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Posts Tagged ‘embryonic research

Science Policy Around the Web – August 4, 2017

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By: Emily Petrus, PhD

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source: pixabay

CTE Research

National Football League Backs out of Funding Brain Research

A new study released this week added more fuel to the fire surrounding the health problems associated with playing contact sports, most notably American football. The study found signs of chronic traumatic encephalopathy (CTE) in the brains of 110 out of 111 former National Football League (NFL) players. Repetitive head trauma is thought to cause CTE, which can result in behavioral and mood disorders and cognitive impairment. Football players donated their brains to the Concussion Legacy Foundation so that scientists could evaluate the impact of playing contact sports on their brains. Currently CTE is only diagnosed post-mortem, so developing effective diagnoses and treatments for living patients would benefit NFL players, soldiers and others at risk of head trauma.

Advancing the science to benefit these groups in theory should serve in the NFL’s interest, however the initial damaging reports demonstrating the dangers their players face didn’t sit well. In 2012 the NFL pledged $30 million to the National Institutes of Health (NIH) for brain research, however the partnership is set to expire this year with about half the money unspent. A 2016 New York Times article revealed some unsettling interactions between the NFL and NIH, when a congressional study found that the NFL tried to direct their funding away from research performed by certain scientists. The NIH was set to award a $17 million grant to Dr. Robert Stern at Boston University to study the link between repeated concussions and CTE, however representatives from the NFL attempted to discredit Dr. Stern’s work. The NIH chose to fund Dr. Stern’s highly ranked proposal, and reserve the NFL’s money for future research. It seems now that future research funded by the NFL and distributed by the NIH is unlikely to happen.

Eliminating conflicts of interest is important for research to remain unbiased and evidence based. Concussion research conducted by the NFL or clinical trials performed by pharmaceutical companies can produce bias results. There is a need for the NIH and FDA to act as fair and unbiased grant reviewers and funding distributors. Even among players at the NFL there is a spectrum of how people feel about the dangers of playing football, best exemplified by the following quotes:

“We live and breathe it and this is what we’re so passionate about. Literally, I would — if I had a perfect place to die, I would die on the field.” – Jamal Adams Jet’s Rookie

“I hope All these young cats that are willing to die for the game of football find a higher purpose in life. Look football is great but I ain’t dying for this sh*t. Lol.” – Martellus Bennett Green Bay Packers Tight End (Twitter)

(Laurel Wamsley, NPR)

 

Human Genetic Engineering

No Super-Babies Yet

The United States has had a long history with avoiding research using stem cells. Since in vitro fertilization (IVF) became possible in the 1970’s we have been debating the ethics of using human stem cells and embryos for research. During George Bush’s tenure as president, stem cell research was explicitly un-fundable with public tax dollars (i.e. from NIH). As scientists found new ways to create stem cells without fetal tissue and Barack Obama’s presidency began, the US finally embraced stem cell research. However, researchers are still not permitted to use public funding to create and destroy human embryos – they can only use already fertilized embryos donated by patients from IVF clinics. If the research is privately funded, then researchers can both make and dispose of human embryos.

This little history lesson sets the stage for a discovery made in America and published this week in Nature, where researchers in Oregon (with collaborators in South Korea and China) were able to use gene editing to remove a heart defect-causing gene in human embryos. This technique is called CRISPR-Cas9, which uses prokaryotic (bacterial) DNA to target desired genes to be deleted or replaced and has already been used to edit embryos (human, other vertebrates, invertebrates and plants) with mixed results. There are reports of both off-target mutations (editing occurring in the wrong place) or mosaic embryos, meaning some cells are edited while others are not. What sets this new paper apart from the pack is the researchers inserted the CRISPR-Cas9 complex at the same time as the sperm, thus the editing began at fertilization. The inserted Cas9 protein was degraded too quickly to be effective at producing off-target mutations, and since the editing happened at conception only one out of 58 embryos was a mosaic. In contrast, waiting as little as 18 hours after fertilization to edit the embryo resulted in 13 out of 54 mosaic embryos.

