Okay, it's one minute after eight and we're going to go ahead and get started. So thank you for attending our very last Grand Rounds of this year in this auditorium at the VA. So the next VA Auditorium Grand Rounds will start the Friday after Labor Day. Our last formal Grand Rounds. which is next week, is part of Research Day, and that will be in HSLC, and you'll be able to get more information about that.
But just know that the Research Day Grand Rounds is not in this particular auditorium. So it's with great honor that I present our fourth chief resident presenting grand rounds in our group of incredible chief residents. So today we're going to hear Dr. Matt Brunner, the Bridges Family Endowed Chief Resident, presenting Evidence-Based, the Role of Complementary and Alternative Medicine in Modern Healthcare.
And I was telling Dr. Brunner when I was looking around the audience, I know that there are some people here who are not... not common cumbersome medicine grand rounds, so welcome, and we're very glad to have you here. So a little bit about Dr. Brenner, who, when I was reviewing his CV, has really done some incredible work. He was an undergrad at University of Michigan in Ann Arbor. He then went on to medical school at Tulane University School of Medicine in New Orleans.
We were lucky enough that he chose us to come for residency, and then he has spent his chief year with us as well. And then... And as I mentioned, he holds the Bridges Family Endowed Internal Medicine Chief Resident. We're striking, I think, four for four this year.
Our chief residents are very smart, very talented, incredibly well-rounded, and he is going to be joining us in hematology oncology. He's working with Dr. Eric Hall right now as a mentor for his fellowship next year in HEMOC. So in looking at his CV, what I was really impressed with is the number of people Peer recognitions that he has received in a very short time in his career.
And I'm going to highlight some of those things. He is a Gold Humanism Honor Society member. In the research world, in 2017, he was the winner of the best research vignette at the Wisconsin ACP meeting.
He was then, as part of that, he went on to present a poster at the National ACP. And the title of that was Restriction of Floral Quality. quinolones to reduce clostridium difficile infection. In this past year, he has received the Dr. Cox Award for Best Mentor and Role Model through the UW Internal Medicine Residency Program and the Resident Excellence in Teaching Award for the Department of Medicine. So his devotion to teaching and working with learners is very clear, and I'm very thankful he's going to be using those skills when he joins us next year.
of the Resident Wellness Social Group. And with that, Dr. Brunner, please come up and present Grand Rounds. Thank you.
Okay, so what I'd like to do is, if you guys don't mind, everyone just bring both hands up like this. All right, keep them here for a second. So I just want to get the feeling of the room.
I'm going to make a statement. If you agree with this statement, I want you to lower your right hand. So I'll be this side for you guys. Here's the statement. When a patient brings up complementary and alternative medicine, I get a negative feeling.
So if you get a bad feeling, if you feel uncomfortable, if you feel anxious, bring your hand down. Second question. I'm worried that complementary and alternative medicine are a threat to the healthcare system. If you're worried about the role of complementary and alternative medicine, bring your left hand down. Alright, so kind of a mixed room, and this fits with the survey data, which says that a decent proportion of conventional medicine practitioners don't trust, and in many cases don't like, complementary and alternative medicine.
We'll come back to that in a second. So, true story, this was a guy's skin tone. So several months before I met him, he was diagnosed with advanced stage GI cancer, underwent a resection, showed up to his outpatient oncology appointment, and said, look, I thought about it. I don't want to do chemo.
I'm going to look for now. natural options. So he falls off of our radar for several months until he comes back and he returns this color because not only does he now have new mets to his liver but he's also been treated with mistletoe injections and high-dose beta-carotene in the interim which turns you orange.
So, to be perfectly honest, when I heard his story as a resident, I got angry. And I was angry at the fact that someone gave this to him and said that it was going to work, that that was legal somehow, but I was also angry at him. Obviously, you shouldn't be angry at your... patients, right?
That's a bad doctor-patient relationship. But it's also perplexing, right? Because patients come in all the time.
You know, smokers who have COPD or lung cancer, guys who eat a brick of cheese every day and have a heart attack. I don't get emotionally tied up in causality and who's responsible for what. You just take care of them. But CAM is different.
And I think that CAM does have a negative resonance with a lot of conventional providers. It's something that a lot of patients are doing. It's this alternative system. We don't necessarily know a lot about it.
And so what I really wanted to do is understand why did I feel this way? Why are patients using this? And really what...
what's the evidence and the philosophy behind it. So that's why I'm doing this talk. Before we get started, I could not define this term six months ago, so I'm putting it up here for everyone.
Maybe you already know it, but epistemology is the study of knowledge and justified belief. So in other words, it's how do we know what we know? Where does truth come from?
