Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘Animal Research

Science Policy Around the Web – October 19, 2018

leave a comment »

By: Ben Wolfson, Ph.D.


Source: Pixabay

Climate Change


Climate Change prompts a rethink of Everglades management

The Florida Everglades is a large area of tropical wetlands that has received significant attention due to the degradation of its unique ecosystem by urban development. The Everglades were designated a World Heritage Sitein 1979 and Wetland Area of Global Importancein 1987, and in 2000 Congress approved the Comprehensive Everglades Restorative Plan (CERP) to combat further decline and provide a framework for Everglades restoration.

For the past 18 years, these efforts have been directed towards curtailing damage from urbanization and pollution. However, as outlined in a congressionally mandated report released on October 16th by the National Academies of Science, Engineering, and Medicine, new strategies may be necessary. In the biennial progress report, an expert panel called for CERP managers to reassess their plans in light of new climate change models. The report focuses on the 7 centimeters of sea level rise seen since 2000, and points out that Southern Florida is especially at risk from climate change and is expected to experience a 0.8-meter rise in sea level by the year 2100.

It is clear that as more is learned about the realities of climate change, the goals and methods of conservation projects are shifting, and past strategies must be adapted to fit the realities of a warming world.

(Richard Blaustein, Science)

Animal Research

NIH announces plan for chimp retirement


In 2015, the NIH announced that it would no longer support biomedical research on chimpanzees, two years after pledging to significantly reduce the numbers of chimpanzees used in research. These decisions were made based on a combination of reduced demand for chimpanzees in research and the designation of captured chimpanzees as an endangered species in 2015.

On Thursday October 18th, the NIH announced the next step in the process of retiring research chimps. While research was stopped in 2015, many of the chimpanzees had nowhere to go and remained housed at laboratories. One federal chimpanzee sanctuary, Chimp Haven, exists in Keithville, Louisiana, however lack of space and the difficulty of relocating some animals has slowed their transition to better habitats.

In the Thursday announcement NIH director Francis Collins outlined the guidelines for future chimpanzee relocation. These include streamlining medical records and determining whether chimpanzees are physical healthy enough to be relocated. Many of the chimpanzees are at an advanced age, meaning they have developed chronic illnesses similar to those experienced by humans. However, Collin’s emphasized that there must be a more acute medical problem for relocation not to take place. In addition both the research facility and Chimp Haven must agree that the former research chimpanzees are capable of being relocated, and disagreements will be mediated by a panel of outside veterinarians.

Collins additionally stressed that while transfer to Chimp Haven is the ideal outcome for all retired chimps, those housed at NIH-supported facilities do not live isolated in cages or in laboratories and are housed in social groups with appropriate species-specific accommodations.

The development of these clear guidelines will expediate chimpanzee relocation while emphasizing chimpanzee health and comfort.

(Ike Swetlitz, Statnews)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

October 19, 2018 at 3:25 pm

Science Policy Around the Web – January 30, 2018

leave a comment »

By: Kelly Tomins, BSc


By RedCoat (Own work) [CC-BY-SA-2.5], via Wikimedia Commons


Yes, They’ve Cloned Monkeys in China. That Doesn’t Mean You’re Next.

Primates were cloned for the first time with the births of two monkeys, Zhong Zhong and Hua Hua, at the Chinese Academy of Sciences in Shanghai. Despite being born from two separate mothers weeks apart, the two monkeys share the exact same DNA. They were cloned from cells of a single fetus, using a method called Somatic Cell Nuclear Transfer (SCNT), the same method used to clone over 20 other animal species, beginning with the now infamous sheep, Dolly.

The recently published study has excited scientists around the world, demonstrating the potential expanded use of primates in biomedical research. The impact of cloned monkeys could be tremendous, providing scientists a model more like humans to understand genetic disorders. Gene editing of the monkey embryos was also possible, indicating scientists could alter genes suspected to cause certain genetic disorders. These monkeys could then be used a model to understand the disease pathology and test innovative treatments, eliminating the differences that can arise from even the smallest natural genetic variation that exists between the individuals of the same species.

Despite the excitement over the first cloning of a primate, there is much work to be done before this technique could broadly impact research. The efficiency of the procedure was limited, with only 2 live births resulting from 149 early embryos created by the lab. In addition, the lab could only produce clones from fetal cells. Now it is still not possible to clone a primate after birth. In addition, the future of primate research is uncertain in the United States. Research regarding the sociality, intelligence, and DNA similarity of primates to humans has raised ethical concerns regarding their use in research. The US has banned the use of chimpanzees in research, and the NIH is currently in the process of retiring all of its’ chimps to sanctuaries. In addition, there are concerns regarding the proper treatment of many primates in research studies. The FDA recently ended a nicotine study and had to create a new council to oversee animal research after four squirrel monkeys died under suspicious circumstances. With further optimization, it will be fascinating to see if this primate cloning method will expand the otherwise waning use of primate research in the United States.

