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Science Policy Around the Web January 14th, 2020

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By Thomas Dannenhoffer-Lafage, PhD

Image by Pexels from Pixabay 

The FDA Announces Two More Antacid Recalls Due to Cancer Risk

The FDA has recently announced voluntary recalls of two prescription forms of ranitidine produced by the generic drug companies Appco Pharma and Northwind Pharmaceuticals. The recall was announced because the drug may contain unsafe levels of N-Nitrosodimethylamine (NDMA), a carcinogen. The FDA had announced in September that it discovered the drug contained NDMA but did not advise consumers to discontinue use of the drug. Ranitidine – commonly known as Zantac – is prescribed to 15 million Americans and is taken by millions more in over-the-counter versions. The drug was recently removed from the shelves of several retailers as a precaution. Zantac was once the best-selling drug in the world. 

The discovery of NDMA in ranitidine occurred when a mail order pharmacy company Valisure tested a ranitidine syrup. When the syrup tested positive for NDMA, Valisure tested other products containing ranitidine and found the same high amount of the carcinogen. Their findings were then reported to the FDA. According to the CEO of Valisure, the presence of NDMA in ranitidine could be due to chemical stability issues. 

The FDA did not recall the drug at that time because of the extreme conditions of the tests and claimed that less extreme conditions resulted in much smaller amounts of NDMA. Valisure also claimed that NDMA was found in high amounts in tests meant to simulate gastric fluid. However, when the FDA performed a similar test, they found no formation of NDMA. This may be due to the lack of sodium nitrate in the FDA’s tests. The FDA acknowledged this issue in testing by warning consumers to avoid food containing high amounts of sodium nitrate such as  processed meats if they wish to continue taking ranitidine. The FDA has also mentioned that the levels of NDMA found in ranitidine were comparable to what might be found in smoked or grilled meats.  

Several lawsuits have been filed asserting that Zantac has caused cases of cancer. However, experts point out that the likelihood of any individual getting cancer from taking the heartburn medicine is low. 

(Michele Cohen Marill, WIRED)

EPA Aims to Reduce Truck Pollution, and Avert Tougher State Controls

The Trump administration has announced a proposed rule change to tighten the pollution caused by trucks. Initiated by EPA head Andrew Wheeler, the new rule will limit emissions of nitrogen dioxide, which has been linked to asthma and lung disease. The change is predicted to curb nitrogen dioxide pollution more than current regulations, but will likely fall short of what is necessary to significantly prevent respiratory illness. 

The administration seems to be following the lead of the trucking industry, which lobbied for a new national regulation that will override state’s ability to implement their own rules, especially those of California. The EPA’s current rule, enacted in 2001, on nitrogen dioxide pollution from heavy-duty highway trucks required trucks to cut emissions by 95 percent over 10 years. This resulted in a 40-percent drop in nitrogen dioxide emissions across the nation. Although no law requires the EPA ruling to be updated, the Obama administration’s EPA had examined further cuts. The cuts were petitioned for by public health organizations and aimed to reduce emissions by another 90 percent by about 2025. California had begun the legal process to make such proposed cuts a reality, but Trump revoked California’s legal authority to set tighter standards on tailpipe emissions. 

This revocation has lead the EPA to move forward on the new rule that would only reduce emission by 25 percent to 50 percent. The trucking industry has pointed out that the current administration has gone to great lengths to understand how the EPA regulations affects them, something that was not standard practice under previous administrations. However, representatives from the American Lung Association have lamented that the current administration is not taking as much advice from major health and environmental groups as compared to previous administrations. 

(Carol Davenport, New York Times)

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January 14, 2020 at 10:30 am

Science Policy Around the Web November 19th, 2019

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By: Andrew Wright Bsc

Source: Pixabay

EPA’s ‘secret science’ plan is back, and critics say it’s worse

​The Environmental Protection Agency (EPA) has been exploring new rules on the incorporation of scientific data in its rulemaking process. The so-called “secret science” rules were originally proposed in 2018 under the EPA’s previous administrator Scott Pruitt, and have since been revised by its new administrator Andrew Wheeler in response to harsh criticism from scientific, environmental, and patient groups. Rather than addressing these criticisms to mollify the proposals detractors, the draft of the newly proposed rule, which was leaked to the New York Times, seems to drastically broaden the scope of which data cannot be used. 

