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Feds found Pfizer too big to nail
04-18-2010, 07:56 PM,
Feds found Pfizer too big to nail
Quote:CNN's Special Investigations Unit reveals internal company documents on Bextra and Pfizer's health care fraud. Watch at 3 p.m. ET Saturday on CNN.

(CNN) -- Imagine being charged with a crime, but an imaginary friend takes the rap for you.

That is essentially what happened when Pfizer, the world's largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.

When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. "It sends a clear message" to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI's Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It's a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Big plans for Bextra

The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.

Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.

Doctors as pitchmen

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.

But an internal marketing plan called for training physicians "to serve as public relations spokespeople."

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, "They pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."

Pfizer's chief compliance officer, Doug Lanker, said that "in a large sales force, successful sales techniques spread quickly," but that top Pfizer executives were not aware of the "significant mis-promotion issue with Bextra" until federal prosecutors began to show them the evidence.

By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.

Too big to nail

But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

"We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients," said Lewis Morris of the Department of Health and Human Services.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns © Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

An imaginary friend

Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer's imaginary friend stepping up to take the rap.

"It is true that if a company is created to take a criminal plea, but it's just a shell, the impact of an exclusion is minimal or nonexistent," Morris said.

Prosecutors say there was no viable alternative.

"If we prosecute Pfizer, they get excluded," said Mike Loucks, the federal prosecutor who oversaw the investigation. "A lot of the people who work for the company who haven't engaged in criminal activity would get hurt."

Did the punishment fit the crime? Pfizer says yes.

It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits -- although it denied wrongdoing -- on allegations that it illegally promoted 12 other drugs.

In all, Pfizer lost the equivalent of three months' profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. "I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one," said Doug Lankler, Pfizer's chief compliance officer.

To prevent it from happening again, Pfizer has set up what it calls "leading-edge" systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.

It's not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.

Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug companies, even Loucks, isn't sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.

"I worry that the money is so great," he said, that dealing with the Department of Justice may be "just of a cost of doing business."
The revolution is not an apple that falls when it is ripe. You have to make it fall. - Che Guevara

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04-19-2010, 10:49 AM,
RE: Feds found Pfizer too big to nail
Pfizer (Johnson & Johnson) is one of the top ten evil corporations IMO.

Pfizer Sued for Using Nigerian Children as Drug Test Guinea Pigs

Strange History of Pfizer Pill: Rogue CIA Agent, Suicide, $$

Record Pfizer $2.3-billion fraud settlement, windfall payout to states for Fraudulent Drug Marketing

Zombie Pfizer Computers Spew Viagra Spam

I say nail them hard and multiple times -- have a conscience America demand accountability.
There are no others, there is only us.
07-11-2010, 08:12 AM,
RE: Feds found Pfizer too big to nail
Quote:Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You
To say that Pfizer has been accused of wrongdoing is like saying BP had an oil spill.
July 10, 2010

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

ut the "world's largest research-based pharmaceutical company" which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer's been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson's disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Worse, it bought Warner-Lambert in 2000, which made Neurontin, knowing the drug's marketing practices were under criminal investigation. (And knowing its Rezulin had been withdrawn.)

And even as it entered into its 2004 CIA for Neurontin, it was off-label marketing the seizure drug Lyrica, called Son of Neurontin, and three other meds, and had to enter into a third CIA, last year's $2.3 billion Bextra settlement which was the largest health care fraud settlement in US history.

The same day the settlement news broke, Pfizer announced it bought the drug giant Wyeth despite its thicket of Fen-Phen heart valve suits and Prempro cancer suits.

And there was more "bring 'em on" chutzpah.

After Vioxx and Pfizer's Bextra were withdrawn from the market for cardiovascular risks, Pfizer sought FDA approval for its Celebrex, the last legal COX-2 inhibitor, also suspected of cardiovascular risks, for use in children as young as two.

And in June, days before Pfizer suspended development of the osteoarthritis drug tanezumab for worsening joints, it touted the drug as "well-tolerated."

As a company, Pfizer, based in New York City with research headquarters in Groton, CT, looks better from the outside than the inside. Its Pac-Man like acquisition of drug companies, Warner-Lambert, Pharmacia (Searle, Upjohn), SUGEN, Vicuron, Rinat and Wyeth (also creating the world's biggest animal drug company) has created a silo structure in which the company's 90,000 employees in 90 countries feel unconnected to a corporate heartbeat. Loyalty is rare as employees in absorbed companies bought for their products alone fear getting pfired and 14,000 scientists bemoan that the company's biggies like Lipitor, Celebrex, Neurontin, Zithromax, Zyrtec and now Wyeth's Prempro weren't created inhouse.

Despite flying doctors to Caribbean resorts to attend drug pitches (by other paid doctors) and bestowing four figure honorariums on them, and Enron moments like a Bextra sales extravaganza with acrobats, dancers and gigantic "fist" logo, Pfizer's Midtown Manhattan offices consist of unimpressive cubes.

After becoming the world's biggest drug company in 2000, Henry A. McKinnell, former Pfizer CEO and a Bushmate (replaced by less conservative Jeffrey B. Kindler) vowed to make Pfizer the "the world's most valued company to patients, to customers, to business partners, to colleagues, and to communities where we work and live." But thanks to the parade of damaging safety and ethics scandals, Esprit de corps is lacking except in some sales units.

"Pfizer is a black hole," Peter Rost, MD, author of The Whistleblower: Confessions of a Healthcare Hitman and probably Pfizer's most famous former employee told AlterNet. "It is nothing but a maze of cobbled together drug companies that aggressively markets drugs it didn't create in a military-like command structure."