The successful cloning of a primate has additionally increased ethical concerns over the possibility of cloning humans. In addition to the many safety concerns, several bioethicists agree that human cloning would demean a human’s identity and should not be attempted. Either way, Dr. Shoukrat Mitalipov, director of the Center for Embryonic Cell and Gene Therapy at the Oregon Health & Science University stated that the methods used in this paper would likely not work on humans anyways.

(Gina Kolata, New York Times)

Air Pollution

EPA ends clean air policy opposed by fossil fuel interests

The EPA is ending the “once-in always-in” policy, which regulated how emissions standards differ between various sources of hazardous pollutants. This policy regards section 112 of the Clean Air Act, which regards regulation of sources of air pollutants such as benzene, hexane, and DDE. “Major sources” of pollutants are defined as those that have the potential to emit 10 tons per year of one pollutant or 25 tons of a combination of air pollutants. “Area Sources” are stationary sources of air pollutants that are not major sources. Under the policy, once a source is classified as a major source, it is permanently subject to stricter pollutant control standards, even if emitted pollutants fall below the threshold. This policy was intended to ensure that reductions in emissions continue over time.

The change in policy means that major sources of pollution that dip below the emissions threshold will be reclassified as an area source, and thus be held to lower air safety standards. Fossil fuel companies have petitioned for this change for years, and the recent policy change is being lauded by Republicans and states with high gas and coal production. The EPA news release states that the outdated policy disincentives companies from voluntarily reducing emissions, since they will be held accountable to major source standards regardless of the amount of emissions. Bill Wehrum, a former lawyer representing fossil fuel companies and current Assistant Administrator of EPA’s Office of Air and Radiation, stated reversing this policy “will reduce regulatory burden for industries and the states”. In contrast, environmentalists believe this change will drastically increase the amount of pollution plants will expel due to the softening of standards once they reach a certain threshold. As long as sources remain just below the major source threshold, there will be no incentive or regulations for them to lower pollutant emissions.

(Michael Biesecker, Associated Press)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

January 30, 2018 at 3:30 pm

Science Policy Around the Web – June 10, 2017

leave a comment »

By: Allison Dennis, BS

Source: pixabay

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)


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)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

June 10, 2017 at 11:33 am

Science Policy Around the Web – February 24, 2017

leave a comment »

By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

An article published in Science discusses a lawsuit filed on February 13 against the U.S. Department of Agriculture (USDA) by an animal law expert at Harvard University. According to the plaintiffs, USDA violated the federal Freedom of Information Act (FOIA) when it removed thousands of animal welfare inspection reports and other records from a publicly accessible website. USDA generated records that document animal facility inspections, enforcement actions, animal censuses, and other information collected by the agency in the course of enforcing the federal Animal Welfare Act.  The law covers animals in more than 7800 facilities, including zoos, roadside circuses, and research laboratories at government agencies and academic medical centers.

The decision to remove the public access to these records may have been a response to a lawsuit involving another law, the Horse Protection Act. The plaintiffs in a 2016 Texas lawsuit accused USDA of violating their rights under the Privacy Act by posting inspection documents required by the Horse Protection Act. A resulting USDA review of all its public postings led the agency to scrub from its website documents generated under both the Horse Protection Act and the Animal Welfare Act.  In the future, the agency announced, people who want access to those records will need to file a FOIA request. The agency’s most recent FOIA report states that it takes an average of 94 days for the agency to respond to a simple FOIA request and 234 days on average for more complicated requests.

In February 13’s lawsuit, the plaintiffs invoke a section of FOIA that requires agencies to make publicly available electronically all records that it has released under FOIA which “because of the nature of the subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” (Meredith Wadman, ScienceInsider)

Science and Immigration

Grad Students, Postdocs with U.S. Visas Face Uncertainty

While U.S. courts are busy handling President Donald Trump’s travel ban on immigration from seven majority-Muslim countries, the temporary shut down of the executive order, the appeal to reinstate the travel ban, the rejection of the immediate restoration of the ban, and more appeals and rulings, graduates and postdoctoral students already in the United States are weighing their options and trying to plan rationally in an unpredictable and fluid situation.

Many scientists in the U.S. are on student or other working visas. All these visas may not be renewable, depending on future executive orders and regulations. The dilemma “simply ruins their future. It’s a catastrophe,” says a Yemeni biologist who is on a university faculty on an H-1B, a 3-year visa for professionals. For years, lawmakers in Washington have tried to reform abuses of visa regulations by companies using visas to bring workers to the U.S. to learn the ropes, and then send the trained workers to other countries where the job can be done cheaply. The H-1B system is contentious: on one side labor advocates want the exploitation of the H-1B system to stop supporting an outsourcing business model. On the other hand, tech companies like Google and Facebook say they can’t get enough visas for top foreign talent, as the cap on the number of H-1Bs issued every year means that sometimes foreign graduates from top U.S. universities, places like the Massachusetts Institute of Technology and the University of California, Berkeley, can’t get one. The travel ban already has harmed the top universities in the U.S., stranding students, faculty and scholars abroad, and making foreign schools more attractive to some of the world’s brightest students.

