{"id":47251,"date":"2014-06-13T19:42:54","date_gmt":"2014-06-13T23:42:54","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47251"},"modified":"2014-06-13T20:04:31","modified_gmt":"2014-06-14T00:04:31","slug":"an-ill-gotten-fortune","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/13\/an-ill-gotten-fortune\/","title":{"rendered":"an ill-gotten fortune…"},"content":{"rendered":"\n

First off, I realize I’m stuck in a loop. I can’t seem to get away from the European Medicines Agency’s U Turn on Data Transparency. So I guess I’ll be stuck here until I’m not – because that didn’t just happen – it was orchestrated and we know who<\/em> did it and a bit about how<\/em>. In some further information…<\/a> we were told by Peter Doshi and the BMJ about the bargaining by AbbVie and InterMune. In in the shadows…<\/a> we saw how the PhRMA<\/font> and EFPIA<\/font> schemed in a concerted attack on Data Transparency aimed at the EMA<\/font>. And now from from Trudo Lemmens<\/a>, we’re shown a letter from PhRMA<\/font><\/a> to the Chair of the US Trade Policy Committee lobbying the US to support their position. I pulled a few representative paragraphs: <\/p>\n\n\n
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May 10, 2013 <\/font><\/p>\n

Mr. Douglas Bell <\/font><\/div>\n
Chair, Trade Policy Staff Committee <\/font><\/div>\n
Executive Office of the President <\/font><\/div>\n
600 17 th Street, N.W. <\/font><\/div>\n
Washington, D.C. 20508 <\/font><\/div>\n

Re: Request for Comments Concerning the Proposed Transatlantic Trade and Investment Partnership, 78 Fed. Reg. 19566 [Apr. 1, 2013]<\/font><\/p>\n

[page 2<\/a>] Another issue of concern to the industry is the EMA’s current and proposed data disclosure policies. The biopharmaceutical industry is firmly committed to enhancing the public health through responsible reporting and publication of clinical research and safety information. Companies publish their research, collaborate with academic researchers, and disclose clinical trial information at the time of patient registration, drug approval, and for medicines whose research programs have been discontinued. However, disclosure of companies’ non-public data submitted in clinical and pre-clinical dossiers and patient-level data sets risks damaging public health and patient welfare. PhRMA and its members urge the U.S. government to engage with the EU in every available venue to ensure responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research by adequately shielding confidential commercial information from inappropriate disclosure. The EMA’s current and proposed data disclosure policies jeopardize these principles…<\/font><\/p>\n

[page 12<\/a>] The EMA’s current practices, in addition to its proposed policies to proactively disclose companies’ non-public data submitted in clinical and pre-clinical dossiers and patient-level data sets, risk damaging public health and patient welfare. Government disclosure of companies’ unprocessed, non-contextualized raw data and technical analysis provides little benefit to practicing healthcare professionals and their patients. On the contrary, disclosure of such clinical trial data, including confidential commercial information, threatens patient privacy by facilitating patient re-identification from anonymized patient-level data sets; encourages second guessing of the EMA’s expert regulatory decisions, thereby undermining patient trust in the safety and effectiveness of approved medicines; and harms incentives to invest in biomedical research. The primary beneficiaries of such non-public information are competitors who wish to free-ride off of the investments of the innovators.<\/font><\/p>\n

Further, failing to protect confidential commercial information contained in regulatory submissions is inconsistent with the EU’s treaty obligations contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights [TRIPS]. In order to benefit public health in the long run, data disclosure policies must preserve patient privacy, respect the integrity of regulatory systems, and maintain incentives to invest in innovative medical research, consistent with 21 C.F.R. §§ 312.130; 312.45(c); 314.430; 601.51(c) and Article 39(3) of TRIPS. For these reasons, PhRMA and its members urge the U.S. Government to engage with the EU in every available venue to resolve this issue…<\/div>\n<\/td>\n<\/tr>\n<\/table>\n

I formatted this for the blog last night, and highlighted parts of it. When I got back to it after work today, I found myself highlighting the rest of it. So I just gave up and let it stand as it is. It’s all infuriating. Data Transparency doesn’t compromise subject’s privacy. It doesn’t reveal confidential commercial information. In fact, this whole business about CSR<\/font>‘s is a ruse. We don’t care about their carefully crafted CSR<\/font> narratives. All we really want is the a priori protocol<\/em>; the IPD<\/font>s for the numeric and categorical results; and access to the CRF<\/font>s to check the IPD<\/font>s and look at the raw comments on AE<\/font>s. It’s no harder to spin a CSR<\/font> than a published paper [if these acronyms put you off, see in the details…<\/a>, achilles’ heel…<\/a>, and the wrong compromise…<\/a> and this figure]:<\/p>\n

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It has been something of a shock to me to find that whenever I try to run down why PHARMA claims that they have proprietary control over the data for Clinical Trials, I end up finding references to Article 39 [3]<\/a> of a trade agreement which hardly seems like a legal mandate that should control the medications we give to human beings. It says:<\/div>\n