 Thank you, Dr. Peroti. Thank you, Tony, for that stage setting. We wanted to begin the day with a patient perspective, and our morning keynote is going to be David Mitchell and David all welcoming you up to the stage up here. David has an incurable blood cancer, multiple myeloma, and the price of his current drugs, and you can check me if I've got the facts wrong here, but $450,000 per year. Like many people, David needs innovation and new drugs for his survival, but he believes drugs don't work if people can't afford them. After more than 30 years at a D.C. Policy Communications firm, he retired in December 2016 to devote his full energy to helping change policy to lower prescription drug prices. The Patients for Affordable Drugs mobilizes patients and allies at the federal and state levels and does not accept funding from any organizations that profit from the development and distribution of prescription drugs. I ask you to welcome David Mitchell, and you're going to talk for about 15 minutes, and then we'll go to Q&A. Does that sound about right? Okay. Thank you. No applause till I'm done. Then we'll see if you still want to clap. I'm David Mitchell, and I left the clicker on the table. And prescription drugs, frankly, are keeping me alive. I'm a relapsed blood cancer patient. I'm in the second line of drugs. If they don't develop some new drugs for me, I will die sooner than I hope. And so innovation and new drug development is terribly important to me, but my journey as a cancer patient taught me that drugs don't work if people can't afford them. So as I have been dealing with this over the past seven and a half years, I became increasingly frustrated because there were not patient voices speaking out on the issue of prescription drug prices, and we know why. Overwhelmingly, patient groups take money from drug corporations. They put the money to good use. They use patient education, patient support. I called the hotlines when I was sick at the initial stages of my disease, very sick, with both the cancer and with the drugs they were giving me. I talked to the help nurses. Those services are incredibly important. We don't want them to go away. But patient groups are inhibited to a degree by their funding on speaking out on drug pricing, maybe with the exception of the multiple sclerosis society, which has been a courageous leader on drug pricing. Some groups, and this is in a story today in post based on a new look at funding of patient groups by drug companies, by Kaiser Health News. Some patient groups even carry the water for drug companies on drug pricing, speak out against proposals that would lower drug pricing. And because of that, we decided we'd do something about it. I will include my wife in that who said, okay, you can retire. You can work for free. We can put in some of our own money and start an organization to fight back on drug pricing. What are we doing? Well, in the little over a year that we've been in existence, we've collected 13,000 patient stories. 8,000 of these stories are up on a map on our website that you can search. We'll get the rest up in time. We're always behind. And we've collected 82,000 email addresses. And that number will grow dramatically in coming months. We are building a community that can be mobilized in support of policies that will lower drug prices. How are we doing that? Tony talked about state legislation. These are two of our patients. One who is testifying in, I think, Washington state. Another who testified in support of the transparency bill, SB 17, last year in California. These are folks who we engage with. We help train and prepare. We fly them where they need to go so that they can testify in lobby. And we are having some impact. You know, bills passed last year in Maryland, in California, in Nevada, although it was only on insulin. It was a very good bill. Oregon just passed a bill. Ohio just took action administratively on PBM transparency and stopped gag clauses. There are bills awaiting Governor's signatures in Kentucky and Arizona on PBM gag clauses. There's a bill still making its way through the legislature in Maryland that would strengthen the bill they passed last year. There's a bill in Colorado. There are bills in Michigan. And we are active in all of those places. We are also active at the federal level. We have not only generated 51,000 communications with Congress on a bill called the Creates Act, which would stop a form of patent abuse, but we have flown patients to Washington. And you see some of them there. Tony was saying that there was an absence of patient stories. It's really remarkable to go with these patients to these meetings and to hear them tell their stories. Stories like Lisa Driggers from South Carolina lives on a farm or her husband has the same disease I have. She was explaining to the staffer that before she left her home to drive eight hours to come and talk to them about the Creates Act, her husband had said, Lisa, I want you to think again about whether we shouldn't just get a divorce. Nobody has to know. We can go to the courthouse and then I can get more aid and I'll have to worry about leaving you destitute when I die. The staffer's faces just like go blank. They're not used to this. A woman named Pam Holt, who's a retired teacher, lost her husband when she was 40 years old, lives in Indiana. Now she is