US federal investigators are re-opening 103 conflict-of-interest cases involving National Institutes of Health researchers, Congress has been told.
The cases, which relate to payments to government scientists by pharmaceutical companies which violated NIH ethics rules, were originally uncovered by members of the House Committee on Energy and Commerce. They are now being re-examined by the Department of Health and Human Services’ Office of Inspector General (IOG), to determine whether further investigation is warranted, HHS Inspector General Daniel Levinson has said in a letter to Representative Joe Barton, the ranking (Republican) member of the Committee.
In 2003, staff at the Committee identified a sample of 81 individual scientists hired by drug companies during 1999-2004 whose consulting agreements were not listed in information provided by the NIH to the panel. The other 22 conflict-of-interest cases were discovered later in an investigation by the agency, which concluded, in July 2005, that of the 81 scientists, 44 had violated one or more of its rules, while 37 were cleared.
The only case to be referred for criminal prosecution was that of Trey Sunderland, chief of the NIH’s Geriatric Psychiatry Branch, who appeared before the Committee’s oversight and investigations subcommittee last June and invoked the Fifth Amendment right against self-incrimination. The committee investigation had revealed that Dr Sunderland had shipped to Pfizer 3,200 tubes of spinal fluid and 388 tubes of plasma collected at the NIH for Alzheimer’s research. The company subsequently paid him $285,000 for consulting work related to the samples. Last December, Dr Sunderland pleaded guilty to criminal conflict of interest in US District Court in Baltimore.
In 2005, the NIH imposed an outright ban on its employees consulting for drugmakers, but the Committee members have remained highly critical of its handling of conflict-of-interest issues. Welcoming the reopened inquiry, Rep Barton said he hoped it would “finally sort things out so everyone can have confidence that the public’s interest is being fully served.” He added: “The NIH specialises in great science, not detective work, and it shows.”
Said Committee chairman John Dingell (Democrat): “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.”
The IOG is also to overhaul how it reviews NIH ethics cases, Mr Levinson reveals. “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, IOG determined that this project was an important next step in examining NIH conflict of interest,” he writes.
“It is vital that department officials conduct their official duties in a manner than does not result in personal benefit or financial gain. The American public must have confidence that important decisions made by government officials are based on merit and are free of improper influence through questionable or improper relationships with the industry that the regulate and/or with which they conduct business,” he adds.
The letter also points out that, while the office’s 2007 work plan also includes an examination of procedures at the Food and Drug Administration which will include, among other things, an assessment of the nature of financial interests disclosed by clinical investigators to the agency, this work will not be starting during the current financial year, because of resources constraints and the higher priority given to the NIH investigations.
At the time of the Committee’s conflict-of-interest probes, its chairman was Billy Tauzin (now chief executive of the Pharmaceutical Research and Manufacturers of America - PhRMA), while James Greenwood (currently chief executive of the Biotechnology Industry Organization - BIO) chaired the oversight and investigations subcommittee.
Meantime, the OIG is sponsoring a Conflict-of-Interest Summit on May 30 in Washington DC, which, it says, “will provide an opportunity for a robust discussion” of these issues. By Lynne Taylor