Tuesday, May 22, 2007

Congressional Quarterly: "Senior Manager Leaves AstraZeneca in Midst of Congressional Scrutiny"

Senior Manager Leaves AstraZeneca in Midst of Congressional Scrutiny
By Drew Armstrong, CQ Staff

As Congress continues to look closely at allegations of illegal marketing of a breast cancer drug by manufacturer AstraZeneca, a senior manager connected to the company’s off-label promotion of the drug, Arimidex, has resigned.

AstraZeneca Spokeswoman Emily Denney confirmed Monday that Scarlett Spring, the company’s national sales director of oncology, will resign from AstraZeneca, as of June 1. Spring was the supervisor of former AstraZeneca Regional Sales Manager Mike Zubillaga, who allegedly encouraged his regional sales team to promote Arimidex off-label and was fired by AstraZeneca in April as part of the company’s investigation into the allegations.

Off-label promotion of drugs by pharmaceutical sales personnel is illegal, according to the Food and Drug Administration.

Denney would not comment on Spring’s departure, other than to say that Spring was leaving the company for personal reasons.

"She announced internally that she decided to leave AstraZeneca for personal reasons to pursue other opportunities," Denney said.

Public scrutiny of the company’s marketing of its cancer medications began in April, when employees familiar with AstraZeneca’s cancer drug marketing operation leveled allegations that AstraZeneca ignored previous warnings the employees issued about being told to promote the drug off-label.

The employees say they first reported the alleged violations through an internal hotline in November 2006. The employees say they waited for five months without receiving a response, and that AstraZeneca only acted on their claims after the employees wrote a letter in March to the Department of Health and Human Services’ Office of Inspector General (OIG), and forwarded copies to a few industry news Web sites several weeks later. The letter detailed their allegations, including the purported lack of action by AstraZeneca.

Meanwhile, AstraZeneca has blamed a "systems error" that caused the results of AstraZeneca’s ongoing investigation into the matter not to be sent back to the employees.

The company faults an error within Global Compliance, an outside company that anonymously transmits employee complaints of ethical violations to AstraZeneca, which then sends a response back through Global Compliance to the employees.

A May 2 AstraZeneca memo sent to the sales team reads, "We subsequently became aware of a systems issue with our prior helpline vendor. Some employees who had reported suspected violations were prevented from receiving the information that AZ had provided as a follow-up to their reports. We address [sic] the systems issue as soon as we discovered it, and we do not expect it to recur. Responding promptly and appropriately to reported violations is a fundamental element of our compliance program," says the memo.

Under AstraZeneca’s compliance system, employees can call Global Compliance with concerns about a legal or ethical violation. Global Compliance then anonymously sends the claims to the company, which investigates them and returns a response that the employees can access with a unique code number.

AstraZeneca’s firing of Zubillaga — which occurred after the disclosure of other internal memos and training materials also provided to Congressional Quarterly by the employees — has been the most public result of its investigation.

The company has declined to state the exact timeline of its investigation. However, in an April 20 statement, AstraZeneca said that some of the claims were being examined before they were made public.

In the November 2006 call to the Global Compliance hotline, AstraZeneca employees say they reported that members of the cancer drug sales team had been instructed by managers to promote the off-label use of the drug Arimidex, also known as anastrozole.

On April 5, 2007, Web sites posted excerpts from a sales team newsletter in which a sales manager named Mike Zubillaga referred to cancer doctors’ offices as "a big bucket of money." According to the group of employees, Zubillaga also was the management figure encouraging the sales force to promote the off-label use of Arimidex. The employees released copies of the OIG letter a week later.

AstraZeneca fired Zubillaga April 6. Denney later confirmed that the company had hired an outside law firm to look into the allegations made in the OIG letter.

The OIG has confirmed that it is looking into the accusations, and House lawmakers are interested as well.

Henry A. Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, has asked AstraZeneca to provide documents on the marketing of the cancer drug. Rep. Pete Stark, D-Calif., also is looking into the claims.

1 comment:

Group of Seven said...

Glad to have Senator Waxman interested now, in addition to Congressman Stark.