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Posts Tagged ‘Stem Cells

Science Policy Around the Web – November 22, 2016

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By: Rachel Smallwood, PhD

Photo source: pixabay

Federal Research Funding

US R&D Spending at All-Time High, Federal Share Reaches Record Low

Recently released data from the National Science Foundation (NSF) showed trending increases in scientific research funding in the US across the past several years. Estimates of the total funding for 2015 put the value at an all-time high for research and development (R&D) funding for any country in a single year. In 2009, President Obama stated a goal to devote 3% of the USA’s gross domestic product (GDP) to research, and we have been making slow progress to that point; in 2015, 2.78% of the GDP went to research. Businesses accounted for the largest portion of overall scientific funding, contributing 69% of the funds. The second largest contributor was the federal government; however, it had the lowest percentage share of the total since the NSF started tracking funding in 1953, and the actual dollar amount contributed has been declining since 2011. Therefore, although the overall percentage of GDP going to research is increasing, that increase is driven by businesses, whereas the GDP percentage contributed by the federal government has dropped to almost 0.6%.

When taking a closer look at types of research, the federal government is the largest funding source for basic science research, covering 45% of the total. However, businesses make up the majority of the funding for applied research (52% in 2014) and experimental development (82% in 2014). This disproportionality in funding types combined with the decreases in federal research spending are concerning for the basic science field. There is more competition for less money, and this concern is compounded by uncertainty and questions about President-Elect Trump’s position on and plans for scientific funding. Aside from a couple of issues, primarily concerning climate change and the environment, he has said very little about science and research. Many scientists, institutions, and concerned citizens will be watching closely to see how science policy develops under Trump’s administration and its effects on federal spending and beyond. (Mike Henry, American Institute of Physics)

Biomedical Research

‘Minibrains’ Could Help Drug Discovery for Zika and for Alzheimer’s

A group of researchers at Johns Hopkins University (JHU) is working on a promising tool for evaluating disease and drug effects in humans without actually using humans for the tests. ‘Minibrains’ are clusters of human cells that originated as skin cells, reprogrammed to an earlier stage of development, and then forced to differentiate into human neural cells. They mimic the human brain as far as cell types and connections, but will never be anywhere near as large as a human brain and can never learn or become conscious.

A presentation earlier this year at the American Association for the Advancement of Science conference showcased the potential utility for minibrains. A large majority of drugs that are tested in animals fail when introduced in humans. Minibrains provide a way to test these drugs in human tissue at a much earlier stage – saving time, money, and animal testing – without risking harm to humans. Minibrains to test for biocompatibility can be made from skin cells of healthy humans, but skin cells from people with diseases or genetic traits can also be used to study disease effects.

A presentation at the Society for Neuroscience conference this month demonstrated one such disease – Zika. The minibrains’ growth is similar to fetal brain growth during early pregnancy. Using the minibrains, Dr. Hongjun Song’s team at JHU was able to see how the Zika virus affected the cells; the affected minibrains were much smaller than normal, a result that appears analogous to the microcephaly observed in infants whose mothers were infected with Zika during the first trimester.

Other presentations at the meeting showcased work from several research groups that are already using minibrains to study diseases and disorders including brain cancer, Down syndrome, and Rett syndrome, and plans are underway to utilize it in autism, schizophrenia, and Alzheimer’s disease. Though there might be a bit of an acceptance curve with the general public, minibrains potentially offer an avenue of testing that is a better representation of actual human cell behavior and response, is safer and more affordable, and reduces the need for animal testing. (Jon Hamilton, NPR)

Health Policy

A Twist on ‘Involuntary Commitment’: Some Heroin Users Request It

The opioid addiction epidemic has become a significant healthcare crisis in the United States. Just last week the US Surgeon General announced plans to target addiction and substance abuse. He also stated the desire for a change in perception of addiction – it is a medical condition rather than a moral or character flaw. Earlier this year, the Centers for Disease Control published guidelines that address opioid prescribing practices for chronic pain, strongly urging physicians to exhaust non-pharmacologic options before utilizing opioids. In response to the rising concern over prescription opioid abuse, steps have been taken to reduce prescriptions and access. This has resulted in many turning to heroin – which is usually a cheaper alternative anyway – to get their opioid fix.