For those worried about the production of designer babies, this study alleviates some of these concerns as well. Although researchers in this study provided a synthetic DNA template for the CRISPR-Cas9 system to rewrite the faulty gene, the cells ended up using the healthy mother’s DNA strands. This means scientists aren’t yet able to create babies to specifications, just strongly favor the existing but healthier parental gene to be passed on to the offspring. There are obvious ethics issues involved in creating human embryos and destroying them in the name of scientific discovery. However, getting rid of fatal diseases by gene editing could be music to the ears of parents who long to have children of their own but don’t want to risk having children affected with lethal conditions. The National Academies of Sciences, Engineering and Medicine have launched the Human Gene-Editing Initiative to tangle with these issues as they arrive to policy forums.

(Heidi Ledford, Nature News)

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August 4, 2017 at 3:31 pm

Science Policy Around the Web – May 12, 2017

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By: Liu-Ya Tang, PhD

Source: pixabay

Biosafety

Basic Scholarship in Biosafety Is Critically Needed

While a significant amount of money funds primary research in life sciences, the portion allotted in biosafety assessment is almost neglected, which can be detrimental to biomedical research. In a recent paper in mSphere, an open-access journal published by the American Society for Microbiology (ASM), the authors reported the status of practicing biosafety in U.S. labs and pointed out the urgent need for funding in this field.

They identified human errors as the dominant component of laboratory biosafety risk, but there was limited data to support a quantitative analysis of human failure rates. Publicly available risk assessments were only focused on mechanical failure rates. They also found that historical biosafety incident data is not adequate, and incidents reporting systems are not sufficiently standardized. So the same mistakes could likely happen in multiple labs. In contrast, other industries, such as the power and transportation industries, have been investing heavily in maintaining safety records and have benefited from doing so. The authors cite an example from the airline industry to address the importance of incident reporting system. After a flight crash outside Washington’s Dulles airport in 1974, the Federal Aviation Administration (FAA) created a no-fault system of reporting aviation incidents and mistakes. FAA has maintained this system ever since, which has helped reduce accident rates by two-thirds compared to that in the early 1970s.

Even though funding for biosafety assessment is much less than that in other industries, the consequences of a potential infectious disease outbreak can be much bigger than any other accidents. Therefore, such funding is urgently needed for three aspects: “(i) development of a national incident reporting system, (ii) primary research programs focused on human reliability assessments, equipment failures, and decontamination efficiencies, and (iii) sharing of best practices.” Investing in biosafety and biorisk management will help enhance laboratory safety practices and improve work performance of our research enterprise in the long run. (Ryan Ritterson and Rocco Casagrande, mSphere)

Human Stem-Cell Research

Attitudes Towards Stem-Cell Research in Europe, Canada and the United States

Human embryonic stem-cell research has caused many political and public debates over moral concerns while providing benefits to human health. In science policy making, public opinion has great impact. To investigate factors that affect international public opinion towards stem-cell research, Allum N. and colleagues analyzed representative sample surveys in Europe and North America, fielded in 2005, when it was a highly contested issue.

The authors found that public attitudes towards stem-cell research has been affected by government decisions, especially in the U.S. During the Bush administration, federal funding only allowed the use of a small number of existing cell lines in stem-cell research. These limitations were removed by an Executive Order from President Barack Obama that expanded NIH support for human stem-cell research. In response to government guidance, public support for stem-cell research in the U.S. rose from 40 percent in 2002 to around 65 percent in 2010. About 65 percent of Europeans and Canadians supported human stem-cell research on the condition that it is tightly regulated. The other influential factor is religion. The authors showed that in all the regions examined, approval for stem-cell research decreased with increasing religious commitment. This pattern was more pronounced in the U.S. and Canada than in Europe. But interestingly, half of even the most religious public supported stem-cell research, which indicated that perhaps the benefits of stem-cell research are being more appreciated. Overall, the majority of people in the surveyed areas hold positive attitudes towards human stem-cell research. (Nick Allum et al, PLOS ONE)

