Winners and losers in this week's cholesterol war

Astra-Zeneca, Crestor +15%
Pfizer, Lipitor +4%
Merck, Vytorin/Zetia -10%
Schering-Plough, Vytorin/Zetia -17%

Drug companies caught redhanded altering Wikipedia.

Want to know what everyone else is reading on BrandweekNRX today?

Go here.

There is a reader tsunami coming by to this post.

Did Astra-Zeneca illegally market Seroquel for off-label use?

The state of Pennsylvania thinks so. In February 2007, Pennsylvania filed a lawsuit against AstraZeneca, and other atypical makers, alleging the drug giant illegally marketed Seroquel off-label for unapproved uses.

Seroquel is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.

And I'm not sure what's going on at AstraZeneca, but this company generates more whistleblowers than anyone else.

So someone thought a few documents might be interesting in light of the allegations above.

The documents below is what AstraZeneca is using to educate doctors about areas Seroquel is not approved for.


Click on them to read and view full size.



But there's more. Seroquel was approved for bipolar depression only very recently, in October 2006.

So what did AstraZeneca do? Well, they made sure doctors were well educated about this area six months before they got the indication. See the date on the business reply card below (click to enlarge).





Did any of this violate anything?



I guess the state of Pennsylvania may think so, but we'll see . . .

AstraZeneca ethics report claims that Zubillaga's interim replacement threatened to fire whistleblowers . . .

I have just received access to the report number and pass code for a recent report on AstraZeneca's ethics violation web site, http://www.azethics.com/. (Click on images to enlarge.)

Report Submission Date
6/18/2007

Reported Company/Branch Information
Name: USA
Location: Mid-Atlantic Oncology Regional Meeting
City/State/Zip: Baltimore, MD, USA

Violation Information
Violation Type
Retaliation

What is your relationship to AstraZeneca?
Employee

Please identify the person(s) engaged in this behavior:
[Name redacted] - Northeast Oncology Regional Sales Director

Do you suspect or know that a supervisor or management is involved?
Yes

If yes, then who?
[Name redacted] - Northeast Oncology Regional Sales Director

Is management aware of this problem?
Do Not Know / Do Not Wish To Disclose

What is the general nature of this matter?
Threats of retaliation against whistleblowers.

Where did this incident or violation occur?
Baltimore, MD

Please provide the specific or approximate time this incident occurred:
June 13th, 2007

How long do you think this problem has been going on?
1 to 3 months

How did you become aware of this violation?
I observed it

Details
June 13th 2007

This took place today at a regional meeting in Baltimore MD. Present were oncology pharmaceutical reps and their district managers from the Mid-Atlantic oncology region.

[Name redacted] is the Northeast Regional Sales Director for oncology. He also served as the interim Mid-Atlantic Regional Sales Director after Zubillaga was fired.

At this meeting [Name redacted] expressed the opinion that the whistleblowers who recently reported violations by AstraZeneca to the media and OIG should be tracked-down and fired, even after someone present pointed out that if AZ had actually responded to its own internal hotline, the whistleblowers would not have been forced to go public. He was the senior manager present.

According to AstraZeneca's Corporate Integrity Agreement with OIG "Consistent with the open compliance environment that AstraZeneca strives to maintain, company policy prohibits retaliation or retribution of any kind following the good faith reporting of a suspected violation."

Follow-Up Questions/Comments
The company has submitted a comment or a question for you to answer.
6/19/2007 8:48 AM - AstraZeneca takes allegations of wrongdoing very seriously. This matter has been sent for further investigation. AstraZeneca will investigate this matter promptly, thoroughly and diligently and will takes appropriate steps based on the outcome of the investigation.

Follow-Up Notes
Jun 27, 2007, 9:56 AM
[Name redacted] had each of us vow that anything said at this meeting would stay secret.

FYI - The premise of this meeting was to 'move forward', after numerous recent scandals, by forming a committee of representatives to make suggestions to management.

Follow-Up Questions/Comments
There are no questions asked or comments posted by the company.

Chat Transcripts
There are no chat transcripts for this incident.

Read AstraZeneca's official policy on retaliation, click on image below!



My new source inside AstraZeneca, "Susan Jones," wrote the following when she sent the report code and password to me:

"Dr. Rost, the premise of our meeting was to form a group of AZ oncology representatives to 'move forward' after the recent scandals in the region. We all agreed to keep what was said at the meeting to ourselves. However, in good conscience, I could not ignore a direct threat to fire whistleblowers by AZ management. What if I was one of the original whistleblowers? [Name Redacted] would have fired me. I picked up your book after the 'bucket of money' scandal and was inspired enough to override my fear and contact you. "

Quote of the day: "The only way to meet our goal is to sell off-label."

From the AstraZeneca board, about Abraxane objectives, here.

Thank you for birthday gifts, Astra-Zeneca!

Astra-Zeneca apparently noticed that I celebrated my birthday a few days ago with a little song.

