By Ameet Sarpatwari and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.
Below are the papers identified from the month of September. The selections feature topics ranging from trends in the utilization of FDA expedited drug development and approval programs, to the prevalence and compensation of academics on the boards of US healthcare companies, to a randomized trial of the affect of FDA use of “breakthrough” language on perceived effectiveness of a drug. A full posting of abstracts/summaries of these articles may be found on our website.
- Anderson TS, Good CB, Gellad WF. Prevalence and compensation of academic leaders, professors, and trustees on publicly traded US healthcare company boards of directors: cross sectional study. BMJ. Sep 29 2015;351:h4826.
- Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications–Loosening the Rules. New Eng J Med. Sep 3 2015;373(10):967-973.
- Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. Sep 15 2015. [Epub ahead of print].
- Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ. Sep 16 2015;351:h4629.
- Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. Sep 23 2015;351:h4633.
- Kim Y, Kornfield R, Shi Y, et al. Effects of Televised Direct-to-Consumer Advertising for Varenicline on Prescription Dispensing in the United States, 2006-2009. Nicotine Tob Res. Sep 18 2015. [Epub ahead of print].
- Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language. JAMA Intern Med. Sep 21 2015. [Epub ahead of print].
- Mendes D, Alves C, Batel-Marques F. Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone. Pharmacoepidemiol Drug Saf. Sep 16 2015. [Epub ahead of print].
- Podolsky SH, Powers JH, 3rd. Regulating Antibiotics in an Era of Resistance: The Historical Basis and Continued Need for Adequate and Well-Controlled Investigations. Annals Intern Med. Sep 1 2015;163(5):386-388.
- Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. Sep 23 2015;351:h4679.
