I had weathered the massive changes in psychiatry I described in the last post pretty well I thought. I had learned that the people on my side of the street weren’t without sin and made a lot of changes of my own from what I learned. I still loved the profession I’d gravitated to even if the formal version had fallen out of love with my kind. I was tolerant of the naiveté of the new medical psychiatrists, many playing in an as yet unfamiliar hard science arena with the typical lack of humility seen among newbies. And I was able to continue to develop in my chosen corner of the world, getting better at knowing when I could help and how to do it. I retired with a sense that I’d come through a tough time learning more than I bargained for, but none the worse for the journey. I settled away from the maddening crowd to think about other things.
After about five years, I agreed to help out as a volunteer in a charity clinic. Knowing it would be very different from my practice, I hit the books to catch up, particularly on my pharmacology. The combination of what I read and the medication regimens of the patients I saw threw me for a loop. In the last post, I talked about cognitive dissonance. But that phrase isn’t big enough to describe that feeling five years ago. About that time, the chairman of the department I’ve been affiliated with from the start was exposed as a crook by a US Senate Investigation, along with several other chairmen including the APA President-Elect. That was a formidable combination and I began to read and write, my way of mastering unimaginable things.
I tell my oft told story once again for a reason. For the next five years, I vetted drug trials, read blogs and papers, learned about things I never thought about before like how the FDA or the NIMH work. At the outset, I didn’t even know which companies made which drugs, what the HAM-D was, or what a LOCF stood for – much less what it meant. I think it took most of the last five years to even catch up with all that had gone on. I had already learned on my own about the withdrawal syndromes, Akathisia, and suicidality with SSRIs the hard way – from patients – but I’d never prescribed an Atypical Antipsychotic, so all of that was new. My writing wandered from place to place without clear focus as I happened on one thing, then another. I wasn’t even sure why I got so involved except that it was about bad things happening in my own field that had gone on literally under my nose, but I had positioned myself off the grid and hadn’t seen. And there was a boatload to see.
I remember when it finally began to crystallize where I ought to direct my attention. One day almost exactly a year ago, quite by accident I came across something new on the GSK web site [a movement…]. Like everyone who has ever read it, I had focused a lot of attention on Paxil Study 329 as a paradigm of something very wrong. That day, the something new was the 329 data laid out in Appendix after Appendix [quietly added a week or so earlier]. I started writing the people I’d met along the way, and David Healy pointed me to Peter Doshi [the Tamiflu guy] who told me how he got it published by looking back at a GSK settlement agreement eight years before with Elliot Spitzer then Attorney General for NY State. So I dusted off my science from a former career and had a go at analyzing that data, starting with the lesson of Study 329: the basics…. Even with all my rusty joints and only an Excel SpreadSheet, I could see that if you had the data in front of you, things got very clear very quickly. All the indirect speculating and sleuthing I’d been learning paled in the face of the real numbers. So a year ago tomorrow, I wrote a short post entitled, the lesson of Study 329: data transparency…. To quote the enigmatic Jacques Lacan, the whole thing moved for me from the symbolic and imaginary registers to the real. That’s a lousy way of saying that I knew what I thought needed to be done about the mess I’d been writing about for four years.
While that was a moment of enlightenment for me, it was old hat for a lot of other people. I just didn’t know who a lot of them were, and I hadn’t figured out what the ones I knew about were really saying. I first thought about David Healy, Ben Goldacre, Fiona Godlee, Ian Chalmers, Peter Doshi, Tom Jefferson. But as I kept looking, just about everyone else I’d cataloged as right thinking along the way was talking in one way or another about data transparency, just under some other name or from some other angle. I don’t mean to go overly simplistic here. But for the last year, I’ve become increasingly convinced that data transparency is the essential next step. Without it, we stay where we are, complaining and chasing rainbows, impotently pointing fingers, guessing at things we have every right and every obligation to know intimately. A lot of people had already figured that out, but I hadn’t. What comes after data transparency? I don’t really know the answer to that question, but something comes next. Without it, there’s nothing.
- the AllTrials Initiative with Ben Goldacre, Fiona Godlee
- the RIAT Project from Peter Doshi, Kay Dickersin, David Healy, Swaroop Vedula and Tom Jefferson supported by the BMJ and PLoS Medicine
- RxISK and the recent posts and petition on the DavidHealy.com
- the Cochrane Collaborations group with Ian Chalmers, Peter Doshi, and Tom Jefferson focused on Tamiflu
- the calls for Transparency from Mad in America
- the European Medicines Agency [EMA]
- the TEST Act
- the efforts of PhRMA and EFPIA
- the suits by AbbVie and InterMune blocking the EMA
- every pore in the skin around PHARMA
- the as yet unknown support from organized medicine