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Archive for June 2016

Science Policy Around the Web – June 28, 2016

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By: Sterling Payne, B.Sc.

Licensed via Creative Commons

Bioengineering and Human Trials

First CRISPR clinical trial gets green light from US panel

Since its discovery, CRISPR-Cas9 has become one of the hottest and most sought-after techniques and area of research in science. Whether owing to its ease of use, wide accessibility, or myriad modifications, the research and public health worlds are captivated by CRISPR. Almost one week ago, on June 21st, the National Institutes of Health (NIH) opened the door for the first use of CRISPR in humans as a potential therapeutic in a clinical trial. The trial in question focuses on the use of T-cells to fight cancer by introducing exogenous genetic material via CRISPR-Cas9, followed by the infusion of the cells into cancer patients.

This is not the first time that a gene-editing technique has been used to edit human cells. In 2014, Carl June, an immunologist at the University of Pennsylvania and scientific adviser on the current trial, led a trial that used zinc finger nucleases to edit T-cells in hopes of preventing viral infection. However, the recent approval of this single CRISPR proposal will most likely pave the way for many more, and in a short amount of time. The advancement of CRISPR-Cas9 in the past few years and its potential use in humans is staggering. However, an influx of clinical trials involving this technique will pose more policy discussions and questions to assure scientists and the public that the technique is being used humanely and ethically. It will be interesting to see how the definitions of what is humane and ethical in the eyes of policy-holders potentially changes in the coming years thanks to CRISPR. (Sara Reardon, Nature News)

Brexit and Research

Researchers deplore U.K. decision to leave the European Union 

On June 23rd, 2016, the electorate of Britain voted in a referendum to leave the European Union, creatively named the “Brexit”. Fast forward several days, and the consequences of the vote on multiple levels – such as global markets, immigration, employment, timelines and next steps – are still being determined. At it’s core, the U.K.’s decision to leave was not largely based on research science. However, multiple British science authorities are flabbergasted by the decision, a majority of whom believe was a mistake.

With Britain’s decision to leave the EU, it will be interesting to see how policymakers deal with the inevitable battles in terms of funding, personnel, and travel. One particular talking point is the fate of the U.K.’s standing in the Horizon 2020 program, a massively financed research initiative with 9 billion British pounds of funding over seven years (2014-2020). The initiative provides a means of support for collaboration across different European countries, and if the U.K. would like to continue as a player in the initiative, they will have to make a decision now and start preparing the necessary documents necessary to become an “associate”, for example. Policymakers have a long, winding road ahead of them in order to ensure the survival of the myriad collaborations and research projects headed by Britain. (Daniel Clery, Science News)

Patent Law

The Supreme Court decision that’s shaking up biotech 

The Supreme Court recently rejected the request to hear an appeal from Sequenom (San Diego, CA), a biotech. company specializing in prenatal testing. Sequenom’s test, MaterniT21, relies on the presence of fetal DNA in the plasma of the mother, allowing for a non-invasive method of analyzing the fetus for certain conditions such as Down’s syndrome (trisomy 21). The patent for the test remained intact until 2013, where in a case against Ariosa Diagnostics, a lower court ruled the patent as invalid. The Supreme Court’s failure to hear Sequenom’s appeal means that the previous ruling stands, and that poses a problem with implications far beyond a single biotech company.

Sequenom turned to the Supreme Court for thorough consideration and a final decision on whether or not their patent remains valid, although it does rely on the naturally occurring process of fetal DNA showing up in plasma. The highest justice’s silence in this situation creates an ambiguity around all patents in the biosciences. At what point does novelty evanesce into nature? Should patents, the protectors of intellectual property, really be granted in a case where natural processes are required to retain their validity? These are the types of questions that are being asked as a result of the Court’s silence, and that could plague future investments in biotechnology, a field that is highly represented by startups. (Douglas C. Pizac, AP/STATnews)

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June 28, 2016 at 2:30 pm

When Industries Attempt to Drive the Scientific Narrative: The NFL and Concussion Research

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By: Valerie Miller, Ph.D.

