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Science Policy Around the Web – August 26, 2016

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By: Leopold Kong, PhD

Adipose Tissue  Source: Wikipedia Commons, by Blausen.com staff, “Blausen Gallery 2014“.

Health Policy

Is there such a thing as ‘fat but fit’?

Nearly 70% of American adults are overweight or obese, raising their risk for health problems such as heart disease, diabetes, and high blood pressure. However, about a third of obese individuals appear to have healthy levels of blood sugar and blood pressure. Whether these ‘fat but fit’ individuals are actually “fit” has been controversial. A recent study published in Cell Reports has sought to dissect differences in the fat cells of the ‘unfit’ obese versus the ‘fit’ obese using tools that probe the patterns of genes being turned on or off. Fat from non-overweight people were also examined in the study. Interestingly, fat of non-overweight individuals and obese individuals differed in over 200 genes, regardless of ‘fitness’. However, the fat of ‘fit’ versus ‘unfit’ obese individuals only differed in two genes. Dr. Mikael Rydén, the lead author of the study commented: “We think that adds fuel to the debate. It would imply that you are not protected from bad outcomes if you are a so-called fit and fat person.” The study also highlights the complexity of fat’s influence on health, and raises the possibility of ‘fat’ biopsies. For example, fat from normal weight individuals following an unhealthy lifestyle may have marked differences that are diagnostic of future obesity. With the rising cost of treating chronic diseases associated with being overweight, further studies are warranted. (Lindzi Wessel, Stat News)

Biomedical Research

Half of biomedical research studies don’t stand up to scrutiny

Reproducible results are at the heart of what makes science ‘science’. However, a large proportion of published biomedical research appears to be irreproducible. A shocking study by scientists at the biotechnology firm Amgen aiming to reproduce 53 “landmark” studies showed that only 6 them could be confirmed. The stakes are even higher when it comes to pre-clinical cancer research. In fact, they are $30 billion higher, according to a recent study, suggesting that only 50% of findings can be reproduced. Primary sources of irreproducibility can be traced to (1) poor study design, (2) instability and scarcity of biological reagents and reference materials, (3) unclear laboratory protocols, and (4) poor data analysis and reporting. A major stumbling block may be the present culture of science, which does not reward publishing replication studies, or negative results. Higher impact journals generally prioritize work that demonstrates something new and potentially groundbreaking or controversial. When winning grant money and academic posts hinges on impact factor, reproducibility suffers. However, with such high potential for wasting substantial funds on medically significant areas, radical changes in science policy towards publishing, peer review and science education is urgently needed. The recent reproducibility initiative aiming “to identify and reward high quality reproducible research via independent validation” may be a step in the right direction. However, a paradigm shift in scientists’ attitudes towards what constitutes important research might be necessary. (Ivan Orannsky, The Conversation)

Biotechnology

In CRISPR fight, co-inventor says Broad Institute misled patent office

The intellectual property dispute over the multibillion-dollar CRISPR gene editing technology has grown increasingly heated in the last months. With the FDA giving the go-ahead for the first U.S. clinical trial using CRISPR and with China beginning a clinical trial this month using this technology, the tension is high. On one side of the dispute is University of California’s Jennifer Doudna whose initial work established the gene-editing technology in a test tube. On the other side is Broad Institute’s Feng Zhang, who within one year made the technology work in cells and organisms, and therefore broadly applicable for biotechnology. Was Zhang’s contribution a substantial enough advance to warrant its own patents? Was Doudna’s work too theoretical and basic? This week, a potentially damning email that emerged from the legal filings of the dispute was made public. The email is from a former graduate student of Zhang’s, Shuailiang Lin, to Doudna. In addition to asking for a job, Lin wrote that Zhang was unable to make the technology work until the 2012 Doudna publication revealed the key conceptual advances. Lin adds: “I think a revolutionary technology like this […] should not be mis-patented. We did not work it out before seeing your paper, it’s really a pity. But I think we should be responsible for the truth. That’s science.” A spokesperson for the Broad Institute, Lee McGuire, suggested that Lin’s claims are false, and pointed out that Lin was in a rush to renew his visa, and had sent his explosive email to Doudna after being rejected for a new post at the Broad Institute. With CRISPR technology promising to change the face of biotechnology, the drama over its intellectual property continues to escalate. (Antonio Regalado, MIT Technology Review)

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August 26, 2016 at 9:00 am

Science Policy Around the Web – August 23, 2016

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By: Agila Somasundaram, PhD

Aedes aegypti, by James Gathany (PHIL, CDC) [Public domain], via Wikimedia Commons

Zika

How big, really, is the Zika outbreak in Florida?

