Friday, October 19, 2002

FDA Deputy Commissioner Lester M. Crawford

If you really want to provoke the ire of the parents of the Number One Children's disability in the United States, autism, then you will continue with your misguided efforts to raid Kirkman Labs in Lake Oswego, Oregon. Personally, I view your "raid" of taurine from Kirkman Labs as harrassment to the one company who has supported the autistic community for over 20 years, when no one else paid any attention to our injured children's health needs. I think the fact that the FDA conducted this seizure is sinister, given the fact that many parents are using supplements on their children in response to noticeable and dramatic improvements after adverse vaccine reactions, whose safety is the responsibility of the FDA.

Why are you raiding supplement labs that help little autistic children regain function and immune system support? My son has personally benefitted from Taurine - I've seen it with my own two eyes, as have thousands and thousands of parents with late-onset autism across the country. What you really should be doing is studying why taurine is effective with children with late-onset autism. Perhaps taurine is effective because some children have been vaccine injured and it supports their immune system? I believe so.

The FDA itself in the 90's reported that no serious side effects were seen in any of 442 research studies in which human subjects were given single amino acids such as taurine. Why deprive autistic children of a nutrient often found helpful to them, when there is no evidence whatever of possible harm?

Secondly, when there are well over 100,000 deaths per year in the US from FDA approved prescription drugs, and immense damage done to children given FDA approved vaccines, why is the FDA expending precious resources seizing safe, nutritional supplements intended to help the very children harmed by these vaccines?

The more interesting question is why there were no seizures of thimerosal-laden vaccine lots after the FDA/CDC/USPHS/AAP joint announcement in July 1999 identifying the potential mercury exposure from the product. If anything should have been yanked from shelves at doctors' offices, clinics and pharmacies, that should have been

I intend to contact every media agency in our state and nationally to have your actions discussed in a public format for scientific response. I am also going to make it my personal business to contact every Senator and/or Congressman and ask them to hold you accountable.

Tory Mead

PUBLIC HEALTH

FDA Seizes 'Autism' Supplements from Kirkman Labs

FDA's Senior Veternarian Lester Crawford Sics US Marshalls on popular

supplier

[Reuters and the NY Times provides the bulk of the informaton for the

following report.]

The US Food and Drug Administration said on Thursday it had ordered

the seizure of hundreds of bottles of a dietary supplement that the agency

said falsely claimed to treat autism.

US marshals raided Humphrey Laboratories of Lake Oswego, Oregon, doing

business as Kirkman Laboratories, and took away bottles of Kirkman's

HypoAllergenic Taurine Capsules, the agency said.

"FDA seized these products because they violate the Federal Food, Drug

and Cosmetic Act," the agency said in a statement. "In accordance with the

Act, all dietary supplement products' labeling must be truthful and not

misleading and may not make any claims that the product will cure, mitigate,

treat, or prevent disease."

The FDA did admit in their statement that "to date no illnesses have

been reported in association with consumption of this product." The FDA

actions are apparently not in response to consumer complaints.

FDA will continue to identify and take appropriate enforcement actions

against fraudulently marketed dietary supplement products that make

unsubstantiated medical claims in their labeling.

"Consequently, the claims that the capsules treat autism caused the

firm's product to be a misbranded food and an unapproved new drug."

Apparently, the offending assertion comes from a description of

Taurine in Kirkman's catalogue that includes the following: "Dr. Jeff

Bradstreet, a physician in Palm Bay, Florida who treats autistic patients

reports good success in treating autism with Taurine."

The FDA said it tracked down the company from its Internet site.

In a reprint of an article that appeared in this newsletter just last

Tuesday, "Stung by Courts, F.D.A. Rethinks Its Rules", the NY Times reported

on the FDA's controversial practices like the raid on Kirkman's:

"After losing a series of court decisions that found it in violation of

the First Amendment's guarantee of freedom of speech, the Food and Drug

Administration has begun a wide-ranging review of regulations that control

what the makers of drugs, supplements, food and cosmetics can say about

their products.

"At issue is the delicate balance between a company's right to

communicate with its customers and the food and drug agency's mandate to

protect the public.

"But the court decisions, which included a stinging rebuke from the

Supreme Court in April, have prompted the agency to ask whether it may, at

times, have gone too far in its insistence that it decides when scientific

truth has been established and what companies can say. At issue are

regulations governing everything from what a drug company can print on a

T-shirt to what a sales representative can say in the privacy of a doctor's

office.

"No one is advocating that false or inaccurate claims be permitted.

But agency officials are asking questions like whether they can continue to

prevent food companies from making health claims for their products and

whether they can continue to insist that drug advertising include a full

accounting of side effects and conditions that may make the drug

inadvisable.

[The full NY Times article can be read at:}

[Kirkman Laboratories can be found at:]

[Contact the FDA at:]

FDA Deputy Commissioner Lester M. Crawford email:

deputy.commissioner@fda.gov

or 5600 Fisher Lane, Rockville, MD 20857, Phone: 301-827-2410, Fax:

301-443-3100