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Archive for February 2016

Science Policy Around the Web – February 26, 2016

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By: Kimberly Leblanc, Ph.D.

photo credit: Alex E. Proimos via photo pin cc

Precision Medicine Initiative

NIH’s 1-million-volunteer precision medicine study announces first pilot projects

On Thursday, the President participated in a panel discussion at the White House Precision Medicine Initiative (PMI) Summit, marking the one year anniversary of the announcement of the Precision Medicine Initiative, which attempts to tailor medical treatments to individuals. The White House and the National Institutes of Health (NIH) announced several pilot projects, including one to work out how to recruit hundreds of thousands of volunteers online. The cohort program is the largest piece of the PMI: A 1-million-volunteer health study that will probe the interplay among genetics, lifestyle factors, and health. Vanderbilt University Medical Center (VUMC) will lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the federal PMI Cohort Program. The university will work out how to engage participants with a website and a phone line for signing up. Verily, formerly Google Life Sciences (renamed in December 2015), in Mountain View, California, will advise the project. To facilitate the contribution of volunteer data, the NIH is launching a program called Sync for Science, added Francis Collins, M.D., Ph.D., director of the NIH, which will “pilot the use of open, standardized applications that will give individuals the opportunity to contribute their data to research, including for the PMI cohort.” Sync for Science will include participation by electronic health records firms Allscripts, Athenahealth, Cerner, Drchrono, Epic, and McKesson, which have committed to deploying the applications required for individuals to donate their health data directly to the PMI cohort, he said. Such technologies will enable individuals to “control and manage their data … coordinate their care among their healthcare providers, and submit their data to researchers if they choose.” The White House also announced a batch of projects being launched by some 40 universities, patient groups, companies, and others to promote personalized medicine. The PMI “is an all-hands-on-deck operation,” John Holdren, director of the White House Office of Science and Technology Policy, said during the press briefing. “We really need the participation of all of these groups to realize the potential of precision medicine.” (Jocelyn Kaiser, ScienceInsider; a genome web staff reporter, genomeweb)

Public Health and Nutrition

Judge upholds NYC rule on restaurant salt warnings

Justice Eileen Rakower of the New York state Supreme Court ruled to uphold a recent regulation in New York City, requiring restaurants with 15 or more locations nationwide as well as concession stands at some movie theaters and sports stadiums to post a salt-shaker warning symbol next to menu items with more than 2,300 milligrams of sodium. That’s the recommended daily limit proposed in the latest Dietary Guidelines for Americans, released in January. Yet Americans are consuming close to 3,440 milligrams a day on average. Most of the sodium we consume is already added to our food, whether its in the processed foods we buy in the grocery or the meals we’re served in restaurants. Mandated salt warnings on menus are intended to make New Yorkers more aware of the link between excessive salt in their diets and high blood pressure, heart disease and stroke, according to health officials.

“I believe that the New York City salt label [on menus] does protect public health,” said Thomas Merrill of the Department of Health & Mental Hygiene. He says it gives people the information they need to make informed choices. New York City adopted the rule in December, and the National Restaurant Association then sued the city’s Board of Health saying the rule unfairly burdened restaurant owners. In court on Wednesday, Rakower denied the restaurant group’s motion for a preliminary injunction to stop enforcement of the rule. Starting March 1, violators will be punished by $200 fines. Unlike the city’s unsuccessful large-soda ban, she said, the rule did not restrict the use of sodium. S. Preston Ricardo, a lawyer for the restaurant group, said the association intended to appeal. Overall, health officials are happy with the judges’ decision. “This is really good news for the health of New Yorkers,” said Dr. Mary Travis Bassett, the city’s health commissioner. (Karen Freifeld with additional reporting by Jonathan Stempel, Reuters; Allison Aubrey, NPR)

