NY Times Article on Zyprexa: Shoddy Journalism


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This is a week when a lot of people in the pharma industry take vacations but I have a feeling that there will be a lot of important meetings at Lilly's headquarters in Indianapolis this week. As if Lilly, and the whole phrama industry, didn't have enough problems the front page of todays New York Times has an article on Lilly's alleged attempts to play down the risks of its top selling drug Zyprexa. These allegations came from documents — which include e-mail, marketing material, sales projections and scientific reports — and they are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. Is this really new news or is it a well timed leak from an attorney who still is in litigation with Lilly on Zyprexa and wants to put more pressure on the Indianapolis pharmaceutical company?



According to the article in todays Times;

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.



But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales. “Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.


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A couple of things about this story seem fishy to me. First, The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues. Second, the release of these documents maybe illegal given the pending litigation of continued Zyprexa lawsuits. This, to me, seems like a well placed story by a savvy attorney who wants to pressure Lilly into a settlement that will, in all likelihood, support a win and of course monetary collection of fees.


As I see it there are a couple of issues here:


1. Did Lilly try and hide Zyprexa's side effects (weight gain) from health care professionals because they didn't want to hurt sales ?


2. Are health care professionals responsible to monitor patients for possible side effects when they start them on new medications?


This author worked for lilly for almost 5 years and during that time, as an employee, I was required to attend quarterly compliance training to ensure that I was aware of marketing compliance guidelines for both health care professionals and patients. I believe that these documents are being taken out of context. Zyprexa may have helped thousands of mentally ill patients lead better lives and be more productive to society. In addition isn't it the obligation of a prescribing physician to monitor patients while they are on prescription medications? The biggest pharmaceutical product in the world, Lipitor, for example requires that physicians monitor patients while on the medication to ensure that liver damage does not occur.


If anything maybe Lilly should have included a stronger warning to health care professionals about the weight gain issue and to monitor patients weight while on the compound. I just don't believe that in an age where every marketing message is archived that Lilly would have tried to hide anything or risk patients health for sales dollars.


Of course decisions like these are made ordinary business and medical people and sometimes they can chose the wrong path despite the efforts to keep patients best interests at heart.
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