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Science Policy Around the Web – September 12, 2014

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By: Bethanie L. Morrison, Ph.D.

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Genetic Testing

Lasker Winner Calls for More Genetic Testing for Cancer
Dr. Mary-Claire King, 2014 Lasker award winner and the woman who discovered the BRCA1 gene, has boldly proposed that all women over the age of 30 be screened for cancer-causing genetic mutations. The details of Dr. King’s proposal were published this week in JAMA. The current guidelines for cancer screenings suggest evaluating only those women who have a family history of breast or ovarian cancer and are in a very high risk pool. Dr. King argues that women will be better off in the future if they have this information at their disposal. They will be in a better position to make life decisions that may prevent the possible onset of breast or ovarian cancer, unlike the current practice of treating the cancer once it appears. Dr. King did make a distinction between receiving genetic screens for known cancer-causing mutations, and general genetic screens. She does not believe that women should be screened for mutations for which function is not well-defined. (Lawrence K. Altman and Roni Caryn Rabin, The New York Times)

 

Regulatory Policy

23andMe CEO navigates health regulation

Anne Wojcicki, CEO of the DNA testing firm 23andMe, recently spoke with the Associated Press about keeping a health care business afloat under the oversight of the FDA. The primary goal of 23andMe is to make genetic testing available and affordable to the general public. Furthermore, they use the testing to create a massive archive of DNA results for use in medical research. In November, the FDA issued a warning to 23andMe to stop marketing its personalized health reports, which indicate to customers any possible genetic predisposition to various medical conditions. This issuance by the FDA caused a dramatic downswing in sales, although the company is still able to sell ancestral and unprocessed DNA data. As a result, 23andMe has hired 4 new health care executives and decided to pursue FDA regulatory approval on each individual health test, a process which could take years.  Ms. Wojcicki indicated that such heavy and constantly changing FDA regulations are very scary for health technology start-up companies, a sentiment held by most of Silicon Valley, whose investors are hesitant to back health technology ventures. (Matthew Perrone, (AP), The Washington Times)

 

Ebola Outbreak

Ebola: ‘Wow, that is really tough’
In an interview with Science, Bruce Aylward, an assistant director-general at the World Health Organization (WHO), responded to the criticism that the WHO has been too slow in its response to the Ebola outbreak in West Africa. “Foreign medical teams and NGOs [nongovernmental organizations] are used to dealing with trauma and primary health care; they’re not trained to deal with pathogens,” remarked Aylward when asked why the WHO appears to have underestimated the severity of the outbreak. The WHO has put more people in the field than has ever been heard of in an Ebola outbreak. The main problem lies in the inexperience of field staff and the lack of funding for proper field hospitals required for containment of the outbreak. The notion of vaccine trials and new therapies being introduced is promising for those who would otherwise not be willing to subject themselves to this dangerous pathogen, but the WHO cannot sit back and wait for the therapies to be approved. They must act now, according to Aylward. The WHO is asking foreign medical teams, primarily from the U.S., France, and the U.K., to stop just thinking of how to help and mobilize their troops before many more people have to die. (Leslie Roberts, ScienceInsider)

 

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September 12, 2014 at 6:00 am

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Science Policy Around the Web – September 6, 2014

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By: Tara Burke, Ph.D.

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Environment

Time to focus on committed, not current, carbon emissions, study argues – A new study published in Environmental Research Letters argues that instead of focusing on annual carbon emissions, scientists and policy makers should track committed emissions. Committed emissions track how much energy infrastructure we’ve already built and adds up the emissions those infrastructures are projected to produce during their forecasted lifetime. The authors of the study argue that this is a superior method of highlighting the climate challenge Earth faces. The traditional measurement of annual emissions has masked the problematic growth of committed emissions. Adoption of committed emissions will hopefully enable policymakers to recognize the implications of today’s policies on future policies and may help developing countries adopt energy infrastructure of lower carbon intensity.  (Eli Kintisch)

 

Infectious Disease

Ebola now threatens national security in west AfricaThe spread of Ebola has become so entrenched in west Africa that it now poses a real risk to the stability and security in the region. The Ebola virus continues to spread and its outbreak is stressing the infrastructure of many west African countries that must still provide basic health, security and commercial practices despite the outbreak. Fear has also become a huge hindrance to stopping the outbreak. Citizens are fearful of hospitals and risk not being treated for other maladies and health workers are afraid to go to their jobs. CDC director, Tom Frieden, is urging the world to respond quickly. He states that “the window of opportunity really is closing”. The CDC recommends scaling up medical supplies and recruiting more health care management experts to the region. The World Health Organization has asked for $490 million to help with the response.   (Dina Fine Maron)

