 Good afternoon everyone. Thank you for joining us for another NeuroEthics seminar. Those of you who are fans of the series will recognize that this is a topic that we have tackled from a different angle before. The title of tonight's seminar is Brain Hacking to Boost Your A-Game, The Ethics of Cognitive Enhancement in Gaming and Competition. I hope you will appreciate that we've got three very different speakers than we have before when we tackled a similar topic. And we've got a great panel tonight. I'm going to introduce them after I give a word of thanks to our sponsors, particularly the Mind Brain Behavior Initiative, the Harvard Brain Initiative, and the International NeuroEthics Society, which allows us to webcast this. If you are watching via the webcast, please feel free to tweet us your questions. We've got somebody who will be monitoring the Twitter feed. Use the hashtag NeuroEthics and tweet at us at HMS BioEthics. Our three speakers tonight, I'm going to briefly introduce and then I'll let them jump into our topic. Our first speaker is Anna Wexler, who is a PhD candidate at the Department of Science, Technology, and Society at MIT, and in particular, for our benefit, she is visiting Scholar this year at the Center for Neuroscience and Society at the University of Pennsylvania. Our second speaker will be Julian Sabulescu, who is the director of Oxford's UAHERO Center for Practical Ethics, where he holds the UAHERO chair and is the director of the Oxford Center for NeuroEthics. And then finally, Aaron Kesselheim is an associate professor of medicine here in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital. He's an expert on regulation of medical devices and he leads the program on regulation, therapeutics, and law. After the remarks tonight, we will have a dinner for anybody here who would like to attend and I will give you directions at the end of the evening. So please stick around and feel free to join us. So first up, we'll have Anna Wexler. Thank you very much. So I'm actually a PhD candidate, as Toss mentioned, in the Department of Science, Technology, and Society at MIT. And my dissertation focuses on the ethical, legal, and social implications of the whole use of brain stimulation. And today, I'm really going to be talking about the social aspect of that, at least for this short talk. And I think we'll hear from Julian more about ethics and Aaron more about the regulations. So, just as a bit of an intro, today we're talking about a specific kind of brain stimulation called TDCS or Transcranial Direct Current Simulation. And it's a technique that provides a constant level of electrical stimulation with a low current to the brain. And the most common way to describe a TDCS device is it's a battery attached to two wires and at the end of each wire is an electrode. And when the electrodes are connected to the scalp, the electrical circuit is completed and the device is thought to deliver a current to the brain. And it's thought that when the anodol or positive electrode is placed over a specific brain area, that brain region shows an increase in cortical excitability and the region under the cathode, there's a decrease in cortical excitability. So basically, it's a low level of current. It's not enough to actually cause the neurons to fire, but it's enough to modulate excitability. So basically, either making it harder or easier for the neurons to fire. This is a picture of an individual receiving TDCS. And I think what's really unique about TDCS, especially in the context that we're talking about today of the home use of brain stimulation, one is that the device is non-invasive, so it sits just on top of the head. So it comes in contrast to other techniques of electrical brain stimulation, such as deep brain stimulation, which are very invasive. Another feature that I think is unique also is that the device is relatively easy to replicate. It's a battery with two wires, essentially. And so again, it comes in contrast to other forms of stimulation. So for example, transcranial magnetic stimulation or TMS, which is currently an FDA-approved treatment for depression. You see here, there's different kinds of coils. That one in the photo there has to have to be a finger-aid coil. That's not really something you can say, making your own basement. So I think TDCS is pretty unique with those two things, so it's not invasive and easy to replicate. I should also say that TDCS is not currently approved by the FDA as a treatment for any indication. So electricity has been used on the body for thousands of years, so dating back to the Roman times when electric fish were used to treat things like headache and gout. Electricity has been used through the mid-18th century, 19th and 20th century. But the modern movement of what we would refer to as TDCS began about 15 years ago when two German neurophysiologists, Walter Paulus and Michael Nietzsche, published a paper showing that passing a weak electrical current through the motor cortex caused human subjects to perform better on motor tasks. This, I believe, it was 0.2 to 1 milliamps of current, so it was very low level. Electroconvulsive therapy, which many of you know, you're with ECT, that's on the order of 500 to 800 milliamps of current, so that's hundreds, many hundreds of times more current. So today, TDCS research in the academic or scientific sphere breaks along two lines, so there is research for TDCS in clinical populations. And that's looking at the effects of TDCS to treat various medical and psychiatric disorders. And then there's research in healthy populations, looking at the effects of TDCS, a learning memory, various kinds of cognitive enhancement. And there's been about 1,000 studies to date, and you can see really, this is a graph of academic journal publications about TDCS by years. And you can see things have really exploded in the last five years in particular. So where did the home use of brain stimulation come from? Well, there seems to be isolated mentions of it, dating back to 2007, maybe earlier, there was one article in a magazine called The Phoenix, which actually a Boston magazine, now they're found. And again, yeah, isolated mentions at various forums. But things really seem to go here in the middle of 2011, late 2012, when suddenly we see a number of blogs, websites, videos, all dedicated to what has become known as do-it-yourself TDCS. And I think the late 2011, early 2012 start date is really interesting. We run a place in sort of a historical or contemporary historical context, looking back to see how it developed. You see between 2010 and 2011, academic mentions of TDCS really more than doubled over there. And then if you also look at a graph of the media mentions of TDCS, you see between 2011 and 2012, there was a really big increase. So it seems that the media mentions of TDCS really increased around 2011, between 2011 and 2012. And then when we see this do-it-yourself movement come up and that kind of lags behind roughly a year for the academic mentions of TDCS. So who are these people known and DIYers? And I should say that's what they refer to themselves as. And it's actually not an easy movement to study because brain stimulation is a very private thing, often done in the comfort of your home. And most of these individuals communicate on a Reddit forum, which is anonymous. But there have been two recent studies, one conducted by Anita Dwa at Stanford about two years ago. So she did a quantitative survey of the community. And I have also done qualitative work interviewing members of the community, looking at websites and blogs related to TDCS. So individuals, both of us found that individuals are mostly male. It's kind of hard to see on this, but they range in age from teens to late 60s, but there's a large percentage of them who are in their 20s and 30s. The phenomenon is definitely a global one, although the Stanford study found that most users were concentrated in the U.S. and Canada. And one interesting study looked at whether neuroscience researchers, or I guess any kind of researcher who studies TDCS, whether they utilize brain stimulation on themselves. And they found that for the most part, researchers who utilize TDCS were not stimulating themselves. So what is the purpose? Why do people stimulate themselves? Well, it kind of is interesting because it breaks along the same line of why scientists are researchers. So you have a simulation for cognitive enhancement for healthy individuals who are looking to enhance, and you have a simulation for treatment. People are trying to self-treat a disorder. So this is figures from the Stanford study. So that found that 59% of people stimulate for cognitive enhancement, 11% stimulate for treatment, and 24% stimulate for both enhancement and treatment. Although I should note that the sample size was pretty small. I didn't do a quantitative study, but my sense for my work was that the numbers for treatment may be a bit higher. And I know the topic of today's talk is about gaming and competition. And we'll see about later that one device, the focus, when it first came out actually marketed itself for gaming. But use in gaming is not something I've seen be popular or become popular when I've looked at the home stimulation community or what the people are using it for. I think it's sometimes being marketed as a gaming device, but I haven't seen it that much, at least in video game or game or communities. So taking a step back, I think was so fascinating, and especially for me coming from the science, technology and society departments. That's really exciting because what you have here are two groups, or I'd say at least two groups. You have researchers and home users utilizing the exact same technology, but just using it in really different ways. So researchers using TDCS in the lab, applying TDCS to subjects for research or experimental purposes. And perhaps most importantly, their use of TDCS exists in a very controlled and regulated environment. You have IRB, you have a lot of standards and a lot of regulations in the lab. Whereas DIYers or home