Bioethics.net

August 2, 2018 6:31 am

What Is a Genetically Modified Crop? A European Ruling Sows Confusion (The New York Times)

Mushrooms that don’t brown. Wheat that fights off disease. Tomatoes with a longer growing season. All of these crops are made possible by a gene-editing technology called Crispr-cas9. But now its future has been clouded by the European Union’s top court. This week, the court ruled that gene-edited crops are genetically modified organisms, and therefore must comply with the tough regulations that apply to plants made with genes from other species. Many scientists responded to the decision with dismay, predicting that countries in the developing world would follow Europe’s lead, blocking useful gene-edited crops from reaching farms and marketplaces. The ruling may also curtail exports from the United States, which has taken a more lenient view of gene-edited foods.

July 30, 2018 3:00 am

European court ruling raises hurdles for CRISPR crops (Science)

Hopes for an easier regulatory road for genetic engineering in European agriculture were dashed today by the Court of Justice of the European Union. In a closely watched decision, the court ruled that plants created with new gene-editing techniques that don’t involve transferring genes between organisms—such as CRISPR—must go through the same lengthy approval process as traditional transgenic plants.

July 19, 2018 12:29 pm

Arizona law would give frozen embryos to spouse who wants baby after divorce (CBS News)

A controversial new Arizona law that took effect July 1 would give Torres access to the embryos. The law requires courts to give embryos to the spouse who plans to use them to have a baby when a couple decides to have a divorce. Supporters of the law say it will protect a partner’s right to his or her embryos. Opponents say it could force people to become parents against their will.

July 18, 2018 9:09 am

Are 'breakthrough' drugs as safe as other FDA-approved medicines? (CNN)

New research questions the quality of drugs given the “breakthrough therapy” designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions.

May 14, 2018 9:00 am

As lab-grown meat advances, U.S. lawmakers call for regulation (Science)

Lab-grown chicken, beef, and duck products are edging toward the U.S. market—despite enduring confusion about how they’ll be regulated. But language buried in a draft spending bill released by a U.S. House of Representatives appropriations panel this week suggests some lawmakers are eager to get rules in place. A one-sentence proposal in the bill would put the U.S. Department of Agriculture (USDA) in charge of regulating products made from the cells of livestock or poultry, and instructs the agency to issue rules about how it will oversee their manufacture and labeling.

April 20, 2018 9:00 am

Why doctors don’t use alternatives to opioids (The New York Times)

As Congress deliberates how to respond to the surging opioid epidemic, a number of bills have been introduced to support the development and Food and Drug Administration approval of a non-opioid pain medication. But the problem in American medicine is not a lack of alternatives to opioids, but the minimal utilization of the many non-opioid treatments for pain that already exist.

April 3, 2018 6:46 pm

California Supreme Court lets stand controversial law allowing DNA collection upon arrest (The Los Angeles Times)

December 22, 2017 9:00 am

Ohio bill would prohibit abortions in Down syndrome cases (CNN)

The bill prohibits abortions after tests reveal Down syndrome in a fetus or if there’s “any other reason to believe” the fetus has the genetic condition. A person performing an abortion in such a case could face a fourth-degree felony charge, and physicians could lose their licenses. The woman seeking the abortion would not be held accountable, according to the bill.

December 12, 2017 9:00 am

Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) (Government of Canada)

Without access to detailed clinical data, health professionals and researchers are unable to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. This approach limits transparency and misses opportunities to promote greater confidence in the oversight of drugs and medical devices. It is also out of step with Health Canada’s key regulatory partners, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration, which have increased clinical data transparency over the past 10 years.

November 9, 2017 9:00 am

Infusions of young blood tested in patients with dementia (Nature)

The first controlled, but controversial and small, clinical trial of giving young blood to people with dementia has reported that the procedure appears safe. It has also hinted that it may even produce modest improvements in the daily lives of people who have Alzheimer’s disease.