? 
	DR. KINGSTON.  That is a fair question.  What we did is, in 
the process of determining what range of interventions were 
appropriate for any specific case, we consulted the specialists who 
handle employee disciplinary action at the agency for any type of 
disciplinary action and we in each case had that specialist 
determine the range that the violation fit into in terms of 
disciplinary action compared to all the other disciplinary actions 
that the agency has taken, and in every case, we have complied with 
the recommendations of those specialists who specifically asked that 
question.  We asked that question. 
	MR. STUPAK.  Are the specialists within the Federal 
government or private? 
	DR. KINGSTON.  No, the specialists are Federal employees 
who specialize in determining what are the appropriate disciplinary 
actions for any specific case, and in every single case we followed 
Federal rules to the letter. 
	MR. STUPAK.  I am glad those guys aren't on the sentencing 
guidelines, let me tell you. 
	Dr. Insel, is it true that the Alzheimer's study that we 
spent so much time on that Dr. Sunderland did, has that been 
discarded now?  Is anyone going to further try to look for biomarkers 
to try for early detection?  Has that study been abandoned? 
	DR. INSEL.  The study isn't abandoned.  There is a--what I 
think you are referring to is called the BIOCARD study, biomarkers 
in elder controls at risk for dementia.  That study is an NIH study. 
 It still has an ongoing and continuing protocol, but it is closed 
at NIH for new accrual of patients. 
	MR. STUPAK.  But the study is still going on? 
	DR. INSEL.  The study is not going on currently.  It is a 
longitudinal study and so we are in a suspended state here. 
	MR. STUPAK.  So in other words, there is no funding going 
into it? 
	DR. INSEL.  There is no funding going into it. 
	MR. STUPAK.  Why don't you get back all the money these 
people took for consulting, put it back in there and fund the study, 
because it is a program that Congress feels very strongly about.  So 
now you have bad apples, now we suspend the study because we can't 
fund it, so why don't we just take these fines and costs--not fines 
and costs, I am sorry--these consulting fees and put it back in? 
	DR. INSEL.  So can I clarify what we mean by suspension? 
	MR. STUPAK.  Sure. 
	DR. INSEL.  This is a longitudinal study.  The hope would be 
that it would go for 20 to 30 years.  We are in I think the 11th year 
of this study. 
	MR. STUPAK.  Right. 
	DR. INSEL.  Right now there have been no new patients entered 
in I believe since January of 2005 at NIH.  The NIMH itself is not 
likely to want to continue to bring in new patients for the study 
because we are shifting and going in other directions. 
	MR. STUPAK.  But you still have the research and things like 
this on this study, right, on the subjects you already have entered 
into the study? 
	DR. INSEL.  Will there be additional research? 
	MR. STUPAK.  Yes. 
	DR. INSEL.  The hope would be that we will find a way to keep 
this going but it doesn't mean that necessarily NIMH has to-- 
	MR. STUPAK.  Well, why can't you keep it going?  Is it money 
or you don't want to have further studies or persons come into it? 
	DR. INSEL.  Well, it is a combination of things.  I think 
the study is meritorious.  I think it is worth doing.  It is outside 
of our core mission.  We would like to use our funds for-- 
	MR. STUPAK.  Well, why did you start it if it is outside 
your core mission and after spending millions of dollars for almost 
2 decades? 
	DR. INSEL.  That is a good question. 
	MR. STUPAK.  Or 11 years. 
	DR. INSEL.  The intramural program, which is the part of our 
agency here in Bethesda where we have got lots of exciting things 
going on occasionally does do projects such as this one that aren't 
that closely connected to the Corps.  I came in and decided that I 
wanted us to be much more mission-focused and so as the leader of the 
agency decided that this was-- 
	MR. STUPAK.  Who is going to do the research then on 
Alzheimer's if you are not doing it? 
	DR. INSEL.  Well, we have two other agencies within NIH, the 
National Institute of Aging and the National Institute of 
Neurological Diseases.  They spend collectively about $656 million 
on Alzheimer's.  So this study is a very, very small piece, but it 
is the clinical research on Alzheimer's in Bethesda in the intramural 
program. 
	MR. STUPAK.  Sure, trying to determine the biomarkers.  
Thank you. 
	MR. WHITFIELD.  Thank you, Mr. Stupak. 
	I think all of us recognize the NIH is the national leader 
and the premier obviously government agency in research and 
development looking for cures of all sorts of diseases and maladies. 
I think all of us also recognize the importance as Dr. Insel said 
the last time he was here of setting the high standards, and in your 
testimony, Dr. Kington, you talked about how after you all started 
looking into this, you had 52 violations.  You disciplined 34 
scientists.  You referred 10 cases to appropriate officials for 
possible violations of criminal laws.  That is for an institution 
that has the reputation that NIH has and how that sort of 
all-encompassing disclosure of ethical violations and--it is sort 
of disturbing.  Are any of you disturbed about it or concerned about 
it or are we making more of it than should be made of it? 
	DR. KINGSTON.  Not at all.  We were all deeply concerned 
about the reputation of the agency and our ability to accomplish our 
mission, which is why we aggressively responded.  We worked closely 
with the department and the Office of Government Ethics to pass 
regulations that now preclude any outside consulting with industry. 
 We aggressively pursued the cases.  We have greatly expanded our 
ethics program so that we feel confident that we are building a 
program that will be the best in the Federal government.  We have 
responded quite aggressively because we were appalled that we had 
a system that didn't appear to be working as well as it could have. 
	MR. WHITFIELD.  Now, had you ever had anything at this scale 
before of violations of NIH ethics rules-- 
	DR. KINGSTON.  I asked that question, and I was told no. 
	MR. WHITFIELD.  So the largest scandal, if we can call it 
that, in NIH's existence then? 
	DR. KINGSTON.  And we certainly hope it will be the last. 
	MR. WHITFIELD.  Now, I think-- 
	DR. INSEL.  I am sorry, if I could add to that.  I think 
when you see a list like this though, one way to understand it is, 
that it is not as if we suddenly collected a number of people who 
had ethical dilemmas.  What was happening here was that there was 
a systemic problem to some extent.  We weren't doing the job we 
needed to do to make the rules clear and to make sure people could 
follow them, and so the scandal came about as a way of forcing all 
of that to change. 
