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For Patients, Does The FDA Play Fair?

They have a tough job, those government doctors, scientists, and bureaucrats who are charged with assessing the safety and effectiveness of proposed new medical products. As you know, they rely largely on studies presented by the applicants.

The Food and Drug Administration (FDA) has the power to not approve a new drug or product or even pull it off the market. Right now it is considering limiting or pulling GlaxoSmithKline’s (GSK) diabetes drug, Avandia, because of newly discovered data that it may have caused heart attack in some patients –- data mysteriously not shown in GSK’s own studies. If the drug is pulled it will cost GSK billions of dollars in lost revenue but, from the FDA’s point-of-view, it will be protecting the public. And, after all, there are safer diabetes drugs on the market as alternatives. Read more »

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

7 Under-The-Radar Healthcare Changes

Kaiser Health News proves its value once again with an under-the-radar story covering some items you won’t see in many other news sources. An excerpt:

“…several lesser-known provisions also take effect in coming months that could have a lasting impact on the nation’s health care system.

These provisions include eliminating patients’ co-payments for certain preventive services such as mammograms, giving the government more power to review health insurers’ premium increases and allowing states to expand Medicaid coverage to low-income adults without children.

While these changes might not have gotten at lot of attention, they could help build support for the law in the run-up to the contentious mid-term elections.”

Their list:

• Prevention For Less
• Knowing Which Treatments Work Best
• Helping Cover Early Retirees’ Health Costs
• Keeping Tabs on Health Insurance Premiums
• Expanded Medicaid Coverage
• Care Coordination for ‘Dual Eligibles’
• FDA Approval For ‘Follow-On Biologics’

Read the full story at the link above for details.

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

Herbal Remedy For UTI? If You’re A Lab Rat, Maybe

Lab ratA patient came into the office the other day carrying a small clipping from a reputable women’s health newsletter touting new research on an herbal remedy for urinary tract infection. Having recurrent bladder infections, my patient naturally was wondering if this was something she should try.

The article was entitled “Herbal Remedy Effective for Urinary Tract Infections” and began with this startling revelation:

The common herbal extract forskolin can greatly reduce urinary tract infections and could potentially help antibiotics kill the bacteria that cause most bladder infections. 

But the article advised that the “popular” remedy was not FDA approved for this indication, so you should “ask your doctor.” Read more »

*This blog post was originally published at The Blog that Ate Manhattan*

Flibanserin: Another Pre-FDA Approval Drug Hype

Money-happy pillThis week the FDA will vote on flibanserin, the much-talked-about drug for women with the condition called hypoactive sexual desire disorder or — because everything in sexual health needs an acronym like ED or PE — HSDD.

On the eve of the FDA vote, CBS last week ran still another story about flibanserin. This drug has received so much news coverage, you’d think it cures cancer.

And CBS did little more than promote the hype even more, saying FDA approval “could translate into a $2 billion market in this country alone” and then failing to challenge the disease-mongering estimate of “10 percent to 30 percent of women” with this condition. It all just goes along with the drug company’s efforts to build a demand before the drug is even approved. Read more »

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

Nutrition And The Government: Donuts For Freedom

An interesting press release from the Competitive Enterprise Institute recently came across our desk and is reproduced in full below. I’m curious what our readers think of it, and of the government’s role in nutritional issues, given the link between nutrition and health:

Institute Calls for Civil Disobedience on National Donut Day

As Government Meddling in Nutritional Issues Mounts, CEI Advises, “Eat Two Donuts Today—One for Yourself, and One for Your Freedom”

Washington, D.C., June 4, 2010 — The Competitive Enterprise Institute today urged Americans to turn National Donut Day into a day of protest against growing government intrusion into nutritional issues. CEI urged people to eat two donuts — “one for yourself, and one as an act of patriotic civil disobedience.” Read more »

*This blog post was originally published at ACP Hospitalist*

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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