Today marks three months in office for Francis S. Collins, director of the National Institutes of Health. His anniversary present from a group of researchers and ethicists was a new plea to do something about financial conflicts of interest in medical research.
Dr. Collins was sent a letter today from 96 people, including a former editor of the New England Journal of Medicine and representatives of the leading association of medical students, asking why the NIH, with a $30-billion annual budget, doesn't spend more of that money to ensure that it is financing unbiased scientific research.
"The recent disclosure of ghostwritten articles, physician payoffs, and the use of academic opinion leaders to increase markets for FDA-regulated products," the letter said, "indicate that ethical lapses may permeate biomedical research."
The letter was organized by PharmedOut, a project established by the Georgetown University Medical Center to educate physicians on ways the pharmaceutical industry influences their decisions on prescriptions.
Groups represented by those signing the letter include the Public Library of Science, the American Medical Student Association, the National Physicians Alliance and the Consumers Union. Individual signers include Jerome P. Kassirer, former editor in chief of the New England Journal of Medicine, and Susan F. Wood, who resigned as director of women's health research at the federal Food and Drug Administration in 2005 to protest political influence inside the agency.
Even with an extra $10-billion from the federal economic stimulus measure, the NIH still has "no mechanism for funding research on how commercial interests affect the choice of medical therapeutics," said Adriane Fugh-Berman, an associate professor at the Georgetown University Medical Center who directs the PharmedOut project.
An NIH spokesman said the agency had no immediate comment, but one bioethicist—who did not sign the letter—said Dr. Collins could be receptive. Thomas H. Murray, president of the Hastings Center, a nonpartisan and nonprofit bioethics research institute in New York, noted that the letter does not ask for much. It requests the director to acknowledge the need for greater research into financial conflicts of interest and then "set in motion" a process for addressing the need, said Mr. Murray. "The letter is actually quite gentle and modest in what it requests," he said.
Comments
1. 11178276 - November 17, 2009 at 06:17 pm
I support basic ethics rules, but an emphasis on "conflict of interest" can be excessive.
ALL researchers have a conflict of interest in favor of interesting results (I am quoting someone, but I forget whom). There are great financial rewards for being published: tenure, salary, and ease in obtaining new funding. As great as is the financial motivation for publishing, prestige and status are at least equally as important.
It would be both misleading and distracting to give an ethical gold medal to anyone doing research with just government and university funds, while raising red flags over anyone with any industry funding.
2. hms3683 - November 18, 2009 at 09:00 am
The headline is interesting itself by promising that actual "ethicists" are involved with this request. Who has made a determination that the physicians, journal editors, former researcher, and anti-pharma directors are "ethicists?" At what point is the title of "ethicist" conveyed? Have the philosophy departments - where generalized ethics is sometimes taught - been consulted in this matter?
As the writer of comment 1 notes, ethical rules and ethical actions might be supported without eliminating conflicts of interest. As far as all the perks attached to the bias in favor of finding something, we sometimes forget what a powerful finding No Significant Difference (NSD) really is. It would be great to look at distribution of federal monies for any medical service and find, for instance, NSD based on race or socioeconomic status. Finding NSD in academic outcomes across the schools of a large educational district would be a very welcome finding. Not all research is biased in favor of finding interesting results.
3. davi2665 - November 18, 2009 at 04:36 pm
There is a difference between the existence of a conflict of interest (COI) and the management of a COI. Many universities have a well established program to manage COIs and assure that a researcher who is being paid fees by a commercial entity, especially by big pharma or a big medical device company to hawk their products, is not then given carte blanche to be PI of a project evaluating that product. A more insidious problem is the researcher who has a well established relationship with a commercial entity studying a particular product or piece of IP, and ends up having his/her tenure, promotion, funding for postdocs and grad students, support for technicians, and general laboratory support depending upon keeping that commercial source happy. Can a researcher truly be objective when facing the possibility that reports of negative results, or data not supportive of the company's product, may well result in losing the source of support and jeopardizing both career and lab support? There is zero mechanism for addressing this. Unfortunately, the data in the literature indicate that for drug studies, those studies supported by the commercial source report positive results far more often then those supported by NIH or an independent source.
An even more troubling issue is how to deal with researchers who receive sizable payments from a commercial source, and then fail to disclose this to NIH when applying for grants to study related products, or failing to disclose (or outright lying) to their university. Some universities refuse to take this seriously due to the $$$ on the table for them. At the very least, NIH should provide guidelines or policies, and not try to turf the issue back to the universities.