{"id":35057,"date":"2013-04-06T21:26:06","date_gmt":"2013-04-07T01:26:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=35057"},"modified":"2013-04-07T15:24:55","modified_gmt":"2013-04-07T19:24:55","slug":"sunlight","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/04\/06\/sunlight\/","title":{"rendered":"sunlight?…"},"content":{"rendered":"
I know it’s not a psychopharmacology drug, but Tamiflu has become the index case for data transparency thanks to the efforts of Peter Doshi, Tom Jefferson, Ben Goldacre, Fiona Godlee, the Cochrane Collaboration and 44,047 current signers of the AllTrials<\/font><\/a> <\/font><\/strong>petition. There have been false alarms before, but this report in the BMJ certainly looks like this one is finally going to be resolved:<\/div>\n
\n
Roche offers researchers access to all Tamiflu trials<\/a>
by Deborah Cohen<\/strong><\/sup>
British Medical Journal.<\/font><\/strong> 2013; 346:f2157 [Published 4 April 2013]<\/div>\n
<\/p>\n

More than three years after the Cochrane Collaboration first asked Roche for the full clinical study reports for its influenza drug oseltamivir [Tamiflu], the Swiss company has offered the collaboration access to “all 74 Roche sponsored trials.” Don MacLean, life cycle leader for Tamiflu at Roche, emailed the Cochrane researchers on 2 April to propose providing data in a staggered approach over the next few months. “In line with European Union law, each CSR [clinical study report] will be edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests,” he wrote. A full phase III clinical study report typically consists of 2000 to 3000 pages, and redaction would be a “large undertaking,” he added.<\/p>\n

The Cochrane group has cautiously welcomed the move, pointing out that Roche has previously promised access to data. MacLean’s email follows GlaxoSmithKline’s decision to release 30 clinical study reports on its influenza drug zanamivir [Relenza] to the same Cochrane group. The group is concerned, however, that data redaction and other problems may make analysis and interpretation impossible. Sile Lane, director of campaigns at Sense about Science, said that by acknowledging that there were 74 trials and agreeing to publish the results, Roche had recognised that arguments in favour of secrecy no longer held.<\/p>\n

“This should be a good moment for them to sign up to the commitment set out at AllTrials for all trials relating to treatments in current use to be registered, and the results reported. It shouldn’t have taken the researchers years of persistence and publicity to get [access to] these Tamiflu results. Roche has an opportunity to tell the public and research community that it won’t happen like this again,” she said. The announcement comes after years of wrangling for access to what the Cochrane group believes to be the full dataset. Instead of offering access to 74 trials, in December 2009 Roche gave the researchers access to one part of 10 Tamiflu trials [each trial report comes in four to five parts]…<\/div>\n

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

hat-tip to Pharmagossip  <\/strong><\/sup><\/div>\n<\/blockquote>\n
It’s a digital matter. Either the Cochrane Collaboration will get enough information to do an adequate meta-analysis or they won’t. And either Roche’s claims of efficacy will be confirmed or they won’t. And so let’s presume that the missing data fails to confirm efficacy. What happens then? I don’t exactly know the answer, but whatever it is, it will be a righter thing that what’s happening now.<\/div>\n

Like most, I have something of an aversion to regulations and procedures. And the history of how all of this came to be is a study in the failure of years of attempted reform through various regulations designed to escape being outfoxed by the pharmaceutical industry. That hasn’t worked. The only way to insure honesty is to have complete data availability minus the subjects names. Dr. Healy brought up an excellent point last week [Not So Bad Pharma<\/a>, April Fool in Harlow<\/a>] in that subjects in clinical trials need to agree to that kind of data transparency up front in their consent forms. The pharmaceutical industry stands to lose a lot here. The truth about drugs will dissuade many from taking medications electively. Blockbusters will be a lot harder to come by and so there will be big changes in the industry as a result of these changes.<\/p>\n

But there really isn’t any other rational choice. The past misbehavior is just too gross to be allowed to continue. In the area of cancer treatment, patients are given a clear picture of a drug’s potential efficacy and safety. That should be afforded to anyone taking any medication. We already generate the data, but then hide it behind a firewall. There’s just no justifying continuing that. One of Ben Goldacre’s best lines is the clear path forward: "… the best disinfectant is sunlight.<\/font><\/strong><\/em>"<\/div>\n","protected":false},"excerpt":{"rendered":"

I know it’s not a psychopharmacology drug, but Tamiflu has become the index case for data transparency thanks to the efforts of Peter Doshi, Tom Jefferson, Ben Goldacre, Fiona Godlee, the Cochrane Collaboration and 44,047 current signers of the AllTrials petition. There have been false alarms before, but this report in the BMJ certainly looks […]<\/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-35057","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35057","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=35057"}],"version-history":[{"count":11,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35057\/revisions"}],"predecessor-version":[{"id":35124,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/35057\/revisions\/35124"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=35057"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=35057"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=35057"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}