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Hello, and welcome to Humanities Matter brought to you by Brill. I'm Lee Jung-Grechault, and this week we'll be looking at key issues in the field of humanities. Hi, and welcome to the Humanities Matter podcast. I'm speaking with Dr.
Martin Edwards. He's a family practitioner in Historian of Medicine, and he's also the author of Control and the Therapeutic Trial. Dr. Edwards, thanks so much for coming on.
Thank you for having me. So first of all, can you tell us why you focused on the meaning or the gravity behind the word controlled in therapeutic trials? Was it a- what does it mean in a trial or science experiment when something is controlled? Well, in the period I'm looking at in my book, between the wars essentially, controlled means whatever you want it to mean, and it is one mother of a word.
And when I first started looking into trial methodology in this area, I was actually looking at something a bit different. And I kept coming across the description of trials as controlled. And at first, one tends to glance over this because controlled trials are- it's a very familiar phrase nowadays, and it's a phrase that has a certain specific meaning. But it- I kept coming across this and became apparent that the word control or control was not being applied to these trials in the sense that it's- that it's- that we will be used nowadays, which is technically to mean our comparison group.
And in fact, it was being used in a very poorly defined, a very nebulous way. And at first this frustrated me because I thought, what are these guys talking about? What do they mean by control? What do they mean by control?
What do they say what they mean by control? But then I realized that actually that was the story. And that this word with its huge connotation- we control is a powerful word. It has connotations of authority and power and subjugation being in control, being in command.
And this word, I argue, was appropriated by one group, the British Medical Research Council, as a sort of rhetorical device to attach to their trials. MRC trials, they maintained, were controlled. They didn't define what it meant and the power of it was enhanced by the fact that it didn't define what it meant. It could mean anything you like.
It could mean a well-regulated trial. It could mean a trial conducted under the authority of someone who was respected or what they were doing. It could mean a well-designed trial. It could mean a trial conducted under rigid controlled conditions, such as in a hospital.
It could mean later on in this period that it could mean a trial with a control group, a comparison group. But generally, they didn't define what it meant. They used the rhetorical power, this very powerful word, to try and appropriate for themselves the right to decide therapeutic efficacy. The background to this is that there was a debate going on between various vested interests as to how you decided whether treatment worked or not.
And the MRC was one group in this. They prioritized a certain methodology, which was laboratory-orientated medical science. But there were lots of other ways of deciding whether a treatment worked or not. For example, traditionally, an experienced clinician would try the therapy out on some of his patients and use his clinical acumen and his wisdom to decide whether it was working or not.
Hospitals started getting on the act and they started having sort of quasi-laboratory trials in hospitals where they tried to control the conditions that diet, the environment of the patients, their exercise, their regimes, their bed routines and so on. In order to introduce only one variable, which was the treatment in question, there were people who started to say, well, we can overcome idiosyncrasies of individual reaction to therapies, which was a confounding factor in any assessment of therapeutic efficacy by throwing large numbers at it. And give the treatment to large numbers of people and maybe compare them with people who haven't had the treatment, the idiosyncrasies will come out in the wash. There are people who said if it doesn't work in the laboratory, it doesn't work.
The laboratory is the scientific modern way to assess therapeutic efficacy. So you had that battle going on and it was quite an acromonious battle sometimes. And the MRC wanted to become the authority, certainly in Britain, that had the right to say whether treatment worked or not, and this is the way you decide whether it worked or not. And as one weapon in that battle, I argue that they appropriated this powerful word control attached to their trials and said, well, our trials are controlled, any other trials are on control, so they can't be any good.
And that's basically the rabbit hole that first looking at the way that the word control is being used, took me down in writing this book. For non-British listeners, can you just briefly explain what the MRC is, the medical research council? Just sort of how they fit into this? Medical research, it started off as a medical research committee, started founded in 1913 as part of the National Health Insurance Act, which was sort of the precursor of the NHS, it introduced state provided medical care for working men in this country who earned below a certain amount.
