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Endocrinologic and Metabolic Drugs Advisory Committee Roster;
http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm096416.htm


Committee Member

Erica H. Brittain, Ph.D.
Expertise: Biostatistics
Term: 05/31/2011 – 06/30/2014
Mathematical Statistician
Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
6700A Rockledge Drive (Room 5132) Bethesda, Maryland 20817



http://www.diabetesincontrol.com/articles/diabetes-news/11242-diabetes-drug-dapagliflozin-rejected-by-fda-panel&action=1&action=1

Diabetes Drug Dapagliflozin Rejected by FDA Panel

A federal advisory committee voted 9 to 6 on July 19 that a first-of-its-kind diabetes drug should not be approved for use because of safety concerns, including a possible increased risk of breast and bladder cancers....

Several committee members said they could have voted either way.

"I changed my mind about four times in the last 10 seconds," said Erica H. Brittain, a statistician at the National Institutes of Health who voted 'no.'
wtf?!?!

About 0.4 percent of women taking the drug got breast cancer, compared with 0.1 percent of the women in the control groups. About 0.3 percent of men getting the drug got bladder cancer, compared with about 0.05 percent of men in the control groups.

The numbers were very small, however, making it hard to draw definitive conclusions. Bristol-Myers and AstraZeneca argued that many of the cancers occurred too soon to have been caused by the drugs. Still, some committee members said the imbalance could not be overlooked. "The breast and bladder cancers, I can't dismiss as being irrelevant or minor," said Dr. Doris B. Strader of the University of Vermont.

FDA Rejects Dapagliflozin for Type 2 Diabetes - MedPage Today
www.medpagetoday.com/Endocrinology/Diabetes/30747?
Jan 19, 2012 - WASHINGTON -- The FDA said it would not approve the novel diabetes drug dapagliflozin until drugmakers Bristol-Myers Squibb and ...

FDA Accepts NDA Resubmission of Diabetes Drug Dapagliflozin
www.medscape.com/viewarticle/808480?
Jul 26, 2013 - If eventually approved in the United States, dapagliflozin will not be the first SGLT -2 inhibitor on the market. Earlier this year, the FDA cleared ...