Latest / Radically Genuine / 143. "The Placebo Effect in Surgery: Are Common Operations Ineffective? with Orthopedic Surgeon Ian Harris"

Transcript

143. "The Placebo Effect in Surgery: Are Common Operations Ineffective? with Orthopedic Surgeon Ian Harris" · Radically Genuine

• Roger K. McFillin, Psy.D., ABPP (00:01.973) Welcome to the Radically Genuine Podcast. I am Dr. Roger McFillin. The power of the mind to heal the body has long fascinated scientists and philosophers alike. The placebo effect, where a person's belief in a treatment can lead to real physiological improvements, is perhaps the most striking example of this phenomenon. Studies have shown placebos can alleviate pain, reduce inflammation, and even improve motor function in Parkinson patients. In my field, the placebo effect is powerful in mental health. In some cases, placebo treatments have rivaled the effectiveness of actual drugs. This isn't just the power of positive thinking, it's the brain actively participating in the healing process, releasing its own painkillers and altering neural pathways. But how far does this effect extend? Could it be influencing outcomes in more invasive medical interventions? Is it possible that some surgical procedures with all their cutting edge technology and skilled practitioners might owe a significant portion of their success to this same phenomenon? Today, we are joined by a guest who's uniquely positioned to explore these questions. He argues that many common surgical procedures from knee arthroscopies to backfusions and cardiac stenting may not be as effective as we think when subjected to rigorous scientific scrutiny. He suggests that in some cases the expectation of healing from surgery might be driving positive outcomes. Could be more than that. We're gonna get into this and much more. His name is Professor Ian Harris. He is an orthopedic surgeon in clinical practice in Sydney, Australia. He is also a professor of orthopedic surgery with a PhD in evidence -based medicine and surgery. He directs a research unit that focuses on outcomes of surgery and has published and presented widely in the field of surgical outcomes. He is the author of Surgery, The Ultimate Placebo and co -authored the book Hypocrisy, How Doctors Are Betraying Their Oath. Professor Harris, welcome to the Radically Genuine Podcast. Ian (02:25.188) Thanks very much for having Roger K. McFillin, Psy.D., ABPP (02:27.691) Now the title of your book certainly caught my attention. I understand the power of placebo in a number of health conditions, most especially in my field in mental health, as well as experiences with pain, but I'd never really considered it in the role of actual surgeries. Now, how do you define the placebo effect? How can my audience members really kind of understand what this means? And boy, how does it relate to actual invasive surgeries where we can objectively measure the actual physiological changes? Ian (02:57.844) Well firstly by and large we don't objectively measure the changes. So most of the surgery for example that I'm involved in is treating pain and so we are relying on subjective measures where placebo may have more of a role. But to the placebo effect very much depends on your definition of placebo and the terminology gets very confusing and we are actually moving away from the term placebo because of the confusion that it causes. By definition, a placebo has no effect. So when we start talking about a placebo effect, it doesn't make sense all of a sudden. And so I think what most people are talking about when they talk about placebo effects and the definition I used in the book is non -specific effects. So anything other the specific effect of the drug, the surgery, the procedure or the intervention that you're having. So surgery may or may not, depending on the circumstances, have a specific effect on the underlying pathology that will influence the patient's outcome. There's other non -specific effects that are not related to the surgery. And you can call them placebo effects, but I think it's probably cleaner and easier to understand if you break them down into things like the natural history of what would have happened to the person anyway, if they'd been left alone and contextual effects. And this gets very close to what a lot of people tie into placebo effects. And that's perhaps the interaction between the therapist and the patient, the patient's expectations, the environment or the setting. that the treatment is in, these things can influence a patient's outcomes. But they're not placebo, they're not nothing. These are tangible things that can influence the outcome. And so yeah, it is confusing with the terminology. so, you know, I think it's better to talk about specific and non -specific effects of the treatments that people Roger K. McFillin, Psy.D., ABPP (05:18.657) Okay, we'll definitely get into that. Let me ask for some clarification though. So wouldn't we in a well -designed study that's controlled, that is blinded, that's standardized, wouldn't we be able to control for let's say like natural recovery by including a non -treatment control group or a weightless control Ian (05:40.504) Yes, and so the best studies to tease out these effects are studies where we have three arms. So this is an arm where patients will have the full treatment, say the surgery. Another arm where patients will have a placebo operation where they don't know if they've had the surgery or not. And a third arm where they don't receive anything. Roger K. McFillin, Psy.D., ABPP (06:07.233) So Ian (06:07.256) No placebo, no treatment, just how are you going? Roger K. McFillin, Psy.D., ABPP (06:11.531) Yeah, so let me just explain my field, which is clinical psychology, and I've done a lot of research on antidepressants. And one of the things that is very clear for me when I examine the totality of the research is that we can't really differentiate the placebo groups from the antidepressant group with any real clinical relevance. And basically what's that saying is when someone actually is provided an inert substance, a sugar pill, for example, they do make some substantial improvements. my understanding of it is my belief around this is it's around the expectancy effect. So their belief that they did actually receive the substance can predict their clinical outcomes. For example, the TADS study, which is the Treatment of Adolescent Depression Survey, what they had was the, they had the participants, the adolescents, their parents, the researchers who were the prescribers actually predict did the person get