[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
Available via the World Wide Web: http://www.access.gpo.gov/
congress/house
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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 � 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.]