 

Biosafety

White House orders biosafety review at federal labs – In the wake of three recent U.S. biosafety and biosecurity incidents, the White House is asking federally funded labs studying infectious agents to inventory samples and review safety and security procedures. These steps are not mandatory for extramural labs with federal funding. The memo asks these labs to perform a ‘Safety Stand-Down’ where leaders will review practices and protocols. During this time, laboratories will also develop plans to consistently monitor their inventory. Additionally, labs are also asked to do an ‘immediate sweep’ for select infectious agents and toxins that may potentially cause harm and make sure these samples are either properly registered or destroyed. While some are supportive of this move by the White House to regulate biosafety, some are criticizing it as too weak arguing that most select agent work occurs at academic or nonfederal labs where these procedures are not required. (Jocelyn Kaiser)

 

 

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September 6, 2014 at 12:58 pm

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Science Policy Around the Web – August 29, 2014

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By: Jennifer L. Plank, Ph.D.

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GMOs

Brazil Considers Transgenic Trees – In September, a public hearing in Brazil will be focused on commercialization of transgenic Eucalyptus trees that have the potential to produce 20 percent more wood. So far, genetically modified trees from major commercialized species have been planted on a large scale suggesting that this hearing will have global implications. Despite potential environmental advantages, the GMO trees have received much opposition. One cause of opposition is the length of time the trees will be alive compared to other GMO crops such as soy and corn. Meanwhile, in the United States, another company, who has generated freeze-resistant eucalyptus, is anxiously awaiting the ruling in Brazil.  (Heidi Ledford)

 

Infectious Disease and Public Health

AIDS Progress in South Africa is in Peril – Until recently, the AIDS epidemic in South Africa has kept undertakers in business. However, within the past 6 years, there has been a dramatic increase in the ability to treat and prevent the spread of HIV. There has been a drastic increase in the number of clinics and health care practitioners prescribing antiretroviral drugs. In fact, each month 100,000 new patients begin a regiment of anti-retroviral drugs, more than any other country in the world. Additionally, maternal to fetal transmission has decreased 90 percent. All of this suggests an astounding success in South Africa. Much of this success can be attributed to the US program PEPFAR, the President’s Emergency Plan for AIDS Relief. Unfortunately, with the PEPFAR pipeline drying up, the programs in South Africa are in danger of not being able to continue their work. (Donald G. McNeil Jr.)

 

Vaccines

Ebola Vaccine to be tested in humans at NIH Clinical Center this fall – In collaboration with GlaxoSmithKline, NIH researches will begin clinical trials of an Ebola vaccine. The trial will test the safety of the vaccine and its ability to induce an immune response. The initial trial will include approximately 20 participants. Similar trials will be conducted in other countries. (Brady Dennis)

 

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August 29, 2014 at 3:21 pm

Science Policy Around the Web – August 22, 2014

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By: Amie D. Moody, Ph.D.

photo credit: Bernt Rostad via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

 

NIH Funding Policy

Closing the “Grant Gap” between racial minorities and Caucasian applicants

Beginning in September, the NIH will begin analyzing the factors responsible for the fact that African American scientists are only two-thirds as likely to receive an NIH grant as a Caucasian applicant. Although the NIH launched a $500 million program to train and mentor minority scientists in 2012, officials recognize that training disparities are not the sole factor in the grant gap. This new initiative will investigate the role of reviewer bias during the grant review process. If racial bias is identified, it would not be a complete surprise after a study published in July found that faculty members at US universities are less likely to respond to interview requests from individuals whose names are associated with women and minorities than those associated with Caucasian males1. However, even if racial bias is not a key factor in the racial disparity of NIH grant awarded, the initiative will hopefully still identify the causes of the gap, allowing the NIH to develop future programs that will address the appropriate needs.   (Sara Reardon)

  1. Milkman, K. L., Akinola, M. and Chugh, D. What happens before? A field experiment exploring how pay and representation differentially shape bias on the pathway into organizations. Soc. Sci. Res. Network. 2014. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2063742

 

Science in Society

The Centers for Disease Control and Prevention (CDC) encourages employees to be model citizens