the placebo drug or did they get the actual antidepressant drug? And the interesting finding from that was if the teenager, for example, believed that they received the antidepressant drug when they indeed only received the placebo, their outcomes were better. And it was vice versa. If they actually believed that they received the placebo when they did only received the antidepressant drug, their outcomes weren't as strong. So I always see the placebo as that power of expectancy of like the power of the mind when you believe that you've received the treatment, it's got some actual measurable Ian (07:55.162) Yeah, and there is evidence that patient expectations do drive outcomes. That's true. But it's interesting, some of the what we call open label placebo studies, where patients are told you are getting a placebo. And then they look at the improvement afterwards. Often in those studies, have two arms and one arm the group that gets the placebo treatment are also given a video showing them how much better they're going to get or they're told and in fact the script for some of those open -label placebo studies is things like you are receiving a placebo these have been shown to be highly effective for your condition in scientific studies and and that's the difference between the two groups It's not the pill, the pill itself doesn't actually contain anything. It's the management of expectations, it's the setting and a lot of it is what you've said. Roger K. McFillin, Psy.D., ABPP (09:05.921) So I'm actually curious what's spurred your interest in this area. how, yeah, like how did you actually start getting focused in this area in surgery? It's not that widely known or discussed. Ian (09:18.842) What interested me was I was a general orthopedic surgeon. So I was doing lots of operations and I wasn't really up to speed with the science and we are not trained as scientists. I didn't have a good understanding of how to interpret the literature. And I knew that there were some questions around effectiveness. I wanted to be more scientific in my practice. And so I just started to question things a little bit and I was very impressed with surgeons, the very few surgeons who were able to interpret the scientific evidence. And I didn't have that skill and I wanted to get that skill. And so that's when I went off and learned evidence based medicine. I did a master's of clinical epidemiology and then went on and did other things. And then I started doing the studies myself. At around that time, I was seeing problems with what I was doing. So for example, I was doing lots of arthroscopic knee surgery like everyone else was. It's one of the most common operations in the world. And I was doing so many of these operations that I developed a waiting list and patients were waiting longer and longer to get into the operating room. And it got to the stage where I would be seeing them three or six months later in the anesthetic room. just prior to going in to have their surgery after having not seen them for a few months. And I'd say to them, how's your knee going? You know, how are you? And they'd say, it's fine. Yep. It's really good. problems. And so many patients would not have any problems with their knee, despite the fact that I booked them for surgery three to six months earlier. And that's because that's often what happens when you leave these things alone. And so that's the natural history. of a lot of conditions that we treat for pain. Roger K. McFillin, Psy.D., ABPP (11:20.833) So with arthroscopic knee surgery, often there's like a meniscus tear or there's something that is clearly needed, looks like it's need of a repairment. So what happens in that natural recovery process? Ian (11:33.306) It's all about the terminology. And the problem is we use the word torn. And people see a torn meniscus like a rent or a cut in your clothing. You you need to sew that back together. Otherwise, it just won't work properly. It'll have a big hole in it. But in reality, meniscus tears are by and large degenerative in nature. They wear and tear. They're like the patches on your elbows or your knees that over many years will just all fray and fall away. And that's not something you can fix with a stitch. And in fact, what we do is we remove the meniscus when we do that surgery most of the time. And so how does removing more of the clothed torn clothing help? You know, it doesn't. And so this is largely a degenerative condition. It's often associated with osteoarthritis. And the meniscus tear is just a sign that the patient has osteoarthritis, which is causing their pain. And repairing it or removing it doesn't make any difference to their pain because it's not the cause of their pain. It's something we can see on a scan. And we fall for that trick all the time in surgery. We have someone with chronic back pain. We do an MRI. The MRI will always show something. Even if the patient doesn't have back pain, the MRI will always show something. And so it's human nature. It's a bit naive, but it's human nature to say, well, there's something on the scan and the patient has pain. Therefore, the thing that I can see on the scan is causing the pain. And mostly it is not causing the pain. Chronic back pain has, you know, is very complex and often not related to a single simple physical cause. Roger K. McFillin, Psy.D., ABPP (13:32.919) This is fascinating because my son who's an athlete was just recently recommended to get arthroscopic knee surgery and we actually declined and he's doing fine. But why would we then do so many of these scopes on young athletes, for Ian (13:49.7) Well, they often have different conditions. for example, we often do arthroscopic surgery to reconstruct torn ligaments. And that can be very helpful for people who have an unstable knee because they've got a torn cruciate ligament. Sometimes people can have a very large acute torn, good meniscus and a young person's meniscus. And we put that back in place and put some stitches in it and it might help their symptoms. So there is a role for these things. But the problem is most arthroscopic knee surgery is done on older people with arthritic changes. And for them, it offers nothing. Roger K. McFillin, Psy.D., ABPP (14:38.525) fascinating. So I want to go back to something you said earlier and you talked about the three arms to a study and one of them being the placebo in the surgical aspect of the clinical trial. So what would that then look like, let's say for arthroscopic knee surgery, if you were going to provide a placebo? Ian (14:56.216) Yeah, so there's been