Clinician's Digest

Clinician's Digest

By Garry Cooper

The End of the Psychotropic Age?

By now, we've grown accustomed to expecting successive new waves of psychotropic medications to make their much ballyhooed appearance on the market, each set of drugs accompanied by claims that they're far more effective than their predecessors, with fewer side effects.

Antidepressant tricyclics gave way to SSRIs, which have more recently led to SSNRIs (which affect norepinephrine levels as well as serotonin); the first generation of antipsychotics was followed by the atypical antipsychotics. But beginning last winter, a series of surprising announcements indicated that even the mighty psychopharmaceutical industry has hit hard times. Claiming that researching and developing psychotropics has become too expensive and unprofitable, both GlaxoSmithKline and AstraZenica said they were suspending or curtailing research on drugs targeting depression, anxiety, and other psychiatric conditions.

These announcements challenged the widespread belief that psychiatric medications were earning billions for the companies that manufactured them. The July 10 issue of Science maintains that, in fact, the special difficulties of developing psychotropic meds have dragged profits down. It takes pharmaceutical companies close to nine years to bring to market a psychotropic (known as a central nervous system or CNS drug), and companies have been shying away from timelines beyond five or six years, according to psychiatrist Ronald Diamond, author of the textbook Instant Psychopharmacology. The long timeframe is partly because the approval process is particularly arduous for CNS meds. They have the lowest FDA approval rate of all medications: only 8.2 percent make it, compared to 8.7 percent for cardiovascular formulations, 19.4 percent for oncological and immunizational ones, and 23.9 percent for anti-infective ones. Moreover, CNS drugs are likelier than other meds to fail in late-stage clinical trials, after millions have already been spent. Psychotropic development costs an average of $849 million, compared to an average of $750 million for other kinds of drugs. Then there's the matter of legal liability. Lilly has paid out an estimated $1.42 billion in lawsuits over its antipsychotic Zyprexa, and GlaxoSmithKline reportedly paid more than $1 billion in Paxil-related lawsuits.

Some observers remain skeptical about the drug companies' motivation in cutting back on psychotropic research. They claim that the pullback may be partly intended to force the government to take over early research and absorb the millions of dollars of costs that eat into profits. Although Congress has allocated about $500 million annually to the National Institutes of Health to accelerate drug development, much of that funding is likely to go to newer anti-infective agents and diseases associated with aging, rather than psychiatric disorders.

So at the moment at least, few new psychotropics are working their way through the FDA's approval pipeline. Nevertheless, there's still some excitement about the prospects of a new generation of psychotropics involving glutamates—neurotransmitters below the level of such familiar ones as serotonin and dopamine, and thought to be among the brain's basic building blocks. But here too the development process involves tremendous precision and possible risks, leaving uncertain how much innovation we can expect from the psychopharmaceutical industry in the coming years.

Can Therapists Save the World?

As the intensity and scale of global issues we face seem to mount daily, many therapists are searching their souls, wondering how to use their clinical knowledge to address the world's problems more directly. But while therapists presumably understand a lot about individual psychology, it remains unclear what role they might play in highlighting issues within the broader culture or elevating the tone of public debate.

This summer, a group of prominent therapists, invited by bestselling authors and prominent couples therapists Harville Hendrix and Helen LaKelly Hunt, codevelopers of Imago Relationship Therapy, met for a weekend as a self-appointed think tank to see how they might join together to address the stresses and challenges faced by couples today outside the consulting room. The group shared a perception that the emerging science of intimate relationships and the insights drawn from couples therapy are having a limited impact on the wider culture. The participants—including Susan Johnson, John Gottman, Daniel Siegel, Michele Weiner-Davis, Marion Solomon, Judith Anderson, Ellyn Bader, and Jette Simon, who all brought their spouses—unanimously agreed that in a society already dominated by high divorce rates and negative attitudes toward marriage, the media continually presents an overwhelming cavalcade of dysfunctional partners. But what might therapists have to offer to address the beleaguered condition of couplehood in America today?

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