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Science Policy Around the Web – January 24, 2017

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By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

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January 24, 2017 at 10:04 am

Science Policy Around the Web – December 13, 2016

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By: Allison Dennis, BS

Source: pixabay

Whistleblowers in Science

Keep your reviewers close and your online, anonymous, post-publication reviewers closer

A recent ruling by the Michigan Court of Appeals has ruled that anonymous online scientific reviews are a protected form of speech. Fazlul Sarkar, a former researcher at Wayne State University, had sued the site PubPeer in 2014 in an attempt to reveal the identity of several anonymous online reviewers to mixed success. Sarkar claimed that the defamatory and public nature of several online reviews posted anonymously to PubPeer had cost him a forthcoming tenure position at the University of Mississippi, one that came with a $350,000 a year salary. These reviews brought into question the validity of several images found in his published works.

While the initial ruling in March of 2015 largely sided with PubPeer to protect the anonymity of their online posters, a follow-up just two weeks later compelled PubPeer to reveal the IP address of a user who had gone as far as to repost quotes from an email response from the Senior Executive Assistant to the President of Wayne State University confirming their knowledge of the online allegations.

PubPeer filed an appeal of the decision by the end March, which garnished the collective support of science and internet moguls, Bruce Alberts, and Harold Varmus, Google, and Twittter in addition to the ACLU who filed amicus briefs in support of online anonymity. The summer brought more trouble for Sarkar as thirteen of his papers were retracted.

On December 9, 2016, the Michigan Court of Appeals found upon further review that Sarkar was “not entitled to unmask the identities of any speakers on pubpeer.com” citing “anonymity protections afforded by the First Ammendment.” Although this ruling does not dismiss Fazlul Sarkar’s case against John and Jane Doe, the protection of anonymity makes the suit moot. (Adam Marcus and Ivan Oranksy, STAT)

Federal Funding

Bipartisan cure found for stalled 21st Century Cures Initiative

In an end of the year push, the House and Senate passed the 21st Century Cures Initiative, a bill aimed at bringing legislation and regulation up to speed with biomedical research. At the end of November, a draft of the bill emerged from negotiations that were largely palatable to both Republican and Democrats across the House and Senate. A previous draft of the bill had successfully passed the House in July. However agreement over the source of funding could not be reached, arresting any further progress of the bill. The passing months brought Fred Upton, the Republican Representative who had originally spearheaded the bill close to the term limit afforded, as the chair of the Energy and Commerce Committee. The results of the recent elections seemed to be enough to incentivize compromise for Democrats in the final months of the Obama administration. Both parties returned to negotiations settling on a combination of funds derived from the selling of petroleum reserves and the Affordable Care Act.

In the end, the bill won 392-26 in the House and 94-5 in the Senate. Highlights of the bill under the title of Development include the accepted substitution of “data summaries” for full clinical trials when a new indication is to be added for a previously approved drug and expansion of off label-uses. The FDA has been tasked with evaluating evidence from the real world in an effort to speed-up and improve patient access. Highlights under the title of Discovery include a $4.8 billion boost to the NIH budget and $1.8 billion power pack for Joe Biden’s Cancer Moonshoot. A complete play-by-play of the winners and losers of the final version of the bill can be found in Sheila Kaplan’s article on STATnews. (Sheila Kaplan, STAT)

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December 13, 2016 at 10:38 am

Streamlining Human Research by Centralizing Review: Could It Slow Things Down?

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By: Leopold Kong, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

       Human research in the United States in the form of clinical trials and other scientific studies has been regulated by Institutional Review Boards (IRBs) since 1974 after the passage of the National Research Act. The initial policies were inspired by the Nuremberg Code, a set of international research ethics principles developed in the aftermath of the second world war when Nazi medical officers conducted large-scale human experimentation atrocities. Policies that regulate IRBs in the United States are codified in the Common Rule, which mandates requirements such as membership qualifications and guidelines for protections of certain vulnerable research subjects. Although the Common Rule has not been modified since 1991, the changing face of medical research has led to recent proposals to improve the efficiency, accountability and qualification of IRBs. What has motivated change? The following situations may be illustrative.

