healthy4u: Study 329

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of <a href="http://hcrenewal.blogspot.com/search/label/Study%20329">Study 329</a>.  The manipulation of Study 329 was a central part of the US government's case against GlaxoSmithKline that was recently settled for $3 billion and resulted in three guilty pleas by the company (look <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/09/twilight-of-anechoic-effect-new-england.html">here</a>.) Mickey's previous voluminous series of posts on this subject are listed <a href="http://hcrenewal.blogspot.com/2012/08/continuing-dissection-of-infamous-study.html">here</a>.  He and others, most notably Dr Jon Jureidini, have attempted to get the journal that published the now widely ridiculed Study 329 retracted.  His three recent posts on the subject are: <a href="http://1boringoldman.com/index.php/2012/12/23/the-lesson-of-study-329-an-unfinished-symphony/" rel="bookmark">the lesson of Study 329: an unfinished symphony…</a>  <a href="http://1boringoldman.com/index.php/2012/12/21/hide-and-go-seek/" rel="bookmark">hide-and-go-seek… </a>  <a href="http://1boringoldman.com/index.php/2012/12/21/a-response-2/" rel="bookmark">a response… </a>  In the most recent of these, he argued, <blockquote class="tr_bq">In this particular case, there are no facts in question. It was a negative trial, declared negative by the people who did it. The paper was ghost-written and reviewed by the sponsor before any of the twenty two authors ever saw a manuscript. The science was jury-rigged to imply a positive outcome where none was supported using well-documented sleight of hand. None of that is speculative. And the article has been a centerpiece for court settlements worth billions of dollars.</blockquote> Yet, the  Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the article. Mickey's opinion in the second of the posts listed above, <blockquote class="tr_bq">One can only conclude that they found this article to be an inconvenient truth, and that Dr. Andres Martin and his colleagues in the American Academy of Child and Adolescent Psychiatry believe that acknowledging that truth would do more harm than good [or maybe even found a way not to see the truth at all, though it's hard to imagine how]. Sooner or later, this whole tawdry saga is going to find its way out of the blogs and courtrooms and into the full light of day. And the question that’s going to be asked is why didn’t Medicine itself deal with the problem? Why didn’t the Journal itself retract the misinformation once they knew about it? Why didn’t the industry sponsor itself call for the retraction as part of their settlement with the DOJ? What possible reasonable reason could there be for leaving a paper that is a lie in their journal without even an expression of concern, much less a retraction? And there aren’t going to be any believable answers.</blockquote> Mickey concluded the most recent post, <blockquote class="tr_bq">The loser in this story is the American Academy of Child and Adolescent Psychiatry, and ultimately psychiatry itself…</blockquote> The longer inconvenient truths are ignored or suppressed, the more inconvenient, and hazardous they will ultimately become.  ADDENDUM (26 December, 2012) - One more post on 1BoringOldMan: <a href="http://1boringoldman.com/index.php/2012/12/26/telling-the-truth-as-a-liability/" rel="bookmark">telling the truth as a liability… </a> Its conclusion <blockquote class="tr_bq">By any criteria, the conclusion to the 2001 Keller et al article is wrong ["Paroxetine is generally well tolerated and effective for major depression in adolescents"]. That’s not the reason that some of us have been so persistent in pushing for retraction. The reason is that it was wrong at the time the article was published, and they knew it was wrong, but published it anyway. We want to make a statement about the integrity of the scientific literature. </blockquote>

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of Study 329. The manipulation of Study 329 was a central part of the US government's case against Glax…