FDA Leadership

Robert Califf confirmed as new FDA head

On Wednesday, after 4 months of delay, the U.S. Senate approved cardiologist Robert Califf, President Obama’s pick to head the Food and Drug Administration (FDA) by a vote of 89 to four. The nomination, announced last September, has faced significant opposition. Senators Edward Markey (D–MA) and Joe Manchin (D–WV) have both used the nomination as a chance to express frustration with the FDA over its response to the epidemic of opioid abuse—to argue that the agency has been too permissive in its approval of prescription opioids, and has failed to consult its scientific advisory board in those decisions. Ill will toward the agency over its approval of genetically modified salmon last November led Senator Lisa Murkoswki (R–AK) to block the nomination and demand that FDA put out guidelines requiring the fish to be labeled (Murkowski later lifted her hold.) And Senator Bernie Sanders (D–VT) also blocked the nomination, citing concerns that Califf wouldn’t be motivated to help combat the rising cost of prescription drugs. There were also personal concerns about Califf and his long-standing ties to the pharmaceutical industry — which funded many clinical trials he oversaw as an academic — and questioned whether his interests lay more with drug companies than with ordinary patients. In a confirmation hearing last fall, Califf defended his past work and said he had no intentions of lowering the FDA’s standards for safety and effectiveness of drugs and devices. After winning confirmation Wednesday, he spoke in a brief interview with the Washington Post about his priorities as FDA commissioner, including a desire to better explain to the public how the agency operates. (Kelly Servik, Science Insider; Brady Dennis, Washington Post)

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February 26, 2016 at 9:00 am

Chipotle closes restaurants nationwide after E. coli and norovirus outbreaks

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By: Amy Kullas, Ph.D.

Chipotle boasts that they exclusively use non-genetically modified organism (non-GMO) foods to ensure safe, healthy ingredients, great taste and care for the environment. However, starting in August of 2015, a series of food-poisoning outbreaks were linked to the restaurant chain. In total: 64 customers in Minnesota were diagnosed with Salmonella, 100 customers in California were diagnosed with norovirus, 53 people contracted Shiga-toxin producing Escherichia coli (STEC) that spanned nine states, 140 students were infected with norovirus and another outbreak of Escherichia coli infected five people in three states. Over 25 people were hospitalized and luckily no one developed hemolytic uremic syndrome (HUS) nor were any deaths reported from any of the outbreaks. HUS is a disease characterized by hemolytic anemia, acute kidney failure, and a low platelet count; most cases of HUS are preceded by an infection with E. coli, Shigella, or Campylobacter. At the beginning of February 2016, the Centers for Disease Control and Prevention (CDC) announced that the “outbreaks appear to be over.” However, it is troubling that the CDC’s investigation failed to “identify a specific food or ingredient” linked to STEC contamination; the Salmonella outbreak was attributed to contaminated tomatoes and the norovirus outbreaks were blamed on sick employees. Chipotle’s director of public relations, Chris Arnold, said: “If there’s a silver lining in this, it is that by not knowing for sure what the cause is, it’s prompted us to look at every ingredient we use with an eye to improving our practices.”

Chipotle has been proactive about taking action to address these series of food-borne pathogen outbreaks. On February 8, 2016, the company shut all of its stores for four hours to hold mandatory food-safety meetings with employees. Chipotle revealed a “comprehensive food safety plan” while also blaming its own employees for the norovirus outbreak. Steve Ells, the founder, chairman, and co-CEO of Chipotle, released a letter stating that while Chipotle’s food safety programs had met or exceeded the industry’s standards, the company is applying additional steps “to be sure all of the food we serve is as safe as it can be,” including:

  • Implementation of high-resolution sampling and testing of many of the ingredients to prevent contaminants,
  • Working with their suppliers to further enhance their food safety programs,
  • Introduction of additional microbiological kill steps to eliminate microbial risk (new sanitation procedures and additional food safety training for employees),
  • Preparation of some of the ingredients at ‘central kitchens’,
  • Marinate meat only at night to reduce raw meats coming into contact with other ingredients,
  • Blanch produce (flash-boiling for 5-10 seconds to kill microbes on the outer surface).

Chipotle’s food safety plan also includes increasing the number of paid sick days for employees (previously employees had only gotten two days of paid sick leave, which is two days more than most of the food industry). The fact that the food industry in general does not provide sufficient sick leave for employees can directly impact the health of the consumer and general public. If an employee returns to work or does not even take time off from work for being sick because he or she needs the money, and prepares food for customers, it is only a matter of time before an outbreak, such as the norovirus outbreaks, occurs.

