California-based Avanir Pharmaceuticals’ mission statement reads, “Every day at Avenir Pharmacueitcals… we focus on the research, development and commercialization of novel medical and pharmaceutical treatments for people with central nervous system disorders. That focus, along with the deep-seated passion of our people, is fueling the development of innovative medical solutions.” Sometimes the mission can stray.
The company, which was acquired by Japanese pharmaceutical company Otsuka, recently entered into a settlement with the Department of Justice (DOJ) as reported in CNN. Actually, in 2017, CNN investigated allegations that the company was acting in inappropriate and potentially fraudulent ways. Apparently, they were aggressively marketing Nuedexta to nursing home residents—truly preying on some of the most vulnerable among our population. Settlements typically don’t involve acknowledgement of guilt, but they can be costly. According to an Otsuka financial filing, this specific settlement could cost $120 million in fines, restitution and legal fees as well as other liabilities. No one is commenting.
We have said this before—biopharmaceutical companies face severe pressure to generate returns on what can be enormous R&D costs. By the time they secure FDA approval after a lengthy clinical trials process, they have little time to spare. Executives put pressure on VPs, VPs push directors, directors pressure associate directors and by the time the rubber hits the road with the sales managers, the pressure is so unbelievably intense that what can turn into some isolate practice turns into a daily occurrence. Everyone up the ladder feels the pressure and at least some numbers are generated, so some may conveniently look the other way—until it’s too late. In this case, it would appear a business culture emerged, at least in some localities where the sales force ethos was to get the elderly to be diagnosed with pseudobulbar affect (PBA) by any means necessary. Then, they would of course need to be prescribed Nuedexta.
That isn’t a way to do business. Short-term wins at the expense of ethics and worse—breaking the law—is a losing strategy.