One of the first steps in treatment and recovery for addiction and dependence is detoxing. However, opioids are highly addictive and many people struggle with the temptation to relapse. Additionally, many of the programs designed to help with the initial detox have long wait lists, are expensive, and may not be covered by insurance, further deterring those with addiction and dependence from getting the help they need. These factors have caused many to start turning to their states, asking to be voluntarily committed to a program on the basis that they are a danger to themselves or others because of their substance abuse. This is currently an option in 38 states. These programs can be held in either privately-run institutions or in state prisons. However, this practice is controversial because if the person’s insurance does not cover their stay, it falls to tax payers to foot the bill. While this is unpopular with some, advocates say the civil commitment laws are important options while there may be no other immediate ways for an individual to get help. (Karen Brown, NPR)

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November 22, 2016 at 9:00 am

Science Policy Around the Web – October 25, 2016

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By: Nivedita Sengupta, PhD

Source: pixabay

Clinical Trials

EMA becomes first major drugs agency to publish clinical-study reports online

On 20th October, the London-based European Medicines Agency (EMA) published details of the full clinical-trial data that it received from pharmaceutical companies, some 100 clinical reports, about two EMA-approved medicines, carfilzomib, a cancer drug, and lesinurad, a gout treatment. The disclosures make the EMA the first major drug regulatory agency to completely publish the results of clinical investigations that drug developers submit while applying for the agency’s approval to market medicines in the European Union. “These clinical study reports (CSR) are much more detailed than the papers that drug firms publish in scientific journals. It includes both positive and negative results, and details of drugs’ adverse effects,” says Larry Peiperl, the chief editor of PLoS Medicine.

Under the rules the EMA brought in six years ago, it had released results of such studies only if third parties asked for them using freedom-of-information requests. However, those rules allowed some drug firms to drag the agency to court to try to prevent their data from being released, arguing it as commercially confidential. However, patients and clinicians have waited long, and about 700 medical and patient organizations had lobbied for clinical data release under the All Trials campaign. “The EMA’s CSR policy adopted in 2014 will benefit both academic research and the practice of medicine as a whole,” says EMA executive director Guido Rasi. It will help academicians to independently re-analyze data even after a medicine has been approved, and will help drug developers to learn from the experiences of others.

The EMA intends to release all CSRs in applications that were submitted since 1st January 2015. It will only edit some commercially confidential information like individual patient data before release. After the clearance of backlog, the EMA says that it will offer public access to around 4,500 clinical reports each year.

Some drug firms are still resisting the release of their data by the EMA. In the latest legal battle this July, an interim judicial EU court order blocked the EMA from releasing toxicity studies on a veterinary medicine called Bravecto (fluralaner), and clinical-study reports on Translarna (ataluren), a treatment for Duchenne muscular dystrophy. The two drug firms concerned, Intervet and PTC Therapeutics, argued that the release of data would infringe on their rights to protect commercially confidential information. However, the EMA has appealed against both decisions on 29th September, and says that it sees the cases as a test of its policy. (Alison Abbott, Nature News)

Biotechnology

In a first, mouse eggs grown from skin cells

For the first time, stem cell researcher Katsuhiko Hayashi of Kyushu University in Fukuoka, Japan, and colleagues have reprogrammed fibroblasts from the tip of an adult mouse’s tail to make eggs, which upon fertilization grew into healthy mice. Earlier, adult body cells were reprogrammed to generate stem cells (induced pluripotent stem cells – iPSCs), which were further induced into becoming a wide variety of other cells but never eggs. Egg cells are much trickier as they represent ultimate flexibility which can create all the bits and parts of an organism from raw genetic instructions. “This is very solid work, and an important step in the field,” says developmental biologist Diana Laird of the University of California, San Francisco. This major development could make it possible in near future to study the formation of gametes — eggs and sperm — an unknown process that takes place inside fetuses. Moreover, if the experiments gets extended to human cells, it could make eggs easily available for research and may eventually lead to infertility treatments.

In this experiment, Hayashi and colleagues made artificial ovaries by extracting ovarian support cells from albino mouse embryos, which were then mixed with primordial germ cell‒like cells created from tail-tip skin cells from a normally pigmented mouse. After 11 days of maturation followed by fertilization, the eggs were transplanted into the uteruses of female mice. Six pups with dark eyes were born, indicating that they came from the tail-tip eggs and not eggs accidently extracted from the albino mice along with the ovarian support cells. The baby mice grew up apparently healthy and have produced offspring of their own.

