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31 mayo, 2013
Natural inmunity against A/H1N1 2009 ( flu virus )
27 mayo, 2013
Derroche y daño en el tratamiento de la hipertensión leve / Iona Heath
Fuente: Estan cambiando los tiempos
Autor: Miguel Pizzanelli
The 2012 Cochrane Review on “Pharmacotherapy for Mild Hypertension”
concluded that antihypertensive drugs used in the treatment of otherwise
healthy adults with mild hypertension (systolic blood pressure [BP],
140-159 mm Hg, and/or diastolic BP, 90-99 mm Hg) have not been shown to
reduce mortality or morbidity in randomized clinical trials. Will this
landmark conclusion affect clinical practice and slow the inexorable
expansion of disease categories? It certainly should because
overdiagnosis and overtreatment are potent causes of both waste and harm
and seem to be operating in the interests of the pharmaceutical
industry rather than in those of the patients whom the industry claims
to serve.
Quien es Iona Heath?
She worked as a GP in London since 1975 and retired 2010. She has held several roles in the Royal College of General Practitioners (RCGP) including chair of the Ethics Committee, the International Committee, and the Health Inequalities Standing Group. She was vice chair of the college and in 2009 was elected college president. She chaired the BMJ Ethics Committee 2004 to 2009 and writes a regular column for the BMJ.
Sacarse el sombrero con esta señora y luego ponerse a leer y pensar en los excesos que podemos cometer.
Compartiremos con ella el taller sobre Prevención Cuaternaria que coordina Marc Jamoulle en la Conferencia Mundial de WONCA en Praga:
"Quaternary prevention, addressing the limits of medical practice"
authors: M. Jamoulle, G. Tsoi, I. Heath, D. Mangin, M. Z. Pezeshki, M. Pizzanelli Báez, A.L. Silva, J. Bernstein. Presenting author: M. Jamoulle, G. Tsoi, I. Heath, D. Mangin, M.Z. Pezeshki, M. Pizzanelli Báez
Agendado:
Día: 26 de Junio, de 10.30 a 12.00
Para ver artículo: http://archinte.jamanetwork.com/article.aspx?articleid=1687525
Quien es Iona Heath?
She worked as a GP in London since 1975 and retired 2010. She has held several roles in the Royal College of General Practitioners (RCGP) including chair of the Ethics Committee, the International Committee, and the Health Inequalities Standing Group. She was vice chair of the college and in 2009 was elected college president. She chaired the BMJ Ethics Committee 2004 to 2009 and writes a regular column for the BMJ.
Sacarse el sombrero con esta señora y luego ponerse a leer y pensar en los excesos que podemos cometer.
Compartiremos con ella el taller sobre Prevención Cuaternaria que coordina Marc Jamoulle en la Conferencia Mundial de WONCA en Praga:
"Quaternary prevention, addressing the limits of medical practice"
authors: M. Jamoulle, G. Tsoi, I. Heath, D. Mangin, M. Z. Pezeshki, M. Pizzanelli Báez, A.L. Silva, J. Bernstein. Presenting author: M. Jamoulle, G. Tsoi, I. Heath, D. Mangin, M.Z. Pezeshki, M. Pizzanelli Báez
Agendado:
Día: 26 de Junio, de 10.30 a 12.00
Para ver artículo: http://archinte.jamanetwork.com/article.aspx?articleid=1687525
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16 mayo, 2013
Global action on social determinants of health
Source: WHO - Global action on social determinants of health
Michael Marmot a
a. Department of Epidemiology and Public Health, University College London, 1–19 Torrington Place, London, WC1E 6BT, England.
Correspondence to Michael Marmot (e-mail: m.marmot@ucl.ac.uk).
Bulletin of the World Health Organization 2011;89:702-702. doi: 10.2471/BLT.11.094862
Closing the gap in a generation is a rousing call.1 Did
the World Health Organization’s Commission on Social Determinants of
Health (CSDH) really believe it to be possible? Technically, certainly.
Yes, there is a greater than 40-year spread in life expectancy among
countries and dramatic social gradients in health within countries. But
the evidence suggests that we can make great progress towards closing
the health gap by improving, as the CSDH put it, the conditions in which
people are born, grow, live, work and age. These include ensuring:
equity for every child from the start, healthier environments, fair
employment and decent work, social protection across the life course and
universal health care. To make such progress, we must also deal with
inequity in power, money and resources – the social injustice that is
killing on a grand scale. At a more fundamental level, our vision is to
create the conditions so that every person may enjoy the freedoms that
lead to improved health – what we call empowerment.