quite a few placebo surgical trials at the moment. We're running one at the moment for shoulder surgery for rotator cuff repair, which is a little bit different to the knee ones. The placebo or the control group can vary quite a lot. So for example, in the one of the most famous knee ones done, the knee study was published in the New England Journal of Medicine. They did an arthroscopic menisectomy. They cut out the torn meniscus. This is in in patients with a torn meniscus. They cut out the meniscus in the active group, in the treatment group. And in the control group, made the incisions, they put the camera in and they looked around the knee, but they didn't touch the meniscus. They didn't cut it away or clean it up or remove it or repair it in any way. They just left it as it was. So that was the placebo group or what I'd rather call the control group because again, people don't understand what placebo is. It's better to say what it is. So we're doing a study at the moment in rotator cuff repair, which is repairing phrase degenerative again, torn, unfortunately we use that word torn because it makes people want to have surgery. Rotator cuff tendons in the shoulder. This is a very common condition. most people over the age of 60 actually have a torn rotator cuff. So it's extremely common. And so we're doing we're doing a study that was initially called a placebo controlled randomized trial, we've removed the word placebo. And what we've called it is a randomized controlled trial of arthroscopic shoulder surgery with rotator cuff repair compared to arthroscopic shoulder surgery without rotator cuff repair. And to me that's just a lot simpler and people know what we're doing then. And so we are doing arthroscopic surgery. We're cleaning out the joint. We're inspecting the cuff. We're trimming away any bone spurs that we see. And then patients are being randomized to have the rotator cuff repaired or not repaired. And when they wake up, they won't know what they had done. They see a different surgeon afterwards who won't know what they had done. They all have the same Ian (17:25.06) physical therapy afterwards, but the therapists don't know what they had done and so on and so forth. So that to me is scientifically the best way of finding out whether actually repairing the rotator cuff makes a difference to patients or Roger K. McFillin, Psy.D., ABPP (17:44.247) So if that's kind of the gold standard then, how have surgeons been making decisions and what has been the evidence to determine how they make these clinical decisions? Ian (17:55.896) Very good question. The evidence for surgery is largely observational. And scientifically speaking, I use the term observational to contrast that with experimental. In other words, a proper scientific comparative study. So the observational evidence that surgeons rely on is that they see people get better. The surgeon that taught them did the same thing. Their colleagues are all doing it. So this seems to be the way that this should be treated. And mostly orthopedic operations develop without experimental evidence. And because the natural history of a sore knee is that it won't be sore three months later, when we operate on every sore knee that we see, then most of our patients will not have a sore knee three months later. And if we operate in between, then we attribute that improvement to the surgery. But that's a logical fallacy because we're not seeing what would have happened had we not operated on them, which is what I started to see when I had patients with a long waiting list and suspected that something was Roger K. McFillin, Psy.D., ABPP (19:13.761) So take me into the mind of a surgeon. I'm assuming at this point that a lot of surgeons want to do surgery. They believe in what they do. They've gone through very rigorous training. They feel like they're very skilled and they believe they can help their patients. So how are you received in your surgical community with this kind of understanding and, you know, discussion and, you know, how can this then inform the training of surgeons? is there any kind of for the lack of a better word, resistance to these type of ideas. Ian (19:53.898) There is this, I think there's acceptance that these randomized controlled trials, these scientific experiments are very high quality and low bias studies, but it doesn't stop people from trying to pick holes in them and therefore completely discredit them. So surgeons will often say things like, well, that study was done in Finland and I don't know the surgeons there. We're much better. over here than they are and in my hands I know that it works even though it didn't work in that study that somebody did. And that's because surgeons are human beings. They believe that what they do works. mean, homeopaths believe that what they do works. mean, people believe that what they do works. And unfortunately that belief though is based biased evidence. It's based on their own observation. So the example I give in some of my talks more recently is I show a chart, a graph from one of these placebo studies. And nearly all of these placebo studies, what you see is over time from before the operation till three months, six months, 12 months after the operation, you'll see on the y -axis, you'll see a line going up, meaning the patient's getting better. their pain is getting less or their knee score is getting better. So after the operation, they improve. But what you see in these placebo studies is you'll see a blue line showing that the active group, the group receiving the menosectomy is getting better and they're 50 % better after six months. But what you see is there's a red line that completely parallels that blue line, which is the placebo group. who also get better and exactly the same amount. But when surgeons are in practice, they're only seeing the blue line. They're seeing patients get better after active treatment that they're providing. What they're not seeing is that patients would have improved exactly the same amount had they not have done anything to them. But they don't see that. They don't know that. Ian (22:18.02) They're only seeing the blue line. And I think that's really driving why surgeons operate, because they believe it works based on the fact that people get better. This is what's home cures for the common cold. Every home cure developed for the common cold works. because every patient gets better after you give the treatment. Roger K. McFillin, Psy.D., ABPP (22:49.537) post hoc ergo proctor hoc fallacy. After this, therefore because of this, you had this great