Defrauding the Desperate: Quackery and AIDS (1987)
The art of quackery has always kept pace with the science of medicine, and it has never been more evident than in the tactics now in vogue for promoting AIDS remedies. No more "eye of newt" and "toe of frog" stirred up by Macbeth's witches. To the contrary, today's proponents of special lotions, potions, diets and pills borrow handily from legitimate science, citing "scientific studies" and using the language of medicine in attempts to lend credence to their claims.
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. And business is booming. According to Congressional hearings, an estimated $1 billion will be spent on fraudulent AIDS therapies this year.
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, the food preservative BHT, 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 that are severely depleted in AIDS, 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.
Meredith Vieira, reporting on fraudulent AIDS therapies on CBS-TV's "West 57th" last April 27, interviewed a man who called himself Dr. Sebi. "Dr. Sebi," said Vieira, "isn't a doctor. He's an herbalist, a man from Honduras who brought his bag of miracles to Brooklyn. His cure for AIDS starts at $500. It's the same regimen of diet and herbs he prescribes for everything." In an earlier television interview with Washington, D.C.'s "Eyewitness News" reporter Ellen Kingsley, Dr. Sebi stated, "We have always charged $250 for the first consultation to get the herbal compounds. On the AIDS, we increase it to $500, because of the psychological reason that goes along with the price. When someone invests enough money, they're going to go along with the program." Sebi has since been arrested for practicing medicine without a license.
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 in vivo 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 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. (See "AIDS Education" in the September 1987 FDA Consumer.)
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 and Biologics' 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 from both these facilities, barring their entry into this country. Before his death in 1985, Rock Hudson traveled to France for expensive treatments with HPA-23, reported by French investigators to inhibit the AIDS virus. Follow-up studies of the drug's safety and efficacy, however, showed excessive toxicity and little, if any, benefit to patients.
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 been in so many diseases preceding this one.
Not all who sell or provide unapproved treatments for AIDS are motivated by personal gain. Homemade concoctions of products such as the photography chemical DNCB, said to help clear up lesions in a skin cancer common in AIDS patients, and AL-721, a compound claimed by its manufacturer to hinder AIDS virus infection, are often provided free to patients by an underground network of "guerilla clinics" springing up around the country. (FDA has approved investigational new drug applications for testing AL-721 in humans. Unless and until studies show the drug to be safe and effective for treating AIDS, however, it cannot legally be promoted or sold for this purpose.) Some of the clinics will also refer patients to underground suppliers of other experimental drugs. An article in USA Today last April estimated that 5,000 to 10,000 patients use these products or seek information about them.
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 fatal 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. Consumers Union 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 last June, New York City's Consumer Affairs Commissioner Angelo J. Aponte reminded his audience that, "Reliance on phony or unreliable cures or treatments can . . . lure people away from genuine therapies or preventives." He told of a physician who reported that one of his patients refused treatment with Retrovir (also known as AZT)—the only currently approved AIDS drug—in favor of going to France for useless injections of a glandular extract costing $10,000.
FDA recently issued a new rule that will permit 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. (See "Experimental Drugs for the Desperately Ill" in the June 1987 FDA Consumer.) FDA also works closely with legitimate sponsors of experimental AIDS drugs, and these are given the agency's highest priority for review.
As for "pond scum" peddlers and the like, FDA has taken direct action against vendors of such products as douches and condom lubricants who falsely advertise them as disease-fighting agents against AIDS. Last July, the agency issued a bulletin updating field staff on the problem and directing the districts to take appropriate action in cases where AIDS fraud is suspected. The bulletin instructed that any product label or accompanying labeling that includes a reference to AIDS, AIDS-related conditions, or the virus that causes AIDS should be considered a candidate for regulatory action. Products promoted to "strengthen" or "enhance" the immune system are also suspect. Field investigators around the country also work 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 the 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.
This article was originally published in the October 1987 issue of FDA Consumer.