RMHI logo
rmhiherbal.org
[HerbalistReview Archives]
[RMHI Home] [HerbalThinkTCM software]
[RMHInet] [Courses/Certification] [FAQ]
[Subscribe/Download] [Tutorials]
[About us] [Contact] [Articles]

— updated 2005-01-27

Herbalist Review, Issue 2005 #1: Urgent - stop FDA attempts to undermine DSHEA

by Roger W. Wicke, Ph.D.

The hidden agenda of the FDA is to increase profits of the pharmaceutical industry under the guise of protecting the public from adulterated herbal and supplement products. If the FDA would apply the same standards to both hebs and synthetic pharmaceutical drugs, almost none of the latter would ever be approved. Fortunately, large numbers of people are recognizing this hypocrisy.

Subtopics on this page…

Copyright ©2005 by RMH-Publications Trust; all rights reserved.








Urgent - your action required to stop FDA attempts to undermine DSHEA

The FDA is currently involved in making new rules that threaten to undermine the intent of DSHEA (The Dietary Supplement Health Education Act). DSHEA mandated that nutritional supplements and herbal products would continue to be regulated as foods, without the prohibitively expensive testing required for new synthetic drugs. Yet the FDA and pharmaceutical interests would like to see this basic principle overturned.

It took 2.5 million consumers contacting Congress in the early 1990s to save access to dietary supplements by passing DSHEA.

Please take a few minutes (that's all it will take) and go to the following online response form to register your demand that the FDA continue to adhere to the spirit and intent of DSHEA. There are only a few days remaining until deadline for comments on this issue - February 1.

Urge them to ensure that any new FDA guidelines for New Dietary Ingredients reflect the intent of Congress and continue to provide complete access to the safe and affordable dietary supplements you and millions of Americans rely on for health.

The next major hump in the road will be the challenge of the Alliance for Natural Health to EU implementation of Codex-style regulations limiting the availability of supplements and herbal products. For updates and more information on supporting this effort and helping our European friends:

http://www.alliance-natural-health.org/index.cfm?action=home

Alliance for Natural Health

Good news in the fight against Big Pharma

Quackbusters, an organization funded by several major drug companies to discredit alternative practitioners of all types, has suffered serious setbacks as a result of several major court decisions.

According to Tim Bolen:

"North Americans have known, or suspected, for some time, that there has been an organized assault by a group, against companies, and practitioners, offering alternatives to the drugs/surgery paradigm. That group calls itself the "quackbusters", and they are a scam."

Bolen reports that recent U.S. court rulings have severely crippled Quackbusters. A recent published Appeals Court decision called its founder, Steven Barrett, biased and unworthy of credibility. Moreover, the National Council Against Health Fraud (NCAHF), a similar organization to Quackwatch, was defeated in similar court actions in California and Wisconsin.

Recently, Barrett, quackwatch.com, the NCAHF, Robert Baratz, and others have been named in a federal Racketeering (RICO) lawsuit in Colorado (CAVITAT v. Aetna Insurance). Aetna has filed four separate motions for dismissal in this case, and each motion has been rejected by the court; the case will proceed.

If you, or anyone you know, has ever been victimized by Quackbusters or any of the parties named in the preceding lawsuit, you may be able to help put these organizations out of business and send a strong message to the pharmaceutical companies that this type of behavior WILL NOT BE TOLERATED.

Please see for more information, including specific advice for former victims of Quackwatch:

http://www.quackpotwatch.org/opinionpieces/quacksurv2005.htm

Will the "Quackbusters" Survive 2005?...

by Tim Bolen

For more background on Quackbusters:

http://www.njnhc.org/articles/swanson-2.htm

Deconstructing the Quackbusters and their myths about alternative health; 4-part series by Kent Swanson

http://www.quackpotwatch.org/opinionpieces/RacketeeringColorado.htm

Quackbusters Accused of "Racketeering" (RICO) in Colorado...

Opinion by Consumer Advocate Tim Bolen; Thursday, August 12th, 2004

http://www.ghchealth.com/forum/post-121.html

Medscape - Your Credibility is on the Line...

An Open Letter to MedScape

Opinion by Consumer Advocate Tim Bolen; Saturday, November 13th, 2004

http://www.happyherbalist.com/quackbusters_busted.htm

California Superior Court Judge Rules on Quackbuster "Credibility" (This is a copy of the original Court document signed by Judge Fromholz.)

MIT scientists promote FDA agenda to regulate herbs

Two scientists at MIT, Shiladitya Sengupta and Ram Sasisekharan, have discovered that there are chemical constituents of ginseng that have opposing effects on blood vessel growth. One isolated constituent promoted blood vessel growth, which is beneficial wound healing, but which they suggest may be problematic in cases of cancer. Another isolated constituent inhibited blood vessel growth - an antiangiogenesis factor that might be useful in cases of cancer. Moreover, the relative ratios of these two constituents were different, depending upon the preparation methods used to process the ginseng before sale.

