University of Florida pharmacy professor Paul Doering said that if this was the 1920s, we'd be talking about medicines derived from plants or animals, which would be similar to many of today's dietary supplements. "That's all we had back then," he said. But Doering said that after World War II, the trend changed from herbal products to the scientific approach. "What we do now is identify the active ingredient, figure out a way to isolate it, extract it, standardize it and put it in a pill," Doering said. "For decades we've been perfectly happy with that."
One reason modern medicine moved away from herbal preparations is that synthetic drugs are easier to purify and standardize. "When you take a 325-milligram aspirin tablet, you get 325 milligrams, give or take a milligram," Doering said. "Herbs on the other hand, can vary widely in their concentrations of active components because they are not prepared under the rigid guidelines that drugs are."
But the natural past is coming around again to meld with the synthetic future, and both lawmakers and consumers are hard-pressed to keep up with the breakneck pace of scientific developments in the fields of pharmaceuticals and dietary supplements.
Varro Tyler, who is a best-selling author and a Purdue University professor emeritus of pharmacognosy -- which is the study of medicines made from plants -- said that because of the many different constituents in plants, the active ingredients tend to be more diluted than those in pharmaceutical drugs. Tyler said self-medicating with herbal remedies for ailments such as mild headaches, the common cold or a strained muscle is probably OK.
"But sufferers of cancer, rheumatism, arthritis or cardiac problems require professional medical treatment," Tyler said. "Self-treatment for such conditions woud be utter folly."
Many industry professionals believe the United States should have three regulatory categories:
1. Dietary supplements, which would be the essential vitamins, proteins and minerals.
2. Natural medicines, such as they have in Europe. This would include botanicals such as St. John's wort, products isolated from fungi such as Red-yeast rice, and glandular derivatives such as steroids.
3. Prescription and over-the-counter drugs.
Thus, the Commission concluded, "The dietary supplement industry has a responsibility not only to affirm that such scientific evidence exists, but also to make summaries of that information available to the public." But obstacles to this goal remain, such as underfunding by the federal government as cited by the President's Commisssion, and the fact that dietary supplements cannot be patented.
Mark Rush, Ph.D., a University of Florida economics professor, said, "In the absence of government action, it is unlikely that any individual firm will spend its money to uncover valid scientific evidence for most of these dietary supplements." "The problem is, each firm figures if it spends its money on expensive testing, all of its competitors will benefit from those studies when the results are published."
Although the federal goverment is trying to address problems in the dietary supplement industry, some Americans say they don't want the government making decisions regarding the health of citizens. This sentiment is as old as the country itself. During the fight for passage of the first Federal Food and Drugs Act of 1906, a Georgia Congressman said, "The Federal Government was not created for the purpose of cutting your toe nails or corns." But government and private sector health officials said that to make good health decisions, people need reliable information.
Sen. Orrin Hatch said Congress is hopeful that under the new leadership of FDA Commissioner Jane Henney, who replaced the highly controversial David Kessler, the agency can meet the challenges of rapid and unprecedented advancement in the biolgical sciences. Rep. Henry Waxman, who generally opposes Hatch, agreed that Henney seems to be up to the task at hand. "If I have learned one thing about dietary supplements over the years, it is that we need to reduce the mistrust and polarization that has surrounded this issue for far too long," Waxman said. "I believe Commissioner Henney understands this, and I look forward to learning her ideas about dietary supplements."
Professor emeritus Varro Tyler said it is impossible to deny the need in the United States for a rational system to regulate and promote the sensible use of herbal medicines and other supplements. Tyler said the "no health-claims" policy for dietary supplement labels in the United States, which only provides for vague statements about structure or function, is satisfactory to no one.
"Since no company is going to spend millions of dollars to prove an herb is effective, it is necessary to change the rules to permit reasonably substantiated claims about effectiveness," Tyler said. "The alternative is to allow the American public to wallow in ignorance."
