THE BUNGLING FDA

[Guest guest]

SOURCE: http://www.redflagsweekly.com/second_opinion/2002_oct21P.html

 

October 21, 2002

 

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 Nicholas 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. Frankly, 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?