Publication Bias Mars Psychiatric Drug Literature

By John Gever, Senior Editor

MedPage Today

Originally Published March 23, 2012

Several negative studies of second-generation antipsychotic drugs were never published, leading to an exaggerated portrayal of the agents' effectiveness in the scientific literature, researchers said.

Of 24 registration trials involving eight products submitted to the FDA, four went unpublished in medical journals -- three of which found that the study drug's efficacy was equivalent to placebo or inferior to an active comparator, according to Erick H. Turner, MD, of Oregon Health and Science University in Portland, and colleagues.

Moreover, five of the 20 published trials "showed some evidence of outcome reporting bias," the researchers wrote online in PLoS Medicine.

Turner and colleagues also noted that the scale of the publication bias was relatively modest -- exaggerating the drugs' effectiveness relative to placebo or active comparators by a nonsignificant 8%. The weighted-average effect size in the published trials was 0.47 (95% CI 0.40 to 0.54), which declined only to 0.44 (95% CI 0.37 to 0.50) when the unpublished trials were included.

The entire review is here.

The research paper is below

Publication Bias in Antipsychotic Trials

Antipsychotic drugs tied to diabetes risk in kids

By Amy Norton
Reuters/Yahoo! News

The antipsychotic drugs that are increasingly being used to treat bipolar disorder, autism and other mental disorders in children may come with an increased risk of diabetes, a new study suggests.

Previous research has linked the so-called second-generation antipsychotics to an increased risk of diabetes in adults. And there's been some evidence that the drugs can cause weight gain in children.

The new findings, published in the journal Pediatrics, add to concerns that the medications may ultimately lead to diabetes in some kids.

Using records from three U.S. health plans, researchers found that children and teens who started on an antipsychotic had four times the risk of being diagnosed with diabetes, versus kids not using any psychiatric medication.

They developed diabetes at a rate of just over three cases per 1,000 children per year. That compared with just under 0.8 cases per 1,000 among medication-free kids.

Second-generation antipsychotics include drugs such as Risperdal, known generically as risperidone, Zyprexa (olanzapine), Seroquel (quetiapine) and Abilify (aripiprazole).

The drugs are used to treat conditions like bipolar disorder, schizophrenia and irritability and aggression in children with autism. They are also sometimes given to children with attention-deficit hyperactivity disorder (ADHD), even though there's no research evidence to support that.

The entire story is here.

Antipsychotics overprescribed in nursing homes

By M. Price

The Monitor on Psychology

September 2011, Volume 42, No. 8

Print Version: Page 11

Physicians are widely prescribing antipsychotics to people in nursing homes for off-label conditions such as dementia, and Medicare is largely picking up the bill, even though Medicare guidelines don't allow for off-label prescription reimbursements, according to an audit released in May by the U.S. Department of Health and Human Services Office of the Inspector General.

The findings underscore the fact that antipsychotics are often used when behavioral treatments would be more effective, psychologists say.

The office reviewed Medicare claims of people age 65 and older living in nursing homes in 2007—the most recent data at the time the study began—and found that 51 percent of all claims contained errors, resulting $116 million worth of antipsychotics such as Abilify, Risperdal and Zyprexa being charged to Medicare by people whose conditions didn't match the drugs' intended uses. Among the audit's findings are:

• 14 percent of the 2.1 million elderly people living in nursing homes use Medicare to pay for at least one antipsychotic prescription.
• 83 percent of all Medicare claims for antipsychotics are, based on medical reviews, prescribed for off-label conditions, specifically dementia.
• 22 percent of the claims for antipsychotics do not comply with the Centers for Medicare and Medicaid Services' guidelines outlining how drugs should be administered, including those guidelines stating that nursing home residents should not receive excessive doses and doses over excessive periods of time.

The report suggests that Medicare overseers reassess their nursing home certification processes and develop methods besides medical review to confirm that medications are prescribed for appropriate conditions.

Why such high rates of overprescription for antipsychotics? HHS Inspector General Daniel Levinson argued in the report that pharmaceutical companies' marketing tactics are often to blame for antipsychotics' overprescribing. Victor Molinari, PhD, a geropsychologist at the University of South Florida in Tampa, says that another important issue is the dearth of psychologists trained to provide behavioral interventions to people in nursing homes. While he agrees that people in nursing homes are taking too much antipsychotic medication, he believes nursing home physicians are often responding to a lack of options.

Many nursing home administrators are quite savvy in their mental health knowledge and would prefer to offer their residents the option of behavioral treatments, Molinari says, but when residents need immediate calming, physicians will turn to antipsychotic medication because it's quick and available. Additionally, he says, many nursing home staff aren't educated enough about nonmedical options, so they go straight for the antipsychotics.

"It follows the saying, 'If your only tool is a hammer, everything is a nail,'" he says. "Nursing homes are not just straitjacketing residents with medications as a matter of course, but because there are a host of barriers to giving them optimal care."