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, 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.

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