Herbs and Health Care in the Twenty-first Century

Varro E. Tyler, Ph.D.

Department of Medicinal Chemistry and Pharmacognosy
School of Pharmacy and Pharmacal Sciences
Purdue University, West Lafayette, Indiana 47907-1333

For I dipt into the future,
Far as human eye could see,
Saw the vision of the world,
And all the wonder that would be....

- TENNYSON, Locksley Hall

Permit me to express my sincere thanks to the organizers of the Tenth National Herb Growing and Marketing Conference (HERBS’95) for the honor of presenting the Otto Richter Memorial Lecture. It hardly seems possible that a decade has passed since I addressed the first Conference in the series held at Purdue University in West Lafayette. That was also the first time I met Otto Richter, whom I subsequently came to admire for his knowledge, his ability, and his integrity. I consider it both a privilege and a pleasure to deliver the following remarks as a tribute to him and to his many important contributions to our area of interest.

when I was a teenager, I inherited from the estate of an uncle, his collection of popular scientific magazines from the first decades of this century. The imaginative covers of many of these depicted inventions that someone was certain would play a significant role in our future. These ranged from self-propelled, passenger-carrying hydrogen balloons and long-distance monorail trains in the transportation field to death rays and giant cannons in the armament area. I do not believe anyone has made a scientific survey to see just how many of these predictions have come true, but I have the impression it is a very small percentage. Further, I do not recall their forecasting any of our current everyday realities, such as jet planes and intercontinental ballistic missiles.

This shows the hazard of making predictions, especially long-range predictions, about the future course of human events. Every January 1, the newspapers are filled with the prophecies of the so-called psychics; every December 31, when their score is tallied, we find that even these "professionals" were not very successful. So, it is obviously hazardous to attempt to foresee the future; the more distant that future, the more hazardous it becomes. however, in a sense that makes it more interesting to try. Besides, fools often do rush in....

I made my most recent attempt to predict the role of herbs in twenty-first-century health care just 10 years ago in a paper presented at the annual meeting of the Society for Economic Botany (1985) which was published in 1986! In it, I made a few short-range predictions that have been validated by the subsequent course of events. For instance, I predicted, "The ‘green wave’ will not only continue to gain momentum, it will reach the shore where its powerful impact will make an indelible impression on the old sea wall, even removing some of it." Placed in context, those remarks meant that people would demand the right to use herbs and phytomedicinals for therapeutic purposes and that laws and regulations would be forced to accommodate their desires.

This prophesy has already been fulfilled, at least in part, by Congress when it passed the Dietary Supplement Health and Education Act of 1994. Recall that FDA Commissioner David Kessler had threatened a year earlier to remove botanicals from the market by implementing a series of proposed regulations scheduled to become effective in 1994. Although he later retreated somewhat from his original position, he nevertheless retained the authority to carry out his threat. Congress is said to have received more mail on this issue than on any other since the Vietnam war; as a result, herbs and phytomedicinals retained their marketability under the euphemistic title "dietary supplements," albeit without labeled therapeutic or health claims. The FDA was charged with the burden of proving them unsafe before it could restrict their sale. Final regulations have not yet been formulated or published but must be made available within two years following enactment of the legislation. Score one preliminary victory of the public.

However, my forecast of a corollary move, so necessary if these products are to be utilized properly in medical care, has not yet come about. Of course, it is still not the twenty-first century ­ quite! I predicted the government would "ease somewhat the unnecessarily rigid standards for marketing new drugs, particularly drugs from plants long in use as folk remedies..." At the moment, the FDA shows little sign of providing any special consideration for this group of products. Because of their long history of use, they are probably not patentable. Therefore, no company is willing to invest the substantial sum required for extensive randomized clinical testing, and lacking these data, the FDA is unwilling to approve them as drugs. It is a classic Catch-22 situation that has nearly destroyed research on the classic plant drugs in the United States.

