<?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>Collaborations &#8211; Policy &amp; Medicine</title>
	<atom:link href="https://www.policymed.com/category/collaborations/feed" rel="self" type="application/rss+xml" />
	<link>https://www.policymed.com</link>
	<description>Legal, Regulatory, and Compliance Issues</description>
	<lastBuildDate>Sat, 16 Nov 2024 15:14:55 +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>Collaborations &#8211; Policy &amp; Medicine</title>
	<link>https://www.policymed.com</link>
	<width>32</width>
	<height>32</height>
</image> 
	<item>
		<title>Unlocking the Fatty Liver Mistry: The Silent Threat of Fatty Liver Disease Unveiled</title>
		<link>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.html</link>
					<comments>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Sun, 17 Nov 2024 09:11:07 +0000</pubDate>
				<category><![CDATA[Clinical Research]]></category>
		<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[fatty liver disease]]></category>
		<category><![CDATA[healthcare podcast]]></category>
		<category><![CDATA[lifestyle changes]]></category>
		<category><![CDATA[liver diagnostics]]></category>
		<category><![CDATA[liver health]]></category>
		<category><![CDATA[liver pathology]]></category>
		<category><![CDATA[liver treatment]]></category>
		<category><![CDATA[metabolic syndrome]]></category>
		<category><![CDATA[Neeraj Mistry]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[Obesity]]></category>
		<category><![CDATA[public health]]></category>
		<category><![CDATA[silent diseases]]></category>
		<category><![CDATA[social determinants of health]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17334</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="556" height="342" src="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg 556w, https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1-300x185.jpg 300w" sizes="(max-width: 556px) 100vw, 556px" /></div>In the inaugural episode of &#8220;Unlocking the Fatty Liver Mistry,&#8221; Dr. Neeraj Mistry, Chief Medical Officer of the Fatty Liver Foundation, shares crucial insights on the often-overlooked health issue—fatty liver disease. With an approachable blend of medical expertise and public health perspective, Dr. Mistry invites listeners to explore the intricate world of liver health and [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="556" height="342" src="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg 556w, https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1-300x185.jpg 300w" sizes="(max-width: 556px) 100vw, 556px" /></div><p>In the inaugural episode of &#8220;<a href="https://clinicalcaresolutions.net/activities/gastroenterology/video-update1-dr-neeraj-mistry/61655/content">Unlocking the Fatty Liver Mistry</a>,&#8221; Dr. Neeraj Mistry, Chief Medical Officer of the Fatty Liver Foundation, shares crucial insights on the often-overlooked health issue—fatty liver disease. With an approachable blend of medical expertise and public health perspective, Dr. Mistry invites listeners to explore the intricate world of liver health and the silent epidemic affecting one-third of the global population.</p>
<p><strong>A Deeper Look at Fatty Liver Disease</strong></p>
<p>Fatty liver disease, commonly brushed aside in medical training, manifests silently within a significant portion of the population, emerging as a pivotal subject in contemporary health discussions. Dr. Mistry articulates the disease’s stealthy nature, emphasizing its lack of symptoms until it progresses to more severe stages, like cirrhosis or liver failure.</p>
<p><strong>The Role of Lifestyle and Social Determinants</strong></p>
<p>The conversation shifts towards the broader spectrum of factors contributing to fatty liver disease, including lifestyle choices and social determinants of health. Dr. Mistry highlights the critical role of diet, medication, and substance intake on liver health, pointing out the liver&#8217;s remarkable resilience until pushed past its limits.</p>
<p><strong>Comorbidities and Global Impact</strong></p>
<p>Dr. Mistry discusses the intersection of fatty liver disease with conditions like obesity, diabetes, and metabolic syndrome, noting a worrying rise in obesity rates among adults and children in the United States. This intersection underscores the urgent need to address these lifestyle diseases, which are expected to increase in prevalence, normalizing chronic health issues that lead directly to liver complications.</p>
<p><strong>Future Directions and Community Engagement</strong></p>
<p>Looking forward, Dr. Mistry reveals plans for upcoming episodes that will delve into the pathology, diagnostics, and new treatments for fatty liver disease. He expresses enthusiasm for community-based screenings that have shown promising engagement results, with individuals showing heightened interest in their health when presented with concrete evidence of liver damage.</p>
<p><strong>Conclusion: A Call to Action</strong></p>
<p>Ending on a hopeful note, Dr. Mistry invites listeners to stay tuned for more detailed discussions on the evolving nomenclature of liver disease and updates from upcoming conferences. His message is clear: understanding and addressing fatty liver disease is not only about treating the liver but also about enhancing overall health through proactive community and healthcare measures.</p>
<p>Stay informed and engaged as we continue to <a href="https://clinicalcaresolutions.net/activities/gastroenterology">unravel the mysteries of liver health</a>, emphasizing early detection and holistic management to mitigate this silent epidemic. Join us in our next episode to learn more about the critical changes in how we define and approach liver health today.</p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.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" /></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 [&#8230;]]]></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 &#8220;blood money&#8221; 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&amp;hvadid=80745417211234&amp;hvbmt=be&amp;hvdev=c&amp;hvqmt=e&amp;tag=mh0a9-21&amp;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&#8217;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>&#8220;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 &#8211; 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!&#8221; 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 &#8211; 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? &#8230; Rebuttal by Thomas P. Stossel, MD</a></h5>
<p>&nbsp;</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>New Patient Newsfeed and Resource Foundation for Patients with Pulmonary Fibrosis Launched</title>
		<link>https://www.policymed.com/2019/01/new-patient-newsfeed-and-resource-foundation-for-patients-with-pulmonary-fibrosis-launched.html</link>
					<comments>https://www.policymed.com/2019/01/new-patient-newsfeed-and-resource-foundation-for-patients-with-pulmonary-fibrosis-launched.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 29 Jan 2019 09:30:57 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=11436</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="414" height="119" src="https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01.png 414w, https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01-300x86.png 300w" sizes="auto, (max-width: 414px) 100vw, 414px" /></div>On January 23, 2019, the Pulmonary Fibrosis Foundation and Responsum Health announced a platform that will help individuals living with pulmonary fibrosis (PF). The free platform, Responsum for PF, is essentially a personalized newsfeed, support resource, and data organizing tool for individuals with PF, that allows patients to easily access trusted, comprehensive, and understandable content. [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="414" height="119" src="https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01.png 414w, https://www.policymed.com/wp-content/uploads/2019/01/responsum-sample-01-300x86.png 300w" sizes="auto, (max-width: 414px) 100vw, 414px" /></div><p>On January 23, 2019, the Pulmonary Fibrosis Foundation and Responsum Health announced a platform that will help individuals living with pulmonary fibrosis (PF). The free platform, <a href="https://pf.responsum.com/pff">Responsum for PF</a>, is essentially a personalized newsfeed, support resource, and data organizing tool for individuals with PF, that allows patients to easily access trusted, comprehensive, and understandable content.</p>
<p>Responsum for PF includes a searchable database of more than 500 article summaries and the ability to contact healthcare providers directly to ask questions regarding the articles or news featured on the platform. Responsum for PF also provides useful health data tools including a shareable Patient One-Sheet and Patient Services, Inc.’s patient assistance program.</p>
