Transcripts For CSPAN2 After Words 20151228

One of the senators who supports the bill said it was the first piece of legislation that he had come across that was both prolife and prochoice. Lets talk about what the right to try malls are. Guest its all about when having your life hangs in the balance its about giving you the right to try to save your life by accessing experimental investigation medicines but before they receive the final green light and the reason that he calls it both prolife and prochoice is because you have a choice of and instead of the right to die law you have not only the option to hasten your death is to try to fight to live and prolong your life. Host you immediately dive into what it has to do with your personal life and i want to read a passage quickly from your book you write about your uncle. There are now multiple treatments with very high k. Rates. It was my fathers only brother and i distinctly remember my dad saying that i was growing up that he died just months before a new treatment was approved. At that moment it hit me if hed been allowed to trade a treatment earlier my father might still have his brother and my cousins might still have their father. Was passed unanimously in a lot of states. Do you think that having a story like that come and there are some stories you tell tell there are probably a lot of legislators that can immediately identify in their own Family Friends lives instances where this has happened. Weve all had people in our lives weve all known people who suffered from a terminal illnesses and many of us have known people where it came in to market and into market and the best available treatment shortly after they passed. So this really hits home for a lot of people and one legislature told me this is a two minute decision and the first is for coffee this is just something that is common sense to people of course you should have the right to try to fight for your life and even if something hasnt been tested if it is safe for human consumption and somewhere along the 15 Year Development process and the only alternative is that you are going to die, you should have the right to try those investigational treatments as long as you know the risk that you are taking. Host at the beginning of the book you write about a mother that has two sons both with muscular dystrophy which is a fatal disease that attacks the muscle. One of the children was able to access experimental drugs but the other was not. Can you tell us that story and go into a little bit of detail about what happened . I tell the story told a story at length and i first read about the story in the Burlington Press in vermont and two of her sons, she has four children but two of her sons have muscular dystrophy which basically will cripple the boys and most who have this will not live past their 20th birthday. One of her sons was able to get into a Clinical Trial and he was doing extraordinarily well and he went from being in a wheelchair part time to being able to play soccer, really incredible progress never be seen to be a co before seen. His brother on the other hand didnt make it into the Clinical Trial. He didnt qualify. So, he had to watch as his brother went out onto the soccer field and he was deteriorating and he got to the point he couldnt even hold a cup of water to his lips. This is a situation where in the United States if you are lucky enough to get into a Clinical Trial many patients will find improvements and many have been cured but the challenge is that its about a 15 year process for that particular treatments to ever make it to market so if you dont get into the Clinical Trials, you die. The right to try is saying if its good enough for people in Clinical Trials, its good enough for all of the people who need it at this time they should appeal to make that choice and as long as they know there are risks and somethings that are some things that are not approving, how much efficacy and things like that. Host when you first got involved in the cause you decided to go after it at a state level. Why did you do that instead of going after congress because the fda is a federal agency. It would be wonderful to see washington reform this and they have the power to do it and in fact the fda already has rules and regulations that enable it to help a lot more people than it chooses to do. But we know that its been 25 years since the fda has made any major reforms that really affects large numbers of people with these terrible terminal diseases for which there are no treatments and so we decided to go through the state legislature is coming and of course i think you mentioned at the beginning of the program that states have adopted this in just a little bit over a year. Its moved with almost unanimous support on a voting margin of 991. It is a left and right and everybody in between type of issue. Host why did you decide to go after people that were terminally ill, what about somebody losing his or her site or somebody with multiple sclerosis or debilitating pain why focus on terminal illness when there are people who are living with difficulties and other racetracks guest we designed the loss of that would prevail in the Supreme Court should be fda tried to challenge the authority of the states. We know one of the things in previous cases that have been important as the safety question. So, focusing on folks with terminal illnesses where their lives to hang in the balance and they have no other options that change the equation we are not talking about rushing medicine for teenagers with pimples or a cough medicine. This is for boys, people with lou gehrigs disease who might have two years to live when they get their diagnosis. The mama thats talked to me said by the time the fda finally approves this particular treatments, we once lost an entire generation of boys. That is unacceptable. We moved through the states because we knew we could get the actions that the patients need. Host this is the agency that is responsible for seeing if drugs are safe and effective and they did reach out to have the interview and they point to the fact that they have Clinical Trials available for which people can then roll to try to use the different treatments and they also have something thats called compassionate use in which you can apply access if you are terminally ill