In November 2015, the consumer advocacy group Public Citizen, and the American Medical Student Association contacted the Office for Human Research Protections (OHRP) to criticize two studies on how longer-than-21-hour shifts of first-year medical students may affect 30-day patient mortality rates. Public Citizen noted that even though the studies forced new residents to work “dangerously long shifts”, placing all involved in danger, they were readily approved by IRBs. Similarly, IRBs approved a study on the hazards of pediatric exposure to lead paint, in which researchers did not clearly reveal to households that they detected high levels of lead in their homes, resulting in neurological problems for at least one child. Also, a publication last year in the European journal Acta Informatica Medica found that only 26.5% of individuals in IRBs correctly answered 11 simple True or False questions designed to test understanding of study design and ethics. Part of the problem may be research fatigue since, according to OHRP, there are only about 3,500 registered IRBs that review more than 675,000 research protocols annually. Inefficiencies in the review process may further exacerbate the situation.

Late last year, Kathy Hudson and Francis Collins, the Deputy Director for Science, Outreach and Policy at the National Institutes of Health (NIH), and the Director of the NIH, respectively, published a Perspective in the New England Journal of Medicine on the proposed revisions to the Common Rule. In order to bring the Common Rule into the 21st century, the revisions will focus on implementing broad biospecimen consent, enhanced privacy safeguards, streamlined IRB review, and requirements for more agencies to follow the Common Rule. One of the more interesting and key revisions to improve review efficiency, the requirement for a single IRB (sIRB) for multisite studies, will be implemented on May 25, 2017. The rest of this essay focuses on this proposed change.

The time it takes for a clinical trial protocol to be reviewed by an IRB depends on the type of review, and varies from location to location. For example, a protocol can be deemed exempt, which might take only 1-2 weeks of review, expedited, which might take a few weeks longer, or be required for full review, which would take even longer. Re-evaluations are required if the protocol is sent through expedited or full reviews every year, after any changes to the method, or after any adverse event in the study. The review generally evaluates proof of human subjects’ training, consent, recruitment materials, and data collection instruments, as well as individual conflicts of interests, all of which may depend on the specific population studied and local restrictions. However, clinical trials are increasingly spread across multiple sites in order to recruit enough people for their studies. Under the current rule, each site must conduct local reviews of the same protocol independently of each other, potentially causing delays due to unneeded redundancies. “The problem that this [proposed sIRB] policy was trying to solve was that we were seeing delays and complications in moving research forward in a way that wasn’t providing commensurate protections for human research participants,” said Carrie D. Wolinetz, NIH associate director for science policy, to Bloomberg BNA.

From December 3, 2014 to January 29, 2015, the NIH received 167 comments from individual researchers, academic institutions, IRBs, advocacy groups, scientific societies, healthcare organizations, Tribal National representatives and members of the general public on the sIRB proposal. Many of the comments were highly positive and supportive of the revision. For example, the Federation of American Societies for Experimental Biology (FASEB), which represents over 120,000 researchers across 27 scientific societies, stated that “[t]his change would facilitate collaborative review arrangements and reduce the obstacles that investigators encounter when embarking on multi-center projects.” David M Pollock, the president of the American Physiological Society, added further support, commenting that the current rule results in “lack of uniformity” while the proposed changes may reduce administrative burden, and improve efficiency and quality of review.

