professional regulation

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UK medicines regulator approves gene therapy for two blood disorders

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BY DENIS CAMPBELL
THE GUARDIAN

Britain’s drugs regulator has approved a groundbreaking treatment for two painful and debilitating lifelong blood disorders, which works by “editing” the gene that causes them.

The Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for Casgevy to be used to treat sickle cell disease and beta thalassemia.

It is the first medicine licensed anywhere that works by deploying gene editing that uses the “genetic scissors”, known as CRISPR, for which its inventors won the Nobel prize for chemistry. Continue Reading →

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There Still Aren’t Any Rules Preventing Rogue Scientists From Making Gene-Edited Babies

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BY EMILY MULLIN
MEDIUM / ONE-ZERO
Around this time last November, Chinese scientist He Jiankui stunned the world when he revealed the birth of the first known gene-edited babies. Working in relative secrecy, he had used CRISPR to modify human embryos in the lab and then established pregnancies with those embryos. Twin girls with edited genomes were born as a result.
The scientific community’s condemnation of He was harsh and swift. He had edited the germline, making a heritable genetic change. There were safety questions about the effects on the twins, and he had not meant to fix a genetic defect or prevent disease. Instead, he tweaked a gene in an attempt to bestow an uncommon, protective genetic trait: resistance to HIV.
Continue Reading →

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Genetically modified mosquitoes breed in Brazil

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BY FABIAN SCHMIDT
DW.COM SCIENCE

An attempt to contain the populations of the yellow fever mosquito Aedes aegypti in Brazil may have failed. It appears that gene mutations have been transferred to the local population.

The British company Oxitec had released about 450,000 male mosquitoes every week in the city of Jacobina in the Bahia region with official permission over a period of 27 weeks. The experminet was designed to control the infectious diseases dengue, zika and yellow fever.

The gene modification called OX513A in the mosquitoes was designed in such a way that the first descendant generation of the mosquitoes, known as F1, would not reach the adult stage and thus not be able to reproduce. Continue Reading →

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Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm

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BY ANTONIO REGALADO
MIT TECHNOLOGY REVIEW
In the wild uproar around an experiment in China that claimed to have created twin girls whose genes were altered to protect them from HIV, there’s something worth knowing—research to improve the next generation of humans is happening in the US, too.

In fact, it’s about to happen at Harvard University. Continue Reading →

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It’s time to talk about who can access your digital genomic data

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BY CURTIS AND HEREWARD
THE CONVERSATION

We are approaching a time when you might be too scared to have your genome sequenced.

Only last week, a US senator called for an investigation into the privacy policies of direct-to-consumer DNA companies. But this is only one piece of a puzzle that is about to get much more connected.

As with any kind of personal data there are a number of concerns regarding collection, transmission, storage and use. But unlike most other data, your genome reveals intimate information about not only you, but also the people to whom you are related.

It’s time to talk about who can access that data, how, when and why. Continue Reading →

Filed under: genomic privacy, professional regulation

‘I want to help humans genetically modify themselves’

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JOSIAH ZAYNER

BY TOM IRELAND
THE GUARDIAN
Josiah Zayner, 36, recently made headlines by becoming the first person to use the revolutionary gene-editing tool Crispr to try to change their own genes. Part way through a talk on genetic engineering, Zayner pulled out a syringe apparently containing DNA and other chemicals designed to trigger a genetic change in his cells associated with dramatically increased muscle mass. He injected the DIY gene therapy into his left arm, live-streaming the procedure on the internet.
The former Nasa biochemist, based in California, has become a leading figure in the growing “biohacker” movement, which involves loose collectives of scientists, engineers, artists, designers, and activists experimenting with biotechnology outside of conventional institutions and laboratories.
Continue Reading →

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DIY Gene Editing: Fast, Cheap—and Worrisome

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BY AMY DOCKSER MARCUS
WALL STREET JOURNAL

Kian Sadeghi has postponed homework assignments, sports practice and all the other demands of being a 17-year-old high-school junior for today. On a Saturday afternoon, he is in a lab learning how to use Crispr-Cas9, a gene-editing technique that has electrified scientists around the world—and sparked a widespread debate about its use. Scientific breakthroughs often raise big ethical questions. Moral concerns around the 1996 cloning of Dolly the sheep or the 2000 announcement of a rough draft of the human genome still reverberate today. The public benefits from scientific advances, particularly in improving health. Continue Reading →

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Genetically Modified Mosquitoes: What Could Possibly Go Wrong?

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BY ADRIENNE LAFRANCE
THE ATLANTIC
History is filthy with stories of pest control gone terribly, terribly wrong. Consider, for example, the infamous tale of how the mongoose got to the Hawaiian Islands. The sleek carnivore was imported in the 1880s as part of a plan by the sugar industry to subdue the rats that wouldn’t stop gnawing through stalks of sugar cane. Mongoose do enjoy a tasty rat supper, when the opportunity presents itself, but there was a problem: Rats are active at night, while mongoose are active during the day. So instead of decimating the rat population, the mongoose came to Hawaii and feasted on native birds and their eggs. Continue Reading →

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Your Genome Belongs To You

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BY SHARON TERRY AND ROBERT COOK-DEEGAN
HEALTH AFFAIRS

Just four years ago, only two people in the world had their genome sequenced:  James D. Watson (co-discoverer of the structure of DNA) and J. Craig Venter (former President of the firm that mounted a private-sector rival to the Human Genome Project).  There are now many thousands of such people.  At genome meetings, scientists are talking about millions of fully sequenced genomes in coming years.  And after that…? It cost roughly a billion dollars to generate the first reference human genome in 2003; last year a company would charge $10,000 for this service.  This year it costs a few thousand dollars. And in a few years we should be able to get our genomes sequenced for a few hundred dollars. At some point, our genomic information will get cheap enough for most of us to take the plunge and “get our genomes done.”  It may be curiosity, or concern about disease risk, or interest in ancestry and biological relationships in the context of social relationships. This seems big and incipient. Continue Reading →

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DNA Test Agreements Disregard Privacy

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BY MARK ANDERSON
IEEE SPECTRUM

Some personal genomics companies rely on so-called “clickwrap” contracts—agreements to which consumers could one day regret having clicked “Agree.”

Anyone today who spends time in the digital world also enters into contracts in the digital world. And while many consumers today just click through so-called “clickwrap” contracts without reading them, one new study suggests that they take greater caution when clicking “Agree” to the legal terms underpinning, say, a personal DNA test. The new study also leaves the door open for consumer advocates to begin pushing toward stronger consumer standards in personal genome contracts, starting with questioning the very logic of the clickwrap model in the personal genome industry. It’s one thing, after all, to breeze through a lengthy contract when the worst-case scenario is the possible dissemination of, say, your history of iTunes purchases or the contents of your Amazon shopping cart. It’s quite another to blithely risk losing control of parts or the whole of your own genome sequence—arguably the one string of personal data that is both the core of a person’s identity, and a nugget of information that could never be changed if it were compromised. Continue Reading →

Filed under: professional regulation