Playing Down the Risks of a Drug
Source: NY Times
It was bad enough when studiesshowed that the newest and most heavily promoted drugs for treatingschizophrenia weren’t worth their high cost. Now the disturbing tale oftheir excessive use has taken a tawdry turn with revelations that EliLilly, a pharmaceutical giant, has consistently played down the risksof its best-selling antipsychotic drug, Zyprexa, and has promoted itfor unapproved uses.
The details were spelled out in The Times this week by AlexBerenson, who drew on hundreds of internal Lilly documents that havesurfaced in legal proceedings. Although Lilly says the documentspresent an inaccurate picture, they offer persuasive evidence that thecompany engaged in questionable behavior to prop up its best-sellingdrug, which creates almost 30 percent of Lilly’s revenue.
Zyprexa belongs to a class of drugs that were billed as asignificant advance over the first generation of antipsychotic drugsbut turned out to have serious flaws. Zyprexa, for example, has atendency to raise blood sugar and to promote obesity, both of which arerisk factors for diabetes. Some 30 percent of the patients takingZyprexa gain 22 pounds or more after a year on the drug, with somegaining 100 pounds or more. Yet the documents show that Lillyencouraged its sales representatives to play down these adverse effectswhen talking to doctors.
The documents also show that Lilly encouraged primary carephysicians — far less sophisticated than psychiatrists in treatingmental illness — to prescribe the drug for older patients with symptomsof dementia even though it was approved only for schizophrenia andbipolar disorder. It is illegal for companies to promote drugs forunapproved uses, but nearly every major drug company is under civil orcriminal investigation for alleged efforts to do so.
Lilly contends that it has never promoted Zyprexa for unapproveduses and has always shown its marketing materials to the Food and DrugAdministration, as required by law. Both claims ought to be tested inCongressional hearings that should focus on how well the industrycomplies with existing laws and how effectively the F.D.A. regulatesthe industry’s marketing materials.