{"id":33217,"date":"2013-02-08T17:25:14","date_gmt":"2013-02-08T22:25:14","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=33217"},"modified":"2013-02-08T17:29:43","modified_gmt":"2013-02-08T22:29:43","slug":"words-to-be-later-eaten","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/02\/08\/words-to-be-later-eaten\/","title":{"rendered":"words to be later eaten&#8230;"},"content":{"rendered":"\n<div align=\"justify\">I started to list all the links to the bruhaha brewing over the <strong><font color=\"#990000\">AllTrials<\/font><\/strong> petition, but decided to summarize instead. There&#8217;s much posturing around the <strong><font color=\"#990000\">Alltrials<\/font><\/strong> petition, and all parties have behaved in an exemplary fashion [except for the other guys]. That&#8217;s it, the whole summary &#8211; meaning that the games have begun. Meanwhile, there are 28,000+ signatures on the petition and Ben Goldacre&#8217;s <strong><font color=\"#200020\">Bad Pharma<\/font><\/strong> was released three days ago. Here&#8217;s one comment for flavoring:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/phrma.org\/media\/releases\/phrma-statement-clinical-trials-bad-pharma\" target=\"_blank\">PhRMA Statement on Clinical Trials and Bad Pharma<\/a><\/div>\n<div class=\"meta\">     <\/div>\n<p>             <\/p>\n<div align=\"justify\"><sup><strong>WASHINGTON, D.C. [February 4, 2013] <font color=\"#200020\">Pharmaceutical  Research and Manufacturers of America<\/font> (PhRMA) Executive Vice President  Josie Martin&nbsp;issued the following statement today:<\/strong><\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup><strong>Dr. Ben Goldacre&rsquo;s book <em>Bad Pharma<\/em> provides a one-sided and factually questionable view of the clinical trial process&nbsp;led  by the innovative biopharmaceutical sector. The book ignores that the  current clinical trial system, which is essential to the development of  new medicines that save and improve lives, is scientifically rigorous,  tightly regulated and working well. &ldquo;The book&rsquo;s unfounded and sensational claims&nbsp;may  attract attention, but they do not advance biomedical science or  patient health. Based on cherry-picked examples and incomplete stories,  the accusations leave countless unanswered questions that could threaten  public health and the development of future medicines. Criticizing the  research process without acknowledging the vigorous oversight&nbsp;and broad commitment&nbsp;to  safe and ethical conduct is a disservice to the tens of thousands of  scientists exploring new medicines and the millions of patients hoping  for cures&#8230;<\/strong><\/sup><\/div>\n<div align=\"center\"><img decoding=\"async\" vspace=\"7\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<div align=\"justify\"><sup><strong>The demands by Dr. Goldacre and the British Medical Journal (BMJ) to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.  It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients. The FDA has the most advanced and rigorous review process for potential new medicines and it is continuously improving its regulatory and scientific capabilities.<\/strong><\/sup><\/div>\n<div align=\"center\"><img decoding=\"async\" vspace=\"7\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/ul>\n<\/blockquote>\n<p align=\"justify\">Why so snappy? Here&#8217;s a paragraph from the introduction to <a href=\"http:\/\/www.amazon.com\/Bad-Pharma-Companies-Mislead-Patients\/dp\/0865478007\" target=\"_blank\">Bad Pharma<\/a>:<\/p>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.amazon.com\/Bad-Pharma-Companies-Mislead-Patients\/dp\/0865478007#reader_B008PCVGKI\"><img decoding=\"async\" vspace=\"7\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/goldacre-1.gif\" \/><\/a><\/div>\n<div align=\"justify\">That&#8217;s why.<\/div>\n<p align=\"justify\"> <img loading=\"lazy\" decoding=\"async\" width=\"150\" hspace=\"4\" height=\"103\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/drama.gif\" \/>Ben Goldacre has been writing about these matters for quite a while, but it appears that his widely viewed TED Talks have skyrocketed him into a position of leadership. He has that combination of qualities that are tailor-made for the job: he&#8217;s <img decoding=\"async\" width=\"110\" vspace=\"4\" hspace=\"4\" border=\"1\" align=\"left\" src=\"http:\/\/1boringoldman.com\/images\/greek-chorus.jpg\" \/>intelligent and knowledgeable; he&#8217;s iconoclastic; and he&#8217;s something of a court jester. Throughout the history of drama, role of truthsayer often falls to the royal fool, or an innocent child [the emperor&#8217;s new clothes], or the Greek Chorus &#8211; some unlikely character perceived as an &quot;outsider&quot; &#8211; someone free from the constraints and protocols of convention. The 1960s were ushered in by the Merry Pranksters and sustained by Abbie Hoffman and the Yippies.<\/p>\n<div align=\"justify\">And he&#8217;s being helped along by PhRMA, or at least by whoever wrote the pompous statement above. One actually wonders who it was written to, their members perhaps? The whole statement goes on to spell out the process and the number of hoops the pharmaceutical industry has to go through to get a drug approved, but spends no time on the fact that the system doesn&#8217;t work &#8211; form without function as they say. And PhRMA ends with a bit of business-ese:<\/div>\n<blockquote>\n<div align=\"center\"><img decoding=\"async\" vspace=\"7\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<div align=\"justify\"><sup><strong>There are currently over 5,000 new medicines in the pipeline,  70 percent of which are potential first-in-class medicines that could  provide exciting new approaches to treating diseases for patients.  Personalized medicines and drugs for rare diseases account for a growing  share of the research being conducted by the biopharmaceutical sector. Clinical trials are critical to fulfilling the promise of this  robust pipeline. Our sector and other stakeholders in the trials process  welcome a constructive dialogue and are focused on protecting the  privacy and safety of study participants, overcoming barriers to greater  participation and discovery. Debating the self-serving claims of Dr.  Goldacre does nothing to advance patient health.<\/strong><\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">My bias in these affairs is a matter of almost daily public record, but it&#8217;s hard for me to imagine that the kind of rhetoric in this PhRMA statement will work anymore. Recall the PHARMA fraud settlement graphs reported by&nbsp; <a href=\"http:\/\/www.citizen.org\/documents\/2073.pdf\" target=\"_blank\"><u><strong><font color=\"#0033cc\">Public Citizen<\/font><\/strong><\/u><\/a> in September [<a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/27\/a-sad-tale-2\/\">a sad tale&hellip;<\/a>]:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" height=\"468\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/public-citizen-1.gif\" \/><\/div>\n<div align=\"justify\">I doubt that snippiness like &quot;<em>Debating the self-serving claims of Dr.  Goldacre does nothing to advance patient health.<\/em>&quot; will carry the day in the face of this kind of evidence&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>I started to list all the links to the bruhaha brewing over the AllTrials petition, but decided to summarize instead. There&#8217;s much posturing around the Alltrials petition, and all parties have behaved in an exemplary fashion [except for the other guys]. That&#8217;s it, the whole summary &#8211; meaning that the games have begun. Meanwhile, there [&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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-33217","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33217","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=33217"}],"version-history":[{"count":31,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33217\/revisions"}],"predecessor-version":[{"id":33248,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33217\/revisions\/33248"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=33217"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=33217"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=33217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}