NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

HHS Inspector General to Reopen
NIH Conflict-of-Interest Cases

WASHINGTON - The Department of Health and Human Services inspector general has informed the Energy and Commerce Committee that his office is reopening 103 conflict-of-interest cases involving National Institutes of Health researchers.

Inspector General Daniel Levinson wrote the committee, explaining that the Special Investigations Unit and Office of Inspector General ethics attorneys are currently examining these cases to determine whether investigation is warranted.

During the last Congress, the committee discovered through its bipartisan investigation that dozens of scientists employed by the government also work for pharmaceutical companies in violation of ethics requirements.

“I am pleased that the inspector general is taking a much-needed closer look at these conflict of interest cases. Even if only a few of these cases result in criminal prosecution, it is clear that the NIH bungled the investigation the first time around,” said Committee Chairman John Dingell, D-Mich. Fortunately, Congress created inspectors general to remove from federal agencies the onerous task of investigating themselves. The committee will continue to monitor this matter closely.”

“The NIH specializes in great science, not detective work, and it shows,” said U.S. Rep. Joe Barton, R-Texas, ranking member of the committee. “I hope the inspector general’s inquiry will finally sort things out so everyone can have confidence that the public’s interest is being fully served.”

In 2003, committee staff identified a sample of 81 individual scientists hired by drug companies between 1999 and 2004 whose consulting agreements were not listed in information NIH provided to the committee. For example, the agreements reported by Pfizer, Inc., ranged from $500 to $517,000 over the five-year period. The other 22 conflict-of-interest cases were discovered later in the investigation by NIH.

In a July 8, 2005, letter, NIH reported that of those 81 scientists, 37 were “cleared” and 44 were found to have violated one or more of NIH’s rules.

On June 14, 2006, Dr. Trey Sunderland, chief of the Geriatric Psychiatry Branch for NIH, and his one-time assistant, Karen Putnam, appeared before the Oversight and Investigations Subcommittee and invoked the Fifth Amendment right against self-incrimination. On Dec. 11, Sunderland pleaded guilty to criminal conflict of interest in U.S. District Court in Baltimore.

Sunderland refused to answer questions 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.

The hearing focused on the collection, storage, tracking and use of human tissue samples in NIH’s intramural research program. The committee investigation showed that Sunderland shipped to Pfizer 3,200 tubes of spinal fluid and 388 tubes of plasma collected at NIH for Alzheimer’s research. The company subsequently paid him $285,000 for consulting work related to the samples.

“I am happy that the HHS inspector general has decided to re-open the 103 violations that the Oversight Investigations subcommittee referred to them three years ago,” said Subcommittee Chairman Bart Stupak, D-Mich. “The subcommittee discovered the violations through documents provided from pharmaceutical and biotech companies which detailed more than a million dollars in payments from the companies to NIH employees. Under NIH guidelines, the employees were required to disclose the payments, but failed to do so. Unfortunately, only Dr. Trey Sunderland’s case was referred for criminal prosecution. I hope the inspector general takes a close look at these other violations.”

Levinson also said that his office is also going to overhaul how it reviews NIH ethics cases. “Because the majority of NIH appropriated funds are distributed to NIH grantees who undertake extramural research and these extramural researchers are not covered by the federal ethics rules that apply to NIH intramural researchers, OIG determined that this project was an important next step in examining NIH conflict of interest,” he said.

(Read letter from the Inspector General)

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