{"id":56507,"date":"2015-05-02T08:00:59","date_gmt":"2015-05-02T12:00:59","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=56507"},"modified":"2015-05-02T00:44:01","modified_gmt":"2015-05-02T04:44:01","slug":"cant-argue","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/05\/02\/cant-argue\/","title":{"rendered":"can’t argue…"},"content":{"rendered":"
Two of the videos in the last  post came from Evidence<\/font>–Live<\/font><\/strong>, a partnership between The BMJ and the Centre for Evidence-Based Medicine in the University of Oxford’s Nuffield Department of Primary Care Health Sciences and their conference<\/a> two weeks ago. The timing couldn’t have been better, coinciding as it did with the WHO<\/font>‘s announcement of their new policy on Data Transparency [see now, back to basics!…<\/a>]. In many ways, the meeting itself was a celebration of the success of the AllTrials<\/font><\/strong><\/a> campaign, amazingly only just over two years old [see click it and sign it…<\/a>]:<\/div>\n
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AllTrials campaign raises the game on clinical-trial transparency<\/a><\/div>\n
PharmaTimes<\/font><\/strong><\/div>\n
by Peter Mansell<\/div>\n
January 10, 2013<\/font><\/strong><\/div>\n

\"JamesThe push from the UK for wholesale transparency of clinical-trial data has taken on a new dimension with the launch of the AllTrials public campaign. An accompanying petition – already close to 3,000<\/strike> over 7,000 signatures at the time of writing – calls on governments, regulators and research bodies to put in place measures ensuring that “all trials past and present” are registered and “the full methods and the results” reported. The initiative follows last month’s call by the UK House of Commons Science and Technology Committee for submissions on transparency and the disclosure of study data as part of a broader inquiry into clinical trials.<\/p>\n

Among the campaign backers are some familiar names in the recent drive for clinical-data transparency: Bad Science – i.e., epidemiologist and Bad Pharma author Dr. Ben Goldacre; the BMJ; the James Lind Initiative; and the Centre for Evidence-Based Medicine. Joining them in the campaign is Sense About Science, a UK-based charitable trust that works in partnership with scientific bodies, research publishers, policymakers, the public and the media to change public discussions about science and evidence.<\/p>\n

Sense About Science director Tracey Brown commented: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements.” Government and regulators “must listen to what the public thinks about this”, Brown insisted. “It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future”…<\/div>\n
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Who is James Lind? He’s the 18th centery British Naval Surgeon who did the first real controlled clinical trial – citrus fruits for Scurvy [he published his data and did a literature review]…<\/sup><\/em><\/div>\n
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Among all the things I’ve learned blogging about all of this stuff, the one that most amazed me was my research into The Proprietary Data Act<\/a><\/em>. I was awed at how quickly the AllTrials<\/font><\/strong> campaign caught on in spite of the active resistance from PHARMA. There were glitches along the way and skirmishes at every turn, but even with that, it put meaning to the phrase "catches on like a wildfire.<\/font><\/em>" At some point along the way, about 9 months ago, I got to wondering about how the Clinical Trial Data had been declared proprietary, wondering what legal hurdles lay ahead. I started looking for what I called The Proprietary Data Act<\/font><\/strong><\/em> on the Internet, and I got nowhere. Here’s what I said last June<\/a> about my research on this topic:<\/div>\n
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So I thought I’d go back to the Proprietary Data Act<\/font><\/strong><\/em> and see why they were given that right in the first place. Only I couldn’t find the Proprietary Data Act<\/font><\/strong><\/em> anywhere no matter what I put in Google®. That happens, so I wrote everyone I knew asking for leads. They kindly agreed to help, but they couldn’t quite recall – Was it Congress back in 1962? Just not sure. So they looked and couldn’t come up with anything either. So how am I going to mount a campaign to Repeal the <\/font>Proprietary Data Act<\/font><\/em><\/strong> if I can’t even find it? <\/div>\n<\/blockquote>\n
And the punch line:<\/div>\n
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I finally heard from some people-in-the-know who had obviously gone on the same Hegira and found nothing either. It just happened<\/em> apparently. The pharmaceutical companies had the data from the CROs they hired, and they kept it to themselves. There is no Proprietary Data Act<\/font><\/strong><\/em>. Never was. I guess it’s something like staking a claim in the Klondike during the gold rush or squatter’s rights. So much for my Repeal the <\/font>Proprietary Data Act<\/font><\/em><\/strong> Movement..<\/div>\n<\/blockquote>\n
It turned out to be a little more complicated than that [except where necessary to protect the public…<\/a>, spellbound…<\/a>], having to do with trade agreements, but it sure wasn’t anything like a Law. I’m still awed that we’ve allowed PHARMA to keep their data under lock and key for so long [50+ years!], or that the regulatory agencies have worked so hard to protect it for them. And I don’t mean to diminish the accomplishments of the AllTrials<\/font><\/strong><\/a> campaign. It was the right campaign, at the right time, done the right way. You just can’t argue with success…<\/div>\n","protected":false},"excerpt":{"rendered":"

Two of the videos in the last  post came from Evidence–Live, a partnership between The BMJ and the Centre for Evidence-Based Medicine in the University of Oxford’s Nuffield Department of Primary Care Health Sciences and their conference two weeks ago. The timing couldn’t have been better, coinciding as it did with the WHO‘s announcement of their new […]<\/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":[5],"tags":[],"class_list":["post-56507","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56507","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=56507"}],"version-history":[{"count":20,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56507\/revisions"}],"predecessor-version":[{"id":56526,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56507\/revisions\/56526"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=56507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=56507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=56507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}