The comments and opinions in this post reflect the opinion of the author, and do not necessarily represent the opinion of PRIM&R or its Board of Directors.
Are you tearing your hair out over financial conflicts of interest (COI) in research? Does it seem that not a day goes by without some article that either makes you sing in agreement or scowl in response, “you know: It’s Just Not That Simple.” Senator Grassley has raised important questions but has he gone to extremes? Is he on a witch-hunt?
I found the February 2, 2009 Boston Globe article amusing: “Harvard will Stiffen Rules at Medical School; Conflict of Interest Will be Redefined” which quoted Dr. Korn as saying: “Harvard’s job is considerably more challenging, because the medical school does not own or control its affiliated teaching hospitals, where clinical faculty members see patients and interact with drug company salespeople.” Further, “most clinical faculty are employees of the hospitals, not the medical school.”1 Other situations raise different challenges, for instance those individuals that are not employees of an entity but may have a faculty appointment.
Welcome to the real world where formula and one-size fits all doesn’t work. Confronted with the practical realities of daily operations, policy applications, and distinct differences between one entity versus another within related organizations, implementation of COI policy can become a dirty business.
Many assert that the medical community should step up to the plate and lead the way not simply by obtaining financial disclosures from individuals, but also by changing multiple policies. Easier said than done. What’s required to protect from genuine bias and what’s merely cosmetic, a bureaucratic add-on with no practical effect?
For example, some advocate for precluding direct funding by pharmaceutical companies to Academic Medical Centers for continuing medical education. Almost everyone agrees that docs participating on speakers’ bureaus for pharma touting particular drugs are an extension of company marketing. Even the most pristine investigator, who truly believes in the drug being assessed for a particular disease or condition—and who’s also a company speaker—incurs at least the appearance of impropriety. It’s akin to Supreme Court Justice Potter Stewart’s response to pornography, I can’t tell you what it is, but “I know it [obscenity/pornography] when I see it.”
I don’t disagree with the appropriate concerns raised about these situations, and the particular nuances that determine the appropriate course of action, but here’s my question: What is the difference between a pharmaceutical company providing a medical center with $50,000 designated for medical education and the company brokering its support of medical education by engaging a third party to orchestrate the education program?
Appropriate separation of responsibilities intra-institutionally will negate any undue influence. Let’s be reasonable, and closely examine relationships before we put the kabash on everything and anything. As one professor challenged, what then should we do if we’re not permitted to accept sponsor funding for such activities, and efforts to obtain funding from the Dean’s office are futile?
Luckily, Dr. Flier, the dean of Harvard medical school agrees with me. He indicated that Harvard’s COI committee probably will focus on continuing medical education. “The medical school sponsors several hundred courses for doctors each year, Harvard officials said, and drug companies pay about 13 percent of the cost. He said the medical school does not allow pharmaceutical companies to influence the content of courses. But some medical schools have adopted additional safeguards against industry influencing education for physicians, such as requiring companies to give money to a central office, which then distributes it to pay for courses. Others are discussing banning industry funding altogether.”2 I agree with Dr. Flier’s opinion that categorically barring company funding for education is counterproductive and unwise.
1: The Boston Globe, 2/3/09 Harvard will stiffen rules for staff at med school, Liz Kowalczyk
2: The Boston Globe, 2/3/09 Harvard will stiffen rules for staff at med school, Liz Kowalczyk (emphasis added)