Archive for 18 febrero 2013

Una “vieja” entrevista a experto en transgénicos de la Unión Europea y la realidad argentina actual

febrero 18, 2013

Entrevista a experto en transgénicos de la UE. « Semillas y Salud.

Esta entrevista es del 2009, pero cobra actualidad y urgencia con la publicación de

Séralini, G.-E., et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. (2012)

ABSTRACT – The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2–3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5–5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3–2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

Entre las conclusiones se afirma que “The results of the study presented here clearly demonstrate that lower levels of complete agricultural glyphosate herbicide formulations, at concentrations well below officially set safety limits, induce severe hormone-dependent mammary, hepatic and kidney disturbances.”

“Other mutagenic and metabolic effects of the edible GMO cannot be excluded. This will be the subject of future studies, including transgene and glyphosate presence in rat tissues. Reproductive and multigenerational studies will also provide novel insights into these problems. This study represents the first detailed documentation of long-term deleterious effects arising from the consumption of a GM R-tolerant maize and of R, the most used herbicide worldwide.”

Hace muchos años que Séralini viene estudiando estos temas, y ha denunciado claramente que las semilleras no dan los datos de sus estudios al conocimiento público, los consideran confidenciales. Además tratan de bloquear la investigación.  Por supuesto que gran cantidad de científicos objetan sus conclusiones, pero así se genera la ciencia. De todos modos es imprescindible recordar la necesidad de aplicar el principio de precaución.

¿Como es posible que el Ministerio de Salud argentino no haya establecido un grupo permanente de investigación sobre estos temas de contaminación por plaguicidas y salud pública? ¿Como es posible que trabajos como el que se hizo en la Sardá sobre clorados en leche materna no hayan podido completarse adecuadamente por falta de fondos para reactivos, ni hayan podido tener un seguimiento adecuado de la maduración neurológica de los niños involucrados?

Is there a cure for corporate crime in the drug industry? | BMJ Editorial

febrero 13, 2013

Is there a cure for corporate crime in the drug industry? | BMJ.

BMJ 2013;346:f755

Tapa BMJ February 2013 - Corporate crime and pharma

Editorial del British Medical Journal que dice, entre otras cuantas cosas:

“nine of the 10 largest drug companies were bound by corporate integrity agreements under civil and criminal settlements or judgments in the United States. The corporate activity that has led to recent government investigations has involved unethical and unlawful practices that are well beyond mere administrative offences.
Whistleblowers’ and other “insider” accounts in the US typically include allegations that companies systematically planned complex marketing campaigns to increase drug sales, which involved illegal and fraudulent activities. These included active promotion of off label, or otherwise inappropriate, use of drugs, despite company knowledge that such use could seriously harm patients.

Al referirse a la falta de medidas de castigo de gravedad apropiada el BMJ dice: “Such timid regulatory behaviour may be symptomatic of the extent to which regulators have been encouraged by governments to be responsive to the commercial interests of industry and to view large drug firms as clients whose fees increasingly fund these agencies.”

Este es el funesto efecto de los PDUFA, que colocan al zorro en el gallinero.

Ver Wikipedia “The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.”

Esta gente -bioeticistas de USA y Europa – pretende pontificar sobre corrupción, y darnos clase, cuando tiene la corrupción instalada hasta los huesos del sistema, y además legalizada, tal como lo denuncia el BMJ.

PhRMA se ofendió

febrero 6, 2013

PhRMA Statement on Clinical Trials and Bad Pharma | PhRMA.

Sin ruborizarse afirman: “Dr. Ben Goldacre’s book Bad Pharma provides a one-sided and factually questionable view of the clinical trial process led by the innovative biopharmaceutical sector. The book ignores that the current clinical trial system, which is essential to the development of new medicines that save and improve lives, is scientifically rigorous, tightly regulated and working well.”

Al final manifiestan en un recuadrito:

“The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives.”

O sea que estábamos errados, no lo hacen con fines de lucro.


Annals of Internal Medicine | SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

febrero 6, 2013

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

vía Annals of Internal Medicine | SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.

Para leer con detenimiento.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.

