In the timeline of the European Medicines Agency progress towards a Data Transparency, there was a rather large bump. They were freely releasing the Clinical Study Reports, some two million pages, when two US companies [AbbVie and InterMune] filed suit to prevent data release, and the European Court suspended the data release pending resolution. After […]
Press Release European Medicines Agency June 12, 2014 European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments EMA Management Board to formally adopt policy in coming weeks The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more […]
I bookmarked this back during the holidays because of the parts that are highlighted, but that was back when we thought that the EMA Data Transparency was settled, but awaiting the resolution of the AbbeVie/InterMune suits [see a deal-breaker?…]. Running across it today, I can see why I flagged it: Drugmakers urge FDA security audit […]
Ever wonder how we knew if a treatment helped people or not before Randomized Clinical Trials? Seems almost imponderable to think about, but it was pretty easy. We just asked them. In this meta-analysis of the antidepressant trials of SSRIs in children and adolescents, Spielmans and Gerwig compiled the subjects own ratings of how they […]
Tomorrow, and tomorrow, and tomorrow, Creeps in this petty pace from day to day, To the last syllable of recorded time; And all our yesterdays have lighted fools The way to dusty death… Macbeth by Wiliam Shakespeare Growing concerns over medicines agency’s proposed rules for transparency EurActiv by Henriette Jacobsen June 11, 2014 A growing […]
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 […]
In 1962, I was in college and even though I was applying to medical school at the time, the Kefauver·Harris Amendment to the Federal Food, Drug, and Cosmetic Act was hardly on a college guy’s radar. But I sure knew about Frances Kelsey PhD, the FDA Reviewer who refused to approve Thalidomide and became a […]
This is how Trudo Lemmons ended his commentary on the recent EMA U Turn on Data Transparency [see a crushing setback…, repeal the proprietary data act…]: EMA’s Proposed Data Release Policy Promoting Transparency or Expanding Pharma Control over Data? PLoS Blogs By Trudo Lemmens May 30, 2014 [full text on-line] In short, EMA’s approach is […]
I got to wondering recently, how Clinical Trial Data got to be proprietary in the first place, the personal private property of the sponsor of the study, their intellectual property. In 1962, the Kefauver·Harris Amendment added proof of efficacy ["in the form of ‘adequate and well-controlled investigations’"] to the FDA’s mandate for drug approval [see […]
Well, I didn’t know it when I wrote in the details… and achilles’ heel…, but I wanted to end with a conclusion before talking about the current controversies. It might be presumptuous of me to sound off about such things being just a retired doctor, but the Clinical Trials world has gotten itself in such […]