And so my objectives for you today are, first of all, I want you to be able to describe the epistemologic differences between conventional medicine and complementary and alternative medicine. Where do we see truth and knowledge coming from versus where are complementary providers? We're going to look at how and why patients use CAM.
which is complementary and alternative medicine. And then lastly, I do want to talk about some barriers to this idea of integrative health. So integrative health is the idea that we are going to sort of rigorously interrogate modalities within complementary and alternative medicine using an evidence-based framework in order to figure out what works. And while certainly I think no one would disagree in principle with the idea of doing the research and figuring out what works, I think there are...
some issues with this that are worth mentioning, especially because this is something that is happening on a national level. So the National Institute of Health has a branch devoted to this, and then many medical schools and large institutions are using complementary and integrative health. My only disclosure is I got a free espresso two years ago at Ash from like an IV iron vendor. I don't even remember the company, so. Okay, and then the only other thing I want to mention is, so I said that I got angry, and you may...
also get angry. Some of you may, during this talk, get angry. Some of the things I say, the beliefs and practices, you might really not like.
But what I want to be very clear about is that that while I will critique beliefs and practices, I'm not critiquing intentions or motivations. Everything that I can tell is that, just like us, the vast majority of complementary and alternative medicine providers believe what they're doing, want to help patients, they've devoted their lives to helping people. So I just want to make that distinction clear before we get started. Okay, so if we're going to talk about CAM, we have to talk about conventional medicine.
If we want to talk about conventional medicine... We need to talk about science. So this is a pretty rough graph of our understanding of the natural world over time. And that inflection point would be like the late Renaissance, the beginning of the scientific revolution.
So we start to measure things systematically, mechanistic understanding, large scale, small scale. And so if we wanted to give the history of conventional medicine, sort of the folk history, right, we'd say, okay, Hippocrates moved to the Middle Ages. us out of the God gave me epilepsy to the imbalance of some natural forces gave me epilepsy.
But the qualitative explanation doesn't have as much depth as maybe a mechanistic explanation, and that's where the scientific revolution gets us. So we start to understand how things work. Our medicine is still brutal and ineffective at this point. at this point.
It's not until we really get to the modern era where we start to get blockbuster drugs like antibiotics and insulin and steroids. So that's great, like things work now. But, science isn't perfect. So at any point in any scientific field, you're probably going to have a mixture of true and false beliefs.
There's internal factors, right? So there's bad data, bad model, bad interpretation. But there's also external factors. Science isn't happening just in a lab, it's a human endeavor.
So there's economic, political, sociocultural forces. and I think a good example of that that we are all well aware of is smoking right so 40s 50s 60s robust data from multiple different lines of analysis epidemiology basic science show that smoking is a huge risk for cancer. It's what we would consider really clear data.
There's all this great data out there and yet public opinion, medical opinion, and regulatory activity lagged behind by decades. The reason is that mixed in with this good info is lots and lots of bad info that was deliberately generated by tobacco companies to muddy the water. So what do we call this this bad science that tobacco scientists were doing, tobacco denialists if you want to call them that.
They knew what the answer had to be and so all they needed to do was slap on a veneer of science to get there. And the term that we use for that is pseudoscience. And so a pseudoscience is a non-science that attempts to mimic science in order to gain legitimacy or justify beliefs.
And so okay there's pseudoscience, there's real science, like where do we draw the line? 20th century philosophers were like, we're going to figure out a logical, a priori distinction, we'll cut it right down the middle, and it totally didn't work. Because it turns out that science is too broad, too varied, to just make this distinction be ahead of time. So instead, what the conclusion of philosophers of science was, is that this has to be determined empirically. If you want to figure out if something is logical, you have to figure out if it's logical.
legit, you have to not only study the concepts and methodologies of a field, but you also have to study the behavior of practitioners and the history of the field. So some things that you might look for None of these on its own would be, you know, a slam dunk, but things like relying on unrepeatable experiments, being unwilling to test or saying that your theories are untestable, or relying on hand-picked examples. So there's a hundred studies. I find the one that supports my belief and ignore the rest.
What do we look for in science? Well, we want science to be progressive. Not actually this kind of progressive. This kind of progressive. So, we have Isaac Newton.
He does a great job with his mechanics, theory of gravity, works really well, explains almost everything, except Mercury has this weird hitch in its orbit, and he can't explain it. People work on this for literally centuries before finally Albert Einstein comes along with general relativity and says, hey, when things are really big, like the sun, they warp space-time. And that's what's causing this weird hitch in Mercury.
So that would be an example of progressivism. There's an unsolved problem. Instead of saying, well, whatever, we're just going to accept this, kept on working towards solutions. Additionally, we want science to be pragmatic. So in other words, a theory is better if it's able to explain more of the evidence.
So what's nice about general relativity is not only does it explain the orbit of Mercury, but it also explains why Newtonian mechanics are a very excellent approximation when you're looking at things at a human scale. The last part is coherence. So the idea of coherence is that things fit together, which I think is best explained with... little diagram.
So you guys are all probably familiar with pneumonia. When we think about pneumonia, we think about pathophysiology. We think about host pathogen response, and this would have broad coherence. So we could look at a lot of cases over a long period of time in lots of different places, and we would see very similar patterns and mechanisms at work. But what's really unique about science is not only is there breath, but there's also depth.
And what depth means is that you can explain higher level mechanisms in terms of lower level mechanisms and vice versa. And in fact, you can even take other fields and find out that they cohere at multiple levels with what you've learned. So what we would say is that if a theory is broader and deeper, we would expect it to be more accurate, more likely to come up with valid predictions.
