democracy. toys doctors and public health executives to discuss regulating vaping and e-cigarette space event hosted by the american enterprise institute in washington d.c. the entire event runs an hour and a half. ♪ [background noises] is started. thank you all for joining us today. we are here to talk about a challenging topic tobacco regulatory policy. it is of interest to me many of you know the fda product regulation lock is just some numbers for us smoke related illness cost $225 billion in direct medical care in one or 56 billion and a loss of productivity for the recent expense from the centers for disease control. i would like to say also it's not just about numbers but it's about people right now. my grandfather died of copd. those numbers are individuals. it's not easy, we have a good panel i think today which we will introduce later. but first i want to my favorite members of congress here. the only cardiothoracic surgeon in congress he also trained in chicago as did i. munford surgical training practice for quite a while before he joined congress he is the vice chair of the health club committee leader on a regulatory policy. so thank you for joining us. >> is great to be with you, great to be with you. so, as a physician and as a member who is involved who's iny in health policy, what do you think we should be doing with this related illness? >> obviously i have some opening remarks if you like me go through these. obviously as a cardiothoracic surgeon allow the patient i took care of over the years had disease processes i also did vascular surgery for everett's analysis vascular disease that was partially related to tobacco-related products. and so for many, many years i've been advocate for a cessation break both of my parents still smoked. as a kid my mom started smoking in the eighth grade. even though i became a doctor i could not convince them to quit until many years later they finally did in their late 50s early 60s. but i think the basic fundamentals of this space is in government bands and those type of things don't really work. we have tried that over the years. education does work. i think we had some success probably maybe 30 years ago starting in the schools. and has to start young. you have to educate young people about something that can happen to them when they are adults many, many years later. and the downside of using these products from a medical perspective is there. i think we have had some success in the education space. i think in the united states at least the number of people who smoke cigarettes for use tobacco products i'm excited my dad stop smoking but continue to chew tobacco products. it's lower than it has been historically but worldwide as you probably know particular in asia it's still pretty substantial problem from a medical perspective. so the one thing you need to do is make sure whatever regulatory process is plus banning products banding productswere not necessu would create a black market for these products that is been shown in other countries. it will happen to the united states. you need to honor educate people and make them so they can make informed decisions about how to utilize these products. >> i think about my grandfather he passed away from copd. you think he quit smoking in his 70s. who shall be a two pack a day smoker taxes and other public policy interventions have reduce the burden of tobacco-related disease significantly. 38 million americans still use combustible cigarettes. what should the realistic public policy goal? >> that is a tough question. over the years the state level tried to use monetary policy to influence a personal behavior taxes basically. with a moderate degree of success are not a big favor of syntaxes i am just telling it what has happened. including in the state of indiana and that is has some effect. when you get to the point where it's affecting you monetarily, as i mentioned both of my parents continued to smoke. and one of the things why they quit because it did get quite expensive. they lived in illinois. but also interestingly i'll try sir about my mother row quickly she was a nurse and still is, she's just retired. the reason she ultimately quit smoking is because the hospital she worked out got rid of their smoking areas in the hospital. the only place you could smoke was outside and so she lived in central illinois in the winter time it was so cold. whatever it takes to get you to quit smoking. stop the medical effects. monetary policy again public education has some effect. i would be interesting to see what your thoughts in the panel's thoughts are on that. is it surprising to anyone that with all of the knowledge we have about these things and other things we do to ourselves that results in an accelerated d physical disease processes, we still have a substantial level of usage or what i will call noncompliance for you are a physician, you know the compliance level for example people taking for hypertensivese or managing their diabetes. even with all the best education we have had we have made a dent in it. good thing we can do for public policy perspective is make sure -- people use these products somewhat -- us not just physical it's emotional. make sure in places that we can be helpful that we have programs in place, tech support people with stress related problems, depression related problems other things that typically will push people more to using tobacco products or narcotics or other things or alcohol particularly. again you cannot mandate things because it's personal behavior. >> i guess thinking about 30 million combustible users obviously the goal is cessation. patch, gum, lozenges live in patients who have been successful at them seven, 12, 10 times a corporate then there are others that are not interested in