Dietary Supplements
Government/Scientific/Pharmaceutical/News Media Grip Over Dietary Supplements
By Bill Sardi
23rd January 2006
Government regulatory agencies, the medical scientific research community, aligned with physician groups, and the news media, combine to create a strong anti-dietary supplement faction in America.The hidden goal of the research community is to create patentable prescription drugs that will some day generate billions of dollars in sales (so-called blockbusters). A conflict arises when one becomes aware that dietary supplements can often duplicate the biological action of many drugs at far less cost, reduced side effects and greater effectiveness. To hide this fact, the research community along with the news media must conduct a continued campaign to steer the public away from dietary supplements. Otherwise there will be far less need for drugs. Either by non-reporting of breakthroughs, or the dissemination of misleading science, or the creation of bogus intake limits on vitamins and minerals, the combined efforts of government agencies, medical researchers and the news media join in the cabal against dietary supplements.
Trudy Lieberman, who recently wrote of the control exerted over the news media by the pharmaceutical industry in the Columbia Journalism Review, quoted an unnamed source as saying �Everyone is in cahoots.� [CJR Issue 4, July/August 2005] With the big five TV networks reported to be raking in $1.5 billion in advertising revenue from the pharmaceutical companies, and Time, Newsweek and the New York Times taking in another $123 million in ad fees, don�t expect the news media to give a fair hearing for dietary supplements.
Don�t expect to appeal to government either. Not only is it well known that �Big Pharma� owns Washington DC via an army of lobbyists and political donations, but it was recently revealed that 38 US Senators held $13.4 million in pharmaceutical investments.
For comparison, the dietary supplement industry is often unfairly portrayed as mega-billion dollar industry ($18.7 billion of sales in 2002), reaping in huge profits, but consider that the sales of just one class of drugs, cholesterol-lowering statins, produced $18.5 billion sales in 2002 alone, with profit margins far exceeding dietary supplements.
Is the dietary supplement industry unregulated?
It is often said that the dietary supplement industry is unregulated and that supplements should undergo the same approval process as drugs. But the drug model is flawed, not only producing unaffordable products, resulting in the use of deadly drugs, even when properly used, that end up killing over 100,000 patients a year. [Journal American Medical Assn. 279: 1200-05 and 1216-17, 1998] More than half of all approved drugs (like Vioxx) produce serious side effects not detected prior to approval. [Journal American Medical Assn. 279: 1571-73, 1998] For comparison, a review of data tabulated by Poison Control Centers finds few if any cases of mortality associated with the use of vitamin or mineral supplements and only a few cases of deaths (mostly involving ephedra) associated with herbal products in over a decade of use.
Dietary supplements: flawed but not unregulated
There is no question that dietary supplements are sometimes mislabeled, may make unsubstantiated health claims on their label or advertising, too often don�t contain the dosage listed on the label, or may not even contain listed ingredients at all. But they are far from being unregulated and must comply with regulations for labeling, purity and relative safety (even something seemingly innocent like table salt is not absolutely safe), or face regulatory and product liability sanctions. [Nutrition Reviews 62:55-9, 2004; Federal Register 65:1000-50, 2000; Nutrition Clinical Practice 20:21-32, 2005]
The FDA itself took nearly 9 years to publish good manufacturing practices for dietary supplements while the news media and other critics continued to blame vitamin pill makers for shoddy products and being �unregulated.� Not a word from the news media about this FDA foot dragging. The dietary supplement industry, fearing greater reprisals, took this criticism on the chin rather than pointing a finger at the FDA.
Supplements held to unattainable standard of safety
If a single person misuses a dietary supplement, and dies from overdose, this adverse report is likely to be spread by the news media. A physician recently reported to the FDA hotline the dietary supplement he was taking caused his heart rate to slow and he had to be transported to the emergency room. The physician provided a history of being a tri-athlete who exercises excessively (thousands of rowing exercises daily), a health history that is consistent with a condition known as �athlete�s heart,� that can result in bradycardia, a slowing of the heart rate. But the dietary supplement was blamed.
