Off Label Drug Pushers

An example of how drug companies get doctors to prescribe medications when their evidence for their effectiveness has not been demonstrated—which is contrary to a law that is rarely enforced—jk.

Heartbreak Of Psoriasis: Amgen Rep Cries Foul

January 3, 2008, Ed Silverman

Last month, we wrote that a former Amgen sales rep in New Jersey sued the biotech for $10 million, claiming she was fired in retaliation for not complying with an improper marketing campaign for its Enbrel med. The case has since attracted interest from the New Jersey Attorney General, according to the attorney for Elena Ferrante. A spokesman for the NJ AG declined to comment, without denying or confirming any conversations have taken place.

Now, another former Amgen sales rep has come forward and he paints a picture of a still broader effort to goose Enbrel sales at a time of increasing competition. The directives to sales reps included pulling patient files from doctors’ offices, letter-writing campaigns to patients and insurers, and orchestrating and attending patient outreach seminars. These activities, however, allegedly involved off-label promotion and patient privacy violations, according to the rep’s attorney, Lydia Cotz, who also represents Ferrante.

“This was a way to get more patients on Enbrel,” says Marc Engelman, a former Southern California sales rep, who agreed to leave last April after objecting to Amgen’s practices and, as a result, receiving poor job reviews. “And I was required to do so by my district manager. Enbrel sales had come to a crawl. And Amgen was gearing up because they knew they were going to take a hit in the marketplace.”

Before we provide further detail, we should note that a spokesman for Amgen, which co-markets Enbrel with Wyeth, wrote us to say that “the company does not comment on pending litigation or personnel matters. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency.” Both rep cases are in various stages of arbitration, by the way, because reps who worked for Immunex, which Amgen acquired in 2001, were required to bring serious disputes to an arbitrator, according to Cotz.

The activities that Engelman describes began in 2005 and 2006, which coincided with the threat of increasing competition from other biologic meds used to treat psoriasis or psoriatic arthritis,[i] such as Genentech’s Raptiva; Abbott’s Humira and Centocor’s Remicade.

Engelman, who his attorney says has filed a notice of claim, charges that an Amgen district sales manager required him…

…to pull patient files as part of a plan to convince insurers to pay for Enbrel for people with mild psoriasis, an unapproved patient population. Enbrel was approved in 2004, but only to treat moderate to severe psoriasis. In 2002, the med was approved for psoriatic arthritis.

According to a taped conversation that we have heard, the district sales manager told sales rep Marc Engelman to pull ICD-9 forms, which contain diagnostic codes, from patient files. After looking at the files, he claims Amgen reps were encouraged to write letters on behalf of doctors to insurers, in hopes of persuading them to cover the cost of Enbrel for patients with all forms of psoriasis. Letters about Enbrel were also sent to all of a doc’s psoriasis patients with an eye toward persuading them to switch to Enbrel or convince those with mild psoriasis to try Enbrel, Engelman further alleges. However, peeking at the files raises questions about patient privacy, otherwise known as HIPAA.

Engelman, 45, apparently wasn’t the only one given such instructions. A memo to sales reps in the South Pacific district tells them about the “importance of proper patient identification. It is one, if not the most important, aspect how the biologic business will grow in 2006. With that said, our focus on office and ICD-9 mailings is a solid ‘target to hit’ in the next few months. This process is a win-win for all involved as the patients that have given up on traditional therapies are educated on new ones, customer’s patient base increases and patient flow for biologics increases,” the memo states.

He also claims that he and other reps were told to coordinate so-called patient outreach programs. “We sent fliers or helped a doctor’s office send fliers to patients. The fliers were advertisements to get patients to come to a community center or a restaurant, where there would be a talk by a physician. We’d pay the physician to talk about biologics. I went to one and it was uncomfortable for me because the patients are right there.”

“We went to patient support groups. We called insurance companies and, sometimes, we pretended to be a person in the (doctor’s) office. The entire purpose was to get whatever was needed for a patient to be approved to be given Enbrel,” says Engelman. “It was a way to increase sales. And we did whatever we had to do to get patients on Enbrel. But I wouldn’t do it. I felt it was wrong and we were crossing lines. But I was punished because other reps were doing these things and having a great success. We received voice mails talking about ’success stories’ involving what other reps had done and ‘you should do this.’ I wouldn’t. And I have to add that, now, some patients are on Enbrel and maybe they shouldn’t be.”