Science Policy For All

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Science Policy Around the Web – October 20, 2017

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By: Patrick Wright, Ph.D

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Image: By Tom Varco [CC BY-SA 3.0], via Wikimedia Commons

Drug Pricing

California governor signs drug pricing transparency law

A recently signed bill in California aims to improve transparency of future changes to drug prices. The new law requires drug manufacturers to provide a 60-day notice of any upcoming price increases of more than 16 percent over a two-year period. It comes as an attempt to assuage public and political concern over increased pricing and price gouging practices in the pharmaceutical industry. For example, a new study in the Journal of Clinical Oncology reports that for a group of 24 FDA-approved, patented, injectable anticancer drugs, the mean cost increase was 18% over a mean follow-up period of 8 years following release, substantially outpacing inflation and unaffected by the addition of competition in the market.

This legislative venture is not without reproach, however. The Biotechnology Innovation Organization, the largest biotechnology industry trade group, issued a statement condemning the California bill, arguing: “This law will neither provide meaningful information to patients nor lower prescription drug costs”. Pharmaceutical companies and drug makers have also contended that whole price increases are not representative of the actual prices paid for medicines with discounts and rebates are considered.

On the other hand, an early positive consequence of the proposed legislation is that it has encouraged some companies including AbbVie Inc to voluntarily pledge a single annual price increase of under 10 percent on branded prescription medications in contrast to the industry-standard practice of biannual, double-digit cost increases.

This law is part of a larger pursuit across states to address rising healthcare and prescription drug costs. Another recent, analogous law in Maryland (House Bill 631) is aimed at price gouging of generic medicines, those drugs created after branded medicines are no longer patented, by companies not facing competition from other distributors; a plea by a pharmaceutical industry group was turned down by U.S. District Judge Marvin J. Garbis in September. Maryland and California are not alone. According to the National Conference of State Legislatures, at least 176 bills on pharmaceutical pricing and payment across 36 states have been introduced in 2017.

(Bill Berkrot, Reuters)

 

Genetic Testing

Gene-expression study raises thorny ethical issues

A National Institutes of Health-backed consortium, known as the Genotype-Tissue Expression (GTEx) consortium, aims to accumulate data about gene sequences and activity across 44 types of human tissue, collected from approximately 1000 anonymous deceased donors. It was established in 2010 to pursue questions related to the propensity of the same DNA sequence that is present throughout a human body to give rise to varied tissues; it aims to identify the genetic factors encoded by nucleotide variants that underpin different levels of gene expression in each of these tissues. To encourage widespread participation toward this cause, the data are made freely available to qualified scientists and companies.

As part of the collection process, loved ones representing the deceased donors are asked to consent on behalf of the donor to provide a medical history and collect genetic information and tissue from the deceased. However, the study was not designed to provide the results of genome sequencing and other tests to the loved ones of the deceased donors. This raises some important ethical considerations regarding informed consent and the potential moral obligations of scientists to donor families and loved ones. Susan Wolf, a lawyer and bioethicist at the University of Minnesota in Minneapolis, stated studies such as GTEx should allow for families to be identified if downstream research discovers a mutation, for example, that would dramatically predispose relatives to cancer if inherited.

Laura Siminoff, a bioethicist at Temple University, led a study to assess the feelings of donor families in GTEx on the entire process, finding that the stress of losing a family member may have clouded the extent of analysis and research pursuits for which they had provided consent; most recalled that they had agreed to donate their relatives’ tissue for research, but little else. Siminoff suggests that the informed-consent process could be expanded to included genetic counseling in tissue-donation projects of this nature.

Currently, three federal agencies play a role in the regulation of genetic testing: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). Generally, CMS is responsible for regulating the clinical laboratories performing genetic testing to ensure testing quality. The FDA regulates the safety and effectiveness of genetic tests and pharmacogenomics (the use of genomic information to predict patient response to a particular drug), as well as genomics tools in clinical research. Finally, the FTC regulates how tests are advertised. Interestingly, the collection of biospecimens from deceased individuals is not legally classified as human subjects research under the Department of Health and Human Services policy regarding the Protection of Human Subjects, but because potentially impactful genetic information could be uncovered in the study that is of direct significance to donor families, possible ethical implications still should be considered on their behalf.

