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Should Vaccines be Mandatory?

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By: Juan I. Moliva, Ph.D.

Image by Angelo Esslinger from Pixabay 

The anti-vaccination movement has been gaining traction across the United States (U.S.) and the world. According to the Centers for Disease Control and Prevention (CDC), the number of measles cases in the first five months of 2019 surpassed the total number of cases per year for the past 25 years, with the number of children unvaccinated for preventable diseases quadrupling since 2001. The CDC also found an increase in the number of vaccine exemptions for kindergarteners across the U.S. While the numbers vary across the country mostly due to laws set in place by each state, in Mississippi, one of three states that do not grant exemptions due to religious or philosophical reasons, the rate of kindergartners with an exemption to one or more required vaccine was 0.1%. Compare that to Oregon, a state that grants exemptions to vaccines due to religious or philosophical reasons, where the rate of vaccine exemptions for kindergarteners is at 7.6%. As the number of individuals choosing not to get vaccinated or choosing not to vaccinate their children continues to increase, the debate as to whether vaccines should be mandatory has taken front stage.

Simply stated, a vaccine is a weakened or killed version of a pathogen that is delivered to the body with the sole goal of stimulating an immune response to protect you against the disease you are being vaccinated against. How is this accomplished? Your immune system has a subset of cells with “memory” that remember the pathogen and if you are later exposed to the pathogen these “memory” cells will eliminate the pathogen before it can make you sick. In the U.S. and most of the world, the general scientific consensus on vaccines is that they are safe and critical for maintaining healthy communities. The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) strongly defended the case for vaccines. Chairman Lamar Alexander (R-TN) said, “The science is sound: Vaccines save lives – the lives of those who receive vaccines and the lives of those who are too young or vulnerable to be immunized.” Like any medication or medical procedure, vaccines do not come without risk, but the advantages vastly outnumber any disadvantages.

Not only do vaccines protect your body from dangerous pathogens, they also protect the community via a concept known as herd immunity. When a high enough percentage of the population is immune, pathogens have a harder time spreading. We rely on this principle to protect those who cannot receive a vaccine. However, vaccine opponents continue to argue that mandating vaccines is a slippery slope towards losing body autonomy. I have spent the last eight years studying vaccines, from basic research to pre-clinical testing through clinical trials and licensing. I have recently come to embrace the belief that the sole exemption for a vaccine that has been proven to be effective is a medical one – the case where you cannot receive a vaccine because your body responds negatively to the vaccine; this includes a weakened immune system that can be caused by chemotherapy or radiotherapy, a congenital condition that leads to an impaired immune system, or a history of serious adverse events related to vaccination such as an allergic reaction to one or more components in the vaccine.

The case against anti-vaxxers surrounds the choices they make on behalf of their children and how those choices affect their children and those in the community. If parents started claiming religious or philosophical exemptions against child safety seats or against buckling their children while driving, would we be arguing in their favor? Seatbelts and safety seats have been proven to save lives by preventing ejection from the vehicle after impact. Vaccines have been medically proven to save lives by preventing death or disability from infectious pathogens after exposure. While we expect not to be involved in a car accident, we rely on seatbelts in case we do. Vaccines work the same way; we do not want to be exposed to deadly pathogens but being vaccinated against these pathogens helps ensure we do not get sick if we do. Childrenare incapable of deciding if they want to be vaccinated as some vaccine regimens are initiated within the first year of life, thus their welfare is entrusted upon their parents. 

In the U.S. we have laws about providing proper nutrition, schooling, clothing, cleanliness, shelter, and many more that protect children’s welfare. Providing vaccines on time should be included as a basic necessity and be treated no different than other child welfare offenses. If an unvaccinated child contracts a preventable disease and is significantly affected to the point of disability or even death, the parent(s) should be directly responsible. A guardian refusing to vaccinate their medically eligible child should be treated like what it is: child endangerment. Take for example the recent case of a six-year-old in Oregon that nearly died of tetanus after sustaining a cut while playing outdoors. The child’s parents had refused to vaccinate the child with DTaP, a safe vaccine intended to protect against tetanus. The boy was held in an intensive care unit for 47 days, undergoing multiple intravenous infusions to alleviate the high fever, hypertension, and tachycardia caused by the infection. All at the cost of over $800,000 for a disease that could have been easily prevented with vaccination. Despite the episode, the boy’s parents continue to refuse the vaccine.

