Playing Down the Risks of a Drug

The details were spelled out in The Times this week by Alex Berenson, who drew on hundreds of internal Lilly documents that have surfaced in legal proceedings. Although Lilly says the documents present an inaccurate picture, they offer persuasive evidence that the company engaged in questionable behavior to prop up its best-selling drug, which creates almost 30 percent of Lilly’s revenue.

Zyprexa belongs to a class of drugs that were billed as a significant advance over the first generation of antipsychotic drugs but turned out to have serious flaws. Zyprexa, for example, has a tendency to raise blood sugar and to promote obesity, both of which are risk factors for diabetes. Some 30 percent of the patients taking Zyprexa gain 22 pounds or more after a year on the drug, with some gaining 100 pounds or more. Yet the documents show that Lilly encouraged its sales representatives to play down these adverse effects when talking to doctors.

The documents also show that Lilly encouraged primary care physicians — far less sophisticated than psychiatrists in treating mental illness — to prescribe the drug for older patients with symptoms of dementia even though it was approved only for schizophrenia and bipolar disorder. It is illegal for companies to promote drugs for unapproved uses, but nearly every major drug company is under civil or criminal investigation for alleged efforts to do so.

Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials.