The Bungling FDA

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http://www.redflagsweekly.com/second_opinion/2002_oct21.html

RFW SECOND OPINION

October 21, 2002

SECOND OPINION

THE BUNGLING FDA

The Agency Seizes Taurine Capsules Sold For Autism And Finally Admits To Its Major Life-Threatening Screw-Up On Anthrax Vaccine

By Regush

The FDA needs to be re-worked from the ground up. The agency is a disaster and there is no end in sight to its steady decline. ly, there are far too many apologists for the FDA - many academic types and weak politicians who don’t like to get too vocal - and not enough strong venom being unleashed about the way this teeter-tottering fool of an organization is going about its business.

Consider the FDA’s latest bungle: the seizure of dietary supplements, namely taurine. At the agency’s request, US Marshals seized hundreds of bottles of Kirkman’s HypoAllergenic Taurine Capsules at Kirkman Laboratories of Lake Oswego, Oregon.

I’m sure this made some of the boffo bigwigs at the FDA think they were actually running an agency that protects the public.

If the FDA thought that these taurine capsules, used by many doctors and parents as part of a dietary approach to autism, were being touted too boldly as a treatment, they could have approached the issue with much less than a big club. The agency might have pressed for some modest change in the Kirkman catalogue that linked taurine to treatment of autism. There was no need to go in and seize a dietary supplement, which, to date, has had no reports of side-effects associated with its use. Taurine is an amino acid and is likely important as an essential ingredient in the diets of autistic children

Consider this piffle: "FDA will continue to pursue products that violate the law…This seizure emphasizes our commitment to protect the public health by keeping the marketplace free from products that make medical claims not substantiated by scientific evidence." That’s FDA Deputy Commissioner Dr. Lester M. Crawford, who obviously needs a lesson in how to prioritize the agency’s business.

Now match that heap of bluster with the FDA’s action, or shall I say, inaction, on the anthrax vaccine. The agency had allowed the U.S. military to inject the vaccine into thousands of service members without it ever having been approved for use against inhalation anthrax. The FDA remained either mute on the subject or it acted as though the military had every right, based on some phantom science and licensing process, to use the anthrax vaccine as it deemed necessary.

So now, after all the years that have gone by with the military illegally injecting soldiers with a suspect vaccine, the FDA has finally admitted, more or less, that older lots of the anthrax vaccine were riskier than once believed. Well, there was evidence from the start in FDA documents and military documents that this vaccine should never have been given to anyone because of bad manufacturing and the lack of appropriate safety and efficacy tests.

Funny how suddenly there is a new product insert for the anthrax vaccine, indicating that it can harm people with immune system problems, can cause a wide range of long-term side-effects and may be responsible for some deaths and birth defects. Many soldiers refused to take the vaccine and were forced out of the military. They had better be given appropriate compensation, maybe starting with a pardon for those who were punished because they understood that they were being forced to submit to a risky product.

What does the FDA stands for? Deceit? Policies such as the illegal support of the military’s obsession with a bad vaccine?

And the FDA makes such a big deal of some taurine caps in a lab in Oregon?