{"id":33742,"date":"2013-03-01T07:00:07","date_gmt":"2013-03-01T12:00:07","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=33742"},"modified":"2013-03-01T04:04:58","modified_gmt":"2013-03-01T09:04:58","slug":"so-much-for-the-good-news","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/03\/01\/so-much-for-the-good-news\/","title":{"rendered":"so much for the good news…"},"content":{"rendered":"
Apparently, the good news reported from Roche about the Tamiflu Clinical Trial Data wasn’t such good news after all [good news…<\/a>].<\/div>\n
\n
Roche says it will not relinquish control over access to clinical trial data<\/a>
British Medical Journal <\/font><\/strong>via Pharmagossip
By Zosia Kmietowicz
March 1, 2013 <\/div>\n
<\/p>\n

Campaigners for full transparency of all clinical trial data have responded with incredulity to a statement from the drug company Roche saying that it would continue to hold back certain information and results from research into its drugs.<\/p>\n

Tracey Brown, director of the charity Sense About Science, said that the company was “on another planet.” In January Brown helped to set up the AllTrials campaign (www.alltrials.net), together with the BMJ and others, for all clinical trials to be registered and reported in full. So far the campaign has collected 37 889 signatures for its public petition to put pressure on researchers, funding bodies, and institutions to take action on the issue. And more than 180 organisations have signed up to the initiative, including the UK National Institute for Health and Clinical Excellence, the Wellcome Trust, the UK Medical Research Council and medical royal colleges, the drug company GlaxoSmithKline, and more than 90 patient groups.<\/p>\n

Researchers from the Cochrane Collaboration have been waiting for three years for Roche to honour a promise it made in the BMJ in 2009 to give them access to full results from research on oseltamivir (Tamiflu) to establish the drug’s effectiveness and safety. Last November they rejected an offer from Roche to allow an advisory board to review what type of analysis of data on oseltamivir would be useful to them, saying that they were waiting for the company to fulfil its promise to them.<\/p>\n

The latest statement from Roche, issued on 26 February, said that the company would continue to vet requests for data that were not publicly available and would allow access only to those it approved. It said that any information that was released through this channel “will be edited in consultation with Roche to ensure patient confidentiality and to protect legitimate commercial interests, including intellectual property rights.”<\/p>\n

Brown described Roche’s response to the campaign for transparency as “poor,” adding “Which bit of ‘all’ and ‘trials’ do they not understand?” She said, “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Thousands of people are calling for all clinical trials to be registered and the findings published. Patients, researchers, and practitioners are petitioning organisations and regulators for change all over the world. Just today the UK’s Health Research Authority signed up, joining a throng of research organisations, regulators, patient groups, and professional bodies.”<\/p>\n

Commenting on the statement, Carl Heneghan, director of the Centre for Evidence-Based Medicine in Oxford, told the BMJ that three in four of the people named on the advisory board are known for their links with drug companies. He added, “What they are planning undermines the notion of what transparent data is and what systematic reviews are about.”<\/p>\n

Tom Jefferson, an independent epidemiologist with the Cochrane Collaboration, said, “Whoever applies [to the Roche advisory board for data] is likely to end up with redacted incomplete CSRs [clinical study reports] like the ones GSK sent us. This will confuse honest reviewers but provide those who want to prove this or that with a full alibi.” He added, “No real independent researcher in their right mind will accept being told what to do and how to do it by pharma KOLs [key opinion leaders]. The time for games is past.”oting the ‘liberation’ of inadequately reported clinical trial data from the past, as GSK is now committed to doing”…<\/div>\n

<\/strong><\/sup><\/div>\n<\/blockquote>\n

At this point, I think it’s reasonable to assume that if Roche is putting up this big a stink about releasing the clinical trial data about Tamiflu, it must mean that there’s something very wrong with the studies, and we just have to ignore what they give as their reason. Apparently, they’ve been caught with their pants down [and billions in the bank]…<\/div>\n","protected":false},"excerpt":{"rendered":"

Apparently, the good news reported from Roche about the Tamiflu Clinical Trial Data wasn’t such good news after all [good news…]. Roche says it will not relinquish control over access to clinical trial data British Medical Journal via Pharmagossip By Zosia Kmietowicz March 1, 2013 Campaigners for full transparency of all clinical trial data have […]<\/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":[2],"tags":[],"class_list":["post-33742","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33742","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=33742"}],"version-history":[{"count":5,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33742\/revisions"}],"predecessor-version":[{"id":33747,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/33742\/revisions\/33747"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=33742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=33742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=33742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}