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Scientists at The American Institute of Biosocial and Medical Research Challenge Irresponsible Attack On Proven Garlic Supplements.


Health/Medical Writers

TACOMA, Wash.--(BW HealthWire)--Dec. 17, 2001

The American Institute of Biosocial bi·o·so·cial  
adj.
Of or having to do with the interaction of biological and social forces: the biosocial aspects of disease.



bi
 and Medical Research (AIBMR) today challenged the results of a recent study on the impact of garlic on the bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
 of saquinavir saquinavir /sa·quin·a·vir/ (sah-kwin´ah-vir) an HIV protease inhibitor that causes formation of immature, noninfectious viral particles; used as the base or the mesylate salt in treatment of HIV infection and AIDS. , a protease inhibitor protease inhibitor (prō`tē-ās'), any of a class of drugs that interfere with replication of the AIDS virus (HIV), by blocking an enzyme (protease) necessary in the late stages of its reproduction.  used by some HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  patients.

AIBMR expressed deep concerns over a press release and resulting publicity around a small study conducted at the National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
).

"The recent attention given to a 9-subject pharmacokinetic study modeling the effect of garlic on saquinavir among HIV patients is very disturbing," said Dr. Alexander Schauss, Ph.D., Director of Natural and Medicinal Products Research at AIBMR, who has studied natural products for more than 25 years. Dr. Schauss noted that, "Saquinavir is not even approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 in the way it was used in the study."

The NIH press release stated that garlic supplements may affect the bioavailability of the HIV protease inhibitor saquinavir, significantly decreasing plasma concentration levels of the drug.

"Information disseminated by the study's authors to the press is incomplete and maybe even misleading," said Dr. Schauss, "because it doesn't reveal the inconsistent response among the nine subjects tested. Nearly half the subjects actually showed an elevation of plasma saquinavir while the garlic supplement was being consumed."

Saquinavir is marketed under the brand name "Fortovase(R)" by Roche Laboratories Inc. According to information provided by Roche, the drug is to be given as a "cocktail" with other protease inhibitors and is not FDA approved as a stand-alone drug for HIV patients.

Based on data from the International Association of Physicians in AIDS Care, saquinavir is only bioavailable an average 4%, with a range from 1% to 9%. Furthermore, it is reported to have significant adverse drug interactions and side effects.

"Studying a drug that is not recommended by the FDA to be used as a stand-alone HIV treatment, and not supported by the AIDS community because of its dosage level, low bioavailability, high cost and significant interactions with many other medications, just has no real world application," said Dr. Schauss.

Dr. Schauss urged caution in drawing conclusions based on any small-scale research.

"Such studies are often proven wrong by larger, more robust clinicals," noted Dr. Schauss, "and, in fact, even the authors of the NIH study point out that, given the bimodal bi·mod·al  
adj.
1. Having or exhibiting two contrasting modes or forms: "American supermarket shopping shows bimodal behavior
 (dichotomous di·chot·o·mous  
adj.
1. Divided or dividing into two parts or classifications.

2. Characterized by dichotomy.



di·chot
) distribution of the effect of garlic, the results may 'simply be inter-patient variability'."

Dr. Schauss went on to say, "This study hardly warrants a warning to avoid the use of garlic in AIDS patients. The very reason physicians recommend garlic to their AIDS patients is to counteract the significant rise in lipid levels (hyperlipidemias) resulting from treatment with such antiretroviral drugs as saquinavir."

Besides being a proven hypolipidemic agent, garlic boasts thousands of clinical studies proving significant health benefits such as reducing cholesterol levels, boosting the immune system and as an antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
.

"I am appalled that anyone would use a dubious study to question thousands of years of proven efficacy and safety," said Dr. Schauss. "I look forward to the day when researchers in the medical community will confer with scientists in the dietary supplement industry to design studies that will truly help make the world healthier."
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Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Dec 17, 2001
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