In papers filed in Brooklyn federal court, the schools (that include Columbia, Duke, Harvard, Johns Hopkins, Princeton, Stanford, Yale, Massachusetts Institute of Technology and several more) said that the order blocking travel from seven predominantly Muslim countries threatens their abilities to educate future leaders from every continent. They said the executive order has “serious and chilling implications” and that the ban “casts doubt on the prospect and value of studying and working here for everyone,” the papers said. (Meredith Wadman, Richard Stone, Science)

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

“Scientists should be permitted to modify human embryos destined for implantation in the womb to eliminate devastating genetic diseases such as sickle-cell anaemia or cystic fibrosis — once gene-editing techniques advance sufficiently for use in people and proper restrictions are in place. That’s the conclusion of a 14 February report from the US National Academies of Science, Engineering, and Medicine.”

The report follows a 2015 National Academies summit between scientists, ethicists, legal experts and patient groups from around the world. At the time of the meeting, given the outstanding scientific, ethical and legal questions surrounding the issue, the organizers concluded that scientists shouldn’t yet perform germline editing on embryos intended for establishing a pregnancy. However, the organizers also stated that altering human embryos for basic research was acceptable.

The latest iteration of this ongoing CRISPR debate moves the bar a little further. The report recommends restricting the technique to severe medical conditions for which no other treatment exists. Eric Lander, president of the Broad Institute of MIT and Harvard, said, “It’s a very careful, conservative position that’s just a little bit beyond an absolute bar.” In the report, the committee also called for international cooperation, strict regulatory and oversight framework, public input into decisions and long-term follow-ups of children who have edited genomes. The report adds that for now, genome editing should not be used for human enhancement, such as improving a person’s intelligence or giving them super-strength.

The report drew immediate criticism from a California-based non-profit organization called the Center for Genetics and Society. “This report is a dramatic departure from the widespread global agreement that human germline modification should remain off limits,” said Marcy Darnovsky, executive director of the center. “It acknowledges many of the widely recognized risks, including stigmatizing people with disabilities, exacerbating existing inequalities, and introducing new eugenic abuses. Strangely, there’s no apparent connection between those dire risks and the recommendation to move ahead.” (Sara Reardon, Nature)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

February 24, 2017 at 11:23 am

The importance of primate research and the responsibility it requires

leave a comment »

By: Brian Russ, Ph.D.

A bill is currently circulating in the Australian Senate to ban the importation of primates into the country for the purpose of research. If enacted into law, it would effectively limit all non-human primate research within the country to that which is currently occurring. At this time, there are three breeding facilities for primates within Australia. The majority of these colonies contain macaque monkeys, the primary primate used in biomedical research. If this bill were to pass, those colonies would not be able to bring in new animals, which in turn would restrict medical advances, as the colonies are the primary suppliers for the all biomedical research on primates in the country. Interestingly, this bill targets a very small number of cases – the Senator who proposed the bill states that between 2000 and 2015 fewer than 800 primates were imported into the country. More likely, the goal of this bill is to push Australia towards the complete cessation of biomedical research on primates. The bill is supported by the Australian organization Humane Research, which advocates for the ban of most animal research within Australia, particularly primate research.

Scientists and advocacy groups in Australia are concerned that this bill will negatively impact biomedical research within the country. Dr. James Bourne, a biomedical researcher and member of the research committee in the Australian government’s National Health & Medical Research Council, recently testified in a Senate committee hearing to express the importance of animal research in Australia and how the ban would detrimentally impact Australia’s biomedical research as a whole. He pointed to the recent outbreak of the Zika virus, to demonstrate how primate research will be critical in developing a vaccine for it and any similar future viral outbreaks. A number of international advocacy groups have also spoken out against this bill declaring that its passing would be a stranglehold on biomedical research within the country. The advocacy group Speaking of Research, which is based in the United States but operates internationally, recently published an open letter to the Australian Senate from a number of biomedical researchers in Australia detailing how primate research has been critical to helping the people of Australia, and how this ban would drastically reduce their effectiveness in the future. The letter explains how biomedical research on primates directly led to the eradication of Polio in Australia (and throughout most of the world), helped to alleviate the symptoms of Parkinson’s disease through the creation of Deep Brain Stimulation, and was critical in the creation of most vaccines used today. While all of these are of great benefit to the word, they only begin to scratch the surface of how biomedical research on animal models benefits the world’s health.

