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Archive for January 2019

Science Policy Around the Web – January 28, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

A Drug That Eases Miscarriages Is Difficult For Women To Get

The CDC estimates that each year in the U.S. alone, over 1 million women suffer miscarriages during the first trimester of pregnancy.  When a woman finds out that her pregnancy is not viable, she is usually given three options: wait for the miscarriage to occur on its own, take medicine to induce the miscarriage, or undergo a surgical procedure (known as a D&C) to remove the contents of the uterus.  For women who want to avoid a surgical procedure but do not want to wait for the miscarriage to occur on its own, the medically induced miscarriage is a favored option. 

Misoprostol is the medication currently prescribed in the U.S. to induce miscarriage.  Although this medication works for many, a single dose of the medicine is ineffective for about 30% of women.  When the medicine is ineffective, women end up either returning to their doctor for another dose or moving forward with surgery.  However, a recent studyin the New England Journal of Medicine found that combining the currently used medication, misoprostol, with mifepristone is more effective than misoprostol alone in inducing miscarriage.  The study followed 300 women experiencing first trimester pregnancy lose and found the combination of misoprostol and mifepristone increased the chance of successfully inducing miscarriage to 90%, a 14% increase over misoprostol alone. 

Although this new study may provide hope for women suffering an early pregnancy loss and wishing to avoid surgical intervention, most doctors in the U.S. are unable to prescribe mifepristone due to current FDA regulations.  Mifepristone was approved by the FDA in 2000 but is currently regulated under what is known as a Risk Evaluation and Mitigation Strategy (REMS).  The REMS designation means that the FDA can restrict how and where the medication is distributed.  For mifepristone, the REMS restriction prohibits its availability in commercial pharmacies; the drug can only be distributed from clinics or hospitals designated as mifepristone suppliers.  

As mifepristone is commonly used for abortions, some argue that the REMS designation for the drug is driven by political motives rather than due to concerns about drug safety.  Currently, medical societies including The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association are trying to overturn the FDA REMS classification of mifepristone.  

(Mara Gordon and Sarah McCammon, NPR)

Ebola Vaccine Supplies Are Expected to Last

The Democratic Republic of Congo (DRC) is currently facing a devasting Ebola outbreak and recently reported 689 confirmed and probable infections and 422 deaths. However, the World Health Organization (WHO) recently announced that they expect to have adequate supplies of an experimental Ebola vaccine to stop the outbreak. 

The experimental vaccine, known as V920, is made by Merck and was first shown to be highly effective in a clinical trial during the West African Ebola crisis of 2014-2016. In the current outbreak, Dr. Peter Salama, WHO’s deputy director-general of emergency preparedness and response, has reported that the vaccine is “highly, highly efficacious”, showing a efficacy rate well above 90%.  

After the West African Ebola crisis of 2014-2016, Merck made an agreement with the WHO and with Gavi, the Vaccine Alliance to maintain a stockpile of 300,000 doses of the vaccine at all times while they worked to get the vaccine licensed. As most Ebola epidemics have been controlled after less than 100 cases, the 300,000-dose stockpile seemed more than sufficient. However, tens of thousands of doses of the vaccine have already been used with the recent outbreak in the DRC, raising concerns that the supply would be depleted.  

Merck’s team lead for the Ebola vaccine project, Beth-Ann Coller, confirmed that in addition to the 100,000 doses of the vaccine that the company has already sent to the WHO, they still have about 300,00 doses on hand. However, due to the uncertainly of around the outbreak, Coller said the company is also exploring options to expand the stockpile further. 

(Helen Branswell, STAT)

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January 29, 2019 at 3:18 pm

Science Policy Around the Web – January 25, 2019

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By: Allison Dennis B.S.

Source: Pixabay

A safe prenatal genetic test is gaining popularity with young moms-to-be and their doctors

The DNA sequencing revolution is giving pregnant women and their doctors an earlier-than-ever-before glimpse into the health of the fetus as it develops. Marketed as the “noninvasive prenatal test” (NIPT), the diagnostic examines small fragments of fetal DNA derived from a blood sample provided by the mother for genetic abnormalities. Small amounts of fetal DNA are released as cells making up the placenta are turned over. This cell-free DNA enters the mother’s blood stream, where it can be accurately detected by NIPT in as early as 10 weeks. By measuring the amounts of DNA derived from each chromosome, the tests can screenfor Down syndrome and other chromosomal abnormalities including Edwards Syndrome and Patau syndrome. The test poses no risk to the fetus, and is highly regarded by OB/GYNs as a highly effective diagnostic tool. It is much less risky and invasive while being more accurate compared to amniocentesis and chorionic villus sampling, which was the previous standard of care for high-risk pregnancies. 

