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October 2001
Tip of the Month
"Miracle Cures" for Acne: Too
Good to Be True?
There are lots of advertised
"miracle cures" for acne. How can you sort out the
undocumented claims for "miracle cures" from scientifically
documented facts about acne treatments? Are "miracle cures"
for acne too good to be true?
While many products are advertised as
treatments to keep acne under control, some products are advertised as
"cures." That is, "cure" as in "acne will go
away and never come back." If undocumented by supporting data, a
claim like that is simply outrageous—a modern-day equivalent of the
all-curing snake oil that was sold by medicine men on the 19th
Century American frontier.
Acne treatment products are advertised in
newspapers and magazines, on television and radio, and on the World Wide
Web. The advertising is aimed at a market of millions of people who have
acne, some of whom are "willing to try anything" to clear up
the skin condition that causes them so much emotional distress. That’s
an attractive market for advertisers who are "willing to try
anything" to induce you to buy their product.
If you have acne and believe you are
"ready to try anything," step back for a moment and view
product claims with healthy skepticism. Apply some truth-of-claims tests
to determine if a product that claims to be a cure for acne is what the
advertising promises:
Do claims use words such as
"miraculous," "amazing," "sensational,"
"scientific breakthrough," "secret formula," or
"centuries-old formula?"
These are classic snake oil claims used
for patent medicines since the 19th Century. Any product that
asks for your 100% gullibility should be suspected of exaggerated
claims.
What proof of effectiveness is
offered?
If the only "proof" is
testimonial—e.g., "I used Product X and my acne was gone in a
week"—be skeptical. So-called testimonials are not scientifically
valid proof of effectiveness. As discussed below when we talk about
clinical trials, even completely honest testimonials can be invalid
because people who want to be rid of their acne can often see a good
result when none really exists. The highest level of proof is
documentation that the product has been tested in clinical trials (see
below) and approved by the U.S. Food and Drug Administration (FDA) for
use as indicated.
Has the product been approved by the
FDA?
A topical or systemic agent that
effectively treats moderate to severe acne is an agent with a potent
physiologic effect. FDA approval assures you that the product has been
tested for effectiveness and safety in clinical trials. Indications for
use will include information about the agent’s side effects. FDA
approval does not assure that a given acne-treatment agent will be
effective in your individual case. Judgments about treatments are best
made by a dermatologist based on his/her knowledge of your medical
history.
What does it mean to have been tested
in FDA-approved clinical trials?
Clinical trials are (1) medical
investigative studies in which human beings are the test subjects, and
(2) required by the FDA for the approval of a new drug or new uses for
an existing drug. Before clinical trials are undertaken, an agent has
usually been studied in laboratory tests and in animals to determine
mechanism of action, efficacy and safety. There are several types of
clinical trials, but the "gold standard" for unbiased study
results is the randomized, double-blind controlled trial (RCT). In the
RCT, study subjects are randomly assigned to a study group or control
group, and neither the investigators nor the study subjects and controls
know who is receiving the treatment under investigation and who is
receiving placebo (a non-drug with no physiologic effect—a "sugar
pill"). Thus, RCTs are "double blind"—both
investigators and people being studied are "blinded" regarding
who is receiving the investigative agent and who is receiving placebo.
| Interestingly, acne
is a condition where substantial "placebo effect" is
observed—that is, people receiving placebo report improvement
in their acne. In many cases this is a manifestation of wishful
thinking, or seeing what you want to see. Without double-blind
objective assessment, such reports of effectiveness may be
accepted without further validation. It is important to keep
this in mind when evaluating glowing testimonials of
effectiveness from people who used a "miracle cure." |
RCTs are also designed to assure that the
number of people being studied will yield a statistically meaningful
result. Product effectiveness and product safety are always investigated
in FDA-approved clinical trials. Pharmaceutical firms sponsor RCTs under
FDA rules to gather the data necessary to win FDA approval for a new
drug or new uses for an existing drug. FDA rules specify conditions
under which the clinical trials are conducted. The studies are conducted
by recognized medical investigators in hospitals and medical centers, or
by physicians in private offices independent of any involvement by the
firm paying for the trials. If a product wins FDA approval, it must be
marketed within FDA guidelines and claims cannot exceed the findings of
clinical trials.
Be skeptical if advertising claims a
product contains "ingredients approved by the FDA." This may
be a way the advertiser uses to make it appear the product was approved
by the FDA.
Does advertising claim the product has
no side effects?
A topical or systemic agent with potent
physiologic effect will inevitably have some side effects. If product
advertising claims to "cure" acne without side effects, be
skeptical.
Is medical examination recommended
before use of the product?
Cleansing agents that reduce excess oil
on the skin can usually be used without medical supervision—unless you
have another skin condition for which you are being treated by a
dermatologist. A product potent enough to claim to "cure"
long-standing or severe acne should not be used without prior
examination by a dermatologist. Of course, it is unlikely that a
dermatologist would recommend use of a "miracle cure" that has
unsubstantiated claims.
In summary, there are two ways to test
the claims of products that are advertised as acne "cures."
One way is to buy the products and try them without attempting to verify
the claims in advance. The better way is to be knowledgeably skeptical
and apply truth-of-claims tests before buying the products.
References
www.FDA.gov/
National Academy of Sciences. Institute
of Medicine. Guidelines for Clinical Practice. 1992.
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