This post originally appeared on The Conversation on May 3, 2018. The Food and Drug Administration recently announced its authorization that permits genetics testing company 23andMe to market a test for gene mutations associated with risk of breast and ovarian cancer. In response, 23andMe CEO Anne Wojcicki asserted that...
Author: Katherine Drabiak, J.D.
Hawaii’s New End-of-Life Law: Do the Additional Safeguards Withstand Scrutiny?
posted by: Katherine Drabiak, J.D.
This post originally appeared on The Hastings Center Bioethics Forum on May 4, 2018. Last month, Hawaii became the seventh state, with the District of Columbia, to legalize physician-assisted suicide. Similar to some of the other state laws, Hawaii’s Our Care, Our Choice Act permits competent adults with...
Engineering Consensus in the Development of Genome Editing Policy
posted by: Katherine Drabiak, J.D.
March 14, 2017
This commentary was originally published as an Essay on the Hastings Center Bioethics Forum here. In the past few weeks media outlets have been reporting on the release of Human Genome Editing: Science, Ethics, and Governance from the National Academies of Science, Engineering, and...
Questions about Deaths in Cancer Trials using Gene-Altered Cells
posted by: Katherine Drabiak, J.D.
January 9, 2017
This article was originally posted on The Center for Genetics and Society’s site here. In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both...
The Problem of Transparency and Human Genome Editing
posted by: Katherine Drabiak, J.D.
June 4, 2016
In the past several weeks, human genetic modification has been dominating headlines. This time, the controversy surrounded the closed door meeting between 130 scientists, attorneys, entrepreneurs, and government officials to discuss the creation of a synthetic human genome. The project, called “Human Genome Project-Write...
Read the Fine Print Before You Send Your Spit to 23andMe
posted by: Katherine Drabiak, J.D.
April 7, 2016
Our genomic sequence constitutes the most sensitive and personal of information: uniquely identifying us, revealing our propensity to develop certain diseases and conditions, and exposing familial connections of close genetic relatives. In recent years, Big Data has taken firm hold in numerous sectors, revolutionizing the volume and...
Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment
posted by: Katherine Drabiak, J.D.
March 8, 2016
In November 2015, FDA published a startling report, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests, which enumerated serious concerns with the current framework it uses to oversee laboratory developed tests (LDTs). LDTs are tests used by physicians to diagnose disease, predict...