Allergan, the maker of Botox, is facing hundreds of millions of dollars in fine
Called "seeding the market," the tactic used by the drug company giant was to make Botox available to doctors for more and more applications, other than just wrinkles, ahead of FDA approval, to boost sales.
Since the late 1990's Botox has become universally known as a treatment for wrinkles. Working by "freezing the face," paralyzing the muscles underlying the skin that can make wrinkles noticeable, Botox is a short-term, and expensive treatment that has to be applied again and again to keep aging faces wrinkle-free (and sometimes expression-free).
Even though the cosmetic applications of Botox quickly created a billion dollar a year market, the makers of Botox at Allergan recognized that even greater markets were possible if the botulism-derived medication were available for other uses. Allegan encouraged physicians to use Botox to treat excessive sweating under the arms, neck spasms, anal fissures, overactive bladder, a painful condition known as cervical dystonia, chronic pain, spastic muscles, and cerebral palsy in children.
Doctors are allowed to make reasonable applications of drugs not previously approved by the FDA. Drug companies, however, are not allowed to encourage them. Whistle blower reports filed between 2000 and 2005 resulted in a lengthy investigation finding that Allergan systematically encouraged doctors to use Botox as a treatment for migraines, even hiring a well-known medical school professor to make a video for a phony front organization called the Neurotoxin Institute. The company hired an advertising agency to promote the unapproved application of the drug, and offered doctors generous kickbacks to treat their migraine patients with injections of the drug.
This kind of medical marketing is wrong
What's the problem with this kind of marketing? Dr. Joshua M. Sharfstein, the principal deputy commissioner of the FDA, told the New York Times in an interview, "What concerns the FDA is that, if companies can promote off-label uses without submitting evidence showing the drug to be safe and effective, it potentially puts patients at risk and subverts the drug approval system."
Patients can be at risk when careful scientific study has not determined the right dosages of drugs--drug companies typically supporting more as better--and the safety of giving multiple injections over time. Using the product off-label also circumvents systems for reporting adverse effects, and bypasses the clinical trials needed to make sure there are no unexpected side effects from treatment.
Allergan admits to misbranding its drug, but denies charges of kickbacks and fraud. Company spokesperson Caroline van Hove insisted that no patients had been harmed as a result of the company's encouragement to doctors to use the drug in off-label applications.
In the meantime, the FDA is considering whether to approve Botox for the application in the whistleblower complaints, relief of pain caused by migraine headaches. The FDA is expected to rule by the end of October on whether this use of the drug will be approved for drug company promotion and advertising, with standards of care for doctors to use the medication safely.