Healthy Skepticism Library item: 12808

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

Johnson LA.
Probe of Amgen marketing, triggered by whistleblowers, widens
Newsday.com 2008 Feb 11
http://www.newsday.com/news/local/wire/newjersey/ny-bc-nj--amgen-questionabl0211feb11,0,1628158.story

Full text:

First one former sales representative, then another from drugmaker 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 ex-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.

In interviews, both said they had been pushed _ but refused _ to have doctors let them examine paper and electronic patient medical files for psoriasis patients who might be switched to Enbrel, a clear violation of patient privacy laws. The reps said they were urged, with other salespeople, to write patients under the doctor’s letterhead inviting them to Enbrel sales pitches disguised as informational seminars, and to seek approval from insurers for coverage.

“When I refused and said my reputation (with doctors) was on the line and I didn’t want to engage in this type of behavior, I suddenly, mysteriously was let go,” Ferrante said.

She and Engelman are seeking lost pay and damages totaling more than $15 million apiece.

Amgen spokeswoman Sonia Fiorenza said Monday that physicians trained to speak at patient outreach programs _ since halted _ were not told to promote Enbrel for patients with mild psoriasis, and they balanced Enbrel’s risks and benefits in those talks.

“We wouldn’t encourage doctors to write prescriptions for … contraindicated patients,” such as those with medical conditions that should have kept them off Enbrel, she added.

But Fiorenza said a 2004 TV commercial promoting Enbrel for psoriasis patients _ which the former sales reps said overstated Enbrel’s benefits and showed healthy actors frolicking in a pool _ was pulled after the U.S. Food and Drug Administration complained in early 2005. A replacement ad “clarifying” some points aired later that year, she said.

Amgen and Madison, N.J.-based Wyeth co-market Enbrel in the U.S. and Canada, where it had sales of $3.2 billion in 2007. Wyeth has not been accused of misconduct, Cotz said.

Now the Senate Finance Committee 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 to 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” 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 practice in Mahwah, N.J., faces a big team of lawyers for Amgen, but said, “I’m dressed for battle.”