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Clinical trials: clearer rules, better protection for patients
Exciting news from Brussels this morning – law that would mean researchers running a clinical trial in Europe have to register the trial before it begins and to publish summary results within a year of its end is a step closer. The committee of representatives from every EU member state government has agreed with the text of the Clinical Trials Regulation proposed by MEPs led by Glenis Willmott. This agreement now has to be formally ratified by the European Parliament and the Council of Ministers (probably in early 2014) but today’s provisional agreement is a fantastic result at a very important stage of negotiation and is down to the hard work of the MEPs and thanks to your input. The legislation will need final approval from the European Parliament.
The proposals agreed today include:
A publicly accessible EU database, set up and run by European Medicines Agency, containing:
A register of all trials carried out in the EU
A summary of results for all trials, uploaded 1 year after the end of the trial at the latest
As well as a summary understandable for a layperson
Clinical Study Reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
A statement that Clinical Study Reports should, in general, not be considered commercially confidential
Fines to be imposed by Member States for non-compliance with the transparency requirements
A requirement for all trials to be registered or published in order to be used to back up a new clinical trial authorisation (will encourage the retrospective registering/publishing of old trials)
The Clinical Trial Master File retained for at least 25 years.
Glenis Willmott MEP said: “For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge they are ineffective, or even dangerous.
We are determined to finalise this before the European elections in May. This legislation will set the global gold standard for transparency in clinical trials, and I call on all EU governments to support the agreement”.
Síle Lane, Director of Campaigns, Sense About Science said: “We are very pleased to hear that EU governments have agreed the draft Clinical Trials Regulation which contains proposals that would mean all clinical trials done in Europe will have to be registered and results reported. Well done to Glenis Willmott MEP who has worked very hard to get this agreement. We know Glenis was helped enormously by the hundreds of individuals and organisations who got involved and told MEPs and Ministers their reasons why transparency is vital. Now is the time for companies and academics to listen to all these voices and commit to registering and reporting results from trials done in the past too. There’s no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients.”
Ben Goldacre, co-founder of AllTrials said: ”This is great news, and patients around the world should be grateful for the fantastic work that has been done on this by politicians in Europe. However we must remember that it only covers new trials, starting from 2014. The vast majority of medicines prescribed today came on the market 5, 10, or 20 years ago. This new law will do nothing to improve the evidence base for those treatments. We still cannot get all the results of all the trials on even the simplest everyday treatments, the antidepressants, the statins, the blood pressure treatments, and more. Those are the drugs that doctors are using right now, and will continue to use for at least a generation. Notably, the law would also do nothing to ensure that researchers and doctors can access all the results of trials on controversial drugs such as Tamiflu.
The campaign for access to trial results began over 20 years ago. Throughout the 1990s and 2000s, industry promised that everything had changed, and that everything had become more transparent. We now know that this wasn’t true. It is unacceptable that results from the 1990s and 2000s should continue to be withheld from doctors, researchers and patients. It is unacceptable to say that these trial results were allowed to somehow continue “disappearing”, even while some of the industry was publicly promising greater transparency. With their reckless belief that they could stonewall forever, too much of the industry have stored up a big problem for themselves, and for patients. We need the results of all trials, of all uses, of all the treatments we prescribe today. Without that, we cannot practice medicine safely and effectively.”
Mark Wilson, CEO, Cochrane Collaboration said: “Cochrane is delighted with today’s agreement on clinical trials transparency; a victory for patients, practitioners and policy-makers across Europe, and a clear and compelling message to decision-makers worldwide. The ratification of the agreement in 2014 will be a key milestone on the AllTrials journey to ‘all results reported’ becoming a reality.”