	MR. WHITFIELD.  Now, I am not going to be an apologist for 
NIH, but you are dealing with some particularly skilled people 
here.  These scientists are involved in very important research and 
I am assuming that salaries paid by the Commissioned Corps and NIH 
generally may not be as high as in the private sector.  I am also 
assuming that they allowed these consulting agreements on the side 
as a way of subsidizing salaries.  Would that be correct? 
	DR. KINGSTON.  It was an allowable way, but it is also 
important to remember that a relatively small minority of all of the 
thousands of scientists at NIH actually engaged in consulting 
activities with pharmaceutical and biotech.  It actually was a 
small number. 
	MR. WHITFIELD.  But now that is banned completely.  Is that 
correct? 
	DR. KINGSTON.  Yes, it is banned completely. 
	MR. WHITFIELD.  Are you going to lose a lot of scientists as 
a result of that? 
	DR. KINGSTON.  It is a concern.  We have begun--even when we 
announced in the Federal Register the new regulations prohibiting 
outside consulting, we made a commitment to the public that we would 
reassess the impact of those regulations on the agency.  There have 
been anecdotal cases of scientists who attributed part of the reason 
why they left the agency recently to these rules.  We are in the 
process of having a more formal evaluation of the impact, and if 
we determine that it is harming the agency, we will come to the 
appropriate decider to decide how we can correct it, but we won't 
do anything that will allow the agency to be vulnerable to the 
allegation of being not perfectly unbiased in our decision-making, 
and anything that might harm the reputation of the agency, we take 
very seriously. 
	MR. WHITFIELD.  So this did send some tremors through the 
entire agency out there.  Would that be correct? 
	DR. KINGSTON.  I think the tremors were deep. 
	MR. WHITFIELD.  Now, the commissioned officers of the Corps, 
I think in your testimony you said they are not under the Uniform 
Code of Military Justice.  Is that correct? 
	DR. AGWUNOBI.  That is correct. 
	MR. WHITFIELD.  And Chairman Barton and Mr. Stupak both 
talked about how the board of inquiry had been delayed because of 
a request from the Justice Department.  The Corps is not required 
by any law to delay the board of inquiry, is it? 
	DR. AGWUNOBI.  Sir, I should clarify just a little on the 
UCMJ.  There are certain circumstances under which the Commissioned 
Corps does subject itself to the Uniform Code of Military Justice, 
the first being our officers were posted to the U.S. Coast Guard.  
As you know, sir, we provide healthcare services to the members of 
the U.S. Coast Guard, our sister service.  The other is when we 
are militarized by the President by executive order.  Now, having 
said that, I would urge the Chair and members to recognize that 
it is a longstanding practice, indeed there is policy that reflects 
this notion of deferring to criminal investigations when we have a 
civil proceeding underway, and it doesn't just apply to the 
Commissioned Corps.  Indeed, if a civilian working in one of HHS's 
agencies was referred for criminal investigation and the Department 
of Justice asked the civilian authorities to delay their civil 
investigation because they were worried that it might impinge upon 
the criminal investigation, there are many circumstances in which 
I imagine even civilians would defer to that situation. 
	MR. WHITFIELD.  Well, I just may point out that in Oversight 
and Investigations, this subcommittee particularly is involved in a 
lot of oversight and investigation regarding issues in which crime 
is involved, and the Department of Justice comes to us frequently 
and asks us to delay anything and everything we are doing and we 
seldom do it.  
	DR. AGWUNOBI.  Sir, the pursuit of justice is tantamount in 
our minds and in our thoughts.  We would be loathe to have a 
situation where our board of inquiry, our investigation into the 
allegations of any Commissioned Corps officer in some way 
jeopardized or hampered the pursuit of a criminal investigation. 
	MR. WHITFIELD.  But what about Mr. Walsh?  There was no 
criminal investigation with Mr. Walsh, was there? 
	DR. AGWUNOBI.  No, sir.  My understanding--I don't know the 
details of either of the cases.  I serve in the appellate process in 
this, in our system and I don't know the details of either case, but 
I do know that the board of inquiry for Mr. Walsh was not delayed 
because of a request by the Department of Justice specifically to 
that case. 
	MR. WHITFIELD.  It was delayed why? 
	DR. AGWUNOBI.  We use an office in the Commissioned Corps to 
perform these investigations, to staff and manage these 
investigations.  A decision was made when the two cases were 
presented to us to do the most egregious at the time, this was 
their determination at the time, Dr. Sunderland, and to 
then--potentially egregious, I should correct and say--and then 
follow with Walsh.  A series of events transpired in which the 
Department of Justice asked us for a 30-day delay, subsequently 
continued to extend their requests for a delay and unfortunately 
that led to a delay in the implementation of the board of inquiry 
for Dr. Walsh until fairly recently. 
	MR. WHITFIELD.  And why couldn't you have done both? 
	DR. AGWUNOBI.  It was determined that in order to provide 
the best service, the most efficient service and to ensure that 
all the procedures and rules that are a part of the Commissioned 
Corps were followed, it was to be--an operational determination was 
made that it was better to do one after the other. 
	MR. WHITFIELD.  But after all of this investigation has 
been completed now, Dr. Kington, I want to make sure I understand, 
10 cases have been referred to the appropriate officials for 
criminal investigation.  Is that correct? 
	DR. KINGSTON.  Yes.  Following standard policies, we 
referred--when there was sufficient concern about a criminal 
violation, we referred I believe a total of 10 to the Inspector 
General. 
	MR. WHITFIELD.  And I acknowledge your commitment to 
maintaining the highest standards for NIH, the institution that is 
involved in such important research for the whole country, for the 
whole world.  Are all you really confident that the changes that 
you have made are sufficient and that things can work very well 
moving forward? 
	DR. KINGSTON.  Now I function as the senior ethics official 
for the agency so I have oversight responsibility for all of the 
personnel-related ethics actions, and I can say without any 
hesitation that we have committed an extraordinary amount of 
thought and resources to actually making sure that we have a system 
that works, and I am confident that when the transformation is 
completed--we are still in the process of doing it--we will have 
an exemplary system and we will be able to prevent many potential 
problems. 
	MR. WHITFIELD.  You have so many different institutes out 
there.  The fact that you are the chief ethical officer, how do you 
get it out to all the institutes so that they are all on board? 
