{"id":12040,"date":"2011-08-15T00:44:19","date_gmt":"2011-08-15T04:44:19","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=12040"},"modified":"2011-08-15T01:20:19","modified_gmt":"2011-08-15T05:20:19","slug":"slow-down","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/08\/15\/slow-down\/","title":{"rendered":"slow down&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/pogoblog.typepad.com\/pogo\/2011\/08\/national-physicians-group-protests-fda-attempts-to-allow-industry-influence.html\"><u><strong><font color=\"#200020\">National Physicians Group Protests FDA Attempts to Allow Industry Influence<\/font><\/strong><\/u><\/a><br \/>       <strong><font color=\"#200020\">POGO<\/font><\/strong><br \/>       By PAUL THACKER<br \/>       August 11, 2011<\/div>\n<p>       <\/p>\n<div align=\"justify\">The  uproar over attempts to loosen conflict of interest rules at the   FDA  has prompted a response from the National Physicians Alliance   (NPA), a  collection of doctors who advocate for patients and public   health. Unlike most physician professional societies, The NPA does not accept funding from pharmaceutical or medical device companies. In a letter to FDA Commissioner Margaret Hamburg they wrote:<\/div>\n<ul>\n<div align=\"justify\"><sup>Unavoidable   bias is introduced by reliance on industry-affiliated  experts and has   contributed to patient harms and scandals, such as FDA  panelists with   industry influence advising on decisions surrounding  Vioxx. For this   reason, we strongly encourage you to reconsider any  loosening of   conflict of interest rules for FDA advisers.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">To buttress their case, the NPA points to a study published last year by Mayo Clinic researcher Amy Wang in the <em>British Medical Journal<\/em> which found industry bias in researchers who were funded by pharmaceutical companies.In an accompanying opinion piece, <em>BMJ<\/em> Editor Fiona Godlee wrote: <\/div>\n<ul>\n<div align=\"justify\"><sup>Articles   that gave a favourable view on the risks were  significantly more  likely  to have authors with financial ties to the  manufacturers of  [diabetes  drugs] in general, and [Avandia] in  particular, than those  with  unfavourable views. The significant  association persisted across a  range  of different methods of analysis.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Godlee  also took to task the FDA office headed by Janet Woodcock,   which  approved first Avandia and then sought to keep the drug on the   market  over objections of safety offices inside FDA.<\/div>\n<ul>\n<div align=\"justify\"><sup>People  are now suggesting that the decision on whether to remove a   drug from  the market should not be made by the same people who approved   the drug  in the first place. I agree. What we urgently need is   independent  post-marketing surveillance.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">The pushback against the FDA is getting more and more forceful, and has not escaped the notice of <em>Politico<\/em> or the <em>British Medical Journal<\/em>.&nbsp; As we mentioned in the past, the whole affair seems to be orchestrated by FDA&rsquo;s Janet Woodcock, who appears to be ignoring facts, in favor of rewarding her friends in industry&#8230;<\/div>\n<\/blockquote>\n<div>Recall this from a few days before:    <\/div>\n<blockquote>\n<p align=\"center\"><u><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2011\/08\/retreat-back-to-regulatory-capture-us.html\" target=\"_blank\"><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     <\/p>\n<p><strong>Weakening FDA Conflict of Interest Rules<\/strong><\/p>\n<div>As <u><strong><a href=\"http:\/\/www.reuters.com\/article\/2011\/08\/01\/us-fda-bias-idUSTRE7703R320110801\" target=\"_blank\">reported<\/a><\/strong><\/u> by Reuters,<\/div>\n<div align=\"justify\">\n<ul><sup>U.S. lawmakers likely will change the criteria for advisers  reviewing new medicines next year because of complaints that the rules  meant to prevent conflicts of interest make it harder to find real  experts. Congressional lawmakers may require the Food and Drug Administration to <em>relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers,<\/em> as part of an FDA funding bill.<\/sup><\/ul>\n<\/p><\/div>\n<div align=\"justify\">This was not purely an initiative of legislators, but was egged on by a top FDA administrator<\/div>\n<div align=\"justify\">\n<ul><sup>The agency often must delay panel meetings while it searches  for experts without conflicts, lawmakers and FDA officials say. Top  doctors are usually the ones drugmakers hire as speakers or consultants. <em>&#8216;We have had difficulty in recruiting highly qualified people.