Now what I do want to point out is that clinical research is somewhat removed from this, right? So these things we're understanding mechanisms, but for clinical research, we're going to look at a mechanism, but we're looking at the net result of that mechanism in a person. So not only is there this huge level of complexity of all the different things that are interacting mechanistically, but there's also inherently value judgments about what is a valid disease state, what's a valid cure, what is an acceptable cure. level of harm. So it's a little bit removed from science, so that's why we have like the bench to bedside process.
We try to be evidence-based about our clinical practice. So you know milkmaids don't get smallpox or find something in a lab, you've got a potential therapy. You do early testing, then you should do multiple really high quality randomized controlled trials, drug approval, over time you get systematic reviews, clinical guidelines, and you know if the thing ends up... not working, not very good effectiveness or not safe, you can either take it back to the lab or it goes away. So one question is, how well does this system work?
I mean, it makes some sense. And just to illustrate this, I want to tell you the tale of oseltamivir. So you're probably familiar with oseltamivir.
It's used for the treatment and prophylaxis of influenza. And it's actually one of the... most commonly prescribed drugs in the world. Countries stockpile this stuff. So in 2009, Cochrane noted that a lot of their efficacy data for reducing pneumonia came from an industry summary.
of 10 different studies. The issue was that only two of the studies were published. So they said, hey, can we just get those other studies because we're coming up with a clinical guideline for this incredibly important med that we're spending billions and billions of dollars on. So this leads to a four-year public media campaign to get this data released. The BMJ is at the forefront.
Finally, Roche releases the internal data. So again, this was data that was going to be used to justify clinical practice that wasn't even available to the public. In fact, 60% of trial data that they had was never published.
And so they came up with this guideline that was based on all the data they had and there's all sorts of articles out there if you want to read about how this whole thing went down. And what they found was that that data that we were going to base our guidelines on that wasn't published actually was pretty good. bad.
So bad randomization and blinding, switching outcomes in the middle of trials, changing the protocol after the trial, missing data, and for example 55% of pneumonia data wasn't based on on any clinical or radiologic criteria. It was just reported as pneumonia. And their conclusion was that ramidase inhibitors have small, nonspecific effects and very likely are not actually related to the purported mechanism of preventing viral shedding.
Now... This is just one case, right? Well, the point I want to make is that for the vast majority of medicines that we are routinely using, we don't have a chunk of the evidence.
Right? We don't have the BMJ going out. there and fighting for every single beta blocker and statin and ibuprofen all those sort of things so the data that we have is in large part data that the company that is selling the drug wanted to have made public. So you can say, okay, but I don't think the net effect of that is very important.
I don't think the scale is very important. And that's a valid viewpoint. I would tend to be a little bit more skeptical. And I would lump my beliefs in with medical skeptics, which is the belief that we are going to systematically overestimate the benefit and underestimate the harms of our treatments because of things like publication bias, selective reporting, all the the other biases and methodological problems, as well as the fact that when we're measuring harms, most phase one trials don't get published, our phase three studies aren't powered or timed to look for harms, and then a lot of our post-market surveillance is just going to be passive observation.
data and many of us who have looked at the evidence hierarchies would say well you know observational data is not very good so we've got this great randomized data for efficacy and it's just observational so what I want to point out here is that our answer to this would be fix the system, I assume. Like, I don't think people are saying, let's abandon science, let's abandon evidence-based medicine. I think most of us would say, open data, data transparency, pretrial registration, all that sort of stuff, would be the right answer.
So, keep that in mind. We are going to come back to this in a little bit. Just to summarize, science should be characterized, ideally, by progressivism, coherence, and pragmatism.
Conventional medicine should ideally be scientific, but there's probably systems that are not. traumatic issues in the way that we look at our treatments. Okay, so that's conventional medicine. So there's different definitions for complementary and alternative medicine, but I'd loosely say that it gets defined as health practices that are not within the convention.
So complementary is in addition to, alternatives instead of, and actually a new term that's coming into vogue is complementary and integrative health, which is the idea that instead of focusing on being different and alternative, we're going to focus on what are the things that really we can move into the mainstream. Still works. Okay.
So, if you were hoping for a comprehensive review of all the different CAM modalities and the evidence for them, I apologize. There's a lot of them. There's a lot of conflicting evidence out there.
But just to kind of summarize some of the things... that are out there, we have things that came about before the scientific revolution. So traditional Chinese medicine, for humors, Ayurvedic medicine. So these are systems. They're qualitative systems, often non-anatomic.
There's mind-body practice. practices like yoga, tai chi, meditation. And then there's natural products, which obviously would be pretty much the only medicine that you had available to you before the scientific revolution.
During the Enlightenment, spinal manipulation, so osteopathy and chiropractic came about. Homeopathy, naturopathy, which we'll talk about. And then in the modern era, things that kind of involve a little bit more science, chelation, orthomolecular medicine, so this is basically the belief that humans are inherently deeply deficient in vitamins and that giving high-dose vitamins will cure a variety of things, including cancer and infections.