Still, there are some indications that the FDA is becoming aware of some of the special needs of herbs and phytomedicinals. Two conferences held in Washington, D.C., in December 1994 and February 1995 were cosponsored by that organization, and number so f FDA personnel attended both.. In addition, the Administration has announced its intention of evaluating complex phytomedicinals as single drugs rather than continuing to insist that each chemical consitutent be evaluated separately. We can at least hope that other necessary concessions leading toward reasonable regulating will be forthcoming in the future.

Some may wonder why I deem it so necessary for botanicals to be marketed as approved drugs in this country, so that topic is worth of some consideration. In the first place, agents used to attain or maintain health are drugs. It seems deceptive to have to refer to them as dietary supplements, and I dislike deception. Another reason is that, in their present category, they cannot be properly labeled with suitable health or therapeutic claims and precautions concerning their use.. This makes it very difficult for the ordinary layperson to use them properly. In addition, although many are useful medicaments, they will never receive the attention they deserve in the curriculums of medical and pharmacy schools unless they are classified as bona fide therapeutic agents. Also, patentable or not, classification as "dietary supplements" will discourage therapeutic research on botanicals; if they are properly classified as drugs, research will be encouraged. Finally - and this will become an area of ever-increasing importance in the health-care systems of the future- insurance companies and federal agencies will not reimburse patients for their purchase cost unless they are recognized as safe and effective drugs.

Let’s pursue this latter point in additional detail. It now appears relatively certain that most medical care in the next century will be conducted on a capitation basis. This means that some enormous health-care provider out there somewhere, as the result of having submitted the lowest bid, will be awarded the contract to provide total care for you and your fellow employees or fellow participants in your group plan. That means this health-care provider will do everything possible to spend as little money as possible on each of the individuals for whom it is obligated to provide care. The provider will want to help you to maintain your health; it will also want to provide the least expensive effective treatment available if you do become ill.

Drugs will be a big item in such programs. They are relatively inexpensive, requiring only modest human effort to prepare and dispense, and are quite economical in comparison to high-tech personal medical services such as open-heart surgery ­ or even a stay in a hospital room. Therefore, if a vasodilator can be effectively used instead of cardiac surgery, the cost-driven medical care of the future will certainly choose the former.

Many herbal medicines fit in very well with this scheme of health managamement. Ginkgo for cerebrovascular insufficiencies, garlic for hypercholesterolemia, echinacea for colds and relate viral infections, valerian as a minor tranquilizer, feverfew for migraine prevention, St. John’s wort for depression - the list could go on and on. However, none of these products will be utilized in such regimented health-care plans, even though they are considerably less costly than synthetic medicines, unless they are classified as safe and effective drugs. It therefore becomes imperative for them to be recognized as the drugs they are if they are to be widely utilized and if their cost is to be reimbursed by a third party.

When I tell people that ginkgo biloba extract is a best-selling prescription drug in Germany, they often look at me askance and then ask why it is sold as a prescription drug. I then point out that there are two identical ginkgo products manufactured by different divisions of the same organization and sold under different trade names in Germany. One is Tebonin® forte, the best-selling prescription drug; the other is rökan®, a popular over-the-counter product. Why two names for the same product? The cost of the prescription drug is often reimbursed by the government; the cost of the OTC drug is not. It’s just that simple.

I think we should not underestimate the significance of drug reimbursement eligibility in the health-care plans of the future. As medical care becomes more socialized in this country - and that seems to be its destiny ­ marketers will almost certainly encounter increased resistance from patients to paying for drugs from their own pockets. Everything else will be paid for; why is it necessary for me to pay for drugs? This thought already dominates the minds of patients in England, France, Germany, and to some extent, even Canada. If herbs are not recognized as drugs, professionals will not endorse them, and they will not be used, at least to any great extent. If, on the other hand, they are classified as drugs, they will be widely used because of their relatively low cost.