Photo credit: DSC5623.jpg via photopin (license)

Earlier this spring, before a congressional panel, the vice president for health and safety of the National Football League (NFL) admitted for the first time that there is a connection between head injuries sustained playing football and chronic traumatic encephalopathy (CTE), which causes devastating memory and psychological problems. Despite the NFL’s longstanding denial of the connection between head injuries sustained playing football and CTE, these comments were made based on the work of Dr. Ann McKee, professor of neurology and pathology at Boston University (BU). Dr. McKee leads the famed “Brain Bank,” which has been collecting and examining the brains of former NFL players, finding that nearly 100 former players brains’ exhibited the degenerative disease. However, the science behind CTE is still in its infancy, and many questions remain unanswered. For example, it is unknown how much risk of developing CTE each player faces, what percentage of players develop CTE or why some players may be more susceptible than others. Additionally, the link between psychological problems that some former players exhibit and changes in (their) brain pathology remains tenuous. Adding to the confusion, CTE can only be diagnosed after a person has died and their brain can be examined. Clearly, a number of larger studies are needed to begin addressing these important questions. Although it would seem that the NFL would be most interested in answering these questions in order reduce player injury and risk while protecting their industry and product, the NFL has been less than forthcoming regarding the risks of concussions and traumatic brain injury, and has attempted to control the science produced regarding concussions.

Flawed Concussion Research

In 1994, amid growing concerns regarding player safety and concussions, the NFL formed a “concussion committee” to investigate the rate of concussions and the long-term harm they may cause players. The committee, comprised mostly of physicians associated with NFL teams, began a study that tracked all concussions diagnosed by team physicians on all teams from 1996-2001, and published a series of 13 peer-reviewed articles in the journal Neurosurgery based on this data. The league has used these articles as evidence that there is no connection between concussions sustained playing football and long-term effects in players. However, a recent New York Times investigation showed that the NFL studies omitted over 100 diagnosed concussions that were reported to the league, more than 10% of the total number. The NFL’s studies, based on this incomplete data, gave the appearance of a reduced rate of concussion among its players. The NFL has long stood by its research, claiming the legitimacy of the published papers because they underwent rigorous scientific peer-review. However, the New York Times received pages of comments and questions between peer reviewers and the committee, showing that reviewers wanted to stop the publication of the papers, with one reviewer stating “many of the management of concussion suggestions are inappropriate and not founded on facts.” The committee rebuffed the criticism and the articles were published.

NFL Tries to Influence Independent Concussion Research

In 2012, the NFL donated $30 million to the Foundation for the National Institutes of Health to study the effects of traumatic brain injury (TBI), including concussions. The research would be overseen by the NIH, and the NFL stated at the time that they would have no influence on how the money was used. Five studies were to be funded, including a seven-year, $16 million grant that would be awarded to study the progression of CTE, with the goal of determining how to detect CTE in living patients. After a rigorous scientific review process and additional review by an NIH advisory council, the National Institute of Neurological Disorders and Stroke (NINDS) awarded the grant to a team of 50 researchers at 17 institutions, led by Dr. Robert Stern, the director of clinical research at BU’s CTE Center. However, as first reported by ESPN’s Outside the Lines, the NFL reneged on its deal to fund the study, and instead tried to lobby the NIH to fund a proposal submitted by the NFL’s own researchers. In response to these allegations, members of the House Committee on Energy and Commerce launched an investigation, and issued a 91-page report detailing the ways in which the NFL publically claimed to fund impartial studies, only to privately attempt to influence the direction of concussion research. BU researcher Dr. Stern has long been critical of the NFL and their denial of the relationship between head injury and brain degeneration. Claiming that Dr. Stern would be unable to perform unbiased research, the NFL instead suggested funneling the $16 million grant to a different project lead by members of the NFL’s brain injury committee, avoiding the peer-review process by the NIH. This plan was subsequently rejected by NIH Director Francis Collins. According to Dr. Walter Koroshetz, Director of NINDS, the actions by the NFL are unprecedented, and that he “was aware of no other instance” in which private donors lobbied the NIH or attempted to direct the grant funding process. Ultimately, the NIH determined that the NFL’s allegations against Dr. Stern were unfounded. The study, which launches this June, is still funded by the NIH, but is being paid for by US tax dollars.

