More Drama on Eve of FDA's Review of Avandia, or Where Is Dr. Martin Freed?

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Avandia_gsk.jpg
On the cusp of the FDA's safety review of Avandia, a couple of indeterminately sized bombshells:

One from Dr. Rosemary Johann-Liang, vis-a-vis Business Week. Johann-Liang, a former manager in the FDA's drug-safety office, said by way of a legal deposition that GSK withheld results of a 2001 Avandia study from the agency. The study reportedly showed that Avandia increased the risk of heart attack.

And another from Gardiner Harris of the NYT, who reported on the buried results of a 1999 GSK-sponsored trial that pitted Avandia against its competitor Actos and an older OAD, glyburide. The results, which have evidently been cloistered at GSK for more than 10 years, were "disastrous," Harris wrote, with respect to Avandia's cardiac risks. According to Harris, Dr. Martin I. Freed, who was in charge of Avandia's development at SmithKline Beechem in 2001 (ie, before the Glaxo merger), wrote that "these data should not see the light of day..."

Unfortunately Harris didn't or wasn't able to track down Freed for the doctor's updated perspectivethat is, Harris did not even write something like "Dr. Freed declined to comment" in his NYT report.

According to a 2007 press release from Adnexus Therapeutics (an R&D arm of BMS), Freed was appointed to the newly created role of Chief Medical Officer; however, at the company's web site, Freed is not currently mentioned among the company's current top management.

The 2007 Adnexus press release described Freed's background, including his pharma experience:

Dr. Freed was Vice President of Clinical Development at GlaxoSmithKline. During his tenure he led [the] clinical development of Avandia, a leading drug in the treatment of type 2 diabetes from preclinical to market. Dr. Freed was also involved in the clinical development of drugs across a broad range of therapeutic areas including metabolic diseases, cardiovascular disease and diseases of inflammation, with experiences ranging from Phase 1 through Phase 4 clinical trials. He participated or directed more than 100 clinical and clinical pharmacology studies, involving thousands of patients, for multiple products. Prior to joining Adnexus, Dr. Freed was Chief Medical Officer at a privately-held biotechnology company Vitae Pharmaceuticals, which has programs across a range of therapeutic areas including hypertension, diabetes, cancer and inflammation. A Fellow of the American College of Physicians, Dr. Freed received his Doctor of Medicine from Pennsylvania State University College of Medicine and graduate magna cum laude with a Bachelor of Arts with Distinction in Biology from the University of Delaware. Dr. Freed is Board Certified in Internal Medicine, Nephrology and Clinical Pharmacology. He performed his internal medicine residency and nephrology post-doctoral training at Temple University Hospital and Yale New Haven Hospital, respectively.

Other web-based searches suggest that Freed is now in Wellesley, Mass. It's unclear if the 50-ish doctor is retired or working.

OAD = oral antidiabetic drug. 

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This page contains a single entry by bmartin published on July 13, 2010 9:20 AM.

Harvard Prof Analyzes Avandia Controversy was the previous entry in this blog.

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