In addition to the discussing the benefits that animal research has provided the world, the letter also points out that animal importation and research is already strictly regulated, for the better. Throughout the world, ethics committees must approve research before it is allowed to begin on any animals, and if a suitable non-animal alternative exists that should be used instead. In the United States, all animal research must be approved by an Institutional Animal Care and Use Committee (IACUC), which is run at local institutions and organized by the independent group the American Association for Laboratory Animal Sciences (AALAS).  Additionally, institutes are also overseen and accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. Institutions that work with AALAS and AAALAC allow these organizations to ensure institutional compliance with law and regulations dealing with the care and treatment of animals at the institutions. The majority of animal researchers welcome having such third party oversight to ensure that the public sees that biomedical researchers take the treatment of animals very seriously. AALAS and AAALAC investigations revolve around what are termed the “Three Rs”: Reduce, Refine, and Replace. That is, Reduce the number of animals needed in biomedical research through better techniques and practices, Refine the processes to minimize distress and any associated pain, and Replace animal models with alternatives when feasible. Organizations like Speaking of Research, the Foundation for Biomedical Research, the National Association for Biomedical Research, along with many others, push for not only better funding and understanding of animal research, but also for the responsible and humane use of animals in said research. Researchers therefore embrace the Three Rs and actively look for ways to encourage researchers to Reduce, Refine, and Replace.

Advocacy groups that seek to ban animal research often attack animal research by suggesting that researchers are not appropriately aiming to replace animals with other alternatives. For instance, Australia’s Humane Research group has a webpage and videos demonstrating that numerous alternatives to animal research are available. Groups that advocate for the use of animal research, however, disagree that we are at a stage in biomedical research were we could truly stop using animals. Advances in biomedical research are constantly evolving, and there may be a day in the future where the use of animals in research is no longer necessary in expanding our understanding of the world and improving the health of the populous; however, they state that we are not currently there.

One such recent advance that will help to Reduce, Refine, and in some cases, Replace animal research is the development of what is being called the mini-brain. While still in the early stages of development, these bundles of human neurons can mimic the functions and structures of parts of the human brain. These “brains” are grown by inducing stem-cells to grow into a particular class of brain cells through a form of genetic programming. This breakthrough could be of huge benefit to the biomedical community as it may allow for the testing of drugs directly on human neurological tissue. Advocacy groups looking to ban animal research and replace it with non-animal alternatives will likely point to these findings as more evidence that animals are no longer necessary for biomedical research. However, one must remember that the creation of these mini-brains would not have been possible without years of research into how stem cells operate, research that was conducted with animals. Additionally, while this research may be useful for drug development, mini-brains do not have the capacity for actual perception or behavior, meaning that tests on the effects of drugs will still require some animal testing to ensure their efficacy and safety.

As research continues to progress it may someday be possible to eliminate the need for animals in biomedical research. Currently, the state of biomedical research necessitates the use of animals, and banning of such research, or even restricting the importation of primates, could severely hinder the advance of cures and vaccines for many serious illnesses. Nevertheless, it is important that the scientist and the public continue to police animal research to ensure that all animals are treated ethically and every attempt is made to practice the Three Rs.

Written by sciencepolicyforall

March 2, 2016 at 9:00 am

Science Policy Around the Web – November 20, 2015

leave a comment »

By: Eric Cheng, Ph.D.

Photo credit : chimpanzee via photopin

Animal Research

NIH to end all support for chimpanzee research

The National Institutes of Health (NIH) plans to retire the last colony of government-owned chimpanzees being held for biomedical research. In a memo leaked this week, NIH Director Francis Collins wrote to NIH administrators: “there is no further justification for the 50 chimpanzees to continue to be kept available for invasive biomedical research.” This would effectively end the federal agency’s chimpanzee research program.

In an interview with Nature, Collins said that, “this is the natural next step of what has been a very thoughtful five-year process of trying to come to terms with the benefits and risks of trying to perform research with these very special animals. We reached a point where in that five years the need for research has essentially shrunk to zero.”

Collins initially placed a temporary moratorium on new studies using chimpanzees in 2011 after an internal research panel questioned their use in medical research.  This decision led NIH to only use chimpanzees for studies of hepatitis and psychological behaviors. In 2013, NIH retired 310 chimpanzees based on recommendations from the US Institute of Medicine (now the US Academy of Medicine) while still maintaining a colony of 50 animals that could only be used in cases where the research meets a necessary criterion such as public-health emergencies.

The remaining chimpanzees owned by NIH will be relocated to a federally-funded chimpanzee sanctuary called Chimp Haven located in Keithville, Louisiana. Chimp Haven is a facility that contains over 200-acres of forest which offers an environment that stimulates behaviors similar to those in the wild. (Jocelyn Kaiser, ScienceInsider)

Food Policy

FDA Rolls Out New Food Safety Regulation

In order to combat foodborne-related illnesses that sicken millions of Americans each year, the Food and Drug Administration (FDA) has released new regulations for both produced and imported foods. These new regulations will allow the FDA to enforce food safety by making food producers and importers accountable for making certain that their products meet US safety standards.