	DR. KINGSTON.  And that is an important question that we 
asked ourselves, how do we have that work.  The way it works is 
that the authorities related to the ethics and government act come 
from the Office of Government Ethics.  Then there is a senior person 
who is the designated agency ethics official, in this case, 
Mr. Ed Swindell.  I report to him for this part of my job, and in 
a similar way, we are restructuring so each of the senior ethics 
officials at 27 individual institutes and centers in turn reports 
to me.  It is in their performance plans.  I have an opportunity to 
respond when they are reviewed every year and we are setting up a 
system of random audits that will assess at multiple levels of the 
agency whether or not the ethics rules are being applied rigorously, 
and we have committed the people and the resources and the 
infrastructure to having this work. 
	MR. WHITFIELD.  And Dr. Trey Sunderland is still an employee 
at NIH and is involved in certain restricted activities.  Is that 
correct? 
	DR. KINGSTON.  Yes. 
	MR. WHITFIELD.  Is he at the mental health institute, 
Dr. Insel? 
	DR. INSEL.  Yes.  If I can respond, there have been a number 
of restrictions of his activities, but again the options we had 
seemed to us were limited.  As you may recall at the last hearing, 
we had a discussion about leave with pay, which was one option that 
I think the subcommittee was interested in.  We felt that was not 
appropriate here.  We have changed his duties so that he is working 
in a different part of the institute.  He does not have access to 
clinical samples that the subcommittee was so concerned about 
before, and there are  a number of other restrictions in terms of 
his outside activities and official duties. 
	MR. WHITFIELD.  And a lot of those samples have been 
returned also, correct? 
	DR. INSEL.  The samples that the previous hearing was 
about, Pfizer samples, have all been returned. 
	MR. WHITFIELD.  At this time I recognize the gentleman from 
Texas, Mr. Burgess, for 10 minutes. 
	MR. BURGESS.  Thank you, Mr. Chairman, and I appreciate this 
ongoing hearing. 
	Now, the comment was made that Dr. Sunderland was hiding 
under the bureaucracy of the Department of Justice, but I guess I 
would just like to know, would Dr. Sunderland leave if he were free 
to do so today? 
	DR. INSEL.  If I can answer, he asked to leave in November 
of 2004 so it is almost the second anniversary of when he asked to 
be allowed to leave the NIH. 
	MR. BURGESS.  So his continued presence there is not 
necessarily voluntary at this point? 
	DR. INSEL.  By no means. 
	MR. BURGESS.  Now, does Dr. Sunderland--let me make sure I 
understand this correctly.  Is he purely involved in research or 
does he have clinical duties as well? 
	DR. INSEL.  His role has been until recently as the Chief 
of the geriatric psychiatry branch which is a clinical research 
branch, so he was seeing patients, seeing subjects in research 
studies. 
	MR. BURGESS.  So he does have responsibilities that involve 
direct patient care? 
	DR. INSEL.  He did.  At this point he is no longer involved 
with direct patient care. 
	MR. BURGESS.  And when did those stop? 
	DR. INSEL.  Oh, I think that goes back to sometime early in 
2005.  I believe it was perhaps either January or February of 2005. 
	MR. BURGESS.  You know, without speculating about the guilt 
or innocence or rightness or wrongness of the situation, there are 
some things that come up certainly with your own investigations and 
with our testimony that we have heard here that would call into 
question someone's judgment, and in the clinical practice of 
medicine, I mean, you are only as good as your judgment.  I just 
wonder the wisdom of leaving someone whose judgment was called into 
question and continuing to deliver clinical care and be involved 
clinically with patients.  In a private or a regular hospital 
setting, that would be cause for summary suspension and a convening 
of a fair hearing and all of the things that you normally would 
associate with loss of hospital privileges.  Either Dr. Insel or 
Dr. Kington. 
	DR. INSEL.  If I may respond, it is important to separate 
out his official duty for which there has never been a question 
about his competence or integrity.  The issues of patient care, 
we have certainly never gotten a complaint about patient harm or 
an issue that is related to his ability as a geriatric psychiatrist 
and I think it is probably fair to say that he is one of the most 
highly sought after and highly respected geriatric psychiatrists 
in the country.  Part of what I think got him into this situation 
was making bad judgments about taking lots of the invitations and 
being used as a sort of opinion leader in the field.  It now appears 
for personal gain as well as for whatever effect he was having on 
the field as well. 
	MR. BURGESS.  Right, and that error in judgment, whether it 
be your hand in the till or inappropriately taking invitations, it 
does beg the question, is that judgment impairment that is now 
evident, is that going to spill over into the clinical setting and 
are patients going to be harmed as a direct result?  Our 
responsibility is to the safety of our patients. 
	DR. INSEL.  Right.  If the question is whether those outside 
duty activities in some ways have contaminated his official duty, 
what he was doing in the hospital, in the clinic, we haven't seen 
any evidence of that. 
	MR. BURGESS.  Just for recapping for my benefit, the BIOCARD 
study, quickly, what was that again? 
	DR. INSEL.  This is a long-term longitudinal study of 
controls of healthy people who are at risk for Alzheimer's disease 
because they had a first-degree relative with the disease. 
	MR. BURGESS.  Dr. Kington, in response to some questions 
that were asked by this committee in June of 2005, the question 
comes up whether the committee was given misleading information 
from the National Institute of Mental Health in response to the 
committee's questions on its request letter concerning spinal 
fluid samples that were collected in the National Institute of 
Mental Health lithium study in early Alzheimer's disease patients. 
 The question I believe was were all the records relating to tissue 
samples regarding Dr.  Molchan's lithium study turned over.  Did we 
get a misleading answer in our request for that answer of a 
question? 
	DR. KINGSTON.  I think in retrospect, there probably was--
it was clear that there was incomplete information that was conveyed 
to the committee but it is also important to recognize that the way 
that these requests were handled were essentially they came 
into--were largely coordinated through the office of the director 
and then delegated to the Director of NIMH to answer the questions.  
He in turn relied on information that was given to him, and the 
answer could only be as accurate as that information that was given 
to him, and Dr. Insel may want to respond as well. 
	MR. BURGESS.  If I could, let me just pursue that for a 
second.  Now, the samples that have been testified to here today, 
Pfizer has returned those samples? 
	DR. KINGSTON.  Pfizer has returned all remaining samples in 
its control. 
	MR. BURGESS.  And that was at what?  A fifth, an eighth, a 
half?  Any rough estimate of how much--
	DR. KINGSTON.  Actually I don't know the exact amount. 
	MR. BURGESS.  So in addition, the National Institute of 
Mental Health has five storage freezers of samples recovered that 
Dr. Sunderland shipped to New York without proper approval.  What 
will the NIH do with the unused and recovered samples from 
Dr. Sunderland's shipments to advance Alzheimer's research?  In 
other words, will these samples indeed be used in an ongoing 
study? 
