\nA guest post by Dr Ben Goldacre: Why are the results of clinical trials hard to find?…<\/a><\/div>\nDr Ben Goldacre, author of Bad Science and Bad Pharma, has written us a piece exposing crazy new European Medicines Agency policies on clinical drug trials…<\/a><\/div>\nus<\/span>vs<\/span>th3m<\/span><\/font><\/strong><\/div>\nby Ben Goldacre <\/div>\nJune 11, 2014 <\/div>\nTough regulations, like a ban on researchers copying trial data or looking at it ANYWHERE but on screen, make it likely results won’t be analysed properly. Over to Ben…<\/p>\n
There’s a big problem in medicine. We use clinical trials to find out which treatment is best. But the results of those trials are routinely withheld from doctors, researchers and patients. This means we can’t make truly informed decisions about the risks and benefits of treatments. Roche withheld unflattering information about Tamiflu for five years, for example, even though we spent half a billion pounds on it in the UK alone. We can’t really tell what the side effects of statins are, because important documents aren’t made available. None of these companies or researchers are breaking the law. Withholding this information is perfectly legal. This affects the whole of medicine, and it’s been going on for decades. Now we have a chance to push things forward. This story needs some boring detail: then we’ll see some photographs of civil servants behaving strangely, and large numbers of patients suffering and dying unnecessarily.<\/p>\n
So. Last year the European Medicines Agency promised – under a barrage of criticism for their previous secrecy – that they would make Clinical Study Reports available to researchers<\/font><\/strong>. These are hugely important documents, thousands of pages long, which give very detailed information about the methods and results of clinical trials. Often, a trial will have design flaws that stop it being a fair test of the treatment. These can be glossed over in the brief report of a trial in an academic journal, and that’s why we need access to these long CSRs<\/font><\/strong>. That’s what the EMA promised. That’s what a new EU law promises [but only for new trials, not the previous trials, on the medicines we actually use today].<\/p>\n
But now, at the last minute, the EMA have suddenly changed their mind. They’ve announced that they will make these detailed CSRs available, but only redacted, and only through some weird “on-screen only” viewing facility. You won’t be allowed to print anything out, add notes, save anything, or even use copy and paste. That’s a doctor from IQWiG: they’re the German equivalent of NICE, only much more muscular. They use these documents on a daily basis. And they are so annoyed by the EMA’s perverse new decision that they are actively mocking the European Medicines Agency through the official IQWiG twitter account. That’s because the new EMA policy is, basically, insane.<\/p>\n
CSRs are highly complex technical documents, thousands of pages along<\/font><\/strong>, and any use of them requires extensive cross-referencing: you need to compare details in one part of the document with numbers in another; codes from one part against descriptions from another; definitions from one trial against the same definitions in another trial; and so on. But that’s not the end of it. This guy has a big sword hanging over his head. That’s because when you look at these documents, you’re now required to sign up to the EMA’s Terms Of Use on CSRs<\/font><\/strong>. These require academics and researchers to sign away various rights, and accept that they are liable to all kinds of things. What, exactly? This is very poorly specified, and because of that, it exposes researchers to what lawyers call “interesting cases”: long, and with potentially limitless legal costs. Big companies are used to using lawyers: that’s the fabric of their work. Individuals and academics are not: think about how much you pay a conveyancing solicitor, or a divorce lawyer. This is a serious imbalance of arms, and it will stifle research. That’s why IQWiG, and lots of us, think that the EMA’s new promises are pretend transparency…<\/p>\n
We now have the support of almost all the professional bodies in the UK, over 100 patient groups, 75,000 members of the public, and massive organisations like Wellcome, NICE, GSK, MRC, and so on. We’ve written to the head of the EMA, the European Medicines Agency, who’ve created this mess. They wrote back, and we think their reply was shoddy, so we’ve written to them again. They are meeting tomorrow to finalise their absurd plans. Our letter is tabled for discussion at their board meeting…<\/div>\n<\/blockquote>\nSince the contentiousness several weeks ago in blog posts and comments involving David Healy and Ben Goldacre and the questions about where Sense About Science and AllTrials allegiances lie, Goldacre, AllTrials, and SaS have become much more active with public posts and twitters galore about the EMA U Turn. I was personally glad to see that, along with their letters to the EMA. For myself, I agree with Dr. Healy that sidling up to GSK is counter-productive and in denial<\/em> about what a war this really is. But so long as AllTrials et al are doing the right thing, I’m glad to see them in the fray [again].<\/div>\n<\/p>\n
But there’s something about this piece that I think requires a comment. Ben Goldacre keeps saying "CSR<\/font><\/strong>s." That can mean the right thing if, and only if, the CSR<\/font><\/strong> is of the variety that has the pre-blind-broken, raw data tables [IPD<\/font><\/strong>s] as appendices [see achilles’ heel…<\/a>]. If it’s the long-narrative-with-only-summary-tables variety, nothing doing. The loose use of terms here can undermine this whole effort, so I monotonously reiterate: <\/div>\n[a priori protocol] + [pre-blind-broken IPDs] + [CRFs re Adverse Events] = [Transparency]<\/font><\/strong><\/em> <\/div>\nA non-negotiable requirement… <\/div>\n","protected":false},"excerpt":{"rendered":"A guest post by Dr Ben Goldacre: Why are the results of clinical trials hard to find?… Dr Ben Goldacre, author of Bad Science and Bad Pharma, has written us a piece exposing crazy new European Medicines Agency policies on clinical drug trials… usvsth3m by Ben Goldacre June 11, 2014 Tough regulations, like a ban […]<\/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-47125","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47125","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=47125"}],"version-history":[{"count":9,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47125\/revisions"}],"predecessor-version":[{"id":47135,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47125\/revisions\/47135"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}