Where Do We Go from Here?

At this point, the general public has been made aware of the potential risks that concussions pose. The issues regarding repeated TBIs were brought to the forefront with the release of the 2015 movie Concussion, detailing the work of Dr. Bennet Omalu, who first discovered CTE. An increasing number of NFL players have been speaking out about player safety and are retiring early due to injury. Also, players have expressed interest in donating their brains to CTE research after death. In addition, rules are changing at all levels of play to reduce the incidence of concussions, and, as parents are becoming more wary of the risks of injury, participation in youth football is declining, although a great deal of questions surrounding concussion and CTE remain unanswered. Most importantly, the public is also now aware that the NFL has been less than forthcoming regarding the risks to player health. It can only be speculated what changes to the sport of football we will see in the upcoming months, years and decades, but for now, the NFL has been put on notice.

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June 22, 2016 at 10:00 am

Science Policy Around the Web – June 21, 2016

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By: Fabrício Kury, MD

Photo source: pixabay.com

Personalized Medicine Costs

The Paradox of Precision Medicine

Precision medicine has been hailed by President Obama as a multi-hundred-million “moonshot” meant to revolutionize medicine in a way never seen before. Its rationale derives from the recent field of research called Genome-Wide Association Studies (GWAS), which seeks to discover, in large and accelerated scale, the genetic basis of disease, novel targets for drugs, and what treatments work for which patients and at what moments and doses. This very rationale, however, can be self-limiting in a capitalist market where economics of scale is required to provide patients with access to otherwise prohibitively expensive treatments. In this lucid review, Janeen Interlandi from Scientific American demonstrates that old-fashioned, non-personalized treatments have recently been demonstrated not only be tremendously cheaper than “bespoke” drugs, but also just as clinically effective. (Janeen Interlandi, Scientific American)

Research Ethics

Scientists Are Just as Confused About the Ethics of Big-Data Research as You

Dubbed “the fourth paradigm” of science (book available for free download here), big data research poses novel ethical questions that might not be appropriately addressable by the current paradigm of ethics centered on the Common Rule and oversight by Institutional Review Boards (IRBs). A study can be ruled exempt from IRB approval if it only utilizes publicly available data – but what is it “publicly available,” exactly? In this article, Sarah Zhang from Wired magazine reviews recent cases of controversy in utilization of large datasets for studies, such as the Facebook Emotion Experiment, and suggests that IRBs might need new sets of skills to safeguard human subjects in the evolving landscape of research. (Sarah Zhang, Wired)

Data Science

The Doctor Who Wants You to Be a Research Parasite

After the editor-in-chief of the New England Journal of Medicine published in January, 2016 a stingy editorial affirming that some clinical researchers regard data scientists as “research parasites,” a wave of controversy exploded and culminated with personalities such as U.S. Chief Data Scientist DJ Patil and National Academy of Sciences President Marcia McNutt publicly using the hashtag #IAmAResearchParasite in defiance. In this article, Taylor Mayol from Ozy introduces Dr. Atul Butte, recently-appointed head of Clinical Informatics at the University of California, who sustains a bold call for more “research parasites” in health care, while additionally characterizing lack of entrepreneurship among academics as “a tragedy” because it is “the right way to truly change the world, by going beyond writing papers.” (Taylor Mayol, Ozy)

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June 21, 2016 at 9:00 am

Science Policy Around the Web – June 17, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Biomedical Research Funding

NIH gets $2 billion boost in Senate spending bill

The Senate approved a $2 billion dollar boost to the National Institutes of Health (NIH) budget for the 2017 fiscal year. This will increase the agency’s overall budget to $34 billion which represents a 6.2% increase from the previous year. This boost in funding represents an increase to NIH’s funding for the second year in a row after more than a decade of stagnate funding. NIH received an additional $2 billion last year.