fighting a cancer and Pam had to go $10,000 into debt last year. She met with her financial advisor in the week before she came to Washington to talk to Congress about this legislation because she needs to refinance her home to pay off the credit card debt. We're bringing stories and real experiences of people who are struggling with high drug prices and we think we're having impact. We haven't changed the world yet, but we're chipping away at it and we think we're making some strides. I want to share this with you. Can we turn it up so they can hear it? A couple of minutes of this story to make the point. The proposed Creates Act would target what critics call illegal but questionable tactics that drug companies use to delay the introduction of cheaper generic medications. The FDA commissioner has called the tactics, quote, shenanigans and, quote, unfair and exploitative tactic practices. Anna Werner has been looking into this. Anna, good morning. What have you found? Good morning, John. Well, this is a situation where critics say that some drug companies who want to hold on to their exclusive sales of a brand-name drug and their profits are playing games to stave off generic competitors, leaving patients out in the cold. So that's it. That's it. It's the drug that's keeping Pam Holt alive, keeping her multiple myeloma, blood cancer, at bay. It's called Revlimid and her copay runs $640 a month. I don't know how anyone can afford that. I really don't. But Holt can't get a generic, not because other companies aren't trying to make one, because critics say Revlimid is one of a number of drugs for which companies are using unfair tactics to stifle generic competition. So that is the message that Pam brought to Washington. But we also worked with CBS this morning in helping their research on this and, of course, made Pam available to them. And this is the work we're doing. We're doing it at the state level. For a moment, I want to talk just briefly about the Creates Act. We, along with other people in this room, we felt like we made some progress, although we didn't get it done. We failed for a second run at it to try and get it into the omnibus funding bill, omnibus spending bill. We ended the fight at that moment with 21 bipartisan cosponsors in the United States Senate, 16 bipartisan House cosponsors, made a real push along with many allies. Pharma ultimately dug in hard, because Pharma acts that as if any chink in its armor would be fatal, and they fought. And despite overwhelming support, Congress did nothing and has yet done nothing to lower drug prices in this session. We're not giving up. We will try and bring Creates back. If there's an opioids bill that we might be able to tack it on to, but we all know how hard it is for this Congress to enact legislation that isn't must-pass legislation. This Congress doesn't do freestanding bills, so we have to hitchhike on something. And if there's a vehicle, we'll take a run at it again and see if we can get it done. If not, there's 2019. And I'll come back to that. The administration is taking some action, small things tinkering around the edges. We are waiting for a comprehensive set of recommendations for the administration to lower drug prices that has been promised, and apparently Secretary Azar and the White House are working on those. You know, they're talking about doing things like allowing patients to pay their co-pays based on the rebate price, not the retail price, at point of sale. That would help some patients. They're talking about doing things, I think partly because pharma is kind of driving the train in the administration to go after PBMs, which need going after. And then, as I mentioned, the point of sale rebate for Part D and maybe capping co-payments at the catastrophic level. It's a crazy system if you take a drug that is really expensive because you pay 5% after you hit the catastrophic level all the way to December 31st. There's no cap on out-of-pocket and out-of-pockets under Medicare Part D for the most expensive drugs, the most expensive 12 drugs range from $4,400 a year to $12,000 a year. So capping out-of-pockets at the catastrophic level would be helpful, but we have to be aware of the impact it would have on premiums. Future directions, as we look to 2019 and a new Congress, we think that patent reform continues to be one of the best places to maybe make strides because there is bipartisan support. That would include REMS abuse, which the Greats Act aims to stop preventing rental of sovereign immunity to stop patent review, product-topping ever-greeting sham citizen petitions, patent thickets, they all need to be addressed, and there is bipartisan support for that. And then we think there is growing energy and opportunity to go after these issues, especially in a Congress that might look differently in 2019. A couple of areas that we are beginning to work in. Many of you may have seen a piece that ran in the proceedings of the National Academy of Sciences a few weeks ago that said that every single one of the 2010 drugs approved by the FDA between 2010 and 2016 were based on funding from taxpayers through the NIH or academic medical centers. We are paying to invent drugs that we can't afford. These drugs are going to bankrupt families and our system, and I'll speak specifically to one. We believe strongly that we need to have a