Neurontin: ‘A Good Drug… Marketed By Bad People’

By Ed Silverman // March 24th, 2010 // 7:32 am

A federal courtroom in Boston is hosting a trial between Pfizer and Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, which claim the drugmaker committed fraud by aggressively promoting off-label use for its Neurontin epilepsy drug. Warner-Lambert, which developed the pill and was bought by Pfizer a decade ago, pleaded guilty in 2004 and paid $430 million to resolve off-label marketing charges brought by the US Justice Department. Now, Pfizer faces a $270 million fraud claim.

To defend the drugmaker, Pfizer attorney Raoul Kennedy made a curious admission to jurors in closing arguments. Neurontin, he said, is “a good drug that, at one time, at least in some parts of the country, may have been marketed by some bad people.” Hmm… Pfizer lawyers also argued that Kaiser docs continued to increasingly prescribe the pill even after Kaiser sued Pfizer in 2005, and that the insurer’s web site also still lists Neurontin as a drug for neuropathic pain.

For its part, Kaiser claims it was misled into allowing prescriptions to be written for migraines and bipolar disorders, among other things, but began talking to its doctors about the off-label marketing after it became known in 2002. As a result, Kaiser claims it would have saved a lot of money if Warner-Lambert, now part of Pfizer, hadn’t misled the insurer. As Bloomberg News notes, a verdict may influence other Neurontin lawsuits against Pfizer. In a ruling last year, US District Court Judge Patti Saris determined that fraud findings against Pfizer could be binding against the drugmaker in future trials.

Tomé "prestado" de Pharmalot

No pierde actualidad...

BAYER: Olivier Brandicourt si es Parke Davis será malo...?: La firma.

Olivier Brandicourt

Medical degree with subspecialty in Infectious Diseases and Tropical Medicine; Masters in Biology, Paris University. Formerly: two years in Congo as doctor; eight years with Tropical Disease Institute, Paris, spent half his time in West and Central Africa working on malaria research; 13 years with Warner-Lambert, Parke-Davis in medical and marketing roles; 1996-98, Vice-President, Global Marketing, Parke-Davis division; 1998-2000, General Manager, Parke-Davis Canada.(...sigue)

Ver


But/Sin embargo...

Methods 
We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports. 

Conclusions 
We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions. (Ver)


Blockbuster making off


 


  How Neurontin became a blockbuster 

Gabapentin never achieved major commercial success as an anticonvulsant. In 1995 Parke-Davis marketing staff proposed an experimental program to test anecdotal claims of efficacy for “neuropathic” pain and other syndromes. Research results were to be published, “if positive”.(8) Immediately after the 1998 JAMA publications, Parke-Davis launched a program of selective publication and intensive marketing, assisted by “Key Opinion Leaders” (KOL).(9) Sworn testimony indicated that Parke-Davis used its “clinical liaison” sales representatives and “Key Opinion Leaders” to market Neurontin “for everything”.(10) By 2003 annual U.S. sales of gabapentin had expanded from $98 million to $2.7 billion/year. 

 

A gradually broadened category of “neuropathic pain” became gabapentin’s most durable market, reinforced by guidelines that refer to gabapentin as “first line treatment”.(11) In B.C. consumption is still rising, at a cost exceeding $30 million during 2009, 63% from public funds (see Figure). 

In February 2010 a U.S. court in Boston is scheduled to hear detailed evidence from published and unpublished DBRCT of gabapentin for pain and other unapproved uses in a civil trial of alleged fraud for the off-label marketing of Neurontin prior to 2004.(12)
Más 

En el año 2000 Pfizer "cierra la compra" de Warner Lambert (Parke-Davis).

Incorpora "activos" 

 Olivier Brandicourt (cont.)

With Pfizer: 2000, Regional President, Latin America; 2002, Regional Vice-President, Central and Southern; four years as Managing Director, UK and Ireland; 2007, Senior Vice-President and General Manager, Pratt Business Unit; US; since October 2008, current position, an organization with more than US$ 22 billion in revenue. Honorary Fellow, Royal College of Physicians, London.

y..."pasivos". 

La mayor farmacéutica del mundo, Pfizer, ha aceptado pagar 420 millones de dólares (355 millones de euros) para detener el proceso judicial abierto en EE UU por haber incentivado a los médicos para que recetasen Neurontin contra enfermedades para las que no está indicado.(Ver)

Ver también en PHARMACOSERÍAS:

PFIZER paga...por Neurontin.

BAYER: Olivier Brandicourt, si es Pfizer será bueno...?

PFIZER paga...por Neurontin.

Pfizer Inc., the world’s largest drugmaker, was ordered to pay a total of $142.1 million in damages for violating U.S. racketeering laws in the marketing of its epilepsy drug Neurontin.

