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.
Showing posts with label Zubillaga. Show all posts
Showing posts with label Zubillaga. Show all posts
Tuesday, May 22, 2007
Thursday, May 03, 2007
Congressional Quarterly: Capitol Hill Scrutinizes Marketing of Breast Cancer Meds"
Capitol Hill Scrutinizes Marketing of Breast Cancer Meds
By Drew Armstrong, CQ Staff
Drug maker AstraZeneca is drawing scrutiny from Capitol Hill over allegations made by a group of individuals claiming to be from inside the company regarding the improper marketing of Arimidex, a breast cancer medication.
A spokesman for the group of current and former employees alleges that AstraZeneca failed to stop unethical and illegal activity related to marketing strategies to sell the breast cancer drug, despite reports filed by the group with an internal compliance hotline. Specifically, the group alleges that AstraZeneca directed its sales force to push for the off-label use of Arimidex — an illegal practice prohibited by the Food and Drug Administration (FDA).
Last week, Rep. Pete Stark, D-Calif., sent a letter to the Health and Human Services Department’s Office of Inspector General (OIG), requesting that the OIG begin an investigation into whether AstraZeneca used sales representatives to illegally promote the drug off-label.
While doctors can freely prescribe drugs for “labeled uses” — those approved by the FDA — it is illegal for drug companies to use their sales forces to promote off-label use. While drug company-employed science experts, known as “medical science liaisons,” are permitted to discuss off-label use with a doctor, they can do so only if the doctor requests such a meeting. Drug company sales representatives are forbidden from encouraging such discussions between doctors and a drug company’s medical liaisons.
The prohibition of off-label marketing is designed to protect patients from drug makers pitching unapproved uses of drugs. The law defers to doctors, however, allowing them to exercise their clinical judgment in such instances.
Congressional Quarterly received several company documents from the group that support the allegations. According to the documents — memos, company training materials and performance evaluations — AstraZeneca sales representatives were allegedly instructed to promote the off-label use of Arimidex by engaging doctors in a discussion about a competing drug called Femara.
The spokesman for the group claims that the sales strategy was designed to spur doctors to set up meetings with AstraZeneca’s medical liaisons. Because the drugs are similar, Arimidex and Femara, made by rival drug maker Novartis, compete for market share both on- and off-label.
According to one memo detailing performance objectives for the sales force, AstraZeneca sales representatives were encouraged to “utilize resources i.e., RSM (regional scientific managers) ... and brand team.” “Regional Scientific Managers” is another term for the medical science liaisons who are allowed to answer physician questions on off-label use.
On a training CD used by AstraZeneca sales representatives, a role-playing scenario between a doctor and salesperson lays out how AstraZeneca representatives can create a discussion with doctors about Arimidex compared to Femara. According to AstraZeneca’s company policy, sales employees are not allowed to make comparisons against competing drugs.
According to AstraZeneca, the company recorded $614 million in sales of the drug in 2006. Worldwide, the drug’s sales totaled $1.5 billion in 2006.
Stark’s letter asking the OIG to investigate appears to have generated results. OIG Spokesman Don White said the office is looking into the allegations.
“At this point, there is just a preliminary evaluation going on,” White said. “I’m not going to make any comment on an ultimate conclusion of a review, ” White added, referring to whether or not AstraZeneca has broken the law. He continued, “We have no indication that there is any kind of breach — we just don’t know yet. We don’t have hard info.”
White did not address specific questions about the documents, or comment on what materials the company might have received from the group making the allegations.
AstraZeneca spokeswoman Emily Denney acknowledged Wednesday that the company has been in contact with the OIG about its own internal efforts to address the allegations.
“We took all those allegations very seriously, Denney said. “We have concluded our investigation of the claims.” She added in a statement, “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.”
Denney said all of the issues reported to the company have now been resolved.
She also emphasized that the company’s sales force has been trained not to share inappropriate material with physicians, but that having some of the information is necessary to do their jobs.
