FDA and the Market In Natural Medicine; S. Hiller

-The Method of Freedom One way people have asked the State to intervene on their behalf is by seeking pro tection from the sale of dangerous foods and drugs. In 1931, after more than 100 people died from a poisonous solvent used to make the wonder drug sulfanilamide, the Food and Drug Administration came into exis tence, one of many new arms sprung forth on the body of expanding government. In 1938, despite intense lobbying against it by Ms. Hiller is a mother andfree-lance writer living in Sebastopol, California. the pharmaceutical and food-processing in dustries, the FDA was fully empowered to protect the public against impure and unsafe foods, drugs, and cosmetics by the Food, Drug and Cosmetic Act. Since then, gener ations of America's children have been taught that consumer confidence in the pu rity of what it imbibes rests on the strong shoulders of its benevolent guardian, the FDA.

Sixty years later, new legislation was passed to clarify what health claims may be made on the labels of packaged foods. The FDA's proposed regulations for the labeling of health supplements created a tremendous stir. The new regulations threatened to choke the trade in herbs and vitamins. Intense protest by consumers as well as producers revealed that public perception of the FDA had changed. No longer some benevolent jolly green giant, the FDA ap peared as the enemy of the public will. And while people protested, powerful interests in the more established medical world gave their unseen support. Clearly the name of the game has changed. The establishment of government as the largest player in every market (and in every aspect of our society) has alienated the populace and fostered a public cynicism that threatens to undermine the very foundations of our society. Hence the current move by the FDA is but one aspect of a deeply entrenched pattern in 520 our society, and in that context, it raises old and troubling questions about the future of freedom in our nation.

Herbs and Vitamins Enter the Mainstream Natural, or alternative, medicine has be come a $14 billion a year business. Of this substantial sum, over $1 billion comes from the sale of herbs and vitamin supplements produced by American manufacturers, most of them small entrepreneurs who distribute their products through some 5,730 indepen dent natural food stores and 1,598 chains. No longer a small group of offbeat coun terculturalists and eccentric health faddists, patrons of such outlets include growing numbers of mainstream Americans who, daunted by the rising costs of conventional treatments, or troubled by their inefficacy in relieving chronic diseases, are seeking other ways to protect or restore their health. Despite repeated attempts by the FDA to control this growing industry, the sale of herbs and vitamin supplements has re mained largely unregulated. Classified as "foods' , by the Proxmire Amendment of 1976, supplements could be sold over the counter provided their ingredients were listed on the label and no health claims were made. But when companies like Kellogg's began to claim that high-fiber cereals could prevent colon cancer, some form of regula tion appeared to be necessary to allow valid health claims to be stated on the label.

Hence the Nutritional Labeling Education Act (NLEA) was passed. The FDA, the regulatory agency assigned to enforce the law, took this opportunity to clamp down emphatically on the widespread use of supplements and herbs. In its 500 pages of amendments to the legislation, the FDA placed severe limitations on the infor mation that could be printed on their labels, arguing that their efficacy had not been sufficiently attested. But it went even fur ther. The FDA asserted that vitamins in larger dosages than those found in ordinary foods, as well as all herbs not used for seasoning, could be reclassified as drugs. At 521 the same time, it threw out the familiar RDA (recommended daily allowance), replacing it with a lower standard, the new RDI (recommended daily intake). In other words, a product containing more Vitamin C than the juice of one orange (some 75 milligrams) could now be classed as a drug, available by prescription only.

Reclassifying supplements as drugs would have a staggering effect on their availability. It costs over $200 million to get a drug approved by the FDA, a complicated process which can take up to ten years. Because herbs have been used traditionally for thousands of years, they cannot be copyrighted, hence profits from their sale would never be sufficient to cover the cost of approval. Drug regulations are so tough that most supplements are likely to disap pear from the shelves, and thousands of small companies will be out of business. Many people rely on the wide variety of substances hitherto available-ranging from the ordinary to the exotic, from garlic ex tract and rosemary oil to the Chinese astral agus and enzyme Co-Q 10. People depend on the ancient gingko leaf to stave off senility; they use echinacea to recover from colds, and Vitamin E to reduce the risk of heart disease. The list is long. Exploring the new realm of herbs and supplements has enabled many patients to cope with chronic diseases like arthritis and lupus, which have not been treatable by more conventional means. Con tact and the experience of taking responsi bility for one's own health have become part of healing for many people who in the past had passively accepted whatever the doctor ordered. The consumer of natural medicines is typically educated and well-informed; reading the many informative new books about healing, consulting the various types of natural practitioners (chiropractors, naturopaths, herbalists, acupuncturists, and so on), and talking with friends and with salespeople at the health food stores has enabled her (or him) to discover treatments with a wide range of benefits and specific application to the individual's needs.