However, many of the comments displayed reservations and harsh criticism. For example Harry W. Orf representing Massachusetts General Hospital was skeptical that the costs to move into the sIRB system would outweigh the benefits, commenting “there is currently little research or data to demonstrate that these potential benefits will materialize.” In much stronger terms, Curtis Meinert from the Johns Hopkins Bloomberg School of Public Health stated,” [t]he expectation is that the change will save money. Good luck on that. The reality is that the change will increase costs given what IRBs of record have to do to acquire the necessary assurances and certifications. The expectation also is that the single IRB will shorten the time to start, good luck on that one also.” Meinert and others, including the Human Subjects Protection Branch at Walter Reed Army Institute of Research, pointed out that the time it takes to start a study is mainly determined by other factors such as the time it takes for investigators to agree on a protocol, not IRB review. Meinert also warns that, “A likely unintended effect of the one IRB requirement is to further diminish the means and incentives for individual investigators to propose and initiate multicenter studies..” Finally, some communities also viewed the revision as a threat to local autonomy and representation. For example, Bill John Baker, the Principal Chief of the Cherokee Nation, commented, “Tribal IRB members have firsthand knowledge of local tribal customs, cultural values, and tribal sensitivities. If Tribal IRB members are not able to participate […] our citizens are affected by persons who are not sensitive to their distinctive needs.”

Analysis of all comments made regarding sIRB by the Council on Government Relations indicated that 51% opposed the proposal while 42% supported it and 6% offered qualified support. Interestingly, most commercial IRBs, which might be more favorably biased towards the needs of industry sponsors, supported this change. A breakdown of the numbers indicates that while the majority of advocacy groups, professional societies, disease registries and individual researchers supported the change, 89% of universities and medical centers, the organizations that are directly involved with clinical trials and representing thousands of researchers and medical support staff, opposed it. “The spirit of the changes are well intended, but it fails to address the fact that roles and responsibilities of the IRB have expanded beyond those initially dictated when the use of IRBs were first formed“ says Annika Shuali, certified clinical research coordinator at the University of Virginia.

Clearly, reforms are needed to update the aging IRB system. In theory, centralization through the sIRB may improve efficiency. However, in practice, the complexities and details of conducting clinical trials at specific sites such as resolving individual conflicts of interest, being compliant with local regulations, and accounting for the specific rights of certain populations make centralization extremely difficult. To address these site-specific issues, local IRB’s may still need to be in place, but now required to communicate to the sIRB, potentially increasing administrative burden, which undermines the original motivation to streamline review. Hopefully, the sIRB revision to be implemented next year will be further revised to address the critiques from the majority of the community.

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Written by sciencepolicyforall

December 3, 2016 at 11:46 am

How Much Neuroscience Funding is the Right Amount?

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By: Brian Russ, PhD

Source: pixabay

       Scientific funding can be a very tricky proposition. Unfortunately, there is a finite amount of money that is put towards science each funding cycle. This means that at any given time funding agencies need to decide where they believe their funds will be best spent. Every funding cycle, one can find different groups lamenting that their favorite topic is “being underfunded” while some other group is getting “too big a piece of the pie”. There is often no right answer to the question of how much is the right amount of funding to provide different topics, and the likelihood is that at the end of the day every group will feel that they are not getting the right amount of respect and funding.

This debate has come to the forefront recently in the fields of psychiatry and neuroscience with a change in the leadership at the National Institute of Mental Health (NIMH). In September, Dr. Joshua Gordon became the new director of the NIMH. Dr. Gordon’s directorship of the NIMH comes after a 13-year period of leadership by Dr. Tom Insel. During the previous administration, there had been an increasing focus on funding neuroscience related work, often at the expense of purely behavioral work, such as cognitive behavioral therapies for psychiatry patients. It is important to point out that the NIMH’s definition of neuroscience research includes basic, translational, and clinical neuroscience research. This direction led to a new research framework for studying mental health disorders termed the Research Domain Criteria (RDoC), which has a very strong neuroscience component. The goal of RDoC is to provide a new framework in which researchers and clinicians can study and treat mental health disorders. The RDoC framework involves neuroscience components of brain circuits and physiology, and cognitive components of behavior and self-reports. The end goal is to provide a more comprehensive description of mental health disorders with the intention of developing cures and treatments. This push toward RDoC, and more neuroscience in general, has led to both praise and criticism of where the NIMH is directing its funding opportunities.

