Insulina Glargina y cancer

Desde Hemos Leido y sin anestesia:


 
Han tenido que pasar cuatro años para despejar las dudas sobre una posible asociación entre el uso de la insulina glargina y el desarrollo de cáncer, ya que, en junio de 2009, tanto la EMEA como la AEMPS emitieron comunicados informando que la bibliografía disponible en ese momento era insuficiente para adoptar medidas reguladoras o recomendar un cambio de tratamiento de los pacientes que utilizan insulina glargina.
 
Esta recomendación tuvo que ser realizada por la alarma surgida tras la publicación en la revista Diabetología, de datos procedentes de cuatro estudios observacionales sobre la posible asociación entre el uso de la insulina glargina y el desarrollo de cáncer, especialmente cáncer de mama.
 
Desde entonces, el CHMP de la EMA solicitó a la empresa que comercializa el medicamento que proporcionara más datos.
 
¿Qué datos se incluyeron en esta revisión de la EMA?
 
La presente revisión incluye datos de tres estudios poblacionales. Dos de ellos fueron estudios de cohortes:
 
         * uno basado en los datos recogidos de alrededor de 175.000 pacientes en el norte de Europa que fueron tratados con insulina glargina, insulina humana o insulina combinada,
 
         * otro con datos de alrededor de 140.000 pacientes en los Estados Unidos.
 
Ambos estudios analizaron la incidencia de cáncer de mama, colorrectal y de próstata con las diferentes insulinas.
 
El tercer estudio fue un estudio “caso-control” llevado a cabo en Canadá, Francia y el Reino Unido. Este estudio comparó 775 pacientes con diabetes que padecía cáncer de mama con un grupo control de pacientes con diabetes que no tenían cáncer de mama. El objetivo era establecer si existía alguna relación entre las insulinas que los pacientes estaban recibiendo y la aparición de cáncer de mama. Este estudio comparó la insulina glargina con insulina humana y otros tipos de insulina.
 
La revisión también incluyó datos obtenidos de una búsqueda exhaustiva de estudios en la literatura científica la investigación de la relación entre la insulina glargina y el cáncer.
 
Basándose en la evaluación de estos estudios, el CHMP ha concluido que, en general, los datos NO indican un aumento del riesgo de cáncer con insulina glargina, señalando que no existe un mecanismo conocido por el que la insulina glargina pudiera causar cáncer y que el riesgo de cáncer no se ha visto en estudios de laboratorio.
 
No obstante, la EMA continuará evaluando nuevos datos que están disponibles en esta área, como parte de la vigilancia rutinaria de los medicamentos.
 
(NOTA DE “HEMOS LEÍDO”: No hemos podido enlazar los estudios mencionados a sus lugares de publicación porque la nota de la EMA no contiene bibliografía).

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Interacción entre inhibidores de la bomba de protones y clopidogrel, un poco más de luz al tema.

Desde Hemos Leido, descubrimos este video, presentado en las Jornadas de Farmacovigilancia ( en Argnetina no conocemos esos términos ) , en dónde se aclara un poco más las probables interacciones y efectos clínicos, farmacinéticos y farmacodinámicos, de los distintos Inhibidores de la bomba de protenes en su interacción con Clopidogrel. Gracias a ellos hoy lo podemos compartir con ustedes. Esperamos sus opiniones.

Suspensión de Tetrazepam por la EMA

Fuente: Martin Cañas, via REDSAF

Evaluaciones finales de la EMA sobre  el principio activo de Myolastán 
Tetrazepam EMA recomienda suspender los medicamentos que lo contienen

EMA, 29 de Abril de 2013

Tras la reciente recomendación del Comité de Evaluación de Riesgos en Farmacovigilancia (PRAC), el Grupo de Coordinación para el Reconocimiento Mutuo y los Procedimientos Descentralizados - Humano (del CMDh) ha aprobado por mayoría la recomendación del PRAC, de suspender las autorizaciones de comercialización de los  medicamentos que contienen tetrazepam, en la Unión Europea (UE). El del CMDh, un organismo que representa a los Estados miembros de la UE, es responsable de garantizar las normas de seguridad armonizadas para los medicamentos autorizados, a través de procedimientos nacionales de autorización de comercialización en la UE.

