Avandia, the Duke Clinical Research Institute and conflict of interest

The  debate over potential bias at the Duke Clinical Research Institute emerging fro  this morning's Avandia hearing inspired a trip to the archives. This story looked at many of the same issues, which came up when  the Duke clinical trials operation was young. By Tinker Ready from The Raleigh News & Observer Genentech and university … Continue reading Avandia, the Duke Clinical Research Institute and conflict of interest

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Is Avandia safe? FDA to consider restrictions on the diabetes drug, local docs in the fray

Dr. Clifford J. Rosen, director of clinical and translational medicine at the Maine Medical Center in Portland,  led the advisory committee that on 2010 set strict limits on the use of the  diabetes drug Avandia after it was linked to  heart problems. The New York Times reported on Sunday on the FDA's  meeting this week, where … Continue reading Is Avandia safe? FDA to consider restrictions on the diabetes drug, local docs in the fray

UCSF v. Beth Israel on FDA on heart device safety

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators. The study was release earlier to counter a similar study in the Journal of … Continue reading UCSF v. Beth Israel on FDA on heart device safety

FDA doc takes heat for strict standards on new cancer drugs

 I had a long wait for the Red Line and a gratis NY Times from the BU Comm school. So, I read this piece about the FDA doc who is trying to protect patients from marginally useful cancer drugs. Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug office "has helped to … Continue reading FDA doc takes heat for strict standards on new cancer drugs

What patients should know about marketing of meds: May 14 MIT event

FROM MIT: Many of us take daily medications for conditions such as high cholesterol or hypertension, but in the face of constant advertising of prescription medications, it’s easy to wonder: is there something newer and better I should be taking? Physician panelists at “Ask Your Doctor"... Medications, Marketing and Safety on May 14 will share … Continue reading What patients should know about marketing of meds: May 14 MIT event

Marcia Angell on the FDA

Former NEJM editor and pharma critic Marcia Angell offers her advice on reforming the FDA on today's Globe op-ed page.  It is time to restore the FDA to its purpose, which is to protect the public from unsafe food, drugs, and devices, not to accommodate the industries it regulates. The change in leadership is reason … Continue reading Marcia Angell on the FDA

Can the Watchmen save Boston doctors from conflicts of interest?

Health Wonk Review is a "roving digest" of notable blogs entries about health policy.  This week, Medicaid Front Page hosts, with an entry that would make my comics-reading son happy - The "Watchmen Edition." Each entry is linked to one of the superheroes in this movie, which is opens today. (My contribution  earned Dr. Jim Kim a Nite … Continue reading Can the Watchmen save Boston doctors from conflicts of interest?