example in your book about bloodletting and how when that was applied to the scientific method and it didn't really hold much water, the resistance in the medical community because they saw it Ian (22:52.992) Exactly. Well, because of this. Ian (23:00.955) Ian (23:11.77) Yeah, and I use a quote from the American Journal of Medical Sciences from 1856. And this quote is so good because it could be any doctor today saying it. And the quote says that physicians are not prepared to discard therapies validated by their own experience and tradition. In other words, observational biased evidence that we're not prepared to discard therapies validated by tradition and our own observation based on someone else's numbers. In other words, someone that I don't know has done a study saying that this procedure doesn't work. Well, I don't believe it because I believe that it works. And that's what they said about bloodletting. And you can kind of understand the doctor's resistance because In treating pneumonia, is what it was commonly used for, they had been performing bloodletting for thousands of years. And it'd been handed down from doctor to doctor saying, this is what you do. You take the blood out and you'll see a lot. won't save every patient, but a lot of them will get better. And they just assumed that they got better because of the bloodletting, when of course they didn't. In fact, they probably got a little worse. Roger K. McFillin, Psy.D., ABPP (24:39.575) think one of the major problems is the published literature right now. I don't know if you're familiar with the work of Dr. John Aynitis from Stanford. You're very familiar. Yeah, he asserts that as much as 90 % of the published medical information that doctors rely on is flawed in itself. So it's, I think there's like a number of things he refers to the published research is not reliable, or it's of uncertain reliability. Ian (24:47.043) Very. Yes. Roger K. McFillin, Psy.D., ABPP (25:08.723) offers no benefit to patients or is not useful to decision makers. Most healthcare professionals are not even aware that this is a problem. And even if they are aware of this problem, most healthcare professionals lack the skills necessary to evaluate the reliability and usefulness of medical evidence. And of course, patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision making. So this is really often a question of informed consent. And I often make the statement, how can a patient consent if one they're not informed, but what if the doctors themselves are not informed? They are led to believe this is the best available evidence and then they replicate it over, over and over again and they're subjected to these own personal biases. So how do we begin to solve this problem, this medical information mess that exists? Ian (25:59.482) Yeah, and so what you're saying is exactly true. You've actually pointed out several problems, but the last problem you point out is the clinician bias. We've shown this in orthopedics where we've looked at patients who've had, say, hip and knee replacements, very common operation. And we've asked the surgeons for hundreds of patients, how satisfied are you with the outcome of the procedure? Because it's never 100%. There's always some patients who don't do very well. And the surgeons, you know, by and large satisfied around 95 % of the time. And then we asked those patients, the patients that we were asking the surgeons about, and we asked them, how satisfied are you with the outcome of the procedure? And it was significantly lower than the surgeons. So surgeons do have a biased perspective on the results of surgery. And there's been a systematic review in this area across all healthcare. And it showed that healthcare providers consistently overestimate the benefits and underestimate the harms of what they do. And when you think about it, it kind of makes sense because, well, everybody thinks that what they do is better, you know, because that's the world they live in. So two thirds of drivers think that they're above average drivers. You know, this kind of thing makes sense. So what's the big deal? Surgeons think that they're better than they are. Who cares? Well, the problem is when a patient comes to see a surgeon and says, well, do I need a knee replacement? I've got arthritis. My knee's a bit sore. But I don't know if I need a knee replacement or not. That surgeon's going to make a recommendation based on the surgeon's perception of the risks and benefits. But that perception is wrong. That perception does not align with the reality. They're going to overestimate the benefits and underestimate the harms when they make that decision. for the patient. And that's a problem. It's the problem you pointed out. just, I'm reinforcing Roger K. McFillin, Psy.D., ABPP (27:59.169) Yeah, it's such a legitimate problem because if we're seeing that a placebo and just sometimes natural recovery or maturation is going to provide improvements, that all comes without the side effects. The side effects are the adverse consequences of the drug, of the surgical procedure. So if we're just relying on scientific evidence, empirical evidence, then in a lot of cases we would make the decision to not intervene. And I think this is more than just in surgery. across the spectrum of a lot of medical interventions. Ian (28:32.216) Yeah, it is. I mean, you said yourself, you look at antidepressants and, you know, I can't think of anything that's more over prescribed than antidepressants. The evidence for them is terrible, but it's an easy way out. A lot of general practitioners think that they work, they get told that they work. A lot of their patients say they feel better afterwards. So they just keep going. And with surgery, it's not so much doing nothing can be just as helpful. Often other non -operative treatments can be very helpful, but we tend to discredit them or not do them. And in fact, we even underfund them. So, knee arthritis is a very good example, I think, because for somebody with terrible knee arthritis, very bad pain and difficulty getting around and needing to use a walking frame or a cane or something like A knee replacement can be very effective. But of course, it gets overdone. Too many people out there are getting knee replacements for very mild knee pain. And they're not happy afterwards. Because a knee replacement doesn't give you a normal knee, it gives you a knee that's a bit stiff, it's still a bit sore, but it's a hell of a lot better than a badly arthritic knee. It's just not a lot better than a mildly arthritic knee. So they've