#invima

InnspiraMED mechanical respirators received endorsement from Invima for clinical trials

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Laura Lucía Becerra Elejalde – [email protected]

The mechanical fans that have been developed under the initiative InnspiraMED They received the endorsement of the National Institute for Food and Drug Surveillance (Invima) to carry out clinical tests on 15 patients from three hospitals and clinics in Medellín.

The three mechanical ventilators developed for the care of…

B. 2009 (stroke X axis: 0.1). FDA Evaluation Report. http://www.bmj.com/investigation/dabigatran

0.1 y 1 son diferentes.

La relación sangrado-eventos (especificamente accidentes cerebrovasculares) y riesgo-beneficio de dabigatran promocionada por Boehringer es un fraude.

¿Donde reclutaron los más de 18.000 pacientes del estudio RE-LY? Re: no sé, los sitios de recrutamiento de pacientes son diferentes entre el registro del estudio RE-LY (ClinicalTrials.gov) y las publicaciones que analizan a profundidad los sitios de reclutamiento. (ver: Lancet – request of retraction).

También existen diferencias entre el registro del estudio RE-LY y su continuación (RELY-ABLE).

http://www.bmj.com/content/349/bmj.g4747/rr/778288

La FDA recomendo hacer seguimiento con uno de los marcadores de anticoagulación, pero Boehringer promocionó el medicamento con la premisa de que no era necesario monitorizar el efecto anticoagulante. Sin embargo, la FDA no opuso ninguna resistencia a este engañoso mercadeo y su papel ha sido más el de una agencia facilitadora que reguladora (igual para otras agencias reguladoras como EMA, INVIMA, etc).

B. 2009 (stroke X axis: 0.1). FDA Evaluation Report. http://www.bmj.com/investigation/dabigatran

Existe un anticuerpo para revertir el efecto anticoagulante del dabigatran.

https://twitter.com/DavidJuurlink/status/612999305453006848

De acuerdo: lo mejor para evitar el sangrado con dabigatran es no prescribir dabigatran (y quizás sacarlo del mercado junto con sus amigos…)

Disclaimer / Liberación de Responsabilidad

En realidad no sé nada, igual muchos podrán decir que esto es tan solo un fraude más de la industria farmacéutica, no creo que le pase nada a Boehringer, ni a dabigatran, ni a apixaban, ni a la FDA, ni a la EMA, ni a Glaxo, ni a paroxetina, ni a la agomelatine, ni a la quetiapina, ni al evolocumab, etc.

La industria farmacéutica continuará haciendo sus fechorias de forma bastante alegre (y nosotros los seguiremos denunciando euforicamente!).

Quizás todo es al final pura conspiparanoía mía producto de un episodio psicótico agudo, pero no creo: no he sido el primero, ni el único, mucho menos seré el último en criticar a los “Nuevos Anticoagulantes Orales”.

Dabigatran: Bye.

0.1 y 1 son diferentes. La relación sangrado-eventos (especificamente accidentes cerebrovasculares) y riesgo-beneficio de dabigatran promocionada por Boehringer es un fraude.

B. 2009 (stroke X axis: 0.1). FDA Evaluation Report. http://www.bmj.com/investigation/dabigatran

0.1 y 1 son diferentes.

La relación sangrado-eventos (especificamente accidentes cerebrovasculares) y riesgo-beneficio de dabigatran promocionada por Boehringer es un fraude.

¿Donde reclutaron los más de 18.000 pacientes del estudio RE-LY? Re: no sé, los sitios de recrutamiento de pacientes son diferentes entre el registro del estudio RE-LY (ClinicalTrials.gov) y las publicaciones que analizan a profundidad los sitios de reclutamiento. (ver: Lancet – request of retraction).

También existen diferencias entre el registro del estudio RE-LY y su continuación (RELY-ABLE).

http://www.bmj.com/content/349/bmj.g4747/rr/778288

La FDA recomendo hacer seguimiento con uno de los marcadores de anticoagulación, pero Boehringer promocionó el medicamento con la premisa de que no era necesario monitorizar el efecto anticoagulante. Sin embargo, la FDA no opuso ninguna resistencia a este engañoso mercadeo y su papel ha sido más el de una agencia facilitadora que reguladora (igual para otras agencias reguladoras como EMA, INVIMA, etc).

B. 2009 (stroke X axis: 0.1). FDA Evaluation Report. http://www.bmj.com/investigation/dabigatran

Existe un anticuerpo para revertir el efecto anticoagulante del dabigatran.

https://twitter.com/DavidJuurlink/status/612999305453006848

De acuerdo: lo mejor para evitar el sangrado con dabigatran es no prescribir dabigatran (y quizás sacarlo del mercado junto con sus amigos…)

Disclaimer / Liberación de Responsabilidad

En realidad no sé nada, igual muchos podrán decir que esto es tan solo un fraude más de la industria farmacéutica, no creo que le pase nada a Boehringer, ni a dabigatran, ni a apixaban, ni a la FDA, ni a la EMA, ni a Glaxo, ni a paroxetina, ni a la agomelatine, ni a la quetiapina, ni al evolocumab, etc.

