New York Times Profiles Doctor Arrested For Off-Label Prescribing

Posted July 27, 2006 · July 27, 2006

The New York Times on Saturday profiled land psychiatrist

Gleason, who federal authorities arrested in March and later charged

for " doing something that has become common among doctors: promoting

a drug for purposes other than those approved by the federal

government. " Federal prosecutors allege that Gleason received large

fees from Jazz Pharmaceuticals to promote the narcolepsy medication

Xyrem as a treatment for depression and pain relief, uses not

approved by FDA. Federal prosecutors allege that Gleason conspired

with Jazz to recommend Xyrem for potentially dangerous uses.

According to the Times, the case has " put the spotlight on the murky

financial relationships between drug companies and the physicians

they use to promote their medicines. " Pharmaceutical companies, which

cannot directly market medications for uses that FDA has not

approved, often sponsor seminars or continuing medical education

classes and pay physicians to make presentations to promote their

products for both approved and off-label uses. The Gleason

case " could establish limits on what doctors can do to help companies

sell their drugs, " the Times reports. Nissen, interim chair of

cardiovascular medicine at the Cleveland Clinic, said that the case

could " have a chilling effect on physicians because, when we give

lectures, we assume that giving an opinion about the use of a drug is

not going to get us into legal difficulty " (Berenson, New York Times,

7/22).

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