As Chipotle’s previous food safety plan had at least met, if not exceeded, the food industry standards, it is important for the entire industry to raise the accepted standards in order to prevent future food-borne pathogen outbreaks in restaurants. Unfortunately, it is unlikely that the food industry will be as proactive as Chipotle for fear of hurting their bottom line. Many restaurants rely on purveyors who use antibiotics or pesticides to increase food production and keep food costs low. Antibiotics and antimicrobials are routinely used in agriculture and are given to livestock (cattle, pigs, poultry, etc.) in their feed or drinking water as well as being sprayed on crops. In fact, it has been estimated that over 50% (other estimates are as high as 70%) of the antibiotics in the United States are used in food production. They are given for a variety of reasons: to help them gain weight faster, use less food to gain weight, and the treatment, control, or prevention of diseases. Many scientists feel that this is contributing to the rapid increase in antibiotic-resistant bacteria. The correlation between antimicrobial use in food production and the dramatic increase in bacterial resistance has triggered a reassessment of agricultural practices in numerous countries, including the U.S. The CDC stated, “up to half of antibiotic use in humans and much of the antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”

As part of the investigation of the norovirus outbreak, the U.S. Food and Drug Administration (FDA)’s Office of Criminal Investigations served a subpoena to Chipotle in December 2015. Chipotle states that they will fully cooperate with the investigation, insisting that these series of outbreaks were isolated incidents. This series of food-borne outbreaks has significantly impacted Chipotle’s bottom line. Chipotle released that it anticipates spending between $14 and $16 million in response to the outbreaks. Furthermore, since the outbreaks began in August, Chipotle’s cost per share has plunged by more than 40%! Some of the customers affected in the outbreaks have announced that they plan to sue the enterprise.

Regrettably, the Chipotle was not the first food-borne outbreak linked to a major restaurant chain. In the 1990’s the restaurant chain, Jack in the Box, suffered a large E. coli outbreak that involved 73 restaurants and over 730 people (four children died and 178 were left with permanent damage). Additionally, there was an E. coli linked to undercooked hamburgers sold by the restaurant giant, McDonalds, in which consumers also died. However before Chipotle’s troubles began, the restaurant had a loyal fan base with its non-GMO practices and other health conscious programs. However, after a restaurant, such as Chipotle, has had its reputation tarnished, how can it begin to woo back consumers? One of Chipotle’s solutions was free burritos. This will help to retain Chipotle’s teen and young adult consumer-base, which represents ~35% of its total consumers. Importantly, this population has not stopped eating at Chipotle despite the outbreaks. Bonnie Riggs, a restaurant industry analyst said, “Their willingness to overlook any food safety concerns to eat Chipotle could be a result of unabashed loyalty.”

While this particular outbreak has received a lot of media attention, it remains up to the food industry as a whole to make food safe again for its consumers or for the federal government to step in to pass laws requiring additional food safety measures. The CDC estimates that each year, “1 in 6 Americans get sick from eating contaminated food.” Since the 1950’s, there have been dramatic changes in the country’s food production and supply (i.e. local environmental changes, decrease in family farms, more imported food, more food additives used, etc.). During this same time frame, there has been an increase in multi-state foodborne outbreaks colliding with new and emerging antibiotic resistant bacteria. Recently, there has been a series of announcements from prominent players to reduce the abuse from industrial farming. These include: McDonald’s stating that it will “phase out eggs from hens kept in cages” and Perdue using no antibiotics in over half of its chicken production. As awareness of the repercussions of industrial farming continues to grow, hopefully there will be more positive solutions from the food production and restaurant industries to increase the overall food safety in agriculture.