and outside of these Clinical Trials. Can you give me more details about this and explain why Health Passion of youth isnt enough to get people to lifesaving treatment. Guest thats right. The fda does have a few clinical treatment programs in a program called compassionate youth that is supposed to help patients in situations with this. The fact is that less than 1 of patients with terminal illness will ever get access to these treatments through the compassionate use program. The program was never designed to help hundreds of thousands of people im a little of the million or so who will be given terminal diagnoses this year. Compassion is an exception to the rule. What we are fighting for is to make compassion the rule. Host held as the whole process work, how does the application work and how long does it take . Guest the fact co. The fact that 99 of patients ever make it through tolls you a lot about whether it is working or not. We know for instance that Cancer Patients almost half try to get into a Clinical Trial the Clinical Trial and 3 will get in so we know that Patients Want access to the treatment and we know that they are not getting them. The reason they dont get them, there are many. Some people dont know about the program. But another one is that the process is so incredibly timeconsuming but most physicians and doctors simply cant navigate the system or have the time to do it. By their own admission just the application paperwork requires bitterly over 100 hours of a physicians time. Its not something he can give to his assistant were interned to figure out. So the doctors who do this basically clear their desks for two and a half weeks to do paperwork for one patient and you can see how if you have hundreds of patients which physicians do this is not a good solution and there are tremendous delays in the right to try. A young woman was in her 30s had Ovarian Cancer and she fought hard for seven years and exhausted all of the conventional treatments and her doctor was with the Anderson Center and that there is something that can help you. We have to go through the compassionate use process. He said he never saw that used in more than ten years so its a sort of mythical unicorn but he was an incredible physician and went through the process and did all of the paperwork and it still took 24 days to turn around their decision. The fact is by the time she got the treatment it was too late even though it had started to reduce the tumors it had been canceled much over the period of time that she passed on and in texas they fought hard for the right to try law and it was too late for andrea, but we are very grateful that it will be in time for other patients who need it. The food and Drug Administration told me they are working on shortening the form. As you said, it took in the 24 days i believe for the turnaround in that case they say they have up to 30 days. Do you think shortening it will help it a little bit as we wait for the right to try law to pass . Spigots find that its really window dressing. First from the position of principle you shouldnt have to beg the federal government for permission to try to save your own life. The person of the situation that has your best interest at heart and knows your case inside and out the first person is you come to patient and the second person is the physician. Frankly, there is no role for the fda and administering compassionate use. Its not for the agency was designed to do nor is it something the agency truly desires to do. When i was conducting interviews for this the interview with the head of the center for new Drug Development at the fda. And we asked a theoretical question of what you in theory like to see tens of thousands of patients accessing compassionate youth given the chance to try some of these promising and border cuttingedge treatments and she said well it would be another burden on the Healthcare System and that attitude is quite prevalent throughout the bureaucracy. Im not saying everyone had that attitude. There are some incredible people fighting for patients. But as an agency commits job isnt to treat patients. Its job is to approve medicines and products for the u. S. Market. Its for physicians to decide whether to help you through other treatments so we would like to see the fda not even have a role in this particular aspect of compassionate use. It should be about the physicians and patients and in fact that is how the system works in europe. Host you talked about how you approach to state legislatures in particular to pass the law and in most cases they passed almost unanimously. In the few cases where the state lawmakers havent voted in favor of the law would have been some of the reasons theyve given or some of the things youve heard where they might have a hesitation about passing the law . As kuwait is passed on a 911 margin, so the dissent is very limited. One is that people are concerned about safety and that stems from the misunderstanding of what the right to try is. This is about equity and about extending to all patients with terminal illnesses the same treatments that are already available in clinical studies and the fda has already said its okay to be tested on people for scientific purposes. We are seeing how about to keel them and extend their lives cost of the safety issue is not it stems from misunderstanding. The pats, organizations oppose this because if you are fighting for your life at the end, often hospice can treat you or they will not cover you and if so they are concerned is that they are probably going to die anyway even if they tried this and they want to make sure they get that quality treatment. We consider those logistical issues. They shouldnt be hurdles to try to save your life. They can be worked out. And they have widespread Compassionate Companies that do help cover the treatments so a lot of them have been thought through before. So the few voices of opposition in the United States i feel like im from perhaps a misunderstanding of what the right to try is worth a request for absolute perfection and certainty in the system where they dont have the luxury of waiting for the perfection. I know that you are approaching this from a state measure, but im wondering if youve heard anything from president ial candidates were if youve been able to meet with any of them discuss