Recently, an opinion piece was published in the New York Times stating that the NIMH needs to reverse their push towards more neuroscience. Specifically, Dr. Markowitz, a research psychiatrist from Columbia University, believes that the NIMH has been funding neuroscience at the expense of clinical psychological research, in the absence of a brain oriented component. His argument is that in the current funding environment only 10% of the NIMH’s research budget is going towards clinical research. From the content of his article the research he is speaking of involves behavioral studies and interventions that contain no neuroscience component. Dr. Markowitz brings up many important points, and his main thesis that we cannot forget about behavioral interventions while pursuing the biological bases of clinical disorders is critical. For example, he makes the strong point that neuroscience research is unlikely to help solve the problem of suicide. And his final argument is for a “more balanced approach to funding clinical and neuroscience research.”

However, one can argue what that balance should actually look like. Is ten percent of the budget actually a small amount? And does that number include the multitude of basic neuroscience studies that are investigating the neural underpinning of a given disease? For example, based on the NIH reporter, schizophrenia research has been funded for approximately 250 million dollars for each of the last three years. A quick look at the total budget (32.3 billion in 2016, with ~25 billion going to research grants) suggests that that would be on the order of about 1% of the total NIH research budget. This is only one disease, and is being calculated from the whole NIH budget, not just from the NIMH budget. Only a portion of that funding is going towards clinical research, as Dr. Markowitz would define it, however the rest of that funding is going to research that will in all likelihood provide clinical benefits to patients down the road, in the form of new physiological targets or potentially new drugs.

So how can one make a determination about the correct of amount of funding that should go towards different mental health fields? Should 25% or 50% of the budget go towards clinical research? It seems that comparing the percent of money going to clinical research versus neuroscience is simply a bad comparison. Neuroscience is not one homogenous topic; it includes tens of, if not over a hundred, different fields. The various mental health fields fighting each other over funding doesn’t help anyone. Both neuroscience and clinical research need to be funded. It seems that the best way to divide the funding from NIMH would not be to specify what field gets priority but instead to fund the best grants regardless of whether there is a specific component involved. This would open the door to more clinical research while not requiring a shift in the priorities of the NIMH, whose mission is to understand and treat mental illnesses though both basic and clinical research. For instance, RDoC already contains both behavioral and self-report components. These components should be given as much priority as the other neuroscience components. If 10% of the budget is given to behavioral work, in this way, that would seem reasonable, possibly even greater than other areas might be getting.

On a final note, while we should always be looking internally at how we are funding different types of science, and if we, the public, are getting our money’s worth out of projects, it is also important for us to ensure that science funding as a whole is increasing. The current funding environment has been relatively static for years. We need, through advocacy and outreach, to get the public and government to provide more funding opportunities to the NIH. As the saying goes “a rising tide raises all boats”.

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November 17, 2016 at 6:53 pm

Science Policy Around the Web – October 28, 2016

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By: Emily Petrus, PhD

Source: Flickr, under Creative Commons

Technology and Health

Can You Please Pass the iPad?

As digital media screens have become more prevalent, doctors have warned parents of its negative impact on developing minds. In 1999, screen time was first addressed, with doctors mandating that no screen time was recommended for children under age 2.   The argument goes that children need parents present in real-time to interact with to develop the ability to read social cues and engage on a personal level.

Now the American Academy of Pediatrics (AAP) has dictated that one hour per day of high-quality educational screen time may be allowed for children between 2 and 5 years of age. For children 18 months to 2 years, some screen time is ok as long as a parent is actively engaged and watching with the child. This is especially relieving for parents of children who have relatives far away who use Skype or FaceTime to communicate. Although this is technically screen time, it does benefit children with those important social interactions and reading facial and vocal cues.

Overall the goal of the AAP is to ensure that media is used in a mindful way, not to replace social interactions but to enhance family discussions and provide supplementary education material for older age groups. They also recommend media-free family time to ensure children develop a healthy relationship with technology. Jenny Radesky, MD, FAAP and lead author for the statement said, “What’s most important is that parents be their child’s media mentor. That means teaching them how to use it as a tool to create, connect and learn.” In relation to screen time rules, it seems the amount of parent involvement and moderation are the keys to success. (AAP)

Mental Health Research

New Director of National Institutes of Mental Health (NIMH)

NIMH has a tall order to fill: bridge the gap from the breakneck speed of basic neuroscience research advances to bring solid and reliable treatments to the clinic. Last month NIMH welcomed a new director, Dr. Joshua Gordon, to take the helm and direct the institute toward a balance between these two priorities. After 19 years as a faculty member at Columbia University, Gordon hopes to bring his experience as both a clinician and a researcher to achieve this delicate result.

