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Posts Tagged ‘EPA

Science Policy Around the Web – December 8, 2017

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By: Roger Mullins, Ph.D.

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Chemical Safety

Chlorpyrifos Makes California List of Most Dangerous Chemicals

Last Wednesday, the California Office of Environmental Health Hazard Assessment (OEHHA) passed a vote to add the organophosphorus pesticide Chlorpyrifos to Proposition 65, an extensive list of over 900 chemicals known to cause cancer, birth defects, or reproductive harm. While Chlorpyrifos was previously considered for inclusion on this list in 2008, updated scientific information gave the OEHHA cause for reassessment.

This new data included further information on the neurodevelopmental toxicity of Chlorpyrifos in humans and wildlife. Of particular concern to this board was its harmful effect on fetal brain development. Central to this decision was the extensive review of scientific evidence provided in the 2014 and 2016 EPA Human Health Risk Assessments, as well as new and additional findings not previously reviewed in these assessments.

On a national level, the findings of earlier EPA risk assessments resulted in a national ban on homeowner use as far back as 2000. The recent 2014 and 2016 reports further cemented the evidence for pervasive neurodevelopmental toxicity and also highlighted the danger of dietary exposure from residues in drinking water and crops. An all-out ban on Chlorpyrifos was proposed in 2015, revoking all pesticide tolerances and cancelling its registrations, but this was ruled out by the current Environmental Protection Agency (EPA) in 2017. This pesticide is still under registration review by the EPA, which re-evaluates their decision on a 15-year cycle.

Inclusion on California’s Proposition 65 list does not amount to a ban within the state, though products containing Chlorpyrifos will have to be labeled as such starting in late 2018. This action on the state level stands in contrast to federal decisions, and is a revealing lesson in regard to the complexity of national response to scientific evidence.

(Sammy Caiola, Capital Public Radio)

Gene Drives

US Military Agency Invests $100m in Genetic Extinction Technologies

Gene-drives, an emerging powerful gene-editing technology, have been drawing considerable attention and controversy for their proposed use in disease vector control. This method involves the release of an animal that has been genetically modified into a wild population, with the aim of breeding in genes that have been designed to reduce the species’ ability to spread disease. These introduced genes are preferentially inherited, resulting in their eventual dominance in the population. For example, a gene could be designed and introduced to provide resistance to a particular parasite or reduce fertility. This technique is proposed for use in controlling mosquito-borne diseases such as malaria and the Zika virus, as well as to halt the spread of invasive species.

Controversy over this technique however also hinges on its strengths. The primary concerns are the likelihood of animals with favorable modifications crossing over international borders, downstream effects on dependent species, and the possibility of irreversible harm to the ecosystem if the technique is misapplied. Appropriately, much of this concern comes from fellow scientists. In light of this, scientists and policy-makers alike have been proactive about addressing the safety and ethical issues presented, coming up with a set of specific guidelines to advance quality science for the common good. These entail an effort to promote stewardship, safety, and good governance, demonstrate transparency and accountability, engage thoughtfully with affected communities, stakeholders, and publics, and foster opportunities to strengthen capacity and education. Consensus on these issues is intended to help move this promising field forward in the face of growing public scrutiny.

Recently, a trove of emails from US scientists working on gene drive technology was acquired under the Freedom of Information Act and disseminated to the media. Some of these emails revealed the Bill and Melinda Gates Foundation’s engagement with a public relations company to influence the UN moratorium on the use of this technology. The Foundation has long been a financial supporter of the Target Malaria research consortium that seeks to develop gene drives for the eradication of Malaria. The concern surrounding the release of these emails realizes the common fear of scientists involved in research with the potential to fall under the public eye, as ironically, even attempts to recruit expertise in portraying your research favorably may be seen as damning.

This will inevitably be true of any powerful emerging technique to come in the future as well. With the advance of science’s ability to address problems effectively, there will be obstacles towards implementing new technologies and addressing concerns from the communities they may affect. Some of these will be valid and cause for moratorium and introspection, and some will be more attributable to sensationalism. Understanding and navigating these differences will be an increasing and ever-present concern for policy-minded scientists.

