July 8th, 2011 by DrWes in Health Policy, Opinion
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It was another headline busting study this week: Pfizer Drug Tied to Heart Risks – a provocative title no doubt fed to the media from the publisher: the Canadian Medical Association Journal. The study was yet another meta-analysis that culled the world’s literature in an attempt to determine if a trend could be found that might implicate Chantix as a causative agent for and increased incidence of heart disease in smokers.
On its surface, the study sounds authoratative, analyzing “14-double-blind randomized controlled trials involving 8216 participants” ranging in duration from “7 to 52 weeks.”
Never mind that 57% (25) of adverse events were weighted from one study and that none of the 14 studies had odds ratios that did not cross the unity line.
Despite this, the lead author concluded:
Despite the limitations of our analysis, our findings have potential regulatory and clinical implications.
Sorry, this is not correct. There are no clinical implications of this trial. Like all metanalyses, meta-anaylses simply cannot determine cause and effect. (Note to main stream media: are you folks listening?!?)
That being said, there’s another concern I have Read more »
*This blog post was originally published at Dr. Wes*
July 5th, 2011 by David H. Gorski, M.D., Ph.D. in Health Policy, Opinion, Quackery Exposed
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The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.
Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, Read more »
*This blog post was originally published at Science-Based Medicine*
July 3rd, 2011 by Jeffrey Benabio, M.D. in Health Tips
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Life is really simple, but we insist on making it complicated. -Confucius
This is certainly true of sunscreens. “Broad spectrum, UVA, UVB, avobenzone, oxybenzone, parsol, sensitive skin, titanium dioxide, SPF 15, 30, 45, 50, 55, 60, 70, 75, 100, 100+, waterproof, sweatproof, spray, cream, lotion, antioxidant…”
We spend about $700 million in sunscreens every year, and many people don’t have a clue as to what’s good or bad, or a waste of money. The Food and Drug Administration has been meaning to help you out with this problem for a while now. Actually for over 30 years (who says nothing gets done in government?). The F.D.A. has made a final decision on sunscreen labels. They’ve sought to make labels simple and accurate to help you choose the right one:
1. The sunscreen must protect against both UVA and UVB rays; that is, it must be broad spectrum.
2. To be labelled as “protecting against skin cancer,” the sunscreen must be an SPF of at least 15. The labels will likely be capped at SPF 50 because SPFs greater than 50 seem to be of little additional benefit.
3. Sunscreens can no longer be labelled as “waterproof” or “sweat proof,” as neither is physically possible, therefore, rendering the claim “misleading.” Sunscreens will be labelled as effective in water for 40 minutes or 80 minutes which is accurate and much more useful.
This simple system should help consumers make better choices, but some say the F.D.A. didn’t go far enough. They did not comment on the safety of various sunscreen ingredients. They have also not loosened up enough to allow for other sunscreens that are widely used in Europe to be sold here in the U.S.
Do you think the F.D.A was too strict or didn’t go far enough?
Photo: Wandering Magpie, Flickr
*This blog post was originally published at The Dermatology Blog*
June 25th, 2011 by AnnMacDonald in Health Tips, Research
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On Saturday, while thousands of Boston Bruins fans gathered at Government Center to celebrate the team’s recent Stanley Cup victory, a hundred or so true die-hards met a few blocks away at a Massachusetts General Hospital conference to talk about complementary and alternative medicine for psychiatric disorders. While I hated to miss the Bruins parade, I’m glad I attended the MGH conference.
I’ve always been a bit of a skeptic about so-called natural therapies for one simple reason: they don’t have to go through the same rigorous testing in clinical trials that medications do. At the same time, I realize that FDA-approved drugs don’t work for everyone. One in three adults with major depression, for example, can’t completely improve their mood and other symptoms even after trying multiple antidepressants.
Clearly, we need better options for treating mental health disorders. The MGH conference convinced me that some types of complementary and alternative medicine—or CAM, for short—might be worth trying. The presenters, all psychiatrists who treat patients at MGH, backed up their recommendations with scientific evidence. Several of them also contributed to the American Psychiatric Association’s recent report on CAM therapies.
We’ll be doing a story on CAM therapies for psychiatric disorders in an upcoming issue of the Harvard Mental Health Letter. For now, here are some things I learned on Saturday: Read more »
*This blog post was originally published at Harvard Health Blog*
June 16th, 2011 by RamonaBatesMD in Health Tips
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Yesterday, the U.S. Food and Drug Administration released the new rules regarding labeling of sunscreen. The goal is to make it easier for the average person to chose a sunscreen.
The new labels will not be in place until next summer, so you need to be aware.
When the new labels are in place, NO sunscreen will be allowed to be labeled as a SUNBLOCK or as WATERPROOF.
Under the new labeling rules
- Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test.
- Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.
- A warning statement will be required on any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14 stating that the product has not been shown to help prevent skin cancer or early skin aging.
In addition to the final rule for sunscreen labeling, the FDA released a Proposed Rule which would Read more »
*This blog post was originally published at Suture for a Living*
