Monday, April 30, 2007

Monogram Bioscience investor comments on allegations of illegal Pfizer HIV premarketing: "I think we're screwed"

Pfizer is seeking FDA approval to sell maraviroc for patients who have tried other treatments and have a form of HIV that uses the CCR5 receptor. Today, Question Authority revealed that a Pfizer whistleblower claims Pfizer illegally premarketed maraviroc.

This didn't sit well with Monogram Biosciences investors. Monogram Biosciences makes a blood test to determine if a patient falls into the category that should be treated with the Pfizer drug. In Pfizer's screening, 56 percent of previously treated patients had a virus that used CCR5.

Here are a few comments about my article, from people with an apparent stake in Monogram Biosciences, posted on the company's financial message board:

"I dont think its a real setback. If they broke the "Marketing" rules then PFE will pay a fine and they'll move on. This has nothing to do with the success, effectiveness or approval of the drug. I doubt that the FDA will sacrafice human lives for the sake of "Marketing". I think this "illegal marketing" reinforces PFE's confidence in this drug."

"did pfe respond to this yet? "

"I think you are smart enough not to believe everything that you see printed or in the net."

"I know. I try to post my finds though, so people can make an informed decision. I hold a very large position in this stock and that article doesn't alter my particular views."

"I agree, there is a lot of BS out there... seems this guy who wrote the article (Dr. Rost) has a personal vendetta against PFE. He has a website where all he does is bash PFE... I just read that he has already retained the services of Katz, Marshall & Banks, LLP to represent this supposed whistleblower. I'm thinking this is much to do about nothing. "

"i think where screwed"

Press about Pfizer's HIV whistleblower affair.

Pharmalot: Did Pfizer Improperly Sell An HIV Drug?

PharmaGossip: Pfizer - maraviroc: whoops there goes another Corporate Integrity Agreement

Brandweek: It's Already a Bad Day at Pfizer, as PR Problems Arise on Lipitor, Maraviroc and Viagra

Bill of Rights: Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval. And Promotion and charging for investigational drugs.

The Black Kitty: Pfizer's First Female Whistleblower: Illegal Marketing of HIV Drug

And . . . one of the big television networks just contacted me . . . but I'm not sure Pfizer's whistleblower is ready to go live, just yet.

Allegations by Pfizer's whistleblower

Question Authority: "You have accused Pfizer of illegally premarketing an unapproved drug, using the sales force. I guess you refer to FDA rules for promotion of an investigational new drug. According to those rules, a sponsor shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. The rules also state that the intent is to preclude commercialization of the drug before it is approved for commercial distribution. Is this what Pfizer did?"

Jane Roe: "Yes they did say that over and over again because Glaxo's CCR5 was such a toxic drug and was dc'd earlier last year. It was really about the commercialization of the drug which means using the sales force to soften the market, market prep, you know the drill."

Eminent Washington D.C. law firm offers to represent Pfizer whistleblower

The law firm Katz, Marshall & Banks, LLP, has just contacted me and offered to assist the Pfizer whistleblower in my story "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval."

David Marshall writes, "I just read your very interesting article on about Pfizer whistleblower Jane Roe, who has aired allegations of unlawful marketing of maraviroc. My law partner, Debra Katz, and I have successfully represented a number of whistleblowers in the pharmaceutical and medical industries (see our web site), and have focused on the very issues that Ms. Roe has raised. We would be glad to speak with Ms. Roe if she does not yet heave a lawyer. Please let her know that we are available if she needs representation."

Katz, Marshall & Banks, LLP, is dedicated to working for social justice by providing high-quality legal representation to individuals, groups and causes that are under-served in our legal system. They are dedicated to using our legal expertise and skills to support the civil rights, increase access to legal services, and obtain equitable and just treatment for employees and consumers. When other avenues of redress have been exhausted, they are the ones who take whatever legal action is appropriate to challenge governmental, corporate and individual wrongdoing, and to win compensation and vindication for those who have been harmed.

Sounds pretty good to me.

Perhaps YOU should contact Katz, Marshall & Banks, LLP?

More info here.

Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval.

The biggest Big Pharma success story last week was described in the headline “FDA panel backs Pfizer HIV drug.”

The drug is maraviroc, and it will be the first CCR5 receptor antagonist on the market. This group of drugs blocks a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells. Barbara Ryan, analyst for Deutsche Bank North America, projects that annual sales will peak at $500 million by 2011.

But now there’s a fly in Pfizer’s ointment; an internal whistleblower, whom we’ll call Jane Roe. She claims that Pfizer used the HIV sales force to illegally promote the drug to doctors before approval.

Roe says that the illegal conduct started already in November 2006, when Pfizer was trying to set up “expanded access sites” throughout the country for a maraviroc experience trial. The sales reps were used as liaisons to help medical affairs enroll new research sites and the sales reps were allegedly asked to promote the “trial,” in which doctors were paid $1200 per patient for one year, along with free drug.

Evidence of this, Roe says, is an “unapproved slide set” for maraviroc, which was given to some HIV sales reps in November 2006. The reps were then asked to give these slides to key doctors (download the-smoking-gun presentation here) The slides were allegedly used to “goose the skids” as well as in verbal discussions which included data outside what was published. Roe claims she was asked to slip the slide presentation on a memory stick to physicians whom the company trusted.

Roe points out that the actual paying of a fee to institutions is not generally wrong but using sales reps to promote a drug before approval violates FDA rules. Normally drug companies avoid using the sales force in any prelaunch activity, because it looks by definition like, well, selling . . . . and they need FDA approval to do that.

Roe says that some reps expressed concern to her, but were unwilling to rock the boat and went along with this unusual task. She says many physicians were also concerned that she and her colleagues were putting themselves in a difficult situation by participating in this program and some were upset.

Roe goes on to say that, "a researcher told the medical director she wasn't interested and said very loudly she did not know we were coming in to strong-arm her. It was during a lunch meeting at her office and very uncomfortable. I think as a result of these actions at the very least people thought we were inept running around with sales reps and a medical director who had never worked in a clinic or had no HIV experience. "

Roe claims this effort was directed by senior sales management and medical affairs, and she has shown me an e-mail from a Pfizer medical director for the HIV team, with an MS, PhD degree after the name, which supports the allegation that there was an ongoing coordination between medical affairs and the sales force to enroll physicians in the trial. Roe also says she was part of several meetings the medical director had with doctors.

In fact, Roe and some others in the sales force were so disturbed by this program that they not only objected to the company, but also recently reported this to the HHS Office of the Inspector General. (Pfizer has been forced to sign a Corporate Integrity Agreement, and any violation of this agreement is handled by the OIG.)

The sales force promotion of the “trial” went on until January 2007, when the sales force involvement was abruptly stopped. Also noteworthy, is that Roe says the sales reps were recently asked to delete all materials related to maraviroc.

A closer scrutiny of the slide presentation reveals that the author name electronically embedded in the presentation is not the doctor on the first slide, but “Peter Pinkowish.”

His name can be found on another HIV related slide presentation, for Bristol-Myers Squibb (available for download here), in which his title is “Medical Editor.” So here we have the first clue that this was a slide show written by someone who appears to be a hired gun. That smells marketing. In yet another medical paper, related to hormone therapy Pinkowish's title is “Medical Writer,” and it wouldn’t be far-fetched to assume that this is a person working for a medical education agency, churning out advertising disguised as semi-scientific papers and presentations for drug companies.

So why would Pfizer risk its reputation, using the sales force to premarket doctors?

Roe responds, "It is my understanding the enrollment has hit several obstacles because as I mentioned the complexity of miraviroc as well as the test that need to accompany it. The research shows half of all people or thereabouts cannot safely take this product. It has become a very difficult issue which is why in my opinion they enlisted the sales force to get buy-in prior to approval. It has become clear that Pfizer's commitment to HIV may depend on the approval and success of this product. Maraviroc provides a needed benefit to HIV patients and even though it may never be a Pfizer blockbuster it fills a gap since the current Pfizer HIV product Viracept is almost 9 years old and not considered first line very often. It seems this was a desperate attempt to impact futures sales; I guess some call this premarketing I call it bullshit and against the law."