	DR. KINGSTON.  And that is under consideration now by NIMH 
and I will let Dr. Insel respond. 
	MR. BURGESS.  You testified earlier that that study was not 
stopped.  Is that correct? 
	DR. INSEL.  There is some confusion here so let us break it 
down a little bit.  There are five freezers.  Not all of those 
involve samples that were returned from Pfizer.  That is actually 
a relatively small part of the entire collection. The five freezers 
do involve samples that have been collected by the geriatric 
psychiatry branch over many, many years.  Most of them are 
cerebrospinal fluid but there are other kinds of samples as well.  
Those aren't going anywhere.  The question remains how they will be 
handled in the future.  There needs to be IRB approval and an 
IRB-approved protocol for them to be used in any sort of ongoing 
or collaborative research.  The options include such things as 
maintaining a repository--because I do believe these are valuable 
samples and apparently other people believe that as well--that could 
be used by a number of collaborators and at this point we do have 
an IRB-approved protocol with a new principal investigator.  If he 
deems it worthwhile, he could find collaborators anywhere who may 
be interested.  In terms of this BIOCARD study, the one that you 
bring up, its value really will have to be determined at some point 
in the future.  Three hundred and fifty subjects, only 14 of them 
have developed any signs of Alzheimer's disease.  It is another 10 
years before we can begin to see the 50 or 60 subjects that will 
then make this such a valuable study.  So we are talking long term, 
and there will be plenty of time to figure out how that will be 
planned out.  It will remain though as something that we can hold 
within--this is government property.  These are NIH samples. 
	MR. BURGESS.  So the delay really hasn't damaged the value 
of the study? 
	DR. INSEL.  Well, the question remains whether those 350 
subjects are still on board or not.  If someone comes back to them 
3 years from now, are they still going to want to participate or 
have we lost the very critical window when changes are taking place. 
	MR. BURGESS.  So at this point, is the BIOCARD study going 
on at NIH or an extramural program anywhere else or in a private 
institution anywhere else? 
	DR. INSEL.  There was a BIOCARD, called BIOCARD 2.0 that was 
begun at North Shore Hospital which was Dr. Sunderland's prospective 
future employee. 
	MR. BURGESS.  Should that make any of us up here suspicious? 
	DR. INSEL.  It makes me very worried that he would have 
anything to do at this point with that study.  That study is actually 
also terminated and the employer has no longer offered him the 
position that was on the table for the last 2 years. 
	MR. BURGESS.  Well, maybe sitting on this committee for the 
last year has made me cynical, but I would be very suspicious about 
that activity at North Shore Hospital in regards to what we have 
learned in this committee.  Would there have been any way to protect 
the patients from the inconvenience and the disruption in the study 
and anxiety from a move by keeping the study at NIH under the 
leadership of someone else in Dr. Sunderland's group?  Presumably 
he wasn't the only one involved in that, so did we have other 
scientists at NIH who could have just simply picked this up without 
inconveniencing and aggravating families? 
	DR. INSEL.  So there will still be samples there so that is 
not going anywhere, but if we are taking about new accrual of 
information so additional people coming in and additional samples 
collected toward the future, who would do that?  When Dr. Sunderland 
announced he was leaving, his deputy, Dr. Robert Cohen, took over.  
He became the principal investigator on this study.  Dr. Cohen then 
decided to leave, I believe in September of 2005, and in the effort 
to find someone else could take this over as a principal 
investigator, Dr. Joel Kleinman stepped forward and he had been 
involved with this study already but he is not someone who would be 
able to do the clinical support and the clinical evaluations of 
patients with Alzheimer's so we have no one in place who is able to 
do that at this time in the intramural program at NIMH. 
	MR. BURGESS.  Have the rules on outside consulting--and 
this is a question for anyone on the panel.  Have the rules on 
outside consulting caused the loss of scientists at NIH?  Are the 
rules overly restrictive at this point? 
	DR. KINGSTON.  We believe the rules are appropriate for this 
current situation but we are in the process of evaluating its 
impact.  As I said earlier, there are individual scientists who have 
said that the rules played a role in their decision to leave the 
agency. 
	MR. BURGESS.  How many scientists have left? 
	DR. KINGSTON.  We are just beginning to collect the 
information on that, but it is anecdotal information only up to 
this point.
	MR. BURGESS.  Is there--I mean, you are the NIH so you are 
all smart people.  Is there a way to construct a program that would 
allow with transparency and full disclosure would allow scientists 
to participate in outside consulting to prevent us from losing 
valuable members of the scientific community? 
	DR. KINGSTON.  And that is a question we plan to ask 
ourselves in the future but we thought that we shouldn't even ask 
that question until we have in place comprehensive, well-managed, 
thorough system of oversight of the rules that we have now which 
are significant.  So at some point as we stated when the rules were 
changed, we plan to go back and ask that very question, is there 
some way to allow more outside activities, but at this point we do 
not anticipate considering that question. 
	MR. BURGESS.  I hope you are not waiting for the Department 
of Justice.  Mr. Chairman, I will yield back. 
	MR. WHITFIELD.  Thank you, Dr. Burgess.  At this time I 
recognize Mr. Stupak for some additional questions. 
	MR. STUPAK.  Thank you, Mr. Chairman.  Mr. Chairman, first of 
al, I would like the statement of the Honorable John Dingell be 
entered into the record, please. 
	MR. WHITFIELD.  Without objection, so ordered. 
	[The prepared statement of Hon. John D. Dingell follows:] 

PREPARED STATEMENT OF THE HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
CONGRESS FROM THE STATE OF MICHIGAN 

  Thank you, Mr. Chairman, for holding this hearing and for 
proceeding in such a bipartisan manner.  The witnesses who are here 
today should provide much useful information.  But I note that the 
Inspector General (IG) of the Department of Health and Human Services 
(HHS) is not present and apparently has little to say on these 
matters.  Congress created the IGs to protect the integrity of the 
Departments in their charge.  President Reagan called the IGs his 
"junkyard dogs."  It appears in this case that this IG had its teeth 
pulled. 
 	The sad fact is that this Inspector General has returned the 
responsibility for policing the Food and Drug Administration (FDA) 
and the National Institutes of Health (NIH) back to those entities.  
