On Tuesday, biotech giant Amgen Inc pleaded guilty in federal court for illegally marketing its former top-seller, Aranesp, a drug used to treat anemia. They are to pay $762 million: $612 million in a civil settlement and $136 million in criminal fines.
Aranesp’s Food and Drug Administration-approved use is to treat anemia in chemotherapy patients, not to treat anemia caused by cancer per se. Amgen also allegedly pushed higher doses and different treatment schedules than approved in the drug’s label to help them lure business over from Johnson & Johnson’s anemia drug Procrit. Aranesp made $2.3 billion in 2011.
Profits Over Patient Safety
The verdict surprised few, not even Amgen itself, which had set aside funds for this explicit purpose. They knew what was coming, what with almost a dozen whistleblower lawsuits and federal and state investigations. It’s still not enough, it seems, for Amgen to lose any federal business or contracts. Losing their ties to Medicare would have crippled their business, according to Reuters.
Part of the deal, however, are measures that should be introduced into every giant pharmaceutical company, of everything from paying doctors to misrepresent and push drugs to killing infants in illegal vaccine trials. These include Amgen’s executives and board of directors members to comply with certain regulations, increase transparency, and hold corporate officers responsible for compliance failure in a five-year period. This plea agreement is to be reviewed by US District Judge Sterling Johnson.
This manner of “pursuing profits at the risk of patients’ safety” (in the words of US attorney Marshall Miller) is all but common practice in biotech and Big Pharma spheres. In fact, this decision sounds like a slightly divergent tune from one made earlier this month by the federal appeals court that let sales representative Alfred Caronia off the hook for making off-label claims about FDA-approved drugs. Caronia’s lawyer even stated outright that the decision “increases the marketability of drugs.”
Natural Health Can’t Cut a Break
While Big Pharma gets to run amok, natural alternatives like raw milk and even vitamin B is facing a complicated future as the FDA looks to remove certain natural supplements off of shelves to bolster sales of companies like BioStratum, which aims to use the vitamins in question in prescription medication.