<?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>relationships with industry – Policy & Medicine</title> <atom:link href="https://www.policymed.com/tag/relationships-with-industry/feed" rel="self" type="application/rss+xml" /> <link>https://www.policymed.com</link> <description>Legal, Regulatory, and Compliance Issues</description> <lastBuildDate>Fri, 04 May 2018 18:31:05 +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>relationships with industry – Policy & Medicine</title> <link>https://www.policymed.com</link> <width>32</width> <height>32</height> </image> <item> <title>AMA CEJA 2010: Financial Relationships with Industry in Continuing Medical Education Version 4.0 – Same Report – Same References</title> <link>https://www.policymed.com/2010/05/ama-ceja-2010-financial-relationships-with-industry-in-continuing-medical-education-version-40-same.html</link> <comments>https://www.policymed.com/2010/05/ama-ceja-2010-financial-relationships-with-industry-in-continuing-medical-education-version-40-same.html#comments</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Thu, 20 May 2010 03:45:05 +0000</pubDate> <category><![CDATA[AMA]]></category> <category><![CDATA[American medical association]]></category> <category><![CDATA[appearance]]></category> <category><![CDATA[bias]]></category> <category><![CDATA[CME]]></category> <category><![CDATA[Conflict of Interest]]></category> <category><![CDATA[Continuing medical education]]></category> <category><![CDATA[Council on Judicial and Ethical Affairs]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[relationships with industry]]></category> <guid isPermaLink="false">http://www.policymed.com/ama-ceja-2010-financial-relationships-with-industry-in-continuing-medical-education-version-40-same/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="250" src="https://www.policymed.com/wp-content/uploads/2010/05/groundhog_day.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" /></div>Insanity: doing the same thing over and over again and expecting different results. Albert Einstein, (attributed) US (German-born) physicist (1879 – 1955) In baseball it is three strikes and you are out, at the American Medical Association (AMA) House of Delegates their Council on Ethical and Judicial Affairs (CEJA) is more like the Bill Murray […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="300" height="250" src="https://www.policymed.com/wp-content/uploads/2010/05/groundhog_day.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" /></div><p><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Insanity: doing the same thing over and over again and expecting different results.</span></p> <p class="MsoNormal" style="text-align: center; line-height: normal; margin: 0in 0in 10pt;" align="center"><strong><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="outbind://1-0000000070B47DC5F832454E913D7E6F8CBE2114640D2000/quotes/Albert_Einstein/"><span style="font-family: 'Arial', 'sans-serif'; color: navy;">Albert Einstein</span></a></span></strong><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">, <em>(attributed)</em><br /> <em>US (German-born) physicist (1879 – 1955)</em></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In baseball it is three strikes and you are out, at the American Medical Association (AMA) House of Delegates their Council on Ethical and Judicial Affairs (CEJA) is more like the Bill Murray Movie </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.imdb.com/media/rm597463040/tt0107048"><span style="font-family: 'Arial', 'sans-serif'; color: purple;">Ground Hog Day</span></a></span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> – Bringing the same recommendations year after year despite the fact that the membership has soundly rejected them.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The American Medical Association (AMA) Council on Ethical and Judicial Affairs (CEJA) released yet again their fourth version <em style="mso-bidi-font-style: normal;"><a href="http://policymed.typepad.com/files/ama-hod---ceja-i---v.4.0-5-18-10.pdf">Report on Financial Relationships with Industry in Continuing Medical Education</a></em> this week.<span style="mso-spacerun: yes;"> </span>The report is basically a word for word copy of the </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://policymed.typepad.com/files/ceja-report-on-cme-2-i-09-1.pdf"><span style="font-family: 'Arial', 'sans-serif';">Winter 2009 version of the report</span></a></span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> that the AMA House of Delegates </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.policymed.com/ama-ceja-2009/"><span style="font-family: 'Arial', 'sans-serif'; color: purple;">referred back to committee</span></a></span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> .</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">There are basically no changes in the tone or wording throughout the document and no changes are made in the document prior to page 5.<span style="mso-spacerun: yes;"> </span>Of the 389 lines leading up to the recommendations only 15 lines were changed.<span style="mso-spacerun: yes;"> </span>All 57 of the references were identical in reference and order to the 2009 report.<span style="mso-spacerun: yes;"> </span>The recommendations are basically word for word the same as the 2009 report.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The ethics report has a conformational bias and fails to mention any of the evidence that contradicts their position or that has been released since their last report.<span style="mso-spacerun: yes;"> </span>They purposely ignored studies released by the Cleveland Clinic, University of California San Francisco and Medscape.<span style="mso-spacerun: yes;"> </span>(We provided the committee copies of the articles)</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The report is constructed to read more like a religious document than a scientific statement and reflects a bias against physician-industry collaboration.