Most U.S. insurance plans only cover the test for mothers older than 35, whose pregnancies are at elevated risk for genetic abnormalities. Yet many younger mothers and their doctors are embracing the diagnostic. Because NIPT also offers the earliest chance for parents to determine the sex of their baby, some OB/GYNs are worried that parents may pursue the test without wanting or understanding the full implications of the results provided. Following a NIPT result indicating an abnormality a more invasive method will be recommended to confirm the diagnosis. Medical professionals and genetic counselors are working together to learn how to best help patients understand complex genetic information so they can make informed decisions regarding their care and not be blindsided by unexpected results.

(Sarah Elizabeth Richards, The Washington Post)

Science with borders: A debate over genetic sequences and national rights threatens to inhibit research

The Nagoya Protocol was adopted in 2010 as part of the United Nations Convention on Biodiversity to undercut the threat of biopiracy by giving countries an express right to any assets derived from the use of biological and genetic materials naturally occurring within their borders. The U.S. did not attend the Convention, but it is subject to following the established standards when interacting with countries who have ratified the protocol. Currently under the protocol, a donor country must certify their permission for an international researcher to take possession of a genetic resource. Prior to the outside party gaining access, both parties agree to the extent of benefit-sharing arising from genetic resource. 

Debate has arisen over the interpretation of the the agreement, specifically whether the sharing the genetic sequences derived from pathogens, the strings of letters that represent their genomes, require the same burden of documentation as the pathogens themselves. Researchers have expressed concern that including sequences under the regulations of this international treaty may hinder disease surveillance and international collaborations. Yet many understand that proteins can be synthesized following the instructions held in the genetic sequences, narrowing the gap between knowing a pathogen’s sequence and producing the physical components characteristic of that pathogen. As it stands, whether genetic sequences must be certified before they are shared is up to the donor country. 

Concern arising from the ambiguity surrounding digital genetic sequences sparked the WHO to draft of a Code of Conduct to guarantee the “open and timely sharing of pathogen genetic sequence data during outbreaks of infectious disease.” As pathogens emerge, it is often necessary to rapidly disseminate genetic data to characterize and track the spread of a particular disease strain. Experts must often work across borders to develop vaccines that match the relevant threat. In the spirit of benefit-sharing, the code requires scientists who obtain sequence data during outbreak situations to collaborate with the scientists who generated the sequence data when possible and acknowledge their contributions upon publication.

At the United Nations Biodiversity Conference held in November 2018, it was agreed that an Ad HocTechnical Expert Group would continue to consider the implications of the protocol on digital sequence information. Hopefully, clarity will be offered on the subject and any changes be adopted at the 2020 United Nations Biodiversity Conference. 

(Helen Branswell, STATNews)

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January 25, 2019 at 5:00 pm

Saving the Chesapeake Bay – Home to 18 million people

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By: Hsiao Yu Fang, Ph.D.

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Source: Flickr

The Chesapeake Bay is the largest U.S. estuary, where freshwater from rivers and streams flows into the ocean and mixes with seawater, making it a rich environment with abundant wildlife. Every year, the Bay produces 500 million pounds of seafood. The entire Chesapeake Bay watershed, which includes six states (New York, Pennsylvania, Maryland, Virginia, West Virginia, and Delaware) and the District of Columbia, is home to 3,600 species of plants and animals and more than 18 million people. Importantly, the actions of these 18 million people directly affect the health of the Bay. To quote the movie Finding Nemo, “All drains lead to the ocean.” Due to the combination of water-born nutrient pollution that comes from human-produced waste and runoff from cities and farms, the Bay has been listed on the country’s “impaired waters” list for decades. Thankfully, recent policy measures to regulate the environmental impact of human activity on the Bay have shown profoundly promising results that with further efforts could fully restore the health of the Bay.