On Friday, officials announced that the Zika virus had spread to a second area in Florida, the Miami Beach, a popular tourist destination. The Centers for Disease Control and Prevention (CDC) has advised pregnant women to avoid those areas, and in fact, advised pregnant couples concerned about exposure to Zika to “consider postponing nonessential travel to all parts of Miami-Dade county”. Officials note that it will be difficult to limit the spread of the virus in this area because aerial spraying may not work very well around high-rise buildings, and convincing beach-goers to wear long sleeves and pants might be hard. With schools starting today, school officials have distributed mosquito repellant cans to parents, and long-sleeved shirts and pants to students. 37 cases of Zika infection have been reported in the two areas in Miami.

Many scientists are concerned that the outbreak may be larger and more widespread than these numbers. Alessandro Vespignani, a computer scientist at Northeastern University in Boston, who is modeling the spread of Zika, says, “Zika is one of those diseases that is always like an iceberg — you just see the tip.” 4 in 5 people who get the virus don’t have any symptoms, and people who get sick exhibit mild symptoms that could easily be confused with the flu. So only 5 percent of cases get detected, says Vespignani. Models predict that 395 people will be infected with the virus by September 15, in Florida. Only about 80 of them will show symptoms, and about 8 pregnant women are likely to get infected during their first trimester, putting their fetuses at risk for microcephaly, says Ira Longini, a biostatistician at the University of Florid and a collaborator of Vespignani. Zika will likely continue to spread until October or November when the weather becomes cooler. The computer models also predict that Texas might be next. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says, “I would not be surprised if we see cases in Texas and Louisiana”, given the recent flooding in Louisiana. Zika virus-carrying mosquitoes breed in stagnant puddles, and there will be a lot of problem getting rid of standing water in flooded areas, says Fauci. (Michaeleen Doucleff, NPR)

Global Health

Debate continues over U.N. role in bringing cholera to Haiti

The 2010 Haiti earthquake claimed over 200,000 lives and injured many more. The cholera outbreak that followed months later resulted in at least 7,000 deaths. Cholera is caused by the bacteria Vibrio cholerae, and is transmitted when faeces from an infected person contaminates drinking water. Many investigations have connected the cholera epidemic in Haiti to sewage leaked from a U.N. base that housed Nepalese peacekeepers. Toilets have been reported to overflow from the base into the nearby stream. In fact, the strain of bacteria in the Haiti epidemic was similar to a strain in Nepal. Even though, for year, the Haitians have been accusing the U.N. for the outbreak, the U.N. has never accepted responsibility. This has led to serious distrust among the Haitians about the U.N. troops. In 2013, a class action suit was brought against the U.N. on behalf of Haitians who were affected by the outbreak. But the U.N. is immune to such legal actions under international law.

Recently, Farhan Haq, spokesperson for U.N. General Secretary Ban Ki-moon, said the U.N. “needs to do much more regarding its own involvement in the initial outbreak.” “What we are doing is trying to see how this can be resolved. How to resolve this? How to do the right thing?” Dr. Louise Ivers, senior health and policy adviser with Partners in Heath (that has treated thousands of cholera patients), said that the U.N. should have acknowledged its role a long time ago. Brian Concannon, the lawyer who brought the class action suit against the U.N., welcomes U.N.’s new statements but is not completely happy. He says the U.N. “clearly did not definitively take responsibility for introducing cholera.” (Jason Beaubien, NPR)

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August 23, 2016 at 8:07 am

Science Policy Around the Web – August 19, 2016

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By: Ian McWilliams, PhD

Photo source: pixabay

Climate Change

Melting ice sheet may expose cold war base, hazardous waste

During the Cold War, the US Army Corps began a top-secret mission to determine the capability of launching nuclear missiles at Russia from a base in Greenland. The military base constructed for this mission, named Camp Century, lies approximately 125 miles inland from the Greenland coast and was later abandoned in 1964 after the Joint Chiefs of Staff rejected the plans to create a nuclear base. When soldiers abandoned the base, it was thought that leftover fuel and waste material would be safely interred, buried under ice for thousands of years.