They key problem of the twenty-first century thus becomes one of how best to achieve this objective. Reluctantly, I have become resigned to the fact that it probably cannot be attained as long as the present decision-makers remain in authority at the FDA. It is always frustrating for ordinary human beings to deal with a bureaucracy, and, unfortunately, the FDA has become one of the most difficult in this respect. The agency, which should be one of the most responsive to public needs in carrying out its much-needed role, has all but ceased to listen to voices other than its own.

Attempting to deal with policy-makers in the FDA always reminds me of a classic science fiction short story by Chan Davis titled "Adrift on the Policy Level". It it, a university professor and businessman acquaintance were attempting to sell executives of a large corporation of the future on the economic significance of an enzyme the professor had developed. After being introduced in tot the corporate maze by a very attentive receptionist, they received less and less attention from each successive higher echelon executive to whom they were referred.

Finally, they reached the level of a decision-maker in the organization, a female regional director who was a master psychologist. With out speaking a word to them, by the expert use of body language she made the would-be entrepreneurs feel so badly about intruding on her valuable time that they sneaked out of her office without ever making their sales pitch to her. As they drove away, the professor remarked to his friend, "Our society certainly rewards its most deserving members". The regional director had simply turned out to be the fittest salesperson, even though she did not necessarily have e the fittest idea.

The dogmatism with which FDA officials cling to their outmoded ideas about the degree and the type of proof required to designate long-used plant drugs safe and effective both astonishes and saddens me. In my entire academic career, I have never experienced an audience more unwilling to listen to my professional thoughts. However, last year I did find one person in Washington willing to listen to my thoughts on the subject. He was John T. Myers, 7th District Congressman from Indiana, who, I believe, was initially opposed to the Dietary Supplement Health and Education Act of 1994, but who, after several exchanges of correspondence, supported it.

This experience causes me to believe that if botanicals are ever to take their proper place as drugs in this country, it will be the result of action initiate by Congress, not by the FDA. This has been the case throughout this century. As most of you are aware, plant drugs utilized prior to 1906, and most fall into that category, were "grandfathered" from the safety and efficacy requirements of both the 1938 Food Drug and Cosmetic Act and the 1962 Amendments to it. Unwilling to accept the will of Congress, the FDA implemented clever Regulations that allowed herbs to be sold, but not as drugs and without any information concerning their therapeutic benefits. Additional Congressional action will be required to assure that herbs and phytomedicinals assume their rightful role as approved medicines in this country. If enough people approach Congress on this issue, I predict it will happen sooner than later.

A factor that may have a profound influence on herbal medicine in the next century will be the economic advantage of keeping persons well rather than treating as long as they remained healthy and ceased to pay them when they became ill. Capitated health care will work that way too, at least as far as profits for the providers are concerned. This would seem to provide enormous opportunities for herbal adaptogens or tonics or stress-fighting products, whatever they are called. The problem is, we simply lack sufficient data to prove whether these herbal health aids are truly effective in human beings.

Let us use ginseng as an example. During the last decade, assessments of the activity of this herb have been published by Staba, by Lewis, and by Bahrke and Morgan. Staba concluded in 1985 that long-term, controlled human experiments are needed to identify beneficial or harmful physiological effects. A year later, Lewis stated that ginseng has no proven efficacy for humans. Bahrke and Morgan, writing just last year, decided that there is an absence of compelling research evidence demonstrating the ability of ginseng to enhance consistently physical performance in humans. If the effects in humans of this "most studied" adaptogen remain unproven, what about the lesser studied ones such as eleuthero and ashwagandha? Their action is obviously much more doubtful.

No organization is going to invest in the millions of dollars required to prove ginseng an effective performance and endurance enhancer because those research costs could never be recovered on an unpatentable commodity. Probably the only way to finance such an activity would be through federally funded grants. The amount, however, would have to be substantial, probably in the neighborhood of $100 million. If the botanical proved to be an effective agent for improving health, this seemingly large sum would be awarded by the savings involved. It would be difficult to obtain funding for such a study. The high cost would be one negative factor; but in addition, I believe that the intolerance of physician panel member should present an insurmountable obstacle to the approval of such a project.