At one point, the conditions of the Chesapeake Bay seemed almost irreversible. Years of population growth and pollution led to a significant decline in animal species, affecting commercial and recreational fishing as well as tourism. Scientists have shown that about one-third of the nitrogen in the Chesapeake comes from air pollution. Pollution in the air emitted from power plants and vehicles is carried over long distances via weather conditions and eventually deposits into the Bay’s waters. As air pollution can travel thousands of miles, the region over which air pollutants are capable of impacting the Bay is known as the airshed; this area is about nine times as large as the Bay watershed. Excess nitrogen and phosphorus pollution in the Chesapeake cause a biological chain reaction that results in “dead zones” – areas with minimal amounts of oxygen. This phenomenon worsens in the summer, when heat and pollution fuel algae blooms, blocking sunlight and depleting life-sustaining oxygen underwater. Aquatic life including fish, crabs, and oysters suffocate in these areas of the Bay affected by dead zones. The Bay used to yield tens of millions of bushels of oysters. Today the annual catch has fallen to less than one percent of historic records.

There have been several attempts through the years to restore the Bay. The Clean Water Act of 1972 reduced industrial pollution to the Bay, though it fell short of its promises of transforming the Bay into “fishable, swimmable” waters. In 1984, the six states within the Bay watershed embarked on another cleanup plan, which again failed to show lasting improvements. In 2010, the Chesapeake Clean Water Blueprint was established, which is the largest water cleanup plan ever managed by the US government. Using the powers granted by the Clean Water Act, the Environmental Protection Agency (EPA) issued new pollution limits for nitrogen, phosphorus, and sediment feeding into the Bay. Subsequently, the six Bay states and the District of Columbia announced formal plans to meet the EPA limits by 2025. What makes the Blueprint unique compared to previous failed attempts is that it will impose penalties on states that fail to act.  Each state is required to reach two-year incremental milestones of pollution reduction. Ideally, once the Blueprint fully achieves its goals, the Bay should no longer be on the impaired waters list.

Almost a decade has passed since the restoration efforts of the Chesapeake Clean Water Blueprint began, and already the Bay shows the potential for becoming a transformative environmental success story. Today, the Bay appears more resilient and capable of adapting to excess pollution loads. Recent studies have shown that the Bay is beginning to replenish oxygen in its waters; repairing what were once underwater dead zones. The Chesapeake Bay Foundation’s (CBF) 2018 State of the Bay Report’s Habitat Indicator Scores show that the resilience of the Bay, quantified as the growth of underwater grasses and resource lands, is slowly increasing from their 2016 levels, despite the record-breaking summer storms of 2018.

While progress has been made in restoring the Bay, more is needed. Bipartisan support from the federal government and from federal-state collaborations is essential to the Bay’s further recovery. The Bay’s overall health remains fragile and additional improvement is not assured. In fact, CBF’s2018 State of the Bay Report released this month showed a decline in the Bay’s health for the first time in a decade. This was due to extreme storm-related weather conditions in 2018 that carried high concentrations of nitrogen, phosphorus, and debris into the Bay.

The Chesapeake Bay’s health has vital impacts on people’s health, jobs, and access to clean drinking water. The forests in the Bay watershed produce safe, filtered drinking water for 75 percent of the watershed’s residents, which is nearly 13 million people. If more action is not taken now, the future cost of inaction will be more dire and expensive than current restoration efforts. The Chesapeake Clean Water Blueprint might be the best and last chance to restore the Bay. Simple, individual actions like conserving water and energy in our daily activities, volunteering in stream and river cleanups, and contacting local representatives and advocating for the importance of protecting the Bay can also go a long way towards contributing to the well-being of the Bay. “Treasure the Chesapeake” is not just a slogan on a license plate – these words underlie a great environmental recovery project, as well as a potential model for water pollution clean-up projects around the world.

