Pfizer Gets Off Easy with $2.3 Billion Fine

Speaking of pharma-sluts, AHRP has weighed in on the $2.3 billion settlement against Pfizer. The story isn’t that Pfizer did something wrong but that the Justice Department finally stopped behaving like the SEC:

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."

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. 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.

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? (More here)