<p>“Our goal is to ensure that every patient has access to the most accurate information available so that they can make informed decisions about their treatment and their life choices,” <a href="https://www.pulmonaryfibrosis.org/our-role/news-media/viewannouncement/pulmonary-fibrosis-foundation-and-responsum-health-launch-new-online-patient-newsfeed-and-resource-platform">said Gregory P. Cosgrove, MD, PFF Chief Medical Officer</a>. “Responsum for PF minimizes the risk that the information patients find online is outdated, inaccurate or misleading.”</p>
<p>“While the Internet offers the promise of unfettered access to massive amounts of information, patients can easily find themselves overwhelmed by too much or underserved by inaccurate, inappropriate or overly complex content. Responsum solves that problem,” <a href="https://www.pulmonaryfibrosis.org/our-role/news-media/viewannouncement/pulmonary-fibrosis-foundation-and-responsum-health-launch-new-online-patient-newsfeed-and-resource-platform">said Andrew M. Rosenberg, Founder and CEO of Responsum Health</a>. “We all agree that a better informed patient makes for better outcomes, and that is our number one goal.”</p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2019/01/new-patient-newsfeed-and-resource-foundation-for-patients-with-pulmonary-fibrosis-launched.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>CMS Releases Data on Antipsychotic Drugs Used in Nursing Homes</title>
		<link>https://www.policymed.com/2018/03/cms-releases-data-on-antipsychotic-drugs-used-in-nursing-homes.html</link>
					<comments>https://www.policymed.com/2018/03/cms-releases-data-on-antipsychotic-drugs-used-in-nursing-homes.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 02 Mar 2018 00:04:00 +0000</pubDate>
				<category><![CDATA[CMS]]></category>
		<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Pharmacy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/cms-releases-data-on-antipsychotic-drugs-used-in-nursing-homes/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1024" height="683" src="https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes.png 1024w, https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes-300x200.png 300w, https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes-768x512.png 768w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></div>According to data from CMS, the percentage of long-term nursing home residents being given antipsychotic drugs dropped from about 24 percent in late 2011 to under 16 percent last year. CMS says the data show its National Partnership to Improve Dementia Care in Nursing Homes, created in 2012, has served its goal to reduce unnecessary [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1024" height="683" src="https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes.png 1024w, https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes-300x200.png 300w, https://www.policymed.com/wp-content/uploads/2018/03/CMS-Releases-Data-on-Antipsychotic-Drugs-Used-in-Nursing-Homes-768x512.png 768w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">According to <a href="https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-02.html?DLPage=2&amp;DLEntries=10&amp;DLSort=0&amp;DLSortDir=descending">data from CMS</a>, the percentage of long-term nursing home residents being given antipsychotic drugs dropped from about 24 percent in late 2011 to under 16 percent last year. CMS says the data show its National Partnership to Improve Dementia Care in Nursing Homes, created in 2012, has served its goal to reduce unnecessary antipsychotic medications in nursing homes.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>The Partnership</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">CMS explains its National Partnership utilized a multidimensional approach which included public reporting, partnerships and state-based coalitions, research, training for providers and surveyors, and revised surveyor guidance to empower and build upon the efforts of organizations across the country. The initial focus of the partnership was on reducing antipsychotic medications. However, it eventually grew into a larger mission of enhancing the use of non-pharmacologic approaches and person-centered dementia care practices.</span><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The National Partnership to Improve Dementia Care announced that it met its goal of reducing the national prevalence of antipsychotic use in long-stay nursing home residents by 30 percent by the end of 2016. It also announced a new goal of a 15 percent reduction by the end of 2019 for long-stay residents in those homes with currently limited reduction rates.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Data Trends</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">CMS reports that between the end of 2011 and the end of quarter one of 2017, the national prevalence of antipsychotic use in long-stay nursing home residents was reduced by 34.1 percent, decreasing from 23.9 percent to 15.7 percent nationwide. All 50 states showed improvement. Some states showed much more improvement than others. The states that have reduced their rate by the most percentage include the District of Columbia (47.8 percent), Tennessee (43.5 percent), California (43 percent), and Arkansas (41.6 percent).</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Reaction</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As <a href="https://www.statnews.com/2018/02/05/antipsychotics-nursing-homes-elderly/">reported</a>, there was mixed reaction to the news from CMS. Dr. Jerry Gurwitz, chief of geriatric medicine at the University of Massachusetts Medical School, is quoted as describing the decrease as “one of the most dramatic changes I’ve seen in my career.” Gurwitz suggests that some nursing homes might be finding other medications that sedate their patients into passivity without drawing the same level of scrutiny as antipsychotics.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Advocacy groups like the Washington-based Center for Medicare Advocacy and AARP Foundation Litigation say even the lower rate of antipsychotic usage is excessive, given federal warnings that elderly people with dementia face a higher risk of death when treated with such drugs.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“Given the dire consequences, it should be zero,” <a href="https://www.statnews.com/2018/02/05/antipsychotics-nursing-homes-elderly/">said</a> attorney Kelly Bagby of the AARP foundation, which has engaged in several court cases challenging nursing home medication practices. Bagby contends that the drugs are frequently used for their sedative effect, not because they have any benefit to the recipients.</span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2018/03/cms-releases-data-on-antipsychotic-drugs-used-in-nursing-homes.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>New Report Demonstrates Effectiveness of IPCE</title>
		<link>https://www.policymed.com/2016/12/new-report-demonstrates-effectiveness-of-ipce.html</link>
					<comments>https://www.policymed.com/2016/12/new-report-demonstrates-effectiveness-of-ipce.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 02 Dec 2016 00:14:00 +0000</pubDate>
				<category><![CDATA[ACCME]]></category>
		<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/new-report-demonstrates-effectiveness-of-ipce/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="320" height="213" src="https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi.png 320w, https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi-300x200.png 300w" sizes="auto, (max-width: 320px) 100vw, 320px" /></div>On April 20, 2016, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) convened a Leadership Summit for Jointly Accredited Providers at the ACCME’s offices in Chicago.   The goal of the summit was to provide an opportunity for jointly accredited providers [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="320" height="213" src="https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi.png 320w, https://www.policymed.com/wp-content/uploads/2016/12/6a00e5520572bb883401b8d2407043970c-320wi-300x200.png 300w" sizes="auto, (max-width: 320px) 100vw, 320px" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">On April 20, 2016, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) <a href="http://www.jointaccreditation.org/education-and-meetings">convened a Leadership Summit</a> for Jointly Accredited Providers at the ACCME’s offices in Chicago.  </span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The goal of the summit was to provide an opportunity for jointly accredited providers – as leaders in the continuing healthcare education community – to work collaboratively to identify organizational models that are effective in promoting and improving interprofessional collaborative practice (IPCP) through interprofessional continuing education (IPCE) and to share success stories that demonstrate the impact of their educational efforts.