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HHS Inspector General To Investigate Allegations That AstraZeneca Improperly Marketed Breast Cancer Drug

HHS' Office of Inspector General is investigating allegations that AstraZeneca failed to stop off-label marketing of its breast cancer drug Arimidex, CQ HealthBeat reports. According to CQ HealthBeat, marketing strategies for off-label use of a drug are prohibited by FDA (Armstrong, CQ HealthBeat, 5/2). Arimidex, when used in combination with Roche's breast cancer drug Herceptin, increases the amount of time some women with breast cancer live without the disease progressing (Kaiser Daily Women's Health Policy Report, 10/16/06).

According to CQ HealthBeat, a spokesperson for a group of current and former employees of AstraZeneca said that the company failed to stop the practice and directed its sales force to advocate for the off-label use of the drug, despite reports filed by the group with an internal compliance hotline. According to company documents, AstraZeneca sales representatives were allegedly instructed to promote the off-label use of Arimidex by engaging doctors in a discussion about a Novartis' breast cancer drug Femara. The spokesperson for the group said the sales strategy was designed to spur physicians to set up meetings with the company's medical liaisons. Drug companies' medical liaisons are only permitted to meet doctors if the physician requests the meeting, and company sales representatives cannot advocate for such meetings, CQ HealthBeat reports. Investigation, Reaction
Rep. Pete Stark (D-Calif.) last week sent a letter to the Inspector General's office requesting that OIG begin an investigation into the allegations. OIG spokesperson Don White said the office is looking into the allegations. "At this point, there is just a preliminary evaluation going on," White said, adding, "We have no indication that there is any kind of breach -- we just don't know yet. We don't have hard info." AstraZeneca spokesperson Emily Denney on Wednesday said that the company has been in contact with OIG about its internal efforts to address the allegations, adding that the company concluded that in "some cases, there was merit to the allegations, and appropriate disciplinary action has been taken." She also said, "Our investigation also revealed that a number of the allegations were either unsubstantiated or a result of misunderstanding."

Mike Zubillaga, a company manager who is named in the allegations, was let go after an internal sales force newsletter surfaced in April that quoted him referring to oncology doctors' offices as a "big bucket of money," CQ HealthBeat reports (CQ HealthBeat, 5/2).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Arimidex; Femara; Herceptin.





HHS, inspectorul general de a ancheta acuzaþiile cã AstraZeneca impropriu comercializate de cancer de sân de droguri - HHS Inspector General To Investigate Allegations That AstraZeneca Improperly Marketed Breast Cancer Drug - articole medicale engleza - startsanatate