CHAPEL HILL -- Because plants have been used to treat illness since before modern humans evolved and will remain popular into the foreseeable future, the nation needs to combine common sense with good science in its response to medicinal herbs.
That's the view of Dr. Varro E. Tyler, one of the world's leading experts on the subject.
"In my opinion, this is a scandalous situation," Tyler said. "Here we have products that are used by one-third of the adult population in the United States with a retail annual market value approximating $4 billion, and the FDA, by establishing artificially high proof-of-efficacy hurdles, refuses them drug approval. Compare this with the situation that has worked so well in Germany for many years in which 'reasonable' amounts of proof are accepted as evidence of efficacy for phytomedicines, allowing the products to become an integral part of mainstream medicine."
Author of more than 30 books, Tyler is distinguished professor emeritus of pharmacognosy at Purdue University and dean of pharmacy emeritus. He spoke Thursday (March 2) at the University of North Carolina at Chapel Hill at the first international scientific conference on medicinal herbs.
"The ancient origins of herbal medicine are indisputable," he said.
Archaeologists have found pollen and flower fragments from different medicinal plants in Neanderthal tombs in Iraq dating back some 60,000 years, the scholar said. Cannabis -- the marijuana plant -- is believed to have been used for more than 8,000 years in China, and opium, first produced in Mesopotamia, has been an important painkiller for some 5,400.
"The mummified human discovered in the Italian Alps in 1991 and now referred to as 'the iceman' possessed two pieces of birch fungus," Tyler said. "Scientists speculate that this 5,300-year-old human was using the fungus as a drug, possibly as a treatment for intestinal parasites."
The golden age of herbal medicine in the United States straddled the latter years of the 19th century and the early years of the 20th up to passage of the Food and Drugs Act of 1906, he said. During their heyday, hundreds of herbal products were available, usually with high alcohol contents, and many of the advertising claims made for them were outrageous.
For the next three decades, herbal extracts anchored the drug side of medical practice in this country. Those compounds were quickly supplanted when scientifically created, remarkably useful synthetic drugs such as the antibacterial sulfanilamide were developed by the Germans and others. Benefits of the new drugs included patent protection that would cover development costs and produce profits as well as standardization that resulted in known strengths.
"In comparison, many of the old botanicals were also effective, but they were discarded because of lack of patentability and subsequent assured profit margins," Tyler said. "Because they often owed their activity to multiple ingredients, many of which remained unidentified, they were difficult to standardize. Uniformity of action was practically unattainable."
Digitalis, valued as a remedy for congestive heart failure but impossible to standardize, typified the problem, he said. By the 1960s, unlike those used in most other countries, almost all U.S. medicines were synthetic.
"Then a curious thing happened," Tyler. "In the '70s and '80s, scientific and clinical reports began to come out of advanced European countries, especially Germany, indicating that the herbal remedies, which had never been totally discarded there, had many substantial therapeutic and economic benefits for the consumer."
Even such all-American herbs such as echinacea and saw palmetto were found by European scientists to have health benefits without significant side effects, and Americans began to demand them. By the late 1990s, annual sales reached almost $4 billion here.
"But all was not well in herbal America," he said. "The Food and Drug Administration had long insisted that to obtain approval as a drug in this country, herbs had to be supported by the same amount of costly evidence of efficacy required for new synthetic drugs.
"Because of lack of patentability of the long-known herbs and consequent lack of market exclusivity, companies were unwilling to make the substantial investment required to prove their efficacy," the scientist added. "Consequently, only a handful of herbs, many of them quite insignificant from the therapeutic viewpoint, have ever received drug approval in this country."
The FDA responded poorly to the growing demand for herbal medicines, and former FDA commissioner Dr. David Kessler called those involved in the field "snake oil salesmen," Tyler said. Kessler seemed intent on removing all such unapproved herbals from the U.S. market, but the FDA backed off when Congress received more complaints than it had on any subject since the Vietnamese war.
"I can imagine, with tongue partially in cheek, our overcrowded courts dealing with cases involving the possession...of a bottle of prune juice purchased for use as an unapproved laxative," Tyler said.
In 1994, the Dietary Supplement Health and Education Act became law. It kept products on the market but did not allow therapeutic claims to be made for them. Instead, the law required a statement on the label noting that the herbs inside were not good for anything.
"Users disregarded the label and turned to other sources, books, pamphlets, fliers and the Internet for information," he said. "Much of what they found was hyperbolic in character, designed to sell the product, not to inform accurately."
New FDA regulations published this January liberalized claims that can be made for herbal products, but remained confusing and inconsistent, the scientist said. Ultimately, those regulations will not meet the public need for accurate information about safety and effectiveness. More importantly, the act failed to establish standards of quality for individual herbal products -- "without question, the biggest single problem in the entire field" today.
"There is absolutely no way that consumers can be assured that what is on the label is actually in the package, other than the reputation of the producer," Tyler said. "Unfortunately, the name of the original producer is often not identified on the label by the marketer."
Another problem is that companies "borrow" science from other reports to claim their products are similarly safe and effective without supporting evidence, he said. A second is that the herbal market is flat now because of the many junk products that offer no real benefits.
Still another is that the news media have blown stories about negative drug reactions involving herbs out of proportion to reality because "negative stories sell newspapers." Too often journalists, physicians and scientists have been unaware of -- or disregarded -- the scientifically valid clinical trials of various herbs that have already been conducted.
For herbs to take their proper place in the nation's medicine cabinet attitudes of uninformed professionals need to change, just as nonprofessionals need to stop subscribing to nonscientific dogma bordering on mysticism, Tyler said. So too must certain manufacturers abandon unsupportable claims and work toward better quality control. The FDA needs to adopt a reasonable policy toward herbal medicine, and the federal government must support meaningful research.
"Even after working in the field of plant drugs for nearly 50 years, I remain an optimist," Tyler said. "After all, for much of that period, natural drug products were scorned by professionals and the public alike. Now they are highly valued, and with good reason, by a very large segment of the population."
Note: Tylor will be at the Smith Center during the conference. Afterwards, he can be reached at (765) 463-5326. Conference co-chair Dr. Lenore Arab's number is (919) 966-7450.
Contact: David Williamson, (919) 962-8596.