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January 23, 2019 at 3:54 pm

Conspiracy Theories and Ebola: How a US Federally Funded Research Facility in the Heart of Sierra Leone’s Ebola Outbreak Acerbated Local Misconceptions about Ebola

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By: Caroline Duncombe

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An inherent distrust follows what one does not understand; scientific endeavors if not explained properly are easily misunderstood. From climate skeptics to CERN’s 666 logo, the world is wrought with conspiracy theories surrounding science. The role of conspiracies should not be underestimated or neglected, especially since such theories are interspersed with layers of truth. Usually conspiracies reside harmlessly on the edge of the web, but during the Ebola outbreak in Sierra Leone an unaddressed rumor resulted in fatal consequences. Rumors revolving around a Tulane University research facility located in Kenema Government Hospital prompted a breakdown in relations between the local populations and international health care workers. This mistrust led to the refusal to permit blood draws for diagnostic purposes during the critical initial stages of the Ebola outbreak. By underestimating the importance of cultural and religious symbolism surrounding scientific research U.S. federal funding agencies, laboratory researchers, and private companies made a crucial mistake. By analyzing this curious conspiracy theory, scientists, funding agencies, and health practitioners can learn from past mistakes and become more aware of the impact of research beyond pure scientific pursuit.

Background

            On May 24th, 2014,a young woman miscarried in Kenema Government Hospital. Given the recent outbreak in nearby Gueckedou, Guinea, Ebola was suspected. A day later, the same hospital reported the first confirmed case of Ebola in Sierra Leone. Soon after, Kenema became a hot zone – the entry point for the Ebola virus to spread throughout Sierra Leone and eventually the world. The repercussions of the Ebola outbreak extend well beyond the 11,310 death count in West Africa to economic, social, medical, and cultural spheres.

The Kenema Government Hospital was not a typical Sierra Leonian public hospital. In fact, the hospital was well-equipped, with the only Lassa fever isolation ward anywhere in the world. The lab dated to 2005, when Tulane University received a $10 million grant from the U.S. National Institutes of Health to study “Diagnostics for Biodefense against Lassa fever”. Since previous investigations of sporadic Lassa fever outbreaks were based out of Kenema, the natural choice for the establishment of first-rate laboratory infrastructure was Kenema Government Hospital.

As the years passed, the Tulane research laboratory acquired more grants and partnerships. One of the principal collaborators was the private for-profit company, Metabiota, which received grants from two U.S. Department of Defense (DoD) agencies – Defense Threat Reduction Agency and Biological Engagement Program – to primarily study the pathogenesis of Lassa fever, a ‘US bioterror threat’. Due to stipulations in NIH grant funding, the substantial amount of money flowing into this “shiny new” research laboratory could not be applied to assisting patients in the “dilapidated, cramped, and poorly resourced Lassa ward only some 50m away” (Bausch). During the Ebola outbreak, the Lassa laboratory’s focus shifted to Ebola, continuing research until the NIH did not renew funding in 2014, primarily due to safety reasons.

The Conspiracy Theory

Following the 2014 outbreak, a conspiracy theory circulating throughout Sierra Leone, essentially claiming that the U.S. created Ebola, or a Lassa-Ebola hybrid, and either intentionally or accidentally released this bioterror weapon from the U.S. NIH and DoD-funded research facility at Kenema Government Hospital. While such a rumor lacked credible evidence, there were specific circumstances surrounding the policies of the research outpost that fed into the narrative – truths that should have been addressed through culturally sensitive policies.

Four main factors converged into a superstitious and suspicious narrative about the Lassa research laboratory. First, by branding the Lassa research facility with a bioterrorism component, the project assisted in drawing out a natural conclusion that bioterror weapons were also present in the laboratory. Tulane University’s initial grant application in 2005 framed Lassa virus as a US biosecurity threat through key words such as “Diagnostics for Biodefense” and “LASV as a biological weapon directed against civilian or military targets necessitates development of… diagnostics.” The framing of the diagnostic development laboratory in terms of a biodefense strategy against the NIAID Category A classification was not an accident, but rather a necessity to gain funding. As Annie Wilkins puts it “whether the prospect of weaponization is regarded as sensationalism or a real concern, all researchers are aware of the utility the bioweapons threat has in obtaining funding.” By emphasizing biodefense and collaborating with the U.S. DoD via Metabiota’s funding stream, a natural linkage between the work of the research outpost and bioweapons developed.