“This is the first time the food importers have fallen directly under FDA regulation,” agency’s deputy commissioner for food and veterinary medicine Michael R. Taylor said.

The US Centers for Disease Control and Prevention estimates that 1 in 6 Americans (or 48 million) get sick, 128,000 are hospitalized, and 3,000 die from foodborne illnesses each year. These new FDA rules should help produce farmers and food importers take steps to prevent problems before they occur such as the outbreak of Salmonella Poona linked to Mexican cucumbers in October of this year which sickened 767 people with 4 reported deaths.

These new policies will cover requirements for growing, harvesting, and packing. They will even consist of standards for water quality, manure use, and employee health and hygiene. Taylor said he is confident that the new rules will improve food safety, but said success is contingent on full funding of President Barack Obama’s 2016 budget request. (Charissa Echavez, The Science Times)

Science and Society

Space mining bill passes in Congress

Introduced by Rep. Kevin McCarthy [R-CA], the bill entitled “An Act to facilitate a pro-growth environment for the developing commercial space industry by encouraging private sector investment and creating more stable and predictable regulatory conditions, and for other purposes.” This bill will allow companies to legally own and sell the resources they extract from objects from space such as asteroids. The selling of these mined resources by private companies is not explicitly denied by the Outer Space Treaty which declared that “outer space, including the Moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means.“  Since these companies are regulated under US law, the law could potentially be interpreted as saying the mined celestial bodies are indeed US property.

Of course, additional language is in the bill stating that these claims are not declarations of sovereignty.

‘It is the sense of Congress that by the enactment of this Act, the United States does not thereby assert sovereignty or sovereign or exclusive rights or jurisdiction over, or the ownership of, any celestial body.’

However, not all countries will see this viewpoint in the same way. The bill also does not address how these shared resources will be allocated with other countries that may also mine the same celestial body. Although the bill is already spurring international debate, real scrutiny of this bill will not come until the UN Committee on the Peaceful Uses of Outer Space‘s annual meeting in April 2016 in Vienna.

This bill already has been passed by the Senate and will be sent to the Oval Office where President Obama is expected to sign it into law. (Sarah Fecht, Popular Science)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

November 20, 2015 at 9:00 am

Science Policy Around the Web – October 31, 2015

leave a comment »

By: Courtney Pinard, Ph.D.

Photo credit: Novartis AG via photo pin cc


How Prevalent is Scientific Bias?

Scientists and clinicians conducting clinical trials must abide by rigorous standards to safeguard against biases. Biomedical animal research has not been held to the same standards, and advocates of robust science have argued that this lack of scientific rigor is why more than half of pre-clinical studies are irreproducible. A recent study published at the University of Edinburgh in the U.K. shows that animal researchers are not using the same standards to prevent bias in study design. Such standards include 1) using randomized trials to prevent scientists from, for example, assigning unhealthy animals to the control group to boost a drug’s effect on the treatment group; 2) ensuring that researchers are blinded when accessing outcomes of an experiment; 3) calculating the correct sample size before starting an experiment; and 4) disclosing any conflicts of interest. The authors of the study examined 2500 papers published between 1992 and 2011 on drug efficacy, and the results were dismal. Only 30% of papers analyzed outcome in a blinded manner, 25% stated randomizing animals to groups, 12% included a conflict of interest statement, and less than 1% of papers reported calculating the needed sample size in advance. When the authors looked at whether institute quality or journal impact factor predicted bias, they found no correlation. The U.K. study is one out of many studies on the topic of scientific rigor that have resulted in growing concern from scientists and the public about irreproducible results in pre-clinical biomedical research.

According to an NIH commentary published last year, the reasons for why scientific bias in animal research is so prevalent are complex and have to do with the attitudes of funding agencies, academic centers, and scientific publishers. Authors of the commentary, Francis Collins and Lawrence Tabak, discuss these attitudes: “Funding agencies often uncritically encourage the overvaluation of research published in high-profile journals. Some academic [centers] also provide incentives for publications in such journals, including promotion and tenure, and in extreme circumstances, cash rewards.”