Functional medicine, which is somewhat difficult to pin down, but they describe it as a systems-based approach to human health that involves ending up using a lot of CAM diagnoses and modalities. And then, obviously, there's lots of diets and supplements that go out and make health claims. So looking at who's using this, 35% of U.S. adults use CAM. That's been stable for over the last 20 years.
These national health interview surveys come out every day. every five. Less than 4% of people are primarily using an alternative practitioner though.
So most people are seeing a conventional practitioner and then maybe seeing a practitioner or just, you know, kind of going out on their own, buying things over the counter. Most common modalities used by far are mind-body and natural products. Additionally, some patients tend to use this at a higher rate, so patients with chronic pain, patients with cancer.
So, if you wanted to know why do people use it, so there's some specific little ideas like the perception of cancer. less harm or maybe you've kind of exhausted all your conventional options. This study tried to look at a little bit deeper like what are the belief structures that support CAM usage.
So this was ASTIN 98. published in JAMA, they took over 1,000 U.S. adults, they asked them, do you use CAM or not? And about 40% did. So then what they said is, okay, we're going to ask you about beliefs, and we'll see which of these beliefs will predict CAM usage using a multivariate analysis. And so the beliefs fit into three different categories. There was distrust in the medical system, desire for greater control over health, and then just sort of your general worldview.
What they actually found out was that worldview, perspective, was what drove it. There wasn't significant differences in trust of the medical system or desire for greater control over health in the two populations. But people who used complementary and alternative medicine were much more likely to answer yes to questions like, I believe in the importance of holism. I believe in the importance of spiritual health. ...virtual health in the consideration of physical health.
I believe in the importance of the environment and environmentalism and reported having a transformational experience in their life. So what I want to point out is that people aren't turning to this because they hate us or because we failed them. I think people are turning to this because it fits in with how they look at the world and how they think things work.
work. It's also worth pointing out that world views, if you've ever discussed anyone, discussed politics and religion with anyone, don't just change because someone gives you a new piece of information. They tend to be robust, internally coherent, have their own internal defense mechanisms.
Okay, so that's one explanation for why patients are using it. What's the evidence? Well, as you're probably aware, there's not a lot of great clinical trials for many modalities of complementary and alternative medicine.
And oftentimes, when they do come out, they're not showing really convincing efficacy, not huge treatment effects. So some examples for some sort of, I'd say, uncontroversial modalities, things that we would all be fine with. recommending or telling a patient to do, things like meditation, yoga, progressive relaxation. There's Cochrane reviews for all these different indications, and what they'll say is, yes or no, maybe there's a small effect, but it's based on low-quality data, and we can't draw any strong conclusions.
So why is this the case? Well, you know, That's a big one. Complementary and alternative medicine doesn't have a natural funding source.
It's outside of conventional medicine. It's not like Merck is gearing up to do a $70 million phase three trial of the size. and as a downstream effect for a long time the vast majority of CAM institutions aren't going to have the money to develop robust research infrastructure, study coordinators, all those things that you need to do to have a system. Additionally, there are issues with blinding and placebo that can happen.
So, how do you appropriately blind a chiropractor to whether or not they're doing their job right? You can't. Additionally, some modalities will rely on complex, synergistic, multimodal approaches, and they would argue that, basically, you can't take a reductionist approach. This only works if everything's happening at the same time, and so if you do randomized control trials, you won't see the actual effects that we're having with patients. So that's the idea of the NCCIH.
So the NIH said, look, a lot of people are using this. We don't have great evidence. So what we're going to do is we're going to have an NIH branch that is focused on integrative health, National Center for Complementary and Integrative Health. And you can see their focus is on mind-body practices and natural products. And so this was sort of the solution, was we're going to move this stuff to the mainstream, the stuff that works, through this mechanism.
So to summarize, CAM modality, CAM practices are basically things outside of the conventional. There's often a limited scientific and clinical basis. And then the idea of integrative health is make CAM EBM.
So as I said earlier, this sounds good in principle, but integrative health is controversial. You can look up articles. There's plenty of articles in mainstream medical literature arguing against this concept. In fact, In fact, Mayo did an interview series or a survey in 2006 where they asked about 400 of their doctors on their views towards CAM.
And what they said was, we would use CAM if you can show evidence that it works. The majority said that. But 70% also said CAM is a threat to the health care system.
So is this a catch-22? Are we saying, okay, if you can show it works, we'll use it, but at the same time, we're not going to invite you in, we're not going to give you the tools to actually do that. And I would say that it is somewhat more complicated than that binary.
And the reason is... this? So first of all, if we just blindly apply the paradigm we have right now, we will have the same biases that we already have in our own system, if you're gonna go along with me on the medical skepticism train just a little bit. But additionally, I think there's some unique issues with some CAM modalities and practitioners that bear some attention. And so we're going to focus on that for the next several minutes.
Three big categories. One is, can you do clinical trials on modalities that are non-or anti-scientific? The second is looking at naturopathy and how epistemologic differences lead to very profound differences in practice and what is considered acceptable. And lastly, we're going to talk about sort of the NCCIH's goal, right? This is a high-quality, randomized, controlled trial of a CAM modality.