users, they're using TDCS at home, applying TDCS to themselves. And whether they're stimulating for cognitive enhancement or treatment, it's self-improvement purposes. But again, most importantly, it's in a completely uncontrolled environment of their house, so they can really experiment freely and do whatever they want, pretty much. So I've studied the interaction between these two groups, and I don't have a lot of time today, but I'm going to share one thing that I've looked at that I think is pretty interesting. And that's where the DIYers or home users interact with scientific knowledge or how they make use of published scientific literature. So when it comes to making or acquiring a device, researchers can purchase, at least in the United States, can purchase one of two devices that have an investigational device exemption, an IDE from the FDA. The two devices that they can utilize right now come from NeuroCon or Soterics. DIYers or home users, on the other hand, don't have the research credentials to purchase these devices. Also these devices are quite expensive. It's not clear that they want to spend many thousands of dollars on a device. So when they come to TDCS or they're interested in self-stimulating, there are a number of options that they have, and I'll just run through them very quickly. So on the left here, you can see that they can build a device. A little bit dark in the photo, but yeah. So there's a lot of schematics online for about $40 or $50. You can buy all the parts that you need and build your own device in your own house. There are TDCS devices and device kits. These are often manufactured by people involved in the DIY TDCS world and community. They range from $40 to $180, but their new devices are constantly appearing on the market. I saw a new one today that I haven't heard of yet. So they're constantly coming up. You have a number, and I should say that some of these devices make claims, so they're marketed for cognitive enhancement. Some of these devices make implying medical claims, and some of them make medical claims outright. I should say the ones in this column. There are other devices that are just marketed as either a TDCS device or as a direct current source without making that one over there. It's just marketed as a current source. It's not marketed for TDCS at all. You have ion tophoresis devices on this next column over there, and these are devices that physicians use. They're current dividing machines use to treat excessive sweating, hyperhydrosis, or use it to facilitate certain kinds of drug delivery, but you can buy them for about $300 online and repurpose them for use on the head. So one thing that's interesting is some scientists actually use ion tophoresis devices in their own studies because they're much cheaper than buying the two devices I showed you on the earlier slides. These are about $300 to $400. So in some cases, you have researchers and the home users actually using the same thing, the same exact device. There's at least one device that's designed directly for TDCS. This is sold from Hong Kong. That's designed and marketed directly for TDCS. It's basically just a current providing machine. And then you have these direct to consumer devices. Currently the only ones on the market are Focus. That's up there. That's the one that initially came out. So that's a wearable headset that came out in 2013. Initially it was marketed to gamers. Now they've kind of expanded their marketing. That's the older version. They now have new headsets. This is the version one. And the device, I actually have it in my backpack. I forgot to take it out. The same device. And that's a Silicon Valley startup. It's a little white triangle that you can connect to your head, connect the electrode to it, pair it with your iPhone, and you either give yourself calm vibes or energy vibes. So it's marketed for mood and headsets. And I think one thing that's interesting when looking at all this is when TDCS first began, or DIY TDCS first began, you saw a lot of these home-built devices and these device kits. But now it's really moving to these direct to consumer devices. So the range of devices are all over the spectrum. So one thing to keep in mind when we're going to hopefully get to regulation later is that there's a lot of variation in these devices. And you've heard me go between DIY and home user. And I think that's because the border between DIY and direct to consumer, DTC is really muddled. Like this is clearly a do-it-yourself device, right? They constructed it once home. And I'd say that this is clearly a direct to consumer. But some of these just kind of fall in the range of the spectrum because they require a certain amount of repurposing. So that's the range of devices. And the overall, I guess, point here, or another one is that when somebody comes and wants to stimulate themselves, you know, they're not involved with the scientific realm. So they're not looking to scientists for knowledge about the kinds of devices. But when they apply TDCS and when they use it on themselves, that's where they're really drawing on scientific paper. So they'll often post scientific articles on the forum. If it's behind a paywall, they'll post a free copy of it. They use video tutorials on electro positioning their gear towards scientists. I found that they hear mostly certain scientific standards like the 10-20 electrode positioning system that scientists use to figure out where on the head, basically standardized electrode placement on the head. And for the most part, they do seem to adhere to this current maximum of 2 milliamps. They also transform existing scientific literature into these user-friendly indexes and guides that are geared towards their needs. So you have all these measurements, this one individual here. You know, instead of reading from these dense scientific papers and extracting the correct electrode orientations that they want, they have these sort of user-friendly menus of cognitive enhancement options that you can browse and decide what you want to get. Another thing that I think is very interesting is that where there are unknowns in scientific literature, DIYers experiment and share their knowledge. So session length and frequency is one area where DIYers kind of really play and push the boundaries. So it's interesting that scientists, you know, if you're getting IRP approval, it's not as easy to get IRP approval for, let's say, 60 minutes of TDCS. If the going standard is 20 minutes of TDCS. But DIYers or home users can stimulate for everyone a lot. So I found that this is one area where they really experiment with the session length and frequency of sessions, too. And I love this quote from one DIYer who wrote on the Reddit forum, Most studies never measured the point at which TDCS stops working. And I think that quote really gives you an indication of where they're coming from and how different it is from where scientists are coming from. And they also kind of extrapolate, if there's a study on depression, they'll extrapolate to treat their own bipolar disorder. Well, now I think their study is not bipolar disorder. But when the first studies were coming out, they would just kind of extrapolate to treat their own disorders using whatever montages they found in the previous studies. So why do we care about the social science aspect of this stuff? Why is it important to study in the community? Well, one, I think it's important for scientists to understand how their second audience utilizes their research. So the fact that there are DIYers or home users reading these papers, using them for their own purposes, I think that's something that researchers need to at least be aware of and shouldn't even think about when they're writing their papers. I think that there are small kernels of value in these DIY reports. Right now there's a lot of talk about the future of TDCS as a potential home treatment for depression, but let's say supervised remotely by a physician. And if that's going to be the case, I think it may be interesting to look at these DIY reports and see what sort of obstacles these individuals encounter in their home use. That's just one example, but I don't think that the whole endeavor should be readily dismissed. I think there is something to be gained by looking at what they're doing. Finally, if you think about proposing methods of engaging with the DIYers or home users, the fact that they look to the scientific community for guidance I think is a really interesting point because that means that there's a line of communication open between scientists and DIYers. So there are other DIY or citizen science movements that kind of, as they don't look to science, don't hold science in such high respect or high regard. And DIYers or home users really do, and so I think that the avenue is open for scientists to communicate directly with DIYers. And finally, I know Aaron's going to talk about regulation a bit more, but just one or two quick points. I think social science is really important for assessing regulatory proposals because one, I think it's important to look at the actual devices that are on the market and really take into account this variation in devices. So right now, the FDA only regulates drugs, those drugs and devices that are marketed for medical treatment. That's an oversimplification, but that's basically the case. So how the manufacturer markets its device or their devices is extremely important. So a device that's marketed for recreational use or a device like a thing that's marketed for mood enhancement is not considered a medical device under the FDA, but a device that's marketed to treat depression is considered a medical device. And because of this, some people have said that there's regulatory gap or lack of regulation. The fact that the device and my backpack that I forgot to pull out, that thing device that is out there on the market, people have said, oh, there's a lack of regulation. But some people have said, oh, there's lack of regulation. Maybe we should propose additional regulation or modify existing regulatory