“Our sales reps have to be accurately aware of the competitive landscape in which they’re operating,” Denney said.
On April 20, Denney confirmed that the company has hired an outside law firm to investigate the allegations, and had already fired one sales manager named by the group.
The group has said in documents posted on industry Web sites that they are in contact with government investigators, but they have so far declined to speak with the media on record.
The documents do not state specifically what AstraZeneca sales representatives were asked to say — whether they emphasized risks from Femara, or played up the benefits of Arimidex — but so far there have been no head-to-head clinical trails between the two drugs, and any claims the sales team made regarding one drug’s efficacy over the other would be suspect.
Meanwhile, proven allegations that AstraZeneca violated company policy over the marketing of Arimidex could carry serious consequences.
AstraZeneca is already operating under a Corporate Integrity Agreement (CIA) with the inspector general’s office that it signed in 2003 over a marketing scandal involving Zoladex, a drug used to treat prostate cancer. Often applied as part of a court verdict, the CIA is an agreement between a company and the government to adhere to certain standards of conduct.
In AstraZeneca’s case, the integrity agreement was the result of a 2003 court case in which it pleaded guilty to charges around the improper sale and marketing of Zoladex. In addition to pledging to adhere to the integrity agreement, AstraZeneca was fined $355 million, and is required to oversee that marketing and sales practices stay “in full compliance with the law.”
Because AstraZeneca is legally bound under the CIA to ensure its marketing practices comply with the law, any violation of company policy could be tantamount to a breach of the agreement with HHS. According to White, the OIG would be responsible for investigating any such breach.
The internal documents were first posted online by Peter Rost, a former Pfizer executive who now writes about the industry, and by Pharmalot.com, an industry news site published by the Star Ledger of New Jersey. Rost is considered a controversial figure in the pharmaceutical world. He was fired in 2005 from his position as a vice president at Pfizer after filing a whistleblower suit against the company and going to Capitol Hill to oppose his company’s position on drug importation.
The inquiry into AstraZeneca’s marketing practices began after the group posted on Rost’s Web site a letter originally sent to the OIG on April 12.
In an electronic copy of the letter provided by the group, the group alleges to the OIG that sales representatives were told specifically by a sales manager to promote meetings between physicians and company medical science liaisons in order to drive off-label uses of Arimidex. In the letter, group says that despite reporting the action to the company hotline, no action was taken by the company.
Following several news reports on AstraZeneca’s alleged mismarketing of Arimidex, Stark asked the OIG to begin an investigation. “I urge you to immediately investigate the allegations described herein, and to open an investigation into the FDA’s oversight of pharmaceutical marketing to physicians,” Stark wrote in his letter.
One AstraZeneca manager named in the developing allegations has already been fired.
Regional Sales Manager Mike Zubillaga was let go after an internal sales force newsletter surfaced in April that quoted Zubillaga referring to oncology doctors’ offices as “a big bucket of money.”
In the newsletter, Zubillaga says, “I see it like this: There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money.”
Zubillaga did not return a phone call. Through his mother, who is taking his calls and declined to be named, Zubillaga said that he wanted to try and put the accusations behind him.
By Drew Armstrong, CQ Staff
Drug maker AstraZeneca is drawing scrutiny from Capitol Hill over allegations made by a group of individuals claiming to be from inside the company regarding the improper marketing of Arimidex, a breast cancer medication.
A spokesman for the group of current and former employees alleges that AstraZeneca failed to stop unethical and illegal activity related to marketing strategies to sell the breast cancer drug, despite reports filed by the group with an internal compliance hotline. Specifically, the group alleges that AstraZeneca directed its sales force to push for the off-label use of Arimidex — an illegal practice prohibited by the Food and Drug Administration (FDA).
Last week, Rep. Pete Stark, D-Calif., sent a letter to the Health and Human Services Department’s Office of Inspector General (OIG), requesting that the OIG begin an investigation into whether AstraZeneca used sales representatives to illegally promote the drug off-label.