Given the continuing budget restraints, and Congress’ awareness about the reproducibility problem, national funding agencies have started to act. The NIH, for example, organized a workshop with over 30 basic/preclinical science journal editors to put together principles and guidelines to enhance research rigor and reproducibility. One such principle is “Transparency in Reporting”, and includes the bias safeguarding standards described above. Strengthening pre-clinical biomedical research will only occur when scientists and policy makers at funding agencies, academic institutions, and journals work together to put these principles into practice, and acknowledge that the “publish or perish” attitude rampant in the scientific culture needs to change. The situation and solution was described succinctly in a recent Nature Editorial on cognitive bias: “Finding the best ways to keep scientists from fooling themselves has so far been mainly an art form and an ideal. The time has come to make it a science.” (Martin Enserink, ScienceInsider)

Big Data

Proposed Study to Track 10,000 New Yorkers

A new proposed longitudinal study will attempt to monitor thousands of households in New York City over the span of decades. Information will be gathered in intimate detail about how people in these households lead their lives, including information about diet, exercise, social activities and interactions, purchases, education, health measures, and genetics. This ambitious project is called the Kavli Human Understanding through Measurement and Analysis (HUMAN) project, and aims to quantify the human condition using rigorous science and big data approaches to understand what makes us well and what makes us ill. According to project leaders, existing large-scale data sets have only provided detailed catalogs of narrow aspects of human health and behavior, such as cardiovascular health, financial decision-making, or genetic sequencing. By measuring the feedback mechanisms between biology, behavior, and our environment over decades, researchers believe that that much more will be understood about how these factors interact to determine human health over the life cycle. For example, according to articles written by scientists in support of the project, the new data could measure the impact of cognitive decline on performing activities of daily living, on family members and caregivers, and on healthcare utilization or end-of-life decisions. A further goal of the project is to provide data to policy makers in order for them to develop evidenced-based public policies.

Anticipating privacy and cybersecurity concerns inherent in such an invasive study, Kavli HUMAN project researchers have established a Privacy & Security Advisory Council, comprised of members in the private, public, and academic sector. The Advisory Council includes bioethicists and patient privacy advocates. In addition to establishing the Advisory Council, project leaders conducted an opinion survey of diverse group of Americans asking whether they 1) think the study should be done, and 2) if they would be willing to participate. The results of the survey suggested that nearly 80% think that the study should be done and more than half were willing to participate. When questions arise about the ethics of collecting such information, Kavli HUMAN project researchers publicly argue that corporations already track Americans’ spending habits, location, and use of technology, and that “people’s data can be better used to serve them, their communities, and society.” (ScienceInsider, Kelly Servick)

Nutrition and Cancer

A Diet High in Red Meat and Processed Meat Increases Risk for Colorectal Cancer

The World Health Organization International Agency for Research (IARC) announced on Monday that eating too many processed meats are cancer-causing and eating too much red meat is “probably carcinogenic to humans.” Red meat is defined as all types of mammalian muscle meat, such as “beef, veal, pork, lamb, mutton, horse, and goat,” and processed meat is defined as meat that “has been transformed through salting, curing, fermentation, smoking, or other processes to enhance flavor or improve preservation.” The IARC reviewed 800 studies that looked at the association of cancer with consumption of red or processed meat in people around the world, of diverse ethnicities and diets. Results of this analysis revealed that the positive association between red and processed meat consumption and cancer was strongest for colorectal cancer. The Global Burden of Disease Project, an independent academic research organization, estimates that 34,000 cancer deaths per year worldwide are attributable to diets high in processed meat. Studies show that meat processing techniques and cooking this kind of meat at high temperatures can lead to the formation of carcinogenic chemicals, and that these compounds appear in parts of the digestive tract. Specifically, the agency said its experts concluded that each 50 gram portion of processed meat eaten daily increased the risk of colorectal cancer by 18 percent. Red meat was not as strongly associated with cancer as processed meat. Some public health experts criticized the bravado of the IARC announcement. In response to public inquiries, they have published a FAQ page where they state that smoking and asbestos are more likely to be causal for lung and other types of cancers. The announcement did not mark a new discovery, since the original report has been out for several years; it was meant to attract public attention and help countries looking to WHO for health advice. According to the director of IARC, “these findings further support current public-health recommendations to limit intake of meat.” (NPR; Anahad O’Connor, New York Times)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

October 31, 2015 at 9:00 am

Science Policy Around the Web – August 14, 2015

leave a comment »

By: Patricia Kiesler, Ph.D.

Photo credit: via

Laboratory Animal Rights

Animal advocacy group targets cat and dog research using novel crowdsourcing campaign

The Los Angeles–based Beagle Freedom Project (BFP) animal advocacy group filed a complaint on Monday with Ohio State University (OSU) and the National Institutes of Health (NIH) alleging that a NIH-funded OSU laboratory has violated NIH rules concerning the use of dogs in biomedical research. In the past, U.S. research facilities would procure dogs from Class B dealers, who would sell animals that they obtained from pounds, breeders and “random sources”. The latter are associated with stolen and abused pets. In 2013, the NIH announced that researchers using the agency’s funds could not procure dogs from Class B dealers, as of October 1, 2014, and could not use such dogs in projects funded in 2015 and beyond. According to BFP, OSU has violated both guidelines. In their complaint, BFP provided records suggesting that the university obtained four class B dogs on October 6, 2014, and that one of the class B dogs was still alive as late as July of 2015. OSU has disputed both accusations and provided evidence to ScienceInsider indicating that the dogs were purchased before the NIH rule went into effect, on September 11, 2014, and said that no class B dogs are currently involved in laboratory research.