The second factor was out of the control of Tulane University: A suspicious coincidence. Due to its proximity to Guinea, laboratory capacity, and fluidity in movement across the Sierra Leone-Guinea border, the first confirmed case of Ebola in Sierra Leone occurred in Kenema Government Hospital. Although there potentially were other cases of Ebola in Sierra Leone, none of the primary health care clinics in the area had the laboratory capacity to officially diagnose Ebola. A natural speculation ensued: what are the chances that the one Biodefense laboratory in Sierra Leone, where the hemorrhagic Lassa fever virus was located, was also the site of the first confirmed case of a “new” bioterror threat that also causes hemorrhagic fever, Ebola? Money draws attention, and the money flowing into this singular laboratory was substantial when compared with other public hospitals in Sierra Leone. For reference, the Sierra Leone Ministry of Health and Sanitation allocated U.S. $20 million budget to run the entire national health system in 2009.

Third, a nurse from Kenema Government Hospital claimed to an audience at a fish market that “the deadly [Ebola] virus was invented to conceal “cannibalistic rituals”. The statement and an already distrustful community culminated into a riot at the hospital on July 25th, 2014. Such a case further cemented the people’s suspicions that the laboratory was “stealing” the blood of Sierra Leonians. Even though collecting blood is necessary for diagnostic tests, there are many deeply held cultural beliefs about blood in Sierra Leone, and many people are reluctant to participate in blood test as a result.

Fourth, the research facility suspiciously and suddenly shut down right at the beginning of the outbreak without much explanation to the community. Additionally, many of the Sierra Leonian staff who could have addressed the suspicions about the facility pre-outbreak have since died while bravely combatting Ebola. All of these factors accumulated into the conspiracy theory that actors involved with the bio-defense grant and the US government created a bioterror weapon and unleashed it on West Africa.

Policy Considerations

The accumulation of these factors demonstrate the importance of cultural sensitivity and awareness when implementing scientific research policies. In 2018, Tulane University and a variety of partners received a new $15 million federally funded grant to study how Ebola and Lassa survivors fought off the diseases. Hopefully, the researchers are opening this facility with a new awareness and increased precautions on the spiritual and social baggage they bring to Kenema. This is especially important when considering the potential for further stigmatization of Ebola survivors if called to Kenema Government Hospital for research or treatment purposes.

There are several policy considerations that could alter the course of this conspiracy and help acclimate the community to both the presence of a well-equipped laboratory and blood draws for diagnostic purposes. Research institutions should refrain from using vocabulary such as “biodefense” and “bioweapon” to describe the purpose of research. A clinician in the Lassa ward pointed out that “The average Sierra Leonian won’t see Lassa Fever as a bioweapon threat. Only in the Western world do they see it like that.” Since the potential for contracting Lassa and Ebola is an everyday reality for Sierra Leonians, research initiatives on such diseases should be spoken about in terms of their potential for public health. Additionally, universities seeking to do medical research should consider the cultural significance of their location, and contemplate ways, including shifting location, that might reduce any negative connotations. Engaging influential spiritual leaders in productive information partnerships could also assist in assuaging local concerns.

Policy considerations should also be contemplated by grant funding institutions like the NIH and DoD. First, grant stipulations should integrate a layer of flexibility for distributing certain supplies and resources for patient care. Second, the NIH and DoD should be cognizant of their bias in funding grants that are written in terms of biodefense interests of the US, especially when related to countries where such a ‘bioweapon’ is an everyday reality. This is especially important because such bias incentivizes deleterious narratives that invokes cultural, social, and medical consequences.  Lack of funding for neglected infectious diseases that only burden developing countries by the US is a complex and important issue that will require deep structural changes – and would require another blog post to contemplate. Yet, a simple solution would be to require scientific grant applications to contain a section in which the applicant considers the cultural and social impact of the work within the community of interest. In addition, community outreach with intentional dialogue on assuaging concerns about sensitive research activities should made be mandatory.