NIMH’s strategic plan for research was laid out in September, with four priorities highlighted to combat mental illness. These include describing mechanisms of complex behaviors, at the molecular, cellular, circuit and genetic levels. Second, characterizing mental illness trajectories to determine best intervention procedures and time points, which would include detecting biomarkers and understanding how behavior reflects neuropathology. Third, NIMH strives to marry tried and true existing treatments with new therapies which can be implemented in community settings, thus bringing help to patients. Finally, NIMH funded research must improve public health, with better clinician education about new treatments, and new service delivery models that can be implemented to reach more patients suffering from mental illness.

These are all monumental tasks but Gordon seems up for the challenge. In a recent Q&A session by Meredith Wadman of Science Magazine, he was asked about the op-ed pieces in the Washington Post and the New York Times by NIMH clinical psychiatrists where they accused previous director Thomas Insel of putting too much priority on basic research and letting clinical neuroscience fall by the wayside. Gordon replied by saying, “I think my first priority is good science. Where there are opportunities in psychiatry for short-term effects, we are going to try to take advantage of them. Absolutely. We’d be mad not to. We know so little about the brain, we have so few truly novel treatments in the pipeline that I’m all ears.” (NIH News Release)

Autism

Autism early intervention – help the parents, help their children

The plight of the working parent has become an important and almost bipartisan issue this election season. Politicians are proposing policies that will help families with paid family leave and some help with childcare costs, however there is a growing segment of people who desperately need even more help. Raising a child with autism is increasingly common, currently 1% of children and young people in the US are on the spectrum.

The cost of having an autistic child can be tremendous, with extra health care expenses, special equipment, classes and educational requirements. Often one parent must leave the workforce to care for their child as they require extensive and specialized care. Early interventions such as classes and therapy are thought to be effective for lessening the symptoms of autism, but until now the trials have been small and have had short end points. This week The Lancet published an article demonstrating that interventions aimed at educating parents of autistic children had long-term (up to 6 years) benefits. 152 children aged 2-4 years old were recruited to the study, with half given interventions that included therapy, monthly support and a parent-mediated 20-30 minute daily session of planned activities. The children who received this extra support reported lower levels of severe autism and had better teacher and parent assessed behaviors. However, the study did not find significant reductions in anxiety or depression or a language benefit.

This study demonstrates that providing education and resources for parents of autistic children are a worthwhile endeavor. Government resources are often aimed at providing services for the child, which are equally important. Parents armed with the proper educational tools can become personalized therapists for their children, which could reduce societal costs and improve outcomes. (Heidi Ledford, Nature)

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October 28, 2016 at 10:50 am

Science Policy Around the Web – August 12, 2016

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By: Danielle Friend, Ph.D.

Photo credit: photo credit: Research Grade Cannabis sativa via photopin (license)

Federal Biomedical Research

The White House plans to make conducting marijuana research easier

Obama is making moves that will make it easier for scientists to access marijuana for research purposes. Currently, the National Institute on Drug Abuse partners with University of Mississippi as the sole source authorized to grow marijuana for scientific research. However, many scientists who would like to study the drug state that because only one institution is authorized to produce the marijuana, researchers often must wait years to obtain it. In order to increase the amount of research grade marijuana available, the Drug Enforcement Administration (DEA) will grant more universities the ability to apply for permission to grow marijuana.

Marijuana is currently approved for medical use in 25 states treat conditions such as Parkinson’s, Crohn’s and Alzheimer’s disease, Tourette’s syndrome, lupus, rheumatoid arthritis, and more. However, although it is approved for medicinal use, it remains unclear how effective marijuana is for treating these diseases, an answer that requires clinical research. Furthermore, whether marijuana impacts the developing brain or causes long-term change in brain function are questions that are simply not known. Increased production of research grade marijuana may allow scientists to answer these questions faster.