That's what everyone remembers the act for, but it also created the MRC. It was a government funded committee with the remit of providing and enhancing and ensuring proper scientific studies of medicine in this country, and that included studies of the efficacy of new treatments. There were, it's an exciting time, between the words of a very exciting time for doctors because lots of new treatments were coming on stream. And I argue in the book that we tend to remember now of the ones that were successful, the antibiotics and vitamins and insulin and so on.
But there were an awful lot of other treatments, which were sort of under the rubric of scientific treatments generally, which generally is a lot of excitement, a lot of enthusiasm, which we tend to forget because the passage of time has led us to believe that, well, actually, they probably weren't as good as we thought they were. But at the time, people didn't know this. People didn't know that insulin was going to be a one-drug and raw pancreas therapy for diabetes, wasn't. And so the whole, an awful lot of new drugs and not just drugs, but treatments, therapies, light therapy, radium therapy, a lot of new therapies to test.
And the personal organization that gained the moral right to adjudicate on therapeutics, adjudicate on how you decide whether treatments work and whether they work or not, would control a large sway that this new and exciting emerging medicine. And so, what happened to the MRC, have that control, I guess, sorry to use the work control there, did they have that authority just because they were government funded? Not entirely. And that's why there was such a battle.
Again, in the book, I mentioned, for example, a very acrimonious fact between Walter Fletcher, the chairman of the MRC in the 1920s, and the Royal College of Physicians, who were one of the many groups saying that, hey, we should be the ones that decide whether treatments work or not. We're much more from the school of hands-on medicine that we are experienced and wise and educated physicians. We've seen thousands of patients. We know, we can tell, we use our clinical acumen.
We can tell the treatments working on that. And if we tried out, we can give you an answer to that question. Fletcher was very dismissive of this. He was very dismissive of clinical ability and clinical acumen in answering questions of therapeutic efficacy.
And he said it was much more relevant to use laboratory-based science. And there's a very acrimonious fact and quite a practice of rude exchanges between, for example, the MRC and the Royal College of Physicians about this. There were lots of other groups of vested interests as well. So simply being a government funded organization did not give the MRC a sort of built-in authority.
And that's why they used tricks, including exploiting the rhetoric of control, a good written word to try and gain it for themselves. And they are the MRC, I should add, are currently one of the two major funders of medical research in this country with the World Contrast. And something that's so interesting, you mentioned all of those different trials that did work and didn't work, that we made these great strides in medicine right between the wars. And you talked about the fact that the impetus behind finding a cure for the flu was that it was sort of part of the war effort that people were worried that actually that pandemic would hurt her.
The war effort, basically. So I'm wondering if you found that there was, I guess, a greater thrust behind that research than maybe we're seeing today or that we see during peacetime, because it was linked with sort of a grander strategy. It just wasn't a health issue, it was actually a security issue. The war was certainly an impetus for finding flu vaccine and effective flu, but it wasn't treatment for flu so much as a preventive vaccine that they were looking for, which I described in the book.
The war was certainly an impetus for that. The 1918 pandemic was still in the memories of people this time, and just reading the NRC paper, this apparent, there was an obviously military people coming and talking to the committee there. It was apparent that there was this terror really of a repeat of an epidemic on the scale of pandemic and the scale of the 1918 pandemic and its potentially devastating effect on the fighting ability of fighting men. So that was certainly an impetus.
I don't know what to say. It changed the some of the research methodology, I think, the amount of secrecy that was assumed that is quite anything, any slight setback in any trial or any trial development was kept secret from public. But I suppose that's expected in wartime. Was that a cup secret from the public because they were worried they would hurt morale?
Yeah, it was to protect morale. So for example, there's a shipload of flu vaccine that was being delivered from America. The Americans had effective vaccine some years before we did. And there's a large consignment of flu vaccine, distant road troops, was sunk by German U-boat action.
And that was, for example, kept secret at the time. That's pretty frightening, actually. When they did get vaccine from the States, there was a what we in Britain had gently caught a cock up that the vaccine had been supplied as live vaccine was supposed to be in a dead vaccine. But the consignment came over and then the Americans said the British are sorry this is actually live vaccine didn't get killed properly.
