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How Lilly Sells Zyprexa

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from: Bonnie Goldstein

Posted Thursday, Feb. 15, 2007, at 5:58 PM ET

In 1996, the Food and Drug Administration approved Zyprexa, an antipsychotic medication manufactured by Eli Lilly. Eight years later, the FDA learned that patients taking the drug increased their risk of contracting diabetes, pancreatitis, and hypoglycemia. The suspicion that Lilly had known about the risk but suppressed that information (which Lilly disputes) prompted numerous state lawsuits and investigations into the medicine's marketing. Despite a protective order preventing parties to the lawsuits from disseminating confidential documents acquired in the discovery process, Jim Gottstein, an advocate for the mentally ill, got his hands on some Lilly marketing memos and shared them with reporter Alex Berenson of the New York Times, who wrote about them in articles that appeared on Dec. 17, 18, ($) and 21. Eventually the documents found their way onto the Web. Soon after the Times stories were published, Lilly settled 18,000 of the legal claims for $495 million—bringing total damages paid to date to more than $1 billion, with more cases pending.

Today's memo (which comes via furiousseasons.com and appears below and on the following 12 pages) is from a 2001 campaign by Lilly's marketing department to encourage doctors to prescribe Zyprexa. Part pep talk and part "message" script, the memo instructs sales reps to tell primary care physicians to prescribe the anti-psychotic drug directly to their patients rather than refer them to psychiatrists (see page three) because such referrals are often "expensive" and "difficult to schedule." On Page 9, Lilly sales reps are instructed to say that the most common side effect of Zyprexa is … "somnolence."

The memo sounds an awful lot as though Lilly wants its sales reps to tell primary-care physicians to prescribe Zyprexa for off-label uses. The law permits doctors to do so, but Lilly's executive vice president of science and technology, has stated flatly: "We do not engage in off-label promotion." That's difficult to square with the script on Page 3. "Doctor, you know your patients better than any other clinician," the memo reads, before describing three patient types a primary care physician would commonly see in his office: "Martha," an aged widow who is difficult for her family to manage at home; "David," who suffers from a probable "mood disorder"; and Christine, a twentysomething who struggles with "a history of poor work performance." None of these hypothetical patients would appear to suffer from schizophrenia or bipolar disorder, which are the only two conditions Zyprexa is approved for.

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hot document
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from: Bonnie Goldstein

Posted Thursday, Feb. 15, 2007, at 5:58 PM ET
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Bonnie Goldstein is a former special investigator to the U.S. Senate and investigative producer for ABC News.
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