frameworks. But if we look at the existing devices on the market, we can see that the proposed regulation would not... would really probably only encompass a small set of devices, right? Because it's not going to encompass the self-built devices. It's not going to encompass any device that markets itself just as a direct current source. It's not going to encompass ion toporesis devices, which are legally out there. People just buy them when they purpose them. A device like Think would actually... it complies with electrical standards. It would probably pass regulation pretty easily. And regulation says nothing about the usage practices. So we're concerned about, let's say, the safety of using a device like Think for 24 hours a day, which I don't think people do and I don't think there's a worry of people doing. Regulation regulates the device, not the use of the device. So that's something to keep in mind. This is just this variation, and if we're talking about regulation and additional regulation, what is it actually going to cover and that's just something to consider? And more generally, I think we have to be careful when we talk about a lack of regulation or a regulatory gap. I think many people have confused the lack of enforcement of regulation with the lack of regulation, and I think that's a really important point. So some of these devices, especially here, do make medical claims or they make implied medical things. So just because the FDA, and so technically, there are medical devices under FDA law or regulations. So just because the FDA hasn't enforced existing regulation against those devices doesn't mean that there isn't regulation. So I think we need to keep in mind the practical nature of the law and the regulatory agencies. The FDA, for example, regulates all of the drugs, cosmetics, and medical devices in the United States. There's a massive market and they can't possibly regulate every single thing. So that's just a note about, yeah, confusing lack of enforcement with lack of regulation. And along those same lines, you know, a device like Think, I don't think it's correct to say it's unregulated because if it's not a medical device, it's a consumer device. And there's plenty of regulation in the United States for a consumer device. So the Consumer Product Safety Commission set safety standards for consumer products. The Federal Trade Commission regulates unfair deceptive business practices but it interprets deceptive very broadly and it has recently taken action against a number of devices and apps that make cognitive enhancements. State authorities have also been involved. So I just think we need to be careful when we talk about something being unregulated. I think that certain agencies haven't enforced the regulations that these devices haul under. So just in sum, I think that people may have jumped to the regulatory question too quickly. So one of the questions to this panel was should the FDA regulate Think? And I don't know if that's the right question to ask right now or at least the right question to ask first. I think that we need to look at, you know, brain stimulation, stimulating the head or brain with electricity makes us uncomfortable. I acknowledge that, I understand that. But I think maybe the better way to approach this issue is actually looking at what are the risks? You know, what are we concerned about? What are the actual dangers? And what's the most practical way of addressing them? And what's the most feasible method that's really going to address our worries? So I think that may be a better place to start. Hopefully we'll get more into that in the discussion. But that's it. Thank you very much. Okay, well thank you very much. So I really would like to express my gratitude to Bob Truog and TOS for inviting me here today. And to Harvard in general. It's a great opportunity to be back. Maybe I will respond to a couple of things that and Anna said as we go along. But one thing I will say is that I think she's correct. This is an enormous amount of information out there in the DIY community that isn't being evaluated. It's a great source of research. And we actually, Roy Cullin could also my collaborator who does TDCS received questions from and requests to collaborate from the DIY community. We actually pursued this. And the advice the University gave us was that we would expose ourselves from legal liability which I think was a great shame. So as as Anna has alluded the problem with TDCS devices for enhancement purposes is that they are regulated differently to if they are marketed for medical purposes. So there's no control. While she's correct that there are certain regulatory controls over anything that's marketed. There's a more specific guarantee over electoral size, place, and stimulation stream, duration etc. And the reason for that is that the FDA and in this case the European Commission regulated according to the stated purpose of the manufacture. So if you state that your device is for medical purposes it falls within FDA regulations and it will be evaluated and it should be evaluated and there should be certain controls on it. But if you say that your device is for cognitive enhancement purposes the very same device escapes the same level of scrutiny. Now I'm not in favour of regulation in general. The only purpose that we wrote this article is that people who use this device for enhancement purposes deserve the same protection, level of information as people who use it for medical purposes. That's a simple claim. So by bringing it within some kind, by treating these by ignoring purpose and treating the device as a device that delivers energy we thought that consumers would have a more reliable way of accessing an instrument with certain quality controls. Now of course they can make their own devices, they can do anything really. But those who want to use with a level of certainty and safety can access it through this window. So we produced this policy paper for the Oxford Mount Scourge, you can download and explore different models and gain the justification. So I will talk more about regulation in the discussion. But I was asked to talk about ethics of using these devices for competitive purposes. So let me focus on that. So obviously one of the main issues in the use of an enhancement technology in any area of life is other risks. There are small, immediate risks possible longer term risks variations between left and right handed people. But the main issue that I just want to draw some attention to is the issue that my colleague Roy Kalman-Condosian has shown is that improvements in one domain can come at a cost of impairments in another domain. So he showed the stimulation of the vital cortex, facilitated numerical learning, whereas automaticity for learned material was impaired in contrast simulation of the dorsal lateral prefrontal cortex, impaired the learning process, whereas automaticity was enhanced. So as another author said it's a little bit like pushing one piece of a complicated mobile. It may have inadvertent effects on other pieces. So although it appears to be very safe at the moment, we really don't know what the long-term effects are. And we don't know what the long-term trade-offs are. And for that reason we believe that it should be used as a research tool, and if it is used in a DIY community, there should be higher levels of safeguards than there are currently. That would be achieved by putting it under a medical devices directive. And the problem in the DIY community is worse. Okay, and there are a number of features of this that make it very interesting from an ethical perspective because it's so easy to perform and so easy to construct, and it's very easy to use it on children. These raise a number of ethical issues in the community use. But I was asked to talk about enhancement in competition, so after spending five minutes in my 20 minutes I'll get to that topic. And this is a general talk because what applies to TDCS applies to any form of enhancement. The arguments I'm going to give aren't specific to TDCS. And they apply to any form of competition. I think I was asked to talk about gaming. I don't know anything about gaming. I've never done one of those games, so I'll try to talk about it, but I've written a lot about enhancement in sport. We're going to also apply to chess. So it's important first to recognize that there are huge numbers of enhancements in competition that are already permitted. So creatine which prevents nutrition, diet and supplementation technology in cycling, radio communication, painkillers in American football and inflammatory drugs. Many players end up crippled because of drugs used to enhance their performance despite injury. And caffeine used to be on the band list in the Olympics increases time to exhaustion by 10%. It's now off the band list and is a legal enhancer. And surgery. There is a famous elbow form of ligament release surgery that I believe it's been used in baseball. Now in the enhancement debate many people believe and indeed much of the regulation is based on a distinction between natural versus artificial. So if something occurs naturally like caffeine people tend to have a positive attitude towards it. If it's distilled into a pill they have a more negative attitude. If it's intravenously administered it's still more negative attitude. In my view the means of delivery has no moral significance. What matters is the outcome or the process by which the agent acts. So to give an example of this distinction in general the use of human erythropoietin or blood doping is bad to raise the hematocrit whereas poxigare chamber or altitude training both of them will raise your hematocrit from 45% to 49%. One is legal and one is illegal. So this distinction I think has been deeply destructive to thinking carefully about the principles that should govern the regulation of enhancement and competitive activities. So what principle should we have? Well the first principle is obviously safety some reasonable level of safety. Now in sport in general the reason that athletes are not