FDA: Pfizer Ignored Warnings, gets record fine. 2.3 billion (Where is the fine for aspartame being marketed as an additive when, in fact, its an addictive, genetically engineered, excitoneurotoxic carcinogenic drug that interacts with other drugs?)

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FDA: Pfizer ignored warnings, gets record fine

 

By Miriam Hill

 

INQUIRER STAFF WRITER

 

In 2005, the U.S. Food and Drug Administration warned Pfizer Inc.

that its ads touting the antibiotic Zyvox as superior to similar

drugs could endanger public health.

 

Pfizer's response?

 

It continued to tell doctors that Zyvox worked better than cheaper

generic competitors and that it was effective for various types of

infections, including those that occur after surgery, even though

there was no scientific evidence to support such use.

 

For a time, the company even promoted Zyvox for use against types of

bacteria against which the drug had little or no effect.

 

Those were among allegations unsealed today as Pfizer agreed to pay

$2.3 billion to the federal government for illegally promoting Zyvox,

the painkiller Bextra, epilepsy and nerve pain drug Lyrica, and the

antipsychotic Geodon.

 

The fine, which had been expected, was the largest ever paid by a

drug company for defrauding the government's Medicare and Medicaid programs.

 

The U.S. Justice Department said that it included the largest

criminal fine in U.S. history - $1.2 billion.

 

Authorities called Pfizer a repeat offender, noting this is the

fourth such settlement of government charges in the last decade. The

government said it would monitor the company's conduct for the next

five years to rein in the abuses.

 

Lawyers from the Philadelphia U.S. Attorney's Office were part of the

federal team that prosecuted the case. Six whistle-blowers, several

of them represented by area lawyers, will receive a combined $102

million for helping the government.

 

Harrisburg psychiatrist Stefan Kruszewski will get $29 million of

that total for his testimony. He said Pfizer sales representatives

pushed him to prescribe Geodon for such symptoms as anxiety and

agitation and for use in children. The FDA had approved Geodon only

to treat schizophrenia and bipolar disorder in adults.

 

" Pfizer targeted pediatrics and adolescents to expand off-label use

and maintained on its payroll an army of more than 250 child

psychiatrists nationwide, " said Plymouth Meeting lawyer Brian Kenney,

who, along with Tavy Deming, represented Kruszewski.

 

Pfizer said it denied the allegations that it promoted Geodon for

unapproved uses.

 

Lawyers Jim Pepper, Steve Sheller, and Brian McCormick of Sheller

P.C. in Center City, who represented Ronald Rainero, a Pfizer

employee who also blew the whistle, said the off-label promotions

helped push Zyvox sales to more than $1 billion.

 

" Ultimately, does off-label marketing work, " Pepper said. " The answer is yes. "

 

The government said the company promoted the four prescription drugs

for uses different from those approved by federal regulators.

 

Doctors often prescribe drugs for so-called " off-label " medical

conditions, but companies can market drugs only for uses approved by

the Food and Drug Administration.

 

Sheller said the government needed to tighten rules around off-label

prescriptions. While an off-label use is sometimes appropriate, he

said, it occurs too often and usually without patient knowledge.

 

" The public are guinea pigs, and we're not told, " Sheller said.

 

To promote the drugs, authorities said Pfizer invited doctors to

consultant meetings at resort locations, paying their expenses and

providing perks.

 

Neil Fishman, an infectious-diseases doctor at the Hospital of the

University of Pennsylvania, said many medical centers and schools,

including his, had cracked down on gifts and payments from drug

companies to doctors to try to lessen industry influence.

 

Fishman said Zyvox was the right drug in some situations, but he also

said Pfizer's marketing overstated the antibiotic's benefits and

underplayed potential problems.

 

" There are other drugs that can do the same job for less money, " he said.

 

FBI Assistant Director Kevin Perkins praised the whistle-blowers who

decided to " speak out against a corporate giant that was blatantly

violating the law and misleading the public through false marketing claims. "

 

Bextra, one of a class of painkillers known as COX-2 inhibitors, was

pulled from the U.S. market in 2005 amid mounting evidence it raised

the risk of heart attack, stroke, and death.

 

A Pfizer subsidiary, Pharmacia & Upjohn Inc., which was acquired in

2003, has entered an agreement to plead guilty to one count of felony

misbranding. The criminal case applied only to Bextra.

 

The $1 billion in civil penalties was related to Bextra and a number

of other medicines.

 

A portion of the penalties will be distributed to 49 states and the

District of Columbia, including $14 million to Pennsylvania and $13

million to New Jersey.

 

" We regret certain actions taken in the past, but are proud of the

action we've taken to strengthen our internal controls and pioneer

new procedures so that we not only comply with state and federal

laws, but also meet the high standards that patients, physicians, and

the public expect from a leading worldwide company dedicated to

healing and better health, " said Amy W. Schulman, senior vice

president and general counsel of Pfizer.

 

Pfizer said the agreement with the Justice Department resolved the

investigation into promotion of all those drugs, plus several related

whistle-blower lawsuits.

 

When Pfizer originally disclosed the settlement figure, it also

announced plans to acquire rival Wyeth for $68 billion. That deal,

which would bolster Pfizer's position as the world's top drugmaker by

revenue, is expected to close before year's end. Wyeth is based in

Madison, N.J., but employs several thousand people in Collegeville.

 

 

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Contact staff writer Miriam Hill at 215-854-5520 or

<http://www.philly.com/inquirer/breaking/business_breaking/hillmb@phillyn\

ews.com>hillmb.

 

 

This story contains information from the Associated Press.

 

 

 

 

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More information on aspartame, www.mpwhi.com, www.dorway.com and

www.wnho.net, Aspartame Toxicity Center, www.holisticmed.com/aspartame

 

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