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">It also states strongly held beliefs as facts.<span style="mso-spacerun: yes;"> </span>Irrefutable truths are rare in nature yet the authors of the report express a dogma about the evils of physician-industry relationships without a trace of fallibility.<span style="mso-spacerun: yes;"> </span>It is as if their privileged positions somehow confer wisdom and certainty.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Report</span></strong></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 10pt;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In comparing the 2010 Report to 2009, the changes begin on page 5 under the heading of “Ensuring the Independence, Objectivity & Integrity of CME.”<span style="mso-spacerun: yes;"> </span>Specifically, the 2010 Report states that:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“Financial relationships inevitably create conditions that can give rise to conflict of interests. When they do arise, not all conflicts are equally problematic ethically; but even minor conflicts of interest can undermine confidence in the independence and objectivity of the individuals, organizations, or activities involved. In some cases, the <strong style="mso-bidi-font-weight: normal;"><span style="mso-bidi-font-style: italic;">appearance</span></strong> of conflict of interest can be as damaging as the existence of an actual conflict.” </span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Although the three options to address COI are the same (avoid, implement strategies, or both), the 2010 Report clarifies language by noting “conditions that <em style="mso-bidi-font-style: normal;">can</em> <em style="mso-bidi-font-style: normal;">give rise to</em>” conflict of interests.<span style="mso-spacerun: yes;"> </span>The new Report also recognizes that “<em style="mso-bidi-font-style: normal;">not all conflicts are equally problematic ethically” </em>but notes that “<em style="mso-bidi-font-style: normal;">even minor conflicts of interest can undermine confidence.” </em>The 2010 Report however takes the same stance as the previous report by stating that the “<em style="mso-bidi-font-style: normal;">the appearance of conflict of interest can be as damaging as the existence of an actual conflict.”</em></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">If a physician educator talks with someone who works with industry couldn’t that<span style="mso-spacerun: yes;"> </span>give the appearance of conflict?<span style="mso-spacerun: yes;"> </span>Who is going to determine and define what constitutes a “minor” conflict?<span style="mso-spacerun: yes;"> </span>With the new reporting requirements under the Sunshine Act, will every doctor who has received $10 from industry be excluded from leading or contributing to a CME program?<span style="mso-spacerun: yes;"> </span>If so, with 94% of physicians reporting relationships with industry, who does CEJA expect will teach CME?<span style="mso-spacerun: yes;"> </span>This has the potential of setting up a CME police state with colleagues settling personal vendettas accusing one another of “potential conflict of interest.”</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Also troublesome, is the idea that an “appearance” of conflict can be damaging.<span style="mso-spacerun: yes;"> </span>This notion is problematic because physicians have the experience and training necessary to recognize that CME programs are funded by industry.<span style="mso-spacerun: yes;"> </span>Allowing physicians to hear all sources of information equally allows them to determine accordingly what weight to give to each.<span style="mso-spacerun: yes;"> </span>Suppressing these programs for what might “potentially” be bias is unnecessary, and preventing industry funded CME essentially violates First Amendment rights of free speech.<span style="mso-spacerun: yes;"> </span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Next, in addressing how to “Avoid Conditions that Can Compromise the Integrity of CME,” the 2010 Report states that:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“The ethical aspiration should be to avoid the potential for bias or the chance that confidence in the integrity and independence of professional education could be diminished.”</span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">This language is different from 2009 because it adds avoiding the “potential for bias or the chance that confidence in the integrity and independence of professional education.” Everything has the potential for bias, and to suggest that avoiding this potential will protect CME is misguided.<span style="mso-spacerun: yes;"> </span>Physicians are capable of determining when and if programs are biased, and at least three recent studies have shown physicians overwhelmingly believe that industry funded CME is not biased. The 2010 report also adds that “In their roles as” CME providers, content developers, and faculty, physicians should strive to avoid financial relationships with industry.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">With regards to “Exceptional Cases,” the 2010 Report added a new section, which notes that:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“Some essential educational activities may not be feasible without financial or in-kind support from industry—for example, the provision of cadavers or high-cost, sophisticated equipment to train physicians in new surgical procedures or the use of new technologies. Such support may be vital to the professional community, but, like individual financial ties, also creates potential for bias.” </span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In addition, in listing criteria for determining when it is ethically justifiable to permit participation by someone who has a direct, substantial, unavoidable, and irreducible financial interest in a CME activity, the 2010 Report added that:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"><span style="mso-tab-count: 1;"> </span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“Comparable criteria might apply when an educational activity cannot reasonably be carried out without financial or in-kind support from sources that have a direct financial interest in physicians’ clinical recommendations.”