Medical News & Perspectives - December 3, 1997

Beware the Tangled Web They Weave

Hundreds (if not thousands) of promoters of unproven, fraudulent, illegal, or even potentially harmful medical products have already set up shop on the Internet's global electronic marketplace. Here are a few examples of such promotions being investigated by the FDA and other regulatory agencies:

Do-It-Yourself Abortion and Sterilization Kits: In June, the FDA issued a warning to consumers not to purchase or use 2 unapproved products that may pose life-threatening health risks. The products, a home abortion kit and a female self-sterilization kit, are being offered for sale on the Net. The abortion kit, which includes a combination of drugs not approved by the FDA for pregnancy termination, is touted as "a complete kit for early pregnancy termination without surgery . . . scientifically proved safe and unrisky." According to the FDA, use of the kit without physician supervision may result in heavy vaginal bleeding and possibly death. In addition, the drugs may cause birth defects if the pregnancy is not terminated.

The self-sterilization kit involves intrauterine insertion of pellets of quinacrine hydrochloride, "an unapproved drug, which can cause ectopic pregnancy, abnormal pregnancies, and permanent damage to a woman's reproductive organs," the FDA warned.

Home-Use HIV Test Kits: In September, the FDA warned consumers and pharmacists about "2 unapproved, fraudulently marketed home-use test kits distributed by Lei-Home Access Care, a division of Jin-Greene Biotechnology, Inc, in Sunnyvale, Calif." One test kit is still being promoted and sold through the Net under the label "Personal HIV Test Kit." The other is labeled the "In-Home Hepatitis A Test Kit." According to the FDA, results from these or other unapproved tests for home use are unreliable. (Only 1 HIV home test kit is currently approved for marketing in the United States—the Home Access HIV-1 Test System [also called the Home Access Express HIV-1 Test System], sold by Home Access Health Corporation, Hoffman Estates, Ill. There is no approved home test for hepatitis A.)

Do-It-Yourself Drug for Bodybuilding and Sexual Enhancement: The FDA is warning the public about the dangers of gamma-hydroxybutyric acid (GHB), which became popular as a steroid alternative for bodybuilding and as a sexual enhancement drug in the 1980s. The manufacturing, distribution, and promotion of GHB was made illegal in the United States and a number of other countries after numerous GHB-related illnesses were reported—including many that required hospitalization and several that resulted in death. Recently, there has been a resurgence of GHB abuse, which is being facilitated by the Net. Some offshore Web sites are still selling GHB through the mail. Others, including several in the United States, provide instructions on making GHB in the home kitchen, and some are selling GHB kits, complete with everything needed to make the illegal drug. One such kit—which costs $162.50, Federal Express delivery included—will make about 180 1-g doses, the Web advertisement says. These sellers are attempting to hide behind the disclaimer that the GHB is "not for human consumption," said Stuart L. Nightingale, MD, FDA's associate commissioner for Health Affairs, Rockville, Md.

One of the GHB-promoting Web sites provides this warning: "Always tell your friends if you are on GHB so that if you pass out they will know why and not freak out! This will save you embarrassment and big hospital bills." It also warns against taking too big a dose the first time because "you don't know if you will become nauseated. Passed out and puking is a bad, bad combination. (Just ask Jimi Hendrix [the rock musician who died of a narcotic overdose].)"

Fen/Phen for Sale: In September, the FDA issued an advisory warning following reports of previously rare valvular heart disease and fatal pulmonary hypertension among patients who were taking the popular drug combination fenfluramine and phentermine (fen/phen) for weight reduction. In response, manufacturers of 2 of the anoretic drugs (Redux and Pondimin) voluntarily withdrew them from the market. (See pp 1728 and 1729.)

Some physicians had been selling the drug combination through the Internet to patients they had never examined or even seen. At least 1 US Web site is still recruiting patients for a fen/phen treatment program (albeit now using a substitute regimen of so-called serotonin and dopamine precursors). The advertisement claims that the program can successfully treat obesity, eating disorders, obsessive-compulsive disorders, nail biting, postmenstrual syndrome, Crohn disease and other inflammatory bowel disorders, asthma, hives, psoriasis, lupus, Sjoegren syndrome and other immune disorders, chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivities, and drug, alcohol, and sexual addictions.

According to the Web advertisement, the therapy also appears affective against multiple sclerosis, amyotrophic lateral sclerosis, and rheumatoid arthritis, and promising results have been obtained in patients with posttraumatic stress disorder, Gulf War syndrome, and AIDS. What's more, it may protect patients from developing viral illnesses and decrease the risk of developing cancer. If patients have "strong reasons" for not being able to come to the treatment center, no problem, the Web advertisement says; patients may be treated and monitored by phone.

—A. A. S.

(JAMA. 1997;278:1724)