<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Innovation – Policy & Medicine</title> <atom:link href="https://www.policymed.com/category/innovation/feed" rel="self" type="application/rss+xml" /> <link>https://www.policymed.com</link> <description>Legal, Regulatory, and Compliance Issues</description> <lastBuildDate>Fri, 01 Mar 2024 02:54:49 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <image> <url>https://www.policymed.com/wp-content/uploads/2018/05/cropped-favicon-32x32.png</url> <title>Innovation – Policy & Medicine</title> <link>https://www.policymed.com</link> <width>32</width> <height>32</height> </image> <item> <title>John Crowley Steps up as BIO CEO</title> <link>https://www.policymed.com/2024/03/john-crowley-steps-up-as-bio-ceo.html</link> <comments>https://www.policymed.com/2024/03/john-crowley-steps-up-as-bio-ceo.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 29 Mar 2024 08:21:35 +0000</pubDate> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=16718</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="332" height="118" src="https://www.policymed.com/wp-content/uploads/2024/02/BIO.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2024/02/BIO.png 332w, https://www.policymed.com/wp-content/uploads/2024/02/BIO-300x107.png 300w" sizes="(max-width: 332px) 100vw, 332px" /></div>Recently, the Biotech Innovation Organization (BIO) announced a new CEO, John Crowley. Crowley is the co-founder of Amicus Therapeutics and long-time BIO board member and former BIO Vice Chair, and he will take over for interim BIO CEO, Rachel King. Crowley assumed the CEO role on March 4, 2024, and according to the BIO announcement, […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="332" height="118" src="https://www.policymed.com/wp-content/uploads/2024/02/BIO.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2024/02/BIO.png 332w, https://www.policymed.com/wp-content/uploads/2024/02/BIO-300x107.png 300w" sizes="(max-width: 332px) 100vw, 332px" /></div><p>Recently, the Biotech Innovation Organization (BIO) <a href="https://www.bio.org/press-release/industry-leader-and-globally-recognized-patient-advocate-john-f-crowley-appointed">announced a new CEO</a>, John Crowley. Crowley is the co-founder of Amicus Therapeutics and long-time BIO board member and former BIO Vice Chair, and he will take over for interim BIO CEO, Rachel King.</p> <p>Crowley assumed the CEO role on March 4, 2024, and according to the BIO announcement, he will “be pivotal in helping BIO reimagine how the world thinks about drug development.” Crowley is the father to two children living with a rare disease, giving him a unique perspective and understanding of the challenges that patients, families, and caregivers face. He has a history of supporting policies that “empower innovation, enable entrepreneurship, and put patients first” and for speaking out about the importance of universal access to medicines.</p> <p>Crowley has <a href="https://bio.news/editors-choice/bio-names-john-crowley-as-new-ceo/">previously served</a> in healthcare research at Bristol-Myers Squibb, leaving that company to start Novazyme Pharmaceuticals, which was ultimately acquired by Genzyme Corporation, where Crowley continued his work as senior vice president. In 2003, Crowley left Genzyme to start Orexigen Therapeutics and a year later, joined Amicus Therapeutics, becoming CEO there in 2005. Crowley has also served in the United States Navy Reserve as an intelligence officer.</p> <p>“In every role I’ve held in my life—biotech founder, U.S. Navy intelligence officer, husband and most importantly, father and grandfather—I have asked myself, ‘What is the mission?’” <a href="https://www.bio.org/press-release/industry-leader-and-globally-recognized-patient-advocate-john-f-crowley-appointed">said Crowley</a>. “When I founded our first company, the mission was to create a therapy to save our children and others from Pompe disease. Today, there are untold millions of children and adults waiting for ‘their’ cures and treatments – as well as literally billions of people who need agricultural advances and climate solutions that biotechnologies can provide. The mission of BIO is the mission of our members: cure patients, protect our climate, and nourish humanity. I am humbled and honored to lead BIO as we enter this golden age of medicine and the coming age of biotechnology. And I am eager to continue working alongside our members and dedicated BIO leadership and staff to drive this mission forward.”</p> <p>“It’s tremendously exciting that John Crowley has agreed to step up and become the next CEO of BIO,” <a href="https://bio.news/editors-choice/bio-names-john-crowley-as-new-ceo/">says Dr. Ted W. Love, BIO’s Board Chair</a>. “It’s a tremendous thing for me on a personal level because I’ve known John for the last decade, and he’s an exceptional leader. He cares tremendously about our industry and what we do, and he’s got great relationships both within our industry, as well as in Washington, D.C., where much of his advocacy occurs, so he really is the right person at the right time to lead this organization.”</p> <p>When looking towards his tenure at BIO, <a href="https://bio.news/editors-choice/bio-names-john-crowley-as-new-ceo/">Crowley notes</a>, “What is hindering patients from getting access—both in regard to knowledge and the actual ability to acquire their medicines? We need to make sure nobody ever goes without their medicines, whether it’s due to out-of-pocket costs or other barriers.” He goes on to say, “[w]e’re going to be able to address those issues by working hand in hand with all of our members, along with the BIO team in Washington, our state affiliates, and all of our partners. We need to educate the public about what biotechnology actually is. And we need to explain to them what our mission is, and what we do.”</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2024/03/john-crowley-steps-up-as-bio-ceo.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Artificial Intelligence in the Health Care Industry – Current Trends</title> <link>https://www.policymed.com/2023/10/artificial-intelligence-in-the-health-care-industry-current-trends.html</link> <comments>https://www.policymed.com/2023/10/artificial-intelligence-in-the-health-care-industry-current-trends.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 31 Oct 2023 08:32:16 +0000</pubDate> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=16432</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div>Artificial intelligence – or AI – is a popular buzzword right now. But what does it mean for the health care industry? While it may be too soon to tell the true impact AI will have on our world, including the health care industry, here are some of the recent announcements and things to keep […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-98-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Artificial intelligence – or AI – is a popular buzzword right now. But what does it mean for the health care industry? While it may be too soon to tell the true impact AI will have on our world, including the health care industry, here are some of the recent announcements and things to keep an eye on in the health care space.</p> <p><strong>HCA Healthcare Using Generative AI</strong></p> <p>Healthcare Corporation of America (HCA), one of the largest health care organizations in the world, <a href="https://hcahealthcaretoday.com/2023/08/29/hca-healthcare-collaborates-with-google-cloud-to-bring-generative-ai-to-hospitals/">announced that it will be using generative AI</a> to help improve its care delivery models. In the announcement, HCA notes that it started a pilot program earlier this year where roughly 75 emergency room physicians at four HCA hospitals started to use Google’s AI technology to quickly and easily document key medical information from conversations during patient visits. In the pilot program, physicians use an Augmedix app to create accurate and timely medical notes and the proprietary platform then leverages natural language processing and Google Cloud’s generative AI technology and speech-to-text processing to convert the data to medical notes, which the physicians then review and finalize prior to them being transferred into the hospital’s electronic health record (EHR).</p> <p><strong>Hackensack Meridian Health </strong></p> <p>Hackensack Meridian Health (HMH), the largest health system in the state of New Jersey, also <a href="https://www.hackensackmeridianhealth.org/en/News/2023/08/30/HMH-Deploys-Google-Clouds-Generative-AI-Tools">announced an expansion of its partnership with Google Cloud</a> to use generative AI solutions to not only improve patient care but also reduce the administrative burden on clinicians, caregivers, and hospital operators. Under their partnership, HMH and Google will use Ekam, HMH’s Cloud Data Platform built on Google Cloud, and Google Cloud’s Vertex AI platform, which supports HIPAA compliance. Through the partnership, HMH hopes to achieve greater administrative efficiencies, enhanced clinical decision-making support, and an equitable patient experience and improved health literacy.</p> <p><strong>Apollo Hospitals </strong></p> <p>In India, Apollo Hospitals <a href="https://timesofindia.indiatimes.com/gadgets-news/apollo-hospitals-partners-with-google-cloud-for-its-digital-platform/articleshow/103441986.cms">announced its partnership</a> with Google Cloud to improve access to health care throughout the country, even in rural areas. Apollo 24|7 will aim to deliver health care experiences to patients in India using telemedicine, online doctor consultations, home medication delivery, and more. Apollo 24|7 will use Google Cloud’s Vertex AI and generative AI models.</p> <p><strong>Bayer</strong></p> <p>One of the world’s largest pharmaceutical companies – Bayer – is also joining the AI train, <a href="https://www.forbes.com/sites/saibala/2023/09/04/bayer-is-rapidly-expanding-its-footprint-with-artificial-intelligence/?sh=5dad7a164df8">entering into a partnership with Google Cloud</a> to improve the clinical trial and drug discovery process using Google Cloud’s Tensor Processing Units (TPUs), a custom-developed application-specific integrated circuit to accelerate machine learning workloads. Bayer hopes that this technology will help to execute large quantum chemistry calculations.