How to Spot Health Fraud
You don't have to look far to find a health product that's
totally bogus--or a consumer who's totally unsuspecting. Promotions
for fraudulent products show up daily in newspaper and magazine
ads and TV "infomercials." They accompany products sold in
stores, on the Internet, and through mail-order catalogs.
They're passed along by word-of-mouth.
And consumers respond, spending billions of dollars a year
on fraudulent health products, according to Stephen Barrett,
M.D., head of Quackwatch Inc., a nonprofit corporation that
combats health fraud. Hoping to find a cure for what ails
them, improve their well-being, or just look better, consumers
often fall victim to products and devices that do nothing
more than cheat them out of their money, steer them away from
useful, proven treatments, and possibly do more bodily harm
than good.
"There's a lot of money to be made," says Bob Gatling, director
of the program operations staff in the Food and Drug Administration's
Center for Devices and Radiological Health. "People want to
believe there's something that can cure them."
FDA describes health fraud as "articles of unproven effectiveness
that are promoted to improve health, well being or appearance."
The articles can be drugs, devices, foods, or cosmetics for
human or animal use.
FDA shares federal oversight of health fraud products with
the Federal Trade Commission. FDA regulates safety, manufacturing
and product labeling, including claims in labeling, such as
package inserts and accompanying literature. FTC regulates
advertising of these products.
Because of limited resources, says Joel Aronson, team leader
for the nontraditional drug compliance team in FDA's Center
for Drug Evaluation and Research, the agency's regulation
of health fraud products is based on a priority system that
depends on whether a fraudulent product poses a direct or
indirect risk.
When the use of a fraudulent product results in injuries
or adverse reactions, it's a direct risk. When the product
itself does not cause harm but its use may keep someone away
from proven, sometimes essential, medical treatment, the risk
is indirect. For example, a fraudulent product touted as a
cure for diabetes might lead someone to delay or discontinue
insulin injections or other proven treatments.
While FDA remains vigilant against health fraud, many fraudulent
products may escape regulatory scrutiny, maintaining their
hold in the marketplace for some time to lure increasing numbers
of consumers into their web of deceit.
How can you avoid being scammed by a worthless product?
Though health fraud marketers have become more sophisticated
about selling their products, Aronson says, these charlatans
often use the same old phrases and gimmicks to gain consumers'
attention--and trust. You can protect yourself by learning
some of their techniques.
The following products typify three fraudulent products
whose claims prompted FDA to issue warning letters to the
products' marketers, notifying them that their products violated
federal law. Two of the products also were added to FDA's
import alert list of unapproved new drugs promoted in the
United States. Products under import alert are barred from
entry onto the U.S. market.
Take a look at these products' promotions. They are rife
with the kind of red flags to look out for when deciding whether
to try a health product unknown to you.
Paula Kurtzweil is a member of FDA's public affairs staff.
Tip-Offs to Rip-Offs
Product No. 1: Pure emu oil
| FDA determined that a pure emu oil product marketed
to treat or cure a wide range of diseases was an unapproved
drug. Its marketer had never submitted to FDA data to
support the product's safe and effective use. |
One Product Does It All
" ... extremely
beneficial in the treatment of rheumatism, arthritis ... infections
... prostate problems, ulcers ... cancer, heart trouble, hardening
of the arteries, diabetes and more. ... "
"completely eliminating the gangrene ...
"... antibiotic, pain reliever ... ."
Be suspicious of products that claim to cure a wide range
of unrelated diseases--particularly serious diseases, such
as cancer and diabetes. No product can treat every disease
and condition, and for many serious diseases, there are no
cures, only therapies to help manage them.
Cancer, AIDS, diabetes, and other serious diseases are big
draws because people with these diseases are often desperate
for a cure and willing to try just about anything.
Personal Testimonials
"Alzheimer's Disease!!!
My husband has Alzheimer. On September 2, 1998 he began eating
1 teaspoon full of ... Pure Emu Oil each day. ... Now (in
just 22 days) he mowed the grass, cleaned out the garage,
weeded the flower beds, and we take our morning walk again.
It hasn't helped his memory much yet, but he is more like
himself again!!!"
Personal testimonies can tip you off to health fraud because
they are difficult to prove. Often, says Reynaldo Rodriguez,
a compliance officer and health fraud coordinator for FDA's
Dallas district office, testimonials are personal case histories
that have been passed on from person to person. Or, the testimony
can be completely made up.
"This is the weakest form of scientific validity," Rodriguez
says. "It's just compounded hearsay."
Some patients' favorable experiences with a fraudulent product
may be due more to a remission in their disease or from earlier
or concurrent use of approved medical treatments, rather than
use of the fraudulent product itself.
Quick Fixes
"... eliminates
skin cancer in days! ..."
Be wary of talk that suggests a product can bring quick
relief or provide a quick cure, especially if the disease
or condition is serious. Even with proven treatments, few
diseases can be treated quickly. Note also that the words
"in days" can really refer to any length of time. Fraud promoters
like to use ambiguous language like this to make it easier
to finagle their way out of any legal action that may result.
Product No. 2: Over-the-counter transdermal weight-loss patch
| FDA issued a warning letter to the marketer of the
weight-loss product described here because it did not
have an approved new drug application. Because of the
newness of the dosage form--skin-delivery systems--FDA
requires evidence of effectiveness, in the form of a
new drug application, before the product can be marketed
legally. |
'Natural'
"Healthy, simple
and natural-way to help you lose and control your weight."
Don't be fooled by the term "natural." It's often used in
health fraud as an attention-grabber; it suggests a product
is safer than conventional treatments. But the term doesn't
necessarily equate to safety because some plants--for example,
poisonous mushrooms--can kill when ingested. And among legitimate
drug products, says Shelly Maifarth, a compliance officer
and health fraud coordinator for FDA's Denver district office,
60 percent of over-the-counter drugs and 25 percent of prescription
drugs are based on natural ingredients.
