Sunday, December 30, 2007

Quote of the year.

PharmaFraud - December 29, 2007 7:14 PM

A Whistleblower's primary goal is to put a stop to the retaliation against him, and to ensure that the problem is corrected.

The reality though, is a company that retaliates against an employee in order to cover up fraud, will never admit wrong doing and will never admit to the fraud. The whistleblower is left with no reasonble option, but to file a qui tam.

I find it very unjust that a whistleblower cannot even begin to seek a remedy for the felonies committed against them until after the qui tam is unsealed.

I will tell you this; by the time a whistleblower has been forced to file a qui tam, the idea of receiveing justice has ceased to exist. And since the employer has made this an issue about money only, you can be damn sure that a whistleblower will squeeze every last penny they possibly can from such a sociopathic corporation.

Based on the consistent behavior of swift and relentless retaliation against anyone who blows the whistle, the best course of action after finding and reporting fraud to the employer one time, is to gather as much evidence as possible, and file a qui tam as soon as possible.

Quote found in response to the post Unsealed qui tam complaint against Pfizer is pressing forward on the Whistleblower Law Blog.

Saturday, December 29, 2007

Tuesday, December 25, 2007

What to do when you don't like your Christmas Porsche

Three Pfizer officials to be arrested.

A high court in Nigeria's northern Kano state has ordered the arrest of the boss of the Nigerian subsidiary of Pfizer International, Ngozi Edozien, and two other officials of the company, Larry Barry and Segun Duro, for failing to honour the court's summons, over the case of illegal administration of a meningitis drug on 200 children in the state in 1996, the local media reported Tuesday.

The presiding judge, Shehu Atiku said it is evident that three of the accused have actually been served with summons to appear before the court on November 6, 2007 but until this time none of them has appeared before the court either out of neglect or disrespect of court or contempt, he said before he issued the warrant of arrest and adjourned the case to January 29, 2008.

Issuing the warrant of arrest against the officials Monday, Justice Shehu Atiku ruled they were in contempt of the court.

The state government has filed a criminal suit against the international drugs company for causing the death of 11 children and various degrees of impairment to many others, by administering the unapproved drug, Trovan, on the kids during an outbreak of meningitis in the state in 1996.

The criminal case has been deadlocked over non- appearance of the accused without which the criminal proceedings cannot commence.

The judge was constrained from issuing arrest warrant to Pfizer International Incorporated by the motion its counsel Nelson Ezuegbu filed challenging the court’s jurisdiction.

“Pfizer International Incorporated having filed a motion challenging the jurisdiction of this court is exempted from the bench warrant”, Atiku said.

The prosecution accused the three accused of delaying proceedings by assigning a lawyer to sign the acceptance of the summons issued them and filing a suit against the policeman who served them before a Lagos state High Court challenging the Kano High Court’s jurisdiction and demanding for $5 billion damages for the alleged breach of their fundamental human rights.

In the criminal case, Kano state government had accused Pfizer of conspiracy, culpable homicide and causing grave harm to the victims of the alleged drug trial.

Hearing in the case, which has attracted international attention, has been adjourned till 29 January 2008.


Sunday, December 23, 2007

Offensive Christmas Carols List

A booklet containing a list titled 'Christmas Carols for the Mentally Disturbed' named psychiatric conditions and suggests festive songs which would suit the illness.

It was created for users of mental health services and was produced by users of Cromwell House in Cromwell Road, Eccles, which is staffed by Salford council care workers and others employed by the Bolton Salford and Trafford Mental Health NHS Trust.

The publishers have now withdrawn the magazine, Marooned, to remove the offending article.

The list was:

1. Schizophrenia - Do You Hear What I Hear?

2. Multiple Personality Disorder - We Three Kings Disoriented Are.

3. Dementia - I Think I'll be Home For Christmas.

4. Narcissistic - Hark The Herald Angels Sing About Me.

5. Manic - Deck The Halls And Walls And House And Lawn And Stores And Office And Town And Cars And Buses And Trucks And Trees And...

6. Paranoid - Santa Clause Is Coming To Town To Get Me.

7. Borderline Personality Disorder - Thoughts Of Roasting On An Open Fire.

8. Personality Disorder - You Better Watch Out, I'm Gonna Cry, I'm Gonna Pout, Maybe I'll Tell You Why.

9. Attention Deficit Disorder - Silent Night, Holy Oooh Look At The Froggy, Can I Have A Chocolate, Why Is France So Far Away.

