{"id":49501,"date":"2014-09-09T12:06:34","date_gmt":"2014-09-09T16:06:34","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=49501"},"modified":"2014-09-10T14:40:33","modified_gmt":"2014-09-10T18:40:33","slug":"in-praise-of-anonymous-contactable-members-of-the-public","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/09\/09\/in-praise-of-anonymous-contactable-members-of-the-public\/","title":{"rendered":"in praise of anonymous, contactable members of the public<\/em>…"},"content":{"rendered":"
Ed Silverman reports here on the end of a long story that has appeared in fragments for several years. It’s about Agomelatine, a Melatonin like compound, and a review article published in the Lancet by Ian Hickie and Naomi Rodgers at the end of 2011. Here’s the Pharmalot<\/font><\/strong> post:<\/div>\n
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Servier Breached Industry Codes by Not Disclosing Clinical Trial Data<\/a><\/div>\n
Pharmalot<\/font><\/strong><\/div>\n
By Ed Silverman<\/div>\n
September 8, 2014<\/div>\n

As the pharmaceutical industry battles with regulators over the extent to which clinical trial information should be released, one drug maker has run afoul of U.K. industry rules for disclosure. The Association of British Pharmaceutical Industry<\/a> has ruled that Servier breached several codes by failing to publish trial results for its Valdoxan antidepressant. Specifically, there were five trials involving U.K. patients between 2008 and 2011 in which Servier did not publish results promptly and three other trials in which results had not been disclosed.<\/p>\n

As a result, the drug maker breached three codes – bringing discredit upon, and reducing confidence in, the pharmaceutical industry; failing to maintain high standards and failing to meet the required timeframe in which to disclose clinical trials, according to the ABPI. The trade group monitors a voluntary industry code and late last week publicized the completed findings<\/a>. Disclosing trial results has been a contentious topic that has immersed drug makers, regulators and researchers following scandals over safety or effectiveness data that was not publicly shared. The debate has mostly centered on the extent to which proprietary trade information, as well as confidential patient data, may be released.<\/p>\n

As we wrote previously, the issue has been particularly troublesome in Europe, where the European Medicines Agency has repeatedly delayed the release of a new policy amid criticism the agency backtracked on a previous commitment to new-found openness. Recently, the regulator indicated formal adoption would take place at a scheduled board meeting next month. The case against Servier emerged after the ABPI last fall published a survey<\/a> suggesting there was greater industry transparency concerning clinical trial data. An unidentified member of the public, however, suspected otherwise and, after reviewing the results, reported possible violations to the industry trade group.<\/p>\n

For its part, Servier “strongly refuted” that it discredited the industry or failed to maintain high standards, and acknowledged only a technical breach concerning a  failure to meet the required timeframe in which to disclose trial results, according to the case report. We asked the drug maker if an appeal is planned and will update you accordingly. Meanwhile, the ABPI findings were publicized in the form of advertisements<\/a> that are running in three publications that are widely read in the U.K. medical industry – BMJ, the Pharmaceutical Journal and The Nursing Standard.<\/p>\n<\/blockquote>\n

Here’s the time-line. Three years ago, Dr. Ian Hickie and a colleague published this review of Agomelatine in depression in the Lancet, I think by invitation from the journal itself. It was published on-line in May 2011 and in print in August 2011:<\/div>\n
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Novel melatonin-based therapies:
potential advances in the treatment of major depression<\/a><\/div>\n
by Ian B Hickie and Naomi L Rogers<\/div>\n
Lancet<\/font><\/strong> 2011 378: 621–631.<\/div>\n
[full text on-line<\/a>]<\/div>\n

<\/p>\n

Major depression is one of the leading causes of premature death and disability. Although available drugs are effective, they also have substantial limitations. Recent advances in our understanding of the fundamental links between chronobiology and major mood disorders, as well as the development of new drugs that target the circadian system, have led to a renewed focus on this area. In this review, we summarise the associations between disrupted chronobiology and major depression and outline new antidepressant treatment strategies that target the circadian system. In particular, we highlight agomelatine, a melatonin-receptor agonist and selective serotonergic receptor subtype [ie, 5-HT2C] antagonist that has chronobiotic, antidepressant, and anxiolytic effects. In the short-term, agomelatine has similar antidepressant efficacy to venlafaxine, fluoxetine, and sertraline and, in the longer term, fewer patients on agomelatine relapse [23·9%] than do those receiving placebo (50·0%). Patients with depression treated with agomelatine report improved sleep quality and reduced waking after sleep onset. As agomelatine does not raise serotonin levels, it has less potential for the common gastrointestinal, sexual, or metabolic side-effects that characterise many other antidepressant compounds.<\/div>\n<\/blockquote>\n
Dr. Hickie may have been impressed with Agomelatine, but a veritable international army of credible critics weren’t, and they wrote letters to the Lancet published in January 2012 saying why:<\/div>\n