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February 24, 2016 at 9:00 am

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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 19, 2016

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By: Fabrício Kury, MD

Affordable Care Act

Obamacare supporters don’t like talking about it — but the individual mandate is working

Among the many goals of the enormous piece of legislation that is the Patient Protection and Affordable Care Act (PPACA), one is to deliver universal health care access in a nation that often ranks no. 1 in the ranking of cost of health care per capita, and without flirting with socialist-minded models such as single-payer health care that would have failed to pass in Congress. Because it is so expensive, health care in the U.S. is largely paid for via health insurances, which act as pools of the risk of needing healthcare and dilute the cost among all insured individuals. However, in a free capitalist market, the health insurances suffer from the fundamental problem of adverse selection, in which only the people who need health care purchase insurance, while those who are mostly healthy opt not to. This becomes a “death spiral” that leads to financial insolvency of insurance companies even despite them going to extreme lengths in denying insurance coverage to individuals expected to be costly. To address this, the PPACA prohibits insurance companies from denying coverage on the basis of pre-existing conditions and at the same time addresses the problem of adverse selection by making it mandatory that everyone (with few exceptions) must have health insurance or otherwise face a financial penalty – the so-called “individual mandate”. Recent statics on enrollment in the ACA show that the financial penalty aspect is working to encourage young, otherwise-healthy people to sign up, exactly as it was intended. (Sarah Kliff, Vox)

Technology and Health Care Policy

When Software Tries to Eat Regulation

In the era of disruptive innovation, billion-dollar unicorns, there-is-an-app-for-that mindset, it is no surprise to hear that ”every smart tech person I know is working in healthcare,” the $3 trillion industry that occupies more than $1 out of every $6 spent in the entire U.S. economy. Underpinning digital revolutions such as Uber, Airbnb, Spotify, even Wikipedia, lies the concept of delivering value in a dramatically rethought manner that longstanding behemoth corporations fail to compete with. Health care, however, cannot be provided by a team of youngsters in a garage because what is at stake is more serious than whether or not you get to find a cab when you need one. Health care is delivered amid walls of regulations that protect patients and assign liability, and health care consumers are not necessarily looking forward to risking security in favor of imaginative, cheaper alternatives. Since 2013, the Food and Drug Administration (FDA) has laid out regulation for responsible innovation in mobile health and followed up final guidance this year, while the HHS Office for Civil Rights offers guidance on adhering to HIPAA for health app developers. In this article, the examples of Zenefits, Theranos and 23andMe demonstrate that the FDA has consistently made clear that the “Ubers” of health care must exist within the same legal framework that safeguard the existing U.S. health care delivery models. (Erin Griffith, Fortune)

Fee-for-Service Heathcare

The Hidden Financial Incentives Behind Your Shorter Hospital Stay

In basically any U.S. market, if you purchase a product and it breaks too soon, you either get a new one or you receive your money back. In U.S. health care, though, up until 2012 if a patient was discharged from a hospital, but soon had to be re-admitted due to a preventable problem such as a poorly disinfected surgical wound, the hospital profited again from the new patient admission. The 2012 Medicare’s Hospital Readmission and Reduction Program, part of the Patient Protection and Affordable Care Act (PPACA), financially penalizes facilities that fail to meet historical measures of what is considered an acceptable rate of re-admissions, but this has been bringing the adverse effect of “workflow gymnastics” to make patients not be re-admitted or at least, not get counted as so. Another approach, the Bundled Payments for Care Improvement initiated in 2013, extends the concept of a single payment per diagnosis to include all care needed by the patient including out-of-hospital care. While these approaches seem to have been successful, they are still built on top of the fee-for-service rationale, where health care is paid for by the number (volume) of treatments provided. The American Hospital Association (AHA) affirms there exists considerable agreement that fee-for-service is one of the major culprits in the decades-old unrelenting upward trend in the percentage of the U.S. gross domestic product that is spent on health care. The opposite model of fee-for-service is capitation, where providers are paid a fixed price to provide all care to a group of individuals regardless of the volume of the care provided. The ACA has made capitation a possible alternative for some types of Accountable Care Organizations, however it is not mandatory, the programs are still temporary, and their details must evolve from the failed capitation models of the 1990s. (Austin Frakt, The New York Times)

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February 19, 2016 at 9:00 am

Zika and Ebola: two different viruses with shared lessons

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By: Rachel Zamoiski, Ph.D., MPH

Photo source: An Ebola isolation unit via pixabay.com

Zika virus has been all over the news lately, but it hasn’t been that long since a different virus was making headlines all over the world: Ebola. The Ebola epidemic of Western Africa, which began in 2014 and ended in January 2016, has resulted in over 28,000 Ebola diagnoses and over 11,000 deaths. While the seemingly near-constant news updates on Zika may remind us of the media coverage of Ebola, the two diseases are very different from each other. However, there are still lessons to be learned from the Ebola outbreak that can be applied to how we deal with this potential Zika epidemic.