John Mack's BlogosphereSurvey: "Four of the top five credible pharmaceutical-related blogs are industry critics."

Las Vegas, NV – April 30, 2007 – A new survey of pharma blog readers presented today at the Healthcare Blogging Summit by VirSci Corporation, publisher of Pharma Marketing News newsletter, reveals that four of the TOP FIVE credible pharmaceutical-related blogs are "industry critics," as rated by industry and non-industry readers alike.

The "industry-critical" blogs with highest credibility are, according to the survey:

Question Authority with Dr. Peter Rost

More info here.

Friday, April 27, 2007

PharmaGiles: Please don't go!

PharmaGiles is leaving the blog world, and ends his blogging career with another one of his classic, funny, tough, beautiful posts.

Read it all here.

Question Authority is really hurting . . . by this news. I simply hope Giles will change his mind. PharmaGiles has been getting better and better at a very rapid pace. So Giles, can't we just be a family, work things out?? Please don't go!

Here are some of PharmaGiles final words:

"Blogs like Question Authority, PharmaGossip and Pharmalot (and I could go on) are now holding the pharmaceutical industry up to a level of scrutiny that they’ve never had from mainstream media before. The AZ business has woken Big Pharma up to the power of the Blog. I believe Big Pharma’s PR wonks will now increasingly look to counter the impact of the “good” blogs by use of corporate-sponsored trolls of their own, burying the truth in reams of trivia, misinformation and weight of negative comment on the "critical" blogs. Some will just act as flack to draw the reader’s attention away from what is really going on. Others will attack the “pharma-unfriendly” blogs rather than the excesses of the industry they are supposed to report on.

There's been a sudden explosion of pharma blogs, hasn't there?...

Pharma Blogosphere's™ author certainly enjoys the largesse of Big Pharma at their events for tame bloggers. So is the Pharma Blogosphere™ the first of these "trojan pharma blogs"? Maybe not, but I think I’ve seen the future there. I wouldn't enjoy swimming in it, methinks..."

An e-mail . . . and a phone call from the U.S. Senate

I just got a phone call from a Senate Investigator, working for the Permanent Subcommittee on Investigations for Homeland Security and Governmental Affairs. Earlier this week they sent the e-mail below. They want to talk . . .

----Original Message Follows----
To: <>
Subject: US Senate
Date: Tue, 24 Apr 2007 17:50:38 -0400

Mr. Rost-

My name is REDACTED and I am a Senate Investigator, working for the Permanent Subcommittee on Investigations for Homeland Security and Governmental Affairs, REDACTED.


If you are interested in talking to me, please either send me an email or give me a call at REDACTED.

Thanks in advance for your help.


Permanent Subcommittee on Investigations
Homeland Security and Governmental Affairs


From Pharma Blogs: Week in Review

Physicians and pharma

On Wednesday, the New England Journal of Medicine released a study that showed 94% of physicians have at least one type of relationship with the drug industry, mostly in the form of receiving food in the workplace or prescription samples. More than one third are reimbursed for costs associated with professional meetings or continuing medical education, and more than a quarter receive honoraria for consulting, lecturing, or enrolling patients in clinical trials, say researchers at Massachusetts General Hospital-Partners Health Care System, Yale University, and the University of Melbourne and Royal Melbourne Hospital in Australia.

"Relationships with industry are a fundamental part of the way medicine is practiced today,” says lead researcher and co-author Eric Campbell, Ph.D., an associate professor of medicine at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School. “The real questions relate to how much is too much and how far is too far. It appears that these relationships benefit physicians and industry, but the important policy question is to what extent do these relationships benefit patients in the terms of the care they receive.”

Dr. Peter Rost puts it more bluntly, saying “U.S. Doctors: 94% of them are Johns.” “Should we be upset with the Johns satisfying their cravings or the ladies of the night meeting their demand and turning tricks?” Dr. Rost asks. “I suggest that most of those companies are just giving the Johns what they want. The Johns are the most highly paid professional group in the country, but money is never enough. Free samples, pizza, and cheap pens clearly are irresistible.”

At the Wall Street Journal’s blog, a post by Jacob Goldstein gives another perspective on the meaning of the study. “Readers of the Health Blog are unlikely to be shocked by the paper’s finding that drug makers court doctors assiduously (and that doctors accept industry’s advances),” Mr. Goldstein says. “But quantifying industry influence may help the profession figure out what, if anything, to do about it.”

Ed Silverman at Pharmalot also commented on the NEJM study, and he provides a link to the funders of the study, the Institute on Medicine as a Profession. According to IMAP, the group “seeks to cultivate a commitment to professionalism that will serve as the primary motivation for physician self-regulation.” (More about the group can be found here.)

Pharma professionals who wish to subscribe to PharmaBlogs: Week in Review may visit

The Whistleblower: Review in Trial Magazine

Review in Trial Magazine, the magazine published by the American Association for Justice (formerly the Association of Trial Lawyers of America).

BooksMay 2007 Volume 43, Issue 5
The Whistleblower: Confessions of a Healthcare Hitman

Peter Rost
Soft Skull Press
224 pp., $14.95

Reviewed by Jason Mark

It is not unusual for plaintiff lawyers litigating pharmaceutical cases to uncover business practices that put profits over safety. We read about it in documents we discover and hear about it in testimony we take during depositions. Unfortunately, that focus on sales, not safety, is common in the marketplace controlled by big pharma.

Peter Rost, a physician and former drug company executive, knows about it, too—but at an almost incomprehensible personal and professional sacrifice. The Whistleblower: Confessions of a Healthcare Hitman could not have been easy for Rost to write, never mind publish. In the hope of setting the record straight, he exposed the corrupt power of a pharmaceutical giant and laid a foundation for positive change in the future. But in doing so, he may have ensured the end of an impressive career.

Rost was vice president of marketing at Pharmacia, a rarely talked-about pharmaceutical company that Pfizer took over in April 2003. He was in charge of U.S. and global marketing of Genotropin, a human growth hormone and flagship drug for Pharmacia that was expected to generate global sales in excess of $600 million. Genotropin was intended for use in short children and adults with growth hormone deficiency.

Rost enjoyed life at Pharmacia. His coworkers were happy and energetic, and the atmosphere was positive.

Enter Pfizer. As Rost describes the takeover, Pfizer dehumanized the once-vibrant Pharmacia workplace. Managers were forced to attend “career transition” school—a course on how to fire the masses of Pharmacia employees who would be casualties of the takeover. And managers were forbidden to provide recommendations for employees leaving the company.

Even worse, Rost claims, was Pfizer’s resolve to destroy anyone who stood in its way or who wanted—as Rost did—to tout the cost and health care benefits of importing drugs, and to tell the truth about Pfizer’s decision to illegally promote off-label use of Genotropin as an anti-aging drug. Rost says the company entered into “favorable contracts” with distributors and doctors working in the anti-aging area and paid them kickbacks through “consulting agreements.” Sales reps who did not agree to Genotropin’s off-label promotion were fired or faced other adverse actions.

Rost, for his part, worked with Pharmacia’s legal department to correct many of the illegal marketing practices. He then went on a truth-telling mission, which appears to have been aimed in part at trying to save his job both during and after the takeover. Pfizer, he thought, might not want to fire someone with enough information about illegal marketing activity to be a serious liability to the company.

But Rost’s actions were not all self-serving. In fact, they’re cloaked with unimpeachable credibility because ultimately they address an issue—the industry’s opposition to drug importation—not specific to him, his job at Pfizer, or even Pfizer itself. Rost took on the entire industry, not because he had an ax to grind, but because of his belief in access to health care and the free market system.

The drug industry’s resistance to importation is, as Rost describes, due to the closed market it controls. Companies fear that importing drugs will cut into their bottom lines.

Rost thinks otherwise. He characterizes drug importation as one of the most important health care issues today and describes how 67 million Americans are without insurance for drugs. “The biggest argument against reimportation is safety,” he writes. “What everyone has conveniently forgotten to tell you is that in Europe, reimportation of drugs has been in place for 20 years.” If other countries could do it, and have done it, then why not the United States? As for company profits, Rost describes how lowering prices and making drugs more accessible can actually increase market share and ultimately create profits.

