{"id":68701,"date":"2016-10-17T16:49:47","date_gmt":"2016-10-17T20:49:47","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=68701"},"modified":"2016-10-18T02:52:59","modified_gmt":"2016-10-18T06:52:59","slug":"accountability-3","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/10\/17\/accountability-3\/","title":{"rendered":"accountability I…"},"content":{"rendered":"\n

"He who controls the narrative, controls the debate."<\/font><\/em><\/strong><\/p>\n

In this particular American political season, one would have to be close to stage four Coma to doubt the veracity of those words. But we have plenty of examples in American medicine that make the same statement. One version that still amazes me is the notion that the raw data from a clinical trial of medication is treated as proprietary, intellectual property. The rationale is that releasing it might breach patient confidentiality, or expose commercially confidential information. They’re not "patients," they are "subjects" who volunteered for one thing. And what’s commercially confidential about their response to an intervention? Yet, in spite of the uproar, industry has held onto that right<\/font><\/em>, making access to data still a rare exception, and very difficult at that. Our re-write of Study 329 was an enormous undertaking, primarily because of the restrictive window we were given to access the data. The sensible program adopted by the European Medicines Agency to release data has likewise been essentially undermined. Data Transparency is on the lips of everyone, including industry – only it just hasn’t happened in real life<\/font><\/em>. The intellectual property<\/font><\/em> meme continues to control the narrative.<\/p>\n

Alastair Matheson has recently clarified another example – ghost writing. Most industry-funded clinical trials are conducted by commercial Contract Research Organizations <\/font>[Clinical Research Organizations<\/font>][CROs<\/font>]. The resultant data is analyzed by company statisticians working with the companies; marketing departments, and a summary of the results are forwarded to a professional medical writers who create a first draft. At that point, the recruited COI-ladened KOL authors enter the review process along with the industry-doctors also on the author by-line. In the past, the medical writers were either unmentioned or mentioned as editorial support<\/font><\/em>. When challenged as ghost-writers – the medical writers\/pharma denied it. But then came the new narrative<\/font><\/em> pointed out by Matheson<\/font>. They claimed that if they’re mentioned in the Acknowledgements by name, they’re no longer ghosts. As absurd as that is, they’ve stuck to the explanation like super-glue.<\/p>\n

While I believe that someday the battle for Data Transparency will finally be won, I expect it’s a long way off. The enemy has very deep pockets. But industry can’t possible claim that the RESULTS are proprietary. They publish them themselves. However, with a little help from the regulatory agencies, industry has essentially created a situation where the RESULTS are similarly under their control, just like the data access:<\/div>\n