national dialogue. It may have been one thing for the NIH to say we wash our hands of pricing when drugs were 15,000 or even 150,000, but not at $500,000 a year for the drug and maybe another half million for the medical treatment to deliver that drug. We met with NIH in early January. They said they'd get back to us, not so much. We sent them a letter a few weeks ago and encouraged that we have a follow-up meeting. We did this with some other allies, haven't heard back. We will move this issue ahead one way or another with or without the NIH, and there are a variety of ways that we can undertake to do that because we believe we have to ask the question, should we be transferring taxpayer-invented IP for drugs that will save people's lives to private companies to commercialize those drugs without having a pricing component at the time of transfer? We believe there needs to be a discussion about whether continuing to do what we're doing is right. CAR-T is the poster child for this. NIH, and I care deeply about CAR-T. There are 12 CAR-T trials underway right now for multiple myeloma. It could be a durable cure for... It could be a durable remission. It could produce a durable remission for me, maybe even a cure. We don't know yet. There's not enough longitudinal data to know. I would love it if CAR-T, the promise of CAR-T was borne out, but at $475,000, which is what Novartis priced its CAR-T drug at, we did a study. We modeled it with a former drug company executive, a former CEO and some economists and pharmacy experts from Harvard and concluded that at $475,000, Novartis is going to realize a 65% profit. That's after we gave them 19% for continuing R&D, which is what they claim is their annual R&D. 65% on a drug that we invented. We tried to figure out then, well, what if we just gave them their historic 27% profit and the 19% R&D? What would the price be? $160,000. This is why we think we have to address this issue of how we are doing what Tony described, which is it used to be that the big drug companies actually took risks, actually invested in early bench science. Now we do that through the NIH, and after the drugs are de-risked, then the drug companies move to acquire the assets. We will have, we do have and will have more resources through a new organization called Patients for Affordable Drugs Now, which is a different kind of organization under the tax code. We can do much more direct lobbying, and we are going to engage in some political campaigns in the coming months to highlight how important prescription drug pricing is to voters, and we are going to be working in supportive candidates who have been helpful on drug pricing and against candidates who have not, and we will be working all over the country. The complete scope is not settled yet, the budget is not settled yet, but stay tuned. I want to say that there are some people in this room who are instrumental in this work, Ben Wakana and Lucy Westerfield. We have a great staff, Ben Wakana, who's our executive director, partner, and we, we together, not only through the work we're doing at Patients for Affordable Drugs, but with people in this room who are allies and others who are not, we think that we can continue to make progress on this issue. It's truly an uphill fight, but we think we can make progress and will in fact do so in the next couple of years. So with that I'll take questions. Thank you, David. We have eight minutes and 17 seconds for Q&A. There's a microphone in the middle of the room, straight dead center, there's another microphone here under the light stand up closer to the stage, and David I'll just kick things off. You started off talking about the patient groups and where the money is going and everything else. There is an interesting issue there with this, particularly to patient groups as opposed to sort of broader slice of the population, they're living this. And there's a legitimate concern of well, if we do things, and this has been promoted, that if we make changes that will suppress innovation. How do you and your conversations sort of counter that or address it and say, because clearly we're all here, we want the innovation. That's not actually the issue. It was on the pricing side. But when you're addressing patients who are in your situation and it's life or death as opposed to the hypothetical, how do you talk to them? The first thing I do is say it's life or death and not hypothetical. It is for me. But here's what I say. When I hear drug companies talk that way, it sounds like extortion to me. It sounds like putting a gun to my head and say, pay the price or you're not going to get the drugs you need to stay alive. It's just wrong that they are allowed to conduct their business that way. But from a substantive standpoint, there are several things. Number one, it has been widely researched and confirmed that there is absolutely no connection between drug prices and the amount of money spent on R&D. Drug companies in this country spend way more on advertising and marketing than they do on R&D. And if we just cut back on that, there would be ample dollars to lower drug prices. Drug companies run profits that average three times the S&P 500, three times. And drug company execs are among the highest paid executives in the country. There's plenty of money there to lower prices without affecting the research and