Notwithstanding ongoing pressure from Pfizer to keep quiet, Rost has demonstrated how one person can assert tremendous pressure against a corporate giant. He writes about how media appearances, newspaper articles, communication with various government agencies, and a general investigatory savvy helped him get his messages out and, at the same time, demonstrate to Pfizer that he was not simply going to go quietly into the night.

Ultimately, Rost was fired. He has brought a False Claims Act lawsuit against Pfizer.

He opens his book by noting some interesting statistics about whistleblowers from a study by Donald Soeken of St. Elizabeth’s Hospital in Washington, D.C. After exposing fraud, 90 percent of whistleblowers were fired or demoted, 26 percent had to seek psychiatric or physical care, 17 percent lost their homes, and 8 percent were bankrupted. Still, only 16 percent said they would not blow the whistle again.

It’s difficult to fathom putting your personal and professional life on the line. But that’s exactly what Rost did, and he tells about it in a compelling story of courage and principle.

Jason Mark practices law in Great Neck, New York.

Thursday, April 26, 2007

Department of Justice implicates "Pharmacia’s senior business executives" in Genotropin kick-back scandal

Brandweek has the amazing and comprehensive story here.

Please note that in the Government’s Sentencing Memorandum (download here), the Department of Justice states that the violations took place . . . “with the knowledge and approval of Pharmacia’s senior business executives.” (Page 8.)

The events described in the sentencing memo took place in 2000, only one year before I joined Pharmacia.

Coming soon: Internal whistleblower alleges major drug company marketed an unapproved drug!

You think the AstraZeneca ZubeGate story with audio tapes was bad?

Wait for the next story I'm working on: Major drug company is alleged to have used the sales force to market a drug way before approval. And the drug is still not approved!

I have the slides, I have the story and I'm talking to another anonymous whistleblower.

Stay tuned.

Wednesday, April 25, 2007

U.S. Doctors: 94% of them are Johns.

The New England Journal of Medicine, today released a study which showed 94 percent of U.S. doctors reporting some relationship with drug or device makers.

The doctors most likely to receive industry payments were the least likely to be caring for the poor.

Female doctors were less likely to receive payments than males.

In total, 83 percent of the docs said they accepted free meals, 78 percent accepted "free" samples, 35 percent accepted reimbursement for CMEs or meetings, 28 percent accepted payment for speaking, consulting, advisory board work or enrolling patients in clinical trials, and 7 percent took free tickets to sporting or cultural events.

This all raises an important question: Should we be upset with the Johns satisfying their cravings or the ladies of the night meeting their demand and turning tricks?

I suggest that most of those companies are just giving the Johns what they want. The Johns are the most highly paid professional group in the country, but money is never enough. Free samples, pizza, and cheap pens clearly are irresistible.

Tuesday, April 24, 2007

AstraZeneca CEO gets involved in ZubeGate

The main press is now picking up significant portions of what I've been writing about AstraZeneca's ZubeGate Affair, please see articles in posts below.

The article in UK's The Independent confirms that David Brennan, AstraZeneca's CEO has now taken a personal interest in this story:

"AstraZeneca will discipline more of its US sales team if allegations of illegal marketing tactics are proven to be true, the drug company's chief executive promised."

The Independent also reports that "AstraZeneca has begun an internal investigation into whether the tapes contravene a ban on comparing rival drugs that haven't been tested against each other in a proper scientific study."

The Independent: "'Grab a handful' training tapes scandal deepens"

'Grab a handful' training tapes scandal deepens
By Stephen Foley
Published: 24 April 2007

AstraZeneca will discipline more of its US sales team if allegations of illegal marketing tactics are proven to be true, the drug company's chief executive promised.

David Brennan's comments came as more confidential training tapes surfaced on the internet, showing how sales reps for the company's cancer drugs are encouraged to talk down rival products.

AstraZeneca has begun an internal investigation into whether the tapes contravene a ban on comparing rival drugs that haven't been tested against each other in a proper scientific study. The company's critics, meanwhile, have passed the allegations to the US department of health and human services, which is monitoring AstraZeneca's sales tactics following earlier ethical lapses.

The new allegations come a fortnight after the company sacked a US marketing manager for comparing the doctor's surgery to "a big bucket of money" and told his salesforce to go and "grab a handful".

In 2003, the company admitted a string of illegal marketing practices, paid $355m (£178m) in fines and compensation to the US government, and promised to abide by a tough five-year "corporate integrity agreement" which promised that there would be no further ethical lapses by its US salesforce. If any of the new allegations are proven and deemed to be a breach of the agreement, the company might be fined again, or even banned from selling drugs to the US government.

The story has been unfolding in slow motion through a number of industry websites and by the efforts of several bloggers, chief among them Peter Rost, a former Pfizer sales executive who has become a thorn in the side of the pharmaceutical industry. Dr Rost has testified to Congress about the dubious marketing practices of the industry, and written the book The Whistleblower: Confessions of a Healthcare Hitman.

Dr Rost has been handed - and published - confidential training tapes used by AstraZeneca sales reps who are trying to encourage doctors to use the company's breast cancer drug Arimidex in preference to a rival product made by Novartis, called Femara. The tapes show reps how to raise doubts over the results of trials of Femara, and then switch back to discussing Arimidex's own positive trial data. Dr Rost said he believed the tapes prove that AstraZeneca is operating illegally. "The only way to make a balanced comparison between two products is to have a well-designed, double-blind, randomised trial with the two drugs in the same trial. But that doesn't seem to bother AstraZeneca; a company for which the lack of comparative trials is a mere nuisance, easily corrected with slick selling.

"AstraZeneca sales, marketing and training have a co-ordinated campaign to sell against Letrozole without any comparative data. Both training examples show exactly how oncology reps can get the doctor to start talking about Letrozole and then compare it to Arimidex without a head-to-head study, and minimise the efficacy of Letrozole by slamming their trial."

An AstraZeneca spokesman said all its marketing presentations aimed to present a "fair and balanced" picture of their drugs. And David Brennan cautioned against pre-empting investigations into the affair, particularly since the source of the allegations was anonymous website tip-offs. He said that misbehaviour within parts of a drug company's sales organisation was rare and "relatively unpredictable", and the important question was how a company dealt with it.

"There was an issue and we took action; if there is another issue, we will take more action. We have in place a very thorough and well-understood compliance programme in the US and across the entire business, with codes of conduct and operating principles and annual training, and I take all that very seriously.

"As for any particular situation at any particular point of time, I would say that the management responded by doing what they thought they ought to do."

Mike Ward, pharmaceuticals industry analyst at Nomura Code, said that investors should keep an eye on the unfolding allegations. "These things usually result in just a slap on the wrist, but, if Novartis wanted to make a song and dance about it, then AstraZeneca could find itself in trouble."

"AstraZeneca's fortunes have sagged lately"

AstraZeneca's fortunes have sagged lately

It has been hurt by competition from generics, failed heart drug
By Meredith Cohn

Originally published April 24, 2007

AstraZeneca PLC, formed from two companies in 1999, has grown into one of the world's largest pharmaceutical companies with 66,000 employees and $26.5 billion in sales last year.

Based in London, it has a stable of top-selling drugs, including Crestor to reduce cholesterol, Nexium for acid reflux disease and Seroquel for treating schizophrenia.

But not everything is going the company's way these days.

Faced with increased competition from generic drugs, it said in February that it would lay off 3,000 workers. A promising heart drug it was developing with another company didn't pan out. And the company recently fired a regional sales director after he made impolitic comments that brought the company's sales practices into question for the second time in four years.

Yesterday, the company sought to boost its fortunes - and its bank of drugs in the pipeline - with the purchase of MedImmune Inc., the Gaithersburg-based maker of FluMist.

"This is very important and strategic for us," said Emily Denney, a company spokeswoman. "More products means more medicines we can deliver to our patients."

Michael J. Werner, president of the Werner Group, a biotechnology consulting firm in Washington, said MedImmune's vaccine business could be of particular benefit to AstraZeneca.

MedImmune has been developing pandemic and seasonal flu vaccines. And it gets royalties for developing technology used to make vaccines such as Merck's Gardasil for the human papillomavirus, which causes cervical cancer.