gone through this big procedure for not much gain. Now we know that for people with mild to moderate arthritis of the knee, simply losing weight or regular exercise can significantly improve their symptoms. But we tend not to offer it. It's seen as too hard. And sometimes to the patient, surgery seems like a quick fix as well. And I've seen many patients where I've said, sure, you've got some arthritis and your knee is sore. I understand that. But we know that for every five kilos of weight that you lose, your pain will significantly improve. It will also improve your general health. And if I can get you exercising regularly as well, we can really get on top of this pain. And you're going to be able to cope a lot better. And you won't need to have a knee replacement. The patient will say, I've tried losing weight, Ian (30:56.29) So just book me in. Let's just get it done. And so they see, I think patients see surgery as less risky than it really is and more beneficial than it really is, just like surgeons do. Roger K. McFillin, Psy.D., ABPP (31:14.135) So let's identify some of those surgeries that are so widely recommended that don't really have strong evidence that they're going to have an effect in the surgical realm. So what else exists outside of like arthroscopic knee surgeries? Ian (31:29.494) And there's a lot of shoulder procedures as well. Shoulder surgery is very common and it's not well supported by the evidence. So some of the most common surgical procedures for shoulder pain are around the problems with degeneration, wear and tear of the rotator cuff, inflammation in the bursa or around the rotator cuff. So they have procedures where Nearly all procedures like that now are done arthroscopically in the shoulder. They used to be done open but not anymore. And that's one of the problems because arthroscopic surgery is lower risk than major surgery. It's usually day only surgery. So it's easy to do and it's seen as kind of low risk. So why don't we just do it anyway and just see how you go. But many studies have shown us that decompressing the shoulder, so -called decompression, is no better than not doing anything or doing a placebo procedure. It appears that repairing the rotator cuff isn't as effective as we think it is, but we need better evidence for that, which is what we're doing now. And in the spine, treating back pain with surgery does not have good evidence, and yet it's commonly done. And in particular, spine fusion. And the fact that it might not be effective can be highlighted by several phenomena. One is that the rates of spine fusion surgery vary widely between geographic regions. Now, the United States is the worst offender for spine fusion surgery. It is, in fact, more common to have a spine fusion operation than a hip replacement in the US. It's extremely common. very high rates and it's about 10 times the rate that it is in other countries like the UK or Scandinavia. And I think part of that is the US is very interventionalist. Surgeons get paid handsomely for operating. They don't get paid so much to not operate. financial drivers are a big thing, unfortunately. I'd like to think they Ian (33:53.976) I'd like to think that all surgeons just operate because they believe it to be effective. But we've shown in particular the spine fusion surgery in Australia because we have a two tiered system. We have a robust private health system where most of our population is covered by private insurance. We have lots of private hospitals, but we also have universal health care and lots of public hospitals where everybody's covered anyway. And we've found that spine fusion surgery is has very high rates. and is increasingly increasing rapidly in the private sector. But it's rarely done in the public sector. And that's because the surgeons don't get paid much to do it in the public sector, so they don't do it. In the private sector, they get paid handsomely to do it. And so it's much more commonly done. Roger K. McFillin, Psy.D., ABPP (34:42.869) It's such an inherent conflict here in the United States in a for -profit healthcare system. And I think it's, it's really a systemic problem because when I talk to physicians here in the United States, they say that in a lot of ways, they're going to have to follow the guidelines that are developed by their major medical organizations. And when you really dig deeper than what's funding the major medical organizations is various industries, the pharmaceutical industry, biotech and so forth. So there's really a financial incentive to more and more invasive surgeries to prescribe more and more drugs, even if the evidence doesn't support their overall effectiveness. And in a lot of cases, we don't even have long -term safety data on this. And there's also, think, a bit of a problem with the way that physicians are trained. And this is an example of a woman I talked to today who was postpartum experiencing what I would say is typical postpartum challenges and struggles and goes into OBGYN and the first thing they want to do is they want to, you know, prescribe a psychiatric drug or they want to put them on hormonal birth control. And this woman doesn't want to do either. And then the doctor says, well, what do you, you know, what do you want for me? That's all I can offer. And so that's a real problem as Ian (35:58.392) Yeah, it is a problem. And I've had surgeons say this to me when I've lectured surgeons and groups of surgeons and I've said, you know, we really shouldn't be doing this, the arthroscopy procedure anymore. say, well, what else can we do? That's all I can offer them. And I have to remind them, well, you can always offer them no surgery. You don't have to operate on every patient that you see. They have this mentality that failure to treat equates to failure to care. But the financial incentive is a big one. I know that the United States in particular have a mindset of market forces will solve everything. But a lot of things, particularly things related to public good, don't fit a for -profit model. They just don't fit. it's very clear to me. that in medicine it doesn't fit a for -profit model and the for -profit model drives healthcare activity. It doesn't drive health. It doesn't improve health. It's not meant to improve health. It's meant to promote healthcare activity. So that means more operations, more drugs being prescribed, more implants being inserted, more injections being done because that's how you generate profit. by doing lots of things to people and it's not necessarily how you make people feel better but that's not the