The illnesses caused by Ebola and Zika are very different from each other. With Ebola, the main concern is the disease itself. Ebola is often fatal, especially in settings without good infrastructure or advanced medicine. The symptoms of Ebola are severe and can involve severe vomiting and diarrhea, as well as uncontrolled bleeding. Ebola is transmitted by contact with the body fluids of an infected person, even after the patient has died. In contrast, the symptoms of Zika are mild. It’s uncertain exactly how Zika is spread, but the primary route of transmission of Zika appears to be via mosquitoes and not direct contact with infected individuals, although other routes of transmission may be possible, as limited reports have emerged of sexual transmission. In addition, recent reports state that scientists have found active virus in saliva and urine, although it is not known if those fluids could transmit the virus. The actual symptoms caused by Zika virus is not particularly concerning when compared to Ebola. While the symptoms of the disease caused by Ebola and its high case-fatality rate were the main concerns of the Ebola outbreak, the greatest concern with Zika is the possible effect on fetuses when pregnant women are infected.

An article in Morbidity and Mortality Weekly Report from January 29, 2016 describes a “possible association” between Zika and microcephaly in babies born to mothers infected during pregnancy. The authors report an increase in cases of microcephaly, defined as a head circumference greater than two standard deviations below the mean, adjusted for gestational age and sex. The babies with microcephaly were born to mothers who either lived in or had visited areas with current Zika outbreaks. The article states that pregnant women should try to avoid contact with mosquitoes, while also noting that “further studies are needed to confirm the association of microcephaly with Zika virus infection.” While the link between Zika and microcephaly is still not well understood, it still seems prudent to advise pregnant women to avoid contact with the virus, out of an abundance of caution.

While it is important to be cautious and not expose people to unnecessary risk, even when the risk is uncertain, it’s also true that an overabundance of caution is not always a good idea. With Ebola, there were efforts to quarantine health workers returning from West Africa even when they posed no threat to public health. These efforts were made largely by politicians, and not by people with medical or scientific expertise, who instead recommended routine monitoring but not quarantine in asymptomatic individuals, as patients needed to be symptomatic in order to transmit the virus to others. This is in contrast with the well-known case of Typhoid Mary, a woman working as a cook who was forcibly quarantined because she was infecting people with typhoid even though she was not sick herself, and was unwilling to stop working as a cook. In situations like that of Ebola, not only does forced quarantine punish people for performing work that should be celebrated and honored, but it also potentially discourages healthcare workers from traveling to disease-ridden areas by stigmatizing them and treating them like prisoners unwelcome in their own country.

Less is known about Zika than about Ebola. With Zika, we don’t really know how infectious it is, or exactly how it’s transmitted. But what lessons are there to be learned from Ebola, to guide our response to Zika?

It’s important to take emerging infectious diseases seriously. One of the downsides of having such effective vaccines against formerly-common illnesses like measles and mumps is that we can forget how powerful and widespread viruses can be. The Ebola outbreak reminded us that viruses still have the potential to infect and kill many thousands of people, both far away and close to home.

Included in the threat of infectious diseases is the widespread fear caused by the perception of a seemingly unstoppable deadly virus. This understandably scared many people and undoubtedly contributed to the unscientific overreaction by many politicians. This underscores the need for good communication in the management and control of infectious diseases. If a politician announced plans to forcibly quarantine cancer patients, there would be widespread outcry and ridicule, because the general public understands cancer well enough to know that quarantine is not an effective method of preventing cancer. The same should be true for new public health concerns as well.

Finally, good data are paramount in understanding and implementing effective methods to prevent and disrupt transmission. Our efforts should focus on collecting good data, clarifying the risks of Zika, and better understanding how it is transmitted, as well as how it’s not transmitted.