"This is an opportunity for them to get into the vaccine space and to do it with a market leader," Werner said.

Astra AB of Sweden and Zeneca Group PLC of Britain joined eight years ago to form AstraZeneca, which has its U.S. headquarters in Wilmington, Del., and has 12,000 employees there and in Waltham, Mass.

Peter Rost, a former Pfizer Inc. marketing vice president who is now an author and blogger on industry practices, said AstraZeneca's size helps explain why it needs to buy another drug-development company.

"It's very big now, and it's hard to discover a new drug that can significantly increase sales," Rost said. "When you make that much money it's hard for any one drug to have a significant impact. It's a Catch-22. ... It's much easier to grow when you're small."

AstraZeneca has had to overcome other problems.

In 2003, the company agreed to pay $355 million to resolve federal criminal and civil charges stemming from pricing and marketing practices concerning its prostate cancer drug Zoladex, according to the U.S. Justice Department.

The company also agreed to sign a corporate integrity agreement. That brings the company an extra layer of scrutiny from the government, Rost said.

AstraZeneca acted quickly when Rost's Web site posted provocative comments that a regional sales director, Michael Zubillaga, had made in a recent internal newsletter. Zubillaga said of doctors' offices: "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."

AstraZeneca fired Zubillaga.

"It was one person, and when we became aware of the comments, which were not in line with the purposes of our company, we moved to dismiss him," spokeswoman Denney said.
Sun reporter Tricia Bishop contributed to this article.

Sunday, April 22, 2007

Secret AstraZeneca Audio Tapes: Violation of Corporate Integrity Agreement?

Question Authority has just obtained internal AstraZeneca training tapes (download below), which appear to confirm that AstraZeneca may be in violation of its Corporate Integrity Agreement with the Office of Inspector General of the United States Department of Health and Human Services. If such a violation is confirmed, it could in a worst case scenario result in exclusion of AstraZeneca from selling drugs to the Federal Government.

Here's the background:

AstraZeneca has been forced to sign a Corporate Integrity Agreement (CIA) with the OIG of HHS, based on past sins and violations. Among the many provisions of this CIA, AstraZeneca employees have to comply with AstraZeneca's own policies and procedures.

The AstraZeneca's policy for product promotion states that "As with all product discussions, all such product comparisons may be made only in the context of an objective, balanced presentation. The benefits of one product and the shortcomings of another may not be singled out."

The only way to make a balanced comparison between two products is to have a well designed, double-blind, randomized trial WITH THE TWO DRUGS IN THE SAME TRIAL.

But that doesn't seem to bother AstraZeneca; a company for which the lack of comparative trials is a mere nuisance, easily corrected with slick selling.

The AstraZeneca whistleblower thinks that proof of this is two audio tracks from the "Arimidex/Faslodex," "Pharmaceutical Sales Specialist Objection Handler for the Tablet PC," which is a CD that was mailed to the AZ oncology sales force in January 2007.

Two of the audio tracks show exactly how to sell AZ's Arimidex against Novartis' letrozole (brand name FEMARA), by minimizing the efficacy message of letrozole, WITHOUT HAVING ANY COMPARATIVE DATA.

Click on the links below to download and listen to the training conversations with a doctor:

Track 7 - Here a sales rep targets a physician who uses letrozole from Novartis. She gets the doc to talk about her use, then proceeds to minimize letrozole efficacy because Novartis used "sub-group analysis" that is "fraught with difficulty" and that the authors say "use caution when interpreting this analysis" in their BIG 1-98 trial.

Track 15 - Similar. Strategy is to generate a conversation about letrozole and then minimize the efficacy of letrozole in node positive patients by bashing the Novartis BIG 1-98 trial because of bad "sub group analysis".


HERE's the deal:

1. AstraZeneca has an Arimidex versus tamoxifen study called ATAC.
2. Novartis has a letrozole versus tamoxifen study called BIG 1-98.
3. There are no studies of Arimidex versus letrozole.

Both training examples show exactly how oncology reps can:

1) Get the doctor to start talking about letrozole and then compare it to Arimidex without a head to head study.
2) Minimize the efficacy of letrozole by slamming their trial.
3) Imply that Arimidex efficacy is better than letrozole WITHOUT ANY COMPARATIVE DATA. Remember, we're talking CANCER patients here, not restless leg syndrome.

And we're talking about a company which has been forced by the United States Department of Health and Human Services to follow certain procedures and ethics, based on their past crimes.

Basically through the documents and audio files published on this site, we've now shown that AstraZeneca sales, marketing and training have a coordinated campaign to sell against letrozole.


The OIG has been notified and will have to determine if this violates AstraZeneca's policy, which by definition also would be a violation of AZ's Corporate Integrity Agreement.

Saturday, April 21, 2007

Pharma Giles: I just love that blog!

Here's what he wrote yesterday:

"I know I can always rely on Dr. Peter Rost to provide some cheering entertainment. And he has not disappointed me. His rigorous bitch-slapping of John Mack’s sneering dismissal of a post by the eminently sane and sensible Ms. Shanley (of “On Pharma” fame) was thoroughly welcome and gave me a good laugh of the “just desserts” variety. "

Continued here.

Pharma Giles ends his post with the following thoughtful suggestions:

As the Judge’s recent (and hopefully one-off) behaviour shows, perhaps what is needed is a code of conduct for Pharma bloggers, rather than for the whiny punters over at CP. Most of us don’t need one of course, because we are all polite, civilised individuals, but maybe such a code would help to keep the odd rogue in check.Out of interest, here’s the “code” I try and stick to (note the word “try”…)

Rule 1: Always acknowledge or link to your sources. We Pharma Bloggers are always nicking stuff off of each other and that’s all part of the fun. But we should leave plagiarism to Pharma middle-management. It has no place here.

Rule 2: If you get stuff wrong, correct it ASAP (I see Dr. Rost. did just that last night on his post about the Pfizer rep allegedly getting slapped.) If the error is pointed out by a fellow blogger, acknowledge that (like I did when I misquoted Fard Johnmar)
Rule 3: Respect the anonymity of those who wish to remain anonymous. People blog for lots of different reasons. I don’t wish to question them or try and find out who they are. (Unlike the Judge, who tried to trawl for info on the ID of Insider for reasons of his own a while back.)

Rule 4: Don’t (be)rate other bloggers, or “dis” them, unless they break the code of conduct. Differences of opinions are fine but should be openly debated without sneering. CP is the place for that.

Rule 5: If you are writing anonymously, then don’t criticise individual non-blogging folk by name. If you’re anonymous, then the subject of your writings should be afforded the same courtesy. That’s why I satirise, albeit thinly sometimes.

Rule 6: Don’t attempt to impose your own rules upon anyone else.

Er, looks like I’ve just broken Rule 6. So feel free to “dis me”. I guess the Judge will anyway, but that’s all part of the fun. So long as it doesn't get nasty...

I know most of us are already working to it anyway, but any suggestions on this “code” thing are welcome though…

Now I am off to start my new blog, intended as an antidote to any pharma blogger who takes themselves seriously…

Have a great weekend, folks. Even you, Judge, and I mean that. I’m sure you are a sweetie really…

Friday, April 20, 2007

AstraZeneca's Zubegate Making Headlines in the UK

And so the story has traveled over the Atlantic, to AstraZeneca's home country.

The Independent has written a detailed account of the story, and ends the article with a quote from yours truly:

Some commentators have suggested that Mr Zubillaga was simply telling the truth, although others have taken offence. Peter Rost, a former marketing executive at Pfizer, who first posted the newsletter on his "whistleblower" blog two weeks ago, wrote: "AstraZeneca lacked the internal controls to make sure the truth didn't get out, and now they are trying to show they are holier than thou, by firing the guy who said what everyone knows to be true ... Instead of a reprimand, AstraZeneca created a sacrificial lamb to cover the corporate rear end."

Quote of the day: Abraxis BioScience

AstraZeneca's "Zubegate" is moving over to Abraxis BioScience's message board on CafePharma.