dropping dead today of the use of doping agents is they're engaging in what's called physiological doping. They're moving within a normal physiological range. They're moving the hematocrit within a physiological range they're using testosterone growth hormone within a normal physiological range and that's quite safe because they're not using super physiological doses. When it comes to TDCS whether it's safe enough to be used as an enhancement it could be used for not only enhancement in gaming but enhancement in the acquisition of motor skills for example in soccer or other sports whether it should be permitted depends on its safety profile and its long term risks. But actually the data that we have makes it look pretty safe especially when it's compared to the risks of sport. I don't know anyone who's been rendered a quadriplegic from using TDCS but there are plenty of American footballers rugby players and other sports people who have been rendered quadriplegic. So when you hear this discussion about the safety of doping agents and performance enhancing drugs it is incredibly safe compared to the inheritance of sport. So on the safety criterion TDCS for the purposes of performance enhancement although I've expressed some concerns probably falls within the range. The second principle that ought to govern the use of enhancement enhancement in sport is one of fairness. And I was in a debate many years ago probably nearly 10 years ago with Dick Pound who's the head of water. The debate was supposed to be should we change the rules to allow performance enhancing drugs in sport. Dick Pound's argument relentlessly was we shouldn't allow it because it's cheating. It's against the rules. Precisely the topic of the debate was whether we should change the rules. If the rules are easy to enforce you could have whatever rule you want and we'll create a level playing field. But why the rules are difficult to enforce because defection is difficult to detect having those kinds of rules perversely creates unfairness because it enables the chinist to gain an additional advantage. Now for this reason physiological doping in sport is so difficult to detect because people are moving within a physiological range. So those who do dope are gaining an unfair advantage. It would be very difficult to detect the use of TDCS particularly because you'd have to have surveillance outside of competition. So any rule that attempted to ban something like the use of trans-grant-liquid stimulation to enhance performance would suffer the same fate as the current regulatory regime on doping and that is because of the difficulty of enforcement there would be unfairness to those who stuck to the rules. So I've argued in the area of sport that we ought to revise our rules that both protect safety but allow better enforcement. So for example in the area of blood doping set a hematogram that was safe and easily measurable. Now, fairness requires enforceable rules to protect safety and again a regulated market where there were certain safeguards on electrode size maximum current delivery and so on would enable the safe use of TDCS and a more liberal use. So again, by controlling safety one can achieve rules that are enforceable. Another objection that many people give to performance enhancement in sport is that it results in coercion unless you take that substance or perform that practice you're not going to be competitive. If you don't take steroids you won't be able to compete in the hunter things. Now, it's a general feature of competition that freedom is restricted. You're not free to decide to compete without training. You're not free to be competitive and you're not free to compete if you don't want to take the risks. Whether these restrictions on freedom these coercive effects and justified turns on whether the activity is sufficiently safe. So again, if we can solve the safety problem the question of whether coercion is justified or unjustified is resolved. Now, the third area that has dominated debate in sport is this concept of doping or performance enhancement being against the spirit of an activity against the spirit of sport. So what it defines the spirit of sport with this long list of idealistic virtues that are interesting and aspirational but hopeless for deciding what sorts of substances should be included on the ban list. What they really are attempting to get at is something about the human condition and achievement. Something about us that makes the achievement ours that makes it distinctively human. Now it's only a matter of time before the blades that oscarpistorius have used will outperform the normal anatomy of even the most elite runners such as Usain Bolt. In fact they've already had to put a number of constraints on the use of that technology to mean that it doesn't outstrip normal human performance. And in my view it was a mistake to allow Pistorius to compete in the able-bodied Olympics because of the domination of the effect of that piece of technology. So what is really getting at here is cheating in the sense of technology overtaking the outcome. The outcome being dominated by the technology that is used. So Tom Murray many years ago had an example of people using roller skates in the Boston Marathon. So once a bionic limb or a blade starts to outperform normal human anatomy the outcome is largely the result of technology. Now many people are concerned about doping in sport in general that it will then be a race between beautiful companies. And the use of TDCS would raise a similar kind of concern that it's the electrical stimulation that is producing the outcome. Now this kind of concern is not true of enhancements that all men train in. Enhancements that increase recovery allow longer, harder training or protect from injury. And that's precisely how steroids work. If I take steroids it will have no effect on my performance in 100 years. Likewise, TDCS typically works by enhancing the effects of training. Simply putting on electrodes without engaging in training is not going to produce an enhancement benefit. So in that way TDCS is like the use of steroids. It requires the same kind of training, effort, struggle and so on. What I do think is much more controversial is motivational enhancement which has received very little attention in the discussion of doping in competitive sport. One of the core qualities that we want from athletes is motivation, discipline and mental strength striving in effort. So a machine that moved somebody's limbs in a gymnasium and caused enormous muscular benefit would be something that removed an essential element of the human condition. And in principle TDCS could undermine this. I'm not aware of studies that have used TDCS to improve discipline and motivation but that would be a controversial application. The use of TDCS to augment and accelerate the acquisition of motor skills however is not something that fits within this category. Interesting that analgesics and anti-inflammatory drugs do precisely this. They remove pain, struggle and effort on the part of rigid athletes. The last criterion that I think or to a last principle that ought to govern how we think about the use of enhancements in sport is the idea of cheating in the sense not of robbing the human contribution but of undermining the nature of the activity. Now none of you probably are aware of this game called cricket but it's a game played in Australia, the West Indies, England and so on. And the ball is normally bulb over arm. And it's and the batsman hits the ball and if the ball goes outside of the stadium they get six runs. In 1981 final of a very famous world series game Australia versus New Zealand won all last ball of the match. New Zealand needed six runs to win so they had to hit a six. They had to hit the ball in the stadium. And this man here, travel chapel the brother of one of Australia's most famous cricketers, Greg Chapel. He was the captain at the time and instructed his brother to bowl and underarm along the ground which made it impossible for him to hit a six. And this was widely denounced as undermining the spirit of cricket and in fact the rules were changed. So what this is getting at is undermining the essential nature of the activity. So I believe drugs like beta blockers that reduce tremor and anxiety ought to be banned in archery, snook shooting or activities that involve essentially a test of humans to control their anxiety or tremor. Likewise, Mike Tyson admitted to taking cocaine before many of his boxing matches. Cocaine will reduce fear and reduce pain. Fear and pain are an essential part of boxing. The use of those drugs are the undermine the nature of boxing. Now fortunately, these kinds of drugs are very easy to detect as they're alien. Now what is the implication of this for TDCS in gaming? If TDCS in gaming increases reaction time this may well be something that undermines the nature of that particular activity. So I've argued that enhancement in competition is permissible if it's reasonably safe compared to the background risks of life and sport. So within the particular rules it doesn't dominate the outcome and it doesn't corrupt the nature of the activity or the test of human ability. Now it's important here I think I'm going to finish now to draw a distinction between training and competition. One way in which TDCS can enhance performances by enhancing learning and acquisition of skills during training. Another way you can act is to enhance performance during competition, for example by increasing reaction time. And in my view the use of TDCS plausibly might be permissible during training. And indeed it would be very difficult to enforce any ban during training. But we may have reasons to ban its use during competition if indeed it has effects that undermine the nature of that particular activity. So about distinguishing between competition and training we may be able to have a more fine-grained approach to use of performance enhancement in sport. So sport and competition are human activities where we decide the rules. At the moment in athletics and various other sports