Each category cited above has its own regulatory dilemmas, but some possible solutions to confusion in the dietary supplement marketplace are beginning to emerge:
• The Botanical Codex Committee of the American Society of Pharmacognosy recommended the preparation of a volume that would present in a well-referenced, concise form, all information necessary for the identification, determination of purity, uses, and safety and effectiveness of the major botanicals.
• The German Commission E monographs, which is a book containing in-depth descriptions of about 300 herbs, has recently been translated into English. About 200 of the herbs in the widely respected book have been approved as safe by the German equivalent of the FDA. However, Commission E does not disclose the scientific basis for its conclusions. A link that provides some of the Commission E monographs can be found at: AMERICAN BOTANICAL COUNCIL
• The U.S. Pharmacopeial Convention is beginning to re-establish standards for herbal supplements in the United States, which will be published in the books, "The U.S. Pharmacopeia XXIII and the National Formulary XVIII, which are published every five years." The U.S. Pharmacopeia was once the authoritative source of legal standards for herbal drugs. For example, until 1882, it was permissible to label Ginseng as a "useful stimulant" based on information in the Pharmacopeia. However, when well-meaning regulators applied 20th century standards to 19th century herbal medicines, the evidence for herbals did not fit in the new system and was discarded.
• Herbal pharmacopeias from other countries, including France, England, Germany, Japan and China, have been recommended by the President's Commission on Dietary Supplements for evaluation by scientific bodies of the U.S. government.
• The Council for Responsible Nutrition, a Washington-based trade group for the dietary supplement industry is releasing a new publication titled the "CRN Reference on Evaluating Botanicals." The book provides an extensive table showing more than 340 botanical monographs.
• Some larger scientific bodies, such as the Centers for Disease Control and the National Institutes of Health, are starting to put together resources that consumers can access for quality information.
• Section 13 of the Dietary Supplement Health and Education Act (DSHEA) established the Office of Dietary Supplements within the National Institutes of Health. As specified in the Act, the duties of the office are:
• Conduct and coordinate scientific research relating to dietary supplements.
• Compile a database of scientific research on dietary supplements.
• Act as a public information clearinghouse.
• Coordinate funding relating to dietary supplements.
The President's Commission points out, however, that "Congress is not funding the Office of Dietary Supplements at the levels authorized by the Act."
But some studies are being funded by private and public organizations. Director Wayne Jonas of the Office of Alternative Medicine reported in 1999 that more than half of the 18 institutes at NIH are supporting clinical research involving complementary and alternative medicine. He estimated the NIH will spend nearly $52 million this year on various projects including research on antioxidants to prevent cardiovascular disease, sponsored by the National Heart, Lung and Blood Institute, and a study on relaxation therapy for caregivers of Alzheimer's patients, sponsored by the National Institute for Nursing Research.
Several new studies on Ginkgo Biloba are being funded around the country. Under the direction of the NIH, the University of Pittsburgh School of Medicine was awarded a six-year, $15 million grant to study the efficacy of Ginkgo Biloba in preventing dementia in older individuals. Based on the first clinical study of Ginkgo Biloba and dementia in the United States, research suggests that a Ginkgo Biloba extract may be of some help in treating symptoms of Alzheimer's disease and vascular dementia. The study may be reviewed in the Journal of the American Medical Association, (Oct. 22/29, 1997). Noted herbal expert Varro Tyler said that Ginkgo Biloba has only shown efficacy in patients with vascular dementia. He said there is no evidence that it improves memory in normal adult humans.
Another study, begun in 1993 by the American Botanical Council, is the Ginseng Evaluation Program (GEP). GEP is seeking to set standards and increase consumer confidence in Ginseng products. About $700,000 has been contributed by the council and more than 20 manufacturers to fund the studies. The council needs an additional $170,000 to evaluate and publish the results. When finished, results will be available at: CONSUMERLAB.COM.
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