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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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Written by sciencepolicyforall

August 4, 2017 at 3:31 pm

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

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By: Valerie Miller, Ph.D.

Photo credit: DSC5623.jpg via photopin (license)

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

Flawed Concussion Research

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

NFL Tries to Influence Independent Concussion Research

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

Where Do We Go from Here?

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

Written by sciencepolicyforall

June 22, 2016 at 10:00 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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Written by sciencepolicyforall

September 22, 2015 at 9:00 am