In the three years since Closing the gap in a generation was
published, there is no question that there is much to make us gloomy:
the global financial crisis and the steps put in place to deal with it
have worse impacts on the poor and relatively disadvantaged; the
persistence of bad governance nationally and globally; climate change
and inequitable measures for mitigation and adaptation and, in many
countries, an increase in health inequity.
On
the positive side, however, much has happened to support my claim that I
am an evidence-based optimist. First at the World Health Organization
(WHO) itself, the doubting voices (what do social determinants have to
do with a disease control organization?) were countered by the argument
that WHO could not possibly ignore what the CSDH called “the causes of
the causes” of ill-health. Specialists across WHO, who formed the CSDH’s
knowledge network on priority public health conditions, showed that
action on social determinants of health was fundamental to disease
control programmes.2 Importantly,
a resolution was passed at the World Health Assembly in 2009 that
called on WHO and all Member States to take action on the social
determinants.
Each
of the WHO Regions has expressed interest in this issue. The WHO
Regional Office for the Americas will make social determinants a theme
for its publication Health in the Americas 2012,
has developed training courses and has been promoting health equity in
the region. Zsuzsanna Jakab, WHO Regional Director for Europe, thought
it essential that work be done to adapt the CSDH findings to the diverse
countries that make up the WHO European Region. She therefore invited
me to lead the European Review of Social Determinants and the Health
Divide. The recommendations from this review will feed in to Europe’s
new public health strategy, Health 2020. WHO, with the government of
Brazil, is organizing the World Conference on Social Determinants of
Health in Rio de Janeiro.
Several
countries have explicitly taken on the social determinants of health
agenda. Brazil, Denmark, England, Norway, Scotland and Slovenia are
among many countries that have commissioned reviews and/or produced
strategies for action on this subject. In other countries such as
Argentina, Chile, Costa Rica and Sri Lanka, there is much focus on and
concern about the social determinants of health and a variety of actions
have been taken. The state of South Australia has made the Health in
All Policies approach a central plank of government action. India, while
not explicitly addressing the social determinants of health has,
nevertheless, pursued policy initiatives that will have important impact
on health equity. These include: rural employment guarantees, food
security, universal health care, social security for informal workers,
education, housing and rights of tribal and forest dwellers. These new
policies and programmes are all welcome but the proof will come from
monitoring their effect on social determinants and health outcomes.
The review of health inequalities in England, published as Fair society, healthy lives,3 adapted
the CSDH recommendations into six domains: (i) give every child the
best start in life, (ii) improve education and life-long learning,
(iii) create fair employment and jobs, (iv) ensure a minimum income for a
healthy standard of living, (v) build healthy and sustainable
communities, and (vi) apply a social determinants’ approach to
prevention. In the wake of this review there are encouraging signs of
impact on policy and practice at national and local level in the United
Kingdom of Great Britain and Northern Ireland.
The
ambition of the CSDH was to create a global movement for social
determinants and health equity. As the global community gathers in Rio
de Janeiro in October for the conference on social determinants of
health, we are at a crucial juncture. Will the call for social justice
and the need to formulate all policies to benefit health equity remain
something, at best, honoured in speech alone? Or will the global
community recognize that action on social determinants of health is not
only vital for health equity but has other highly desirable societal
outcomes including social cohesion, reduction of crime and civil unrest,
a more educated workforce and the freedom for people to lead lives they
have reason to value.4
Translate to Chinese
Translate to Chinese
References
- Closing the gap in a generation: health equity through action on the social determinants of health. Geneva: World Health Organization; 2008.
- Blass E, Kurup AS. Equity, social determinants and public health programmes. Geneva: World Health Organization; 2010.
- Review M. Fair society, healthy lives: strategic review of health inequalities in England post-2010. London: Marmot Review; 2010.
- Sen A. Development as freedom. New York: Alfred A Knopf; 1999.
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20 abril, 2012
Data trials open for the whole world
1 European Medicines Agency (EMA), London, United Kingdom, 2 Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Saint-Denis, France, 3 Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom, 4 Medicines Evaluation Board (CBG-MEB), Den Haag, The Netherlands
Citation: Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202. doi:10.1371/journal.pmed.1001202
Published: April 10, 2012
Copyright: © 2012 Eichler et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: No specific funding was received for writing this article.