Although bipartisan support exists for vaccination at the federal level, it is unlikely federal law eliminating philosophical and/or religious exemptions would come to pass as public health policy is traditionally left to the states. State legislatures are beginning to introduce laws that will help limit the increase in numbers of preventable disease cases due to lack of vaccination. New York state recently passed legislation forbidding religious and non-medical exceptions to vaccines. After signing the bill, Governor Cuomo (D-NY) said, “While I understand and respect freedom of religion, our first job is to protect the public health.” Washington state, plagued by surging number of measles cases, also recently banned personal and philosophical exemptions to the MMR vaccine, which protects against measles, mumps, and rubella. Merely going to a public park or a grocery store can place unvaccinated children or immunocompromised individuals at risk of contracting a preventable disease. Such was the case of a six-year old boy with leukemia that died of measles after being exposed by his intentionally unvaccinated siblings. Senator Bill Cassidy (R-LA), a former physician, stressed: “If you are such a believer in liberty that you do not wish to be vaccinated, there should be a consequence and that should be that you cannot infect other people.” While I agree that autonomy over one’s body is important, the government has the right to require a reasonable level of vaccination for all citizens as a matter of public health. 

In the U.S. where freedom and personal liberty are valued above all else, mandatory vaccination would have a lengthy and challenging uphill battle. Additionally, data suggests that mandatory vaccination does not necessarily increase vaccination coverage. Instead, the U.S. could increase vaccinations via financial incentives similar to the system in place in Australia whereby parents receive monetary compensation when their children meet vaccination requirements. However, the most successful approach might be akin to the one the CDC implemented over sixty years ago to encourage stricter vaccination requirements by the states. By providing educational support, the CDC engaged parents, policymakers, and state and local health officials at every level to increase vaccination coverage. Education is one of the most effective ways to counter vaccination noncompliance. Specifically, educating people on the alternatives to vaccines – the morbidity and the mortality associated with lack of vaccination – was shown to be the most effective strategy. Educating why vaccines are so crucial is the most powerful weapon to combat vaccine non-compliance. 

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Written by sciencepolicyforall

August 14, 2019 at 10:00 am

Posted in Essays

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Disparity in the Global Supply and Demand for Vaccines Against Rotavirus

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By: Lawrence Wang

Image by Arek Socha from Pixabay 

Vaccines are extremely important for individual and global health. These life-saving biologics are especially important for children in developing countries, who suffer disproportionately from vaccine-preventable infectious diseases. One of these infectious diseases is rotavirus, which causes severe diarrhea and kills around 200,000 young children and babies per year1. Effective vaccines against rotavirus are responsible for saving countless lives and reducing suffering around the world.

In November 2018, the major pharmaceutical company Merck canceled a long-term commitment it made with GAVI (The Global Alliance for Vaccines and Immunization) to provide its rotavirus vaccine, RotaTeq, to four countries in West Africa (Burkina Faso, Cote d’Ivoire, Mali, and Sao Tome) for $3.50 a dose. Simultaneously, Merck increased RotaTeq shipments to China where a course sells for $40, nearly 12 times more than in West Africa2. Merck reported that the reason for this termination was “supply constraints” and an “unprecedented increase in global demand” for Rotateq3. Vaccines that were earmarked for West Africa were instead diverted to China, where they would protect millions of Chinese children while leaving millions of West African children vulnerable.

