For some time now I've been telling you that one of the key weapons being used against us at the Codex Committee on Nutrition and Foods for Special Dietary Use is the scientifically fraudulent paper titled "A Risk Assessment Model for Establishing Upper Levels for Nutrients" that was generated by the pharmaceutically funded National Academy of Sciences. This paper utilizes many of the non sensical acronyms developed by Dr.John Hathcock, currently of Council for Responsible Nutrition, but formerly of the FDA's office of special nutritionals (where he worked alongside Dr.Beth Yetley, the only person from the US Codex delegation with voting power, as the government rep on the delegation.)
In the editorial below, Dr.Brian Leibovitz exposes Hathcock's use of confusion as a weapon, and also illustrates several examples of how science is intentionally distorted in order to attack dietary supplements- he shows here how studies are rigged against us, and how confusion is used as a weapon to turn people against the use of natural products. Please read this carefully and keep it in mind the next time you read an article reporting on some alleged "scientific" study that attacks vitamins...
One of the Bad Science (BS) Award candidates this issue is John Hathcock, Ph.D., Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, FDA. The reason? He is the sole author of a paper that, to the best of my knowledge, introduced the most absurd acronyms and ridiculous equations in a single article (1). This is true with respect to both quantity and quality.
This paper, published in Nutrition Reviews, introduced novel acronyms as well as toxicology acronyms adapted for nutrition:
ADI (acceptable daily intake)
SF (safety factor)
NOAEL (no-observed adverse effect level)
LOAEL (lowest observed adverse effect level)
RfD (a reference dose that probably will not cause deleterious effects over a lifetime of exposure)
Ufs (uncertainty factors)
MF (modifying factor)
SI (nutrient safety index)
SL (safety limit)
Hathcock's definitions and calculations were both equally unenlightening and senseless- not to mention confusing:
"For calculation of the RfD, the SF has been refined into multiple components described as uncertainty factors, UF s and a modifying factor, MF. Thus, the RfD is defined by the following equation: RfD = NOAEL (or LOAEL)/ (UF x MF) where UF represents one or the product of several uncertainty factors [emphasis added] generally tenfold each. An additional factor, the MF, is used as necessary to account for areas of uncertainty that are not explicitly addressed by the usual factors [emphasis added.]"
"To assess the comparative safety of nutrients, a nutrient safety index (SI) has been defined as a ratio that is analogous in several ways to the therapeutic index (TI) for drugs. The SI was defined as the minimum toxic dose divided by the recommended intake: SI = LOAEL/ RI. This SI is useful for comparing the relative hazard posed by overconsumption of different nutrients. In this analysis, an SI of 10 does not indicate that an intake of up to 10 times the RDA is safe. Instead it indicates that such an intake provides no margin of safety [emphasis added]."
"If appropriate and adequate human data are available, a safety limit (SL) could be calculated as follows: SL = LOAEL / SF where LOAEL is the lowest observed adverse effect level derived from clinical reports and SF is a safety factor that provides an acceptable margin of safety. The SF could be either fixed or variable [emphasis added]."
Safety limits may be calculated by the SRM [square root method] and MPM [midpoint method] as follows:
SL= (LOAEL- (LOAEL -RDA)/2) or equivalently
SL = (LOAEL + RDA) divided by 2 x (the arithmetic mean)
Square Root Method:
SL= (LOAEL /SF) = LOAEL / SI 0.5
Where SI= LOAEL/RDA or equivalently
SL = (LOAEL x RDA) 0.5(the geometric mean)"
The confidence in and reasonableness of safety limits, regardless of the method used to define them, will be enhanced if the objectives [emphasis added], data criteria, and the quantitative method have been agreed upon ahead of time by groups responsible for nutrition and health policy [emphasis added]."
The scientific translation: agree on the policy (results) prior to conducting the research. Furthermore, why should "groups responsible for nutrition and health policy" - not bonafide nutritional scientists- be the final arbiters of scientific truth?
Beta Carotene (and antioxidants in general) recently took it on the chin from a single study published in the New England Journal of Medicine (NEJM) (2). The article reported a null effect of vitamin E, and promoting effect of Beta Carotene, on lung cancer in heavy smokers.
Media coverage was horrendous. The LA Times (April 12, 1994) published a column titled "Study questions value of antioxidant vitamins". The front page of USA Today (April 13, 1994) contained a column with the headline "Vitamins don't make smokers cancer proof" Even worse was the cover story on the April 25, 1994 issue of Newsweek, entitled "Are supplements still worth taking?"