</p> <p><strong>iCAD, Inc. </strong></p> <p>iCAD, Inc., <a href="https://www.itnonline.com/content/icad-and-google-health-expand-integration-google%E2%80%99s-ai-technology-icad%E2%80%99s-profound-breast">recently announced</a> that it will amend its prior development and commercialization agreement with Google. This amendment will allow iCAD to integrate Google’s AI technology with its ProFound Breast Health Suite for 2D mammography for use worldwide, upon regulatory approval. This may be particularly helpful, as a <a href="https://www.nature.com/articles/s41586-019-1799-6#citeas">study of six radiologists</a> found that Google’s mammography AI system outperformed human readers.</p> <p><strong>Ginkgo Bioworks</strong></p> <p>Another recent partnership with <a href="https://investors.ginkgobioworks.com/news/news-details/2023/Ginkgo-Bioworks-and-Google-Cloud-Partner-to-Build-Next-Generation-AI-Platform-for-Biological-Engineering-and-Biosecurity/default.aspx">Google Cloud is with Ginkgo Bioworks</a>. Under the agreement, Gingko will make Google Cloud its primary computing services provider and Google Cloud will provide funding (an unspecified amount) to help the company “achieve certain milestones over the next three years,” including in the areas of large language models for biological engineering, generative AI enterprise search, and developing improved central data repositories.</p> <p><strong>Huma Therapeutics</strong></p> <p>Huma Therapeutics also <a href="https://www.huma.com/resources/google-cloud-healthcare-gen-ai-med-palm2">recently announced use of Google Cloud’s generative AI</a> to enhance the company’s regulated disease management platform to help health care professionals better optimize patient care delivery. Huma’s technology platform maintains a range of vital signs, biomarkers, and patient-reported data that are displayed on a health care provider dashboard, which allows providers to care for many more patients than they would be able to in-person, helping to alleviate workforce pressures and expand greater access to health care.</p> <p><strong>Meditech</strong></p> <p>Meditech also <a href="https://medcitynews.com/2023/09/google-meditech-generative-ai-technology-healthcare/">announced an amendment to its partnership</a> with Google Cloud by which it will work to embed Google’s generative AI into its EHR for specific use cases, particularly cases where the company believes it has potential to alleviate physician burnout. One such use is by using Google’s large language models for search and summarizing EHR and data harmonization, allowing physicians quick access to a longitudinal view of their patient.</p> <p><strong>More on Artificial Intelligence</strong></p> <p>Google <a href="https://cloud.google.com/blog/topics/google-cloud-next/next-2023-wrap-up">published an article</a> on all of the partnerships and updates announced during its Google Cloud Next ’23, including some of the aforementioned partnerships. Additionally, the United States Senate Committee on the Judiciary Subcommittee on Privacy, Technology, and the Law <a href="https://www.judiciary.senate.gov/committee-activity/hearings/oversight-of-ai-legislating-on-artificial-intelligence">held a hearing</a> on legislative artificial intelligence in many capacities, including potentially health care. During NVIDIA’s Chief Scientist and Head of Research Bill Daly’s testimony in the hearing, he noted that already, the collaborations between health care industry and academic institutions has “led to large language models that can accurately predict a patient’s risk of 30-day readmission, among other clinical outcomes.” Daly went on to paint a potential future picture, imagining “a world where AI-driven chatbots assist healthcare providers, helping them ask the right follow-up questions and ensuring that every possible issue is considered and evaluated and that the treatment is the best possible, meets all patient needs, and is explained to the patient in a way they can understand.”</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2023/10/artificial-intelligence-in-the-health-care-industry-current-trends.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>PhRMA Submits Comments to USITC Regarding Section 332 Investigation</title> <link>https://www.policymed.com/2023/04/phrma-submits-comments-to-usitc-regarding-section-332-investigation.html</link> <comments>https://www.policymed.com/2023/04/phrma-submits-comments-to-usitc-regarding-section-332-investigation.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 28 Apr 2023 08:16:56 +0000</pubDate> <category><![CDATA[COVID-19]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[International]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=15997</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1024" height="1024" src="https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks.png 1024w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-150x150.png 150w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-300x300.png 300w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-768x768.png 768w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></div>The United States International Trade Commission (USITC) is investigating the impact of expanding the waiver of intellectual property commitments on COVID-19 vaccines to diagnostics and therapeutics under the World Trade Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a brief to the USITC regarding its […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1024" height="1024" src="https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks.png 1024w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-150x150.png 150w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-300x300.png 300w, https://www.policymed.com/wp-content/uploads/2017/06/PhRMA-Expels-Members-from-Its-Ranks-768x768.png 768w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></div><p>The United States International Trade Commission (USITC) is investigating the impact of <a href="https://catalyst.phrma.org/intellectual-property-waiver-on-covid-19-innovation-is-unnecessary-and-harmful">expanding the waiver</a> of intellectual property commitments on COVID-19 vaccines to diagnostics and therapeutics under the World Trade Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).</p> <p>The Pharmaceutical Research and Manufacturers of America (PhRMA) <a href="https://phrma.org/resource-center/Topics/Policy-Paper/PhRMA-Comments-to-USITC-on-COVID-19-Diagnostics-and-Therapeutics-Supply-Demand-and-TRIPS-Agreement-Flexibilities">submitted a brief</a> to the USITC regarding its Section 332 investigation, “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities,” outlining risks from the TRIPS waiver that PhRMA believes undermine the pandemic response and future preparedness.</p> <p>The brief outlines five key points that emphasize PhRMA’s belief that the USITC should not focus on IP waivers, but should instead focus efforts elsewhere. PhRMA noted that: (1) the biopharmaceutical industry innovated and produced safe and effective vaccines and treatments to combat COVID-19 in record time; (2) industry’s success in combatting COVID-19 was founded on intellectual property protections, including the baseline protections provided by the TRIPS Agreement; (3) extending the waiver would jeopardize the innovation underway to develop new COVID-19 treatments; (4) extending the waiver to COVID-19 therapeutics and diagnostics would weaken American medical innovation and leadership, outsource American jobs, and diminish America’s ability to respond to future pandemics and health crises; and (5) focus on issues impacting distribution and administration of COVID-19 vaccines and therapeutics.</p> <p>With respect specifically to the importance of the intellectual property protections in manufacturing the COVID-19 vaccines and therapeutics, PhRMA notes that innovation takes resources and if there is no likelihood of return, few would make the investment. However, intellectual property protections allow innovators to recover costs – and potentially make a profit – before others are allowed to make a similar product. PhRMA also points to laws, government agencies, institutions, policies, and programs, that are built on the concept that intellectual property drives innovation.</p> <p>PhRMA further notes that the TRIPS Agreement promotes access to medicine by establishing a baseline of critical intellectual property rights protections that must be afforded to World Trade Organization (WTO) members. The TRIPS Agreement then provides legal framework needed to incentivize global investment in innovation for new vaccines and therapeutics.</p> <p>PhRMA also noted that the TRIPS Agreement “establishes a common baseline, not a ceiling for IP-protection” and that members can protect intellectual property “to a greater extent than that required under the TRIPS Agreement.” The United States, among others, have entered into legal agreements to provide a more robust protection, such as the United States-Mexico-Canada Agreement. Without even the baseline protection, manufacturing or even exporting an innovative product outside of the United States puts the innovator at risk of unauthorized copying by competitors, which can stymy medical innovation throughout the world.</p> <p>In addition to the brief, PhRMA Vice President of International Policy Kevin Haninger made an <a href="https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Policy-Papers/PhRMA---USITC-Oral-Hearing-Statement.pdf">oral hearing statement</a> to the USITC on March 29, 2023. Haninger’s oral statement was in line with the brief submitted by PhRMA, focusing on the five points.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2023/04/phrma-submits-comments-to-usitc-regarding-section-332-investigation.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Thomas P. Stossel, MD Prolific Researcher, Defender of Physician Industry Collaboration 1941-2019</title> <link>https://www.policymed.com/2019/10/thomas-p-stossel-md-courageous-advocate-prolific-researcher.html</link> <comments>https://www.policymed.com/2019/10/thomas-p-stossel-md-courageous-advocate-prolific-researcher.