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FDA Announces Regulations Regarding Medical Mobile Apps

FDA has published an announcement about regulations regarding medical mobile applications.

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, Read more »

*This blog post was originally published at ScienceRoll*

Can Pharmacogenomic Tests Help To Improve Public Health?

Adverse drug events are a serious public health problem. Consider the following facts:

  • an estimated 82% of American adults take at least one medication and 29% take five or more;
  • 700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually;
  • $3.5 billion is spent on extra medical costs of adverse drug events annually;
  • at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented.

How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended applications of pharmacogenomics research include identifying responders and non-responders to medications, avoiding adverse events, optimizing drug dose and avoiding unnecessary healthcare costs.  The Food and Drug Administration has added pharmacogenomic information to the labeling for more than 70 drugs. Labels may include information on genetic determinants of clinical response or risk for adverse events.

In spite of current enthusiasm about pharmacogenomics in the research community, Read more »

*This blog post was originally published at Genomics and Health Impact Blog*

How Effective Are Antidepressants?

Antidepressant drugs have been getting a bad rap in the media. I’ll just give 3 examples:

  • On the Today show, prominent medical expert :-) Tom Cruise told us Brooke Shields shouldn’t have taken these drugs for her postpartum depression.
  • In Natural News, “Health Ranger” Mike Adams accused pharmaceutical companies and the FDA of covering up negative information about antidepressants, saying it would be considered criminal activity in any other industry.
  • And an article in Newsweek said  “Studies suggest that the popular drugs are no more effective than a placebo. In fact, they may be worse.”

Yet psychiatrists are convinced that antidepressants work and are still routinely prescribing them for their patients. Is it all a Big Pharma plot? Who ya gonna believe? Inquiring minds want to know:

  • Are antidepressants more effective than placebo?
  • Has the efficacy of antidepressants been exaggerated?
  • Is psychotherapy a better treatment choice?

The science-based answers to the first two questions are Read more »

*This blog post was originally published at Science-Based Medicine*

A New Treatment For Lupus

Lupus, an autoimmune disease, [recently] turned up on the front page of the Wall Street Journal (WSJ). It cropped up, also, on the first page of the New York Times business section, and elsewhere. Scientific American published a nice online review just now. The reason is that the FDA has approved a new monoclonal antibody for treatment of this condition.

The drug belimumab (Benlysta), targets a molecule called BlyS (B-lymphocyte Stimulator). The newspapers uniformly emphasize that this drug marks some sort of triumph for Human Genome Sciences, a biotech company that first reported on BlyS in the journal Science way back in 1999. BlyS triggers B cells to produce antibodies that in patients with lupus tend to bind and destroy their own cells’ needed machinery, causing various joint, lung, liver, kidney, brain, blood vessel and other sometimes life-threatening problems. So if and when Benlysta works, it probably does so by blocking aberrant autoimmune B-cell activity.

The newspapers don’t give a lot of details on the drug’s effectiveness, except that it appears to help roughly one in 11 patients, and the main benefit may be that some lupus patients on Benlysta can reduce their use of steroids, which have long-term and toxic effects on many organs. The most recent major medical publication on a trial on the drug came out in the Lancet two weeks ago.

Some reported caveats are that the drug has not been adequately tested or approved for patients with severe kidney or neurological manifestations of the disease, and that its activity, marginal as it is, appears to be less in patients of African heritage based on trials completed thus far. Additional trials are in the works.

The drug is expensive, to the updated tune of $35,000 per year. According to the WSJ: “Estimates of how many Americans are affected range from 161,000 to 1.5 million.” (How’s that for a wide ballpark figure? Likely a function of how hard it is to define and establish diagnosis for this disease, which anticipates how hard it will be to measure this drug’s effects — see below.) The same WSJ piece says analysts expect the drug to become a blockbuster, with annual sales eventually topping $1 billion. Read more »

*This blog post was originally published at Medical Lessons*

Bad Medical Marketing: An Ad The FDA Should Pull

If ever a medical device company crossed a line with their marketing, this one has. Essure, which makes a sterilization device for women, is trying to scare men away from vasectomy in order to drive women to use their device.

“We made men watch footage of an actual vasectomy,” says the female voiceover — and then they proceed to show men’s reactions to watching a surgical procedure, with “That’s frickin’ gross, man” being the most memorable quote. The final tagline: “You can only wait so long for him to man up.” Yeah, and to be sure he doesn’t, they’ve created this ad.

The ad is slimy, harmful, obnoxious, and just plain stupid. A couple’s decision as to which sterilization procedure is best for them should be one informed by real information, not frat-boy marketing.

How dare they? The FDA should pull this ad — now.

**********

Addendum: I just emailed the FDA at BadAd@fda.hhs.gov. Feel free to copy my message below and send your own email:

To the FDA,

I find this ad for Essure both inflammatory and unethical. I am incensed at the impact this ad could have on couples’ informed choices about sterilization. I ask that you mandate that the company who makes Essure immediately pull this ad, both from the Web and from any media outlet where it’s playing.

Thank you for your attention to this matter.

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

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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