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 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 the November issue of the journal Epilepsy & Behavior (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. "At the end of the day, [the FDA] expects and demands compliance, and rightly so."
The open letter published in Epilepsy & Behavior 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. A couple of the companies are working with their speakers to create a large set of company-approved slides that include not only promotional material on the drug, but also disease-state slides. That would allow speakers to put together a talk from a larger and more diverse pool of company-approved materials. Meanwhile, other companies have signaled their willingness to allow speakers to create different talks and have approved those talks on an individual basis. But because the process is time consuming, Dr. Benbadis said those companies aren’t advertising the availability of that option.
A shift back toward greater flexibility is critical if these talks are going to survive, Dr. Benbadis said. "These talks serve a purpose, I think, for the companies and for us and for the community."