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 04 Oct 2019 09:01:28 +0000</pubDate> <category><![CDATA[ACRE]]></category> <category><![CDATA[Collaborations]]></category> <category><![CDATA[Conflict of Interest]]></category> <category><![CDATA[Editorials]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12775</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="267" height="189" src="https://www.policymed.com/wp-content/uploads/2019/10/Thomas-Stossel.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>On September 29th, Thomas Stossel, one who inspired me to start Policy and Medicine, died working out at his local gym on Cape Cod. Tom was a pioneer in medical product development, gifted researcher, and always ready to stand against injustice. Tom is a Princeton University and Harvard Medical School educated physician, trained in internal […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="267" height="189" src="https://www.policymed.com/wp-content/uploads/2019/10/Thomas-Stossel.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p>On September 29<sup>th</sup>, Thomas Stossel, one who inspired me to start Policy and Medicine, died working out at his local gym on Cape Cod. Tom was a pioneer in medical product development, gifted researcher, and always ready to stand against injustice.</p> <p>Tom is a Princeton University and Harvard Medical School educated physician, trained in internal medicine at the Massachusetts General Hospital and in hematology at Boston Children’s and Peter Bent Brigham Hospitals. He was chief of hematology-oncology at the Massachusetts General Hospital from 1976-1991, head of experimental medicine at Brigham and Women’s Hospital from 1991-1998, co-director of hematology at Brigham and Women’s Hospital from 1998-2006, and co-director of translational medicine at Brigham and Women’s Hospital from 2011-2014. He has served on several scientific advisory boards and has been active in medical associations, including the American Society for Clinical Investigation and former President of American Society of Hematology. He has also been editor in chief of The Journal of Clinical Investigation and of the Current Opinion in Hematology. Tom worked tirelessly in his translation science lab at Harvard for many years laser focused on discovering the movement of blood proteins.</p> <p>Tom also had the opportunity to serve as a fellow of the Manhattan Institute and the American Enterprise Institute (AEI), defending the medical research enterprise.</p> <p>Tom and his wife Kerry Maguire, DDS, MSPH, established a 501(c)3 foundation, <a href="http://www.optionsforchildren.org/">Options for Children in Zambia</a>, where they worked together in dental prevention and treatment in orphanages in Zambia. He also established a sickle cell disease clinical and research center in collaboration with the University of Zambia in Lusaka, Zambia.</p> <p>Tom has three children: a son, Scott Stossel, the National Editor of The Atlantic magazine; his daughter Sage Stossel is a cartoonist and author/illustrator of several children’s books; and his daughter Tamara Sakala-Stossel is a graduate student at Northeastern University. He is also survived by his younger brother television commentator John Stossel.</p> <p><strong>His Impact on Physician-Industry Relationships </strong></p> <p>In early 2008, I received an email from Tom suggesting that something needed to be done about the Jihad that was taking place in medicine to rid academic medicine of their ties with industry. He pointed to the <a href="https://www.policymed.com/2010/10/drug-reps-off-campus-promoting-professional-purity-by-suppressing-commercial-speech.html">Brennan paper</a>, and coming reports by the Institute of Medicine (IOM), the Macy Foundation, the Association of American Medical Colleges (AAMC), and others calling for academia – and medicine in general – to rid themselves of the bonds of working with industry, akin to hippies from the 60’s freeing themselves from the social norms at the time. His concern was that by cutting the ties with industry, the attack on industry-physician relationships could cause innovation to come to a halt, or at the very least slow down to a trickle. It was his contention that the close relationship between physicians and industry had brought a golden age in medical innovation starting with vaccines, and in the 1990’s and 2000’s increasing to statins, antibiotics, and chemotherapy. He believed that the relationship had greatly increased live expectancy and decreased deaths from heart disease and cancer.</p> <p>In May of that year (2008) Tom and David Shaywitz coined the term “Pharmascolds,” initially in the <a href="https:///weekly-standard/attack-of-the-pharmascolds">Weekly Standard</a> and then more expansively in in a <a href="https://www.wsj.com/articles/SB123914780537299005">Wall Street Journal Op Ed</a>. This phrase defined those who attempted to discredit researchers for taking “blood money” for working with industry to develop life saving therapies.</p> <p>So, the two of us developed a relationship that lasted over the years. I was fortunate to assist him and several other researchers with forming the Association of Clinical Researchers and Educators (ACRE), to fight back against this Jihad that was developing. The first ACRE meeting was held in July 2009, at Harvard’s Brigham and Women’s Hospital; it was so full that people were sitting in the aisles, and the meeting was even covered in <a href="http://archive.boston.com/news/local/massachusetts/articles/2009/07/23/new_doctors_group_challenges_conflict_of_interest_policy_effects/">Boston Globe</a>, <a href="https://www.nature.com/news/2009/090729/full/460556b.html">Nature</a> and <a href="https://prescriptions.blogs.nytimes.com/2011/07/22/some-professors-are-promoting-more-industry-ties">New York Times</a>. Four weeks before the meeting, Tom informed me that he was leaving for the next three weeks to go to Zambia (his other passion) to work on a dental mission setting up clinics throughout the country and teaching dentistry with his <a href="https://forsyth.org/person/scientist/kerry-maguire">wife, Kerry</a>. I was a little scared with four weeks before the meeting and a lot of preparation to go, but with the help of Alan Garber, Rafael Fonseca, Lance Stell, Michael Weber, Bruce Gingles, Paul Richardson, Michael Gonzalez-Campoy and Diann Rhode we pulled it off.</p> <p>Since then, Tom went on to speak and write in favor of physician-industry relationships at countless events, senate hearings and in written editorials. In 2015, he published the seminal book on physician industry relationships, <a href="https://www.amazon.co.uk/s?k=pharmaphobia&hvadid=80745417211234&hvbmt=be&hvdev=c&hvqmt=e&tag=mh0a9-21&ref=pd_sl_3pfpk6jzc1_e">Pharmaphobia. How the Conflict of Interest Myth Undermines American Medical Innovation</a>.</p> <p>Tom described how he got into the conflict of interest battle “backwards.” As a Harvard-based researcher, Tom was focused on how cells traveled throughout the body. He also authored several textbooks and wrote over 300 papers. In 1987, a small local start up named Biogen asked him to be on their scientific advisory board. Having never worked with industry or been on something like that before, he thought it would be a great challenge. On the board, he was impressed with the excellence of science they presented and their integrity, it served as a contrast to the infighting he saw in academia. Overall, Tom didn’t profit from his work with industry. A quick look at the <a href="https://openpaymentsdata.cms.gov/physician/425806/summary">Open Payments database</a> (which he fought against) shows that he would only receive pittances for his involvement with them. His passion was saving lives and seeing science develop into products that could help patients. His work was to benefit others.</p> <p>In 2017, Tom left Harvard to focus full time as a scientific advisor for BioAegis Therapuetics based on his discovery of <a href="https://en.wikipedia.org/wiki/Gelsolin">gelsolin</a>, a blood protein being tested in community acquired and severe pneumonia.</p> <p>Tom had a passion for excellence and was the guy willing to put his finger in the dyke to save the life sciences industry from self-destruction. Tom’s voice will be missed, as he was perhaps the most articulate proponent of the need for clinicians and scientists to work together to develop and disseminate information about new therapies.</p> <p><b>Quotes from some of his colleagues </b></p> <p>“I’ve never anyone quite like him. Tom was an amazing, multi-talented, accomplished, energetic, creative, courageous, relentlessly truth-seeking/telling, always entertaining, very funny, generous, altruistic and a loyal friend. The world is worse for his loss.” Lance Stell</p> <p>“Tom fought deeply established and highly organized injustices. He did so mostly on his own time and out of his own pocket. He earned generous and continuous NIH grants for more than 40 years but was never awarded real money to fight the battle that few others were willing to take up. I don’t think anyone else quite had his energy and resolve to set the record straight. He was especially proud of his Options orphanage in Zambia and I saw parallels with his ethics campaign. As Lance once said, Tom had remarkable and completely admirable qualities.” Bruce Gingles</p> <p>“I learned so much from Tom and greatly respected his intellect, wit and willingness to right wrongs even when collective group-think stood in the way.” Carey Kimmelstiel</p> <p>“Tom Stossel was a mensch. He had the unique ability to be intensely courageous, intellectually sophisticated and charming. Tom was like a brother, a mentor, a role model and a friend. Future doctors might not recognize the name Tom Stossel, but they will see his legacy in the form of medical innovation helping patients – and will not know they owe that to Tom. He was an optimist, who fought against the ideological current and for what is right. He was that salmon swimming upstream. While Tom received every accolade academicians could hope for, at heart, he was the honey badger!” Rafael Fonseca</p> <p>“truly unique individual. His spirit will remain with us.” Henry Black</p> <p>“fearless, independent, and deeply compassionate”, David Shaywitz</p> <p>“so smart and passionate and mischievous.” Sally Satel</p> <p>Tom will be remembered by the legacy he left behind. It can be said of him that he finished well.