Tetrazepam,  perteneciente a la clase de las benzodiazepinas, se utiliza en varios Estados miembros de la UE para el tratamiento de las contracturas dolorosas (por ejemplo, en el dolor de espalda y dolor de cuello) y espasticidad (rigidez excesiva de los músculos).

La posición del CMDh se enviará ahora a la Comisión Europea, que adoptará una decisión jurídicamente vinculante en toda la UE.

La revisión de tetrazepam fue desencadenada por la Agencia Nacional Francesa para la Seguridad de Medicina y Productos de Salud (ANSM), a raíz de notificaciones de reacciones cutáneas graves asociadas al uso de este fármaco en Francia. Después de haber evaluado todos los datos disponibles sobre el riesgo de reacciones cutáneas, incluidos los datos posteriores a la comercialización en la UE y de la literatura publicada, el PRAC concluyó que tetrazepam se asocia con un riesgo bajo, pero aumentado,  de reacciones cutáneas graves (incluyendo el síndrome de Stevens-Johnson, necrólisis epidérmica tóxica y síndrome DRESS) en comparación con otras benzodiazepinas. El Comité también tomó nota de que, a la luz de los riesgos identificados, los datos disponibles sobre la eficacia de tetrazepam no eran lo suficientemente robustos como para apoyar su uso en las indicaciones autorizadas.

El del CMDh acordó con la conclusión PRAC que los beneficios de estos medicamentos no son mayores que sus riesgos, y adoptó una posición definitiva que las autorizaciones de comercialización deberían suspenderse en toda la UE.

La suspensión de las autorizaciones de comercialización puede ser levantada si las empresas que comercializan estos medicamentos proporcionan datos que identifiquen un determinado grupo de pacientes en quienes los beneficios de los medicamentos que contienen tetrazepam superen los riesgos.

Fuente:

EMA. Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh. 29/04/2013. http://bit.ly/12fXvcn

Fingolimod and arrythmias in first prescription

European Medicines Agency (Photo credit: Wikipedia)

 Conflict of Interests: the editor of this blog, has been  perfomed and Health Evaluation Thecnology Assessment for Novartis, in 2011. Phase III studies shows heart blocks and  no one death. Eventhough Novartis has established a politic of control of at least 6 hours in a medical center. This policie is being supported by Novartis, at least in Argentina. The last pessure has shown that over almost 30K patients in treatment with the drug, just only one person died, and the conditions were no that the Novartis deals. I've signed a contract without restrictions to any relevant information. In spite of the prescrire statement, and I agree more studies are needed, but the quality of life is the strongest issue, being the first oral treatment that really equation risk/benefit is good enough (at the state of art today)  in multiple sclerosis. This statement has been written in order to encourage to all researchers, all over the world to declare their interest conflicts. The original paper has not been published yet. It has been writen in spanish, and my compromise is to ask to allow to Novartis to be published. 

Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients

The European Medicines Agency (EMA) has refused to supply Prescrire with the detailed data in its possession on cases of death which occurred following the first dose of  fingolimod (Gilenya°). This lack of transparency spells danger for patients.

Fingolimod (Gilenya°) is an immunosuppressant which has been authorised since March 2011 by the European Medicines Agency (EMA) for certain patients with multiple sclerosis. The pre-marketing evaluation data already revealed cardiac arrhythmia, among other disorders. In April 2011 Prescrire recommended limiting use of fingolimod to rigorously supervised clinical trials.

In December 2011, the US Food and Drug Administration (FDA) reported the sudden death of a patient within the first 24 hours of taking fingolimod. On 22 December 2011, in response to the FDA alert and faced with EMA’s silence, Prescrire asked EMA for a review of the serious adverse effects of  fingolimod, and for the initial European Periodic Safety Update Report (PSUR), which must be filed with EMA within 6 months of the marketing authorisation, i.e. in September 2011.

It was not until 20 January 2012 that the European Agency issued a public announcement on the subject, stating that there had been 3 other sudden deaths and 3 unexplained deaths. Three days later, on 23 January 2012, just 34 minutes before the legally mandated deadline, EMA informed Prescrire that its request for information dated 22 December was rejected, on the grounds that a European re-evaluation of fingolimod was under way: the re-evaluation had been initiated 3 days earlier.

On 7 February 2012, Prescrire reiterated its information request, this time to EMA Director Guido Rasi, vigorously contesting EMA’s grounds for refusal. As of 17 February 2012, EMA’s Director has not replied to Prescrire.