As ovarian cells from mouse embryos were still needed to support the growth of eggs in vitro this could be a potential problem when trying to replicate the experiments in humans. “It’s yet unclear how support cells in ovaries foster egg development. Researchers can’t yet reproduce the supporting cells in the lab and so need to get those cells from embryos,” Hayashi says. (Tina Hesman Saey, ScienceNews)

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October 25, 2016 at 10:55 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 – February 23, 2016

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By: David Pagliaccio, Ph.D.

Kris Krüg via Photo Pin cc

Science in Schools

Climate confusion among U.S. teachers

Despite the vast agreement among scientists that global warming is occurring due to human activities, many difficulties persist in conveying this to middle and high school students. A new survey published in Science indicates that 74.3% of middle and high school science teachers discuss global warming but only at median rate of 1.5 class hours. Importantly, only 54% of teachers are clearly stating that fossil fuel use is a major cause of global warming rather than natural causes. The remainder presents a mixed message about the role that humanity plays in global warming vs. natural factors, denies humanity’s role, or does not present the causes of global warming. This may be due to several causes. Luckily, few teachers felt outside pressures from parents, school administrators, etc. to not teach about climate change. Instead, it appeared that a large percentage of teachers did not know the consensus among scientists and thus try to present a two-sided case about global warming. Further, less than half of teachers reported having formal training on climate change during their education though newer teachers were more likely to discuss the human causes of global warming. The authors also indicate a role for sociopolitical ideology where teachers with a more conservative view of the government’s role were less likely to emphasize teaching about the causes of climate change. The authors call for improved training, continuing education, and content materials, including updated textbooks, to aid in addressing this issue as well as trying to work to improve science literacy. (Eric Plutzer, Mark McCaffrey, A. Lee Hannah, Joshua Rosenau, Minda Berbeco, and Ann H. Reid, Science Education; USNews.com; NPR)

Science Funding

Budget 2017

President Obama has requested increased science funding in his fiscal year 2017 budget, yet people have concerns over the strategy for this and the likelihood of it passing Congress. Particularly, he requested an additional $825 million be allocated to the National Institutes of Health (NIH), but this money was set to come from mandatory funds. Further, $1 million of the NIH’s current budget was slated to be moved from regular appropriations processes to mandatory funds. There are concerns that Congress will not approve these mandatory funds, which require that a dedicated funding source be established. If approved, this new money would go to support new cancer initiatives, the Precision Medicine Initiative, and the BRAIN initiative with little going to the other NIH institutes. The Food and Drug Administration (FDA) would also not get much of a general increase in funding but would get money specifically for its role in Precision Medicine Initiative and the new cancer programs – also from mandatory funding. The President has also called for a $500 million increase in funding for the National Science Foundation (NSF) coming from both discretionary and mandatory spending streams. Again, there is doubt that Republicans will approve of allocation through mandatory spending streams that will require selling federal assets, which would leave only a small increase in NSF funding through discretionary spending. While there are many increases in science funding budgeted for, many people are disappointed in the means of funding allocation and are less than optimistic for passing this proposed budget. (Science News Staff, Science Insider)

Federal Regulations

Could FDA E-Cigarette Regulations Help More People Quit Smoking?

While e-cigarettes are generally expected to be safer than traditional cigarettes due to the lack of tar from burning tobacco, research is limited and major health organizations currently do not recommend using e-cigarettes to help people quit smoking. Despite the large and expanding market for e-cigarettes, there are essentially no federal rules or regulations regarding anything about the e-cigarette industry, including sales and advertising. Several attempts have been made to regulate e-cigarettes with the FDA first trying to regulate e-cigarettes as a drug-device combination in 2009. This was overruled by the courts, which deemed e-cigarettes a tobacco product in the next year. Further, the President’s Family Smoking Prevention and Tobacco Control Act allowed the FDA to regulate some tobacco products but did not specifically list e-cigarettes. In 2014, the FDA called for authority to specifically regulate e-cigarettes and is awaiting final approval. While no real federal regulations are in place, some states have enacted minimum purchasing age laws, tax e-cigarettes, or call for e-cigarettes to only be used in places where other tobacco products can be used. The science regarding the potential harms of e-cigarettes and any potential benefits to smoking cessation are lacking leading to much fractured debate over regulatory policy, which will continue as the FDA’s role continues to unfold. (Michael P. Eriksen, USNews.com)

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February 23, 2016 at 9:00 am

Science Policy Around the Web – February 5, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Environment, science and society

Congress approves bill to ban plastic microbeads in skin care products

Plastic microbeads used in a variety of personal-care products from soaps to face washes will be phased out starting in 2017. Microbeads are tiny plastic particles used as an abrasive in many beauty products such as facial scrubs, soaps, and toothpastes. These beads do not dissolve and can remain in the environment for decades.