The increase to NIH’s funding is the result of bipartisan negotiations between Senate Labor, Health and Human Services, and Education Appropriations Subcommittee Chairman Roy Blunt (R.-Mo.) and Ranking Member Senator Patty Murray (D-Wash.)

“Last year, for the first time in 12 years, we were able to have an increase in [funding to support] NIH research,” Blunt said at a subcommittee meeting to unveil the budget proposal. “We have worked hard to repeat that this year.” Adding that he hopes to establish a pattern of increases for health research funding, he further noted that “if you are going to have an annual pattern, year two is critical. So we’re proposing for the second year in a row we make a substantial commitment to NIH research.”

The bill will include $1.39 billion for Alzheimer’s disease research, a $100 million increase for Obama’s Precision Medicine Initiative, an additional $100 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) brain-mapping project, and $50 million in new spending for a federal initiative to combat antimicrobial resistance. Not mentioned is the $670 million proposal for Vice President Joe Biden’s proposed moonshot to double progress against cancer. (Jocelyn Kaiser, ScienceInsider)

Federal Accountability

House sharpens oversight of new NSF facilities

The U.S. House of Representatives approved bill H.R. 5049 by a vote of 412 to nine which would direct the National Science Foundation (NSF) to audit its major multi-user research facilities. This bill was passed in response to the problems that have plagued NSF’s National Ecological Observatory Network (NEON) under construction at dozens of sites across the country. Last December NSF fired the contractor, NEON Inc., citing a potential $80 million cost overrun and continued delays in completing the project.

The passage of the NSF Major Research Facility Reform Act of 2016 would direct the NSF to audit its major multi-user research facilities in order to prevent such cost overrun problems in the future. The Congressional Budget Office estimates that conducting these audits required by the legislation would cost about $2 million annually and $10 million over the 2017-2021 period. Specifically, the bill would require NSF to analyze how much every large research project would cost by the first year of the start of construction.

NSF officials remain concerned on how these changes in legislation would affect how audits are conducted and the use of management fees for a contractor. Such additional restrictions on management fees could potentially scare off some highly qualified would-be bidders for future projects. In addition, they believe that the proposed audits would not have caught the problems that NEON faced. (Jeffrey Mervis, ScienceInsider)

Infectious Diseases

Zika virus added to the FDA Priority Review Voucher Program Act

U.S. Senators Amy Klobuchar (D-Minn.) and Al Franken (D-Minn.) supported emergency funding to help stem the spread of the Zika virus in the United States. Over $1 billion in emergency funds passed the Senate today on a bipartisan basis to help mitigate the spread of Zika and respond to outbreaks of the virus.

“The Zika virus is a real threat, and we need action to curtail its spread and encourage the development of treatments and a vaccine,” said Franken. “This emergency support will help fight back against the disease, and now, we need to work with the House of Representatives and with President Obama to make sure that the funding measure becomes law. This is far too important of an issue to ignore.”

The Centers for Disease Control has reported that over 150 pregnant women in the U.S. have been diagnosed with Zika virus, which can cause a range of birth defects including devastating neurological defects. There are currently no known treatments or vaccines for the disease. The funds will be used to control mosquitos that carry the Zika virus, raise awareness of Zika virus disease, provide education on how to reduce risk of becoming infected, and accelerate development of a vaccine. (Congressional Research Service)

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June 17, 2016 at 9:00 am

Science Policy Around the Web – June 16, 2016

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By: Ian McWilliams, Ph.D.

Kris Krüg via Photo Pin cc

Climate Change

Underground injections turn carbon dioxide to stone

In the race to stop or reverse global warming, scientists in Iceland have discovered a method that could trap the greenhouse gas carbon dioxide (CO2) underground by turning the gas into stone. Researchers found that injecting CO2 into volcanic rock leads to the formation of carbonate minerals. Though the project, termed CarbFix, is still in development it could have important implications for climate change and for incentivizing clean energy policies.

