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As Genetic Testing for Breast Cancer Gene Mutation Expands, Questions Arise About Treatment Decisions

Posted by on May 18, 2018 in Uncategorized | Comments Off on As Genetic Testing for Breast Cancer Gene Mutation Expands, Questions Arise About Treatment Decisions

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 the test represents a “major milestone in consumer health empowerment.” Media articles following this announcement made it clear even if the test provides an accurate result, there are significant limitations for...

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Hawaii’s New End-of-Life Law: Do the Additional Safeguards Withstand Scrutiny?

Posted by on May 18, 2018 in Uncategorized | Comments Off on Hawaii’s New End-of-Life Law: Do the Additional Safeguards Withstand Scrutiny?

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 a terminal illness and a diagnosis of less than six months to live to obtain a lethal prescription to use to take their own lives. Proponents assert the new law, in addition to giving patients a measure of control, autonomy, and...

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Engineering Consensus in the Development of Genome Editing Policy

Posted by on Mar 14, 2017 in Uncategorized | Comments Off on Engineering Consensus in the Development of Genome Editing Policy

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 Medicine. The report concluded that following more research, it would be ethical to initiate clinical trials using heritable, germline genome editing for therapeutic purposes subject to a set of conditions. Described by some as a “fantastic development,”...

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Questions about Deaths in Cancer Trials using Gene-Altered Cells

Posted by on Jan 9, 2017 in Uncategorized | Comments Off on Questions about Deaths in Cancer Trials using Gene-Altered Cells

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 aimed at immunotherapy-based cancer treatments that have sparked widespread hope. Despite these deaths, the trials continue to move forward. Media coverage of trials related to gene therapy has portrayed the clinical research rollercoaster.  Just this past...

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The Problem of Transparency and Human Genome Editing

Posted by on Jun 4, 2016 in Uncategorized | Comments Off on The Problem of Transparency and Human Genome Editing

  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 Testing Large Synthetic Genomes in Cells” aims to synthesize a complete human genome in a cell line within ten years, with the future goal of translating such basic science into clinical applications.  Rather the...

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Media Misstates the Message: Investigate CDC Whistleblower’s Claims

Posted by on Apr 22, 2016 in Uncategorized | Comments Off on Media Misstates the Message: Investigate CDC Whistleblower’s Claims

Media headlines are abuzz around the decision to pull the documentary Vaxxed: from Conspiracy to Cover-Up from the Tribeca Film Festival.  As a disclaimer, I have not viewed the film.  What is deeply troubling, however, is how numerous media outlets (here and here) have misconstrued the film’s message calling for an examination of vaccine safety and efficacy.  Instead, headlines and news content repeat erroneous assertions that are contrary to scientific evidence and focus exclusively on the controversial Dr. Andrew Wakefield as a red...

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Read the Fine Print Before You Send Your Spit to 23andMe

Posted by on Apr 7, 2016 in Uncategorized | Comments Off on Read the Fine Print Before You Send Your Spit to 23andMe

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 velocity at which businesses can collect, curate, and use digital information. Consumers can track what they eat, their fertility, whether they are exercising, and how much they are sleeping. Combining these...

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Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment

Posted by on Mar 8, 2016 in FDA Regulation, Genetic Test, Genomics, Health Law, Regulation of Emerging Technology | Comments Off on Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment

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 risk of disease, and guide critical therapy decisions. This report revealed grave shortcomings in test accuracy, reliability, and ability to provide clinically meaningful information to physicians and patients in a number different tests,...

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