However, climate change has now threatened those plans. The increased ice melt could reveal the base as early as 2090 and it is estimated that tens of thousands of gallons of diesel fuel, wastewater, sewage, and other chemicals could be exposed. Adding to concerns is the nuclear generator housed in the frozen base. Although the base never became a site for nuclear weapons, the low-level radioactive coolant from the nuclear generator is still stored in the base. If ice melt continues to occur at an accelerated rate, some have expressed concern that these chemicals could be released into the environment by seeping into waterways causing a potential environmental catastrophe. (Stephen Feller, UPI)

Microbiome

Mouse microbe may make scientific studies harder to replicate

Reproducibility is an issue that has been the subject of much debate in the scientific community recently. Now, scientists are concerned that the microbiome may further complicate the issue. The collection of commensal microorganisms that reside on or within the body is referred to as microbiota, and it is now well known to affect the health of the host. Although researchers have taken meticulous steps to ensure that experimental animals are housed in identical conditions, including sterile bedding, strict temperature control, and standard light cycles, determining experimental variability due to differences in their microbiome have remained elusive. As researchers explore the issue further they have found that mice from different vendors have very different compositions of bacteria in their gut that could explain some inconsistencies in researchers’ experiments.

Although it is not mandated, taking steps to control for microbiome may aid in the reproducibility crisis. Segmented filamentous bacteria (SFB) have been identified as a notable concern, and some vendors are providing SFB positive or SFB negative animals separately. Although it is unlikely that SFB is the only culprit for differences in studies, researchers continue to explore new variables in rodent husbandry in an effort to improve reproducibility of scientific results. To add to the dilemma, because the species that constitute the microbiome are constantly changing, it is difficult to characterize, and impossible to standardize. Since mice share their microbes through eating each other’s feces, cage-mates can have similar microbiomes that provide natural microbiota normalization for littermates. (Kelly Servick, Science)

Precision Medicine

Spiking genomic databases with misinformation could protect patient privacy

New initiatives, like the Precision Medicine Initiative (PMI), are helping to cultivate the human genome into usable sets of data for research purposes. This pursuit is founded upon the willingness of participants to allow their genetic information to be pooled for analyses, but many have expressed concerns over the privacy of this genetic information. It has previously been shown that individuals can be identified from their anonymized genomic data and this has prompted researchers to look for additional security measures. Computer scientists Bonnier Berger and Sean Simmons have developed a new tool to help achieve this goal by using an approach called differential privacy. To increase privacy, a small amount of noise, or random variation, is added to the results of a user’s database query. Although the information returned would provide useful results, it would make it more difficult to conclusively connect this data to a patient’s identity. A similar method has been used by the US Census Bureau and the US Department of Labor for many years.

However, some scientists, including Yaniv Erlich, have concerns that adding noise to the dataset will reduce users ability to generate useful results. Erlich stated that “It’s nice on paper. But from a practical perspective I’m not sure that it can be used”. In the search for privacy, free form access to the data is limited. This “privacy budget” limits the number of questions that can be asked and excludes hundreds or thousands of locations in a genome. Additionally, because noise naturally increases error, it weakens the overall conclusion that can be drawn from the query. Simmons expects that answers will be close enough to be useful for a few targeted questions. The tradeoff for increased security is that databases protected this way could be instantly accessible and searchable, which cuts down on getting access to databases such as those managed by the National Institutes of Health. Simmons added that this method is “meant to get access to data sets that you might not have access to otherwise”. The group plans to continue to refine this method to balance the needs of researchers for access to these data sets while maintaining patient privacy. (Anna Nowogrodzki, Nature)

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August 19, 2016 at 11:08 am

Science Policy Around the Web – August 16, 2016

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By: Melissa Pegues, PhD

Photo source: Hu et al, 2016, under ACS AuthorChoice License

Public Health

Researchers find unsafe levels of industrial chemicals in drinking water of 6 million Americans.

A recent study by University of California Berkeley and Harvard University scientists found unsafe levels of firefighting chemicals in drinking water throughout the U.S. Over 36,000 samples collected by the Environmental Protection Agency (EPA) were analyzed for levels of polyfluoroalkyl and perfluoroalkyl substances (PFAS). Levels were detectable with 194 water supplies, but levels exceeded the EPA’s recommended safety limit in 66 of those water supplies. Those 66 water supplies were found across 14 states and affect up to 6 million people.