Injecting CO2 underground into sedimentary rock (i.e. sandstone) or depleted oil wells has long been an attractive method of carbon capture and storage  (CCS), but there are concerns that fissures in the rock layers could lead to leakage of CO2 back into the atmosphere. In a joint effort, Icelandic, American, and French scientists proposed that injecting CO2 into layers of basalt could improve this method. Basalt is rock formed by volcanic activity and contains metals such as calcium and magnesium that can react with CO2 to form carbonate minerals, such as calcite, in a process known as carbonation. In this injection process, CO2 is first separated from gaseous emission then dissolved in water to form carbonic acid that is injected into basalt formations 400 to 800 meters below the surface in Iceland. A heavy carbon tracer was included in this mix so that the scientists could track the sequestration of carbon. Over a year and a half after their initial injections, the researchers found that 95% of the injected carbon had been converted to calcite and other minerals, surprising the researchers that carbonation could happen so quickly.

Though these results are promising, many hurdles remain. The carbonation process is resource intensive and requires large amounts of water and electricity, which may limit its environmental impact and commercial scalability. Additionally, while basalt is found around the world and could allow for the indefinite storage of billions of tons of CO2 with minimal leakage risk, introducing large amounts of CO2 into the ground could lead to unforeseen consequences. Although the researchers admit they were surprised by how quickly the CO2 turned to stone in their initial trials, it remains unknown how long the process will take on a commercial scale.

Members of CarbFix admit that the largest obstacle is still a financial one. With no price on carbon emissions, power companies have little to no incentive to pursue this technology. Still, the project has great potential.  Since we depend on fossil fuels and likely will for many more years, “we have to decarbonize our energy infrastructure” according to study author Juerg Matter. Matter further stated that “if it’s mineralized within a human lifetime, then we know we are on a successful pathway”. With improvement, turning CO2 to stone could become a viable strategy for controlling greenhouse gas emissions and curb the deleterious effects of our energy dependence. (Eli Kintisch, Science Magazine)

Cancer Therapeutics

U.S regulator says too many drug makers chasing same cancer strategy

Immunotherapy has revolutionized the field of oncology, but some worry that too many companies are focused on developing therapeutics that target the same pathways. At the American Society of Clinical Oncology’s annual meeting last week, Dr. Richard Pazdur, head of the Food and Drug Administration’s (FDA) Office of Oncology Drug Products commented on the abundance of therapies that disable the protein PD-1, which unleashes the immune response against tumors. So far Merck, Bristol-Myers Squibb, and Roche have all received FDA approval for therapies that target PD-1, and many more drug makers are developing similar strategies. Though these drugs have had remarkable success in the treatment of skin, lung, and bladder cancers, Pazdur encouraged companies to pursue other strategies and to invest in more novel drugs.

Pharmaceutical companies have countered that the future of cancer therapy is combining therapies to target multiple mechanisms of disease simultaneously and that approval for their own PD-1 targeting drug will allow for greater flexibility. Approximately 20 percent of patients treated with PD-1 blockers respond to treatment, with some having long-lasting remissions. However, a recent study demonstrated that combining two different immunotherapy drugs increased survival compared to treatment with either drug alone.  While most of the studies have been done in patients with advanced disease, Pazdur and other experts agree that earlier use could be beneficial for many diseases. Indeed, these treatments are currently being tested in a wide variety of cancers at earlier stages. Furthermore, there are significant costs associated with these therapies with an average price of $150,000 per year. Competition could also help lower the costs, leading to greater benefits for patients. (Deena Beasley, Reuters)

STEM Education

Genuine research keeps students in science

A new study has found that actively involving students in learning rather than in traditional lectures and labs can help lower the attrition rate in STEM fields. In a program at the University of Texas, instructors in the College of Natural Sciences replaced standard introductory courses with a three-course sequence that focuses on problem-solving and hypothesis-driven research. The program, called the Freshman Research Initiative (FRI), was launched in 2005 and has since seen thousands of students complete the program. Participants choose a research stream in which they will experience hands-on learning alongside faculty and graduate students. With numerous research topics that include everything from autonomous robots to genomics to white dwarf stars, students have the opportunity to explore unanswered questions and contribute to larger research projects in faculty-led laboratories.

