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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

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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