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Current Blogs
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Aug
26
Written by:
Marc Ullman
8/26/2009 3:34 PM
On May 1, 2009 FDA issued an urgent alert warning consumers “to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario.” According to the Agency’s press release, it had received 23 reports of serious health problems, including one death, that appeared to be associated with the use of the dietary supplement. At the same time, Iovate issued a “voluntary recall” of 64 different Hydroxycut products, covering, according to some news reports over 9 million product units.
On June 6 and June 18, 2009 FDA updated its list of drug products it was monitoring for “potential signals of serious risks” indicating that the Agency was reviewing the status of GSK’s Alli (orlistat) OTC weight loss drug and was “continuing to evaluate this issue to determine the need for any regulatory action” Alli was, however, allowed to remain on the market. On August 24, 2009 FDA issued an “Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat” stating that the “Review includes both prescription drug Xenical and OTC drug Alli”. The “communication” stated that “FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.” Despite this, the Agency advised that “consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”
Just in case you’re still wondering who wins as between the supplement industry and GSK, consider the following:
● In April 2004 FDA banned the sale of ephedra containing dietary supplements based upon the Agency’s conclusion that such products constituted an unreasonable risk to public health. As part of the basis for its action FDA cited a 2003 Rand Corporation study that concluded, in part, “Over the short term (four to six months), ephedrine, ephedrine plus caffeine, and supplements containing ephedra or ephedra plus caffeine promoted modest increases in weight loss, about 2 pounds per month more than the weight loss of persons taking the placebo.” This level of weight loss was found to offer no benefit to public health.
● On February 7, 2007 FDA approved the sale of Alli as an OTC weight loss remedy. The Agency took this action despite reports of severe side effects including “incontinence” (uncontrollable diarrhea) and “oily spotting” (anal leakage). Among the factors cited by FDA in support of its decision was evidence that Alli users lost 5-10 pounds over 6 months, about a 50% increase compared with diet and exercise alone. Unless FDA uses some kind of “new math” that I have yet to hear of, this amounts to slightly less than the 2 pounds a month it found insignificant for ephedra.
9 million units of recalled Hydroxycut and one ban of ephedra later, it seems that as between the supplement industry and GSK there is little doubt who wins at FDA.
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4 comment(s) so far...
Re: GSK vs. The Supplement Industry: Who Wins?
Marc,
Once again your incisive mind cuts through the clutter around this issue and illuminates the ridiculous inequity we are confronting...AGAIN!
Even if we could (and we never should) put aside the expectation of equitable treatment under the law (or warped interpretation there-of by the regulatory authority), even if we set aside the fact the despite the unlevel playing field, GSK supported the creation of a citizen petition (since when is a corporation a citizen) with the expressed goal of banning the sale of their competitions products, what is inexcusable is that so-called members of our industry have cuddled up to GSK and given them a seat at the table. This is truly a manifestation of the Helsinki syndrome where the abused celebrates and protects the inflictor of injury. It is deeply concerning to me that our industry has not vociferously engaged this issue.
But then again - this industry has had us all deeply concerned for the past twenty years...
By Kenn Israel on
8/29/2009 12:59 PM
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Re: GSK vs. The Supplement Industry: Who Wins?
Clear guidelines for review of dietary supplement efficacy via controlled clinical trials and the review of safety via adverse event reporting are lacking. Even the FTC guidelines for what is construed as acceptable quality data for evidence of efficacy of supplements are only vague with only a fleeting mention of biostatistical significance and good conduct. Hence, the FDA will continue to use pharmaceutical standards to assess dietary supplements when there is an issue of safety and efficacy.
I don't know enough about this issue but I assume that GSK's adverse event reporting system for their drug (OTC and ethical) is more robust compared to Iovate's system which is probably still evolving. Also Marc has not mentioned about sample size and p values of the efficacy outcomes of the Hydroxycut and Olli trials. Hence its difficult to comment which is a better product. What may appear as FDA bias against the supplement industry may actually only be application of scientific and statistical principles of judgement. Sure the FDA is made of humans who are also prone to bias and are clearly not "blinded" to the product and the data when they sit in judgement!
I think that the root cause is that we don't have a set of clear guidelines designed by FDA for evaluating dietary supplements in the market. Till such time as better guidances evolve for specifically this industry, we will have to raise the bar of our own science to meet pharmaceutical methods of evaluation of products for safety and efficacy. I'm NOT recommending larger, costlier trials like Phase III, but smaller yet more scientific designs and GCP conduct, followed by Large Simple Trials (LST), which are cheaper, more practical and conclusive.
By Jayesh Chaudhary on
9/7/2009 8:33 PM
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Re: GSK vs. The Supplement Industry: Who Wins?
Jayesh,
The issue here is not the size or quality of clinical trials designed to support claims. Rather the issue is one of inequal treatment. When it comes to a dietary supplement, ~25 potentially serious adverse event reports is sufficient to force the recall of millions of product untis. For GSK's Alli (with all of its well-documented health related side effects) that same number warrants "further investigation". For ephedra-containing dietary supplements, weight loss of 2 pounds a month is considered to provide no public health benefit. For Alli, it is considered significant enought to warrant approval oa an OTC switch-over.
By Marc Ullman on
9/7/2009 8:37 PM
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Re: GSK vs. The Supplement Industry: Who Wins?
Remember the banning of Ephedra? I went to the FDA website as soon as I could and also found a cough syrup that was killing children. But the cough syrup was allowed to stay on the market because it was "safe when used as directed". If ephedra supplements had been taken as directed they would be safe too ( but the old, overweight pitcher needed to lose weight fast to make the team....). This is old news, but still obviously easier on Pharma. That's what happens when your competitor (FDA/Pharma) is your regulator.
Now if you really want to get excited pay attention to the even more sly front on this war, contraindication. Our industry is in danger of being contraindicated out of existence (think St. Johns Wort here). For example I still think anthraquinones are the antibacterial in Aloe, but now they are being removed because they are "sensitizers". No, they are one of the actives by my observation, but now aloe products wont be as effective.... And any natural remedy that competes with a pharma product will "interact" with the treatment, again a contraindication. I hope I am wrong.
By Steve Baugh on
11/16/2009 9:28 PM
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