AIDS-Related Quackery and Fraud
Acquired immune deficiency syndrome
Acquired immune deficiency syndrome (AIDS) is a fatal disease caused by the human immunodeficiency virus (HIV). This organism can remain in a person's body for years before symptoms appear and the individual is considered to have AIDS. The virus disrupts the functioning of the body's immune system, rendering the infected individual progressively unable to resist organisms that would normally be harmless.
Most people infected with HIV are adults in their twenties, thirties, and forties, but the disease can occur at any age. The initial stage of the disease is a brief illness that typically includes fever, sore throat, skin rash, swollen lymph glands, headache, and malaise. This phase, termed acute HIV syndrome, usually lasts one to two weeks and is followed by a period in which the virus keeps multiplying but causes no symptoms. The median length of the symptom-free period in untreated individuals is about ten years, but the disease progresses much faster in some people and may remain quiescent indefinitely in a small percentage of others. Thus, at any given time, most individuals who carry the AIDS virus exhibit no signs of illness. However, regardless of the stage of the disease, an infected person can transmit the virus to others.
Once clinical symptoms appear, the course of the disease can vary considerably, depending in part on the extent of immune damage and the treatment received by the patient. Eventually most people with AIDS become thin, easily fatigued, and prone to diarrhea, swollen lymph glands, and multiple infections. Pneumocystis carinii pneumonia, other opportunistic infections, and a skin cancer called Kaposi's sarcoma are life-threatening complications. In addition, some patients suffer from dementia. Opportunistic infections are caused by organisms that normally are harmless but can thrive when immunity is impaired.
Finding a cure for AIDS has been very difficult because HIV infects several types of cells and inserts a copy of itself into their genetic material (DNA). This "tricks" the cells into treating the virus's genes as their own. The virus is then safe from attack by the body's immune system and is reproduced each time the host cells reproduce.
Although no cure for AIDS has been found, significant progress has been made. Early treatment of HIV-infected individuals can delay the onset of AIDS and increase survival time. Progress has also been made in preventing or fighting Pneumocystis carinii pneumonia and several other AIDS-related infections.
Quackery and Fraud
The fact that AIDS causes great suffering and is deadly has encouraged the marketing of hundreds of unproven remedies to AIDS victims. In addition, many companies in the "health food" industry have produced vitamin concoctions claimed to "strengthen the immune system" of healthy persons. John Renner, M.D., president of the Consumer Health Information Research Institute, who attended meetings of groups promoting unorthodox methods, has commented that "many of the expert quacks in arthritis, cancer, and heart disease have now shifted into AIDS" and that "every quack remedy seems to have been converted into an AIDS treatment". The "cures" he observed have included processed blue-green algae (pond scum), BHT (an antioxidant used as a food preservative), pills derived from mice given the AIDS virus, herbal capsules, bottles of "T cells", and thumping on the thymus gland . Some firms have offered to freeze and store bone marrow, claiming that it could be used to restore an AIDS victim's marrow when AIDS began to deplete the body's supply of bone marrow, which manufactures the body's blood cells. Autohemotherapy -- a worthless procedure in which a sample of the patient's blood is withdrawn, exposed to hydrogen perioxide and then replaced -- has also been recommended .
Many Mexican cancer clinics offer their unproven treatments to AIDS victims, and a black market has developed in drugs that have shown promise but lack FDA approval because the agency is not convinced they are safe and effective. Several drugs available without a prescription in Mexico are being smuggled into the United States. Drugs are also imported through "buyers' clubs", which obtain the drugs from other countries where they are legally prescribed or used in clinical trials. "Legitimate" buyers' clubs require a prescription written by an American physician who supervises the patient's care. However, some buyers' clubs obtain drugs for people who are not under medical care. Some also supply drugs to victims of cancer, Alzheimer's disease, chronic fatigue syndrome, and other diseases. The FDA appears willing to permit buyers' clubs to operate, even though technically illegal, provided: (a) patrons are purchasing drugs for their own use under medical supervision; (b) the club does not commercialize or promote its products; and (c) the products do not present "unreasonable" safety risks .
Some entrepreneurs have attempted to exploit public fear of acquiring AIDS. Covers for public toilets and telephone receivers have been marketed with claims that they will prevent transmission of the AIDS virus. Such products are worthless because AIDS is not transmitted in this manner. Nor can it be transmitted by means of a mosquito bite. Rubber dental dams to prevent direct contact during oral-genital sex have been marketed despite the minuscule likelihood of HIV transmission by this route.
A few people have marketed shares of companies falsely claimed to have developed an effective method of diagnosing or treating HIV infections. Several individuals and groups have claimed that the U.S. Army, the Central Intelligence Agency, the World Health Organization, and Russian agents have conspired in various ways to eliminate blacks or gays by introducing HIV into vaccines for smallpox, polio, and/or hepatitis . A few skeptics have even claimed that HIV is not the cause of AIDS , even though the evidence that it does is overwhelming.