The Microbead-Free Waters Act of 2015 was introduced by Congressmen Frank Pallone, Jr. (NJ-6), Ranking Member of the House Energy and Commerce Committee, and Fred Upton (MI-6), Chairman of the Committee. It is believed that “these tiny plastic particles that are polluting our environment are found in products specifically designed to be washed down shower drains,” said Pallone. “And many people buying these products are unaware of their damaging effects on the environment.” This view is in alignment with research that shows how these beads slip through wastewater treatment systems and into waterways. Sherri A. Mason, an environmental chemist at the State University of New York in Fredonia, estimates that 11 billion microbeads are released into the nation’s waterways each day.

At the state level, states such as Illinois and California already have passed microbead bans while more than half of the states are considering them. However, the growing number of state and local laws with conflicting restrictions and timelines helped to motivate the sponsor of the bill in the Senate. The federal legislation will prohibit the manufacture of products containing plastic microbeads as of July 1, 2017, and phase out sales of the product over the next two years. The federal law will take precedence over state laws that are starting to phase out microbeads over similar concerns. (Congressional Research Service)

CRISPR technology

UK scientists gain license to edit genes in human embryos

A team of British scientists has received permission to edit genes in human embryos for scientific studies. Although there is currently a voluntary moratorium observed by scientists worldwide on DNA alterations that could be passed down to subsequent generations, the proposed studies would not contradict them because the altered embryos will not be implanted into a womb.

On February 1st, the British regulatory agency that oversees reproductive biology, the Human Fertilization and Embryology Authority, approved an application by Kathy Niakan, of the Francis Crick Institute in London, to utilize a new genetic editing technique called Clustered regularly-interspaced short palindromic repeats or CRISPR (or CRISPR/Cas9) to alter human embryos. This CRISPR system enables researchers to precisely remove specific DNA sequences.

In the United States, Congress has banned the government from supporting research where a human embryo is destroyed. This ban, however, does not apply to privately or state funded researchers. “This type of research should prove valuable for understanding the many complex issues around germline editing,” said George Daley, a stem-cell biologist at Boston Children’s Hospital in Massachusetts. “Even though this work isn’t explicitly aiming toward the clinic, it may teach us the potential risks of considering clinical application.” (Ewen Callaway, Nature)

Federal Research Funding

White House wants $1 billion for Vice President Biden’s cancer moonshot. Where will it come from?

In his next upcoming budget, President Barack Obama will ask Congress for $755 million for cancer research. This will bring the total price tag of Vice President Joe Biden’s cancer “moonshot” to $1 billion. However, it is still not known if Congress will agree to this new funding proposal for 2017. In addition, it is also not known how much existing money will be reshuffled at the National Institutes of Health (NIH) in order to support this year’s moonshot plans.

Currently, the White House plans to immediately fund the Moonshot initiative with $195 million in “new cancer activities” at NIH for the 2016 fiscal year. Most of this spending is predicted to occur at the National Cancer Institute (NCI) which already received a $264 million boost in new money this year as part of the overall $2 billion NIH budget increase. Although researchers are “very excited and enthusiastic” about the initiative, they have questions about exactly where the money will come from, says Jon Retzlaff, managing director for science policy and government affairs for the American Association for Cancer Research in Philadelphia, Pennsylvania. Bolstering certain NCI programs partway into the fiscal year may force the institute to divert funds from other programs.