quitting eared. >> that is true. >> what you think we should do for them? >> i don't think there's much we can do. >> again if you try to do for example hypothetically say you and bandit cigarettes. that immediately creates a black market. what that does get outside your regulatory space you have a black market for products people don't have any intention of quitting that will not work. i will be honest with you i do not know the answer to that question. i was just a certain percentage of people are going to use these products. for a multitude of reasons. i think also recognized even though there's a physical addiction of your nicotine receptors in your brain and it makes it hard to quit there is a psychological aspect of this also that is why think in some respects and products that address those having something in your hand and slightly more successful i do not have the data right in front of me then alike and, for example. i'm not sure what we have to offer other than education and make sure the products available are safe and not coming from a black market that may or may not be safe. that's about all we can do. when things talked about the different fda centers. the center for tobacco products is the only regulatory center it's harmful and can kill people yet the center seems to lack what we would describe as the urgency of now. so we think about tobacco product review millions of eat cigarettes are electronic and nicotine cessation products and kind of like it was the 1980s. you know you have failed as a regulatory center when that nice that pediatricians are suing you and asking you to make regulatory paired that pediatricians are angry you probably know that market regulator made a mistake. they don't collect user fees among e cigarettes. they have to use other funds to regulate explosive marketplace and is minds of product applications. and some ways to get that's almost unfair to the agencies. what do you think congress should do about this if anything? >> i always think congress should act and not allow executive branch agencies to regulate. i will speak openly from the legislative branch person. we can but that's obvious thougy not always our role. i think for example in this particular space you mention it from the beginning the goal would be cessation people not to use these products. that is not going to happen. i understand the fda, we do know it to regulate a product we knew we note nicotine is bad your health. the actor recognized as a group of people out there that are going to be using potentially unregulated and black-market products. and so it depends on what you see your role as. if you see your role as, if they don't quit using them then we are not going to help them then we are just not going to do anything. that's not the proper approach. they need to look more closely about how obviously minimizing the impact of uses of nicotine products but if they're going to be utilized then the role is probably public safety and make sure the products are safe. the products are what they say they are, and we found that to be true that some these products are now at this say they are. there are other things in them that are very damaging. they need to really reconsider not doing anything. >> is actually interesting. you mention i think we talked for the principle of meeting people where they are. some people want to quit, some people don't spread can we meet them somewhere in the middle? of harm reduction as the path toward cessation. in addition to be an internist n public health position. i prescribed -- having patients not use ivy fentanyl is a huge win for me as a physician and a huge win for society. the lower risk tobacco products could fill that role? i would say potentially yes if it regulated appropriately. there are a lot concern about youth access it. any child who is using a tobacco product is a public policy failure on our end. i guess the question is are there things the fda could do to prevent the usage? >> again yes. whether that's regulation or using their platform for educational purposes. let me just give you a little bit of the idea of the scope of potential problems. you would think it's not as common my daughter lives in d.c. from seventh grade through high school went to one of the d.c. private schools a prominent private school i'm not going to mention the name. she told me that the jewel usage was rampant in her school. and i know the parents. i know the kids. if you are an outsider looking in you and say no way at that school are all these kids caring around jewels. they are. the problem is substantial. certain things that make sure that there is an educational process for not only the kids but the parents. yes are there certain products occasionally need to be banned, yes? if they are products for example i was kind and you may agree or disagree with this, but back in the day on the forefront of trying to get the flavored products more regulated and less not available those lumens the kids tend to use. right? all the flavored jewels and suffer the most popular. so at least to make it so the availability of this product is not as prevalent. and i think that has happened to a certain extent. i don't think there's a silver bullet here, i really don't spread. >> i don't think there's a silver bullet. he say it's education but it's also sales and marketing. where are the products sold? how are they distributed? and we had some success there in the flavored juul products and stuff like that. i think the first thing is to recognize the extent of the problem. i did not even realize myself until my daughter at the time was in ninth grade or tenth grade and she said none of the parents no member of the little things look like thumb drives you carry them around. >> what's interesting about that is the