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Ethical Concerns of DNA Databases used for Crime Control

By Aziza Ahmed

Genetic databases for crime control have become a national topic for debate after the arrest of the Golden State Killer, also known by his real name, Joseph James DeAngelo.

At the time of his arrest, DeAngelo was 72 years old and had committed more than 50 rapes and 12 murders. While his arrest was celebrated as a law enforcement victory, a host of questions emerged because of the way law enforcement officials eventually found DeAngelo: through a combination of traditional detective work and utilization of data from a crowd-sourced genetic database. In this case, police searched GED-Match, a website created by the Mormon church where users can share genealogical information and find “familial” DNA matches

The Golden State Killer case reignited numerous debates on the issue of DNA searches and the use of DNA evidence, but with a twist. The big question is, should investigators utilize genetic databases, whether run by the government or by private agencies and individuals, to identify the families of suspects, if doing so will lead them to the culprit?

Though the opportunities for crime-solving by utilizing DNA database searches may be vast, new technologies and innovative uses of them do not occur in a vacuum. Instead, novel uses of technology demand consideration of a vast number of ethical issues, and mandate careful interrogation of the potential impact of DNA databases on crime control. Read More

3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More

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The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

Anya Prince on Gene Therapy and Exacerbating Health Care Inequalities

Anya Prince, a legal scholar and thought leader in the field of genetic discrimination, will present a new paper at Monday’s Health Law Workshop that interrogates whether gene therapies will exacerbate inequalities in health care, as more treatments enter the market. “Gene Therapy’s Field of Dreams: If You Build It, Will We Pay?” focuses on some of the many issues raised by the prices of gene therapies.
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Silver Spoons and Golden Genes: Designing Inequality?

A recent web series sparked controversy with the headline that “Designer babies aren’t futuristic. They’re already here.” The online articles make the case that disparate access to frozen embryo screening for debilitating diseases—sickle cell anemia, Tay-Sachs, or cystic fibrosis—is “designing inequality into our genes.”

The authors are right that reproductive technology isn’t open to everyone. A single cycle of in vitro fertilization (IVF)—the tool that combines sperm and egg in a lab—costs 57% of the average American’s annual income in 2018. The multiple cycles it usually takes to get a baby costs upwards of $100,000. Just fifteen states make insurers cover reproductive technology. Even these often limit coverage mandates to married couples unable to conceive, thereby denying equal benefits to non-traditional families.

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You Received Genetic Test Results from Direct to Consumer Companies or from Research – Will Your Doctor Be Happy to See You?

By Ellen W. Clayton

You recently responded to a TV advertisement by a direct to consumer (DTC) genetic testing company because you wanted to find more of your relatives. The company also offered to send you your genomic data.  Although not what you originally had in mind, you decided to send the data to another DTC company for interpretation to learn more about your health. Unfortunately, you were told that you are at risk for a condition you had never heard of.  Even though the company sent some educational information, you quickly decided to call your doctor for more information and to start prevention or treatment.

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Opportunities and challenges for user-generated licensing models in gene-editing

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Read More

NEW REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD (Harvard University Office of the Vice Provost for Research)

The Harvard Embryonic Stem Cell Research Oversight (the “ESCRO”) Committee, an ethics oversight committee charged with reviewing research protocols involving human embryos, human embryonic stem cells, and certain activities with non-embryonic human pluripotent stem cells, recently issued a report exploring the ethical issues related to the creation of synthetic human embryos.

Ethical committees such as the Harvard ESCRO occasionally receive inquiries to deliberate upon the ethical implications of emerging research technologies where there is no existing or established guidance to rely upon. Deliberating in these gray areas is not a simple task, but the Harvard ESCRO has developed a general framework for navigating this ethical terrain in real time. In these instances, the Harvard ESCRO generally consults with its peer oversight bodies, reviews data from the scientific and bioethical literature and from other scientists and ethicists in the field and, from time to time, convenes symposia to broaden the discussion around such emerging technologies.  Read More