Currently, Biden plans to continue the moonshot’s financial momentum in the White House’s FY 2017 budget request to steer $75 million to the U.S. Food and Drug Administration for moonshot activities, and $680 million for NIH. If this request will be approved by Congress is still up in the air, Retzlaff notes. This is because the budget request calls for using “mandatory funds” to pay for these increases. Mandatory funds are not directed through the regular annual appropriations process, but instead the money comes from dedicated sources approved by Congress. Using mandatory funds preempts congressional oversight which is generally not supported by lawmakers. If approved, this additional funding will represent an increase of about 15% over what the federal government is already spending on cancer research, the nation’s second leading cause of death. (Jocelyn Kaiser, Science magazine)

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February 5, 2016 at 9:00 am

Science Policy Around the Web – September 1, 2015

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By: Daniël P. Melters, Ph.D.

Picture source: Dr. Torsten Wittmann, UCSF via Nikon’s Small World, 2003 Photomicrography Competition

Clinical Stem Cell Regulations

China announces stem-cell rules

Long-awaited regulations by the Chinese government meant to curb rogue stem cell clinics offering unproven treatments have been announced. Overall, these new regulations have been welcomed by stem-cell scientists in China and the rest of the world. The measures offer a straightforward path towards clinical studies. China’s stem cell clinics have been subject of criticism by Chinese government and the scientific community, but these clinics keep offering desperate patients costly, and most likely, ineffective treatments. These were often labelled as clinical trials as a cover to charge patients.

The new measures outline requirements for such studies, including obtaining a patient’s informed consent and using clinical grade stem cells that have been approved by an independent body. Only authorized hospitals will be allowed to carry out such stem cell treatments. These hospitals will be forbidden to charge patients or advertise their treatment options. Researchers who plan to do a pilot study, will have to register with the Chinese health ministry and show documentation in line with pharmaceutical companies trying to get a drug approved in the US. The mechanism laid out for clinical studies looks pretty similar to those in other countries, and more rigorous than some. But the measures might not apply to military hospitals, or to private clinics affiliated with military hospitals, which have in the past fallen outside health-ministry jurisdiction in China. Despite the general optimism, there is one major concern. The new measures are unclear in how it will be enforced. (David Cyranoski, Nature News).

CRISPR and GMOs

Genetic Modification Market

Alphabet, soon-to-be Google’s mother company, might enter the genetic modification market, a business that seems far away from the advertisement-supported search engine. Recently, Google has invested in the CRISPR genetic modification company Editas Medicine via its ventures. Combined with a report from The Information website and contemplations by one of its leaders, Linus Upson, about genetically modified mosquitoes, and it is not too surprising that Google is thinking about this direction. Their goal seems to be in line with the British-based company Oxitec: eliminate disease-carrying mosquitoes to improve human health globally by using genetically modified mosquitoes.

Although the potential of GMO mosquitoes to combat diseases like malaria and dengue are established, the use of CRISPR makes some scientist cautious. CRISPR can be used to employ a technology called “gene drive”. Recently, a group of leading scientists wrote a paper calling for caution in deploying this technology broadly. The main fear: that gene drive has the potential to genetically modify an entire population into GMOs and do it many times faster than naturally evolving species, via a mutagenic chain reaction. To introduce these genetic changes, CRISPR is currently the most obvious technology of choice.

Whether or not Alphabet will produce a viable product, their interest in genetic editing technologies should be a clear sign to the legislatures in Washington, DC that existing regulations need to be updated, and new regulations be introduced to guarantee the safety of people and our environment.

Scientific Reproducibility

Earlier this week, a study was published in Science repeating 98 original psychology papers. Brian Nosek, a social psychologist and head of the Center for Open Science in Charlottesville, Virginia, selected 98 papers from three psychology journals to independently replicate the published results. Only 39% of the 100 repeats were successful. This number is derived from the team’s subjective scaled assessments for success or failure. Furthermore, the team tested if the original studies indeed did find significant results, and 97% of the original studies did, but only 36% were the same results as published. In addition, the team found that the average size of the effects found in the replication studies were only half of that what was reported. Although this study is only a very small sample of all the psychology studies published each year, it is important to realize that scientist should be less confident about their claims.

Nosek’s work is part of the Reproducibility Project which started in 2011 amid many reports of scientific misconduct and retractions, in part as a result of the blog Retraction Watch, founded in 2010. Not only are psychology studies subjected to validation by replication, a similar study in on the way in the field of cancer biology, where critical experiments are reproduced by independent groups who will only use the published protocols. The first results of such verification trials has also call for a critical analysis of preclinical cancer research standards. The team leader of the current psychology replication study does propose a potential solution: in addition to the Transparency and Openness Promotion Guidelines, the scientific community should devote 3% of scientific funding to replication studies. Currently, it is about zero.