Even Science, (the most widely read scientific journal) got into the act. "Beta Carotene: Helpful or Harmful?" (3) was the title of a recent editorial that concluded that the NEJM study provides support for skepticism, and a moratorium on unsubstantiated health claims about Beta carotene and other antioxidants." This editorial also stated that, "A more frightening explanation is that Beta carotene itself is carcinogenic. In light of the Finish results, is it safe to expose thousands of people to large doses of Beta Carotene?" The NEJM article has successfully introduced an element of doubt regarding nutrient supplements that will linger long after the study has been thoroughly discredited. Therein lies the real danger: "confusion as a weapon" accomplished via "science by design."
The introduction of this abominable article, and the widespread media coverage, has left an almost indelible mark on the average person. When confronted with conflicting information, many people simply give up believing anything about nutrition: "If the experts can't even agree, why should I bother to listen to any of them?"
The concept of confusion as a weapon is described above, and was detailed in my article "Nutrition at the Crossroads" (4). Examples include: the oat bran study; the PDCAAS (the new measure of protein quality); the RDI, PDV, and DV (nutrient requirement labeling acronyms); Chaparral- induced "hepatoxicity"; and L-tryptophan as the cause of Eosinophilia Myalgia Syndrome (EMS).
Sadly, this paper has undoubtedly confused many people about the value, and safety, of beta carotene (and other nutrient) supplements. Confusion, in turn, acts to decrease supplement usage. This is really an example of "science by design."
I've heard a lot of speculation about mechanisms that might account for the reported beta-carotene associated increase in lung cancer. Some examples include: 1) Finns make poor subjects; 2) Beta carotene treated individuals, believing they were protected, smoked more; 3) Beta carotene might prooxidize in lung tissue, as it can in vitro; and 4) radiation from Chernobyl somehow interacted (negatively) with Beta carotene.
The NEJM study is a travesty of science- an experiment designed to fail-and does not deserve the honor of our speculation about possible mechanisms for its flawed findings.
This study brings to mind an observation attributed to Louis Pasteur: "Be very careful when you look for something, or you will surely find it." This is exactly what occurred in the NEJM study, as the doses were simply too low to do the job.
Beta carotene supplements provided only 20 mg/day- far too low a dosage to expect beneficial effects (expecially in a challenged system, as described below). The investigators should have used at least 140 mg/day of beta carotene, as these intakes have proven effective.
The dose of vitamin E was even worse- a measly 50 mg (or 50 IU per day of dl-alpha tocopheryl acetate! This is not even twice the RDA for vitamin E- hardly a therapeutic amount! The intake of vitamin E should have been in the 1,500- 2,5000 IU/day.
The effectiveness of any given dose, naturally, depends on the system. Heavily challenged systems, like smoking 20 cigarettes per day fo 36 years (as in the present study) require higher than the therapeutic doses routinely used. Because of its lack of applicability to the real human predicament, this article is not worth the paper its printed on.
There is a serious problem with the preparation (and presentation of) results in the present study. The authors designed a nice study protocol (the 4 groups listed below) save for the inadequate doses used. In the results section, however the only comparisons were: with or without beta carotene and with or without vitamin E.) No tables or figures contained data for those receiving the supplement combination (the alpha tocopherol and beta carotene group)!
"The participants were randomly assigned to one of four supplementation regimens: alpha tocopherol alone (N= 7286), alpha tocopherol and beta carotene (N= 7278), beta carotene alone (N= 7282) or placebo (N= 7287). Thus, a total of 14, 564 men received alpha tocopherol, and 14, 560 received beta carotene."
Thus, any benefits of one nutrient, (eg vitamin E alone) would be masked because the "without vitamin E" group contained false data from those given beta carotene alone and from placebo-treated subjects. Incidentally, there was no mention of what placebo was used. They did, however point out that "all formulations were colored with qunnoline yellow" (a synthetic food dye with known toxicity) (5)
The finding that "dumbfounded the experts" (3) was the statistically significant increase in lung cancer in the beta carotene treated group. But the authors weren't exactly convinced of their own work:
"In light of all the data available, an adverse effect of beta carotene seems unlikely; in spite of its formal statistical significance, therefoer, this finding may well be due to chance."
This statement is an oxymoron: statistical significance, by definition, means that the results are NOT due to chance. If the authors don't even believe their own data, why should anyone else have any confidence in their findings? The statement above is a type of academic insurance-insurance against the likelihood of being proven wrong about beta carotene and lung cancer.
Perhaps the worst responses to this publication were the blatantly exaggerated extrapolations. The authors, and consequently the media, used the most outlandish extrapolations- and not surprisingly, wound up with some incredible conclusions. The main finding, a null effect of vitamin E and a promoting effect of Beta carotene, became, "Vitamins cause cancer", and then "All Supplements are worthless and possibly harmful" in the course of two or three days. To infer that ALL nutrient supplements are worthless and potentially harmful from ANY single article (especially the present one) can only be described as truly moronic.
