The authors reached these conclusions by reviewing 24 FDA-registered premarketing trials for eight second-generation antipsychotics, including Abilify, Risperdal and ziprasidone. They then compared the results in the FDA’s review documents to the results presented to clinicians and researchers in medical journals.
The authors found that premarketing trials submitted to the FDA for four of the drugs remained unpublished and that all of them yielded unflattering results. Three showed the second-generation drugs had no significant advantage over placebo. In the fourth, the drug was superior to placebo, but it was significantly inferior to a much less expensive competing drug.
In the published trials, there was some evidence that the journal articles over-emphasized efficacy of the new drug. For example, an FDA review revealed that one of the newer drugs, iloperidone (Fanapt), was statistically inferior to three different competing drugs, but this information was not mentioned in the corresponding journal articles.
Despite these findings, the researchers also found publication bias had little impact on the drugs’ overall apparent efficacy. The authors concluded continued investigation of publication bias could improve the current evidence base.
Related Articles on Medication Safety:
Beaumont Health Implements Barcoding System to Boost Patient Safety
Natividad Medical Center Issues Action Plan After CMS Finds Medication Safety Deficiencies
FDA Releases Draft Guidance for Drug Safety Plans
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