Several studies have shown that a significant percentage of people with AIDS use unproven treatment:
- A study of patients hospitalized in Illinois found that 18 out of 50 with AIDS and two of 30 patients with cancer had used "alternative" treatments. Acupuncture was used by 15 of the AIDS patients, mental imagery by 12 of them, massage therapy by 11, megavitamins by 10, acupressure by 8, unapproved medications by 7, and a high-cereal diet by 1 patient .
- A study of 79 patients attending the St. Louis AIDS Clinical Trials Unit found that 44 (56%) had tried an "alternative" remedy. The most commonly used were vitamins (46% of patients), herbal therapy (16%), imagery or meditation (14%), and nonapproved drugs (14%). Most patients using these methods thought they had improved their general well-being but readily admitted that the benefit was largely psychologic. The average yearly cost was $356, but 14 of the patients spent between $500 and $2,700, and two patients spent more than $9,000 each .
- Interviews with 114 patients attending the AIDS Clinic of the University of California San Francisco Medical Center indicated that 25 (22%) had taken one or more herbal products during the 3 months before the survey. The study's authors expressed concern that herbal extracts can produce diarrhea, liver toxicity, and other symptoms common in AIDS itself .
- Dutch sociologists who interviewed people who used alternative treatments reported that 46% assumed that the treatment was effective, 66% thought it would strengthen their resistance, and 34% said they felt better because they had the feeling of being actively involved in their treatment .
Many health-food retailers claim to carry products that can help HIV-infected patients by boosting their immune system. This claim is false. In 1989, volunteers of the Consumer Health Education Council telephoned 41 Houston-area health-food stores and asked to speak with the person who provided nutritional advice. The callers explained that they had a brother with AIDS who was seeking an effective alternative treatment for HIV. The callers also explained that the brother's wife was still having sex with her husband and was seeking products that would reduce her risk of being infected, or make it impossible. All 41 retailers offered products they said could benefit the brother's immune system, improve the woman's immunity, and protect her against harm from HIV. The recommended products included vitamins (41 stores), vitamin C (38 stores), "immune boosters" (38 stores), coenzyme Q10 (26 stores), germanium (26 stores), lecithin (19 stores), ornithine and/or arginine (9 stores), gamma-linolenic acid (7 stores), "raw glandulars" (7 stores), hydrogen peroxide (5 stores), homeopathic cell salts (5 stores), Bach flower remedies (4 stores), blue-green algae (4 stores), cysteine (3 stores), and herbal baths (2 stores). Thirty retailers said they carried products that would cure AIDS. Not one recommended abstinence or use of a condom . More recently, researchers at the University of Alabama (Birmingham) asked employees of 20 local health-food stores in Birminglam what they recommend for people with AIDS. Again, a wide variety of herbs and other products were recommended .
In 1996, the Massachusetts Attorney General obtained a restraining order against Marjorie Phillips of Brockton, Massachusetts, after charging that she had engaged in consumer fraud on the Internet. Her "New Discoveries" Web page advertised information on the cause and cure of HIV infection. One version of the ad proclaimed that customers could be "HIV Negative in Six Weeks!" Phillips further advertised that HIV infection was caused by a flatworm that could be eliminated by using herbs or administering a SyncroZap, a 9-volt battery-powered device that would eliminate the flatworms in seven minutes .
Several companies have marketed bogus home-use test products. In 1989, the FTC secured a consent agreement in which three people agreed to stop marketing their "Medico" test kit and to pay $62,000 in consumer redress . In 1997, the FDA warned pharmacists and consumers about "Lei-Home Access HIV Test", which was being illegally marketed by Lei-Home Access Care, a division of Jin-Greene Biotechnology, Inc. in Sunnyvale, California .
In 1999, the FTC announced that it had tested several kits advertised on the Internet and found that they didn't work. In every case, the kits showed a negative result when used on a known HIV-positive sample - that is, when they should have shown a positive result. These kits can give people who might be infected the false impression that they are not . In February 1999, a federal judge sentenced Larry Greene, 51, of Los Banos, California, to 63 months in prison for marketing unapproved kits and furnishing bogus test results to several purchasers . The FDA has issued a public warning about one of these products, the EZ MedTest distributed by Cyberlinx Marketing, Inc., of Las Vegas, Nevada .
Although ads for home-use kits may say they are for sale outside the U.S. only, consumers in the U.S. have been able to purchase them. Some ads state or imply that the kits have been approved by the World Health Organization (WHO) or a similarly well-known health organization, or that the home-use test kits have FDA approval. WHO does not approve or license HIV test kits. However, it has not approved any HIV test kit where the test in done by the user. The FDA has approved the Home Access Express HIV-1 Test System, in which the user collects the sample at home but sends it to a laboratory for analysis.
In July 1999, Allen J. Hoffman, Odus M. Hennessee, and Donald L. MacNay, M.D., were indicted on criminal charges of conspiring to commit violations of federal drug laws in connection with the promotion, sale, and distribution of "T-UP", an aloe vera concentrate they claimed was effective against cancer, AIDS, herpes and other auto-immune disorders . According to the indictment:
- T-UP was promoted by mass mailings of promotional materials, including an audio-tape entitled "There is Hope: You Do Not Have To Die!", and a brochure entitled "Boost Your Immune System".
