Pfizer Is Sued Over Lipitor Marketing
By DAVID ARMSTRONG
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.

Write to David Armstrong at david.armstrong@wsj.com