Tuesday, April 17, 2007

Philadelphia Inquirer: "Additional AstraZeneca staff disciplined"

Posted on Tue, Apr. 17, 2007
Additional AstraZeneca staff disciplined
By Thomas Ginsberg
Philadelphia Inquirer Staff Writer

AstraZeneca P.L.C. said yesterday that it was actively investigating some employees for improper promotional activity and already has taken corrective action after other undisclosed lapses.

London-based AstraZeneca, with U.S. headquarters in Wilmington and major operations around Philadelphia, made the statement in the face of persistent questions about its firing 10 days ago of a regional sales director, Michael Zubillaga, 50, of Kennett Square.

Zubillaga, in an internal newsletter, had exhorted sales representatives who call on cancer doctors to view those doctors' offices as a "bucket of money." After industry bloggers obtained and published his comments on the Internet, casting the company in a negative light, AstraZeneca fired him for allegedly violating its policy on ethical conduct.

But another comment by Zubillaga, in the same newsletter, appears to highlight a more troublesome issue underlying the firing. Zubillaga was quoted as lamenting that sales reps last year had been too slow to promote AstraZeneca's cancer drug Arimidex in direct comparison to Novartis AG's treatment, Femara.

"We should have changed our strategy with our core messages earlier in regards to selling against letrozole," Zubillaga says in the newsletter. Letrozole is the generic name for Femara.

Such direct comparison or counter-promotion of two drugs could be improper, since neither company has tested the products directly against each other.

The U.S. Food and Drug Administration prohibits drug companies from promoting their products without valid or FDA-approved data and requires them always to present "fair" and "balanced" data in their sales pitches.

Sales reps who make such comparisons, in violation of company or FDA policy, could be penalized individually.

Peter Rost, a former Pfizer Inc. marketing executive and now author of the blog Question Authority (www.peterrost. blogspot.com), said anonymous sources had sent him documents indicating that AstraZeneca sales managers might have subtly ordered or encouraged sales reps to make the improper comparison.

Rost said the source, or sources, of the documents was the same who initially sent him the Zubillaga newsletter that turned out to be genuine.

In response, AstraZeneca said in a statement:

"The company takes claims of misconduct very seriously and investigates these in a timely and effective manner. Investigations concerning the specific claims referenced were initiated. Some claims reported prior to this incident were investigated and concluded with appropriate corrective action being taken. More recent claims are actively being investigated."

A spokeswoman, Emily Denney, said she could not immediately explain "corrective action" and declined to say whether the affected employees worked in sales or performed other duties.

AstraZeneca already is under heightened scrutiny by regulators from the U.S. Department of Health and Human Services for illegal marketing and billing involving another cancer drug, Zoladex, in 2003. It paid $355 million to settle the case and must report suspicious or improper activities by its employees to regulators.

Under its Corporate Integrity Agreement with regulators, the company must report any infractions, such as those alleged by Rost's sources.

Denney emphasized that the company has made proper disclosure to authorities. "In each instance, AstraZeneca acted in a manner consistent with its compliance program requirements and its obligations," Denney said.

Don White, a spokesman for the Department of Health and Human Services, declined to confirm or deny whether investigators had received recent complaints regarding AstraZeneca promotions of Arimidex.

AstraZeneca's share price closed up 73 cents, or about 1.3 percent, to $56.70 on the New York Stock Exchange.

AstraZeneca employs about 5,000 in the Philadelphia region.

Contact staff writer Thomas Ginsberg at 215-854-4177 or tginsberg@phillynews.com.


Health Watch Center said...

Hi Thomas Ginsberg,

I am new here...have found your blog very informative and helpful for everyone who want to know about health information...as I am a new reader wanted to say hi and start my journey here...keep the good work going...

Self Help Zone

hastalvistababy said...

Wow. Really interesting stuff!

Sending it to some buddies of mine (no salesmen in the lot, thankfully :).