Psychopharm R&D Cutbacks: Crisis or Opportunity?

The scientific journal Nature ran an editorial this week with a rather ominous headline: “Psychopharmacology in Crisis.”  What exactly is this “crisis” they speak of?  Is it the fact that our current psychiatric drugs are only marginally effective for many patients?  Is it the fact that they can often cause side effects that some patients complain are worse than the original disease?  No, the “crisis” is that the future of psychopharmacology is in jeopardy, as pharmaceutical companies, university labs, and government funding agencies devote fewer resources to research and development in psychopharmacology.  Whether this represents a true crisis, however, is entirely in the eye of the beholder.

In 2010, the pharmaceutical powerhouses Glaxo SmithKline (GSK) and AstraZeneca closed down R&D units for a variety of CNS disorders, a story that received much attention.  They suspended their research programs because of the high cost of bringing psychiatric drugs to market, the potential for lawsuits related to adverse events, and the heavy regulatory burdens faced by drug companies in the US and Europe.  In response, organizations like the European College of Neuropsychopharmacology (ECNP) and the Institute of Medicine in the US have convened summits to determine how to address this problem.

The “problem,” of course, for pharmaceutical companies is the potential absence of a predictable revenue stream.  Over the last several years, big pharma has found it to be more profitable not to develop novel drugs, but new niches for existing agents—a decision driven by MBAs instead of MDs and PhDs.  As Steve Hyman, NIMH director, told Science magazine last June,  “It’s hardly a rich pipeline.  It suggests a sad dearth of ideas and … lots of attempts at patent extensions and new indications for old drugs.”

Indeed, when I look back at the drug approvals of the last three or four years, there really hasn’t been much to get excited about:  antidepressants (Lexapro, Pristiq, Cymbalta) that are similar in mechanism to other drugs we’ve been using for years; new antipsychotics (Saphris, Fanapt, Latuda) that are essentially me-too drugs which don’t dramatically improve upon older treatments; existing drugs (Abilify, Seroquel XR) that have received new indications for “add-on” treatment; existing drugs (Silenor, Nuedexta, Kapvay) that have been tweaked and reformulated for new indications; and new drugs (Invega, Oleptro, Invega Sustenna) whose major attraction is a fancy, novel delivery system.

Testing and approval of the above compounds undoubtedly cost billions of dollars (investments which, by the way, are being recovered in the form of higher health care costs to you and me), but the benefit to patients as a whole has been only marginal.

The true crisis, in my mind, is that with each new drug we psychiatrists are led to believe that we’re witnessing the birth of a blockbuster.  Not to mention the fact that patients expect the same, especially with the glut of persuasive direct-to-consumer advertising (“Ask your doctor if Pristiq is right for you!”).  Most third-party payers, too, are more willing to pay for medication treatment than anything else (although—thankfully—coverage of newer agents often requires the doctor to justify his or her decision), even though many turn out to be a dud.

In the meantime, this focus on drugs neglects the person behind the illness.  Not every person who walks into my office with a complaint of “depression” is a candidate for Viibryd or Seroquel XR.  Or even a candidate for antidepressants at all.  But the overwhelming bias is that another drug trial might work.  “Who knows—maybe the next drug is the ‘right’ one for this patient!”

Recently, I’ve joked with colleagues that I’d like to see a moratorium on psychiatric drug development.  Not because our current medications meet all of our needs, or that we can get by without any further research.  Not at all.  But if we had, say, five years with NO new drugs, we might be able to catch our collective breaths, figure out exactly what we’re treating after all (maybe even have a more fruitful and unbiased discussion about what to put in the new DSM-5), and, perhaps, devote resources to nonpharmacological treatments, without getting caught up in the ongoing psychopharmacology arms race that, for many patients, focuses our attention where it doesn’t belong.

So it looks like my wish might come true.  Maybe we can use the upcoming slowdown to determine where the real needs are in psychiatry.  Maybe if we devote resources to community mental health services, to drug and alcohol treatment, pay more attention to our patients’ personality traits, lifestyle issues, co-occurring medical illnesses, and respond to their goals for treatment rather than AstraZeneca’s or Pfizer’s, we can improve the care we provide and figure out where new drugs might truly pay off.  Along the way, we can spend some time following the guidelines discussed in a recent report in the Archives of Internal Medicine, and practice “conservative prescribing”—i.e., making sensible decisions about what we prescribe and why.

Sometimes, it is true that less is more.  When Big Pharma backs out of drug development, it’s not necessarily a bad thing.  In fact, it may be precisely what the doctor ordered.

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22 Responses to Psychopharm R&D Cutbacks: Crisis or Opportunity?

  1. Steve says:

    Except for dementia meds, perhaps.

    Steve

  2. Iatrogenia says:

    See also http://www.guardian.co.uk/science/2011/jun/13/research-brain-disorders-under-threat?INTCMP=SRCH

    Note the similarities in phrasing between the June 13 Guardian article and the June 14 Nature article. (Shame on you, Nature!)

    This must be part of a public relations effort by the pharmaceutical companies, who, having reaped enormous profits from antidepressants but closed down research as injury lawsuits paid out $$ millions, are now manipulating governments into insuring their risks.

    Yep, take a good look at where psychiatric research comes from.