And there was a great debate about whether this could be used or not, the British decided not to use it. But again, they kept secret that this had happened and it wasn't made public at all. And I wonder what is going on today with our current pandemic, which kind of leads me to my next question. You write that individuals use subjective measures to judge a therapist's effectiveness.
We're seeing this today with the coronavirus, different experts or maybe people masquerading as experts who are recommending certain types of drugs that may or may not work. But you also talk about this debate in 1925 when general practitioners recommended eating raw pancreas as a treatment for diabetes. And basically, they came in conflict with these biocanist physicians who claim that the experiment wasn't accurately controlled. So do we know who was right at the end of that was in use of controlled just the type of slander here?
If you ask me as a 21st century clinician who was right using 21st century notions of evidence, I would say that the notion that eating raw pancreas could cure diabetes or controlled diabetes was roundly trounced and was dead inaccurate. If you ask me that question as a historian, it's a rather nuanced response and it depends what you mean by work. When you say does a treatment work, it depends what you mean by does it work? And throughout my book, really, one theme running through that, which I think I hope becomes persuasive as you read the book, is that determining whether a treatment works or not is a social construct.
There are gold standards, but they are socially constructed gold standards. So nowadays, they're randomized controlled trial and in the hierarchy of evidence about metronalities and systemically fumes are gold standards for treatment efficacy. It doesn't have to be that way, and it wasn't that way, even just a few decades ago. And when you look at how even doctors who are avowed evidence-based medicine practitioners actually make clinical decisions in real life, there are a lot of other factors, including previous experience and belief and understanding of the patient in front of them that color, their judgment, when choosing a therapy.
And I think there's a similar process going on with the raw pancreas debate and with some of the more bizarre or left-field understandings of coronavirus and treatment now. In the raw pancreas debate, the people advocating taking raw pancreas while on the whole GPs general practitioners, and they're using a different notion of evidence. They gave me their patients, saw their effect on their patients, and said in my clinical experience, this treatment is effective. They did that to be taken seriously.
The MRC had none of it. They would have none of that. And they would not believe the general practitioners claims, and they tested them into the laboratory, and because they didn't stand out in the laboratory analysis, they didn't believe the GPs' clinical claims. And then the MRC used the rhetoric of control to attach their own studies to try and to win this debate, which ultimately they did.
I think nowadays notions of understanding effectiveness of remedies are a lot more nuanced and complex than we think they are. Even if we think we are evidence-based practitioners who know about the hierarchy of evidence, who know how to appraise an randomized controlled trial, notions of evidence are still as untreaded sub-genivable, more nuanced than that. And so personal, expert testimony or testimony of someone who is trusted is still important. I think it's not too extreme to say in this day and age that might extend to something coming on the internet.
And conspiracy theorists may prefer to believe something which they perceive as coming from a sympathetic group of people, which says, for example, 5G full-mass are the cause of coronavirus symptoms, which is, I don't know that's much in the space, but certainly an ongoing problem here. And people have been setting fire to 5G full-mass in an attempt to destroy them. And I think it comes down to which sources of information you find credible. And there's a lot of intuition and old-fashioned faith and gut feeling still going through that.
Yeah, that's really interesting that you mentioned that because the BBC had talked about that this morning that some people might believe that vaccines don't work because they have heard that not through a new source or through a medical source, like let's say the CDC or something here in the United States. But they hear it through people that they know on Facebook groups. So let's say you have a pet group on Facebook and you trust the people in that group because they give you good advice about dogs. You're also going to trust them about other things.
So I guess that gets to what you're talking about this social construct concept, but I guess I'm still a little bit confused on how these therapies can work depending on sort of what social group you're in because at the end of the day, some therapies work and some therapies don't correct. Not if you're asking me as a historian though, because one reason I first started being interested in the evaluation of therapeutic efficacy and testing whether treatments work or not, is because I'm a clinician primarily and I then started some academic training and I haven't worked in the history of medicine. And one thing that struck me was that card-carrying historians of medicine who would rather rip off their right arms than be described as internalist historians or weakish historians had a bit of a blind slot when it comes to the right side. And I think this is one example of where clinical insight can help generate research questions in the history of medicine.