the right to try law. Guest we havent taken this to the candidates. Weve been so busy in the states moving this along that we have been working at the federal level as an afterthought. It takes so long to get anything decent as far as reforms in congress that we really felt like time was of the essence and we needed to move quickly through this space. Once this issue was brought to our attention in fact how it even became an issue is that the Cancer Treatment Cancer Treatment centers for america have learned about the other work and they came to us us and said we have Cancer Patients we want to treat and we know that for some of them the most effective treatments that are out there are pending approval at the fda or europe or other places in the world. Is there anything you can do and can you think of any way to help us be able to improve our patients access to these treatments in the business of curing people in healing people and we are being stymied by these rules that make you wait 15 years for a drug to come to market is there anything you can do and it is of the essence so we focused on the state legislature where people are closer to their constituents in every state that has passed with muscular dystrophy and all sorts of other really try and go masses. And that policymakers feel they see those folks as we mentioned earlier they had an experience like this in our immediate families in search of a friendship groups and no matter your politics your heart goes out to people you would like to see people access treatments if they can possibly be available. Host you just talked about the availability of some drugs in europe. A chapter in the book you share about some patients traveled across the world to access drugs that are still being developed that are showing a lot of promise. Can you tell a little bit about some of the stories . Guest some of them have been the standard of care for ten or sometimes 20 years and theyve been fully developed and so havent gone through the fda process. I will tell you one in particular about a boy named diego was 11. He lives in arizona and when he was diagnosed with a type of bone cancer in his legs he noticed his pain and take a long story to make a long story short, the doctor said the block, the best available treatment for you isnt available in the United States and you are going to need to go overseas. So he and his family actually moved to england for almost a year in order to get the treatments that saved his life. That drug has been the standard of care in europe for some time and also israel and another i think two dozen countries. When they tried to get the same drug approved in the United States even after it was already the standard of care in all of the tests showing all over the world they demanded the company tests on 900 people at its clinic will try a. Of 900 patients, that is more than would be diagnosed with osteosarcoma for this particular type. So they are not going to look at other evidence and they come up with things that are insurmountable barriers to try to get these things approved. So here you have something that is a standard of care and his lifesaving and the only people in the United States that can access it today can afford to go abroad and i think that we all know patients that cant afford to travel are few and far between. Host they say that these given the way of collecting data and some pharmaceutical companies can be a little bit nervous about providing these drugs because whatever adverse effects occur have to be reported to the fda. And as you mentioned earlier, Clinical Trials are concerned to be scope controlled and who gets to appear in the Clinical Trials. With some of your responses to concerns like that . All of these have been worked out in europe. We dont have to recreate the wheel. We can take some lessons that have been learned and apply them here. One of the things i think physicians and patients when they get these treatments you want to contribute and want their information recorded. People talked about the openended Clinical Trials where you let people in with more conditions and its actually more reflective of the real world. There is a talk about Clinical Trials looking for athletes with tumors in other words they want to focus on just that treatments but the reality is that most patients have multiple conditions going on if you are excluded from Clinical Trials so with Something Like the right to try when you have a bigger sample of people that record that information end up with better scientific information that would serve patients in the long run those are some of the things we are talking about. Many companies are concerned that if you treat patients that were close to the end which by definition under the right to try laws theyve exhausted all the standard treatment, so they are near the end unless they can get something to help them and they know that there is an increased risk of what they call in adverse event happening and they are afraid of the fda looks at that and there is a patient death of the fda would say that its the treatment rather than the condition of the patient i dont know how overstated or if that is accurately stated. I hear talk that the fda would slow down their trials or ask them for more which would increase the cost. But the fda has seldom done that in a way that we have been able to find. But that said, in the defense of the company right now it takes an average of 1 billion or more and about 15 years to get a treatment from the beginning to the end and actually get it on the pharmacy shelves so its understandable if they dont want to take on any additional risk to be able to raise that kind of money especially if you are a startup where the new developments are coming from we cant afford to take any risk the fda might delay the final approval by treating patients who are in tough circumstances so those are real concerns. On the other hand, ive also spoken to the ceos who are in favor of the rights to try and in particular one i spoke with has a product that is in stage three which means it is very close to coming to market within two to three years. But for the particular disease that this drug is designed for, its a very rapid and i would say why would you be willing to treat patients who are at the end within a few years you will he will be on the