And, any product--synthetic or natural--potent enough to
work like a drug is going to be potent enough to cause side
effects.
Time-Tested or New-Found Treatment
"This revolutionary
innovation is formulated by using proven principles of natural
health based upon 200 years of medical science."
Usually it's one or the other, but this claim manages to
suggest it's both a breakthrough and a decades-old remedy.
Claims of an "innovation," "miracle cure," "exclusive product,"
or "new discovery" or "magical" are highly suspect. If a product
was a cure for a serious disease, it would be widely reported
in the media and regularly prescribed by health professionals--not
hidden in an obscure magazine or newspaper ad, late-night
television show, or Website promotion, where the marketers
are of unknown, questionable or nonscientific backgrounds.
The same applies to products purported to be "ancient remedies"
or based on "folklore" or "tradition." These claims suggest
that these products' longevity proves they are safe and effective.
But some herbs reportedly used in ancient times for medicinal
purposes carry risks identified only recently.
Satisfaction Guaranteed
"... Guarantee:
If after 30 days ... you have not lost at least 4 pounds each
week, ... your uncashed check will be returned to you ...
."
Here's another red flag: money-back guarantees, no questions
asked.
Good luck getting your money back. Marketers of fraudulent
products rarely stay in the same place for long. Because customers
won't be able to find them, the marketers can afford to be
generous with their guarantees.
Product No. 3: Unapproved weight-loss product
marketed as an alternative to a prescription drug combination
| FDA issued an import alert for a Canadian-made weight-loss
product whose claims compared the product with two prescription
weight-loss drugs taken off the market after FDA determined
they posed a health hazard. |
Promises of Easy Weight Loss
"Finally, rapid
weight loss without dieting!"
For most people, there is only one way to lose weight: Eat
less food (or fewer high-calorie foods) and increase activity.
Note the ambiguity of the term "rapid." A reasonable and
healthy weight loss is about 1 to 2 pounds a week.
Paranoid Accusations
"Drug companies
make it nearly impossible for doctors to resist prescribing
their expensive pills for what ails you ... ."
"It seems these billion dollar drug giants all have one relentless
competitor in common they all constantly fear--natural remedies."
These claims suggest that health-care providers and legitimate
manufacturers are in cahoots with each other, promoting only
the drug companies' and medical device manufacturers' products
for financial gain. The claims also suggest that the medical
profession and legitimate drug and device makers strive to
suppress unorthodox products because they threaten their financial
standing.
"This [accusation] is an easy way to get consumers' attention,"
says Marjorie Powell, assistant general counsel for the Pharmaceutical
Research and Manufacturers of America. "But I would ask the
marketers of such claims, 'Where's the evidence?' It would
seem to me that in this country, outside of a regulatory agency
it would be difficult to stop someone from making a claim."
Think about this, too: Would the vast number of people in
the health-care field block treatments that could help millions
of sick, suffering patients, many of whom could be family
and friends? "It flies in the face of logic," Barrett says
on his Quackwatch Website.
Meaningless Medical Jargon
"... Hunger Stimulation
Point (HSP) ..."
"... thermogenesis, which converts stored fats into soluble
lipids ..."
"One of the many natural ingredients is inolitol hexanicontinate."
Terms and scientific explanations such as these may sound
impressive and may have an element of truth to them, but the
public "has no way of discerning fact from fiction," Aronson
says. Fanciful terms, he says, generally cover up a lack of
scientific proof.
Sometimes, the terms or explanations are lifted from a study
published in a reputable scientific journal, even though the
study was on another subject altogether, says Martin Katz,
a compliance officer and health fraud coordinator for FDA's
Florida district office. And chances are, few people will
check the original published study.
"Most people who are taken in by health fraud will grasp
at anything," he says. "They're not going to do the research.
They're looking for a miracle."
Truth or Dare
The underlying rule when deciding whether a product is authentic
or not is to ask yourself: "Does it sound too good to be true?"
If it does, it probably isn't true.
If you're still not sure, check it out: "Look into it--before
you put it in your body or on your skin," says Reynaldo Rodriguez,
a compliance officer and health fraud coordinator for FDA's
Dallas district office.
To check a product out, FDA health fraud coordinators suggest:
- Talk to a doctor or another health professional. "If it's
an unproven or little-known treatment, always get a second
opinion from a medical specialist," Rodriguez says.
- Talk to family members and friends. Legitimate medical
practitioners should not discourage you from discussing
medical treatments with others. Be wary of treatments offered
by people who tell you to avoid talking to others because
"it's a secret treatment or cure."
- Check with the Better Business Bureau or local attorneys
generals' offices to see whether other consumers have lodged
complaints about the product or the product's marketer.
- Check with the appropriate health professional group--for
example, the American Heart Association, American Diabetes
Association, or the National Arthritis Foundation if the
products are promoted for heart disease, diabetes or arthritis.
Many of these groups have local chapters that can provide
you with various resource materials about your disease.
Joining Forces to Fight Fraud
Health fraud isn't confined to the United States only. It's
worldwide, and to help combat it in North America, the United
States has joined with Canada and Mexico to share knowledge
and coordinate enforcement activities related to fraudulent
health products, services and devices.
In announcing their decision in December 1998 to adopt the
Joint Strategies Agreement, the countries agreed to:
- share information on current trends in health fraud
- cooperate in detecting health fraud along borders
- share information about significant investigations in
their country
- consider each others' requests to investigate domestic
activities and coordinate related enforcement activities
- develop and distribute joint consumer and business education
messages about health fraud.