PFAS are use in a wide variety of products that include food wrappers, clothing, non-stick coating on pans, and firefighting foam. The study’s lead author, Xindi Hu, stated that “virtually all Americans are exposed to these compounds”. The chemicals are also commonly found at airports and military bases where firefighting foam is used in large volumes during training exercises and can then wash into surface and ground waters. They are also found at industrial plants that use them in manufacturing. They have been used for decades and persist once they are in the environment. Hu added, “They never break down. Once they are released in to the environment, they are there”.

The chemicals have been associated with a variety of health problems that include cancer, hormonal changes, thyroid problems, and high cholesterol. The federal government does not currently regulate PFASs, but they are on the EPA’s list of unregulated contaminants. Although it is difficult for the EPA to issue new regulations for contaminants, the agency has issued health advisories for these substances that urge utilities around the country to follow more stringent guidelines. Some communities have reacted to this advisory with one Alabama community declaring its tap water unfit to drink until officials could install a high-powered filter. Other communities in New Hampshire are receiving bottled water until the problem is addressed. (Brady Dennis, The Washington Post)

Global Health

A study takes the globe’s blood pressure and finds a dramatic rise

A recent study has found that greater than 30 percent of the global population now suffer from high blood pressure. Researchers at Tulane University’s School of Public Health and Tropical Medicine looked at numerous studies of individuals to determine rates of high blood pressure. The group led by Dr. Jiang He focused on people over the age of 20 and gathered data from 90 countries to assess the change in rates of hypertension between 2000 and 2010. The group found that there has been a dramatic increase in hypertension rates in low- and middle-income countries with an increase from 24% to 32%. Dr. He stated that “definitely it’s an epidemic”. Dr. Andrew Moran of Columbia University gave a cautionary interpretation of the study results citing that the current study inferred rates of hypertension from many countries, rather that collecting direct measurements. However, the trends from this study correlate with increases in obesity in low- and middle-income countries, further supporting the results of this new study. Additionally, the study did find a decrease in hypertension rates in high-income countries.

High blood pressure, also referred to as hypertension, can contribute to heart disease, chronic kidney disease, and stroke. Hypertension is currently the leading preventable cause of death world wide, and the World Health Organization is striving to reduce rates of non-communicable diseases. The increase in hypertension rates are thought to be associated with urbanization in low- and middle- income countries. Urban diets tend to be high in fat and sodium, and when coupled with high stress and low physical activity are thought to lead to hypertension. Although there are drugs available to effectively treat high blood pressure, many people in less wealthy nations may not have access to health care or be able to afford the cost of medications. Lifestyle changes have been demonstrated to reduce hypertension rates. Moran commented that “it’s probably more realistic to focus on improving diets of people in rapidly urbanizing developing world by encouraging lower calorie intake as well as reducing salt in people’s diets”. (Richard Harris, NPR)

Polio

Polio eradication faces setback as Nigeria records first cases in two years

Nigeria has faced a major setback to the eradication of polio with its first cases of wild poliovirus in more than two years. In July, two children were found paralyzed by polio in the Gwoza district of the Nigerian state of Borno. In response to these new cases, health officials have stated that they will begin emergency-vaccination campaigns.

Polio causes paralysis in approximately 1 in every 200 infections. Although once feared worldwide, efforts to eradicate the disease, such as the Global Polio Eradication Initiative, have reduced the number of cases by 99%. Because wild poliovirus cannot survive outside the human body, it is possible to eradicate the disease. Stopping the virus before it spreads further from Nigeria is crucial to the success of eradication efforts and will require millions of dose of vaccine and the coordination of several countries and numerous health organizations. The first of six vaccine campaigns will target children in the state of Borno. Further vaccination campaigns will extend to reach children across northeastern Nigeria and neighboring countries of Chad, Cameroon, and Niger.

Eradication efforts have been hampered by violent attacks by Boko Haram, an Islamic militant group, that has targeted the northeastern states of Nigeria. Global Polio Eradication Initiative spokesperson, Oliver Rosenbauer, said that “clearly cases were missed” and that “It was to be expected that there would be problems with the quality of surveillance”. Although there will be setbacks and more cases are likely, Nigeria and the rest of the world can eradicate poliovirus eventually. Nigeria now joins Afghanistan and Pakistan as the only other countries that have never interrupted the spread of polio. However, significant gains have been made in battling the virus in recent years. (Ewen Callaway, Nature)

 

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August 16, 2016 at 10:09 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 – August 9, 2016

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By: Thaddeus Davenport, Ph.D.

