Drosperinone

English: Logo of the . (Photo credit: Wikipedia)

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

BACKGROUND:  Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/10/2012 - Drug Safety Communication - FDA]

Previous MedWatch Alert:

[10-27-2011]

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Disclose payment by big pharma

Fda (Photo credit: Wikipedia)

The federal government announced Friday that all drug and medical device makers must publicly disclose payments made to physicians and hospitals in the United States.
All drug companies and medical device makers must publicly disclose what they are paying individual physicians in the United States, the federal government announced Friday.
 The information will be made public starting Sept. 2014. This comes after a number of lawsuits resulting in billions made in settlements regarding payments made to doctors. Several large drugmakers have already put the data on their websites, which you can access through the ProPublica Dollars for Docs feature. Two of the companies who have already released their data are Johnson & Johnson and Pfizer.
 ProPublic is updating the Dollars for Docs database and will expand the data to 15 companies through late 2012.
 The data set for release in September 2014 includes payments made from August to December of 2012. Drug companies must hand over the information to the government by March 2014 and will have 45 days to review the data for accuracy before it is publicly released.
 The figures were supposed to be released in 2013 as part of 2010's health care reform law. The Obama administration has given no explanation for the delay. Brian Cook from the Centers for Medicare and Medicaid Services is "working to release the regulations as soon as possible," he said in an email.
 Sen. Charles Grassley, R-Iowa, wrote the White House on Tuesday asking officials to provide a release date for the regulation.
 "Letting the sun shine in and making information public is basic to accountability," Grassley said in the letter to White House Chief of Staff Jacob Lew. "The sooner we can properly implement this law, the sooner we can establish greater accountability for patients and consumers, especially with medical research."
 Physicians on FDA advisory panels have had to inform the agency about conflicts of interest for years. The FDA determines when a waiver due to financial conflict is necessary and keeps monetary arrangements between physicians and drug companies under wraps — even from other members of the panel.
 "The question is whether there's some residual fondness for the company because they did pay you," said Sidney Wolfe, director of the health policy research group at Public Citizen. "More disclosure is better."
 Disclosure of payments made may bring more scrutiny on doctors serving on FDA advisory boards which help the administration decide on the approval of a new drug.
 The Project on Government Oversight has urged the FDA to disclose data since 2010. A year ago the group wrote the FDA again after four advisory panel members backed Yaz, a birth control pill made by Bayer AG. Despite the concern that Yaz and other birth control pills in its class come with a higher risk of blood clotting, the drug was approved. It was discovered the four advisors had worked for Leverkusen, the Germany-based Bayer company that makes generic versions of Yaz.
 Ned Feder, staff scientists with the Project on Government Oversight, believes it is difficult to locate skilled advisory member while avoiding conflicts entirely.
 "In areas of medicine that are popular these days, I think it's hard to find enough skilled reviewers without possible conflicts of interest and this means that a good committee may have a few such members with possible conflicts," he said.
 "The solution, I think, is not to insist on limiting committees to members without conflicts," Feder said. "Simply disclose the financial arrangements of all committee members."
 Director of medical programs for the Pew Health Group, Allan Coukell, agrees.
 "No drug can be developed or tested without the participation of physicians who enroll patients in clinical trials," he said. "That's an essential part of drug development and we need it to continue."
 When the new regulation is active in 2014, there will be penalties for drugmakers who don't properly report their data. These fines range from $1,000 to $10,000 per violation. If a drug company is found to have deliberately failed to report a payment, the fine could be as much as $1 million.


Read more: http://www.digitaljournal.com/article/342738#ixzz2KBkT0j8O

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Quien es quien en la batalla de los biotecnologicos

Image via CrunchBase

Via: Lista e-farmacos

Fuente: http://www.elespectador.com

Un difícil decisión fue la herencia que le dejó el ex ministro de Salud Mauricio Santa María a su sucesora, Beatriz Londoño: firmar un decreto con las reglas de juego para participar en el multimillonario negocio de los medicamento biotecnológicos en Colombia.

No parecen días fáciles para la ministra Londoño. “El justo medio”, que recomendaba Aristóteles y que consiste en buscar en todas las acciones de nuestra vida la medida justa entre el exceso y el defecto, parece muy difícil de lograr en este caso. Los pacientes reunidos en más de 140 organizaciones, las casas farmacéuticas nacionales y las multinacionales, los gremios del sector, los académicos, la Academia Nacional de Medicina, todos juegan con cartas distintas y las posiciones parecen irreconciliables.