This appears to be a comment by an Abraxis BioScience sales rep. If so it supports what AstraZeneca's "Fantastic 7" have claimed:

"If I were a MSL or DSM, I will be very concerned because they are all complicit in off-label promotions. I have been told many times by my manager to use MSL to promote off-label and NEVER to put anything on email or in writing.

AZ counterpart received the same instruction. It is time we unite and do what the Gang of Seven at AZ has done. We should be policing our MSL, DSM, BF, CM, JH, RAMs, and make sure that we document and report all illegal activities. I still don't know the basis for my ridiculously high sales target!

Pharmalot: Congress gets involved in AstraZeneca's Zubegate

The AstraZeneca Scandal: Congress Is Curious
By Ed Silverman

The 'Zube Affair,' as industry insiders now call the swirling accusations of off-label marketing surrounding the drugmaker, has caught the eye of Congressman Pete Stark, according to a congressional aide.

The Democrat from California, who is a member of the House Ways and Means Committee, and currently chairs its health subcommittee, wants to learn more about the allegations that have cropped up over the past two weeks, the source tells Pharmalot.

Already, the HHS Office of Inspector General is "aware" of the allegations that cancer meds were illegally promoted by sales managers and sales reps, although the agency has declined to say whether an investigation is under way.

The Congressional interest, which could result in an investigation, may take the scandal to a new level. Until this week, the two-week-old controversy was largely a topic of interest on the Internet among bloggers and AstraZeneca sales reps.

Story continues here.

Another secret AstraZeneca document revealed!

The "Fantastic 7" whistleblowers from AstraZeneca have sent another secret AstraZeneca document to Question Authority and Brandweek.

I was trying to gather some additional facts before posting, but Jim is now throwing things up so fast, that I guess there is no point in me delaying . . . please note that neither one of us have independent corroboration that this is an authentic document, however, it was sent to us by the same person who started this whole affair by sending the AZ "Zube" Oncology Newsletter to me.

This document was allegedly written by Matt Lehman, Brand Director for Arimidex, on January 9, 2007, and the "Fantastic 7" claim it was sent to the entire AstraZeneca oncology sales force.

And no one outside AstraZeneca is supposed to read this document. We know this, because in bold letters it says the document is "not for proactive distribution or discussion outside of AstraZeneca."

The message in this memo is--again--how inferior Novartis' letrozole is compared to AstraZeneca's drug and starts with this line in the first paragraph:

"Our friends at Novartis have just poured gasoline on that fire that we all stoked…..IMAGINE THAT!"

This can only be interpreted as AstraZeneca selling against letrozole, which allegedly contributed to AstraZeneca regional sales director Mike Zubillaga getting fired, and may violate AstraZeneca's policy for product promotion: "As with all product discussions, all such product comparisons may be made only in the context of an objective, balanced presentation. The benefits of one product and the shortcomings of another may not be singled out."

Then the memo goes on to claim that Arimidex is "the only AI with a 5-year consistent, and well established safety profile"

The "proof" provided for this statement is a study which doesn't use Arimidex (!), but tamoxifen vs. letrozole, and Lehman writes, "Although the overall incidence of cardiac adverse events did not differ significantly between the two treatments, a trend for higher grade cardiac events on letrozole compared with tamoxifen was seen." (Translation: It didn't prove a thing, but it looks good for us because letrozole looks worse than another drug.)

The author seems to understand this, because he throws in this ambiguous statement: "To be clear, the paper is for background use only and we don’t advocate anyone using this publication to sell Arimidex but attached are a couple thoughts on how this paper relates to our Arimidex messaging."

Then he can't resist ending the memo with this conclusion:

"Ladies and gentlemen, this is the time to capitalize on what may very well be the biggest opportunity in 2007 for Arimidex."

(Translation: The big opportunity is to sell Arimidex against letrozole using data from a study that didn't even use Arimidex. But don't tell anyone I told you.)

Too bad for AstraZeneca that someone just did that.

Download Matt Lehman's entire memo here.

Thursday, April 19, 2007

AstraZeneca: Advertising Mike Zubillaga's job

Requisition #1780554

Date Posted: 04-18-2007
Functional Area: Sales
State: Pennsylvania
City: Philadelphia
Territory: Mid-Atlantic
Other States: N/A
Field/Home based position: No
Search Band: Band 6
Department: Oncology -Mid-Atlantic

Provides leadership and direction of resource allocation at a regional level to achieve company objectives and meet customer needs within the therapeutic area.

-Ensures sales forecasts and operational budgets are met or exceeded within the therapeutic area at a regional level.
-Develops strategies and tactics in collaboration with product teams to provide optimal financial return within the therapeutic area.
-Works with the Regional Sales Director for Managed Care to ensure pull through of managed care strategies with customers within therapeutic area and region.
-Sets objectives, coaches/mentors, assesses performance and addresses skill development for direct reports.
-Works with Regional Business Director of Sales Operations to assess sales performance and market trends for TA and to determine appropriate adjustments to resource deployment plan to meet or exceed objectives.
-Participates on multi-disciplinary teams to provide perspective on cross functional and sales related issues (eg. specialty TA alliances).
-Proactively identifies best candidates and ensures diverse backgrounds are represented.


Minimum Requirements:
-Bachelor's degree.
-Minimum of 10 years experience in pharmaceutical sales or healthcare, including management experience in field sales.
-Demonstrated leadership, financial management and communications skills.
-Thorough understanding of customer segments and market dynamics within the therapeutic area.
-Ability to lead and manage local field sales leaders and to develop staff through coaching and mentoring.

Preferred Background:
-MBA and prior experience in a commercial function.
-Demonstrated presentation and negotiations skills.

Internal and External Contacts/Customers:
-Works with product teams, Senior Area Sales Director and National Sales Director - TA to provide input to product strategies, sales forecasts, and optimal sales force deployment plan for region.
-Works with Business Zone Director and other Area Sales Directors within region to optimize utilization of deployed resources to ensure sales return.
-Works with deployed sales training personnel to identify and define training needs for the region and therapeutic area and to ensure maximum impact of training programs.
-Works with deployed marketing operations personnel to develop customized programs / materials for the therapeutic area and region.
-Develops relationships with key external customers as appropriate.

Reporting Relationship:
-Direct Reports - Local Area Management
-Indirect Reports - Sales Representatives and Deployed Regional Resources

John Mack: "The Howard Stern of drug blogging?"

John Mack is a lovely guy, but his predilection to spin data faster than the drug industry spins PR doesn't increase his credibility. And his choice of language is reaching a new low, only matched by some FCC banned shock jocks.

First, let's start with the data spin. John has done a blogosphere survey, which we all helped steer our readers to, but the only thing we've seen so far is spin, spin, spin.

John's major objective seems to be to show snippets of data that shows his blog ranks high.

To do this he cuts the respondents into different groups, and he favors selecting the results only from individuals who happen to work for the drug industry.

In fact, in a post today on the PharmaBlogosphere, culling the data this way, and looking for "readability," "credibility" and "usefulness" the only three blogs that made it into all three top five lists was . . . surprise, John's blog PharmaMarketing, Eye on FDA, and In the Pipeline.

Two of those blogs are so dry, you'd have to be a scientist to enjoy them, and one of the blogs that made it onto one of those lists, Pharma Watch, isn't even available to the public!

I graciously note that even though my blog didn't make it into any of John's spin-controlled lists, he still couldn't resist the temptation to write about Question Authority, and this is what he said:

"Sorry, Peter, Question Authority -- popular as it might be among all readers -- did not make the "Industry Top 5" in any category! But I will say this: Industry readers thought that Question Authority was more supportive of the industry than did non-industry readers! In fact, it was second on that list (behind Pharma Marketing Blog) of blogs that the industry thought supportive. Perhaps if the survey was done over again today, industry respondents would have a different opinion! Perhaps more closely aligned with a view expressed on CafePharma; namely, "This Rost guy is a Michael Moore crony that is an industry and medical community outcast that has nothing better to do then sit at his computer all day long blogging about things he knows little about, blowing things out of proportion, and surfing porn."

I don't think the "industry supportive" result was surprising. I didn't spend 20 years in the drug industry not liking it. It is a great industry. The fact that I disagree with a few delusional drug company CEOs is a different story. I expect history to prove me right and their nose diving share prices to prove them wrong. Just one example, look at what I wrote about Pfizer's Exubera long before the analysts realized this thing was a flop.

