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Latest Posts

Required MRI Screenings Following Breast Implants: Unnecessary?

It’s amazing what you will find sorting through more than 20 years of stuff.  This picture of 3 implants includes:  top — an old McGhan double lumen (silicone gel implant surrounded by a saline implant); bottom left – Dow Corning textured silicone implant; and bottom right – Dow Corning smooth silicone implant.  Dow Corning has not made breast implants since approximately 1992.

Last week the FDA met to discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants.  As a condition of placing silicone implants back on the market in 2006, both Mentor and Allergan (McGhan) were supposed to enroll patients in 10-year-long follow up studies on side effects related to implants.  The aim was for 80,000 women.

I agree these studies are needed, but it is difficult to get women to return year after year.  This is evident in the data presented at the meeting: Read more »

*This blog post was originally published at Suture for a Living*

Red Tape Alert: New FDA Rule Puts Allergan In A Double Bind

I was reading my daily MedPage Today news, when I came across this amusing example of regulatory unintended consequences. As we all know, pharmaceutical companies are not allowed to promote off-label uses of their medications – doing so is punishable with billions of dollars in fines (just ask Pfizer). But a new set of rules created by the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program essentially requires Allergan to provide safety information about off-label uses of the drug — uses that are illegal for them to discuss.

So Allergan has to file a law suit to resolve the issue of being required (by the government) to do something the government considers criminal.

And the winner is?

Lawyers!

Latest Interviews

The Surprising Economic Burden Of ADHD (Attention-Deficit Hyperactivity Disorder)

If you can read this you need to download a more recent browser It is estimated that as many as million U.S. adults have ADHD Attention-Deficit Hyperactivity Disorder A recent research study publication-pending suggests that the economic burden of ADHD on America could be as high as billion annually. I…

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Is The Adderall Shortage A Harbinger Of Future Drug Supply Problems?

If you can read this you need to download a more recent browser Today most- if not all- Doctor’s offices are strained by the shortage of some prescription medication or vaccine. A month ago President Obama signed his executive order directing the FDA to take steps to reduce drug shortages…

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Latest Cartoon

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Latest Book Reviews

Book Review: The First Step To Improve Health Care Is A Close Examination Of How It’s Delivered

My friend and former Chair of the CFAH Board of Trustees Doug Kamerow has written a book that I think you will like. Besides being a mensch and witty as heck Doug is a family doctor and a preventive medicine specialist. In his new book Dissecting American Health Care Commentaries…

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“Your Medical Mind” Explores Factors That Influence A Patient’s Medical Decisions

Recently I had a conversation with Shannon Brownlee the widely respected science journalist and acting director of the Health Policy Program at the New America Foundation about whether men should continue to have access to the PSA test for prostate cancer screening despite the overwhelming evidence that it extends few…

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Book Review: Food Truths, Food Lies

Food Truths Food Lies written by family physician Eric Marcotte M.D. may be the most refreshingly evidence-based diet book of the decade. You will not find a single mention of super-foods magical berries or supplement must-haves in the entire book. What you will find is the cold hard truth about…

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