U.S. District Judge Patti Saris in Boston yesterday upheld a jury’s finding that Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals deserved the award over the companies’ claims that Pfizer illegally promoted Neurontin for unapproved uses. Saris tripled the jury’s award of $47.3 million under a provision of the Racketeer Influenced and Corrupt Organizations Act of 1970.

.../...

New York-based Pfizer currently faces more than 300 suits accusing it of illegally promoting Neurontin or hiding its health risks. Lawyers for ex-Neurontin users contend the drugmaker knew the medicine posed a suicide risk and failed to disclose it to patients and doctors.

The company also has settled at least two suits alleging the drug played a role in users’ suicides, paying almost $400,000 in one of the accords, people familiar with the deals said last year.

PFIZER "manipula" ensayos clínicos con Neurontin...(I)

CHICAGO (Reuters) - A study of internal company documents suggests Pfizer Inc altered or omitted unfavorable study findings to expand its epilepsy drug Neurontin's market, U.S. researchers said on Wednesday, offering a look at how drugmakers influence scientific research.

Clinical trials are supposed to answer a specific, predetermined scientific question, but a comparison of Pfizer documents and published studies on Neurontin for conditions other than epilepsy found that eight out of 20 study reports never made it into medical journals.

And in eight of the 12 published studies, the primary outcome -- the answer to the main scientific question -- was changed by Pfizer, the world's biggest drugmaker, from the original study design. .../...

The studies, all funded by Pfizer, showed how the drug worked in people with problems like migraines or pain, which are off-label uses of the drug. (Ver...)

PFIZER tambien "juega sucio"...

Mas...

" El fabricante farmacéutico Pfizer, a principios de esta década, manipuló la publicación de estudios científicos para reforzar los usos de su fármaco contra le epilepsia, Neurontin, en otros trastornos"

"Los emails y otros documentos internos de Pfizer recogidos para una potencial demanda colectiva contra la compañía, representa una de las miradas más detalladas de como un fabricante farmacéutico controla lo que los médicos y los consumidores conocen sobre un fármaco"

• "Debemos retrasar la publicación del 224, porque sus resultados no fueron positivos" estas palabras pertenecen a Jhon Marino, ejecutivo de Marketing, en un mail de septiembre del 2000 dirigido a Angela Crespo, Senior Manager de grandes mercadoos de Neurontin.


• " Será más importante como NOSOTROS reescribimos el estudio" le escribía Michael Rowbotham, lider del equipo de Neurontin, a Angele Crespo, debido a la presión que el investigador inglés estaba ejerciendo para la publicación del estudio por razones éticas. Otra frase de Michael Rowbotham: " no estamos permitiéndole escribirlo por sí solo"

Tomo estos resúmenes (prestados) del Blog de Ovidio Vidal LA REBLOGTICA (entra y podrás ver la nota completa y visitar además este interesante colega)

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

PFIZER contraataca...

A raiz de la nota en New York Times sobre NEURONTIN que comentamos Javier Sampedro en el diario EL PAIS (España) (09/10/2008) publica un amplio artículo


"Vendo enfermedades a la carta. Y remedios"


en que hace una recopilación de todos los tópicos actualmente circulantes: "Disease mongering" (Tráfico de enfermedades), Ray Moyhan, PloS, Vacuna del papiloma (Gardasil MERCK)/(Cervarix GSK) , osteopenia/riesgo de fracturas en mujeres post menopáusicas (Evista LILLY)/(Actonel P&G), piernas inquietas (Requip GLAXO), hiperactividad (Ritalina NOVARTIS).

A modo de colofón añade una nota:


"Pfizer manipuló datos sobre Neurontin."


Y no "deja títere con cabeza"...

Periodista Digital titula:



Ahora PFIZER hace pública una nota:


"Desde Pfizer negamos esta acusación en base a las siguientes:"

Consideraciones sobre el artículo de EL PAIS



En PHARMACOSERÍAS hace ya tiempo que todo esto lo habiamos ya tratato en profundidad.

Ver anteriores

PFIZER "manipula" ensayos clínicos con Neurontin...(II): Cuestionando su integridad...

Recibo de Galo Agustin Sanchez, director de la Oficina Extremeña de Información y Evaluación de Medicamentos (siempre será nuestro "mentor" en PHARMACOSERÍAS) éste análisis del trabajo publicado en NEJM que complementa nuestro "post" anterior:


"Este es un ejemplo más de sesgo de información que utiliza esta empresa para la propaganda mercantil, vulnerando el código ético de la investigación con medicamentos, e incluso el de marketing comercial, cuestión que es difícil de investigar, y que, gracias a un grupo de investigadores, entre los que está Lisa BERO, se transparenta."