the rules are zero tolerance to performance enhancing drugs in sport. No attention has yet been paid to the use of TDCS in sport but it will very likely enhance performance. And our attitude to that I hope will take a more fine-grained approach than the current zero tolerance to the use of any external or artificial technology to enhance performance. Another area where it's likely to be used is in the improvement of cognitive performance in examinations. Duke University has already banned the use of cognitive performance in cognitive enhancing drugs in that university despite having been shown on a large meta-analysis to be safe and we'll need to rethink whether TDCS is something that ought to be banned during examinations or not. If it enhances the ability to learn why as again as any of the current enhancements substantial human effort and training it seems no different to the use of computing or information technology to enhance the effects of effort. So let me finish there. Alright, well thanks. Thanks to us for inviting me. It's been a really interesting conversation and I'm looking forward to doing a little bit of commentary on this from a regulatory point of view. I have to admit not knowing much about TDCS before I started thinking about this conference but I think the conversation has been interesting and hopefully this my review of some of the regulatory and legal issues will add to this conversation and I'll push back a little bit on some of the some of that as regulatory realism and talk a little bit about what regulation offers in this area. So let me just first start with a little bit of why we regulate and why it is that the FDA regulates devices and the answer is because of all of these quack devices that emerged over the past 100 years prior to the FDA's regulatory scheme the devices in the middle are the Perkins tractors to work via some electromagnetic pulses. It's interesting actually in the context of what we're talking about today that a lot of the quack regulatory devices on which the FDA regulatory scheme is built all involved electromagnetism and affecting the brain waves I mean you can see the guy in the upper right hand corner has his brain wave hat on the drown radionics device in the upper left hand corner is from the doctor to the patient in their house and when the patient put a little bit of blood in the device and then the doctor called and told them which device, which knobs to move to which dials, to which levels again a very kind of DIY approach to treating illnesses at home with medical devices all of which are complete and utter nonsense right and actually in the case of taking care of illnesses in these cases harmed people because they were not getting evidence-based medicine instead they were using these devices and I think the question is whether or not we know where TDCS falls in the spectrum of all of these devices I think it's also interesting that it seems like all three of us happened to pick this particular advertising picture as one way of describing displaying what a TDCS device is and I think that also goes to the power of the question of why we regulate in this area and the answer is because there are a lot of people out there using a lot of money in marketing to take advantage of people and to separate people from their money in bad ways and I think that that is the over-line and in particular if it's dangerous is the over-line justification for why it is that we can't just sort of throw up our hands and say well we're never going to be able to get into everybody's living room and therefore relying on regulation in this area is kind of a false promise. In my short amount of time today I want to talk about five considerations that as I was thinking about this occurred to me as being relevant to consider first the FDA mission and then the definition of what a device is implications of regulation alternatives to regulation and where we go from here and I also want to try to make this a little interactive is a way of stimulating another part of the brain so please answer let's try to make this as much of a back and forth as possible. That way I don't have to call on the two or three people in this room whose names I know and we can spread it around a little bit. So the FDA's mission I think is an important thing to start off by considering and this is actually in the U.S. Code and numbers three and four are a little bit beside the point but I think that numbers one and two are most relevant to the issue here what is the thing that pops out to somebody most about what the FDA's mission is? Properly and efficiently. I don't see that word so that's a few words in. What are actually the first few words? Protecting the public health. So protecting the public health is the underlying goal and it should invigorate whatever the FDA does both in number one and number two so the question I think one of the essential questions here is is there a risk to public health that TDCS offers and I think that that is still something that is very much up in the air but you know the FDA gets involved when there is a risk to the public health okay so and you know does the FDA have authority in here and there's been a little bit of discussion about whether or not the FDA has authority here and so I think it's also worthwhile to think about what the FDA's definition of a device is. So here's the FDA's definition of a device. A device is an instrument apparatus, implement machine contravence, implant, in vitro reagent or other similar or related article including any component, accessory thereof that is recognized in an official national formulary of the pharmacopoeia is number two intended to diagnose diseases or other conditions or to cure mitigate, prevent disease or number three intended to in fact the structure or any function of the body and which does not achieve its primary intended purpose through chemical action or within the body. So another question for somebody in the audience does this definition seem to cover TDCS as a gaming or TDCS or gaming products like TDCS that can be used for gaming but can also be used for other purposes? Yes I think very clearly right it falls here under the even if you know I think that Anna was brought up a lot of points where TDCS has been sold as an intent to diagnose diseases in which case it would fall under number two but in number three it very clearly intends to affect the structure and function of the body and therefore the FDA has de facto control over it. Now whether or not the exercise that control is a different story and indeed the Supreme Court agrees with the sense of the room and this is a quote from a Supreme Court case in 1969 Congress fully intended that the act to be as broad as its literal language indicates and equally clearly broader that any strict medical definition might otherwise allow in view of the well accepted principle that remedial legislation such as the Food Drug Cosmetic Act is to be given a liberal construction consistent with the act's overriding purpose to protect the public health. So there's a reason that it was defined as broadly as it is and the Supreme Court has recognized that. Now in reality the goal here is that again it is the question whether or not it is intended to affect the structure or intended to diagnose. So first of all again this is from the point of view of a seller. So the idea here is that there is regulation over the market in which a product is attempting to be sold to a person and the FDA determines this intent on the basis of the objective intent of the manufacturer. So the intent is determined by the expressions shown surrounding the distribution of the article including the labeling claims the advertising matter or oral and written statements. So how a person who is selling a device intends the device to be used through their advertising or marketing materials is ends up leading to the FDA's control over the matter. There is an additional part of the of the regulations that will allow the FDA to impute this kind of intent if the manufacturer knows or has knowledge of the facts that would give him notice that a device is introduced in interstate commerce and is then used for conditions or purposes other than the ones for which he offers it. So this is you know again would theoretically cover selling a device for one thing just as hey you know it's a direct current you do what you want with it but if 90% of the people out there are using it for TDCS then that could theoretically impute to the manufacturer knowledge of the use. Now I would point out that this is kind of breaking news this sort of third bullet down there is that the FDA has proposed in the last few weeks to delete this rule from the from the code of federal regulations and to take this imputed knowledge out of the federal regulations as a way of deregulating in this area. But I would just point out that this currently is on the books that the knowledge provision creates this imputed intended use. So what is if we're trying to think about if you're intending to affect the structure and function of the body what is a structure function claim that would impute this intent? And one way we can think about this is in the context of dietary supplements which are statutorily excluded from the Food Dark Cosmetic Act due to a piece of fairly ridiculous legislation from 1994 and are allowed to make structure and function claims, but are not allowed to make disease claims. So one of the issues in the context of dietary supplements is how to distinguish a structure function claim from a disease claim I thought it would be interesting to put this up here to try to explain what a structure function claim is. So among the first two of the top there, promotes digestion and relieves acid indigestion which of those is the structure function claim? Raise your hands who thinks that promotes digestion is the structure function claim? And who thinks it's relieves acid indigestion? How about the second one? Maintains normal bone density. Who thinks that's the structure function claim? And who thinks supports cartilage