market and the fda wont have any trouble with that and what he said to me was by the time the fda finally approves this treatment, not a single one would still be alive at the bottom line here also concerned with patients, so i think what youre going to see is in the mix. Then you see others who say i will be damned if im going to lose one or patient and i will start treating people today. We know people are being treated under the law today for just that reason. Host when you talk about the ceos that you just spoke to is that the one you talk about for the pharmaceutical companies that have been reluctant to say anything about the right to try laws the ceo that you are talking about in your book at a different position. Tell us about that story. So, the person many people wanted to be off the record that the story in the book that i tell us about Richard Gardner the ceo of a company for patients in terrible conditions and his company five years ago in a Clinical Trial treated a patient died the name of ted. He has lou gehrigs disease but instead of being in a wheelchair or passed on which was his diagnosis, he is walking and is the first person to have ever recovered from als. But what he will tell you is that its been five years to get the treatment and in the meantime, theyve died of lou gehrigs disease lucky enough to get into that the Clinical Trial to be alive today. He had a brain tumor and talks about what i was like as a father and we tell that story in the book. How is he doing now . Hes doing great now and its a remarkable story to see him with his wife and kids and every day to him he speaks about in spiritual terms of the blessings and he talks about the importance of the right to try to fight for their lives even when it seems hopeless and people tell you that. There are not any good to treatments and its treatments and its just in the course of writing this book people have testified that absolutely devastating. In the Clinical Trials once youve been treated in the Clinical Trial. Should his disease comes back in full force. He can also be the last person to die of it. Said he needs more of the drug to continue to improve. Its possible. Its unknown right now what theyve been able to determine so far is that the higher the dose the greater. So it looks like its something that he may need again. He cant run a full marathon that he can walk a five k. He has strengths in his arms, for movement of his limbs and for patients just retaining your lung capacity is a miracle so i dont know that we would see that its been entirely eliminated the doctors dont see many signs of it that way they do in a typical patient anymore. There were others in the trial but also have some pretty spectacular results. How stupid is an incredible story. Is there any indication when it might take the market . Guest i havent talked about that for a few months so i would encourage people interested in this to go to stem. Com and look at the companys website. I know that the ceo answers a lot of his own emails firsthand. Who does but these days . It is quite remarkable. Thats one way to talk about that. But ive also heard that there are some other treatment that are quite promising and i dont know the names of all of the companies. But theres a lot of traffic on this and patients talking about different things. One of the messages i hope people listening today well take back to their loved ones or even for themselves is that its good to have hope. There are some things out there for a lot of these illnesses that people may not be aware of and we are hoping that we can help them gain access to the best available. Host into the way to do that is through legislation. I want to go back to the states and in one part of the book i will read it directly you write in recent years activists on the left have gone to the states to pass initiatives on everything from medical Marijuana Legalization to the right of assisted suicide. If states have the authority to give access to marijuana and drugs to end lives, certainly they have the authority to end Cancer Patients access to medicines to save their lives. One of the recent developments in california this year governor jerry brown who is a democrat past the right to die law which allows physicians to provide life ending drugs to their patients. However, he vetoed the rights to the trial which i think was a little bit surprising to some people. Here is what he wrote about the right to die law. He wrote i do not know what i would do if i were dying in a prolonged excruciating pain. I am certain however that it would be a comfort to consider the options afforded by the bill and i went into the night that right to others. Thats what he wrote about right to die when asked about right to try, his later supported the compassionate use clause and he said that the state shouldnt get in the way of that. Were you surprised that this was the ruling and what do you think of those arguments i think that its an absolute shame the law passed unanimously in the assembly and there were a lot of patience for would have benefited from the right to try. But the governor told people is what you want to end your life thats fine with me. Thats your value to me that if you want to fight to save your life the fda had enough times and so do most patients. I believe that you will see the California Assembly goes back and send suspected Governor Brown. This is one of the most outrageous things that we have seen in the right to terminate your life but not the right to fight to live. Even people that support Governor Brown feel like that is so fundamentally antifreedom, antieverything that we stand for in america. The spirit of trying to fight to save your life and its off to dismiss the right of people who decide they want to hasten their death through the right to die law. But many people if given the option would choose to fight and they ought to have that right. Its their choice, not the government. But Governor Brown have done is absolutely shameful. Lets talk about some of the logistics. Lets say you live in a state in which the rights to try has been passed. How do you go about actually trying the drug and what are some of the steps you need to take and some of the requirements to access these drugs . I have a chapter about how to do this in the book kind of a little hand guidebook if