</span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">CEJA Recommendations</span></strong></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The 2010 Report <span style="color: #010202;">adds that financial and/or in-kind support of CME from sources that have a direct financial interest in physicians’:</span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“Creates conditions in which financial interests could influence the availability and/or content of education. Similarly, current, recent (within the preceding 12 months), or anticipated (e.g., royalties or ownership interest) financial relationships between such firms and individuals who develop content for or teach in CME create conditions in which CME content may be influenced inappropriately.”</span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The 2010 Report also adds the recommendation that </span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“<span style="color: #010202;">When possible, CME should be provided without funding or in-kind support from sources that have a direct financial interest in physicians’ clinical recommendations, and individuals who develop content for or teach in CME should have no current, recent, or anticipated direct financial interest in the educational subject matter, since avoiding such arrangements strengthens the confidence that physicians acquire and maintain knowledge, skills, and values that are independently judged important by the profession.”</span></span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CEJA 2010 report recommendation also notes that:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"><span style="mso-tab-count: 1;"> </span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><em style="mso-bidi-font-style: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“In some circumstances, however, access to appropriate, high quality, independent CME may be seriously impaired if support from industry is refused. For example, when expensive equipment is needed, accepting funds or in-kind support from multiple, competing firms might result in more independence than refusing such support. When such support is needed, physicians who organize CME, teach in CME, or have other roles in continuing physician education should adhere to the guidelines below to protect the interests of patients and promote the integrity and independence of education. </span></em></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">As a result, the 2010 Report made these same recommendations as last year’s report:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.75in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">1.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">When funding or in-kind support is provided by sources with a direct financial interest in physicians’ recommendations:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.25in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="1" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l2 level2 lfo1; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The educational activity has been planned by the provider based on needs identified independent of and prior to solicitation or acceptance of the support; and</span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="2" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l1 level2 lfo2; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CME provider can articulate a compelling reason(s) to accept such support for the educational activity or activities; and</span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="3" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l5 level2 lfo3; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CME provider declines any support that is conditioned on the provider’s acceptance of advice or services concerning educational content, faculty, content developers, or other educational matters; and </span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.25in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="4" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l3 level2 lfo4; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The source and magnitude of the funding or in-kind support are clearly disclosed;</span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="5" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l0 level2 lfo5; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CME provider mitigates the potential for influence, for 1 example, through the use of firewalls, blind trusts, having multiple rather than single sources of support, or other mechanisms; and <em style="mso-bidi-font-style: normal;">(New requirement)</em></span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"> <ol style="margin-top: 0in;" start="1" type="1"> <li style="list-style-type: none;"> <ol style="margin-top: 0in;" start="6" type="a"> <li class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; color: #010202; mso-list: l4 level2 lfo6; mso-layout-grid-align: none; tab-stops: list 1.0in;"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CME provider routinely audits the level of industry support it receives to ensure that it maintains the independence and integrity of its educational mission and programs.</span></li> </ol> </li> </ol> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.75in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">2.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">When participation as a content developer or faculty member by an individual who has <em>modest </em>financial relationship with the commercial supporter is necessary to ensure that physicians have access to appropriate, high quality professional education:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">a.