We’ve been following the saga of MindFreedom and the attempts to make court documents associated with a Zyprexa lawsuit public. Last week, a website was successful in publishing all of the Zyprexa documents online in PDF format. The documents are hefty in number (there were 360 in total!) and would take someone a few days to review in detail and in-depth. Furious Seasons has published about a third of the Zyprexa documents on their website now.
After reviewing some of the documents, it appears they contain more than a few zingers in there that I can understand why a company wouldn’t want made public. The marketing of a pharmaceutical medication is often not pretty and often has little to do with the research and science behind the medication. Defending that medication against an increase of serious negative side effects (including death) is messier still, as these memos and communications show.
Basically what you find in the documents, based upon my reading, is a company trying to understand and deal with the negative effects of one of its medications, Zyprexa. Some of those attempts are probably not ideal, but some of them are expected in the brainstorming process — for instance, to legally indemnify doctors who prescribe Zyprexa. Probably not ethical, but an attempt by the company to show their confidence in the medication and its safety and effectiveness.
Eli Lilly and Company were concerned over a possible black-box warning that would be attached to Zyprexa, after reports surfaced of deaths associated with Zyprexa in 2003. In 2004, the FDA issued a “Dear Doctor” letter describing the increased risks associated with Zyprexa and Hyperglycemia or Diabetes Mellitus. Memos like this one show the Eli Lilly corporate response team swinging into action with ideas on how to deal with the issue. Here’s an APA (psychiatric) convention FAQ sheet, which makes for an interesting read, as does this one about medical efficacy and safety beliefs.
I’m no pharamceutical apologist (although we do accept pharmaceutical funding via advertising), but I do believe that pharmaceuticals are an important modern treatment component for many serious mental disorders. They are not a cure-all by any means, and each psychiatric medication has its benefits and drawbacks. The public and prescribing professionals deserve the right to know and have full disclosure of a drug’s benefits and drawbacks ahead of time, however. When a pharmaceutical company withholds such information (e.g., by failure to publish negative findings or findings that don’t benefit the company’s efforts), I believe they do a great disservice to not only people who may take the drug in the future, but also to the company’s shareholders and scientists.
Tip o’ the Hat to Philip over at Furious Seasons for his work on these documents and his initial observations. There are so many documents to work through, it may be awhile before the public learns everything associated with this episode.