Until last spring, Marc Engelman was a successful salesman for biotech giant Amgen Inc. His specialty: selling Enbrel, a powerful psoriasis treatment that costs nearly $20,000 a year.
The highly profitable medication is approved only for patients with serious forms of the skin disease and comes with side effects including an increased risk of severe infection and congestive heart failure.
But after five years at Amgen, Engelman says he left the company after failing to go along with aggressive and possibly improper marketing practices to boost Enbrel sales beyond its approved uses. The Laguna Niguel resident contends that the company required salespeople to gain access to patient medical information in doctors' offices and market the drug directly to patients, many of whom may not have needed the medication.
Another former employee, Elena Ferrante of New Jersey, says she was fired in 2005 for the same reason. Both are seeking damages in arbitration proceedings.
Amgen, based in Thousand Oaks, insists that its sales force plays by the rules. "Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency," spokesman David Polk said. As for the arbitration cases, he said, "the company does not comment on pending litigation or personnel matters."
Federal privacy laws strictly protect patient medical information. Allowing salespeople access to confidential patient information could violate those laws, experts say.
Doctors are allowed to prescribe a Food and Drug Administration-approved drug for any reason. But drug companies are barred from marketing drugs for uses beyond what's listed on its label, or so-called off-label uses.
In recent years, many top drug companies, but not Amgen, have been fined by the federal government as much as hundreds of millions of dollars for violations, and the industry has increased self-regulation -- although critics say the practice remains pervasive.
The former employees' allegations against Amgen come as the company is confronting a host of regulatory and financial pressures. Its stock lost a third of its value last year after studies found its top-selling anemia drugs may increase the risk of heart attacks and strokes in some patients. Amgen cut as many as 2,600 jobs, about 13% of its total, this fall.