As for John, I think the quote he picked up from CafePharma shuould have stayed on CafePharma. It is one thing for an anonymous idiot to post drivel about porn on CP, another thing for John to make it his own, by using it the way he did.

What made me react is not only this comment, but John also--in the name of being funny--posted this unprecedented "composite comment" from CafePharma about On Pharma, (On Pharma is written by a wonderful journalist; Agnes M. Shanley, Editorial Director for Putman Media, Inc.'s Pharma Group):

"The only word that can accurately describe you is inept. Are you kidding me? Stick your ethics up your ass. Listen up, you skeevy retard: You should have clean hands before you start spewing moral turpitude...Typing fagbot on an internet forum is not the same thing as screaming it out while waiting at the counter for my BK Broiler. You remain an idiot! Selfish egotistical asshole. If you are so interested in doing the right thing why don't you ... get into a circle jerk?"

So in conclusion, c'mon John, stop twisting the data to make yourself look good, show us the whole blog survey thing, and PLEASE, shape up your approach to your fellow bloggers. In fact, another blogger wrote me today about that last comment . . . so I know I'm alone saying that no one in the blog world expects silk gloves, but we also don't think paraphrasing or adopting the worst of CafePharma is the way to go, unless your objective is to be known as John Mack, the "Howard Stern of drug blogging."

Pharmagossip: Too funny

Check this one out . . . created by PharmaGossip: Thanks PharmaGossip for the fatigues!

Don't miss clicking on the music player . . .

Create Your Own PaloozaHead - Visit

Pfizer: Quote of the day


"Rost is hero. He put up with the same shit we do and tried to do something about it."

"Either that, or we are all chicken sh*t"

"Pfizer Looks Like a Bond Replacement"

Pfizer (PFE) reports on Friday, and just like tearing off a band-aid, investors are hoping the earnings release to be quick, and relatively painless.

Nobody’s expecting anything spectacular on the “good news” front, while many issues both short and long term swirl around the company like vultures (or maybe that’s just the generics).

Just to get things framed, let’s start with the boilerplates.

Continued here.

AstraZeneca: Quote of the day


"If push came to shove, I'm sure the "Group of Seven" could easily be composed of 700, or a lot more from AZ, if enough of us had the Cajones to act on our beliefs (including me).

We tolerate what is going on out of convenience and security, but we know in our hearts what is right or wrong, legal, illegal. or simply unethical.

Whenever we "go along", we are as guilty as our management. There is no in-between.

Don't condemn anyone who is doing the right thing whan you damn well know that you should be doing the same."

AstraZeneca's "Zube Affair" on CNBC

Mike Huckman over at CNBC News covers the still unfolding Astra Zeneca scandal in the first of two segments today. You can watch the video on CNBC here, or below.

Pharmalot: "The AstraZeneca Scandal Comes To TV"

A very insightful commentary by Ed Silverman, so good that I'm reproducing the entire post:

April 19, 2007
The AstraZeneca Scandal Comes To TV

This morning, CNBC aired a two-minute segment. And this is signifcant. Here's why:

Ever since the 'bucket of money' affair erupted earlier this month, the mainstream media has largely sat on its hands, even though there has otherwise been intense coverage over the past few years of industry pricing and promotion. Other than a couple of stories in The Philadelphia Inquirer, the scandal has remained the exclusive province of a few blogs.

For those who might have missed it, here's a thumbnail recap: an AstraZeneca regional sales manager was fired 13 days ago after a few blogs posted an internal newsletter containing his crass comments that a doctor's office is like a 'big bucket of money.' Then, anonymous AZ employees began a whispering campaign by feeding a few bloggers, starting with whistleblower Peter Rost, info about alleged off-label marketing of a cancer drug.

For a week, AstraZeneca was silent, but last Friday was forced to reply to the blogs, after it became cleear the issue wasn't going away. And the response was revealing, not so much for what was said, but for the fact that a major drugmaker acknowledged scrutiny from something other than the traditional circle of journalists. For the first time, big pharma is coming to grips with this new reality, which is that blogs - those unrelenting, instananeous, spontaneous purveyors of fact, smarminess and occassional outrage - are watching their every move.

As this site indicated, there's no going back. And now television has picked up the story. CNBC's two-minute segment included the a shot of the newsletter and a visit to Mike Zubillaga's manicured McMansion in Kennett Square, Pa., although he wouldn't answer the door. (He was demur with Pharmalot last week, too). Moreover, the report underscored the ongoing concern over alleged illegal marketing practices that taint the industry's collective reputation. An updated segment is supposed to air on the cable channel later today.

Does this suggest the mainstream media isn't interested in such stories? Not at all. But this episode does suggest that traditional journalistic conventions are being challenged in following what is already a very competitive beat. Much as it has in the political world, the game is changing. And all sorts of people appear unprepared, especially big pharma.

You can watch the CNBC segment here.

CNBC News Covers the AstraZeneca "Zube Affair" Today

Mike Huckman over at CNBC News will cover the still unfolding Astra Zeneca "Zube Affair" with the "Fantastic 7 Whistleblowers" today, at 11:30 AM EST and around 4 PM EST.

Clinical Psychology and Psychiatry: "Peter Rost is ON FIRE!"

"Peter Rost is ON FIRE!"

"I bow down to Peter Rost. Why? Let's see... He broke the latest AstraZeneca Arimidex off-label marketing scandal. Rather than being a one-time story, it has continued to unfold, looking worse and worse for AZ. Rost continues to serve up hot AZ insider information, as the scandal grows wider in scope.

He has also backed up his brand of investigative journalism with evidence (here and here) that points quite directly at AZ marketing their product in an off-label fashion. And the plot continues to thicken, as you can see here.

Keep up the good work Peter!"

More here.

Thank you Clin Psych!

Wednesday, April 18, 2007

Auto theft protection coming next year.

Or could it be drug company PR spin?

STEERING WHEEL VIOLENTLY SHAKES WHEN TOUCHED - For more funny videos, click here

Flying Cat

Unbelievable. Hat tip Arborath.

To AstraZeneca's law firm: Arnold & Porter

For your reading enjoyment:


The AstraZeneca "Fantastic 7" have a question.

Scarlett Spring is AstraZeneca's National Sales Director Oncology.
She was also the boss of fired Regional Sales Director, Mike Zubillaga.

Pfizer sales meeting ends in fist fight

A Pfizer sales rep allegedly got pummeled by an upset doctor. The sales rep claims she "was left with a swollen chest and face and a burst blood vessel in her eye," and was called a "black monkey."

Full story here.

AstraZeneca Sales Reps Open Up

. . . on CafePharma today:

There is not a SINGLE pharma company that is in full compliance with OIG, PhRMA, etc. Face it, we're all paid based on sales, and the only way to really make $$ is to bend/break the rules a bit. All this corporate BS about "ethical" selling, etc is nothing but lip service to protect the higher-ups. Good script numbers is an excellent deodorant, and I don't know a single sales manager that will reward it's sales people based on no growth, but good compliance with regs. Those people are kicked-out. As long as you are delivering scripts, thery don't care how you're doing it.

If you truly believe the above, you are no better than any of them. You are lying to the people of this country and putting lives at jeapordy. There is no such thing as a little lie in life or in the law...and there is nothing ethical about skirting the truth. If your bonus is the ultimate end in your life, and that matters more than truth or dignity, then I can only hope that I never do business with you or anyone like you. You are a disgrace to this company and to yourself...And I don't give a damn if you believe that everyone else does it, why shuold'nt you. It doesn't wash!

Yeah, OK Mr. Ethical! I suppose if I opened up your bag at any point in your "career" I'd find no home-made sales-aids or unapproved articles? You've never engaged in a conversation or answered a question from a prescriber about an off-label use of your drug? Suuuuuurrrrrrre. I'll bet you're one hell of a salesperson! Doucehbag

You're right about one thing...I am one hell of a salesperson. But, wrong about the rest. I follow a strict rule of ethics in sales and life, not AZ's, and still have been quite successful, although I am now in the process of seeking employment in another industry - largely due to my utter disappointmet in AZ and the rest of pharma.

