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Enbrel Marketing Scheme Violated HIPAA, Former Amgen Employees Claim

Jan 11, 2008 | Parker Waichman Alonso LLP

Two former Amgen employees are charging that the drug maker engaged in illegal marketing practices in an attempt to increase sales of the drug Enbrel.  The former Amgen salespeople claim that they were encouraged by the company to illegally access patient records to induce insurance carriers to pay for Enbrel, an extremely pricey drug.

According to the drug’s website, Enbrel is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body's immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies.   The Food & Drug Administration (FDA) first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

Elena Ferrante of Montvale, New Jersey, who was terminated by Amgen in 2005, and Mark Engelman of Laguna Niguel, California, who resigned from the company last year, is suing Amgen for lost wages and other compensation after refusing to participate in improper promotion of Enbrel.  Enbrel is approved only for treating moderate to severe psoriasis, but the former employees say they were expected to engage in promotion efforts that sometimes included patients with less severe disease.

Ferrante and Niguel claim that Amgen sales reps were instructed to go into dermatologists' offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition.  When calling the insurance companies, they were instructed not to identify themselves as Amgen sales reps.  Rather, they allege that they were told to say that they weres “calling on behalf of Dr. So-and-so.”

The representatives also allege that the Amgen sales force was told to write letters on behalf of doctors, seeking advance approval so doctors could write prescriptions for Enbrel. Doctors writing prescriptions would benefit from frequent patient visits to have the drug injected.

If proved, the allegations could cause Amgen serious trouble.  The Health Insurance Portability and Accountability Act (HIPAA)  contains very tough sanctions for disclosing someone's health information — up to 10 years in jail and a $250,000 fine if the information was transferred or used for commercial advantage.  Physicians who agreed to participate in the alleged Enbrel marketing scheme could also be in trouble.

An attorney for the two former Amgen employees told the Associated Press that the New Jersey attorney general's office is investigating and has interviewed Ferrante.  According to the Associated Press, that office would not confirm or deny any investigation of Amgen or Enbrel.  However, last fall, the New Jersey attorney general convened a task force to investigate how the doctor-patient relationship is affected by the widespread practice of drug and medical device makers giving physicians gifts and fees for researching, consulting and speaking about their products.