According to the 2018 proposed rule, all raw data would have to be made available for studies that assessed a “dose-response” relationship, a bedrock of toxicity research. This could be difficult, if not impossible, when considering patient privacy protection laws and proprietary information requirements that would prevent the dissemination of that data. In the new draft rule, this set of constraints is imposed on all scientific studies used to guide agency procedures, instead of just dose-response studies. The draft also seeks comment on whether these restrictions should be imposed retroactively. According to the draft rule, if the underlying data were not made available, the EPA would be able to “place less weight” or “entirely disregard” those studies.  

While the draft does provide room for a tiered data-sharing approach such as those implemented at the National Institutes of Health and the Food and Drug Administration and allows for political appointees to provide exemptions, critics worry that these new requirements will effectively remove science from the EPA’s decision-making process.  Thus far, the EPA’s scientific advisory board has not been afforded the opportunity to weigh-in.

(David Malakoff, Science)

‘Insect apocalypse’ poses risk to all life on Earth, conservationists warn

A recent study looking at insect populations in the UK suggests that up to half of all insects have been lost since 1970 and that 40% of all known insect species are facing extinction. Due to the complexity of ecological systems that rely on insect biodiversity to function properly, this level of insect loss could lead to “catastrophic collapse” on a global scale. 

This study demonstrates a similar severity of insect decline as has been seen in other regions around the world. In Puerto Rico, for example, insect biomass has declined between 10 and 60 times and has led to the destruction of its rainforest’s food web. In Germany, 75% of flying insects have vanished in the past 27 years.

Solutions to address what is now considered Earth’s sixth mass extinction event are becoming increasingly complex as failing components of anthropogenic damage to the global ecosystem are beginning to interact. However, conservationists suggest that insect numbers could be rapidly recovered through a combination of pesticide reduction and land management. 

(Damian Carrington, The Guardian)

Written by sciencepolicyforall

November 19, 2019 at 11:59 am

Science Policy Around the Web October 18th, 2019

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By Ben Wolfson PhD

Source: Pixabay

Scientific integrity bill advances in U.S. house with bipartisan support

On Thursday the U.S. House of Representatives Science Committee voted to advance scientific integrity bill H.R. 1709 to the house floor by a vote of 25 to six.

H.R. 1709 would require federal research agencies to develop their own clear principles that would protect scientists and the research they carry out from political influences. The bill originates from a 2010 executive order by then-President Obama instructing Federal departments and agencies to “share tools and good practices to improve the implementation of scientific integrity policies across the Federal government”. While some agencies have adopted these policies already, if passed the bill would turn the order into a law requiring all to do so.

The bill comes two years after the Trump Administration restricted Federal Scientists at U.S. Department of Agriculture and the Environmental Protection Agency (EPA) from discussing agency research with news media in February of 2017. In October 2017 the Administration blocked scientists from the EPA from discussing their research at a conference, and censored Interior Department Biologists from voicing concerns about the impact of the border wall on wildlife in October of 2017. Earlier this month, dismissed EPA science advisors gathered to rebuke the EPA’s handling of pollution standards standards.

House Democrats initially did little to separate H.R. 1709 from these actions, leading Republicans to believe that it was a direct rebuke to the Trump Administration. However, Thursday morning the Science Committee stated that “scientific integrity transcends any one Party.” While the initial bill gave scientists the right to talk to the media without agency clearance, Democrats met their Republican colleagues halfway by removing the language, leaving all media decisions up to the agency.

Now that H.R. 1709 has passed in the Science Committee, it needs to win approval from the House of Representatives before moving to the Senate and eventually for signing by President Trump.

(Jeffrey Mervis, Science)

Written by sciencepolicyforall

October 19, 2019 at 9:50 am

Science Policy Around the Web September 20th, 2019

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By Allison Cross, PhD

Image from Flickr

Hunt for Cause of Vaping Illness Suggests Multiple Mechanisms of Damage

A vaping-related respiratory illness has affected nearly 500 individuals across 3 dozen states and has been linked to 6 deaths since the first case was reported back in April. Experts, however, are still uncertain about what is causing the nationwide outbreak and even what the condition is exactly.  

report earlier this month from the FDA suggested they may have identified the source of the problem, vitamin E acetate,  a common contaminate in vaping products.  However, more recent information indicates that no single contaminate was identified in all product samples tested from sick individuals. To date, the only thing found in common among the nearly 500 individuals who have fallen ill is that they recently vaped in the US or its territories.  

