Revisit your conflict of interest policies to ensure comprehensive coverage

MDs say COI indiscretions happen

IRBs and research institutions occasionally should revisit their conflict of interest policies and update them to make certain they effectively protect human subjects, as well as pass the "smell" test.

Passing the "smell" test might be the more difficult challenge.

Consider the fact that most clinical investigators have had some sort of relationship with pharmaceutical companies.

"These can range from friendly visits with drug reps, where they leave you pens and notepads to five-figure consulting agreements or speaking fees," says Brad Noren, MA, CIP, research and contracts administrator for Oregon Health and Science University in Portland, OR.

"Once you've realized that there is this very pervasive relationship between physicians and companies developing drugs and devices, then you have to step back and figure out how it best can be managed," Noren says.

Recent literature strongly suggests that physicians are aware of these interactions with industry and the potential or appearance of conflict of interest, Noren notes.1-4

"But, interestingly, it's been shown that they readily suggest that their colleagues are more easily influenced by these drug rep visits than they are themselves," he says.

A common threshold for a financial COI is $10,000 to $15,000," Noren says. "But even when you set the threshold, $10,000 for a physician who makes six figures a year is quite a different thing that it would be to a lab technician or junior researcher."

And when a financial COI is revealed to the general public, it often sounds worse than it is: "If your Joe Citizen brings home $25,000 a year, then a $10,000 annual consulting fee for a few hours of work seems rather outrageous," Noren says.

One way to update the COI policy would be to have someone other than the investigator decide whether a particular relationship poses a conflict and needs to be changed, Noren suggests.

Here are two questions to ask when assessing a potential COI:

  • Would this relationship look to a reasonable person like a competing interest is exerting an undue influence on the research?
  • And if the PI is also a physician, does unrestricted gift money from the company somehow influence the physicians' prescribing patterns?

Answering those two questions in advance would provide some COI protection to the physician/PI and put the PI above the appearance of an improper relationship, Noren says.

"Some methods of managing a conflict of interest include letting the investigator keep stock in the company, but not letting him be involved in analysis of data," Noren says. "He will not be the one to review the inclusion/exclusion criteria and enroll subjects."

Another management option would be to have the investigator divest himself of the stock, but that would be in an extreme case, Noren says.

"That's certainly something that a COI committee would be justified in at least offering as one possible solution to the investigator," he says.

Some medical campuses are even taking the extreme action of managing potential COI by not allowing pharmaceutical company representatives to visit their campuses, Noren notes.

For example, the University of Pennsylvania School of Medicine published in 2007 its policy to strictly regulate the activity of pharmaceutical representatives by prohibiting meals and gifts.3

"The American Medical Student Association [Reston, VA] has come out strongly against doctors receiving gifts of any kind, and they argue the awareness of this potential conflict must be a more prominent part of the medical professional's education," he says.

"So people on some campuses can't take a pen or gift or accept lunch," Noren says. "It's possible that this will be a trend that spreads, but it's a decision that has to be made at an institutional level, and you would have to have buy-in from faculty."

References

  1. Wall LL, Brown D. The high cost of free lunch. Obstet Gynecol 2007;110:169-173.
  2. Schramm J, Andersen M, Vach K, et al. Promotional methods used by representatives of drug companies: A prospective survey in general practice. Scand J Prim Health Care 2007;25:93-97.
  3. Wasserstein AG, Brennan PJ, Rubenstein AH. Institutional leadership and faculty response: Fostering professionalism at the University of Pennsylvania School of Medicine. Acad Med 2007;82:1049-1056.
  4. Collins J. Professionalism and physician interaction with industry. J Am Coll Radiol 2006;3:325-332.