miércoles, 13 de agosto de 2014

PFIZER: Rapamune herencia "caida" en desgracia...desde la Isla de Pascua

Rapa Nui caido Isla Pascua Chile


Pfizer settles off-label Rapamune case for $35M 



Pfizer will pay $35 million to settle with 41 state attorneys general for alleged off-label marketing and promotion of immunosuppressive drug Rapamune by legacy company Wyeth, New York's attorney general, Eric Schneiderman, said today. Pfizer acquired Wyeth in 2009 for $68 billion. 

In the settlement, Schneiderman said Wyeth allegedly promoted the drug for use in liver, heart and drug transplants when the drug was only approved for use after kidney transplants. “Patients and consumers need to have confidence in the truthfulness of claims made to them by medical providers without having to worry about drug companies manipulating the doctor-patient relationship,” he stated. 

Rapamune* (sirolimus) was originally approved by the FDA in September 1999 to help patients better tolerate kidney transplants and lessen the chance of rejection. Neither drugmaker has admitted to liability or wrong-doing. 

The complaint further alleged that Wyeth violated consumer protection laws by misrepresenting the drug's uses and benefits through promotional talks by Wyeth-retained doctors and misleading presentations of data as well as funding of studies at hospitals and transplant centers designed to encourage off-label use of Rapamune

The settlement follows last year's $490.9 million agreement between Pfizer and the Department of Justice to resolve criminal and civil liability over Rapamune marketing. Of that sum, $257.4 million went to the federal government and states to resolve prosecutors' civil claims that Wyeth allegedly violated the False Claims Act by promoting the drug for unapproved uses, and that those uses were therefore not covered by Medicare, Medicaid or other federal programs. 

In that same 2013 settlement, Pfizer also paid out $233.5 million for a criminal fine and forfeiture under a plea agreement with US District Court in Oklahoma City after Wyeth pled guilty to a FDCA (Federal Food, Drug and Cosmetic Act) misbranding violation. The deal came after information which alleged that Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients and that the sales force was later encouraged to target all transplant populations to increase sales. 

Stuart Delery—the acting assistant attorney general for the Justice Department's Civil Division at the time—stated: “Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. This was a systemic, corporate effort to seek profit over safety.” (Ver)

(*)Uno de los fármacos más populares de los últimos años es la rapamicina. Con este nombre, Sirolimus, o el nombre comercial de Rapamune se emplea en la terapia post transplante, para prevenir la restenosis después de una angioplasia (traduzco: para que no se inflamen las arterias después de una operación) en la terapia contra el cáncer y en muchas otras. Curiosamente una molécula con tantas aplicaciones y tan efectiva tuvo unos orígenes modestos y muy remotos.

Wyeth homenaje Rapamicina/Isla Pascua
La historia empieza en la isla de Pascua, donde unos científicos de la empresa Wyeth pasaban las vacaciones. La empresa, experta en buscar antibióticos procedentes de hongos, pedía a todos sus empleados que recogieran muestras de suelo de los países que visitaban. En la tierra que recogieron se encontraron unas cepas del hongo Streptomyces hygroscopicus, del que se aisló una molécula de la familia de los policétidos macrocíclicos, a la que se le denominó rapamicina. El nombre proviene de la denominación que los antiguos navegantes proveniente de Tahití dieron a la isla de Pascua: Rapa Nui. Este compuesto interesó inicialmente por tener una actividad antifúngica, pero carente de valor práctico. Era muy caro y muy inestable. No obstante, la rapamicina no había dicho su última palabra. Se descubrió que era muy tóxica para los glóbulos blancos. En condiciones normales un compuesto que machaque al sistema inmune es un veneno, pero hay veces que conviene mantener a raya a este sistema. Básicamente: después de un transplante para prevenir un rechazo. Aquí es cuando empieza el éxito de la rapamicina como fármaco.(Ver)

Ver también:

RAPAMICINA: El elixir de la "eterna juventud" está en Isla de Pascua...

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