(Arthur Neslen, The Guardian)

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December 8, 2017 at 1:35 pm

Science Policy Around the Web – September 26, 2017

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By: Rachel F Smallwood, PhD

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Public health

Air Pollution Tied to Kidney Disease

A new study has reported a link between kidney disease and air pollution. Using data collected from over 2.4 million veterans, researchers were able to examine this relationship by consulting NASA and EPA pollution data. They found that glomerular filtration rate, a measure of kidney function that quantifies how much blood is passing through the kidneys to be filtered, decreased as levels of fine particulate matter less than 2.5 microns in diameter (PM 2.5) increased. These particles are small enough to enter the bloodstream where they then enter the kidneys. The authors estimate that 44,793 cases of chronic kidney disease and 2,438 cases of end-stage renal disease can be attributed to PM 2.5 levels that exceed EPA standards.

Kidney disease is just the latest disease that can be partially attributed to air pollution. Pulmonary conditions, cardiovascular disease, and stroke have been established as being contributed to and exacerbated by air pollution. Earlier this year, it was reported that air pollution also increased the risk of Alzheimer’s and dementia. With so many researchers reporting on such a wide variety of adverse health effects due to air pollution, it is becoming more imperative to address these issues and not lose ground in the struggle for cleaner air. Citizens and policymakers need to be educated about the importance and vigilant about the risks of air pollution. They need to work together to find ways to reduce pollution levels, not just for the planet for future generations, but for the health of today’s.

(Nicholas Backalar, The New York Times)

Biomedical Research

Scientists grow bullish on pig-to-human transplants

Speaking of kidney disease, the list of people in the United States waiting to receive a kidney transplant has almost 100,000 entries. One solution that scientists and physicians have long considered is xenotransplantation – harvesting donor kidneys and other organs from animals like pigs, which naturally have human-like anatomies. Until now, there have never been any demonstrations that have come close to being acceptable for trials in humans. However, that may be changing. A few research groups are reporting that they are close to moving into human trials and have begun early talks with the FDA.

They have been testing their methods by implanting pig kidneys and hearts into monkeys. The monkeys typically have an extreme immune response, which is what the groups have been attempting to ameliorate. Researchers have not been able to completely eliminate the immune response, but recently they reported that a transplanted kidney lasted over 400 days in a macaque before rejection. A transplanted heart lasted 90 days in a baboon before experimental protocol required that they stop the experiment. A previous experiment demonstrated the ability to keep a pig heart viable when implanted into an immune-suppressed baboon’s stomach for over two years, though it was just to test the biocompatibility and the baboon still had its autogenous heart.

This success is partially attributable to CRISPR technology, which has allowed scientists to remove portions of the pig DNA that intensify the immune response. The International Society for Heart and Lung Transplantation laid out bare minimum of requirements for moving xenotransplantation into human trials. They require at least 60% survival of life-supporting organs for at least 3 months with at least 10 animals surviving. Scientists also need to provide evidence that survival could be extended out to 6 months. These experimental results and minimum requirements are informative for expectations of xenotransplantation: it is not a permanent solution (at least not any time soon). However, they may provide temporary solutions that give patients more time while they are waiting on transplants from human donors. This is good news; over 7000 people died on an organ transplant waiting list in 2016. For those just trying to get through with dialysis or who just need a few more months before receiving their heart, these xenotransplants could mean the difference between life and death.

(Kelly Servick, Science)

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September 26, 2017 at 4:58 pm

Science Policy Around the Web – August 1, 2017

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By: Sarah L. Hawes, PhD

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Climate Science

Conducting Science by Debate?

Earlier this year an editorial by past Department of Energy Under Secretary, Steven Koonin, suggested a “red team-blue team” debate between climate skeptics and climate scientists. Koonin argued that a sort of tribalism segregates climate scientists while a broken peer-review process favors the mainstream tribe. Science history and climate science experts published a response in the Washington Post reminding readers that “All scientists are inveterate tire kickers and testers of conventional wisdom;” and while “the highest kudos go to those who overturn accepted understanding, and replace it with something that better fits available data,” the overwhelming consensus among climate scientists is that human activities are a major contributor to planetary warming.

Currently, both Environmental Protection Agency Administrator, Scott Pruitt, and Department of Energy Secretary, Rick Perry, cite Koonin’s editorial while pushing for debates on climate change. Perry said “What the American people deserve, I think, is a true, legitimate, peer-reviewed, objective, transparent discussion about CO2.” That sounds good doesn’t it? However, we already have this: It’s called climate science.