While doctors can freely prescribe drugs for “labeled uses” — those approved by the FDA — it is illegal for drug companies to use their sales forces to promote off-label use. While drug company-employed science experts, known as “medical science liaisons,” are permitted to discuss off-label use with a doctor, they can do so only if the doctor requests such a meeting. Drug company sales representatives are forbidden from encouraging such discussions between doctors and a drug company’s medical liaisons.
The prohibition of off-label marketing is designed to protect patients from drug makers pitching unapproved uses of drugs. The law defers to doctors, however, allowing them to exercise their clinical judgment in such instances.
Congressional Quarterly received several company documents from the group that support the allegations. According to the documents — memos, company training materials and performance evaluations — AstraZeneca sales representatives were allegedly instructed to promote the off-label use of Arimidex by engaging doctors in a discussion about a competing drug called Femara.
The spokesman for the group claims that the sales strategy was designed to spur doctors to set up meetings with AstraZeneca’s medical liaisons. Because the drugs are similar, Arimidex and Femara, made by rival drug maker Novartis, compete for market share both on- and off-label.
According to one memo detailing performance objectives for the sales force, AstraZeneca sales representatives were encouraged to “utilize resources i.e., RSM (regional scientific managers) ... and brand team.” “Regional Scientific Managers” is another term for the medical science liaisons who are allowed to answer physician questions on off-label use.
On a training CD used by AstraZeneca sales representatives, a role-playing scenario between a doctor and salesperson lays out how AstraZeneca representatives can create a discussion with doctors about Arimidex compared to Femara. According to AstraZeneca’s company policy, sales employees are not allowed to make comparisons against competing drugs.
According to AstraZeneca, the company recorded $614 million in sales of the drug in 2006. Worldwide, the drug’s sales totaled $1.5 billion in 2006.
Stark’s letter asking the OIG to investigate appears to have generated results. OIG Spokesman Don White said the office is looking into the allegations.
“At this point, there is just a preliminary evaluation going on,” White said. “I’m not going to make any comment on an ultimate conclusion of a review, ” White added, referring to whether or not AstraZeneca has broken the law. He continued, “We have no indication that there is any kind of breach — we just don’t know yet. We don’t have hard info.”
White did not address specific questions about the documents, or comment on what materials the company might have received from the group making the allegations.
AstraZeneca spokeswoman Emily Denney acknowledged Wednesday that the company has been in contact with the OIG about its own internal efforts to address the allegations.
“We took all those allegations very seriously, Denney said. “We have concluded our investigation of the claims.” She added in a statement, “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.”
Denney said all of the issues reported to the company have now been resolved.
She also emphasized that the company’s sales force has been trained not to share inappropriate material with physicians, but that having some of the information is necessary to do their jobs.
“Our sales reps have to be accurately aware of the competitive landscape in which they’re operating,” Denney said.
On April 20, Denney confirmed that the company has hired an outside law firm to investigate the allegations, and had already fired one sales manager named by the group.
The group has said in documents posted on industry Web sites that they are in contact with government investigators, but they have so far declined to speak with the media on record.
The documents do not state specifically what AstraZeneca sales representatives were asked to say — whether they emphasized risks from Femara, or played up the benefits of Arimidex — but so far there have been no head-to-head clinical trails between the two drugs, and any claims the sales team made regarding one drug’s efficacy over the other would be suspect.
Meanwhile, proven allegations that AstraZeneca violated company policy over the marketing of Arimidex could carry serious consequences.
AstraZeneca is already operating under a Corporate Integrity Agreement (CIA) with the inspector general’s office that it signed in 2003 over a marketing scandal involving Zoladex, a drug used to treat prostate cancer. Often applied as part of a court verdict, the CIA is an agreement between a company and the government to adhere to certain standards of conduct.
