In the summer of 2003 the U.K. Department of Health warned doctors against prescribing any serotonin reuptake inhibitor (SSRI) except fluoxetine for depressed youths, claiming that other agents were not effective and may increase the risk of suicidal thinking or attempts. Shortly thereafter, the U.S. Food and Drug Administration (FDA) undertook its own analysis of data from clinical trials and in October 2004 decided to require a "black box" warning about clinical worsening and suicide risk for all antidepressants prescribed for adolescents. However, both the U.K. and FDA analyses revealed deficiencies and ambiguities in the data and many questions remained—questions that have since engendered ever-more-detailed analyses and meta-analyses by several research groups.
During this two-year period of inquiry, a task force created in 2003 by the American College of Neuropsychopharmacology (ACNP) has been exhaustively evaluating evidence of the safety and effectiveness of SSRIs for pediatric depression. The task force not only examined all published clinical trial data, but it also reviewed data reported to the U.K. Medicines and Healthcare Products Regulatory Agency as well as the FDA analyses and more recent reports made public online. The final report of the task force was published in the January issue of the journal Neuropsychopharmacology.
The concluding paragraph of the risk evaluation first points to some evidence of increased suicidality on the basis of data from clinical trials, then questions the validity of this evidence, and then counters it with evidence of the benefits of SSRIs indicated by other lines of research: "SSRIs and other new generation antidepressant drugs, in aggregate, are associated with a small increase in the risk of AE [adverse event] reports of suicidal thinking or suicide attempts in youth." However, data from questionnaires used to measure suicidal ideation in clinical trials do not show any increase, "raising concerns over ascertainment artifacts in the AE report method." The paragraph ends: "Three other lines of evidence in youth, epidemiology, autopsy studies, and recent cohort surveys, do not support the hypothesis that SSRIs induce suicidal acts and suicide, instead indicating a possible beneficial effect, and that a negligible number of youth suicides are taking antidepressants at the time of death."
The epidemiologic evidence presented in the report indicating a reduction in suicide risk with SSRIs is based on U.S. and international studies of suicide rates. The World Health Organization found an average decline in the rates among persons aged 15 to 24 years of about 33 percent across 15 countries over the past 14 years. The reduction followed three decades of increases. "In only three countries did the start of the decline precede the introduction of SSRIs, indicating a relationship of prescription of SSRIs to suicide rates," the report notes. U.S. studies have found that counties with the highest prescription rates for SSRIs and the greatest increase in prescription rates have had the lowest suicide rates and the greatest declines in suicide rates among both youths and adults.
In a chilling summary paragraph on the epidemiologic evidence, the report states: "The FDA's recent black box warning could serve to initiate a natural public health experiment. The change in labeling may be accompanied by a reduction in antidepressant prescriptions, particularly for youth. An unintended consequence of this policy could be an increase in youth suicide. That is an empirical question to be examined in the near future."
The evidence from toxicological analyses at autopsy comes from national studies in Sweden, which included both adults and youths, and smaller studies of youths in the United States showing that more than 80 percent of depressed patients at the time of suicide were not taking antidepressants—a figure closer to 90 percent for adolescents. On the basis of these studies the report concludes that "Suicide is more likely when depressed individuals are untreated, rather than on antidepressants, and that may apply even more strongly in youth compared with adults."
Finally, the evidence from cohort studies presented in the report comes from analyses and meta-analyses—and a separate reanalysis by the task force—of data from clinical trials that involved only adults, which have included many more participants than pediatric trials. These studies have found no relationship between suicidality and SSRIs. The task force's reanalysis confirmed the statistical power of these studies and led it to question the power of the pediatric studies and to call for further research focused on higher-risk populations, such as adolescents with a history of suicidal behavior.
The "ACNP Task Force Report on SSRIs and Suicidal Behavior in Youth" is available online at www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html.