One additional barrier that stands in the way of scientists conducting marijuana research is the fact that marijuana is considered a schedule I drug, meaning it has no recognized medical benefit. Schedule I drugs have the most restrictions and this category also include drugs such as heroin, LSD, ecstasy, methaqualone, and peyote. In order to conduct marijuana research, researchers must first obtain a Schedule I drug license which is often very difficult and time consuming. However, the DEA suggested earlier this year that they may move marijuana to a less restricted category, thus allowing researchers to more easily to the drug. (Catherine Saint Louis and Matt Apuzzo, New York Times)

Stem Cell Research

The National Institutes of Health reconsiders moratorium on human-animal stem cell research

The National Institutes of Health (NIH) announced this month that it is reconsidering the ban on some human-animal stem cell research. For quite some time now, researchers have been transplanting human cells into animals to study things like cancer and tumor formation. However, the specific transplantation of stem cells, cells that have the ability to become many cell types in the body including skin cells, blood cells, into cells that make up the kidneys, brain, has been banned.

Lifting the ban on human stem cell chimera research would allow scientists to conduct experiments like growing human kidneys in pigs, kidneys that could later be given patients waiting a transplant. This advance could significantly decrease the wait time on organ donor lists.

While advances such as growing organs for patients in need of transplants sounds intriguing, several concern regarding the use of human-animal stem cell research still remain. Dr. Paul Knoepfler, a scientist at the University of California, Davis is concerned about ethical issues that may arise when, for instance, human stem cells are injected into an animal’s brain. “There’s no clear dividing line because we lack an understanding of at what point humanization of an animal brain could lead to more human-like thought or consciousness,” he stated. Despite the changes mentioned above, the NIH will still ban funding for research that would result in an animal with human sperm or eggs that would then be bred.

The change to the human-animal stem cell ban is currently in a 30-day public comment period where members of the public can voice concerns and questions regarding the proposed changes prior to change taking place. More information can be found in a blog post written Dr. Carrie Wolinetz, the Associate Director for Science Policy at the NIH. (Gina Kolata, New York Times)

Zika

Phase 1 begins for Zika vaccine

The National Institute of Allergy and Infectious Diseases (NIAID) announced this month that it will begin a safety and efficacy clinical trial for a vaccine against the Zika virus. The director of NIAID, Dr. Anthony S. Fauci, M.D. stated “A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative….NIAID worked expeditiously to ready a vaccine candidate, and results in animal testing have been very encouraging. We are pleased that we are now able to proceed with this initial study in people.”

The first stage of the clinical trial will include approximately 80 volunteers ages 18-35. During this safety and efficacy portion of the trial, healthy volunteers will be randomly divided into one of four study groups. Each participant will receive a vaccination at their first visit, and half of the participants will receive one additional vaccination eight weeks or 12 weeks later. The remaining participants will receive two additional vaccinations. Each participant will receive the same dose at each vaccination. Participants will then return for follow-up visits after the first vaccination so investigators can monitor their health to determine if the vaccine is safe. Investigators will also take blood samples to test the immune response to the vaccine. Findings from these trials are expected to be completed by January of 2017. Should the findings indicate that the vaccine is both safe and effective, NIAID plans to begin more to phase two clinical trials, a phase where the vaccine is given to a larger group of volunteers to further evaluate the vaccines safety and efficacy. This they believe, will begin in early 2017.

