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Off-label Drug Marketing: Insidious And Under-Recognized

There’s an important paper in PLoS Medicine, “Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints.” The authors provide this background on off-label marketing:

“An important part of the (drug) approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups in which the drug can be used and the approved doses of the drug.

Physicians can, however, legally use FDA-approved drugs ‘off-label.’ That is, they can prescribe drugs for a different disease, in a different group of patients, or at a different dose to that specified in the drug’s label. However, because drugs’ manufacturers stand to benefit financially from off-label use through increased drugs sales, the FDA prohibits them from directly promoting unapproved uses. The fear is that such marketing would encourage the widespread use of drugs in settings where their efficacy and safety has not been rigorously tested, exposing patients to uncertain benefits and possible adverse effects.”

The authors conclude: Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Medicine Won’t Fix Life

The man who twirled with rose in teeth
Has his tongue tied up in thorns
His once expanded sense of time and
Space all shot and torn
See him wander hat in hand –
“Look at me, I’m so forlorn –
Ask anyone who can recall
It’s horrible to be born!

– Bruce Cockburn, from song “Shipwrecked at the Stable Door”

I found the discussion around my recent post about treating colds very interesting. Sick people come to the office to find out how sick they are. Most people don’t want to be sick, and when they are sick they want doctors to make them better.

Most people.

Some people want to be sick, and some doctors want to make people sick. I am not talking about hypochondriacs — people who worry that they may have disease and become fixated on being sick. I am not talking about malingerers — people who pretend to be sick so they can get medications. I am talking about the slippery slope of defining disease. Read more »

*This blog post was originally published at Musings of a Distractible Mind*

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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