Healthy Skepticism Library item: 12613

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pollack A.
New Jersey Investigating Amgen’s Marketing of a Psoriasis Drug
The New York Times 2008 Jan 18
http://www.nytimes.com/2008/01/18/business/18amgen.html

Full text:

New Jersey’s attorney general has begun investigating whether the biotechnology giant Amgen violated patient confidentiality laws in its effort to sell its drug Enbrel.

The investigation was prompted by accusations from two former Amgen sales representatives, who said they had been pressured by their managers to gain access to patient data to find people with psoriasis who might be candidates for treatment with Enbrel.

The attorney general, Anne Milgram, who has been looking into pharmaceutical marketing practices, said in a news release Thursday that the state had issued a subpoena to Amgen for “a comprehensive array of documents and information” related to the sale, marketing and prescribing of Enbrel.

Ms. Milgram said she was also looking into whether Amgen had engaged in off-label marketing. Enbrel is approved for moderate or severe psoriasis, but the two former sales representatives say the company tried to sell it for mild psoriasis as well.

The two former employees are now in arbitration with Amgen, saying they lost their jobs because they did not engage in what they considered illegal practices. One, Elena Ferrante, who was a sales representative in New Jersey, said she was fired in 2005. The other, Marc Engelman, whose territory was Southern California, said he quit last year after getting a poor performance review.

A spokeswoman for Amgen, Mary Klem, said that the accusations were “completely without merit” and that Amgen would cooperate with the investigation. She said Amgen representatives were instructed to “follow compliance guidelines with absolute consistency.”

Federal laws prohibit the sharing of medical information with unnecessary parties, though there are different interpretations of the rules. It is not clear whether there were violations in this case or, if there were, whether they were by Amgen or by the doctors

The accusations come as Amgen is facing declining sales of its popular anemia drugs because of safety questions.

Enbrel, first approved as a treatment for rheumatoid arthritis, is also a big-selling product. But its growth as a treatment for psoriasis has at times been slower than expected, in part because insurers balked at its cost, up to $20,000 a year.

Mr. Engelman said in an interview recently that sales representatives were told to find doctors willing to search through patient records to find patients with psoriasis, or to let the Amgen representatives find candidates in the same way.

The doctors would then be asked to write to the patients suggesting Enbrel, though Amgen employees might do the work and pay for the postage, he said. Mr. Engelman also said Amgen representatives would sometimes call or write to insurance companies, posing as a member of the doctor’s staff, to try to arrange reimbursement.

“You knew these patients’ data when you were calling the insurance company,” he said. “You would know the patient’s name when you are stuffing the envelope.”

Mr. Engelman provided a voice mail message that his manager had left for him, as well as a memo urging him to have searches of patient records done at two or more medical practices.