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    Re: Dr. Shoemaker's Treatment Protocol

    Posted by Greg Weatherman on 9/25/03


    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.


    Greg Weatherman

    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.
    > 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: 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).
    > 2,011 ctns/60 packets ea.
    > 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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