The conspiracy theory exacerbated the already high level of mistrust in Western interventions during the outbreak. As the Washington Post emphasizes, the lesson from this case study is “that winning the trust of communities at risk is absolutely indispensable to limiting the impact of the inevitable next Ebola epidemic in West Africa.” Hopefully, the Tulane University research center in Kenema Government Hospital has learned from past mistakes, and seeks to engage the community and douse suspicions against their research upon re-opening the laboratory this year. Conspiracy theories usually integrate truth with speculation. The traditional method of ignoring such theories or flat out denying (as was the case with Tulane University) may have detrimental consequences as seen during the Ebola outbreak in Sierra Leone. The power in a conspiracy theory is not necessarily its truth, but it’s power to persuade people that it is true. And as scientists who are often focused on the facts, we often have a hard time understanding that concept. When doing research, it is crucial to be cognizant of the social perception of science and attempt to build bridges between gaps of understanding on cultural practices and scientific endeavors.

 

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January 17, 2019 at 6:34 pm

Science Policy Around the Web – January 15, 2019

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By: Patrick Wright, Ph.D.

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Source: Pixabay

All Seven of the FDA’s Recent Commissioners Agree It Should be Independent—But Not on How to Accomplish It

From 2016 onward, former Food and Drug Administration (FDA) commissioners have called on Congress to make the FDA an independent agency that would no longer fall within the purview of the Department of Health and Human Services (HHS). The idea was initially proposed at the Aspen Ideas Festival in Colorado in 2016, which subsequently lead to the crafting of formal bipartisan white papers detailing the proposal to be used by current and upcoming administrations; these two companion white papers were recently released via the Aspen Institute and the January edition of Health Affairs.The co-authors of these white papers, seven former Commissioners of the FDA spanning 30 years of service, propose a new framework in which the FDA is reconfigured as an independent federal agency. The hope would be to make the FDA a cabinet-level agency (e.g. the Environmental Protection Agency) or an autonomous entity with powers similar to the Securities and Exchange Commission. These changes would help minimize the extent of bureaucracy (e.g. falling under HHS but funded as though it is part of the Department of Agriculture) and interference from other bodies. The FDA currently operates as one of eleven Operating Divisions under the HHS Secretary’s oversight, along with agencies such as the National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA).

The current structure allows other HHS agencies to have input on FDA policymaking, despite not necessarily having any familiarity with the innerworkings of FDA policy. David Kessler, the commissioner under George H.W. Bush and Bill Clinton, stated that there are “150 people in between the commissioner and the president, and they all think they’re your boss—that’s the problem”. A recent example of the results of external influence was in 2011 when the HHS Secretary at the time, Kathleen Sebelius, barred the decision by then-FDA Commissioner Dr. Margaret Hamburg to allow emergency contraception to be sold over the counter.

In the Aspen Institute white paper, the Commissioners state: “The goal of independence is to accommodate efficient, science-based decisionmaking by reengineering the processes through which FDA regulations and guidances flow from proposal to final form”. Many objectives that can be achieved with increased independence of the FDA as an entity are outlined in the paper, including the ability to enhance transparency of the Agency and thus sustain public confidence and to ensure predictable decisionmaking exclusively grounded in scientific evidence. Given the breadth of the FDA’s regulatory umbrella, newfound independence would have profound implications on the agency’s ability to address public health issues.

(Ike Swetlitz, StatNews)

Bipartisan Bill on Sexual Harassment Signals Strong Interest by Congress

A recently introduced bipartisan bill, the Combating Sexual Harassment in Science Act of 2019 (H.R. 36, 116thCongress), directs the National Science Foundation (NSF) to implement a number of strategies to combat sexual harassment in STEM academic and research settings. It was introduced by Eddie Bernice Johnson (D-TX) and Frank Lucas (R-OK), leading members from the House Committee on Science, Space, and Technology.

The bill allocates $17 million to the NSF Director to award grants to expand research efforts to “better understand the factors contributing to, and consequences of, sexual harassment affect individuals in the scientific, technical, engineering, and mathematics workforce, including students and trainees”; collect relevant national survey data on the issue; update the report on responsible conduct of research by the National Academies to include evidence-based practices for fostering a climate intolerant of sexual harassment; and work with the National Academies to assess the influence of sexual harassment in institutions of higher education on the career advancement of individuals within STEM. The NSF implemented a policy in 2018 that requires institutions receiving NSF funds to disclose whether they have put a funded investigator on administrative leave pending the conclusion of a harassment investigation or have found an investigator guilty of sexual harassment. Under this NSF policy, funds will be reallocated to another investigator at the institution; decisions to terminate a grant to an investigator found guilty of sexual harassment would depend on the capacity of the institution to continue the research without the original investigator.