you go inside of one of the chapters and we have of the Goldwater Institute helped navigate the system and we are going to try that in the best of our ability. People certainly do everything that we can. The walls are new in some states and physicians dont know what to do yet. Its implementing the seachange in the way that the treatments become available to patients at what it boils down to is a physician who needs to be believed that a particular investigational treatment is indicated for you and they have that information they can look at the research and patients often times have that information before doctors because they are exchanging every little bit of information as it becomes available when its released from the Clinical Trials. They are their own best advocates. So the physician needs to think that something is indicated for you and in some cases it may be two positions at each one is just a little bit different and then the manufacturer or the maker of whatever the treatment protocol is has to be willing to give it to you. You cant force the company to do that and if so then that treatment can be administered. Lets say that it exists in another state, how does it have to be shipped, who pays for that and for some of the logistics of getting the drugs to the person that needs at . If you are a patient and have the right to try in your state, things are going to be a little bit simpler for you. If you are a patient in a state that likes california for instance but doesnt have the right to try, you can travel to almost ideally all of you are states that have adopted this and allow you to come in and get treatment in that state. You can go into that state and as long as you can find a physician that indicates the treatment for you, you can go ahead and get the treatment. If you are a manufacturer, you cant ship the treatment across state lines without violating the states law. Why is that . Because whatever the the truth but is treatment is it already has one from the government and that is what permits the transit state lines to the manufacturers can already do this and as we said earlier, these drugs are being developed in phase two or three, so they are moving quite far along and this is just about opening the door of this sooner for people who dont have five or six years too late. Maybe the only has five or six weeks left and the treatment is just the thing they needed need to be able to live. Can you walk us through the different phases of the trial so we make sure that the viewers understand what the drugs are doing when they might be able to access them and what risk they might be taking . The process in general is about 15 years from the Research Stage all the way to the pharmacy shelves. There are three main phases before you can even get into the first you have to have basically millions of dollars testing your product in animals and other ways and you have to have quite a bit of data before you can get to face number one with a copy 60s detesting. Its one where the product gets tested on people for the first time and basic safety is shown. Two and three is about efficacy and dozing and how much of something do you need. And what is the right amount of the dozing somewhere between 20 to 60 of the drugs in phases two and three automatically will be given the green light. Many will not, but its Something Else thats important for people to because just because the drugs dont clear the fda, it doesnt mean that they are ineffective. This may mean that its not effective in a large enough population for it to be valuable to the fda that it might help fight of the patients so you will see many people were much for expert in this than i am but you will now see talk of ipv6 was the nih that was revisiting over 100 trials for Cancer Treatment and they are actually now retesting all of these different drugs and checking them against different genetic markers because some thing if you have a certain type of genetic if you have certain genetics that will be effective for use use of maybe a dozen top 95 of the stops 5 and it may be the only thing that helps you so science has come far enough along now that we are beginning actually to get to the point that we can tailor the medicine for individuals and the fda process by and large has not learned to accommodate that yet and that is good to be critical. Medicine will be completely different ballgame 25 to 50 years from now. We talked about Clinical Trials and how involved they are and what the process is like taking years and years. One of the instances that comes to mind immediately is the drug hadnt even been tested yet it was used as experimental treatment to help those who had been working in west africa to come back to the United States. As an example like that make you feel as though there are exceptions that can work out and how do you respond to Something Like that . While some of the first half that comes to mind for me is that i am extremely grateful that theres people who were able to take it. It saved many lives and people all over the world are very grateful for that. Even though it had never been tested in humans it was what they thought was good to be the best available and so all the rules and regulations were off and people got treated. It was an emergency situation and that is fantastic. It saved lives. We wish that they would do more of that somebody did at the institute under the freedom of information act, we asked them to tell us about the process of the decisionmaking process that they used to judge that it was such an emergency that the rules were off the table that they could immediately get something to people even though it had never even been tested in human beings before and get all yet all of these patients with terminal illnesses cant access any of these medicines that could save their lives. And the mother that we talked about with the two boys with muscular dystrophy said you know what time it is an emergency to my son and thats a fact. When you have brain cancer that is an emergency to you and your family because it is the same. Your life is on the line. Well, they refused to share their decision they can process and it is weve taken them to court on that to force their hand. The fda right now has the power literally of life and death over american citizens and regardless of what you think about