  3. David Allen says:

    Actually, there has not been any major advance in psychopharmacology since the SSRI’s showed effectiveness in OCD. The atypicals were just antipsychotics with different toxic side effects; not more effective than the typicals. Everything else has been a me-too or a sedative. The dementia drugs do very little.

    There is nothing new on the horizon because of the profession’s myopic focus on neurotransmitters and receptors. We’ve beat that horse to death. We need to be looking more at such phenomena as neural networks, neural plasticity, synapse formation. So far, big Pharma has had zero interest.

  4. Iatrogenia says:

    “….The true crisis, in my mind, is that with each new drug we psychiatrists are led to believe that we’re witnessing the birth of a blockbuster….”

    Steve, why do psychiatrists keep on taking the bait? Fool me once, shame on you, fool me twice — it’s been 20 years of the pharmaceutical industry making fools of psychiatrists. When are they going to learn? Or are they looking out for their own revenue streams and would rather subject patients to unnecessary risks to keep their appointment books full?

  5. moviedoc says:

    What about Suboxone for opiate addiction, recently available in a sublingual film less likely to be used by kids or diverted and a patch? And in the pipeline is an implant that lasts 6 months. Then there’s the depot injection of naltrexone which also helps alcoholics. What about the less abusable new lisdexamfetamine for ADD and new preparation of Oxycontin? What about clozapine? Can cause death. Of course many with schizophrenia seem to prefer that “side effect,” even without using the drug, but I’m glad we didn’t stop development before its invention. Even the me-too drugs occasionally work for a patient where all else has failed.

    So Steve says we’ll redirect the “resources.” Tell me how many investors will pony up millions to bet on reaping profits from the next of the hundreds of versions of psychotherapy. My prediction is there won’t be any resources.

    • Tom says:

      Who the hell cares if investor’s reap profits from our treatments? It is only important that our patient’s profit!

      • moviedoc says:

        The investors care, Tom. Why would they invest if there’s no promise of return? Would you throw $10k of your hard earned cash into development of a new psychotherapy method?

  6. Rob Lindeman says:

    Agree. The experience from internal medicine and anti-hypertensives is instructive. Who knew dirt-cheap Lasix was so effective?

  7. Jackie says:

    This is probably not doable (otherwise it would have been done already, right?) but I wish these big pharma people would find a way to tinker with Lithium to make it more tolerable for people.

    I read over and over again that Lithium is the most effective treatment for Classic Bipolar but that people don’t stay on it because it has to be taken twice daily, has a lot of side effects, narrow therapeutic window, requires frequent blood testing, and so on. Now, I’m reading that in very preliminary lab studies, Lithium is showing promise for the treatment of Alzheimer’s Disease.

    What a service to humanity it would be (in my opinion) if big pharma worked on the development of a patented, extended-release, lower side-effects form of Lithium.

  8. Duane Sherry says:

    Lithium is available in a few less-toxic forms –

    Joan Matthews Larson, Ph.D. lost her son to “bipolar disorder”…

    The Bio-Recovery Center is a good resource for less-toxic forms of lithium –

    http://www.healthrecovery.com/contact-us

    Also, Famous Water has elemental amts of lithium in the number 3 and 4 levels –

    http://www.famouswater.com/

    A psychiatrist would likely argue that these amounts would not make a difference, and/or cross the blood brain barrier. But people have found great relief in these smaller amts of lithium.

    Homeopathic practitioners use lithium… once again, in tiny amts….
    Long-before allopathic medicine took hold, people found healing with homeopathy –

    http://homeopathyusa.org/

    Duane

    • moviedoc says:

      Duane, you’ll probably be surprised to hear that I, moviedoc, have dabbled in homeopathy. Here’s Moviedoc’s Homeopathic Cure for Drowning.

      • Humor is therapeutic.
        What can I say?

        I find it kind of interesting that so many conventional docs dismiss homeopathy….insisting that once something is diluted to such an extent that it too small to have any power… like an atom, I suppose.

        And of course, atoms have no power….
        I guess the folks in Hiroshoma and Nagaski never got the memo!

        Ooops, I got serious, when you were trying to add some humor to the mix…

        Here’s a good one –

        What’s the difference between a psychiatrist and God?
        … God doesn’t believe he’s a psychiatrist.

        Duane Sherry

      • Jackie says:

        Let’s all have an atom for dinner tonight — see what it does for the hunger pangs.

  9. Duane Sherry says:

    Steve,

    You wrote:

    “When Big Pharma backs out of drug development, it’s not necessarily a bad thing. In fact, it may be precisely what the doctor ordered.”

    My comment:

    Thank you!

    Duane Sherry

  10. Carol Levy says:

    As a chronic pain patient I have become accustomed to psychotrophics, among others (such as anticonvulsants like neurontin, tegretol, etc) having secondary uses/off label for those with chronic intractable pain.
    To walk away from the R&D seems only a way to spite the investors as more and more become dx’ed with CIP, and psychiatric disorders that might respond to medication (and therefore make them more money)
    Certainly trying other modalities first, such as relaxation techniques, cognitive therapy etc. for both populations is an excellent idea (obviously, when appropriate) but I see no upside to the downsizing of R&D.
    On the other hand – maybe the ‘breather’ is also necessary but the two do not seem mutually exclusive to me.
    Carol
    http://apainedlife.blogspot.com/

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