(Ewen Callaway, Nature)

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October 20, 2017 at 9:02 am

Science Policy Around the Web – October 17, 2017

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By: Charles Wright, Ph.D.

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Source: Public Domain Pictures

Gene Therapy

FDA experts offer a unanimous endorsement for pioneering gene therapy for blindness

Gene therapy, an approach long hailed for its potential to cure intractable genetic diseases, finally has some successes in getting regulatory approval.  Recently, the U.S. Food and Drug Administration (FDA) approved the first-ever gene therapy treatment for a fatal brain disease.

Last week, another gene therapy approach—this time for a blinding disease that strikes in early-to-late childhood—also received endorsement by a 16-0 vote from the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The vote provides encouragement for patients suffering from Leber congenital amaurosis, type 2 (LCA2), which Voretigene neparvovec (Luxterna) from Spark Therapeutics aims to treat. However formal regulatory approval is still pending . Leber congenital amaurosis, although rare with an estimated prevalence of only 1:50,000 – 1:100,000, devastates vision at an early age. Newborns may show visual impairment immediately after birth, and most LCA patients lose most of their vision by the time they reach 20-30 years of age. Voretigene neparvovec aims to treat patients with mutations in the RPE65 gene, characteristic of LCA2, through gene therapy.

The recent string of successes in gene therapy comes years after the field struggled to rebuild itself after tragedy.  In 1999, the death of a participant in a trial to treat a rare metabolic disorder forced FDA to strengthen its oversight of gene therapy trials. With the first formal FDA approval for a gene therapy awarded just months ago, the recent approvals for other treatments since then suggests gene therapy may have reached a turning point.  In the future, gene therapy may be common for a variety of diseases.

If voretigene neparvovec receives FDA approval, it will be the first gene therapy treatment for a blinding disease.

(John Carroll, Science)

The Scientific Workforce

Why I’m pushing for a postdoc union

Postdoctoral fellows face a bevy of obstacles that threaten to derail even the most brilliant and committed young scientists from a research career.  Many postdocs unfortunately become intimately familiar with them in the lab; funding, publications, and tenure-track positions elude trainees and can keep postdocs from establishing themselves as independent researchers for years.  The harsh reality of the postdoc lifestyle often causes problems outside the lab as well.  Low pay, long working hours, and relationship strain all take their toll.

In response to these issues, some postdocs try to form unions to force academia to respond.  The subject of postdoc unions often pits researchers against university administrators, and the legal standing of postdoc unionization remains in flux.  Universities may claim unionization ultimately harms postdoc employment, as supervisors may write less than glowing recommendation letters for post-docs who missed work due to labor disputes. Nevertheless many postdocs feel unions may help provide a platform for receiving the benefits they need.

Brian Weitzner at the University of Washington (UW) in Seattle proposes collective bargaining rights for postdocs employed at UW campuses across the state.  In the past several months, while he and other postdocs prepare for a vote on whether to unionize, he talked with UW postdocs who share his concerns.  Fair pay, health insurance, and protection for victims of sexual harassment in the laboratory all motivate him to seek the establishment of a formal avenue with universities for resolving these and other issues.

UW postdocs are working with a local chapter of United Automobile Workers to navigate the steps needed to form a union. Their petition to vote is currently being reviewed by the Washington State Public Employment Relations Commission.

(Brian D. Weitzner, Science Careers)

Genomics

The rise and fall and rise again of 23andMe

Four years ago, the DNA-testing firm, 23andMe, teetered on the edge of oblivion.  Then, in 2015, 23andMe made the news again when it announced regulatory approval to sell a test for a rare genetic disease directly to the public.  Now, the company offers testing for 10 genetic diseases to consumers and continues to supply genomics data to collaborators to aid in drug development.

