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Unproven Medical Treatments Lure Elderly
by Kristine Napier

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 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, or write FDA, HFE-88, 5600 Fishers Lane, Rockville, MD 20857.

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

Approximately 80 percent of older Americans have one or more chronic health problems.

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 the 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.

A Closer Look

Here's a closer look at some unproven therapies promoted for a variety of ills common in older people:

Cellular therapy promoters claim an extract from animal hearts can strengthen human hearts, eye extracts can cure eye disease, and so on. FDA says there are no scientific studies demonstrating the safety and effectiveness of cellular therapy for any medical purpose and warns of health problems, including severe allergic reactions and death.

Chaparral is an herb used in teas, capsules and tablets that promoters purport delays aging, cleanses the blood, and treats cancer. In early 1993, FDA warned consumers not to use it because it had caused serious liver and kidney troubles. Most manufacturers voluntarily withheld chaparral- containing products from sale, and consumers are advised not to use remaining products.

Coenzyme Q-10, a synthetically produced version of a naturally occurring enzyme, is promoted to slow aging by enhancing the immune system. Not only is there no proven benefit, but it may be dangerous for people with poor circulation, according to Edward L Schneider, M.D., of the National Institute on Aging. Overall, there is no evidence that "boosting" the immune system delays aging, nor is there any evidence that it's possible to do so, according to Schneider.

DHEA (dehydroepiandrosterone) is a naturally occurring chemical. Because levels decline with aging, some scientists speculate it may play some role in aging processes. But there is not proof that DHEA delays aging, according to Schneider.

DMSO, or dimeltyl sulfoxide, is a solvent similar to turpentine promoted for arthritis relief. In a sterile form called Rimso-50, it is approved by FDA for treating a rare bladder condition called interstitial cystitis. For this approved use, it is instilled into the bladder for short times (20 to 30 minutes). This is the only approved human use. There are no controlled studies demonstrating its safety and effectiveness in relieving swollen, inflames arthritis joins, and in an impure form it can harbor bacterial toxins that can enter the bloodstream even when applied topically. It is one of the few compounds rapidly absorbed through the skin. It can be especially dangerous if used as an enema, as recommended by its promoters.

Electrical stimulators are approved by FDA when prescribed by physicians for various conditions, including after-stroke therapy. However, FDA has not approved them for wrinkle removal and face lifts.

Geranium, an inorganic, nonessential element sold as a dietary supplement. Promoters claim it prevents and treats Alzheimer's, and advise users to apply bandage wraps with it to treat arthritis and headaches. Not only is geranium ineffective, but is has caused serious irreversible kidney damage and death, according to FDA.

Gerovital-H3, originating in Romania more than 30 years ago, was brought here illegally and sold as a cure for arthritis, atherosclerosis, angina pectoris, hypertension, deafness, Parkinson's disease, depression, diabetes, and impotence. One of its ingredients is procaine hydrochloride, an anesthetic approved for dental use. No health claims for Gerovital have been substantiated, and FDA considers it an unapproved new drug. It has caused low blood pressure, respiratory difficulties, and convulsions in some users.

Herbal products are centuries-old, but mostly unproven, "cures" for everything from constipation to anxiety. They are available in various forms, including teas, capsules and tablets. Some are potentially dangerous. Chamomile tea, for example, can cause a severe allergic reaction in people allergic to ragweed. Lobelia can cause vomiting, breathing problems, convulsions, and even coma and death when used in large amounts; people with heart disease are especially susceptible. Comfrey has caused severe and even fatal liver disease. (See "Beware the Unknown Brew: Herbal Teas and Toxicity" in the May 1991 FDA Consumer.)

Lecithin, a naturally occurring component of certain body tissues, is touted for lowering cholesterol and treating Alzheimer's disease. There's no proof that it's effective for either one.

Low-intensity lasers are promoted to relieve arthritis pain, but FDA has not approved them for this or any other use.

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

Magnetism: Pressure dots with tiny magnets affixed to adhesive strips that are worn over the arthritic area are promoted for curing arthritis; a magnet in men's briefs is purported to cure impotence; and a magnet used a suppository is promoted for curing hemorrhoids. There is no scientific basis for any of these claims.

Retin-A has been approved by FDA as a topical treatment for acne. The agency, however, has not determined whether it is safe and effective as a wrinkle remover.

RIFE generator promoters claim that they can insert a person's photograph into their device and diagnose medical conditions. FDA has not approved the marketing of this device, nor is there any scientific basis for this claim.

RNA, or ribonucleic acid, a natural body chemical that carries genetic information, is a common ingredient in anti- aging compounds and is also promoted for Alzheimer's. Promoters claim it rejuvenates old cells, improves memory, and prevents wrinkling. But there have been no controlled scientific studies to back up these claims.

