October 1, 1987
Double, double toil and trouble;
Fire burn and cauldron bubble.
Eye of newt, and toe of frog,
Wool of bat, and tongue of dog.
Aiming their wares at the sophisticated consumer who is wary of fraud yet desperate for help, quacks invent scientific-sounding rationales for their products, hoping they might help the medicine go down--thus the use of terms such as "immunoaugmentative therapy" and claims to "bolster the immune system." But what's really going down is fraud.
Dr. John Renner, chairman of the Midwest Council Against Health Fraud, based in Kansas City, Mo., has surveyed the market of fraudulent AIDS products, prompting him to state that "everything has been converted into an AIDS treatment." Remedies include processed blue-green algae (referred to by some as "pond scum") selling for $20 a bottle, injections of hydrogen peroxide, pills derived from mice that have been given the AIDS virus, and herbal capsules that were found to contain poisonous metals. Additional "therapies" include thumping on the thymus gland--an immune system organ--to produce white blood cells (which are severely depleted in AIDS patients), massaging the skin with a dry brush, bathing the body in a chlorine bleach solution, and exposing the genitals and rectum to the sun's rays at about 4 p.m. One man, masquerading as a Ph.D., was injecting his patients with a processed byproduct of their own urine at $100 per injection.
These charlatans don't limit their pitches to people who already have AIDS or are infected with the AIDS virus. The fear generated by this disease has created a potentially unlimited clientele, and anyone is fair game. Especially dangerous are product claims that misinform the public about AIDS prevention and virus transmission. "Sani-Form," a piece of plastic designed to fit over a telephone mouthpiece, was promoted to protect against infection from public phones. That the product is rubbish constitutes less disservice to the public than does the suggestion that AIDS can be transmitted simply by touching an instrument used by someone with AIDS.
While products like Sani-Form reawaken groundless fears of catching AIDS through casual contact, a more insidious danger lies with false claims that a product will protect against infection in situations that do present a risk, such as practicing high-risk sex. This was the case with Lubraseptic, a product approved by the Food and Drug Administration for use as a condom lubricant/spermicide. When studies showed that nonoxynol-9, the active ingredient in Lubraseptic, could kill the AIDS virus in vitro (in the test tube), the manufacturer began to promote the product as an AIDS preventive. However, laboratory test results often differ from results in a living organism and do not constitute proof of how a chemical will work in the human body. Unsubstantiated claims such as this one instill a sense of security where none is warranted, perhaps leading users of the product to ignore precautions that are known to help protect against spreading the disease.
Despite the quacks, FDA has not seen as many fraudulent AIDS products on the market as had been anticipated. This is in part because AIDS affects only a small percentage of the population. As the disease becomes more widespread, the market of fraudulent products is expected to grow.
The big money in AIDS fraud, according to George Blatt, director of FDA's Health Fraud Staff in the Center for Drugs Evaluation and Research's office of compliance, probably comes from the sale of unproven products or "treatments" advocated by foreign promoters or clinics. People with AIDS, or their friends or relatives, are spending millions of dollars to obtain these drugs or therapies abroad or--illegally--in this country. Two highly publicized overseas promoters offering bogus treatments are Dr. Lawrence Burton's Immunology Researching Centre in the Bahamas and the Hauptmann Institute in Austria. FDA has issued import alerts against products for both these facilities, barring their entry into this country.
Others have been lured by claims that megadoses of vitamin C help the body's immune system fight the AIDS virus. Various claims for vitamins, nutrients, and special diets are proving as popular in AIDS quackery as they have in so many diseases preceding this one.
Not all who sell or provide unapproved treatments for AIDS are motivated by personal gain. For example, certain remedies such as homemade herbal products, are believed by some to combat the AIDS virus or enhance immunity. These products are often provided free to patients by an underground network.
Well-intentioned proponents of these products contend that the substances may provide help, or, at the very least, hope, and that people have the right to try whatever may offer them hope, even if it is a worthless remedy. This argument is especially compelling for people with AIDS or other life-threatening diseases with no known cure.