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A <a href="http://www.jointaccreditation.org/sites/default/files/2016_Joint_Accreditation_Leadership_Summit_Report_0.pdf">new report</a>, crafted based on the 2016 Joint Accreditation Leadership Summit, shows how IPCE contributes to improving healthcare team collaboration and patient care. The <a href="http://www.jointaccreditation.org/sites/default/files/2016_Joint_Accreditation_Leadership_Summit_Report_0.pdf">report</a> includes best practices, challenges, case examples, key recommendations, and data about the value and impact of IPCE.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Report Highlights</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><em>Inclusive Team</em></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">IPCE builds team collaboration across multiple professions, from chaplains to community health workers – from physicians to psychologists – from safety experts to social workers. Additionally, teamwork takes a fundamental, on-going commitment to the principles of IPCE – the secret to collaboration is to actually collaborate.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><em>Patient-Centered Teams</em></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">IPCE also creates a safe space where all learners, including patients, have a voice. Education that includes patients as planners, teachers, and learners, motivates powerful and lasting change. The report encouraged participants to ask: how is the structure helping patients? What professions affect patient outcomes? It is important to remember that the purpose and value of the program is to support the patient.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><em>Cultural Care, Compassionate Value</em></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">By bringing together teams, IPCE effectively builds skills that are essential for improving care for patients and communities, such as cultural competency, compassionate values, and communications. The report notes that IPCE is a philosophy and that you “have to be a true believer, keep on living it, preaching it,” encouraging leaders to “infuse your enthusiasm into the program.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><em>Public Health Priorities</em></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">IPCE programs partner with institutions and communities to address quality, safety, and public health concerns such as sepsis, obesity, end-of-life care, heart disease, and cancer.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Recommendations</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The report also included eight recommendations for creating and sustaining a successful ICPE program: develop buy-in from leadership; support your organization’s strategic mission; build your IPCE team and model best practices; involve patients; implement a phased-in approach; focus on quality; measure outcomes; and communicate the value of IPCE.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Videos</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Along with the report a <a href="http://www.jointaccreditation.org/videos">series of videos</a> was released, which feature educators describing their goals and accomplishments, what brings them joy and pride in their work, and advice for creating IPCE programs.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Comments from Leadership</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">All three jointly accredited provider groups support the report, with each having a representative <a href="http://www.jointaccreditation.org/new-report-demonstrates-effectiveness-interprofessional-continuing-education-advancing-team">offer comments</a> on the report.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“This report illustrates how jointly accredited providers are working every day to make a difference. These efforts have made, and will continue to make, a substantial difference to healthcare teams and the patients they serve. Interprofessional continuing education creates empowered teams that think courageously together, solve complex problems, and see the value of their own and their colleagues’ contributions. I encourage health system leaders and other stakeholders to recognize that an investment in education is an investment in people and to think about how they can leverage the power of education to support their community of clinicians and patients.”— Graham McMahon, MD, MMSc, President and CEO, ACCME</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“We are not going to change the healthcare system unless professionals in practice learn from, about, and with each other and foster that learning in the students coming up behind them. This report shows the important work being done by jointly accredited providers and documents the benefits and outcomes of their work. As accreditors, it shows us what we need to do better to support that work going forward.”—Peter H. Vlasses, PharmD, DSc (Hon), BCPS, FCCP, Executive Director, ACPE</span></p>
<p><span style="font-style: inherit; font-weight: inherit; font-family: arial, helvetica, sans-serif; font-size: 12pt;">“As evidenced by this report, our community of continuing education providers has demonstrably improved collaborative care among healthcare professionals and patient outcomes. ANCC is so proud of the enthusiasm, commitment, and dedication that shines through in their examples. We hope that the stories and strategies provide both inspiration and practical tips for educators across the healthcare professions who are striving to benefit patients by building stronger teams.” — Kathy Chappell, PhD, RN, FNAP, FAAN, Senior Vice President, Certification/Measurement, Accreditation and Research, ANCC</span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2016/12/new-report-demonstrates-effectiveness-of-ipce.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>Prescriber Education Campaign on Opioids Launched</title>
		<link>https://www.policymed.com/2016/09/prescriber-education-campaign-on-opioids-launched.html</link>
					<comments>https://www.policymed.com/2016/09/prescriber-education-campaign-on-opioids-launched.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Thu, 29 Sep 2016 00:01:00 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Opioids]]></category>
		<category><![CDATA[Patient Organizations]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/prescriber-education-campaign-on-opioids-launched/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="302" height="227" src="https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi.jpg 302w, https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi-300x225.jpg 300w, https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi-86x64.jpg 86w" sizes="auto, (max-width: 302px) 100vw, 302px" /></div>We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse of prescription pain relievers. From Congressional investigations, to Executive branch actions, to a letter from the Surgeon General, many of our country’s leaders are concerned about the epidemic and are constantly trying [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="302" height="227" src="https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi.jpg 302w, https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi-300x225.jpg 300w, https://www.policymed.com/wp-content/uploads/2016/09/6a00e5520572bb883401bb09379ea8970d-800wi-86x64.jpg 86w" sizes="auto, (max-width: 302px) 100vw, 302px" /></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;">We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse of prescription pain relievers. From </span><a style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;" href="http://www.policymed.com/2016/02/senate-hearing-on-opioid-epidemic-focuses-on-limiting-multiple-access-points.html">Congressional investigations</a><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;">, to </span><a style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;" href="http://www.policymed.com/2011/04/fda-opioid-rems-white-house-proposes-mandated-certified-cme-.html">Executive branch actions</a><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;">, to </span><a style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;" href="http://www.policymed.com/2016/09/surgeon-general-sends-out-letter-on-opioids.html">a letter from the Surgeon General</a><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; text-transform: initial;">, many of our country’s leaders are concerned about the epidemic and are constantly trying to craft solutions.