In 2007, 23andMe first gained prominence with its home-delivered kit that consumers could use to learn more about their genome.  After the company analyzed the data, costumers would receive information about their ancestry, predisposition to disease, and other miscellaneous facts such as whether they carried DNA variants that impacted their earwax consistency or urine smell after eating asparagus.  23andMe would also pool customers’ de-identified data together to analyze and sell to other pharmaceutical companies or research collaborators.

As 23andMe grew in popularity, critics became concerned that consumers were being overly impressed by advertisements indicating they could use their own genetic information to better inform personal health decisions even though many links between the DNA sequence variations reported by the test and disease remain dubious.  Alarmed by the possibility patients could make decisions about their health on information that had not been fully validated, FDA warned 23andMe it would need to provide evidence of the accuracy of the tests and ability of consumers to understand the results to continue marketing their kit as a health tool.  23andMe ignored the FDA’s warnings until the regulatory agency finally issued a cease-and-desist letter.

Since then, 23andMe decided to work with the FDA to approve the genetic tests included in its kit. The company can still only sell genetic tests directly to customers for a small number of diseases but is working with the FDA to expand its offerings to the general public.  In the meantime, the company still works with research collaborators to find new disease-relevant DNA variations, like those possibly involved in clinical depression.

Ultimately, 23andMe hopes its business model will lead to new therapies for disease.

(Erika Check Hayden, Nature)

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October 17, 2017 at 5:10 pm

Science Policy Around the Web – October 13, 2017

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By: Maryam Zaringhalam, Ph.D.

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Research Funding

Why gun violence research has been shut down for 20 years

The mass shooting in Las Vegas has reinvigorated the debate around gun control. In turn, scientists and policymakers have renewed the call for more support around gun violence research. According to Alan Leshner, CEO-emeritus of the American Association for the Advancement of Science, “Gun violence is not something you can solve by just intuition and common sense or ideology.” Rather, research is required to make evidence-based policies around the best possible prevention strategies.

Gun violence research, despite its mortality rate, receives less funding and fewer publications than other leading causes of death according to an article published in JAMA earlier this year. The gap is attributable in large part to the Dickey Amendment, first passed in 1996 and reauthorized every year since. The provision, named for former Congressman Jay Dickey, mandated that the Centers for Disease Control and Prevention (CDC) could not use funding “to advocate or promote gun control,” effectively banning federal research into gun violence.

Prior to the amendment’s passage, the CDC was responsible for the bulk of research around gun violence, which informed policies aimed at violence prevention. Since the Sandy Hook Elementary shooting, The Department of Justice’s National Institute of Justice has resumed funding for gun violence studies, awarding 13 grants since 2014. Still, the bulk of funding is provided by private sources, such as the Joyce Foundation, which has spent over $53 million over the last 15 years on gun violence prevention research and advocacy.

While the Dickey Amendment has been reauthorized every year since 1996, Dickey himself has reversed his thinking on the issue: “We need to turn this over to science and take it away from politics.” While Congress is considering restrictions on ‘bump stocks’ with the support of the National Rifle Association, the political winds remain unfavorable for reopening research support.

(Todd C. Frankel, The Washington Post)

 

Women in Science

Disturbing allegations of sexual harassment in Antarctica leveled at noted scientist

Last week Science broke the news about an investigation into David Marchant, an Antarctic geologist and department chair at Boston University (BU), accused of sexually harassing two of his former graduate students while they were in the field in Antarctica. The accusations speak to an alarming trend highlighted in an online survey in PLOS ONE that found 71% of 512 female respondents reported being sexually harassed during fieldwork. Marchant’s case is one in a number that have come to light in recent years, highlighting sexual harassment and gender discrimination in science.

The allegations come at a time when U.S. universities and the U.S. government are struggling to address sexual harassment. In 2011, the Obama administration clearly defined sexual harassment as a form of gender discrimination under Title IX, directing schools to evaluate harassment claims based on a “preponderance of evidence” rather than prove allegations “beyond a reasonable doubt,” as is required for a criminal conviction. On September 22, 2017 Education Secretary Betsy DeVos submitted guidance that universities should instead consider a “clear and convincing standard” of proof. On October 12, 2017 California Representative, Jackie Speier, introduced a bill that would codify the “preponderance of evidence” standard.

