But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drug’s manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.
The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.
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F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, even if it is not indicated on the medicine’s label. But drug companies are tightly constrained in what they can say about their medicines. Companies can promote drugs only for their federally approved purposes — their so-called “on label” use.
“Off label” promotion by drug companies is illegal, and since 2000 drug makers have paid large fines to settle federal criminal cases over off-label prescriptions.
Pfizer, for example, paid $430 million in 2004 to settle allegations that it had promoted Neurontin, an anti-epilepsy medicine, for pain and bipolar disorder.
Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor “continuing medical education” sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies.
The American Medical Association considers continuing-education sessions valuable and believes that doctors should be free to prescribe drugs for off-label use, according to Dr. Edward Langston, a member of the A.M.A. board.
In general, though, he said, the A.M.A. believes doctors should rely on peer-reviewed research, not anecdotal evidence, when they write off-label prescriptions.
The Accreditation Council for Continuing Medical Education, which oversees the groups that create medical education sessions, loosened its rules in 2004 so that speakers would not have to disclose whether a recommended use is on-label or off-label, said Dr. Murray Kopelow, the council’s chief executive.
“The A.C.C.M.E. abandoned the distinction between off-label and on-label,’’ Dr. Kopelow said. Instead speakers should make recommendations based on accepted medical and scientific evidence, he added.
