Indictment of Doctor Tests Drug Marketing Rules

Indictment of Doctor Tests Drug Marketing Rules

continued

Some lawyers who have reviewed Dr. Gleason’s case, but are not representing him, say they agree.

Dr. Gleason has been trapped in the complex rules that cover what doctors and drug manufacturers are allowed to say about prescription drugs, according to Harvey A. Silverglate, a lawyer in Boston who specializes in civil liberties cases.

“What they are doing is criminalizing conduct that is not clearly criminal,” said Mr. Silverglate, who is not involved in Dr. Gleason’s defense.

Neither the F.D.A. nor the United States attorney’s office in Brooklyn, which indicted Dr. Gleason, would comment on the case. Nor would David Loftus, a public defender who took over the case after Dr. Gleason determined he could not afford a private lawyer. Jazz Pharmaceuticals, which has not been charged, also declined to comment.

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.

In other words, the F.D.A. rules allow drug makers to pay independent doctors to discuss medicines in ways that might be illegal for the companies themselves. Beyond the federal rules, guidelines by doctors’ groups give physicians wide latitude to talk about off-label use.

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.

Dr. Gleason acknowledges that he did not follow those evidence-based guidelines when discussing Xyrem in hundreds of speeches and seminars from 2003 to 2006. The talks were paid for by the original maker of Xyrem, a company called Orphan Medical. Orphan was acquired by Jazz Pharmaceuticals in June 2005.

In one seminar cited in the federal indictment, a session last August in Denver, Dr. Gleason told doctors that “table salt is more dangerous” than Xyrem — a statement scoffed at by other experts on the drug.

An Aid to Sleep Quality

Xyrem’s active ingredient GHB is a fast-acting central nervous system depressant developed as an anesthetic in the 1960’s. The drug improves sleep quality, enabling narcoleptics to stay awake the next day, according to physicians who specialize in treating sleep disorders. But because GHB can suppress breathing, overdoses can cause coma or death.

“It has the potential to do a lot of good if it’s used properly, the potential to do a lot of harm if it’s used improperly,” said Dr. Martin Scharf, the director of the Tri-State Sleep Disorders Clinic in Cincinnati, who said he had studied GHB in hundreds of patients since the early 1980’s.

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Last updated: 7/06

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Indictment of Doctor Tests Drug Marketing Rules