Archive for 31 enero 2013

Orphan Drugs for Rare Diseases Gain Popularity With Pharmaceutical Companies –

enero 31, 2013

Esta estrategia comercial se ve en la práctica con la judicialización de las demandas de pacientes por acceso a estos medicamentos en cumplimiento del indiscutible derecho a la salud. Sin embargo, debería haber un amplio debate social al respecto, ya que en algunas situaciones esto puede generar un aumento de la inequidad del sistema (ver Ferraz en Health&Human Rights. Como se puede ver en el artículo del NYT abajo, las farmacéuticas sostienen e impulsan las asociaciones de pacientes.

The right to health in the courts of Brazil: Worsening health inequities?

Octavio Luiz Motta Ferraz

Orphan Drugs for Rare Diseases Gain Popularity With Pharmaceutical Companies –

Making ‘Every Patient Counts’ a Business Imperative

BEDMINSTER, N.J. — Drug companies are fond of saying that every patient counts, but in the world of orphan diseases, entire business plans are built around the idea.

That is why Andrew E. Jablonski, a 26-year-old from Lincoln, Neb., was a guest of honor this month at NPS Pharmaceuticals, a small New Jersey company that is about to begin selling Gattex, its only approved drug. Mr. Jablonski, who was born missing most of his intestines and has a condition known as short bowel syndrome, is central to the company’s mission to win over the tiny pool of patients — fewer than 5,000 nationwide — that the drug is intended to treat.

Over the last two years, NPS has carefully tended its relationship with Mr. Jablonski, helping to finance his nonprofit, the Short Bowel Syndrome Foundation, and flying company leaders to visit him in Lincoln. On Jan. 15, he met with the chief executive and strategized with marketing employees about how to promote Gattex to his social network of 1,000 patients and caregivers.

“It’s a nice, close relationship,” Mr. Jablonski said. “I’m an asset to them, as they are an asset to me.”

NPS hopes that Gattex will ultimately bring in hundreds of millions of dollars in annual sales and help establish the company in the increasingly hot orphan drug market, where companies can charge premium prices to treat overlooked diseases with little or no competition. NPS expects to charge about $300,000 a year for Gattex, a breathtaking price tag that is nonetheless on par with other ultra-orphan drugs on the market.

Development of these drugs is increasingly attractive to pharmaceutical companies, which are searching for new sources of revenue as sales of more traditional, mass-market drugs have been lost to generic competition. The orphan drug market was worth more than $50 billion in 2011 and turns out blockbusters at the same rate as the broader industry, according to a recent Thomson Reuters analysis. Pfizer opened a rare disease unit in 2010, and in 2011, Sanofi acquired the biotech company Genzyme, considered one of the pioneers of the orphan drug industry.

As orphan drugs have become increasingly popular, companies have honed their marketing techniques, knowing that they cannot afford to lose a single patient. Following in the footsteps of drug makers like Vertex, which makes the cystic fibrosis drug Kalydeco, NPS has formed close bonds with advocates like Mr. Jablonski and hired so-called patient care coordinators who will do everything from making sure that Gattex is delivered to patients’ doorsteps to writing appeal letters if an insurer refuses to pay for it.

PLOS Medicine: Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin

enero 31, 2013

PLOS Medicine: Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin.

Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin

  • S. Swaroop Vedula,
  • Tianjing Li,
  • Kay Dickersin

Editors’ Summary


To be credible, published research must present an unbiased, transparent, and accurate description of the study methods and findings so that readers can assess all relevant information to make informed decisions about the impact of any conclusions. Therefore, research publications should conform to universally adopted guidelines and checklists. Studies to establish whether a treatment is effective, termed randomized controlled trials (RCTs), are checked against a comprehensive set of guidelines: The robustness of trial protocols are measured through the Standard Protocol Items for Randomized Trials (SPIRIT), and the Consolidated Standards of Reporting Trials (CONSORT) statement (which was constructed and agreed by a meeting of journal editors in 1996, and has been updated over the years) includes a 25-point checklist that covers all of the key points in reporting RCTs.

Why Was This Study Done?

Although the CONSORT statement has helped improve transparency in the reporting of the methods and findings from RCTs, the statement does not define how certain types of analyses should be conducted and which patients should be included in the analyses, for example, in an intention-to-treat analysis (in which all participants are included in the data analysis of the group to which they were assigned, whether or not they completed the intervention given to the group). So in this study, the researchers used internal company documents released in the course of litigation against the pharmaceutical company Pfizer regarding the drug gabapentin, to compare between the internal and published reports the reporting of the numbers of participants, the description of the types of analyses, and the definitions of each type of analysis. The reports involved studies of gabapentin used for medical reasons not approved for marketing by the US Food and Drug Administration, known as “off-label” uses.