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The existence and magnitude of any financial interests are clearly disclosed; and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">b.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Steps are taken to eliminate or mitigate the potential influence of those interests.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.75in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">3.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">When participation as a content developer or faculty member by an individual who has <em>direct, substantial, and unavoidable </em>financial interest in the educational subject matter (e.g., as the inventor of a new device) is required because the individual is a uniquely qualified expert:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">a.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">there is a demonstrated, compelling need for the specific CME activity in the professional community that cannot otherwise be met; and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 2.5in; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">b.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">the CME provider is able to justify its determination that the individual is uniquely qualified; and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 2.5in; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">c.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">steps are taken to mitigate the potential influence of the unavoidable financial interest (e.g., using independent review of content); and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 2.5in; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">d.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">the nature and magnitude of the individual’s specific financial interest in the subject matter are clearly disclosed; and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 2.5in; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 1.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">e.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">the activity contributes overall to the timely development of a pool of qualified, independent experts in the relevant field.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.75in; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.75in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: Arial;">4.</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Arial;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Continuing medical education that is offered for credit has adhered to all applicable professional standards for accreditation.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The change to this part of the recommendations amounted to a simple reordering of the same recommendations for instance:</span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The first guideline is the same as the third guideline from the 2009 report;</span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The second guideline is the same as the fourth guideline from the 2009 report;</span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The third guideline is the same as the fifth guideline from the 2009 report; </span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The 2010 report removes the guideline that </span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">“funding or in-kind support should be provided only by sources that have no direct financial interest in a physician’s clinical recommendations;</span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The fourth guideline in 2010 adds a new requirement that “Continuing medical education that is offered for credit has adhered to all applicable professional standards for accreditation.”</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Discussion</span></strong></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">The CEJA 2010 Report while making very minor changes, has ignored various studies over the past year, which have shown that industry funded CME does not produce bias. This is despite the fact that these studies were provided with confirmed receipt by members of the committee.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In particular, CEJA ignored:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">A </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.policymed.com/2010/02/cleveland-clinic-study-of-cme-bias-found-no-evidence-of-difference-between-supported-and-non-support.html"><span style="font-family: 'Arial', 'sans-serif';">Cleveland Clinic</span></a></span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> study of almost 100,000 participants, which </span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">found no evidence that commercial support results in perceived bias in CME activities, and bias level was quite low for all types of CME activities and was not significantly higher when commercial support was present;</span></p> <p class="MsoNormalCxSpMiddle" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">A study by </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.policymed.com/2009/10/extremely-low-rates-of-bias-reported-in-commercially-supported-cme-activities.html"><span style="font-family: 'Arial', 'sans-serif';">Medscape, LLC</span></a></span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">, </span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">of over 1,000,000 physician CME participants, which found very little reporting of bias (less than 1%) and no difference between bias reported in commercially supported vs. non supported CME activities; and</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in;"> <p class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: -0.25in; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-add-space: auto;"><span style="font-family: Times-Roman; color: #010202; font-size: 12pt; mso-fareast-font-family: Times-Roman; mso-bidi-font-family: Times-Roman;">–</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 7pt; mso-fareast-font-family: Times-Roman;"> </span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">A </span><span style="font-family: 'Times New Roman', 'serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.policymed.com/2010/02/ucsf-study-shows-absence-of-bias-in-commercially-supported-cme-.html"><span style="font-family: 'Arial', 'sans-serif';">UCSF study</span></a></span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> of </span><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">213 directly sponsored live CME activities<span style="color: #010202;">, which found that </span>“the vast majority of CME activities were perceived by participants to be free of commercial bias.