</p> <p><strong>To remember Tom we encourage you to donate to his family mission <a href="http://www.optionsforchildren.org/donate">Options for Children in Zambia</a></strong></p> <p><strong>Biographies of Thomas Stossel</strong></p> <p><a href="https://en.wikipedia.org/wiki/Thomas_P._Stossel">Wikipedia</a></p> <p><a href="https://www.manhattan-institute.org/expert/thomas-p-stossel">Manhattan Institute</a></p> <p><a href="https://www.forbes.com/sites/johnlamattina/2016/01/19/a-medical-leader-steps-up-to-defend-biopharma-tom-stossels-pharmaphobia/#1a92a3f73e5a">Forbes</a></p> <p><a href="https://connects.catalyst.harvard.edu/Profiles/display/Person/20854">Harvard Catalyst</a></p> <p><a href="https://www.goodreads.com/author/show/12100779.Thomas_P_Stossel">Good Reads</a></p> <p><strong>Videos of Thomas Stossel</strong></p> <p><a href="https://www.youtube.com/watch?v=Y-UL9I0HN1Q">John Stossel – Pharmaphobia</a></p> <p><a href="https://www.youtube.com/watch?v=zSozcVtS2VQ">Newsmax Now | Tom Stossel discusses his new book “Pharmaphobia”</a></p> <p><a href="https://www.youtube.com/watch?v=lhj3x_BygFE">Thomas Stossel on big pharma without tears</a></p> <p><a href="https://www.medscape.com/viewarticle/844683">Pharmaphobia Author: Industry Relations Spur Innovation</a></p> <p><em><a href="https://vimeopro.com/mghpsychiatry/mghpsychiatry/video/66180567">COMMERCIALISM IN MEDICAL CARE, EDUCATION AND RESEARCH: CONFLICT OR HARMONY OF INTERESTS?</a></em></p> <p><a href="https://www.youtube.com/watch?v=wzNFkKdHirE">Tom Stossel Talk, Medical Grand Rounds, Mayo Clinic in Rochester</a></p> <p><a href="https://www.youtube.com/watch?v=cWfob1UTxV4">The Medical Conflict of Interest Mania: Dr. Thomas Stossel on Physician Regulation</a></p> <h5><a style="text-transform: initial;" href="https://www.youtube.com/watch?v=Qg1_N0umqNg">Are Prescription Drugs Safe? … Rebuttal by Thomas P. Stossel, MD</a></h5> <p> </p> <p><strong>Policy and Medicine Articles covering Thomas Stossel, MD</strong></p> <h5>06/2008 <a href="https://www.policymed.com/2008/06/massachusetts-1-3.html">Massachusetts S2660: Should Gifts Be Banned?</a></h5> <h5>06/2008 <a href="https://www.policymed.com/2008/06/ama-ceja-how-di.html">AMA CEJA – How Did We Get Here</a></h5> <h5>04/2009 <a href="https://www.policymed.com/2009/04/its-time-to-fight-the-pharmascolds.html">It’s Time to Fight the ‘PharmaScolds’</a></h5> <h5>05/2009 <a href="https://www.policymed.com/2009/05/fda-standards-need-to-be-maintained.html">FDA: Standards Need to Be Maintained</a></h5> <h5>07/2009 <a href="https://www.policymed.com/2009/07/acre-association-of-clincal-researchers-and-educators-charter-meeting-highlighted-in-boston-globe.html">ACRE: Association of Clinical Researchers and Educators Charter Meeting Highlighted in Boston Globe</a></h5> <h5>8/2019 <a href="https://www.policymed.com/2009/08/association-of-clinical-researchers-and-educators-nature-science-reviews-meeting.html">Association of Clinical Researchers and Educators: Nature Reviews Meeting</a></h5> <h5>10/2009 <a href="https://www.policymed.com/2009/10/milwaukee-journal-sentinel-doctors-presentations-help-patients.html">Milwaukee Journal Sentinel: Doctors’ Presentations Help Patients</a></h5> <h5>02/2010 <a href="https://www.policymed.com/2010/02/cardiology-today-conflict-of-interest-an-outdated-phrase-for-physicianindustry-relationship.html">Cardiology Today: Conflict of Interest an Outdated Phrase for Physician-Industry Relationship?</a></h5> <h5>05/2010 <a href="https://www.policymed.com/2010/05/endocrine-today-benefits-of-collaboration-in-create-cures.html">Endocrine Today: Benefits of Collaboration to Create Cures</a></h5> <h5>07/2010 <a href="https://www.policymed.com/2010/07/pharmaceutical-companies-helping-poor-countries-the-forgotten-benefit-of-innovation.html">Pharmaceutical Companies Helping Poor Countries: The Forgotten Benefit of Innovation</a></h5> <h5>07/2010 <a href="https://www.policymed.com/2010/07/physician-payment-sunshine-act-natures-unintended-consequences.html">Physician Payment Sunshine Act: Nature’s Unintended Consequences</a></h5> <h5>12/2010 <a href="https://www.policymed.com/2010/12/thomas-stossel-md-on-cnn-working-with-industry-to-improve-patient-care.html">Thomas Stossel, MD on CNN – Working with Industry to Improve Patient Care</a></h5> <h5>12/2010 <a href="https://www.policymed.com/2010/12/thomas-stossel-money-in-medicine-a-sin-or-salvation.html">Thomas Stossel: Money in Medicine a Sin or Salvation</a></h5> <h5>02/2011 <a href="https://www.policymed.com/2011/02/university-of-miami-business-forum-the-business-of-healthcare-defining-the-future.html">University of Miami Business Forum: The Business of Healthcare – Defining the Future</a></h5> <h5>03/2011 <a href="https://www.policymed.com/2011/03/university-policies-make-them-easier-or-harder.html">University Policies Make Them Easier or Harder?</a></h5> <h5>03/2011 <a href="https://www.policymed.com/2011/03/clarifying-conflict-of-interest.html">Another Dip Into the Muddy Waters of COI</a></h5> <h5>04/2011 <a href="https://www.policymed.com/2011/04/university-medical-centers-coi-policies-and-innovation-talk-the-talk-but-not-walk-the-walk.html">University Medical Centers COI Policies and Innovation: Talk the Talk but Not Walk The Walk</a></h5> <h5>06/2011 <a href="https://www.policymed.com/2011/06/the-unhealthy-separation-of-marketing-and-education-support-from-research.html">The Unhealthy Separation of Marketing and Education Support from Research</a></h5> <h5>07/2011 <a href="https://www.policymed.com/2011/07/association-of-clinical-researchers-and-educators-claiming-lost-ground-advancing-patient-care.html">Association of Clinical Researchers and Educators: Claiming Lost Ground — Advancing Patient Care</a></h5> <h5>9/2011 <a href="https://www.policymed.com/2009/11/boston-magazine-features-thomas-stossel-md-co-founder-of-association-of-clinical-researchers-and-educators.html">Boston Magazine Features Thomas Stossel MD and Co Founder of Association of Clinical Researchers and Educators</a></h5> <h5>10/2011 <a href="https://www.policymed.com/2011/10/a-hard-look-at-physician-industry-relationships-and-ad-hominem-attacks-by-critics.html">A Hard Look at Physician-Industry Relationships and Ad Hominem Attacks by Critics</a></h5> <h5>11/2011 <a href="https://www.policymed.com/2011/11/thomas-stossel-addressed-american-college-of-surgeons-where-has-all-this-concern-lead.html">Thomas Stossel Addressed American College of Surgeons: Where Has All this Concern Led?</a></h5> <h5>07/2012 <a href="https://www.policymed.com/2012/07/medical-progress-is-not-easy-complaining-about-it-is-much-easier-than-progress.html">Medical Progress is Not Easy: Complaining About it is Much Easier than Progress</a></h5> <h5>01/2012 <a href="https://www.policymed.com/2012/01/physician-payment-sunshine-wall-street-journal-and-forbes-where-is-the-evidence-for-patient-benefit.html">Physician Payment Sunshine: Wall Street Journal and Forbes – Where is the Evidence For Patient Benefit?</a></h5> <h5>04/2012 <a href="https://www.policymed.com/2012/04/study-finds-high-impact-medical-journals-guilty-of-anti-industry-bias.html">Study Finds High-Impact Medical Journals Guilty of Anti-Industry Bias</a></h5> <h5>02/2013 <a href="https://www.policymed.com/2013/02/thomas-stossel-honored-with-brigham-and-womens-humanitarian-award.html">Thomas Stossel Honored with Brigham and Women’s Humanitarian Award</a></h5> <h5>12/2013 <a href="https://www.policymed.com/2013/12/pbs-debate-should-doctors-be-paid-by-pharmaceutical-companies-to-promote-their-drugs.html">PBS Debate: Should doctors be paid by pharmaceutical companies to promote their drugs?</a></h5> <h5>04/2014 <a href="https://www.policymed.com/2015/04/thomas-stossel-american-cancer-society-professor-of-medicine-at-harvard-medical-school-and-a-visiting-scholar-at-the-america.html">Doctor’s Article Counters The “Myths That Undermine Medical Research”</a></h5> <h5>05/2015 <a href="https://www.policymed.com/2015/05/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation.html">Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation</a></h5> <h5>06/2015 <a href="https://www.policymed.com/2015/06/the-importance-of-private-investment-into-research-and-development.html">The Importance of Private Investment into Research and Development</a></h5> <h5>06/2015 <a href="https://www.policymed.com/2015/06/the-importance-of-private-investment-into-research-and-development.html">The Importance of Private Investment into Research and Development</a></h5> <h5>04/2016 <a href="https://www.policymed.com/2016/04/specialty-pricing-drugs-how-did-we-get-here-and-where-do-we-go.html">Specialty Pricing Drugs: How Did We Get Here and Where Do We Go</a></h5> <h5>04/2017 <a href="https://www.policymed.com/2017/04/dr-stossel-corrects-a-common-misconception.html">Dr. Stossel Corrects a Common Misconception</a></h5> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/10/thomas-p-stossel-md-courageous-advocate-prolific-researcher.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>CMS Primary Care First Model to Launch Early 2020</title> <link>https://www.policymed.com/2019/07/cms-primary-care-first-model-to-launch-early-2020.html</link> <comments>https://www.policymed.com/2019/07/cms-primary-care-first-model-to-launch-early-2020.html#comments</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 26 Jul 2019 09:05:44 +0000</pubDate> <category><![CDATA[CMS]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12418</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="860" height="589" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png 860w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-300x205.