<\/em>  And we&#8217;ve had delays in having panels because of this,&#8217; Dr. Janet  Woodcock, head of the FDA&#8217;s drugs center, told a House of  Representatives hearing earlier this month. The result is that 23 percent of FDA advisory panels have vacancies,  more than double the agency&#8217;s stated goal, according to the FDA&#8217;s  quarterly report at the end of May.<\/sup><\/ul>\n<\/p><\/div>\n<div align=\"justify\">The rationale was that those paid by drug and device companies are the most expert:<\/div>\n<ul>\n<div align=\"justify\"><sup>The FDA tightened guidelines in 2007 to minimize industry  ties that could sway a panelist&#8217;s view, partly inspired by the scandal  with Merck&#8217;s pain reliever Vioxx. Ten of the 32 panelists advising the FDA on the drug consulted for  drugmakers. Nine of the 10 recommended putting the drug back on the  market after it was pulled in 2004 over concerns about heart risk.<\/sup><\/p>\n<p> <sup> The restrictions go too far, say lawmakers who want the FDA to approve  more new medicines, in part because they promote American jobs. <em>&#8216;No longer can we deny experts simply because they have ties to industry,<\/em>&#8216;  said Georgia Representative Phil Gingrey during a House of  Representative hearing on FDA funding last month. The committee&#8217;s  chairman, Fred Upton from Michigan, <em>called the conflict of interest rules &#8216;rigid and unrealistic.&#8217;<\/em><\/sup><\/p>\n<p><sup>  <em>Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules.<\/em> Biogen Idec CEO George Scangos said the guidelines &#8216;exclude a lot of people who would be the best qualified.&#8217;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Of course, the drug and device companies have been touting their paid  &quot;key opinion leaders&quot; as the best and the brightest for a long time.  There is plenty of evidence, however, that they are mainly those whom  those companies find the most compliant, and in many cases, those who  are willing to be stealth marketers on those companies&#8217; payrolls.&nbsp;  <strong><font color=\"#200020\">&quot;Key opinion leaders&quot; supported by commercial grant funding may seem  like experts to academic medical institutions&#8217; leadership who now value  outside funding more than teaching and research excellence.<\/font><\/strong><\/div>\n<p>    <\/p>\n<div align=\"justify\">Furthermore, as reported  by Politco, the Project on Government Oversight, a watchdog group,  chastised FDA leadership for exaggerating the difficulty of finding  unconflicted experts, concluding in their letter to the FDA  Commissioner, &quot;to gain the public trust, we must ensure that the FDA  relies on the best available information for its policies, rather than  personal opinions and biases.&quot;&nbsp; So far, government officials seem to be more worried about the opinions of corporate leaders than the public trust&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\">This story is rotten from start to finish with the pharmaceutical industry fighting to maintain its influence on drug approval by the FDA &#8211; Congressmen, even FDA employees involved. But there&#8217;s another aspect of the story worth considering. &quot;<strong><font color=\"#200020\"><em>&#8216;We have had difficulty in recruiting highly qualified people.<\/em>  <em>And we&#8217;ve had delays in having panels because of this<\/em>,<em>&#8216;<\/em> Dr. Janet  Woodcock, head of the FDA&#8217;s drugs center, told a House of  Representatives hearing earlier this month.<\/font><\/strong>&quot; I&#8217;ll bet that&#8217;s true. So many of our academicians, our experts, are tied to the pharmaceutical industry that they&#8217;re having trouble recruiting anyone who is &#8216;clean&#8217; to sit on FDA panels, saying a bunch about how thoroughly the upper ranks of medicine have been infiltrated, or should I say, bought. And what&#8217;s the hurry anyway? If anything, we need to slow down&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>National Physicians Group Protests FDA Attempts to Allow Industry Influence POGO By PAUL THACKER August 11, 2011 The uproar over attempts to loosen conflict of interest rules at the FDA has prompted a response from the National Physicians Alliance (NPA), a collection of doctors who advocate for patients and public health. Unlike most physician professional [&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-12040","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12040","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=12040"}],"version-history":[{"count":12,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12040\/revisions"}],"predecessor-version":[{"id":12053,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12040\/revisions\/12053"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=12040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=12040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=12040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}