Healthy Skepticism Library item: 10113
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
Edwards J.
AstraZeneca Internal Probe Over for Now
Brandweek 2007 May 3
http://www.brandweek.com/bw/news/recent_display.jsp?vnu_content_id=1003580607
Notes:
See also:
Your Handy AZ Bucket of Money Timeline!
http://www.brandweeknrx.com/2007/05/your_handy_az_b.html
Full text:
NEW YORK — AstraZeneca has ended the internal investigation of its drug sales reps who were the subject of anonymous allegations that they promoted two cancer drugs inappropriately or for unapproved “off-label” purposes.
“Appropriate disciplinary action has been taken” against the offending staffers, AZ said in a statement.
The investigation was sparked in mid-April when regional sales director Mike Zubillaga was fired after he published an internal company newsletter that suggested the company should have been more aggressive in comparing its cancer drug Arimdex to Novartis’ rival drug, Femara ( Brandweek.com April 13).
As there has been no medical study comparing the performance of the two drugs, such a comparison was a violation of AZ’s “corporate integrity agreement” with the Department of Health and Human Services. Such violations potentially expose drug companies to hefty fines.
The scandal quickly took on a life of its own on blogs and bulletin boards, where AZ employees traded anonymous allegations-and defenses-of the company’s actions. At one point, CNBC camped outside Zubillaga’s Kennett Square, Penn., house, to demand an interview. He declined to step outside his front door.
“We have concluded our investigation of the claims arising from the newsletter and other reports. In some cases, there was merit to the allegations and appropriate disciplinary action has been taken. Our investigation also revealed that a number of the allegations were either unsubstantiated or a result of misunderstanding,” the company said.
The company declined to elaborate on what it found, how many executives were involved or how harsh the discipline against them was.
The company also said that it believed none of its staff who had complained internally about the newsletter were the subject of workplace “retaliation” by their bosses. “We underscore that we do not tolerate retaliation against people who raise legitimate issues and that we found no credible evidence for that here.”
And, AZ said, the company will report its findings to the HHS’s Office of the Inspector General, which polices AZ’s cancer drug promotions.
AZ’s marketing departments came under the control of the federal government in 2003, when AZ paid $350 million to settle an investigation into its marketing of Zoladex, a treatment for prostate cancer. The company had been accused of illegally allowing doctors to sell free samples of Zoladex, and falsely inflating the drug’s price in Medicare reimbursements.
The incident, which initially became known because Zubillaga’s newsletter compared cancer doctors’ offices to “a big bucket of money” that drug reps should dip their hands into, quickly spiraled into a favorite topic on drug blogs (including BrandweekNRX). Zubillaga declined comment Thursday.
The blog posts bombarded AZ with a series of leaked documents and anonymous e-mails describing allegations that sales reps had secret meetings that were not to be mentioned in e-mails or voicemails so that they could discuss off-label marketing plans for another AZ cancer drug, Faslodex, and other promotion tactics that lay outside the scope of the company’s integrity agreement.
The unfolding scandal also enveloped Abraxis, a Los Angeles company that markets Abraxane, a cancer drug that AZ’s sales force was jointly promoting. Abraxis did not return a call for comment at press time.
The anonymous whistleblowers at AZ, who in a string of e-mails to bloggers and journalists styled themselves “The Group of 7,” alleged that a group of AZ reps held a joint meeting with Abraxis executives in which they were instructed on how to steer doctors into off-label discussions with company medical science liaisons. Such conversations are not per se a violation of FDA rules, but attendees at the meeting were instructed not to mention it in voicemails or e-mails, the Group of 7 claimed.
The issue will likely rear its head again in the coming months, as both the OIG and members of Congress have pledged to investigate AZ’s cancer drug marketing.