La industria farmacéutica continuará haciendo sus fechorias de forma bastante alegre (y nosotros los seguiremos denunciando euforicamente!).

Quizás todo es al final pura conspiparanoía mía producto de un episodio psicótico agudo, pero no creo: no he sido el primero, ni el único, mucho menos seré el último en criticar a los “Nuevos Anticoagulantes Orales”.

—

(adendo)

The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator or All of These?

Roseann B. Termini. Widener University – School of Law Anthony Knabb DiDonato. Widener University – School of Law

June 26, 2013

Food and Drug Policy Forum, Vol. 3, No. 11, 2013

Abstract:

What would transpire if the United States Federal Food and Drug Administration (FDA) did not exist? The mission of the FDA is the promotion of the public health through prompt and efficient review of clinical research, and the taking of appropriate action on the marketing of regulated products in a timely manner. But, is the FDA a regulating agency? Is the FDA a watchdog agency? Or is the FDA a facilitating agency? The simplest and most obvious answer is that the FDA functions as all three. The relationship between the multi-functional role of the FDA and how to ensure that drug companies will comply with the agency provides the basis for this article.

Drug manufacturers have motivation to produce safe and efficacious products – market reputation and profit. In other words, it is in the best interest of drug manufacturers to self-regulate because without safe and effective products, drug firms would self-destruct. So why does the FDA find it necessary to implement stringent approval processes and postmarket drug surveillance? History strongly suggests that although most companies would undertake appropriate precautions to ensure public safety, quackery and negligence can never be fully eradicated, thus justifying regulation and a strong regulatory body to promulgate laws.

The expanse of FDA regulation is all-encompassing. That is, FDA regulatory authority extends to numerous products such as foods, human and veterinary drugs, medical devices, cosmetics, dietary supplements, biologics, and tobacco. However, this article will focus on pharmaceutical regulation to explore the interplay between FDA and the regulated industry. First, an historical overview will provide the origin for the need, foundation, and development of regulation geared towards drug law regulation as it exists in the United States today. Second, the FDA will be analyzed based on its functions as regulator, watchdog, and facilitator. Each of the three sections will address the ultimate question posed of how the FDA can ensure that drug companies will comply with regulations, and further draw conclusions as to whether the pharmaceutical industry could, or would, self-regulate so as to comply with Congressional mandates in the absence of the FDA.

A look back at history, case law, and the expansive reach of the FDA strongly suggests that while many, if not most drug companies, would comply or attempt to comply with federal law to ensure public health, a climate without a strong administrative agency to oversee the pharmaceutical industry cannot be justified.

Number of Pages in PDF File: 25

Keywords: food and drug law, FDA, Food and Drug Administration, administrative law, public health, pharmaceutical industry

Texto completo disponible en el siguiente enlace: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2297947

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) – Colombia.

— (adendo) The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator or All of These?

—

(adendo)

The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator or All of These?

Roseann B. Termini. Widener University – School of Law Anthony Knabb DiDonato. Widener University – School of Law

June 26, 2013

Food and Drug Policy Forum, Vol. 3, No. 11, 2013

Abstract:

What would transpire if the United States Federal Food and Drug Administration (FDA) did not exist? The mission of the FDA is the promotion of the public health through prompt and efficient review of clinical research, and the taking of appropriate action on the marketing of regulated products in a timely manner. But, is the FDA a regulating agency? Is the FDA a watchdog agency? Or is the FDA a facilitating agency? The simplest and most obvious answer is that the FDA functions as all three. The relationship between the multi-functional role of the FDA and how to ensure that drug companies will comply with the agency provides the basis for this article.

Drug manufacturers have motivation to produce safe and efficacious products – market reputation and profit. In other words, it is in the best interest of drug manufacturers to self-regulate because without safe and effective products, drug firms would self-destruct. So why does the FDA find it necessary to implement stringent approval processes and postmarket drug surveillance? History strongly suggests that although most companies would undertake appropriate precautions to ensure public safety, quackery and negligence can never be fully eradicated, thus justifying regulation and a strong regulatory body to promulgate laws.

The expanse of FDA regulation is all-encompassing. That is, FDA regulatory authority extends to numerous products such as foods, human and veterinary drugs, medical devices, cosmetics, dietary supplements, biologics, and tobacco. However, this article will focus on pharmaceutical regulation to explore the interplay between FDA and the regulated industry. First, an historical overview will provide the origin for the need, foundation, and development of regulation geared towards drug law regulation as it exists in the United States today. Second, the FDA will be analyzed based on its functions as regulator, watchdog, and facilitator. Each of the three sections will address the ultimate question posed of how the FDA can ensure that drug companies will comply with regulations, and further draw conclusions as to whether the pharmaceutical industry could, or would, self-regulate so as to comply with Congressional mandates in the absence of the FDA.

A look back at history, case law, and the expansive reach of the FDA strongly suggests that while many, if not most drug companies, would comply or attempt to comply with federal law to ensure public health, a climate without a strong administrative agency to oversee the pharmaceutical industry cannot be justified.

Number of Pages in PDF File: 25

Keywords: food and drug law, FDA, Food and Drug Administration, administrative law, public health, pharmaceutical industry

Texto completo disponible en el siguiente enlace: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2297947