The clinical trial for the new vaccine is part of the U.S government’s response to the outbreak of Zika in the Americas. Increased concern about the virus has spread across the United States as the first cases of locally transmitted Zika in Florida and an infant death in Texas associated with the virus have been documented. Although the first phase of the trial began this month. Dr. Fauci said he is concerned about running out of money to launch the larger phase two next year. President Obama asked Congress to approve $1.9 billion in emergency funding for Zika in February, but lawmakers were not able to agree on a funding package, and have since left for their August recess. Without more money, the future trial phases may be delayed. (NIH news release)

Public Health

New steps for reducing the Opioid Epidemic

President Obama signed new legislation into law in late July aimed at mitigating the growing opioid epidemic in the United States. The growing concerns regarding opioid abuse have risen from data indicating that deaths associated with prescription opioids have increased by 16% while death associated with heroin have increased by 28% since 2013. Even more strikingly, deaths associated with synthetic opioids like fentanyl and tramadol have increased by 79% between 2013 and 2014 alone. In fact, deaths associated with heroin, prescription drugs, and opioid pain relievers surpassed death associated with car accidents as the leading cause of injury-related deaths. Given these statistics, opioid abuse has been a hot topic across party lines. Early on in the primaries for both democrat and republican nominations, Hillary Clinton discussed the priority of developing legislation to end the epidemic while other candidates including Jeb Bush, John Kasich, Chris Christie, and Carly Fiorina all expressed interest supporting such legislation.

The new billed also known as the Comprehensive Addiction Recovery Act of 2016 or S.524 and H.R 953 had received strong support across party lines. The Senate version of the bill passed 92 to 2 and the House version received co-support from 53 Democrats and 21 Republicans.

The new bill uses several approaches to help reduce opioid use and addiction by:

  • Increasing the availability of naloxone, a drug used to prevent deaths associated with opioid overdose. Plans including providing naloxone to law enforcement and other first responders.
  • Improving methods for monitoring opioid prescriptions. In fact, the CDC released new guidelines earlier this year for the prescription of opioids. This part of the bill will help states better track where prescriptions are going and who is prescribing them. Better monitoring will also help prevent current opioid users from receiving more drug than is need for pain relief.
  • Providing increased resources to treat individuals with addiction rather then implementing punishment or incarceration.

Although President Obama supports the new bill, he suggested it will hopefully be the first step among many to combat the epidemic. “This legislation includes some modest steps to address the opioid epidemic,” the president said in a statement. “Given the scope of this crisis, some action is better than none.” (CJ Arlotta, Forbes)

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August 12, 2016 at 12:00 pm

Science Policy Around the Web – July 12, 2016

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By: Cheryl Jacobs Smith, Ph.D.

photo credit: via photopin (license)

Health Policy

20 Years after Dolly the Sheep Led the Way—Where Is Cloning Now?

Scientist Dr. Ian Wilmut cloned a mammal, Dolly the Sheep, from an adult sheep’s mammary gland. Born on July 5, 1996, Dolly has “[…] changed everything,” says Dr. Alan Trounson, Dr. Wilmut’s colleague. Cloning a mammal changed the scientific dogma of its time and opened up a Pandora’s box of possibilities with significant consequences.

The impact of cloning on basic science has surpassed expectations. Cloning’s biggest impact has been in the advancement of stem cell and developmental biology. Stem cell biologist, Shinya Yamanaka, said via email, “Dolly the Sheep told me that nuclear reprogramming is possible even in mammalian cells and encouraged me to start my own project.” Dr. Yamanaka uses adult cells to make stem cells that can form a wide range of other cells – in a way, reversing their biological clock back to infancy so the cells are “young again” and capable of forming a wide range of other cells. Because they are artificially created and have a variety of features, they are call induced pluripotent stem (iPS) cells. The rise of these iPS cells has reduced the need for embryonic stem cells, an acrimonious ethical dilemma tightly bound with stem cell research.

“Dolly’s birth was transformative because it proved that the nucleus of the adult cell had all the DNA necessary to give rise to another animal,” says stem cell biologist Robin Lovell-Badge, head of the Division of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute in London. Despite the successes achieved with cloning Dolly the Sheep, we likely will not see a cloned human any time soon. The technique used to clone Dolly the Sheep has been unsuccessful in the species closest to humans, primates. Additionally, Dr. Wilmut says, “Just because it may work in the sense of producing offspring doesn’t meant to say we should do it. The likelihood is that you would get pregnancy losses, abnormal births. I wouldn’t want to be the person who looked a cloned child in the face and said ‘very sorry.’” Others think that the recent advances in gene-editing technology (such as CRISPR), to correct genetic errors, will diminish the need to clone. Additionally, the thought of cloning a deceased loved one or beloved pet has reduced in popularity because of the recognition that the environment affects behavior along with genetics. It is unlikely the cloned subject would be a “true” clone when it comes to personality traits that helped create the initial bond.