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-768x526.png 768w" sizes="auto, (max-width: 860px) 100vw, 860px" /></div>Primary Care First is a set of voluntary five-year payment model options that reward value and quality by offering payment model structures to support delivery of advanced primary care. According to CMMI, Primary Care First is based on the underlying principles of the existing CPC+ model design. Recently, CMS held a webinar about the model, […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="860" height="589" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png 860w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-300x205.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-768x526.png 768w" sizes="auto, (max-width: 860px) 100vw, 860px" /></div><p>Primary Care First is a set of voluntary five-year payment model options that reward value and quality by offering payment model structures to support delivery of advanced primary care. According to CMMI, Primary Care First is based on the underlying principles of the existing CPC+ model design. Recently, <a href="https://innovation.cms.gov/resources/pcf-model-informational-webinar-series.html">CMS held a webinar about the model</a>, and this article helps explain more information about Primary Care First, along with some feedback from industry.</p> <p><strong>Primary Care First</strong></p> <p>According to CMS, the model reflects a regionally-based, multi-payer approach to care delivery and payment. The agency argues that Primary Care First fosters practitioner independence by increasing flexibility for primary care, providing participating practitioners with the freedom to innovate their care delivery approach based on their unique patient population and resources. Primary Care First rewards participants with additional revenue for taking on limited risk based.</p> <p>In Primary Care First, CMS will use a focused set of clinical quality and patient experience measures to assess quality of care delivered at the practice. A Primary Care First practice must meet standards that reflect quality care in order to be eligible for a positive performance-based adjustment to their primary care revenue. These measures were selected to be actionable, clinically meaningful, and aligned with CMS’s broader quality measurement strategy. Measures include a patient experience of care survey, controlling high blood pressure, diabetes hemoglobin A1c poor control, colorectal cancer screening, and advance care planning. CMS will assess quality of care based on a focused set of measures that are clinically meaningful for patients with complex, chronic needs and the serious illness population.</p> <p>Primary Care First aims to improve quality, improve patient experience of care, and reduce expenditures. CMS believes the model will achieve these aims by increasing patient access to advanced primary care services, and has elements specifically designed to support practices caring for patients with complex chronic needs or serious illness. The specific approaches to care delivery will be determined by practice priorities. Practices will be incentivized to deliver patient-centered care that reduces acute hospital utilization. Primary Care First is oriented around comprehensive primary care functions: (1) access and continuity; (2) care management; (3) comprehensiveness and coordination; (4) patient and caregiver engagement; and (5) planned care and population health.</p> <p><strong>Webinar Slides</strong></p> <p>The webinar was a comprehensive look at Primary Care First. Below are a few slides that help flesh out CMS’s thinking on this model.</p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-12419" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-1.png" alt="" width="856" height="600" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-1.png 856w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-1-300x210.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-1-768x538.png 768w" sizes="auto, (max-width: 856px) 100vw, 856px" /></p> <p>Explanation of CPC + Model vs Primary Care First</p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-12420" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-2.png" alt="" width="848" height="604" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-2.png 848w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-2-300x214.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-2-768x547.png 768w" sizes="auto, (max-width: 848px) 100vw, 848px" /></p> <p>States Primary Care First is available.</p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-12421" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-3.png" alt="" width="864" height="584" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-3.png 864w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-3-300x203.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-3-768x519.png 768w" sizes="auto, (max-width: 864px) 100vw, 864px" /></p> <p>Payment Model</p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-12422" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-4.png" alt="" width="868" height="614" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-4.png 868w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-4-300x212.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-4-768x543.png 768w" sizes="auto, (max-width: 868px) 100vw, 868px" /></p> <p>Risk Stratification</p> <p><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-12423" src="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png" alt="" width="860" height="589" srcset="https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5.png 860w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-300x205.png 300w, https://www.policymed.com/wp-content/uploads/2019/06/PCP-Slide-5-768x526.png 768w" sizes="auto, (max-width: 860px) 100vw, 860px" /></p> <p><strong>Responses</strong></p> <p><a href="https://www.medpagetoday.com/practicemanagement/reimbursement/80131">MedPage Today has an interesting article</a> on this model describing stakeholder feedback. In particular, MedPage explains that Primary Care First’s early reviews “reveal that longstanding conflicts remain between, on the other hand, budgetary savings and administrative feasibility goals and, on the other hand, more ambitious desires in parts of the medical community redesign care to elevate the role of effective primary care (regardless of the short-term costs),” Tom Miller, JD, resident fellow at the American Enterprise Institute, a right-leaning think tank, said in an email to the outlet. “Perhaps more medical outcomes per se could be improved by simply paying primary care doctors more, but that assumes away the political food fight it would require to get there.”</p> <p>A more straightforward approach to “subsidize patients more directly to find and receive the care that they could choose to receive would upset providers either benefiting from the current system or imagining that they could be winners in the next round of political reimbursement roulette, labeled ‘value-based,'” he added.</p> <p>Gail Wilensky, PhD, senior fellow at Project HOPE in Bethesda, Maryland, and a former CMS administrator, said in an email to MedPage Today that the difficulty with the model “seems to be the amount paid is too small and too unreliable … That is certainly consistent with the ongoing CMS attempts. It is certainly reason to be skeptical although the results will only become clear after it is tried, assuming [the] CMS goes forward with it … It has been discouraging how difficult it has proven to be to affect change in this area.”</p> <p><strong>Commentary</strong></p> <p>There are some critics of the program, in that it is largely limited to large practices and there is no clear delineation on what the bonus or penalties are eventually going to look like. HHS has made this clear that this is a next step for the innovation center but only a step and not a final solution. Hopefully we will have a final solution for primary billing of which we as country are at the bottom compared to other countries. Eventually, this model could save billions of funds.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/07/cms-primary-care-first-model-to-launch-early-2020.html/feed</wfw:commentRss> <slash:comments>1</slash:comments> </item> <item> <title>Will Opioids Be Replaced Anytime Soon?</title> <link>https://www.policymed.com/2018/10/will-opioids-be-replaced-anytime-soon.html</link> <comments>https://www.policymed.com/2018/10/will-opioids-be-replaced-anytime-soon.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Wed, 10 Oct 2018 09:12:49 +0000</pubDate> <category><![CDATA[Innovation]]></category> <category><![CDATA[Opioids]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=11133</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="200" height="200" src="https://www.policymed.com/wp-content/uploads/2018/10/download-4.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/10/download-4.png 200w, https://www.policymed.com/wp-content/uploads/2018/10/download-4-150x150.png 150w, https://www.policymed.com/wp-content/uploads/2018/10/download-4-100x100.png 100w" sizes="auto, (max-width: 200px) 100vw, 200px" /></div>Arena Pharmaceuticals has been focused recently on researching and developing a non-opiate for the treatment of gastrointestinal pain. The drug, olorinab, is considered an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid 2 (CB2) receptor. A recent Phase 2a trial of olorinab resulted in positive topline results, following a randomized, open-label, eight-week study […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="200" height="200" src="https://www.policymed.com/wp-content/uploads/2018/10/download-4.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/10/download-4.png 200w, https://www.policymed.com/wp-content/uploads/2018/10/download-4-150x150.png 150w, https://www.policymed.com/wp-content/uploads/2018/10/download-4-100x100.png 100w" sizes="auto, (max-width: 200px) 100vw, 200px" /></div><p><a href="http://www.arenapharm.com/wp-content/uploads/2018/09/IASP-Olorinab-Reduces-Colitis-Induced-Visceral-Hypersensitivity-in-Rats.pdf">Arena Pharmaceuticals</a> has been focused recently on researching and <a href="https://finance.yahoo.com/news/arena-pharmaceuticals-reports-positive-phase-200100140.html">developing a non-opiate</a> for the treatment of gastrointestinal pain. The drug, <a href="https://www.arenapharm.com/pipeline/apd371/">olorinab</a>, is considered an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid 2 (CB<sub>2</sub>) receptor.