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In addition to these studies there is a </span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://policymed.typepad.com/files/acre-response-paper---10-14-09-final.pdf"><span style="font-family: 'Arial', 'sans-serif'; color: purple;">body of evidence</span></a></span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';"> that shows that this relationship with industry is beneficial to society.<span style="mso-spacerun: yes;"> </span>By only including the exact references from previously rejected CEJA reports and not including a single citation from thirty or more provided to the committee, it seems almost unethical for the committee to make these recommendations.<span style="mso-spacerun: yes;"> </span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">By not including a single additional reference to the report reflects the haphazard process that the CEJA committee seems to take after receiving input from their constituencies.<span style="mso-spacerun: yes;"> </span>It’s hard to imagine how much scholarship went into this document, given it is identical to the previous years. To save face CEJA should withdraw this report.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">In failing to address this crucial evidence, CEJA has continued to make the same errors in their recommendations to limit industry interaction, involvement and funding of CME. As their report itself states, “individual physicians have an ethical obligation to dedicate themselves to continue to study, apply, and advance scientific knowledge” and to “maintain a commitment to medical education.”<span style="mso-spacerun: yes;"> </span>This commitment is expected for physicians to “commit themselves to lifelong learning and to maintain their clinical knowledge and skills through CME and other professional development activities.”</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">CEJA must go back to the drawing board and start from scratch.<span style="mso-spacerun: yes;"> </span>They must realize that “industry support for CME helps to meet the costs of programs and activities in the face of uncertain funding from other sources.” It also reduces “costs to individual attendees and makes CME more accessible, especially for physicians in resource poor communities.” </span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">Ultimately, without industry support of CME, 50% of programs would be eliminated immediately, and physicians in rural areas would face significant difficulty finding live programs, and specialists would be left with limited options for learning about new advances in their respective fields.<span style="mso-spacerun: yes;"> </span>These negative consequences would have a significant impact on patient outcomes and would create unnecessary burdens for physicians trying to maintain licenses and stay up-to-date with effective new treatments and technologies. </span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">With the 2010 report continuing to cite that “to date there is no empirical evidence to support or refute the hypothesis that CME activities are biased,” CEJA’s recommendations must be changed, otherwise “access to appropriate, high quality, independent CME will be seriously impaired if support from industry is refused.”</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">This report is about continuing medical education.<span style="mso-spacerun: yes;"> </span>As a medical educator, if your student was sent home with requested changes to his paper it would be highly unlikely that they would then re-submit basically the same paper the next year and unconscionably four semesters in a row and expect to eventually pass.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">With four tries and little effort on CEJA’s part to correct the problem, we recommend that the report be rejected by the House of Delegates once and for all.<span style="mso-spacerun: yes;"> </span>Perhaps we won’t have to relive “</span><span style="font-family: 'Times New Roman', 'serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial;"><a href="http://www.imdb.com/media/rm597463040/tt0107048"><span style="font-family: 'Arial', 'sans-serif'; color: purple;">Ground Hog Day</span></a></span><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt; mso-fareast-font-family: 'Times New Roman';">” yet again.</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">The CEJA Report will be discussed:</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">AMA House of Delegates</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">Location: <span style="mso-tab-count: 1;"> </span>Hyatt Regency Chicago</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">Committee: <span style="mso-tab-count: 1;"> </span>Reference Committee on Amendments to Constitution and Bi Laws</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">Date:<span style="mso-spacerun: yes;"> </span>Sunday June 13, 2010</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">Time: 1pm – 4:00pm</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"><span style="font-family: 'Arial', 'sans-serif'; color: #010202; font-size: 12pt;">Room: <span style="mso-tab-count: 1;"> </span>Regency C</span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none;"> <p><span class="asset"><span style="font-family: 'Arial', 'sans-serif';">June 2010 