AIG of Drugmakers Pfizer Is Too Big to Be Guilty: Ann Woolner
Commentary by Ann Woolner
Sept. 4 (Bloomberg) -- Pfizer Inc. sales folks had one
tough customer in psychiatrist Stefan Kruszewski. He didn’t buy
their pitch to prescribe the anti-psychotic drug Geodon to
children, a use that hadn’t been approved by federal regulators.
Nor did he go for the so-called off-label uses they
suggested, such as treating dementia in the elderly.
Kruszewski didn’t just say no. He went and checked the
research and saw Geodon could have serious cardiac side effects
not mentioned by the salesmen, who boasted of its relative
safety, according to his lawyer, Brian Kenney. And he noticed
that Pfizer was paying his peers to promote the drug to other
psychiatrists.
But the worst for Pfizer was that Kruszewski didn’t keep it
to himself. He found a lawyer, Kenney, who specializes in
whistleblower cases, and they took what they had to the
government.
So did John Kopchinski, who sold Pfizer’s arthritis drug
Bextra but not as aggressively as the bosses wanted. They told
the sales force to pitch it for post-surgical pain, acute pain,
migraines and a host of other conditions for which the drug had
been rejected by the U.S. Food and Drug Administration, says
Kopchinski’s lawyer, Erika Kelton.
Nor would he advise doctors to boost the recommended dosage
to two, four, even eight times the amount approved, though other
salespeople did.
“The sales managers were having us do what was blatantly
illegal,” Kopchinski told the BBC. Those who did were rewarded
financially. He refused, was fired and spent the next six years
depleting his retirement funds.
Bextra Banned
Bextra, by the way, was yanked from the market in 2005
because it increased the risk of heart attacks and strokes.
Thousands of users have sued, and Pfizer settled.
Now Pfizer, while denying almost all of the charges, is
paying a record sum of $2.3 billion to settle criminal and civil
government allegations. The Justice Department says the company
marketed off-label uses for Bextra, Geodon, Zyvox and Lyrica and
paid kickbacks to doctors for pitching and prescribing those and
other drugs. We are talking everything from Aricept to Zyrtec.
“We regret certain actions taken in the past, but are
proud of the action we’ve taken to strengthen our internal
controls,” Amy W. Schulman, senior vice president and general
counsel of Pfizer said in a statement.
Value of Information
The Pfizer case shows the value of inside information, and
how federal law rewards those who provide it. For blowing the
whistle on the world’s largest drug company and, in some cases,
for putting their livelihoods at risk, the six Pfizer
whistleblowers are getting anywhere from $2.3 million to $51.5
million each, taken from the $2.3 billion settlement.
The salesman, Kopchinski of San Antonio gets the top
reward. Kruszewski, a Harvard-trained psychiatrist in
Harrisburg, Pennsylvania, is next with $29 million.
Federal and state medical programs will get a chunk of the
settlement to reimburse them for having made payments based on
false claims.
However hefty the settlement, Pfizer is fortunate to avoid
criminal prosecution. Given the scope of the alleged misconduct,
potential for harm to the public, mistreatment of employees who
insisted on following the law and its history as a repeat-
offender (excuse me, make that a repeat-settler), it got off
lightly.
Four times before the drug giant or its subsidiaries have
been slammed by the government for the same kind of conduct.
To resolve claims it promoted off-label uses of Neurontin,
an anti-seizure drug, Warner-Lambert, owned by Pfizer, paid $430
million in 2004, and Pfizer said it would institute a compliance
program.
Growth Hormone
Three years later, Pfizer’s Pharmacia & Upjohn Co.
divisions agreed to pay almost $35 million to settle charges
related to the human-growth hormone Genotropin. Among the
allegations was that the drug was being promoted as an anti-
aging treatment.
That same subsidiary has again pleaded guilty, this time as
part of the overall settlement with Pfizer for its promotion of
Bextra.
So how does Pfizer get away with civil settlements given
its history? The penalties have ranged from hand slaps to a
light punch in the gut, none of which have hurt the company
enough for things to change. Last year Pfizer earned $8.1
billion on sales of $48.3 billion.
The New York-based company repeatedly winds up as the
target of government accusations. Its misdeeds cost federal and
state programs hundreds of millions of dollars, says the Justice
Department, not to mention the human suffering that comes with
taking the wrong drug in the wrong dosage.
Just Like AIG
But Pfizer is the pharmaceutical equivalent of insurance
giant American International Group Inc., which was too
interwoven into the global economy to be allowed to fail.
Likewise, if Pfizer were convicted of a crime, it would face
debarment from federal programs. And that would mean that
Medicaid and Medicare patients would have to either somehow pay
pocket for vital medicines the company produces or go without.
“You have to balance the desire, an appropriate desire, to
punish the company against the harm to patients,” says attorney
Kelton.
Pfizer is again pledging to beefing up its compliance
program, and there is a way to make it credible.
This time, it should put Kruszewski and Kopchinski in
charge of it, assuming they still want to work.
(Ann Woolner is a Bloomberg News columnist. The opinions
expressed are her own.)
To contact the writer of this column:
Ann Woolner in Atlanta at
awoolner@bloomberg.net.
Last Updated: September 3, 2009 21:00 EDT