The war against industry-sponsored medical education is in full tilt. In recent anti-pharma news, industry employees have been barred from giving talks during at least two important upcoming medical meetings, and oncologists from Vermont, Minnesota, and Massachusetts were forbidden from partaking in the snacks provided at corporate exhibit booths during a recent annual cancer society meeting. These developments come on the heels of a movement already well under way at medical centers around the country: ending the free lunch.
Every year, the pharmaceutical industry spends billions of dollars on educational programs for doctors, many of them involving food and drinks. Doctors who are experts on a new medication are paid handsomely by the drug's maker to speak to other doctors—over a fancy dinner or a casual lunch—about updates on treating a particular disease that (no surprise here) the new drug just so happens to treat. This approach isn't the only way that doctors continue their post-med-school education, but it is a mainstay, and not just because of the free and tasty grub. These sessions help move the latest medical advances out of the lab and into daily practice.
But with the mounting concern about ties between doctors and the pharmaceutical industry, commercially supported medical education is being axed from hospitals and university medical centers around the country. Not only is this change unfortunate for anyone with a doctor, but it also doesn't make any sense.
When the FDA approves a new drug, the package label notes a very specific indication, and pharmaceutical companies may only market the drug for that purpose. But often the appropriate use, or standard of care, differs from the use the FDA approved. For example, when Remicade was first marketed for the treatment of Crohn's disease, the approved, or on-label, indication was a single intravenous infusion. In reality, Remicade needs to be given on a continual, long-term basis. Patients given a single infusion quickly develop antibodies against the drug, resulting in an allergic reaction on subsequent exposure. But a long-term trial would have delayed getting it to patients in need—Remicade was a much better treatment than what was already available for Crohn's. So although the well-respected doctors who served as trial investigators knew that routine use of Remicade needed to be long-term, they decided to submit the single-dose data for regulatory review. The FDA regulates how a drug is marketed, not how it's used by doctors. While Remicade's manufacturers couldn't advertise the drug for long-term use, trial investigators could demonstrate the appropriate, off-label, use. For several years, gastroenterologists from the world's top medical centers, who'd been part of Remicade's development since its inception, traveled around the world, instructing doctors on how to use the drug.
That practical knowledge could never have been gleaned from a journal article or the package insert. Generally, the published reports of clinical trials present complicated statistical analyses about a drug's likelihood to benefit patients. They don't teach how to use the drug. Physicians needed in-person training. They needed to hear an expert discuss the ins and outs of a new medication—what side effects to expect, how to manage them, how long to wait between infusions, when dose adjustments might be needed. That was the only way to ensure the optimal treatment of patients with Crohn's disease. Most, if not all, of those sessions were paid for by the drug's maker and often included food and drinks.
But sessions like this—meetings with key opinion leaders over lunch, dinner, or a snack to discuss the latest advances in treating this or that condition—are being banned left and right. Since at least June of 2009, the University of Pittsburgh, Mount Sinai School of Medicine, Stanford University School of Medicine, Johns Hopkins School of Medicine, and several other prominent institutions have prohibited industry-funded meals. Politicians and other federal overseers are concerned that commercially supported medical education leads to misuse of drugs—in particular, that doctors who have enjoyed a meal on the pharmaceutical company's tab will prescribe an expensive drug even if it is not the best treatment option. Like that curl of smoke carrying an irresistible scent in an old cartoon, pharma-provided victuals, the thinking goes, woo doctors into mindless, expensive prescribing.
But cauterizing industry-sponsored education leaves a huge gap in care. Stephen Hanauer, one of the clinical investigators who developed Remicade and who has been paid to speak to doctors about it, explains that as Remicade teaching sessions have been nixed, misuse of the drug has risen—and Hanauer thinks that the two phenomena are connected. Hanauer now regularly sees Crohn's disease patients who were treated inappropriately with Remicade. Uneducated about its off-label use, the physicians gave the drug as a single infusion, which led to resistance, leaving patients with very limited treatment options. The investigators also discovered that breaks between doses need to be kept short, but many gastroenterologists haven't had the chance to learn that, resulting in unnecessary sickness.
Many drugs are used off-label on a regular basis. Clinical trials are done in a vacuum, and even when the standard-of-care use does not differ quite so starkly from the on-label use, doctors still require hands-on learning. Right now, the most effective way to do that is through commercially supported medical education so that the speakers can be paid and the session can be done in a way that works within doctors' busy schedules.
But surely there must be other options. Can't doctors meet with the experts in the absence of fancy cheese? Not necessarily. Teaching sessions often take place during the lunch hour. As Hanauer, who practices at the University of Chicago School of Medicine, describes, the elimination of paid lunches sent hungry doctors to the cafeteria instead of the lecture hall. "But the lines were so long that they missed the conference," he says. "So attendance at our grand rounds conferences went to miniscule." Now the doctor has a sandwich but isn't up to date on how to treat a serious disease. That may sound silly, but it's often the mundane reality. "There are sometimes times when residents have to choose between lunch and a conference," Richard Goldberg, an oncologist at the University of North Carolina, wrote in an e-mail.