There's there have been historians of medicine who've been very suspicious and I've come across some of them suspicious of clinicians working in history of medicine because they think we are inevitably high bound by our conceptions or clinical and more than understanding and so on. And it's truly actually behind as much as we can. But also I think there are examples where clinical experience can generate questions and this is one because I think pretty well any practitioner will tell you it is fiendishly difficult. Often on a one to one basis to know whether a treatment is working for the patient in front of you, whether those antibiotics have made any difference to shortening the duration of that infection in that individual, whether these anti-hypertensive or having a significant effect on this patient's blood pressure.
You can be sure that they're effective on the population in a randomized controlled trial, but the degree of the effect on the patient is often difficult to judge. And historians often seem to have this notion that it's pretty obvious if treatments work or not. And so there's a sort of what I would describe as a theory of internalism that on the whole over time empirically put treatments at work will be retained and treatments that don't work will be discarded. And so treatments will improve over time because on the whole you retain big ones and you get those ones.
I don't think that's true. Because as I said, this difficulty of deciding whether a patient of one of you is responding to your particular treatment. And so you need a systematized means to decide whether treatments are working or not. Now that can be the opinion of worries and experienced clinicians trying to dream about.
It can be a randomized controlled trial. But it can be other methods. They all have their problems. And I do discuss this a bit in the last chapter of my book, some of the problems, some of the subjectivity that is inherent even in randomized controlled trials and metronomacies.
And there is no, we can now say we believe the randomized controlled trial is the way to assess whether treatments are working or not. Fair enough. But we don't have to believe in that. And this is a completely off the subject of this image of my book.
But if you talk to practitioners of alternative or complementary medicine, some of them will say randomized controlled trials have no place in judging the efficacy of our treatment because the RCT, the randomized controlled trial is designed for and only works with allopathic medicine. It is not designed for, for example, anti-punch or homeopathy, which is depends on more sort of idiosyncratic understanding of the needs of the patient in front of you. And therefore cannot be applied. We need other means of assessing the effectiveness of therapy, for example.
So I would challenge you that it is not obvious whether treatment works or not. Or sometimes it is, I mean, for example, insulin, in diabetes, the patient stops dying. So sometimes it is pretty obvious. But very often it is not.
And I think we still have some treatments now that are due to this effectiveness. They don't carry on for various reasons. Doctors want something to offer. They are used to it for malearity.
So in your opinion, there is not really this concept of those types of therapies will eventually die out. You know, like let's take, I don't know, using leeches or something to bleed people. I feel like that is an example of eventually we saw this evolution of science and we figured out that that doesn't work. What you're saying is you don't really believe that always happens.
So we sort of figure out over time what works and what doesn't and things sort of sort each other out. I think I'm not arguing against the randomized controlled trial as the goal standard for judging efficacy. I think at the moment it's the best that we've got. It has its problems and its flaws and it's limited in the questions it can ask and answer.
But yeah, I think that evidence based medicine is meaning that we are gradually and it is a gradual process, discarding some therapies which have been ineffective and constraining ones that are affected. And I would commit myself to the condition to that endeavor. But in my over my clinical career, I have seen treatments for example, such as inserting grommets in in children or prescribing the de-congestants for children with the blue ear for example. And throughout my career, those have been questions and people have been trying to get it to stop doing them, but they are still commonly administered treatments.
I was a say for other reasons of familiarity and intuition. Intuitively, it makes sense if you stick out a hole in the headroom and someone with blue ear to do it and train it, it's going to get better. Intuitively, if you give these kids a peak injustice, they won't block their nasal passages then they're going to do station chains in the middle ear better. The intuition doesn't translate to clinical practice if you do study it with randomized controlled trial.
But I think intuition and this imperative to offer something to the patient is still powerful and in medicine. Interesting. Dr. Martin Edwards, thank you so much for being here.
Thank you very much, it's been a pleasure. Dr. Martin Edwards is the author of Control and the Therapeutic Trial. You are listening to the Humanities Matter podcast.
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