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The <a href="http://www.drugfree.org/">Partnership for Drug-Free Kids</a>, an organization committed to helping families struggling with their son or daughter’s substance abuse, created the “<a href="http://www.searchandrescueusa.org/reduce-opioid-abuse/">Search and Rescue</a>” campaign, a prescriber education campaign developed with support from the Food and Drug Administration (FDA) that gives healthcare providers the resources they need to prescribe opioids responsibly and prevent the misuse and abuse of medicine in their practices. The campaign was piloted in Maryland and Rhode Island in 2014, and expanded to six states in 2015. On September 15, 2016, the Partnership for Drug-Free Kids announced the national launch of the campaign.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The goal of the “<a href="http://www.searchandrescueusa.org/reduce-opioid-abuse/">Search and Rescue</a>” campaign is to equip prescribers with skills to be proactive in identifying and helping patients at risk for prescription drug abuse. The campaign will attempt to connect prescribers to training, information, and resources that can help educate them, and the FDA encourages them to share the educational content with their peers.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>FDA and Partnership Comments on “Search and Rescue”</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Dr. Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research (CDER), is, <a href="http://www.drugfree.org/newsroom/partnership-drug-free-kids-announces-national-launch-search-rescue-opioid-prescriber-education-campaign/">along with the FDA</a>, “proud to support this campaign to educate and inform providers about the risks of addiction and the misuse and abuse of opioids in their efforts to treat their patients’ pain responsibly and prevent the misuse and abuse of these drugs.” She <a href="http://www.drugfree.org/newsroom/partnership-drug-free-kids-announces-national-launch-search-rescue-opioid-prescriber-education-campaign/">further noted</a>, “educating the healthcare community on appropriate prescribing of prescription opioid medications is a cornerstone of the FDA’s Opioid Action Plan, and continues to be a top priority for the agency, as well as for the Department of Health and Human Services (HHS) and across the federal government.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">According to <a href="http://www.drugfree.org/newsroom/partnership-drug-free-kids-announces-national-launch-search-rescue-opioid-prescriber-education-campaign/">Marcia Lee Taylor</a>, President and CEO of the Partnership, “Today’s opioid epidemic has reached alarming and tragic proportions, with 78 opioid overdose deaths occurring daily in the United States. Addressing this dire national problem requires a multi-pronged approach, involving parents, educators, community leaders, treatment professionals and healthcare providers. The Partnership is proud to apply its communications expertise to the challenge of reaching and helping educate prescribers, who can and must be a huge part of the solution.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>The Website</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Search and Rescue website offers many resources for providers, including <a href="http://www.searchandrescueusa.org/pdmp-access/">information on each state’s PDMP</a>, <a href="http://www.searchandrescueusa.org/opioid-abuse-resources/#videos">brief educational videos</a>, a <a href="http://www.er-la-opioidrems.com/IwgUI/rems/training.action">database</a> with accredited CME/CE REMS-compliant activities, an <a href="https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf">opioid risk assessment</a>, links to a <a href="http://dpt2.samhsa.gov/treatment/directory.aspx">SAMHSA treatment locator</a> to help patients find a local opioid treatment program, and a quick <a href="http://www.searchandrescueusa.org/pdf/Search_and_Rescue_Essentials.pdf">fact sheet</a> for prescribers. </span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Other Ways Search and Rescue is Helping</strong></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The “Search and Rescue” campaign makes innovative use of <a href="https://twitter.com/search?q=Search%20and%20Rescue%20opioid&amp;src=typd">social media</a>, optimized search, and earned media to reach family physicians, physician assistants and nurse practitioners, focusing on sending them to the website to learn more.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Partnership is working with other national organizations, including the American Medical Association Task Force to Reduce Prescription Opioid Abuse, the American Academy of Pediatrics, the American Dental Association (ADA), and others, to promote “Search and Rescue” to their members.</span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2016/09/prescriber-education-campaign-on-opioids-launched.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>Senate HELP Committee Continues Work on 21st Century Cures Corollary</title>
		<link>https://www.policymed.com/2016/03/senate-help-committee-continues-work-on-21st-century-cures-corollary.html</link>
					<comments>https://www.policymed.com/2016/03/senate-help-committee-continues-work-on-21st-century-cures-corollary.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 23 Mar 2016 00:05:00 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Congress]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/senate-help-committee-continues-work-on-21st-century-cures-corollary/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="344" height="229" src="https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b.jpg 344w, https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b-300x200.jpg 300w" sizes="auto, (max-width: 344px) 100vw, 344px" /></div>&#160; Earlier this week, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on a package of legislative measures that are targeted at facilitating medical innovation. This hearing, the second in a set of three, is the Senate&#8217;s response to the House-passed 21st Century Cures Act (H.R. 6). We wrote about the [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="344" height="229" src="https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b.jpg 344w, https://www.policymed.com/wp-content/uploads/2016/03/6a00e5520572bb883401b7c8258b14970b-300x200.jpg 300w" sizes="auto, (max-width: 344px) 100vw, 344px" /></div><p>&nbsp;</p>
<p><span style="font-family: Arial; font-size: 12pt;">Earlier this week, the Senate Health, Education, Labor, and Pensions (HELP) Committee <a href="http://www.help.senate.gov/hearings/s1878-s1077-s1101-s2055-s1767-s1597-s2512-and-nomination-of-dr-john-king">held a hearing</a> on a package of legislative measures that are targeted at facilitating medical innovation. This hearing, the second in a set of three, is the Senate&#8217;s response to the House-passed 21<sup>st</sup> Century Cures Act (H.R. 6). We wrote about the first hearing, and a recap can be found <a href="http://www.policymed.com/2016/02/senate-help-committee-moves-closer-to-creating-corollary-to-21st-century-cures.html">here</a>. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">While the second meeting featured much partisan debate and fanfare, the Committee advanced all seven medical innovation measures before them, with six passing by voice and one measure passing by roll call vote of 20-2. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">In opening statements, Senator Lamar Alexander, Committee Chairman, acknowledged the anticipated contention on the panel over what he referred to as a &#8220;surge&#8221; of additional mandatory funding requested by Democrats for the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Even expecting contention, the Chairman expressed optimism about the Committee&#8217;s capacity for compromise, stating that if the Committee successfully creates an innovation agenda, it may be the &#8220;most important legislation passed this year.&#8221; </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">As may be expected, Ranking Member Senator Patty Murray and Senator Elizabeth Warren both showed strong support for increasing mandatory funding for the FDA and the NIH, each introducing an amendment to S. 1878: one to create a medical device evaluation system and the other to create a biomedical innovation fund. Senator Murray also expressed concern that some of these bills may increase FDA responsibilities and not compensate the FDA for that. While both senators started out firmly believing that any agreement needed to include increased funding, they both withdrew their amendments, including any requests for additional funding, in order to find other consensus points and come to an agreement. