{"id":37420,"date":"2013-06-13T19:00:58","date_gmt":"2013-06-13T23:00:58","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=37420"},"modified":"2013-06-14T07:40:59","modified_gmt":"2013-06-14T11:40:59","slug":"a-bold-remedy","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/06\/13\/a-bold-remedy\/","title":{"rendered":"“a bold remedy”…"},"content":{"rendered":"
To every thing there is a season, and a time to every purpose under the heaven…<\/font><\/strong><\/em><\/div>\n
Ecclesiastes 3:1, Corinthians II 6:2<\/font><\/strong><\/sup><\/em><\/div>\n

In the story of every tension, there’s a time for reflection and understanding, and then there’s a time for action. But what action? The strange professor in my World Religion I Course had a lecture he’d given countless times, always with the same passion as the first day he wrote it. "Primitive man," he said, "had only two paths to follow in the face of an inhospitable nature." After a long pause, he continued, "Pious Petition – praying to the universe for mercy, And…" After another pause, he adopted an impish grin, "Magic! – trying to force the universe into compliance." He went on to talk about how the former became religion and the latter was the precursor to science [the pity was, that first lecture kept us from dropping the course, but the following months could only be called soporific].<\/p>\n

The time for just decrying the shameful abuse of clinical trials in psychiatry and the rest of medicine has passed. The books and blogs are joined in a monotonous lamentation of the way clinical trials have been conducted. Prophet<\/em>ically, the first major action with traction was a petition<\/em> – AllTrials<\/font><\/strong><\/a> – not totally pious<\/em>, but a request nonetheless. In the background, the magicians have been stirring. The Cochrane Collaboration<\/a>, Peter Doshi, and Tom Jefferson have been playing hard chess with Roche around the billion dollar efficacy questions with Tamiflu. Healthy Skepticism and others have dogged the JAACAP over Paxil Study 329 for a decade. Dr. David Healy’s Pharmageddon and Rxisk database have taken on trials as well as adverse effects in general. Comes now RIAT<\/font><\/strong> [Restoring Invisible and Abandoned Trials<\/font><\/strong>] backed by a broad collaboration proposing a plan to add some teeth to the demands for clinical trial reform, focusing on missing and jury-rigged studies. The plan was announced today by the British Medical Journal<\/font><\/strong> and PLoS Medicine<\/font><\/strong>:<\/p>\n\n\n\n
BMJ Press Release<\/font><\/strong><\/a><\/p>\n

Experts propose restoring invisible and abandoned trials “to correct the scientific record”<\/font><\/strong><\/sup> <\/p>\n

<\/td>\n<\/tr>\n
<\/p>\n
Experts are today calling for all unpublished and misreported trials to be published or formally corrected within the next year to ensure doctors and patients rely on complete and accurate information to make decisions about treatments. <\/div>\n

Sponsors and researchers will be given one year to act before independent scientists begin publishing the results themselves using previously confidential trial documents. <\/p>\n

The BMJ and PLOS Medicine have already endorsed the proposal and committed to publishing restorative clinical trial submissions – and will discuss it in more detail at a meeting in London on Friday 14 June 2013. <\/p>\n

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Around half of all clinical trials for the medicines we use today have never been published – and a whole range of widely used drugs have been represented as safer and more effective than they are, putting patients at risk and wasting public money. <\/p>\n

The authors of the declaration, led by Peter Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine, will contact manufacturers of trials, asking them to signal their intent within 30 days to publish previously unpublished trials and formally correct previously misreported trials (i.e. to restore abandoned trials). <\/p>\n

They propose that if anyone who declares an intention to publish or correct does not do so within one year, all publicly available data for such trials should be considered “public access data” that others are allowed to publish. <\/p>\n

This declaration, they say, “offers sponsors and trialists an opportunity to publish or formally correct their studies” – or otherwise see those abandoned studies published or republished by others. <\/p>\n

New freedom of information policies means the public and the authors have access to around 178,000 pages of previously confidential trial documents and clinical study reports for widely used drugs for depression, heart disease, epilepsy and influenza. Some trials remain unpublished years after completion, while others have been published but have been shown to contain inaccuracies. <\/p>\n

They say they are committed to seeing the findings from abandoned trials published – and misreported trials corrected and republished – and they set out a method for responsibly restoring invisible and abandoned trials (RIAT). “We see RIAT as a collaborative, global effort, and over the next year we hope to discuss and debate our proposal at appropriate venues,” they write. <\/p>\n

As such, they call on others to join them as volunteers “in place of those who should have but did not make trial reports visible and accessible.” And they ask medical journal editors to endorse the concept of restorative authorship to “help the effort to complete and correct the scientific record.” <\/p>\n

In an accompanying editorial, editors at The BMJ and PLOS Medicine say Doshi and colleagues “offer a bold remedy” to help restore the integrity of the clinical trial evidence base. <\/p>\n

They explain that the results of clinical trials “are a public, not a private, good” and that the public interest “requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials.” <\/p>\n

