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03 May, 2018

New cancer drugs: poorly evaluated, ineffective and overpriced

Many new cancer drugs are sold by drug companies at exorbitant prices, while their therapeutic benefit – when there is one – is usually modest.

Of the 92 new drugs analysed in Prescrire's French edition in 2017, 28 are cancer treatments; 20 out of 28 were authorised on the basis of a single clinical trial, often of poor methodological quality because these trials were not comparative, or they had biases due to their non-blinded character, or the drugs were authorised on the basis of laboratory or radiological criteria, and did not necessarily result in the prolongation of life or improved quality of life.
Several reviews published in international journals in 2017 confirmed the extent of this phenomenon in Europe, as already seen in the USA. One study showed that during the period 2009-13, of the 68 cancer indications authorised by the European Medicines Agency (EMA), 44 were approved without evidence of benefit in prolonging life. With hindsight of at least 3.3 years after they were marketed, for 36 authorised indications, there was still no evidence of increased life expectancy or improved quality of life. According to this study, and another covering the period 2009-16, the survival gain, when there was one, was less than 3 months for half of the patients.
Despite little or no progress for patients, pharmaceutical companies are marketing new cancer drugs at increasingly high prices. A study showed that in 2016, in France, the cost per year of life gained was up to 176 000 euros. Exorbitantly priced drugs for minimal, if any, benefits. This development in the medicines market places an unsustainable burden on the financial resources of national health insurance systems, to the detriment of other public expenditure.
©Prescrire 1 May 2018

24 April, 2018

La compañía vende el medicamento bajo la marca Depakine para la epilepsia y Depakote y Depamide para tratar trastornos bipolares



24.04.2018 - 16:00
Nuevo varapalo para Sanofi. La Agencia Reguladora de Medicamentos y Productos Sanitarios de Reino Unido (MHRA por sus siglas en inglés) ha prohibido su medicamento para la epilepsia y el trastorno bipolar para su uso en mujeres o niñas en edad fértil, debido a su relación con miles de defectos de nacimiento.
Concretamente, el regulador de Reino Unido ha prohibido el uso del medicamento a menos que esté en un programa especial de prevención del embarazo. Esta acción sigue una recomendación europea de llevar controles más estrictos.

Otros países europeos están en conversaciones con las autoridades locales para implementar medidas similares

Así, las mujeres deben cumplir con la anticoncepción durante todo el tratamiento, someterse a pruebas de embarazo si se les solicita y firmar un formulario que reconozca el riesgo de tomar el medicamento cada año.
En este sentido, otros países europeos están en conversaciones con las autoridades locales para implementar medidas similares. Por su parte, Sanofi ha dicho que trabajará para garantizar el despliegue efectivo de los nuevos pasos de reducción de riesgos.
Precisamente, Sanofi ahora está trabajando para producir envases más pequeños para alentar la prescripción mensual y también está añadiendo una imagen de advertencia de pictogramas en su etiqueta de valproato.
Sanofi vende este medicamento bajo la marca Depakine para tratar la epilepsia y Depakote y Depamide para los trastornos bipolares. También está disponible en versiones genéricas.
Porque salud necesitamos todos... ConSalud.es

23 April, 2018

Evidence Based Medicine

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  • Tom Jefferson1
  • Lars Jørgensen
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    © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.