Competing interests: All authors work for drug regulatory agencies. The authors have declared that no other competing interests exist. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies, or the committees or working parties of the regulatory agencies the authors work for.
* E-mail: hans-georg.eichler@ema.europa.eu
Provenance: Commissioned; externally peer reviewed.
Linked Policy Forum
This Perspective discusses the following new Policy Forum published in PLoS Medicine:
Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201.doi:10.1371/journal.pmed.1001201
Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy.
In this issue of PLoS Medicine, Doshi and colleagues argue that the full clinical trial reports of authorized drugs should be made publicly available to enable independent re-analysis of drugs' benefits and risks [1]. We offer comments on their call for openness from a European Union drug regulatory perspective.
For the purpose of this discussion, we consider “clinical study reports” to comprise not just the protocol, summary tables, and figures of (mostly) randomized controlled trials (RCTs), but the full “raw” data set, including data at the patient level [2]. We limit discussion to data on drugs for which the regulatory benefit-risk assessment has been completed.
Why Trial Data Should Be Open for All Top
First and foremost, we agree with Doshi et al. that clinical trial data should not be considered commercial confidential information; most patients enrolling in clinical trials do so with an assumption of contributing to medical knowledge, and “non-disclosure of complete trial results undermines the philanthropy” [1].
The potential benefits for public health of independent (re-)analysis of data are not disputed and, in an open society, trial sponsors and regulators do not have a monopoly on analyzing and assessing drug trial results. Yet, the different responsibilities of regulators and independent analysts have to be acknowledged. Regulators, unlike academicians, are legally obliged to take timely decisions on the availability of drugs for patients, even under conditions of uncertainty.
Going beyond the merits of independent meta-analysis, we foresee other, potentially more important benefits from public disclosure of raw trial data. For example, RCT datasets enabled the development of predictive models for patient selection to appropriate treatments [3],[4]. Taking this notion a step further, we envisage machine learning systems that will allow clinicians to match a patient's electronic health record directly to RCT and observational study data sets for better, individualized therapeutic decisions (L. Perez-Breva, personal communication).
Large, information-rich datasets are needed to support the computer science and artificial intelligence research required to develop and test these applications. Developing such tools is usually not a priority for, and often beyond the capabilities and resources of, even the largest pharmaceutical companies. These endeavors might best thrive in an environment that invites research from beyond the current stakeholders in health [5]. Making rich datasets available for research is a means to open health research.
Why Trial Data Should Not Be Open for All Top
There are indeed many good arguments for unrestricted and easy access to full RCT data. Yet, simply uploading all trial data on a website would entail its own problems.
First among those is the issue of personal data protection or patient confidentiality, a concept that is very different from commercial confidentiality. There is a small risk that personal data could inadvertently be publicized. There is also a small risk that an individual patient could be identified from an anonymized dataset, for example, from trials in ultra-rare diseases. Achieving an adequate standard of personal data protection is not an insurmountable obstacle, though, and proposals for best practice for publishing raw data are available [2]. However, implementation is not straightforward, standards will need to be agreed upon up front, and data redaction may in a few cases be resource intensive.
Our second caveat is likely more contentious. We do not dispute that financial conflicts of interests (CoIs) may render analyses and conclusions “vulnerable to distortion” [1]. However, surrounding the ongoing debate over sponsor-independent analyses is an implicit assumption that “analysis by independent groups” is somehow free from CoIs. We beg to differ. Personal advancement in academia, confirmation of previously defended positions, or simply raising one's own visibility within the scientific community may be powerful motivators. In a publish-or-perish environment, would the finding of an important adverse or favorable drug effect at the p<0.05-level be more helpful to a researcher than not finding any new effects? Will society always be guaranteed that a finding that is reported as “confirmatory” was not the result of multiple exploratory re-runs of a dataset? We submit that analyses by sponsor-independent scientists are not generated in a CoI-free zone and, more often than not, ego trumps money. Independent analyses may therefore also be “vulnerable to distortion”. We are concerned that unrestricted availability of full datasets may in some cases facilitate the publication of papers containing misleading results, which in turn lead to urgent calls for regulatory action. In a worst case, this would give rise to unfounded health scares with negative public health consequences such as patients refusing vaccinations or discontinuing drug treatment[6],[7].