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23 Dec 2012

Continuing Dissection of the Infamous Study 329

On the 1BoringOldMan blog, semi-anonymous blogger Mickey has been dissecting in detail the infamous Study 329 that GlaxoSmithKline used to promote Paxil (Seroxat, paroxetine) as safe and effective for children and adolescents, when the study data, rigorously analyzed, showed that was not the case.  Study 329 was an important part of the US Department of Justice case against GSK that resulted in a record $3 billion settlement (see this <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">post</a>).  The posts so far are: <a href="http://1boringoldman.com/index.php/2012/08/19/26298/">A Pretty Rotten Era   </a> <a href="http://1boringoldman.com/index.php/2012/08/21/a-movement/">A Movement</a> <a href="http://1boringoldman.com/index.php/2012/08/22/to-make-distortion-possible/">To Make Distortion Possible</a> <a href="http://1boringoldman.com/index.php/2012/08/24/the-lesson-of-study-329-the-basics/">The Lesson of Study 329: the Basics</a> <a href="http://1boringoldman.com/index.php/2012/08/25/the-lesson-of-study-329-efficacy-drift-to-trends-and-2s/">The Lesson of Study 329: Efficacy Drifts to Trends and 2s</a> <a href="http://1boringoldman.com/index.php/2012/08/26/the-lesson-of-study-329-conventions-and-protocols/">The Lesson of Study 329: Conventions and Protocols</a> <a href="http://1boringoldman.com/index.php/2012/08/29/the-lesson-of-study-329-uh-oh/">The Lesson of Study 329: Uh-oh</a> <a href="http://1boringoldman.com/index.php/2012/08/29/the-lesson-of-study-329-data-transparency/">The Lesson of Study 329: Data Transparency</a> <a href="http://1boringoldman.com/index.php/2012/08/30/the-lesson-of-study-329-the-authors/">The Lesson of Study 329: the Authors</a> This does not seem to be the end of the series, but the last post yesterday did have a striking conclusion: <blockquote>But, for the moment, I am stuck on the piece that is, to me, the most fundamental lesson from this story, and unfortunately many similar stories in the industry-funded clinical trial literature that fills our journals. The authors of this study did not function as physicians, clinicians, scientists, or even authors. Some were there because of their previous credentials. Others were there to build up future credentials. But they weren’t there to do what they presented themselves as doing. Researchers are practicing medicine too. I might be seen as naive to see this as the center of this story. If that’s the case, I’ll go to my grave being naive. Medicine has been my life, and this isn’t Medicine. There’s no place or tradition for physicians, particular physicians in high places, taking part in this kind of bullshit – particularly all the while claiming otherwise. The fact that it has been a widespread practice isn’t an excuse. That’s also an even stronger indictment. There are many principled neuroscientists working in this difficult area of medical science who’ve been tarnished by this kind of pseudoscience. There are many psychiatrists and other practitioners who’ve actually trusted these deceitful articles. And there are untold numbers of patients who’ve been medicated un-necessarily or even directly harmed by this and other capricious advise coming out of these studies – this one in particular. Rather than functioning as the advisers of ill people, these were physicians who actively participated in capitalizing on patients’ illness. </blockquote>However, despite the seriousness of these concerns, and their corroboration in the Justice Department document that pushed GSK to settle for so much money, my alma mater, Brown University, where Dr Martin Keller, the lead author of Study 329, was Chair of Psychiatry, has consistently refused to revisit the study, and consistently failed to publicly refute the accusations against Dr Keller, nor to accept them and take appropriate action.  The University supposedly conducted an internal investigation of the matter, but has not seen fit to make it public.  When <a href="http://chronicle.com/article/Academic-Researchers-Escape/133325/">asked again</a> about this, Brown's new President, Christina Paxson, referred the inquiry to the public relations people: <blockquote>'The recent announcement by the U.S. Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,' Darlene Trew Crist said in a written response. 'We have no further statement to make at this time.'</blockquote> Given the seriousness of the allegations, and the <a href="http://www.brown.edu/about/mission">University's mission</a>: <blockquote>The mission of Brown University is to serve the community, the nation, and the world by discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry, and by educating and preparing students to discharge the offices of life with usefulness and reputation. </blockquote>the logic of the administration's refusal to have a public discussion of this case escapes me. As I have <a href="http://hcrenewal.blogspot.com/2008/09/brown-university-student-journalists.html">said before </a>(in 2008!), the appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide. Also see comments by Alison Bass <a href="http://alison-bass.com/blog/2012/08/why-academic-researchers-involved-in-fraudulent-paxil-study-escape-scrutiny/">on the Alison Bass blog</a>, and by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2012/08/ghostwriting-still-no-consequences-for.html">on the Hooked: Ethics, Medicine and Pharma blog</a>. ADDENDUM (4 September, 2012) - There have been two additional posts on the 1BoringOldMan blog on Study 329: <a href="http://1boringoldman.com/index.php/2012/09/02/the-lesson-of-study-329-the-hurdles/" rel="bookmark">the lesson of Study 329: the hurdles… </a> <a href="http://1boringoldman.com/index.php/2012/09/04/the-lesson-of-study-329-naked-emperors-fractious-queens/" rel="bookmark">the lesson of Study 329: naked Emperors, fractious Queens… </a> ADDENDUM (4 September, 2012) - See also <a href="http://alison-bass.com/blog/2012/09/calls-for-action-against-authors-of-fraudulent-paxil-study-are-getting-louder/">this post</a> on the Alison Bass blog. ADDENDUM (5 September, 2012) - See <a href="http://www.pharmalot.com/2012/09/controversial-paxil-study-author-retires-from-brown/">this post</a> on the retirement of Dr Keller by Ed Silverman on PharmaLot. ADDENDUM (10 September, 201) - See the final two posts in the 1BoringOldMan series: <a href="http://1boringoldman.com/index.php/2012/09/06/the-lesson-of-study-329-were-only-as-sick-as-our-secrets/" rel="bookmark">the lesson of Study 329: “we’re only as sick as our secrets”… </a> <a href="http://1boringoldman.com/index.php/2012/09/08/the-lesson-of-study-329-epilogue/" rel="bookmark">the final lesson of Study 329: epilogue… </a> His conclusion in the next to last post of the series: <blockquote>Something terrible happened in psychiatry, an alliance between the pharmaceutical industry and a number of our leaders who allowed their academic credentials to be used for commercial purposes. It happened on a large scale, and in the process shamed all of us, whether we were involved or not. Many of the people we looked to to guide us fell into the role of key opinion leaders – a marketing term that meant that they could influence what we did and how we practiced. And in that new role, medical degrees, academic positions, the methods of science, and psychiatric experience became little more than marketing tools in a commercial campaign. Such was the case with Study 329 – an article that has become exemplary because it is now so painfully well known – a symbol for the failings of an era. It needs to be retracted simply because it was wrong on purpose – and we all know it. And yet no involved person, institution, or organization highlighted in that last paragraph has swallowed their pride, or guilt, or denial, or arrogance and called for retraction.</blockquote>[Italics and bold typeface added for emphasis]

Continuing Dissection of the Infamous Study 329

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31 Aug 2012