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British drug maker AstraZeneca has been subpoenaed by two states in conjunction with the sale, safety, and marketing of its antipsychotic Seroquel. Last month, the company received a subpoena from the California Attorney General’s office, this one coming shortly after the Alaska Attorney General’s office issued its own subpoena. They are also the subject of an informal inquiry by the U.S. Securities and Exchange Commission. The SEC is looking into allegedly improper payments made to doctors and government representatives outside the United States.

Last week, the company announced a 30 percent gain in third-quarter net profit to $1.59 billion, attributing its success in part to expanded use of Seroquel for the treatment of manic bipolar disorder. In 2005, sales of Seroquel totaled about $2.76 billion. Earlier this month, the FDA officially approved the drug for the treatment of bipolar depression. It had already been approved for schizophrenia, and now it is the only drug approved for both depressive and manic bipolar behavior. Seroquel and Nexium, an ulcer drug, account for more than half of AstraZeneca’s sales.
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Loaded with fat, salt, cholesterol, and calories, KFC’s chicken may never be considered a healthy eating option. However, the fast-food chain is taking steps to reduce the health risks of its products by eliminating artificial trans fat in its cooking oil. The overhaul is expected to be completed by April of 2007 in all of its 5,500 outlets.

The impetus for the conversion lies in large part with the New York City Board of Health. The board is considering whether to place an outright ban on artificial trans fats in city restaurants. In addition, the Center for Science in the Public Interest (CSPI) had sued KFC Corp. in June because of the company’s inclusion of trans fats in their foods. After KFC’s announcement, the CSPI decided to drop out of the lawsuit.
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By Marc Greilsamer

Suppressed data? Secret informants? Fall guys? Welcome to the pharmaceutical industry, which is filled with enough mystery and intrigue to satisfy even the most demanding crime-drama aficionado. Yet, the issues that come into play in this gigantic, lucrative industry are quite real–and are certainly matters of life or death.

Questions and accusations are swirling around the German drug maker Bayer A.G., their heart-surgery drug, Trasylol (aprotinin), and the risk of potentially fatal side effects. But what distinguishes this case from most run-of-the-mill drug-safety controversies is the fact that Bayer may have withheld, either intentionally or errantly, pertinent information about Trasylol from the U.S. Food and Drug Administration.

On September 21, the FDA held a meeting of their Cardiovascular and Renal Drugs Advisory Committee specifically to discuss the safety of aprotinin injection, which is sold by Bayer under the trade name Trasylol. (Trasylol is used to reduce blood loss, prevent low blood pressure, and limit the need for transfusions in patients undergoing major heart surgery.) The main question at hand at the meeting: Is Trasylol usage associated with elevated risk of renal failure, myocardial infarction, heart failure, or stroke?

Present at that meeting were two Bayer executives: Michael Rozycki, Ph.D., director of U.S. regulatory affairs, and Pamela Cyrus, M.D., vice president of U.S. medical affairs. Joined by two outside professors, the Bayer group made a presentation to the committee that included an overview of the subject, a risk-benefit assessment, a review of clinical data, and a discussion of the methodology of two independent studies published in 2006–one in Transfusion and one in the New England Journal of Medicine–that called into question the safety of Trasylol. They were also asked to provide their own “recent safety and efficacy data” to the committee.
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