Just as organized religion has been beset throughout history by countless heresies, sects and splinter groups, so too has organized medicine. Ever since the ancient Greeks began to make a science out of healing human ills, there have been medical mavericks to challenge the established practices of their day.
Today, a 160-year-old splinter group known as homeopathy—one of the first to challenge medical orthodoxy in America—is enjoying a rebirth of popularity, only a few years after observers had predicted its almost certain demise.
Homeopathy (pronounced hoe-mee-AH-puh-thee) originated in Europe in the early 1800s and quickly spread to the United States. It centered around the idea of treating disease by administering highly diluted preparations of substances that cause the same symptoms the patient is experiencing. For instance, ipecac is a drug that causes vomiting; it is commonly used in the emergency treatment of certain types of poisoning. Homeopathic physicians, however, prescribe ipecac for patients suffering from nausea or vomiting. While the dose is highly diluted, the treatment, according to the principles of homeopathy, cures by stimulating the body’s natural defense mechanism to fight whatever is causing the ailment.
The age that gave birth to homeopathy—the period roughly from 1780 to 1860—has been called the “Age of Heroic medicine.” For most ailments, physicians prescribed extensive blood letting. Some doctors had so much faith in bleeding that they were willing to reove up to four-fifths of the patient’s blood. Other widely accepted therapies of the day included blistering—placing caustic or hot substances on the skin to draw infections out of th body—and administering emetics, to induce vomiting, and cathartics such as calomel or other dangerous chemicals to purge the bowels. Massive doses of calomel not only cleansed the bowels, they also caused teeth to loosen. hair to fall out, and other symptoms of acute mercury poisoning. Such “heroic” therapy often prolonged the illness, if it did not kill the patient outright.
These drastic medical practices set the stage for the radical ideas of a young German physician, Samuel Hahnemann. Soon after he began practicing, Hahnemann became disenchanted with the lack of effectiveness of heroic medicines and instead began prescribing for his patients exercise, a nourishing diet. and fresh air. He also became interested in the science of drugs and began conducting experiments on the effects of medications. It was the results of these experiments that led him to develop his principles of homeopathy.
One of his earliest experiments involved quinine. already in use to treat malaria. Hahnemann was skeptical of the theory that quinine cured the disease through its astringent and bitter characteristics and “strengthening qualities it exerts on the stomach:’ according to one medical text of the time. So he gave the medicine to himself and noted the effects: His extremities grew cold, his pulse quickened. his head throbbed, he became thirsty, and he developed a fever—in sum, the very symptoms of malaria. Hahnemann theorized that the drug’s power to cure lay in its ability to produce those symptoms. This and other “provings,” as he called his experiments, led to his first principle of homeopathy—the Law of Similars, or “like cures like.” To treat a patient, the homeopathic physician carefully matches all the symptoms to the one medicine that produces those same symptoms in a healthy person. This, of course, is the opposite of conventional drug treatments where, for example, a decongestant is given to ease a cold and antibiotics are given to kill infecting germs, not to mimic their effect on the body. Hahnemann believed that symptoms were a sign of healing and should be stimulated, not stilled.
Another homeopathic principle theorized by Hahnemann was his Law of lnfinitesimals, or minimum dose. This law declared that the smaller the dose, the more effective it would be in stimulating the “vital force” of the body. Minuscule doses were prepared by repeatedly diluting the active ingredient.
Like ipecac, which is derived from the roots of a South American shrub, most homeopathic medicines are made from plants, animals or minerals. Homeopathic drugs are prepared by repeatedly diluting the active ingredient by factors of 10. A 6X on the label of a homeopathic medication means that the 1-to-10 dilution was done six times, rendering a final product in which the active ingredient is one part per million.
As Americans have become increasingly infatuated in the past few years with all things “natural,” homeopathy has also had a resurgence as a result of this back-to-nature movement, offering a “non-chemical.” way of treating illness without side effects. In recent times, this promise has been especially appealing to cancer patients, who find it hard to cope with the often terrible side effects of conventional chemotherapy,
But as homeopathy’s popularity has grown, some homeopathic drug manufacturers and practitioners (not necessarily possessing a bona fide medical degree) have strayed from the original tenets of this medical sect. Traditional homeopathy was known, above all else perhaps, for its benign treatment of patients. But for those today who are seeking alternative medical treatments, some of the new practices conducted in the name of homeopathy pose a serious danger and have raised the concern of the Food and Drug Administration.