Version:<span style="mso-spacerun: yes;"> </span><a href="http://policymed.typepad.com/files/ama-hod---ceja-i---v.4.0-5-18-10.pdf">AMA HOD – CEJA I – V.4.0 5-18-10</a></span></span></p> <p class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;"><span class="asset"><span style="font-family: 'Arial', 'sans-serif'; font-size: 12pt;">December 2009 Version: <a href="http://policymed.typepad.com/files/ceja-report-on-cme-2-i-09-1.pdf">CEJA Report on CME 2-I-09</a></span></span></p> <p> </p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2010/05/ama-ceja-2010-financial-relationships-with-industry-in-continuing-medical-education-version-40-same.html/feed</wfw:commentRss> <slash:comments>1</slash:comments> </item> <item> <title>Partners Policy Stifles Innovation</title> <link>https://www.policymed.com/2010/02/partners-policy-stifles-innovation.html</link> <comments>https://www.policymed.com/2010/02/partners-policy-stifles-innovation.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 23 Feb 2010 02:27:00 +0000</pubDate> <category><![CDATA[Academic Organizations]]></category> <category><![CDATA[Conflict of Interest]]></category> <category><![CDATA[Harvard]]></category> <category><![CDATA[medical innovation]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Partners Healthcare]]></category> <category><![CDATA[relationships with industry]]></category> <category><![CDATA[speaking ban]]></category> <guid isPermaLink="false">http://www.policymed.com/partners-policy-stifles-innovation/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="517" height="268" src="https://www.policymed.com/wp-content/uploads/2010/02/feature-dr-1.gif" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" /></div>A recent article in Harvard’s Crimson examined the newly announced changes in Partners’ Conflict of Interest Policy, and how some doctors are concerned about the policy’s reach. We previously wrote that one physician has already resigned because of the new policy. The article mentioned Harvard Medical School assistant professor Paul M. Copeland gives industry-sponsored talks […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="517" height="268" src="https://www.policymed.com/wp-content/uploads/2010/02/feature-dr-1.gif" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p class="MsoNormal" style="margin: 0in 0in 10pt; line-height: normal;"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;">A recent article in </span></span><a href="http://www.thecrimson.com/article/2010/2/19/policy-medical-partners-drug/"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="color: #800080; font-family: Arial;">Harvard’s Crimson</span></span></a><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;"> examined the newly announced changes in Partners’ Conflict of Interest Policy, and how some doctors are concerned about the policy’s reach. We previously wrote that </span></span><a href="http://www.policymed.com/2010/01/partners-physician-resigns-over-speaking-ban.html"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;">one physician has already resigned</span></span></a><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;"> because of the new policy. </span></span></p> <p class="MsoNormal" style="margin: 0in 0in 10pt; line-height: normal;"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;">The article mentioned Harvard Medical School assistant professor Paul M. Copeland gives industry-sponsored talks each year, and heads the endocrinology division at Partners Healthcare-affiliate North Shore Medical Center. He specifically stated that he does not do such talks for the money.</span></span></p> <p><span style="font-family: 'Arial','sans-serif';">He told the Crimson that “these information sessions—or “talks for docs”—improve patient care, and all the material he presents has been approved by the Food and Drug Administration.” Unfortunately for Copeland, he can no longer register for the 2010 speaking cycle because of Partners new policy.</span></p> <p><span style="font-family: 'Arial','sans-serif';">As we have previously explained, the </span><a href="http://www.policymed.com/2010/01/partners-health-care-policy-implementation-on-cme.html"><span style="font-family: 'Arial','sans-serif';">revised policy</span></a><span style="font-family: 'Arial','sans-serif';"> puts restrictions on Partners employees, “including bans on speaking at industry-sponsored events and receiving stock options from pharmaceutical companies. Outside pay for senior officials sitting on boards of drug or medical device-making companies has been capped as well.” The policy considerations began in the fall of 2007, when “Partners Healthcare embarked on a conflict of interest review to better define the relationship between industry and medicine as well as strengthen oversight of physician activity with drug companies.”</span></p> <p><span style="font-family: 'Arial','sans-serif';">Regarded as one of the strictest policies in the nations, “some Partners employees caution that the new restrictions may be too broad and could ultimately stifle essential physician activity.” Specifically, Dr. Copeland asserted that continuing medical education (CME) talks sponsored by drug companies “provide doctors with the latest information on treatments, address patient care issues, and educate physicians about the proper role of medications.” Under the new policy, doctors will be losing this valuable information, and will be forced to receive information elsewhere (where and from who?), and sometimes at a great inconvenience. </span></p> <p><span style="font-family: 'Arial','sans-serif';">He further noted that at CME programs “he regularly fields an hour’s worth of questions from doctors who attend his talks about case studies and alternative treatments.” As a result, Dr. Copeland believes the new policy is so “disheartening” because “Patients and doctors benefit from these talks, and the policy will “have detrimental effects on physicians’ activities, such as continuing medical education.”