Jo...J&J no paras de pagar. Ahora a "pasar por caja" en Arkansas / RISPERIDAL / RISPERDAL

Drugs giant Johnson & Johnson (J&J) has been ordered by a US judge to pay $1.1bn (£690m) for downplaying the risks involved in taking its anti-psychotic drug Risperdal.

The state of Arkansas sued J&J and its subsidiary Janssen Pharmaceuticals over its marketing of the drug in 2007.

A number of US states have already found the firms guilty of similar charges and fined them accordingly.

Janssen said it was "disappointed" with the judge's decision.

The company added that if its motion for a retrial was denied, it would appeal the fine.

"During the nearly three-week trial, Janssen presented abundant evidence showing the company acted responsibly and fully complied with all laws and regulations regarding Risperdal," it said in a written statement.

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J&J acuerda pagar 1.000.000.000 dolares ($ 1 Billion) por...

J&J PAGA...pero lo "no debido" por Risperidal.

RISPERIDAL Johnson & Johnson: Fraude en Texas (Medicaid)

J&J acuerda pagar 1.000.000.000 dolares ($ 1 Billion) por...

By Margaret Cronin Fisk, Jef Feeley and David Voreacos Jan. 6 (Bloomberg)

Johnson & Johnson will pay more than $1 billion to the U.S. and most states to resolve a civil investigation into marketing of the antipsychotic Risperdal, according to people familiar with the matter.

J&J, the world’s largest health products company, reached an agreement last week with the U.S. attorney in Philadelphia, according to the people, who weren’t authorized to speak about the matter. Negotiations over a possible criminal plea are still under way, they said.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J has said in Securities and Exchange Commission filings. The company said it has been in negotiations with the U.S. to settle the investigation.

J&J, based in New Brunswick, New Jersey, disclosed in August that it reached an agreement to settle a misdemeanor criminal charge related to Risperdal marketing. The company is discussing paying about $400 million more to settle that portion of the investigation, one of the people said.

“We’re not going to comment on rumor or speculation,” Teresa Mueller, a J&J spokeswoman, said in a phone interview.

.../...

Federal Drug Act

“Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of Risperdal,” J&J said in its August SEC filing. “Certain issues remain open before a settlement can be finalized.”

“The ultimate resolution of the above criminal and these civil matters is not expected to have a material adverse effect on the company’s financial position,” J&J officials said in the filing.

The agreement in principle on the criminal charge is “pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,” the company said.

Risperdal is a member of a class of drugs, known as atypical antipsychotics, that includes Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel.

Lilly, AstraZeneca and two other J&J competitors making these drugs have paid $2.7 billion to resolve government marketing claims, particularly that the companies pushed the drugs for unapproved uses.

Lilly paid more than $1.7 billion to resolve state and federal investigations over Zyprexa and AstraZeneca has paid almost $590 million. Pfizer Inc. paid $301 million for its drug Geodon.

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J&J PAGA...pero lo "no debido" por Risperidal.

RISPERIDAL Johnson & Johnson: Fraude en Texas (Medicaid)

J&J paga, paga, paga...por Risperidal

Un jurado de Pensilvania condenó el martes a la multinacional Johnson & Johnson a pagar 8.000 millones de dólares en daños por no advertir que una de sus drogas usadas en psiquiatría hincha el pecho de los hombres, aunque el gigante farmacéutico desestimó el fallo y anunció una apelación.

Johnson & Johnson y su filial Janssen Pharmaceuticals fueron atacados en el Tribunal de Quejas Generales de Filadelfia por Nicholas Murray, por un paciente que afirmó que el Risperdal, un medicamento recetado para tratar la esquizofrenia y el trastorno bipolar, le había hecho crecer el pecho.

Johnson & Johnson reaccionó con un comunicado en el cual consideró que la suma es “extremadamente desproporcionada” en comparación con la compensación inicial establecida en USD 680.000.

“La compañía confía en que esta decisión cambiará”, señaló, para acotar que “exigirá de inmediato que se desestime este veredicto excesivo e injustificado”.

El gigante farmacéutico aseguró que el tribunal había violado los derechos de la defensa, incluida la prevención de que Johnson & Johnson presentara “elementos clave” en el etiquetado de Risperdal.

J & J enfrenta una serie de reclamos en los tribunales estatales por no advertir adecuadamente sobre este efecto del Risperdal, particularmente en Pensilvania, California y Misuri (centro). 

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Jo...J&J no paras de pagar. Ahora a "pasar por caja" en Arkansas / RISPERIDAL / RISPERDAL

El Risperdal, aprobado para el tratamiento de adultos por la agencia federal Administración de Alimentos y Drogas (FDA) en 1993, generó ventas por unos 737 millones de dólares en 2018. AFP

RISPERIDAL Johnson & Johnson: Fraude en Texas (Medicaid)

AUSTIN – A major pharmaceutical firm funneled kickbacks to Texas health officials, distributed false marketing materials and deployed phony advocacy groups to get its top-dollar schizophrenia drug prescribed* to low-income Texans, the state alleges in a new filing in a major fraud lawsuit.

