{"id":11799,"date":"2011-08-09T00:57:04","date_gmt":"2011-08-09T04:57:04","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=11799"},"modified":"2011-08-09T22:56:39","modified_gmt":"2011-08-10T02:56:39","slug":"time-for-some-potentially-disillusioning-research","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/08\/09\/time-for-some-potentially-disillusioning-research\/","title":{"rendered":"time for some [potentially disillusioning] research&#8230;"},"content":{"rendered":"<div align=\"justify\">Dr. Poses has a troubling post up at Healthcare Renewal about recent developments in important reform measures. He mentions a weakening of the FDA COI rules, a weakening of the NIH COI policies, and backing down from disbarring the Forest Laboratories CEO. All are disturbing developments. I&#8217;ve included his comments on the NIH COI policies:<\/div>\n<blockquote>\n<div align=\"center\"> <u><strong><a target=\"_blank\" href=\"http:\/\/hcrenewal.blogspot.com\/2011\/08\/retreat-back-to-regulatory-capture-us.html\"><font color=\"#200020\">Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off<\/font><\/a><\/strong> <\/u><br \/>   <strong><font color=\"#200020\">Healthcare Renewal<\/font><\/strong><br \/>  by Roy Poses<br \/>  August 8, 2011<\/div>\n<p align=\"justify\"><sup>After some brave words about transparency, integrity and all that, US  government officials seem to be running back to the arms of the health  care corporate CEOs.<\/sup><\/p>\n<div><sup><strong>Weakening FDA Conflict of Interest Rules<\/strong><\/sup><\/div>\n<div align=\"justify\"><sup> &#8230;<\/sup><\/div>\n<div><sup><strong>Weakening NIH Conflict of Interest<\/strong><\/sup><\/div>\n<div><sup>As <u><strong><a target=\"_blank\" href=\"http:\/\/http\/\/www.nature.com\/news\/2011\/110801\/full\/476017a.html\">discussed<\/a><\/strong><\/u> in Nature,<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup>Francis Collins hailed it as a <em>&#8216;new era of clarity and transparency in the management of financial conflicts of interest&#8217; <\/em>(S.  J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400&ndash;2402; 2010).  But the director of the US National Institutes of Health (NIH) may have <em>spoken too soon<\/em>  when he described a new rule, proposed last year, that would require  universities and medical schools to publicly disclose online any  financial arrangements that they believe could unduly influence the work  of their NIH-funded researchers. Nature has learned that <em>a cornerstone of that transparency drive &mdash; a  series of publicly accessible websites detailing such financial  conflicts &mdash; has now been dropped<\/em>.<\/sup><\/div>\n<\/ul>\n<div><sup>In more detail,<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup>The NIH&#8217;s parent agency, the Department of Health and Human  Services (DHHS), proposed the new rule in May 2010, after congressional  and media investigations revealed that prominent NIH grant recipients  had failed to tell their universities or medical schools about lucrative  payments from companies that may have influenced their  government-funded research. The DHHS called the proposed websites &#8216;an  important and significant new requirement to&thinsp;&hellip; underscore our commitment  to fostering transparency, accountability, and public trust&#8217;. Under the  proposal, institutions with NIH-funded researchers would determine,  grant by grant, if any financial conflicts existed for senior scientists  on the grant. For example, these would include receiving consultancy  fees, or holding shares in a company, &#8216;that could directly and  significantly affect the design, conduct, or reporting&#8217; of the research.  The institutions would post the details online, where they would stay  for at least five years.<\/sup><\/div>\n<\/ul>\n<div><sup>But of course the medical schools decided that it would just be too much trouble to do all this:<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup>&#8216;The websites don&#8217;t appear out of nowhere,&#8217; says Heather  Pierce, senior director of science policy at the Association of American  Medical Colleges (AAMC) in Washington DC. They would <em>&#8216;require  employees to not only create the website but to pull the information,  review it, and make sure it is up to date and accurate&#8217;.<\/em><\/sup><sup><em> <\/em>That is not the only objection from the powerful academic lobbies.  During the public comment period last summer, the Association of  American Universities and the AAMC submitted a joint statement saying:  &#8216;There are serious and reasonable concerns among our members that the  Web posting will be of little practical value to the public and, without  context for the information, could lead to confusion rather than  clarity regarding financial conflicts of interest and how they are  managed.&#8217;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><sup>  Given how academic medical institutions have expanded their  administrations and bureaucracy, the enormous amounts they spend on  management, and the huge <u><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/search\/label\/executive%20compensation\">compensation<\/a><\/strong><\/u>  they give their executives, and further given how much of their  revenues come from government sources (Medicare, Medicaid money for  patient care, Veterans Administration money supporting many faculty  members, Medicare money funding graduate medical education, and NIH and  other government research grants), the notion that getting a few  staffers to process disclosures would be administratively or financially  burdensome is just laughable.