</span></p> <p><span style="font-family: 'Arial','sans-serif';">The article also cited Medical School professor David B. Acker, who is also chief of obstetrics at Brigham and Women’s, who supports the new policy and believed it came late. In addition, Medical School professor Charles N. Serhan, who served on the committee that issued the policy recommendations, also applauded the policy’s aims to rein in conflicts of interest issues, but he “cautioned that its expansive reach does not come without costs.”</span></p> <p><span style="font-family: 'Arial','sans-serif';">As a member of the committee who issued the recommendations, he told the Crimson that as a result of the policy, “the pendulum is a little too far in one direction in that our rules are now too tight and could actually stifle innovation.” Consequently, Dr. Serhan asserted that “with time, the policy has to come back to some equilibrium.” Such comments are problematic as a member of the committee itself admits the new policy to be extreme. </span></p> <p><span style="font-family: 'Arial','sans-serif';">Mass. General’s chief surgeon Andrew L. Warshaw also noted his concerns with the new policy in regards to “certain initiatives such as surgical fellowships, which are generally dependent on industry funding. He noted that although he understood the goals of the policy, the impact may cause these fellowships to “suffer from the crackdown on outside funding.” He further gave the example of a general surgeon who wanted to learn minimally invasive techniques, a scenario that is commonly funded by outside interests, and asked: “Is it a bad thing when someone gets training that they wouldn’t normally get and helps patients?”</span></p> <p><span style="font-family: 'Arial','sans-serif';">Another clinical professor at the Medical School, Barry W. Levine, who has worked at Mass. General for four decades, “says he is still figuring out how the new policy will impact his profession.” Dr. Levine’s experience consists of 18 years of speaking about lung disease on behalf of drug companies like AstraZeneca and GlaxoSmithKline. He told the Crimson that “he does not plan to take on any more speaking engagements until the implications of the policy become clearer.”</span></p> <p><span style="font-family: 'Arial','sans-serif';">Like Dr. Copeland, Dr. Levine believes “the new regulations stymie critical education about asthma and emphysema for doctors in underprivileged communities.” For example, “he routinely meets physicians who do not have access to pulmonary function machines, which are critical for diagnosing these diseases.” Dr. Levine firmly believes that such meetings are not promoting a drug. He also added that “the drug companies sponsoring the talks he participates in have no power to censor what materials physicians present, as long as the information has been approved by the FDA.”</span></p> <p class="MsoNormal" style="margin: 0in 0in 10pt; line-height: normal;"><span style="font-family: Arial;"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;">As other physicians and institutions consider the effect of this policy and alternatives, committees should consider answering the following question presented by Dr. Copeland: </span><span style="mso-bidi-font-family: Arial;">“Is it a bad thing when someone gets training that they wouldn’t normally get and helps patients?” In answering that question, committees should recognize that regardless of the source of funding, the training <em style="mso-bidi-font-style: normal;">will</em> help patients. </span></span></p> <p class="MsoNormal" style="margin: 0in 0in 10pt; line-height: normal;"><span style="mso-bidi-font-family: Arial; mso-bidi-font-size: 12.0pt;"><span style="font-family: Arial;">Ultimately, the growing concern among doctors at Harvard and at Partners regarding the new conflict policies will have to resolve the difficult question of maintaining the necessary relationship between industry and medicine without distorting physician incentives. As is evident from the doctors cited above, the current policy places restrictions that “may be too broad and could ultimately stifle essential physician activity.” Moreover, as one of the committee members who created the policy himself stated, bringing the policy back to “equilibrium” now is critical before it stifles innovation. </span></span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2010/02/partners-policy-stifles-innovation.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Boston Magazine Features Thomas Stossel, MD Co-Founder of Association of Clinical Researchers and Educators</title> <link>https://www.policymed.com/2009/11/boston-magazine-features-thomas-stossel-md-co-founder-of-association-of-clinical-researchers-and-educators.html</link> <comments>https://www.policymed.com/2009/11/boston-magazine-features-thomas-stossel-md-co-founder-of-association-of-clinical-researchers-and-educators.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 02 Nov 2009 06:21:42 +0000</pubDate> <category><![CDATA[ACRE]]></category> <category><![CDATA[Editorials]]></category> <category><![CDATA[Boston Magazine]]></category> <category><![CDATA[Harvard Medical School]]></category> <category><![CDATA[Marcia Angell-Relman]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[relationships with industry]]></category> <category><![CDATA[Thomas Stossel]]></category> <guid isPermaLink="false">http://www.policymed.com/boston-magazine-features-thomas-stossel-md-co-founder-of-association-of-clinical-researchers-and-educators/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="199" height="263" src="https://www.policymed.com/wp-content/uploads/2009/11/BostonMagazineCover.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>Last week Boston Magazine feature the Association of Clinical Researchers and Educators in an article titled: Bitter Pills: Harvard Medical School is under fire from critics for its ties to Big Pharma. While the school tries to sort it all out, two professors battle for its soul. They feature two Harvard Professors Marcia Angell-Relman, MD […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="199" height="263" src="https://www.policymed.com/wp-content/uploads/2009/11/BostonMagazineCover.