Researchers have analyzed the results from this initiative and found that, while there was no statistically significant different in grade point average, 94% of FRI students completed a STEM degree compared to 71% of non-FRI students. Students from underrepresented minority groups also achieved high retention and graduation rates through the program, further demonstrating that the initiative could be a successful alternative to traditional internships. These results may provide insight into how to incentivize students to complete their education and could point the way for a cost-effective approach to reach President Obama’s challenge to produce 1 million more STEM-trained workers by 2020. (Jeffrey Mervis, Science Magazine)

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June 16, 2016 at 11:00 am

The Campaign to Battle Zika

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By: Melissa Pegues, Ph.D.

On February 1, 2016 the World Health Organization (WHO) declared the Zika outbreak a public health emergency, meaning that the response requires the coordination of global partners to detect infections, control mosquito populations, and develop vaccines and diagnostic tests to prevent the spread of the disease. With concerns that Zika will move into the US as summer begins, there is an urgent need to contain the epidemic. Congress, however, has been slow to respond and continues to debate how exactly to fund the fight.

Zika infection is rarely fatal and is commonly accompanied by symptoms such as rash, fever, and joint pain, but some do experience more serious symptoms including Guillain-Barre syndrome, a rare form of paralysis. However, Zika gained significant publicity when medical professionals in Brazil and other Latin American countries noticed a frightening association between Zika virus infection in pregnant women and babies born with microcephaly. Microcephaly is a rare birth defect where infants are born with underdeveloped brains and smaller than average head size. Although only considered an association for many months, studies of Zika infection in pregnant mice and monkeys have found evidence supporting the link between Zika infection and microcephaly. In support of the mounting evidence, Tom Frieden, the director of the Centers for Disease Control (CDC), recently stated that “It is now clear that the virus causes microcephaly.

While research moves quickly to demystify the Zika virus, the political system has failed to gain a foothold amongst the confusion. The White House had requested $1.885 billion towards the Zika fight in February, and in a rare bi-partisan effort, Marco Rubio (R-FL) and Bill Nelson (D-FL) topped Obama’s request with a $1.94 billion proposal that included $144 million for vaccine research that would also include funding for research into dengue fever and chikungunya. That proposal ultimately never came to a vote. The Senate has approved $1.1 Billion in emergency funds and the House of Representatives has offered a bill that would reallocate just $622 million from existing programs for the Zika response, but neither measure has been passed by both chambers.

The Capital Hill battle over Zika has revealed a number of underlying political viewpoints that each affect how politicians respond to this crisis. Republicans worry that abortions may increase due to the severe birth defects associated with Zika infections in pregnant women, and with evidence mounting that Zika can be sexually transmitted, Republicans are debating whether the better message is use of contraception or abstinence. Federal public health officials have countered that they do not believe their role is not to tell women if they should become pregnant, but rather focus on preventing spread of the disease. Pope Francis has weighed in and suggested that the use of contraception is acceptable to help prevent the spread of Zika.

On the other hand, Democrats have expressed concern over use of pesticides. In a proposal meant to help control mosquito vector populations, Senator John Cornyn (R-TX) suggested easing regulatory restrictions on pesticides. Democrats have accused Republicans of trying to exploit fears and countered that exceptions for use of pesticides already exist. The White House also commented that the Republican-led House’s proposal removes Clean Water Act protections that are not acceptable during this emergency. Democratic representatives Peter DeFazio (D-OR) and Grace Napolitano (D-CA) stated “Over the years, proponents of exempting pesticide spraying from the Clean Water Act have used the crisis of the day as the reason to support their legislation.”

While Congress debates how to best combat Zika, the CDC reports that the number of cases of pregnant women in the US with the virus has climbed to 279 as of late May, and multiple models are predicting the spread across the US. Furthermore, WHO chief, Margaret Chan, has cited a number of policy failures that allowed for lapses in mosquito control and the spread of Zika. At a recent World Health Assembly meeting, Chan said Zika took the world by surprise and revealed fault lines in the world’s collective preparedness. In addition, the spread of Zika, resurgence of dengue, and the emerging chikungunya threat are prices paid for “a massive policy failure that dropped the ball on mosquito control in the 1970s.”