10. Obessive Complusive Disorder - Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells, Jingle Bells,.


The best movie of 2007

I watched "The lives of others" yesterday. 2 hours 18 minutes. Riveting. I stayed up until 1:30 AM to finish the movie. Do not miss this captivating film!

Oh, by the way, it got an Oscar for best foreign language film. Don't hold that against it.

Friday, December 21, 2007

Pfizer Regional Sales Director Blooper . . .

Transcription of Voicemail #1: (meant to be only sent to management colleagues)

“Good morning management team, this is Xxxxx. First of all I want to thank you all for getting your Capabilities ratings for your representatives by this past Sunday, the 16th. What this has allowed is for me to, uh, see a performance differentiation worksheet based on Capability ratings by position. As you know, you were all asked to differentiate by performance with your representatives, ah, this year. And, um, what we’re looking for in the greater organization is the bell curve that, uh, gives us, uh, approximately a 20%, um, allocation of representatives that are at a, uh, high, performance category, that would be 3.6 and higher.

“Uh, the majority in that middle category, around, uh, 65 to 70%, and then the low category, below a 2.5 rating, ah, somewhere in the range of, uh, about 10% or so. Unfortunately, when I look at performance differentiation, we’re a little bit skewed here. We have 60% of our representatives, of our TSRs, are rated at 3.6 or higher. 35% of them are rated at a 2.6 or higher and only 5% are at a below expectations or lower, at 2.5 or lower.

“Obviously, when we all get together, in about a week and a half here, after the holidays, to talk about performance differentiation, our one-on-ones about each of your districts, ah, I’m going to be looking to many of you, ah, to reassign some ratings for your representatives. I’m not so concerned about the low side, the 2.5 or below, but we do ABSOLUTELY need to differentiate our true high performers from our middle performers. So I’m looking more to flip these averages around from high to low. So, please be prepared, and if you have any questions, please give me a call.

Transcript of Voicemail #2: (intentionally sent to all sales colleagues)

“Good afternoon this is >>>>>>> and this message is going out to the entire >>>>>region sales team. This morning I sent out a voicemail message that was intended for the district managers, but I inadvertently copied each and every one of you. I want to let you know that the contents of that message are OK for each and every one of you to listen to. Ah, frankly, it’s the end of the year, when we are all very involved with the year end assessments on the management team. And with those year end assessments, it is important that we differentiate the performance of each and every one of you in your individual territories. And we need to clearly differentiate our top performers from our middle performers. And our middle performers from our bottom performers. And that was the intent of that message. Your district managers and I will be having meetings the first week of January where we will be discussing each and every one of you based on a capability review and a sales review to ascertain how you are rated and differentiated and put into our performance management system for 2008 regarding your performance in 2007.
This is not unlike any process that we’ve gone through in the past 4 years that we’ve been with the Pfizer corporation. If any of you have any questions..."

Source: Cafe Pharma

It is tough when people are better than what the consultants with the bell curve tells you they should be . . . so when reality doesn't fit the theory, adapt reality.

"The 2007 Golden Clipboard Awards"

The 2007 Golden Clipboard Awards is something DrugWonks came up with . . . I guess one person's hero is another person's villain, here are the uncensored but abbreviated views of Peter Pitts:

The Bronze Clipboard: Representative Henry Waxman

A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority” trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.

The Silver Clipboard: Dr. Steven Nissen

Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.” A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.” What’s the frequency, Steve?

2007 Golden Clipboard Winner: Dr. David Graham

David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.” Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides.

Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.

Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,” he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.

For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.

More Lipitor trouble for Pfizer . . . does Lipitor really save lives?

Yesterday the WSJ reported about the most recent qui tam suit against Pfizer, and now there are people who claim . . . Lipitor doesn't save lives.

Hagens Berman Sobol Shapiro yesterday filed a third amended complaint in the Polansky v. Pfizer case. The amended complaint provides more detail and additional clarity about the allegations that Pfizer used an orchestrated campaign to increase the of off-label use of Lipitor. To view the complaint, click here.

The lawsuit claims Pfizer illegally boosted sales of its most successful drug, Lipitor, through a scheme designed to convince physicians to prescribe the drug for non-approved uses through ‘education programs.’