Kaiser Commission estimates of effects of Medicaid cuts: Several states have cut Medicaid eligibility or are considering cuts. Very few of the low-income working-age adults who would lose eligibility would have any alternative insurance options, according to a policy brief from the Kaiser Commission on Medicaid and the Uninsured. The vast majority, particularly those with the lowest incomes, are likely to be left uninsured. The commission examined 2002 data from the National Survey of America's Families, which had a representative sample of nearly 45,000 families. The analysis focused on the seven million low-income adults aged 19 to 64 who had public insurance coverage through Medicaid, the State Children's Health Insurance Program, or a state-specific program. Only 8 percent of this population had an employer who offered insurance, although 38 percent were working or had a spouse who was working. In addition, fewer than 1 percent of those who would lose eligibility would be able to find nongroup premiums that would be affordable (less than 5 percent of their income, according to current research), whereas nearly 60 percent would face premiums that would be more than 25 percent of their income. The policy brief is available on the Kaiser Commission Web site at www.kff.org/medicaid/7449.cfm.
Handbook to reduce criminalization of people with mental illness: The Bazelon Center for Mental Health Law has created an online resource for mental health organizations and advocates who want to improve the response to people with mental illnesses who come into contact with the criminal justice system. The Criminal Justice/Mental Health Advocacy Handbook is a how-to guide that describes five steps to conduct a campaign to build effective alliances and gain the attention of media and policy makers. For example, in 18 detailed pages, step 3, "Know your Audience," describes how to understand the perspectives of and create alliances with the courts, law enforcement, corrections, juvenile justice, the mental health system, and elected officials. A final section has lists of and links to advocacy resources and potential funding sources. The handbook is available on the Bazelon Center's Web site at www.bazelon.org.
Web forum for schizophrenia researchers: Researchers can now keep abreast of developments through the Schizophrenia Research Forum, a Web site launched with funding from the National Institute of Mental Health. The site bills itself as a "virtual community" where researchers can link-up with colleagues and potential collaborators; learn about new findings, meetings, and funding opportunities; and critique each other's articles and ideas. The site includes original news stories and interviews with leading scientists, as well as live chats with experts that will be archived for later viewing. Among specific forums that invite contributions are "Current Hypotheses," which presents theory reviews, and an "Idea Lab," where less formal treatments are posted. Citations of current schizophrenia-related papers, with links to PubMed abstracts, are posted each week as part of a searchable database going back to 2000. The site offers an extensive annotated index of relevant Web sites with information, downloadable software, databases, and other Web-based technologies for scientists. Other resources include jobs listings and links to departments and institutes involved in schizophrenia research worldwide. Future plans include a searchable database called SchizophreniaGene. The site, sponsored by NARSAD, The Mental Health Research Association (previously known as the National Alliance for Research on Schizophrenia and Depression), is at www.schizophreniaforum.org.
Programs to assist transition-age youths: Many federal programs can address the wide range of needs of youths with serious mental health conditions who are making the transition into adulthood. The Bazelon Center for Mental Health Law has identified 57 programs, operated by more than 20 different agencies in nine departments of the federal government. Moving On is a collection of fact sheets about these programs. Each offers information about the program's purpose, services and funded activities, the administering federal agency, grantee and beneficiary eligibility, and a brief assessment of the program's impact. Programs are grouped into 12 categories: mental health services, substance abuse services, health services, basic supports, school-based programs, higher education, skills for people with and without disabilities, housing, family planning and parenting assistance, social services, and youths involved with the criminal justice system. Moving On is available on the Bazelon Center's Web site at www.bazelon.org.
New data on prevalence of major depression among adolescents: About 2.2 million adolescents aged 12 to 17 (9 percent) experienced at least one DSM-IV major depressive episode in the past year, according to a report released by the Substance Abuse and Mental Health Services Administration (SAMHSA) based on data from the 2004 National Survey on Drug Use and Health. Depression Among Adolescents reports that older teens were more likely to experience a major depressive episode. An estimated 12.3 percent of those aged 16 or 17 suffered from an episode in the past year compared with 9 percent of those aged 14 or 15 and 5.4 percent of those aged 12 or 13. The analysis found that 40.3 percent of the adolescents who experienced a major depressive episode received treatment in the past year. Treatment rates were similar among the male (37.7 percent) and female (41.3 percent) adolescents and higher among whites (44.9 percent) than among blacks (28.9 percent) and Hispanics (36.8 percent). Adolescents who had health insurance at the time of the survey were more likely than adolescents who did not to have received past-year treatment for depression (41.2 compared with 26.9 percent). The report is available on the SAMHSA Web site at www.oas.samhsa.gov/newpubs.htm.