… Given the industry’s lack of innovation over the past three decades and the history of aggressive marketing of psychiatric medications, some might understandably say, “good riddance.” But by almost any measure we need better treatments, both medications and psychotherapies, for the entire range of mental disorders. It is never a positive sign for those with mental illness when thousands of scientists and millions of dollars are shifted away from research on these disorders. What can NIMH do about this? Without the large budget and the scientific expertise for medication development, how can NIMH compensate for the pharmaceutical industry’s shift in focus? Is it appropriate for NIMH to invest public dollars in an area that many pharmaceutical companies have deemed too risky for investment? In the next blog, I will suggest that what many are calling a “crisis in medication development” may be an opportunity for NIMH innovation.
At NIMH and in our broad research community, this has been a year of exciting discoveries and scientific progress, as we strive to make a difference for those with mental illness. Here are 10 breakthroughs and events of 2011 that are changing the landscape of mental health research.
Complexity: Discovering New Sources of Genetic Variance… Transcriptome: Developing Brains Have Unique Molecular Signatures… Induced Pluripotent Stem Cells: Disease in a Dish… De Novo Genetic Variants… Epigenomics: How Experience Alters Behavior… Grand Challenges in Global Mental Health… Precision Medicine… NDAR… New Culture of Discovery: Team Science… Public Private Partnerships…
As the pharmaceutical industry withdrew from psychiatric medication research and development this year, several new public-private efforts began to re-define the pathway for discovering new treatments. Arch2POCM, a public-private partnership comprising academic, industry, and regulatory scientists and clinicians, created a “precompetitive” initiative, free of intellectual property, for identifying new medications for schizophrenia and autism (20). One Mind for Research grew out of Patrick Kennedy’s moonshot for the mind, building an umbrella organization for neuroscience research related to all brain diseases. The Critical Path Institute led the way with common data elements for clinical research and new tools to promote data sharing. In addition, the Biomarkers Consortium brought industry, advocates, FDA, and NIH together to define biomarkers for neuropsychiatric diseases.
Two of the biggest defectors are the two British companies Astra Zeneca and GSK, who have shuttered all their laboratories for mental health research for good, closing facilities all over the world including those the US, UK and Italy and elsewhere. Also, Pfizer bought Pharmacia/Upjohn and closed their CNS research center in Kalamazoo, Michigan; bought Parke Davis and closed their CNS research center in Ann Arbor, Michigan; bought Wyeth and closed their CNS research center in Princeton, NJ; and then for good measure closed their own CNS research center in the UK. Merck closed their CNS research center in the UK where I worked in the 1980s, then bought Organon/Schering Plough and closed their CNS research center in the UK/Scotland for good measure. I could go on and on. This has had a devastating impact especially on the US and the UK. In fact, the UK has gone from a leader in CNS Pharma Research Centers, to having no big Pharma CNS research at all, with thousands of unemployed R and D scientists there and no prospect of CNS therapeutic innovation coming from their shores in the foreseeable future.
So, we have gotten what many of us have asked for. No Pharma. But that also means no new drugs. This has sparked a crisis in mental health therapeutic research worldwide but especially in the UK and US. The UK in fact is having a crisis meeting at the Royal Society of Medicine in August, where I am attending with about a dozen others, including the head of the NIMH from the US, the head of the MRC from the UK, and various UK and US academic and industry leaders to discuss what we should do about this. The last time I went to such a meeting was in 1987, where I co-chaired a meeting on this same topic with the famous Paul Janssen [now deceased], the prize winning inventor of Haldol, Risperdal, Fentanyl, Lomotil, and more. At that time I stated that the future could not be more promising. What a difference 25 years makes! Returning now to the same Royal Society of Medicine with others, but now with our collective tail between our legs, we are stating that “things could not be worse.” Were the last 25 years of mental health treatments discoveries so worthless as to discard these efforts for the future?
Brain circuitry model for mental illness will transform management, NIH mental health director says
British Medical Journal
by Caroline White
1 September 2011
The third change was the recognition that mental ill health is a complex mix of genetic and experiential factors. “This is not new,” he [Tom Insel] affirmed. “But what is new is the ability to probe the genetics of the disorder.” But whether the drug industry will take up the challenge, in the absence of plentiful molecular targets, is unclear, he suggested. “[It] has invested in me too compounds—and sometimes in compounds that are identical to someone else’s. And let’s be frank, that has worked really well for them,” he said. But he declared, “Antipsychotics and antidepressants are not very good.” Much more research into the biology of mental illness was needed, he said.
In the last twenty-five years, psychiatry has undergone a radical change, becoming focused almost exclusively on pharmaceutical interventions. Practicing psychiatrists see patients for short medication visits, and any psychotherapy is done by people in other mental health specialties. Whether this happened as a result of Managed Care and the changes in Third Party reimbursements, was a movement generated by the biologically oriented psychiatrists, or at the behest if the pharmaceutical industry, the specialty has defined itself by drug treatment, particularly ever changing new drug treatments. With empty pipelines for new drugs and pharmaceutical companies shutting down their CNS Drug Development programs, what will be left? Is the gold rush of the last 25 years about to end, leaving only ghost-towns as monuments to a bygone era? another busted bubble?
Mickey,
Ironically, psychiatry has put itself in the position of a patient who needs to change the direction of their life. Psychiatry has pointed fingers of blame for its own failures – pharma, managed care, de-institutionalization, and on-and-on-and-on…
Psychiatry needs to make some major changes in the way it conducts itself –
The field needs to make amends; search inside to find answers; find new ways to deal with challenges; develop better relationships; earn trust; claim full responsibility for its actions…
If psychiatry is willing to do the work, there’s a chance for its survival… otherwise, it will be a ghost-town (with a haunted past).
On a more festive note, here’s to the spirit of Christmas –
http://www.youtube.com/watch?v=dsMf-6F1aVM
My best,
Duane
“Ironically, psychiatry has put itself in the position of a patient who needs to change the direction of their life.”
EXCELLENT POINT! Really sums it up.
Excellent point, Duane…I do sometimes ponder the concept of “mental illness”. I’m not opposing the concept and I think it’s been helpful in some ways….some folks probably appear on the planet with different mental and emotional and psycological challenges…just like some folks show up with physical handicaps. But ultimately, our society holds people accountable for their behavior. So, John Hinkley remains under lock and key because we, as a society, aren’t going to let him have an opportunity to attempt to assassinate another President. And the sicko who held Jaycee Dugard captive…well, I frankly don’t care how “ill” he is. Same for the whack job who took Elizabeth Smart into captivity. And those mothers with post-partum stress disorder who drove their children into lakes. This is where I remain confused….are these “illnesses”??? Don’t we still hold them responsible (or at least we imprison them to keep their behaviors from affecting others)? Seems like pretty complicated questions to me.