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p class="MsoNormal" style="margin: 0in 0in 3.4pt; line-height: 12.25pt; mso-margin-top-alt: auto; mso-outline-level: 2;"><span style="font-size: 12pt; font-family: 'Arial','sans-serif';">Last week Boston Magazine feature the Association of Clinical Researchers and Educators in an article titled: </span><span lang="EN" style="font-size: 12pt; text-transform: uppercase; color: #333333; font-family: 'Arial','sans-serif'; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-weight: bold; mso-font-kerning: 18.0pt; mso-ansi-language: EN;"><a href="http://www.bostonmagazine.com/articles/bitter_pills/"><span style="color: #800080;">Bitter Pills: <span style="text-transform: none; mso-font-kerning: 0pt;">Harvard Medical School is under fire from critics for its ties to Big Pharma. While the school tries to sort it all out, two professors battle for its soul<strong>.</strong></span></span></a></span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-font-kerning: 18.0pt; mso-ansi-language: EN;">They feature two Harvard Professors Marcia Angell-Relman, MD a former acting editor and chief at the New England Journal of Medicine who wants Harvard to adopt a policy of </span><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">basically cutting all ties to drug makers. <span style="mso-spacerun: yes;"> </span>In her words doctors “should have no financial interest in companies whose products they are evaluating,” she argues. No stocks. No money for speaking or writing for industry forums. Drug reps shouldn’t be allowed on campus.</span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">In combating her cut all ties approach is Thomas Stossel, MD<span style="mso-spacerun: yes;"> </span>a Harvard hematologist <span style="mso-spacerun: yes;"> </span>and brother of libertarian journalist John Stossel. When Angell wrote an op-ed in the <em><span style="font-family: 'Arial','sans-serif';">Globe</span></em> several months ago, Stossel promptly penned a rebuttal in <em><span style="font-family: 'Arial','sans-serif';">Forbes</span></em>. When Stossel was invited to speak at a 2007 public panel on pharma influence issues, Angell blasted the choice, saying that to include him amounted to “standing the whole thing on its head.” The two are “matter and antimatter,” says one acquaintance. “Put them in the same room and the universe might explode.” </span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">In fact, Angell and Stossel have been in the same room at least once. At what should have been a fairly dry meeting of the American Society of Hematology in 2002, they gave dueling talks. Angell spoke in broad terms about the “dissolving” boundaries between academia and industry; the fact that medical meetings had become “a massive trade show…with free goodies.” Stossel got more personal. “I don’t need to feel morally superior to drug companies,” he said. “Let’s object to sanctimony.” Today, in person, he’s even more barbed: When it comes to research credentials, he says, “I don’t even consider myself in the same universe as Marcia Angell.” </span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">Like Angell, Stossel is well aware that Harvard physicians pull in a lot of money from drug companies. Unlike Angell, he sees that as a good thing. Stossel traces improvement in Americans’ health directly to breakthroughs funded by the pharmaceutical industry. Limit doctors’ interactions with that industry, he argues, and you limit the power of the market to drive innovation. </span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">Stossel also argues that the various controversies concerning Harvard and Big Pharma are overblown. The Pfizer rep with the cell phone wasn’t plotting a corporate takedown of the student protesters; he was taking photos of a public event out of personal interest. The professor who didn’t reveal his links to cholesterol drugs wasn’t technically doing anything wrong; Harvard only now requires that doctors disclose conflicts of interest in all public venues, including classrooms. </span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">Stossel even refuses to condemn Biederman, the child psychiatrist, though he won’t quite defend him, either. “The second you show me solid evidence that he should have backed off on some conclusion and didn’t, he’s toast,” says Stossel. “But I bet what [the ongoing investigation] will find is that he didn’t do anything wrong.” Besides, he points out, having one bad apple among almost 10,000 faculty members is a risk worth taking. “We have to tolerate some bad behavior if we want progress,” he says. </span></p> <p style="line-height: 12.25pt;"><span lang="EN" style="font-family: 'Arial','sans-serif'; mso-ansi-language: EN;">This past summer Stossel cofounded the Association of Clinical Researchers and Educators (ACRE), an advocacy group for doctor/drug company partnerships. It has been ruthlessly parodied—most notably as Academics Craving Reimbursement for Everything—but it has also attracted some followers, even among Harvard med students, some of whom say they’re uncomfortable with the protesters’ divisive stance. Angell’s acolytes are “a vocal minority,” says Vijay Yanamadala, a med student who sides with Stossel. “We all agree on more than we disagree.” </span></p> <p class="MsoNormal" style="margin: 0in 0in 10pt;"><span lang="EN" style="font-size: 12pt; line-height: 115%; font-family: 'Arial','sans-serif'; mso-font-kerning: 18.0pt; mso-ansi-language: EN;">This article outlines that Harvard is currently revising their conflict of interest policies but will not be cutting back on all ties to industry as some like Angell-Relman would like.</span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2009/11/boston-magazine-features-thomas-stossel-md-co-founder-of-association-of-clinical-researchers-and-educators.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel> </rss>