Leading NIH Scientist Refuses to Testify in Congressional InvestigationDoctor Won't Address Claims of Exploiting Public Office for Personal Gain
WASHINGTON
- A senior National Institutes of Health (NIH) researcher invoked his Fifth
Amendment right against self-incrimination rather than tell Congress about his
decision to share thousands of priceless human tissue samples with Pfizer and
the $600,000 he received from the drug company over much of the past decade.
After they were subpoenaed to testify, Dr. Trey Sunderland, chief of the
Geriatric Psychiatry Branch for NIH, and his one-time assistant, Karen Putnam,
appeared at a hearing of the House Energy and Commerce Subcommittee on Oversight
and Investigations. Both declined to answer questions.
"The ability of NIH researchers to obtain samples from people and the
resources and the freedom to research relies on basic trust," said U.S.
Rep. Ed Whitfield, R-Ky., chairman of the Oversight and Investigations
Subcommittee. "Unfortunately, the evidence shows that Dr. Sunderland
used his public office to provide spinal fluid and plasma samples to Pfizer. He
did not disclose these consulting arrangements to NIH - this subcommittee
exposed them."
The hearing focused on the collection, storage, tracking and use of human
tissue samples in the NIH's intramural research program. According to a
year-long, bipartisan committee investigation, Dr.
Sunderland
shipped to Pfizer 3,200 tubes of spinal fluid and 388 tubes of plasma collected
for Alzheimer's research and the company subsequently paid him $285,000 for
consulting work related to the samples. All told, the report shows that
Dr. Sunderland received more than $600,000 in payments from Pfizer from 1998 to
2004 for outside consulting and speaking without any record of prior approval or
disclosure in his government financial report filings. (The committee
staff's report is available at http://republicans.energycommerce.house.gov.)
"What we have learned from this investigation to date is that NIH lacks
adequate controls for human tissue samples, human subject protection, and the
scientific conduct of many of its senior employees," said U.S. Rep. John D.
Dingell, D-Mich., ranking member of the full Energy and Commerce Committee.
"Accountability must be restored to NIH's own research programs."
Dr. Thomas Insel, director of NIMH, sought to distinguish collaboration from
consultation with outside parties, such as drug companies. He
characterized collaboration as a joint partnership with private entities, a
practice that can be productive and is encouraged by NIH management. Paid
consultative arrangements with outside companies were, until recently, allowed,
but fell under more restrictive conditions. According to the staff report,
Dr. Sunderland appeared to be engaged in both at the same time - in violation of
existing NIH rules.
"That would not have been approved," Dr. Insel said when asked of
Dr. Sunderland's activity. He said NIH was aware of Dr. Sunderland's
collaboration with Pfizer and the decision to transfer the samples, but that the
researcher failed to seek approval for or disclose the hundreds of thousands of
dollars in consultative payments.
The Sutherland-Pfizer partnership focused on treating Alzheimer's disease.
Specifically, they sought to identify "biomarkers" that could provide
patients and families with advance warning of the disease and possibly increase
treatment options. Dr. Sunderland also took the unusual step of signing
away the government's patent rights, giving Pfizer sole financial rights to what
could be a medical blockbuster.
The Pfizer scientist then in charge of the program, Dr. David Friedman,
called the initiative "highly successful," noting that the drug giant
is actively pursuing the idea and has updated its patents.
"I don't think you could put a value on the samples," Dr. Friedman
said.
Dr. Insel and Dr. Michael Gottesman, NIH's deputy director for intramural
research, agreed that improvements in the agency's handling and tracking of
human tissue samples are warranted and that some reforms have already been
implemented.
Dr. Gottesman said NIH is providing additional guidance to researchers
collaborating with private industry; will require written documentation of any
transfer of human tissue samples; will pursue more rigorous oversight; and in
coming months complete a comprehensive review across the National Institutes of
Health to determine what additional steps should be taken.
"Not only am I skeptical that the NIH has in place the appropriate rules
and safeguards to track samples that should remain in NIH's possession, but I am
concerned that those safeguards are not properly enforced," said U.S. Rep.
Bart Stupak, D-Mich., ranking member of the subcommittee. "Working
with Chairmen Barton and Whitfield and Mr. Dingell, I will push NIH to ensure
this never happens again and tissue samples are not exploited by pharmaceutical
companies for pure commercial gain."
Lawmakers expressed concern at the fact that Dr. Sunderland has faced no
disciplinary action to date and remains in his current position, collecting full
pay and benefits. Dr. Insel said NIH has completed an internal
investigation and made disciplinary recommendations in November 2005 to the
Public Health Service Commission Corps, where Dr. Sunderland is technically
employed.
"It's not good enough to be clean," Dr. Insel said of NIH's
approach to ethics. "It has to be Camelot."
"We have a person who, on the surface, suffered no repercussions.
None. And you talk about a Camelot?" said U.S. Rep. Joe Barton,
R-Texas, chairman of the full Energy and Commerce Committee. "In
spite of the public changes that have been made at NIH, there really does not
appear to be a cultural change where the institution and the members of the
institution condemn the kind of behavior that apparently Dr. Sunderland has
exhibited. It's really, really disappointing."
Investigations by the Department of Justice and the Health and Human Services
Inspector General are now underway, Dr. Gottesman testified.
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