Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariCharlie LeeFrazer Tessema, 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, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

Below are the abstracts/summaries for papers identified from the month of February. The selections feature topics ranging from the compliance of manufacturers with clinical trial reporting requirements, to estimation of possible savings that could be attained for diabetics purchasing insulin, to documentation of how frequently pharmaceutical industry-sponsored charity patient assistance programs cover off-label uses of a drug. A full posting of abstracts/summaries of these articles may be found on our website.

  1. DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on a cohort study. Lancet. 2020 Feb 1;395(10221):361-369. Epub 2020 Jan 17.
  2. Feldman WB, Rome BN, Lehmann LS, Kesselheim AS. Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary. JAMA Intern Med. 2020 Feb 3. [Epub ahead of print]
  3. Griffith KN, Jones DK, Bor JH, Sommers BD. Changes In Health Insurance Coverage, Access To Care, And Income-Based Disparities Among US Adults, 2011-17. Health Aff (Millwood). 2020 Feb;39(2):319-326.
  4. Kang SY, Socal MP, Bai G, Anderson GF. Off-Label Coverage of High-Cost Drugs by Independent Charity Patient Assistance Programs. J Gen Intern Med. 2020 Feb 24. [Epub ahead of print]
  5. Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV. New drug approvals in oncology. Nat Rev Clin Oncol. 2020 Mar;17(3):140-146. Epub 2020 Feb 4. Review.
  6. Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. BMJ. 2020 Feb 5;368:l7078.

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.