Pharmaceutical Industry Disclosure Practices

Doctors and Drug Companies
by Jerome Kassirer, Boston Globe Op-Ed(July 6, 2005)

Drug companies spend billions of dollars each year on educational programs for doctors in the form of "unrestricted educational grants." The companies swear that in supporting physicians' meals, meetings, and events, all they care about is educating doctors, but the US Senate is now asking how much of the content of these programs is education and how much is product marketing.

Given the impending expansion of prescription drugs through Medicare, it's certainly appropriate for the government to be worrying. In their recent letter, the Senate Finance Committee asked 23 major drug companies to provide extensive data on these grants, including their purposes, total expenditures, and the identity of the recipients. Cautioning about "potential for abuse," the letter expressed concerns that industry-sponsored programs might increase cost "and may encourage the use of typically newer, more expensive drugs." For emphasis, the committee gave them only weeks to respond.

The ultimate recipients of these funds, namely hospitals, medical centers, medical schools, professional medical organizations, and individual physicians, should also worry about the disclosures. Except for a handful of people, nobody has raised questions about whether "unrestricted" grants are truly unencumbered; whether there are hidden incentives for some kind of "payback." Nobody has inquired how recipient organizations arrange to get the grants, how much they receive, or how they administer the grants. Congress has finally opened the Pandora's box of industry sponsorship of continuing medical education, and once it discovers where the money is going, it seems likely that they will come calling, not just on the grantors, but also on the recipients.

Why does medicine have a problem? Because industry pays for well over half of the expense of doctors' continuing medical education. Virtually all the continuing education departments in hospitals, medical centers, and medical schools rely on drug-company funding. Everybody does it, and when four drug companies gave the Massachusetts General Hospital's Psychiatry Department $6.5 million dollars to spread its educational expertise, the reaction was muted.

Professional societies are equally dependent on drug-company money. They rely on grants for operating expenses, for running enormous annual meetings, and for developing treatment recommendations for practicing doctors. Societies solicit funds by peddling chunks of their annual meetings. For sale: company tote bags, a rodeo, a barbecue, or a cocktail party.

Drug companies also pay individual doctors to speak at national meetings, medical center conferences, and restaurant back rooms. A Boston physician lectures in a fine restaurant within walking distance of Yale Medical School; a top physician joins 200 others in a drug-company sponsored seminar about a single drug, with the promise that he will become a company-paid speaker.

The concern is hidden bias. Do directors of educational programs intentionally choose company-sponsored physicians to give the talks? Do they allow conflicted speakers to hawk drugs for purposes not approved by the FDA?

Some medical societies have been suspected of bias because their medical practice recommendations were formulated by physicians being paid for speaking or consulting by companies that could gain from slanted recommendations. The medical societies argue that industry-paid experts can dominate in such deliberations and that disclosing all financial connections magically avoids bias.

Unfortunately, these disclosures do not tell a doctor whether such recommendations (that they use in everyday practice) are balanced. And how can we expect company-paid speakers to be objective when their talks are regularly observed by company representatives? Many financially conflicted speakers undoubtedly bend over backwards to be even handed, but they won't last long on the circuit unless they speak favorably about their sponsor's products.

Should physicians take gifts, meals, and speaking honoraria from industry when reporters do not? Isn't the veracity of medical information as critical as civic or political news? It makes no sense that financially conflicted physicians should be developing educational materials and practice guidelines. Many organizations and individuals are likely to be embarrassed by Congress's disclosures, and medicine risks having its reputation sullied further. Practicing doctors need to trust the recommendations of academic physicians and their professional societies, and people need to be able to trust their doctors.

Medicine must begin to extract itself from the open arms of the drug industry. In turn, the pharmaceutical companies, by engaging so many physicians and organizations in its marketing ventures, is doing a disservice to the very profession that it relies on to analyze, recommend, and prescribe its products. Industry too must back off.

Extracting medicine from industry's educational ventures will be painful, but probably less painful than inappropriate and more costly medical care or the opprobrium of a disenchanted public.

Dr. Jerome P. Kassirer, a professor at Tufts University School of Medicine, is author of "On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health."

Pharmaceutical Industry Disclosure Practices