Senate Looking into Amgen's Ethics in Marketing Enbrel

by Linda A. Johnson, The Associated Press
Monday, February 11, 2008

TRENTON, N.J. -- First one former sales representative, then another from drug maker Amgen Inc. claimed they were fired or forced out for refusing to go along with unethical, even illegal practices to boost sales of the pricey drug Enbrel among psoriasis patients.

Now two federal agencies and four state attorneys general are investigating the practices of the company, according to the sales reps' New Jersey lawyer, who said memos and other material show that the health of some patients likely was jeopardized.

 

Amgen's sales force was pushed to encourage dermatologists to switch psoriasis patients from other treatments to Enbrel, even if they had common medical conditions Enbrel could have worsened, said former saleswoman Elena Ferrante of Montvale, N.J., who said she was fired in August 2005 after eight years of "outstanding" performance reviews.

Ferrante said doctors were paid to host outreach programs where they would laud Enbrel to psoriasis patients -- even those with just a mild form of the disfiguring skin condition. Use of Enbrel, a blockbuster genetically engineered drug that patients inject once or twice a week, is not approved for people with mild psoriasis, who normally get inexpensive topical creams or generic pills.

"They wanted the whole market share," Ferrante's lawyer, Lydia Cotz, said of Amgen. "Whatever they needed to get it, they were just stepping up their tactics."

Amgen, of Thousand Oaks, Calif., denies any wrongdoing.

Enbrel can cost up to $26,000 a year, according to Amgen. It's only approved for patients with moderate to severe psoriasis and can have severe side effects, even fatal infections. The drug also is used for rheumatoid arthritis and rarer autoimmune disorders.

Enbrel was first approved as a psoriasis treatment in April 2004. That opened a huge new market, as about 7 million Americans have some degree of psoriasis, Ferrante said.

That's when Amgen started pushing very aggressive, unethical marketing strategies for Enbrel, said Ferrante and another former Amgen rep, Marc Engelman of Laguna Niguel, Calif. He said he resigned last year after getting his first negative performance review because, like Ferrante, he would not use such tactics.

Now the Senate Finance Committee is examining Amgen's marketing practices. Its ranking Republican, Sen. Charles Grassley of Iowa, had staff members interview the two former sales representatives, Grassley spokeswoman Jill Kozeny said.

According to Cotz, staff from the U.S. Securities and Exchange Commission and the attorneys general of New Jersey, New York, Connecticut and Florida have contacted her and requested documents or interviews as they investigate Amgen's behavior.

New Jersey last month subpoenaed "a comprehensive array" of documents and information concerning the marketing, sale and prescription of Enbrel. A spokesman for Attorney General Anne Milgram said Friday the investigation continues.

In Florida, a spokeswoman for Attorney General Bill McCollum said the office is "in a review process" and has not yet demanded information from Amgen. Spokespeople at the SEC and New York Attorney General's Office declined comment. The Connecticut Attorney General's Office did not respond to requests for comment.

Fiorenza said Amgen is cooperating with New Jersey authorities and "expects all staff to behave in a responsible and principled way" as outlined in the company's code of conduct.

The two cases are being handled by independent arbitrators, as required by Amgen's employment contracts.

Cotz, who has a two-lawyer office in Mahwah, N.J., faces a big team of Amgen lawyers, but said, "I'm dressed for battle."