For example, when this Committee asked the IG on a bipartisan basis 
to determine if the employees at the FDA were accepting drug company 
money and other favors such as those we uncovered at NIH (including 
at least one instance where an FDA official had received permission 
to engage in 14 separate activities at drug company expense), the 
IG declined.  We were informed the IG would merely analyze the FDA 
conflict-of-interest policies for us. 
	A fundamental purpose of the Inspector General is to 
investigate possible instances of criminal misconduct by HHS 
employees.  Without that independent checking, or at least the 
possibility of that review, the laxity and coziness that led to 
the current problems will continue.  I hope the result of this 
current investigation will encourage the Administration to reexamine 
the role of the HHS Inspector General and to determine how best 
to utilize that office. 

	MR. STUPAK.  Let me ask this question.  It seems like now we 
take this issue very seriously but I have to stop and wonder what 
was going on before this subcommittee staff and probably the L.A. 
Times really pushed you into doing something here.  It has been 4 
years I think when we first brought this to your attention, and 
when I look at Exhibit #3 that I asked about earlier and it says 
on here, for so many of them, it says infraction, failure to adhere 
to procedures before engaging in outside activities which tells me 
failure to adhere means they didn't get permission before they 
engaged in outside activities.  Either they were never asked, they 
never asked to engage in outside activity for a drug company or 
whatever it is or they were never told.  So do you have to fill 
out--even before this investigation, do you have to fill out a 
yearly financial disclosure form about your outside activities? 
	DR. KINGSTON.  It depends upon the specific position that a 
person is in.  There are approximately 6,000 individuals who every 
year are required to report a confidential disclosure of financial 
status and then there is another 600 or so who every year are 
required to report one that is publicly disclosed and much more 
detailed. 
	MR. STUPAK.  Well, I would take it a medical officer would 
have to disclose, correct? 
	DR. KINGSTON.  Probably.  It depends upon the specific--
	MR. STUPAK.  A senior investigator? 
	DR. KINGSTON.  Again, probably. 
	MR. STUPAK.  Well, actually every one of these that you put 
down on this three or four page document that have failure to adhere 
to procedures before engaged in outside activities.  They should have 
put forth this disclosure form before they engaged in outside 
activities, correct? 
	DR. KINGSTON.  They should have requested permission and then 
having received permission and completed the activity, they should 
have reported the income. 
	MR. STUPAK.  But if they didn't receive the permission, then 
as a backup they should have at least reported the income that they 
received, right? 
	DR. KINGSTON.  Right.  It didn't negate the failure to 
receive prior approval-- 
	MR. STUPAK.  So they failed to disclose or would it be 
considered making false statements when they signed the form then, 
perjury when they signed the form? 
	DR. KINGSTON.  I am not sure of the legal term but it is 
considered a significant violation when the employee reports and 
signs that they are disclosing everything when they haven't. 
	MR. STUPAK.  If it is a significant violation, then why are 
most of these a letter of caution, the action taken against them? 
	DR. KINGSTON.  For each case we considered a range of 
factors, again guided by Federal rules, the severity of the action 
in question, the amount of the activity, whether or not the activity 
was approvable, and there was a continuum of severity.  For those at 
the most extreme end, we recommended termination.  Everything else 
is dependent upon the specifics of the individual case. 
	MR. STUPAK.  Sure.  Convince me that I am wrong, but here is 
what I see.  I spent 12 years in law enforcement.  If we even did 
anything a shade like this, we were fired on the spot, okay?  And 
if we wanted a board of inquiry, we had to appeal it ourselves.  
The department sure didn't give us a board of inquiry.  We had to 
do it ourselves.  Here is what it tells me.  I look at this list 
and all these people, it tells me one of a couple things going on 
here.  The agency was so reluctant to investigate, it tells me this 
has been going on for a long, long, long time.  The soft pedaling 
is because people who would have been severely penalized for which 
they did, which we believe they should be, probably would have 
started to talk to the press then and said this has been going on 
X amount of years which then leads to the question, what is the 
tentacles of the drug companies in the NIH?  As Chairman Whitfield 
says, you do all of our research, all the maybe world's best 
research, but is it all tainted because of payments made and the 
influence of drug companies and others on the research being done 
by NIH?  Is that--am I wrong on that? 
	DR. KINGSTON.  We recognize that there was a problem, and 
we responded aggressively.  We asked for and received permission to 
ban this type of activity completely at the agency.  We did that.  
With regard to soft penalties, I would say that we responded in a 
way that complied with every single Federal rule, regulation, and 
policy which guides the penalties and a range of factors are taken 
into consideration.  I would not characterize what we did as soft 
pedaling.  Quite the contrary.  We did exactly what was appropriate 
and we considered all of the factors that we are required by law 
to consider when we make penalty decisions. 
	MR. STUPAK.  Here is the problem.  You didn't even know what 
was going on until this committee and the L.A. Times put it in 
front of you and insisted you do it.  The response we initially 
got--I have been on this committee now for 10 years--was sweep it 
under the rug, forget it, it is not going to happen, but because of 
this staff up here, and the subcommittee staff did a great job 
here, and some L.A. Times articles, you never would have done it.  
So you wouldn't know to ban it if you don't know it exists.  How 
can you ban something if you don't realize there is a problem?  It 
has been a problem for a long time, and you were so reluctant to 
do it so your comments about we are aggressive doing this and that, 
you can't ban something you didn't know was going on.  You had a 
financial disclosure form that these people all violated.  Every 
one of them had to do it.  They all violated it.  So I am really 
concerned that the research may not be of the quality and the 
integrity we hope it would be and we rely upon it to be for the 
American people. 
	DR. KINGSTON.  I would disagree strongly with the 
characterization that the industry has tentacles that call into 
question the validity of our research.  This was a very small 
number of individuals.  Many people on the list that you are holding 
now were found not to have violated rules.  The numbers that were 
found to have violated with penalties was 34.  We have 18,000 
employees.  We have a history of remarkable accomplishments.  
When we were informed, I agree, with the information that the 
committee provided to us and other investigations provided to us, 
we did a much more detailed review of the system.  Perhaps we 
should have done that sooner.  As soon as we had information, we 
aggressively investigated, and as soon as we could, we obtained 
permission to ban this activity entirely.  I strongly disagree 
with the characterization that there are fundamental questions 
about the validity of our science.  NIH has an extraordinary 
reputation.  That doesn't mean that we can't improve things.  We 
took your allegations and questions very seriously and we acted 
aggressively, and NIH is a different agency now as a result of 
your bringing this problem to our attention. 