Once again the European Agency is refusing to provide patients and healthcare professionals with important information on adverse effects after the drug has come onto the market, information that is itself the fruit of the reporting work carried out by patients and healthcare professionals.

In May 2011, EMA had already invoked a re-evaluation under way to justify its refusal to provide Prescrire with information on pioglitazone (Actos°), which increases the frequency of bladder cancer and is no longer reimbursed by France’s national health insurance system. The European Commission has maintained the marketing authorisation for pioglitazone.

In early 2012, the European Medicines Agency and the European Commission’s Directorate General for Health and Consumers are behaving just as they did before the Mediator° fiasco. They give the benefit of the doubt to drug companies rather than to patients, and dispense information about adverse effects only sparingly. It is high time that they get back to their primary mission: protecting patients’ health, which should take precedence over protecting the financial interests of pharmaceutical companies.

©Prescrire 20 February 2012

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EU Parliament and EMA conflict of interests

Flag of the European Parliament 1973-1983. Later replaced by the common European flag. (Photo credit: Wikipedia)

 EU Parliament says no and no again to EMA: Independent groups echo decision
-------------------------------------------

PRESS RELEASE

Brussels, 15 May 2012 - Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) welcome and support the European Parliament's decision to postpone the discharge of the European Medicines Agency's (EMA) accounts (2012).  For the second year in a row, the Parliament has postponed this decision due to concerns, among others, about the management of conflict of interest risks at the Agency.

Greater independence is needed to ensure the reliability of EMA's advice. The EMA relies on scientific experts to evaluate the safety and efficacy of medicines that could enter the European market. However, findings of inconsistencies and omissions in experts' interest declarations have motivated the European Parliament to call for an overhaul of the system that is now "primarily based on trust rather than on verification" (European Parliament, 2012).  We echo the Parliament's call on the EMA to check, systematically and at random, declarations of interest and to verify their contents in order to avoid conflicts of interest that could harm public health (European Parliament, 2012).

Katrina Perehudoff of HAI Europe, states: "The EMA is ultimately responsible for the quality and independence of scientific advice provided by its experts, therefore it is essential for the EMA to be not only accountable for experts' complete and accurate declarations of interest, but also for their thorough scrutiny."

Improved policies to remove the risk of conflicts of interest are still needed at EMA. Disappointingly, in 2012, the EMA's policy on handling the declared interests of its staff members still does not guarantee that medicines files will at all times be handled by independent regulatory staff (EMA, 2012). We call not only for the adoption of stronger staffing rules to ensure public trust in the regulatory process, but also for their rigorous enforcement.

The European Parliament has already asked for further information about how EMA's policy on handling the declared interests of its staff members is being implemented (European Parliament, 2012). Last week, the European Parliament also reflected concerns raised by civil society about the EMA's application of the Staff Regulation. Citing the example of the Agency's former Executive Director and his post-service employment by a consultancy that advises, among others, pharmaceutical companies, the European Parliament described the EMA's management of the case as "clear proof that the Agency did initially not apply the Staff Regulations properly, which in turn raises serious questions about their application of the rules in general" (European Parliament, 2012). 

Jörg Schaaber of ISDB, states: "Improperly handled risks of conflicts of interest notably arising from managing staff who join the EMA after working for the industry, or who leave the Agency to work for pharmaceutical companies, casts a shadow on the independence of the EMA and on its capacity to independently evaluate medicines."

The EU Parliament has a crucial role to play in eliminating conflicts of interest at EMA. Last week's vote is a step in the right direction. As part of its role in holding Agencies accountable to European citizens, we urge the European Parliament to commit to the elimination of conflicts of interest at the EMA. It is particularly important that conflicted experts do not participate in EMA's Committees. Among others, two concrete and short term actions could be:

- ensuring that the future patient and healthcare professional representatives belonging to the Management Board (EMA, online) and/or to the Scientific Committees, for example as proposed Commission appointees, do not represent organisations sponsored by the drug and medical device industry, and are free of conflicts of interest (MiEF and ISDB, 2010).

- requiring that the European Court of Auditor's Special Report on conflicts of interest management is made publicly available, and requiring the Agency to explain any shortcomings identified and the measures taken or intended to take to rectify shortcomings and prevent any further shortcomings.