the right to try with the the policies i might be promoting today, the American People have the right to know how the fda is making decisions that will lead some people to live while they leave others to die. The examples for some people who are a little bit critical or skeptical of the right to try law have said to me just in interviews that ive done for u. S. News and world report they are concerned that the rights to to try balls will only be able to be accessed by people who have a lot of money or who have a lot of connections and resources. How do you respond to that criticism . The Current System is one where he i have a terrible situation like that where if a trait that is only available in europe, who do you think can go to europe . We have a situation right now where they will develop about 30 of the most innovative treatments to get to market their before they do here so if you are steve jobs for instance, and i have a chapter that includes him in there. You can go abroad to get some of these treatments that may be standard or investigational and if you are a regular person in this country, you cant afford to do that little of the fact you dont have to call to go overseas to be treated for a year so the Current System is one that i hate to say but it favors anybody because all patients should have access to these things here but if anyone is favored obviously it is the people with the resources to be able to go abroad and seek some of his treatments and thats the same with compassionate youth. If you have good resources you are much more likely to be up to find a doctor and to compensate a doctor for taking two and a half weeks literally to clear their desks and do the paperwork thats required, to have the connections in congress that will prevail on the company to release a drug for you or your loved ones. Regular folks at the door slammed in their face and i tell those stories and books. What the right to try to does for me it is the great equalizer. If your positions as something is indicated, you could be in a world part of the country with almost no money but if it is indicated you can find a company to give you that manufacturing just that cost is all they can charge then you at least have access and that is a far better situation than the one we have today as imperfect as it may be it is still far better a great improvement. Host to charge you mentioned is for the drugs in particular were to travel from state to state . And who pays for that . Guest writenow, so i mentioned here a few times and i like to look there because theyve been through this and most of the Insurance Companies will cover investigational treatments because investigational treatments in fact are more standard for people and so we would expect the Insurance Industry here to follow suit and come along. Right now of course most companies dont cover experimental treatments because they cant access them so if you are asking Insurance Companies to do something for which there is never really been a market so at this point in time, we would expect that patients would selfpay and we also know that there are Many Companies right now who would they when they do have compassionate you for Clinical Trial will give the product away for free or they will charge just the cost of production which is all they can charge. They can take advantage of people. That actually cuts both ways. Here we are with people with their lives in the balance and many of whom would be willing to pay just about anything to try to save the lives of their loved ones and we are asking companies to give something away eventually that costs a billion dollars to develop. Now a billion dollars can be a drop in the bucket but a lot of the most innovative treatments are coming out of small labs with four or five doctors and they dont have a lot of extra drugs available. Even though they might have the willingness to part with it if they did so those are real challenges that will need to be tackled if the system isnt going to be perfect but at least the right to try opens the door and it begins to get the movement going and that is critical. Host so you are speaking with Insurance Companies about this possibility or what are you hearing from them . I havent spoken with Insurance Companies yet. But i have spoken with people who are working overseas with Insurance Companies and they are telling me they have a strong sense that the companies will come in to be helpful with this so i think it will take a little bit of time but its interesting when you talk to the patients about this, this is a great theoretical discussion and yes everybody wants insurance to cover treatments but you know the patients are saying dont let that be a barrier to my treatments like if i have to hold fundraisers for the rest of my life so i can see my kids grow up i will do it. Sorry to get choked up about real peoples lives are at stake here so the insurance question is a real one and we want to address it and deal with it but lets not let that be a disincentive for people today. Host would extend for people i know that the wall is still new but to make use of the right to try law what can you tell us about people that have done so . Guest of course no one is required to let us know that they are either being treated or that they are treating patients under the law. But weve had multiple people come to us whove entered into treatments and are being treated today. This post i want to tell you because i want to respect their privacy. But we do know that there are treatments that are occurring and people are beginning to utilize the law as new as they are and were we are so glad to see that and i hope that ive been able to see and whats been reported through my organization is only the tip of the iceberg. I hope many more are being treated in as many more are gearing up to treat people under these laws many folks be the only the fda or federal government has the authority to permit these treatments and that is a myth and in fact the right to die that weve been talking about ten years ago when oregon, about ten years ago passed that law federal government said you cant do that that is within our purview so they went to court and the u. S. Supreme court said no impact the states do have the authority to determine whether they want to offer this to the citizens of their