ALLIANCE FOR HUMAN RESEARCH PROTECTION

A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org 

 

FYI

The level of corruption that the pharmaceutical industry engages in--with

assistance by prominent academic physicians who prostitute their academic

credentials for cash--is beyond compare in its impact on undermining public

health and depleting healthcare budgets.

 

The Justice Department announced that it has reached a settlement with

Pfizer, who agreed to pay $2.3 billion penalty to settle civil and criminal

charges for its illegal promotion practices related to the drugs, Bextra and

Lyrica (approved for pain), Geodon ( approved for schizophrenia and acute

manic depression in adults), and Zyvox (antibiotic to treat infection). It

is the largest fine ever levied for fraud in the Medicare and Medicaid

programs...

 

According to The New York Times, Obama administration officials - criticized

by Republicans on Capitol Hill for failing to crack down on fraud in the

government's health programs - sought to highlight the case by having Health

and Human Services Secretary Kathleen Sebelius make the announcement.

 

However, The New York Post reports, "In an unusual twist, the head of the

Justice Department, Attorney General Eric Holder, did not participate in the

record settlement, because he had represented Pfizer on these issues while

in private practice."

http://www.nypost.com/seven/09022009/news/nationalnews/pfizer_to_pay_record_

2_3b_penalty_for_dr_187785.htm

 

Pfizer, the world's largest drug manufacturer has the dubious distinction of

being a corporate "repeat offender"-- rogue pharmaceutical corporations

knowingly and deliberately put patients' lives at risk by violating federal

law prohibiting the marketing of prescription drugs for uses that have not

been tested and approved by the FDA.  

 

New York State Attorney General, Andrew Cuomo, said:

"Pfizer ripped off New Yorkers and taxpayers across the country to pad its

bottom line. Pfizer's corrupt practices went so far as sending physicians on

exotic junkets as well as wining and dining health care professionals to

persuade them to prescribe the company's drugs for patients in

taxpayer-funded programs."

 

According to the Geodon whistleblower suit filed by Dr. Stefan Kruszeuski,

and unsealed yesterday, Pfizer illegally promoted the sale and use of Geodon

for a variety of off-label conditions, including depression, bipolar

maintenance, mood disorder, anxiety, aggression, dementia, attention deficit

hyperactivity disorder, obsessive compulsive disorder, autism, posttraumatic

stress disorder, and for pediatric, adolescent and geriatric patients.

 

According to Dr. Kruszeuski's attorneys,  Kenney, Egan, McCafferty & Young,

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

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

nationwide." Kenney stated that, "Pfizer regularly paid generous speaking

fees to these child psychiatrists to give what were basically promotional

lectures about the benefits of Geodon to their peers, who were naturally

also child psychiatrists, despite the fact the drug is not FDA-approved or

medically indicated to treat children at all. The purpose and intent of

paying so many child psychiatrists is clear -- to gain a foothold within the

fastest growing market for antipsychotics -- children. The practice of

expansive off-label use is dangerous, particularly in children because the

drug has not been evaluated for its safety for the unique physiological make

up of children."

 

Furthermore, Pfizer's marketing campaign also urged doctors to switch

patients on other allegedly more dangerous atypical antipsychotics, such as

Zyprexa, Seroquel and Risperdal, to Geodon. According to Kenney, Pfizer's

switching campaign "endangered patients by ignoring or materially

understating Geodon's serious, and even life threatening, side effects.

Among Geodon's most dangerous side effects is its potential to affect the

heart's rhythm, a condition known as QT prolongation. If the QT interval is

increased excessively, conditions are created whereby unstable heart rhythms

can intercede and disrupt the normal, regular rhythm essential for heart

function." According to Kenney, "such ventricular rhythm disturbances

greatly increase the risk of sudden cardiac death."

 

Zyvox (linezolid) is an antibacterial agent that is approved by the FDA to

treat certain types of infections, including nosocomial pneumonia and

complicated skin and skin structure infections ("CSSSIs") due to Methicillin

Resistant Staphylococcus Aureus ("MRSA"). Worldwide sales of Zyvox totaled

$1.115 billion in 2008.

 

According to the Zyvox Qui Tam whistleblower complaint filed by the Sheller,

P.C. Law Firm, Pfizer ignored a 2005 FDA Warning Letter to stop promoting

its antibiotic ZyvoxR as clinically superior to the significantly less

expensive, generic vancomycin when its own FDA-approved label indicated

otherwise.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/E

nforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmac

euticalCompanies/ucm054813.pdf

The drug giant also defrauded federal and state taxpayers by marketing Zyvox

off-label.

