personalized medicine: mid-course rest stop…

Posted on Wednesday 20 April 2011

Like its recent fore-runners, evidence-based medicine and translational medicine, personalized medicine is a pretty good concept. They are all terms to describe some way to improve something that’s wrong with the way things are now, or the way they have been in the past. As with almost any such new idea, there are twists and turns as they meander from the mainstream of physical medicine into psychiatry. Interestingly, in this case, the practical ramification of all three of these conceptual frameworks as they flowed into psychiatry was the same – an increasing emphasis and reliance on large scale clinical trials.

The evidence-based medicine idea was particularly influential in psychiatry which had been dominated by psychoanalytic thinking [by definition subjective]. The idea of evidence-based medicine had arisen in medicine proper as a movement to get conjecture and speculation out of the mix and replace it with solid science. In psychiatry, it brought about a massive paradigm shift well known to all of us, that ultimately moved psychiatry from the eclectic into the realm of a neuroscience. Some joked that "we lost our mind" and were left with only brains, but that’s actually more true than humor. And translational medicine had an equally profound impact on psychiatry. Translational medicine posited that the traditional boundaries between town and gown, academia and industry, government and both, were slowing the flow of new treatments to the patients who needed them. So many of those boundaries came down in response. Clinical trials of drugs moved from the snail’s pace of academic centers to a new and growing international clinical trials industry.

Comes now personalized medicine. The concept is exciting. With the massive leap of the human genome project, the idea that genetic markers and mechanisms are within our grasp and will lead to many things- including the actual measurements of genetic markers that will aid in selecting treatment. Already what came before personalized medicine is being called "trial and error" medicine. As with any new concept, the idea of "biomarkers" has overgrown the genetic meaning. Particularly in psychiatry, personalized medicine literally means any thing or things that you can measure that will direct treatment. Psychiatry hasn’t had much it could measure – a VDRL, some drug levels, toxicology screens. So something to measure has an added fascination and novelty – the possibility of certainty in a world of ambiguity.

Who would want to argue against these reformations? It would be folly to mount an argument in the form of "we need to return to non-evidence-based medicine medicine! who needs evidence anyway?" or "this translational medicine is getting in the way of the slow plodding way medicine should be operating" or "personalized medicine, bah humbug! what was wrong with  the good old ‘trial and error’ method?" But there’s a problem that comes with any new paradigm. If you voice skepticism, or point out potential problems, or suggest that we not throw out the "baby with the bath water," you can immediately be discounted as stuck in your ways, unenlightened, or biased by a rigid adherence to some passe` way of thinking. Evangelicism and self-righteousness seem to always accompany reform. It’s a pity, because new paradigms are just the next old paradigms. While the solution is to accept differing paradigms as an inevitable competition, that’s not what usually happens – at least in the short term

But such lofty considerations are not the point of my writing about this. My concerns are much more banal – corruption. We have witnessed an unheralded level of corruption in the domain of psychiatry in the last several decades. We all know about pharmaceutical industry’s invasion of academic and non-academic psychiatry influencing continuing medical education, academic programs, research, prescribing practices, almost everything. Unfortunately, many psychiatrists have joined in the fun working as paid drug reps for pharmaceutical firms. Research studies have been misrepresented, jury-rigged, even ghost-written. And these very paradigms – evidence-based medicine and translational medicine – have been perverted to facilitate the corruption, including the rise of a Clinical Trial Industry that is hardly something to be proud of.

The people and the rhetoric behind the current rallying cry for personalized medicine worry me. Many of them have been on the edge [or in the center] of extreme conflicts of interest and other blatantly corrupt practices. When I listen to to those participants at the Mayflower Action Group Initiative [MAGI?], I felt some real shudders. And when I was going through the Brain Research site, I had some similar feelings. There are other examples. There are plenty of opportunities in personalized medicine for inappropriate and unwarranted profiteering, and it seems important to see them in advance instead of chasing them like these last two or more decades. So what can go wrong? What has already gone wrong? It’s not personalized medicine per se that has me concerned. It’s some of the persons/groups involved with personalized medicine

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