{"id":58623,"date":"2015-07-31T16:36:26","date_gmt":"2015-07-31T20:36:26","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=58623"},"modified":"2015-07-31T16:36:26","modified_gmt":"2015-07-31T20:36:26","slug":"the-why-of-it","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/07\/31\/the-why-of-it\/","title":{"rendered":"the why of it…"},"content":{"rendered":"\n

For as much time as I’ve spent thinking about Randomized Clinical Trials in my retirement years, I never gave them a moment’s thought in two different medical careers. I didn’t really have much of an idea how drugs became approved, or how drug patents worked. As odd as that may sound, I expect that was true for the overwhelming majority of my contemporaries. In Internal Medicine, I learned about medications from textbooks rather than journal articles. In psychiatry, a person like me practicing psychotherapy doesn’t write many prescriptions, and I still relied on textbooks or review articles rather than looking at Randomized Clinical Trials. With rare exceptions, I rode on the "trailing edge" of medications, waiting until drugs were in widespread use before learning about them or prescribing them. The concept of a "pipeline" delivering a stream of new medications wasn’t even in my consciousness. I guess I thought that new medications came along when and if they were discovered. Writing this makes me feel incredibly naive – but I think that’s just the way it was. The only class of drugs I can recall actively keeping up with were the antibiotics – and that was because of those microbes’ incredible ability to become resistant.<\/sup><\/font><\/em><\/p>\n

So, in my oft told story, five years after retiring I had started volunteering some and was completely horrified at the drug cocktails the patients were taking. Then one morning, I read this over a cup of coffee: <\/div>\n
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Top Psychiatrist Didn’t Report Drug Makers’ Pay<\/a> <\/div>\n
New York Times<\/font><\/strong><\/div>\n
By GARDINER HARRIS<\/div>\n
October 3, 2008 <\/div>\n

<\/p>\n

One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators. The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers…<\/div>\n<\/blockquote>\n
The chairman of the department I’d been a part of for then thirty-four years? arrangements with drug makers? a crook!? So that’s when I started to learn about Randomized Clinical Trials, and drug approval processes, and PHARMA, and more corruption than I would have thought possible.<\/div>\n

Flash forward to the present. Over the intervening seven years, I’ve learned a lot about RCTs. About halfway back, I realized that the pharmaceutical companies being able to keep the raw data secret, or being able to simply not publish results they didn’t like, were an essential ingredients in the problem and I’ve spent a lot of my time involved in the fight for Data Transparency. There’s a lot more wrong – things like the alliance between academic medicine and industry, guest authors and ghost authors, the intrusions of third party carriers into medical care, etc. But frankly, I’ve spent so much time learning the ropes [with the help of some really good teachers], that it has been hard to get far enough away from the details to have an overall perspective on the big picture<\/font><\/em>.<\/p>\n

<\/a>When I first read David Healy’s book, Pharmageddon<\/font><\/a> [2012], I was still learning about Randomized Clinical Trials [RCTs], and I had looked at a number of them in as much depth as I could given the inaccessibility of the actual trial data. I could see how much subtle distortion there had been in the analyses and presentations in journal articles. The book added the history of RCTs and gave me a valuable perspective on how this tangled system had come into being  over the years. But there was one point that I didn’t intuitively grasp at the time. He seemed to be saying that there was a basic flaw in the RCT system over and above the distortions. At the time, It seemed to me that if the RCTs were properly conducted, properly analyzed, and properly reported that everything would be fine. I could tell he thought otherwise, but I just didn’t get the why of it<\/font><\/em> on first reading.  <\/p>\n

And I might as well add Evidence-Based Medicine<\/font><\/em> and Measurement-Based Medicine<\/font><\/em> in here along with RCTs. On the one hand, what is the alternative to evidence-based medicine? Wild guesses? And yet, every time I hear Evidence-Based Medicine<\/font><\/em> [EBM], I wince involuntarily. The one that gets the biggest wince is Evidence-Based Psychotherapy<\/font><\/em> [which means Cognitive Behavior Therapy (CBT)]. Well, I get it now – what’s wrong with RCTs – what Healy was saying. Rather than talk about the the why of it<\/font><\/em>, I’ll refer you to the horse’s mouth, because Dr. Healy is in the middle of talking about it again on his blog:<\/div>\n