On September 16th, the U.S. Centers for Disease Control and Prevention activated its Emergency Operations Center (EOC) to help to enhance operations and provide additional support to CDC staff working to identify the cause of the disease.  The CDC advices those concerned about the outbreak to refrain from using e-cigarettes or vaping products.

E-cigarettes and other vaping products have recently been under scrutiny by those concerned about the recent increase in popularity of vaping among adolescents.  Many have been pushing for a ban on flavored e-cigarettes as these products are believed to be deliberately targeting youth.  The recent outbreak has led to renewed calls for a total ban on these and other vaping products.  In response to the outbreak, regulators in New York approved a ban on the sale of flavored e-cigarettes on Tuesday the 17thand Michigan followed suit on Wednesday.   The health and human services secretary, Alex M. Azar II, also announced that the FDA is outlining a plan for removing flavored e-cigarettes and nicotine pods from the market, though finalizing this ban will take several weeks. 

(Emily Willingham, Scientific American)

Trump’s decision to block California vehicle emissions rules could have a wide impact

California has long struggled to reduce smog in its cities and for almost 4 decades, as a part of the federal Clean Air Act, they have been granted special permission by the EPA to set their own air pollution standards.  This may soon change however as President Trump announced that the administration plans to revoke California’s authority to set its own automotive emissions standards. The Trump administration, instead, aims to set a single national standard for automotive emissions. Many are concerned, however, about the more lenient national standard proposed by the Trump administration. 

Although California is only 1 of 49 states, the implications of revoking California’s authority to set its own emission standard are far reaching.  The Clean Air Act currently allows others states to adopt the standards set by California and, as of today, thirteen other states and Washington DC abide by California’s stricter standards. 

The plan currently proposed by the Trump administration aims to freeze fuel-efficiency standards for all vehicles after 2020.  Experts estimate that this new standard would increase average greenhouse gas emissions from new vehicles by 20% in 2025 compared to the level projected under the current rules.  

California leaders have pledged to challenge the decision by the Trump administration in court.  It is likely that other states and environmental groups will join in support of California and it is possible that the lawsuit makes its way all the way to the supreme court. 

 (Jeff Tollefson, Nature

Written by sciencepolicyforall

September 20, 2019 at 5:44 pm

Science Policy Around the Web August 1st, 2019

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By Andrew Wright BSc

Image by Steve Buissinne from Pixabay 

Major U.S. cities are leaking methane at twice the rate previously believed

While natural gas emits less carbon dioxide (CO2) when burned, if allowed to enter the atmosphere as methane (CH4) it can act as a greenhouse gas that is 20-80 times more potent than CO2. Some of this impact is supposed to be mitigated by the relatively low amount of leaked methane, roughly 370,000 tons in six major urban areas studied according to a 2016 report from the EPA. However, a new study in the journal Geophysical Research Letters analyzed those same metropolitan centers and found that the EPA has underestimated methane release by more than half. By taking simultaneous measurements of ethane, which appears only in natural gas supplied to homes and businesses, researchers were able to delineate the sources of leakage, as natural sources and landfills do not give off ethane. 

From their analysis, the total estimate from the six cites studies was 890,000 tons of CH4, 84% of which was from methane leaks. While the authors of the study are unsure as to why the EPA estimates are so low, they suggest it could be because the EPA only estimate leaks in the distribution system, rather than endpoint leaks in home and businesses. While these results cannot be reliably extrapolated to newer cities which may contain infrastructure more resilient to leakage, they could engender further study to gather a clearer picture of national methane release.

(Sid Perkins, Science)

 

Japan approves first human-animal embryo experiments

On March 1st the Japanese science ministry lifted a ban on growing human cells in animal embryos and transferring them to animal uteri. While human-animal hybrid embryos have been made before, functional offspring have not been allowed to develop.  The first researcher to take advantage of this new regulatory scheme is Hiromitsu Nakauch, the director of the Center for Stem Cell Biology and Regenerative Medicine at the Institute of Medical Science at the University of Tokyo and a faculty member at Stanford University. His long-term goal is to grow human organs in animals such as pigs, from which the functional organs could be extracted and transplanted into human patients. His intent is to start in an early embryonic mouse model, then a rat model, and finally a pig model with embryos that form for up to 70 days. 