state. They do have this right and there are a lot of reasons for that. There is a lot of historical precedent and other precedent which i go into in some detail in a chapter in the book that tells you that we are on sound legal footing here. This is a fundamental liberty right and it is one that the American People have a right to. The state guarantees are passing and we are really just indicating what most americans probably already assume they have the right to. Its quite fundamental to be able to try to fight to save your life and we are basically caught fighting something that frankly as americans should already be the practice into the wall of the land but unfortunately the way the fda regulations have worked over the years, that right has been eroded. Host most states have been supportive of these laws but you talk about some of the challenges and how you have legal standing. Are you concerned there might be some challenges to the right to try law lacks guest its anyones guess if the federal government will try to. It would be the department of justice to have to come after a doctor or a patient and you know, i think it would be quite a bold move for the department of justice to walk up to a cancer patient and say i know this is probably saving your life that we are going to take this treatment way from you today and try to prosecute you. You know, i dont know if there is a political willpower for them to try to do Something Like that. This is something that is overwhelmingly supported by the American People. It is overwhelmingly supported by doctors and physicians in the establishment. But doctors say in here talking about all different kinds of doctors, 80 or more see that as long as a the patient is informed about the risk of something that a doctor and a physician should be able to treat them with the best available care and in fact they feel like that is the oath they have taken and to not be able to treat patients, to have their hands tied when they know that the best available treatment for instances in switzerland for one particular illness which i talk about in the book, you know, its heartbreaking and they feel that it is unethical created so its possible that the fda will try to come after these folks but we are prepared to defend the patients and their doctors. We have a very strong court record and we would be proud to stand up for them in court. Host the right to try law to protect patients and physicians and for mystical companies from prosecution if someone were to try to act on some of these expendable drugs without going through Clinical Trials and compassionate use and they lived in a state that didnt pass the right to try law what kind of charges are they looking at and penalties should they be concerned about . Guest if you are trying to do this in an area the law doesnt protect you, im not exactly sure what would happen and i wouldnt encourage people to break the law. We are going to move this as quickly as we can in the other 26 states and in the meantime hopefully there is a neighboring state where you can get treatment. But again i will say this. When your life is hanging in the balance, thats your decision and certainly i wouldnt be about civil disobedience and i think very few of us would claim anyone who tried that. Host going into the state that accepts the right to try law and brings it back to one that doesnt it would be okay to come is that legal . Guest you could bring your treatment if it was in a form of a pill or Something Like that idea be that you could bring it back to your state. But depending on what is happening with you you may need your physician care for the treatment. There are just so many conditions that are individual to the patient treatments that its hard to get a blanket answer but if somebody has a particular question we would try to answer it as best we could at the institute. Some states still havent passed the right to try law. What state are you headed to next year . Guest we are hoping all of them will hear about this and learn about it and get going. We know pennsylvania and ohio are considering and we think that there will be some movement in vermont so this is just everywhere. Its passed in virginia, florida, texas, large states, small states for the first is colorado which is a democratic stronghold and its passed in texas which is a fairly conservative state. Again this is just something that has nearly unanimous support and it isnt that the right to try balls are perfect and it isnt that they will solve every problem that has ever existed but it is such a tremendous improvement over what we have now which is basically a closeddoor if you have a terminal illness and youve exhausted the conventional treatments and there are a lot of drugs and a 15 Year Development window that can prolong and save lives but it is such an incredible improvement over where we are today that theres just this incredible support for it and again i would draw people to some of the chapters in the book where i talk about we keep using the term an investigation experimental and while they may be experimental and investigational in the u. S. , there are dozens of and maybe even hundreds of drugs that have been approved in the european union, in israel and japan and other countries where the Standard Operating Procedure that works better sometimes been some of the things we use like chemo as we also call in the congress and the fda in this case to allow for reciprocity for heaven sake if something has been approved overseas through a legitimate agency, Regulatory Agency which countries i mentioned are, but our patients have access to those medicines. Host i look forward to following the story in the u. S. News and world report and i hope that im able to see different ways that patients have been able to access drugs because of the right to try law. Thank you so much for joining us today on cspan. Guest thank you. My pleasure. That was after words, booktv Signature Program in which authors of the latest nonfiction books were interviewed. Watch past programs online at booktv. Org. But right to try balls are is all about when your life hangs in the balance when you have a terminal illness its about giving you the right to try to fight to save your life by accessing experimental investigational medicines while theyve received the final green light