Tuesday, April 17, 2007

AstraZeneca - the Zubillaga saga contd.

The News Journal reports:

Less than two weeks after it fired a pharmaceutical sales manager for comments in a company newsletter, AstraZeneca was defending itself again Monday.

The maker of such drugs as Nexium, a treatment for acid reflux disease, and Crestor, a cholesterol-reducer, said it is investigating recent allegations posted on pharmaceutical industry blogs questioning the company's sales and marketing practices. One allegation said some of the company's salesmen were being pushed to promote the sale of one of its cancer drugs for unapproved uses.

"As we learn about these things through whatever mechanism, we investigate them and take them seriously," Emily Denney, an AstraZeneca spokeswoman, said Monday.

Denney's comments come after AstraZeneca issued a statement on Friday, reading in part, "We have a robust compliance program that calls for responsible sales and marketing practices that comply with applicable laws, regulations and industry standards, such as PhRMA [the Pharmaceutical Research and Manufacturers of America] and the American Medical Association guidelines, as well as AstraZeneca's internal policies."

Denney declined Monday to address the specifics of any of the allegations making the rounds on several websites, including those made by a group calling themselves "The AstraZeneca Group of Seven," whose unidentified members say they are employees of the company.

Denney declined to detail what actions the company was taking to address the online allegations.

On Friday, Pharmalot, a blog written by Ed Silverman, who covers the pharmaceutical industry for The Star-Ledger newspaper of Newark, N.J., ran a portion of what purports to be a letter from "AstraZeneca Group of Seven" to the U.S. Department of Health and Human Services' Office of Inspector General. The letter said AstraZeneca's salesmen were encouraged in a November 2006 meeting to promote the company's Faslodex cancer drug for so-called "off-label" uses and to compare it to competitor Novartis' Femara cancer drug, even though no head-to-head clinical trials had been done.

Drug companies are not allowed to promote their products for other than FDA-approved uses, but there's no prohibition on doctors prescribing them for so-called off-label uses.

Don White, a spokesman for the Office of Inspector General, said Monday he could "neither confirm nor deny that we have received the letter, but we are aware of the situation."

If AstraZeneca were found to have marketed its drugs improperly, the company could run afoul of its Corporate Integrity Agreement with the Office of Inspector General, which could jeopardize its ability to sell to Medicare and Medicaid.

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