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Thursday, September 10, 2009

Dual Standard at FDA

Remember SARS?

I do, and back in 2002(2003 and 2004) there was a similar campaign by the FDA to ban any information about natural products useful for respiratory illnesses including the mass marketing of SARS.

Sound familiar? Seems like another mass marketing campaign is underway on the latest version of a created respiratory illness. The same ploy seems to be apparent according to Marc Ullman's article below about Alli and competing products from the natural products industry.

This has been a repetitive behavior for decades now, includes the tryptophan / Prozac war and a few other events.

I happened to have been attacked by the FDA when the SARS controversy was raging. In typical government style due process was absent and the charge of the light brigade was in full force.

How I learned about it was from an article in the Seattle PI where reference was made to the product I offered for flu at that time (and still offer) that may be helpful. The PI staff writer quoted me yet never made any effort to contact me and speak with me directly. I tracked him down and eventually after getting to the top gun managed to get a retraction in the on-line version of the PI.

Not being alone in the number of products attacked by Mark McClellan's goons I created a web page listing the products attacked along with information about them. Most of the data on this page, except for using Echinacea, works well for the current "swine flu" issue. (Echinacea and some other natural products cause too much of a stimulation of your immune system for this created virus compound.)

The other action I took was to contact McClellan, a Harvard grad, and provide him with the clinical data about the product on my web site. This product was studied thoroughly in clinical research at Dana Farber, the well known cancer institute, a part of Harvard. The product was also proven effective.

The only data that FDA allowed to be in the news was about experimental product under development at Roche, and not proven to be effective.

The mind set is that nothing can be used or considered effective against anything unless it comes from Big PhARMA. This of course is one major reason why the mainstream "health"industry is on its self-created collision course.

Now you see another instant replay over liver damaging Alli and a weight loss/diet supplement.

Another word to the wise from Natural Health News...
GSK vs. The Supplement Industry: Who Wins? Written by: Marc Ullman 8/26/2009


FDA receives “32 reports of liver injury including 27 requiring hospitalization” in users of GlaxoSmithKline’s Alli OTC weight loss drug. FDA receives 23 reports of liver injury including one death in users of the dietary supplement Hydroxycut. Guess which one is still on the market.


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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