{"id":40587,"date":"2013-10-07T10:45:38","date_gmt":"2013-10-07T14:45:38","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=40587"},"modified":"2013-10-07T10:49:18","modified_gmt":"2013-10-07T14:49:18","slug":"why-indeed","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/10\/07\/why-indeed\/","title":{"rendered":"why indeed?&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.washingtonpost.com\/business\/economy\/pharmaceutical-firms-paid-to-attend-meetings-of-panel-that-advises-fda-e-mails-show\/2013\/10\/06\/a02a2548-2b80-11e3-b139-029811dbb57f_story.html\" target=\"_blank\">Pharmaceutical firms paid to attend meetings of panel that advises FDA<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Washington Post<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By Peter Whoriskey<\/div>\n<div align=\"center\" class=\"small\">October 6, 2013<\/div>\n<p>              <\/p>\n<div align=\"justify\">A scientific panel that shaped the federal government&rsquo;s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.  The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group &ldquo;an essential collaborative effort&rdquo;&#8230;<\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.jsonline.com\/watchdog\/watchdogreports\/emails-point-to-troubling-relationship-between-drug-firms-regulators-b99113286z1-226692641.html\" target=\"_blank\">Emails point to &#8216;troubling&#8217; relationship between drug firms, regulators<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Milwaukee&middot;Wisconsin Journal Sentinel<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By John Fauber<\/div>\n<div align=\"center\" class=\"small\">October 6, 2013<\/div>\n<p>              <\/p>\n<div align=\"justify\">Federal health industry regulators and executives of companies that make pain drugs have held private meetings at expensive hotels at least once a year since 2002 through an organization funded by the drug companies, according to emails obtained through public records requests and provided to the Journal Sentinel\/MedPage Today.  Each year a handful of drug companies have paid up to $35,000 each to send a representative to meetings of IMMPACT, where they could discuss clinical trial testing procedures with officials from the U.S. Food and Drug Administration and other government agencies. IMMPACT&#8217;s stated goal is to improve the design of clinical trials conducted to develop new pain treatments.  The emails raise concerns about a pay-for-play arrangement in which drug companies were able to buy access to invitation-only meetings where they could meet with FDA officials and affect FDA pain drug policy, said Michael Carome, director of health research for the watchdog group Public Citizen&#8230; <\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.immpact.org\/index.html\">Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials<\/a><\/div>\n<p>       <\/p>\n<div align=\"justify\">The mission of the Initiative on Methods, Measurement, and Pain  Assessment in Clinical Trials [IMMPACT] is to develop consensus reviews  and recommendations for improving the design, execution, and  interpretation of clinical trials of treatments for pain. The first  IMMPACT meeting was held in November 2002, and there have been a total  of sixteen consensus meetings on clinical trials of treatments for pain &#8211;  fourteen on trials for chronic pain in adults, one on trials for acute  pain in adults, and one on trials for pediatric acute and chronic pain.  Invited participants come from academia, regulatory agencies [US Food  and Drug Administration, European Medicines Agency], US National  Institutes of Health, US Veterans Administration, consumer support and  advocacy groups, and industry. The disciplines represented at meetings  varies but has included anesthesiology, clinical pharmacology, internal  medicine, law, neurology, nursing, oncology, outcomes research,  psychology, rheumatology, and surgery. For all IMMPACT meetings, an  attempt is made to include broad representation while limiting the size  of the meeting to promote vigorous and frank discussion and debate&#8230;<\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<p align=\"justify\">These stories are so common that it&#8217;s easy to become inured to hearing them and let them just drift away:<\/p>\n<table cellspacing=\"0\" cellpadding=\"o\" border=\"0\" align=\"center\">\n<tr>\n<td><sup><\/p>\n<div align=\"justify\">in&middot;ure  [in(y)oor]<\/div>\n<div align=\"justify\">verb<\/div>\n<ul>\n<div align=\"justify\">1. accustom [someone] to something, esp. something unpleasant&#8230;<\/div>\n<\/ul>\n<p>            <\/sup><\/td>\n<\/tr>\n<\/table>\n<p>    <\/p>\n<div>Well, here&#8217;s a little something that might help make this one stick in your mind:        <\/div>\n<blockquote>\n<div align=\"right\" class=\"big\">from the <strong><font color=\"#200020\">Journal Sentinel<\/font><\/strong><\/div>\n<p align=\"justify\">&quot;The whole picture is a troubling one and it warrants an independent investigation,&quot; said Carome, who has seen the emails. <strong><font color=\"#990000\">Carome pointed to an initiative that sprang from the IMMPACT meetings  &mdash; a new FDA policy on how to conduct clinical trials of drugs. The new  method, known as enriched enrollment, allows drugs companies to weed out  people who don&#8217;t respond well to a drug or who can&#8217;t tolerate taking it  before the actual clinical trial begins.