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Is The FDA Too Lenient When Reviewing Medical Devices?

I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.

But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »

*This blog post was originally published at Andrew's Blog*

Stents Break The Bank And FDA Gets Bigger Budget

ACP Internist continues its look at subjects important to internal medicine. Today, we follow the money.

Evidence-based medicine
The U.S. could save one-third of the $15 billion spent on stents annually if all doctors followed COURAGE trial conclusions and used generic drugs first, and stents only if pain persists. William Boden, FACP, headed that trial, and now says that reimbursement drives clinical practice. Dartmouth’s Elliott Fisher, MD, says this “perverse incentive” doesn’t improve health care. (Wall Street Journal, CNN)

Physician reimbursement reform
Following the Food and Drug Administration’s record-breaking budget allocation, seven former agency commissioners and interest groups are still saying it’s not enough to make up for years of underfunding. Even regulated industries want more funding to boost the public perception of product safety. (ACP Internist, Los Angeles Times)

*This blog post was originally published at ACP Internist*

Heart Disease Awareness And The Four Hottest Controversies In Cardiology

heartFebruary is National Heart Disease Awareness Month, and so I invited Dr. Bill Kussmaul to make me aware of some of the hottest controversies in cardiology.  His tips and insights are invaluable to busy primary care physicians looking for the bottom line on thorny issues. Dr. Kussmaul is the Associate Director of the Cardiac Catheterization Laboratory at Hahneman Hospital in Philadelphia and an Associate Editor of the Annals of Internal Medicine. You can listen to our conversation or read my transcript below:

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Controversy #1: Cholesterol and Statin Therapy

Dr. Val: Who should receive high-dose statin therapy? Read more »

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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