(*) Risperidal

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Zyprexa, Risperdal...no se justifican frente a productos "viejos" en niños...

Lilly, J&J Antipsychotics Don't Top Old Drugs in Kids (Update2)

By Rob Waters and Tom Randall

Sept. 15 (Bloomberg) -- Best-selling antipsychotic medicines by Eli Lilly & Co. and Johnson & Johnson caused more side effects and were less effective for children with schizophrenia than a little-used 30-year-old generic drug costing one-fourth as much.

For the study, published today in the American Journal of Psychiatry, 116 children ages 8 to 19 were given molindone, an older drug available as a generic, or a newer antipsychotic, either Lilly's Zyprexa, which generated $4.8 billion in sales in 2007, or J&J's Risperdal, with $4.7 billion in revenue.

Según el estudio TEOSS, recientemente publicado, ZYPREXA y RISPERIDAL no justifican su uso frente a los antipsicóticos tradicionales mucho mas económicos.

Le pones hasta el alma a "LEPONEX" frente a todo el mundo para que, despues de 15 años, te digan que...era el mejor.

* Fewer deaths with clozapine than newer drugs

* Call to consider cheap generic as first-line treatment

* Finnish study fuels debate on atypical antipsychotics

Al ser trasladado a España en 1994 uno (entre muchos) de los problemas que encontré eran las dificultades impuestas, por las autoridades sanitarias, a la prescripción/dispensación de LEPONEX/CLOZARIL.

En Perú, de donde venía, la situación era la misma pero el "mercado" mucho mas pequeño.

Clozapina fué introducida al mercado en la década de los 70 y prohibida, por una década, por un posible efecto secundario mortal (en un 2% de casos los pacientes perdían leucocitos mientras lo tomaban). En la década de 1980 regresa al mercado con severas restricciones y advertencias sobre su uso. En muchos países desarrollados, se recomienda usar clozapina sólo en casos extremos, cuando los pacientes han probado otras dos medicinas sin resultados favorables.

Los "atípicos" (risperidal y sucesores...) aprovechan circunstancias y entran a precios exorbitantes.




Junto con el Dr. Francisco (Paco) Forcadell del Dptº Médico, José Ignacio (Nacho) Schoendorff del Dptº de Marketing y el equipo de Visita Médica (Sandoz España) se conforma un"comando de campaña" que no deja "sin tomar" todo Servicio de Psiquiatría existente.



Se recorrió el pais entero, "pateamos" Majadahonda (y autoridades) hasta lograr una flexibilización, un registro de pacientes que facilitaba "en algo" el uso.

El "armamentario": argumentos que sustan lo que hoy, 15 años después, "nos reconoce" la victoria.




"Los investigadores llegaron a la conclusión de que drogas más nuevas como la quetiapina, haloperidol y risperidona acrecientan el riesgo de muerte en un 41%, 37% y 34%, respectivamente, si se comparan con medicinas más antiguas.

En contraste los pacientes que toman clozapina tienen un 26% de menor incidencia de muerte."


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J&J...otra vez? no j...

Largest multi-state consumer settlement ever

New York State Attorney General Eric Schneiderman on Wednesday announced a record $181 million settlement with Janssen Pharmaceuticals and its parent company Johnson & Johnson to resolve charges of improper marketing and advertising of the powerful anti-psychotic drugs Risperdal and Invega.

The settlement, joined by 36 other states and the District of Columbia, represents the largest multi-state consumer protection-based pharmaceutical settlement in history. New York will receive nearly $9 million.

In the complaint filed Wednesday in New York County Supreme Court, Attorney General Schneiderman charged that from 1998 through at least 2004, Janssen Pharmaceuticals engaged in deceptive and misleading practices when it marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses.

As a result of the states' investigation, Johnson & Johnson agreed to change its marketing of Risperdal and Invega, and to cease promoting “off-label” uses of the drugs not approved by the U.S. Food and Drug Administration (FDA).

Off-label use refers to prescribing a drug for a condition other than what it’s been approved for, or to an age group other than that for which the drug was originally intended.

“Pharmaceutical corporations’ illegal promotion of drugs for off-label uses must stop. Consumers, including parents of children with serious mental disorders and vulnerable patients should be able to trust their doctor’s advice without fear that drug companies are manipulating their physician’s independent judgment,” Schneiderman said.

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J&J acuerda pagar 1.000.000.000 dolares ($ 1 Billion) por...

Jo...J&J no paras de pagar. Ahora a "pasar por caja" en Arkansas / RISPERIDAL / RISPERDAL

J&J PAGA...pero lo "no debido" por Risperidal.

Federal prosecutors in Boston say health care giant Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug.

They say J&J paid the kickbacks, in the form of special rebates and other payments, to Omnicare Inc., the country's biggest company providing pharmacy services to nursing homes. Prosecutors allege Omnicare pharmacists then recommended that nursing home patients with signs of Alzheimer's disease be put on the powerful schizophrenia drug Risperdal. (Ver...)