Ended up having a positive result. But despite this, there was a lot of controversy and concerns regarding this trial when it came out, which I think bears some attention. So we'll start with homeopathy. So who here has heard of homeopathy before?
All right, so most of you have heard of this. The idea is light cures light. So if I drink a bucket of EVP and I get insomnia from the caffeine, right, that's an effect. Something in a large dose causes a negative effect. Like cures like would suggest that if I take caffeine in a very small dose, that would cure insomnia.
So the idea is that I want to get things that cause symptoms in large amounts and then get them in very, very small amounts to cure those same symptoms. And so the idea here is dilution. So a common dilution is doing 1 to 10 or 1 to 100 and then doing that 30 times. times.
Now the issue with this is that for the vast majority of things, if you take a caffeine solution and dilute it this many times, the chance that you have a single molecule of caffeine in your final substance is far less than one in a trillion. So you don't have your active ingredient. So the idea is this notion of water memory, which is that water somehow is retaining this quaternary structure, this energetic resonance of a material that was previously dissolved in it, and that that's going to carry out the therapeutic effect.
Now... This is incoherent with modern science. In order for this to be true, in order for water to have some sort of memory, that would rely on us changing our views of physics and chemistry, not even to mention we don't explain how that would... have an actual therapeutic effect on a person.
So we would say that in terms of our current understanding of science, this is exceptionally implausible. And if you do a clinical trial on something that has a very low pretest probability, then your results, if they are positive, are more likely to be false positives than true positives. So this is an issue.
Additionally, when you look at high-quality data for homeopathy, it does suggest that the effects are consistent with placebo. So there's a number of reviews of homeopathy, meta-analyses that are produced within the homeopathic literature, and a common method would be, since there weren't a lot of random... randomized controlled trials, what you do is you take a bunch of different treatments for different indications, and you pool them together, and you come up with a pooled odds ratio.
And the argument is this pooled odds ratio is going to reflect sort of the net efficacy of the field. So this study in 2005, Shang et al. came out, and they said, okay, we'll play that game. So we're going to do this.
We're going to take trials of homeopathy, but we're also going to grab some allopathic trials and do those simultaneously. So what they do is they take 110 trials of homeopathy that are randomized controlled trials, and then they find 110 allopathic trials that are matched by indication. They randomly select them from the Cochrane database, so they're not systematically choosing better trials. And then they looked at the pooled odds ratio, and both of them showed evidence of efficacy, and the effect was statistically significant. However, when you restrict your analysis only to the high-quality trials, that specified randomization blinding and were intentioned to treat, the effect was only retained for the allopathic trials.
So the homeopathic trials, the pooled odds ratio was very close to one, not statistically significant. And so when this came out... there was sort of obviously an intellectual back and forth salvos, but the argument was, look, using the same methods that previous researchers had used to show that homeopathy works, we can show that if you just look at the higher quality studies, that effect disappears. Another approach was what the Australian government did. So this was published in 2015. They were trying to figure out, do we want to pay for homeopathy?
Is there evidence of efficacy? So what they did is they took all English language systematic reviews of homeopathy and took the trials out. They also opened it up to the public. said, hey, any trials that you think are high-quality trials, you can send in to us, and we'll look at them. And so then they looked, is there a single indication for which there is multiple high-quality trials that show evidence of efficacy?
The answer was no. So, those are two pretty big studies that came out. But you're like, okay, I still believe in homeopathy, I'm not convinced.
And this is where the weight of the evidence and the quality of the evidence becomes very important. but also very problematic. Because if you want to find things that show that it works, there's certainly a lot of low-quality literature, and there are some high-quality randomized controlled trials that show effectiveness. But again, we have to look at the weight of the evidence, not just a single trial. trial.
Additionally, there's plenty of meta-analyses out there. I mean, meta-analyses are a big problem, not just in CAM. We have way too many meta-analyses, too, probably.
But what I want to point out, I don't want to create a false equivalence between, you know, oseltamivir and these homeopathy trials. So we certainly have problems with drugs, probably many more than we know. We overestimate their efficacy, but as modality, we have a lot of things that are incredibly effective within the modality of pharmacology. On the other hand, with homeopathy, we still can't find that. So, my takeaway is that, one, clinical trials of non-and anti-scientific modalities is going to be a bad idea.
Because we're not going to know what to do when we get a positive. And you're going to end up spending a bunch of money on a bunch of different things that have a low probability of working out in the first place. I would say that homeopathy does have characteristics of a pseudoscience, in that practitioners rely on hand-picked examples. There's unrepeatable experiments in terms of trying to prove water memory that were subsequently, say, disproven. on further investigation, but still get cited.
And then also, it is effectively impossible to prove a negative. So if we're going to look at things that are very unlikely to be true, and then we study them, and then we get negative studies, you could always say, say, well, I would have done the study another way. Or we could always do more studies. You can't prove by induction that homeopathy doesn't work. So that's one issue.