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September 1, 2015 at 9:00 am

Science Policy Around the Web – July 18, 2015

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By: Courtney Pinard, Ph.D.

Mental illness

Long-Term Adverse Effects of Childhood Mental Illness

According to the National Institute of Mental Health and the Centers for Disease Control and Prevention, 13% of children in the U.S. have a diagnosable mental illness resulting from changes in brain circuits, behavior, and cognition. A child with a mental illness is more likely to function poorly as an adult than a child without a mental illness. This was the conclusion from a population-based study published this week in the Journal of the American Medical Association (JAMA) Psychiatry. The study examined survey results of 1420 male and female participants from 11 rural counties in North Carolina, to assess if a psychiatric illness in childhood was more likely to predict negative outcomes later in life such as criminal activity, inability to keep a job, divorce, multiple addictions, multiple psychiatric problems or suicidality. Survey responses were taken over two periods, between 9 and 16 years of age and between 19 and 26 years of age. Out of the 1420 participants, 466 (30%) met criteria for subthreshold psychiatric problems only, 527 (26.2%) displayed behavioral or emotional disorders during childhood, and 427 (42.7%) never met these criteria. Participant survey responses taken between 19 and 26 years of age indicated adverse long-term outcomes for adults in the subthreshold psychiatric and behavioral/emotional disorder groups. Participants with a childhood psychiatric disorder were six times as likely to have one adverse adult outcome compared to those with no history of psychiatric problems. Those with milder symptoms were three times as likely to have problems as adults. Interestingly, many of the adult outcomes studied were related to symptoms of antisocial personality disorder. Mild cases of mental illness including emotional or behavioral disorders may remain outside of diagnosable cases, especially during childhood. While it may not be surprising that children with a mental illness often display continued impairment into adulthood, the novel findings here are that the long-term adverse effects were evident even after controlling for sex, race, childhood family hardship variables, and adult psychiatric status. (Ina Yang, NPR)

Stem Cell Research

Using Stem Cells in Research Shows Promise for Autism Models

Federal policies allowing for responsible scientific research involving human stem cells were put in place in 2009 to help scientists better understand the human body, discover new drugs, and replace tissue damaged by disease, aging, or injury. Neuroscientists can use stem cells to study disorders of brain development, such as autism spectrum disorder (ASD). Autism spectrum disorder affects 1 in 68 children in the U.S. Most cases lack a clear genetic basis, and the difficulty of re-enacting human brain development has prevented a full understanding of ASD. A new study published in the journal Cell, by the laboratory of Dr. Flora Vaccarino, the Harris Professor of Child Psychiatry and Professor of Neurobiology at Yale School of Medicine, used a three-dimensional neuron network derived from stem cells derived from the skin of four autistic patients to investigate developmental changes in individuals with severe ASD. While no known underlying genomic mutation could be identified, the researchers did find an upregulation of genes involved in cell division and synapse formation. The number of inhibitory neurons in the neuron network had also increased. A specific gene, FOXG1, was found to be responsible for the overproduction of these inhibitory neurons and correlated with patient symptom severity. Through the use of stem cells, this study may have found one biomarker of ASD that could be a potential drug target. (Melissa Healy, Los Angeles Times – Science Now)

Global Health

Crowdsourcing Simple Solutions to Save Millions of Lives

Every two minutes, a woman dies in childbirth. One in ten newborns needs help breathing and many die without proper care. Clean drinking water is rare in some parts of the world. These global health problems may be eradicated with new cost-effective innovations. The Innovation Countdown 2030 is a list of 30 innovations set up by the international nonprofit, PATH, with the goal of identifying, evaluating, and showcasing health technologies with great promise to save lives. The top 30 were chosen by independent health experts and include a uterine balloon tamponade developed by Massachusetts General Hospital used to stop bleeding in hemorrhaging women, a Zimba Batch Chlorinator to chlorinate water, and a Laerdal Upright Resuscitator to help babies breathe. Most of the innovations on the list are currently in use or undergoing trials in developing countries. With projects like The Innovation Countdown, PATH aims to help make the Sustainable Development Goals, as defined by the United Nations, into reality. (Ina Yang, NPR)

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Written by sciencepolicyforall

July 18, 2015 at 9:00 am