BU’s Equal Opportunity Office is currently investigating Title IX complaints filed by two of Marchant’s former graduate students over the last year. According to Science, they have “interviewed numerous people, elicited a 200-page rebuttal from Marchant, and received at least four letters in his support plus at least five letters supporting [the former graduate student who filed the complaint].”

Marchant is now one of a number of senior male scientists who have been accused or found guilty of sexual harassment. These scientists span the disciplines — including astronomer Geoff Marcy, paleoanthropologist Brian Richmond, linguistics expert Florian Jaeger, and molecular biologist Jason Lieb — and have spurred a larger conversation around sexual harassment and discrimination in the scientific community. Last week, the National Academies of Science convened their fourth committee meeting on the Impacts of Sexual Harassment in Academia. The study is investigating the influence of harassment on the “career advancement of women in the scientific, technical, and medical workforce.” The committee will soon issue a consensus report, including identification of policies and practices that have been effective in combatting harassment.

(Meredith Wadman, Science)

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October 13, 2017 at 5:11 pm

Science Policy Around the Web – October 10, 2017

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By: Kseniya Golovnina, PhD.

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source: pixabay

Gene Therapy

In a First, Gene Therapy Halts a Fatal Brain Disease

 The first historic gene therapy approval by the U.S. Food and Drug Administration in August 2017 opened a new era for the treatment of serious and life-threatening diseases. One month later Bluebird Bio announced the successful start of Lenti-D therapy in the clinical trial and gave a flutter of hope to cure cerebral adrenoleukodystrophy (CALD) also known as Lorenzo’s Oil.

Adrenoleukodystrophy (ALD), a rare disorder that affects one in 21,000 male births worldwide, is caused by mutations in the ABCD1 gene that lead to the subsequent accumulation of very long chain fatty acids in tissues, including the myelin of the central nervous system. The most severe form of ALD, known as cerebral ALD (CALD), involves the progressive destruction of the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. This leads to deafness, blindness, seizures, loss of muscle control and dementia, resulting in permanent disability or death. Symptoms of CALD progress rapidly if untreated and the only current treatment is stem cell transplantation.

Gene therapy is a technique for correcting defective genes responsible for disease development.  It utilizes viruses to deliver unmutated copies of the genes, such as the ABCD1 gene, to the cells of the patient’s body. First, blood from the patient is collected by apheresis, depleting immune response T cells and enriching progenitors of all blood cells (hematopoietic stem cells, HTS). The HTS cells are then infected with a virus carrying a functional copy of the gene, before returning the cells to the body.

Bluebird Bio is now pursuing Lenti-D therapy which uses lentiviruses to deliver a functional copy of the ABCD1 gene to patients with ALD. Results published in the New England Journal of Medicine, reported that 15 out of 17 patients (88%) were free from major functional disabilities two years after the hematopoietic stem-cell gene therapy. These results demonstrate the therapy’s efficacy over the 76% benchmark established by radiotherapy-free survival at 24 months. Bluebird’s Chief Medical Officer David Davidson expressed excitement about the patients’ progress. He announced that the first four patients treated in the expansion cohort are also doing well, as measured by their amount of the functional ABCD1 gene.

(Gina Kolata, The New York Times)

Drug pricing

FDA acts to encourage generic competition for complex drugs

What kind of feelings do you have when pharmaceutical companies announce their prices for upcoming exciting gene therapies and other innovative, life-changing bio pharmaceuticals? Positive news about development and success of first-of-their-kind drugs can be undermined by anxieties that patients will not be able to afford them. High drug prices can prevent accessibility of new therapies vital for many patients, and market analysts predict rapid inflation in healthcare spending over the next few years due to the aging US population.

