Re: Dr. Shoemaker's Treatment Protocol

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John,

The product was recalled do to "product instability". This means there is
a concern that some but not all of the product may not perform as intended
for the FDA approved medical treatment. The FDA probably requires a
minimum of 1 year for "product stability" if the label expiration date is
based on a 1 year experation form the date of manufacture.

The pharmaceutical company probably runs QA/QC to practice "due
diligence". They may have discovered the "product was not stable after 6
months" for a particular batch or lot. The product was probalby sold
before they had knowledge since it cost money to store product in a
warehouse. The pharmaceutical company probably notified the FDA
so "negligence" could be a limited issue for future lawsuits.

This happens all the time. The FDA website is littered with product
recalls for food and drugs. Note a specific lot was named:

Lot no. 1A32512 Exp. Date 2/29/2004

A similiar common occurence is ground beef with E. coli.

Dr. Shoemaker does not claim "ALL" cases of mold can be cured. In fact, he
states on a regular basis that longterm exposure may be untreatable for
some health effects if there is sufficient damage to the proteinaceous
sheathe around nerve cells.

I understand your confusion and I know you mean well.

Regards,

Greg Weatherman
gw@aerobiological.com
***************************************************

On 9/22/03, johncodie wrote:
> Doctors increasingly recommend a low-fat diet for cholesterol control.
> But instead of garlic, physicians promote prescription drugs like
> cholestyramine (Questran). Cholestyramine is effective, but it costs $1
> to $2 a day, requires regular professional monitoring that adds to its
> cost, and may cause side effects, notably constipation, vomiting, loss of
> appetite, bleeding, and vitamin deficiencies. In addition, animal
> research hints that cholestyramine might accelerate tumor growth.
>
> What we have here is a public-health no-brainer. Some people with
> superelevated cholesterol levels might still need cholestyramine, but
> everyone with high cholesterol should be encouraged to eat at least one
> clove of garlic a day.
>
> Unfortunately, if growers or marketers attached this information to bags
> of the aromatic bulbs, the FDA could confiscate their garlic. Ditto if
> they reprinted it in a pamphlet and mailed it to consumers or supermarket
> produce buyers.
>
> Why? Because under FDA regulations, using garlic to reduce cholesterol
> makes the culinary herb a "drug." To the FDA, the assertion that "garlic
> reduces cholesterol" constitutes a "new drug claim." The FDA has never
> approved this claim, and it is a violation of FDA regulations to make
> unapproved claims on drug labels or promotional materials.
>
> SafetyAlerts
> June 25, 2003
> Bristol-Myers Squibb Has Recalled Cholestyramine
> (SafetyAlerts) - The Food and Drug Administration (FDA) has released the
> following information.
>
> PRODUCT
> Cholestyramine for Oral Suspension, USP Powder, 4 grams cholestyramine
> resin, USP, per packet, 60 single dose packets, Apothecon. Recall # D-259-
> 3.
>
> CODE
> Lot no. 1A32512 Exp. Date 2/29/2004.
>
> RECALLING FIRM/MANUFACTURER
> Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ, by
> letters on April 11, 2003.
> Manufacturing Firm: Bristol-Myers Squibb Company, Prinston, NJ. Firm
> initiated recall is ongoing.
>
> REASON
> Superpotent (6 month stability).
>
> VOLUME OF PRODUCT IN COMMERCE
> 2,011 ctns/60 packets ea.
>
> DISTRIBUTION
> Nationwide.
>
>
> Your right not a total product recall. It appears the garlic growers are
> looking for reasons to promote the health benefits of their product.

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