Unproven Medical Treatments Lure Elderly

by Food and Drug Administration (FDA)

Americans spend upwards of $20 billion each year on unproven medical treatments. Sixty percent of those who try untested therapies are over 65 and spend an estimated $10 billion on them, according to a 1984 House Subcommittee on Health and Long-Term Care report, "Quackery: A $10 Billion Scandal."

Approximately 80 percent of older Americans have one or more chronic health problems, according to John Renner, M.D., a Kansas City- based champion of quality health care for the elderly. He says their pain and disability lead to despair, making them excellent targets for deception.

"Despite disappointments with promised cures, they continue to hold out hope that the next quick 'cure' will work," says anti-fraud activist Stephen Barrett, M.D.

Frightened of losing a parent or grandparent, family members, too, encourage them to "try everything," especially unproven remedies, according to Barrie R. Cassileth, Ph.D., writing in CA — A Cancer Journal for Clinicians.

And, indeed, sometimes people get better when using unproven treatments. But because these therapies have not passed scientific muster, it is impossible to know if improvement is associated with the treatment, represents spontaneous change, or is due to the "placebo" effect. (A placebo is an inactive substance with no known therapeutic value. The "placebo effect" is the phenomenon of people getting better while taking an inactive substance they believe to be therapeutic.)

"It's important to remember," says Barrett, "that many conditions get better on their own, or appear to get better if we believe they will."

What's the Danger?

Taking a chance on unproven treatments is not simply useless, it is often dangerous, according to the Food and Drug Administration, which divides such products into two categories: direct health hazards and indirect health hazards.

Direct health hazards are likely to cause serious injuries. For example, muscle stimulators, promoted falsely as muscle toners, carry a risk of severe electric shock.

Indirectly harmful products are those that cause people to delay or reject proven remedies, according to FDA. For example, if cancer patients reject proven therapies in favor of unproven ones, their disease may advance beyond the point where proven therapies can help.

All types of unproven therapies can be economically harmful, often draining precious dollars from older Americans' limited resources.

FDA's Health Fraud Staff, in its Center for Drug Evaluation and Research, investigates any product for which a disease claim is made. Joel Aronson, director of the Health Fraud Staff, points out that once a manufacturer claims a product can treat or prevent a disease or condition, "whether that product is bottled water or an herb, it is considered a drug and falls under FDA jurisdiction." A product is also considered a drug if it claims to alter the structure or function of the body.

FDA's Center for Food Safety and Applied Nutrition becomes involved with issues such as health claims for herbs, vitamins, and other dietary supplements (see "Dietary Supplements: Making Sure Hype Doesn't Overwhelm Science" in the November 1993 FDA Consumer). For a reprint of this article, contact your local FDA office.

FDA's Promotion and Advertising Staff, in its Center for Devices and Radiological Health, investigates health and disease claims made about devices. Byron Tart, acting director, explains that such devices fall into two main categories: devices approved for some medical use but promoted for an unapproved use, and devices not approved for any medical use at all.

Targeting Older Americans

Commonly, unproven products are pushed zealously on the elderly. Promoters often claim their products prevent aging and such conditions as arthritis, Alzheimer's disease, heart disease, and impotence.

According to the National Institute on Aging, however, "while a healthy lifestyle will help delay many of the conditions associated with aging processes, no preparation or device can stop aging." The 1984 House Subcommittee report estimated that people spent at least $2 billion per year on anti-aging remedies. Some anti-aging products are also promoted to either prevent or treat Alzheimer's disease. According to JoAnn McConnell, Ph.D., of the Alzheimer's Association, "so-called new 'cures' for Alzheimer's surface constantly."

But there are no cures, which may cause Alzheimer's patients and their families to be susceptible to products holding out false hope.

There is, however, one approved treatment for Alzheimer's disease: the drug Cognex (tacrine hydrochloride), which was approved in September of 1993 specifically to treat symptoms of Alzheimer's disease. "It is not a cure for Alzheimer's disease," says FDA Commissioner David A. Kessler, M.D., "but it provides some relief for patients and their families."

Particularly susceptible to deception are the 37 million Americans — many of them over 65 — who have arthritis. One reason is that arthritis symptoms come and go, causing people to associate their spontaneous relief with a new "remedy." The Arthritis Foundation says that older Americans spend an estimated $2 billion annually for unproven arthritis remedies.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.