watchful waiting no more…

Posted on Saturday 2 February 2013

Health Care’s Trick Coin
New York Times: OP-ED
February 1, 2013

… Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge.

Medicine routinely overcomes enormous technical challenges, and there is nothing complicated about the changes needed to prevent Johnson & Johnson, or Roche — or anybody — from withholding information. The F.D.A. has proposed reforms to its systems for assessing artificial hips. And a campaign, supported by the National Physicians Alliance, has begun at demanding that results be publicly reported for all trials, dating back to at least the 1990s, on all treatments currently in use. We need competent legislation, enforcement and leadership from medical academic bodies, all clearly stating that nonpublication of trial results is nothing less than research misconduct.

This will take place against a clamor from industry stakeholders. They have worked hard to silence discussion on these problems, by pretending that the flaws have already been fixed. Why? Because this strategy is their only hope. There is no defense for withholding information on treatments used by patients around the world.
In a former life as a director of psychiatry residency training in a time of famine, I worked for a good chairman – but he was tired. He’d started a Department in the 1950s, taking over from a group of Existentialists who were on the forefront of the wave of the experiential therapies that would flower in the flower-child 1960s, but didn’t slightly fit a main-line university system. He’d built a department that had grown into something of value. By the time I came along, it was the mid-1970s, and in a time of cholera. The godsend of funding for psychiatry in the 1960s had become a vague memory. Nationally, Mel Sabshin and Robert Spitzer were rebuilding their version of a psychiatry for the coming 1980s; locally, my chairman was watching his creation begin to erode; and personally, I lived in a world of more problems than solutions.

The chairman, as old men will do, talked in stories [like I’m doing right now]. His favorite was his father saying, "At the end of my day, I clean off my desk. Don’t go home with unsolved problems." And, indeed, his desk was pristine. It wasn’t lost on me that the most likely time for him to tell me that story was when we were in my office where my desk was a monument to the unsolvables. Now that was a problem I could fix. I just kept two offices – one for show and one around the corner for doing work in. I even made up a private counter-story. "If you clean off your desk at the end of the day, that means no problem has had more that 24 hours worth of thought – an endless train of short-term solutions." If he’s looking down right now, I think he’s chuckling. His was actually a good lesson for me to learn. It just didn’t fit the times.

I developed a problem-solving technique of my own. "If you’re faced with an unsolvable problem, neither despair nor try to solve it right now unless it’s the direst of emergencies. Put it in the very front of your mind and wait until a solution presents itself." I spent my days in controlled procrastination, busily scanning the universe for solutions. If I was short a resident to fill all of our obligated positions for the next rotation, I just waited [and worried, and scanned]. Sure enough, some of the best residents I ever had just seemed to suddenly show up – changing specialties, drawn to Atlanta, mustering out of the service. I guess it’s an extrapolation of the medical principles of watchful waiting and benign neglect [the emphasis is on watchful]. Frantically trying to solve unsolvable problems is like therapeutic zeal, a recipe for disaster. Of course, my method didn’t always work, but it was sure better than the alternative in those difficult days. In fact, as I recently tried to say in my on history ramblings, the poverty and controversy of those times set the stage for some solutions that caused many of our current difficulties. It’s that worst of all demons, the law of unintended consequences.

I didn’t involve myself in these problems of modern psychiatry and the academic·pharmaceutical complex in my retirement because I thought I needed to be part of any solution. After leaving academia, my patients showed up with plenty enough unsolvable problems to keep me busy, and I’ll have to admit that the years in my academic job were good training for helping them not act impulsively and wait until the road up ahead was clear, and a viable solution presented itself [it’s why they’re called patients]. I got interested in the goings on in psychiatry in my latter days because it’s interesting, but mostly because it’s absolutely outrageous, shameful. And it’s taken me a long time to even get up to speed on what the problems really are. This blog has become like my old work desk, a catalog of problems on post-it notes stuck all over the place.

Academic Psychiatry joining up with the Pharmaceutical Industry, supported by the American Psychiatric Association, was an active process. It was built on a vision of the future people believed in at the time, and a growing disillusionment with the past. It also happened to be a solution that solved the pressing practical problems of the hour. And it had a loophole big enough to drive a Mac Truck through, but it didn’t show at the time, at least to most of us. It wasn’t even talked about. The loophole was secrecy – secrecy about conflicts of interest, secrecy about authorship, secrecy about money changing hands, secrecy about raw data, secrecy about adverse effects, even secrecy like the processes of the DSM-5 Task Force. Our endless gratitude is directed to those who spent their days all along exposing that secrecy against a gradient of shared silence. So right-thinking people began to hack away demanding that sources of funding, conflicts of interest, and true authorship be declared. As it became clear that Clinical Trials were at the center of the problem, a variety of fixes have been put in place, but haven’t stemmed the tide. They had loopholes of their own.

If this were those days long ago when I was a human problem container, hypervigilant and scanning for solutions, I would see Ben Goldacre as that wandering resident-to-be who casually stumbled into my office, a seemingly heaven sent solution to my pressing practical problem. He even looks the part. It’s not that his solution is unknown to us. People like David Healy, Bernard Carroll and Bob Rubin, Jon Juriedini and Healthy Skepticism, the Cochrane Group, and many others have been tirelessly running around with flashlights focused in those dark corners for years. But their heirs, Ben Goldacre, Peter Doshi, and a growing cadre of others, are finally in a position to do something with that lead. They’re not personally encumbered with the past that created this mess. That the secrecy has been the central problem is old news, but they’ve turned the fact that "[t]here is no defense for withholding information on treatments used by patients around the world" from a discouraging lament into an action plan and taken it to the streets where it belongs. They are looking the old loophole directly in the eye and finally in a position to confront it openly. More power to them [literally].

Of course, the resistance is fierce. The old guard in industry, medical finance, and academia knows that the definitive fix is going to unleash enormous problems – the very problems that the academic·pharmaceutical complex solved in the first place, some new ones it caused all by itself, and thrown in, a few modern add-ons. But that doesn’t really matter. Those things need to see the light of day too. From my perspective, the period of watchful waiting is quickly passing…
    February 2, 2013 | 5:50 PM

    Actually, as summarized here:, we’ve been trying to raise awareness of the problem of research suppression for at least 10 years.

    February 2, 2013 | 5:56 PM

    1BOM, Dr. Roy, et al. . .

    I’m sure you feel you’ve been in a wilderness, shouting to the heavens, with very little reward. Mickey, one of your commenters, Dr. Hassman, pointed out the apparent futility of the task. (I’ve shared that sentiment . . . something akin to hopelessness.) But voices that will not be stilled, who continue to speak (to an ever-changing audience) will be heard. On a different subject, a discussion ensued about critical mass–the point where the tide WILL change. The commenter acknowledged that we cannot know when critical mass will be achieved, what one single act becomes the proverbial straw that breaks the camel’s back . . . but as a long-time follower of things medical, economic, political, it’s voices like yours that just keep plugging along, providing needed information and perspective. So while I do more than lurking than participating, please know your efforts are appreciated. (Poses, Carroll, Silverstein–you, too, deserve an equal measure of thanks.)

    February 2, 2013 | 8:45 PM

    How about the obverse: “Withholding data not only misleads doctors who would treat you, but it’s an insult to the patients who have a similar diagnosis(es) and who might benefit from your questions to the same doctor they go to.”
    Elizabeth, PhD, RN

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