Among the balloons that exploded during this super-heated summer was the intensifying debate over the worth of psychotropic medications.
Marcia Angell, the distinguished ex-editor of the New England Journal of Medicine, kicked things off with a ferocious two-part attack in The New York Review of Books on antidepressants, antipsychotics and, in general, medications to treat psychiatric disorders. Her argument distills charges often made much more sloppily: that psychiatrists dispense unnecessary and potentially harmful drugs. She impugns both the medications and the motives of the psychiatric profession. Both deserve clarifying responses.
Angell reviews several recent books claiming that careful analyses of studies of psychotropic drugs, done to win FDA approval, reveals that many are no more effective than placebos. Then why are they in such wide use? Angell sees a conspiracy of psychiatrists and drug companies for their mutual benefit, with patient benefit only a distant concern.
In her telling, it started in the late '50s, when psychoactive drugs began to appear. Psychiatrists, competing for patient income with a surging number of psychologists, pushed what Angell calls the "medicalization" of mental illness -- the idea that mental illness is a product of brain chemistry -- so that only they (and not their non-medical doctor brethren) could prescribe the necessary medication. Then, her theory goes, these psychiatrists invented diagnostic criteria -- in the form of the American Psychiatric Association-approved Diagnostic and Statistical Manual (DSM III) -- to match illnesses to available medications. The DSM writers, she charges, were deep in the pocket of the drug companies, who paid them personally and financed their professional organizations.
Like most conspiracy theories, it's breathtaking in its audacity. And, like other conspiracy theories, it becomes difficult to dissect the real from the imaginary.
First, it's preposterous to describe decades of scientific work linking emotional states and disorders to brain chemicals as basically a psychiatric plot to capture more of the mental health market. She writes (as do others) as if psychiatrists were bored by less remunerative talk therapy and wanted to hype their income by quickly dispensing pills. In fact, the drive for medication was fueled by the surprising observation that they were better treatments for mental illness than talk therapy or earlier sedative drugs. With apologies to Angell, more effective and less toxic medications for devastating illnesses such as schizophrenia, major depression, bipolar depression, OCD and panic disorder are as significant, in terms of public health, as finding new cancer medications.
Second, Angell's assertion that the DSM was a thinly-veiled ploy to justify medications ignores its real value, which is promoting reliable clinical communication. Before DSM, diagnosis was basically a labeling free-for-all. A particular diagnosis meant very different things to different people. The drive to make diagnosis less subjective was not an effort to create a market for medications, but to make psychiatric communication effective. Nothing in the DSM, notes my colleague Dr. Donald Klein, former director of research at Columbia's New York State Psychiatric Institute and member of the original DSM III task force, "pushes" medication -- or any other form of treatment.
That some psychiatrists and professional organizations take money from pharmaceutical companies is a fact. It may be true that some allow such money to influence their treatment decisions. This problem plagues all branches of medicine, but psychiatry is particularly affected, as it still lacks diagnostically sufficient laboratory methods. In recognition of the public's current distrust of pharmaceutical companies, the Child Mind Institute does not accept their funding. But we are staunch advocates for more research into mental illness, and the pharmaceutical industry is one of the biggest funders of basic and treatment science. This is simply a fact. A researcher's work cannot be dismissed simply because funding came from a drug company. There's a desperate shortage of funding for research, and not developing new treatments, or not pushing the science forward, in order to avoid the appearance of corporate ties is a far more troubling eventuality.
Which brings us to the issue of the studies Angell says show that antidepressants and other psychoactive medications aren't appreciably better than placebos. Peter Kramer, the author of "Listening to Prozac," responded to this charge in a piece in The New York Times, in which he argued that the studies Angell highlighted were undermined by the biased process by which patients were recruited. Many recruits were not, in fact, clinically depressed, so most get better over time, whether on placebos or real medications. There is a further claim that even the patients who do get psychoactive medications get better because of a sort of "extra strength" placebo effect: The side effects of the medication let them know they're getting the real thing, which undermines double blind precautions and makes them inclined to feel improved. This ridiculous notion must surprise the companies whose side-effect-rich medications never make it through the FDA review for efficacy.
Dr. Klein also explains that there is a real challenge to getting good, clinically useful data out of studies performed after a company gets a patent, in the process of seeking FDA approval for marketing. Because the clock starts ticking as soon as a new medication is patented, a drug company's goal is to move through the testing process as rapidly as possible. So in the first phase of human studies, doses are picked that will not cause FDA rejection because of side effects. The goal is often to use the lowest dose likely to produce statistically significant benefit, however marginal, over the placebo alternative. The result is that the studies' dose is often too small to regularly be clinically useful.
What's the takeaway of all this?
Good studies for psychiatric treatments are desperately needed. In the meantime, we have patients, in our case children and adolescents, who desperately need help. These children may be out of control, overwhelmed by anxiety, dangerously aggressive, disorganized in their communication, floundering in school. We need to help them. Medications, often along with behavioral therapy, can have a transformative effect. If they don't help, we are not forced to continue using them. We would like to see objective research catch up with the clinical realities but can't wait until that happens. Furthermore, falling back on pure non-pharmacological treatment is not the better alternative, since these treatments have rarely undergone objective evaluation.
As to the issue of psychoactive drugs actually harming patients by altering their brain chemistry over the long term, which Angell posits, here too data is lacking. It makes no sense to forego present benefit because of undemonstrated future harms. We try to weigh the risks of psychoactive drug treatment against the risks of forgoing treatment. That risk often includes academic failure, dropping out of school, substance abuse and even suicide. Unfortunately, the risks of avoiding demonstrated useful treatments are not something critics, like Angell, consider.
Harold S. Koplewicz, M.D. is a leading child and adolescent psychiatrist and the president of the Child Mind Institute. For more about Dr. Koplewicz, go to childmind.org, which also offers a wealth of information on childhood psychiatric and learning disorders.