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 Subcommitte 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
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.
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.
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. ?
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.
Kristine Napier is a registered
dietitian and writer in Mayfield Village, Ohio.
A REPRINT FROM FDA CONSUMER MAGAZINE
Printed December 1994.
FOR MORE INFORMATION
FDA U.S. Postal Inspection Service
HFE-88 (monitors products purchased by mail)
5600 Fishers Lane Office of Criminal Investigation
Rockville, MD 20857 Washington DC 20260-2166
Federal Trade Commission Arthritis Foundation
(regarding false advertising) P.O. Box 19000
Room 421 Atlanta, GA 30326
6th St and Pennsylvania Ave., N.W. (ask for their free
Washington, DC 20580 brochure "Unproven
Remedies")
National Institute on Aging
NIA Information Center Alzheimer's Association
P.O. Box 8057 919 North Michigan Ave.
Gaithersburg, MD 20898-8057 Suite 1000
Chicago, IL 60611
(1-800)272-3900
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:
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*U.S. Government Printing Office 1995-386-968/00034
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