However, H.R. 36 currently does not outline appropriate actions that federal agencies should take upon receipt of information from institutions of any harassment. To address this, Representative Jackie Speier (D-CA), aims to reintroduce a bill she wrote in 2016 that would require agencies to consider any finding of sexual harassment against a research when deciding to award funding. These collective efforts point to an increased drive by Congress to tangibly address this issuethat has been plaguing the scientific research spectrum.

(Jeffrey Mervis, Science)

 

 

 

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January 15, 2019 at 8:58 pm

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Science Policy Around the Web – January 11, 2019

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By: Mary Weston, Ph.D.

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Source: Wikimedia

A Virus Even More Dangerous Than Zika to Pregnant Women

According to a recently published paper, Rift Valley Fever Virus (RVFV), a mosquito-borne virus found in Africa and the Middle East, may be even more damaging to fetuses than the Zika virus.

RVFV largely affects livestock, causing death and 90%-100% abortions in cattle. In humans, RVFV infections cause anything from mild flulike symptoms to severe liver problems. In 2016, a study associated the development of RVFV infection while pregnant with an increased likehood of miscarriage, but nothing further was known. However, a new study published last month in Science Advances shows that RVFV may severely harm human fetuses if contracted by women while pregnant.

The paper investigated how the virus affects pregnant rats, finding that 40% more pups died compared to uninfected controls and all surviving offspring contracted the virus. Further, the infected mothers’ placentas contained more virus than any other tissue. Upon testing human placenta tissue, they discovered that RVFV infects specialized cells that supports the region of the placenta where nutrients flow in, an area typically resistant to viral infections. According to the Dr. Amy Hartman, the infectious disease specialist at University of Pittsburgh who led the study, “Zika must take the ‘side roads’ into the placenta to infect a fetus, while the Rift Valley fever virus can take the ‘expressway.’”

Given that RVFV is carried by the same mosquitos found in Europe and America, there is a risk the virus could spread beyond Africa and the Middle East. Currently, there are no human vaccines or treatment for Rift Valley Fever and the World Health Organization has classified the disease as a potential public health emergency. Last week, the Coalition for Epidemic Preparedness Innovations launched a call for proposals to develop human vaccines against RVFV and Chikungunya virus, providing $48 million to finance up to eight projects

(Emily Baumgaertner, New York Times)

 

Prescription Drug Costs Driven By Manufacturer Price Hikes, Not Innovation

A new report published in Health Affairs argues that the rampant cost increase of many prescription drugs in the US is primarily due to price inflation, not the entry of new products or improvements to existing therapies.

The study compared pharmacy claims from the University of Pittsburgh Medical Center Health Plan and pricing data from First Databank, a company that collects prescription drug sales data, over the period of 2008-16. They found that the average costs of brand-name oral drugs annually increased 9.2%, while brand-name injectable drugs increased an average of 15.1% every year, five to 8 times the rate of general inflation. For example, the Health Care Cost Institute cited that the cost of insulin doubled from 2012-16.

The costs of generics and specialty drugs also increased during these time periods, but the authors determined that was due primarily to new product entry. During 2008-16, many blockbuster brand-name medications, such as Lipitor, lost their patent protection. There is typically lag time between becoming a generic and the time required to file generic applications. Thus, initial prices of generics are more closely matched with brand-name prices until more competition enters the marketplace, which factored into the report’s observed increase in generic pricing.

William Shrank, the chief medical officer of the UPMC Health Plan and an author on the study, argues that since rising costs are not improving treatments, policy makers may want to get involved. “This observation supports policy efforts designed to control health care spending by capping price inflation to some reasonable level,” he says.

Total US spending on prescription drugsin 2017 was $333 billion, a 0.4% increase from 2016, but a 41% increase compared to $236 billion in 2007. Additionally, according to a 2017 Commonwealth Fund study, US residents pay more for medications than any other high-income countries. Recently, efforts towards lowering/regulating prescription drug costs has received bipartisan support and this new report may help further those proposed regulations.

(Alison Kodjak,NPR)

 

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January 11, 2019 at 4:44 pm

Science Policy Around the Web – January 8, 2019

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By: : Jennifer Patterson-West, Ph.D.