El estudio que publica el New England Journal of Medicne en su último número, que muestra los resultados encontrados tras comparar los documentos internos sobre ensayos promovidos por Pfizer o Parke-Davis sobre gabapentina con los protocolos de dichos ensayos y con el informe publicado (en caso de haberlo):


De 20 ensayos para los que se dispone de documento interno de la compañía farmacéutica, sólo en 12 encuentran el correspondiente informe publicado. Pues bien, el sesgo de información aplicado a la promoción de la gabapentina consistió en lo siguiente:

1) En 8 de los 12 ensayos publicados la variable principal no coincide con la variable principal descrita en el protocolo. En seis de estos ocho, se han inventado una nueva variable principal.

2) En dos ensayos no se distingue entre variable principal y secundarias.

3) En otros dos ensayos se relega a la categoría de variable secundaria lo que estaba protocolizado como variable principal.

4) En 5 ensayos no se informa del una o mas variables principales definidas en el protocolo.

5) En los ensayos que dieron no significativos (p > 0.05) en el documento interno para la variable principal definida en el protocolo, o bien no se informa de modo completo o bien se cambia la variable principal.

6) La variable principal estaba cambiada (respecto a la del protocolo) en 5 de los 8 ensayos clínicos que comunicaban resultados estadísticamente significativos a favor de gabapentina.

7) De los 28 resultados principales comunicados en los ensayos clínicos publicados, 12 fueron introducidos post-hoc (un atentado para la validez).

Y en esta "batalla" Galo no está solo...

...

On one hand, you can see how the company wouldn't want to release information about failed studies. It's not like we require Google to release every failed search algorithm it comes up with, or make Procter & Gamble disclose every rejected ad campaign.

But we're talking about people's health, here. Determining whether a drug is successful in treating a disease or condition requires knowledge of failed experiments, not just the ones that work. Without the negative information, doctors and patients cannot reach proper, informed decisions about the effectiveness of the drug.

.../...

In Pfizer's case, things only get worse. Of the 12 studies that were published, eight had their primary measurement of success changed before being reported. Now, there are legitimate reasons to change a primary endpoint, but it's usually a big red flag for doctors, investors, and the Food and Drug Administration, and all of them are right to be wary of such clinical trial results. Changing one or more primary endpoints on two-thirds of the studies makes that red flag as big as New York. (Ver...)

BIG PHARMA’S CRIME SPREE

Rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger.

BIG PHARMA’S CRIME SPREE is a riveting report by David Evans in the current issue of Bloomberg Markets Magazine relying on recent criminal legal settlements. It leaves no doubt about the fact that Big Pharma's business practices are defined by criminal activities. Finding cures is not even remotely a consideration by pharmaceutical executives, as it would present a financial conflict of interest.





But those fines are tiny compared to the revenues from criminally marketed sales:
Eli Lilly Zyprexa sales from criminal marketing yielded the company $36 billion from 2000 to 2008.

And Pfizer's recent $2.3 billion settlement in fines and penalties for the illegal marketing of Bextra, Geodon, Zyvox and Lyrica pales in comparison to the $16.8 billion the company garnered from its criminal marketing of these drugs. Indeed, the total penalties Pfizer has paid in settlements--$2.75 billion, since 2004--is but 1% of the company's revenue of $245 billion from 2004 to 2008.

.../...

Pfizer and its executives have thus successfully avoided criminal culpability while paying the settlements but maintaining that it was not responsible for the illegal actions of the dozens of companies it acquired--actions that continued after Pfizer acquired them:

Bloomberg reports:

"From 1995 to 2005, Pfizer purchased more than 20 companies. Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer’s Sept. 2 guilty plea and FDA correspondence with Pfizer.

Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey–based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999. Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties."

Ver...

Ver Pfizer Broke the Law by Promoting Drugs for Unapproved Uses

No puedes dejar de revisar...

PFIZER: Aquellos polvos trajeron estos lodos...

Mas...


Mas...

Tocamos el tema y adelantamos la que se estaba "liando". Ahora "revienta" con lo publicado en NEJM.
Lo tocó tambien Ovidio en La Reblogtica

El comentario (y lo que prometen siga...) en Hemos leido

"El caso Neurontin ha puesto en evidencia los mecanismos de acción de una campaña de marketing, sus objetivos y estrategias, tácticas y programas, y la participación de médicos e instituciones. La campaña utilizó sistemáticamente el engaño y la desinformación para crear una base de evidencias sesgadas y manipular las creencias de los médicos y su comportamiento a la hora de prescribir. No se encontró que por si mismo, los métodos de promoción fueran ilegales, lo ilegal fue promover una prescripción fuera de las indicaciones autorizadas. Así pues, la importancia de este caso se centra, en gran medida, en que destapa métodos de promoción de la industria que pueden ser extensos, pero que siguen sin percibirse, dado que raramente se procesa a compañías por promoción ilegal."


y en El Comprimido

"...para que el paciente D. Juan Sinremedio, anciano con pluripatologías, plurimedicado, no ingrese en un hospital con un problema derivado de un mal uso o abuso de medicamentos derivados de una mala prescripción, o una prescripción basada en el sesgo propiciado por la industria farmacéutica."

ya lo dicen todo...

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