David Healy: Do randomized controlled clinical trials add or subtract from clinical knowledge
David Healy’s response to Jean-François Dreyfus’ response
I somehow missed Jean François’ reply until a few days ago and this, allied to the difference between localism and universalism and a developing capitalism that he notes, has shaped my reply.
I read his reply after the shocking discovery of more than 1,000 bodies of children buried in the grounds of Canadian residential facilities where they had been sent for “education.” Historical context is important here, just as it is when grappling with Hitler’s nomination for a Nobel Peace Prize in 1937. For several centuries, Western ruling classes viewed it as their duty to bring enlightenment to natives sunk in ignorance. This duty obliged Canadians to send indigenous children to residential schools, often run by Christian denominations, to stamp out their native culture. As this happened, the ruling class began to celebrate the local knowledge of indigenous people, suggesting it often fitted them better to the Canadian environment than our knowledge did – an idea that has grown even stronger since. Grasping the historical context does little to assuage the savagery of cutting children off entirely from their families and roots with many children dying grim deaths and families destroyed.
As a result of history, Irish Canadians meted out some of this savagery. Ireland had been a laboratory for English social experiments. Before it was thought possible to do this in England, Dublin was given the first police force, ostensibly to support public order but primarily to protect Protestant property. Before anywhere else in the world, and even after the Famine sent half the population to North America, an extraordinary mental hospital building program gave Ireland double the number of mental hospital beds per head of the population ever found anywhere.
This oppression didn’t make the Irish nicer or better people, incapable of repeating what had been done to them. When liberated, they repeated at home what had been done to them to women who had children born out of wedlock, and abroad in Australia, North America, India and elsewhere the Irish in British armies contributed to an oppression of indigenous peoples. We Irish, just as much as anyone else, can quickly slip into viewing what happened to us as benighted while priding ourselves because of “progress” we have made we are immune to perpetrating anything like that to anyone else.
Beyond the Irish situation, nation-state “civilization,” it seems, brings with it a wish to get the national garden in the best possible shape – while at the same time increasingly viewing the wilderness as beautiful where once the word connoted ugliness. Is this the same thing as capitalism? Nation-states certainly enable national capitalist enterprises and now perhaps risk being replaced by them.
The funneling of indigenous children into education and the sterilization of indigenous women is now called eugenicist because of the period in which it happened. What happened to the Irish was not eugenicist – because the idea wasn’t around. It just happened. After a period of amnesia, as happened in Germany two decades after the War, Canadians have begun to discuss a “cultural genocide” (rather than genocide).
Have we (Irish and others) progressed to the point where this couldn’t happen again?
We have introduced civilization (RCTs) into the regulation of drugs. These cultivate the one flower we want for the patch in the garden of a drug’s indication and not anything else. RCTs are designed to eliminate the wilderness - the 99 other blemishes, as companies see them, that drugs cause or weeds the drugs fertilize.
Far from RCTs being a good way to evaluate a drug, companies could even get oil of snake on the market using them. Once the new sacrament arrives on the market, corporations can then ensure that regulators, academic physicians, guideline makers and politicians would never dare to call oil of snake snake oil.
Far from therapeutics now being even as semi-science based as it was in the 1950s and 1960s, we have returned to the patent medicines era – where the information that drives sales is the branding on a label not the largely fake contents of the label. We are no more privy to genuine information on the effects/contents of these drugs now than we were in 1906.
In 1938, we put an Act in place that focused on the safety of drugs – just as Traffic or Airline Authorities or Stock Exchange Authorities focus on the safety of planes and roads and investing, rather than focus on efficacy.
In 1962, we added a bureaucratic check on efficacy aimed at enhancing safety, but which has sabotaged safety instead.
Based on some sense that they have unique access to a truth, nations have weeded out people on the basis of race, class and sex. Disease has been an even greater source of stigma than race, class or sex and the German extermination program began with the mentally ill and handicapped.
Disease has lost its stigma now – provided people are taking their medication. Tell a group you have epilepsy but are not on anticonvulsants, AIDS but are not taking Triple Therapy, depression but are not on treatment and everyone gets uncomfortable. Medicines control stigma, except when someone has an adverse effect. Those wrecked by a drug are doubly stigmatized. They are losers by virtue of a disease they have they must declare in order to bring their adverse reaction to light and also by virtue of their sacrament resistant disorder.
This, rather than Gerald Klerman’s mistaken version of the notion, is Pharmaceutical Calvinism. There is an elect who are already saved and there is the rest of us, who are to be consigned to Outer Darkness. Our difficulties with the sacraments mark us out as not being among the elect.
It can now take three decades for obvious and significant side effects of drugs, even when conceded by companies before launch, to be recognized in clinical practice and patients given some chance of avoiding a grisly suicide, familicide, a dependence worse than that caused by opioids, or permanent sexual dysfunction – this is just on serotonin reuptake inhibiting antidepressants.
By all means have an efficacy criterion and use RCTs for this purpose. But acknowledge that safety needs to be established and this can only be done in co-operation with the “natives.” Ensure access to all trial data and stop saying RCTs are a good way to evaluate a drug. Stop allowing doctors to tell patients they are crazy for thinking their drug could be causing a problem that has not shown up in an RCT.
Instead, let’s have doctors who welcome patients as co-collaborators, research assistants, who in addition to telling us what drugs like the SSRIs actually do in real life may be able to save us from the mess into which our healthcare is descending. Let’s recognize that the people who come to us on a treatment, especially those suffering an adverse effect have an indigenous knowledge about what it is like to be on this drug, knowledge that our current ways of practicing mean doctors no longer have, knowledge that is worth more than the general knowledge algorithms throw up.
Treatment induced death and disability are likely now the modal forms of death and disability for people who get put on treatment and life expectancy before Covid had stalled or in some countries had begun falling. Let’s stop sacrificing people on the altar of some higher truth as we now are.
August 12, 2021