BioEdge: The scandal of wasted research dollars: "Twenty years ago, a British statistician complained in the BMJ that much medical research was “seriously flawed through the use of inappropriate designs, unrepresentative samples, small samples, incorrect methods of analysis, and faulty interpretation.”
Today, says the BMJ’s former editor, the influential writer Richard Smith, the only word to be changed in that diagnosis is probably “much”. It should now be “most”. And he complains that the leaders of the medical profession are not interested in changing the situation."
'via Blog this'
Monday, February 10, 2014
Evidence based medicine is broken - BMJ
Des Spence cites “poor regulation” as one of the phenomena that compound the profit-driven pollution of Evidence-Based Medicine (EBM).[1] He is not alone. This conception seems to be gaining in popularity.[2,3]
Indeed, the current regulation is handmaiden to the polluters, as this partial list of examples indicates:
• The regulation does not demand that the research agenda be driven strictly by patient needs, not corporate interests.
• It is silent about the adequacy of selection criteria, outcome measures, and statistical significance, three variables that are often used by the polluters to manipulate evidence.
• It says nothing about what should count as scientific and unscientific research. This lacuna allows the latter to take place too, provided, of course, that it labels itself as "scientific".
• The regulation introduces exceptions to the head-to-head rule, exceptions that allow the polluters to test every new drug against placebo or no treatment thereby showing us exactly what they want: efficacy, but not necessarily over the current treatment.[4]
• It does not ban regulators, health care institutions and medical professionals from having financial conflicts of interest. Worse than that, "transparency", the only thing it insists on and quite feebly so, gives both the doctor and the patient nothing but the misleading impression that they can make a truly informed choice.
• The regulation does not ban subject recruitment through financial incentives, a practice capable of introducing outcome bias.
• It does not ban seeding trials, i.e., marketing exercises concealed as scientific research.
• It does not ban manipulative advertising to both doctor and patient inside or outside "scientific" journals.
• It does not ban medicalisation and “me too” drugs.
• It does not regard polluted information, whether it involves misconduct or not, as a sufficient condition for rendering disclosure inadequate. Thus, it lets informed consent degenerate into a legal fiction and the principle of autonomy into a cynical farce.[5]
• Worst of all, it is perfectly ethical: being the codified expression of the collective conscience of our medicine, it naturally purports to be moral.
• It is silent about the adequacy of selection criteria, outcome measures, and statistical significance, three variables that are often used by the polluters to manipulate evidence.
• It says nothing about what should count as scientific and unscientific research. This lacuna allows the latter to take place too, provided, of course, that it labels itself as "scientific".
• The regulation introduces exceptions to the head-to-head rule, exceptions that allow the polluters to test every new drug against placebo or no treatment thereby showing us exactly what they want: efficacy, but not necessarily over the current treatment.[4]
• It does not ban regulators, health care institutions and medical professionals from having financial conflicts of interest. Worse than that, "transparency", the only thing it insists on and quite feebly so, gives both the doctor and the patient nothing but the misleading impression that they can make a truly informed choice.
• The regulation does not ban subject recruitment through financial incentives, a practice capable of introducing outcome bias.
• It does not ban seeding trials, i.e., marketing exercises concealed as scientific research.
• It does not ban manipulative advertising to both doctor and patient inside or outside "scientific" journals.
• It does not ban medicalisation and “me too” drugs.
• It does not regard polluted information, whether it involves misconduct or not, as a sufficient condition for rendering disclosure inadequate. Thus, it lets informed consent degenerate into a legal fiction and the principle of autonomy into a cynical farce.[5]
• Worst of all, it is perfectly ethical: being the codified expression of the collective conscience of our medicine, it naturally purports to be moral.
In light of these examples we should ask ourselves: If the polluters of medical knowledge can tick the ethical box, then what does that say about our ethic?
Having said that, the notion of poor ethic-regulation can be both misleading and self-defeating if it is taken to entail that an ethical-regulatory change could help purify EBM. This is not only false. It actually plays to the hands of the polluters.
The belief that there must be some truly humanistic ethic-regulation out there that could help purify EBM is totally absurd. As long as our medicine depends financially on and must buy its tools from the polluters — in short, as long as it remains under their thumb — it will reject such an ethic-regulation wholesale or, more dangerously, co-opt it to suit their interests. There can be no other option. If we wish to have a truly humanistic ethic, we should get ourselves a truly humanistic medicine first.
1 Spence D. Evidence based medicine is broken. BMJ 2014;348:g22.
2 Goldacre B. Bad Pharma. London:Fourth Estate, 2012.
3 Gøtzsche PC. Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare. London:Redcliffe, 2013.
4 WMA Declaration of Helsinki 2013; pt. 33.
5 Epstein M. Legal and institutional fictions in medical ethics: a common, and yet largely overlooked, phenomenon. J Med Ethics 2007;33(6):362-364.
http://www.bmj.com/content/348/bmj.g22/rr/680463
BioEdge: Evidence-based medicine comes under attack
BioEdge: Evidence-based medicine comes under attack: "evidence-based medicine has its critics, as a bilious outbreak of comment and letters in the BMJ demonstrated recently. Early last month a Glasgow GP, Des Spence, said that the system of EBM had been corrupted. “If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen,” he wrote.
How could anyone fault the notion of treatment based on scientifically validated evidence? No one. But the critics of EBM argue heatedly that the standards for the evidence are often low and tainted by commercial or personal interests."
http://www.bioedge.org/index.php/bioethics/bioethics_article/10841
How could anyone fault the notion of treatment based on scientifically validated evidence? No one. But the critics of EBM argue heatedly that the standards for the evidence are often low and tainted by commercial or personal interests."
http://www.bioedge.org/index.php/bioethics/bioethics_article/10841
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