With the outbreak of Zika spreading, many concerns have arisen over how to respond to Zika and prepare for other emerging threats. In a recent essay, Ronald A. Klain, the White House Ebola response coordinator from 2014 to 2015, urged Congress to put aside their differences and fund preventive measures for new epidemics. He stated that the threat of emerging disease is “not coming to the United States: It is already here.” In support of this, the Senate recently voted 93-2 to move forward with negotiations with the House of Representatives. Public officials have continued to urge politicians to focus on controlling the disease, but Chan stated that for now “all we can offer is advice. Avoid mosquito bites. Avoid pregnancy. Do not travel to areas with ongoing transmission.”

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June 15, 2016 at 9:00 am

Posted in Essays

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Science Policy Around the Web – June 10, 2016

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By: Nivedita Sengupta, Ph.D.

photo credit: Tc Morgan via photopin cc

Animal Welfare and Biotechnology

US government issues historic $3.5-million fine over animal welfare

The US Department of Agriculture (USDA) fined Santa Cruz Biotechnology, a major antibody provider, over alleged violations of the US Animal Welfare Act. The penalty so far is the largest in USDA’s history accounting to US $3.5 million.

As one of the leading producer of monoclonal antibodies, the company extracts antibodies from animals such as goats and rabbits for research after injecting the animals with proteins to stimulate antibody production. After inspection of the company’s facility in California, USDA found evidence of mistreatment of goats and rabbits in their facility. Agency inspectors reported goats with untreated coyote bites and massive tumors, and rabbits housed in cruel conditions. They also discovered that Santa Cruz Biotech was keeping 841 goats in a hidden facility. In 2007, USDA lodged three animal-welfare complaints against Santa Cruz Biotechnology. Before a scheduled hearing on the USDA complaints, more than 5,000 goats and rabbits disappeared from Santa Cruz’s facilities and the incident was completely ignored by the company. Santa Cruz would not confirm whether the animals were killed or sold.

The news of animals disappearing lead to a public outcry and scientists turned to social media to boycott Santa Cruz’s products. Dr. Stephen Floor, a biologist at the University of California, Berkeley, commented that his lab has since sought out other antibody providers. Even though the quality and type of antibodies varies widely and researchers tend to stick with products from a single company to ensure that their experiments are replicable, they definitely also want to ensure that animal rights are protected.

After contesting the government complaints, an agreement was made on 19th May in which the company “neither admits nor denies” that it violated US animal-welfare regulations. However according to the settlement agreement Santa Cruz Biotech will pay the fine as part of the settlement. It also includes permanent revoking of Santa Cruz Biotech’s government license to sell, buy and trade or import animals. Moreover it demands the company to cancel its registration to operate as a research facility that uses animals. So far Santa Cruz Biotech and Covington & Burling, a Washington DC law firm representing the company have not given any comments regarding the settlement. However the settlement ends the long running investigation and also points at the fact that not only proper regulations, strict vigilance is also needed to protect the laws. (Sara Reardon, Nature News)

Mosquito Control Policies

US reviews plan to infect mosquitoes with bacteria to stop disease

The United States (US) Environmental Protection Agency (EPA) is under process of reviewing an application from the biotechnology start-up MosquitoMate to use the bacterium Wolbachia pipientis as a tool against the Asian tiger mosquito Aedes albopictus. MosquitoMate plans to market Wolbachia as a pesticide to kill only mosquitoes and leave other insects untouched. The EPA sought for public-comments on this matter before making the decision.

