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    Stopping Health Threats, Finding Cures: The Latest in Health Research

    From combating the opioid crisis to finding better cancer treatments, top leaders offered insights on high-profile health and medical issues at Research America’s 2017 National Health Research Forum Sept.7 at the Newseum in Washington, D.C. Featured speakers included Dr. Francis Collins, Director, National Institutes of Health; FDA Commissioner Dr. Scott Gottlieb,  Dr. Anne Schuchat,  CDC; and Hon. Patrick Kennedy, member of The President’s Commission on Combating Drug Addiction and the Opioid CrisisWatch video highlights and read more about the event below.

    Hello everyone, and welcome. I’m Valarie Basheda, WebMD’s Director of News and Special Projects. Today we’ll be watching the National Health Research Forum, a once-a-year gathering of top leaders talking about issues and innovations in health and medicine research. We’ll be livestreaming the event taking place at the Newseum in Washington, D.C.

    Writer Bara Vaida is at the Newseum for WebMD and will be sending updates during the event.

    The event features three expert panels, each followed with a Q&A from the audience.

    Dr. Mikael Dolsten, president of worldwide research & development of Pfizer, will kick off the program shortly after 11:30 a.m. with a keynote address.

    The first panel, “Addressing Escalating Health Threats: the Role of Research in Combating the Opioid Crisis and Other Urgent Community Health Challenges”, will get underway at 11:45. Panelists include: Dr. Anne Schuchat, principal deputy director, Centers for Disease Control and Prevention; Gopal Khanna, director, Agency for Healthcare Research and Quality; Massachusetts Governor Charlie Baker;  former Congressman Patrick J. Kennedy; Seth Ginsberg, co-founder and president, Global Healthy Living Foundation;  and  Lucinda Maine, Ph.D., R.Ph.,executive vice president and CEO, American Association of Colleges of Pharmacy.

    You can also follow the conversation on #RAForum17.

    Bara Vaida’s updates from Dr. Michael Dolsten and the first panel:

    • Mikael Dolsten: We want average development of new medicines to take 5 years or less instead of close to 10 years development time.
    • Dolsten: We want to see sustained funding levels for National Institutes of Health and a US regulatory system for the 21st century and a health care system that ensures great patient access.
    • Seth Ginsberg: We are treating pain okay. We need to treat pain much better. Instead of indicting the entire medical community, I’d prefer to look at this from a glass half-full perpsective and look at all the ways we as society can improve chronic pain.
    • Lucinda Maine:  There is no simple answer to solving opioid crisis. One is definitely research and the other is education. On the research side, it goes from understanding pain as a neurological phenomenon, to finding non-addiction strategies for addressing pain more effectively, to real understanding the social and economic and behavioral issues that would help clinicians and regulators make better choices at the individual patient level and the population level. We have to have better data and understanding of genetics and addictive qualities. There is so much we don’t know, that is where education comes in. There is real lack of education for patients and clinicians.
    • Patrick Kennedy: There aren’t an adequate number of non-opioid pain reliever drugs available to Americans to treat those with high risk for addiction.
    • Anne Schuchat: As clinicians we have to do better. The CDC issued guidelines for pain (prescriptions) last year. The guidelines were: think twice before starting people on these medicines, and if you do, have a plan, start slow. We need to prevent more people from becoming addicted. As a result, we have had a response to these guidelines. We have seen some decreases in (pain prescriptions) by health (insurance) plans but we have (also) seen more medical schools adopt (the guidelines) into the core curriculum but it is just the beginning, we have a huge culture of medical practice that has to change.
    • Kennedy: There is a huge lack of interest in medicine to provide medication assisted treatment (to those who are addicted to opioids.)The American Medical Association ought to ask all members to write for medication-assisted treatment (for opioid addiction). Right now just 10 percent of providers write for it, though all the other experts say this is the gold standard for care. Only 10 percent of physicians adhere to this gold standard of care. Why? Because they don’t want to treat “addicts.” We aren’t a popular bunch.
    • Schuchat: To address the opioid crisis: This is a culture change. There is a huge issue with (health care) providers in culture change and with the public. We need the public to be asking, do I really need (that pain prescription)? We are trying to get a public service advertising campaign that will be launching soon to (get) that prescription culture to change. Since so many people, 2 out of 3 people, who are addicted to heroin started with prescription opioids. We need to tackle this on every front.
    • Kennedy: We need to stop talking about how to solve the opioid crisis and start acting. Get rid of the barriers. Provider education is a barrier. (Health insurance) reimbursement is a barrier. The Drug Enforcement Agency is a barrier.
    • Charlie Baker: We have not done anywhere near as much investigate research around what works around addiction as we have around so many other areas and I would love to see the feds get serious with respect to this issue with research protocols and best practices as the feds are in so many other areas. If we think this is a crises then the feds ought to step up and play a bigger role in what helps and what works and why.
    • Baker: You can’t think about (the opioid crisis) just in terms of treatment and recovery, You have to think about it in terms of prevention and education. I am a healthcare guy but the healthcare community created this crisis because they got extraordinarily casual about this. You can’t write 80% of the world’s opioids and not expect consequences to that. There has been information out there for awhile (about the crisis), but for one reason or another it didn’t find its way into the public bloodstream until we were way down the road. We have got to get to the prevention and education part of this or we won’t get to where we need to be.
    • Maine: When I talked to people in Europe, they say we eliminated our (opioid) abuse problem by requiring electronic prescribing. And what we think about what we have learned in the U.S. is we could squeeze down and get to the appropriate prescribing that addressees some pain well but what don’t we know about is the unintended consequences of making that portal very low and then igniting illicit drug use.
    • Schuchat: We don’t (how many people are dying of (opioid overdoses) but we are making progress. We track deaths …but there is a lot of missing data and delay … We know (there were) 64,000 deaths in 2016.
    • Kennedy: So we don’t have a real handle on the size and scope (of this crisis) and I thank you (Dr. Schuchat) for confirming that.
    • Baker: In Massachusetts, if you play a sport in high school you have to participate in a pre- meeting with parents and coaches and the medical community… and now opioids are part of that discussion. So the parents and kids know about it. The more they talk about it, the less likely they are to be surprised by this. A  huge reason why this (epidemic) has happened is that people didn’t talk about it…. they were embarrassed. So the more that we can get people to talk about it, the education and treatment methodologies that can help and for folks to not shy away from it. People love to talk about illness but they don’t love to talk about addiction and it’s a big problem. The fact that you are talking about it is good and we should do more of it.

