Science Policy For All

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Science Policy Around the Web – December 9, 2014

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By: Jennifer E. Seedorff, Ph.D.

Flu Season – Public Health

Potential for a deadlier flu season

This flu season has the potential to be an especially bad season. This year the predominant circulating flu strain is a H3N2 virus, and historically the H3 strains have been associated with more severe flu seasons, including increases in hospitalizations and deaths. This season may be especially bad because some of the circulating H3 viruses have mutated since the strains for the vaccine were chosen, and these mutations may mean that the vaccine may be less effective against the mutated strain. Despite the mismatch between the flu strains and the vaccine, vaccination is still highly recommended. The vaccine will still provide protection against other strains of flu, including the unmutated H3N2 strain that is also in circulation, and may still provide a “weak defense” against the mutated strain, according to the CDC.   Additionally, this year CDC recommends that anti-viral drugs like Tamiflu (oseltamivir) be given to vulnerable patients with flu symptoms without waiting for a positive flu test, since these drugs work better when given earlier in the infection. Dr. Thomas Frieden, director of the CDC, said that, “Flu is unpredictable, but what we’ve seen thus far is concerning.” (Donald McNeil, Jr. New York Times)

 

NASA

Successful test flight of the Orion spaceship

NASA’s Orion spaceship successfully completed its first unmanned test flight on December 5th. Orion is intended to replace the retired shuttle for manned spaceflight, including missions to the Moon and eventually Mars. Mark Geyer, NASA’s Orion program manager, commented on the successful flight and splashdown in the Pacific, “It’s hard to have a better day than today.” This 4.5 hour unmanned spaceflight was intended to test the performance of critical re-entry systems, including its thermal shielding. The Orion spaceship is being developed in parallel with a new launch rocket that will likely be ready around 2017-2018. Amos reports that commentators are “worried that the policy as laid out cannot continue in its current guise.” John Logsdon, a historian, commented that, “the first Orion launch with a crew aboard is 2020/21, and then nothing very firmly is defined after that, although of course NASA has plans. That’s too slow-paced to keep the launch teams sharp, to keep everyone engaged. It’s driven by the lack of money, not technical barriers.” Ellen Stofan, NASA’s chief scientists said that, “We have all these technologies mapped out and we’re asking, ‘what is the most sustainable path we can get on (to acquire them)?’” Despite concerns about the pace of development and future missions, Friday’s launch was a reason for celebration. As mission control commentator Rob Navias said, “There’s your new spacecraft, America.” (Jonathan Amos, BBC News)

 

Regulatory Policy – FDA

New drug labels to include more information on risks of medications during pregnancy

In June 2015, the Food and Drug Administration (FDA) will begin to require labels on prescription drugs and biologics to include more information on risks to pregnant and breastfeeding women, and on the reproductive risks to both men and women. Prior to this rule change, drugs were given a letter grade based on known or unknown risks of the medication during pregnancy and breastfeeding. “The ABC system was useless. Every thing was C, and all it said was there was no known data during pregnancy but that wasn’t necessarily the case,” said Jacques Moritz, director of gynecology at Mount Sinai St. Luke’s and Mount Sinai Roosevelt in New York. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research, FDA, wrote, “Our new method provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, the breastfeeding children, and women and men of reproductive age.” The new rule will require that the information packets included with medications approved since 2001 include subsections on “Pregnancy,” “Lactation,” and “Females and Males of Reproductive potential” and include a summary of risks and the data to support the conclusions.  The rule will not require companies to do studies on the risks during pregnancy and lactation, but will require them to provide the information, if it exists. “Oftentimes the research is out there in the medical literature,” Kweder said and that, “oftentimes companies know about it,” but may not include it. (Brady Dennis, Washington Post and Sabrina Tavernise, New York Times)

 

GMOs – EU

Compromise in debate over genetically modified plants in the European Union

Recently, a compromise was reached in the approval process of genetically modified (GM) plants for cultivated in the European Union (EU). Approval of genetically modified crops has been particularly controversial in Europe where resistance and support for GM crops varied greatly amongst the member states. Prior to this compromise, approval by the EU Commission would have allowed GM crops to be grown in all member states, some of which have laws that ban cultivation of GM plants. This compromise agreement will allow individual member states to overrule EU approval of GM crops in their state. This agreement should help to speed up the approval process, but still needs to be approved to come into force. The compromise of letting individual member independently decide on whether to allow GM crops to be grown has met with resistance from both supporters and defenders of GM crops. Still the EU commissioner of Health and Food Safety Vytenis Andriukaitis called the deal “a significant step forward, after 4 years of intense debates . . . (The agreement will) give the democratically elected governments at least the same weight as scientific advice when it comes to important decisions concerning food and environment.” (Daniel Cressey, Nature News)

 

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Written by sciencepolicyforall

December 9, 2014 at 2:16 pm

Posted in Linkposts

Tagged with , , , , , ,

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