The strategy involves rearing and environmental release of mosquitoes infected with a particular strain of Wolbachia which do not allow the paternal chromosomes of mosquitoes to form properly following mating. The released male mosquitoes will mate with the wild females which do not carry the same strain of Wolbachia. As a result the fertilized eggs will fail to hatch and the pest population will dwindle. MosquitoMate has tested Wolbachia in A. albopictus in three states over the past three years. According to Stephen Dobson, founder of the company, the approach resulted in reduction of wild mosquitoes by more than 70% in those areas. Apart from A. albopictus MosquitoMate is also using Wolbachia to target Aedes aegypti, thought to be the main vector for Zika. Other countries like China are also conducting field trials of Wolbachia to regulate the mosquito population.

The ongoing releases of large mosquito population can be expensive and hence the non-profit international collaboration, Eliminate Dengue, is testing another approach that requires rearing of fewer mosquitoes. It uses a starter set of mosquitoes carrying a different Wolbachia strain to infect the wild population. This strain of Wolbachia do not interfere with the development of the offspring but the infection prompts an immune response which consumes key cellular resources, thus making them ineffective at transmitting viruses.

So far MosquitoMate’s field testing plans have not prompted any public resistance. By contrast, US residents have protested against proposed trials of genetically engineered mosquitoes developed by Oxitec of Milton Park, UK. Both Oxitec and MosquitoMate alter the male mosquitoes using lethal reproductive weapon but Oxitec modifies mosquitoes with a gene, instead of bacterium Wolbachia.

Considering the current increasing incidence of Zika and also other mosquito transmitted deadly viruses like dengue and Chikungunya, many countries are considering new options for reducing mosquito populations. “We need as many effective tools as we can get, so we need to give Wolbachia a try,” says Tom Scott, an entomologist at the University of California, Davis. (Emily Waltz, Nature News)

Heart Disease

Protective gene offers hope for next blockbuster heart drug

Rare mutations though often regarded as harmful, sometimes can be beneficial too. On May 18th, scientists at DeCODE Genetics, subsidiary of the biotechnology giant Amgen reported in the New England Journal of Medicine a genetic variant found in Icelanders which lowers the risk of heart disease by more than one third. This variant was identified by comparing genomes of thousands of Icelanders with their medical record. In this study, about 2,600 Icelanders were fully sequenced and limited genomic data and family-tree records was used for another 398,000 inhabitants. After analyzing all the genomic data it was found that 1 in 120 Icelanders has a mutation resulting in inactivation of one copy of the ASGR1 gene. People having the mutant variant have lower levels of non-high-density lipoprotein (non-HDL) cholesterol, compared to the wild type population. Moreover, in follow-up analysis on approximately 300,000 people from Iceland as well as 4 other countries also revealed that carriers of this variant were 34% less likely to develop heart disease. Besides this, the variant didn’t seem to cause any adverse health effects. So far scientists have found that as a result of the variant, a protein is inactivated which recycles a class of sugar-coated proteins. However which biomolecules are precisely affected and what results in a significantly-decreased risk of heart disease is still under study.

This rare mutation could be the basis for the next blockbuster drug for heart disease. Kari Stefánsson, a geneticist at DeCODE Genetics (bought by Amgen in 2012) in Reykjavik stated that Amgen headquarter in California has already prepared drugs which mimics the effect of this genetic variant found in Icelanders. The level of protection provided by the ASGR1 mutant variant is comparable to that offered by another human gene variant discovered earlier. The earlier gene variant also reduced cholesterol levels and the drugs developed to mimic the mutation, blocks the PCSK9 protein that influences blood cholesterol levels. Furthermore this drugs were approved by the US Food and Drug Administration last year. PCSK9 inhibitors have been advertised as the next blockbusters in cholesterol-lowering drug market.

However Kari Stefánsson argues that the ASGR1 variation reduces risk of heart-disease more substantially than expected, just on the basis of its effect on cholesterol alone. This makes the ASGR1 variation potentially more valuable. “This is a genetic discovery that is pointing to the possibility of manipulating something other than just blood lipids,” he says. “We have no drugs, really, that affect the risk of coronary heart disease that work on alternative mechanisms.” (Ewen Callaway, Nature News)

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Written by sciencepolicyforall

June 10, 2016 at 11:00 am