Infectious Diseases

Local Transmission of Zika Virus in Miami

Most of the world became aware of Zika virus earlier this year when doctors in Brazil noticed a correlation between Zika virus infection in pregnant women and microcephaly in their newborn children. Recent articles in the New York Times on July 29th and August 1st report a notable shift in the course of the Zika virus epidemic – local transmission of the virus within the United States. In the last year, there have been over 1600 cases of Zika virus detected in the United States, but nearly all of these were imported infections, in which individuals became infected while traveling in Zika-endemic regions or through sexual transmission of the virus from people traveling outside of the United States. Because the Zika-carrying mosquito species, Aedes Aegypti is resident in parts of the continental United States, many people expected that it was only a matter of time before Zika virus would be transmitted locally within the United States. On July 29th, the Centers for Disease Control and Prevention and the Florida State Department of Health reported that Zika virus was transmitted to at least four individuals in the Wynwood neighborhood of Miami. By August 1st, the number of individuals infected in the neighborhood had risen to fourteen, and the CDC issued a travel advisory discouraging pregnant women from traveling to the affected area. Though Congress went to recess last month without passing a bill to provide funding for the fight against Zika virus, perhaps, and hopefully, the news of local Zika transmission will motivate bipartisan action in Congress to fund mosquito control efforts and basic research on this still poorly understood virus. (Pam Belluck, New York Times)

Clinical Research

First CRISPR-based clinical trial set to begin this month

The gene-editing technique commonly referred to as CRISPR-Cas9 has received significant attention over the last year because of its impressive potential to target, cut, and modify nearly any sequence of interest within a genome. David Cyranoski reported for Nature News that scientists in China are poised to be the first to use CRISPR-Cas9 technology in a human clinical trial. The trial will enroll individuals with metastatic, non-small cell lung cancer, for whom other treatment options have failed. T cells, immune cells capable of killing infected, cancerous, or otherwise afflicted cells, will be removed from these individuals and modified using CRISPR-Cas9 to delete the gene for a protein called PD-1, which plays a role in downregulating the immune response. It is hoped that removing PD-1 will make the participants’ T cells better able to mount an immune response against cancer cells. As an additional measure of safety, the genome of modified cells will be sequenced in order to confirm that there are no off-target modifications outside of the PD-1 gene that might impact the safety or validity of the study. Initially the trial will test the safety of introducing CRISPR-Cas9-modified cells into ten individuals at three different dosages, while also monitoring the effect of the treatment on cancer progression. A similar trial is set to begin in the United States later this year. These will be important proof-of-concept studies to show that CRISPR-Cas9 can be applied safely and effectively in the treatment of disease. (David Cyranoski, Nature News)

Drug Development – Antibiotic Resistance

New Funding for Antibiotics Development

Bacterial resistance to antibiotics is a significant and emerging threat to public health. Methicillin resistant Staphylococcus aureus (MRSA) – a commonly reported and widely feared strain of S. aureus – is one example of a bacterium that was once readily treatable with penicillin and related antibiotics, but which became difficult to treat after acquiring resistance genes. As current antibiotics become less effective against pathogenic bacteria, doctors are running out of tools to treat infections. An important hurdle to addressing the problem of antibiotic resistance is obtaining the funding necessary to support basic research. Unlike drugs to treat chronic health problems, effective antibiotics designed to cure infections of limited duration, are not necessarily a good investment for pharmaceutical companies. Asher Mullard reported for Nature News that CARB-X – Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator- a public-private partnership supported primarily by the US government, Wellcome Trust, and the UK-based Centre for Antimicrobial Resistance hopes to provide US $350 million to motivate and accelerate the development of new antibiotics over the next five years. While many biotechnology companies support the initiative, some researchers, including Kim Lewis a researcher at Northeastern University, worry that CARB-X is too heavily focused on drug development instead of the discovery of novel antibacterial compounds. Despite their limitations CARB-X and other similar programs will likely provide valuable incentives for biotechnology and academic researchers to work towards better antibiotics for the common good. (Asher Mullard, Nature News)

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August 9, 2016 at 9:00 am

Science Policy Around the Web – August 5, 2016

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By: Fabrício Kury, MD

Genetic engineering

‘Gene drive’ organisms should be tested in field trials, not widely released, experts say

While the Zika virus shows spread into the US, with mosquito-borne transmission having been reported in Miami, the scientific community is eager to kick-start the use of the new biotechnology called Gene Drive. This technique allows for the creation of genes that cheat the trial of chance and get passed on to nearly 100% of the offspring. This way, it is possible to alter the genome of entire populations of species, for example, by making populations of Aedes mosquitoes unable to transmit the Zika or Malaria viruses — if not plainly kill all the Aedes.

