The cost of medical care in the United States—of which prescription drugs are the foundation—is growing almost as fast as the list of side effects with each new patented drug. Many Americans go bankrupt paying for these medicines despite the fact that there are more affordable, safer, and (often) more effective natural alternatives. So why don’t more Americans use them?
The US Food and Drug Administration was originally charged only with ensuring the safety of foods and drugs. But in 1962, Congress passed the Kefauver-Harris Amendment, also called the Drug Efficacy Amendment. It put the FDA in charge of also ensuring the effectiveness of the drugs they approve—a task the agency has never shown itself qualified to handle. This caused the cost of approval to soar, because it required effectiveness to be demonstrated through outrageously expensive double-blind random-controlled trials (RCTs).
No free speech about science!
Decades of research has affirmed that natural products are safe and effective, and in many cases, are a desirable alternative to pharmaceutical drugs for promoting health, alleviating symptoms, and curing disease.
Food and supplement producers are legally allowed to make structure/function claims. These are claims that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.”
However, supplement manufacturers are not legally allowed to make disease claims. A disease claim, under federal law, is any health claim that gets specific. For example, “promotes heart health” would not be a disease claim, but “lowers blood pressure” would be. Legally, one cannot even cite scientific studies showing that vitamin D prevents and treats the flu, because influenza is considered a disease, so this is forbidden.
A 1999 peer-reviewed report in the Journal of Natural Products published by the American Chemical Society, the world’s largest scientific society, concluded that tart cherries may relieve pain better than aspirin and other anti-inflammatory drugs. The consumption of about twenty cherries reduces inflammation in a manner similar to that of aspirin or the cox-2 inhibiting drugs, without the side effects of gastric bleeding or vitamin depletion that are associated with these drugs.
When cherry growers began to cite the scientific research, the FDA sent a warning letter to twenty-nine companies that market cherries, threatening regulatory action if they did not remove the scientific information regarding the anti-inflammatory properties of cherries from their websites. The FDA declared cherries to be “drugs” the moment health claims for a disease became associated with the product.
While one arm of the FDA was threatening cherry growers, another arm approved for a new type of cox-2 inhibiting anti-inflammatory drug that claimed it was safer than non-steroidal anti-inflammatory drugs such as ibuprofen. The new cox-2 drug was advertised on television and in print without the availability of long-term safety data. It was subsequently learned that this drug was no safer than aspirin. No action was taken against the drug maker that submitted misleading preliminary safety data in its application for FDA approval. It is now known that this anti-inflammatory drug caused thousands of side effects and was associated with the deaths of an estimated 20,000 Americans, mostly due to heart attacks.
If more consumers knew about the benefits of natural products, fewer people would opt for pharmaceutical drugs—a situation which the FDA will not tolerate.
Censorship in action
If a supplement manufacturer wants to make a statement about a product, and the FDA deems that statement to be a “disease claim,” then the manufacturer must take the product through the extremely lengthy and outrageously expensive drug approval process—it costs hundreds of millions of dollars, sometimes over $1 billion, for each product. (The same holds true for what they call a New Dietary Ingredient, which is any supplement or ingredient introduced or significantly modified since 1994.) In this way, the FDA prevents supplement manufacturers from informing consumers about potential health benefits, and restricts the introduction of innovative new ingredients.
Doctors are reluctant to prescribe medications that are not approved by the FDA—they can lose their licenses for doing so, since their actions might be seen as falling outside the so-called “standard of care.” This is especially true for doctors wishing to prescribe therapeutic levels of vitamins and other supplements to their patients.
All prescription medicines are patented (we used to call them “patent medicines”), and the patent protection lets the manufacturer recoup all the money they had to spend to get the product approved. Natural substances—in this case, food or nutritional supplements—cannot be patented. Without patent protection, dietary supplement manufactures are unable to recoup the cost of a drug-like preapproval process.
The bottom line: Supplement companies are forced by law to keep silent about the scientific research concerning their natural products.
This ensures that consumers are in the dark about the benefits of safer, cheaper, and often more effective natural products—and that American medicine continues to be dominated by pharmaceutical drugs.
Supplements are not drugs!
Forcing dietary supplements into a regulatory framework that was designed only for pharmaceuticals raises cost for consumers, decreases innovation and choice, and could force tens of thousands of safe supplements out of the market. Defending dietary supplements from attacks by the media, the pharmaceutical industry, and elected officials who prefer a pre-market approval approach is one of ANH-USA’s top priorities.