and joint function is the structure function claim? So you can see how this eventually goes helps maintain normal cholesterol levels hands for structure function claim provides relief of occasional constipation provides relief of chronic constipation supports the immune system, supports the body's antiviral capability. You can see how shades of gray, this kind of distinction really is and how in the minds of a consumer one of the things in the left hand column may very well quickly merge into thinking one of the things in the right hand column. But these are the kinds of distinctions that the regulatory system tries to draw successfully or not. Anyway, these are the structure function claims in each of these pairings. As an alternative to thinking about the structure function claims, the FDA put out a guidance earlier this year defining a general wellness product to explain what it does not intend to exercise its valid legal regulatory authority over. And the FDA has said that it does not intend to examine devices that are general wellness products and intended use that relates and defined a general wellness product as an intended use that relates to maintaining or encouraging a general state of health or intended use that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases. So and in some examples of what a general wellness product is that the FDA has set out right that they're not going to exert their regulatory authority over there. They give examples of a mobile app that plays music to reduce stress or a pulse rate monitor for use during exercise or a mechanical face exfoliation device as so called general wellness products. It's also very clearly pointed out in this guidance that this does not apply to devices that again present inherent risks to a user safety such as invasive devices, products that involve intervention that may pose a risk to a user safety, raise novel questions of usability. So these are all again in the context of the FDA's oversight of a public health or their kind of mission to protect the public health. If one of these general wellness devices in some way seems to implicate the public health, the FDA is actually going to exert its regulatory authority over it. So what in the same sort of vein spirit as the previous slide what is a general wellness claim and how do you distinguish that from a disease or structure function claim? Okay, so can you name the general wellness claim? So in the first one promotes a healthy weight versus treats obesity. So it depends for people who think that the general wellness claim is promotes a healthy weight. Okay, so there's pretty good consensus on that. Second one improves mental security, concentrating and problem solving to prevent dementia. Second one tracks fitness to reduce risk of heart disease. Which one will the FDA not be concerned about? Anybody cares? So the first one for falling outside of the FDA's implementation of its authority. Hands for the first one. Hands for the second one. Tough one. Again this is really really difficult. It raises the issue of how easy it can be to use fancy words in marketing tools to try to dupe consumers and patients into using products that have no real efficacy and are potentially unsafe. So anyway here are general wellness claims that the FDA would exclude. This is from Anna's paper in the Journal of Biolethics, which I thought was a great paper and I would suggest that people download. This is some examples of marketing language used in the sale of consumer TDS devices. So charge your mind, power your mind, make your synapses, fire faster. Are these wellness claims? How closely do they shade into health and structure function claims or disease treating claims such that we should be concerned about them and the FDA should be more closely overseeing the basis behind these statements. So what are some of the implications of FDA regulation in this area? If a TDCS device is officially regulated as an FDA device like it appears that two of them might have been approved in some way or cleared in some way I don't know if that actually is the case or if they're just being sold through more direct channels. But if you are a device that is regulated by the FDA then you are required to have some good manufacturing practices in the construction of your device and you are required to report adverse events that are reported to you by consumers to the FDA and then there are the possibility of special controls that are specific to a particular device including particular labeling requirements mandatory performance standards so they might even be a post market surveillance program that your device is subject to by virtue of being under the FDA's umbrella. Devices are generally classified into one of three risk categories. Here they are the first risk category are subject to basically general controls only and these are the very low risk devices and to get these on the market you basically just have to tell the FDA that you're selling them and then go off and sell them. The second class are the moderate risk devices and these are subject to some performance standards and again you know the and then the third class of devices are the highest risk devices and these are the implantable cardiac defibrillators the second one down there is a mechanical heart you know these are the highest risk devices that are used to sustain life and so where would TDCS fall in this classification system probably class 2 they're probably not a class 3 device they're probably a class 2 device which subject them to some performance standards oversight by the FDA and in order to get a class 2 device in the market you do not have to actually do any clinical tests all you have to do is show that your device is substantially equivalent demonstrate through some basic engineering tests that your device is substantially equivalent to an approved device by demonstrating to the FDA that you have the same intended use the same basic technological characteristics such that the device is roughly the same safety and effectiveness as a device that's already on the market and if it is substantial equivalent then you file the 510K pre-market notification unless it turns out there's some sort of exemption for your device again clearance through this 510K pathway for moderate risk devices rarely requires any real experimental or clinical data and 98% of devices that are forward through the FDA of the 3-4,000 devices that are clear via the 510K process each year are clear without any questions or changes after a relatively cursory review by the FDA officers of course once your device is a clear medical device you are then subject to general FDA rules regarding making sure that your manufacturing practices are up to stuff and in particular related to the promotion of the device in that you can only promote the device for the use for which the FDA has cleared it and not related to other potential uses of the device outside of that one particular use that you had submitted okay so what are some of the alternatives to regulation and one of the alternatives is what about the FTC if the FDA doesn't act in this area how about maybe is there a sufficient regulatory oversight from bodies like the FTC or the Consumer Product Safety Commission so let's think about the FTC for a second the FTC regulates all consumer product advertising so if you think it's a lot of work to regulate foods and drugs and cosmetics then just try regulating all advertising right so you can imagine that here the regulation is even more thinly spread out than in the FDA the section 5 of the FTC act prevents unfair deceptive marketing practices the question is what is a deceptive marketing practice of the Food Drug Cosmetic Act under the FTC act is a much lower hurdle than under the Food Drug Cosmetic Act even as it relates to medical devices the FTC uses the standard of competent and reliable scientific evidence if you're making a health related claim which is lower than the standards used for drugs and some medical devices and in particular the FTC has been getting in some legal trouble recently by trying to impose higher standards in the context of health claims made by certain juices pomegranate juices and some of the courts have come down on the FTC for trying to impose high scientific standards for meeting this competent and reliable evidence so the question of what competent and reliable evidence is is a pretty vague one anyway so overall the FTC standards are more lenient than the FDA also in part because of the goals of the FTC are different than the goals of the FDA the goals of the FDA are to protect public health the FTC is worried about consumer deception so the FDA will act in the context of protecting unwary and vulnerable consumers from rapacious and unethical businessmen the FTC won't necessarily because this is the marketplace and if you make bad choices in the marketplace even though things are theoretically clearly laid out for you the FTC isn't going to be as concerned for you as the FDA will so I think the FDA in general is a better regulatory oversight for these sorts of devices so here are my conclusions and then I guess we'll open it up to questions so TDCA for gaming probably falls under the food drug cosmetic act definition of a medical device given what we don't know about the safety of TDCS it's unclear whether or not the FDA would prioritize regulation in this space unless there is evidence of public health harm there really is no scientific reason that manufacturers of these devices should fear the FDA or should fear science and the need to prove that their devices actually do the things that they're claiming to do through real randomized blinded studies I think the fact that they do suggests a lot about their underlying confidence in these devices to actually do the things that they do and by the way the FTC oversight of marketing claims as an alternative is not likely to have much teeth in this area so thanks everyone can I just have our speakers maybe join us in the front we're going to have about 20 minutes for questions I'm not going to bring