News

The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”

A National Academy of Sciences (NAS) report urging a more coordinated approach to prevention and treatment of depression in parents-because of its impact on children-hit the streets just as Congress began considering legislation to reform the US health insurance system. The NAS report made a number of recommendations for changing the approach of both public and private health insurers toward depression, although the front-line troops expected to deal with the problem are primary care physicians, who already treat 70% of patients with depression.

As a standing member of the Editorial Board of Psychiatric Times, I read with particular interest the front-page story in the March issue, “Pharmonitor: Reality-Checking and Journalistic Integrity” by Editor in Chief Ronald Pies, MD. In it, Dr Pies pointed out that “disclosures do not guarantee scientific or journalistic objectivity and accuracy.” He set out the critical scientific questions that ought to be asked, and he promised that “Pharmonitor” would be “a reader-driven commentary . . . focusing on articles and reports in Psychiatric Times that the reader considers biased.”

Although the onset of psychotic symptoms before the age of 13 years is exceedingly rare, the incidence of schizophrenia rises sharply after the onset of puberty.1 Only 1% of the population has schizophrenia and 30% of these patients experience an onset of psychotic symptoms by age 18 years.2-8 The period that precedes the onset of frank psychotic symptoms (ie, the prodromal phase) has not been well characterized in early-onset schizophrenia-spectrum disorders (EOSS), but retrospective reports have shown that symptoms include high levels of depression and anxiety, emerging cognitive and social deficits, unusual thought content, and (not infrequently) school failure.

I had intended not to reply to the silly suggestion made by the DSM-V leadership that I wrote my critique out of financial motivations. I had expected that we would be conducting a useful discourse on the concrete issues and was surprised by the unenlightening personal exchange. Unfortunately, the DSM-V leadership refuses to discuss any of the substantive questions I have raised and instead, I am told, persists in the shallow rationalization that whatever I say is about royalties.

For pharmaceutical companies, off-label use of a drug represents a substantial “gray market,” to which the company is unable to sell their product directly, yet may be a significant revenue stream. Some drugs have been used more for off-label purposes than for originally approved indications.1

The Great DSM Debate

In a shot recently fired around the online world, commentary about the DSM-V process by Allen Frances, MD, has sparked heated debate that continues to reverberate around the psychiatric world.

This statistic is as familiar as it is startling. According to the National Comorbidity Survey-Replication (NCS-R), the peak age of onset for any disease involving mental health is 14 years. True for bipolar disorder. True for anxiety. True for schizophrenia and substance abuse and eating disorders. The data suggest that most mental health challenges emerge during adolescence. If true, this brings to mind an important developmental question:

There is currently a small but impressive evidence base that shows that psychological and interpersonal factors play a pivotal role in pharmacological treatment responsiveness.

Telemedicine-the use of electronic technologies to deliver medical care at a distance-continues to gain popularity and widespread use in all medical specialties, including psychiatry. However, many residents enter their training without any clinical experience in telemedicine in general or its applications in psychiatry.

I read with great interest and considerable apprehension Dr. Frances’ assessment of the DSM-V developmental process ("A Warning Sign on the Road to DSM-V," Psychiatric Times, July 2009).

I wrote, directed, coedited, and financed DisFigured because it’s a movie I wanted to see. I’m not a woman and I don’t have an eating disorder, but the issues of appearance, control, isolation, and our complicated relationships with our bodies seem universal to me. They are also sadly underexplored or horribly twisted in almost every form of media. I am particularly aware of this because my wife Jenn is beautiful, graceful, stylish and-according to popular culture-fat.

PTSD filled a nosological gap by providing a way to characterize the long-lasting effects of trauma exposure.1 This led to a plethora of previously lacking scientific observations. Now the existence of PTSD is being called into question because some of the original assumptions that helped make the case for it have proved to be incorrect.2-4 However, it is possible to update some of the flawed assumptions of PTSD without rescinding the diagnosis. There is no reason to throw the baby out with the bathwater.

Currently the Veterans Administration (VA) is the world’s largest recipient of per patient funding for PTSD. The VA treats 200,000 veterans with this diagnosis annually at a cost of $4 billion. But research calls into question the very existence of the “PTSD” syndrome, and its diagnostic formulation remains invalid. We do not minimize the suffering of those who experience trauma or the need for comfort and restitution. We seek only to reexamine research evidence, to clarify the impact of culture on diagnosis, to reevaluate the consequences of trauma, and to ensure optimal allocation of resources.