They admit that the problem is more complex, as the action of each of these compounds may be modulated by the presence of sugar groups attached as side chains to these molecules, and the specific modulatory effect depends upon the location of attachment.

Based on these discoveries, the two MIT researchers have concluded that the FDA should regulate ginseng as a drug, because many herb businesses are selling ginseng to the public with various health claims. Moreover, they have developed what they claim is a rigorous method for standardizing herbal supplements and intend to convince the FDA to mandate their process as a means of quality control in the manufacturing of herbal supplements.

Commentary:

While Sengupta and Sasisekharan should be congratulated for their discoveries regarding ginseng, their conclusion that ginseng should be regulated by the FDA requires a gigantic leap of logic that goes far beyond considerations of biochemistry.

Traditional Chinese herbalists have long recognized that ginseng is indicated in a wide range of debilitated conditions, as long a specific criteria are met - a significant number of the following symptoms must be present: fatigue; dehydration; weak pulse; pale complexion and tongue; withdrawn, quiet behavior; poor resistance to infections; low stamina and stress tolerance. Moreover, ginseng is specifically contraindicated in such conditions as high blood pressure, irritability and agitation, and abdominal bloating.

Ginseng is classified as an adaptogenic herb by most herbalists. Adaptogens typically have complex chemical constituents with multiple effects, many of them regulatory in nature or of a dual nature. The effects on blood vessel growth that Sengupta and Sasikharan have discovered are typical of such dual effects. Adaptogens may often manifest paradoxical effects in different individuals - for example, lowering blood sugar in individuals with high levels, but increasing levels if they are too low.

Attachment of sugar side chains to complex biomolecules is a common means for the body to alter their cell wall permeability. A chemical without such a side chain may not be able to penetrate the cell wall, but with the sugar group attached, it may pass through easily. Without the ability to penetrate cell walls, many chemicals will show much reduced physiologic activity. The human body is capable to a great degree of accepting, rejecting, or altering the chemical constituents of foods and herbs for its own needs. Alteration, breakdown, and reconstitution of ingested molecules are routine aspects of digestive and cellular metabolism.

To suggest that merely because the effects of ginseng are variable with respect to blood vessel growth, it must be regulated by the FDA is a non sequitur unworthy of scientists supposedly guided by logic and reason. Let's examine this chain of logic to see where it leads.

According to an article in Biochemistry (Moscow), "The dietary constituents selenium, N-acetylcysteine, vitamin D3, curcumin, flavonoids, and several fatty acids (i.e., eicosapentaenoic acid) have all been shown to inhibit angiogenesis in vitro and/or in vivo." These constituents are found in a wide range of common foods - vegetables, spices (turmeric), fish oils, flax seed, etc. Copper, arginine, and glycine are pro-angiogenic dietary constituents and play an important role in normal tissue repair.

Simply because something has an anti-angiogenic effect does not mean that it will be healthy - thalidomide is a potent anti-angiogenic drug, and it had truly horrible effects on developing fetuses. The body requires angiogenic factors to promote normal tissue growth and repair, yet anti-angiogenic factors are also beneficial in the diet to keep this necessary process under control. For almost every biochemical process in the body, there are complementary or opposing processes that regulate it and keep it in balance.

In summary, the mere fact that two MIT scientists have discovered both anti-angiogenesism and pro-angiogenesis factors in ginseng is no earth-shattering discovery. Such compounds have been found in a wide variety of foods. This should not be surprising; foods are foods because they contain the fuel and building blocks of life. If ginseng is such a danger to the public that it needs to be regulated, then fish, wine, vegetables, flax seed, liver, and shellfish are equally dangerous. Must we have corrupt FDA officials invade our food shops and kitchens too?

The FDA has a hypocritical double standard with respect to safety. Deaths from prescription medications barely merit an eye blink in the media, even though non-error, adverse effects of medications are the fourth leading cause of death (106,000 deaths/year). Yet a single death or negative effect from an herbal product often results in shrill demands by the FDA for increased regulation.

In summary, I suggest that researchers Sengupta and Sasisekharan stick to herbal research and refrain from comments on herbal politics and regulation until they have properly informed themselves on how the American system of drug and food regulation really works. For starters, how about reading the following?

http://www.rmhiherbal.org/review/2003-2.html

Orwellian schemes for maximizing health-care industry profits

- How these endanger the practice of herbal medicine

Note especially the section in the preceding article on the various types of official mischief that can result from mandatory biochemical standardization of herbal products, in contrast to voluntary certification, which may help to increase herbal product quality:

http://www.rmhiherbal.org/review/2003-2.html#t-bioc

Promote adoption of regulatory standardization of biochemical profiles for herbal products.

Sengupta and Sasisekharan may hope to patent their method, and their profits may be huge if the FDA mandates their scheme to regulate herbal products. The public should be aware of the biases in scientific research arising from financial self-interest. Now that herbal products have become a multi-billion dollar industry, corporations and their cooperative FDA cronies are being assisted by scientists hoping to share some of the profits, at the expense of the public's freedom of choice.

References