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May 12, 2017 at 11:07 am

Science Policy Around the Web – May 24, 2016

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By: Allison Burrell, MS, MPhil

photo credit: koya979/Shutterstock

Human Development

Embryology policy: Revisit the 14-day rule

Human developmental biology is at a crossroads. Recently, two labs reported a breakthrough that advances the field of embryology, but ushers in ethical and legal quandaries. Human embryos were grown in vitro for 12-13 days, well beyond the previous 9-day record and nearly double the typical 7-day survival. In vitro research uses cells outside their normal environment. Currently the regulatory and legal statute, going back decades, limits in vitro human-embryonic research to 2 weeks. Also known as the 14-day rule, this regulation is based upon a delineation in development called the ‘primitive streak’ that occurs after the first 14 days after fertilization. Following the formation of this streak, the embryo loses its ability to split into two independent embryos, thus solidifying its status as a biological individual; although, in vivo this also represents the completion of implantation. In vivo means within the organism, and in this context refers to an embryo naturally growing inside a woman’s womb. However, in the lab when culturing embryos in vitro, implantation does not occur, whereas in vivo embryogenesis implantation into the placenta would occur after the 14-day mark. Therefore, since these experiments are completed in vitro the 14-day rule shouldn’t be considered the boundary when moral status begins, and legal research tissue ends. Now, with the impetus of researchers forging past this so-called ‘line in developmental sand,’ regulators must reevaluate the limit.

First suggested in 1979, by the US Department of Health’s Ethics Advisory Board, the 14-day limit is now law in at least 12 countries, and referenced in numerous other reports and guidelines related to embryonic research throughout the world. With re-evaluation of the limit on the table, this could conjure up philosophical and ethical debates. It must be firmly stated that the 14-day rule is a policy tool, written to ensure a figurative space for embryonic research in a pluralistic society.

One could argue that the rules should not necessarily be changed just because researchers are now able to grow embryos beyond the 14-day boundary. It was initially created not only because 14 days was unattainable, but due to a physiological observation. Yet this policy tool is just that, a tool. A tool used to preserve the trust of the public while still allowing for research to move forward. The regulations that govern the circumstances surrounding embryonic growth in vitro must be amended. And in doing so, the emendation of the 14-day rule will address scientific, as well as moral concerns. To encourage a thoughtful revision, developmental biologists should communicate, to the public as well as to international policy makers, why embryonic research is important, and how a possible extension of the 14-day rule will aid that research.

In the interim, the International Society for Stem Cell Research (ISSCR)  has released updated guidelines for stem cell research and clinical translation. Even with the publication of guidelines, the interdisciplinary task force that led the revision must maintain close collaborations with international foundations and governments to prevent public criticism and the implementation of restrictions that hinder the progression of the embryonic research field. (Insoo Hyun, Amy Wilkerson, and Josephine Johnston; Nature)

Microbiology – BREAKING NEWS

Rebuilding trust in biology : An opinion ahead of the NSABB microbiology biosecurity meeting

Today (May 24, 2016), the National Science Advisory Board for Biosecurity (NSABB) will meet at the National Institutes of Health (NIH) to discuss and vote to approve the revised NSABB report. Back on January 7-8, 2016, the NSABB met to consider the risks, benefits, ethics, and policy surrounding gain of function studies, particularly regarding infectious pathogens, leading to the final report. This debate officially started 18 months ago, and will culminate today.

The primary purpose of meetings like this is to implement biosecurity policies designed to protect the public from research projects that could pose a risk to national, and global safety. The promise that new biological technologies will be beneficial and safe is still on shaky ground and public trust in this research is flagging. Infractions are still occurring, as just last week it became apparent that certain labs at the Centers for Disease Control and Prevention (CDC) were subjected to secret sanctions and suspensions for mishandling bioterror pathogens. Prior to that, the NIH stumbled upon a 30-year old smallpox virus in a neglected freezer when the virus should have only been safely secured at either of two dedicated storage facilities in the world, in which this freezer was not located. And additionally, the US military erroneously sent live infectious anthrax from a secured facility to over 200 labs in the world.

These infractions barely touch the surface, since smaller minor breaches are not regularly reported in the news. That this is occurring ad nauseam in countries with strict biosafety regulations, makes one wonder how many incidents slip through the cracks in these countries as well as ones with lesser regulations.

