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?
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
