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NIMH Distances Itself From DSM Categories, Shifts Funding To New Approaches
New submitter Big Nemo '60 writes with news that the National Institute of Mental Health is seeking to modernize the diagnosis of mental illness through the use of neuroscience, genetics, etc. From the article: "The world's biggest mental health research institute is abandoning the new version of psychiatry's 'bible' — the Diagnostic and Statistical Manual of Mental Disorders — questioning its validity and stating that 'patients with mental disorders deserve better.' This bombshell comes just weeks before the publication of the fifth revision of the manual, called DSM-5."
More importantly, they are going to be shifting funding to research projects that seek to define new categories of mental illness using modern medical science, ignoring the current DSM categorizations: "The strength of each of the editions of DSM has been 'reliability' .. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. ... NIMH has launched the Research Domain Criteria (RDoC) project to transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system. ... It became immediately clear that we cannot design a system based on biomarkers or cognitive performance because we lack the data. In this sense, RDoC is a framework for collecting the data needed for a new nosology. But it is critical to realize that we cannot succeed if we use DSM categories as the 'gold standard.' ... Imagine deciding that EKGs were not useful because many patients with chest pain did not have EKG changes. That is what we have been doing for decades when we reject a biomarker because it does not detect a DSM category. We need to begin collecting the genetic, imaging, physiologic, and cognitive data to see how all the data — not just the symptoms — cluster and how these clusters relate to treatment response."
Oh, I'd be the last to deny that the quality of mental health care is deeply uneven(with the limited exception of scheduled substances, where the DEA may end up knocking on your door) if it's FDA approved, any doctor can prescribe it, so there are a lot of drugs being handed out either by dubiously qualified generalists, or by the wrong flavor of specialist. My point was just that, since our knowledge of the brain is so poor(and our methods for sampling an in-vivo brain so... crude) the list of objective chemical markers dwindles alarmingly swiftly once you get past a relatively short list of endocrine issues.
And that most of the research money the Pharma companies spend is on doing clinical trials to see which ones actually work in humans after the university researchers have found potential candidates testing in cell cultures and animal models.
Hell no. About 15% of drugs come from academic research, the rest are invented by biotech or pharma companies. For the most part academic labs identify new drug targets. Most of the compounds they develop to test their hypotheses are for the most part useless as actual active pharmaceutical ingredients due to toxicity, bioavailability, and metabolism.
As a researcher I can confirm this, but also the parent.
Traditionally the drug companies have relied on methods equivalent to "brute force" programming, test a library of a few thousand possible drugs and see which works. But this is getting harder, it seems they have run out of low hanging fruit, so instead they take some existing understanding and use that to make the drug. By doing this they get the drug and the profit but only by relying on taxpayer funded research. Remember the drug does not need to have been made by government researchers to be reliant on tax funded research for its existence. The researchers find a target the drug companies take it from there, but increasingly it is the first part that is most expensive.
It may in fact be cheaper for society to do all this on the government dime, there is a lot of waste in the drug industry a lot of it from its very nature as private research. Fixing this would involve the government massively increasing research funding and deliberately killing an industry, not likely in the short run.
[source needed]
Sorry, a couple of years ago I looked at a year's worth of drug approvals and came up with 15%. The actual data (1998-2007) say 24% came from academia:
http://www.nature.com/nrd/journal/v9/n11/full/nrd3251.html
Firewalled, but there is a great discussion at In The Pipeline that breaks out the numbers:
http://pipeline.corante.com/archives/2010/11/04/where_drugs_come_from_the_numbers.php
Of course more and more university research is funded by Pharma these days, especially the efforts that are most likely to lead to new drugs. Which column would you put that drug in?