Dietary supplements are simply being called to perform at an unattainable standard � absolute safety. Dietary supplements are safer than aspirin, ibuprofen, chlorinated tap water, table salt, and most vaccines, yet they are demonized by the press. For comparison, in 1999 it was estimated that over-the-counter drugs like aspirin and ibuprofen cause 16,5000 avoidable deaths annually in the U.S. [New England Journal Medicine 340:1888-99, 1999]
When it was alleged that kava kava, an anti-anxiety herb, might cause liver problems, based upon preliminary reports emanating from Europe, the FDA issued a bulletin asking consumers and physicians to report side effects, which demolished sales of this herb.
A report in the Journal of Drug Safety indicates adverse events caused by kava �are, in general, rare, mild and reversible.� [Drug Safety 25: 251-61, 2002] Critical analysis of the 19 suspected adverse reports in Europe involving kava, revealed only one single patient where a very probable causal relationship could be established between kava treatment and the development of toxic liver disease. A worldwide alert was issued from just one proven side effect. [Phytomedicine 10:440-6, 2003]
Lax enforcement
There are an estimated 29,000 dietary supplements marketed in the U.S., some by marginal or new small companies that aren�t adept at complying with regulations. There appears to be lax enforcement of Food & Drug and Federal Trade Commission regulations, with many perpetrators doing business for years until sanctions are applied. This appears to be by intent in order to perpetuate the public image that dietary supplements and their manufacturers are not to be trusted.
Studies selectively skew results
The scientific community participates in this subterfuge, creating pseudoscience or derogatory studies, to create the false impression that high-dose dietary supplements are unsafe. [International Journal Toxicology 22:387-90, 2003]
When a report published in The Annals of Internal Medicine [Released to news media Nov. 10, 2004; published Jan 4, 2005, Volume 142: pages 37-46] analyzed 19 clinical trials involving vitamin E supplements and concluded that high-dose vitamin E (above 400 units) �may increase [deaths] and should be avoided,� it took iconoclast Michael Fumento to point out that this combined �meta-analysis� selectively excluded other studies that totaled less than 10 deaths and failed to point out that two studies involving 2000 units of vitamin E showed fewer deaths among supplement users. [The Vitamin E Witch Hunt, www.fumento.com ]
Discoveries buried beneath negative headlines
When a July 2005 study published in the Journal of the American Medical Association found that for cardiovascular death, �there was a significant 24% reduction� among healthy female vitamin E supplement users, but there was no effect for cardiovascular disease or cancer prevention, the latter facts were headlined by the news media while the reduction in cardiovascular death was buried in lower paragraphs. The news media essentially copied a press release word for word from the National Institutes of Health without obtaining contrary opinions or even carefully examining the study. [Journal American Medical Assn 294: 56-65, 2005] Anticipate future positive studies involving dietary supplements will be downplayed or ignored.
Vitamin Breakthroughs Ignored
A greater disservice is done to the public, not only when these falsehoods continue to be aired, but also by news sources that even fail to report major breakthroughs when they involve dietary supplements.
When the Annals of Internal Medicine published a report in 2004 that intravenous vitamin C could achieve blood concentrations 70 times greater than optimal oral intake, which would be sufficient to kill cancer cells, not a word was mentioned by the news media that this landmark study vindicated studies conducted by Drs. Linus Pauling and Ewan Cameron 28 years earlier, which claimed that vitamin C infusions prolonged the lives of terminal cancer patients. [Annals Internal Medicine 140: 533-7, 2004; Proceedings National Academy Sciences 75:4538-42, 1978; 73:3685-9, 1976] Then the National Library of Medicine subsequently censored other original reports involving vitamin C published by Dr. Pauling by not listing in its vast archives papers published in the Journal of Orthomolecular Medicine.*
Furthermore, the Annals of Internal Medicine report also revealed that oral-dose vitamin C can achieve blood serum concentrations three times greater than previously thought possible, and the longtime falsehood that mega-dose vitamin C pills create nothing more than �expensive urine� was also exposed. But even when this study was pointed out to health reporters at the New York Times, Washington Post, CNN, Associated Press, USA Today, and elsewhere, it was ignored.