Hence the proposed regulations gener ated a flurry of letters exceeding those 522 THE FREEMAN • SEPTEMBER 1994 written in protest of the Vietnam War. Final approval of the FDA recommendations was accordingly delayed another year, until De cember 1993, in the hope perhaps that the furor would die down. It hasn't. Two new bills that would nullify the new regs were presented to the Congress and thousands more letters have been received. More than 200 representatives and 60 senators have indicated support for these bills. The Senate bill passed through committee this past summer. As of this writing, unless an indus try plea for an extended moratorium is granted, implementation of the revised rules will begin. In accord with its generic role of guardian of the public safety, the FDA has taken great pains to portray itself in the media as the benign protector of a public besieged with "pills and potions" touted as "cure-aIls" by "quacks and charlatans." It claims to be merely doing its job, and on the surface, its presentation is convincing to the unin formed. The ancient art of herbalism, and the relatively new use of megavitamin treat ments, have become commercialized.

Glossy brochures tout their marvelous prop erties. Certainly inflated claims have been put forth in some advertisements and bro chures, particularly in appealing to our se nior citizens, encouraging patients to be lieve they could do without their prescribed medications, with unfortunate conse quences. A few schlock companies sell substandard products at inflated prices, with no impartial evaluation or control. Even then, should it be the task of government, through whatever agency however protec tive and benign, to make the public's health decisions for them? In any case, the FDA is hardly benign. It has been known to invade doctor's officesin full battle regalia, knocking down the door even when the officewas open for business, pulling out phones and removing files at gunpoint. That is what happened two years ago to Jonathon Wright, a Seattle M.D. who I used vitamin shots to treat allergies in his patients. In 1990, armed federal agents raided the home and business of Ken Scott, owner of Highland Laboratories in Mount Angel, Oregon, because Scott had distrib uted reprints of magazine articles informing his customers of the value of newly discov ered health aids like enzyme Q-I0. Over a dozen stores in the Midwest were raided not long ago for displaying boxes of teas which mentioned "vitality" or a body part (' 'ColonCleanse' ') on the label.

"The Arbiter of Truth" One could imagine a protective agency guarding the public health by monitoring the quality of foods and medicines. But today's Food and Drug Administration is not it. Contrary to the tenor of the Food, Drug and Cosmetic Act which charged it with "pro tecting the health of the nation against impure and unsafe food, drugs and cosmet ics," the FDA has become a crude agency of enforcement, with little or no respect for the intelligence of the citizenry. Said FDA Commissioner David Kessler: "The Amer ican public does not have the knowledge to make wise health care decisions. . . FDA is the arbiter of truth." (quoted in Stop the FDA, eds. John Margenthaler and Steven Fowkes, p. 83) This "arbiter of truth" has spread mis leading information about the dangers of natural medicines. The truth is, herbs and vitamins are virtually harmless. Herbal for mulas have been used worldwide for thou sands of years. Noone has died from an overdose of Vitamin C or checked into a rehabilitation center for abuse of B-6 or A.

The Poison Control Center reports no deaths from any of these substances. On the other hand, many approved pharmaceuti cals have been the cause of death (by overdose), insanity (Halcion), or serious addiction (Vicodin is the latest example.) The fact is, the FDA knows little about the appropriate use of herbs and supplements, and reacts more or less hysterically in the rare instances where they fail. When two people died after using the Native American plant chaparral, the FDA took it off the shelves. "Twenty-five hundred people had used it that year." said herbalist Rosemary Gladstar in a talk at Copperfield's bookFDA AND THE MARKET IN NATURAL MEDICINE 523 store. "If they used the same standards for aspirin, or just about any other pharmaceu tical, there would be nothing left on the shelves!" The very idea of plant medicine seems to summon up dark images of witch craft or charlatanism, or both, in the minds of the FDA agents. In truth, natural medi cine is not a cult. "It's a different para digm," said Roy Upton, head of the Natural Health Care Alliance, in a phone conversa tion in 1992.

If the FDA's intention was simply to monitor the quality and use of natural health aids, it could surely do so without making them unavailable. The Herb Research Foundation suggested the creation of a qual ity control board much like the one that exists for cosmetics; the FDA turned it down. Manufacturers have asked for a new category for herbs and supplements such as exists in European countries, where camo mile and gingko are sold in pharmacy shelves as "phytomedicines" (plant medi cines). That was rejected too. The proposed regulation of natural treat ments therefore raises serious questions about the role of the FDA in monitoring the medicine market. Does the FDA work for us, or is it working to protect powerful pharmaceutical corporations from undes ired competition? Have regulations become so cumbersome that they actually interfere with the responsible development of effec tive treatments? What about our right to choose appropriate medical treatments ac cording to the dictates of conscience and pocketbook? Is the public so foolish that government must make these choices for them? Then who will protect the people from the protectors?

