Educated People Want to Take Charge of Their Own Health
Ms. Hiller is a mother and freelance writer living in Sebastopol, California.
How much government intervention is appropriate in a free market has been the subject of lively debate for many years. This debate is characterized by the inconsistent demands people make on the State. In 1934, Walter Lippmann commented:
The pure doctrine of non-intervention in production in trade has never, in fact, been practiced anywhere. One could argue plausibly that most men have shown in their behavior that they wished to impose free capitalism on others and to escape it themselves. Employers have believed in it for their employees, and have appealed to it against factory laws and unionism. But they have not hesitated to call upon the State for protection against foreign competitors.
—The Method of Freedom
One way people have asked the State to intervene on their behalf is by seeking protection 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 existence, one of many new arms sprung forth on the body of expanding government. In 1938, despite intense lobbying against it by the pharmaceutical and food-processing industries, 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, generations of America’s children have been taught that consumer confidence in the purity 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 appeared 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 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 become 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 independent natural food stores and 1,598 chains. No longer a small group of offbeat counterculturalists 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 remained 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 regulation 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 information that could be printed on their labels, arguing that their efficacy had not been sufficiently attested. But it went even further. 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 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 disappear 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 extract and rosemary oil to the Chinese astralagus 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. Contact and the experience of taking responsibility 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 generated a flurry of letters exceeding those written in protest of the Vietnam War. Final approval of the FDA recommendations was accordingly delayed another year, until December 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 industry 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-alls” by “quacks and charlatans.” It claims to be merely doing its job, and on the surface, its presentation is convincing to the uninformed. The ancient art of herbalism, and the relatively new use of megavitamin treatments, have become commercialized. Glossy brochures tout their marvelous properties. Certainly inflated claims have been put forth in some advertisements and brochures, particularly in appealing to our senior citizens, encouraging patients to believe they could do without their prescribed medications, with unfortunate conse quences. A few schlock companies sell sub standard products at inflated prices, with no impartial evaluation or control. Even then, should it be the task of government, through whatever agency however protective 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 doctors’ offices in full battle regalia, knocking down the door even when the office was 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 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 MountAngel, Oregon, because Scott had distributed reprints of magazine articles informing his customers of the value of newly discovered health aids like enzyme Q-10. 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 “protecting the health of the nation against impure and unsafe food, drugs and cosmetics,” 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 American 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 misleading information about the dangers of natural medicines. The truth is, herbs and vitamins are virtually harmless. Herbal formulas have been used worldwide for thousands of years. No one 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 pharmaceuticals have been the cause of death (by overdose), insanity (Halcion), or serious addiction (Vieodin 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 bookstore. “If they used the same standards for aspirin, or just about any other pharmaceutical, there would be nothing left on the shelves!” The very idea of plant medicine seems to summon up dark images of witchcraft or charlatanism, or both, in the minds of the FDA agents. In truth, natural medicine is not a cult. “It’s a different paradigm,” said Roy Upton, head of the Natural Health Care Alliance, in a phone conversation 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 quality 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 camomile and gingko are sold in pharmacy shelves as “phytomedicines” (plant medicines). That was rejected too.
The proposed regulation of natural treatments 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 undesired competition? Have regulations become so cumbersome that they actually interfere with the responsible development of effective treatments? What about our right to choose appropriate medical treatments according 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 entrepreneurs. They are examples of the very type of independent enterprise which historically has been the lifeblood of the American economy. Traditional Medicinals, makers 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 regulations 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 requiring 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-informed 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 magazine articles about their conditions and seeing natural health practitioners who are licensed to perform chiropractic, acupuncture, and other treatments.
The FDA amendments to NLEA specifically 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 stores which distribute supplements because 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 cancer and AIDS.
It feels good to take care of oneself. Patrons of natural food stores derive satisfaction 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 of Medicine 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. Agencies 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 accountability.
Although Lippmann was not opposed to government intervention himself, he cautioned that “the domain of authority should be as limited as possible.” It may be fitting to end with Lippmann’s concluding remarks:
. . . 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. No one 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 dangerous, that it is useful but costly. However 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 manipulation 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.