The plaintiff, who once served as the company’s director of outcome management studies, was fired after he claims he called into question the companies marketing tactics. The lawsuit alleges Pfizer produced and distributed material for off-label uses, without FDA approval, in an effort to expand its market and profits.

Among the list of alleged violations includes hosting continuing medical education events for physicians, including dinner and valet service, which essentially served as a sales pitch for alternate uses of the drug.

The suit alleges these educational programs deliberately misrepresented the drug's label to encourage Lipitor therapy for people in the moderate-risk category who didn't need the drug. To date Lipitor is the most successful prescription drug worldwide with sales last year of $13.6 billion. To view a recent article in the Wall Street Journal about the lawsuit click here.

But there's more, a new web site claims Lipitor doesn't save lives, especially not among women, and uses graphs such as these ones to prove its point:

Swedish seaman song about Christmas away from home . . .

Just to get you in the right mood:

En politiskt korrekt jul i New York

Lead article over at the Swedish business daily I write for . . . "A politically correct Christmas in New York," or, En politiskt korrekt jul i New York.

Happy Holidays . . . or Merry Christmas?

Let the fight begin!

Thursday, December 20, 2007

Pfizer's new product line: Whistleblowers

The Wall Street Journal
Pfizer Is Sued Over Lipitor Marketing
December 20, 2007; Page B5

A former Pfizer Inc. official in a lawsuit accused the company of illegally boosting sales of its top-selling drug Lipitor through an elaborate campaign of misleading educational programs for doctors.

Jesse Polansky, claims that the educational campaign was a key part of a marketing strategy that "led thousands of physicians to prescribe Lipitor for millions of patients who did not need medication" and could be harmed by overly aggressive treatment.

The lawsuit was filed in U.S. District Court for the Eastern District of New York in February 2004. It was immediately sealed to allow federal prosecutors time to decide if they wanted to intervene in the case. In August, the government said it wouldn't intervene, lifting the seal. Pfizer was served a copy of the suit yesterday, according to Dr. Polansky's lawyer, Steve Berman of Hagens Berman Sobol Shapiro.

The failure of the government to intervene may signal that prosecutors are skeptical about the merits of the case. The government hasn't intervened in other cases which led to huge fines against drug companies. One example is another case involving Pfizer, this one for the off-label marketing of Neurontin.

Pfizer said, "We believe this case has no merit. Furthermore, after reviewing the allegations in this complaint, the government declined to intervene in this action... . Pfizer does not condone the off-label promotion of our products. We believe that our sales and marketing practices are solely based on our prescription information as approved by the U.S. Food and Drug Administration."

Dr. Polansky was Pfizer's director of outcomes management strategies from 2001 to 2003, and his responsibilities included reviewing some of the marketing materials for Lipitor and other Pifzer products. He says he was fired by Pfizer after complaining about marketing he considered to be improper. Dr. Polansky now works as the senior medical officer for Medicare in a unit that investigates fraud and abuse at the big government health insurer.

The suit seeks compensation for Dr. Polansky as a whistleblower under laws that could give him a share of money recovered for any overpayments made by federal health-insurance programs.

Lipitor, a type of cholesterol treatment known as a statin, is the world's biggest-selling drug , with sales of $13.6 billion last year, according to IMS Health.

The allegations against Pfizer echo concern elsewhere that continuing medical-education programs for doctors are often sales pitches for "off-label" uses of drugs. A congressional committee this past summer said it was concerned there was little oversight of these programs -- where doctors are often wined and dined -- or enforcement when companies use them as marketing tools.

Pharmaceutical companies are prohibited from marketing drugs for indications other than what the FDA approves them for, although doctors aren't prohibited from prescribing them for unapproved uses. Independent educational programs can discuss off-label uses that aren't FDA approved. But Dr. Polansky's lawsuit charges that the Pfizer-funded programs weren't independent.

The Lipitor educational programs were run by companies paid by Pfizer through "unrestricted educational grants," the lawsuit says. It alleges that the educational programs were integrated into the marketing plan for the drug, citing an internal Pfizer marketing plan for Lipitor with a page titled "Medical Education Platform Supports the New Positioning."

Among other things, Dr. Polansky says Pfizer wanted to extend Lipitor use beyond the indications found on the drug's label by targeting people at moderate risk of developing heart disease or having a heart attack. He said the educational programs for doctors deliberately misrepresented the drug's label to encourage Lipitor therapy for people in the moderate-risk category who didn't need the drug.

