A survey of hospital review boards that watchdog experiments on patients shows that one in three members takes money from companies that make drugs and medical devices that come under study.
What’s more, many of those with conflicts rarely or never disclose their financial ties, researchers found.
The study of 100 university medical centers is said to be the first to look at financial conflicts of interest on hospitals’ institutional review boards. IRBs are little-known committees responsible for protecting patients in research experiments.
The study’s findings are alarming, said some patient advocates.
If the review board “is riddled with financial conflicts of interest, it’s not going to be as protective as it should be,” said Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group.
The study was published in this week’s issue of the New England Journal of Medicine.
Corporate funding of medical research is common and a mainstay in the translation of scientific discoveries into medical treatments. But in the last five years, there has been heightened scrutiny of the financial ties between researchers and the companies that make experimental drugs and devices.
The question: Do medical researchers always act in the best interest of science — or patients — if they are also getting royalties, consulting fees or other benefits from the makers of the products being tested?
Volunteer boards
All federally funded research must be reviewed and approved by IRBs, which consider patient safety as well as ethical conflicts. Most members of these boards are volunteers, usually doctors or scientists themselves, who get no extra pay for their service.
They are expected to be more sensitive to ethical concerns than the researchers they monitor, said Dr. Jerome Kassirer, a former New England Journal of Medicine editor who wrote a book in 2005 on medical conflicts of interest.
Now researchers are “finally getting around to looking at all the ways that pharmaceutical companies can have an adverse influence on health,” Kassirer added.
In the study, led by Eric Campbell of Massachusetts General Hospital and Harvard Medical School, 575 members of IRBs at 100 universities were surveyed; they were promised anonymity.
About 36 percent — or more than 200 respondents — reported at least one form of industry financial ties in the previous year.
Roughly 15 percent — or about 80 respondents — said that in the previous year, they were asked to review at least one research study that was sponsored by a company with which they had a relationship or by a competitor of that company. Both situations constitute a conflict of interest, the study’s authors noted.
Of those respondents, more than half said they always disclosed their conflict to other board members, but 35 percent said they rarely or never did. Nearly one in five said that regardless of their conflicting ties, they always voted on whether to approve the proposed clinical study.
Federal regulations bar IRB members from voting in a review of a study in which they have a conflict of interest. “This (the study’s results) reflect a significant lack of law enforcement,” Wolfe said.
Lack of awareness
It may also reflect a lack of awareness, said Campbell, the lead author.
Of all the study’s respondents, fewer than half said their review boards had a formal written definition of what makes a conflict of interest.
As for patients, a second study published in the journal, suggested that those fighting for their lives were more focused on being cured than worrying about conflicts of interest by researchers.
The study, led by researchers at the National Institutes of Health, involved cancer patients enrolled in clinical trials. Most said such conflicts did not worry them, and 77 percent knew little about the issue.