product market regulator i would say has failed on both fronts. so the center for tobacco products in the long term has not succeeded either creating a harm reduction marketplace that is available to current combustible users who don't want to quit which is millions of people. and at the same time is not counterbalance that by the need to prevent. the agency handled both to be creative and requires it to engage with all stakeholders including probably some people the agency might not want to engage with. it also requires the urgency now. the thing that amazes me is a public policy guy you probably feel similarly the other fda product centers understand their space. they understand gene therapy for example could change someone's life. i could change that patient's life the oncology products group also understands the alternative to not having a therapy is death if it's a last line therapy. but if for some reason we going to the tobacco product regulation phase the center got sued by the pediatricians to make product to market decisions we don't have product standards. the vaping -induced lung injury which is found to be firm vitamin e solve up that was not authorized to be put in. that's product alteration that's a failure regulation and that's from a lack of product standards which to me as i said as a former cedar medical officer and product reviewer it is amazing to me we are operating a space without product standard without guidance without industry standards. obviously support product regulation. the fda is not engage over the last decade to produce these as a huge public policy failure that has resulted in combustible millions of combustible users that don't necessarily have a great set of alternative options. and youth usage we have the worst of both worlds and some of the best of both worlds. >> i agree with basically everything you just said. from my standpoint you asked what congress could do legislatively. we try to address them in some of these things. but i will be honest with you practically on my side of the veil on the republican side people are reluctant to give the fda any new authority or assign them authority legislatively to the fda. i found out to be the case in a laboratory developed testing and other areas. i was working on the flavored jewels i have these discussions with colleagues on my side of the aisle they were reluctant to legislatively take action as it relates to the fda. which was probably a mistake because of the things you pointed out there are a legislative blind spots i want to make clear i'm not against regulation i am against unnecessary, costly, ineffective regulation. >> absolutely. that is the challenge. >> which is unfortunate but we have a of cost effective ineffective regulation where we spent billions of dollars we don't have product standards for new product market being regular by the agency. the agency says they don't have that money they don't have enough staff. if we take that at face value it maybe we should give them user fees to support hardly technical staff crating the regulatory infrastructure which in the longterm is going to promote puc health or. >> that's it and in the pharma space spent a very big success. let me say this from a legislative branch perspective has anyone heard of a federal agency that is not said they need more money? no it will laugh but it was a joke. >> i tried i'm not a comedian. my point to that is sometimes that is true. but many times it is the lack of will or the inability of the agency to repurpose some of what they already have it. sometimes it is money no doubt. it definitely is a staffing issue in a lot of ways. you saw that with what happened in the food product area boom had the baby formula situation. they are way understaffed and do not have enough money to the proper oversight they do that's real. it's not a bad idea user fee concept is something that's been proven to be successful. >> do you think given the significant focus on cannabis legalization, cannabis would most likely be regulated under harm reduction standard very similar to how tobacco products are currently regulated. as a necessary prelude for we have any more discussions about cannabis that we should fix tobacco product regulation first? >> probably. the reality is, obviously people abusing tobacco products for centuries. and in the u.s. we've had up moderate success of decreasing that for the medical perspective so probably. but they are two separate issues honestly for medical perspective. again i have my own view on legalization of thc products. they are a big moneymaker for the states for example. a lot of the legalization movement is driven by money. from a medical standpoint again we may agree or disagree on this but it has been shown in the developing grade chronic thc's results and long-term cognitive deficits or problems. and so we are talking about child use of juuls and other things. we are going to legalize thc products nationally and that movement continues we are not being aggressive in the so-called developing brain aspect of our fellow citizens and the douglas up until age 26 or 27 per people don't realize for. >> it might continue into our 30s. >> might wife would argue it's still ongoing. [laughter] but in all seriousness it would be nice to get the tobacco piece right first. and then try to address that. i do think we are going to have to do something were going to have to draw something on the national level as it relates to state thc products. let me say one thing that's a little different between the two also. because thc is a scheduled a one drug the amount of research that has been done on the medical problems the potential medical problems related to chronic thc use is not there is much as you think so that's a little different than you see in the