Herbal teas, pills and elixirs, and many of the top quality vitamins sold in health food stores are produced by independent entre preneurs. They are examples of the very type of independent enterprise which his torically has been the lifeblood of the Amer ican economy. Traditional Medicinals, mak ers of herbal teas, was started on the West Coast by three young people who packaged their formulas in brown paper bags and distributed them to stores in a pick-up truck; it is now a multi-million dollar' business. Another reliable herb company, Herb Pharm, was begun by a man growing herbs in his own garden. The people who started these and other companies were motivated by belief in their products, as well as by the profits which provide for their livelihood. The regulations proposed by FDA will effectively put many of these companies out of business. The stringent qualifications for drug approval, the cost of testing, and the long period of time involved will be deadly to enterprises which have no other product lines to sustain them. The only companies that will be able to handle the new regula tions will be the big pharmaceutical giants who are securely entrenched in the medicine market.

The regulations will also likely favor the medical establishment itself, because some herbs and high-dosage supplements will be available only by prescription, hence requir ing a visit to the doctor before purchase. Doctors have not been educated in the use of herbs, they do not tend to believe in their efficacy, and they often discourage reliance on supplements. Whether their attitudes are medically more correct will not be argued here. The point is, the current movement towards self-care will be abrogated in favor of the old model of doctor dependency. Since supplements and herbs may carry no health claims, manufacturers advertise their proper use in the pages of health magazines and mail order catalogues. Like advertisements everywhere, these can be more alluring than informative. Well-in formed clerks in stores try to guide custom ers to the products that will best suit their needs. But by and large, people who buy herbs and vitamins have come to their own conclusions from reading books and maga zine articles about their conditions and see ing natural health practitioners who are licensed to perform chiropractic, acupunc ture, and other treatments.

The FDA amendments to NLEA specif ically state that informational materials about the uses of vitamins and herbs will become illegal. Books about the uses of natural treatments will not be sold in the 524 THE FREEMAN • SEPTEMBER 1994 stores which distribute supplements be cause these materials constitute claims! The natural health movement represents an effort by educated people to take charge of their own health. They have become tired of visiting their doctors to get prescriptions for expensive drugs that do not cure their illnesses. Most viruses, for example, do not respond to antibiotics, but some doctors continue to prescribe them. Some patients have discovered that they can beat back colds and flu with echinacea, the purple coneflower that grows abundantly in the United States, or with ginseng and other herbs that stimulate and balance the immune system to do the job it is meant to do. Some have even claimed to benefit from natural herbs and vitamins in the treatment of can cer and AIDS.

It feels good to take care of oneself. Patrons of natural food stores derive satis faction from exploring their own treatment modalities. Some work, some do not seem to work as well, but independent people value the freedom to make their own choices and learn their own lessons. Why, then, should government intervene? An article in the June 18, 1992, New England Journal ofMedicine quotes current FDA Commissioner David Kessler: "If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility . . . then the whole rationale for the agency would cease to exist." Kessler's remark is clear confirmation that belief in the worth of the individual in our society has been displaced or superseded by belief in the greater worth of the Agency! This is indeed a sorry state of affairs. Agen cies are, after all, but formal arrangements of individuals who have less at stake in the choice of medicines than the individual whose life is on the line-and far less ac countability.

Although Lippmann was not opposed to government intervention himself, he cau tioned that "the domain of authority should be as limited as possible." It may be fitting to end with Lippmann's concluding re marks: . . . liberty is one of the conditions of human progress. Without it the dead hand of the past is forever upon the future, and our present ignorance is the enemy of our increasing enlightenment. Noone in his senses supposes that the whole of human activity can be free. But it is the prejudice if you like, the proven faith I believe, of free men that the domain of authority should be as limited as possible. And so, even when free men enlarge authority, as in the western world they must, they do it in the knowledge that it is expedient and not glorious, that it is necessary but dan gerous, that it is useful but costly. How ever much they may alter their methods, adapting them to new circumstances, it will continue to be their base conviction that the state is the servant and not the master of people. (Emphasis mine) The FDA's threatened coercive manipu lation of the market in natural medicine is, I think, symptomatic of a disastrous trend in American government to do for the people what people prefer to do for themselves. In so doing, it threatens to become the master of a weakened and dependent population no longer capable of directing its own fate and eventually subject to the rule of tyranny.

Surely that is not what America wants. D Correction, Please! The Free Market Works Fine, Except ... "In health care today, fundamental principles of the marketplace do not apply. Prices are not determined by supply and demand... " -"America's Economic Outlaw: The U.S. Health Care System," The New York Times October 26, 1993 I don't know why I keep picking on The New York Times for my column. Maybe it's because it reflects the conventional wis dom of today's policymakers, which is wrong more often than not about the basic principles of economics. Late last year, as health care became a national issue, The Times ran a cover story contending that America's health care sys tem "operates with almost total disregard for basic economic principles" and there fore deserves special treatment by govern ment. "Prices are not determined by supply and demand or by competition among pro ducers. Comparison shopping is impossible.