Randomised Clinical Trials
When people criticise homeopathy they are usually assuming allopathy, conventional medicine, is perfect, that it is perfectly suited to treating the sick and that medicine is perfectly suited to the allopathic (conventional) approach. Yet a debate about five years ago in the Times Literary Supplement raised many questions and one conclusion was that outcomes to the benchmark of perfection, Randomised Clinical Trials, are often deficient due to the pressure on scientists to “publish or be damned.” There are other criticisms, among which are ethical and scientific.
Writing in the Financial Times¹ recently, the Undercover Economist, Tim Harford, raised an ethical issue with such medical trials. He says that with the dramatic expansion of such trials in education, economics, medicine, the social sciences, it’s appropriate we ask some hard questions. (Harris Coulter was one of the first to ask such hard questions – see below.)
Tim Harford gives the example of one epidemiologist, Archie Cochrane, who once ran a Randomised Clinical Trial (RCT) of coronary care units:
… with the alternative treatment being care at home. He was vigorously attacked by cardiologists: how could he justify randomly denying treatment to patients? The counter argument is simple: how could we justify prescribing treatments without knowing whether or not they work?…
I should leave the final word to Archie Cochrane. In his trial of coronary care units, run in the teeth of vehement opposition, early results suggested that home care was at the time safer than hospital care. Mischievously, Cochrane swapped the results round, giving the cardiologists the (false) message that their hospitals were best all along.
“They were vociferous in their abuse,” he later wrote, and demanded that the “unethical” trial stop immediately. He then revealed the truth and challenged the cardiologists to close down their own hospital units without delay. “There was dead silence.”
In conclusion, Harford says, “When considering an intervention that might profoundly affect people’s lives, if there is one thing more unethical than running a RCT it’s not running it.”
Does it all come down to ethics? Well this should be taken for granted, especially for drug companies under the World Medical Association’s “Helsinki” declaration, but as we have seen this is frequently flouted². Too often business takes precedence over ethics.
As mentioned above, Harris Coulter, the medical historian,³ criticised controlled trials. He claims that controlled trials were introduced to bring order into this wasteland of fragmentary hypotheses and discarded theories but is methodologically grotesque (p. xxix). The vaunted peer review system is merely an additional barrier ensuring that ideas departing from received truths have a rough passage to the pages of scholarly publication.
The inability to define “disease entity” means that the so called controlled clinical trial lacks scientific value.
Such trials are premised upon the presumed existence of “homogeneous groups” of patients – smaller samples of a disease entity. But if the disease entity can’t be defined, neither can the sample, and decades of experience have demonstrated that clinical trials suffer seriously from inability to assemble patients into “homogeneous groups.”
Coulter refers to Austin Bradford Hill who provided statistical support for the clinical trial and who criticised it severely at the end of his life. Insensitive and incapable of revealing the all important small differences among patients because of the ‘biological variation of the human material with which we have to deal… for example, results would be useless applying the same treatment to people suffering from typhoid and typhus before the two were differentiated.”
Coulter says that from an empirical point of view, the “homogeneous group” is “homogeneous” only in respect of the common symptoms – which do not determine the uniqueness which is the key to successful treatment.
Before proceeding with trials premised upon the assumption that homogenous groups can be assembled, allopathic Rationalism (as opposed to homeopathy for example which is empirical) needs to prove this to be possible. In fact the controlled clinical trial is an example of utopian thinking… “largely disregarded in practice.” No trial has ever been performed matching the book definition. Coulter here gives some examples from other authorities.
To prove his point, Coulter explains that at a 1987 “consensus conference” representing several hundred specialists in clinical trial methodology, when asked why clinical trials were in such a state of crisis, concluded: trial protocols are often inadequate; that results are ambiguous and uninterpretable, that they are corrupted by too many commercial considerations and that the gap between the trial and clinical realities cannot be bridged. But for legal, economic and institutional reasons “controlled clinical trials” continue to be organised and implemented.4
¹Undercover Economist (April 25, 2014)
‘There are perils to treating patients not as human beings but as means to some glorious end’
The random risks of randomised trials By Tim Harford
²See my posts: here and here
On the Helsinki Declaration see Ethically Refusing and Withholding Treatment
³Divided Legacy Vol. IV, Harris Coulter: click here or here
4Divided Legacy, Vol.4, p.227
For an authoritative presentation on Randomised Clinical Trials and evidence-based medicine by Dr Lionel Milgrom available here or freely here: RCTs and evidence-based medicine.
The Unprincipled Randomization Principle in Economics and Medicine