In AstraZeneca’s case, the integrity agreement was the result of a 2003 court case in which it pleaded guilty to charges around the improper sale and marketing of Zoladex. In addition to pledging to adhere to the integrity agreement, AstraZeneca was fined $355 million, and is required to oversee that marketing and sales practices stay “in full compliance with the law.”
Because AstraZeneca is legally bound under the CIA to ensure its marketing practices comply with the law, any violation of company policy could be tantamount to a breach of the agreement with HHS. According to White, the OIG would be responsible for investigating any such breach.
The internal documents were first posted online by Peter Rost, a former Pfizer executive who now writes about the industry, and by Pharmalot.com, an industry news site published by the Star Ledger of New Jersey. Rost is considered a controversial figure in the pharmaceutical world. He was fired in 2005 from his position as a vice president at Pfizer after filing a whistleblower suit against the company and going to Capitol Hill to oppose his company’s position on drug importation.
The inquiry into AstraZeneca’s marketing practices began after the group posted on Rost’s Web site a letter originally sent to the OIG on April 12.
In an electronic copy of the letter provided by the group, the group alleges to the OIG that sales representatives were told specifically by a sales manager to promote meetings between physicians and company medical science liaisons in order to drive off-label uses of Arimidex. In the letter, group says that despite reporting the action to the company hotline, no action was taken by the company.
Following several news reports on AstraZeneca’s alleged mismarketing of Arimidex, Stark asked the OIG to begin an investigation. “I urge you to immediately investigate the allegations described herein, and to open an investigation into the FDA’s oversight of pharmaceutical marketing to physicians,” Stark wrote in his letter.
One AstraZeneca manager named in the developing allegations has already been fired.
Regional Sales Manager Mike Zubillaga was let go after an internal sales force newsletter surfaced in April that quoted Zubillaga referring to oncology doctors’ offices as “a big bucket of money.”
In the newsletter, Zubillaga says, “I see it like this: There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money.”
Zubillaga did not return a phone call. Through his mother, who is taking his calls and declined to be named, Zubillaga said that he wanted to try and put the accusations behind him.
Saturday, April 07, 2007
Fired AstraZeneca Sales Director's Colleagues are Merciless
The firing of AstraZeneca Sales Director Michael Zubillaga is met with scorn by his colleagues. Here are some of the comments on AstraZeneca's message board on CafePharma:"Evil flourishes when good men do nothing." Maybe someone finally spoke up...
The Zube was canned. What sweet justice. He was an "insider" with many many buddies at HQ. Guaranteed many are worried themselves now. So long, Zube.
Just think of the arrogance behind those words. What an arrogant prick to think of cancer patients as "cash" in your pocket. Unfortunately, this is the only face of AZ that any one out there will see.
Quote:
Originally Posted by Anonymous
this is what Pharmalot writes....Here's a thought or two: AstraZeneca says the newsletter was published "outside" of the required approval process. What does that mean? And it was the Winter edition newsletter, which means it circulated for awhile. Why was he fired now? No one inside the company saw this until now? Or was it because the drugmaker was embarassed the remarks became public? If AstraZeneca was really upset, why didn't the company act sooner?http://pharmalot.com/
Absolutely, he was probably applauded for his comments until they were leaked. AZ protected the good old boy until it went public, then so long zubillaga. they probably gave him one hell of a severance though.he was such a jackass.
Mike, from one AZ employee to another, I hope you f-----g rot selling the used cars on the worst car lost imaginable. Your stupid attitude just undid all the effort that's gone into trying to turn our industry's reputation around. C--------r.
At PharmaGossip, however, early results from a poll that just went up indicates most PharmaGossip readers feel that "Zube" shouldn't have been fired, because he just told it like it is and AstraZeneca is trying to put out a fire the company is responsible for starting. (click below to vote in the PharmaGossip poll, and to check current status):
Finally, one blogger took the position that "Zube" really had a really big mouth. That sentiment was illustrated over at Bill of Rights with the image to the left.And Impactivti used the Donald Trump covered above, in a post with the headline "Speaking your Mind - and Paying the Price"
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