Informe-Malvinas-corregido.pdf

febrero 6, 2013

Análisis de la Salud Colectiva Ambiental de Malvinas Argentina – Córdoba

Una investigación socio-ambiental y sanitaria a través de técnicas cualitativas y relevamiento epidemiológico cuantitativo

vía Informe-Malvinas-corregido.pdf.

Ruderman L, Cabrera Fasolis B, Dozzo G, Nota C, Avila Vazquez M.
– Red Universitaria de Ambiente y Salud/Médicos de Pueblos Fumigados,

– Catedra de Medicina Psicosocial, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba,
– Cátedra de Alergia e Inmunología, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba,
– Cátedra de Medicina I, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba

– Cátedra de Clínica Pediátrica, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba

Conclusión
 A través de este análisis cualitativo y cuantitativo de la salud colectiva ambiental de la ciudad de Malvinas Argentinas, podemos reconocer que presenta el perfil de enfermedades que se reitera en las poblaciones expuestas a pesticidas aerolizados de la Argentina, y que no hay políticas de mitigación en marcha.
El alto impacto encontrado en salud reproductiva, respiratoria y dermatológica y la distribución espacial de las mismas, incluyendo tumores y canceres, con un gradiente mayor en las zonas más expuestas a los pesticidas, reflejan grados de vulnerabilidad ambiental muy grandes.
La vulnerabilidad social y económica de la población es de las más altas en la Provincia de Córdoba y la capacidad del Estado municipal de responder a la demanda de enfermedad es mínima.
Someter a esta población a un nuevo golpe en su salud ambiental, como el que generará una enorme planta de semillas transgénicas de Monsanto en su jurisdicción no es recomendable desde el punto de vista médico e intolerable desde el punto de vista social.
Gracias  MAV por el acceso al material original en texto completo.

Alarmante informe sobre la salud en Malvinas Argentinas | ECOS Córdoba – Ecología Colectiva de las Organizaciones Sociales

febrero 5, 2013

Alarmante informe sobre la salud en Malvinas Argentinas | ECOS Córdoba – Ecología Colectiva de las Organizaciones Sociales.

De la investigación desarrollada se concluye que: “La vulnerabilidad social y económica de la población es las más alta en la Provincia de Córdoba y la capacidad del Estado Municipal de responder a la demanda de enfermedad es mínima. Someter a esta población a un nuevo golpe en su salud ambiental, como el que generará una  enorme planta de semillas transgénicas de Monsanto en su jurisdicción no es recomendable desde el punto de vista médico, y  es intolerable desde el punto de vista social.”

Contactos:

Medardo Ávila Vázquez | medardoavilavazquez@yahoo.com.ar | 351-15-5915933

Luciana Ruderman | lucianaruderman@yahoo.com.ar | 351-15-3724132

Más información:

Red de Ambiente y Salud, Médicos de Pueblos Fumigados

Privacidad garantizada…

febrero 4, 2013

Whose DNA is it anyway? | Bioethics.net.

Se garantiza la privacidad en los ensayos clínicos y en la recolección de muestras para farmacogenómica…

Whose DNA is it anyway?

Yaniv Erlich, a computer informatics and genetics researcher at the Whitehead Institute, and his colleagues published a paper in Science where they explained that Erlich and his then graduate student Melissa Gymrek had re-identified 50 of the 1000 Genomes samples. Erlich and Gymrek developed a tool that allowed them to quickly identify repeated areas of DNA on the Y chromosome and applied that technique to 10 male samples from 1000 Genomes. Comparing that information to other web-based genetic databases—from the Center for Study of Human Polymorphisms (CEPH) and the National Institute of General Medical Sciences Human Genetic Cell Repository at the Coriell Institute—provided ages, geographic location, and even family trees that enabled Erlich and Gymrek to identify 50 of the 1000 Genomes donors. In short, they could re-identify the de-identified data.

El Asma, los Niños y los Pesticidas | Red Universitaria de Ambiente y Salud – Medicos de pueblos fumigados

febrero 3, 2013

El Asma, los Niños y los Pesticidas | Red Universitaria de Ambiente y Salud – Medicos de pueblos fumigados.