</p> <p>A recent Phase 2a trial of olorinab resulted in positive topline results, following a randomized, open-label, eight-week study that investigated two different doses of the drug administered three times per day. All patients in the study were diagnosed with quiescent to mild active Crohn’s disease associated with chronic abdominal pain.</p> <p>During the study, reductions in pain were seen within the first week of treatment and a statistically significant improvement from baseline abdominal pain scores were found at weeks four and eight. <a href="https://www.fiercebiotech.com/biotech/arena-three-for-three-as-crohn-s-drug-meets-proof-concept-test">Arena also said</a> the pain relief not only kicked in rapidly but lasted through the entire eight-week study with both doses that were tested.</p> <p>Olorinab was also found to be safe and generally well tolerated in this study with no clinically significant changes in heart rate or blood pressure, no psychotropic effects, and no discontinuations due to adverse events.</p> <p>“There is a strong clinical need for non-opiate treatments for the management of chronic abdominal pain in patients with gastrointestinal disorders, including Crohn’s disease, ulcerative colitis and irritable bowel syndrome,” <a href="https://finance.yahoo.com/news/arena-pharmaceuticals-reports-positive-phase-200100140.html">stated Bruce Yacyshyn, MD</a>, Professor Medicine in the Division of Digestive Diseases at the University of Cincinnati College of Medicine and Medical Director for Inpatient Gastroenterology at UC Health University Hospital. “The exciting results from this initial Phase 2a study in patients with Crohn’s disease leaves me optimistic for the potential of olorinab as a novel approach for the management of GI pain. I look forward to the further development of this interesting compound as an aid in the management of this complex group of patients.”</p> <p><a href="https://finance.yahoo.com/news/arena-pharmaceuticals-reports-positive-phase-200100140.html">Preston Klassen, MD, MHS, Chief Medical Offer of Arena, said</a>, “The intent of this Phase 2a study of olorinab was to get directional information on the safety, tolerability and therapeutic potential to reduce gastrointestinal pain in patients with Crohn’s disease and symptoms of chronic abdominal pain. Despite its small size and uncontrolled design, this trial provides early results that suggest a robust clinical response and supports continued, rapid development of olorinab, potentially targeting several diseases in which gastrointestinal pain is a hallmark. We look forward to providing additional detail on the development path forward during Arena’s R&D Day on October 4th.”</p> <p>Analysts at Cantor Fitzgerald <a href="https://www.fiercebiotech.com/biotech/arena-three-for-three-as-crohn-s-drug-meets-proof-concept-test">have described olorinab</a> as an “underappreciated asset” in Arena’s pipeline with a profile that could position it favorably against other cannabinoid receptor modulators and say the new data “clearly establish olorinab as a viable drug worthy of advanced development.”</p> <p>While Olorinab is just in the trial phase and seems to only be indicated for a very small patient population, it is worth watching to see if other companies follow suit with a non-opioid alternative to pain medication for various conditions and needs.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2018/10/will-opioids-be-replaced-anytime-soon.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Announces Pilot Program for Orphan Drug Submissions</title> <link>https://www.policymed.com/2018/06/fda-announces-pilot-program-for-orphan-drug-submissions.html</link> <comments>https://www.policymed.com/2018/06/fda-announces-pilot-program-for-orphan-drug-submissions.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Wed, 06 Jun 2018 09:32:57 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=10559</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="281" height="180" src="https://www.policymed.com/wp-content/uploads/2018/05/download-1-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/05/download-1-1.jpg 281w, https://www.policymed.com/wp-content/uploads/2018/05/download-1-1-210x136.jpg 210w, https://www.policymed.com/wp-content/uploads/2018/05/download-1-1-279x180.jpg 279w" sizes="auto, (max-width: 281px) 100vw, 281px" /></div>The FDA had more than 700 orphan drug designation requests last year. As a result, the FDA recently announced a new pilot program designed to make the request process easier. Along with a new form for the submissions process, FDA will make more resources available to sponsors. Orphan Drug Submissions FDA released an on-line tutorial […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="281" height="180" src="https://www.policymed.com/wp-content/uploads/2018/05/download-1-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/05/download-1-1.jpg 281w, https://www.policymed.com/wp-content/uploads/2018/05/download-1-1-210x136.jpg 210w, https://www.policymed.com/wp-content/uploads/2018/05/download-1-1-279x180.jpg 279w" sizes="auto, (max-width: 281px) 100vw, 281px" /></div><p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">The FDA had more than 700 orphan drug designation requests last year. As a result, the FDA recently announced a new pilot program designed to make the request process easier. Along with a new form for the submissions process, FDA will make more resources available to sponsors.</span></p> <p class="MsoNormal"><b style="mso-bidi-font-weight: normal;"><span style="font-family: 'Arial',sans-serif;">Orphan Drug Submissions</span></b></p> <p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">FDA released an </span><a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm597126.htm"><span style="font-family: 'Arial',sans-serif;">on-line tutorial</span></a><span style="font-family: 'Arial',sans-serif;"> to guide sponsors through the submissions process. There is also a new inter-FDA consult process which streamlines and standardizes communications. FDA has also pledged to eliminate its backlog of orphan drug designations and recently held a </span><a href="https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm"><span style="font-family: 'Arial',sans-serif;">public meeting</span></a><span style="font-family: 'Arial',sans-serif;"> to discuss scientific and regulatory issues related to cancer treatments.</span></p> <p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">FDA also entered into an </span><a href="https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/OtherMOUs/ucm597454.htm"><span style="font-family: 'Arial',sans-serif;">understanding with the National Organization for Rare Disorders</span></a><span style="font-family: 'Arial',sans-serif;"> to conduct outreach with patient affairs staff. The goal is to enhance the incorporation of patient experience into regulatory discussions.</span></p> <p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">Specifically, FDA explains the Memorandum of Understanding (MOU) will define “the framework for collaboration between the Food and Drug Administration (FDA) and the National Organization for Rare Disorders (NORD). FDA and NORD share a common goal to improve the safety of the American public when using FDA-regulated medical products.<span style="mso-spacerun: yes;"> </span>FDA and NORD will collaborate to promote scientific progress in innovation, patient education, drug safety communications, training, research, including risk evaluation and mitigation strategies (REMS), and adverse event reporting. Before any specific collaboration is initiated or implemented, the parties shall develop separate written agreements for collaborations.<span style="mso-spacerun: yes;"> </span>Where applicable, the agreements shall incorporate by reference this MOU.”</span></p> <p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">“As part of this process, we’re planning a joint series of pilot listening sessions on rare diseases. We recognize that early and iterative engagement can improve clinical and regulatory understanding of diseases and conditions; provide a common understanding of the most urgent patient needs; and inform drug development programs,” </span><a href="https://blogs.fda.gov/fdavoice/index.php/2018/02/taking-new-steps-to-meet-the-challenges-of-rare-diseases-fda-marks-the-11th-rare-disease-day/"><span style="font-family: 'Arial',sans-serif;">Gottlieb said</span></a><span style="font-family: 'Arial',sans-serif;">.</span></p> <p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">Gottlieb continued: “Over the course of 2018 we’ll continue our efforts to increase the consistency and efficiency of our reviews of rare disease products. We remain committed to supporting rare disease research on diagnostics, therapies, and potential cures. We’ll also continue to evaluate how to best support investment in rare diseases; and to encourage the development of drugs that target rare, unmet patient needs. A lot of devastating and rare conditions still lack approved therapy. During this Rare Disease Week, it’s gratifying to review the steps we’ve taken, and to commit to more progress in the future, and making sure that our framework supports the needs of patients.”</span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2018/06/fda-announces-pilot-program-for-orphan-drug-submissions.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>US Health IT Policy Lags Behind</title> <link>https://www.policymed.com/2018/03/us-health-it-policy-lags-behind.html</link> <comments>https://www.policymed.com/2018/03/us-health-it-policy-lags-behind.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 12 Mar 2018 00:43:00 +0000</pubDate> <category><![CDATA[Electronic Health Records]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">http://www.policymed.com/us-health-it-policy-lags-behind/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="298" height="200" src="https://www.policymed.com/wp-content/uploads/2018/03/US-Health-IT-Policy-Lags-Behind.