Scientific Integrity Investigations
Scientific work in government agencies should be held to the highest standards of integrity. Biomedical research and public health are areas of special concern to POGO.

Scandals large and small in recent years have shown that more public disclosure, public discussion, and congressional oversight are needed to improve the integrity of work in the Department of Health and Human Services, especially in two of its agencies: the National Institutes of Health and the Food and Drug Administration. POGO has begun to examine some issues at these agencies, as described in the documents listed below in chronological order.


POGO Letter to Senator Kennedy Regarding the Production of the Pandemic Flu Vaccine, March 6, 2008.

POGO Alert -POGO: Government Pandemic Flu Vaccine Program Lacks Leadership, March 6, 2008.

POGO Report - Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program, March 6, 2008.
The U.S. is in a race to prepare for the mass production of a vaccine before the next influenza pandemic strikes.  In a pandemic, there could be deaths in the hundreds of thousands in the U.S. and in the tens of millions worldwide.  A vaccine will limit the harm caused by the influenza virus when it appears and spreads.  Yet the current government plan for production of the vaccine for pandemic flu does not reflect the urgency of the problem nor the critical leadership it deserves.  In addition, a lack of sufficient disclosure has beset the program to date.

Report faults NIH on conflicts, New Scientist Blog, by Bob Grant, January 18, 2008.
More than a year ago, Ned Feder, former National Institutes of Health researcher and now staff scientist at the Project On Government Oversight, wrote in a letter appearing in the The Scientist that NIH-funded scientists "have been filing financial disclosure statements within their own institutions. However, their disclosure statements are kept secret, within each institution." Feder asked the question, "Why not require easily accessible public disclosure of the statements?" It now seems that the US Department of Health and Human Services Office of the Inspector General (OIG) has caught on to Feder's observations. An OIG report, published this week, contained three findings … In other words, NIH not only doesn't keep very good track of conflicts among the scientists it funds, but it also fails to recognize the types of conflicts that it's not keeping track of. (Huh?) All this because it r elies solely on NIH grantees' home institutions to provide this information on conflicts of interest. So the OIG made three recommendations to the NIH so that it might shore up the situation before it gets even more out of control … Feder told The Scientist that these recommendations are only the beginning of what needs to be done to fix the way NIH manages conflicts of interest among NIH-funded researchers. "I agree with the recommendations in the [Inspector General's] report, which in my opinion are the minimum that is needed to deal with conflicts of interest," he said. According to the report, NIH agreed with two of these recommendations, but objected to obtaining detailed information about conflicts of interest from grantee institutions. … But according to Feder, increased government oversight of conflicts of interest at grantee institutions is crucial. "I recognize the severe drawbacks to another layer of government oversight," he said, "but even so I think thi s kind of oversight is needed." Feder said that leaving grantee institutions to manage their own conflicts of interest and to pass along summary information to the NIH will continue to cause problems. "There are too many examples where this self-policing has been abused," he said.


HHS Watchdog to Recheck Ethics Cases, Forbes (Associated Press article), by Rita Beamish, March 30, 2007.
Federal health investigators are undertaking a broad review of conflict-of-interest policies at the National Institutes of Health, with potentially wide ramifications involving the agency's oversight of nonfederal scientists who conduct research with government money.  The review "will determine the extent to which the NIH oversees grantee institutions' financial conflict-of-interest issues," according to the Department of Health and Human Services' investigative branch. ... Without disclosure to the public by grant recipients, ethical conflicts easily arise, said Ned Feder, investigator for the advocacy group Project on Government Oversight.  "Many senior scientists in academia supported by NIH also have well-paid private arrangements with drug companies, arrangements that may harm their medical research," he said.

HHS Watchdog to Re-Check Ethics Cases, WashingtonPost.com (Associated Press story), by Rita Beamish, March 29, 2007. 
U.S. criminal investigators are re-examining cases against 103 scientists at the National Institutes of Health, most of whom were cleared in previous ethics probes or received light reprimands or warnings over conflict-of-interest complaints.  Following strong criticism from Congress, the investigative arm of the Department of Health and Human Services also has begun a review of conflict-of-interest policies at the NIH, one of the world's premier medical research centers. ...  Ethics advocates said they hoped new reviews would reveal any conflicts that might have tainted past medical research. "Who knows how much damage these conflicts of interest have done to the NIH mission of protecting the public's health?" said Ned Feder, a former NIH scientist who works now with the private Project on Government Oversight. "A review of the facts and the policies is long overdue."  Current rules covering NIH employees do not apply to outside researchers who receive NIH grants. Grant rules stipulate that outside institutions enforce their own conflict-of-interest policies and voluntarily report any conflicts.


HHS IG’s Investigations Plans, Copy of a letter from Inspector General Daniel Levinson to Rep. Joe Barton, Ranking Member, House Committee on Energy and Commerce, March 23, 2007.

Disclosure for Extramural NIH Researchers? The Scientist (subscription), Letter to the Editor by POGO’s Ned Feder , February 2007.
Scientists in the NIH’s extramural program have been filing financial disclosure statements within their own institutions. However, their disclosure statements are kept secret, within each institution. Why not require easily accessible public disclosure of the statements?

Feds charge Alzheimer’s Researcher, CBS News, December 5, 2006, by Rita Beamish, Associated Press.
In a rare federal prosecution, a leading government Alzheimer's researcher was charged Monday with a criminal conflict of interest for performing lucrative private drug company work that overlapped his official duties. Prosecutors alleged Dr. Trey Sunderland of the National Institutes of Health received $285,000 in improper consulting fees and travel expenses from Pfizer, Inc., for work on early indicators of Alzheimer's at the same time he also oversaw similar NIH business with the drugmaker. … Ned Feder, a former NIH scientist now with the non-profit watchdog group Project on Government Oversight, said "in this and similar cases NIH authorities have made it habit of covering up or minimizing wrongdoing. They are still hiding the details of other scientists' conflicts of interest over the past 10 years."

Scientists Who Serve, The Washington Post, Letter to the Editor by POGO's Ned Feder, Wednesday, November 15, 2006; Page A20
Clearly some researchers at NIH want the extra pay of private consulting on top of a full-time NIH salary. ... If they leave, they could be replaced by scientists more dedicated to public service.

Paid Consulting and Conflicts of Interest at NIH. Memo from Ned Feder (10 pages plus attachments), then a Scientific Review Administrator at NIH, toElias Zerhouni, Director, NIH, July 26, 2005. (The memo was written before Feder retired from NIH to become an investigator at POGO.) In his memo Feder challenges Director Zerhouni to correct serious deficiencies in the handling of conflicts of interest in the NIH’s intramural program. Feder suggests that one step in dealing with these deficiencies is to disclose as much as possible, as quickly as possible, about the details of past consulting by NIH scientists and their possible conflicts of interest.In April 2007 POGO sent a copy of the memo to the Inspector General, DHHS (see below, April 4, 2007); a few weeks previously, the IG had announced that he would be examining these problems (see below, March 20 and 23). Other related documents:


Founded in 1981, the Project On Government Oversight (POGO) is an independent nonprofit that investigates and exposes corruption and other misconduct in order to achieve a more accountable federal government.


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