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Source: Wikimedia

The world debates open-access mandates

 Plan S is a European-backed program devised to ‘accelerate the transition to full and immediate Open Access to scientific publications’ that is schedule to take effect on January 1st, 2020.

Open access mandates are not a new concept, 74 research funders in Europe already require that paper be made free at some point. The key difference between these existing mandates, which typically permit a 6- or 12-month delay after publication, and Plan S is that article funded by Plan S will be immediately available.

Shortly after the announcement of the program on September 4th, 2018, DeltaThink, a U.S. based consulting firm, began estimated the market influence of the program.  They released a news post stating that the initial 11 European funding agencies in the program accounted for roughly 3.3% of articles published in 2017, and their funding represent less than 1% of the approximately $2 Trillian spent globally on Research and Development (R&D). These metrics are not adequate to drive a global shift toward immediate Open Access.

Thus far, 16 funders have formally joined the program, including the Bill and Melinda Gates Foundation which was the first participant outside Europe. The program has also drawn support from many scientists that would welcome a transformation of the current system that keeps research publications behind paywalls.

Brian Hitson, the Director of the U.S. Department of Energy (DOE) Office of Scientific and Technical Information which is responsible for the agency’s public access policy has stated, “We don’t anticipate making any changes to our model.”  Current policies implemented by U.S. Federal agencies require that all peer-reviewed paper on funded work be made freely available within 12 months of publications. This policy allows published work to remain behind a paywall after initial publication restricting immediate access to the results.  The U.S. isn’t the only federal research funders that plan to maintain currently policies, both Canada and the Russian Science Foundation have indicated that they do not plan to join Plan S.

However, statements released last month by China’s largest government research funder and two national science libraries supporting the goals outlined by Plan S came as a surprise to many.  China accounts for 18.6% of articles published globally in 2016, more than any other country.  Therefore, a similar Open Access policy in China could have a profound impact on the publishing industry even if China doesn’t formally join Plan S.

Another impending participant is India, the third biggest producer of scientific paper globally. The Principal Scientific advisor to India’s government, Krishnaswamy VijayRaghavan, stated that they will “very likely” join Plan S.

As more funding agencies consider joining Plan S, others wait to see how other details of the program are settled.  One concern is the cap on Author Charges that funders will pay for Open Access publications, which Plan S has yet to announce.  If Plan S succeeds in gaining enough support then a shift toward a fairer publishing system and a worldwide transition to Open Access will become more probable.

(Tania Rabesandratana, Science)

 

NIH hospital’s pipes harbored uncommon bacteria that infected patients

 

Last month, a publication in the New England Journal of Medicine written by National Institutes of Health (NIH) researchers disclosed that at least 12 patients at the NIH clinical center were infected with Sphingomonas koreensis from 2006 through 2016.

S. koreensis is an uncommon waterborne bacteria previously reported in only two clinical cases. The first report of a S. koreensis as a human pathogen was a case study of a single patient in 2015.

A clustered outbreak of S. Koreensis of six inpatient individuals at the NIH clinical center over a six-month period in 2016 prompted an epidemiological investigation to identify the source of the infection and determine effective intervention strategies.

Isolates from these patients indicated that four patients were infected with multidrug-resistant S.koreensis. Eight additional clinical isolates containing S.koreensis were identified during the investigation dating back to 2006, only one year after the new hospital opened.

Genetic testing of the bacteria indicated that all isolates shared >99.8% identity suggesting a shared reservoir. Extensive testing of facilities found S.koreensis on sink faucets in patient rooms as well as in the water they came out, but not in the municipal water entering the hospital.  To eliminate the reservoir, the free chlorine concentration and hot-water temperature were adjusted resulting in no further infections since December 2016.

Dr. Tara Palmore, one of the NIH researchers, points out that although S. Koreensis is a weak bacterium, it have the potential to cause additional illness in highly immunosuppressed patients.  This outbreak in which three infected patients ultimately died during inpatient treatment demonstrates how even abundant and often nonthreatening bacteria can severely impact the health of immunosuppressed patients.

(Ike Swetlitz, STATnews)

 

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Written by sciencepolicyforall

January 8, 2019 at 12:05 pm