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
distinguished by an unrivaled series of corruption allegations.
In fact, 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withdrawn.)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 in-house.
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,� said 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 10 years on the leukemia drug Mylotarg, which was
given an accelerated approval, and allow
people to take it as guinea pigs for 10 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!
Nor does it hurt that
CEO Jeffrey B. Kindler was elected a director of the Federal Reserve Bank of
New York in 2009 and board chairman of the lobbying group PhRMA in 2010.
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 is a Chicago
columnist/cartoonist who writes about public health. She may be reached at martharosenberg@sbcglobal.net.