This situation exemplifies the disparity in the global supply of, and demand for, vaccines. Many vaccines are produced by large pharmaceutical companies like Merck that are based in wealthy nations (e.g., Merck’s headquarters are in New Jersey, USA). In general, developed countries have more agency in purchasing and providing vaccines for their citizens at higher prices. Developing countries, on the other hand, usually lack the money to pay for vaccines and are consequently reliant on free or subsidized vaccines. Profit-driven companies such as Merck are thus incentivized to sell their limited supply of vaccines to countries that can afford to pay more.

GAVI and UNICEF (United Nations Children’s Fund) are organizations that work to address disparities in vaccine access between industrialized and developing countries by buying and delivering vaccines to poor countries around the world4,5. However, they still rely on pharmaceutical companies to produce the vaccines that they distribute. When Merck notified GAVI and UNICEF that it would stop supplying discounted RotaTeq doses to the four West African nations, their only recourse to address the unexpected vaccine supply shortage was to help the affected countries switch to anot­­her rotavirus vaccine produced by a different company2.

This potentially problematic situation was avoided by a multilateral collaboration between aid organizations, governments, and manufacturers. Specifically, other pharmaceutical companies like GlaxoSmithKline (GSK), Serum Institute of India, and Bharat Biotech stepped in to fill the dearth left by Merck by pledging to supply their rotavirus vaccines (Rotarix, Rotavac, and Rotasiil) to the four West African countries. These countries are expected to switch to these alternative vaccines (which are actually cheaper than Merck’s) in 2020 after their supplies of RotaTeq run out6.

While this story ostensibly has a happy ending, it also highlights inherent problems in the way vaccines are supplied to the world, specifically poorer nations. These nations are reliant on aid organizations like GAVI and UNICEF to provide them with free or discounted vaccines, which are in turn dependent on profit-driven pharmaceutical companies to produce and supply the vaccines. Why can’t these multinational pharmaceutical companies, which have vast resources at their disposal, just produce more vaccines when there is a shortage?

The answer to this question is multifactorial. Firstly, vaccine production is complicated and only multinational pharmaceutical companies have the sufficient expertise, infrastructure, and manpower to produce high-quality vaccines that are safe and effective at scale. Thus, even these companies need advanced warning to produce millions of vaccine doses. Secondly, the prices for vaccines have been increasing in recent years, mostly due to high fixed overhead costs and exclusive licensing practices that preclude competition7. Thirdly, vaccines represent only about 2-3% of big pharma’s trillion-dollar production portfolio and are not the most profitable part of their portfolios8. Thus, pharmaceutical companies have little incentive to pick up the slack. How, then, can the costs of vaccines be reduced and who is supposed to step up to make vaccines when big pharmaceutical companies fall short of their obligations?

One potential solution to reduce the cost of vaccine production is for smaller pharmaceutical companies to produce generic vaccines. Generics are alternative versions of patented drugs and vaccines that are supposed to work just as well as the original formulation. In fact, India has become one of the world’s leading producers of generics and is a major source of vaccines and drugs for Africa. The issue with this solution is that the generics manufacturing industry is fraught with regulatory issues such as poor quality control and lack of oversight9. Africa is most starkly affected by these issues because manufacturers ship their lowest-quality drugs to the continent. Some of these products are completely counterfeit, with no active ingredients, while others have only a fraction of the active ingredients listed10. Without fixing quality control and oversight of generics manufacturing, this is not a viable long-term solution to provide vaccines to poor countries.

Another potential solution to increase vaccine coverage in Africa specifically would be to empower the continent to manufacture its own vaccines. Though Africa is home to nearly 17% of the world’s population, it produces less than 1% of the world’s vaccines and spends millions purchasing vaccines from foreign entities. For instance, African governments imported $900 million worth of basic vaccines for children in 201411. GAVI and UNICEF could partner with pharmaceutical companies to spearhead capacity building in specific African countries so they could produce their own vaccines, instead of making them dependent on vaccines from third parties. Apart from providing vaccines, this strategy would potentially build local biomedical capacity, provide jobs, and incentivize highly educated African expatriates to return to their home countries12.