Climate scientists have been forthright with politicians for years. Scientific consensus on the hazards of carbon emissions lead to the EPA’s endangerment findings in 2009, and was upheld by EPA review again in 2015. A letter to Congress in 2016 expressed the consensus of over 30 major scientific societies that climate change poses real threats, and human activities are the primary driver, “based on multiple independent lines of evidence and the vast body of peer-reviewed science.”

Kelly Levin of the World Resources Institute criticizes the red team-blue team approach for “giving too much weight to a skeptical minority” since 97% of actively publishing climate scientists agree human activities are contributing significantly to recent climactic warming. “Re-inventing the wheel” by continuing the debate needlessly delays crucial remediation. Scientific conclusions and their applications are often politicized, but that does not mean the political processes of holding debates, representing various constituencies, and voting are appropriate methods for arriving at scientific conclusions.

(Julia Marsh, Ecological Society of America Policy News)

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Data Sharing, Open Access

Open Access Science – getting FAIR, FASTR

Advances in science, technology and medicine are often published in scientific journals with costly subscription rates, despite originating from publicly funded research. Yet public funding justifies public access. Shared data catalyzes scientific progress. Director of the Harvard Office for Scholarly Communication and of the Harvard Open Access Project, Peter Suber, has been promoting open access since at least 2001. Currently, countries like The Netherlands and Finland are hotly pursuing open access science, and the U.S. is gearing up to do the same.

On July 26th, bipartisan congressional representatives introduced The Fair Access to Science and Technology Research Act (FASTR), intended to enhance utility and transparency of publicly funded research by making it open-access. Within the FASTR Act, Congress finds that “Federal Government funds basic and applied research with the expectation that new ideas and discoveries that result from the research, if shared and effectively disseminated, will advance science and improve the lives and welfare of people of the United States and around the world,” and that “the United States has a substantial interest in maximizing the impact and utility of the research it funds by enabling a wide range of reuses of the peer-reviewed literature…”; the FASTR Act mandates that findings are publicly released within 6 months. A similar memorandum was released under the Obama administration in 2013.

On July 20th, a new committee with the National Academies finished their first meeting in Washington D.C. by initiating an 18-month study on how best to move toward a default culture of “open science.” The committee is chaired by Alexa McCray of the Center for Biomedical Informatics at Harvard Medical School, and most members are research professors. They define open science as free public access to published research articles, raw data, computer code, algorithms, etc. generated through publicly-funded research, “so that the products of this research are findable, accessible, interoperable, and reusable (FAIR), with limited exceptions for privacy, proprietary business claims, and national security.” Committee goals include identifying existing barriers to open science such as discipline-specific cultural norms, professional incentive systems, and infrastructure for data management. The committee will then come up with recommended solutions to facilitate open science.

Getting diverse actors – for instance funders, publishers, scientific societies and research institutions – to adjust current practices to achieve a common goal will certainly require new federal science policy. Because the National Academies committee is composed of active scientists, their final report should serve as an insightful template for federal science agencies to use in drafting new policy in this area. (Alexis Wolfe & Lisa McDonald, American Institute of Physics Science Policy News)

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August 1, 2017 at 7:38 pm

Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

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Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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June 10, 2017 at 11:33 am

Science Policy Around the Web – May 31, 2016

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By: Emily Petrus, Ph.D.

Biomedical Research Salaries

Higher Salary for Postdocs Coming Soon

What do a Metrobus driver and a recent biomedical PhD graduate in have in common? Their salary! Although both positions are important to keeping society moving forward, figuratively or literally speaking, one can imagine the disparity between the educational time commitment between these two positions.

New rules set forth by the US Department of Labor dictate that employees with annual salaries falling below $47,476 must be paid overtime for hours they work beyond 40 hours per week.  Research scientists who have recently (typically within 5 years) received a PhD in biomedical sciences will undergo additional training before the next step in their career, similar to residency among medical school graduates.  These highly skilled postdoctoral researchers are called postdocs, and they fall below this threshold, with an average starting salary of $45,000.

This gives research organizations such as academic universities and the National Institutes of Health two options: track the hours their postdocs log at the bench and pay them overtime, or raise the base salary above the threshold.  Because scientific research rarely falls neatly into a 9-5 time table, NIH director Francis Collins is leading the NIH to increase postdoc pay to avoid logging hours for overtime pay.  Most academic research labs follow NIH guidelines for postdoc salary, so the NIH’s commitment to increase their pay should spill over into most other areas of biomedical research.  In a recent article penned by Collins and Thomas Perez, the U.S. Secretary of Labor, they called on the nation to “embrace the fact that increasing the salary threshold for postdocs represents an opportunity to encourage more of our brightest young minds to consider choosing careers in science.”

