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Drug Company Inducements to Doctors: Not Par for the Course
Peter Lurie, M.D., M.P.H.
Ever get the feeling that, when it comes to the drugs you’re prescribed, you’re just a small speck (maybe a white, dimpled one) being batted about by forces beyond your control? Turns out that if you lived in certain parts of South Carolina around the turn of the millennium, you just might have been.
Documents recently released in a court proceeding in Spartanburg, SC, reveal the unthinkable: patients’ fates (as measured by the drugs they were prescribed) were actually determined by the roll of a golf ball.
Seems that a doctor in South Carolina, out for round with a drug rep for Zyprexa manufacturer Eli Lilly (What’s that about, anyway?), entered into a bet. Each time the rep carded a par (for those of you not wearing tartan plus-fours, that means getting the ball in the hole in a predetermined number of shots), the doctor would agree to start a new patient on Zyprexa. “I got four pars out of nine holes,” boasted Lilly rep Vince Sullivan in the court documents. “I said I wanted my four new patients.”
The documents do not say whether unsuspecting patients wound up on Zyprexa, a drug for schizophrenia, but they do suggest an alarming pattern of potentially illegal promotion by Lilly.
The court case turns on the notion of off-label promotion. When the FDA approves drugs, it does so for particular conditions. Companies are forbidden to promote the drug for any condition other than the approved one, although doctors are free to prescribe the drug for any condition they choose. Thus, off-label promotion is illegal, but off-label use is not.
But many a drug company has pushed itself still further into the black by fostering off-label use.
This September, for example, drug mega-corporation Pfizer was forced to swallow an all-time U.S. record $1.2 billion in federal criminal fines for illegally promoting Bextra and other drugs. With civil fines included, Pfizer’s settlement reached $2.3 billion, a decidedly modest sum when set against the company’s 2008 net income of $8.1 billion. The previous criminal fine record holder? Lilly’s $515 million fine in January for its promotion of, you guessed it, Zyprexa.
Lilly’s fine was the product of a settlement with the Department of Justice and more than 30 states. But South Carolina opted out, hoping to fare even better in home-state court. The embarrassing documents were unearthed in that legal proceeding. South Carolina alleges that illegal off-label promotion for uses such as depression, agitation and anger cost the state $200 million in inappropriate Zyprexa prescriptions.
Indeed, the Lilly rep’s unseemly behavior wasn’t confined to the golf links. Many doctors like to supplement their already sizable incomes with service on speakers’ bureaus. At drug company-sponsored meetings typically held in popular vacation destinations or high-end restaurants, these physicians present medical information that has been repeatedly demonstrated to favor their sponsors.
Not just anyone can give these talks, in which the docs are often kept on-message by company-produced slides. “If his [prescription] numbers go up, maybe he can talk,” said Sullivan, he of the four-par round.
Evidently, the novelist Paul Gallico had it right when he observed that “If there is any larceny in a man, golf will bring it out.”