super tuesday:
the age of molecular diagnosis and the dawn of the age of companion diagnostics…

Posted on Wednesday 14 March 2012

On February 29th, I said I smell a campaign… I take no joy in having been right about that. I thought it was a Lilly [Cymbalta] and Pfizer [Pristiq] show, but I see Forest Laboratories [Viibryd] has joined in the mix [sponsoring the Emslie/Gibbons Medscape C.M.E.]. Looking over the list of authors in that Journal of Child and Adolescent Psychopharmacology free issue, a lot of the authors are recycled from last time around [Karen Dineen Wagner, Benedetto Vitiello, Martin Keller, Graham J. Emslie, John S. March].

If you think about it, it’s an amazing piece of theater. Dr. Gibbons kicks things off with an article saying that the original analyses that lead to the "black box" warnings  of suicidal risk in kids on antidepressants was  wrong, and does a media blitz. Then, a month later, he has a companion article that says antidepressants are effective in kids with mild and severe depression after all. That’s followed by his doing a Medscape C.M.E. with the guy, Dr. Graham Emslie, who has been involved with almost every adolescent clinical trial of the antidepressantss in adolescents ever done. On the same day as the C.M.E., an edition of the Journal of Child and Adolescent Psychopharmacology came out with a symposium edited by Dr. Emslie on adolescent depression as a free issue filled with articles by the traditionally pharmaceutical-influenced KOLs. Meanwhile, one of them, Dr. John March, recently published Drug development in pediatric psychiatry: current status, future trends that concludes:
As described in a recent article by the NIMH Director, Tom Insel, on transforming psychiatry as a clinical discipline, the age of symptomatic diagnosis and current generation treatments is passing; the age of interventions that emerge from the revolution in translational developmental neuroscience has begun. The twin NIMH Council workgroup reports on translational developmental neuroscience and interventions research, respectively, which shift the National Institute of Mental Health away from current generation treatments and toward early phase clinical pharmacology, presage the development of just these kind of preemptive treatments. Because these newer interventions will emerge from an improved understand of the fundamental biology of the illnesses, they should be more effective in patients who are ill and, excitingly, will eventually become preventive if not preemptive, e.g. they will be delivered to very young children who are at risk but not yet showing early signs of mental illness. As a result, pediatric psychiatry will increasingly become the front end [the most important end] of a lifespan developmental model for mental illnesses. More than a little humility is required as this vision unfolds over the next many years. For a while, studies in adults will still lead studies in youth: developing interventions for mentally ill youth will emerge once the fundamental biology catches up such that science drives innovation and innovation drives application in the form of interventions. As part of this process, biomarkers on the road to stratified and ultimately personalized medicine will be a key development – finally, the age of molecular diagnosis and the dawn of the age of companion diagnostics to optimize treatment for psychiatric illness. For the field of pediatric psychopharmacology to thrive it will be important to embrace and actively participate in this revolution, including addressing its ethical implications, so that mentally ill youth are viewed as a key target population and, consequently, truly preemptive, preventive and curative interventions will be developed for children by first intent.
I’m thinking that this campaign is bigger than I knew. I included Dr. March’s piece for the phrase, "For the field of pediatric psychopharmacology to thrive it will be important to…" This is a time when the use of psychiatric medications in children has become increasingly controversial. Biederman’s Bipolar Child craze seems to finally be passing. There’s an outcry about the widespread treatment of kids with stimulants. There’s a dire warning about using antidepressants in children. The specter of obesity and metabolic problems haunts the use of atypical antipsychotics. What’s a poor pediatric psychopharmacologist to do these days? I guess somebody thinks the answer is to mount an all out campaign against the warnings and the doubts.

But I don’t think all of us agree that the point is for the "field of pediatric psychopharmacology to thrive." In fact, given it’s track record, I’m thinking this groundhog might just take another look and go back in the hole. Here’s Graham Emslie’s track record:

 

So while Emslie and Gibbons try to unhappen the past and revive its grand hopes, Dr. March exhorts us to look into yet another new future based on the visions of Tom Insel, the prophet of translational developmental neuroscience.

