1 Boring Old Man

Of course, as soon as you write something like "There have only been two issues [before this one] that have grabbed my attention sufficiently to move me to action…," you realize that you’re dead wrong. What about all those cases that had been treatment failures taken on over the years? I guess I’d say the same thing – progress well justifying the effort, even if only partial success. But then again, that’s just the way of things.

These questions about modern psychiatry have many dimensions for me personally. I came to psychiatry on the lam from the limitations of hard science in the care of the sick. But not long after I arrived, psychiatry rededicated itself to hard science, and I had to move to the side to pursue my own path. Fortunately, that worked out well for me. Over the next several decades, I thought that a lot of the hard science of mainstream psychiatry was fairly amateur and way overblown, but passed it off as new-kids-on-the-block or the-brain’s-a-tough-nut-to-crack. What I didn’t pay enough attention to was that medicine in general and psychiatry in the specific was industrializing – the Insurance Industry, the Government Industry, the Hospital Corporations, the HMOs, the PPOs, the Pharmaceutical Industry, the Medical Device Industry, etc. And the thing I missed altogether was how central and dangerous the Clinical Trial Industry had become in the process.

It’s ironic to me that the very things that drew me to psychiatry – the subjectivity and ambiguity – made the specialty an easy mark for the medical industrial revolution. Industry doesn’t do subjectivity and ambiguity, and in the process of legitimately demanding objectivity, industries took the opportunity to slash and burn, and later pillage my new specialty – unfortunately with the willing participation of some of my new colleagues. Specifically, the alliance between the pharmaceutical industry and a subset of psychiatric opinion leaders used the emerging clinical trials industry to create an industry of their own – bolstered by a sales and distribution force from within psychiatry itself. If there’s a historical example in medicine of something this rotten happening on such a grand scale, I don’t know what it is.

So back to my optimism. I really think all of this is going to change, is already changing. The corrupt pharmaceutical clinical trials with their hired medical writers are the focus of the government, right-thinking physicians and clinicians, and increasingly the media. The psychopharmaceutical industry is itself on the lam from CNS drugs after taking some hits in the courtroom and running out of clones. The tainted KOLs have numbered days. And psychiatry itself is under a number of microscopes, particularly with the DSM-5 debacle. The welcome move for data-transparency and data-sharing is now medicine-wide and getting a lot of exposure. Science seems to be fighting for itself. For example:

Ushering in a New Era of Open Science Through Data Sharing
The Wall Must Come Down
^{by Joseph S. Ross and Harlan M. Krumholz}
JAMA. Published online March 18, 2013

^{It may appear that the clinical research enterprise is functioning well, even thriving. Nearly 30000 trials globally are recruiting patients, and results from 75 trials are published daily in biomedical journals. However, there is a crisis, with an attendant opportunity, that requires change. A wall surrounds much of these clinical research data, sequestering knowledge, impeding the free flow of information, and obscuring a clear view of the totality of evidence relevant to many research questions and clinical decisions. Nearly half of clinical research trials are never published. Moreover, publications are often incomplete, selectively reporting favorable outcomes and infrequently reporting relevant safety findings. Motivations and explanations for this phenomenon vary, but whether intended or not, selective publication distorts the medical evidence and inhibits the flow of information that is vital to decision making by patients and their clinicians.}

^{To ensure that patients and clinicians are able to make fully informed decisions about pharmaceutical agents, biological products, and medical devices tested through clinical trial research, an era of open science through data sharing is necessary. This step to establish a more transparent scientific process has already been taken by other fields, including genetics, physics, molecular biology, and the social sciences. Sharing maximizes the value of collected data and promotes follow-up studies of secondary research questions using existing data. Sharing also minimizes duplicative data collection, which in turn reduces research costs and lowers the burden on human research participants while positioning clinical trial data as a public good. Importantly, sharing maximizes the value of collected data, promoting follow-up studies of secondary research questions. Sharing also respects the contributions of the patients who consented to participate. Data management and analytic decisions have critical implications for interpretation and should be evaluable. If science is to be progressive and self-correcting, then data, not just summary conclusions, must be open to independent scrutiny. In addition, multiple examinations of clinical trial data are often necessary, particularly when pharmaceutical, biologic, and medical device sales depend so substantially on the results of only a few large clinical trials.}

^{Clinical trial funders, in particular drug manufacturers, may soon have no choice but to share. While the European Medicines Agency has been releasing clinical trial reports on request since 2010 as part of its access-to-documents policy, the agency recently announced that it will provide full access to complete clinical trial data sets to outside investigators beginning in 2014. The possibility of a new era of research is within reach. The wall is crumbling, albeit slowly, and momentum is gaining toward open science through data sharing. The imperative is to find successful pathways to share data that are attentive to all stakeholder needs, yet serve the best interests of society. The full potential of the clinical research enterprise can be realized by creating a culture that promotes sharing and provides credit to those who do—and consequences for those who do not.}