By Maya Sabatello Stakeholders’ engagement is key to achieving the promises of precision medicine research. It is needed in order to establish a sufficiently powered cohort of diverse groups that will allow tailoring disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It is also needed to ensure that research priorities are…
By Susan M. Wolf & Wylie Burke Translational genomics challenges the traditional view that research and clinical care are distinct activities that should be governed by separate norms, rules, and law. Beginning with the Belmont Report and emergence of regulations governing the conduct of research with human participants, the conventional view has been that there are…
By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! Our annual Back To School Special returns in time for a new semester. In this second part, we welcome TWIHL All-Stars Erin Fuse Brown, Zack Buck, and Jessica Roberts. In this part, topics included state health laws in the time of Trump, price and cost issues, ERISA, MIPS, a fraud and abuse case…
By I. Glenn Cohen As has now been well-covered in the news, Nature just published a paper from Mitalipov’s lab at the Oregon Health and Science University that used CRISPR/Cas 9 gene editing to correct the MYBPC3 mutation associated with hypertrophic cardiomyopathy — a heart muscle disease that affects 1 in 500 people. The more…
By Mary A. Majumder, Christi J. Guerrini, Juli M. Bollinger, Robert Cook-Deegan, and Amy L. McGuire The 21st Century Cures Act was passed with support from both sides of the aisle (imagine that!) and signed into law by then-President Obama late last year. This ambitious legislation drives action in areas as diverse as drug and…
By Alena Buyx, MD PhD Ever wondered what happens to the biological material you leave behind when you check out of the hospital? Nothing much, is the usual answer. However, the little bits of blood, tissue, and urine are potentially valuable for medical research; miniscule amounts of it may already allow sophisticated analyses, including genetic ones….
Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below: Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual…
By Sarah Ali-Khan and E. Richard Gold As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013…
By Effy Vayena and Alessandro Blasimme In January 1999, Scott McNealy, CEO of Sun Microsystems (now part of Oracle Corporation), announced that we should no longer be concerned with privacy, since consumers ‘have zero privacy anyway’ and should just ‘get over it.’ His argument, that in the era of information technology we have become unable…
This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Here, Dana Mahr examines claims of empowerment in participatory health platforms and the implications of this for participants and biomedical research more broadly. Background on the symposium is here. You can call up all of the…