development pipeline. And finally, I'll make the point again, drug companies are not doing the basic science to invent new drugs. CAR T is a perfect example. $200 million invested by NIH into CAR T. The seminal paper that was published by Dr. Carl June at the University of Pennsylvania showing that CTL 19, which has become Kim Raya, the CAR T drug from Novartis, the seminal paper that Carl June published in August of 2011 was funded in part by the NIH. And it was after that paper in 2012 that Novartis moved to acquire the global rights in perpetuity to all the cars developed at U Penn. We paid to invent the drug, we de-risked the drug, and then Novartis said, this is a viable business opportunity, we'll go get the rights to that and commercialize it and bring it to market. They took risk, they still had to finish some small clinical trials, but they also got an orphan drug tax credit. They got a priority review voucher that was worth a couple hundred million dollars. So we also supported them in that phase of their research. So I believe that, and I tell patients this, there's ample money in the system to allow us to reduce prices and still maintain a robust R&D pipeline, principally because we're paying for it through our taxes. And could you step up, please identify yourself as well? Thank you, I'm Bruce Strechter from Doctors for America. And David, thank you for that presentation. I just had one question. What's a process you go through to develop the policies that you support? Well, the process actually started before we launched talking to experts, some of whom are in this room, and trying to gauge which policy approaches, A, would have the greatest impact, B, which were most likely to come to fruition, and even if they weren't, did we have to be in favor of them anyway? Then we put those policy approaches before our board, we have a bipartisan board, and then we put those policy approaches before a patient advisor group and made sure that everybody was comfortable with where we were heading. We will tune our policy priorities again, heading into next year, and we'll put it through the same kind of filter. Again, I'll just point you to the mics if you have questions. I want to follow up on the funding cycle that you described. When you're talking to state legislatures or administration officials or members of the Congress, is this news to them? Which part? As you're describing that we're funding the front end, we're paying for it on the back end, and de-risking products, how do they react to that? I think that overwhelmingly, when people hear that, they become even more incensed and more enthusiastic about doing things to curb drug prices. If you put the question, should we be doing something about drug prices, doing more to lower prices of drugs that are developed using taxpayer support, about 90% say we need to do something. And I think at the state level, policymakers are somewhat surprised to learn that what Pharma is telling us, that they go boldly to develop all these new drugs to save my life, when in fact they go boldly to spend more on advertising and marketing and on lobbying and on campaign contributions than they do on R&D. I think that folks have their eyes open and it helps change the conversation. Thank you. One more question, Jim. Hi, David. Thank you for that inspiring talk. These are issues. I'm Jim Wilkins from Fair Access Medicines. From where? I'm sorry? Fair Access Medicines. So there's one clarification about pharmaceutical companies. They spend more than 95% of their money on two things. One is share buybacks and the other is dividends. Share buybacks actually drive executive compensation. And they're highly incentivized to buy back their shares and basically drive their salaries up. That's one thing. And the other clarification I wanted to make was actually the NIH has driven innovation forever. It's not just in the past few years. The NIH is the engine that drives pharmaceutical innovation and when the pharma companies complain that they have to have money for R&D, it's a total sham. It's propaganda. So I'm totally in support of what you're doing and we hope actually at Fair Access Medicines to actually make some drugs and compete with the pharmaceutical industry head on. Thank you for your comments. I'll just put a finer point on the stock buyback piece. We wrote a letter in support of a woman, in fact I referenced the woman, Lisa Driggers from South Carolina, who was afraid of losing her farm because of the cost of her drugs. We actually ran a petition and sent the petition to Selgene saying help Lisa Driggers. So they wrote me back and said we're going to contact Lisa and they did and offered to be helpful. Lisa said you could allow a generic to come to market. That would be helpful for all of us. But they wrote me back a letter and said we're spending 40% of our revenue on R&D. So we went through their 10Ks. They're spending 21.1% of their revenue on R&D. According to their CEO in a stockholder presentation, a shareholder presentation, an analyst presentation that was made in January of this year. And they've spent more $3.9 billion over the last year on stock buybacks. More than they've spent on R&D. So Farm is all too happy to twist the facts, even say things that aren't necessarily true in order to defend positions that are indefensible. So thank you all very much.