¿Quien “demoniza” a la industria farmaceútica?

febrero 3, 2013

Investigadores y bioeticistas que ven con simpatía al “mercado de la salud” y cosas semejantes a menudo se quejan de que no hay que “demonizar” a la sufrida industria farmacéutica… Pareciera que es un sesgo de los bioeticistas latinoamericanos “de izquierda” o algo así, y que no está fundado en evidencias sino en prejuicios ideológicos… puede ser, pero por eso nos preguntamos:

¿ Quien dice

“Drug firms often develop products that have minor value,  and neglect  investing  in  significant  innovative therapies.”

“They often behave as if they have no responsibility for how physicians prescribe or patients use drugs.”

“They sometimes promote drugs in ways that endanger the public’s  health.”

“They  market drugs  for uses where risks outweigh the benefits.”

“They  fuel  inappropriate  prescribing while earning income from improper drug use.”

“Worse, drug firms have slanted the information available  to  public  officials  who  decide whether to authorize the sale of drugs and who monitor the risks of drugs on the market.”

“They bias the information available to physicians, hospitals, policymakers, and insurers and thereby corrupt the practice of medicine.” ?

(Tomado de “Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform” by Marc Rodwin “). Lo interesante es que está ampliamente fundamentado y con una bibliografía extensiva.

Lo dicen investigadores del Edmond J. Safra Center for Ethics Research Lab de la Universidad de Harvard. Lessig, Miller, Rodwin, Light, y unos cuantos más. Comentan que su trabajo incluye, entre otras cosas, el Special Issue on Conflicts of Interest in Medicine Vol. 40, Issue 3 of The Journal of Law, Medicine & Ethics , dedicated to exploring conflicts of interest in medicine from a variety of fresh and powerful perspectives. Articles contributed by Lab Fellows and Faculty Associates include the “Introduction: Insights from a National Conference” by Aaron Kesselheim and David Orentlicher; “Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence” by Christopher Robertson, Susannah Rose and Aaron Kesselheim; “Conflicts of Interest and Your Physician: Psychological Processes That Cause Unexpected Changes in Behavior” by Sunita Sah; and “Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform” by Marc Rodwin.

Furthermore, Professor Rodwin is currently editing a Special Issue of JLME on Institutional Corruption and Pharmaceutical Policy, scheduled for publication next year.

No parece un nicho izquierdista dedicado a demonizar a la industria ¿no?  🙂

Entonces, le sugerimos a la gente que trabaja para las CROs, los diversos “Comités de Ética Independientes”, y a las asociaciones que apoyan/se apoyan en la industria farmacéutica que publiquen. Que publiquen papers, plenos de ejemplos concretos que desmientan las afirmaciones que hacemos, y que parece que más de uno comparte. Este blog está abierto para publicar sus refutaciones científicas, basadas en la evidencia.

Independent Clinical Trials to Test Drugs: The Neglected Reform

febrero 3, 2013

Alguien que habla claro sobre el conflicto de intereses básicamente inherente a la industria farmacéutica, cuyo objetivo primario (el lucro), no es precisamente la búsqueda de conocimiento para el beneficio común. Y esto corrompe la investigación, los tratamientos, la medicina, y las instituciones, llegando hasta la OMS. Los dos trabajos de Rodwin son excelentes y se pueden bajar gratis en texto completo de SSRN, que es un portal recomendable.

Independent Clinical Trials to Test Drugs: The Neglected Reform by Marc Rodwin :: SSRN.

Drug  manufacturers  face  a  fundamental  conflict  of  interest.  Pursuit  of profit  compromises  their  impartial  assessment  of  their  drugs’  benefits  and risks. 1  Their biased evaluation can corrupt public knowledge of drugs, lead to  marketing  unsafe  and/or  ineffective  drugs,  and  undermine  rational physician  prescribing. 2   Over  the  last  century,  federal  regulation  has mitigated but not eliminated this problem, which corrupts drug therapy and
medical practice. 3

This  article  explores  a  reform  proposal  that  precludes  bias  in  clinical trials used to test drugs. Simply stated, it removes all drug firm influence on the  design  and  conduct  of  clinical  trials  used  to  decide  whether  to  allow marketing of a drug. Recently advocated by several leaders in drug policy and research, this reform proposal has a long history, but was neglected for over half a century due to pharmaceutical industry opposition, and so the federal  government  pursued  alternative  strategies  to  counter  bias,  which proved  ineffective. When  regulation  of  manufacturer  controlled  clinical trials  failed  to  eliminate  bias,  flawed  practice,  and  fraud,  public  officials
increased oversight relying on the same flawed approach.

