[U.S. Food and Drug

This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site.
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 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

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
     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

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 no proof that DHEA delays
aging, according to Schneider.
     DMSO, or dimethyl 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, inflamed arthritic joints, 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.
     Germanium, an inorganic, nonessential element sold as a dietary
supplement. Promoters claim it prevents and treats Alzheimer's, and
advise users to apply bandage wraps saturated with it to treat arthritis and
headaches. Not only is germanium ineffective, but it 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
     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.
     Magnetism: Pressure dots with tiny magnets affixed to adhesive
strips and 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 as 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 Alzheimerœs. 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,
promoted to slow aging and treat Alzheimerœs. According to the National
Institute on Agingœs 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.

Avoiding Fraud
     According to FDA, these red flags should make you think twice
about remedies not prescribed by your doctor:
œ    celebrity endorsements
œ    inadequate labeling (a legitimate nonprescription medication is
labeled with indications for use, as well as how to use it and when to seek
medical help)
œ    claims that the product works by a secret formula
œ    promotion of the treatment only in the back pages of magazines,
over the phone, by direct mail, in newspaper ads in the format of news
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:
œ    It's effective for a wide range of disorders, such as cancer, arthritis
and sexual dysfunction. (œBut," says FDA's Aronson, "don't misinterpret
this and believe a product promoted for only one disease is safe and
œ    It's all natural.
œ    It's inexpensive and has no side effects.
œ    It works immediately and permanently, making a visit to the doctor
     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 advice: "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. 
Kristine Napier is a registered dietitian and writer in Mayfield Village,
For More Information:
5600 Fishers Lane
Rockville, MD 20857

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

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

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

Arthritis Foundation
P.O. Box 19000
Atlanta, GA 30326
(ask for their free brochure "Unproven Remedies")

Alzheimer's Association
919 North Michigan Ave.
Suite 1000
Chicago, IL 60611
(1-800) 272-3900
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
     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. 

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