	MR. STUPAK.  At least for me, I don't see it as a different 
agency.  Four years, you still can't make a decision on some of 
these people.  You soft-sold these people.  You should have got 
them for falsifying records if nothing else, if you couldn't get 
them for the money, and-- 
	DR. KINGSTON.  If it was a question of criminal violations, 
even a question of a criminal violation, we referred it to the 
appropriate authorities.  We do not have the authority-- 
	MR. STUPAK.  Every one of these who have failure to 
disclose, you submitted those failure-to-disclose forms to the 
Department of Justice for criminal investigation?  Is that what 
you are telling me? 
	DR. KINGSTON.  I am not a lawyer.  I know which 
specific-- 
	MR. STUPAK.  You don't have to be-- 
	DR. KINGSTON.  --criminal code-- 
	MR. STUPAK.  --a lawyer to refer it. I am just asking you, 
did you refer all these then? 
	DR. KINGSTON.  We referred all of the allegations that 
considered that we thought were in consultation with the Office of 
the Inspector General might involve criminal violations.  We 
referred every one that reached that threshold to the Inspector 
General following standard policies that we use to decide how to 
refer every day when there are questions about various activities 
at the agency. 
	MR. STUPAK.  But when you look at this whole thing, you 
still can't for us tie together requests for outside activities, 
leave to do work, or financial disclosures.  It seems like you are 
still grappling with those issues and how to address it at NIH and 
how you are going to deal with it in the future.  You have 
proposals-- 
	DR. KINGSTON.  We are-- 
	MR. STUPAK.  You have proposals 4 years later. 
	DR. KINGSTON.  No, we are grappling with it.  In fact--
	MR. STUPAK.  You are grappling with it?
	DR. KINGSTON.  In fact now, NIH employees cannot receive 
permission to conduct outside consultation with pharmaceutical or 
biotech. 
	MR. STUPAK.  I thought you said before an IBR or something 
like that, you said, right? 
	DR. KINGSTON.  No, it is unequivocal.  NIH-- 
	MR. STUPAK.  Let me--
	DR. KINGSTON.  --employees may not consult-- 
	MR. STUPAK.  As of when? 
	DR. KINGSTON.  As of promulgation of the rules about a year 
ago. September of 2005 I believe were the final supplemental 
regulations under the Ethics in Government Act. 
	MR. STUPAK.  What happens if I fail to disclose my outside 
activities now under these new rules that you have?  What happens? 
	DR. KINGSTON.  As before, when an employee is found to have 
failed to disclose and comply with the Federal rules, we open a 
review of the case, usually managed by the Office of Management 
Assessment in consultation with the ethics officials involved, and 
then that turns on the whole case of-- 
	MR. STUPAK.  So in these new rules, if I violate these new 
rules, you don't spell out what the penalties are? 
	DR. KINGSTON.  The penalties are determined by Federal 
regulations and-- 
	MR. STUPAK.  So we are right back to where we are here today. 
	DR. KINGSTON.  Actually, no. 
	MR. STUPAK.  Because every one of these people had to fill 
out the form, they didn't do it properly, they did not get permission 
or they failed to disclose and there is no discipline other than a 
letter of caution.  Even under your new rules, if I fail to disclose 
or I don't get permission, it is going to go back to the same board 
that is going to take a look at the Federal rules and regulations 
and say hmm, well, I guess we give them a letter of caution again 
because that is what you did already.  You set the precedent.  I 
would think-- 
	DR. KINGSTON.  No, we followed-- 
	MR. STUPAK.  --you would have some new rules-- 
	DR. KINGSTON.  --Federal law. 
	MR. STUPAK.  I would think you would have some new rules and 
those new rules say if you fail to disclose, you will get a minimum 
3 to 7 days off, depending on the amount of money, it may be higher. 
 It could even result in termination.  I would think that is what 
you would want to do to keep the integrity, but to go back into this 
and say well, we will look at the Federal law and see what Federal 
law says and maybe a couple years later we will make a decision.  I 
don't have any confidence in what you are going to do.  I see us 
right back to where we are right here, and maybe in 6 years if we 
are still up here, all of us who have been here for a while, we will 
come back and say oh, I guess we are back at hearing number eight 
on this NIH research and the influence and fail to disclose, failure 
to give financial disclosures and all that and we are going to be 
right back where we are. 
	DR. KINGSTON.  NIH is not where we are.  Unequivocally we 
are not where we were.  The rules prohibit consultation as an outside 
activity with industry.  It is not allowed.  Anyone who does it is 
violating Federal regulations.  We are not the agency that we were 
before.  We have a greatly expanded, more comprehensive ethics 
review system.  I have no question that if anyone actually comes 
and actually drills down and looks at how we are actually 
implementing rules, you will see that we are rigorously reviewing 
and enforcing the regulations.  We are a different agency in this 
dimension as a result of this review. 
	MR. STUPAK.  Without some affirmative statement, they will 
look at the past precedent, and based upon past precedent, every 
lawyer will argue that is what you have to do because that is what 
you did in 2006 and that is what you are going to have to do in 
2010 and 2014.  I will stand by my statement which I basically mean, 
this has been going on for a long time, long before this committee 
brought it before, and I believe the tentacles of the drug companies 
influence the research of the NIH, much to the dismay of the 
American people. 
	DR. KINGSTON.  We disagree with that characterization. 
	MR. BURGESS.  The gentleman's time has expired.  Do you have 
any objection if I have a second round of questions?  Thank you.  
Dr. Kington, I can't believe that with that last thought, I mean 
clearly there is a benefit for having a relationship between a pure 
research structure which is the National Institutes of Health and 
the private companies, the pharmaceutical companies and the biotech 
companies on the outside.  There is no question that there are great 
things happening at the NIH but in order to deliver those great 
things into the treatment rooms and into the operating rooms and 
into the hands of the American people, it does require a 
collaboration between NIH and the private sector.  Would you agree 
with that statement? 
	DR. KINGSTON.  Yes. 
	MR. BURGESS.  And I guess I am also a little troubled 
because I haven't been here for 10 years and when I came in, it was 
roughly around the time that you promulgated the new rules that were 
very restrictive as far as allowing researchers at NIH to collaborate 
or to work in consultation with outside sources, and again, I am 
concerned about a young person who shows great promise and a great 
mind not availing themselves of a career at the NIH because after 
all, it is a dead-end job.  You can't go anywhere.  Your earnings 
are capped and you will do far better if you work for someone in one 
of the pharmaceutical houses or one of the biotech companies.  Is 
that a concern of the NIH? 