Superoxide dismutase (SOD) is a normal body chemical that is promoted as being able to slow aging and treat Alzheimer's disease. According to the National Institute on Aging's Schneider, writing in the New England Journal of Medicine, some studies have shown higher tissue levels of SOD in longer-living species. A survey of a large number of different animal species revealed, in fact, that the longest- lived species, human beings, had the highest tissue levels of superoxide dismutase. But there is no evidence that SOD works to delay aging or prolong life, nor is there any evidence that taking SOD tablets raises blood or tissue levels of SOD.

Hearing Aids

FDA is taking action to improve the patient care of people who buy hearing aids. Though hearing aids have significantly improved the quality of life for many older Americans, the agency is concerned that some manufacturers are making unsubstantiated claims about their devices and are giving inaccurate portrayals of their devices' risks and benefits.

The agency last November proposed changes to hearing aid regulations to require a hearing assessment in all cases before a person is sold a hearing aid. The regulation will also require that this assessment be done by a qualified health professional licensed by the state. A public hearing on the proposal was held Dec. 6 and 7 near FDA headquarters in Rockville, Md.

Although a 1977 regulation restricts hearing aid sales to people who have had a hearing evaluation by a doctor within six months, FDA Commissioner Kessler pointed out that the "regulation also included a provision allowing fully informed adult patients to waive the medical examination." Kessler said this waiver has been "overused and misrepresented."

Before proposing the regulation changes, FDA reviewed promotional materials for a number of hearing aids and found that several manufacturers were making unsubstantiated and misleading claims that created unrealistic expectations about the performance of the devices. In addition, the materials failed to disclose significant information and did not accurately disclose the device's potential risks and benefits.

At press time, FDA was reviewing public comments on the proposed regulation changes.

Avoiding Fraud

According to FDA, these red flags should make you think twice about remedies not prescribed by your doctor:

    * celebrity endorsements

    * inadequate labeling (a legitimate non-prescription medication is labeled with indications for use, as well as how to use it and when to seek medical help)

    * claims that the product works by a secret formula

    * promotion of the treatment only in the back pages of magazines, over the phone, by direct mail, in newspaper ads in the format of new stories, or 30-minute commercials in talk show format.

The Arthritis Foundation says the following claims are also warning signs that a "cure" has but questionable therapeutic value:
    * It's effective for a wide range of disorders, such as cancer, arthritis and sexual dysfuntion. ("But, say FDA's Aronson, "don't misinterpret this a believe a product promoted for only one disease is safe and effective.")

    * It's all natural

    * It's inexpensive and has no side effects.

    * It works immediately and permanently, making a visit to the doctor unnecessary.

Older Americans, along with younger folks, should remember that falling victim to health fraud is "not a matter of being weaker or foolish," says Renner. "It is a matter of being in pain or having more than one chronic illness--or both."

Barrett offers a final word of advise: "When you feel your physician isn't doing enough to help, don't stray from scientific health care in a desperate attempt to find a solution." Instead, ask your physician to provide a more detailed explanation or to refer you to another doctor.

For More Information

American Cancer Society
1599 Clifton Road, N.E.
Atlanta, GA 30329
(404) 320-3333
(800) ACS-2345

Arthritis Foundation
P.O. Box 19000
Atlanta, GA 30326
(800) 283-7800

National Institute on Aging
NIA Information Center
P.O. Box 8057
Gaithersburg, MD 20898-8057

Alzheimer's Association
919 North Michigan Ave., Suite 1000
Chicago, IL 60611
(800)272-3900

Federal government resources on health fraud and alternative medicine are:

FDA
HFE-88
Rockville, MD 20857
(301) 443-3170

Office of Alternative Medicine/NIH Information Center
6120 Executive Blvd., EPS
Suite 450
Rockville, MD 20852
(301) 402-2466

U.S. Postal Inspection Service (monitors products purchased by mail)
Office of Criminal Investigation
Washington, DC 20260-2166
(202) 268-4272

Federal Trade Commission (regarding false advertising)
Room 421
6th St. and Pennsylvania Ave., N.W.
Washington, DC 20580
(202) 326-2222

Kristine Napier is a registered dietitian and writer in Mayfield Village, Ohio.

A REPRINT FROM FDA CONSUMER MAGAZINE Printed December 1994.

This article originally appeared in the March 1994 FDA Consumer Publication No (FDA) 94-1218

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE*FOOD AND DRUG ADMINISTRATION

We hope you found this reprint from FDA Consumer magazine useful and informative. FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information of FDA-related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine. For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857

*U.S. Government Printing Office 1995-386-968/00034