Although these salary increases will increase the pressure on labs already struggling with tight funding, it may serve as an incentive for future generations to choose biomedical research careers over driving a Metrobus. (Beryl Lieff Benderly, Science Articles)

Chemical Safety

United States poised to approve major chemical safety overhaul

Did you know that companies can use new chemicals in their products without demonstrating their safety for consumers or the environment? How about that the Environmental Protection Agency (EPA) cannot ask them to remove it until they demonstrate toxicity, which requires a costly amount of research and legislative action? If this sounds backwards to you, take heart: the House of Representatives has approved a long overdue overhaul of the Toxic Substances Control Act (TSCA).  This measure is expected to be approved by the Senate and President Obama with the next few months.

The TSCA was originally passed in 1976, and contains wording difficult for environmentalists, consumers, and even industry to follow. The original act required the EPA to consider regulatory costs during safety review, effectively reducing the importance of science-based research into chemical safety for consumers and the environment while favoring regulatory cost saving measures. It also made toxicity testing difficult by the EPA by requiring the minimal (“least burdensome”) amount of testing instead of full-fledged studies. The new TSCA will enable the EPA to order companies to prove chemicals are safe for consumers and/or the environment before introducing them to the marketplace, to hopefully avoid another issue such as the widespread use of asbestos in construction until the 1970’s.

Other components of the revised TSCA include an emphasis on reducing numbers of animals used in toxicity studies by replacing them with other testing methods when possible. The act also aims to identify and increase studies on “cancer clusters,” areas of the country which have higher incidences of cancer which may be due to environmental effects.

The revision of the TSCA is arguably the biggest environmental legislative success since the Clean Air Act amendment of the 1990’s. By containing clearer language, it makes the act “a careful compromise that’s good for consumers, good for jobs, and good for the environment” – said John Shimkus (R-IL). (Puneet Kollipara, ScienceInsider)

Mental Health

Children in Poverty at Risk for Increased Incidence of Mental Health Issues

Is it the chicken or the egg?  When it comes to mental health and poverty, it can be difficult to determine causation versus correlation: are mentally unstable people unable to provide for themselves, or is the stress of poverty causing mental health issues?  A recent study in children has determined a third genetic component to the puzzle, related to how the structure of DNA differs between poor and healthy children.

Although it has long been known that children from families below the poverty line have increased incidences of mental and physical ailments such as depression and diabetes, many have pointed to environmental factors such as relatives smoking or poor nutrition as the main culprits. New evidence suggests exposure to stress in utero and during childhood changes the very DNA of these children. Serotonin is a neurotransmitter important for maintaining “happy” brain chemistry and is often targeted for treating depression. New researchers found that the DNA for a serotonin transporter protein is altered in poor children, which may decrease the amount of serotonin allowed to get into brain cells. This was also correlated with higher levels of stress, indicating that growing up in poverty can change fundamental biological components and create lifetime mental health issues for these children.

Growing up in poverty is stressful for children; however there are ways to attenuate their suffering.  High quality, affordable, preschool and childcare is one way the government can step up to the plate.  “Headstart” is a program which enables children of families below the federal poverty line to enjoy a stimulating, warm environment and may reduce the burden of their families to choose between working and providing for their families or staying home to avoid daycare expenses. There are a multitude of issues creating stressful environments for poor families, but providing high quality child care and healthy meals for kids for part of the day is a small investment towards a big, epigenetic payoff in generations to come. (Sara Reardon, Nature News)

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May 31, 2016 at 12:00 pm

Science Policy Around the Web – February 12, 2016

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By: Rebecca A. Meseroll, Ph.D.

