Oldspeak:”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. Profit is Paramount.”
From Martha Rosenberg @ Alter Net:
The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.
But 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.
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 (And knowing its Rezulin had been withdrawn.)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?