The Food, Drug, and Cosmetic Act, passed by Congress in 1938, contains a section recognizing as drugs the remedies included in the Homeopathic Pharmacopeia of the United States. This was mainly due to the efforts of Senator Royal Copeland, who also happened to be the foremost homeopathic physician of his day. While this gives a basis for the legal acceptability of homeopathic medicines, it also made them subject to all the requirements of the new law.
For decades, FDA was largely unconcerned with homeopathic drugs. As the popularity homeopathy had enjoyed during the 19th century waned with the advent of modern medicine, homeopathic drugs made up a smaller and smaller share of the medicinal market. Further, while these drugs had never been proven effective by well-controlled clinical studies like those used to test conventional medicines, they at least appeared safe because of the extreme dilution of their active ingredients. In light of competing regulatory priorities, homeopathy was a medical backwater.
But in the mid to late 1970s, homeopathy began its comeback. FDA field offices began to notice more and more imports of homeopathic medicines. New homeopathic drug companies began to spring up, reviving an industry that had been small and dormant for years. Soon, ads for homeopathic drugs were appearing in such popular publications as People magazine. Books on homeopathy were published, such as Homeopathic Medicine at Home by Dr. Maesimund Panos and Jane Heimlich, which urged readers: “As the image of penicillin is tarnished by the reality of allergic reactions, why not examine Belladonna (a homeopathic—and, therefore, safe—remedy prepared from deadly nightshade) as an appropriate treatment for strep throat.”
The growth of the homeopathic movement is exemplified by the sales increases of homeopathic drug firms. While still only a small fraction of the sales of conventional drugs, sales of some homeopathic companies experienced a jump of up to 1,000 percent over just a three- or four-year period in the late 1970s and early 1980s. And while previously a large share of the drugs were exported, mainly to third world countries such as India, Bangladesh and Cambodia, the late 1970s saw more and more homeopathic drugs being sold in the United States.
William Nychis, of the Drugs and Biologics Fraud Branch in FDA’s Center for Drugs and Biologics, estimates that there are now between 50 and 60 firms marketing homeopathic remedies in the United States. “Four years ago, the industry was only a tenth of what it is now,” says Nychis. The American Association of Homeopathic Pharmacists estimates that as many as a million Americans are using homeopathic drugs.
To get a clearer picture of the booming homeopathic drug industry, FDA surveyed 12 manufacturers in the spring of 1982.
Some of the findings were disturbing. One of homeopathy’s stated principles is that the medicine and dose used to treat a disease must be highly individualized for each patient through painstaking examination by a physician specially trained in the workings of homeopathy. Yet the survey found many homeopathic drugs being marketed over-the-counter (OTC), sometimes for serious medical conditions such as heart and kidney disease and cancer. An extract of tarantula was being sold for multiple sclerosis; an extract of cobra venom for cancer, OTC homeopathic remedies were being sold through the mail and in health food stores.
Home-remedy kits containing a variety of homeopathic remedies were also being sold. A book accompanying one such kit instructs stroke victims to take one homeopathic remedy to allay anxiety and another to “encourage healing of the brain injury and absorption of extravasated blood.” Another book accompanying one of the kits, Homeopathic Remedies for Physicians, Laymen and Therapists, was written by three homeopathic physicians under the auspices of the Himalayan Institute, established by Swami Rama outside Chicago. Another book cautions owners to keep the kit out of reach of small children. Not that the contents could hurt the youngsters: “A homeopathic remedy, even an entire vial consumed at one gulp, is not toxic or poisonous,” the authors said, “but a toddler, intent on sampling the sweet-tasting pills, can wreak havoc on your kit,” the book warns.
