Campaign Launched Against Dietary Supplements
by Bill Sardi by Bill Sardi
At a time when the Food and Drug Administration is under criticism for approving unsafe drugs, and when pharmaceutical companies are being called to task for not disclosing negative studies of their products, a concerted effort is being launched against dietary supplements. The obvious reason — don’t let the public discover dietary supplements as alternative to prescription drugs that can duplicate the biological action of most prescription medicines with far lower costs and side effects.
Harvard Medical School in a joint effort with the FDA and the Institute of Medicine, has released a report that says: "Unlike drugs, which must be proven safe before they can be sold, the current law allows sale of supplements unless the Food and Drug Administration can prove them harmful." The assumption is that prescription drugs are safer than supplements because they have undergone an FDA approval process. But a review of data from the US Poison Control Centers indicates vitamin and mineral supplements are linked with few if any deaths over the past few years and deaths linked to use of herbal products, except for ephedra, are few. For comparison, just the use of non-steroidal pain relievers like aspirin and ibuprofen cause an estimated 16,000 deaths annually. Side effects from properly used prescription drugs, administered by nurses in hospitals, result in over 100,000 deaths annually. The FDA approval process does not guarantee safety.
Public Citizen, the Ralph Nader group, indicates 181 FDA-approved drugs should be recalled because they are not as safe as other drugs or are ineffective. An FDA drug reviewer, Dr. David Graham, had to publish his report on the hidden dangers of Vioxx outside of the country in the British Medical Journal. His job was later threatened for not following FDA protocol even though an estimated 139,000 Americans died prematurely from the use of Vioxx.
Many drug side effects are the result of nutritional deficiencies caused by the medications themselves. But the FDA is stubbornly resistant to warn the public how to avoid drug side effects by taking companion supplements. For example, statin cholesterol-lowering drugs deplete the body of coenzyme Q10 which can result in a mortal condition called rhabdomyolysis. Acetaminophen (Tylenol) is toxic to the liver and acetaminophen use is the leading cause for liver transplants. The antidote for acetaminophen poisoning is N-acetyl cysteine, a sulfur-based dietary supplement. The FDA has resisted appeals to combine these nutrients into the drugs or mandate that supplements be prescribed as companions.
Another mistaken complaint is that dietary supplement manufacturers don’t have to report adverse reactions as do drug companies. Yet the FDA is obviously working in league with the drug companies to hide negative reports that could trigger the recall of many drugs.
Another false assumption in the report is that dietary supplements interfere with prescription medications. Hilary Tindle, MD, a research fellow at Harvard Medical School, and lead author of the report, says: "This is especially critical as more becomes known about the adverse effects associated with individual dietary supplements as well as their interactions with prescription drugs." But vitamins and minerals are essential for life and it is the drugs that interfere with the nutrients, not the other way around.
There is a concerted effort to regulate dietary supplements, which is in reality a smoke screen to limit dosages of vitamins and minerals that can replace many prescription drugs. For example, high-dose vitamin B6 and vitamin C reduce blood pressure equally as well as prescription medications. High-dose folic acid is a safe anti-depressant. High-dose vitamin D is as effective as many blood pressure pills. High-dose vitamin C can prevent a form of unstable plaque that causes most sudden-death heart attacks. Pharmaceutical companies are attempting to patent altered vitamin D molecules to treat cancer when high-dose vitamin D is inexpensive and has the same biological action.
Later in the year, CODEX, a trade organization linked with the World Health Organization, hopes to limit dosages of vitamins and minerals under the presumption high doses cause significant side effects. The Institute of Medicine report appears to be softening up the public for these limitations.
The report discloses the real reason for restrictions against dietary supplements — in their own words: "In the past five years the biggest change was an increase in use of herbal supplements." The pharmaceuticals companies see herbal remedies advancing while their problematic nostrums are being discredited.
The dietary supplement industry is continually characterized as some giant behemoth that must be curbed. The industry was responsible for $18.7 billion in sales in 2002. For comparison, the sales of just one class of drugs, statins for cholesterol, nearly equal the entire annual sales of dietary supplements.
Both the Harvard and Institutes of Medicine reports advised users of dietary supplements to disclose their supplement regimens to their doctors. But doctors are poorly educated in the use of vitamins, minerals and herbal products and would offer little help to consumers.