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.
The backlash against commercial support has also led many prominent medical centers to ban faculty from receiving significant amounts of industry dollars for teaching and consulting. But these professors are often the top experts in their field, the ones at the research helm. Promotional talks given by drug reps—who are company employees, not doctors—are monitored by the FDA, and any discussion of off-label use is strictly prohibited. That's for good reason; the only people telling doctors how to use a drug should be doctors who know how to use the drug. But if these doctors are prohibited from giving talks, then how is that going to happen?
Continuing medical education programs are another option. The pharmaceutical industry spends more than $1 billion a year on educational programs that are also CME-certified (see Table 6 here)—that is, doctors attending them can earn the credit hours they need in order to keep their medical licenses. These programs do permit off-label discussion of drugs. However, CME guidelines are strict. Programs must present a balanced view of all treatment options for a given disease, and pharmaceutical companies may not influence the program.
Fair enough. Companies shouldn't be able to determine the content of any educational program, especially one that qualifies for CME credit. But as this wall has thickened, pharma has pulled away from funding CME programs, which means fewer free educational opportunities for doctors. Unsponsored, in-person CME programs can cost hundreds to thousands of dollars, which starts to pinch the wallet, even for doctors, who aren't all loaded. The reluctance stems not only from the lack of opportunity to influence doctors but also fear of being seen as promoting a drug. Many companies have decided it's just not worth the risk or trouble. Besides, some universities are already pushing industry out of CME programs, too.
Without programs being brought to their door, most doctors will get their necessary credits in one fell swoop at their specialty's annual conference, which offer CME sessions. But an hour-long talk in a giant lecture hall is hardly the intimate atmosphere truly needed to learn about a new drug. More than 30,000 people attended the recent annual meeting of the American Society of Clinical Oncology, the largest meeting for cancer health care professionals. Presenting new drug data to an audience of thousands precludes the pertinent dialogue that's possible in a smaller setting. And waiting until the annual meeting rolls around doesn't seem like the best way to stay on top of the latest developments. Furthermore, the balanced nature of CME programs often leads to a very watered-down presentation of cutting-edge advances. A seminar may present several speakers discussing multiple treatments for a disease without honing in on the specifics of using one essential new tool. The content, the size, and the impersonal nature of these talks don't deliver the level of detail that doctors must know as they inject a new foreign substance into a living, breathing human.
The same goes for the plethora of online videos and other materials produced without commercial support. There is no substitute for a small group of people listening to a doctor talk about how to treat a disease. And there is no substitute for the commercial support required to run such programs.
In a recent study, academic researchers were paid a modest honorarium to travel around the country teaching more than 14,000 doctors about new treatment guidelines for high blood pressure. Each researcher met with small groups of doctors to educate them about the latest advances. In counties where the most sessions took place, adherence to the guidelines rose by more than 8 percent. In counties with the fewest such sessions, adherence decreased by 2 percent. The approach that the pharmaceutical industry has been taking for years is actually an effective way to educate doctors.
The concern about industry's influence over medical care is obviously well-founded. There are plenty of cases in which doctors have promoted unproven off-label use or have become unduly biased toward prescribing a drug that they learned about through a pharma-paid program. And it's doubtful that companies would shell out so much money if their bottom lines didn't stand to benefit.
But the entanglement caused by for-profit drug development can't be undone by eliminating the free lunch. As one physician suggested, perhaps pharmaceutical companies should be required to pay for medical education. After all, if companies are going to unleash new drugs into the world, shouldn't they be responsible for teaching people how to use it? Ousting commercial support is creating a huge chasm in medical education, leaving doctors not only hungry but also starved for knowledge.