What Did the Researchers Do and Find?

The researchers identified trials sponsored by Pfizer relating to four off-label uses of gabapentin and examined the internal company protocols, statistical analysis plans, research reports, and the main publications related to each trial. The researchers then compared the numbers of participants randomized and analyzed for the main (primary) outcome and the type of analysis for efficacy and safety in both the internal research report and the trial publication. The researchers identified 21 trials, 11 of which were published RCTs that had the associated documents necessary for comparison.

The researchers found that in three out of ten trials there were differences in the internal research report and the main publication regarding the number of randomized participants. Furthermore, in six out of ten trials, the researchers were unable to compare the internal research report with the main publication for the number of participants analyzed for efficacy, because the research report either did not describe the primary outcome or did not describe the type of analysis. Overall, the researchers found that seven different types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including intention-to-treat analysis. However, the protocol or publication used six different descriptions for the intention-to-treat analysis, resulting in several important differences between the internal and published documents about the number of patients included in the analysis.

What Do These Findings Mean?

These findings from a sample of industry-sponsored trials on the off-label use of gabapentin suggest that when compared to the internal research reports, the trial publications did not always accurately reflect what was actually done in the trial. Therefore, the trial publication could not be considered to be an accurate and transparent record of the numbers of participants randomized and analyzed for efficacy. These findings support the need for further revisions of the CONSORT statement, such as including explicit statements about the criteria used to define each type of analysis and the numbers of participants excluded from each type of analysis. Further guidance is also needed to ensure consistent terminology for types of analysis. Of course, these revisions will improve reporting only if authors and journals adhere to them. These findings also highlight the need for all individual patient data to be made accessible to readers of the published article.

¡Ojo con los “subestudios” y los “beneficios compartidos”!

enero 31, 2013

Creo que mientras este tema no esté bien aclarado, desde Latinoamérica no debemos seguir enviando muestras biológicas al norte, especialmente cuando estos envíos vienen empaquetados y disfrazados de “subestudios” farmacogenómicos dentro de otros protocolos “de investigación”, y que luego servirán para generar patentes y medicamentos a los que nuestros pueblos no tendrán acceso.

Benefit sharing: it’s time for a definition
D Schroeder
J Med Ethics,2007;33:205–209.
Schroeder da una definición que habría que debatir, pero que es interesante:
Benefit sharing is the action of giving a portion of advantages/profits derived from the use of human genetic resources to the resource providers in order to achieve justice in exchange with particular emphasis on the clear provision of benefits to those who may lack reasonable access to resulting products and services.
Claro que habría que ver qué se considera “justicia” y “dar una parte”, pero se puede empezar a discutir sobre el tema.




Monsanto y su seudociencia contra el pensamiento autónomo. Lo político tras los organismos transgénicos.

enero 29, 2013

Monsanto y su seudociencia contra el pensamiento autónomo. Lo político tras los organismos transgénicos. Boletín N° 508 de la Red por una América Latina Libre de Transgénicos..

Biotech Firms, Billions at Risk, Lobby States to Limit Generics

enero 29, 2013

Big Pharma se pone nerviosa frente a la introducción de biosimilares e intenta evitarlo haciendo lobby. Ya practican el reverdecimiento (evergreening) de patentes para evitar que salgan los genéricos. Caramba ¿y el libre mercado?

Nota en el New York Times de hoy:

Biotech Firms, Billions at Risk, Lobby States to Limit Generics.

Países a los que llegamos en el último año

enero 26, 2013
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¡Llegamos a casi todo el mundo!

enero 26, 2013

Llegada del blog en el mapamundi

Table of Contents, Vol 14, No 2 (2012), Health and Human Rights

enero 26, 2013

Table of Contents, Vol 14, No 2 (2012), Health and Human Rights.

Los números de 2012

enero 26, 2013

Los duendes de las estadísticas de prepararon un informe sobre el año 2012 de este blog.

Aquí hay un extracto:

600 personas llegaron a la cima del monte Everest in 2012. Este blog tiene 12.000 visitas en 2012. Si cada persona que ha llegado a la cima del monte Everest visitara este blog, se habría tardado 20 años en obtener esas visitas.

Haz click para ver el reporte completo.

Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine : The Lancet

enero 22, 2013

Dr Stanley WB Ewen  & Arpad Pusztai PhD

Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine

vía Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine : The Lancet.