With Zika, we should be cautious, and take precautions to avoid the virus even when we don’t fully understand its effects. At the same time, our response to this public health crisis, as well as others in the future, should be based on good data, and not politics or scare tactics.

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February 17, 2016 at 9:00 am

Science Policy Around the Web – February 16, 2016

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By: Julia Shaw, Ph.D.

Photo Credit: Kara Wall

The Environment

NYC waters are teeming with plastic particles, study finds

A recent study, conducted by the environmental group NY/NJ Baykeeper, has concluded that the waters around New York City are a “soup of plastic.” Inspired by a similar study of the Great Lakes, NY/NY Baykeeper collected water samples from the East River, the Hudson River in New York Harbor area, and the Passaic River and Raritan Bay in New Jersey and analyzed them for their plastic content. This study found an average of 256,322 plastic particles per square kilometer, with approximately 165 million plastic bits floating in the Harbor area. Plastic microbeads used in exfoliating skin care products contributed tens of millions of particles alone. The Microbead-Free Waters Act of 2015, which goes into effect in July 2017, will require companies to cease selling microbead products. Carcinogenic chemicals can also adhere to plastic particles, and be ingested by fish and shellfish mistaking the particles for food. As a result, city and state officials are advising women who are or may become pregnant and children to avoid eating seafood caught in the waters around New York City. A spokeswoman for the mayor said reducing plastics and other waste is a priority for the administration, which is working to put in place a ban on plastic-foam food containers as well as engaging in a public awareness campaign encouraging the use of reusable bags, mugs, and bottles in place of disposables. (Karen Matthews, Phys.org)

Global Health

Zika Virus Test is ‘Weeks, Not Years’ Away, WHO Says

Though first discovered almost 70 years ago in Uganda in 1947, the Zika virus has not been well-studied. However, the latest outbreak of Zika in Latin America is about to change that. On February 1st the World Health Organization (WHO) declared Zika virus a global public heath emergency. Zika virus is related to other mosquito-vectored viruses including those that cause dengue, yellow fever, and West Nile, but no test specific for Zika is commercially available. However, ten companies have developed assays to either directly detect viral particles in the blood or to detect specific antibodies raised against the virus. According to the W.H.O. assistant director general for health systems and innovation, Dr. Marie-Paule Kieny, these assays bode well for the first commercial tests being available in a matter of weeks following independent validation and regulatory approval. Symptoms of infection include fever, rash, joint pain, and red eyes, yet the most startling consequences are an apparent link to the neurological disorders microcephaly and Guillain-Barre syndrome in babies born to women exposed to the virus while pregnant. The government of El Salvador has advised women to delay any pregnancies until 2018, and the Centers for Disease Control and Prevention and the WHO are recommending pregnant women avoid travel to areas where the virus is actively circulating. Because the virus also appears capable of sexual transmission, the WHO further advises couples living in endemic areas to use condoms. Two early vaccine candidates, one from the National Institute of Allergy and Infectious Diseases (NIAID) and another from an Indian pharmaceutical company, Bharat Biotech, are being developed, yet Dr. Kieny cautions that “vaccines are still at least 18 months away from large-scale trials.” (Sewell Chan with contributions from Donald G. McNeil Jr., The New York Times)

Biomedical Ethics

Karolinska Institute vice-chancellor resigns in wake of Macchiarini scandal

Anders Hamsten, vice-chancellor of Stockholm’s Karolinska Institute (KI) has stepped down amidst ongoing controversy surrounding the work of surgeon Paolo Macchiarinini, a visiting professor at KI from 2010 through October 2015. A recent documentary that aired on Swedish public television re-ignited interest in the case, which involved the implantation of artificial trachea into eight patients, six of whom have since died. While originally hailed as a great success for regenerative medicine, questions have been raised concerning the accuracy of Macchiarini’s published papers describing the effectiveness of the technique. Hamsten led an investigation into Macchiarini’s work last year following the submission of whistleblower reports detailing suspected research misconduct by the surgeon, however, Hamsten cleared Macchiarini of all charges. In November, KI awarded Macchiarini a new 1-year contract. In a recent article published in the Swedish newspaper Dagens Nyheter, Hamsen reversed his opinion stating, “[I]t seems very likely that my decision in this case was wrong. I realize it will be difficult for me to continue working as Vice Chancellor of Sweden’s most successful university with credibility and effectiveness.” The Macchiarini misconduct case is set to be reopened and responsibility for the inquiry transferred to the Central Ethical Review Board of Sweden. (Gretchen Vogel, ScienceInsider)