I honestly do not know if the apparent negativism of certain medical doctors toward phytomedicinals is based on tradition, experience, or outright ignorance. Perhaps all three factors are involved, but the latter is probably the most significant. Al of us tend to oppose, or at least not support, that about which we know nothing. Whatever the cause, the intolerance is often evident.

For example, the prominent epidemiologist Paul Knipschild of Limburg State University in the Netherlands has, with colleagues, conducted several meta-analyses of the result of human clinical studies on herbal medicines. Their report on garlic was published in English the British Journal of Clinical Pharmacology in 1989. Their meta-analysis of ginkgo biloba extract studies appeared in the same journal in 1992. Prior to these efforts, in 1988, an analysis of ginseng studies by Prof. Knipschild was published in the Dutch language in the Pharmaceutish Weekblad, a pharmacy journal of very limited circulation. In that article, he noted (in translation), "Biomedical research has not yet been able to issue a decisive statement on the effect of ginseng on vitality". Then he commented further on the difficulty in publishing the results of human experiments on ginseng. His own review article has been submitted to other periodicals but was not accepted for reasons that were unclear to him. Even publication in the Dutch language journal was preceded by a lengthy evaluation process.

Professor Knipschild’s statements bring to light a very interesting situation with respect to ginseng specifically, but it is one that may be applicable to herbal studies in general. While the experts decry the lack of human clinical trials, could it be that a selective publication process prevents those studies from being published in the widely read English-language journals? If so, that would be another herbal Catch-22 circumstance, indeed. I recall the faulty ginseng-abuse syndrome paper in the Journal of the American Medical Association and the erroneous ginseng hairy-baby case in the same journal, but I cannot recall any report of a pro-ginseng clinical trial having been published there in recent years. I also remember the 1994 article in Lancet in which Swedish investigators could not detect ginsenosides in six preparations analyzed, Knipschild is correct, and the studies needed to prove the effectiveness of ginseng in humans have not been conducted because they cannot by published, that is a serious indictment of the scientific method which should concern all parties, pro- or anti- ginseng, pro- or anti-phytomedicinals.

Before going too far in blaming the FDA, conservative physicians, prejudiced publishers, and others for the herbal chaos that now prevails in this country, we need to place a large measure of responsibility for the situation squarely on the shoulders of another group at least equally culpable ­ namely, the herb producers and marketers themselves. In my opinion, the herb industry has long been its own worst enemy when it comes to tarnishing the image of botanicals. Unproven hyperbolic claims of efficacy probably have done more harm than any other activity in the field, but we cannot overlook poor quality control, deceptive labeling, adulteration and sophistication , resistance to standardization of dosage forms, continued sale of herbs known to be harmful, and failure to support research, as well as numerous other practices that project a terribly negative image for the industry as a whole. We cannot expect government and other health-care practitioners to support and endorse our activities unless we place our own house in order first.

Recently, I have been working with Steven Foster to prepare a chapter on herbal medicine for the 11th edition of the Handbook of Non-Prescription Drugs scheduled to be published early next year by the American Pharmaceutical Association. This chapter, which was solicited by the editors, is a real breakthrough in legitimizing the use of herbs and phytomedicinals because it tends to place them on a par with other common self-selected remedies.

In connection with the chapter, the editors requested tables designating, by trade name, some of the more common products together with appropriate details concerning their composition. To obtain that information, I wrote nearly a score of the leading producers and distributors, explaining our need and requesting appropriate data. A very few responded immediately in considerable detail. Some eventually sent a pamphlet intended for any consumption that told little except how wonderful their product(s) was. Some of the largest ­ and supposedly more reputable ­ firms did not respond at all! (Some, I suppose, will alter wonder why their products were omitted from our listings.) If the industry reacts in this evasive, or even negative, manner to people who are really attempting to assist them, it is little wonder that they have failed to establish good rapport with their critics. Recognizing that this statement applies to many but not to all, I still find it necessary to repeat my conviction that the herbal products industry in the United States is its own worst enemy!

