The marketing of Enbrel is the now the subject of an investigation by the New Jersey Attorney General’s Office. The Enbrel probe will look into allegations that Amgen, the maker of the psoriasis drug, instructed Enbrel sales representatives to violate patient confidentiality rules and engage in the illegal promotion of off-label uses of the drug in an effort to increase sales. According to a press release from the New Jersey Attorney General, a subpoena was issued to Amgen for “a comprehensive array of documents and information” related to the sale, marketing and prescribing of Enbrel.
The New Jersey Attorney General’s office began its Enbrel probe after two former Amgen employees charged that the drug maker engaged in illegal marketing practices. 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. Enbrel has not been approved for patients with less severe psoriasis.
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 were “calling on behalf of Dr. So-and-So”.
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. Promoting Enbrel to treat less severe psoriasis could also land Amgen in hot water. Although doctors are free to prescribe approved drugs in any manner they see fit, it is illegal for drug companies to actively promote such off label uses.
Enbrel 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 first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include severe psoriasis and other conditions.
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April 25th, 2009 at 8:01 pm
More than 4.5 million adults in the United States have been diagnosed with psoriasis, and approximately 150,000 new cases are diagnosed each year. An estimated 20% have moderate to severe psoriasis. Psoriasis occurs about equally in males and females. Recent studies show that there may be an ethnic link. It seems that psoriasis is most common in Caucasians and slightly less common in African Americans. Worldwide, psoriasis is most common in Scandinavia and other parts of northern Europe. It appears to be far less common among Asians and is rare in Native Americans.
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