Según Juan Gonzalo Zapata y Roberto Steiner, investigadores de Fedesarrollo, “en general, se ven posiciones encontradas en donde una parte defiende como argumento central que la seguridad, la eficacia y la calidad deben primar sobre el estímulo a la competencia. De otra, se defiende la necesidad de fomentar la competencia en el mercado de los biotecnológicos, pues existe una serie amplia de barreras de acceso que impiden que la industria farmacéutica nacional participe actualmente en este mercado”.

El mercado de los medicamentos biotecnológicos asciende en Colombia a US $1.000 millones anuales. Siete de los medicamentos más recobrados al Fosyga en los últimos años corresponden a estos fármacos producidos por medio de tecnologías genéticas y moleculares para combatir, principalmente, enfermedades autoinmunes como la artritis y diferentes tipos de tumores. La Federación Latinoamericana de la Industria Farmacéutica (FIFARMA) estima que en 2012 los medicamentos biotecnológicos representarán el 12% del total de las ventas mundiales de medicamentos de prescripción.

Estos son los jugadores enfrentados por el decreto del gobierno, sus posiciones y algunos de sus “puntos débiles”.

1. Casas farmacéuticas multinacionales: Bayer, Pfizer, Abbot, Roche, Schering, Baxter, Boehringer Ingelheim y Eli Lliy. Gozan de una posición dominante en el mercado. De los biotecnológicos más recobrados al sistema de salud, sólo uno de ellos compite con un genérico. Hay que reconocer que esta industria invierte millones de dólares en innovación para crear nuevas tecnologías y medicamentos que permitan dar respuestas a problemas de salud vigentes. Gracias a esas inversiones, el arsenal farmacéutico con el que hoy contamos ha crecido y evolucionado. Su mayor debilidad es que en el pasado reciente abusaron del monopolio del que gozan gracias a la protección de datos y patentes y, en no pocas ocasiones, inflaron los precios a niveles irracionales.

2. Casas farmacéuticas nacionales: Quieren arrebatarle una parte del mercado de los biotecnológicos a sus competidoras internacionales produciendo sus propias moléculas genéricas o importando otras que circulan en el exterior. Buscan que el decreto sea lo suficientemente flexible para registrar sus fármacos. Su debilidad es que no siempre resulta sencillo demostrar la calidad y eficacia de las copias de medicamentos. Su capacidad de presión es mucho menor que la de sus principales contradictores, las casas internacionales.

3. Asociaciones de Pacientes: A través de Pacientes Colombia, movimiento social que agrupa a 146 organizaciones de pacientes de todo el país, han manifestado su rechazo al decreto propuesto por el gobierno. La mayoría de estas asociaciones corresponden a pacientes que padecen enfermedades susceptibles de ser tratadas con medicamentos biotecnológicos. Su posición podría resumirse en: ¿para qué permitir que entren genéricos si podríamos seguir recibiendo los fármacos de las mejores marcas que gozan de la mejor reputación de calidad? Uno de sus puntos débiles es que muchas reciben financiación de la industria farmacéutica multinacional.

4. Academia Nacional de Medicina: Ha cuestionado el decreto del gobierno. Aunque abiertamente no se opone a los “biosimilares” o copias, los requerimientos que pide al gobierno implementar para su registro prácticamente equivalen a cerrar la puerta. Un punto débil: esta semana se conoció que su principal asesor en el tema, el toxicólogo Camilo Uribe, ha sido dos veces condenado por la justicia por peculado y fraude procesal.

5. Gremios médicos: Los distintos gremios médicos han sido muy pasivos hasta ahora. En un tema tan delicado y de tanto impacto para la salud pública se esperaría de ellos una participación más activa y un debate científico de más alto nivel.

6. Gobierno: La Ministra de Salud, Beatriz Londoño, parece dispuesta a escuchar a todas las partes involucradas pero por la redacción del decreto actual da la impresión de que ya está jugada por abrir el mercado para que entren los genéricos y así aliviar un poco el apretado gasto del sistema de salud. Su defensa ha sido que está siguiendo las recomendaciones de la Organización Mundial de la Salud. Su punto débil: las presiones internas y externas de alto nivel.