So yesterday I got this wonderful box with all kinds of goodies from Astra-Zeneca:

Pens, notepads, tumor measuring device, bags, hand gel . . . thank you so much, Astra-Zeneca!

AARP picks up on "Bucket of Money" scandal.

Link here.

AstraZeneca's "Group of 7" Says Goodbye and Gives AstraZeneca Credit for the Company's Clean-Up Efforts.

The notorious whistleblowers in AstraZeneca's "Group of Seven" have announced that they are going into hibernation after blowing the whistle on a variety of scandals in AstraZeneca's oncology sales division.

"We see that the company is making an effort to clean up their act and want to give them a chance to do so. To their credit, there has been no 'witch hunt' to discover our identities or retaliate against us. It's time for Congress, the Senate and the OIG to investigate what we've reported."

When asked if they would ever resurface in the media again, they replied:

"If AstraZeneca responds appropriately to its internal Code of Conduct Hotline, you'll never hear from us again. It won't be necessary for us to go to the government, Fortune Magazine, The Wall Street Journal, The Philadelphia Inquirer, Congressional Quarterly or, most importantly, Dr. Peter Rost. Peter will be the first one to hear from us. He has our utmost respect and trust."

And with that the world's blog readers cried; not only because it seemed so noble what the "Group of 7" had done, but also because they gave AstraZeneca credit in their last public statement; and most of all, because we already miss them.

As for me, I'm crying because now they're gone forever and I will never find out who they really were. Question Authority will not be the same without them.

But they will live on in our past posts and memories as the group that changed both the blogging world and the corporate world forever, that long, sunny spring in the year 2007, which was so filled by internal newsletters, audio tapes, slide presentations and other gloriously revealing documents.

Are you a lawyer? AstraZeneca will hire you as sales director!

AstraZeneca is a company which is taking unprecedented action to discipline its Oncology sales force. Normally lawyers are overseeing what sales reps do. Now AstraZeneca is replacing the sales force with lawyers.

Mike Zubillaga, AstraZeneca's fired Oncology Regional Sales Director has been replaced by Rose Ann Scanlon.

Scanlon was promoted to Regional Sales Director for the Mid-Atlantic Business Center effective June 1.

Having been with AZ and its predecessor companies for 14 years, Scanlon most recently served as Senior Director, Promotional Regulatory Affairs (PRA). Prior to PRA, she serviced as Assistant General Counsel in the Legal Department for six years. During this time, she led a team which served many areas of the US and global businesses, including Oncology and CNS therapeutic areas. Prior to joining AZ, Rose Ann was an associate at a Philadelphia law firm.

Scanlon has a J. D. from Villanova and B.S. in Finance and Marketing from the University of Delaware. Scanlon and her husband enjoy spending time with their son and two daughters biking and playing in the sand at the shore.

Question Authority's Disco Hit: Harvey, the Moaning Sales Rep.

This is for those of you who have already enjoyed AstraZeneca's Arimidex sales training featuring "Harvey the sales rep," in my prior post, AztraZenca rep: "I'm not pouting."

I now have a SPECIAL TREAT from the AstraZeneca "Fab 7":

The "Here's Harvey" Disco Hit!

THIS IS A REMIX of the sigh that Harvey gives before his first question and his memorable comment "I'm not pouting,"

There are instant classics, such as, "I don't think you answered his question," "Uhhh," "Or whatever," "Blow it off," "Yes or no," "I'm not pouting," "I'm back," "Yadiyada," "Or whatever."

Enjoy the Harvey Remix disco hit here!

AztraZenca rep: "I'm not pouting."

Yeah, right.

Listen to new AstraZeneca oncology live training . . .

AstraZeneca makes sure reps don't talk about other drugs and things get a bit heated between the rep and the trainers.

Clearly this appears to be "new" to the sales force:

Rep Harvey: "Are we never ever going to answer another question about another drug, no matter how simple or whatever . . . are we just going to blow it off?"

Trainer: "That's correct."

Harvey is "not pouting" he says.

Please note the comment that "cross trial comparisons are completely inappropriate."

The tape gives the feeling that things are tense over at AstraZeneca and that the reps are mighty unhappy with the "new direction."

Click here to listen.

The Question Authority Spy Radio . . .

. . . is up and running.

With equipment such as this one we've managed to obtain highly confidential recordings from inside AstraZeneca.

Inspired by Pfizer CEO Jeff Kindler's spy network, our spies work for you all the time.

You can listen to the latest recording revealing AstraZeneca's secret reorganization plan here.

Hint: The plan involves replacing all sales people with lawyers. And I'm not kidding.

AstraZeneca puts lawyer in Regional Sales Director job!

Yesterday, National Oncology Sales Director Scarlett S. resigned from AstraZeneca. Today, according to an internal AstraZeneca source, the new National Sales Director Eric Vogel announced who would replace the recently fired Mike Zubillaga as Mid-Atlantic Regional Sales Director.

Her name is Rose Ann Scanlon, currently Senior Director of Regulatory and Promotional Affairs and formerly Assistant General Counsel for AstraZeneca.