Another breakthrough negated
When resveratrol, a dietary supplement derived from grapes or other botanical sources, was widely reported to have anti-aging properties via its ability to repair DNA, and was the likely agent responsible for the �French paradox,� the fact the French have lower rates of cardiovascular disease despite their fat laden diet [Nature 425:191-6, 2003], researchers at the University of South Carolina, funded by a pharmaceutical company, spread misinformation (pseudoscience) that resveratrol in dietary supplements was not �biologically available.� [Drug Metabolism Disposition 32:1377-82, 2004] Yet resveratrol is biologically available from wine and is being used in a pill in a cancer prevention study in Europe. This falsehood was widely spread by the news media to discourage the public from using red wine pills.
Failings of modern medicine passed over
The failings of prescription drugs often go unreported, with mortal consequences.
Recently, when Dr. Harumi Okuyama of the Graduate School of Pharmaceutical Science at Nagoya City University, in Nagoya, Japan, published an urgent call for physicians worldwide to back away from prescribing cholesterol-reducing medications because there was no evidence that they reduce mortality rates, and to embrace the use of omega-3 fish oils that have been shown to effectively reduce the incidence of cancer, heart disease and all-cause mortality, it was as if his paper was never published. Not a word about this in the news media. [Journal Pharmaceutical Society of Japan- Yakugaku Zasshi 125: 833-52, 2005] The strategy here is, don�t report negative news.
Trudy Lieberman, in her Columbia Journal Review report, cited the reluctance of the news media to report on the failings of Vioxx, the anti-inflammatory drug that was approved by the FDA under the false claim it reduced the risk for gastric ulcers commonly caused by other pain killing drugs. Vioxx was found to have induced the premature death of thousands of Americans due to blood clots and heart attacks. The evidence of serious drawbacks involving Vioxx was published in the New England Journal of Medicine, which most major health reporters receive an advanced edition of, four years prior to the Vioxx recall.
Health reporters for the major news media all receive advance announcement of major health breakthroughs and can handsomely profit from this insider information by investing in drug company stocks prior to a major drug-related news story.
The analog game
While major news sources employ award-winning journalists to cover health-related topics, most whom are trained in the medical sciences and biology, these reporters fail to report for the common good. Researchers funded by the National Institutes of Health as well as pharmaceutical companies are all participating in the game of creating analogs, that is, re-arranged natural molecules that can be patented and developed into prescription drugs at exorbitant profits. This fact is never reported to the public.
Patentable analogs promoted over natural molecules
For example, selenium is a trace mineral that astounded the cancer research world in 1996 when Larry Clark, then a researcher Cornell University, reported that a 200- microgram selenium supplement (SelenoExcell�) dramatically reduced the risk for most cancers. This was one of those double-blind, interventional, placebo-controlled studies that modern medicine keeps demanding of the dietary supplement industry. {Journal American Medical Assn. 276: 1957-63, 1996]
So, do oncologists suggest their patients supplement with selenium to prevent cancer? Instead, cancer researchers continue to investigate the use of ebselen, a synthetically produced selenium drug (analog), to treat cancer. [Anticancer Drugs 16:569-79, 2005]
Researchers are calling for the public to consume higher doses of vitamin D, which cannot be achieved from food or food fortification and only from dietary supplements, based upon numerous studies widespread vitamin D deficiency and that higher-dose vitamin D prevents cancer, osteoporosis, hypertension, autoimmune disorders, and many other maladies. [Journal Nutrition 135:310-6, 2005] But researchers continually claim vitamin D analogs must be used to prevent calcifications. [American Journal Kidney Diseases 38:S34-40, 2001]
Yet up to 4000 units/day, ten times the Recommended Daily Allowance and twice the safe upper limit, has been found to be safe, with toxicity starting till 40,000 units are consumed for many months. [American Journal Clinical Nutrition 73:288-94, 2001; 69:842-56, 1999] Calcification from use of vitamin D supplements is only a concern in a small number of people, while millions suffer and die from vitamin D deficiency. There are continued efforts to scare the public away from meaningful doses of vitamin D in dietary supplements.
