With lawsuits and regulatory scrutiny increasing, pharmaceutical companies are tightening the reins on their promotional programs. But now physicians are pushing back, asserting their right to go off the script even when they're being paid by the drug companies.
“No respectable speaker wants to recite a company's [slide] deck,” said Dr. Selim R. Benbadis, director of the comprehensive epilepsy program at the University of South Florida and Tampa General Hospital, who also does promotional speaking for drug companies at so-called “dinner talks.”
For Dr. Benbadis, getting the drug companies to give back some of the control over these promotional talks has become a “crusade” of sorts. He has reached out to many notable physicians in the epilepsy community and to the drug companies themselves in an effort to find some common ground.
Last fall, he and five other academic epilepsy specialists penned an open letter to the pharmaceutical industry, telling them in no uncertain terms that they would not simply present a company's slide deck. “No expertise is needed to recite the company's slides, and this can be easily done by pharmaceutical representatives ('drug reps'),” they wrote. “We want to educate physicians more broadly, and believe it can be done ethically and legally while still delivering a useful message for both sides.” The letter was published in November (Epilepsy Behav. 2010;19:544-5).
Although most drug companies have long maintained an official policy that their slides be presented without editing, the common practice of speakers has been to add some of their own slides to try to craft a talk that was broader and more informative than a presentation on a single drug.
“The companies never liked this, but they had what I call a 'don't ask, don't tell' policy,” Dr. Benbadis said.
But in the last couple of years, largely because of lawsuits about off-label promotion, the companies have begun to enforce their existing policies. That shift has been frustrating for many physicians who give these types of promotional talks, Dr. Benbadis said. The lack of freedom makes physicians less likely to want to give the talks, he said, but it also makes the talks much less interesting for attendees.
The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the drug and biotechnology industry, said that companies provide physician speakers with materials to ensure that the content of these talks complies with language approved by the Food and Drug Administration. “While companies take great pains to ensure that the physicians they engage to speak on their behalf are experts in their field, the companies themselves remain responsible for the content of the program,” Diane Bieri, PhRMA executive vice president and general counsel, said in a statement.
The open letter offered a few suggestions for new ways to approach these talks. The preferred option, the authors wrote, would be for drug companies to give unrestricted educational grants to CME-granting institutions for educational programs for physicians. Short of that, the companies could make the faculty responsible for the content of the talk. For example, companies could ask their faculty speakers to sign a waiver exonerating the company of liability for any claims they make. Another possibility would be to create a new type of educational event that would be not quite CME but not quite a promotional program. Finally, the authors suggested that companies could allow a two-part program with a promotional portion and an educational portion.
Since the letter was published, there has been some progress, Dr. Benbadis said. In general, representatives from the drug companies agree that some type of accommodation needs to be made, he said, although some are more willing than others to do this.
But other physicians see CME talks as a better alternative for physician education. Dr. Jacqueline A. French, a professor of neurology at New York University and the president of the Epilepsy Study Consortium, said that the restrictions currently in place regarding the dinner talks make it very difficult to provide open and unbiased information.
The situation highlights the gap that exists in medical education, she said. Educators need to start thinking of creative ways to get information out to physicians so they can stay up to date on new therapeutics, Dr. French said.
Susan Chimonas, Ph.D., codirector of research at the Institute on Medicine as a Profession at Columbia University, New York, agrees that providing medical education under the umbrella of CME is a better option. Although the authors of the open letter are well intentioned, Dr. Chimonas said, there are many proposals for better ways to organize medical education, and physicians would be better served by working toward that goal rather than trying to figure out how to tweak the industry talks so that they are “less offensive.”