 

The complaint charges: "The widespread off-label promotion of Zyvox by

Pfizer for non-FDA approved purposes poses a grave public risk because it

increases the risk that linezolid resistant eterococci will develop and also

increases the risk that more Zyvox resistant bacterial strains will

develop."

 

According to the company's annual reports, approximately $4.4 billion worth

of Pfizer's Zyvox was sold from 2000 to 2008. Explosive sales for the drug

increases averaged close to 200% per year. They also caused public health

concerns of drug resistance and immunity, according to court and public

documents.

 

Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion

charge to the company's earnings had been taken in the fourth quarter of

2008.

In other words, $2.3 billion in criminal penalties are inconsequential to

Pfizer--the penalties have already been absorbed by profits from its

criminal marketing practices.  Indeed, the company reported profits....!

 

When a company repeatedly engages in criminal actions, illegally promoting

FDA-licensed controlled substances for uses NOT licensed--it puts people's

lives at risk. 

The FDA has the legal authority to take decisive action so as to prevent

rogue companies, such as Pfizer, from continuing to sell drugs that the

company illegally promoted.   

 

What prevents the government from delicencing drug products that companies

criminally promoted for unapproved, unsafe uses?

 

Peter Rost, former Pfizer vice-president who blew the whistle on its illegal

marketing of the growth hormone, has the most complete dossier on Pfizer's

activities and legal settlements on his blog: http://peterrost.blogspot.com/

 

Of note: $102 million of the settlement money will be shared by six

corporate whistleblowers.

 

Under the False Claims Act, so-called "qui tam" whistleblower actions, a

term derived from English Common Law meaning "he who sues on behalf of the

king as well as himself," allow private citizens with knowledge of fraud to

help the Government recover ill-gotten gains and additional civil penalties.

The FCA allows the Government to collect up to three times the amount it was

defrauded, in addition to civil penalties between $5,500 and $11,000 per

false claim. Whistleblowers usually have received rewards representing 15 to

25 percent of qui tam recoveries...

 

Left out in the cold are the ultimate victims of Pfizer's criminal

activities: why is no one representing the individuals who suffered serious

ill effects from the illegally marketed unsafe drugs in the settlement

negotiations?

 

 

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

 

 

http://finance.yahoo.com/news/Pfizer-to-pay-record-23B-apf-1176280604.html?x

=0

Associated Press

Pfizer to pay record $2.3B penalty over promotions

By DEVLIN BARRETT

 

WASHINGTON - Pfizer Inc., the world's largest drug maker, will pay a record

$2.3 billion civil and criminal penalty over unlawful prescription drug

promotions.

 

Announcing the settlement Wednesday, the Justice Department said that it

included the largest criminal fine in U.S. history - $1.2 billion. The

agreement also included a criminal forfeiture of $105 million.

 

Authorities called Pfizer a repeat offender, noting it is the fourth such

settlement of government charges in the last decade. They said the

government will monitor the company's conduct for the next five years to

rein in the abuses.

 

To promote the drugs, authorities said Pfizer invited doctors to consultant

meetings at resort locations, paying their expenses and providing perks.

 

"They were entertained with golf, massages, and other activities," said Mike

Loucks, the U.S. attorney in Massachusetts.

 

Loucks said that even as Pfizer was negotiating deals on past misconduct,

they were continuing to violate the very same laws with other drugs.

 

Six corporate whisteblowers who first brought the misconduct to light will

share $102 million of the settlement money.

 

FBI Assistant Director Kevin Perkins praised the whistleblowers who decided

to "speak out against a corporate giant that was blatantly violating the law

and misleading the public through false marketing claims."

 

Associate Attorney General Thomas Perelli said the settlement illustrates

ways the department "can help the American public at a time when budgets are

tight and health care costs are rising."

 

The overall settlement is the largest ever paid by a drug company for

alleged violations of federal drug rules.

 

The government said the company promoted four prescription drugs, including

the pain killer Bextra, as treatments for medical conditions different than

those the drugs had been approved for by federal regulators.

 

Use of drugs for so-called "off-label" medical conditions is not uncommon,

but drug manufacturers are prohibited from marketing drugs for uses that

have not been approved by the Food and Drug Administration.

 

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 and 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 civil penalty will be distributed to 49

states and the District of Columbia, according to agreements with each

state's Medicaid program.

