PFIZER: El que la hace (BEXTRA y...) la paga. No es "lírica" sino "la mayor de todas las multas", puro y duro..."

El gigante farmacéutico Pfizer ha llegado a un acuerdo con el Gobierno de EE UU para pagar una cifra récord de 2.300 millones de dólares (unos 1.617 millones de euros) para resolver los cargos civiles y criminales que pesaban contra la empresa por la promoción ilegal de cuatro de sus medicamentos. Es la mayor multa de la historia por un caso similar y supera los 1.420 millones pagados por Eli Lilly and Co por la promoción ilegal de uno de sus productos contra la esquizofrenia. (Ver...)

El acuerdo incluyó 1.300 millones de dólares por cargos criminales sobre formas de venta del antiartrítico ya retirado del mercado en el 2005, Bextra (Valdecoxib), como así también 1.000 millones de dólares por cargos civiles respecto a promoción por fuera de prospecto, y no autorizados por la FDA, del mismo Bextra, el antipsicótico atípico Geodon (Ziprasidone), el antibiótico Zyvox (Linezolid) y la droga para dolor neuropático y epilepsia, Lyrica (Pregabalin).

Con excepción de Bextra, los demás medicamentos tienen estatus blockbuster, con ventas en el 2008 por 1.007 millones de dólares para Geodon, 1.115 millones de dólares para Zyvox y 2.602 millones de dólares para Lyrica, la segunda especialidad en ventas de la compañía neoyorquina. (Ver...)

Pfizer Inc., the world's largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions, the Justice Department announced Wednesday.

The department said the $2.3 billion settlement included a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture of $105 million.

"Combating health care fraud is one of this administration's top priorities," Associate Attorney General Thomas Perelli said in announcing the settlement. He said it 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. (Ver...)

PFIZER: "The Highlanders" serie (IV)..."Me two...", "Me three...", "Me four"...

Former Pfizer sales rep Blair Collins‘ whistleblower lawsuit contains a detailed guide to how some of Pfizer’s reps allegedly promoted their drugs. Among the tactics they allegedly used were recommending the antidepressant Zoloft for girls who failed to make the cheerleading squad; and staging talks in which doctors recommended prescribing Viagra for women who had difficulty reaching orgasm. (Ver...)

Blair begins his suit — which was settled by Pfizer as part of the $2.3 billion Bextra deal with the Department of Justice — by describing the budgets that Pfizer’s reps and marketing staff had at their disposal on an annual basis. The suit gives these numbers.

Pfizer’s $2.3 billion settlement of the off-label Bextra case overshadows another case wrapped into the agreement, that of Ronald Rainero, a former district manager at Pfizer in New York City, regarding the antibiotic Zyvox.
In the case, Rainero alleged that Pfizer pushed Zyvox off-label for use against all infections of the superbug MRSA. The company did this even though Zyvox costs eight times as much as vancomycin and even though catheter patients treated with Zyvox had an eight percent greater chance of dying than with another antibiotic. (Ver...)

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PFIZER: "El que la hizo...paga Pfizer..."

Pharmacia&Upjohn la hizo...ahora Pfizer paga...:

"Pharmacia & Upjohn Company, Inc., a subsidiary of Pfizer Inc. was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead, according to the U.S. Attorney’s office.

.../...

In addition, as announced on Sept. 2, Pfizer agreed to pay an additional one billion dollars plus interest to settle civil allegations that it fraudulently promoted and marketed Bextra, as well as three other drugs in its portfolio, Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug, as well as claims that it paid kickbacks for these, as well as other drugs, to induce physician prescribing." (Ver...)

Ufff...hicieron de todo.

PFIZER: "The Highlanders" serie (III)..."Me too..."

Pfizer sales reps allegedly promoted Bextra to the NHL’s Columbus Blue Jackets, even though it was only approved for arthritis and menstrual pain — and not the injuries or surgery that hockey players experience. (Plus the Blue Jackets are an all-male team.) The accusation came in one of the whistleblower claims wrapped into the $2.3 billion Bextra settlement.
The complaint was brought by former Pfizer sales rep Glenn DeMott, who joined the company via UpJohn in 1987. He claims that Pfizer management made efforts to get its massive sales force to comply with its agreements with the federal government to only market drugs for approved uses, but that regional and district sales managers routinely ignored these attempts.



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The Worst Drug Company Marketing Techniques (I): PFIZER

Earlier this year, Pfizer, the world's largest pharmaceutical company, pleaded guilty to a fraud charge and, along with its subsidiary, agreed to pay a record $2.3 billion fine. The penalty stemmed from allegations that the company advocated the use of certain drugs for treatments beyond what had been approved by the FDA.

In the case of Bextra -- which has since been withdrawn from the market due to concerns about the drug's safety -- Pfizer executives reportedly encouraged the company's salespeople to recommend the painkiller for the alleviation of pain unrelated to arthritis or menstrual discomfort, the only conditions it had been approved to treat.

This wasn't Pfizer's first violation for off-label marketing: in 2004, it was hit with a $430 million penalty after it was charged with recommending its epilepsy drug Neurontin for other uses.

Ver anterior...

Ver caso BEXTRA en PHARMACOSERÍAS

Ver caso NEURONTIN en PHARMACOSERÍAS

"Momento" Glaxo&Abbott&Merck& AZ&Pfizer&Lilly: Big Pharma Big Fines...Memento.

"Today's announcement of the largest health fraud settlement ever reached between a pharmaceutical company and federal and state governments demonstrates that despite the seemingly large sums, the fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.

The industry is therefore tacitly encouraged to continue its illegal activity."

Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group July 2, 2012

Click sobre imagen para ampliar

Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”

Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.

AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.

Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales.

Abbott was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.

GlaxoSmith Kline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.

Source The Department of Justice

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"Multibillion-dollar fines are inadequate to tackle misconduct when penalties can be paid from post-tax profits. Indeed, there seems to be such an arrogance about money, that on the same day that GSK was being fined $3 billion, the Association of the British Pharmaceutical Industry argued that the UK Government should reinvest the $5 billion expected from NHS drug savings back into the industry. GSK and other drug companies have come adrift from the standards of the societies they seek to serve. They need to rediscover corporate citizenship, beginning with the individual integrity and accountability of their employees."

Moral decay at GSK reaps record US$3 billion fine The Lancet Vol 380, Iss 9836, Pag 2, 7 July 2012

Big Bad Pharma - The FT editorial in full

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GLAXO El show debe seguir: "Myth of Mild" Advair en Las Vegas aportado como prueba (Exhibit 28A) de "malas prácticas..."