JAMAby Kathy L. Hudson, PhD; Michael S. Lauer, MD; and Francis S. Collins, MD, PhDSeptember 16, 2016.
New England Journal of Medicineby Deborah A. Zarin, M.D., Tony Tse, Ph.D., Rebecca J. Williams, Pharm.D., M.P.H., and Sarah Carr, B.A.September 16, 2016
STAT politicsBy Charles PillerSeptember 16, 2016
Well, speaking of launches! Francis Collins [Director of the NIH], Deborah Zahn [Boss at ClinicalTrials.gov], Robert Califf [new FDA Commissioner] and Ben Goldacre [ClinicalTrials Everyman] in the STAT piece – big guns all around. And then add this to the mix:
Promoting innovation and access to health technologiesSeptember 2016
A lot of good words in these reports. The spirit is there in all of them at first reading. It’s not yet time to pick apart those encouraging words and see if they will translate into actionable changes in the Clinical trial process. That’s for a close reading of the official documents when they’re fully available. But we can frame some important things to look for.
In the past, there have been reforms that should have worked, at least helped. They have failed us for several reasons, but one stands out. After the trumpets stopped blaring, they were just forgotten. The people doing the trials either didn’t do them, or didn’t do them right, or didn’t do them on time. The people in charge didn’t keep up with them or do anything in response to infractions if they even knew about them. They sounded good, but they flunked compliance, surveillance, and enforcement. So as we’re looking over these various changes and reforms, these provisions are paramount. Without these elements, it’s just another failed exercise.
I’m just going to be glad they’re doing something, and that the agencies seem to be working together for a change. These links are here for starters, but now it’s time to read them and their official versions and see what’s behind the good words, with an eye out for compliance, surveillance, and enforcement. Feel free to join in the fun…
feels like we haven’t left the launch pad tho :/
Part of the question is whether or not rank and file physicians (especially psychiatrists) will prioritize these issues, learn enough to truly understand them, and become part of the force that prevents the recurrent pattern of forgetting we’ve seen over the past 10-15 years. 2004,2008,2012,2016, we keep seeing these 4 year cycles. I continue to wonder whether impact on one’s standing among one’s professional colleagues has any significant role to play. Looking back at this from about 6 years ago:
http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html
the second ground of disapproval has largely disappeared from our professional communities. Not just within academia, or within professional societies, but more importantly it appears largely a non-issue for the great majority of “unaffiliated” physicians (especially psychiatrists?).
How important, or not, to traction around these issues, is this vacuum? Though professional societies themselves may not be the solution, for many reasons (e.g., http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html?showComment=1291822229945#c3601988985998975311 ) what stops front line clinicians from taking these factors into account? They are not in danger of retribution as might be those in academia or those within the power structure of the professional academies.
I keep coming back to Dr. Wagner with all this because this academic physician’s participation in the activities targeted by AllTrials and RIAT are probably better documented than for almost any physician, let alone psychiatrist. Especially given that, unlike some others who leveraged their original careers, it appears that the career itself was built around those approaches
http://1boringoldman.com/index.php/2016/07/07/authority/#comment-264308
1bom, I don’t know what your experience is with this, but in the vast majority of instances rank and file psychiatrists have practically no interest in that. Though AACAP certainly made no effort to inform members of Dr. Wagner’s approach across Study 329, CIT-MD-18,…etc, I suspect that none of that would have changed the outlook of most members.
It seems to me that rank and file physicians (especially psychiatrists) holding a communal memory would act as a bulwark against the forgetting. Instead, if anything, our professional community seems a force in the other direction.
How to address this remains a mystery to me. It feels more like a cultural issue (how will engagement impact me in the eyes of my peers) for most. Piling on more proof seems like it won’t be the whole answer.
I am reminded of this:”But as a Child, Adolescent and General Psychiatrist in private practice, I have neither the time nor the skills to carefully evaluate the positions taken either by Le Noury et al [1] or Keller, et al [2].”
http://www.bmj.com/content/351/bmj.h4320/rr-32
I mean, this was from over a decade ago:
http://www.nytimes.com/2004/11/29/business/contracts-keep-drug-research-out-of-reach.html
And, that article isn’t even focusing on Study 329.
CIT-MD-18 would seem to remove much doubt.
Yet in regards what I am discussing that still will make little to no difference.
It seems it will take something more than just more information.
As an aside: A nice reminder that “growing” the “franchise” “fun” occurs throughout medicine. Recalling the trial you attended 1bom: They have much more than a 1% market. Now, they just need to legislate their way to obtaining the big payer.
http://www.nytimes.com/2016/09/16/business/epipen-maker-mylan-preventative-drug-campaign.html