<\/font><\/strong> Experts say that approach makes it much more likely a drug will prove  effective and possibly win FDA approval. It&#8217;s also cheaper for drug  companies to conduct such trials.<\/p>\n<p align=\"justify\">However, the approach has drawn criticism because it essentially  stacks the deck in favor of the drug. More importantly, experts say,  drugs tested that way are not likely to reflect what will happen when a  drug gets on the market and is prescribed for large numbers of people. &quot;It&#8217;s in fact cheating,&quot; said Patrick McGrath, a pediatric pain expert at the Dalhousie University in Halifax, Nova Scotia.<\/p>\n<div align=\"justify\">On its website, the FDA says enriched enrollment is a potentially  powerful strategy for the pharmaceutical industry because, when used  appropriately, it can result in smaller studies, shortened drug  development time and lower development costs. &quot;While enrichment won&#8217;t save a drug that doesn&#8217;t work, it will help  find one that will,&quot; Bob Temple, the agency&#8217;s deputy director for  clinical science, wrote in a piece posted on the FDA&#8217;s website last  December&#8230;<\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<div align=\"justify\">Here&#8217;s that article from the FDA about enrichment enrollment. The examples given make perfect sense, and make no mention of the fact that the idea comes from IMMPACT or that it might be used in trials of pain medications. But perhaps there&#8217;s a hint in the title &quot;<strong><font color=\"#200020\">More successful Drug Trials<\/font><\/strong>&quot; rather than &quot;<strong><font color=\"#200020\">More Effective Drugs<\/font><\/strong>&quot;:    <\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/blogs.fda.gov\/fdavoice\/index.php\/tag\/clinical-trial-enrichment\/\">Strategies for More Successful Drug Trials<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">FDA Voice<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By Bob Temple, M.D.<\/div>\n<div align=\"center\" class=\"middlel\">FDA Deputy Director for Clinical Science<\/div>\n<div align=\"center\" class=\"small\">December 17, 2012<\/div>\n<p>        <\/p>\n<div align=\"justify\">Today FDA is issuing a <a target=\"_blank\" href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM332181.pdf\">draft guidance<\/a> that spells out how drug developers can use such strategies, known as clinical trial enrichment, to greatly increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective. These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs.<\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<div align=\"justify\">Abuse of prescription pain medications is a major public health problem in the US &#8211; rampant here in the southern wild. Volunteering in a free charity clinic, I had so many people hitting me up for pain medications that I modified my DEA certification to eliminate my ability to even prescribe them. There&#8217;s no reason for a psychiatrist to prescribe those drugs anyway. In other instances, I&#8217;m still enough of an Internist to refill our patients&#8217; medical drugs when I see them to provide relief to our overworked primary care docs, but not &quot;<em>pain meds<\/em>&quot;. I can now honestly say, &quot;<em>Can&#8217;t do it<\/em>,&quot; because &quot;<em>Won&#8217;t do it<\/em>&quot; just lead to arguments and fights. Life is too short for such things. The notion that we need to grease the wheels of Clinical Trials to get more <em>pain meds<\/em> on the market is genuinely irrational. It&#8217;s an area where we&#8217;re doing just fine [since the dawn of time]. Reading Dr. Temples&#8217; FDA write up, it sounds like an area where <em>pain meds<\/em> should be banned from enriched enrollment rather than the program&#8217;s bedrock. <\/div>\n<p><\/p>\n<div align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"110\" border=\"0\" align=\"left\" hspace=\"4\" height=\"100\" src=\"http:\/\/1boringoldman.com\/images\/whistleblower.gif\" \/>Another reason this story ought to stick in your mind is that it involves <strong><font color=\"#200020\">Academia<\/font><\/strong>, the government&#8217;s <strong><font color=\"#200020\">FDA<\/font><\/strong>, and <strong><font color=\"#200020\">PHARMA<\/font><\/strong>, and it has been <a target=\"_blank\" href=\"http:\/\/www.immpact.org\/meetings.html\">going since 2002<\/a> without anyone making any noise. The potential for Conflict of Interest jumps off the page in these articles, yet silence has prevailed for over a decade. Why hasn&#8217;t there been a whistleblower? Why indeed!&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Pharmaceutical firms paid to attend meetings of panel that advises FDA Washington Post By Peter Whoriskey October 6, 2013 A scientific panel that shaped the federal government&rsquo;s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-40587","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/40587","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=40587"}],"version-history":[{"count":21,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/40587\/revisions"}],"predecessor-version":[{"id":40608,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/40587\/revisions\/40608"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=40587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=40587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=40587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}