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By Mara Levy Published: 2007-12-10 19:54
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Pharmaceutical Giant Accused of Playing Down Risks of Top Selling Drug

By Mara Levy
Published: Monday, January 29, 2007 - 13:52

Last month, hundreds of internal company documents detailing efforts by Eli Lilly, the sixth largest American drug maker, to play down risks of the company’s best selling antipsychotic medication, Zyprexa, were obtained by several websites and organizations, including NPR and The New York Times. The pharmaceutical giant has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. Several thousand additional cases are still pending.

In a flurry of articles dating back to mid December, 2006, The New York Times has aided in exposing a possible cover up worthy of the big screen. It all began with a Massachusetts doctor, David Egilman, who was a consulting witness in a case against Eli Lilly. Dr. Egilman had in his possession a treasure trove of internal Lilly documents, including marketing reports, e-mails, and research studies that, among other things, showed the drug company had withheld some damaging information regarding their best-selling pharmaceutical, Zyprexa. Although sealed by the court as part of that litigation, a lawyer from Alaska, James B. Gottstein, who was pursuing unrelated litigation, somehow got word of Dr. Egilman’s holdings, and sent him a subpoena for copies. By the time Lilly’s lawyers got wind of the request, some of the materials had not only been released and posted on various websites, but also shared with some pretty powerful members of the media, including New York Times reporter Alex Berenson.

With over $4.2 billion in sales last year alone, doctors have used Zyprexa to treat more than 20 million people worldwide. First approved by the Food and Drug Administration in 1996, Zyprexa (generic name: olanzapine) is an atypical antipsychotic prescription drug for the treatment of Schizophrenia and Bipolar Mania. The long list of off-label uses include prescriptions for the treatment of panic and anxiety disorders, borderline personality disorder, obsessive-compulsive disorder, autism, and psychotic depression. According to their website, “it is believed that Zyprexa works by adjusting the imbalance of chemicals in the brain that may cause psychotic symptoms.” Side effects of the drug may include fatigue, constipation, dry mouth, weakness, upset stomach, tremors, dizziness, and difficulty regulating body temperature. The leaked documents show that as early as 1999, Lilly played down the additional risks of weight gain, high blood sugar, and diabetes, fearing that they would hurt sales. Although Lilly continues to deny the claim, in 2003, the FDA asked them to add a warning statement to their product label informing patients about the increased risk of diabetes and hyperglycemia while taking the medication.

While the investigation into Eli Lilly’s actions are far from over, as reported by NPR.org, the scandal has also launched a courtroom battle over, “whether bloggers are entitled to the same free-speech protections given to reporters for newspapers and other media.” Websites posting the leaked documents were shut down last month. The links may or not be restored, depending on the court’s ruling which could come at any time. Lilly argues that, “releasing the documents could harm patients and physicians, because the documents tell only part of the story about Zyprexa.”

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