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Tracking the Zyprexa Story
The controversy surrounding the Eli Lilly anti-psychotic drug Zyprexa would seem to have reached its culmination with the announcement of a $500 million settlement for 18,000 lawsuits on January 5, 2007. This is in addition to a $700 million settlement reached in 2005 for 8,000 lawsuits from patients who developed diabetes and other complications due to their use of Zyprexa since the drug’s introduction in 1996.
The Zyprexa story is a fascinating study, involving as it does at least three legal issues – one of them constitutional in nature – as well as having to start with an understanding of the drug and its effects on mental disorders.
Starting Out
A good place to start understanding the Zyprexa story would be Eli Lilly’s Zyprexa website at Zyprexa.com which provides basic product information, explanations of schizophrenia and bipolar disorders (for which the medication is prescribed), and other information.
The initial rumblings about the side effects of Zyprexa (especially that of diabetes in patients taking the medication, as well as reported deaths due to complications caused by the drug) came from a Duke University study conducted in 2002. This study reported finding that at least 283 patients who took the drug developed diabetes. The study also revealed that 23 of these reportedly died.
This Duke University study apparently spurred science writer Robert Whitaker into an investigation of Zyprexa. In 2003, Whitaker had gathered enough materials and presented these in his book, Mad in America, which was published in 2003. In this book, Whitaker detailed FDA records never disclosed to the public about clinical trials that already showed problems with the new drug.
The controversy spilled over into the public arena in 2004, when the first class action suit was filed against Eli Lilly.
The Zyprexa Ripples
The class action suit against Eli Lilly and Zyprexa soon brought lawyers out of the virtual woodwork, with various lawyers’ websites focusing specifically on the matter and its legal implications – and many of them with links to “Consult with a lawyer” in the event the reader was an affected patient. Among these websites are Online Lawyer Source and Free Advice which touched on the legal aspects of the Zyprexa issue. There were also other websites dedicated for health professionals.
The ‘Constitutional’ Issue
Another aspect of the Zyprexa controversy concerned the lawsuits filed against various journalists and web sites which had also drawn attention to the matter. As detailed by New York Times reporter Tom Zeller Jr. in a January 2007 article, the issue stemmed from Eli Lilly internal documents which were in the hands of a consulting witness in the ongoing litigation against Eli Lilly. The documents, however, were under court seal as part of the litigation process.
An Alaskan lawyer, James B. Gottstein who was handling an unrelated litigation case against Eli Lilly for clients in Alaska, somehow got wind of the documents and subpoenaed them for his own use. In an exchange of communications, the Eli Lilly lawyers told Mr. Gottstein to back off; Mr. Gottstein’s response was that it was too late and the documents had already been released.
Copies of the Eli Lilly documents found their way to the New York Times and became the basis for a series of articles by NYTimes reporter Alex Berenson, which detailed some of the key issues behind the controversy. Among these articles are one which detailed the human tragedy of Zyprexa and another which focused on Eli Lilly’s efforts to market the drug “off the label.”
Other websites also focused on the issue, among them health advocacy groups MindFreedom International and the Alliance for Human Research Protection. New York Judge Jack B. Weinstein ordered Mr. Gottstein to provide a list of people to whom the documents had been sent, and followed this with an injunction against 14 people, Mindfreedom and AHRP as well as a wiki site (zyprexa.pbwiki.com) from further discussing and disseminating the documents in the internet.
The matter has become a sort of cause with the Electronic Freedom Foundation joining the fray, representing “John Doe,” a reporter on the wiki site, and focusing on the fundamental right of free speech and access to information for the public good.
Tracking the Zyprexa story has taken some rather convoluted terms, but it is an interesting study in medicine, law and fundamental rights. |
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