She is referenced in this article.

AstraZeneca is known in the drug industry as a hard-selling organization. For them to put a lawyer without any sales experience in a sales director job is - I'm looking for a word here - befuddling.

It would appear AstraZeneca's internal problems are very serious indeed.

Don't miss these stories on Brandweek and Pharmalot!

Brandweek just posted some very interesting internal AstraZeneca documents. . . AZ Group of 7 Believe OIG Probe of Arimidex Marketing Is Stalled

And Pharmalot just published a must read post courtesy of the AstraZenca whistleblowers: The Nine Commandments Of Whistleblowing

You should definitely read both these posts!

Finally, Brandweek also published Hello, AZ Group of 7. Lawyers Would Like to Talk to You!

I have the response to that one from the AstraZeneca whistleblowers: Nope.

AstraZeneca's Scarlett S. waves goodbye.

As you may recall, after the AstraZeneca allegations revealed in April on Question Authority, Regional Oncology Sales Director Mike Zubillaga was terminated and his boss, National Sales Director Scarlett S. resigned. (Story here.)

In a Memorial Day voice message this weekend Scarlett informs her people of her successor, Eric Vogel: Listen here.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

AstraZeneca's Business Policies: More holes than a Swiss cheese.

We've had ZubeGate, CupGate and so on. Now it's time for AstraZeneca's BagGate.

Only BagGate isn't really about violating AstraZeneca's policy. It is about AstraZeneca's business policy itself.

The AstraZeneca policy says, "Often a corporate sponsorship includes an opportunity for the sponsor to place a goodwill or courtesy ad in a program book for the event/program being sponsored. When the contribution / sponsorship is to a 501(c)(3) non-profit organization, the advertisement placed in a program booklet (or other promotional materials for the organization/event) should be a GENERAL CORPORATE AD, WITH NO REFERENCE TO A SPECIFIC PRODUCT OR PRODUCTS."

So, when AstraZeneca sponsored a "Race for the Cure" breast cancer event in Philadelphia on Sunday, May 13th, 2007, oncology sales representatives didn't hand out brochures with branded ads, because that would have been forbidden.

Instead they handed out thousands of branded ARIMIDEX and FASLODEX tote bags to the 45,000 or so participants. The whole thing was televised on on CBS News.

Kirsten Evrair, Director, Brand Corporate Affairs, AstraZeneca Oncology released the following statement:

"I can confirm that tote bags were given away to attendees at Race for the Cure this past Sunday in Philadelphia. This activity did not violate AstraZeneca policy."

And Kirsten is absolutely correct.

An advertisement placed in a program booklet or other promotional materials cannot have a reference to a specific branded product, according to AstraZeneca policy.

But handing out thousands of tote bags with reference to branded products is perfectly OK.

You have to admit that it appears as if AstraZeneca sales people are running circles around the people who write AstraZeneca business policy manuals.

Or is it the people who are writing business policy manuals who are running circles around everyone else?

AstraZeneca: Policies made of Swiss cheese.

Former US AstraZeneca CEO Lars Bildman: Craziest Big Pharma CEO Ever?

Make up your own mind about Lars Bildman, AstraZeneca's former CEO in the U.S.

Read how current AstraZeneca reps remember him here.

And read about how he was fired after making sex clubs part of doing business at Astra, here.

Does AstraZeneca use of patient image violate HIPAA?

The AstraZeneca Oncology Newsletter "which keeps on giving" has a number of photos on the front page.

One of the images has the caption, "Below Left: Lynn Mariano-Hons, Onc 3, at a Breast Cancer Awareness Event."

The AstraZeneca "Fantastic 7" whistleblowers have provided a slightly altered photo (below), with crime tape, hiding the identity of the patient.

Because here's the potential problem with that photo:

If the second person is a patient, (and the metal pole to carry intravenous injections suggests this), then is this a violation of HIPAA law protecting patient privacy?

If the patient in the image signed a written release to have her image printed in AstraZeneca's newsletter, then AstraZeneca is free and clear.

Considering the many problems associated with this newsletter, I think we can all agree that if I bet a million bucks that AstraZeneca can't produce such a release, I'm likely to get rich very quick.

Not that AstraZeneca would take me up on that offer.

But, of course, if AstraZeneca presents such a release I will publicly apologize for my suspicious mind, stop blogging about AstraZeneca for a full week, and publish said media release instantly.

Stay tuned.

And even without HIPAA law, any person who appears in a picture in a commercial context should sign a media release, to protect the company from claims of "invasion of privacy."

It isn't likely the lady in the image knows this, so AstraZeneca should be just fine. Or should they?

Cruella Lustworthy and St. Cupcakes

Another amazing story by Pharma Giles who has returned to blogging.

St. Cupcakes, the internationally-renowned school for would-be pharmaceutical sales representatives, with senior schoolmistress, Ms. Cruella Lustworthy (pictured left).

You can learn all about this place over at Pharma Giles.

Click here to go there.