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.