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The measures approved in the Committee are as follows: </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/1878/text?q=%7B%22search%22%3A%5B%221878+The+Advancing+Hope+Act+2015%22%5D%7D&amp;resultIndex=1">Advancing Hope Act of 2015</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill amends the Federal Food, Drug, and Cosmetic Act (FDCA) to expand the priority review voucher program for rare pediatric diseases to including treatments for both sickle cell disease and pediatric cancers. The voucher program will be extended by removing the provision that terminates the program one year after the FDA&#8217;s issuance of three rare pediatric disease vouchers. However, a voucher may not be issued for a rare pediatric disease product, if a voucher was ever issued for the product as a tropical disease product. Additionally, a drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of their intent to do so upon submission of their new drug application. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The bill&#8217;s sponsor, Senator Robert Casey explained that this program is integral to fostering innovation and incentivizing private companies to invest in rare children&#8217;s diseases. Such an incentive is necessary because private companies tend to not see a return on research investment in this area. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This is the one measure passed via a roll call, following adoption of the following amendments: <span style="color: black;">(1) specify the criteria for &#8220;rare pediatric disease,&#8221; (2) insert a section related to rare pediatric disease product applications, (3) require the comptroller to conduct a study on the GAO report on the effectiveness of awarding priority review vouchers for the sponsorship of rare pediatric disease product application, and (4) require the results of the study to be reported to congress.</span> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/1077/text?q=%7B%22search%22%3A%5B%22The+Advancing+Breakthrough+Medical+Devices+for+Patients+Act+2015+1077%22%5D%7D&amp;resultIndex=1">Advancing Breakthrough Medical Devices for Patients Act of 2015</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill amends the FDCA to expand the FDA&#8217;s priority review of breakthrough medical devise to include all classes of devices. Currently, only new or highest risk (Class III) devices are eligible. However, this bill would make it so that upon a sponsor&#8217;s request, the FDA would be forced to determine whether a device meets the criteria for priority review as a breakthrough device. </span></p>
<p style="background: white;"><span style="font-family: Arial; font-size: 12pt;">To expedite the development and review of designated medical devices, the FDA must: &#8220;assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive and timely communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, [and] assign staff to address questions by institutional review committees concerning investigational use of the device.&#8221; </span></p>
<p style="background: white;"><span style="font-family: Arial; font-size: 12pt;">Senator Richard Burr emphasized the idea that this measure would not change the standards that devices are required to meet in order to reach the market, but instead simply changes the approach by which device approvals can be accelerated. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/2055/text?q=%7B%22search%22%3A%5B%22The+Medical+Countermeasures+Innovation+Act+2015+2055%22%5D%7D&amp;resultIndex=1">Medical Countermeasures Innovation Act of 2015</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill encourages the development of medical countermeasures in case of biological attacks and naturally occurring outbreaks. This bill is intended to build upon the Pandemic and All-Hazards Preparedness Act, by leveraging the innovation of the private sector through priority review vouchers. The urgency of this problem has been exemplified with the Ebola and Zika outbreaks over the past year. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/1101/text?q=%7B%22search%22%3A%5B%22%5C%22s1101%5C%22%22%5D%7D&amp;resultIndex=1">Medical Electronic Data Technology Enhancement for Consumers Health Act</a> </span></p>
<p style="background: white;"><span style="font-family: Arial; font-size: 12pt;">This bill amends the FCPA to exclude several classes of devices from FDA-regulation as a medical device. Some of the included classes are: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals. </span></p>
<p style="background: white;"><span style="font-family: Arial; font-size: 12pt;">The bill also states that the FDA must classify a medical device accessory according to its intended function, not the classification of the medical device with which it is used. </span></p>
<p style="background: white;"><span style="font-family: Arial; font-size: 12pt;">This measure was adopted without any discussion. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/1767/text?q=%7B%22search%22%3A%5B%22The+Combination+Products+Innovation+Act+2015+1767%22%5D%7D&amp;resultIndex=1">Combination Product Regulatory Fairness Act of 2015</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill attempts to address regulations on combination drug and device products. There was little discussion accompanying this bill, but Senator Casey did briefly speak out in favor of the measure, noting that it will allow for improved communication with the FDA and manufacturers. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/1597/text?q=%7B%22search%22%3A%5B%22Patient+Focused+Impact+Assessment+Act+2015+1597%22%5D%7D&amp;resultIndex=1">Patient-Focused Impact Assessment Act of 2015</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill amends the FDCA to require the package of information published by the FDA upon approval of a new drug to include documentation of efforts to assess patient engagement. The required documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including any patient preferences and patient-reported or caregiver-reported outcomes. The FDA is also required to annually summarize, and publish, the data that is collected in this documentation. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">Senator Susan Collins, a cosponsor of the bill, believes that patient input is a valuable resource and should play a larger role in FDA decision-making. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The <a href="https://www.congress.gov/bill/114th-congress/senate-bill/2512/text?q=%7B%22search%22%3A%5B%22Adding+Zika+Virus+the+FDA+Priority+Review+Voucher+Program+Act+2512%22%5D%7D&amp;resultIndex=1">Adding Zika Virus to the FDA Priority Review Voucher Program Act</a> </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">This bill also amends the FDCA, to add the Zika virus to the list of tropical diseases under the priority review voucher program. The priority review voucher program awards a voucher to the sponsor of a new drug or a new biological product that is approved to prevent or treat a tropical disease, which allows the holder of the voucher to have a future new drug or biological product application acted upon by the FDA within six months. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">Chairman Alexander mentioned at the outset of this meeting that the Zika virus is a top concern and priority for the HELP panel. </span></p>
<p><span style="font-family: Arial; font-size: 12pt;">The final HELP Committee on medical innovation is slated for April 6, 2016, at which time Chairman Alexander hopes to have a final package ready for floor consideration. </span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2016/03/senate-help-committee-continues-work-on-21st-century-cures-corollary.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>&#8220;Reconnecting the Dots — Reinterpreting Industry–Physician Relations&#8221; Provides A Balanced Look At Physician-Industry Collaboration and Conflicts of Interest</title>
		<link>https://www.policymed.com/2015/05/reconnecting-the-dots-reinterpreting-industryphysician-relations-provides-a-balanced-look-at-physici.html</link>