    The philosopher of science, Thomas Kuhn,1 would probably have called our reliance on biomedical journal trial evidence a paradigm. It has served us well, allowing the building of the philosophical2 and practical3 backbone of evidence-based healthcare. However, like all paradigms sooner or later it has begun to creak. Our reliance on journal articles needs a redefinition, if not a shift. In the last decade,4 evidence has accumulated,5 across a spectrum of different interventions,6 that journal publications7 cannot be trusted. Article reports of clinical trials suffer from a grave illness which is curable, but needs a concerted approach to prevent the growing threat of reporting bias.8 When some of us started looking at the alternative sources of evidence for our Cochrane review of neuraminidase inhibitors9 for influenza nearly a decade ago, we discovered that below every 10-page trial report lies a far deeper and more complex web of data and information needing attention. That is, if the trial was published in the first place.
    The first problem is sheer bulk. For every page of journal article, there may be up to 8000 pages of regulatory data on the same clinical trial.10 We call it a compression factor.
    The next problem is bias. We reasoned that even the most faithful servant of evidence would not be able to publish a 10-pager based on a regulatory report without a radical selection of information and data. As we have no idea what the criteria for choosing which plum to publish are, this introduces unfathomable bias. Sometimes the bias is so bad that it distorts single trial reports, but it also distorts the findings of systematic reviews, as our neuraminidase inhibitor story shows.9
    Evidence of distortion in the results of research is now overwhelming, and it mainly comes from studies comparing journal articles with other sources of information.11 These sources include register entries and different types of regulatory data now on offer, from regulators’ reports to clinical study reports (the regulatory equivalent of a journal publication), to overviews of whole trial programmes. Secreted and confidential up to a few years ago, clinical study reports are now coming to light from regulators and industry sources with seeming unstoppable momentum. Latest to look at releasing clinical study reports is the mighty Food and Drug Administration.12 The catalyst to this change was the Nordic Cochrane Centre’s dogged insistence of access and the European Union Ombudsman’s support,13 which ultimately led the European Medicines Agency to change its policies.14 15
    The thing about clinical study reports is not just that they provide missing information on such pedestrian details like what’s in a placebo or even what it looks like.9 They also provide sufficient data for carrying out stratified analyses, and more often report patient-relevant outcomes lay bare the shabby way in which we currently look at and analyse harms.6 16 17
    So, should we ignore evidence from journal articles? If steps are not taken urgently to address the situation, then ‘probably’ would be our answer. By the law of Garbage In Garbage Out, whatever we produce in our reviews will be systematically assembled and synthesised garbage with a nice Cochrane logo on it. One major problem is our ignorance of the presence of garbage, as its invisibility makes its distortions credible and impossible to check. This is how some of us happily signed off a Cochrane review with findings which had been completely and invisibly subverted18 by reporting bias.
    Garbage, however, is often neutral, but some articles are not neutral. They can be carefully contrived pieces of marketing,19 part of a global jigsaw. We can only guess at what their purpose is and what the true results are. We need to stop producing reviews based on articles (or at least solely on articles) and seriously and urgently look at drawing from data sources which allow alternative explanations and conclusions from the data, because the data set is detailed and near-complete.
    How do we redefine the ‘E’ paradigm? We recently published an index of all prospective comparative studies on human papillomavirus vaccines we could find.20 The index is made of study IDs and (where possible) a description of their content. Predictably, only 62% of the completed studies had been published and none of the non-industry-sponsored studies’ underlying documentation was available. Ninety-five per cent of studies were listed on regulatory or industry trial registers or journal publication databases, but only 48% of completed studies listed on ClinicalTrials.gov had study results posted. It took us 3 months to complete the index, starting from correspondence with regulators and adding studies by identifying them by cross-referencing from several other sources: industry, registers and other regulatory documents. Not as straightforward as an electronic database publication search. But that’s the point. It is more difficult and complex because you are getting close to what really happened in the trials and how they were really run. Your labour is rewarded with a near-complete overview of the development of an important intervention often given to millions of healthy folk or patients around the world. Clinical study reports are still commercial documents, but they are written for the wise and cannot, and should not, omit anything (although they may have internal inconsistencies21). If there are distortions, they may be approved or overlooked by regulators.
    Indexing, at least for now, is more resource-intensive than electronic database searches. The two can be run together and perhaps should be combined. But looking for regulatory data and compiling an index will give us a very good idea of what we are missing and what the limits of our reviews are.
    Ethics and Evidence both begin with ‘E’.
    • Competing interests TJ was a corecipient of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children; https://www.journalslibrary.nihr.ac.uk/programmes/hta/108001#/). TJ is also in receipt of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011–2014, TJ acted as an expert witness in a litigation case related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997–1999), GSK (2001–2002), Sanofi-Synthelabo (2003) and IMS Health (2013). In 2014–2016, TJ was a member of three advisory boards for Boehringer Ingelheim. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. TJ has a potential financial conflict of interest on the drug oseltamivir. TJ was a cosignatory of a complaint to the European Ombudsman on maladministration in relation to the EMA investigation of possible harms from HPV vaccines. LJ has no competing interests to declare.
    • Provenance and peer review Commissioned; internally peer reviewed.
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