around a handheld mic for everyone to use in this room if you just speak up we'll pick you up on the mic so it will be heard on the webcast I know that Anna had some questions or some comments that she wanted to raise about regulation but maybe I could take the first crack because Aaron your remarks have some thoughts for me so as a neurologist I'm not particularly worried about the risk of these TBCS devices I am concerned about the possibility of diverting people who need therapies from therapies that are known to be effective and I'm particularly worried that people with psychiatric illnesses could read some of these wellness claims of the manufacturers and think okay well this would be a better way for me to treat my disease than the behavioral therapy or medications which are shown to work and so then I was reassured when you first said one of the roles of the FDA is to prevent that type of harm but then my despair sank in again as you mentioned that they're considering removing that knowledge condition from the manufacturers it seems clear to me that that's a potential risk of the way they want to market these things and that they will know that they should know that it's happening and if the FDA doesn't require them to respond to that risk it seems like we're opening up the possibility of harping people in that maybe that's a narrow population but maybe it might not be to all that narrow I think that's right I think that is a major concern and I think that that's one of the reasons why you do want to have a scientific regulatory body like the FDA that is skill that determining what kind of studies are necessary and how to evaluate the evidence and I think that's why you want to have that sort of organization overseeing this kind of possibility if you're talking about devices that are outside of the ambit of health and wellness of medical care then I think that the concern is less especially if those devices are safe but I think that there remains questions on both of those issues that we just don't have the data on we don't know if they're safe as Julian pointed out and we don't know how these devices are being used and whether or not these advertising claims are you know appropriately communicating the risk and benefits of that just to respond to what you were saying at least from what I've seen in the community itself I don't see people going to them as a first line treatment for now and I think a lot of the manufacturers again are careful not to make these big medical claims and so I haven't seen people going to them as a first line of treatment but I have seen a lot of people who have struggled at least right about on the forums and people I've spoken to who struggle with depression for many years and then they decide to try it to be safe so I think it might change but I could say now that's definitely not what I'm saying Shouldn't there also be special considerations made if it is being used to a lot of people with psychiatric problems that perhaps this is a more vulnerable population than the people who are using it to play video games and that the potential diversion would be something really important in that those people could be more risk or less risk averse in using it for longer than other people have killed them to do because they feel like maybe they've done treatment and it hasn't worked Do you mean special regulatory considerations? No I just mean like is that I guess wouldn't that inform considerations of that around just protecting that group Well it's similar to the use of our children our parents using it on children so this is one of the really big problems of this sort of technology that it's difficult to control how it's used so embedding some kind of design of protections I think would be a useful thing to do to limit numbers of treatments amount of current and so on but the use of children is going to be I think even more problematic than all of our and could I ask folks who want to ask a question just to introduce yourselves as you as you start your question I'm Albert of the School of Neurology Nice to meet you So this was great thank you I just had three quick comments or questions because they said in regards to the safety I wouldn't say as a neurologist I'm not concerned about the safety I'm very concerned about the safety because I think there are lots of things we don't know about it one of them this is cumulative dose we have absolutely no idea what happens over a life span with these interventions or even were to look because of the potential risk of the different impact that includes the question of combining with I think it's really I agree with the performance but it raises the question that you could things that we know we can decrease with TDCS for example the optimism bias so if you decrease the optimism bias or even better if you increase it would people be more willing to train in a more risky way and because of that increase the risk of the game that they are playing because of the way that they are playing it differently so I think safety is still a very uncharted territory in all its domains the second question I had was in regards to fairness we know that there is a very different effect of TDCS on different individuals on the basis of genetics on the basis of state on the basis of what they just did do afterwards we know for example that smart people are made smarter because of this state dependency effect more so than those with the IQ so it could TDCS in a bizarre way be a way to create a brain based modulation a way to create greater inequality rather than to deal with that in some regulations the final point that I actually wanted to quickly discuss but you were just starting to talk about I get literally daily calls from patients parents telling us about the TDCS that they are doing on their kids there are huge clinics in the United States treating autism with TDCS on kids there are two clinics doing TDCS in persistent vegetative state talking scaling I don't know that there is any regulation to this there is really applicable and I do you mean the clinics using it as an all-flable treatment it's an all-flable treatment of an auto-device and they're not and they're not doing it in the context of the study they're not studying they're all new to the device they're charging somewhere between 30 sessions and doing somewhere between 10 and 30 sessions and treatment with alcohol as a group part of the thing happy that something is being done okay yeah I just want to say I'm working on a project about the all-flable use right now because I think it's a very big issue so basically yeah all-flable means taking a device for one indication and using it to treat another to jump in on the regulations but people are taking these iantoferesis devices which are improved to treat access spending more for drug delivery and basically using them on the head on the brain for cognitive enhancement and for treatment so I'm actually looking at all those different clinics right now and I think that's a real stretch with the all-flable I'm in the beginning stages of this project but yeah I think that's a really important point and that's a big issue and I think when people criticize the do-it-yourself community and home users that this population of accredited physicians who are using these treatments does not receive the same level of scrutiny and I think if you want to be consistent in our critiques that I think we need to apply that to them as well sure that sounds like a great study I would send it to the New England Journal or JAMA when you're done with it because it sounds like we really need that kind of knowledge out there you know I think that it's probably most people in the room know that the FDA doesn't regulate the practice of medicine that off-label use of drugs is very common and off-label use of this device in this case obviously is growing in its scope but you know the FDA doesn't at least as we sit here this minute there are a lot of challenges in the courts about this the FDA doesn't allow devices to be promoted for off-label uses and what we have seen time and time again over decades and decades of experience is that promotion of products for off-label uses incredibly enhances the use of the product in those ways and so I think that it would be a mistake to think about the fact that itself is being used off-label and then to say well this is a call for less regulation I think that we should enforce the regulation that's on the books and if the FDA doesn't have the scope of legal authority to get to these cases and you know I think it's also probably the case that there are some off-label marketing that is done through under subtle ways that the FDA could probably investigate then we have to turn to professional societies and other ways of trying to manage maverick physicians who are potentially harming you can I just comment back to so I agree that big issue by this nuance so I don't think that it's all maverick physicians doing it I think there are people appropriately extracting knowledge from the literature and from the analysis of offering it to patients where it's an appropriate use of on-label device with appropriate oversight so I think the biggest response to that is just to get data I think that if there were actually studies in those circumstances and if there was funding for those studies and if a lot of these companies that were making so much money off of these devices were actually funding studies of the devices that they're being used then we would figure out in what circumstances these kinds of things work and what they don't unfortunately I think enough people are happy making money in the short term that they're not thinking about that you know thinking along the same direction you know one thing we do not know is that how much passable effect and how much psychological dependence of the device after long-term exposure and you know from the in a very large perspective you know more than I do that you know for short-term exposures versus long-term exposure you know the devices are very different I did some work at the