Zika research funding

Obama requests $1.8 billion in emergency funds to fight Zika

President Obama issued a statement of intent to request $1.8 billion from Congress to develop resources to combat the spread of Zika virus both internationally and domestically.  Zika, which is transmitted by the Aedes aegypti mosquito, has spread rapidly around Central and South America, the Caribbean, and the Pacific Islands in the past year, and is an emerging public health threat, especially due to its possible link with congenital microcephaly, a severe birth defect, in children born to women infected with the virus during their pregnancy.  The funds requested by the president would be used for a variety of purposes in an aggressive effort to contain the spread of the virus, including mosquito control, research on the virus and a potential vaccine against it, public education campaigns, and support personnel and equipment for areas where the outbreak is ongoing.  Congress will have to decide whether to grant the funds, which would be part of the 2017 budget, later this year.  While there is much to be done to minimize the impact of Zika, health officials indicate there is no cause for alarm about large-scale spread of the virus in the United States at present, but women who are pregnant or considering becoming pregnant are advised to use caution when planning travel to countries affected by Zika. (Jon Cohen, ScienceInsider and Mark Landler, The New York Times)

Climate change policy

Supreme Court stays climate change regulations

The Clean Power Plan, developed by the U.S. Environmental Protection Agency (EPA) at President Obama’s behest last year, sought to reduce carbon dioxide emissions from power plants by 32% compared to 2005 levels.  The EPA’s rules would require states to create their own plans, due to the agency by September of this year, detailing how they would reduce emissions beginning in 2022.  This week, however, the US Supreme Court granted a request put forth by many states and power companies to put the regulations on hold on the grounds that they are outside of the purview of the EPA.  Thus the regulations are set up to endure a lengthy legal battle, as the case will not come up in appeals court until June, after which it will likely be appealed to the Supreme Court, who would not hear the case until 2017.  Although the Supreme Court did not give its reasons for granting the stay, experts suggest that the Court may be telegraphing its wariness about the legality of the regulations by making this decision before the case has gone through a lower court.  The Obama administration remains confident and environmentalists hopeful that the regulations will hold up in court, however it may be necessary in the future for Congress to pass climate change legislation before progress can actually be made. (Jeff Tollefson, Nature and Robert Barnes and Steven Mufson, The Washington Post)

HIV and organ transplantation

First HIV-positive organ transplants to occur in the United States

Years of advocacy led to the passage of the HIV Organ Policy Equity Act in 2013, which lifted a ban on research into organ donations between HIV-positive individuals, and now the life-saving promise of the law is about to come to fruition. Doctors at Johns Hopkins received permission from the United Network for Organ Sharing to perform the first kidney and liver transplants between HIV-positive donors and recipients in the US, and they are prepared to conduct the procedures as soon as the first patients are ready. Johns Hopkins will be the first in the world to perform liver transplants between an HIV-positive donors and HIV-positive recipients, however doctors in South Africa have had success with kidney transplants of this kind since 2008.  It has been estimated that organs from more than 500 potential HIV-positive deceased donors have gone unused each year because of previous prohibitions, thus this new source of HIV-positive donor organs for HIV-positive recipients is expected to improve wait-times for all patients hoping for an organ to become available.  The current HIV-positive transplants will utilize only organs from deceased donors, as more research must be done to determine the outcomes of kidney donation for HIV-positive patients. (Daniel Victor, The New York Times and Ariana Eunjung Cha, The Washington Post)

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February 12, 2016 at 9:00 am

Science Policy Around the Web – December 11, 2015

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By: Kimberly Leblanc, Ph.D.

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Climate Change Policy

In symbolic move, Congress votes to gut Obama climate plans

Early last week, the U.S. House of Representatives approved two measures that would block the Environmental Protection Agency’s (EPA’s) first-ever limits on carbon dioxide emissions from new and existing power plants. Just two weeks prior, the senate approved the same two measures, S.J. Res. 23 and S.J. Res. 24. In addition, a number of states, industry groups, and companies have taken the fight to the courts, asking judges to overturn EPA’s rules for new power plants. The legislative and judicial push is in response to Obama’s Clean Power Plan. The plan includes two EPA regulations that will limit greenhouse gas emissions from the power sector. One regulation sets carbon dioxide emissions limits for new and future power plants. The other, effective since August, sets similar limits on existing power plants, but offers options that states can choose between to achieve the emission limits. These options are ranging from energy-efficiency measures to renewable energy to emissions trading. The power plan seeks to cut CO2 emissions from the power sector by 30% from 2005 levels by 2025. Obama plans to veto the bills, so the votes are largely a symbolic gesture, a way to send a message to the global leaders meeting in Paris at the United Nations Conference on Climate Change that U.S. lawmakers may not carry out any deal. (Puneet Kollipara, ScienceInsider).

