- The Washington Times - Monday, October 4, 2004

Irena Medavoy, a former actress and the Hollywood wife of a movie mogul, is suing her doctor. She claims the Botox injections she took to relieve her migraines caused such lethargy and loss of libido that she missed several Oscar after-parties and a trip to the south of France. Her physician, Dr. Arnold Klein, is a dermatologist who has been injecting Botox into Ms. Medavoy to remove her wrinkles for years. So, she can’t blame Botox or her doctor, exactly. Instead, she and her lawyers are suing Dr. Klein and Allergan, the maker of Botox for using the drug to treat migraines at all. Botox is not approved by the Food and Drug Administration as a migraine treatment, which is therefore a so-called off-label use.

Off-label drug use is likely to become the junk-science litigation bonanza of the 21st century. When he was a practicing attorney, Sen. John Edwards convinced a jury — in the absence of any medical evidence — that a Caesarean-section birth caused an infant’s cerebral palsy. The Medavoy lawyers want to convince the jury that off-label use is inherently dangerous independent of the actual biological mechanisms and scientific evidence itself.

Peter Huber’s seminal work on how trial lawyers manipulate juries with suspect medical information, “Galileo’s Revenge: Junk Science in the Courtroom,” described the Edwards approach as follows: “The jury sees the undisputed trauma first, the disputed negligence second, the undisputed cerebral palsy third. It is a perfect set-up for misinterpreting sequence as cause.”

Now trial attorneys are avoiding science altogether and seeking instead to paint off-label drug use as unscientific, untried and inherently dangerous. Not coincidentally, Ms. Medavoy now alleges that off-label use of Botox for migraines amounts to using her as a “guinea pig.” And during the trial, much has been made of Dr. Klein’s consulting arrangement with Allergan in an effort to depict off-label use as nothing more than a collusive activity between a doctor and drug company to promote Botox for unapproved uses.

In fact, Dr. Klein’s off-label prescribing of Botox was on many levels a common clinical decision, essential to providing good care. There is nothing untoward or suspicious about off-label prescribing. Indeed, federal courts and the FDA have established that physicians have wide discretion in prescribing drugs as they see fit.

Secondly, off-label prescribing is a well-established and well-documented part of medical practice. Research on off-label uses has to be pursued in ways that the medical and scientific communities accept or treatment would never expand to a larger group of patients. Indeed, progress against and effective treatment of cancer, AIDS, eating disorders, heart disease, pain and mental illness depend upon the off-label use of hundreds of medicines.

Botox is no exception. The most comprehensive review of the safety of Botox in multiple conditions found that it has an “excellent safety and tolerability profile across a wide range of cosmetic and therapeutic uses.” The majority of uses for Botox, including as a treatment for cervical dystonia, were originally off-label but were the standard of care prior to FDA approval. In fact, off-label use of Botox has become the treatment of choice to help kids with cerebral palsy walk again. It also treats clubfeet in infants without the use of surgery and has become an important treatment for patients suffering from post-stroke spasticity — all off-label uses.

The Medavoy lawsuit is attracting front-page headlines and lead stories in major media outlets because the plaintiff has portrayed herself the Erin Brockovich of the Botox set. But if the press begins to ignore the science and the facts of the case — and off-label use — doctors and drug companies everywhere should be prepared for a wave of litigation as powerful and devastating as the junk-science lawsuits that powered the breast- implant tsunami of a decade ago. Indeed, lawyers are setting up call centers and Web sites to trawl for Botox off-label horror stories for additional litigation.

If Ms. Medavoy wins, progress against disease would literally grind to a halt. Doctors would stop prescribing off-label; researchers would find it more difficult and more expensive to conduct research; and drug and biotech companies would only invest in the most conservative of compounds and experiments. The Medavoy team is still betting that the Hollywood hype devoted to the case will overshadow the damage a successful suit could do to ongoing important medical research involving Botox and other medicines. Let’s hope the jury in this trial will side with science rather than opportunism and what can only amount to a case of Hollywood-style extortion.

Robert Goldberg is director of the Manhattan Institute’s Center for Medical Progress.

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