BFP has gathered this evidence against OSU through a unique crowdsourcing technique. Public supporters browse the BFP’s website and its list of more than 1200 cats and dogs kept at 17 public research universities in the U.S. and “adopt” one of these animals. BFP then sends supporters a Freedom of Information Act request form, which they fill out and send to the university housing the animal. Any information collected (health records, protocols, necropsy reports, etc.) is forwarded to BFP. Through this strategy, the animal advocacy group has generated hundreds of public records requests to engage the public and pressure universities to release animals and/or end their research. (David Grimm, ScienceInsider)

Scientific publishing policy

Courts refuse scientists’ bids to prevent retractions

Two scientists have sought to prevent journals from retracting or expressing concern about their papers this year. But U.S courts have dismissed their legal bids. Guangwen Tang from Tufts University in Boston, MA had hoped to stop the American Journal of Clinical Nutrition from retracting her 2012 paper on the value of providing Golden Rice to children. This rice is a genetically engineered form of rice that is rich in b-carotene for use as a source of vitamin A. Following Tufts University ‘s discovery that parents had not been informed that the rice provided to their children was genetically modified, the journal decided to retract her paper and did so after the court’s ruling. Mario Saad from the University of Campinas in Sao Paulo, Brazil had also hoped to prevent the journal of Diabetes from publishing expressions of concern about four of his papers. The journal said online that it had been alerted to potentially manipulated images in his studies and that was concerned about the reliability of some of his data. The first investigation launched by the University of Campinas found mistakes, but no dishonesty, in Saad’s work and the conclusions of a second investigation have yet to be released. The court, however, swiftly denied his injunction bid and a request to reconsider thereafter. As a result, Diabetes published print concerns regarding all four of his papers.

“In both cases, the courts decided that the scientists’ requests would deny journals their right to free speech. The decisions do not prevent the scientists from suing for damages from defamation, however, and legal action is ongoing in both instances”. But a scientist suing a journal to stop retractions is unheard of and researchers may find it difficult to win defamation cases against publishers in the U.S. as defamation charges have a high burden of proof in this country; “plaintiffs [would] have to show that publishers acted with malice or reckless disregard”. (Monya Baker, Nature News)

International – Children’s health

Mexico bans giveaways of baby formula at hospitals in an effort to encourage breastfeeding

Mexico has one of the lowest breastfeeding rates in Latin America with only one in seven mothers breastfeeding exclusively during their babies’ first six months. This poor record is amplified in a country where millions live in extreme poverty and drinking water is often unhealthy. In an effort to increase breastfeeding rates, the Mexican government has banned free baby formula at hospitals. But Mexican health authorities said that baby formula could still be supplied at a doctor’s request and would be available for purchase. Mexico’s measure follows the World Health Organization’s recommendations that exclusive breastfeeding for the first six months of life and continued breastfeeding for up to two years or beyond supplemented with complementary foods provide health benefits to babies that translate into adulthood. These recommendations have recently been supported by a long-term study in Brazil that involved nearly 3,500 babies who were followed up 30 years later. The research, published in The Lancet Global Health last April, found that those who had been breastfed the longer scored higher on intelligence tests as adults. They were also more likely to reach higher educational attainment and to earn greater incomes. Although breastfeeding was evenly distributed across social class and the researchers tried to rule out main confounders including mother’s education, family income and birth weight, experts agreed that further research was needed to explore any possible link between breastfeeding and intelligence. The large sample size and number of factors monitored, however, made this a powerful study. (BBC News)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

August 14, 2015 at 10:00 am

Science Policy Around the Web – June 26, 2015

with one comment

By: Amy Kullas, Ph.D.

Public Health Policy: Organ donation

State policies have had little success on increasing organ donation

There is an extreme shortage of transplantable solid organs in the United States, which poses a considerable public health challenge. Presently, an estimated 125,000 patients require an organ transplant and of these patients, almost 80,000 remain on active waitlists for these organs nationally. Unfortunately more than 6,000 of these patients are expected to die this year while waiting for a transplant.

Since 2010, all states and the District of Columbia have implemented at least two donation-related policies. These policies varied from dedicated funds for donor recruitment activities to paid leave after donation to tax incentives. Unfortunately, many of these polices (with the exception of revenue policies) have had “no robust, significant association with either donation rates or number of transplants.” The revenue policies have people donate to a “protected state fund” which is used to fund activities to promote organ donation. These policies correlated with a modest “5.3% in the absolute number of transplants.” This brings up an interesting question and proposition: should individuals be financially compensated for donating an organ?(Chatterjee, et al, JAMA Internal Medicine)

Humans, Climate Change and Animal Extinction

The sixth mass extinction is among us. Is there anything left to do?

