Thank-you Jacob for posting this up. I guess, like you, I don't think EBM is working that well; and Amy, we're on your side, against quackery: not all critiques of EBMs are saying that EBM and the RCT are rubbish Even lesser methods such as the the longitudinal cohort study has been useful, and have certainly saved lives, (though EBM via the RCT etc has killed a few too), though the tobacco companies are still advertising in the BMJ about their cigarette packaging, well done BMJ. EBM is really important, Healey would say so too I'm sure.
For me, it's important to specify that this should not just be EBM, but the praxis of EBM, or how does it work 'in-practice'. It should be a 'practice' open to scientific, philosophical, political, economic and therefore social debate. It involves issues of human subjectivity, free will, humanism, and the meaning of life, no less. I would challenge you (and me), EBMers, to recognise that you (and me) have not sufficiently moved on, and looked beyond the scientific method to the praxis of EBM, to the culture and practice, of 'Our Time' now, the time that dictates its practice and, unfortunately, malpractice. You, we, the EBMers have become the Reactionaries, the Establishment - we seem to be wedded to a particular way of operating that feels unable to recognise the importance of the human, philosophical, psychoanalytical, economic and the 'free-market' in healthcare provision. Where are the revolutionaries we need now?
For some research questions, such as: "Does antidepressant X improve the mood of depressed children compared to placebo?" or does fertiliser X yield a better crop than placebo?' the RCT can be quite appropriate, and the 'best', as a research method - but of course this is highly dependent on the research question. So, not only should we examine the method, outcomes, the availability of results and their presentation but the 'questions' as well.
EBMers know only too well that, even for the relevant question, the RCT has serious limitations - the lack of information about long term harms, over-and-biased interpretation and unjustified rhetoric by enthusiastic authors, and the lack of applicability to a given individual with their own particular pharmacogenetics making treatment indications a bit of a lottery, etc. We also know that some research questions are of dubious relevance globally, and that some important questions cannot be answered by RCTs. So much is obvious.
However, becoming less obvious now, we EBMers could argue that the complete range of research methodologies would just as vulnerable as the RCT to 'gaming' (as Healey puts it) : the vested biases in interpretation of outcomes and then the lack of accuracy and transparency of risk communication and politicisation: the paternalism of (public health) treatment guidelines - (see for example the ongoing breast cancer screening controversy), leading to a misinformed and overtreated public. (Not all of which can be blamed on the drug companies).
So, a new idea for us, we need to examine why all research, and the praxis of EBM, becomes corrupted and leads to huge harms and skewed implementation globally. What is the dominant accepted way of being that makes us responsible for this tragedy?
Contra Healey, I claim that its not the method, the RCT, that is the biggest problem with the malpractice of EBM (though it is an abused method), but the forces, outside of science, that are driving contemporary research agendas, and driving their criminal corruption by the drug companies, aided and abetted by some of the medical profession. It seem clear that corporate crime won't be cured just because of more regulation, as David Healey rightly says, after all, the drug companies fund the regulators and governments won't let big companies fail, for political and economic reasons. Thus,
Davis
and Abraham, in a review of corporate crime by the drug industry, suggest that (1):
….courts might be reluctant to impose penalties that
would threaten the financial survival of companies.
………. …..similar shifts ( ... for additional funding, in the USA, for FDA funding for fraud detection) are less likely
in the UK
given the government’s determination to ‘reduce burdens on business’.
……..regulators have been encouraged by governments to
be responsive to the commercial interests of industry and to view large drug
firms as clients whose fees increasingly fund these agencies…….
For EBMers one of our challenges is to respond to the manipulation of practice by the political economy, and to take responsibility for not just the science, but the messy praxis of EBM, to grapple with the conflicting pressures between being a caring humanitarian medical scientist on the one hand, but within a pervasive healthcare structure that is driven by a belief in the value of corporate competition, tenders for business, industrial espionage and financial efficiency, that in effect turns a deaf ear to any radical opposition. Corporate practice seems to be overly dominated by the Profit Motive and EBMers serious about praxis should not turn a blind eye to this. Thus: GlaxoSmithKline (GSK) wanted to extend the market for the commonly
used antidepressant Paroxetine to children, and conducted a series of trials in
children. However at the
end of the trials there was no clear benefit in treating depression. Rather than tell doctors and patients, or
withdraw the drug, a secret internal company memo concluded: (2
"It would be commercially unacceptable to include a
statement that efficacy had not been demonstrated, as this would undermine the
profile of Paroxetine."
Nonetheless, in the year after this memo, 32,000
prescriptions for Paroxetine were issued to children in the UK
I claim that these two poles, for you and for I as individuals - the 'Subject's' well meaning intention ( to improve the quality of life) versus the powerful demands to do the work of the 'system', to maximise profit, are contradictory, and we as EBMers are internally divided in our individual 'selves' by this contradiction. We are condemned to be a revolutionary in spirit but a counter-revolutionary 'in our time'.
Perhaps this contradiction prompts and leads to the desire for change that we witness in debates and 'agreements to disagree' over such issues as the effectiveness of regulation of the drug industry and overdiagnosis (again, witness the breast cancer screening controversy for a good example), and some level of disillusionment with bureaucratic quality controls e.g. QOF ( Quality Outcomes Framework where GP's, the family doctor's, income is dependent on such things as getting patients to complete questionnaires allegedly validated to justify a diagnosis of, and treatment for, depression) in the UK. Perhaps we should open up the discussions to include these wider cultural influences.
Is our individual consumption of and contribution to the marketisation of health care, including the impacts of the large pharmaceutical firms, not likely to be one of the main drivers of over diagnosis and overtreatment? Hasn't DH missed this crucial dimension by focusing on the downsides of a particular research method, and hasn't BG missed this point by focussing on the need for more regulation. Hasn't the EBM Establishment turned a blind eye?
Shouldn't we now take action to respond to the contradiction between 'caring' as a subject position for an individual and being positioned by the business model as a worker for a system that is dominated by the Profit Motive, the prime driver for the operating system. Most of us are brought up since a young age to believe that the free market is always best - the failure of regulation to rein in the drugs companies and the focus on a tick box culture leading to poor hospital care epitomised by the Staffordshire enquiry, demonstrate that this principle should be challenged.
(1) Davis
C, Abraham J. Is there a cure for corporate crime in the drug industry? BMJ
2013Available from: URL: BMJ2013;346:f755
Owen
Owen P Dempsey
Marxist