The NSABB’s focus today on debating gain of function mutations run the risk of jeopardizing the reputation of the “global biomedical research enterprise.” One way to gain public trust is to provide transparency in the process, which is why the report and meeting minutes are published online, and the meeting is also public. A second way is to give scientists leading this research the responsibility of helping encourage responsible behavior amongst colleagues to prevent accidental and premeditated misuses of biology. Thirdly, accountability is an imperative tenet towards gaining public trust. Creation and enforcement of new scientific norms that do not detract from the goal of honesty through accountability are changes that can’t come too soon. Lastly, transparency must be reiterated in relation to potentially hazardous experiments, such as inserting a gene, or genes, responsible for airborne transition to a virus that currently can only be transmitted via mosquito bite. This experiment may inform scientists how said gene(s) are responsible for airborne evolution, and thus enable the prevention of future deleterious outbreaks. But if this airborne mutant recombinant pathogen were to be accidentally released, or fall into the wrong hands, it could quickly become an epidemic or bioterrorism tool. Science that enforces trustworthiness, accountability, transparency, open communication and feedback, organized vetting of new technologies, and responsibility can, and will, allow for the growth of science in a safe and beneficial path. (Filippa Lentzos and Nicholas Evans, The Guardian)

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Written by sciencepolicyforall

May 24, 2016 at 11:00 am

Science Policy Around the Web – September 22, 2015

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By: Kaitlyn Morabito, Ph.D.

photo credit: 2-cell via photopin (license)

Embryonic Research

U.K. researcher applies for permission to edit embryo genomes

Stirring up an old controversy about “designer babies”, a scientist at the Francis Crick Institute in London has applied for “a license to edit the genes of human embryos” from the UK’s Human Fertilization and Embryology Authority (HFEA). In an effort to research early human development, researcher Kathy Niakan would like to use genomic editing to better understand this process. The use of genomic editing of embryos would be solely for use in the laboratory and not used for reproduction. This application comes on the heels of calls from the scientific community to evaluate the risks and benefits of using these emerging and established techniques in embryonic research as well as develop new guidelines for their use. In the US, this research would be not be illegal, but would not be eligible for funding from the National Institutes of Health due to federal law. (Gretchen Vogel, ScienceInsider)

Public Health

Experimental Ebola drug ZMapp gets fast track status from FDA

With the Ebola epidemic still raging in West Africa, the Federal Drug Administration (FDA) has fast tracked approval of ZMapp, an antibody-based Ebola drug that initially made headlines for its experimental treatment of Dr. Kent Brantly and Nancy Writebol.  In total, the drug was used in nine infected patients in Africa, the US, and Western Europe.  However, the efficacy of the drug cannot be evaluated since it was not administered in a controlled clinical trial.  The drug has been shown to be effective when given within forty-eight hours of infection in monkey studies.  ZMapp consists of three monoclonal antibodies that were generated in mice and acts by binding to the virus to prevent attachment and entry into new cells.  ZMapp will need to be shown to be both safe and able to induce an immune response in human before it will be given approval by the FDA. (Debra Goldschmidt, CNN.com)

NFL Head Trauma

87 of 91 tested ex-NFL players had brain disease linked to head trauma

According to a study by the US Department of Veterans Affairs and Boston University, ninety-six percent of tissue samples tested for chronic traumatic encephalopathy, CTE, were positive.  CTE is a brain disease thought to be caused by trauma to the head and has become a headline regarding the safety of NFL players.  The samples came post-mortem from NFL players who were concerned that they may be suffering from CTE, so the overall prevalence in former NFL players is unknown.  Although publicized as being found mainly in athletes involved in repetitive brain trauma, CTE strikes non-athletes as well including people who experience grand mal seizures and abuse.  CTE can only be diagnosed post-mortem and is defined by the build-up of tau protein in the brain leading to neurological symptoms.  This is not the first time the NFL has addressed this issue, and have previously settled with former NFL players to cover medical expenses for disorders associated with repeated head trauma.  Additionally, the NFL has been working to decrease head trauma through changing regulations and evaluation procedures. (Jason Hanna, Debra Goldschmidt and Kevin Flower, CNN.com)

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September 22, 2015 at 9:00 am