The CDC’s mission is to “protect America from health, safety and security threats, both foreign and in the US” 24/7 (http://www.cdc.gov/about/organization/mission.htm). The CDC puts much effort into encouraging public awareness of potential threats and personal preparedness for when disasters do arise. However, upon looking into its own “house,” officials realized that its employees were not implementing the preparedness measures that they implore the public to adopt. Therefore, in conjunction with the Federal Emergency Management Agency (FEMA), the CDC created the Ready CDC program. To instill community level preparedness within the CDC “community” of employees, Ready CDC provides it employees the support they need to participate, the tools and resources required for personal preparedness and the education to practice “actionable behaviors,” like making emergency kits and family disaster plans. By implementing these measures within their own workforce, the CDC hopes to study behaviors of preparedness, like a community’s resistance to change, to understand if their efforts are effecting the desired changes. At the core of this program is the desire to effectively respond when disaster strikes, and studies show that an individual is more likely to assist in an emergency if that person feels their family will be okay in their absence.

 

Space Policy

NASA paving the way to use 3D-printed instruments in space

NASA is already making full use of 3D printing to manufacture items like rocket engine parts and photographs from the Hubble Space telescope. However, by the end of September they hope to have printed an entire camera from 3D printing materials. The goal is to cut down the time and cost of manufacturing, particularly on components that have tiny features that are difficult, or impossible, to accomplish with traditional manufacturing techniques. In addition to building cameras, Jason Budinoff, an aerospace engineer at the Goddard Space Flight Center, is working on techniques to 3D print the high quality mirrors that are so important in telescopes. Although these items will have to withstand rigorous testing to see if they can tolerate the stresses of deep space, Budinoff is hopeful.   (Kelly Dickerson)

 

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August 22, 2014 at 5:22 pm

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Science Policy Around the Web – August 15, 2014

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By: Bethanie L. Morrison, Ph.D.

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Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

 

Global Health

Using experimental drugs and vaccines against Ebola is ethical, WHO panel says

A 12-member World Health Organization (WHO) ethics panel has approved the use of experimental drugs to combat the latest Ebola outbreak in West Africa, the worst outbreak on record. Panelists and other disease experts initially worried that testing the experimental drugs in rural Africa may be seen as racist, yet after seeing the positive results of the experimental ZMapp on two Americans infected with the Ebola virus, they have put those concerns aside. While agreeing that the compassionate use of experimental therapeutics is warranted in this situation is a huge hurdle that had to be overcome, there are many more policy considerations that will be up for discussion at the next convening of ethics panel members in Geneva at the end of the month. Some of these roadblocks include whether to distribute the therapeutics to health care workers first, which authority makes the decisions about individual patient treatment and, most importantly, the fact that the experimental drugs in discussion are only available in limited quantities.  “Much more ethical work needs to be done to create a sound infrastructure for compassionate use in humanitarian emergencies,” wrote Arthur Caplan, a bioethicist at New York University.   (Kai Kupferschmidt)

 

Diplomacy, Defense,  and Technology

Pentagon’s breakthrough human brain-inspired computer chip to power drones

Researchers at the Pentagon, as part of the Defense Advances Research Projects Agency (DARPA), have created a computer chip inspired by the synapses of the human brain. The chip, which contains over 5 billion transistors and more than 250 million life-like “synapses,” requires only a fraction of the electricity typically required to power commercially available computer chips. The decrease in energy requirements for the chip will make it much easier for military field use. In addition, the chip is powerful enough to “give unmanned aircraft or robotic ground systems with limited power budgets a more refined perception of the environment,” says Gill Pratt, the DARPA program manager. This will take some of the burden off of system operators as drones should be able to distinguish threats more accurately. Ultimately the development of this chip will allow for a much wider range of portable computing applications used for military and defense.   (Douglas Ernst)

 

Science Communication

Ebola May Pose Little Threat to U.S., but It Looms Large on Twitter

Ebola is trending on Twitter. This fact has social scientists and biomedical scientists on high alert for completely different reasons, both of which converge on the implications of appropriate scientific communication.   Jonah Berger, a professor of marketing at the Wharton School of the University of Pennsylvania, has found that heightened emotions increase story sharing, regardless of the truth.   While Ebola remains a very rare disease, the emotions that its horrific symptoms stir up in the general public are very strong, enticing people to share stories regardless of the validity of their sources or the impact that spreading potentially false information may have on people and policy makers. People want to be more a part of the conversation and be “in the know” than a part of the alternative. While strong emotional issues are great for the social media model of marketing, they may not have the same impact on the biomedical research community who now has to spend countless amounts of time and resources explaining why the Ebola virus is not one to be concerned with in day to day living. Perhaps this is not such a bad thing; as it has pushed people like Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention (CDC), to release fact sheets about Ebola and other “emerging threats.”    (Joshua A. Krisch)