Johnson & Johnson and Sanovi about the drug device combinations but my impression is that we need the device as an option you know in addition to the medications Frins and I virtual conductive shop you know versus anti-depressions also compared with the current McKinnon study on virtual magnetic stimulation they are all different modalities and I prefer you know more option but I agree perfectly with you the panel we need a long-term safety you know surveillance and modalities yeah we do and just to speak to your first point I think that there's been a lot of talk about safety and risk and I think that a lot of things are getting locked into this word safety and you made this distinction you distinguish this on your side but we have whatever you want to call it and then there's the long-term effects which are really unknown so along the lines of the short-term effects you know what we do know is in both TTCS studies and home users I mean you get redness tingling, itching, fatigue, maybe nausea and some people but I don't know if they plan and again this comes down to your question of whether this is a public health risk I don't know this is a good example while we need to search ethics because you can't do a long-term study of TTCS you can't do a long-term study of pharmacological problem enhancement what you need to do is go out there in the community and use every person as a data point and audit what's happening but ethics committees won't allow you to do that and that's crazy because the data is accumulating we could be using it and we could be seeing what's happening and that needs us to and this is going to happen more and more as users take control of what they're doing and if they do that we might as well as systematically as we can get data from that's a great missed opportunity and the way to do that would be to bring it within the FDA system because then you have adverse events reported to the FDA you have a structure for knowing for having certain devices being associated with certain makes and uses and you can sort of start to systematize the data I guess I would disagree that you couldn't do a long-term study of these products I think you probably could figure out a way of doing that but you know we don't have to wait necessarily on that to start to collect data on the on the uses that are already out there but to the short-term there has been no hospitalization instances that I'm aware of and in the 2DCS literature there was one recent review came out saying that in the 10,000 subject studies so far there has been no adverse events so in terms of public health risk there's always shocking themselves that nobody has died from this and to my knowledge nobody has been hospitalized so just to sort of keep that in mind can I address that one so Bruce Satter Children's Hospital and I developed treatments for other diseases and maybe I take a little bit of a less-as-more approach when it comes to regulation and I knew nothing about this when I came into the room so what I heard is that there are a lot of people out there using it research going on, maybe it has some demonstrated positive effects and some things and maybe there's potential for abuse later on but what I've heard is probably potential maybe for harm but no demonstrable harm and so I worry about jumping to regulation at a time when there's no demonstrable harm so I'll just throw that up they agree with that and also I think we need to see what are the risks here, what is the potential and how exactly would regulation if regulation would address that for those who oppose it, how would regulation work like that and are there alternate methods so people have proposed an open engagement approach so actually interacting with the community publishing things that give the community guidelines about what's known and what's not known and I think that could be a much more flexible approach, it's more fluid than having regulation or having something that really doesn't fall under the medical device structure now proposing some way that it would somehow get into the medical device structure I mean so, yeah, so I completely agree, I think there are issues but I think maybe regulation is the best way I agree with you, I don't like regulation either but you're delivering energy to the brain and you're going to do it for a long time and we've already shown that there I tried to sort of quickly look at this, there are some downsides you can impair learning you can also impair performance in one domain when you improve in another so it's not a straightforward getting your ears pierced intervention and I think the FDA and the European Devices Directive gives you the consumer a higher level of protection in terms of quality of information the kind of the structure of the device and so on so in that sense I think that while it's in 10 years time it pans out that there aren't any long-term effects in a way that I agree but at this point I think we ought to err on the side, not of restricting access but in ensuring that people know what they're doing so getting back to your very interesting point about increasing optimism I think this is going to these sorts of effects motivational effects, effects on desires this is going to be much more challenging than affecting your numerical ability to remember things and then I think you need to really know what the risks and benefits are to make sure that you decide that's what you want to do and so you really need a much higher level of information that you'll get with the usual product disclosure as you see through the lower level of regulation you have here so I agree with you I think this is a fantastic experiment that we should let run and see what happens but I think that we ought to have control over the information, auditing of effects and structure the experiment a much better way than we are now I would agree and I would only add the fact that we don't know of any hospitalizations in a community where nobody knows about anything does not reassure me that this is a safe device it inspires me I'm not a neurologist but it seems like this is a potentially unsafe device from what it does and it inspires me to want to gather more data on this issue and not to throw up my hands at regulation right now as something that will just impede our access before we know one way or other what it does two more questions one is can you just comment on the basis of evidence from the advocacy of DCES in enhancement anything two meta-analyses and one of them shows an effect and the other one doesn't but the studies or some of them are just a one-off intervention and they're included in the meta-analysis so from the group in Oxford we've always shown quite striking effects on improving numeracy in children with dyscalculia so there have been studies that have shown quite striking effects when you pool all of the studies because they're so variable and some of them are only a single episode of TDCS the effects look quite weak but by reading the evidence and maybe my clinical colleagues will have a better impression is that it really does have an effect in certain conditions so far do you have any is that your take on the data so far I would agree because I think there is very good data generally at the power small studies we will aggregate across multiple studies in Oxford South because studies are sometimes as weak a lot of studies with small sample sizes seems to be I mean my colleagues statement is it's still an experimental technique and it should be it should be viewed as an experimental technique and it isn't the sort of cutting edge but that's why I think once you move to this DIY use I'm not sure that people really realise that it's purely an experiment they find a study that shows an effect and that's how it's going about group on memory and we're a long way from that second question if it turned out to be an effective word if it was another similar technology that was effective I wanted to ask you particularly why you thought that a device that affected pain tolerance for example would be undermining the sport but not or a competition but not a device that enhanced benefit from training it seems like they're both affecting attributes that are very helpful in this sport as you've seen in American football if you remove pain you increase injury and so it's unsafe at that level but also there and again what you think sport is is up for grabs but you might think that a part of sport is dealing with pain and participation and giving people anesthetics or local anesthetics prior to participation is removing something that is essentially part of the struggle now it would take a different view to say well you know we don't care about the pain we just want to see the performance we want to see as excellent a performance as possible and we don't care if the person ever walks afterwards sports arbitrary it really is up to us to define there isn't any deep and this is the mistake people make in anti-doping legislation there is no kind of deep set of right principles that govern sport and it's just what do you want what sort of sport do you want where I said recovering from injury I remember Ben Johnson the first high profile anabolic sterol in Higgs 100 meters ran 9.8 seconds he said on radio if you want a human being to run under 10 seconds you have to do so much training you will have injuries and in order to recover from those training you have to take steroids there are 10 people who have run under 9.8 seconds or under only one of them has no doping allegation hanging over their head all the other night have either been proven to be doping or had serious doping allegations you don't run low speeds without getting injuries so we want to see people breaking 10 seconds you want to see people breaking 10 seconds on downscales we are about 5 minutes past so I want to thank our speakers once again applause didn't they get a chance to ask for a question please join us for dinner again the room is 3.04 so there are stairs out in the atrium it's fairly obvious or some of us will know the way can need you there next slide