Did Abraxis BioScience instruct AstraZeneca to use illegal marketing in their quest to increase sales?

In a February 2007 press release, Abraxis BioScience reported record revenue of $765 million in 2006 versus $521 million for 2005. They made that money selling a new version of an old cancer drug at $4,200 per dose.

That new drug is called Abraxane and it has pushed Abraxis BioScience stock from $5 in 2002 to $27 in 2007. The lofty stock price has made Abraxis CEO and Chairman, Dr. Patrick Soon-Shiong a billionaire; Dr. Soon-Shiong owns 84 percent of the stock, today worth about $3.8 billion.

Dr. Patrick Soon-Shiong is controversial; he has been criticized for hyping his research results and he has been accused of ripping off investors. Even his own brother, an early backer, sued him for fraud and fired him—twice—from the company they started. Their fight lasted two years and destroyed their relationship. But in the end, it is Dr. Soon-Shiong who has prevailed.

Today, Dr. Soon-Shiong is making money hand over fist. After all, his “new” drug costs 25 times more than an older, generic version (paclitaxel). There is, however, little difference between the new drug and older therapy; in fact, they both use the same active molecule. The only difference is that in Abraxane paclitaxel is bound to a protein, to make it easier to inject. And Abraxane doesn’t help patients live longer than the old, generic, version of the drug.

It is also noteworthy that an independent review article of Abraxane and similar drugs in “Annals of Oncology” concluded, “do these agents represent anything more than old wine in a new bottle? With currently available data, we have to say, ‘not really’.”

So how has Abraxis BioScience been able to sell so much of a drug that isn’t really much better than the old version and how has Dr. Patrick Soon-Shiong been able to get so rich?

Some AstraZeneca oncology sales reps think they have part of the answer. They claim that those rapidly escalating sales may have been built upon off-label marketing.

AstraZeneca co-promotes Abraxane with Abraxis BioScience, and those sales representatives claim that at a joint sales meeting between AstraZeneca and Abraxis, which took place in December 2006 in Pittsburg, things went awfully wrong.

The meeting was led by AstraZeneca Regional Sales Director Mike Zubillaga, who has since been terminated by AstraZeneca, together with an Abraxis Medical Science Liaison (MSL) and two District Sales Managers; one from Abraxis and one from AstraZeneca.

Eight AstraZeneca oncology sales reps and eight Abraxis reps participated in the training, and they received the assistance of a whopping seven oncologists, who made some extra cash, tutoring the sixteen sales reps.

According to some of those AstraZeneca sales reps, the Abraxis Medical Science Liaison made it known that the Abraxis MSLs were available for off-label discussions (such as lung cancer) with oncology doctors, and that the AstraZeneca reps should use them as a resource. Then the Abraxis District Sales Manager allegedly pointed out that coordination of these meetings should be done by cell phone only, and that email or voicemail should be avoided.

If these allegations are true, this all sounds very familiar.

In May 2004, Pfizer’s subsidiary Warner-Lambert paid a $430 million fine for off-label promotion of Neurontin. The Department of Justice stated that Warner-Lambert “utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.”

And the sales efforts for Abraxane are clearly paying off. Over 20,000 people have been treated with Abraxane, and sales are expected to reach $1 billion by 2010.

But that may not be how things play out.

Because those concerned AstraZeneca sales reps who participated in the meeting with Abraxis BioScience didn’t stay silent. They claim a “Code of Conduct report was submitted through the AstraZeneca hotline shortly thereafter.” They also told me that, “thus far we are not aware of any investigation or interviews by AZ. No official response from them as of today.”

So when AstraZeneca took no visible action, and did not respond, the AstraZeneca oncology sales reps decided to talk to me. And that’s the reason you’re reading this story today.

UPDATE: AstraZeneca has now responded to the sales reps. Five months after the first report was made, they finally left a message on the hotline for their internal whistleblowers, AFTER the story was leaked to the press.

Tuesday, April 17, 2007

Kid's Cold Orchestra - Små grodorna (The Small Frogs Song)

Here's a well known Swedish children's song.

If you want to see more, go to the state owned Swedish Pharmacy Monopoly, here.

And do your own thing. Try clicking on the children!

AstraZeneca hires Arnold & Porter to investigate oncology scandal?

There is unconfirmed information that AstraZeneca has just hired the famous white-shoe law firm Arnold & Porter to investigate the recent oncology sales force scandal that has resulted in the dismissal of one regional sales director. AstraZeneca did not reply to a request for comment on this development.

Arnold & Porter, one of the "Big Three" Washington, D.C., firms, has built its stellar reputation advising on antitrust matters, as well as M&A, intellectual property and bankruptcy.

A&P is also known as a firm with a heart - it's got a top pro bono practice and has made the "Best Company to Work For" lists in numerous publications. A&P has 700 attorneys in seven offices worldwide.

Many associates praise Arnold & Porter as the "most laid-back, non-confrontational firm" in D.C. "Very liberal and very accepting," it is a firm where "people feel free to be themselves," making it "a very comfortable place to practice law."

"The firm encourages attorneys to develop their own individual strengths without a cookie-cutter approach, resulting in an interesting and idiosyncratic group," explains an associate.

Additionally, at A&P "there is a notable lack of cruelty" with regard to how partners relate to their underlings. "Partners treat associates like people, are friendly, but professional," describes another insider.

A&P's cozy work environment has been widely noted. The firm frequently makes appearances on Working Mother's "100 Best Companies" in recognition of the firm's flexible scheduling, child-care options and parental time off.

In fact, it is the only law firm to earn the magazine's salute for two consecutive years. In 2005, Arnold & Porter made Fortune magazine's prestigious list of the "100 Best Companies to Work For," gracing the list for the fourth consecutive year. It also achieved a No. 3 ranking on The American Lawyer's "A list" which measures, among other things, firms' associate satisfaction and workplace diversity.

I'm not making any of this up. You can read for yourself here, in "Why work for Arnold & Porter?"

Want to know caption to this image?

Then go here.

Bad boyz: "AZ is bad, Rost is worse, the OIG is the worst"

"AZ is bad, Rost is worse, the OIG is the worst."
Read more on this thread, here.

AstraZeneca Oncology Scandal Spreading to Biotech Company?

Back in April 2006, AstraZeneca decided to do a deal with Abraxis BioScience to co-promote the cancer therapy ABRAXANE, see press release here.

But as you already know, problems were brewing in the AstraZeneca Oncology sales force.

And one of the persons, now known as the AstraZeneca "Fantastic Seven" whistleblowers decided to speak up. This person did that on CafePharma on March 15, 2007, and wrote to me this morning and said that the following posts on this message thread on CafePharma "are real."

We all know that CafePharma is an ongoing mud fight, notorious for all kinds of nasty language, gossip and unsubstantiated claims.

But, let's play along and see what the whistleblower who brought down AZ Oncology Regional Sales Director Mike Zubillaga, claims "to be real":

#32 Just got back from an Abraxane meeting in Pittsburgh with our Abraxis counterparts. The Abraxis manager told all of us not to use email when dealing with Regional Scientific Managers but to stick to cells phones.AZ's Mid-Atlantic Abraxane DSM 'RD' was present & said nothing. This leads me to believe that what they are asking us to do is illegal. Is anyone else seeing this in other parts of the country?

#33 Lemme the RSM recruit for ad boards and sell Abraxane off-label. Keep it quiet. No email or voicemail. Cell phones only.

#35 Avoiding email is a way to hide evidence. I remember getting off the bus at a national oncology meeting years ago and being asked for my laptop so they could record the hard drive. This was during the Zoladex investigation. They pieced together every suspicious transaction. That included business plans, email, work day appraisals, evaluations and call notes. When reps were questioned they had everything laid out in chronological order. We were also told that at any time a federal investigator could knock on our with a subpeona. Comforting thoughts. So if you want to "be happy" that's fine. Just remember that if things go south the managers will step aside and let you take the blame because you signed off on the policy and can't produce a CYA document.

#36 This reminds me of the Neurontin case where MSL/RSMs were used to promote off-label:"Warner-Lambert also used "medical liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin."