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February 16, 2016 at 9:00 am

Science Policy Around the Web – February 12, 2016

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By: Rebecca A. Meseroll, Ph.D.

Zika research funding

Obama requests $1.8 billion in emergency funds to fight Zika

President Obama issued a statement of intent to request $1.8 billion from Congress to develop resources to combat the spread of Zika virus both internationally and domestically.  Zika, which is transmitted by the Aedes aegypti mosquito, has spread rapidly around Central and South America, the Caribbean, and the Pacific Islands in the past year, and is an emerging public health threat, especially due to its possible link with congenital microcephaly, a severe birth defect, in children born to women infected with the virus during their pregnancy.  The funds requested by the president would be used for a variety of purposes in an aggressive effort to contain the spread of the virus, including mosquito control, research on the virus and a potential vaccine against it, public education campaigns, and support personnel and equipment for areas where the outbreak is ongoing.  Congress will have to decide whether to grant the funds, which would be part of the 2017 budget, later this year.  While there is much to be done to minimize the impact of Zika, health officials indicate there is no cause for alarm about large-scale spread of the virus in the United States at present, but women who are pregnant or considering becoming pregnant are advised to use caution when planning travel to countries affected by Zika. (Jon Cohen, ScienceInsider and Mark Landler, The New York Times)

Climate change policy

Supreme Court stays climate change regulations

The Clean Power Plan, developed by the U.S. Environmental Protection Agency (EPA) at President Obama’s behest last year, sought to reduce carbon dioxide emissions from power plants by 32% compared to 2005 levels.  The EPA’s rules would require states to create their own plans, due to the agency by September of this year, detailing how they would reduce emissions beginning in 2022.  This week, however, the US Supreme Court granted a request put forth by many states and power companies to put the regulations on hold on the grounds that they are outside of the purview of the EPA.  Thus the regulations are set up to endure a lengthy legal battle, as the case will not come up in appeals court until June, after which it will likely be appealed to the Supreme Court, who would not hear the case until 2017.  Although the Supreme Court did not give its reasons for granting the stay, experts suggest that the Court may be telegraphing its wariness about the legality of the regulations by making this decision before the case has gone through a lower court.  The Obama administration remains confident and environmentalists hopeful that the regulations will hold up in court, however it may be necessary in the future for Congress to pass climate change legislation before progress can actually be made. (Jeff Tollefson, Nature and Robert Barnes and Steven Mufson, The Washington Post)

HIV and organ transplantation

First HIV-positive organ transplants to occur in the United States

Years of advocacy led to the passage of the HIV Organ Policy Equity Act in 2013, which lifted a ban on research into organ donations between HIV-positive individuals, and now the life-saving promise of the law is about to come to fruition. Doctors at Johns Hopkins received permission from the United Network for Organ Sharing to perform the first kidney and liver transplants between HIV-positive donors and recipients in the US, and they are prepared to conduct the procedures as soon as the first patients are ready. Johns Hopkins will be the first in the world to perform liver transplants between an HIV-positive donors and HIV-positive recipients, however doctors in South Africa have had success with kidney transplants of this kind since 2008.  It has been estimated that organs from more than 500 potential HIV-positive deceased donors have gone unused each year because of previous prohibitions, thus this new source of HIV-positive donor organs for HIV-positive recipients is expected to improve wait-times for all patients hoping for an organ to become available.  The current HIV-positive transplants will utilize only organs from deceased donors, as more research must be done to determine the outcomes of kidney donation for HIV-positive patients. (Daniel Victor, The New York Times and Ariana Eunjung Cha, The Washington Post)

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Written by sciencepolicyforall

February 12, 2016 at 9:00 am