    After QA with the first panel ends, FDA Commissioner Dr. Scott Gottlieb will offer remarks and hold an audience Q&A.

    Bara Vaida’s updates from Commissioner Gottlieb’s remarks:

    • There are more 550 new drug applications (pending related to new gene therapies.
    • We need to modernize along with the new platforms we are evaluating,
    • We need to ask, how do we adjust our approach when the primary complexity with a new product isn’t the clinical question of whether it works … and when the risk isn’t acute toxicities but more long-term and theoretical risks like the (long) term effects of gene therapy interventions. These questions challenge us to adjust our regulatory policies and our mission.
    • We will be issuing a roadmap that will serve as an organizing format (for the FDA regulatory process) in the coming weeks.
    • How I am thinking about solving the opioid crisis from the FDA perspective, we have an important role to play, in terms of how we look at medical assisted therapy, and non-addictive pain therapies. We are also looking at the biggest role we can play is in reducing overall (opioid) exposure and (prevent) new addiction crises. It will take a lot of work and we are part of that. We have an outsize influence… through the legal prescription (process), we know that a number of patients that are exposed to opioids will become addicted, so to reduce it we need to reduce exposure and make sure fewer are written. So no more 30-day supplies for tooth extraction. Only if you have developed a complication. …we can require more controlled dispensing. So more 3 to 5 days supplies (of opioids). We be putting out proposed regulations on our thinking soon. We can work with provider groups to provide (more) labeling of these products and what the appropriate dispensing should be. We can work with the dental community, so that it should not be more than 3 to 5 day doses (of opioids) – that is one way we can achieve those goals. The reality is the only way to solve this and the enormity of it, is if we bend the rate of new addiction and we have to address that.

    The second panel is about to get underway. It’s called “’Failing Faster’ and Other Successes: an Update on Efforts to Speed Medical Progress.” Panelists include:  Nancy Brown, chief executive officer, American Heart Association; Dr. Victor Dzau, president, National Academy of Medicine;  Dr. Mark McClellan, director, Duke-Robert J. Margolis Center for Health Policy, Duke University; Dr. Joe Selby, Executive Director, Patient Centered Outcomes Research Institute; Joel W. Beetsch, Vice President of Patient Advocacy, Celgene; and Scott Whitaker, President and CEO, AdvaMed.

    Bara Vaida’s updates from the second panel:

    • Victor Dzau: We (have to) look at the price of drugs. How do we figure out how much you would like to be paid and why? Unless we address that, then we can’t take advantage of all these new drugs (in the pipeline.)
    • Mark McClellan: More needs to be done to know if a drug or device is affecting a patient in a way that matters to them. Alot of what matters to patients isn’t captured (by the healthcare system).
    • Dzau: We ought to talk about economic analysis in (clinical) studies…Drug pricing and (insurer) payment need to be part of a clinical trial. These (trials) need to make case on whether you realize the economic and cost effective savings. To me, any new drug (should be) cost effective, not just do the job, it has got to be better than what we have.

    Good afternoon, everyone. I’m Aaron Sheinin, senior news editor @WebMD. The final panel of the day, “Ending Disease: What’s Possible? Probable? Within Reach?” will begin soon. Panelists include Dr. Francis Collins, director of the NIH; Gary Reedy, chief executive officer, American Cancer Society; William N. Hait, M.D., Ph.D., global head, Janssen Research & Development, LLC, Janssen Pharmaceutical Companies of Johnson & Johnson; Dr. Loew-Friedrich, Chief Medical Officer, UCB;  Dr. Mikael Dolsten, president of worldwide research & development, Pfizer; Ann Cary, dean, University of Missouri-Kansas City School of Nursing and Health Studies; David Neal,  Senior VP of Global Academic Research, Elsevier.

    Bara Vaida’s updates from the third panel:

    • Ann Cary: Zip code is as important as genetic code in terms of (health) outcomes.
    • Cary: What does a world without disease look like? One of the things I think about related to that has to do with productivity. Imagine the economic impact if people were to live longer and healthier. Imagine the opportunity for further research once you get that economic reinvested in whatever the country decides, so one would be an economic engine from increased productiv. We would have more innovation and innovating longer. The downside to that is what about the overpopulation?
    • Francis Collins: We are working on developing economic models with the entire public and private health community to better cooperate on medical research together.

    Thank you for joining us today. We appreciate you being with us and hope you found today’s event informative.

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