primary driver of a for -profit system. Roger K. McFillin, Psy.D., ABPP (37:40.823) So let me ask you a question about the nocebo effect, which is essentially like the opposite of the placebo effect that describes a situation where a negative outcome occurs due to the belief that the intervention will cause harm. And this is sometimes a forgotten phenomenon in the world of medicine and safety. So let's say for an example that you recommend physical therapy and time. And then the patient believes that that's not enough, that they require surgery. Are you seeing that that then is going to negatively influence the course here and the outcome? Ian (38:20.314) Not so much because it depends on what the patient has been told. So if the patient believes or has been told by the surgeon that they need to have an operation, that they need to have their spine fused, otherwise they'll be in terrible pain. And the person that told them that is a brain surgeon or someone that patients tend to believe. And then someone else comes along and says, no, no, we're not going fund that or we're not going to support that we're going to send you to this therapist instead who's going to give you some exercises well that patient's not going to get better that that patient you know to to them that patient has been denied effective treatment and all the physical therapy in the world is going to do nothing to change that patient because they are being given a treatment they have been told will not help them So that's true. So everything you've said is true in that situation. But it's not true in the situation where they go to see a surgeon and the surgeon says, look, I'm sorry, I know that you have back pain at the moment, but the evidence is that fusing your spine will not make you better. It'll expose you to significant risks. And I don't recommend it. But I do know that you can get some improvement with this treatment or that treatment. Well, then their expectations will change and their response to that treatment will be much more favorable. So we need to remove the conflict where there's one group of people saying don't have surgery and there's a group of surgeons saying you have to have surgery. That creates problems for patients. We have to stop the surgeons from recommending the operation in the first place. So we have be more scientific in our clinical practice. And that's one of my big drivers. And it's one of the reasons why I'm promoting science left, right and center. But I promote science for the public as well as for the practitioners. But practitioners have to be more scientific. They're getting more scientific. They're more scientific now than they were 20 years ago. But there's a lot of resistance. And I would have to admit there's a lot of resistance from Ian (40:43.94) certain countries and it's not just the US, it's many southern European countries, lot of places I've been, they just don't understand that a scientific study will be more likely to be telling you the truth compared to what you see with your own eyes that doesn't make sense to them. Whereas other countries embrace this kind of stuff, I Scandinavia is probably the greatest example, UK as well. where they believe the scientific studies and they don't do these procedures. mean the rates of knee arthroscopy, spine fusion, the shoulder operations are dramatically lower in many countries who are more accepting of the scientific method than other countries that are. Roger K. McFillin, Psy.D., ABPP (41:33.493) Are you familiar with the field of psycho neuroimmunology? It's kind of a burgeoning. Yeah, it's a burgeoning new field. It's a study of the interaction between psychological processes in the nervous and immune systems of the human body. So it's kind of a subfield of psychosomatic medicine, which does a lot of work around the placebo effect. And one of the things that I'm gathering is the placebo effect is really robust in certain conditions and then not so robust in others. Like for example, Ian (41:38.179) Is that what I'm not? Roger K. McFillin, Psy.D., ABPP (42:02.879) depression, pain, fatigue, allergies, irritable bowel syndrome, Parkinson's disease, headaches, you know, they tend to have these stronger response to placebos, but it's obviously it's more than just the positive expectations, which you referred to earlier. It's the relationship that exists between the provider. It's even the rituals around receiving medical care. It's the authority status of who the provider is. Ian (42:23.172) Yes. Roger K. McFillin, Psy.D., ABPP (42:30.401) So the greater confidence or the higher the level of education and awards and just a positive reputation in the community, all these things seem to influence the outcomes. So my question here is how do we then ethically use this evidence to improve outcomes by altering the way we train physicians? Ian (42:55.45) Yes, I thought you were going to say, by the way we practice, but I guess it's the same thing. Yeah, I think any therapist that spends a lot of time with patients knows that their outcome will depend greatly on the interaction between the therapist and the patient and bringing the patient along with you and getting them to trust you and things like that can can be very helpful. Any physical therapist knows that even though on the surface they're only relying on physical actions on the patient to achieve their result, they know that talking to the patient, reassuring them when they're distressed, things like that can make a huge difference to them. And yeah, I think we need to teach that, that this is a big part. And again, I don't call it a placebo, I call you know, being nice to the patient or getting them to understand or educate them. Because I am a bit of a critic of some of these studies. You mentioned the irritable bowel syndrome, because that's where lot of the famous placebo studies are. But these studies are not very good either, because they're not just treating the placebo, they're changing the patient's expectations. And many of these studies in gynecological surgery and other areas where they've used placebos. And even for back pain where placebo has been used to treat patients with back pain, they've shown, for example, long term results of placebo claiming that the placebo effect is a long term result. But a lot of those long term results only look at the placebo group. So they're saying we treated this group with placebo, we followed them for five years, and they're better now than they were before we started treating But they're not comparing that to how much better the patient would