I want to talk next about naturopathy. So, naturopaths, the reason I chose naturopaths are a couple things. One, naturopaths are in a sense a very ham provider. They use a wide variety of ham modalities.
Two, their footprint is pretty rapid expanding. So initially it was limited to mostly the Northeast and Northwest. Now Doctor of Naturopathy is a recognized degree in over 23 states. And then lastly, if you go to pretty much any naturopathic school or website, they will go to great lengths to contrast and compare their clinical scope of practice with ours. They advertise as primary care physicians.
So what sets us apart? And I would say that the big thing that kind of stands out to me is that there's a fundamental epistemologic difference that I'd summarize as saying ancient wisdom. So if you look at the STEER, which is one of the most prestigious naturopathic schools in the country, on their website, they say their approach is to blend centuries-old knowledge into philosophy that natures the most effective healer with current research on health and human systems.
So right here, this is epistemology, right? This is saying that knowledge is coming from things that have been done for a long time. time, because this has, I guess, been vetted by people's experience, and a philosophical viewpoint that nature is the best healer.
Now, that's obviously not a testable assertion. Now, science is in there. We'll get to it in a sec. But if you look at what comes out of this epistemologic view, so one of the undergirdings of naturopathy is the idea of vitalism. So this is the idea that living things have a life force, an intrinsic spirit, and a life force.
and that diseases result from imbalances in this. And so therefore, the goal of therapy should be to remove things that take you away from your natural state, because if you get back to your natural state, then nature can heal you. Additionally, there are strains of rejection of reductionism in randomized controlled trials.
And so the idea here is that in naturopathic literature and in naturopathic practice, there is complex... complex multimodal treatments, and they would argue you can't separate out one bit of this and test it. You really need to look at the whole thing to understand how our motor system works.
...modality works, which makes sense in a vitalistic context, right? If there's a bunch of different things that are all contributing to these imbalances in vital force, you'd want to get them all out of the way so you can heal appropriately. So, just to kind of sketch this out schematically, we would say that, you know, from a naturopathic perspective, green is positive, red is negative, yellow is mixed. So, epistemology comes from these things that were wrapped up in ancient wisdom and then also science.
So that's going to support views like vitalism in nature, and then the use of CAM. Science has good things. Science is effective.
There's things that work. But it is reductionist, and they would argue it's not fit for the study of their modality. And additionally, oftentimes you will find references made to the problem that science is funded and controlled by political entities, corporate entities, and professionals such as ourselves.
So how does this go into practice? Well, as I said, they advertise as a primary care physician. They do a mixture of conventional training and CAM training. So they get pharmacology, pathophysiology, but they're also getting homeopathy courses. I think Bastyr has five or six of those, and botanical medicine.
I would argue that there's widespread use of unproven and disproven modalities. So this is the sort of the Harrison's of naturopathy. Any CAM modality that you can think of is listed in here. And I went through about 10 different sections and I couldn't... find one that they said, there's not really good evidence this works.
It's more of a justification for why they think it works and then an explanation of how to use it. And so things like homeopathy, energy healing, the the four humors, so things that we would say are anti-scientific, things that are outdated, get used. And I don't actually know if this guy was treated by a naturopath, but there are naturopathic oncology fellowships and mistletoe and vitamins feature pretty heavily in it. Initially, there's mistrust of well-established standards of care, and I'd say the main one that we look for is vaccinations. So surveys of naturopaths, so much higher rates of vaccine skepticism, as well as patients who go to see naturopaths have...
much lower rates of vaccination. So to kind of summarize, there are fundamental epistemologic differences between naturopaths and conventional providers. And I would argue that from our perspective, from a science and evidence-based perspective, This leads to unacceptable clinical behaviors. If you're getting your knowledge from things like just a general philosophy or belief that things that people have done for a long time is naturally effective, I mean, you could start doing bloodletting. You could start giving people mercury, because those were around for hundreds of years.
Additionally, negative evidence may not change practices. Again, this comes back to epistemology. If you believe that truth is not just going to come out of clinical trials, or that what you do is not testable in clinical trials, then you might not believe negative evidence.
So my conclusion would be that, at least as currently constructed, I don't see how naturopathy would fit into a science and evidence-based healthcare system. system. If you have people who are going around with very, very different and in fact oftentimes antagonistic beliefs towards what we've based our system on, I think it's very hard to make that work in a coherent way. Last thing I want to point out is the TACT trial. So this was a trial of chelation.
So chelation, we know, gets used for heavy metal poisoning. But additionally, in the 50s and 60s, there were some trials looking at it for coronary artery disease and thought that you... removing calcium.
This didn't really have any good clinical evidence, and when they did, like, cadaver and animal studies, it looked like the calcium in the plaques wasn't really any different because you're removing a trivial amount of calcium. Okay. So it goes out of the mainstream, but there are still people who continue to do this.
And in fact, and they justify it with antioxidant or maybe the idea that there's some other heavy metal poisoning that are leading to downstream effects, they start expanding the use greatly. So it gets used for a lot of things like autism, cancer, Alzheimer's, schizophrenia. Now, all the data for this is coming from within the chelationist community and coming within chelationist and CAM journals.