Luego de esta publicación Arpad Pusztai fué despedido, y a Stanley Ewen lo jubilaron.

La REDUAS investiga ¿que espera el Ministerio de Salud para poner este tema como una prioridad nacional de investigación?

enero 22, 2013

La Red Universitaria de Ambiente y Salud (REDUAS) es una coordinación entre profesionales universitarios, académicos, científicos, miembros de equipos de salud humana en sus distintos niveles y demás estudiosos, preocupados por los efectos deletéreos de la salud humana que genera el ambiente degradado a consecuencias de la actividad productiva humana, especialmente cuando esta se da a gran escala y sustentada en una visión extractivista.

La REDUAS surge como una de las decisiones tomadas en el 1º Encuentro de Médicos de Pueblos Fumigados, realizado en la Facultad de Ciencias Médicas de la Universidad Nacional de Córdoba y organizado por el Modulo de Determinantes Sociales de la Salud de la Cátedra de Pediatría y por la Cátedra de Medicina I de dicha Facultad; concretado el 26 y 27 de agosto de 2010

La REDUAS se construye para unir, coordinar y potenciar el trabajo de investigación científica, asistencia sanitaria, análisis epidemiológico y divulgación ,difusión y defensa del derecho a la salud colectiva, que realizan equipos que desarrollan este tipo de actividades en 10 provincias distintas de la Republica Argentina y que se encuentran activados por el problema del daño a la salud que ocasiona la fumigación o aspersión, sistemática de más de 300 millones de litros de plaguicidas sobre casi 12 millones de personas que conviven con los sembradíos de cultivos agroindustriales.

Para avanzar en ese sentido se propone aportar al debate público por la necesidad de construir prácticas productivas que permitan una supervivencia feliz de la especie humana en la superficie terrestre y de la responsabilidad publica, privada, colectiva e individual en el resguardo de esas condiciones ecológicas.

Considerando al derecho a la salud, como uno de los valores sociales que debemos tratar de privilegiar en el análisis de las decisiones políticas y económicas que se toman en nuestra sociedad, creemos necesario ampliar la difusión del conocimiento de los datos científicos que se dispone, y que muchas veces se invisibilizan; aportar a la generación de nuevos datos e informaciones experimentales y observacionales – poblacionales; y potenciar la voz de los equipos de salud, investigadores y pobladores en general afectados en sus derechos por agresiones ambiéntales generadas por practicas productivas ecológicamente agresivas.

Scientific American: las grandes semilleras transnacionales impiden la investigación científica sobre sus semillas genéticamente modificadas.

enero 22, 2013

Do Seed Companies Control GM Crop Research?

vía Do Seed Companies Control GM Crop Research?: Scientific American.

“Scientists must ask corporations for permission before publishing independent research on genetically modified crops.”

Ver también FW Engdahl

GMO Scandal: The Long Term Effects of Genetically Modified Food on Humans

Scientific Tests Must Be Approved by Industry First



Mercaderes en el Templo: hegemonía del paradigma bio-comercial en Psiquiatría.

enero 17, 2013

Mercaderes en el Templo: hegemonía del paradigma
bio-comercial en Psiquiatría.
Jose García-Valdecasas Campelo, Amaia Vispe Astola.
Rev. Asoc. Esp. Neuropsiq., 2011; 31 (110), 321-341.

La colega y amiga Estela Quiroz nos ha enviado esta excelente reseña de lo que ocurre en el ámbito de la “psiquiatría bio-comercial”, que es extrapolable al campo de la salud en general.

RESUMEN: En el presente trabajo nos proponemos llevar a cabo una reflexión sobre la influencia de la industria farmacéutica en la psiquiatría actual, a través de una revisión de cuatro aspectos: la formación docente y científica que damos y recibimos, así como sus  sesgos;  la  nosografía  psiquiátrica  contemporánea  y  sus  próximas  evoluciones  según  anuncia  ya el DSM-V; la eficacia y efectos secundarios de los fármacos que prescribimos, medidos a través de estudios no dependientes de las empresas que venden dichos productos; y, en último lugar, el papel que juega el gasto farmacéutico que provocamos y si se justifica o no, teniendo en cuenta la coyuntura de crisis económica global en la que estamos inmersos. Finalmente, elaboraremos unas conclusiones en base a lo revisado y a nuestra propia experiencia personal en la relación de nuestra disciplina con la industria. Apuntaremos, humildemente, algunas posibles soluciones para lo que consideramos una situación problemática de la psiquiatría.