The FDA is conscious of the stress expensive drugs put on both patients and the entire healthcare system. Under the leadership of current Commissioner, Dr. Scott Gottlieb, one of key goals of the the FDA is to bring more competition from generics to help drive prices down. On October 2, 2017 the agency prepared draft guidance specifically aimed at copycats of complex therapies and therefore trying to clear the way for generic drug makers to the market.

Gottlieb wrote in his blog post that the agency is looking for more efficient regulatory pathways with robust reviews and communication with pharmaceutical companies for abbreviated new drugs applications (ANDAs). He highlighted that “early and better meetings between FDA and sponsors can improve development timelines. The agency acknowledged that the complexity of the approval process may be discouraging to generic drug makers. The new guidance aims to clarify these complexities by outlining how genetic makers can prove “sameness” by showing that there is no difference in response to generic drug compared with the original. This is the second update for ANDAs process and Dr. Gottlieb assured that FDA will continue to progress in this reformation.

(Linda A. Johnson, The Associated Press)

 

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October 10, 2017 at 10:11 pm

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Science Policy Around the Web – October 6, 2017

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By: Allison Dennis, B.S.

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source: pixabay

Homelessness

An outbreak waiting to happen: Hepatitis A marches through San Diego’s homeless community

San Diego’s homeless population, the fourth largest among US cities, has been battered by a Hepatitis A outbreak since early 2017. The outbreak may have been brought on by the conditions that arose when homeless people were locked out of public bathrooms and further displaced from popular downtown areas by City officials in anticipation of the Major League Baseball’s All-Star Game last summer. The Hepatitis A virus, which is transmitted person-to-person and through the fecally contaminated environment, affects the liver, resulting in fatigue, yellow skin, diarrhea, and discolored urine. Its 50-day incubation period combined with its ability to survive outside the body for months, provides the virus an extensive time frame to spread from a single carrier. So far 481 people have reported infections, and 17 people have died.

The city is now struggling to respond. 54,000 people have already been vaccinated and a state law has been temporarily relaxed, allowing paramedics to administer the vaccine to at risk individuals. New portable bathrooms and hand-washing stations have been installed near homeless encampments. However, providing stable housing for the homeless remains an outstanding obstacle. In July, the San Diego Housing Commission announced an $80 million, 3-year initiative, Housing First-San Diego, which will provide incentives to landlords, 700 housing vouchers, and the construction of additional voucher-eligible housing. Housing First refers to a US government endorsed approach to providing stable housing, free of conditions, as a first step in addressing homeless people’s healthcare needs. Stable housing is fundamental to addressing the health needs of homeless populations both for prevention and treatment.

(Usha Lee McFarling, STATnews)

Science Funding

Does your state get its fair share of federal research dollars?

Representative Bill Foster is proposing a change to the way the National Science Foundation (NSF) distributes funding across the country. Twenty-nine years after it’s creation, NSF began a formal program to address the disparities in its funding across the fifty states, territories, and commonwealths of the United States, recognizing that scientific funding was being predominantly steered towards institutions housed on either the East and West coasts. The Established Program to Stimulate Competitive Research (EPSCoR) currently allocates additional funds specifically to the twenty-five states, two territories, and one commonwealth winning less than 0.75% of NSF’s Research and Related Activities budget. Additional funds are supplied to these states for improving infrastructure, funding grants that fell under the cutoff for funding through traditional NSF programs, and supporting workshops and outreach. In fiscal year 2016, $160 million was allocated for the EPSCoR program compared with $5,500 million for the Research and Related Activities budget.

Bill Foster is arguing that EPSCoR is now disproportionately benefiting small states, proposing eligibility should be determined on a per capita instead of per state basis. This seems to be a change of pace from Bill Foster’s previous calls to eliminate the program altogether. Barring the passage of the proposed bill into law, NSF does not have plans to change the way they calculate eligibility, citing the popularity of the current program with congress.

(Jeffrey Mervis, Science)

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October 6, 2017 at 10:24 pm

Science Policy Around the Web – October 3, 2017

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By: Allison Dennis, B.S.

