How Allergan Sponsored a History of Sausages to Promote Botox Illegally

(MoneyWatch)  Did you know that Emperor Leo VI of Byzantium banned sausage manufacturing in the 800s? You do now, thanks to the Neurotoxin Institute, a front group allegedly funded by Allergan (AGN), according to one of the whistleblower cases behind the company's $600 million settlement with the feds.

The Neurotoxin Institute was one of at least five front groups funded by Allergan that helped persuade doctors to use Botox for conditions not approved by the FDA, according to the lawsuits. The Byzantium-sausage-ban factoid was part of a timeline history of botulinum toxin that the Neurotoxin Institute produced to educate physicians -- sausages were an early source of botulism poisoning, it turns out, and toxin-infected sausage fat was later studied as a treatment for nervous disorders.

According to a complaint by Dr. Amy Lang, who performed medical education work for Allergan, and Charles J. Rushin, a "neuroscience medical consultant" (Allergan's terminology for sales rep), while the Neurotoxin Institute appears to be a legit continuing medical education group for physicians, it's actually a marketing arm for Allergan:

Allergan sponsors a website at the web address: www.neurotoxininstitute.org, which purports to be operated by The Neurotoxin Institute, and given its ".org" top level domain name, claims to be a noncommercial public interest organization. However, the domain name is registered to Healthworld, located at 100 Avenue of the Americas in New York City. Healthworld is part of Ogilvy Healthworld, an international health care advertising agency with more than 50 offices around the world. Importantly, Ogilvy Healthworld and its predecessor entities have a long history of providing marketing services to Allergan.

Among the things doctors can learn on the Allergan-sponsored site are:

• Understand the conceptual basis and mechanism of action underlying the therapeutic application of BoNTs in a broad array of clinical conditions.
• Review a range of clinical applications in which BoNT has been shown to have some effect.

Botox is not approved for a "broad array" of conditions. Botox Cosmetic is approved for one condition -- face wrinkles -- and Botox Therapeutic is approved for five comparatively rare conditions, such as cervical dystonia.

Another complaint alleges that Allergan funded these three groups:

• Covance Market Access, which Allergan sponsors with $5-10 million a year. It allegedly provides a hotline to advise doctors on off-label reimbursement.
• The Alliance for Patient Access, funded by Allergan, concentrated on "lowering coverage barriers by payors for off-label use," according to the suit.
• The Worldwide Education and Awareness for Movement Disorders Organization, funded by the AfPA. WE MOVE promoted pediatric Botox use.
• Alphamedica: Administered the Botox speakers bureau which enabled Allergan to pay for "preceptorships," in which doctors were paid $1,000 to allow a sales rep to shadow them at work, according to the suit. The payments were essentially kickbacks to encourage doctors to write prescriptions, the suit alleges.

Allergan continues to research new uses for Botox. According to CBS News, the company has studies under way on migraines, spasticity, overactive bladder, enlarged prostates, Parkinson's disease, clenched teeth, spinal cord injuries, hyper sweating, eyelid twitching, depression, arthritis and curvature of the penis.

Related:

• Allergan's $600M Headache: DOJ Probe Could Spur FDA Scrutiny of Botox Data
• Allergan Earnings Boost Came Courtesy of Its Army of Hollywood Stars
• Vultures Circling Botox Maker Accused of Hiding Deaths From FDA
• Justice Department's Botox Probe Costing Allergan $100M -- And There's No End in Sight
  
• Allergan Insists DOJ Subpoena and Lawsuit v. FDA on Botox Are Unlinked

Image by Flickr user Stefano A, CC.