The corruption lies at the root:  drug firm control over clinical trials, and so to be effective, reforms need to eliminate this problem.

Otro trabajo:

Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform

Marc A. Rodwin
Suffolk University Law School
October 16, 2012
Journal of Law, Medicine and Ethics, Vol. 40, p. 511, 2012
Suffolk University Law School Research Paper No. 12-40

El texto en rojo, negritas y subrayado ha sido modificado por mi, el estilo académico de Rodwin es impecable, y jamás haría eso.

Acceso a la atención y derecho a la salud – Boletín OMS 2013

febrero 1, 2013

Universal health coverage anchored in the right to health

Gorik Ooms a, Claire Brolan b, Natalie Eggermont a, Asbjørn Eide c, Walter Flores d, Lisa Forman e, Eric A Friedman f, Thomas Gebauer g, Lawrence O Gostin f, Peter S Hill b, Sameera Hussain h, Martin McKee i, Moses Mulumba j, Faraz Siddiqui f, Devi Sridhar k, Luc Van Leemput a, Attiya Waris l & Albrecht Jahn m

a. Institute of Tropical Medicine, Nationalestraat 155, Antwerp 2000, Belgium.
b. University of Queensland, Brisbane, Australia.
c. University of Oslo, Norwegian Centre for Human Rights, Oslo, Norway.
d. Center for the Study of Equity and Governance in Health Systems, Guatemala City, Guatemala.
e. University of Toronto, Dalla Lana School of Public Health, Toronto, Canada.
f. Georgetown University, O’Neill Institute for National and Global Health Law, Washington, United States of America.
g. Medico International, Frankfurt am Main, Germany.
h. BRAC University, James P Grant School of Public Health, Dhaka, Bangladesh.
i. London School of Hygiene and Tropical Medicine, London, England.
j. Center for Health Human Rights and Development, Kampala, Uganda.
k. University of Oxford, Blavatnik School of Government, Oxford, England.
l. University of Nairobi, Nairobi, Kenya.
m. University of Heidelberg, Institute of Public Health, Heidelberg, Germany.
Correspondence to Gorik Ooms (e-mail: gooms@itg.be).

Bulletin of the World Health Organization 2013;91:2-2A. doi: 10.2471/BLT.12.115808

European Commissioner for Development Andris Piebalgs recently pointed out the need for “updated and modernised [Millennium Development Goals], providing decent living standards for all – a set of minimum floors below which no one should fall”.1 He added that “these ‘MDGs plus’ would provide the basic rights that every citizen on the planet should expect … with, where necessary, for the poorest countries, the support of the international community through continued overseas development assistance”.1

We concur with Commissioner Piebalgs’ demand for basic rights for all people and feel that the right to health and its imperative of narrowing health inequities should be central to the post-2015 international health agenda. We take this stand as members of Go4Health, a consortium of academics and members of civil society tasked with advising the European Commission on the international health-related goals to follow the Millennium Development Goals (MDGs). What does this mean, given that the present MDGs on maternal health, child health and infectious disease control will probably be succeeded by the goal of universal health coverage, defined by the World Health Organization (WHO) as universal coverage with needed health services and financial risk protection?2,3

First, we view an aggregate health goal such as universal health coverage as an improvement over the current set of disparate goals. Ensuring the right to health requires a comprehensive approach. Universal health coverage anchored in the right to health, while building on efforts to meet the present health-related MDGs, would raise the bar for improving health care overall.

Second, although we support making universal health care one of the post-2015 development goals, we feel that universal health coverage is not enough, as defined by WHO and typically conceived,3 to ensure the right to health. For the right to health to become a reality, policy-makers must strive for a healthy physical and social environment (e.g. safe drinking water and good sanitation, adequate nutrition and housing, safe and healthy occupational and environmental conditions and gender equality.)4 These “underlying determinants of health” are partially captured in the present MDGs and their corresponding targets, although under different goals (e.g. nutrition under MDG 1, to eradicate extreme hunger and poverty, and water and sanitation under MDG 7, to promote environmental sustainability). These determinants and many more that are needed for a sustainable healthy environment should figure prominently in the post-2015 health agenda.

