Over half a million
Americans use Botox to smooth out facial wrinkles and relieve muscle disorders.
The drug has been used for 20 years and is approved in dozens of countries.
But demonstrating yet again that Tinseltown is not like the rest of America,
a high-profile Hollywood couple has brought the first-ever suit against the
makers of Botox. In February, former Russian model Irena Gerasimenko, the
wife of Hollywood producer and studio mogul Michael Medavoy, will face-off
with Botox manufacturer Allergan, Inc. in a California court. Ms. Medavoy
is also suing Dr. Arnold Klein, alleging that he prescribed her an excessive
While the suit may create beneficial publicity for the Medavoys' Hollywood
careers, the legions of Botox users across America should simply turn the
other cheek because Botox is safe.
A purified form of the botulism toxin, Botox paralyzes muscles when injected
into the face, smoothing wrinkles. Although Botox facial renewals are a hit
in Hollywood, 60 percent of Botox sales are for its myriad therapeutic uses.
The drug is a proven treatment for muscle spasms, cervical dystonia, excessive
blinking, crossed eyes, and excessive sweating and muscle stiffness caused
by stroke and cerebral palsy.
Ms. Medavoy, whose husband Michael is the current chairman of Phoenix Pictures
and former chairman of Tri-Star and Orion, alleges that she began taking
Botox to treat her migraine headaches, but that Botox then somehow caused
these headaches. She also claims that Botox caused fever, respiratory problems
and hives, although she admits in her complaint that some of these symptoms
While the complaint does not explain what house chores she did before taking
Botox, Ms. Medavoy contends that she can no longer perform "wifely duties."
Furthermore, her husband initially alleged that her illness deprived him
of, "her companionship, intimacy and services." However, Mr. Medavoy later
inexplicably withdrew from the lawsuit.
The question now facing thousands of Americans is whether Botox is safe at
recommended dosages. The overwhelming evidence indicates that it is.
Dr. William Hanke of the Indiana University School of Medicine stated, "Botox
is a very important new drug and is totally safe. It has been used for 20
years in this country for eye muscle dysfunction problems. The FDA approved
Botox long ago for that indication and it has been used off-label for wrinkles
since the late 1980s."
According to the journal Dermatology Times, typical side effects of
Botox include bruising, swelling, brief pain at the injection site, and headaches,
but these symptoms generally go away within a few days. Dr. Sheldon Pollack,
a professor of dermatology at the University of Toronto, noted that Botox
is a temporary treatment and any complications are temporary.
A recent study by Dr. Allison Brashear, an associate professor of neurology
at the Indiana University School of Medicine, showed Botox could successfully
treat muscle spasms in stroke patients. She concluded, "We all know Botox
is safe but our study pointed this out because most of these people had vascular
disease and the average age was 61. None of the patients had any difficulties
whatsoever with the injections."
Ms. Medavoy's suit accuses Allergan of illegally promoting Botox as a treatment
for headaches, because the FDA has not approved it for that purpose. However,
regulatory authorities in 21 countries have approved Botox as a cosmetic
treatment. The FDA itself has approved Botox to treat "severe glabellar lines,"
vertical lines that can appear between the brows. This is exactly the opposite
of a situation where a drug is approved only for life-saving purposes despite
serious side effects.
Dr. Stuart Nightingale, a chief medical officer at the U.S. Department of
Health and Human Services, explained, "Off-label use is legal and, with important
qualifications, generally embraced by physicians and other health care providers,
health care institutions, insurers, pharmaceutical companies, and even the
FDA. The FDA has observed that unapproved uses may be appropriate and rational
in certain situations, and that advances in medical knowledge and practice
inevitably precede labeling revisions."
Although clinical trials continue to gauge Botox's effectiveness for treating
headaches, the results are encouraging. David Swope, a Loma Linda University
Medical Center neurologist, said, "Botox has probably been one of the most
important advances in neurology in the last 20 years." Dr. Jeffrey Unger,
who runs a California headache clinic, noted, "Studies have shown that Botox
reduces emergency room visits for migraine sufferers by 50 percent."
While a California jury will likely have the final word on Ms. Medavoy's
claims, the medical verdict is in. Americans can save face because Botox
Marc A. Levin is an appellate lawyer, President of the American Freedom Center, and Associate Editor of The Austin Review.