					<comments>https://www.policymed.com/2015/05/reconnecting-the-dots-reinterpreting-industryphysician-relations-provides-a-balanced-look-at-physici.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 19 May 2015 00:30:00 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Conflict of Interest]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/reconnecting-the-dots-reinterpreting-industryphysician-relations-provides-a-balanced-look-at-physici/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="140" src="https://www.policymed.com/wp-content/uploads/2015/05/6a00e5520572bb883401b8d1161473970c-800wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>Lisa Rosenbaum, MD recently published an article entitled “Reconnecting the Dots—Reinterpreting Industry-Physician Relations,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="140" src="https://www.policymed.com/wp-content/uploads/2015/05/6a00e5520572bb883401b8d1161473970c-800wi.png" 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;">Lisa Rosenbaum, MD recently published an article entitled “<a href="http://www.nejm.org/doi/full/10.1056/NEJMms1502493" target="_blank" rel="noopener">Reconnecting the Dots—Reinterpreting Industry-Physician Relations</a>,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions between physician-scientists and industry at the basic or translational research level are equally clear,” she states. “The question, then, is how to best manage conflicts of interest while preserving the collaborations on which medical advances depend.”</span></p>
<p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Collaborations and Conflicts of Interest</span></strong></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“Physician-industry interactions have been critical to the development of a large percentage of the medical products that allow physicians to prevent heart attacks, cure cancers, and restore mobility to the elderly,” Thomas Stossel, M.D., a distinguished Harvard hematologist and research <a href="http://www.policymed.com/2015/05/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation.html">recently noted</a>. “Despite such progress and the role of physician-industry interactions in fomenting it, physicians are reducing or severing their relationships with biopharmaceutical and medical device companies out of fear that their patients will mistakenly view such interactions as a sign of corruption, rather than expertise.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">To this end, Rosenbaum sets out to find a “reasoned approach” to physician-industry interactions that acknowledges both the benefits of the collaboration, while recognizing the risks of bias involved. To lay the foundation of her paper, she starts off by describing the release of “controversial new cholesterol guidelines” in November 2013, which expanded the target population for preventative statin therapy. The criticism against the guidelines was swift, she noted from experience, from those who believed that the primary beneficiary of these guidelines would be the pharmaceutical industry.</span></p>
<p style="text-align: justify; padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">In a <em>New York Times</em> op-ed, for example, a cardiologist and another physician and industry critic argued that making more patients eligible for statin therapy would “benefit the pharmaceutical industry more than anyone else.” Objecting to using statins for primary prevention, they drew from a medical journal article that one of them had coauthored emphasizing the frequency of side effects. This frequency turned out to be exaggerated, necessitating an erratum in the journal. Yet no one was questioning the editorialists’ credibility in the public press; rather, the editorialists challenged the credibility of the guideline writers: “The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Rosenbaum’s article provides a counter to such industry-skeptics, who are often amazingly uncritical in their dismissal of important industry-collaborative efforts. “One could argue that people also deserve to know that statins are, in many cases, the best drugs we have to prevent cardiovascular disease and that the committee had spent 5 years reviewing the evidence to identify the patients who would benefit most,” she writes.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">She also outlines the steps taken to avoid the introduction of conflicts into the guidelines, given that 7 of the 15 committee members did have current or previous industry ties:</span></p>
<ul>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">First, the members with current industry ties were not allowed to vote on the quality of the evidence statements or the recommendations, and none of the members without industry ties have developed ties since the guidelines were published.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Second, because of past concerns about conflicts, the committee used an independent contractor, appointed by the National Heart, Lung, and Blood Institute, to choose the studies on which the recommendations were based.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Third, though the controversy centered on primary prevention for people whose 10-year risk of a cardiovascular event exceeds 7.5%, the guidelines make clear that this cut point is merely a threshold for initiating discussion about statins, rather than a mandate to start treatment with one.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Fourth, the resulting guidelines are actually no boon to companies selling patent-protected drugs: most statins are available in generic versions, and the guidelines recommend against using (patent-protected) drugs that improve lipid levels but that hadn’t, at the time of guideline writing, been proven to improve outcomes.</span></li>
</ul>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Despite laying out the facts behind the guidelines, Rosenbaum notes: “the greater difficulty is that whereas a rational approach to regulating industry interactions requires careful parsing of such nuances, our general feelings about industry interactions, as the easy dismissal of the statin guidelines illustrates, can be impervious to relevant detail.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">On cue, a response to Rosenbaum’s article in <a href="http://www.healthnewsreview.org/2015/05/criticism-of-nejms-defense-of-industry-physician-relations/">Health News Review</a> did indeed seem impervious to the details: “Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs.” The article’s conclusion? “Don’t trust what comes out of a drug company (or medical journals?) and verify, verify, verify.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">One of the many interesting points Rosenbaum raises in her article is that discussions of bias have been limited to the financial. In fact, she argues, bias is perhaps strongest and most risky when scientists or doctors have a professional stake in the outcomes of their research: discovering a breakthrough, developing novel treatments, publishing journal articles, etc.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Rosenbaum does not gloss over the harm greed can cause, outlining the misleading Vioxx studies that minimized the drug’s risks and ultimately resulted patient harm. However, she believes an overemphasis on a drug’s risks can be harmful as well. “Vioxx’s continued relevance to our management of physician–industry interactions lies in the lingering impression that some companies will do anything to profit, even if it means suppressing evidence to patients’ detriment — an impression reinforced by subsequent Big Pharma scandals,” states Rosenbaum.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perhaps the most memorable two paragraphs of Rosenbaum’s article are when she pinpoints the reasons behind many deep set suspicions of industry: </span></p>
<p style="text-align: justify; padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For the many physicians whose primary interactions with industry are of the marketing variety, the beneficial nature of other industry relationships may lack emotional traction. We see the attractive pharmaceutical reps in our offices. We eat the lunches (or walk away hungry). Our patients, heeding the “Ask your doctor” mantra of drug ads, request medications we may not believe should be prescribed. We hear that our prescription habits are being monitored so that we can be targeted for better sales. And we observe colleagues, their suits sharp, their skin tanned from a free Hawaiian vacation, their children’s college education covered, and though we may take some satisfaction in eschewing pharmaceutical largesse, still, for some, the resentment burns.</span></p>
<p style="text-align: justify; padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">By contrast, how visible to us are physician-scientists whose National Institutes of Health grant applications go unfunded, and who therefore increasingly rely on industry support for their laboratories? Does it cross our minds, when we prescribe statins after a myocardial infarction, how much collaboration between industry and physician-scientists was required to develop them? When we read an editorial by someone who is “conflict-free,” do we wonder whether someone else whose industry ties prevented authorship might have had unique expertise to share? Of course, the fact that the benefits of industry interactions are often imperceptible does not excuse the more easily imagined offenses. But the visibility imbalance helps explain why our aversion to certain industry behaviors deeply colors our overall impressions of industry.</span></p>
