'The nine most terrifying words'



By SANDRA DUFFY

There seems to be a weekly expose' of the Food and Drug Administration's failure to protect the American public. Most of them are aimed at pharmaceuticals causing death, kidney failure, liver failure, strokes or heart attacks. Statistics show more than 100,000 people a year in this country die from pharmaceutical side effects.

Ronald Reagan once said: "The nine most terrifying words in the English language are, 'I'm from the government and I'm here to help.' " When it comes to the FDA, Reagan may be right.

Clearly, there is a problem at the FDA and Americans are acting as guinea pigs for the pharmaceutical companies, testing the long-term effects of many drugs. Is it any surprise then, that 71 percent of people over 50, and 80 percent of people with cancer, are using some sort of alternative health care treatment?

Does the FDA have a role in regulating dietary supplements that may be an alternative to pharmaceuticals? The Dietary Supplement Health and Education Act (DSHEA, 1994) was the result of a large grassroots movement to protect citizens' right to free access to supplements. DSHEA defined supplements as neither a food nor a drug to protect them from the jurisdiction of the FDA.

Supplements do not have to be approved by FDA, as drugs must. FDA does have jurisdiction to protect the public against harm and fraud from dietary supplements. However, FDA interprets harm and fraud in such a broad manner that it includes supplements used as an alternative to "proven medical treatments." If taken to its logical conclusion, that would mean that if a Western medical treatment exists for a condition (no matter how dangerous or debilitating), using a dietary supplement as an alternative is always harmful under FDA's interpretation of harm.

FDA assumes adverse interactions between drugs and supplements to be the fault of the supplement. The FDA also asserts that ineffective supplements are fraudulent and that supplements which cause adverse effects must be removed from the marketplace. Those standards, if applied to pharmaceuticals, would leave few on the market.

The FDA fulfills its enforcement role against dietary supplements aggressively -- so aggressively one would almost think FDA sees its role as protecting the market share of the pharmaceutical companies. https://www.rmhiherbal.org/a/f.ahr6.fda.html

Seeing the rise in use of supplements, pharmaceutical companies have been buying supplement companies. With the help of the FDA, Big Pharma, has found a way to gain an economic advantage in the field: Give a supplement prescription status and have it covered, at wildly bloated costs, by health insurance.

A recent example of this scheme has FDA conferring prescription status for a single brand of fish oil. Alternative health care practitioners have been touting the efficacy of fish oils for decades, for its essential fatty acids and Omega-3s, which can prevent or treat cardiovascular disease, cholesterol, triglycerides, arthritis, diabetes, depression, failing memory and other conditions.

Reliant Pharmaceutical obtained FDA approval of its fish oil product, which it named Lovaza. It costs $200 a month; a comparable non-FDA approved product costs $20 a month. In the first nine months of 2007, Reliant sold $206 million of the product. FDA approved the following marketing claim: "Dietary supplements are not substitutes for Lovaza. Every other omega-3 product is a dietary supplement, which means it is not approved for the treatment of any specific disease or medical condition, like very high triglycerides."

Disingenuously, the claim does not say that dietary supplements do not work; it says they are not approved. But, under the DSHEA, no dietary supplement is required to be approved by the FDA. In December 2007, GlaxoSmithKline bought Reliant for $1.65 billion. All high-quality fish oil products do what Lovaza does. FDA has given GlaxoSmithKline a license to dupe the public. Vitamin C, CoEnzyme Q-10 and Vitamin E would be good future candidates for this big money-making scheme.

The sharp contrast between FDA treatment of pharmaceuticals (including supplements pharmaceutical companies can afford to put through the FDA approval process), and supplements under the DSHEA, exposes the FDA as a protector of Big Pharma and not the American public.

President Bush's 2008-2009 budget gave FDA $2.4 billion (including $628 million in industry user fees -- a whole other topic). The increase over prior budgets will pay for an additional 526 full-time employees. If these additions bring us more of the same -- dangerous drugs and persecution of safe alternatives -- then Reagan was right: Our government is not there to help us -- it is harming our health and our pocketbooks.