#38 The off-label promotion of Abraxane IV or Faslodex injection would be considered fraud under the False Claims Act

Clearly none of this is actual proof of anything. But considering what has been going on inside AstraZeneca over the past couple of weeks, and considering that this whistleblower has already been proven right once, he may be right about this too.

I guess AstraZeneca's legal department just got one more issue to investigate and send to the OIG per their Corporate Integrity Agreement.

As for Abraxis BioScience, they better make sure they start their own probe.

Wouldn't look good if AstraZeneca came clean and Abraxis got caught with their pants down. Not that we know if anyone has done anything wrong.

But once the accusations start flying like mud in the air, friendly co-promotion partners can rapidly tear each other apart.

Pharma Blogosphere: "Rost Rocks!"

Thank you, John Mack, for this write-up:

Round the Sphere: Rost Rocks, AZ PR Meltdown

Does Peter Rost (Question Authority) rock your world or wreck it?

If your world is the pharmaceutical industry and the AstraZeneca corner of it in particular, you probably would say that he is wrecking your world.

To us bloggers in the Pharma BlogosphereTM, however, Rost Rocks!

Think of Rost in his best "deep throat" outfit sitting on a park bench in Wilmington, DE (US headquarters of AstraZeneca). Mysterious people stop by and sit next to him for a few minutes and then leave. Rost throws some crumbs on the ground and immediately a flock of pigeons swoops in and gobbles them up!

Continued here.

And what's more. John has a kind heart. See end of his post. Thanks John!

The News Journal: "AstraZeneca's sales practices questioned"

AstraZeneca's sales practices questioned
By GARY HABER, The News Journal, Wilmington, Delaware
Posted Tuesday, April 17, 2007

Less than two weeks after it fired a pharmaceutical sales manager for comments in a company newsletter, AstraZeneca PLC was defending itself again Monday.

The maker of such drugs as Nexium, a treatment for acid reflux disease, and Crestor, a cholesterol-reducer, said it is investigating recent allegations posted on pharmaceutical industry blogs questioning the company's sales and marketing practices. One allegation said some of the company's salesmen were being pushed to promote the sale of one of its cancer drugs for unapproved uses.

"As we learn about these things through whatever mechanism, we investigate them and take them seriously," Emily Denney, an AstraZeneca spokeswoman, said Monday.

Denney's comments come after AstraZeneca issued a statement on Friday, reading in part, "We have a robust compliance program that calls for responsible sales and marketing practices that comply with applicable laws, regulations and industry standards, such as PhRMA [the Pharmaceutical Research and Manufacturers of America] and the American Medical Association guidelines, as well as AstraZeneca's internal policies."

Denney declined Monday to address the specifics of any of the allegations making the rounds on several Web sites, including those made by a group calling themselves "The AstraZeneca Group of Seven," whose unidentified members say they are employees of the company.

Denney declined to detail what actions the company was taking to address the online allegations.

On Friday,, a blog written by Ed Silverman, who covers the pharmaceutical industry for The Star-Ledger newspaper of Newark, N.J., ran a portion of what purports to be a letter from "AstraZeneca Group of Seven" to the U.S. Department of Health and Human Services' Office of Inspector General. The letter said AstraZeneca's salesmen were encouraged in a November 2006 meeting to promote the company's Faslodex cancer drug for so-called "off-label" uses and to compare it to competitor Novartis' Femara cancer drug, even though no head-to-head clinical trials had been done.

Drug companies are not allowed to promote their products for other than FDA-approved uses, but there's no prohibition on doctors prescribing them for so-called off-label uses.

Don White, a spokesman for the Office of Inspector General, said Monday he could "neither confirm nor deny that we have received the letter, but we are aware of the situation."

If AstraZeneca were found to have marketed its drugs improperly, the company could run afoul of its Corporate Integrity Agreement with the Office of Inspector General, which could jeopardize its ability to sell to Medicare and Medicaid.

In 2003, the company pleaded guilty to violating the Prescription Drug Marketing Act by providing free samples of its Zoladex cancer drug to physicians, who then billed Medicare, Medicaid and other federal insurance programs. The company agreed to pay $355 million to settle criminal and civil charges and agreed to enter into the agreement that allowed it to continue to sell its products to Medicare and Medicaid as long as its sales and marketing practices complied with the law.

Denney, the AstraZeneca spokeswoman, said Monday the company is living up to the terms of its agreement with the government.

"In each instance, we've acted in a matter that's consistent with our compliance program and its obligations under the Corporate Integrity Agreement," she said.

Earlier this month, Michael Zubillaga, of Kennett Square, Pa., who worked at AstraZeneca's sales office in Wayne, Pa., was fired after he was quoted in an interview in a company newsletter comparing physicians' offices to "a big bucket of money" from which they can "grab a handful."

Contact Gary Haber at 324-2878 or

Philadelphia Inquirer: "Additional AstraZeneca staff disciplined"

Posted on Tue, Apr. 17, 2007
Additional AstraZeneca staff disciplined
By Thomas Ginsberg
Philadelphia Inquirer Staff Writer

AstraZeneca P.L.C. said yesterday that it was actively investigating some employees for improper promotional activity and already has taken corrective action after other undisclosed lapses.

London-based AstraZeneca, with U.S. headquarters in Wilmington and major operations around Philadelphia, made the statement in the face of persistent questions about its firing 10 days ago of a regional sales director, Michael Zubillaga, 50, of Kennett Square.

Zubillaga, in an internal newsletter, had exhorted sales representatives who call on cancer doctors to view those doctors' offices as a "bucket of money." After industry bloggers obtained and published his comments on the Internet, casting the company in a negative light, AstraZeneca fired him for allegedly violating its policy on ethical conduct.

But another comment by Zubillaga, in the same newsletter, appears to highlight a more troublesome issue underlying the firing. Zubillaga was quoted as lamenting that sales reps last year had been too slow to promote AstraZeneca's cancer drug Arimidex in direct comparison to Novartis AG's treatment, Femara.

"We should have changed our strategy with our core messages earlier in regards to selling against letrozole," Zubillaga says in the newsletter. Letrozole is the generic name for Femara.

Such direct comparison or counter-promotion of two drugs could be improper, since neither company has tested the products directly against each other.

The U.S. Food and Drug Administration prohibits drug companies from promoting their products without valid or FDA-approved data and requires them always to present "fair" and "balanced" data in their sales pitches.

Sales reps who make such comparisons, in violation of company or FDA policy, could be penalized individually.

Peter Rost, a former Pfizer Inc. marketing executive and now author of the blog Question Authority (www.peterrost., said anonymous sources had sent him documents indicating that AstraZeneca sales managers might have subtly ordered or encouraged sales reps to make the improper comparison.

Rost said the source, or sources, of the documents was the same who initially sent him the Zubillaga newsletter that turned out to be genuine.

In response, AstraZeneca said in a statement:

"The company takes claims of misconduct very seriously and investigates these in a timely and effective manner. Investigations concerning the specific claims referenced were initiated. Some claims reported prior to this incident were investigated and concluded with appropriate corrective action being taken. More recent claims are actively being investigated."

A spokeswoman, Emily Denney, said she could not immediately explain "corrective action" and declined to say whether the affected employees worked in sales or performed other duties.

AstraZeneca already is under heightened scrutiny by regulators from the U.S. Department of Health and Human Services for illegal marketing and billing involving another cancer drug, Zoladex, in 2003. It paid $355 million to settle the case and must report suspicious or improper activities by its employees to regulators.

Under its Corporate Integrity Agreement with regulators, the company must report any infractions, such as those alleged by Rost's sources.

Denney emphasized that the company has made proper disclosure to authorities. "In each instance, AstraZeneca acted in a manner consistent with its compliance program requirements and its obligations," Denney said.

Don White, a spokesman for the Department of Health and Human Services, declined to confirm or deny whether investigators had received recent complaints regarding AstraZeneca promotions of Arimidex.

AstraZeneca's share price closed up 73 cents, or about 1.3 percent, to $56.70 on the New York Stock Exchange.

AstraZeneca employs about 5,000 in the Philadelphia region.

Contact staff writer Thomas Ginsberg at 215-854-4177 or