- T-UP was also promoted on interstate radio broadcasts, by videotapes, by word-of-mouth, by telephone, and on the Internet.
- Intravenous administration of the T-UP cost the patients or their family members approximately $12,000 for a two-week course of treatment.
- Hoffman and T-Up, Inc. sold 2 oz. bottles of "T-UP Aloe Juice" to cancer patients and other customers for approximately $75.00 a bottle.
MacNay, who had practiced orthopedic surgery in Manassas, Virginia, had his license revoked in February 1998 by the Virginia Board of Medicine, which cited fraud, unprofessional conduct, and gross malpractice. Four patients he had treated in 1997 had died shortly after receiving his aloe therapy. In 2000, after pleading no content to mail fraud and conspiracy to produce an unapproved drug , he was sentenced to two years in prison. In November 2001, Hoffman was sentenced to 46 months in federal prison and one year of supervised probation and ordered to pay $222,506 in restitution .
In December 2001, Steven Tondre, of Rancho Palos Verdes, California, was sentenced on four misdemeanor charges of selling a misbranded product to which he had pled guilty in federal court. He was placed five years' probation, fined $4,000, ordered to pay more than $12,000 in restitution, and given 10 days to take down his Web site. The charges arose from his marketing of "EXP", a colloidal silver solition that he sold for $50 per quart. The Web site claimed that "EXP" would prevent and cure AIDS by "hyperoxygenating the blood" and that "whenever EXP comes into contact with single cell pathogens or any microbial bacteria or viruses, EXP immediately incapacitates and destroys them before they have a chance to multiply or mutate".
For additional Information
- National AIDS Health Fraud Reporting Hotline (888) 332-1820 offers recorded information in English and Spanish 24 hours a day. Counselors who can discuss AIDS fraud issues will be available Monday through Friday from 6 PM through 9 PM, Eastern Standard Time, with Spanish-speaking counselors available on Monday evenings. The project is sponsored by the FDA and managed by the Florida HIV/AIDS Hotline.
- Texas AIDS Health Fraud Information Network maintains an excellent page with links to new developments. The agency can be reached at (800)758-5152 or (214) 655-5309.
- Segal M. Defrauding the desperate. FDA Consumer 21(8):17-19, 1987.
- Green S. Oxygenation therapy: Unproven treatments for cancer and AIDS. Scientific Review of Alternative Medicine, SpRing/Summer 1998.
- Braun, JF and others. A guide to underground AIDS therapies. Patient Care 27(12):5370, 1993.
- Wycoff RF. Testimony before the Subcommittee on Crime and Criminal Justice, Committee on the Judiciary, U.S. House of Representatives, May 27, 1993.
- Sampson WI. AIDS fraud, finances, and fringes. New York State Medical Journal of Medicine 99:9295, 1993.
- Harris SB. The AIDS heresies: A case study in skepticism taken too far. Skeptic 3(3):4279, 1995.
- The Evidence That HIV Causes AIDS. National Institute of Allergy and Infectious Diseases Fact Sheet, October 10, 2000.
- Hand R. Alternative therapies used by patients with AIDS. New England Journal of Medicine 320:672673, 1989.
- Rowlands C, Powderly WG. The use of alternative therapies by HIV-positive patients attending the St. Louis AIDS Clinical Trials Unit. Missouri Medicine 88:807-810, 1991.
- Kassler WJ and others. use of medicinal herbs by human immunodeficiency virus-infected patients. Archives of Internal Medicine 151:2281-2288, 1991.
- Wolffers I, de Moree S. Alternative treatment as contribution to care of pwHIV/AIDS. International Conference on AIDS 10(2):66 (abstract no. 540B), 1994.
- Martin N. AIDS fraud rampant in Houston. Nutrition Forum 7:16, 1990.
- Phillips LG, Nichols, MH, King WD. Herbs and HIV: the health food industry's answer. Southern Medical Journal 88:911-913, 1995.
- Massachusetts Attorney General news release, April 3, 1996.
- FTC cites false claims for purported "in-home" aids diagnostic test; court-filed judgments settle charges. FTC news release, Oct 3, 1989.
- FDA. FDA warns consumers about two unapproved home-use test kits. News release, Sept 26, 1997.
- Federal Trade Commission. Home Use Tests for HIV Can Be Inaccurate, FTC Warns. FTC Consumer Alert, June 1999.
- U.S. Department of Justice. Businessman sentenced to over five years: Selling bogus HIV-testing kits. News release, Feb 17, 1999.
- Kurzweil P. Internet sales of bogus HIV test kits result in first-of-kind wire fraud conviction. FDA Consumer 33(4):34-35, 1999.
- Michaels DM. Warning: HIV Rapid Home-Use test kits distributed by Cyberlinx Marketing, Inc. cannot be trusted. Do not use them! July 6, 1999.
- U.S. Department of Justice. Indictments in "T-Up" Case. News release, July 7, 1999.
- James M. Doctor pleads guilty in scheme to market unapproved drug. Baltimore Sun, March 30, 2000.
- Willis L. Man gets term of 46 months in aloe vera case: Concoction distributed as a treatment for cancer. Baltimore Sun, Dec 1, 2001