In his suit, Dr. Polansky also said the Pfizer programs included deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins. While kidney disease is recognized by some doctors as a risk for heart disease, it isn't part of the federal guidelines that factor into Lipitor's approved use.

The Christmas Tree Jumper

He was arrested and expelled.

Have a beatbox Christmas . . .

Wednesday, December 19, 2007

12 Days of Christmas - Indian Version

Purse snatcher gets whiplash.

Harvard Business Review wants me to review them . . .

And, who could resist such an invitation? After all, I do have a certain respect for HBR.

Harvard Business Review has apparently just published some new research about segmenting consumers in the health care industry. Consultants Caroline Calkins and John Sviokla surveyed 570 people about their attitudes toward staying healthy, their financial needs, and their financial confidence. Their research revealed four distinct types of health care consumer, each with different desires and needs that fall along personal health and wealth lines.

Getting an unfit and happy consumer—one who is overconfident about their health and distrustful of providers—to pay for a service requires a different approach than one who is healthy, wealthy, and wise—very health conscious and financially confident. Health/wealth segmentation helps providers, insurers and employers engage with customers much more effectively.

The article is free online here; I didn't dare copy any segements, because before I got to the actual article it said "All content that appears in HBR Online, whether text or graphics, is copyrighted by Harvard Business School Publishing and, beyond the limits above, may not be reproduced, published or distributed, in whole or part, online or offline, without the express written permission of Harvard Business School Publishing."

Images from 2007

Feature Photo 1st Place. John Moore, Getty Images. Mary McHugh mourns her slain fiance, Sgt. James Regan, a US Army Ranger killed in Iraq, at Arlington National Cemetery May 27, 2007. Mary

Spot News 1st place. Adem Hadei, Associated Press. A woman takes her dead son into her arms, as she grieves for her six-year-old son, Dhiya Thamer, who was killed when their family car came under fire by unknown gunmen in Baqouba, capital of Iraq's Diyala province, 60 kilometers (35 miles) northeast of Baghdad, Iraq, on Sunday, Sept. 16, 2007. The boy's ten-year old brother, Qusay, was injured in the attack as the family returned from enrolling the children in school, where Dhiya was to begin his first year. "Last Touch"

General News 3rd Place Jenn Ackerman, Ohio University. Jasmine Sodergren dangles from the arms of her husband, Tim Sodergren, in the couple's first greeting after his 15-month deployment in Afghanistan. An Uplifting Homecoming

Tuesday, December 18, 2007

Pharmaceutical litigation consultant ranking moves higher.

Search for pharmaceutical litigation consultant:

Search for pharmaceutical marketing witness:

Search for pharmaceutical marketing expert:

Search for pharmaceutical expert witness:

Australian Medical Association calls for ban on circumcision in infant boys.

In a press release, Paul Mason, Children's Commissioner, says non-medical circumcision is a breach of human rights. And the AMA's President, Haydn Walters, says they would support a ban on the practice, except where there are medical or religious reasons. He says there is only rarely a medical need to carry out the procedure.

"There were quite a lot of folk myths around the advantages of circumcision. They've almost all been debunked," Prof Walters said.

"There are some minimal advantages in some circumstances, particularly in some infectious diseases, but they're overwhelmingly balanced by disadvantages in other areas," he added.

For those interested in un-circumcision, there are new tools, among them the TLC Tugger. (Warning, explicit images of foreskin regrowth.)

And, since this post is getting some serious traffic, no, I'm not trying to sell the "Tugger" and simply thought the whole thing was hilarious.

In fact, there are quite a few products in this growing area . . . is another one.

You tape whatever is left onto the steel thingy, then pull.

They sell their stainless steel contraption with the following words:

"When a man is circumcised, he loses the protection that is essential to protecting the nerves on the head of the penis. The surface of the glans penis is not skin but a thin mucus membrane. When exposed to constant friction and abrasion to clothing or the harshness of drying from the air, it loses sensitivity because the glans develops a layer of protective tissue to make up for the lack of foreskin."

"Restoring the foreskin will help you regain that lost sensitivity, making sex more enjoyable and making the experience highly sensual. Uncircumcised men enjoy more sensitivity at the head of the penis because their nerves are kept fresh and protected in a warm and moist environment. They also report having more comfortable erections because of the extra shaft skin that is built when the foreskin retracts."

