March 17th, 2011 by Felasfa Wodajo, M.D. in News
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The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.
What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.
According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10: Read more »
*This blog post was originally published at iMedicalApps*
March 15th, 2011 by Elaine Schattner, M.D. in Opinion, Research
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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*
March 11th, 2011 by Peggy Polaneczky, M.D. in Better Health Network, Opinion
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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.
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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*
February 24th, 2011 by Harriet Hall, M.D. in Health Tips, Research
1 Comment »
I was surprised to get this e-mail from a reader:
Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.
My co-bloggers and I have addressed these issues repeatedly.Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again — and maybe by writing this post I can make it easier for new readers to find the information.
Food, Medicine, or Something In Between?
The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.
Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).
So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1,000 times the intended amount.
The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality. Read more »
*This blog post was originally published at Science-Based Medicine*
February 22nd, 2011 by PJSkerrett in Opinion, Research
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Media channels are a-twitter with the news that zinc can beat the common cold. CBS News, the LA Times, the Huffington Post, and hundreds of others are treating a quiet research report as big news that will have a life-changing effect. After reading the report and doing a little digging into the dark side of zinc, I’m not rushing out to stock up on zinc lozenges or syrup.
The latest hubbub about zinc was sparked by a report from the Cochrane Collaboration. This global network of scientists, patients, and others evaluates the evidence on hundreds of different treatments. In the latest review, on zinc for the common cold, researchers Meenu Singh and Rashmi R. Das pooled the results of 13 studies that tested zinc for treating colds. By their analysis, taking zinc within 24 hours of first noticing the signs of a cold could shorten the cold by one day. They also found that taking zinc made colds a bit less severe.
Sounds good so far. But instead of saying, “Hey, take zinc if you have a cold,” the researchers concluded like this:
“People taking zinc lozenges (not syrup or tablet form) are more likely to experience adverse events, including bad taste and nausea. As there are no studies in participants in whom common cold symptoms might be troublesome (for example, those with underlying chronic illness, immunodeficiency, asthma, etc.), the use of zinc currently cannot be recommended for them. Given the variability in the populations studied (no studies from low- or middle-income countries), dose, formulation and duration of zinc used in the included studies, more research is needed to address these variabilities and determine the optimal duration of treatment as well as the dosage and formulations of zinc that will produce clinical benefits without increasing adverse effects [bold is mine], before making a general recommendation for zinc in treatment of the common cold.”
Not exactly a ringing endorsement. Read more »
*This blog post was originally published at Harvard Health Blog*