Sadly, Dolly died on February 14, 2003, at the age of six due to a lung infection common among animals who are not given access to the outdoors. What started out as an unexpected discovery (Dr. Wilmut and his colleagues admit Dolly’s birth was a lucky accident) has paved the way for significant discoveries in stem cell biology and in how we view one another as people. 20 years after Dolly the Sheep scientists, ethicists, and society are still putting all the pieces together to figure out the mysteries of life and who should hold the key of creation. (Karen Weintraub, Scientific American)

Breast Cancer Research

NIH launches largest-ever study of breast cancer genetics in black women

A $12 million collaborative research grant awarded to Dr. Wei Zheng, M.D., Ph.D., of Vanderbilt University, Christopher Haiman, Sc.D., of the University of Southern California, and Julie Palmer, Sc.D., of Boston University will support the largest-ever study of breast cancer genetics in black women. The collaborative research project, funded by the National Cancer Institute (NCI) part of the National Institutes of Health (NIH) will build on years of research cooperation among investigators who are part of the African-American Breast Cancer Consortium, the African-American Breast Cancer Epidemiology and Risk (AMBER) Consortium, and the NCI Cohort Consortium. These investigators are from various institutions and will share biospecimens (such as patient blood, urine, etc.), clinical characteristics, and resources from 18 previous studies, resulting in a study population of 20,000 black women with breast cancer.

Acting Director of the NCI, Douglas R. Lowy, M.D. says, “This effort is about making sure that all Americans – no matter their background – reap the same benefits from the promising advances of precision medicine. Survival rates for women with breast cancer have been steadily improving over the past several decades. However, these improvements have not been shared equally across the board – black women are more likely to die of their disease and have a more aggressive breast cancer subtype that is more difficult to treat. The exact reasons for these disparities are unclear, although previous studies suggest that the underlying causes are multifactorial with a complex interplay between genetic, environmental, and societal factors.”

“This $12 million grant — in combination with previous investments — should help advance our understanding of the social and biological causes that lead to disparities in cancer among underserved populations,” said Robert Croyle, Ph.D., director of NCI’s Division of Cancer Control and Population Sciences (DCCPS), which is administering the grant. “A better understanding of the genetic contributions to differences in breast cancer diagnoses and outcomes among African-Americans may lead to better treatments and better approaches to cancer prevention.” (NCI Press Officers, NIH)

Science Education

Schools Look to Legos to Build Science Interest

Superintendent Nikolai Vitti of the Duval, Florida school district has proposed spending $187,700 to set up Lego robotics teams in 50 schools, an increase from the 36 schools currently operating such clubs. The long-term vision is to have robotics teams in all 161 Duval public schools. The hope is that this extracurricular activity will spark students’ engagement in technology fields and hopefully get them more involved in math, science and computers in class.

Mr. Vitti wants the school district to work with Renaissance Jax, a nonprofit Lego League and affiliate partner for “For Inspiration and Recognition of Science and Technology” (FIRST). FIRST organizes thousands of robotics and technology competitions around the country from kindergarten through 12th grade. The contract would involve training teachers and volunteers to run the teams and to coordinate practices and competitions.

FIRST team surveys show that 86 percent of participants say they are more interested in doing well at school, 84 percent are motivated to take challenging math and science courses, and 80 percent are more interested in Science-Technology-Engineering-Math (STEM)-related jobs. What’s more, the gender gap in science and technology is not apparent at the tournaments. Mechanisms such as these introduced early on and throughout children’s education may help to increase student’s desire for a STEM education and decrease STEM bias among men and women. (Associated Press, U.S.News)

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Written by sciencepolicyforall

July 12, 2016 at 10:00 am