Zyxprexa:Eli Lilly's Turn In The "Hot Seat"
Sales are up, Eli Lilly’s share price closed at $59.28 yesterday and its blockbuster anti-psychotic drug Zyprexa® had worldwide sales in excess of $4.0 billion in 2006. So, what is wrong with this picture? Apparently, there are new questions about the accuracy of the safety data that were submitted by Eli Lilly to FDA as part of the Zyprexa new drug application (NDA) in 1996. The FDA has questions about a Lilly document from February 2000 that suggests that patients taking Zyprexa in clinical trials were three and half times as likely to develop high blood sugar (hyperglycemia) than patients who were not taking the drugs. According to FDA, this bit of information was not submitted as part of the Zyprexa NDA. Instead, the company submitted data to the agency that indicated that patients treated with Zyprexa developed high blood sugar at a rate of 3.1% whereas those taking placebo developed hyperglycemia at a rate of 2.5%. Further, there are other documents from Feb. 2000 that indicated that Lilly scientists discussed whether Zyprexa’s label should changed to alert doctors of the risk of hyperglycemia associated with the drug. These documents along with internal e-mail messages contradict public statements that were made by Lilly about Zyprexa’s risks and overall safety.
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Regulatory affairs is one of the hottest and fasting growing career tracks in the pharmaceutical, biotechnology and medical devices industries. The trouble is,there is very little formal training available to prepare individuals for careers in regulatory affairs. Historically, most regulatory affairs professionals honed their skills through on-the-job training. This meant that the only way to pursue a career in regulatory affairs was to first get hired at a pharmaceutical or biotechnology company and then transfer into the regulatory affairs department to learn your craft. Not surprisingly, due to expansive growth of the biotech and medical devices industries, there are ongoing shortages of regulatory affairs professionals, most notably in the area of regulatory writing. In an attempt to deal with these shortages, a number of universities including .jpg)
The Motley Fool on Friday
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As many of you may know, I sometimes moonlight as a medical writer to put food on the table to feed my family. Several graduate students and postdoctoral fellows have approached me at career fairs and asked “How do I become a medical writer?” Until now, I really did not have a good answer to that question (maybe because I do not know how I became a medical writer?). That said, a colleague of mine, .jpg)
The mere mention of the word ‘vaccine” used to cause pharmaceutical executives to shudder and recoil with fear. Aside from Merck, GlaxoSmithKline and Sanofi-Aventis no other pharmaceutical companies wanted to touch vaccines with a “10-foot pole”. This was largely due to liabilities issues surrounding vaccine use and also because vaccines are less financially lucrative than therapeutic products. My, how things have changed in the past five years! 