Press Release

Embargoed Until Contact

December 08, 2011

Sue Ducat
Director of Communications
(301) 841-9962


New Studies on Prescription Drugs: Clinical Trials Reporting, Off-Label Marketing, and Managing Use of Antipsychotics


Three papers in the December 2011 issue of Health Affairs examine a range of issues involving prescription drugs


Bethesda, MD -- Federal rules and regulations related to transparency of prescription drug studies and prohibitions on off-label marketing are the focus of papers in the December 2011 issue of Health Affairs. In addition, a separate study examines the effect of prior authorization restrictions on the use of antipsychotic drugs.


A brief summary of each of the three papers follows:


  • Despite a 2007 law requiring that certain prescription drug clinical trials be registered on the public database, fewer than one in eight studies are reported within one year of being completed, write Michael R. Law and colleagues from the University of British Columbia. Surprisingly, clinical trials funded by the pharmaceutical industry are three times more likely than trials funded by the National Institute of Health to disclose results on the site. An incomplete record of trial results could skew the information that trials provide, the authors state. They call for additional enforcement of reporting requirements to enable more comprehensive and less biased studies and meta-analyses of the clinical efficacy, off-label use, and safety of prescription drugs.

  • False Claims Act investigations of off-label prescription drug marketing by pharmaceutical companies may not be effective in reducing non-evidence-based off-label drug use and associated spending, according to Harvard Medical School's Aaron S. Kesselheim and coauthors. Using the example of gabapentin (Neurontin), the authors review how off-label use of this drug continued to grow during the government's investigation of illegal off-label marketing and declined only after the manufacturer agreed to pay a $430 million penalty. Despite the fact that the US government has collected approximately $8 billion since 2004 from fraud enforcement actions against manufacturers who market drugs for off-label use, the effect of these settlements on actual prescribing trends may be muted because the gains from increased sales far outweigh financial penalties. Greater resources for enforcement are needed to stop drug companies from off-label marketing, the authors say, especially now that prescription drug coverage has expanded under Medicare Part D.

  • To better manage prescription drug spending, forty-five states and the District of Columbia are increasingly relying on preferred drug formularies and prior authorization requirements. Although these requirements may be appropriate for some medications, the University of Georgia's William B. Vogt and colleagues question the use of such restrictions on psychotherapeutic drugs--particularly newer, second-generation or "atypical" antipsychotic drugs. Prior authorization is intended to prompt substitutions of less expensive typical antipsychotics for atypical antipsychotics. However, prior authorization can reduce the use of both classes of drugs, raising the specter of schizophrenic patients' going without drug treatment. The authors note that poorly controlled schizophrenia can have an impact on other direct costs by lowering the probability that a patient will rejoin the labor market and increasing the likelihood of contact with law enforcement. The authors call for more research to help determine how much of the utilization reduction was a reduction in questionable use and how much was a reduction of appropriate medications. Comparative effectiveness research could also help guide more appropriate prescribing of antipsychotic medications, they conclude.
About Health Affairs

Health Affairs is the leading journal at the intersection of health, health care, and policy. Published by Project HOPE, the peer-reviewed journal appears each month in print, with additional Web First papers published periodically and health policy briefs published twice monthly at Read daily perspectives on Health Affairs Blog. Download weekly Narrative Matters podcasts on iTunes.