<p style="text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Read Rosenbaum&#8217;s <a href="http://www.nejm.org/doi/full/10.1056/NEJMms1502493" target="_blank" rel="noopener">full article in the New England Journal of Medicine here.</a>  </span></p>
<p>&nbsp;</p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2015/05/reconnecting-the-dots-reinterpreting-industryphysician-relations-provides-a-balanced-look-at-physici.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation</title>
		<link>https://www.policymed.com/2015/05/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation.html</link>
					<comments>https://www.policymed.com/2015/05/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 08 May 2015 00:30:00 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Conflict of Interest]]></category>
		<category><![CDATA[NIH]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="200" height="300" src="https://www.policymed.com/wp-content/uploads/2015/05/6a00e5520572bb883401b7c786b8e8970b-800wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>&#160; Long a champion of physician and industry collaboration, Thomas Stossel, M.D., has published a new book entitled Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation. In it, Stossel, a distinguished Harvard hematologist and researcher, decries the conflict of interest movement as detrimental to medical progress and ultimately the patients who would benefit [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="200" height="300" src="https://www.policymed.com/wp-content/uploads/2015/05/6a00e5520572bb883401b7c786b8e8970b-800wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p>&nbsp;</p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Long a champion of physician and industry collaboration, Thomas Stossel, M.D., has published a new book entitled <a href="http://www.amazon.com/Pharmaphobia-Conflict-Interest-Undermines-Innovation/dp/1442244623" target="_self"><em>Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation</em></a>. In it, Stossel, a distinguished Harvard hematologist and researcher, decries the conflict of interest movement as detrimental to medical progress and ultimately the patients who would benefit from new, innovative therapies.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Writing about conflicts of interest has been an increasingly surefire way to get published—the Journal of the American Medical Association even has its own <a href="http://jama.jamanetwork.com/collection.aspx?categoryID=5577&amp;page=1">conflict of interest category</a>. What’s often missing from both sides of the mostly academic “COI” debate, however, is a relation back of nebulous concepts to what is important: tangible medical innovations and patient well-being.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">One of the reasons Dr. Stossel’s writing is so engaging is that he bucks this trend by illustrating in plain language what is at stake. “Physician-industry interactions have been critical to the development of a large percentage of the medical products that allow physicians to prevent heart attacks, cure cancers, and restore mobility to the elderly,” <a href="http://www.realclearpolicy.com/blog/2015/05/05/pharmaphobia_the_conflict-of-interest_myth_1285.html">he writes</a>.</span></p>
<p style="text-align: justify; padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Over the course of my career, medicine and industry have together made spectacular progress against diseases. Cardiovascular deaths are down 60 percent, HIV has been converted from a death sentence to a chronic disease, and cancer mortality is at a historic low. Despite such progress and the role of physician-industry interactions in fomenting it, physicians are reducing or severing their relationships with biopharmaceutical and medical device companies out of fear that their patients will mistakenly view such interactions as a sign of corruption, rather than expertise.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">In addition to the large amount of ink being spilled in academic journals on COI, Stossel characterizes a number of recent legislative measures as being similarly “pharmophobic.” He points specifically to the medical device excise tax and the Physician Payments Sunshine Act, which requires pharmaceutical and device companies to report any payments to physicians and teaching hospitals of more than $10. These payments are reported on a publicly accessible website, “with minimal explanations,” he notes, which “stigmatiz[es] relationships that are critical to the development and dissemination of new medical products.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">“[O]ne of the highest-paid physicians in the Sunshine database is a world-famous<strong> </strong>vascular surgeon<strong> </strong>who received royalties for his invention of multiple aneurism repair devices,” Stossel illustrates. Similarly, &#8220;Paul Offit, who invented the rotavirus vaccine that is believed to have reduced the <strong><a href="http://www.cdc.gov/vaccines/pubs/surv-manual/chpt13-rotavirus.html#goals">incidence of hospitalizations for rotavirus-induced diarrhea</a></strong> by more than 85 percent among U.S. toddlers since its addition to the childhood-vaccine schedule in 2006, is often <strong><a href="http://www.skepticalraptor.com/skepticalraptorblog.php/debunking-myths-dr-paul-offit/">maligned for his industry ties</a></strong>.&#8221; Stossel concludes: “Such cases, along with research grants for clinical trials, dominate the largest payments documented under the Sunshine Act. They are unequivocally beneficial and should not be stigmatized in this manner.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Dr. Stossel’s book also aims to illustrate just how important private industry has been to these amazing breakthroughs. Again, he is the perfect spokesman for this. “I’ve done medical research for most of my career, and people say that I’ve been successful at it,&#8221; he notes. “I hope that this research will save lives someday, but only drug and device companies can make that happen.”</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">He writes:</span></p>
<p style="padding-left: 30px; text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Publicly supported academic research certainly advances medical knowledge. But converting that knowledge to clinical benefits isn’t straightforward. Helping patients justifies public research funding, but obtaining such funding depends far more on impressing grant review committees with the novelty and virtuosity of research than with its practical medical applications. I know, because following these precepts has certainly contributed to my success. I have had continuous government research funding for over 45 years, have published research papers in prestigious scientific journals, won prizes, and been elected to elite scientific societies. Yet no one has lived one second longer or better as a <em>direct</em> result of my research.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">But regulations, largely stemming from the conflict of interest movement has only served to impede medical innovation. “Regulations always slow things down, and compliance and enforcement divert precious funds from research and development,” states Dr. Stossel. “It takes on average 16 years and costs over $2 billion to get a new drug approval by the FDA.” This delay matters:</span></p>
<p style="text-align: justify; padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For patients desperate for new treatments and cures, such delays can be lethal. Marketing restrictions mean doctors don’t learn about drug and device advances. Delays or prevention of potentially innovation-promoting relationships between researchers and industry have been documented. The myth that device and drug development isn’t difficult and expensive encourages enactment of taxes on companies and calls for price controls. Both inhibit innovation.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">&#8212;</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Dr. Stossel stands as a rare counter to the COI movement, and provides years of experience and patient-centered arguments to back it up. <a href="http://www.amazon.com/Pharmaphobia-Conflict-Interest-Undermines-Innovation/dp/1442244623" target="_self"> <em>Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation</em> </a>is out now and <a href="http://www.amazon.com/Pharmaphobia-Conflict-Interest-Undermines-Innovation/dp/1442244623">available here</a>. Also, <span class="asset asset-generic at-xid-6a00e5520572bb883401bb082ab4fb970d img-responsive"><a href="http://policymed.typepad.com/files/pharmaphobia-qa.pdf">read  a Q&amp;A</a> with Stossel about his book.</span></span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span class="asset asset-generic at-xid-6a00e5520572bb883401bb082ab4fb970d img-responsive">In full disclosure, Thomas Sullivan, Editor of Policy and Medicine is listed in the preface to Pharmaphobia, he receives no remuneration from the sales of this book or his work with Dr. Stossel.  </span></span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2015/05/pharmaphobia-how-the-conflict-of-interest-myth-undermines-american-medical-innovation.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
