Month: February 2016

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

I. Glenn Cohen Leave a comment

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Read More

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

The Petrie-Flom Center Staff Leave a comment

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

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Genomic data sharing: How much oversight is necessary?

Genetics in Medicine Leave a comment

By Mahsa Shabani

Introducing data sharing practices into the genomic research has brought a number of concerns in research ethics and governance to the fore. For instance, research participants and the general public raised concerns about potential privacy issues in personal genomic data protection, as well as the scope of the secondary uses. In order to address such concerns, Data Access Committees (DACs) were seen crucial in the governance of main genomic databases such as the database of Genotypes and Phenotypes (dbGaP) and the European Genome-phenome Archive (EGA). Surprisingly, the component of access review, the structure, and the functionality of such committees have been barely scrutinized to date.

In a recent study published in Genetics in Medicine, we solicited the opinion of 20 DAC members and experts on genomic data access. Specifically, the interviewees were asked about the goals of access review and their experiences with reviewing the ethical and scientific aspects of proposals. The respondents unanimously agreed that the complexity of the access review should correspond with the concerns associated with genomic data sharing. In this regard, privacy risks often seemed possible, yet were not viewed as an imminent threat. The respondents could only recall a few examples of re-identification of genomic data in the past, yet could not promise full privacy protection given the evolving nature of the field. Regardless of the scarcity of such incidents, the controlled-access model is generally considered necessary to maintain public trust. As a DAC member put it: “I think the future of science depends upon high levels of public trust and you can only have high levels of public trust if people feel the data sharing is being managed.” Read More

Discussion of Drug Addiction: Is It All About Race?

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By: Matthew Ryan

During the Presidential primary season, one public health issue has gotten particular attention: heroin drug addiction. Candidates from both parties have spoken eloquently and passionately about the need to resolve drug addiction with public health solutions. The current language and proposals are far different from tough law-and-order rhetoric from the 1980s during the cocaine addiction epidemic. These differences should not be overlooked: they should inform how race impacts our perceptions as both public health practitioners and policy-makers.

In a post on Medium, Jeb Bush spoke vulnerably about his daughter’s heroin addiction. He wrote, “As a father, I have felt the heartbreak of drug abuse. I never expected to see my precious daughter in jail… She went through hell… and so did I.”

Carly Fiorina has also spoken powerfully about losing her stepdaughter to drug addiction. In an email to supporters, she was emphatic, “If you’re criminalizing drug abuse and addiction, you’re not treating it—and you’re part of the problem.” Read More