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

By Ameet Sarpatwari, Michael S. Sinha, 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.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from promoting patient interests in implementing the federal right to try act; to the percentage of US patients with cancer who benefit from genome-driven oncology, to Medicare spending on brand-name combination medications and their generic constituents. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Brodersen J, Kramer BS, Macdonald H, Schwartz LM, Woloshin S. Focusing on overdiagnosis as a driver of too much medicine. BMJ. 2018 Aug 17;362:k3494.
  2. Darrow JJ, Beall RF, Kesselheim AS. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2018 Aug 24. [Epub ahead of print]
  3. Lynch HF, Zettler PJ, Sarpatwari A. Promoting Patient Interests in Implementing the Federal Right to Try Act. JAMA. 2018 Aug 13. [Epub ahead of print]
  4. Marquart J, Chen EY, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Benefit From Genome-Driven Oncology. JAMA Oncol. 2018 Aug 1;4(8):1093-1098.
  5. O’Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Proteinand Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncol. 2018 Aug 1;4(8):e180798. Epub 2018  Aug 9.
  6. Sacks CA, Lee CC, Kesselheim AS, Avorn J. Medicare Spending on Brand-nameCombination Medications vs Their Generic Constituents. JAMA. 2018 Aug 21;320(7):650-656.
  7. Wang SV, Schneeweiss S, Gagne JJ, Evers T, Gerlinger C, Desai R, Najafzadeh M. Using real world data to extrapolate evidence from randomized controlled trials. Clin Pharmacol Ther. 2018 Aug 14. [Epub ahead of print]
Ameet Sarpatwari

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.

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