Also of concern to FDA, state regulatory agencies, and the homeopathic profession itself is the practice of homeopathy by persons who are not doctors. Currently, most homeopaths have a degree from an accredited medical school and then take postgraduate studies in the principles of homeopathy. Many go on to serve an apprenticeship under a senior homeopathic physician. They are licensed by the state to practice medicine. FDA has found, however, that homeopathic drugs to treat serious diseases, including injectables, are winding up in the hands of unlicensed, untrained “practitioners” who call themselves homeopaths to profit from the practice’s popularity. In one reported case, a woman with breast cancer abandoned her chemotherapy treatments and was being treated instead with a product promoted as “homeopathic interferon.” (No such medicine is recognized by the Homeopathic Pharmacopeia.) The woman eventually died of cancer.
In another case, an Idaho man who called himself a “naturopath” and who used homeopathic medicines in his “practice” was sentenced to 15 years in prison for the death of one of his patients. (See “The Doctor Is In Jail” in the October 1981 FDA Consumer.)
Still other “doctors” are using homeopathic drugs in conjunction with a device called an “electro-acupuncture” machine. The device is used with the drugs to both diagnose and treat diseases, including serious conditions such as cancer. The machines, however, do not really involve acupuncture but are electronic gadgets along the line of various fraudulent devices common in the 1950s and 1960s.
Dr. David Wember, a homeopath practicing in suburban Washington, D.C., and vice president of the National Center for Homeopathy, said that while he sees a place for OTC homeopathic remedies for mild illnesses such as colds and flu, he is outraged by promotions of OTC homeopathic drugs for cancer and other serious diseases. “The treatment of serious diseases ought to be the responsibility of qualified physicians, whether homeopathic or allopathic [conventional],” he said.
There are also those in the homeopathic drug industry who take issue with such marketing practices, Jay Borneman, vice president of John A. Borneman and Sons Inc., a 75-year-old homeopathic drug firm in Norwood, Pa., spoke of an “us-versus-them” attitude in his industry. He referred to firms marketing OTC homeopathic drugs for serious conditions as new kids on the block who have come along with a new product and want to get it on the market quickly, so they get under the homeopathic ‘umbrella’. “
Borneman denounced the promotion for serious diseases of such quack products as “homeopathic interferon.” He cautioned consumers that if any drug—whether or not it purports to be a homeopathic remedy—”looks outlandish or unreasonable, it’s probably not for real.”
“A serious condition is a serious condition,” he stressed, “whether you choose to treat it through standard allopathic or homeopathic medicine.” Serious diseases such as cancer or heart disease should be treated by a physician, he said, not through use of OTC drugs—homeopathic or otherwise.
While FDA is not empowered to regulate the practice of medicine (that authority rests with the states), it does have responsibility for the safety and effectiveness of marketed drugs. The agency has detained dozens of shipments of homeopathic drugs being imported into this country and promoted for serious diseases. Drugs of any kind, promoted for serious diseases, should be labeled as prescription products.
Late in 1984, the agency sent regulatory letters to two homeopathic drug companies threatening possible legal action unless the firms changed their marketing practices. The two, Biological Homeopathic Industries (BHI) of Albuquerque, N.M., and Botanical Laboratories of Bellingham, Wash., were judged to be among the most flagrant violators in their marketing of numerous homeopathic drugs for very serious disease conditions.
BHI was warned regarding the labeling of its Anticancer Stimulation Tablets, Antivirus Homeopathic Remedy, and other products promoted for such diseases as mumps, eye infections, inflammation of the ovaries, and whooping cough. The anticancer drug was promoted over-the-counter “to stimulate the body’s own natural defense system . . . against degenerative cells.” Dosage instructions stated the product could even be given to children under 6. “We are unaware of any substantial scientific evidence which demonstrates that any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use,” the agency wrote.
Botanical Laboratories was warned about its marketing of homeopathic drugs for treating such conditions as angina, heart irregularities, epilepsy, brain disorders, pneumonia and gout. In its regulatory letter to Botanical Laboratories, FDA said that, as with BHI, none of the firm’s products had been proven safe or effective.
The agency told both firms that if they failed to bring their products into compliance with the Food, Drug, and Cosmetic Act, it was prepared to seize the products and/or seek court injunctions.
While the practice of homeopathy enjoys a long history in America, the public has a right to be protected from unsafe or ineffective drugs of any kind marketed in this country.
_____________________
This article appeared in the March 1985 issue of FDA Consumer Magazine, which Mr. Rader edited.
This page was revised on May 7, 2006.