[The study] shows without any significant doubt that we are now entering the sixth great mass extinction event,” said Paul Ehrlich, the Bing Professor of Population Studies in biology and a senior fellow at the Stanford Woods Institute for the Environment. Ehrlich and his co-authors warn that this “extinction threatens humanity’s existence” and that soon we will pass the point-of-no-return. Ehrlich further says, “There are examples of species all over the world that are essentially the walking dead.” The overall consensus among scientists that the current extinctions rates have reached levels that have not been encountered since the dinosaurs’ downfall, approximately 65 million years ago.

As the human population continues to increase at an almost exponential rate, the laundry list of how humans are brutalizing Mother Earth is also increasing. Some of which include:

  1. Clearing the land for farming, then clearing the farmland for housing, etc.
  2. Introduction of invasive species
  3. Record high carbon emissions driving global warming and ocean acidification
  4. Toxins that leach into water supplies and can poison fragile bionetworks

But is there anything left for humanity to do? It is a complex ‘yes.’ The authors write, “Avoiding a true sixth mass extinction will require rapid, greatly intensified efforts to conserve already threatened species, and to alleviate pressures on their populations — notably habitat loss, over-exploitation for economic gain and climate change.” (Rob Jordan, Stanford Report)

Animal Rights and Biomedical Research

Captive chimps to be categorized as an endangered species

On June 12, the US Fish and Wildlife Service (USFWS) announced that it is classifying captive chimpanzees (approximately 1750) as endangered under the Endangered Species Act. The new designation will give 700+ chimps in U.S. research laboratories, in addition to those in zoos and in ‘entertainment’, the same protection as their counterparts in the wild. Bottom line, biomedical research involving chimpanzees is going to dramatically change when the classification is implemented on September 14. USFWS will start requiring a permit for doing scientific research on captive chimps, along with their sale and import.

Biomedical research involving chimpanzees had already significantly decreased since 2013 when the National Institutes of Health (NIH) pledged it would retire the majority of its captive chimps, leaving only 50 animals available for potential projects. Yet, only 66 chimps have officially been retired since June 2013. These retired chimps are transitioning to sanctuaries.

John VandeBerg, the former director of the Southwest National Primate Research Center in San Antonio, highlights how this decision will affect biomedical research, such as the development of vital vaccines. VandeBurg gives the grim forecast “There will be a lot of people who die who would not have died.” (Sara Reardon, Nature and David Grimm, Science)

New Science Policy Blog!

National Institutes of Health Office of Science Policy launches new blog

The National Institutes of Health (NIH) Office of Science Policy (OSP) has launched a new blog “Under the Poliscope: Bringing Science Policy Into Focus.” The blog will showcase some of the activities of the OSP as well as focusing on science policy matters in a general context and emerging issues of interest to the life science and biomedical communities.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

June 26, 2015 at 9:00 am

Science Policy Around the Web – May 5, 2014

leave a comment »

By: Tara Burke

Photo credit: Novartis AG via photo pin cc

Photo credit: Novartis AG via photo pin cc

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

UK proposes greater transparency on animal research – The government of the United Kingdom wants to drop rules that prevent release of any confidential information on animal research. This is part of a continuing push towards openness about such research methods. Animal-rights groups have complained about these rules for years. If this rule is repealed it would help to maintain the public trust about research activities being performed in the UK. If implemented, the names and locations of animal research would be kept out of the public domain. This anonymity was important to researchers who feared their safety from extremist animal rights protestors. To further protect researchers, the government is also considering creating a new criminal offense of ‘malicious disclosure’ of animal research information. This is aimed at preventing attempts by anti-research extremists to ‘out’ researchers online. (Daniel Cressey)

White House Science Adviser Criticizes FIRST Act – John Holdren, The White House science adviser, expressed the first public reaction from the White House to the Frontiers in Innovation, Research, Science, and Technology (FIRST) Act, a 2-year reauthorization of NSF programs. Holdren, whose views are in line with most academic leaders, commented that FIRST would “have an extraordinary unfortunate effect” on the NSF, a $7 billion research agency. The FIRST act worries leaders of the scientific community because it shifts the NSF’s focus from funding the best basic research across all areas of science and engineering to more applied research. Holden argues FIRST would narrow the focus of NSF to science applied to various national interests other than simply advancing the progress of science.  FIRST is expected to be approved this month by the science committee of the U.S. House of Representatives. (Jeffrey Mervis)

Planet headed toward ‘post-antibiotic era’ when treatments don’t work: WHO – In an attempt to alert all countries around the world, the World Health Organization (WHO) reported that antibiotic resistance has developed in all parts of the world. WHO stresses that this problem is so serious it could threaten the achievements of modern medicine. Keiji Fukuda, WHO’s assistant director-general for health security, said that the international community needs to take significant actions to improve efforts to prevent infections. He also stresses that there needs to be changes in how antibiotics are prescribed, produced and used. (Lenny Bernstein)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

May 5, 2014 at 9:32 am