This measured approach is in stark contrast to the recent controversy regarding CRISPR edited babies in China, but has still been met with a certain level of ethical skepticism. Bioethicists are particularly concerned that the human cells being injected into animal embryos, induced pluripotent stem (iPS) cells, may deviate from their intended target (in this case the pancreas) and affect the host animal’s cognition. According to Nakauchi, the experimental design, which involves eliminating the gene for the target organ and injecting human iPS cells to compensate, is such that the cells should only be involved in a specific part of the animal. 

While Nakauchi’s group used this method to successfully grow a pancreas in a rat from mouse cells, they have had limited luck putting human iPS cells into sheep embryos. Given the evolutionary distance between mice, rats, pigs, and humans it may be difficult for experimenters to produce more satisfactory results. To address this Nakauchi has suggested that he will be trying genetic editing techniques as well as using various developmental stages of iPS cells.

(David Cyranoski, Nature)

 

 

Written by sciencepolicyforall

August 1, 2019 at 12:23 pm

Science Policy Around the Web – April 2, 2019

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By: Patrice J. Persad Ph.D.

Image by Jason Gillman from Pixabay

Worrisome nonstick chemicals are common in U.S. drinking water, federal study suggests

What lurks in our drinking water—and all its effects on organismal health—may be more of a mystery than what resides in the deep recesses of our oceans. In a recent investigation conducted by the United States Geological Survey and the Environmental Protection Agency (EPA), manmade per- and polyfluroalkyl substances (PFAS) tainted drinking water samples were analyzed. PFAS, which put the “proof” in water-proof items, are substances of concern, or, more aptly, contaminants of emerging concern (CECs), given their potential carcinogenicity and permanence in ecosystems. Perfluorooctane acid (PFOA), a PFAS discontinued in production domestically, was at a concentration over 70 nanograms per liter (ng/l) in a sample. A trio of other PFAS surpassed this concentration level, as well. A standard level issued by federal agencies has yet to transpire. However, the Centers for Control of Disease(CDC) attests that the existing cut-off of 70 ng/l is unacceptable in that it is not sufficiently low, or conservative, with respect to human health. 

The Environmental Working Group(EWG) suspects that over 100 million individuals in the U.S. drink water with PFAS. Citizens currently advocate for authorities to test drinking water samples and disclose PFAS concentrations. Without setting standards, accountability for future detriments to health is up in the air. Only through discussion with the public, policy makers, the research community, and parties formerly or currently producing PFAS can we set safeguards to protect our water supply plus well-being. 

(Natasha Gilbert, Science)


To Protect Imperiled Salmon, Fish Advocates Want To Shoot Some Gulls

In recreating the fundamental question “Who stole the cookies from the cookie jar?”, nature’s version spins off as “Who stole the juvenile salmon from Miller Island?” In this spiraling whodunit mystery, an unexpected avian culprit surfaces: the gull. According to avian predation coordinator Blaine Parker, surveys revealed that a fifth of imperiled salmon were whisked away by gulls near channels flowing out of dams. Gulls also spirited away these juvenile fish from other avian predators, such as Caspian terns. Parker maintains that not every gull is a perpetrator of decreasing the species’ numbers; gulls can assist with the population control of other birds who feast on the juveniles. Therefore, he supports killing the individual gulls disturbing juvenile salmon booms—lethal management.

Although there has been precedent of sacrificing avian species for the security of juvenile salmon, several entities denounce lethal management of wayward gulls affecting the young fish’s survival rates. The Audubon Society of Portlandpoint out that the Army Corps. of Engineers’ modifications to dams for warding away gulls, or other airborne predators, are slipshod and ineffective, if not inexistent. The U.S. Army Corps., despite this criticism, avows that killing specific gulls is only a final resort. From Parker and these organizations’ opposing viewpoints, a new mystery migrates to the surface. Will killing avian predators populating dams and waterways have a significant impact on the endangered salmons’ survival? Research collaboration on ecological impacts may be a way to tell or reassess the futures of both juvenile salmon and gulls. 