Capsaican, the pungent principle of Cayenne pepper, is also the active ingredient in Zostrix(R)- an analgesic cream from GenDerm Corporation, Lincolnshire, IL. Zostrix(R) contains 0.025% capsaicin- a phenolic antioxidant similar to curscumin (from Turmeric). Zostrix(R) is approved for the treatment of arthritis and other inflammatory conditions. The first page of an advertisment (6) in the New England Journal of Medicine stated in large print that Zostrix(R) is:
The obvious implication is that other approved adjuncts don't work. The details were on the second page of the advertisement. "Zostrix (R) works safely and economically. Zostrix(R) is free from systemic side effects, and has no known drug interactions. When used properly, Zostrix(R) is inexpensive pain therapy. In fact when treating a single knee joint, a 20 gm tube can last up to a month.
There is no problem with the concept of using capsaicin to treat inflammation: the data clearly show taht it is effective for inflammation as well as pain relief (via a reduction in the levels of the substance )). The concentration of capsaicin, however, is extremely low (0.025% by weight); hence, Zostrix (R) is simply a very diluted form of this remarkable non-vitamin nutrient.
Cayenne pepper contains not less than 0.5 % (dry weight) of capsaicin. A small, inexpensive (about $2.00) bottle (45.4 gm) of Cayenne at the grocery store contains about 227 mg of capsaicin. A similar amount is provided by about 45 tubes of Zostrix(R) (each 20 gm tube contains 5 mg capsaicin). The cost of 45 tubes (at $15.50/ tube) is $698.
Thus about $2.00 worth of Cayenne pepper yields about $7000. worth of Zostrix(R) This astronomical markup of approximately 350 fold (35,000 percent) is yet another example of a nutrient (or herb) being converted to an expensive prescription item. FDA restrictions on Cayenne seem likely, as the sales of Zostrix(R) will suffer if the non prescription form is allowed to remain on the market. The confusion, in the Cayenne pepper caper, is due to nomenclature: the name Zostrix (R) offers no clue as to the origin or nature of its active ingredient.
1. Hathcock, JN Safety limits for nutrient intakes: concepts and data requirements. Nutr Rev 51:278-285, 1993
2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and Beta Carotene on the incidence of lung cancer and other cancers in male smokers. New Engl J Med 330: 1029-1035, 1994.
3. Nowak R. Beta Carotene: Helpful or Harmful? Science 264: 500-501, 1994.
4. Leibovitz B. Nutrition at the Crossroads. J. Optimal Nutr 1:69-83, 1992.
5. Budavari S, O'Neill MJ, Smith A, et al., (editors) The Merck Index, 11th Edition, Merck & Co. Inc. Rahway, NJ 1989, pg. 1286.
6. The New England Journal of Medicine, December 9, 1993
Next Codex Mtgs Re Vitamin Issue
CCNFSDU in Berlin
June 19- June 23, 2000
47th Session of Codex Executive
June 28-June 30, 2000 in Geneva
What to Do:
Contact Your Countries Delegate to the Codex Committee on Nutrition and Foods for Special Dietary Use
(Beth Yetley in USA, Margaret Cheney in Canada)
Tell Them To Oppose the Draft Guidelines for Vitamins and Minerals & That the Paper Titled "A Risk Assessment Model for Establishing Upper Levels for Nutrients" Is Unscientific, Biased Against Vitamin Use, Was Paid for by Pharmaceutical Interests, Is Anti Consumer, And a Complete Expose Is Available at
International Advocates for Health Freedom is a true grass roots, decentralized movement of vitamin consumers world wide opposed to the pharmaceutically rigged Codex Shell Game, to the United Nations, the World Trade Organization, and to all Statist Elements of Coersion, Wherever they may be found, anywhere in the world. As Free people, we are Sovereign over our own BODIES, With a God Given Unalienable Right to Ingest Any Substance of Our Choosing, (Especially Vitamins and Minerals) Into OUR BODIES As We See Fit.
We hereby put all unelected CODEX bureaucrats,UN and WTO Supporters World Wide,Employees of the FDA, HPB, MCA, MCC and similar drug cartel stooges on NOTICE that We Believe Strongly in the American Second Amendment Right to Bear Arms As Well as in the Right to Freedom of Speech & In All Unalienable God Given Rights, Both Numerated and Unenumerated, As Set Forth in the 9th Amendment to the United States Constitutition.
Learn the TRUTH about the Battle in Seattle:
International Advocates for Health Freedom
http://www.iahf.com/, email: email@example.com
Tel. Within N.America 800-333-2553, Overseas 540-745-6534
IAHF POB 625 Floyd, VA 24091 USA