Still, Pfizer's vast product line, its $50 billion a year revenues -- exceeding some states' entire budgets -- and reputation for having the best trained sales reps make it the team to beat for competing salesmen and examples of Pfizer envy dot Cafepharma, the drug industry chatroom considered pharma's washroom wall.

"Glad they did it," wrote a poster about last year's Department of Justice (DOJ) Bextra settlement. "Pfizer is only sticking it to the American person when they perpitrate a fruad (sic) of this magnitude. The rest of you who sat by and said nothing are no better than a bunch of crooks. My father always said, 'you lie, you cheat, you steal; you can't do one without doing them all'. You must be so proud...I would take that name badge off when I walk into an office if I were you."

"If you think that Pfizer is the only drug company that has dealt with off-label promotion issues you are sadley (sic) mistaken," perpitrated the next poster.

"You are so right. All the other companies are doing it, so we did too. Waaah, waaah, waaaaah! (stomping my foot). It's not fair! It made us so much money! Patients don't matter, money does," wrote the next poster. Characterizations about wives and mothers followed.

Patients also resent Pfizer and have sued over Chantix, Lipitor, Celebrex, Bextra, Neurontin, Lyrica, Viagra, Zoloft and other drugs. Pfizer downplayed Lipitor's "serious and irreversible side effects" says Mark Jay Krum, an attorney representing plaintiffs in a class-action suit, and "is willing to promote the drug at any cost." Say that.

Even the DOJ calls Pfizer incorrigible. "...illegal conduct was pervasive throughout the company and stemmed from messages created at high levels within the national marketing team," it wrote in the Bextra sentencing memo. "Employees, including district managers, explained that they did not question their supervisors about the illegal conduct that they were being instructed to carry out, because to do so would be considered a 'CLM' or 'Career Limiting Move.'"

Still the FDA needs to take some blame for waving iffy Pfizer drugs through, especially under the 1992 Prescription Drug User Fee Act (PDUFA) in which drug companies "buy" accelerated approvals.

Why did the FDA allow Pfizer to make money for ten years on the leukemia drug Mylotarg, which was given an accelerated approval, and allow people to take it as guinea pigs for ten years while "confirmatory" studies establishing its safety and efficacy were still outstanding? Patients who took Mylotarg while on chemotherapy had more deaths than those just on chemotherapy in a clear example of the lethal metrics of rushed through drugs.

Why was Pfizer's pain drug tanezumab, an injected monoclonal antibody made from bio-engineered immune cells, even considered for knee pain except for the profits in such Frakendrugs?

Why was Pfizer allowed to continue clinical trials on children, or anyone, after the FDA found Geodon overdoses in April -- and why is Geodon, rejected once by the FDA and promoted by Richard Borison MD who is in Hancock State Prison for research fraud -- hello -- on the market? Obama appointees Commissioner Margaret Hamburg, MD and principal deputy commissioner Joshua Sharfstein, MD come from public health backgrounds but it will be hard to turn the FDA ship around.

And speaking of dangerous drugs, what's up with Pfizer's anti-smoking drug Chantix?

In 2007, Texas musician Carter Albrecht, who played with Sorta and Edie Brickell & New Bohemians, became a poster boy for Chantix' unpredictable mental effects when he was fatally shot trying to kick in a neighbor's door. In 2008, with 988 adverse effects reported including seizures, heart trouble and suicides, the FDA banned airline pilots and air traffic controllers from taking it. Thanks for that. Last year it gave Chantix a black box warning to "highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs."

Most pharma watchers agree that financial penalties, including last year's $2.3 billion Bextra settlement, won't upend Pfizer whose one year budget for R & D alone is in the billions. Yet the DOJ repeatedly lets Pfizer pawn off guilty pleas to the False Claims Act (which include a ban on Medicare, Medicaid and VA eligibility) on its shell companies and keep doing business with the government. Why?

"Pfizer is the largest drug company in the world and if you include its generics unit it makes literally hundreds of different drugs. Getting tough would mean no Lipitor, no Viagra, no Bacitracin, no Cipro, no Zithromax, no Sutent, et cetera," says Jim Edwards, a pharmaceutical reporter on Bnet and former managing editor of Adweek. "The government is not really in a position to be cutting itself off from all that medicine."

"So many Medicaid, Medicare and VA drugs come from Pfizer, the government would never convict them," agrees Peter Rost. "It would stop the drug flow."

And then there's lobby power.

Just as former Louisiana Republican representative Billy Tauzin left the House Committee on Energy and Commerce which oversees the drug industry and resurfaced as head of PhRMA, Pfizer recently hired Gregory Simon who served on Obama's transition team and as chief domestic policy advisor to Vice President Gore to head its "global policy effort." Its senior corporate counsel until 2008, Arnold Friede, had an FDA background and Pfizer's former senior vice president for worldwide public affairs, Richard Bagger, has re-emerged as New Jersey Governor Christopher Christie's chief of staff. Hey, you guys look familiar!

Even the Bextra settlement arouses cynicism since $102 million of it went to a doctor and five former Pfizer reps who served as whistleblowers on the case, one getting $51 million.

Isn't making big money off pharma how the trouble started?

Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.
© 2010 Independent Media Institute. All rights reserved.

Other threads on Pfizer's Nigerian massacre:

Pfizer to pay £50m after deaths of Nigerian children in drug trial experiment

Pfizer Used 200 Nigerian Infants & Children As Test Subjects
There are no others, there is only us.
07-11-2010, 02:35 PM, (This post was last modified: 07-11-2010, 02:35 PM by h3rm35.)
RE: Feds found Pfizer too big to nail
PhUCKing PhARMA's at it again... go PhIGURE. Pfizer's also one of the worlds leading manufacturers of vaccines.
[Image: conspiracy_theory.jpg]

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