		<item>
		<title>New Poll Shows Majority of Americans Are Concerned About Pace of Medical Progress</title>
		<link>https://www.policymed.com/2015/02/new-poll-shows-majority-americans-are-concerned-about-pace-of-medical-progress-and-agree-with-many-t.html</link>
					<comments>https://www.policymed.com/2015/02/new-poll-shows-majority-americans-are-concerned-about-pace-of-medical-progress-and-agree-with-many-t.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 27 Feb 2015 00:30:00 +0000</pubDate>
				<category><![CDATA[Collaborations]]></category>
		<category><![CDATA[Congress]]></category>
		<category><![CDATA[Innovation]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">http://www.policymed.com/new-poll-shows-majority-americans-are-concerned-about-pace-of-medical-progress-and-agree-with-many-t/</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="159" src="https://www.policymed.com/wp-content/uploads/2015/02/6a00e5520572bb883401b8d0ddb735970c-800wi.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>According to America Speaks, a compilation of public opinion polls commissioned by Research!America, the majority of Americans agree with the central tenets of the 21st Century Cures Bill.  &#8220;Majorities across the political spectrum say it is important that the new 114th Congress takes action on assuring the discovery, development and delivery of treatments and cures for [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="159" src="https://www.policymed.com/wp-content/uploads/2015/02/6a00e5520572bb883401b8d0ddb735970c-800wi.png" 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;">According to <em>America Speaks</em>, a compilation of public opinion polls commissioned by Research!America, the majority of Americans agree with the central tenets of the <a href="http://www.policymed.com/2015/01/21st-century-cures-initiative-introduces-significant-legislative-proposal.html" target="_blank" rel="noopener">21st Century Cures Bill</a>. </span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">&#8220;Majorities across the political spectrum say it is important that the new 114th Congress takes action on assuring the discovery, development and delivery of treatments and cures for diseases in the first 100 days of the legislative session (75% Democrats, 64% Republicans and 60% Independents),&#8221; states Research!America. &#8220;As Congress considers numerous proposals in support of research, including the 21st Century Cures draft legislation aimed at speeding the delivery of lifesaving treatments to patients, it is notable to see public support in favor of accelerating medical progress.&#8221;</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;"> <a class="asset-img-link" style="float: left;" href="http://policymed.typepad.com/.a/6a00e5520572bb883401b8d0ddb4f4970c-pi"><img decoding="async" class="asset asset-image at-xid-6a00e5520572bb883401b8d0ddb4f4970c img-responsive" style="margin: 0px 5px 5px 0px; border: 1px solid #000000;" title="Speed Drug Approval Pic" src="http://policymed.typepad.com/.a/6a00e5520572bb883401b8d0ddb4f4970c-800wi" alt="Speed Drug Approval Pic" border="0" /></a></span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">The report found that an increasing percentage of Americans say the U.S. Food and Drug Administration (FDA) should move more quickly in order to get new treatments to patients, even if it means there may be risks. In 2015, 38% favor faster regulatory review, compared to 30% in 2013 (see the graphic to the left). Meanwhile, 25% say the FDA should act more slowly in order to reduce risk, even if it means patients may wait longer for treatments.  Another 19% are undecided on this question and 18% do not agree with either position.  </span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">When it comes to rising health care costs, 46% say research to improve health is part of the solution, while 28% are not sure and 26% say research is part of the problem. Meanwhile, 41% say that the roughly 1.5% of government spending allocated for biomedical and health research is not enough. Nearly one-third (29%) say it is about right, 21% are not sure and 9% say it is too much.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">Furthermore, 44% say they are willing to pay $1 per week more in taxes if they were certain that all of the money would be spent on additional medical research, while 32% say no and 24% are not sure.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">Currently, only 27% of Americans believe the U.S. has the best health care system in the world, but more than half say it is important that the U.S. is a leader in medical and health research. Furthermore, confidence in the current system in the U.S. for evaluating the safety of vaccines and recommendation for when they should be given dropped to nearly half, compared to 85% in 2008.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;"> </span></p>
<p><span style="font-family: arial, helvetica, sans-serif;"><br />
Among the polling results:</span></p>
<ul>
<li><span style="font-family: arial, helvetica, sans-serif;">70% of Americans agree basic scientific research that advances the frontiers of knowledge, even if it brings no immediate benefits, is necessary and should be supported by the federal government.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">80% of Americans say it’s important that elected officials at all levels listen to advice from scientists.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">78% of Americans say it’s important that our nation supports research that focuses on improving how our health care system is functioning.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">A plurality (44%) say they’re willing to pay more in taxes if they were certain that all of the money would be spent on additional medical research, and</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">More than half (53%) say it’s important to make the R&amp;D tax credit permanent</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">56% of Americans favor expanding federal funding for research using embryonic stem cells.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">More than half (55%) of Americans are willing to share their personal health information to advance medical research. An even higher percentage (60%) say they will share personal health information so that health care providers can improve patient care, and 46% percent are willing to share information so public health officials can better track disease and disability and their causes.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">73% of Americans say the federal government should assign a higher priority to improving education focused on science, technology, engineering and mathematics (STEM) and careers in those fields.</span></li>
<li><span style="font-family: arial, helvetica, sans-serif;">Studies show that certain health problems such as diabetes, heart disease and infant mortality happen more often among minorities or citizens with lower incomes. More than two-thirds of Americans (69%) say it is important to conduct medical or health research to understand and eliminate these differences.</span></li>
</ul>
<p><span style="font-family: arial, helvetica, sans-serif;"> View the full report:  <span class="asset asset-generic at-xid-6a00e5520572bb883401b8d0ddb2fd970c img-responsive"><a href="http://policymed.typepad.com/files/americaspeaksvol15.pdf">Download AmericaSpeaks Volume 15</a></span></span></p>
<p><span style="font-family: arial, helvetica, sans-serif;"><span class="asset asset-generic at-xid-6a00e5520572bb883401b8d0ddb2fd970c img-responsive">Research!America notes that their online polls are conducted with a sample size of approximately 1,000 U.S. adults, age 18+, with a maximum theoretical sampling error of +/- 3.2%. Data are demographically representative of adult U.S. residents. Polling in this publication was conducted by Zogby Analytics.</span></span></p>
<p><span style="font-family: arial, helvetica, sans-serif;"> </span></p>
]]></content:encoded>
					
					<wfw:commentRss>https://www.policymed.com/2015/02/new-poll-shows-majority-americans-are-concerned-about-pace-of-medical-progress-and-agree-with-many-t.html/feed</wfw:commentRss>
			<slash:comments>0</slash:comments>
		
		
			</item>
	</channel>
</rss>