be had they not have received the placebo. So again, a lot of this placebo research is as flawed as the observational evidence that I criticize for surgery. And in fact, we've looked at we've measured the placebo effect for surgery published this recently in JAMA Network Open where we looked at a whole lot of surgical procedures where Ian (45:18.87) is they've been compared to placebo and where they've been compared to no treatment. And we found no difference in the placebo arm, the improvement seen in the placebo arm of the studies, compared to the improvement seen in the no treatment arm of the studies. So we actually found no placebo effect in surgery, which surprised me. But when you think about kind of makes sense. And we found two thirds of the improvement in surgical patients across the board, even patients who had surgery, two thirds of the improvement was due to the natural history of the condition. Roger K. McFillin, Psy.D., ABPP (46:01.823) Yeah, I mean, it's fascinating because I think about the downstream effect of some of these things, these interventions. So for example, like for the treatment of clinical depressions, a severe clinical depression, one of the most effective treatments is something called behavioral activation. So it's really getting the patient to become more active again and gave socially a face and complete responsibilities, which allows the person again, receive that social reinforcement and then to feel good about taking care of their responsibilities as well as just moving the body again and all these things are really important. Now if you provide somebody a placebo and you convince them that they have a brain chemical imbalance and they believe it's something wrong with them and you give them a placebo and now they feel better, they might naturally then begin to engage in that same process which is just becoming more activated and engaging with people And so how do you tease out between like, what's the response? Now the placebo can start that process and get them to start moving again, but it doesn't necessarily mean that's the mechanism of action. The mechanism of that action would be all the things that happen after the placebo is provided. So the question is then from an ethical standpoint, we actually now outside of surgery, but maybe with pain, for and mental health. Should we actually be prescribing placebo drugs since people actually believe these things help? Ian (47:24.974) Probably not, because systematic reviews of the placebo effect, this is a Cochrane review of placebo drugs, show that they have very little effect. And if they do, it's very short lived. But if you can show that giving a placebo helps a patient with depression or pain, the examples you've given, more than not giving the placebo or other things being held equal, then you are justified in using It's just that I think in a lot of these studies all other things aren't being held equal. So that's the problem. But yeah, I have no problem with giving any treatment that has been shown to be more effective than not giving Roger K. McFillin, Psy.D., ABPP (48:13.471) I think you recently published on this idea of the decline effect. So maybe I think it was Lyrica, if I remember correctly. So I mean, it's similar, right? So you give a placebo, there might be a short term effect. And then in time, it doesn't have the same effect. And we see this with drugs as Ian (48:20.438) It was, Ian (48:31.31) Yeah, there's two things. Well, if there is a placebo effect for drugs, it's probably short lived. The decline effect is a bit different. That's when you newly introduce a drug. It appears to be very effective. And the studies show amazing results. And everybody's saying that this is a revolutionary drug. And let's do more studies. But the more studies you do over time, the less effective it becomes. And part of this is due to the fact that the more studies you're doing are more scientifically grounded. And so you're actually teasing out the true effect over time, which is much less than we suppose. And we found this for Lyrica and over a 20 year period from sort of 2000 to 2020, when you look, line up all of the randomized controlled trials, and there were a lot of them done for Lyrica for many different. conditions, but basically for neuropathic pain, which is what it's designed for, it got less and less effective, such that in the last five years, the studies show that it's not effective at all. But interestingly, for Lyrica, over all of the time periods, for all of the studies, even the first five years, even the early good so -called effective studies showed that it never reached clinically important benefit. So here's a drug that has never been shown to have a clinically important effect and now more recent studies show that it has no effect beyond chance or what you would expect anyway and yet it's one of the most commonly prescribed drugs in the world. Roger K. McFillin, Psy.D., ABPP (50:19.777) So would you suggest that when it comes to evaluating studies that you look beyond just a statistical difference, that you try to really understand how robust that difference is and how clinically meaningful it is over Ian (50:35.322) Definitely, yeah. And this is what we do with surgical studies. We're not looking for a statistical effect. We're looking for a clinical effect. So if we show that this big expensive operation like a spine fusion, you know, which costs like $100 ,000 and exposes you to enormous risks and several days in hospital, improves your pain by, you know, three points out of 100. and it's statistically significant, we don't care because that's really nothing. Nobody's going to go through such a huge procedure for such a small benefit. But if we showed that it improved your pain, you know, 20 or 30 points out of 100, then that's something that people might be willing, a risk that people might be willing to take or a cost that they might be willing to pay to get such an important benefit. So it has to be important, not significant. Roger K. McFillin, Psy.D., ABPP (51:36.555) which is the major problem here in the United States with FDA approval with drugs. For example, they just need to see two trials that have demonstrated a statistical difference over placebo. And when it comes to the published research, our physicians and those who are recommending the interventions are often just reading the abstract or the conclusions and the conclusions are really just demonstrating that this drug was statistically superior over a placebo and that's enough to convince the prescribers or the clinicians