The double standard in American’s drug policy towards children
” … This cartoon is about Ritalin and Adderall, the two most popular amphetamine stimulant drugs used to “treat” ADHD in children. It attempts to demonstrate the double standard in American’s drug policy towards children by showing how corporate-sponsored drugs are openly and widely prescribed to children as medicine, while home-made drugs are classified as dangerous substances that will land you in prison (even if two drugs are chemically identical!)…
… I believe it is time we abolished the industry of psychiatry and its disastrous “treatment” of children with dangerous, mind-altering chemicals. If we continue to allow these profit-minded psych doctors to drug an entire generation with amphetamines, the long-term consequences to society will no doubt be devastating. Children do not need mind-altering drugs to demonstrate normal, balanced behavior. They simply need honest nutrition, responsible parenting and to be kept away from refined sugars, petrochemical food additives and processed foods.”
Harvard University students agreed by vote that plastic single-use water bottles should no longer be sold on campus, leaving the fate of plastic water bottles in jeopardy at the Ivy League institution.
The offered solution is creating stations on campus that can effectively filter and process out chemicals where students and faculty may refill glass or metal containers or even reusable plastic containers.
APMIS : acta pathologica, microbiologica, et immunologica Scandinavica, Swan SH, Dec 2000
DES is the most carefully scrutinized EDC and its history provides valuable insights into the current evaluation of less well-studied EDCs. This review summarizes the health effects of prenatal exposure to diethylstilbestrol (DES) and emphasizes the role of DES as the first endocrine disrupting chemical (EDC). Vaginal clear cell adenocarcinoma (CCAC), the most severe consequence of prenatal exposure to DES, affected only 0.1% of exposed females, while the far more prevalent teratogenic and reproductive effects of DES were only discovered when DES daughter were screened for CCAC. Initial studies, conducted before most DES daughters had tried to conceive, examined vaginal cancer and vaginal, cervical and uterine abnormalities. Subsequently, several controlled studies demonstrated the increased risk of adverse reproductive outcomes in DES daughters. While most DES daughters can eventually experience a live birth, this is less likely in women with genital tract abnormalities, in whom there is a two-thirds chance that each pregnancy will be unsuccessful. In DES sons, who have been far less studied, results suggest male reproductive toxicity, but are less consistent. The importance of dose and gestational age at initial exposure are discussed, and the implications of DES findings for the evaluation of risks from current EDCs emphasized.
Doctors like to think they’re above being influenced by the pharmaceutical industry, but the evidence suggests otherwise
” This week GlaxoSmithKline, one of the biggest drug companies in the world, said it would stop paying doctors to give lectures promoting their drugs. Some patients might be surprised to hear that their NHS doctor ever participated in such a practice, and that is one of the great merits of this announcement: it will help shine a light on a hidden corner of medicine. ”
Chaque année, au mois d’octobre, notre environnement se pare de rose et de placards innombrables appelant à partir en croisade contre le cancer du sein grâce à la mammographie.
Pourquoi une telle volonté des responsables de santé publique, des médecins, des associations ou des laboratoires?
Les femmes sont-elles réellement bien informées des risques qu’elles encourent en se soumettant à un tel dépistage?
Et les bénéfices qu’on leur fait miroiter existent-ils vraiment?
Révoltée par l’obstination des gynécologues à lui imposer la mammographie, Rachel Campergue a mené sa propre enquête.
Ce qu’elle découvre est effarant:
Infantilisant les femmes, les pouvoirs publics promeuvent la confusion entre prévention et dépistage.
Les médecins ne disposent pas des connaissances adéquates garantissant que les consentements qu’ils arrachent à leur patientes sont effectivement «informés».
Quant aux associations, elles sont les agents d’un business juteux qui profite avant tout aux fabriquants de biens de santé.
La conclusion de ce travail foisonnant, précis et non dénué d’humour, est sans appel: une mammographie n’équivaut pas à une vie sauvée, et, si vous choisissez d’en passer une tous les deux ans, faites-le en toute connaissance de cause.
How withholding clinical trials degrades the evidence base
Science & the City interviews Dr Ben Goldacre – author of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients – who discusses the pervasive bias in reporting clinical trials of medications.
Dr Ben Goldacre calls for all trials to be registered and for all trial results to be reported. Otherwise, he says, doctors, researchers, and patients are prevented from making discerning decisions about treatments and the field of evidence-based medicine is pointlessly hobbled.