Precision Medicine - Personalized, Problematic, and Promising.
LJ Jameson & DL Longo. Here.
The FDA and Genomic Tests - Getting Regulation Right.
BJ Evans, W Burke, GP Jarvik. Here.
(See previously by Evans, here and here.)
The FDA and Genetic Testing. [Response to Evans et al.]
ED Litwack, E Mansfield, J Shuren. Here.
(On the FDA's flexibility see also here).
Three articles circle the topic of clinical variant databases and the expansion in a rolling basis of genes tested:
Gene Panel Sequencing and the Prediction of Breast Cancer Risk.
DF Easton et al. Here.
ClinGen - The Clinical Genomic Resource.
HL Rehm et al. Here.
Curating the Way to Better Determinants of Genetic Risk.
EG Phimister. Here.
For a discussion of the six articles in Genomeweb (subscription), here.
An observation -
NEJM sometimes must shorten the titles of longer articles for the "splash pad" on its home page that represents the article. In the case of Easton's article, they add a striking editorial spin in rephrasing the title - by parachuting in the banner "Caveat emptor" which does not appear in the Eaton article.
A follow-up: JAMA (June 3, 2015)
A week later, JAMA publishes a pair of two-pager op-eds on precision medicine, focused on the President's Precision Medicine Initiative (here).
The Precision Medicine Imitative: A New National Effort
Ashley EA [Stanford] JAMA 313:2119, here.
A Public Health Perspective on a National Precision Medicine Cohort: Balancing long term knowledge generation with early health benefit.
Khoury MJ [CDC] & Evans JP [Duke] JAMA 313:2117, here.
Khoury's article delves into some of the complexities of the million-person sequencing cohort that has been proposed. For example, what would you do if you find occult cases of carriers of the fatal disorder Huntington's disease? Khoury and Evans write:
The references 5 and 6 on "bins" are:
For a journalist writing on genomics "hype," see here at Mendelspod commenting on a Buzzfeed article here.
For a June 22, 2015 article in JAMA on hype in personalized medicine, see:
Joyner MJ & Paneth N (2015) Seven Questions for personalized medicine. JAMA (epub), here.
Writing in part: The average annual cost of new targeted cancer drugs frequently exceeds $100 000 per year. The authors of a recent trial of ivacaftor and lumacaftor for CF pointed out that these new medicines had effects on FEV in the first second of expiration “in the range of the magnitudes of change seen in studies of other cystic fibrosis therapeutics.”These include azithromycin, hypertonic saline, and ibuprofen. [But] Ivacaftor costs $300 000 per year, whereas a 1-year supply of ibuprofen costs approximately $30, and unlike ivacaftor, it can be used by all patients with CF. [refs omitted]Joyner wrote a NYT op-ed last January, "Moonshot Medicine Will Let Us Down," here.
To discuss how the changing healthcare system and Medicare policy affects your company, association, or investments, contact Dr Quinn through FaegreBD Consulting.