Enbrel Marketing Scheme Violated HIPAA, Former Amgen Employees Claim

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Enbrel Marketing Scheme Violated HIPAA, Former Amgen Employees Claim

Date Published: Friday, January 11th, 2008

http://www.newsinferno.com/archives/2363

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.

This entry was posted on Friday, January 11th, 2008 at 8:45 am and is filed

under Legal News, Pharmaceuticals.