December 8th, 2011 by Jann Bellamy in Health Policy, Opinion, Quackery Exposed
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In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)
Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.
Limit CAM? Not happening
Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products Read more »
*This blog post was originally published at Science-Based Medicine*
August 13th, 2011 by David Kroll, Ph.D. in Health Policy, Opinion
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A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
June 29th, 2011 by Mark Crislip, M.D. in Health Tips, Research
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At home the kids’ current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.
Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.
My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other. Read more »
*This blog post was originally published at Science-Based Medicine*
June 15th, 2011 by RyanDuBosar in News
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Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.
Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.
Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psychiatry (n=116), and rheumatology (n=111).
Drugs approved during the 1980s and 1990s had the highest overall number of adverse drug events, while newer medications had significantly more labeled adverse drug events than older medications.
“The findings aren’t unexpected,” wrote Dr. Duke and colleagues in the Archives of Internal Medicine. Newer drugs face more rigorous clinical trials and postmarketing surveillance than older medications. More commonly prescribed drugs are more likely to generate more reports of adverse events. The high volume of events in neuropsychiatric medications “may relate as much to patient population as to the effects of the drugs themselves.”
But, Dr. Duke and colleagues concluded, “The presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”
While the Food and Drug Administration tried to revamp warning labels in 2006, labels have grown more complex since then. “This finding underscores the tremendous challenge faced by the FDA in reversing the long-standing trend toward overwarning.”
*This blog post was originally published at ACP Internist*
June 11th, 2011 by John Di Saia, M.D. in Health Policy, News
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TRENTON — Minors in New Jersey wouldn’t be able to get Botox injections unless a doctor says it’s medically necessary and documents the reason, under a bill moving through the Assembly. The Assembly Health and Senior Services Committee approved legislation Thursday to clamp down on doctors injecting people under 18 with botulinum toxin for cosmetic purposes. The Federal Drug Administration already bars anyone under 18 from getting Botox for cosmetic reasons. The new state legislation would go further by requiring doctors to document in a patient’s chart the noncosmetic medical reason for performing the procedure on a minor. Botox is used widely to smooth out facial wrinkles, but also can be used to treat headaches and spasms.
Source: app.com/article/20110520/NJNEWS10/305200023/Botox-regulations-minors-pass-NJ-committee
?odyssey=mod_sectionstories
This prospective law in New Jersey would make Botox injections illegal in minors without a doctor’s statement that it is medically necessary. Unfortunately this is not to say such a law would have the desired effect. There are docs who will write those “permit slips.” Watch how many of these Botox-using minors get headaches.
I am not really a fan of laws restricting the flow of medicines. I do not believe they work well. Then again Read more »
*This blog post was originally published at Truth in Cosmetic Surgery*