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Policy Evaluation

How to collect better data on government programs—and improve privacy, too

Of the 11,976 bills that have became law in the US how do we know which have achieved their goals? Of the $3.9 Trillion spent by the federal government in 2016, how much made a measurable impact on society? The Evidence-Based Policymaking Commission Act, which had been introduced in the house by Paul Ryan in April of 2015 and signed into law on March 30, 2016, called for the creation of a federal panel to inventory the vast amounts of data already collected by the federal government and make recommendations for how it could be shaped into effective tools for policymakers. The conclusions drawn by the panel of economic and public policy experts were recently released in a report. Forefront was addressing the security practices that would be necessary to protect sensitive information. As such, rather than propose a consolidated data bank, the commission recommends the use of a secure portal to consolidate data temporarily and as-needed. The report idealizes the Department of Commerce, which oversees the Census Bureau, as the would-be home of the National Secure Data Service.

Inspiration for the integration of data into policy may need to be distilled from examples outside the federal government. For example, the Bill and Melinda Gates foundation has approached this issue by outlining a largely flexible framework that can be used for the purpose-driven evaluation of “an ongoing or completed intervention, project, policy, program, or partnership.” The focus on a purpose-driven approach allows those closest to the project to define what types of evaluation will be most useful. However, the marked advantage in this approach is the acknowledgement of evaluation criteria early in the project’s implementation.

Evidence that city governments might already be employing in a data-driven approach comes from Boston’s Resilient Strategy, a report which outlines “utilizing new and existing data sources to advance resilience and racial equity across the city.” Following up the report, the Mayor of Boston recently undertook the establishment of the Economic Mobility Lab, which will take a “laboratory” approach to understanding what works in promoting upward economic mobility and security.

However, discussions with the Oversight and Government Reform Committee for the U.S. House of Representatives, which largely veered off topic, revealed that the report would only be a small step towards using scientific evidence to inform policy decisions as a routine practice at the legislative level. Members of the committee seemed focused on how findings of the commission could be used to promote partisan agendas, rooting out fraud or undermining policies thought to be unscientific for example. Until lawmakers begin turning the recommendations of the commission into law, they will go unrealized, prompting Katherine Abraham and Ron Haskins, the former chair and co-chair of the concluded commission, to lead a continuation as part of a new Initiative hosted by the Bipartisan Policy Center.

(Jeffrey Mervis, Science)

Natural Disasters

One More Thing For Puerto Rico To Worry About: Disease-Ridden Mosquitoes

Hurricane winds and rain can destroy mosquito populations. Unfortunately, the haste with which they bounce back may outpace the time taken by their human counterparts to rebuild roofs, reinstall screens, wait in line for gasoline, stock up on clean drinking water, open the windows to catch relief from un-air-conditioned houses. All this time outside increases people’s exposure to mosquitos. Displaced families may gather in shelters or stay with friends, increasing the spread of communicable and disease. Hurricane flooding may immediately increase nuisance mosquito populations, those species that do not carry disease. However populations of Aedes aegypti mosquitos, those that spread Zika, dengue, West Nile, and chikungunya virus, may see surges in population, 2 weeks to 2 months after a hurricane, when adult Aedes aegypti mosquitoes find ample opportunities to lay eggs in stagnant pools of water accumulated during rains.

Following Hurricane Katrina in 2005, Tulane University reported a twofold increase in West Nile virus in affected counties. Following earthquake caused floods in Costa Rica in 1991, a significant outbreak of Malaria was experienced. Luckily, not all flooding conditions or human activities following a disaster result in outbreaks. Last month, the Air Force Reserve was dispatched to begin aerial spray applications of Texas areas affected by Hurricane Harvey to control pest insect populations. Local authorities in Florida have already begun treating areas that have accumulated water since Hurricane Irma with insecticides. However, whether aerial-spray programs will be implemented towards combating the rise of mosquito populations following Hurricane Maria in Puerto Rico remains unclear.

The recognition that disparities in normal living conditions are linked to the spread of vector-born diseases has many public health officials worried about the recovery of people in Puerto Rico in contrast with Florida and Texas, all of which share a habitat for the Aedes aegypti mosquito.