Ethical Biomedical Research

The truth about fetal tissue research

On December 3, the Republican-led US Senate voted to strip Planned Parenthood of government funding. On November 27th, a gunman killed three people at a Planned Parenthood clinic in Colorado Springs, Colorado. According to one law enforcement official, the shooter said “no more baby parts” after his arrest. These events are a reaction to covertly filmed Planned Parenthood videos, in which senior physicians bluntly discussed their harvesting of fetal organs from abortions for use in research. In 2014, the National Institutes of Health (NIH) funded 164 projects – 0.27% of the NIH’s budget – that used human fetal tissue for research. While the use of fetal tissue may be discomforting, the tissue, which is obtained legally with informed consent and without profit and which would have otherwise been discarded, has already led to major medical advances.

Vaccines for hepatitis A, German measles, chickenpox and rabies were developed using cell lines grown from tissue from two elective abortions that were performed in the 1960s. German measles “caused 5,000 spontaneous abortions a year prior to the vaccine,” said Dr. Paul Offit, an infectious-disease specialist at Children’s Hospital of Philadelphia. “We wouldn’t have saved all those lives had it not been for those cells. Fetal tissue was “absolutely critical” to the development of a potential Ebola vaccine that has shown promise, said Dr. Carrie Wolinetz, the NIH’s associate director for science policy. Fetal tissue has also been critical to the development of mouse models with humanized immune systems that have led to significant advances in HIV research, drug discovery, and vaccine development. Fetal tissue is being used to make significant advancements in research into cancer, autism, schizophrenia, juvenile diabetes, Huntington’s disease, eye development and disease, Hepatitis C, and more. Scientists point out that if there were better alternatives, they would turn to them. But those techniques are still being refined, and some fields are likely to remain reliant on fetal tissue, such as the study of fetal development.

The question for many scientists is what the fallout of the controversy will be. Since July, four bills that would criminalize or otherwise restrict the research (H.R. 3171, H.R. 3729, H.R. 3215, H.R. 3429) have been introduced in the US Congress, and lawmakers have launched similar efforts in a dozen state legislatures. (Missouri, Arizona and North Dakota already ban the research.) Overall, scientists think hard on the ethics of their work. “We are not happy about how the material became available, but we would not be willing to see it wasted and just thrown away” says Larry Goldstein, a neurobiologist at the University of California San Diego School of Medicine. (Meredith Wadman, Nature magazine and Scientific American, see also Scientists say fetal tissue remains essential for vaccines and developing treatments, by Collin Binkley and Carla K. Johnson, Associate Press, PBS News )

Research Funding and Bias

Research group funded by Coca-Cola to disband

The Global Energy Balance Network, a group of researchers spanning several U.S. universities whose research focused on metabolic energy balance, announced last week that it was shutting down. The group was financially backed and created by Coca-Cola, and public health authorities had been voicing concerns for months that the group’s mission was to play down the link between soft drinks and obesity. In a statement issued in August, the group’s president, Dr. James O. Hill, acknowledged that Coca-Cola had provided the money to start the Global Energy Balance Network, but insisted that Coca-Cola had “no say in how these funds are spent” and that it “does not have any input into our organization.” But a series of emails obtained by The Associated Press and reported last week suggested that Dr. Hill had allowed Coke to help pick the group’s leaders, create its mission statement and design its website. The group’s vice president, Steven Blair, said in a recent video announcing the new organization “Most of the focus in the popular media and in the scientific press is, ‘Oh they’re eating too much, eating too much, eating too much’ — blaming fast food, blaming sugary drinks and so on, and there’s really virtually no compelling evidence that that, in fact, is the cause.”

There is, in fact, compelling evidence that exercise has only minimal impact on weight compared with what people consume, although exercise has other significant health benefits. Furthermore, a recent analysis of beverage studies, published in the journal PLOS Medicine, found that those funded by Coca-Cola, PepsiCo, the American Beverage Association and the sugar industry were five times more likely to find no link between sugary drinks and weight gain than studies whose authors reported no financial conflicts. Last month, amidst the controversy, the University of Colorado School of Medicine said it would return a $1 million grant that Coca-Cola had provided to help start the organization. The University of South Carolina had also accepted $500,000 from Coke to help start the group, but a spokesman for the university did not return phone calls or messages asking what the university planned to do with the money it had taken. (Anahad O’Connnor, New York Times)

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December 11, 2015 at 9:00 am