In the book Health Quackery, published in 1980, the editors of Consumer Reports addressed this issue in examining the controversy surrounding Laetrile as a cancer treatment. Proponents of the drug, including some physicians, reasoned that little or no harm could come from permitting terminally ill patients to use a worthless drug. The editors disagreed, stating that "the use of Laetrile as a treatment for terminally ill cancer patients stands in blatant violation of the basic patient right not to be duped and not to be offered a false sense of hope." They went on to say that "these patients also have the right to responsible, honest medical care of high quality for as long as they live. Dying patients rarely, if ever, require deceptive drug treatment."
In a speech before the National Association of Consumer Agency Administrators, former New York City Consumer Affairs Commissioner Angelo J. Aponte reminded his audience that, "Reliance on phony or unreliable cures or treatment can ...lure people away from genuine therapies or preventives."
In 1987, FDA issued a new rule that permits terminally ill patients greater access to experimental drugs. This should help combat health fraud and eliminate the need for desperate patients to go abroad seeking help. The regulation is carefully designed to protect the welfare of patients and to safeguard the drug testing and approval process. FDA also works closely with legitimate sponsors of experimental AIDS drugs, and these are given the agency's highest priority for review.
FDA has seen a dramatic increase in the number of over-the-counter drugs promoted to enhance or strengthen the immune system against a plethora of disease conditions, ranging from the common cold to AIDS. The agency issued several bulletins to its field staff directing them to take action against any products represented directly or indirectly as effective for preventing or treating AIDS. In fiscal years 1988 and 1989 the agency approved 66 actions against AIDS-related products that were being marketed in violation of the law.
Recently, FDA enjoined two individuals in Michigan who were manufacturing a homemade product known as "Entelev" or "Cancell," which they promoted for the treatment of AIDS, cancer, and other serious disease conditions.
Field investigators around the country also worked with state governments to combat health fraud. To help contain the growth of fraudulent AIDS products, the agency has established a special initiative, coordinated by its Office of Consumer Affairs, to monitor the problem and to work with other organizations to educate the public.
The consumer must remember that AIDS is a quack's dream come true. An incurable, fatal disease surrounded by fear and ignorance is tailor-made for the enterprising huckster who will stir up a cauldron of deceit to turn a quick profit. And, if the experts are right in their predictions, more and more of these profiteers will be on the scene selling their wares. When the product is hope, let the buyer beware.
Watch out for "amazing breakthroughs" in anything medical; breakthroughs are few and far between, and when they happen, they're not touted as "amazing" or "miraculous" by any responsible scientist or journalist.
Be wary of products advertised as "natural," "painless," "fast-working," "inexpensive," "fantastic," or "guaranteed to work." Some of these claims, such as fast-acting, painless and inexpensive, can be validly used in labeling or advertising to accurately describe certain over-the-counter medicines or preparations. But they are also classic terms of the trade for quacks and should be regarded with suspicion in unusual circumstances, especially as used to promote cures or treatments for chronic or devastating diseases.
Don't be taken in by the advertiser's attempt to scientifically explain how the product works--for example: "Basically, the process involves the use of cell cultures derived from embryonic tissues." Sophisticated as this may sound, it is pure nonsense.
AIDS quackery in particular makes much of medical mumbo-jumbo. With all that's written and broadcast about AIDS, it doesn't take a genius to figure out that claims to strengthen immunity pave the way for profit in this disease. Thus, the flood of assertions to bolster the immune system through "natural therapies"--vitamins, minerals and special diets. Special lights, acupuncture, guided imagery, and bottled T-cells (critical immune cells that are depleted in AIDS) have also been touted as immune system enhancers. Advertisements for "anti-AIDS pills, "anti-AIDS formulas," and "disease-fighting agents against AIDS" signal trouble, too.
Beware of treatment that can only be obtained across the border or across the ocean. Esoteric-sounding but vague "immunoaugmentative therapies" and the like are extremely expensive and risky.
There's no quick fix for AIDS. Before you reach for your wallet, listen to the language and consider the consequences.
Marian Segal is a member of FDA's public affairs staff.