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FDA Takes Step To Preserve The Effectiveness Of Cephalosporin Drugs For Treating Disease In Humans

Image by the USDA Agricultural Research Service

Cephalosporins will be used in livestock only for very specific exceptions, after years of debate about the role of antibiotic resistance in farming and how it leads to new strains of microbes with the potential to shift into humans.

The FDA took this step to preserve the effectiveness of cephalosporin drugs for treating disease in humans, the agency announced in a press release.

In 2008, the FDA issued and then revoked an order that prohibited cephalosporins in food-producing animals with no exceptions. Three years later, the agency’s ban includes several exceptions:
–It doesn’t limit cephapirin, which the FDA doesn’t think contributes to antimicrobial resistance;
–Veterinarians will still be able to Read more »

*This blog post was originally published at ACP Internist*

FDA Sends Warning Letters To California Surgical Centers For Misleading Advertising Of The Lap-Band

The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.


We have blogged on 1-800-Get-Thin and Lap-band surgery in general before. Read more »

*This blog post was originally published at Truth in Cosmetic Surgery*

Hand-Held Device To Aid In The Detection Of Intracranial Hematomas: Ready For Prime Time?

I read this headline and said, “Wow!, finally I won’t need to CT all those patients’ heads!”

FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

Helps to determine if immediate CT scan is needed

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

via Press Announcements > FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull.

But then, wait, said I, is it any good? Read more »

*This blog post was originally published at GruntDoc*

Antidepressants To Treat Dementia: How Can They Help?

“Wow, Celexa?”

“Yeah, who knew?”

I overheard this conversation in the ladies’ room immediately after a session speaker advised treating agitation and aggression in dementia with citalopram. Indeed, there was a bit of a murmur in the audience when Dr. Aleta Borrud made the suggestion during her talk at the Mayo Update in Hospital Medicine 2011 course.

Part of the reason for the reaction may be– as a physician I spoke with noted– that Read more »

*This blog post was originally published at ACP Hospitalist*

Can The Approval Process For Cancer Drugs Be Accelerated?

If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr. Rick Pazdur, the FDA leader for oncology drug approval. Some desperate patients and family members have referred to him as “Dr. No.”

Just the other day I interviewed a respected breast cancer survivor and patient advocate who has high respect for Dr. Pazdur.  Musa Mayer of New York City is a 22-year breast cancer survivor and author of three books about breast cancer. She’s devoted her life to educating other patients about cancer and also playing a role in public policy. She has become a favorite patient representative on FDA cancer advisory boards and regularly weighs in when breast cancer drugs are being considered.

In my interview with Musa, she explained Read more »

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

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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