Third, specifying people’s entitlements is necessary but not enough. One important reason for the failure to attain all MDGs is the ambiguity of the “shared responsibility” mentioned in Article 2 of the Millennium Declaration: “We recognize that, in addition to our separate responsibilities to our individual societies, we have a collective responsibility to uphold the principles of human dignity, equality and equity at the global level.”5 If we want “every citizen on the planet” to claim his or her right to health, the post-2015 health agenda must specify how citizens will participate in the decision-making processes surrounding their health services and their physical and social environment. Furthermore, the agenda should also explicitly describe the accountability mechanisms that will make it possible for people to claim – not beg for – additional national public resources and international assistance, if needed.

Finally, we are concerned not just about the substance of the post-2015 health goals, but also about the process of formulating them. We have entered a post-2015 frenzy, as evidenced by the appointment of a high-level panel expected to submit a report to the United Nations Secretary-General in the first half of 2013.6 Go4Health is committed to ensuring that any post-2015 health development goals are articulated in collaboration with the communities whose health is at stake. However, truly participatory consultations take time and require a continuing relationship among researchers, governments and those communities. Such an approach should be adopted to prevent goals from being formulated by policy elites after token and superficial consultations, which would be at odds with the rights that must underpin the new goals.


References

  • Piebalgs A. Achieving the MDGs and looking to the future. Luxembourg: European Commission; 2012. Available from: http://europa.eu/rapid/press-release_SPEECH-12-707_en.htm [accessed 30 November 2012].
  • Evans DB, Marten R, Etienne C. Universal health coverage is a development issue. Lancet 2012; 380: 864-5 doi: 10.1016/S0140-6736(12)61483-4 pmid: 22959373.
  • World Health Organization [Internet]. Positioning health in the post-2015 development agenda. Geneva: WHO; 2012. Available from: http://www.who.int/topics/millennium_development_goals/post2015/en/ [accessed 30 November 2012].
  • General Comment No. 14. The right to the highest attainable standard of health. In: Twenty-second session, Committee on Economic, Social and Cultural Rights, Geneva, 25 April–12 May 2000 [Internet]. Geneva: CESCR; 2000 (E/C.12/2000/4). Available from: http://www2.ohchr.org/english/bodies/cescr/ [accessed 30 November 2012].
  • Resolution 55/2. United Nations Millennium Declaration. In: Fifty-fifth United Nations General Assembly, New York, 5–8 September 2000 [Internet]. New York: United Nations; 2000 (A/RES/55/2). Available from: https://www.un.org/ga/55/ [accessed 30 November 2012].
  • United Nations Secretary-General [Internet]. Secretary-General assembles high-level panel on post-2015 development agenda: appointing 26 members of government, civil society, private sector (press release). New York: Department of Public Information, News and Media Division; 31 July 2012. Available from: http://www.un.org/News/Press/docs/2012/sga1364.doc.htm [accessed 30 November 2012].

Getting More Generous with the Truth: Clinical Trial Reporting in 2013 and Beyond

febrero 1, 2013

Getting More Generous with the Truth: Clinical Trial Reporting in 2013 and Beyond.

The PLOS Medicine Editors (2013) Getting More Generous with the Truth: Clinical Trial Reporting in 2013 and Beyond. PLoS Med 10(1): e1001379.

“The pharmaceutical industry is at a critical point in its relationship to society. Much of the early promise of the pharmaceutical industry in revolutionizing health care has not continued, with pipelines for innovative drugs drying up (including in critical areas such as neglected diseases [1]), an increasing number of me-too drugs flooding the market, and concern over spiraling drug costs. Trust has become an even more fundamental issue, in that many who study the output of pharmaceutical companies simply do not believe there is complete and accurate representation of the data on which study reports of clinical trials are based.”

Recomendable para leer entero. El trabajo al que se refiere está en una entrada anterior del blog.