	DR. KINGSTON.  It is a concern.  We believe that we offer a 
really extraordinary and unique place to conduct scientific 
research.  It is also important to note that we can still and do 
engage in collaborative research with industry.  We do it using many 
different mechanisms including what is called a CRADA, a cooperative 
research and development agreement, which is done in a very 
transparent, open, competitive way in which we actually have an 
explicit agreement to work together with industry to develop an area 
of science.  So there are opportunities for our scientists to 
work collaboratively in their official capacity and we are concerned 
about, that we have to provide the type of environment that allows 
us to continue to recruit and retain the very best researchers and 
we will be monitoring that on a continuing basis. 
	MR. BURGESS.  And in general, has Congress been helpful to 
you toward that goal or hurtful? 
	DR. KINGSTON.  This has been a painful process for us but we 
think that we are a better agency as a result. 
	MR. BURGESS.  Let me--and I will just say, I have made 
several trips out to the NIH and I am always just absolutely 
astounded by the way your researchers have the ability to look over 
the horizon and see things that are coming that the rest of us would 
never even consider.
	But Dr. Niederhuber, let me just ask you a couple of 
questions.  We have had you here and I came in late and I don't know 
whether anyone has bothered you or not on this panel.  Dr. Thomas 
Walsh, that name has come up.  You are familiar with Dr. Walsh? 
	DR. NIEDERHUBER.  Yes. 
	MR. BURGESS.  Now, as I understand it, Dr. Walsh was involved 
in some of the same types of activities that Dr. Sunderland was, but 
perhaps not nearly to the degree that Dr. Sunderland was involved.  
Is that a fair characterization? 
	DR. NIEDERHUBER.  Yes, I think that is fair. 
	MR. BURGESS.  In your--and by the way, welcome and 
congratulations on being the new head of the NCI.  I think that is 
tremendous.  Andy Esenbach was always a good friend.  I look forward 
to him doing good things over at FDA.  But have you exercised your 
supervisory authority to restrict Dr. Walsh's workplace activities 
and some of his outside activities given the nature of the 
allegations? 
	DR. NIEDERHUBER.  Yes.  We have certainly restricted his 
outside activities as Dr. Kington has indicated.  Dr. Walsh, as you 
may know, is probably the world's expert on antifungal agents and a 
very distinguished and compassionate physician.  He still is a very 
valuable part of the clinical team in terms of the patient work that 
we do at NCI because of that expertise. 
	MR. BURGESS.  Would you regard the infractions alleged to 
have been committed, were they serious violations? 
	DR. NIEDERHUBER.  We certainly agree that these were 
serious.  These were in many ways acts of omission in terms of 
reporting, shouldn't have taken place, certainly violated the code 
of conduct for the NCI and the NIH. 
	MR. BURGESS.  Was there consideration given to terminating 
the relationship with this individual? 
	DR. NIEDERHUBER.  Yes. 
	MR. BURGESS.  And what was the decision there? 
	DR. NIEDERHUBER.  We in November of 2005 made that 
recommendation. 
	MR. BURGESS.  That his service would be terminated? 
	DR. NIEDERHUBER.  Yes. 
	MR. BURGESS.  And what is the status of that currently? 
	DR. NIEDERHUBER.  That is--as Dr. Agwunobi has said, the 
Admiral has said, it is under current review. 
	MR. BURGESS.  So that--Admiral, that is under the same 
status that we were informed for Dr. Sunderland? 
	DR. AGWUNOBI.  No, sir.  A board of inquiry has been ordered 
 by the Acting Surgeon General. 
	MR. BURGESS.  Can a scientist at the National Cancer 
Institute accept gift donations specifically to support his lab or 
her lab from a drug company in exchange for services performed for 
the drug company, Dr. Niederhuber? 
	DR. NIEDERHUBER.  Not at this time. 
	MR. BURGESS.  At any time in the past has that been--
	DR. NIEDERHUBER.  I am not sure I know the answer to that.  
I defer that to Dr. Kington.  He would probably know the history 
better than I do. 
	DR. KINGSTON.  I don't believe it was ever explicitly 
approved to have a quid pro quo, but again, this is a sort of 
special area of law that I am not specifically familiar with. 
	MR. BURGESS.  Well, Dr. Niederhuber, currently does the NCI 
conduct any conflict-of-interest review over gifts such as these, 
gifts that would be given to a specific researcher in return for 
specific work? 
	DR. NIEDERHUBER.  Gifts can--at this time, we have a system, 
and Dr. Kington can also comment on this, but we have a system 
through the foundation of NIH in which we keep our science and our 
scientists really at arm's length so it is a way of continuing to 
work with the private sector, but it is done through a process and 
a foundation that keeps our scientists directly away from the source 
of those gifts and the company.  Is that a fair--do you want to 
comment further--
	DR. KINGSTON.  And we would be happy to sort of comment for 
the record in more detail about this specific question if there are 
specific questions you had about how the policy was implemented for 
accepting gifts. 
	MR. BURGESS.  Very well.  Well, under what conditions would 
a scientist at the National Cancer Institute be able to assist a 
drug company with advisory meetings with the FDA? 
	DR. NIEDERHUBER.  Well, we have--we are working on putting a 
very specific policy in place.  That is not quite completed yet.  
Dr. Kington can comment again on that.  But the only way at this 
time that I am aware that one of our distinguished scientists with 
specific expertise that could be helpful to the American people, 
helpful to the specific committee of the FDA reviewing a particular 
question would be in the official line of duty as an expert, more 
or less an expert witness to that, not as a representative of any 
outside agency. 
	DR. KINGSTON.  It is important to note that NIH employees 
may not under Federal law appear before the Food and Drug 
Administration as a representative of a private company.  It is a 
violation of Federal law to do that.  There may be circumstances in 
which the expertise of an NIH scientist is appropriately brought to 
bear to aid the sister agency in assessing the science and that can 
and does happen.  As Dr. Niederhuber pointed out, we are in the midst 
of developing clearer guidelines so that everyone understands what 
the criteria are for deciding when it is appropriate to do that. 
	MR. BURGESS.  Well, again, I want to thank everyone for--oh, 
I beg your pardon.  The Chairman is back.  The Chairman is 
recognized for-- 
	CHAIRMAN BARTON.  I just have a few wrap-up questions.  I 
want to go back to try to tie this thing down on this court of 
inquiry with the Assistant Secretary for Health and I mispronounced 
your name, Agwunobi.  Is that close? 