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>As described in a recent opinion article, Health IT Now and the Bipartisan Policy Center convened a work group of organizations representing clinicians, patients, hospitals, and technology companies to assess the current regulatory landscape, identify the most pressing needs of users, and develop consensus on the ideal future role of government in a post-meaningful use […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="298" height="200" src="https://www.policymed.com/wp-content/uploads/2018/03/US-Health-IT-Policy-Lags-Behind.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As described in a <a href="https://www.rollcall.com/news/opinion/health-policy-lags">recent opinion article</a>, Health IT Now and the Bipartisan Policy Center convened a work group of organizations representing clinicians, patients, hospitals, and technology companies to assess the current regulatory landscape, identify the most pressing needs of users, and develop consensus on the ideal future role of government in a post-meaningful use era, and a rapidly evolving delivery system and technology environment. Their report can be accessed and read <a href="https://bipartisanpolicy.org/library/health-it-and-digital-health/">here</a>.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“For too long, federal regulation of health IT favored reporting and process over care and treatment. HHS must create a new era in which government rules provide tangible benefit to consumers; doctors see patients, not computer screens; and the private sector propels our health care system into the future without fear of an outdated regulatory framework holding us in the past. We have envisioned a system that is suited for the health IT challenges and opportunities of tomorrow. We want to make sure Washington sees that vision, too,” <a href="https://www.rollcall.com/news/opinion/health-policy-lags">writes</a> Janet Marchibroda, director of the Health Innovation Initiative for the Bipartisan Policy Center, and Joel White, executive director of Health IT Now.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Report and Recommendations</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The work group members came together with the common understanding that while robust specifications were helpful in the early stages of HITECH implementation, over time, the level of prescriptiveness regarding health information technology (IT) contained within the Centers for Medicare and Medicaid Services (CMS) Electronic Health Record (EHR) Incentive Programs, CMS’ Merit-based Incentive Payment System (MIPS), and the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program, have contributed to dissatisfaction and increased burden among technology users and developers.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As a result, the work group’s report made several recommendations. Broadly, they encourage the federal government to provide assurances that protect consumer protections while leaving the evolution of products to the private sector. Additionally, the federal government’s role should continue playing a role in non-regulatory ways, like funding research to identify successful practices and adopting standards within health IT to signal government support.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><u>The work group agreed on the following key principles for an ideal oversight framework for health IT and digital health</u>:</span></p> <ol> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Encourage innovation by being flexible, technologically neutral, and not overly prescriptive; encouraging good development processes, rather than specific features and functions; supporting minimally necessary standards and baseline protections; and avoiding creation of unreasonable barriers to entry.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Be risk-based, assuring that the level of oversight is based on the risk of harm to patients.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Be stable and predictable, meaning that any changes must be implemented with sufficient notice and not create or add to uncertainty.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Be accountable to the public and enforceable, by gaining considerable input, making performance transparent, and assuring enforcement, as applicable.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Reflect the principles of a learning health system, by undergoing continuous improvement and innovation and embedding best practices as new knowledge is captured through experience.</span></li> </ol> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><u>The oversight framework should address the following six technology outcomes</u>:</span></p> <ol> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Interoperability. Technology should facilitate interoperability and information sharing, which play a critical role—along with other technology outcomes—in advancing higher quality, more cost-effective, patient-centered care.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Usability. Technology should reflect evidence-based, user-centered design principles; human factors science; and best practices. It should not create unnecessary burden on end users. It should be culturally competent, enabling access by users with diverse languages and abilities.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Safety. Technology should not create patient harm. Instead, it should help reduce patient harm by supporting the delivery of safer care.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Security. Technology should assure that information is available and accessible only to authorized individuals and processes and also provide assurance that information is not altered or destroyed in an unauthorized manner.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Patient Access to Information. Technology should enable and not create barriers to patients’ access to their own health information.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support for an Evolving Health Care System. Technology should be adaptable and flexible enough to meet the changing needs of users and an evolving health care system.</span></li> </ol> <p> </p> <p> </p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2018/03/us-health-it-policy-lags-behind.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Dr. Stossel Corrects a Common Misconception</title> <link>https://www.policymed.com/2017/04/dr-stossel-corrects-a-common-misconception.html</link> <comments>https://www.policymed.com/2017/04/dr-stossel-corrects-a-common-misconception.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 21 Apr 2017 00:06:00 +0000</pubDate> <category><![CDATA[Editorials]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">http://www.policymed.com/dr-stossel-corrects-a-common-misconception/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="745" height="400" src="https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception.png 745w, https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception-300x161.png 300w" sizes="auto, (max-width: 745px) 100vw, 745px" /></div>Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard Medical School, who has recently published several articles on how to remove barriers to medical innovation, and how medical innovation actually happens. This article highlights the impressive research by Dr. Stossel, supporting his position that […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="745" height="400" src="https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception.png 745w, https://www.policymed.com/wp-content/uploads/2017/04/Dr.-Stossel-Corrects-a-Common-Misconception-300x161.png 300w" sizes="auto, (max-width: 745px) 100vw, 745px" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard Medical School, who has recently published several articles on how to remove barriers to medical innovation, and how medical innovation actually happens. This article highlights the impressive research by Dr. Stossel, supporting his position that private investment does much more to push the progress of medicine along than people think.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">One article, <a href="http://www.wsj.com/articles/dont-thank-big-government-for-medical-breakthroughs-1483660786#livefyre-comment">published in the Wall Street Journal</a> on January 5, 2017, addressed the assumption that “the root of all medical innovation is university research, primarily funded by federal grants.” He noted that the assumption is incorrect and that it is the “private economy, not the government,” that “actually discovers and develops most of the insights and products that advance health.”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The article opens with complimenting Congress for passing the 21<sup>st</sup> Century Cures Act, claiming that it “will promote medical innovation,” while at the same time telling readers to be “wary, however, of the $4 billion budget boost that the law gives to the National Institutes of Health.” In addition to his Wall Street Journal article, Dr. Stossel wrote a <a href="http://www.nationalaffairs.com/doclib/20161230_Stossel.pdf">more in-depth article in National Affairs</a>, arguing the same points, with more research and information embedded into the article. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">There were few findings in medical science that could significantly improve health until the late 19<sup>th</sup> and early 20<sup>th</sup> centuries, with innovation primarily coming from “physicians in universities and research institutes that were supported by philanthropy.” Dr. Stossel notes, however, that things changed after World War II when the National Institutes of Health became the major backer of medical research, changing incentives. Universities that previously lacked research operations started to develop them, and existing programs were largely expanded. As noted in Dr. Stossel’s article in National Affairs, “for decades, Congress allocated generous and growing funds to the NIH that enabled it to provide many research grants to universities. As a result, universities expanded their laboratory facilities and research faculties — and the government-academic biomedical complex, or GABC, was born.”