The Journal of History     Fall 2005    TABLE OF CONTENTS

Pharmaceutical Updates

Author unknown

Tucked away "like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful," says New York Times columnist Bob Herbert in his latest editorial, A Gift for Drug Makers. The provision is set to prohibit judges from awarding punitive damages if a drug has received approval from the Food and Drug Administration. Herbert states the obvious: "We know the F.D.A. has failed time and again to ensure that unsafe drugs are kept off the market. To provide blanket legal protection against punitive damages in such cases is both unwarranted and dangerous." Jim VandeHei writing in the Washington Post, says it even more directly: "The medical malpractice bill backed by President Bush would prevent consumers from seeking punitive damages from the makers of Vioxx and Celebrex, two popular pain medications recently linked to increased risks of heart attacks and strokes, according to legal experts on both sides of the issue." Are those dangerous drugs really so important that the manufacturers must be shielded from all responsibility? A recent article in Forbes Magazine titled Just Say No says that changes in diet and lifestyle might be every bit as effective as the costly and side-effect laden drugs:

"Millions of us are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise--harped on by physicians for decades--are more effective and a lot cheaper. The results of pill dependence are insidious and devastating: billions of dollars in ever-higher drug costs; millions of people enduring sometimes highly toxic side effects; and close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the elderly, one major study estimates. And every few years comes the ultimate medical catastrophe: a miracle cure that turns out to be toxic."

Vera Hassner Sharav of the Alliance for Human Research Protection comments that justice would not be served by efforts to block citizens from seeking just compensation from corporate giants who deliberately conceal hazardous effects of drugs, vaccines, or medical devices to boost sales. She asks: "Why should drug manufacturers who knew the drugs they sold and advertised as "safe," to have lethal side effects, be shielded from responsibility?" - - - (1/16/2005)


Like much of the rest of the world (Canada) (U.S.A.) (ANZO) (Europe) South Africa has a legislative proposal, inspired by pharmaceutical interests, to "ensure the safety of natural remedies" including herbs and nutritional supplements, proposing to subject them to the extensive testing routines normally applied only to allopathic (pharmaceutically produced) medicines. In what may be a harbinger of international reversal of position, South African Health Minister Manto Tshabalala-Msimang said at a recent international conference on natural products and molecular therapy at the University of Cape Town Medical School, that the proposal "is likely to be changed." Mrs. Tshabalala-Msimang urged delegates to expose "the false dichotomy that had arisen between natural and allopathic medicine," adding that "this is a division fostered by the need to make money from patented drugs through discrediting the use of natural products." It is not the first time South Africa has taken a position in opposition to "conventional wisdom" in health matters. In June last year, South Africa argued in Codex Alimentarius discussions on food labelling, that health information about foods must be made available to consumers, a position unfortunately not shared by many of the other delegations. Also in Codex discussions about guidelines for food supplements, South Africa was the only country to stand up and denounce the generally negative tone of the proposed guidelines, arguing that "[b]ecause foods contain many substances that promote health and prevent chronic diseases, people should therefore be encouraged to select a healthy diet and supplement this diet with those nutrients for which the intake from the diet is insufficient to meet the requirements necessary for the prevention of chronic diseases and/or for the promotion of health beyond the demands of preventing micronutrient deficiencies." Again, the proposal did not pass. AIDS - one of the great health challenges for the African continent - has perhaps been a catalyst in this change of direction. An earlier program involved trials on AIDS patients, treating them with traditional medicine and nutrition instead of toxic anti-retrovirals, apparently with "promising results." Here is the report from The Mercury, 'The Quality Paper,' in South Africa: - - - (1/17/2005) The German Federal Institute for Risk Evaluation, formerly the Federal Office for Consumer Health Protection, has established a risk assessment model for deducing maximum safe levels of nutrients provided in supplements and fortified foods, according to a recent report of . The report was published in two parts, one dealing with minerals, the other with vitamins, both available in PDF format - so far only in German language (Minerals here) (Vitamins here). We will have to wait some months for a translation. Germany has long been one of the most restrictive countries on vitamin and mineral products, perhaps because of the relative strength of its pharmaceutical industry, which sees a threat to profits on pharmaceutical drugs as more and more people seem to turn away from drugs and try the "natural option." Germany is also hosting and chairing the once-a-year meeting of a Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) of the international Codex Alimentarius. The committee recently finalized a Codex Guideline for Vitamin and Mineral Supplements, which states that "upper safe levels" are to be set for vitamin supplements. The procedure used to determine such dosage restrictions will be discussed in a workshop jointly organized by the FAO and the World Health Organization. The recent publication by the Federal Institute affords us a glimpse of the direction this international process is taking, although formally it is "only" a proposal on how to put the dosage restrictions of the European Food Supplements Directive into effect. No doubt however, once used in Europe, Germany and the European Union will lobby for these same principles to be applied internationally, by making them part of the Codex procedure for setting "upper safe levels." The guideline is up for approval in July this year (2005), and the exact procedure will be determined by FAO/WHO. The coming rules will hit what is arguably the safest product category in existence by a wide margin - natural health products. Supplements and herbal products are safer than normal, everyday foods and infinitely safer than pharmaceutical medicines. Medicines are often found to be highly toxic despite bearing the authorities' seal of approval. Modern medicine and specifically adverse drug reactions have been identified as a major cause of death in the Western world.

Editor's note: CODEX is attempting to cause people to think that vitamins, minerals, and herbs are detrimental to our health, when just the opposite is true.


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