The danger of Gene Drive is our lack of knowledge about the impact of drastic alterations in the behavior or biology of one species, and also the consequences from the quick removal of a pervasive species from an ecosystem. The slow progress of Zika into the U.S. through warmer and wetter edges such as Florida and Puerto Rico seems like a window of opportunity for attacking the spread of the disease while it is still relatively isolated. However, the National Academies of Sciences, Engineering and Medicine call for tightly controlled experiments before wide use of the gene drive. As MIT Media Lab professor Kevin Esvelt put it, “there is a nontrivial chance that [the genes] will spread from a single organism released into a wild population into most or all members of the local population — and very possibly into every population of the target species around the globe.” (Ike Swetlitz, STAT news)

Technology and Healthcare

Why lawmakers are trying to make ransomware a crime in California

Ransomware is a type of malware (a “virus”) that can make money for a hacker very quickly. The ransomware program encrypts files in the target computer, then demands a ransom, usually to be paid in cryptocurrency (the most popular is Bitcoin) which can be hard to track, to release the key that decrypts the files. Hospitals are perfect targets for ransomware attacks because they are often big institutions, are mostly unprepared to defend themselves against cybercrime, and hold precious data in its computers. Most often, ransomware makes the system of computers functionally “locked inside a black box” or completely unable to be used, creating mounting losses and outright risks that outweigh the price of the ransom.

This includes the medical data that is kept private inside those computers and becomes locked behind the ransomware’s military-grade encryption. Other times, the cyberattack consists of “kidnapping the privacy” of the patients. Here the hacker makes a copy of the data and requests a ransom not to release it to the public. In 2015 alone, 113 million patients had some or all of their health records stolen, and the hospital hacks showed increase of 600%. It has been called “The Year of the Hospital Hack.” Moreover, according to the FBI, ransomware as a broader industry is on the rise. In the first three months of 2016, victims of ransomware lost more than $209 million, compared to $25 million in the entire 2015. (Jazmine Ulloa, Los Angeles Times)

Affordable Care Act Effects

How I Was Wrong About ObamaCare

The strategy implemented by the Patient Protection and Affordable Care Act (PPACA, “ObamaCare”) for the purpose of controlling health care costs is one that strives for paying for healthcare by value provided instead of service provided. The promoted understanding, as summarized by former health policy advisor to the Obama administration Dr. Ezekiel Emanuel, 2011, is that such force will pressure the health care industry to undergo vertical consolidation into Integrated Delivery Systems. These systems, whose likes could be named as Kaiser Permanente, Geisinger Health Care System, and Intermountain Healthcare, are consolidations of all types of providers (physician, imaging, therapy, nursing, surgery, home care, specialty care etc.) and strives to be at least internally coordinated to provide the best value per cost, since its payment is not completely tied to the number of procedures or services performed.

Two PPACA-derived value-based reimbursed programs were launched in 2012 — the smaller and more cautious Pioneer Accountable Care Organizations, reserved for groups of providers with more experience in integrated health care delivery, and the larger and more ambitious Shared Savings Program Accountable Care Organizations. Their data has been released along the past year. The data shows that, along the first performance year of the Medicare Shared Savings Program, 58 ACOs generated $705 million in savings, feat which earned them $315 in bonuses as per the program’s workings, leaving net $260 million in savings to CMS. In April this year, the first study of the official CMS claims data indicated that the better savings were among the ACOs classified as small groups of providers. This is understood as evidence against the “Kaiserification” of healthcare as envisioned by Dr. Emmanuel, since the savings come not from having all providers as employees of a big conglomerate, but instead in giving more autonomy and power to the health care provider at the forefront of the contact with the patient. (Bob Kocher, Wall Street Journal)

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Written by sciencepolicyforall

August 5, 2016 at 11:00 am

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