Government bans vitamin pills
Government agencies restrict vitamin pills, not only by warning the public away from perfectly safe doses of vitamins via the bogus Recommended Daily Allowance, but also by outright black listing of vitamin pills.
The Recommended Daily Allowance (RDA) was established for perfectly healthy people, not growing children, pregnant moms, smokers, diabetics, athletes, people under stress, hospitalized individuals, the elderly who often have difficulty absorbing nutrients from foods, nor users of medications that deplete certain nutrients (examples: aspirin depletes vitamin C and folic acid; most cardiac drugs deplete the body of coenzyme Q10; diuretics deplete the body of minerals and vitamin B1, which can induce heart failure). But there is no mention of these exceptions when the RDA is listed on foods and dietary supplement labels.
The RDA is outdated and does not apply to most Americans. But consumers read a label stating a dietary supplement provides �100% of the RDA� and they falsely feel assured it supplies the proper dosage of nutrients needed to remain healthy. That is far from the truth.
The RDA for vitamin C, vitamin D, vitamin B1, folic acid, vitamin B12 and magnesium need updating, but the Food & Nutrition Board is virtually unresponsive to recent scientific findings which conclusively show there is widespread nutrient deficiency that raises disease risks.
Drs. Steve Hickey and Hilary Roberts, authors of the book The Ridiculous Daily Allowance ( www.lulu.com/ascorbate ) have petitioned the Food & Nutrition Board along with other antioxidant researcher to overhaul the RDA for vitamin C, based upon the realization the RDA was established without calculating for the half-life (degradation rate) of vitamin C in the body. So far, there is no word from the Food & Nutrition Board concerning a re-evaluation of the RDA for vitamin C.
And yes, the government actually bans the acquisition of vitamin pills. Despite the fact the poor exhibit the worst nutrition and the greatest prevalence of disease, the Food Stamp Act bars participating households from purchasing vitamin pills. The poor can buy Cocoa Puffs, but not a multivitamin. Objections were raised against payment for vitamin pills when agricultural interests said recipients would purchase less of their products. Some 20 million poor Americans cannot buy vitamin pills with Food Stamps.
(Senate Bill 1546 would fix this.)
Dr. Bruce Ames, a renowned researcher at the University of California Berkeley, says
�It is a distortion of priorities for much of the world's population to have an inadequate intake of vitamins or minerals�at great cost to health�when a year's supply of a daily multivitamin/mineral pill costs less than a few packs of cigarettes. The poor, in general, have the worst diets and have the most to gain from improving their multivitamin and mineral supplementation and diet,� says Dr. Ames. [European Molecular Biology Organization) Journal (6, S20�S24, 2005]
The government bans coverage for vitamin pills outright for the poor, Medicare also prohibits payment for dietary supplements, and scares the rest of the population away from perfectly safe doses by imposing poorly substantiated limits (RDA, Tolerable Upper Limit).
There you have it � a cabal against dietary supplements. The naïve American public can�t fathom such a widespread plot against pills. How much longer the public will continue to blindly heed the RDA and other scare tactics against dietary supplements is unknown.
Copyright 2006 Bill Sardi, Knowledge of Health, Inc.
* Webmaster's Comment. The National Library of Medicine also refuses to list the journal Fluoride which reports on fluoride's high toxicity. Fluoride is added to drinking water and dental health products based on unfounded claims about its contribution to dental health. At the same time, the Library does list off-topic journals such as 20th Century British History and African Economic History. The editor of Fluoride is interviewed here.
..