By: Bethanie Morrison
Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.
FDA considers trials of ‘three-parent embryos’ – A new and controversial fertility technique aimed at women who are carriers of mitochondrial disease has been given guarded approval in the UK. The primary purpose of this technique, called mitochondrial DNA replacement therapy, is to prevent the passage of genes that cause severe mitochondrial diseases to children by way of removing the nuclear genes from the egg that has mutated mitochondrial DNA (parent #1) and placing them into a donor egg containing healthy mitochondria (parent #2) and continuing with in vitro fertilization (parent #3). In the US, there are ethical concerns as to whether the benefit of decreasing the risk of spreading devastating disease outweighs the moral objections likely to be raised with altering the human germ line. As the FDA has the power to regulate any form of gene therapy, including the transfer of mitochondrial DNA in embryos, mitochondrial DNA replacement will be up for discussion at the meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee next week. The FDA will develop its regulations based on recommendations that stem from this meeting. “It’s going to be hard to find what a fair balance is,” says Doug Wallace, a mitochondrial geneticist at the University of Pennsylvania. (Gretchen Vogel)
Secretary of State Kerry lashes out at climate change skeptics – While giving a speech to Indonesian students, government officials and civic leaders in Jakarta on Sunday the Secretary of State called out skeptics of climate change for believing shoddy science and for having their heads in the sand regarding what he referred to as, “the world’s largest weapon of mass destruction.” The Secretary suggested that the solution to the climate change problem is a new global energy policy that shifts reliance from fossil fuels to cleaner technologies, a policy strongly backed by President Obama. In the days prior to his visit to Indonesia, Secretary Kerry had been in Beijing, a world leader in greenhouse gas emissions, discussing progress on a joint US-China policy initiated by Kerry last year to curb greenhouse gases via the reduction of vehicle emissions, improving energy efficiency of buildings, the advancement of electric power grids, capturing and storing carbon emissions and gathering greenhouse gas data. It is the hope of the US that collaboration with China will inspire other developing countries to work together and with developed nations to combat climate change. (AP)
Medicines made in India set off safety worries – The FDA is getting serious about oversight of foreign pharmaceutical plants that export their drugs to the US. Pharmaceutical companies based in India supply the US with 40% of its over-the-counter and generic prescription drugs, yet these labs are coming under intense scrutiny by the FDA for safety lapses, falsified test results and for the sale of counterfeit medications. The heightened scrutiny is the result of a law passed in 2012 requiring further regulations on overseas pharmaceutical plants. The FDA inspected 160 Indian drug plants last year alone. India exports roughly $15 billion of pharmaceuticals each year, and the increased scrutiny and regulations placed on the industry has led to the closing of many plants and has caused further devastation of the already declining economy. While India has allowed the FDA to enter and investigate its drug production processes, the same cannot be said for China, which is the largest producer of counterfeit medication in the world. Despite strong efforts made by the FDA, China has failed to provide the logistics necessary to allow the FDA to enhance its China-based staff. Unfortunately, the US depends solely on China for many of its imported drugs so the upper hand may still belong to China at this point. (Gardiner Harris)
Have an interesting science policy link? Share it in the comments!