ENDS

References:
European Medicines Agency, 2012. Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency [online]. Article 4.3. Available at : http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/02/WC500122908.pdf

European Medicines Agency. Management Board [online]. Available at:http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000098.jsp&mid=WC0b01ac0580028c2f Accessed on 15 May 2012.

European Parliament, 2012. Decision of 10 May 2012 on the closure of the accounts of the European Medicines Agency for the financial year 2010 [online]. Point 1. Available at: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-175 Accessed 15 May 2012.

European Parliament, 2012. Resolution of 10 May 2012 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010 [online]. Points 25, 27, 29, 31, 33 and 34. Available at:http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-175 Accessed 15 May 2012.

Medicines in Europe Forum and International Society of Drug Bulletins, 2010. EMA's policy on conflict of interest: improvements needed [online]. Available at:http://www.isdbweb.org/documents/uploads/press/EMA_COI_Final.pdf

----------------------
Link to this press release online: http://haieurope.org/wp-content/uploads/2012/05/15-May-2012-Press-Release-EU-Parliament-says-no-and-no-again-to-EMA.pdf

HAI Europe. Health Action International (HAI) is an independent global network of health, consumer and development organisations working to increase access to essential medicines and improve their rational use. More info:www.haieurope.org. Contact Katrina@haieurope.org

ISDB. International Society of Drug Bulletins (ISDB), founded in 1986, is a world wide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry. Currently, ISDB has nearly 80 members in more than 40 countries around the world. More info: www.isdbweb.org. Contact: press@isdbweb.org

MiEF. Medicines in Europe Forum (MiEF), launched in March 2002, covers 12 European Member States. It includes more than 70 member organizations representing the four key players on the health field, i.e. patients groups, family and consumer bodies, social security systems, and health professionals. Such a grouping is unique in the history of the EU, and it certainly reflects the important stakes and expectations regarding European medicines policy. Admittedly, medicines are no simple consumer goods, and the Union represents an opportunity for European citizens when it comes to guarantees of efficacy, safety and pricing. Contact: pierrechirac@aol.com

Katrina Perehudoff

European Projects Manager
Health Action International, Europe
Overtoom 60/II
1054 HK Amsterdam
The Netherlands
Tel: +31 20 683 3684
Fax: +31 20 685 5002
Email: katrina@haieurope.org
Follow HAI Europe on Twitter or Facebook  

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Conflicto de Intereses, industria farmacéutica, EMA

EL MUNDO
 viernes 30/09/2011

La Agencia Europea del Medicamento (EMA) ha cumplido su promesa de hacer públicos los conflictos de interés de los expertos implicados en la evaluación de fármacos. Ha lanzado una base de datos, de libre acceso a través de internet, en la que da cuenta de las posibles influencias espurias de quienes le asesoran sobre la retirada o aprobación de nuevos productos.

La nueva página web recoge los nombres de aproximadamente 5.000 científicos y ya se han publicado las declaraciones de conflictos de interés de la mitad de ellos. En los próximos meses se consignarán las del resto.

Esta iniciativa forma parte de una estrategia de transparencia anunciada por la EMA hace casi un año. Las nuevas reglas clasifican a los expertos que participan en las actividades del organismo en tres categorías: con conflictos de interés directos, indirectos o sin ninguna relación con entidades -sobre todo de la industria farmacéutica- que pueda afectar a su imparcialidad.

En función de la posible merma de la objetividad de cada asesor, la EMA restringirá su participación en determinadas actividades o, incluso, decidirá su exclusión total. Asimismo, manifiesta en un comunicado su intención de desplegar "un enfoque más proactivo tanto en la identificación de potenciales conflictos de interés como en la búsqueda de expertos alternativos".

La EMA es la agencia centralizada, con sede en Londres, que se encarga de la evaluación científica de los productos que desarrollan las compañías farmacéuticas para su uso en la Unión Europea. Su falta de transparencia ha sido criticada desde distintas instancias, incluido el Parlamento Europeo, cuyos miembros han llegado a negarse a aprobar sus presupuestos hasta que la EMA no endureciese el control sobre los posibles conflictos de interés.


enlace : http://tinyurl.com/MAC-Emea


Martín Cañás
Fundación Femeba
La Plata  (Argentina)
farmacol@femeba.org.ar

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