An new report questions the efficacy of antipsychotic medications, which are approved for the treatment of serious disorders such as schizophrenia and include drugs such as Abilify (aripiprazole), Zyprexa (olanzapine), Risperdal (risperidone), and Seroquel (quetiapine).
According to The Washington Post, psychiatrists might not be fully aware of the issues surrounding these drugs. When eight atypical antipsychotic drugs were presented to the U.S. Food & Drug Administration for approval—based on 24 studies—four studies were never published in professional journals. Not surprisingly, those four studies presented the medication reviewed in less than flattering lights.
In three of the unpublished studies, the new drug performed no better than a placebo or sugar pill, the fourth study revealed that although the antipsychotic helped patients more than a placebo, older, cheaper drugs were of greater help to patients, said The Post. “That’s bad if you’re marketing the drug,” said Erick Turner, the psychiatrist at Oregon Health & Science University who conducted the new analysis, said The Post. The analysis appears in the journal PLoS Medicine.
The analysis found that two of the unpublished studies—involving Abilify and over 300 patients—found Abilify to be no more effective than a sugar pill for the treatment of schizophrenia. The other two studies involved Geodon (ziprasidone). One revealed that Geodon was no more effective than a placebo; the second found that while Geodon was more effective than a placebo, it was not as effective as the cheaper Haldol (haloperidol), said The Post. Also, four published studies conducted on Fanapt (iloperidone) omitted unflattering data indicating that other drug choices worked better.
With this information left out of the professional journals on which the medical community often relies, psychiatrists do not have a full understanding of the true efficacy of atypical antipsychotics, noted The Post. “I think [psychiatrists] should be aware that what they’re reading in journal articles could be sanitized,” Turner said.
As we’ve explained, antipsychotics are powerful drugs approved for very serious psychiatric conditions, such as schizophrenia and bipolar disorder; however, they are often used off-label to treat vulnerable populations, such as seniors with dementia—and most recently, Medicaid children and, in one startling report, college students suffering from sleep issues. Although atypical antipsychotics’ use is on the rise for a range of off-label conditions, the drugs are only effective for a few such diagnoses. The drugs can also lead to sedation and can contribute to weight gain and diabetes. Still, it is becoming increasingly common to see these powerful medications being used to treat serious depression, among other ailments, such as anxiety, attention deficit disorder, behavior issues in the very young and very old, and sleep issues.
Turner pointed out, said The Post, that when data from the negative, unpublished studies was added to the positive data from published studies, the overall efficacy of atypical antipsychotics for the treatment of schizophrenia fell by about 8%. The negative studies were well hidden on the agency’s website and require a statistical understanding to read the results, said The Post, noting that Turner previously worked at the FDA and described it as if he “was living in this highly censored environment” where negative studies are not published.
The phenomenon—publication bias—an issue on which Turner is actively working to expose (he recently tackled a similar problem with antidepressants) is when a new drug is presented in a positive light, while negative data is buried, explained the Post.