tobacco. we know the tobacco situation for decades now. we have to maybe address the first. some people are saying maybe we should put thc is a schedule one a or scooter to schedule to so we can do research and get more information that will inform us about regulatory framework we need a national level for those products. >> seems reasonable to me. those products are potentially harmful. we need a functional regulator. i'm a huge fan of the fda the tobacco space we have a dysfunctional regulatory regiment. >> enjoyed our conversation. we opened up the questions we have monopolized your time. >> can i just say something? personal thank you for inviting me. when secondly i want to follow up a little bit on the thc and why research is necessary. because there is a disagreement on the harmfulness of these products amongst our fellow citizens pay some states have legalized that not recognizing what the national center for drug or pro- policy of the white house has had information on this for long time. cook so there's a disagreement there that is why think partially we need to look hard at a way we can study it more. >> i want to follow that up as a final thing on the thc products. >> i agree wholeheartedly. the other saying we do not want to replicate the mistakes he made with one a product market for decades and another product. >> agreed. >> are some questions here any questions from the audience? >> usually when i do these types of things if i don't go to question or start calling on people. i'm kidding, i'm kidding. [laughter] >> i am at the institute and lead a policy department look department look anintegrated has a variety of behaviors that carry risk whether it's opioid and illicit drug use. cannabis, tobacco, things of that nature. we hear quite a bit around the dangers of e cigarettes and other nicotine -containing products. but nicotine on its own as a fairly benign stimulant it is a deliberate modality that delivers harm or whether it's the combustion of burning tobacco and cigarettes or cigars or things of that nature. otherwise we would not have things like nicorette on the margaret market. i am interested in asking about the education component so we know the majority in the united states incorrectly believe it's the main agent that causes cancer and other burdens of disease. in the full transparency at work for the association of medical colleges for a decade. for intimate experience with curricular change at the national level and teaching hospitals and know the slow pace of that. what do you think the fda or the government can do to help fill in the gaps in the education but particularly around nicotine and cancer some of these in novel products that don't carry that same lethal risk? >> i think people in medicine and know when you burn tobacco when you inhale the smoke there's over 200 different types of compounds in their including carcinogens and nicotine although is addictive it is not one of the primary damaging things that you inhale are you chronically have as it relates to tobacco products. i think most physicians understand for the most part and so there needs to be more people using like a vaping product or something. traditional cigarettes doesn't mitigate risk it doesn't take you to no risk of anything. you should not use these products from a medical perspective. so that is the first step. you can comment on this too. getting a message to the public as a whole. i'm a politician to i consider getting a message to 700,000 people in my congressional district is really hard. you can do all of these things and messaging and go into a town hall and i would say 90% of the people, and they are good people educated people. the american people over all are educated people compared to people around the world. they have no idea even talk about a certain subject for months or years. medicine is very similar to that. it's going to be a long-term project. the salt these alternatives how long they've been on the marketplace may be 25 years or so. fifteen or 20 years. that is a short timeframe when it tries to convince people in my view of the medical benefits or negative aspects of this. and it could be see the data and more data in the future. for example if your 25 years old and not smoking cigarettes but you are vaping, 25 or 30 years that you may have an instance of lung cancer that is 1100th of a would've been for a 25 year old smoking cigarettes but we don't have that data right now. to try to convince people how that's going to help me, to try to convince them is going to help them 30 years from now is from my perspective it's pretty hard. >> he don't think that's a silver bullet to long-term concerted effort. i do think you and your thinking about fda and avoiding and not addressing this is a mistake. it may take years for us to mitigate and get there. >> a big fan of taking a poster not taking action. something passive aggressive it's a regulatory strategy for tobacco is not a good regulatory strategy needs to be proactive the communications question i agree with you it's going to be a massive educational undertaking. probably needs to come from a variety of sources the fda needs to be a part of it they can't do it all by themselves. some people trust the fda others don't trust the fda after allowthe strike we have had. having a public education campaign for physicians about the risk continuum commonsense nonpartisan thing that we all should agree on and the agencies should be doing they not doing a decade into it the existence of the product center. >> i've enjoyed having you here i am sure you have a lot of places to go we have taken more than allotted. >> is fun though. >> will skim around of applause. >> transition to our panel we back in a minute or two. >> thank you. ♪ [background noises]
Related Keywords