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August 15, 2014 at 6:00 am

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Science Policy Around the Web – August 8, 2014

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By: Kaitlyn Morabito

photo credit: Microbe World via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

American Ebola patients become serum test subjects. -With no approved vaccine or treatment for Ebola infection, two American health care workers infected in Liberia were given an unapproved drug in hopes of preventing death. Zmapp, a combination of three humanized monoclonal antibodies, has not previously been tested in humans, but has shown promise in non-human primates. These drugs bypassed the usual FDA requirements of human clinical trial safety and efficacy testing.   Following administration of the drug, one of the patients showed a “miraculous” recovery. However, Ebola researchers are skeptical of the antibody cocktail leading to such quick improvement.   (Monte Morin)

Geopolitics disrupt scientific exchange with Russia.   -The rocky political relationship between the US and Russia is impacting the scientific community. Due to guidelines restricting travel of US government scientist to Russia, scientists from the DOE and NASA have been forced to cancel plans to attend scientific conferences in Russia including the International Atomic Energy Agency’s conference on fusion. Policies regarding travel differ between agencies and the approval process is nontransparent, confusing and frustrating scientists seeking to travel to Russia. However, many other US-Russian projects are seemingly continuing without a hitch including a long term project RUSLCA involving US NOAA.   (Eli Kintisch)

Flores bones show features of Down syndrome, not a new ‘Hobbit’ human. – Unique characteristics of a skull and leg bone found in a cave in Flores Indonesia in 2004  led to the description of a new species, Homo floresiensis. However, re-examining of the bones by researchers has led to the conclusion that they are in fact not from a new species, but likely from a hominoid with Down syndrome. Scientists came to this conclusion by calculating cranial volume, craniofacial asymmetry, and occipital-frontal circumference. Furthermore, no other remains found at the same site had any of the unusual characteristics, suggesting that these bones represent an abnormality among this population.    (Science Daily)

 

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August 8, 2014 at 6:00 am

Science Policy Around the Web – August 3, 2014

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By: Tara Burke, Ph.D.

 

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US. confirms 2 Americans with Ebola coming home for treatment – Two American volunteers who were working to stop the largest outbreak of Ebola in history have contracted the virus. They are now being flown to the U.S. for treatment and the evacuations should be completed by next week. Emory University announced that it would be treating one of those patients. This decision has provoked fear among Americans, who fear the spread of the virus in the U.S. A spokeswoman for the Centers for Disease Control and Prevention explained that the transportation and treatment of these patients would not cause an Ebola outbreak in the U.S. and reiterated that Ebola is not transmitted through the air and can only spread by direct contact with bodily fluids of a person who is sick and showing symptoms. (Joel Achenbach, Brady Dennis, Lenny Bernstein)

 

F.D.A. Acts on Lab Tests Developed In-House – On Thursday, the Food and Drug Administration (FDA) announced that it would start to regulate medical laboratory testing. The FDA stressed that these tests need to be validated and checked before they go into use. This issue had been a tug of war in Congress between some Democrats pushing for this regulation and some Republicans trying to stop it. Some laboratories and pathologists vehemently oppose this new regulation. They feel this regulation is unnecessary and will only increase the cost and time needed to develop tests. The agency said it would phase in the requirements over nine years and that they would focus on tests where wrong results would result in the highest level or risk to the patient. (Andrew Pollack)

 

Surgeon General Calls for Action to Reduce Skin Cancer Rate – The acting surgeon general, Dr. Boris D. Lushniak, called for urgent action to reduce the rate of skin cancer. Skin cancer is the most commonly diagnosed cancer in the U.S. but is also one of the most preventable. The rates of melanoma, the deadliest form of skin cancer, rose by 200 percent from 1973 to 2011. Additionally, melanoma is one of the most common cancers among teenagers and young adults. Dr. Lushniak advises Americans to reduce their exposure to harmful rays of the sun and tanning beds. The report comes on the heels of an announcement by the F.D.A. saying they would require manufacturers to put black-box warnings on tanning beds warning against their use to individuals under 18 years of age. (Sabrina Tavernise)

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August 3, 2014 at 9:16 pm

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