(Courtney Flatt, Northwest Public Broadcasting/National Public Radio



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Written by sciencepolicyforall

April 3, 2019 at 10:32 am

Science Policy Around the Web – March 26, 2019

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By: Neetu M. Gulati Ph.D.

Image by Dimitris Vetsikas from Pixabay

Sunscreen ban aimed at protecting coral reefs spark debate – among scientists

Corals around the world have begun “bleaching,” turning white and expelling the algae that live within them. After a 2015 study found that oxybenzone can harm corals, environmentalists have worked to bar the sale of sunscreens containing the chemical. Last year, Hawaii was the first US state to ban sale of sunscreens containing oxybenzone, as well as another harmful chemical octinoxate, which are found in up to 75% of sunscreens on the US market. The ban will go into effect in 2021. Florida and California are considering similar laws. However, while some are fighting to limit the use of these toxic chemicals, others say the major issue is not sunscreen – it’s climate change.

Evidence indicates that harmful chemicals and warming oceans due to climate change are both damaging corals and leading to bleaching. Scientists agree that the major contributing factor is climate change and the chemicals play a lesser role. Nevertheless, they disagree about what should be done. C. Mark Eakin, an oceanographer and the coordinator for NOAA’s Coral Reef Watch program, commented “if we don’t deal with climate change, it won’t matter what we do about sunscreens.” Furthermore, some people believe there is not enough clear evidence explaining how damaging these chemicals can be. While many scientists share this viewpoint, others think that every step towards saving the corals matters. Some lawmakers agree with this philosophy; Teri Johnston, the mayor of Key West, Florida, said of banning the harmful chemicals, “if it’s something we can do to minimize damage to reefs, it’s one small step we’re going to take.” The city of Key West banned the sale of sunscreens containing oxybenzone and octinoxate last month, an act that will go into effect in 2021.

Damage to coral reefs is a complicated issue, with multiple stressors likely to be involved: not only climate change and sunscreens, but also pollution and other harmful chemicals. While many are worried about protecting the reefs, there is also concern as to how these bans will affect human health. In response to the Hawaii ban, the Skin Cancer Foundation put out a statement which said, “by removing access to a significant number of products, this ban will give people another excuse to skip sun protection, putting them at greater risk for skin cancer.” 

One possible solution is to expand the number of ingredients permitted in sunscreen, to allow for other protective chemicals that are less harmful to the environment. The FDA has not expanded its list of approved ingredients in approximately 20 years. Comparatively, Europe allows for more chemicals, hopeful that any one single chemical will have a less harmful environmental impact when more diversity of ingredients is allowed. Towards this end, the FDA recently proposed new regulationsto improve American sunscreens.

(Rebecca Beitsch, Washington Post

In a first, U.S. private sector employs nearly as many Ph.D.s as schools do 

The career landscape for burgeoning PhDs has changed drastically in the last 20 years; while the number of PhDs awarded has increased, especially in the fields of life and health sciences, the proportion of PhDs employed in tenured and tenure-track positions has declined. This is in contrast to what some current faculty members, who may assume that tenure track positions are the standard path for PhDs, and other career paths are “alternative.” According to the Survey of Doctorate Recipients from the US National Science Foundation (NSF), in 2017, for the first time, private sector employment of PhDs (42%) is nearly equivalent to employment by educational institutions (43%). This is in stark contrast to 1997, when educational institutions employed 11% more PhDs than the private sector. While the survey takes into consideration all PhDs under the age of 76 who are employed full-time in the US, it is expected that newer PhDs are less likely to secure tenure-track positions. 

As career trajectories change, some universities are using new information about PhD outcomes to improve programming for current graduate and prospective students. According to the Coalition for Next Generation Life Science, ten academic institutions have released data onlineabout the career outcomes of their PhD graduates, with more institutions planning to release similar data by the end of next year. The data indicates the traditional model of training, which treats graduate school like an apprenticeship to becoming faculty, is outdated. Other skills that transfer beyond educational institutions, may be necessary to successfully train the next generation of PhDs. 

(Katie Langin, Science)



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Written by sciencepolicyforall

March 26, 2019 at 5:00 pm