And... If you look at sort of summaries of this by allopathic providers, it doesn't meet what we would consider high quality. So this is the sort of stuff that we would, ourselves, probably not be advertising because it doesn't...
fit in with a science and evidence-based rubric. But the idea was, okay, maybe this could work, and so the NCCIH funded a trial for coronary artery disease. This had all the hallmarks of a decent study, right? Large, multi-sender, randomized, placebo-controlled, double- blinded, respected cardiologist as the lead author, NIH funded.
And so what we're looking at is coronary artery disease for patients, coronary artery disease patients with previous MI getting chelation, which contained high dose of chelation. dose vitamins versus placebo. Outcome was a quintuple endpoint, which no one's favorite endpoint to have five, but okay. Results were weakly positive.
So there was a hazard ratio of 0.82. It's pretty close to the statistical cutoff, but really the effect in diabetics and people with anterior MI was much more pronounced. And so in the discussion section, what the author said was, look, this shouldn't be used.
to change clinical practice right now, but this can be treated as an exploratory analysis. We should probably study this in people with diabetes anterior MI. Published in JAMA 2013. So that sounds... If I told you that this was a drug, you'd be like, yes, this is uncontroversial, right? But it's not a drug.
It's CAM. And so there is a lot of controversy. So there's concerns pre-trial. One was that there wasn't really a clear justification. The justification was that a lot of people are doing it.
it. It was about 110,000 adults per year were doing this, which is a large number of people in a stadium, but if you look at the U.S. healthcare system, the number of patients with Alzheimer's, autism, schizophrenia, coronary artery disease, it's a fairly small amount. And again, we still don't have a mechanism. There's not phase one and phase two trials that were done through the NIH. It's also a burdensome therapy.
I mean, it's one thing to give someone a statin. It's another one to tell them to show up for 43-hour sessions. sessions to get chelation.
Additionally, there was controversy about the involvement of chelationists. So again, these are people who have been practicing this widely and advertising it for a variety of things without really strong evidence for decades. They're on the Data Safety Monitoring Committee, they're site investigators, and this sort of immediately piqued some people.
They were like, are we going to like this? So that's pretty much it. pre-trial.
The day of the trial, the same edition of JAMA, one of the editors of JAMA writes an article questioning the reliability of the data. It says 60% of the sites were CAM clinics, where they're not only been selling chelation for a long time, but a lot of other things that, again, we wouldn't get behind in the mainstream. This place is not the sort of place that we would choose to fund an NIH trial.
And additionally, there's irregularities in the data that are made more concerning because of this. So the fact that the dropout rate was high, it was 50% higher in placebo, which normally dropout rates tend to be higher in the treatment arm because they're having side effects. And there was a question of, was this related to unmasking of the patients? Additionally, the sponsors had access to the data throughout the study.
11 interim analyses were done. So, I mean, if Roche did a study and there's 11 interim analyses and they got to look at the data during it, we would probably be really suspicious. And then on top of that, there's these chelationists that were already sort of emotionally triggered not to like. And look, it's not like the mainstream was all like burn it down, right?
Sanjay Kahl is a prominent cardiologist at UC. UCLA. He said, hey, let's take a step back. Maybe we are letting our biases get control of us. If you look at this diabetic data, it's in fact so good that even if you were exceptionally skeptical of this premise beforehand, the data would at least suggest for a reduction in skepticism and more research.
So, sort of the net fallout was the big heart people were like, okay, we'll move this out of the waste bucket and put it at 2B, but we definitely need more studies. Skeptics, still mad. If you look at the NCCIA...
like if you look up chelation on their site it doesn't mention anything about anything other than the tax trial they talk about the tack to which is coming out in diabetics in the interior mi but they are very proud of this study. That's my baby. He's very cute. The last chelationists were like, chelation works.
Great. This doesn't change their practice, right? They're still doing chelation for a wide variety of things without robust evidence.
So to summarize this, there was things that seemed a little bit irregular in this study. in terms of the dropout and the interim analyses and all that sort of stuff. And if you add on top of it the fact that there's a bunch of people that we would say are not practicing responsible medicine in charge of this, trial, involved in this trial at any level, every level, makes it really hard for this to get wide acceptance. Additionally, there was concerns about, are we legitimizing people who are doing things?
that we would consider irresponsible. I mean, again, if you're making people NIH site investigators and putting them on the data safety monitoring board and then they're going out and practicing things that doesn't really have that well of understood harms and saying that it works for a wide variety of conditions for which it doesn't seem very likely, it's not really what we want to be doing. So I just want to sum this up with an argument for integrative health skepticism. What I would say is that science is our best approach to understanding the world. Evidence-based medicine is the paradigm by which which we become scientific about human health.
And this thing, there are problems with it, no question. A lot of our data is probably not as good as we think it is. But if we simply apply this paradigm to CAM as it currently is, we are going to find spurious effects. We are going to find false positives.