Quote of the day: "It's never, ever right to change the primary endpoint of a study, especially after all the data are in"

You guessed it right . . . we're talking about the study that is infamous before it's even been presented.

The lead researcher of this long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.

Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug. The study, called Enhance, tested 720 people to determine whether a combination of Schering-Plough's Zetia and Merck's now off-patent cholesterol fighter Zocor works better than Zocor alone.

The WSJ has the story.

Monday, December 17, 2007

Welcome to the whistleblower club, Dr. Kessler.

David Kessler, former FDA chief, was kicked out from his half-a-million-dollar job as dean of the University of California at San Francisco’s medical school, after pointing out - repeatedly - that a university fund had $100 million less than he was told it would have when he joined the school.

Full story in Los Angeles Times.

Welcome to the club, Dr. Kessler.

Parenting - It's not that hard.

Wednesday, December 12, 2007

Is Europe a country?

Gotta love American education.

A Former Lilly Insider Blows the Whistle on Criminal Activity in Sweden

John Mack has written a story about a new Swedish pharma whistleblower: Lilly, Sweden, Bribes and Conspiracy Theories

This is must read. Also, you can listen to John's interview of John Virapen on December 20:

Side Effects: Death
A Former Lilly Insider Blows the Whistle on Criminal Activity in Sweden

Guest: John Virapen, an ex-Eli-Lilly-executive and author of the book "Side Effect: Death" (published in Sweden and Germany)

Live Podcast Date: Thursday, 20 December 2007, 10 AM Eastern US time

Duration: Approx. 30 minutes

Go to the Pharma Marketing Talk Channel Page to listen live to the podcast on the Web with your browser. You will also be able to participate in an online chat with the host and speaker to ask questions!

LOOK - a movie made entirely of surveillance tapes . . .


1) At lunch time, sit in your parked car w/sunglasses on and point a hair dryer at passing cars. See if they slow down.

2) Page yourself over the intercom. Don't disguise your voice.

3) Insist that your email address is: or

4) Every time someone asks you to do something, ask if they want fries with that.

5) Encourage your colleagues to join you in a little synchronized chair dancing.

6) Put your garbage can on your desk and label it "IN."

7) Develop an unnatural fear of staplers.

8) Put decaf in the coffee maker for 3 weeks. Once everyone has gotten over their caffeine addictions, switch to espresso.

9) In the memo field of all your checks, write 'for sexual favors.'

10) Reply to everything someone says with, "That's what you think."

11) Finish all your sentences with "In accordance with the prophecy."

12) Adjust the tint on your monitor so that the brightness level lights up the entire work area. Insist to others that you like it that way.

13) Dont use any punctuation

14) As often as possible, skip rather than walk.

15) Ask people what sex they are. Laugh hysterically after they answer.

16) Specify that your drive-through order is "to go."

17) Sing along at the opera.

18) Go to a poetry recital and ask why the poems don't rhyme.

19) Find out where your boss shops and buy exactly the same outfits. Wear them one day after your boss does. (This is especially effective if your boss is of the opposite gender.)

20) Send e-mail to the rest of the company to tell them what you're doing. For example, "If anyone needs me, I'll be in the bathroom, in Stall #3."

21) Put mosquito netting around your cubicle. Play a tape of jungle sounds all day.

22) Five days in advance, tell your friends you can't attend their party because you're not in the mood.

23) Call 911 and ask if 911 is for emergencies.

24) Call the psychic hotline and don't say anything.

25) Have your co-workers address you by your wrestling name, Rock Hard Kim.

26) When the money comes out of the ATM, scream "I Won!", "I Won!" "3rd time this week!!!"

27) When leaving the zoo, start running towards the parking lot, yelling "Run for your lives, they're loose!"

28) Tell your boss, "It's not the voices in my head that bother me, its the voices in your head that do."

29) Tell your children over dinner. "Due to the economy, we are going to have to let one of you go."

30) Every time you see a broom, yell "Honey, your mother is here!"

Monday, December 10, 2007

Big Mouth Syndrome

Pill Art

Andy Diaz Hope uses digital photographs and reassembles the original image in a mosaic of gelatin pill capsules, each containing small portions from the original prints.


Friday, December 07, 2007