	DR. AGWUNOBI.  Thank you, sir.  That is perfect. 
	CHAIRMAN BARTON.  I at least want to try to get your name 
right.  When do you expect the court of inquiry to be convened on 
Dr. Sunderland? 
	DR. AGWUNOBI.  As per our policy, sir, when we receive 
clearance from the Office of Inspector General, we will proceed.  
The orders have been written and the board is currently suspended 
pending receipt of that clearance. 
	CHAIRMAN BARTON.  When do you expect to get that? 
	DR. AGWUNOBI.  Sir, I would be reluctant to guess. 
	CHAIRMAN BARTON.  Well, guess. 
	DR. AGWUNOBI.  Sir, not knowing the ongoing details of the 
criminal investigation, not knowing what the allegations are 
specifically and where and what-- 
	CHAIRMAN BARTON.  Are you going to do anything as a 
consequence of today's hearing to try to expedite the convening of 
that board of inquiry? 
	DR. AGWUNOBI.  Sir, I can assure you that as soon as we 
receive clearance to proceed, we will proceed immediately. 
	CHAIRMAN BARTON.  But you are not going to do anything to 
get clearance to proceed? 
	DR. AGWUNOBI.  Sir, we are going to continue to seek to 
avoid any intervention that would hamper the pursuit of justice in 
a criminal investigation. 
	CHAIRMAN BARTON.  So you are not going to do anything? 
	DR. AGWUNOBI.  Sir, we are following all our policies and 
we stand ready to-- 
	CHAIRMAN BARTON.  No, you are not.  You are sitting on your 
bottom and you are not doing anything.  Be honest about it. 
	DR. AGWUNOBI.  No, sir.
	CHAIRMAN BARTON.  How long has it been since Dr. Insel 
recommended Dr. Sunderland be terminated? 
	DR. AGWUNOBI.  I am not sure when Dr. Insel made the 
recommendation. 
	CHAIRMAN BARTON.  How long has it been, Dr. Insel? 
	DR. AGWUNOBI.  I can tell you that the NIH first 
responded--first indicated to us in December of 2005, I think that 
is correct, they would like for us to pull together a board of 
inquiry.  The order was written pretty much within 60 days and 
suspended quickly upon the receipt of a request to do so. 
	CHAIRMAN BARTON.  Dr. Insel, how long has it been?  Is he 
correct?  Is that November of 2005? 
	DR. INSEL.  I think the letter was November 21, 2005. 
	CHAIRMAN BARTON.  Are your hands tied until this court of 
inquiry is convened? 
	DR. INSEL.  Well, as far as I can tell, we are using up our 
options.  We can restrict activities but he is still with us until 
we have a decision from the Commissioned Corps. 
	CHAIRMAN BARTON.  And Dr. Kington, is it NIH policy that 
when another agency requests your agency to do something, you stop 
everything you are doing and don't take any further action until 
that agency is satisfied with its action? 
	DR. KINGSTON.  I don't think as a rule there is an explicit 
policy but in general-- 
	CHAIRMAN BARTON.  Well, is it a rule that if the Department 
of Justice--that there is going to be no pressure exerted on the 
Commissioned Corps to do this court of inquiry until the Department 
of Justice says it can?  Is that your rule? 
	DR. KINGSTON.  No, but the practice has-- 
	CHAIRMAN BARTON.  Do you have the ability to do the court 
of inquiry without the permission of the Department of Justice? 
	DR. KINGSTON.  We don't conduct the board of inquiry.  The-- 
	CHAIRMAN BARTON.  I know that. 
	DR. KINGSTON.  --Commissioned Corps does, so we can't--so 
the answer is, we cannot. 
	CHAIRMAN BARTON.  But the Inspector General is part of 
Dr. Zerhouni's management team. 
	DR. KINGSTON.  Well, actually,  the Inspector General is an 
office of the Secretary of the Department.  They are the official 
liaison with the Department of Justice for us so--but in any case, 
the board of inquiry--we can't conduct a board of inquiry. 
	CHAIRMAN BARTON.  I understand that.  I am not asking you 
to conduct it.  I am asking you to help expedite it.  The 
Commissioned Corps is not going to do anything.  They will be 
sitting here 3 years from now saying they can't do anything if the 
Department of Justice has an ongoing investigation. 
	DR. AGWUNOBI.  Sir, we are in constant communication with 
the Department of Justice.  We are working closely with-- 
	CHAIRMAN BARTON.  As far as I am aware, it is not a law of 
the United States that one agency cannot conduct its own disciplinary 
action subsequent to a criminal investigation at another agency.  
Now, that may be the practice and that may be a gentleman's agreement 
but it is not the law. 
	DR. AGWUNOBI.  Sir, it is a policy within the Commissioned 
Corps that we-- 
	CHAIRMAN BARTON.  Well, I am going to formally recommend that 
you make an exception to that policy.  You have somebody thumbing 
his nose at the entire NIH code of ethics and you folks don't seem 
to care.  This committee cares.  And I am going to call Dr. Zerhouni 
and I will talk to the Inspector General and we are going to get in 
touch with the Department of Justice, but it is a farce of what the 
American people think is right and wrong to not be able to go 
forward because the Department of Justice has a pending 
investigation.  I have worked with the Department of Justice for 
20 years and they have some investigations that go on for 20 years.  
So if you wait for them to finish their investigation, you may be 
waiting.  In fact, you may retire without it happening, and my guess 
is, if I have the staff call over to DOJ or I call the Attorney 
General, they're going to say we haven't told the Commissioned Corps 
they can't do their board of inquiry; we just let them know that we 
have a pending investigation.  I mean, I have been down that road 
before.  So, you know, this is not a good day for truth and justice 
in the American system because you have at least one individual who 
appears to have really committed some egregious violations and he is 
not being held accountable, and I think that is wrong.  And with 
that, I yield back, Mr. Chairman. 
	MR. BURGESS.  I thank the Chairman of the full committee.  
With that, not seeing any other Members who wish to speak, I want to 
thank the panel of witnesses for their attendance today and their 
testimony.  We certainly appreciate their participation in this 
hearing. 
	This hearing will stand adjourned.  The record will remain 
open for the requisite 30 days. 
	MR. STUPAK.  And Mr. Chairman, just one more.  Written 
questions will be included in for the hearing? 
	MR. BURGESS.  Correct. 
	MR. STUPAK.  Thank you. 
	[Whereupon, at 3:31 p.m., the subcommittee was adjourned.] 

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