<\/sup><\/div>\n<p>  <\/p>\n<div align=\"justify\"><sup>  At least Iowa&#8217;s Republican Senator Charles Grassley, seemingly one of  the last politicians in Washington who cares about the integrity of  government programs and spending, is upset. As <u><strong><a target=\"_blank\" href=\"http:\/\/blogs.nature.com\/news\/2011\/08\/senator_urges_white_house_not.html\">reported<\/a><\/strong><\/u> again by Nature,<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup>The US Senate&#8217;s leading advocate for government transparency  wrote today to the White House&#8217;s budget office, demanding that it  protect a proposed rule that would obligate universities to post their  publicly-funded biomedical researchers&#8217; financial conflicts on a  publicly accessible website.<\/sup><sup><em> The public&#8217;s business should be public<\/em>&#8230; I urge OMB to follow  through and approve a rule that includes a publicly available website,&#8217;  Senator Charles Grassley, Republican of Iowa &#8230;, wrote in in <u><a target=\"_blank\" href=\"http:\/\/blogs.nature.com\/news\/Grassley.omb.pdf\"><strong>this letter<\/strong><\/a><\/u> to Jacob Lew, the director of the White House&#8217;s Office of Management and Budget (OMB).<\/sup><\/div>\n<\/ul>\n<div><sup>  Furthermore, he wrote:<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup><em>I am troubled that taxpayers cannot learn about the  outside income of the researchers whom the taxpayers are funding, and  this flies in the face of President Obama&#8217;s call for more transparency  in the government.<\/em><\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><sup>  We will see if his protest does any good, but again it appears that  government officials are more worried about the revenues of big health  care organizations than the needs of the public.<\/sup><\/div>\n<p>  <\/p>\n<div><sup><strong>Retreating from Threats to Disbar Forest Laboratories CEO<\/strong><\/sup><\/div>\n<div align=\"justify\"><sup>&#8230;<\/sup> <\/div>\n<div align=\"justify\"><sup><strong>Summary<\/strong>  After a bit of blustering by the current US administration about  transparency and integrity it appears to be back to business as usual in  the US capital. Over the last 20 years, government has increasingly  answered to corporate CEOs instead of &quot;we, the people.&quot; Protecting  patients&#8217; and the public&#8217;s health has given way to protecting the  financial health of large health care organizations, and the  compensation of rich CEOs. Federalism is giving way to corporatism. As  long as this continues, expect our health care system to continue its  slow collapse. Eventually, expect the CEOs to get in their private jets  and escape while the rest of us picks up the pieces.  Until we dispel the fog of corporatism that has spread over the  government that was once supposed to be of the people, by the people,  and for the people, expect no real health care reform, and expect  continuing rising costs, declining access, and worsening patient care.  Obviously, true health care reform would start with the government and  its officials putting patients&#8217; and the public&#8217;s health first, way ahead  of the financial comfort of corporate CEOs.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\"><img decoding=\"async\" width=\"200\" vspace=\"3\" hspace=\"4\" border=\"1\" align=\"right\" src=\"http:\/\/consusrankings.com\/wp-content\/uploads\/2008\/03\/princeton-university-006-290x200.jpg\" \/>The two recent surveys showing the increase in prescriptions of psychoactive drugs by Primary Care Physicians posted below [<u><a href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/08\/08\/medicine-at-its-worst\/\" target=\"_blank\"><strong>medicine at its worst&hellip;<\/strong><\/a><\/u>] highlight the stakes involved in reform, and the Hospital Corporations and PHARMA lobbies will not go down easily. In spite of all the punitive settlements against PHARMA, they&#8217;ve still made a killing, and they are obviously fighting tooth and toenail to block the needed reforms and transparency. It would be naive to assume that reform would be easy. Senator Grassley is a Saint, maybe the first Republican Saint since Lincoln, but he can&#8217;t do it by himself. But the part that gets to me is that the Academic Institutions are on the wrong side of this battle. &quot;<strong>During the public comment period last summer, the Association of   American Universities and the AAMC submitted a joint statement saying:   &#8216;There are serious and reasonable concerns among our members that the   Web posting will be of little practical value to the public and, without   context for the information, could lead to confusion rather than   clarity regarding financial conflicts of interest and how they are   managed.&#8217;<\/strong>&quot; There&#8217;s something terribly wrong about that alignment. That&#8217;s something that I just don&#8217;t understand. My notion of academia must be even more naive than I know. I guess it&#8217;s time for some [potentially disillusioning] research&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Poses has a troubling post up at Healthcare Renewal about recent developments in important reform measures. He mentions a weakening of the FDA COI rules, a weakening of the NIH COI policies, and backing down from disbarring the Forest Laboratories CEO. All are disturbing developments. I&#8217;ve included his comments on the NIH COI policies: [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-11799","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11799","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=11799"}],"version-history":[{"count":12,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11799\/revisions"}],"predecessor-version":[{"id":11890,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11799\/revisions\/11890"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=11799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=11799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=11799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}