They conclude: “If we do not act on this opportunity to refurbish and restore abandoned trials, the medical research community will be failing its moral pact with research participants, patients, and the public. It is time to move from whether to how, and from words to action.”<\/div>\n

<\/strong><\/sup><\/td>\n<\/tr>\n<\/table>\n

<\/p>\n

It’s supported by two articles, an analysis and an editorial, both published today, both available open access on-line:<\/div>\n
\n
Restoring invisible and abandoned trials: a call for people to publish the findings<\/a>
Analysis<\/font><\/strong>
British Medical Journal<\/font><\/strong>
by Peter Doshi, Kay Dickersin, David Healy, S Swaroop Vedula, and Tom Jefferson<\/strong><\/sup>
June 13, 2013
[full text on-line]<\/strong><\/sup><\/div>\n<\/blockquote>\n
\n
Restoring the integrity of the clinical trial evidence base<\/a>
Editorial<\/font><\/strong>
British Medical Journal<\/font><\/strong>
by Elizabeth Loder and Fiona Godlee [BMJ] and Virginia Barbour and Margaret Winker [PLoS Medicine]<\/strong><\/sup>
June 13, 2013
[full text on-line]<\/strong><\/sup><\/div>\n<\/blockquote>\n
\n
Restoring Invisible and Abandoned Trials: A Creative Approach to a Public Good; Now a Creative Approach to Implementation is Needed<\/a>
Blog<\/font><\/strong>
PLoS Medicine<\/font><\/strong>
By Margaret Winker and Virginia Barbour<\/strong><\/sup>
June 13, 2013
\t [full text on-line]<\/strong><\/sup><\/div>\n<\/blockquote>\n
 <\/div>\n
If the original authors and journals won’t fix questionable studies, they propose having someone else do it for them by republishing. Likewise, if it hasn’t been published and it should’ve been published and they still don’t publish it, someone else will. They call this "restorative authorship<\/em>." As you can see in the tables accompanying the article<\/a>, they currently have "only a small fraction of the masses of abandoned clinical trials<\/em>" in hand, but they have two journals willing to publish RIAT articles and are putting out a call for other data-sets obtained through litigation or foi. But, for example, they already have enough data to reanalyze the infamous Paxil Study 329 [my candidate for #1 on the "restorative authorship<\/em>" list]: <\/div>\n
\n
Academic freedom<\/font><\/a> is the belief that the freedom of inquiry by faculty members is essential to the mission of the academy as well as the principles of academia, and that scholars should have freedom to teach or communicate ideas or facts [including those that are inconvenient to external political groups or to authorities] without being targeted for repression, job loss, or imprisonment… Academic tenure protects academic freedom by ensuring that teachers can be fired only for causes such as gross professional incompetence or behavior that evokes condemnation from the academic community itself.<\/strong><\/sup> <\/div>\n<\/blockquote>\n
Access to publication in the scientific journals of medicine is contingent on peer review, both before and after publication. And removal [retraction] is governed by the accuracy of the data itself, not the analysis or conclusions of the authors which is more the stuff of academic freedom and debate. All the graphs, tables, statistics, and narrative are derivatives, the authors’ way of looking at the data, but no substitute for the data itself. <\/div>\n

The pharmaceutical clinical trials have been accepted into our scientific literature based on the assumption that the academic authors know the rules and are accurately representing the data. But there is widespread evidence that this is an erroneous assumption. Many of the academic authors are compromised by conflicts of interest [or are not even the actual authors]. The traditional counterpose is peer review, but this has been blocked by a firewall with the claim that the raw data is private property. <\/p>\n

There are only two solutions to this problem. The first is to deny access to the academic literature to any study withholding public access to the raw data itself. That is the approach taken by the AllTrials<\/font><\/strong><\/a> petition – an eminently sensible solution. But it doesn’t address the volumes of studies already published, and their authors and sponsors aren’t being forthcoming. I guess they’re claiming the rights of a former loophole<\/font><\/strong><\/em>. <\/p>\n

The academic literature of medicine is not in the domain of the proprietary rights of the marketplace<\/font><\/strong><\/em> or the rights of a former loophole<\/font><\/strong><\/em>. It’s governed by the principles of academic freedom<\/font><\/strong><\/em>. Both the AllTrials<\/font><\/strong><\/a> petition and the RIAT<\/font><\/strong> proposal<\/font><\/strong> represent direct and appropriate assertions of those principles, embodied in the right of peer review<\/font><\/strong><\/em>… <\/div>\n","protected":false},"excerpt":{"rendered":"

To every thing there is a season, and a time to every purpose under the heaven… Ecclesiastes 3:1, Corinthians II 6:2 In the story of every tension, there’s a time for reflection and understanding, and then there’s a time for action. But what action? The strange professor in my World Religion I Course had a […]<\/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":[5],"tags":[],"class_list":["post-37420","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/37420","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=37420"}],"version-history":[{"count":60,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/37420\/revisions"}],"predecessor-version":[{"id":37494,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/37420\/revisions\/37494"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=37420"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=37420"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=37420"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}