All of this simply shows that we have some problems to solve before herbs and phytomedicinals can begin to play significant roles in the health-care systems of the twenty-first century. But if there were no problems, we would have neither challenges nor opportunities, and humankind would have little to do. One of the things that will give us plenty to do in the future will be the search for new drugs. In many cases, it will be a race against time to examine numerous species chemically and physiologically before they are lost forever from the face of the globe.

In the last 30 years, the search for new drugs from higher plant sources has not been very fruitful. If we count only isolated chemical entities used per se ­ that is, without chemical modification ­ there have been only three success stories during that period. These were the anitcancer alkaloids vinblastine and vincristine from he Madagascar periwinkle and another antitumor agent, taxol, from the Pacific yew. If we add semisynthetic modifications of naturally occurring molecules to our list, we must include etoposide, another oncolytitic agent. It is prepared from podophyllotoxin, a constituent of the American mandrake or mayapple.

To these isolated or semisynthetic chemical drugs I would add eight herbal products that, in my opinion, have been adequately tested during the last decades to allow their use as safe and effective drugs. Ginkgo, garlic, echinacea, and saw palmetto would be my number one recommendations, followed closely by feverfew, valerian, milk thistle, and hawthorn. These plants or plant extracts, particularly in standardized dosage forms, offer definite advantages in treating the conditions for which they are indicated and should be a part of our everyday materia medica well into the next century.

Nevertheless, this paucity of newly developed or newly proven useful remedies of natural original reminds us that additional research is needed ­ indeed, urgently needed ­ if we are to be able to investigate even a small part of the total species of plants in the world before they are slashed and burned into extinction by a burgeoning plants in the world before they are slashed and burned into extinction by a burgeoning population. That race will probably be lost in the next century, but not before a number of new and useful plant remedies for viral diseases, deceases of unknown etiology, and even genetic diseases have been discovered.

I have always regarded myself as an optimist, but I must admit that I am not very sanguine about the outlook for health care or anything else in what I regard as the remote future ­ the second half of the twenty-first century. Our profligate use of nonrenewable resources such as petroleum, our immense population problem, and the accompanying loss of human individuality and dignity will probably make it a world in which I would not care to live. However, in the short term ­ the next 50 years ­ I believe that herbs and phytomedicinals can fit very nicely into the health-care system. I also believe that they will earn such a place there, of their own merit, if we are smart enough and persistent enough to overcome some of the obstacles that currently prevent them from occupying their rightful place.

Let us all continue to devote our lives to this attainable goal. It will benefit all people and is, therefore, worthy of our best efforts!



SUGGESTED READING

Bahrke, M.S. and Morgan, W.P.: Evaluation of the Erogenic Properties of Ginseng, Sports Medicine 18:229-248 (1994)

Davis, C.: Adrift on the Policy Level, in Science Fiction of the Fifties, Greenberg, M.H. and Olander, J., eds., Avon Books, New York, 1979, pp. 367-386

Knipschild, P.: Ginseng: pep of nep?, Pharmaceutisch Weekblad 123: 4-11 (1988)

Tyler, V.E.: Plant Drugs in the Twenty-first Century, Economic Botany 40: 279-288 (1986)

Tyler, V.E.: Medicinal Plant Research: 1953-1987, Planta Medica 1988: 95-100 (1988)

Tyler, V.E.: Should Herbal Remedies Remain in FDA Regulatory Limbo?, Nutrition Forum 9: 41-45 (1992)

Tyler, V.E.: Herbs of Choice: The Therapeutic Use of Phytomedicinals, Pharmaceutical Products Press, Binghampton, New York, 1994, 209 pp.

United States Congress (103rd, 2nd session): Dietary Supplement Health and Education Act of 1994, Senate Report 103-410, 49pp.


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