Proposed guidelines kick industry off campus
Proposed guidelines kick industry off campus
Think-tank Pew Charitable Trust issued a set of conflict-of-interest recommendations that could significantly alter relationships between universities and the pharmaceutical industry.
The non-profit convened a group of experts to update the 2008 conflict policies the Association of American Medical Colleges created in 2008. While the pharmaceutical industry may perceive the recommendations as yet another attack on access, Pew notes in the introduction that protecting “the integrity of education and training and the practice of medicine within the medical center” are the motivating factors behind its recommendations.
A summary of some of the recommendations is below. And yes, lunch is off the table.
Industry-sponsored lectures and meetings
Showing up, let alone speaking at company events and lectures, is a no-no, and for one reason: FDA regulations limit what can be discussed, which means these events are not academic ones at which professionals can compare treatment options from more than one company, or discuss off-indication applications.
Continuing medical education
The task force says there is no room for industry participation, including lectures, online discussions of medical literature, or making product or device recommendations. The task force does provide an out, but it would require the following:
- Money from multiple companies goes into a general, blind fund. No single company can provide more than 50% of the funding for a program
- Doctors have to kick in some of their own cash, i.e., by paying for their own meals
- Venue must be in an academic setting or “other appropriate venue conducive to education”; no resorts
Pew's explanations for these barriers are based on studies that indicate the subtle ways interactions can influence preferences. Pew writes that the 50% funding limit, for example, is to prevent favoring one treatment class over another, and that having doctors bear some financial responsibility could dilute individuals' innate sense of reciprocity for kindnesses, such as gifts. The task force notes that social science and neuroimaging prove this built-in sense of obligation.
The task force also cuts off objections that these measures could kill off patient referrals that keep clinical trials full and research programs running by citing a University of Michigan policy that went into effect in 2010. This policy created a grant program for the dean's office, marketing department and hospital that would be used for CME courses and to show the relationship between CME and referrals. Pew says U. of M. faculty did not see a difference after two years, and any impact was minimal because most of them were grand rounds and those “were never dependent on industry support.”
Pew's task force says reps have no place in academic settings because they are biased and may “intentionally omit information” about drug treatments.
The no-rep stance goes beyond worries about marketing angles, however: the task force says pre-professionals do not need reps because trainees can get drug information through online information that is not funded by the pharmaceutical industry.
Although reps may argue they bring samples, and not just information, Pew's team writes that if academic centers decide to opt-in, they should bypass sales reps and requisition them through a third party.
Food and gifts
The task force writes that although most schools don't ban food at accredited CME events because a third-party generally handles the money for these programs, that this does not sanitize the transaction because attendees know where the money is coming from. Pew says doctors should have to pay for their meals “to minimize any sense of reciprocity” in such situations.
This does not mean doctors can't be fed when working with the industry as consultants and “food is part of fair market compensation for clearly delineated services and not a gift.”
Pew's task force says faculty and industry-funded speaking engagements do not mix, whether it's for the public, students, community physicians, patients or other HCPs, or essentially any scenario in which drug companies influence content, including engagements set up by speakers' bureaus. GlaxoSmithKline gets name-checked in this section, per a company policy that requires speakers use company slides.
The task force takes an additional jab at faculty who work with speakers bureaus, calling them “de facto ‘marketers in academic robes'” who “lend a patina of academic endorsement to the promotional agenda of the sponsoring companies.”
Pew draws a line between what qualifies as good and off-limits consulting.
In short: consulting is alright in the context of designing clinical trials, improving medical devices and talking with the industry about what kind of research to pursue in the future, and that all of these are fine with the task force as long as the services align with clearly written contracts that have specific deliverables and compensation tracks with “fair market value for comparable services.”
Consulting that does not fit this template includes using academics as marketing foils, such as getting feedback on promotional materials or marketing strategies.