(Maggie Koerth-Baker, FiveThirtyEight)

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October 4, 2017 at 10:55 am

Science Policy Around the Web – September 29, 2017

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By: Allison Dennis, B.S.

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Hospital Budgets

Another health care deadline looms: Payments to safety net hospitals due to expire

On October 1, 2017, America’s healthcare safety net will face its first in a series of annual funding cuts to Disproportionate Share Hospitals payments scheduled by Obamacare. This safety net is held together by hospitals that shoulder the responsibility of serving the uninsured, Medicaid, and economically-vulnerable patients, often at a financial loss. The American Hospital Association reports that hospitals are only reimbursed 88 cents for every dollar they spend on Medicaid patients. Further insufficiencies arise when hospitals adhere to The Emergency Medical and Treatment Labor Act of 1986, which mandates the treatment of patients seeking emergency services regardless of their ability to pay. Highly profitable hospitals that attend communities where these patients represent a marginal burden can absorb the cost through lost profits. However, hospitals serving communities where these patients pose an undue burden are supported by subsidies from federally-funded, state-matched, Disproportionate Share Hospitals payments. The scheduled cut for this year would reduce the $21 billion allocated state-by-state in fiscal year 2017 by a total of $3.6 billion, $2 billion from federal contributions combined with $1.6 billion from state contributions.

Obamacare expanded Medicaid to cover individuals up to 138% of the Federal Poverty Level, set at $33,948 for a four-person household and $16,642 for an individual, reducing national levels of uncompensated care. Further, the law provided opportunities for individuals to purchase insurance coverage through HealthCare.gov, while implementing penalties for those who chose to forgo coverage. Lawmakers included a schedule for reducing Disproportionate Share Hospital Payments on the assumption that the proposed changes in the healthcare system would be sufficient to reduce the financial burden on safety net hospitals, lessening the need for federal and state assistance.

The rate of uninsured Americans did fall to 8.8% in 2016, compared with 16.3% in 2010. However the extent to which this change has improved revenues for safety net hospitals remains unclear. Further occluding the readiness of hospitals to cope with the budget cut are the unique challenges each may face. The agreement to extend discussions of the 2018 fiscal year budget past the October 1 deadline may give lawmakers the last minute chance to forgo the cuts for yet another year.

(Max Blau, STATnews)

Pharmaceutical Regulation

You’ve heard about precision medicine. Now get ready for precision drug ads

In 2016, $5.7 billion, about $17.5 per person, was spent by pharmaceutical companies on traditional advertising. But how many of those ads were seen by the people who need them? Their recent interest in the online giants Facebook and Pandora, suggests that pharmaceutical companies are looking to enter the new age of advertising, targeted ads. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 prevents insurance companies and healthcare providers from sharing an individual’s health information, especially when it may be used for marketing purposes. However, being privy to a person’s private interactions with their electronic devices may be far more revealing about a user’s health than conversations with their doctor.

The FDA has been tasked with regulating pharmaceutical advertising on the internet. However, applying the rules surrounding pharmaceutical adverting in the age of 140 character limits and browser history mining will take some reimagining. So far, the FDA’s approach to limiting inappropriate advertising has been to call it when they see it. In 2015, the FDA famously issued a warning letter regarding an Instagram post made by Kim Kardashian, seemingly promoting a prescription-only anti-nausea pill. Nevertheless, in 2017, Pfizer successfully experimented using geographical information to target ads to online consumers without any FDA upset.

This comes as a growing field of research is investigating the observation that the words used to describe a particular disease may influence the treatment options a patient gravitates towards. Parents who were told their child had “pinkeye” instead of an “eye infection” were more likely to give their child a course of antibiotics, even when doctors stated the treatment was likely ineffective. Altering the language appearing in targeted ads on platforms like facebook may further provide means for social experimentation, adding another layer of concern for the FDA.

(Rebecca Robbins, STATnews)

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September 29, 2017 at 7:40 pm