Here’s this week’s (slightly edited) installment of the Yale Friday Newsletter. Enjoy!
- Jessica Mantel, Accountable Care Organizations: Can We Have Our Cake and Eat it Too? SSRN
- Kieran Healy & Kimberly Krawiec, Custom, Contract, and Kidney Exchange, SSRN/Duke L.J.
- Eliott Fisher et al, A framework for evaluating the formation, implementation, and performance of accountable care organizations, Health Affairs
- Ronald Bayer et al, Repackaging Cigarettes — Will the Courts Thwart the FDA? NEJM
- Vicki Girard, Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement Approach that Focuses on Punishment? SSRN/FDLI Food & Drug Forum
Cross-posted at HealthLawProfs
Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.” The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:
Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.
In certain respects, this article is an expansion of a previous piece three of us wrote on the Genomics Law Report last year discussing Myriad Genetics’ response to the rise of whole-genome sequencing technologies in the context of diagnostic genetic testing. The current EJHG expands upon that discussion, while still using Myriad Genetics as a case study, particularly the company’s development of a proprietary database of DNA sequence variants (including variants of uncertain significance, or VUSs) and related clinical information pertaining to the breast cancer genes BRCA-1 and BRCA-2.