Aside from CoIs, independent analysis per se is no guarantee of high quality. The regulatory community has been confronted with meta-analyses that were later contradicted by additional evidence [8] or found to be flawed [9]. We argue that independent analyses warrant a similar level of scrutiny as sponsor-conducted analyses do.
Finally, re-analysis of trial data could be misused for competitive purposes.
The Way Forward? Top
We consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data. What is needed is a three-pronged approach:
- Develop and agree upon adequate standards for protection of personal data when publicizing RCT datasets. Most stakeholders will likely agree that adequate standards of data protection are a sine qua non, so the issue should be primarily of a technical and legal nature. We emphasizeadequate standards because excessive demands and unrealistically high standards may in effect become an “anti-commons” and frustrate important public health gains.
- Ensure general adoption of established quality standards of meta-analyses and other types of (confirmatory) data re-analysis that may warrant regulatory action.
- Establish rules of engagement: In the area of observational studies based on health care databases, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has recently published guidance for raw data sharing; these rules of engagement follow the principle of maximum transparency whilst respecting the need to guarantee data privacy and to avert the potential for misuse [10]. Others have come up with broadly similar proposals [11]. Conceivably, analogous principles (e.g., data sharing only after receipt of a full analysis plan) could be applied to regulatory RCT data [1].
Moreover, we take it as self-evident that the same standard of openness should apply to all (drug) trial data, whether sponsored by industry, investigator-initiated, or sponsored by public grant-giving bodies. Likewise, the same standard of third party scrutiny should be applicable to all secondary data analyses. Regulatory inspections of data and analyses carried out by commercial sponsors are routine. Would all sponsor-independent researchers allow the same level of inspections applied to their analyses?
We welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health.
Author Contributions Top
Wrote the first draft of the manuscript: HGE. Contributed to the writing of the manuscript: HGE EA AB HL GR. ICMJE criteria for authorship read and met: HGE EA AB HL GR. Agree with manuscript results and conclusions: HGE EA AB HL GR.
References Top
- Doshi P, Jefferson T, Del Mar C (2012) The imperative to share clinical study reports. PLoS Med 9:FIND THIS ARTICLE ONLINE
- Hrynaszkiewicz I, Altman DG (2009) Towards agreement on best practice for publishing raw clinical trial data. Trials 10: 17. Available: http://www.trialsjournal.com/content/10/1/17. Accessed 9 March 2012.
- Selker HP, Ruthazer R, Terrin N, Griffith JL, Concannon T, et al. (2011) Random treatment assignment using mathematical equipoise for comparative effectiveness trials. Clin Transl Sci 4(1): 10–16. FIND THIS ARTICLE ONLINE
- Kent DM, Hayward RA, Griffith JL, Vijan S, Beshansky JR, et al. (2002) An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase. Am J Med 113(2): 104–111. FIND THIS ARTICLE ONLINE
- Nielsen M (2012) Reinventing discovery: the new era of networked science. Princeton and Oxford: Princeton University Press.
- Poland GA, Jacobson RM (2011) The age-old struggle against the antivaccinationists. N Engl J Med 364: 97–99. FIND THIS ARTICLE ONLINE
- Lofstedt R, Bouder F, Chakraborty S (2012) Transparency and the FDA – a quantitative study. J Health Communications. In press. FIND THIS ARTICLE ONLINE
- Michele TM, Pinheiro S, Iyasu S (2010) The safety of tiotropium — the FDA's conclusions. N Engl J Med 363: 1097–1099. FIND THIS ARTICLE ONLINE
- European Medicines Agency (2011) Questions and answers on the review of angiotensin II receptor antagonists and the risk of cancer. Available:http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2011/10/WC500116862.pdf. Accessed 9 March 2012.
- European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (2011) The ENCePP Code of Conduct for Scientific Independence and Transparency in the Conduct of Pharmacoepidemiological and Pharmacovigilance Studies. Available:http://www.encepp.eu/code_of_conduct/documents/CodeofConduct_Rev2.pdf. Accessed 9 March 2012.
- Young SS, Karr A (2011) Deming, data and observational studies. Significance 8(3): 116–120.FIND THIS ARTICLE ONLINE
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