Complementary Alternative Cardiovascular Medicine

14 Alternative Cardiovascular Medicine
one-third of the world’s population. However, the best accepted forms
of herbal therapy today are those that are supported by modern clinical
research, usually involving semipurified, standardized extracts of single
herbs or simple combinations of fewer than six herbs, in contrast to the
complex mixtures characteristic of TCM remedies. The highest quality
research is on single-herb extracts, such as ginkgo, St. John’s wort, and
saw palmetto.
GOVERNMENT REGULATION OF HERBAL PRODUCTS
Although many believe that herbal medicine was displaced by safer
or more effective medicines, the truth is that synthetics overtook natural
medicines in the pharmacy because of economics and regulation, not
science and medicine. In the early 20th century, the US Congress,
alarmed by questionable “patent medicines,” established the Food and
Drug Administration (FDA) and required foods and drugs to be proven
safe before they could be sold. As more sophisticated and expensive
research methods were devised, it became increasingly expensive to
establish the safety of drugs. In 1962, Congress passed the additional
requirement that drugs be proven effective, further increasing the cost of
drug approval. Drug industry statistics set the cost at an average of $350
million to prove that a drug is safe and effective, and it can take 5–12 yr
or more to gain approval. Drug companies can recover research and
approval costs through the sale of the drug but only if the company has
the exclusive right to sell it. However, herbal medicines are rarely patentable,
denying companies the exclusive right to sell them. Patent law
prevents people from claiming that they invented substances or technologies
that were already known. Common substances such as ice or
ginseng, have been known for too long to be patentable. If a company
choses to spend $350 million to prove that ginseng is safe and effective,
anyone could sell it as a safe and effective drug. The effect of regulation
and economics on plant-based pharmaceuticals has been chilling. Since
1962, not a single new complex plant drug has been approved in the
United States. Because herbs could not be sold as medicines, they were
regulated as foods or occasionally as food chemicals (additives). Today,
herbs, as well as vitamins and minerals, are regulated as dietary supplements
in the United States.
The Introduction of DSHEA
The relationship between the FDA and the American herb industry
has been highly adversarial for the past 30 yr. In 1994, the US Congress
unanimously passed a bill called the Dietary Supplement Health and
Education Act (DSHEA), which defined dietary supplements as special