to be able to recommend that drug and they don't understand the actual methodology and the statistical outcomes of these studies. so you're really, me, it's about financial gain. It's about the impact of industry and the pharmaceutical industry in particular when it comes to these drugs. And they've really dominating the medical system here in the United States. How different is it in Australia with the influence of pharmaceutical? Ian (52:39.972) Well, yeah, well in the US they fund the TGA. The TGA wouldn't exist without them. And you know from antidepressants that when you summarize all of the studies that have been published, they kind of look effective. But when you summarize all of the studies that have been done, in other words, include all the studies that the drug companies did not publish, you find that they're not effective. Even the studies that are effective, there's problems with them because they're too short term. The outcomes aren't necessarily clinically relevant. In cancer surgery, this is a big problem because they approve cancer drugs based on something called tumor size. So they can say, this drug led to a significant reduction in the size of the tumor. And you might think, well, that's great then. Let's use that drug. But then other studies have shown that doesn't necessarily translate. to a clinical benefit for the patient. It doesn't make them live any longer. It doesn't reduce their pain. It just shrinks the size of the tumor. And you think, that doesn't make any sense. But then you think, it's quite plausible because, OK, it shrinks the size of the tumor in the first month. Then the tumor comes back twice as strong afterwards. You don't know what happens. There's all sorts of things that could happen. or it's only shrunk the less important part of the tumor and the really aggressive cells are still living. So it's just what we call a surrogate outcome. It's not the outcome we're interested in. And I'm sorry, I've wandered off. I've forgotten your original question. Roger K. McFillin, Psy.D., ABPP (54:21.483) Yeah, I mean, that no, that was a that's a perfect answer where we're actually, you know, talking about the robust nature of, of clinical outcomes and how just systemically Ian (54:30.823) yeah, I think you're asking me what it's like in Australia is a different. Yes, slightly different. So we have an equivalent of the TGA of the FDA called the TGA, therapeutic goods, administration or something like that. And, but they really only approve things to make sure they're safe. That this device isn't going to electrocute you or something like that. You know, this is this is a, this has been shown to be safe. So knock yourselves But we have another excellent system, which is the Pharmaceutical Benefits System. And that is a group of scientists. And they have to review the evidence. And they look at not just statistical significance, they look at all of the studies, they look at clinical importance, they look at cost effectiveness, they look at cost per quality adjusted life year, all these sorts of evidence, economic analyses. and they say, yes, this drug is worth funding. And then the government says, OK, put it on the list, we'll fund it. And so patients get subsidized drugs that are effective. But if that drug isn't highly effective, it doesn't get funded. And so to me, that's an excellent system. And we have the same thing for medical procedures, but there's a big flaw, which I'll highlight at the end. So if you have a new surgical procedure, for example, a new way of treating shoulder pain or something like that, then that doesn't get listed on the government's list for reimbursement, which means insurers won't reimburse it, the government won't reimburse it unless you show rigorous scientific evidence that this surgical procedure works. And you think, wow, what a great system. And I worked in that system and I thought, this is so good. But the huge flaw is that that system came in in 1985. And in 1985, they said, well, what are we going to put on the list to start with? And we have to start this list of procedures. What are we going to put on the list? And they go, well, we'll just put on the list everything that we're currently doing. so all of the operations, nearly all of the operations that are on the list. Ian (56:56.826) were just plopped on the list in 1985 and never had any evidence for them. so spine fusions, knee arthroscopies, shoulder decompressions, all of these procedures are on the list. If you have a new procedure, you can't get it on the list without really good evidence. But if it's already on the list, nobody's looking too hard at it. And that's the flaw in the system. Roger K. McFillin, Psy.D., ABPP (57:18.817) Fascinating. Yeah. Yeah. Well, this has been a fascinating conversation. To all the listeners out there, I do recommend this book, Surgery, the Ultimate Placebo, especially if you're a certain age range and you're considering all your options. But also, listen, if you are a medical professional, surgeon, you're a researcher, you're a clinical psychologist like me, You have a responsibility in being able to provide best evidence to support your client's informed decision -making, which is an ethical and legal imperative. We have to better understand the limitations of our interventions, especially given the risks, the substantial risks that are involved in pharmaceuticals, invasive medical interventions like surgeries and so forth. Being aware of this type of information, it's life -saving. It can change a person's quality of life. And there are so many different factors that are involved within the healing process. And it's really up to us to understand how to implement those in a, in a safe way, in a way that leads to positive outcomes. Cause listen, all this comes down to, doc is about a high quality of life. People want to live a high quality of life and feel as well as they can, as long as they can. And if we have scientific information that supports our ability to do this, then we have to really open, honest, transparent with people in our communities. And we have to be more transparent in public forums and so forth because there's so much financial conflict of interest that really wants to push as many pills, procedures, potions, whatever they exist, they're trying to push them onto the people in order to really drive their bottom line. Professor Ian Harris, I really want to thank you for a radically genuine conversation Ian (59:22.17) Thanks for your attention. Roger K. McFillin, Psy.D., ABPP (59:26.493) Okay, I'm gonna stop this and