Researchers Attack Conflict-of-Interest Rules : Medicine: Backers of the proposed federal regulations cite a need for unbiased judgment. But academic scientists say the guidelines will delay the development of drugs.
Academic medical researchers are mounting an aggressive campaign against a set of proposed federal conflict-of-interest rules that they say would significantly delay the development of drugs and impede progress in critical scientific research.
The draft regulations were inspired by disclosures that some researchers had received federal grants to test products in which they had financial interests. Their dual role raised questions about their ability to perform their work objectively.
The new guidelines, which would apply to non-governmental scientists who receive federal grants, would sharply curtail the financial relationships that have flourished in recent years between researchers and industry. They were proposed by the National Institutes of Health and the Alcohol, Drug Abuse and Mental Health Administration.
“The measures will be disincentives to maintaining a productive relationship for the sake of weeding out the relatively few transgressors,” said Dr. Douglas Kelly, associate vice president for biomedical research for the American Assn. of Medical Colleges. The rules “will only discourage people from coming into our profession or continuing in it,” he added.
Dr. Robert T. Schooley, a highly regarded AIDS researcher at Harvard University who has routinely accepted consulting fees from drug companies, says he believes the regulations could cost the United States the competitive edge it has long enjoyed in biomedical research.
“If we adopt these rules and the drug companies can’t get the advice they need to get drugs safely and expeditiously evaluated, we’ll turn the pharmaceutical industry over to the Japanese, like many of our other industries,” he said.
“Those of us in academic medicine are not interested primarily in money. If we were, we wouldn’t be in academic medicine--we’d be working directly for drug companies or doing something else.”
Supporters of the measures say they are necessary to preserve the integrity of medical research and ensure that its outcome is not influenced by financial motives.
“We have to have a system which supports medical research in a way that distances the researchers from the immediate pressures of the marketplace,” said Dr. Arnold Relman, editor of the New England Journal of Medicine, the first medical journal to require its authors to disclose financial holdings in companies whose drugs are the subject of their research.
“I believe it is very important for our society to be able to count on the unbiased, uninfluenced, dispassionate scientific judgment of academic investigators when it comes to biomedical technology,” Relman said. “If the whole academic biomedical enterprise simply becomes a business, society has lost something essential. What can you absolutely trust?”
The regulations were proposed after revelations that some physicians studying experimental drugs had held stock or stock options in the companies producing those drugs. In one case, doctors who tested the experimental heart drug TPA had held stock or stock options in Genentech, the drug’s manufacturer.
In another, it was disclosed that a Harvard Medical School scientist tested an experimental eye ointment on hundreds of patients between 1984 and 1986 at the Massachusetts Eye and Ear Infirmary. The drug, developed as a therapy for dry eyes, apparently failed to work on most of the subjects. A subsequent inquiry found that the researcher had allegedly played down the study’s negative findings while at the same time selling his rights to the formula and his stock in the company he had helped establish to market the ointment.
The National Institutes of Health came under increasing pressure, particularly from Congress, to develop a system to prevent such abuses. Last June, James B. Wyngaarden, then the director of the NIH, promised the House Government Operations subcommittee on human resources and intergovernmental relations that the NIH would draft guidelines to protect the integrity of the $7 billion in grants it awards every year.
“These proposed guidelines should not stifle research creativity or technology transfer . . . but rather provide guidance concerning the safeguards needed to ensure unbiased performance and reporting of research results,” the NIH said.
The proposed guidelines, which are open to comments from the public until Dec. 15, would require researchers who receive federal grants to disclose the sources of all their income. They would forbid researchers and their families to have personal equity holdings or options in any company that would be affected by the outcome of their research or that manufactures a product or equipment being studied in the research project.
The regulations would also prohibit researchers from sharing any information or products derived from the NIH or Alcohol, Drug Abuse and Mental Health Administration-funded studies with any company with which a conflict exists until the information or products were made publicly available.
Finally, researchers would be barred from receiving grants from the NIH or the ADAMHA to evaluate a company’s product if the researchers were receiving honorariums or fees from the company or held a management position with it. The prohibition might apply--the regulations are not clear on this--if the researcher’s financial ties to the company had already been severed at the time of the research grant.
It is this regulation that many in the academic community and the biotechnology industry feel would seriously impair medical progress. Few companies, they argue, have enough in-house expertise to design and launch drug trials, for example, and private firms must be free to seek the knowledge from the very best sources.
“This would really cut the critical interactions between the people in academia--who know about drug development--and American industry, which needs their expertise,” said one California researcher who requested anonymity. “I think it will really hurt the research.”
Sam Broder, the director of the National Cancer Institute--who as a full-time federal employee is already bound by many of these restrictions--says the rules need to be far more flexible than proposed. He says he does not believe grant recipients should be treated as if they worked for the government full-time.
“I don’t think you can start with the assumption that an industry-academic collaboration automatically gives a conflict of interest,” he said. “It’s very common that the very best people in the country would be sought as consultants by private companies. This will make it very difficult for companies to seek a talent pool.”
Broder believes that if the current guidelines had been in place, the rapid development of the AIDS drug AZT--which reached the U.S. market in record time--would have been retarded and possibly blocked.
“AZT required an intimate interaction between the government, the private sector and academia,” he said. “It required a three-way partnership. No one part would have been able to do it alone.”
Harvard University’s Schooley was paid by Biogen Inc., a Cambridge, Mass., company, to help design a clinical trial for the experimental AIDS therapy CD4. Biogen had developed the product but did not know how to set up a patient study. Schooley is now conducting a CD4 trial under an NIH grant.
“Under the new rules, I would either have to not do the studies or not be involved as a consultant to Biogen in developing those studies,” he said. “If I had to make a choice, I’d probably choose not to be a consultant, because I want to be involved in the research. But I believe it’s much more efficient and smarter to be with it right from the start. If I chose to do the consulting for no money, then I might have to generate funds from somewhere else.”
But Dr. Leonard Minsky, executive director of the National Coalition for Universities in the Public Interest, a group founded by Ralph Nader, insists that when researchers take both public and corporate money, it only “undermines the dispassionate, objective view that a scientist must have--unless he is a saint.”
“I don’t care who he is,” Minsky said. “If he’s getting large sums of money from pharmaceutical houses (with an interest) in drugs he is investigating, he has a built-in bias. Maybe he’s wearing contact lenses and he’s forgotten that he’s wearing them--but he’s wearing them.”
The American Assn. of Medical Colleges’ Kelly, who is former chairman of the USC School of Medicine’s department of anatomy and cell biology, says his organization is soliciting reactions from its members. He says he expects the organization to propose an alternative to the NIH guidelines that would give the researchers’ institutions the larger role in policing for conflict of interest.