In January, I sat through a trial watching slide after slide of Call Notes written by drug reps about their efforts detailing Risperdal to Child Psychiatrists off-label and giving them articles that disproved reports about obesity, diabetes, etc. [claims that were actually true]. I can see another generation of drug reps carrying reprints of Dr. Gibbons recent articles extolling the virtues of the SSRIs and SRNIs in child and adolescent depression. And maybe in the future, one of you will be observing the trial of a suit brought by parents of kids who suicided on Viibryd, or Cymbalta, or Pristiq, watching similar slides – but I hope not.

Yesterday was a busy day. My wife had an outpatient surgical procedure at 0-dark-thirty AM. It was a miracle of modern medicine itself – the insertion of an artificial joint into her big toe. Sitting in the waiting area, I pondered the wonders of modern medicine that can replace a painfully frozen toe with titanium and silicon. Afterwards, the surgeon spent 15 minutes proudly talking to me about the recent advancements in science that lead to the new toe-joint technology. Medicine is like that. Doctors identify with the advances as if they, themselves, made the discoveries. I felt really good about the symbiotic relationship between the foot surgeons and their toe joint developers. Of course I wondered if he had any financial connection with the toe-joint company, but I didn’t ask. I guess I’m not much different that anybody else in that regard. I’d rather hold onto my Marcus Welby fantasies that the world of Medicine is unafflicted by commercial forces. And it wasn’t lost on me that there were a couple of direct-to-consumer advertisements [fibromyalgia and depression] on the inevitable waiting room television, but not a one for improved big toe-joint devices for Hallux Rigidus.

I’ve spent a lot of time recently engaging Dr. Gibbons on a scientific plane – boning up on Number Needed to Treat calculations or reading about the methods for computing Effect Sizes from the available data to show the error of his ways. But yesterday, watching him talk on that video [Medscape C.M.E.], I wondered why I was bothering to do all of that. I felt like I’d been violating my cardinal rule for living [never accept an invitation to go crazy]. This doesn’t have anything to do with science. It’s about tapping the child and adolescent depression market, and I expect Dr. Gibbons knows that since he’s hitting the big tent with a drug maven in a C.M.E. video paid for by a pharmaceutical company that just acquired a new antidepressant [Forest Laboratory, Viibryd]. I actually find all of this kind of embarassing…

AND: Speaking of embarassing, I just learned that the Medscape C.M.E. that I’ve been raving at is old – done three years ago. Gibbons was apparently already on the bandwagon even back then. I don’t know if the age of the C.M.E. exonerates him or indicts him further… or both… but it puts it back in Forest’s Lexapro days [lower right graph above] instead of today’s newly acquired Viibryd…
  1.  
    March 14, 2012 | 6:09 PM
     

    The shills at the top might very well know exactly what they’re doing, and what they’re doing is making a lot of mental health professionals true believers.

    During my recent and only commitment at the age of 50, I commented at a group meeting on the fact that there were three copies on one wall of a NAMI poster claiming that great people in history suffered from mental illness. The list included Abraham Lincoln and diagnosed him with Depression.

    A social worker on that staff told my friend of thirteen years that he should go to the NAMI website to get insight into my mental illness. NAMI was being treated as if it were an authority on mental illness and not a company run by drug company lobbyists.

  2.  
    Stan
    March 14, 2012 | 9:13 PM
     

    This all is really a runaway freight train…Pharma & Institutionalized Psychiatry has ownership of the railroad, will never relinquish power, or pull the stop lever until they have every man, women, & child under their unyielding chemical control.

    It is fast becoming unpleasantly obvious that the only solution may soon come down to manually pulling up the tracks, and then going about blowing up all the stations. 🙁

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