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Daniel Levinson, inspector general of the US Department of Health and Human Services, has said that his office will reopen 103 cases of conflicts of interest among scientists at the US National Institutes of Health (NIH).
The investigation will be carried out by the inspector general's Special Investigations Unit, staffed by five criminal investigators.
Mr Levinson's office was active in prosecuting Lester Crawford, the former head of the Food and Drug Administration, who was fined nearly $90000 (£46000; €67000) for falsely reporting he had sold stock in companies regulated by the FDA while he still owned the shares (BMJ 2007;334:492, doi: 10.1136/bmj.39142.592130.DB)
The special unit will also investigate conflicts of interest among about 40000 scientific teams at about 2000 universities, medical centres, and non-profit institutions that receive research grants from NIH, potentially a much bigger problem. The NIH's rules on conflicts of interest do not apply to outside researchers, who are supposed to be regulated by their institutions.
Although the NIH requires institutions to adopt similar policies, “the agency conducts virtually no oversight and has no rules regulating the behavior of government grant recipients who double dip on industry payrolls,” says the Integrity in Science project of the non-profit Center for Science in the Public Interest.
“It's a situation ripe for investigation,” Merrill Goozner, director of the integrity project, said. He questioned how thoroughly universities monitored conflicts of interest among their researchers and how well NIH reviewed university monitoring. Neither NIH nor the universities may be doing thorough oversight, he said.
NIH is the largest funder of biomedical research in the United States. About 80% of its annual budget of $28.6bn is given in about 40000 grants to outside researchers.
Mr Levinson described his office's investigation in a letter to the representatives John Dingell (Democrat, Michigan), chairman of the House of Representatives Committee on Energy and Commerce, and Joe Barton (Republican, Texas), the former chairman. The bipartisan committee oversees biomedical research and development, health and health facilities, food and drugs, and public health, among its other responsibilities.
NIH's problems with conflict of interest began in 2003 when the Los Angeles Times (7 Dec 2003, p A1) reported that a small number of the 17000 NIH employees had received millions of dollars in income from outside sources such as drug companies since 1995.
Restrictions on after-hours consulting work by NIH scientists had been relaxed by Harold Varmus, the Nobel prize winner who then headed NIH, in an attempt to recruit leading scientists who could earn more at universities (BMJ 2004;329:10, doi: 10.1136/bmj.329.7456.10-b). Scientists who acted as consultants to industry were supposed to file disclosure forms with NIH, but some did not, even while consulting for companies related to their NIH work (BMJ 2005;330:559, doi: 10.1136/bmj.330.7491.559-a).
In early 2005 NIH tightened the rules. It forbade about 5000 senior scientists from consulting for drug, biotechnology, and medical device companies, healthcare providers, and research institutions that received major support from NIH. They were told to sell shares or options that they or their families held in such companies (BMJ 2005;331:472, doi: 10.1136/bmj.331.7515.472-b).
The energy and commerce committee's own investigation turned up 81 scientists who had received consulting fees from drug companies but had not reported them as required. In July 2005 the committee was told that, of the 81 scientists, 37 had been “cleared” and 44 were found to have violated NIH's rules.
One scientist, Trey Sutherland, chief of NIH's Geriatric Psychiatric Branch, eventually pleaded guilty to criminal conflict of interest in the US District Court in Baltimore, says the committee (BMJ 2006;333:1237, doi: 10.1136/bmj.39062.603495.DB). He refused to answer questions about sharing thousands of samples of human tissue from his research on Alzheimer's disease with Pfizer, for which he received $285000.
Chairman Dingell said, “Even if only a few of these [reopened] cases result in criminal prosecution, it is clear that the NIH bungled the investigation the first time around.”