Web edition: April 28, 2009
Observed Institute of Medicine president Harvey Fineberg, this morning: every week seems to bring more news accounts citing a breach of medical ethics — “some problem of a conflict of interest, some failure to reveal a financial relationship between a clinician or a researcher and [a] company, some failure to divulge negative research results.”
Such bias — real or just implied — is hardly new, he acknowledges, but seems to appear with ever-increasing frequency. These cases certainly have prompted substantial attention beyond the curiosity of investigative reporters — i.e. within medical associations, academic boards, even the halls of Congress, Fineberg noted. So his organization decided to explore what could be done to divorce the conduct of medicine and medical training from influence by drug companies and other interest groups.
Today, the Institute of Medicine of the National Academies released a 392-page report of its findings. On hand to explain and field questions about its contents were three of the 17 experts who put together the new report. And one rather distressing finding offered up by panelist Eric Campbell of Massachusetts General Hospital and Harvard Med School is how insidious industry’s tie to medicine has become.
“Relationships between physicians, researchers and drug companies are ubiquitous in every aspect of medical education, medical research and patient care,” Campbell says. It’s hard to find other fields "in which relationships with [industry] are so pervasive.” His own research from about a decade ago — and cited in the new report — found that 43 percent of scientists in the 50 most research intensive universities reported having received gifts from industry in the previous three years.
A decade-old study coauthored by another of the panel’s authors, Lisa Bero of the University of California, San Francisco, was also cited in the report. It found that some eight percent of principal investigators in UCSF medical studies reported personal financial ties to the organization that had funded their research. Some took speaking fees, others consulted, served as paid scientific advisers or held stock in a firm.
Such relationships can — indeed have — led to biased reporting of research data. And the new Institute of Medicine report offers several disturbing examples. Like when the manufacturer of an implantable heart defibrillator “failed to report critical, potentially fatal design defects for more than three years.” Or when the maker of a blood substitute shut down a clinical trial — and then sat on its data for five years; those data “showed significant increases in the rates of mortality and heart attacks in the group receiving the experimental intervention,” the report notes.
Baseball umpires don’t dine with or travel to spring training with players from the New York Yankees, says Campbell. Judges don’t dine with attorneys that bring cases to their courts. Indeed, he contends, the tie between medicine and the industry that makes most of the drugs and devices on which physicians depend appears “unique.”
So the committee asks the medical establishment to consider how to prevent unholy alliances. And where links of a potentially questionable nature have developed, the report offers tips on how and to whom notification of these links should be forwarded.
But the report's principal recommendation is that medicine and Big Pharma obtain a divorce — preferably an amicable separation, but at least a full severing of improper ties. And it offers suggestions on how to do that.
For instance, “We call on physicians, no matter where they practice, not to accept gifts from drug companies, to decline participation in presentations or publications whose content is controlled by industry, and to limit their use of drug samples and interactions with drug representatives,” noted Bernard Lo of UCSF. This medical ethicist chaired the panel that drafted the new report.
Among his panel's other notable recommendations:
1) Congress should require that pharmaceutical, device and biotechnology companies report on some public website all payments they make to physicians, researchers and medical organizations. "Such a public record would deter inappropriate relationships,” Lo said, and help medical institutions, publishers and others verify that physicians and researchers who do work for them have disclosed all real or potential conflicts of interest.
2) Medical centers and other research institutions should establish a policy prohibiting human trials if the researchers "have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research." Any exceptions should be made public and allowed if only if no unbiased researchers can be found. And even then, the report said, a mechanism must exist to make data on the potential bias publicly available.
3) Research centers and hospitals should prohibit faculty, students, residents and medical fellows from: accepting “items of material value” from industry; giving presentations or writing papers where content is controlled by industry or “written by someone who is not identified as an author or who is not properly acknowledged;” consulting without a written contract and receiving payment at “fair market value" for services; using or distributing drug samples provided by industry “except in specified situations for patients who lack financial access to medications.”
4) Most state licensing boards, medical-specialty boards and hospitals require that physicians commit to lifelong learning. Indeed, participation in continuing medical education, or CME, courses can be essential for a doctor to remain licensed or certified. The new report finds that industry provides roughly 25 percent of the funding to run CME courses offered by professional societies, more than half of the costs to medical schools for CME courses and almost 75 percent of the costs incurred by outside commercial groups who offer CME courses. That’s got to change, the IOM panel argues. Indeed, Lo says, “the goal would be to have a [CME] system . . . that is free of industry or industry influence.”
Drug companies aren’t likely to warm to these recommendations, which seek to put clinicians and other researchers at more than arm’s length — like maybe across town. And many docs are going to lament the good old days when they could count on free lunches (literally), free samples of drugs that they could send home with patients, and sometimes all-expenses-paid travel to Caribbean resorts or ski lodges to attend programs teaching them about new drugs or procedures.
Most journalists have been living by a similar conflict-of-interest-limiting credo for at least a half century. We don’t join organizations that have a vested interest in the issues we cover. We don’t let an outside interest group coauthor our stories or censor our reporting. We don’t accept free meals, much less airfare and accommodations, for an event where publication of a story is required.
The same way readers expect that our observations and reporting has not been “bought” by a vested interest, we all hope that important decisions about how physicians manage our medical care have not been bought by drug companies offering the priciest gift or most flashy junket.
I just hope the IOM report’s recommendations usher in a more data-driven era of medicine.
Lo, B. and M.J. Field, Editors. Conflict of Interest in Medical Research, Education, and Practice. Institute of Medicine: The National Academies, Washington, D.C. (April 28):392 pp.