It's not only for the same issues that we have, but issues like testing non-scientific modalities, involvement of people that we would say are radical, and at the very least threaten the perception of the world. perception of data integrity. I'd also say that there's concern that if you're doing this kind of research in many cases it's not going to change minds in the sense that we are going to be very skeptical of these modalities of having these practitioners involved and that camp practitioners often have alternative epistemologies.
So even if the evidence doesn't support what they're doing, I mean, they've been doing it for decades without any support. It's justified in other terms. So I don't know if you can say that a negative... trial in chelation would really have changed opinions, although they can't prove that. Last, there's a risk of legitimizing people that we really don't want practicing medicine on people.
So I don't think that this is a dead concept. I think that we just do need to change our approach. We need to have strong justifications for what we're doing.
It can't be there's a lot of people doing it. There's a lot of people who do a lot of stuff. We don't study those things in $30 million.
NIH studies. I think that we do need to consider both modality and practitioner to make sure that when we are studying a modality, we are working with trustworthy, responsible partners in the CAM community. And I strongly believe those people are out there.
I mean, you can... I spent a lot of time the last six months reading, obviously, articles, textbooks, but also blogs, also comments on papers that get published. And just as we have skeptics in our community, there are skeptics in the CAM community.
community who say, hey, look, like the way people are doing things, this isn't really acceptable. We're not going to be able to help a lot of people with what we believe in unless we can show it works. We have to show that it works in a way that's scientific and clinically robust.
So I guess just to sum up, look, I mean, we're in charge. We're the conventional medicine system. We're the man.
We're the stewards of the healthcare system. And so, it is on us to make sure that public institutions are upholding the ideals of science and evidence-based medicine. Because at the end of the day, I think that's really the only thing that we can all agree on.
Okay. So thank you very much. I want to thank some special people.
My wife, Margaret, my son, Ronan, my dog, Thor, and my cat, Bella. I want to thank Dr. Vogelman. I want to thank my co-chiefs, Anne, Sam, and Brian. You guys are awesome and have made this year amazing. I want to thank my mentors over the years, Eric Hall, Nasia Safdar, and Lois Weissman.
And lastly, I want to thank Jeremy Smith, who helped me with this presentation. Thank you. Thank you.
Questions? So, the question was, are people who are seeing CAM providers more or less satisfied? I think that it's hard to kind of, I mean, I'll be honest, I don't have a great answer for you.
It'd be hard to summarize. For example, in the TAC trial, they looked at quality of life and found that it was no different. My guess is that for a wide variety of things, though, people are going to be more satisfied by their CAM practitioners in the sense that, one, by choosing CAM, they are already sort of ready to believe, and placebo effect can be incredibly powerful at the very least.
Not to even speak of... efficacy. Additionally, a lot of CAM providers like naturopaths will spend an hour or an hour and a half with their patients every visit. And so I think that has a powerful therapeutic effect. And that's certainly one of the things that, you know, I'm sure that we would love if we could have hour and a half long visits.
Obviously within our healthcare system, it's not really feasible right now. But I think that is, that's definitely something that we would at least want to adopt. and appreciate the sort of spiritual and holistic care component that they bring.
Danny? I think my question is, on a more practical level, as an allergist, when these patients come to me, the naturopath is recommending they get IgG testing, TGF beta testing, or biochemical assays. How do you think that ties into the naturopath model? Because it seems to me that's just simulating some of the bad trends in allopathic medicine. Lots and lots of testing to help patient satisfaction.
Well, so the question was, naturopaths use some diagnostic tests that are, you know, very lab, chemically. So how does this fit in with the philosophy? So as I pointed out, I mean, naturopaths do, they have a lot of...
of science training in their course. And so I think that fits in with their worldview. In terms of the nosology, the actual diseases like IgG-mediated allergies and adrenal fatigue, stuff like that, that comes out of this.
testing. Those are things that there's really not evidence for. And so I would say that yes, they're doing a lot of diagnostic testing. What they're taking out of it is different than what we would take. We would get IgGs and say this represents food tolerance, not food intolerance.
In thinking about your gift as a cancer provider who is faced with a lot of the... ...study experience, so I expect it. Oh, geez. Demonstrating a significant difference in recurrence mortality, three-fold, arguing against alternative medicine and in favor of Western medicine.
When faced with that, how would you counsel a patient who says, you know what, I know I've got no response from breast cancer, but the mistletoe and red disease seems really effective? So the question was, you know, when there's robust data that a CAM approach is going to be much less effective, but a patient wants to pursue it, how do you discuss it? So I think that's where the idea of world... is really important.
My guess would be, because I'm not even a fellow yet, but my guess would be that you can ask them why they want it. You can be patient, and that ultimately if you're going to change someone's mind on this issue, it would be extremely implausible to take someone from, I want to do mistletoe and vitamin C, to sign me up for Folfax. in a single meeting.
I think if you want to do that, I think it's going to be about developing a relationship. Because if you can show someone that you care about them, if you can show that you really believe what you're doing, then maybe over time that's going to change their mind. worldviews are cognitive and emotional.
You just throw data at it. It doesn't fit in. So I think being patient and respectful is very important.
Okay, any other questions? Come up to the front. We're after nine. Thank you.