 

"These agreements bring final closure to significant legal matters and help

to enhance our focus on what we do best - discovering, developing and

delivering innovative medicines to treat patients dealing with some of the

world's most debilitating diseases," said Amy W. Schulman, senior vice

president and general counsel of Pfizer.

 

Justice officials discussed details of the deal at a news conference with

FBI, federal prosecutors, and Health and Human Services Department

officials.

 

In financial filings in January, the company had indicated that it would pay

$2.3 billion over allegations it had marketed the pain reliever Bextra and

possibly other drugs for medical conditions different than their approved

use. The civil settlement announced Wednesday also covered Pfizer's

promotions of three other drugs: blockbuster nerve pain and epilepsy

treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine

other medicines. Pfizer said the agreement with the Justice Department

resolves the investigation into promotion of all those drugs, plus several

related whistleblower lawsuits.

 

Under terms of the settlement, Pfizer must pay $1 billion to compensate

Medicaid, Medicare, and other federal health care programs. Some of that

money will be shared among the states: New York, for example, will receive

$66 million, according to the state's attorney general, Andrew Cuomo.

 

"Pfizer ripped off New Yorkers and taxpayers across the country to pad its

bottom line," Cuomo said. "Pfizer's corrupt practices went so far as sending

physicians on exotic junkets as well as wining and dining health care

professionals to persuade them to prescribe the company's drugs for patients

in taxpayer-funded programs."

 

Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion

charge to the company's earnings had been taken in the fourth quarter of

2008.

"No additional charge to the company's earnings will be recorded in

connection with this settlement," he said.

 

In her statement, Schulman said: "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."

 

"Corporate integrity is an absolute priority for Pfizer," she said, "and we

will continue to take appropriate actions to further enhance our compliance

practices and strengthen public trust in our company."

 

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 drug maker by revenue, is expected to

close before year's end.

 

Shares of Pfizer dropped 14 cents to $16.24 in midday trading.

____

AP Business Writer Linda A. Johnson in Trenton, N.J. contributed to this

report.

~~~~~~~~~~

 

NY Times

Pfizer Pays $2.3 Billion to Settle Marketing Case

By GARDINER HARRIS

 

WASHINGTON - Top aides in the Obama administration announced a $2.3 billion

settlement on Wednesday with the pharmaceutical giant Pfizer Inc. over the

company's illegal promotion of its now-withdrawn painkiller, Bextra.

 

It is the largest fine ever levied for fraud in the Medicare and Medicaid

programs, and Obama administration officials - criticized by Republicans on

Capitol Hill for failing to crack down on fraud in the government's health

programs - sought to highlight the case by having Health and Human Services

Secretary Kathleen Sebelius make the announcement. The agreement also

includes some promotional practices involving other Pfizer drugs - Zyvox,

Geodon and Lyrica.

 

The settlement had been expected. Pfizer, which is acquiring a rival Wyeth,

had reported in January that it had taken a $2.3 billion charge to resolve

claims involving Bextra and other drugs.

 

Marketing fraud cases against pharmaceutical companies have become almost

routine, with almost every major drug maker being accused of giving

kickbacks to doctors or shortchanging the Medicaid program on prices.

Prosecutors said that they have become so alarmed by the growing criminality

in the industry that they have begun hiking fines into the billions of

dollars and will soon start charging doctors individually as well.

 

Under the agreement with the Department of Justice, Pfizer will pay a $1.3

billion criminal penalty related to Bextra and $1 billion in civil fines

related to a number of medicines. In addition, a Pfizer subsidiary,

Pharmacia & Upjohn Company, will plead guilty to violating the Food, Drug,

and Cosmetic Act for its promotion of Bextra.

 

In January, prosecutors announced that they would fine Eli Lilly $1.4

billion for its illegal marketing efforts on behalf of Zyprexa, an

antipsychotic.

 

Although the fine amounts began to soar during the Bush administration, top

administration officials rarely touted the cases or appeared during news

conferences about them. The Zyprexa case was announced by federal

prosecutors in Philadelphia.

 

Ms. Sebelius's decision to make the Pfizer announcement in a news conference

in Washington suggests that the political environment for the pharmaceutical

industry has become more treacherous - despite the industry's commitment to

save the government $80 billion as part of efforts to change the health care

system.

 

In addition, Pfizer has reached agreements with attorneys general in 42

states and the District of Columbia to settle state claims related to its

promotional practices concerning Geodon. The company will pay $33 million to

the settling states and will take a charge in that amount to third-quarter

2009 earnings.

 

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