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Since that time, improvements in health have rapidly occurred. Also during that period, funding for the National Institutes of Health has lagged behind the growth of an aging population in need of medical innovation while private investment in medicine has largely kept pace with the aging population and “is the principal engine for advancement.”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">In his National Affairs article, Dr. Stossel discussed research papers submitted for publication, noting:</span></p> <blockquote><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Although revered by academics as a quality filter, “peer review” of research papers submitted for publication (and of grants for research funding) is a flawed enterprise. As scientific journals found success in providing researchers the priority and credit they were looking for, the volume of submissions began to exceed the supply of journals’ publication space. The practice of peer review — having selected experts render opinions regarding the quality of articles submitted to journals — was designed to solve that problem. Today, electronic publication has eliminated the space problem, but a prestige hierarchy of journals has replaced it with a false scarcity. Researchers covet attention in the most prestigious journals, and the high-profile journals sustain their elevated status by arbitrarily rejecting the majority of articles submitted to them. The monopoly power of these journals, fueled by researchers’ vanity, allows indifferent editors to delay decisions about whether to publish research articles until dueling authors and reviewers come to a resolution. The referees of these disputes provide a quality of service that would be expected from the nature of the reviewers: anonymous, unpaid cronies or competitors of a paper’s authors. As a result, research data can languish in obscurity for months or years while authors work their way down the prestige pecking order and finally obtain a place to publish.</span></p></blockquote> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">According to Dr. Stossel, more than 80% of new drug approvals originate from work solely performed in private companies and such drug approvals come on average 16 years after the beginning of clinical trials, which typically cost $2.5 billion from start to finish. Therefore, it appears even if academics and NIH really wanted to create a new drug, economic reality would get in the way.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The National Affairs article notes that, “achieving innovation requires wanting to innovate more than trying to impress reviewers of research papers or grant applications. It involves trial-and-error efforts that academic-review committees dismiss as “fishing expeditions” and that violate the scholarly premium on ‘hypothesis-driven’ studies. Success in academe also demands sticking to one’s research ‘brand.’ By contrast, innovation usually requires shifting gears to employ different technologies and experimental approaches. Such inconsistency reliably leads grant-application reviewers to discount an applicant’s qualifications.”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Dr. Stossel closes his Wall Street Journal article by stating:</span></p> <blockquote><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Despite its exaggerated role, basic research in universities does advance human knowledge, train scientists, and contribute to medical advances—albeit uncommonly and inefficiently. But the system is unsustainable. A better approach would be to encourage academics to join with industry, where the financial resources and drive to innovate reside. Unfortunately, the biomedical complex demonizes corporations. If academic institutions stopped demeaning the activities needed to develop medical products, industry might take a greater interest in supporting their research.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Great advances in health care have been made, but there are still important challenges, from obesity to dementia. One step toward addressing them would be for Washington to adopt the right approach to medical innovation—and to stop simply throwing money at the current inefficient system.</span></p></blockquote> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2017/04/dr-stossel-corrects-a-common-misconception.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Will There Be an Uptick in FDA NDA Approvals This Year?</title> <link>https://www.policymed.com/2017/04/will-there-be-an-uptick-in-fda-nda-approvals-this-year.html</link> <comments>https://www.policymed.com/2017/04/will-there-be-an-uptick-in-fda-nda-approvals-this-year.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 18 Apr 2017 00:15:00 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">http://www.policymed.com/will-there-be-an-uptick-in-fda-nda-approvals-this-year/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="525" height="340" src="https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year.png 525w, https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year-300x194.png 300w, https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year-210x136.png 210w" sizes="auto, (max-width: 525px) 100vw, 525px" /></div>Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug approvals (NDAs) was not due to a shift in FDA standards or policies. The number in 2016 (22) is remarkably lower than the total in 2015 (45). Could there be changes […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="525" height="340" src="https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year.png 525w, https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year-300x194.png 300w, https://www.policymed.com/wp-content/uploads/2017/04/Will-There-Be-an-Uptick-in-FDA-NDA-Approvals-This-Year-210x136.png 210w" sizes="auto, (max-width: 525px) 100vw, 525px" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug approvals (NDAs) was not due to a shift in FDA standards or policies. The number in <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm">2016</a> (22) is remarkably lower than the total in <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm">2015</a> (45). Could there be changes in 2017?</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Report from event: Uptick in 2017?</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><a href="http://raps.org/Regulatory-Focus/News/2016/11/04/26130/FDA%E2%80%99s-Jenkins-on-Decline-in-New-Drug-Approvals-in-2016-Not-due-to-Standards-Shift/">Regulatory Focus</a> reported from the <a href="http://www.previsionpolicy.com/">Prevision Policy</a> conference, quoting Jenkins directly: “There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss individual applications, a handful of the complete response letters (CRLs) issued in 2016 were due to good manufacturing practice (GMP) deficiencies and the need for FDA to conduct inspections. But Jenkins did say that there has been an uptick recently in the number of applications received, meaning the number of approvals could increase in 2017.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm">Recent news</a> of an FDA approved drug to treat Parkinson’s disease lends some evidence to that claim. The drug, Xadago (safinamide), is an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>MERIT Act</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Introduced by Rep. Larry Loudermilk (R., Ga.), the Modern Employment Reform, Improvement, and Transformation (MERIT) Act, <a href="https://www.congress.gov/bill/115th-congress/house-bill/559">H.R. 559</a>, would make it easier to “drain the swamp” by removing federal employees for poor performance or misconduct. The MERIT Act allows for due process: It requires notice in writing to the employee in question from the head of an agency and provides an opportunity to respond with an appeal. The Merit Systems Protection Board is required to issue a decision within 30 days of the appeal. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><a href="http://www.nationalreview.com/article/445992/regulatory-reform-congress-trump-priorities-food-drug-administration">The National Review</a> suggests this Act could be quickly applied to the FDA. They argue: “In recent years, in both the formulation of policy and the evaluation of individual products, the FDA has made egregious errors and arbitrarily expanded its authority in extra-statutory ways that have had important consequences. Most of these missteps have been in the direction of excessive risk-aversion or heavy-handed regulation, although a few, such as oversight of herbal dietary supplements and compounding pharmacies, have been marked by laxity, timidity, or outright incompetence.”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is unclear if this would increase the success rates of NDAs, but indicates the close intersection between the political environment, FDA policy, drug pricing, and even the regulators themselves.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Scott Gottlieb’s Impact?</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">President Trump’s nomination for FDA Commissioner, Scott Gottlieb, could result in faster approval of drugs as reported by <a href="http://thehill.com/blogs/pundits-blog/healthcare/323914-president-trumps-fda-nominee-could-mean-better-drugs-sooner-at">the Hill</a>. Gottlieb could introduce a new regulatory paradigm focused on competition to accelerate innovation, dramatically shorten the time from development to patient access, and sharply reduce the prices for new drugs. Rather than settling for the status quo that rewards delayed access and excessive caution, he can promote early access and fast learning.</span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2017/04/will-there-be-an-uptick-in-fda-nda-approvals-this-year.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel> </rss>