Unfortunately, global vaccine stakeholders are hesitant to invest in building vaccine production capacity in Africa. For instance, profit-driven pharmaceutical companies tend to invest in healthy markets that will yield stable returns on their investments. Before investing in building a manufacturing facility, these companies must first ensure that the vaccines they produce will be bought for a certain price at a certain time12. Besides, It will be an uphill battle if Africa cannot produce vaccines more cheaply than other countries like India, which has already optimized infrastructure for producing vast quantities of vaccines cheaply13. Overall, there are many economic barriers that prevent Africa from developing its own vaccine manufacturing infrastructure.

In conclusion, the recent story revolving around providing rotavirus vaccine for West African countries exemplifies the complex challenges in supplying vaccines for the world, especially developing countries that contain some of the world’s most vulnerable populations. Despite the relatively vast resources that global organizations and companies like GAVI, Merck, GSK, and UNICEF have at their disposal, the demand for life-saving vaccines continues to outstrip the supply of vaccines. The bottom line is that vaccines are a vital component to the health of people and nations, and access to these medicines ought to be a universal human right.

  1. https://www.who.int/immunization/diseases/rotavirus/en/
  2. https://www.npr.org/sections/goatsandsoda/2018/11/01/655844287
  3. https://www.fiercepharma.com/pharma/amid-china-launch-merck-cites-supply-limits-plan-to-scale-down-rotateq-shipments-africa
  4. https://www.gavi.org/
  5. https://www.unicef.org/
  6. https://www.npr.org/sections/goatsandsoda/2019/05/31/726863111/it-looked-as-though-millions-of-babies-would-miss-out-on-a-lifesaving-vaccine
  7. https://www.who.int/immunization/programmes_systems/procurement/market/en/
  8. https://www.theatlantic.com/business/archive/2015/02/vaccines-are-profitable-so-what/385214/
  9. https://www.statnews.com/2019/07/22/indian-pharmaceutical-industry-drug-quality-charges/
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4105729/
  11. https://www.dw.com/en/africa-wants-to-manufacture-its-own-vaccines/a-46151389
  12. https://www.frontiersin.org/articles/10.3389/fpubh.2019.00056/full
  13. https://www.thehindu.com/sci-tech/health/trusting-the-science/article25861183.ece

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Written by sciencepolicyforall

August 7, 2019 at 2:45 pm

Where to have a baby? Newborn screening is not created equal.

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By: Emily Wires, Ph.D.

Image by PublicDomainPictures from Pixabay 

In 2017, there were an estimated 3,855,500 live births in the United States, one of whom was my son. Within the first days of life, infants are tested for heritable disorders that can hinder physical and/or cognitive development. Unfortunately, the same set of potentially life-saving tests are not equal for all 3,855,500 infants. 

Since its conception in the 1960ss, newborn screening has been recognized as an essential preventative public health initiative. Serving as a frontline for early detection, conditions included on the screening panel are often considered rare and early intervention is essential to improved quality of life. The Newborn Screening Saves Lives Act was signed into law in 2008 and sought to bring public awareness among parents and health professionals as well as improve newborn screening programs.   

Currently, the panel of tested disorders varies state to state — yes, that means your baby’s health trajectory can be influenced by state lines. When considering birth location, most expecting parents grapple with the pros and cons of hospital versus birthing center versus home birth, but many are naïve to state regulations. Newborn screening standards, specimen collection, and follow-up procedures are implemented by state health departments. Contact information for newborn screening laboratories and follow-up program are available for individual states. Variations in statutes often extend beyond the panel of testable conditions, spilling over to funding for both screening programs and treatments, laboratory standards, and parents’ rights of refusal. To address discrepancies among states, the Department of Health and Human Services (HHS) has provided a Recommended Uniform Screening Panel (RUSP) that includes 34 core conditions and 26 secondary conditions and serves as a suggestive resource for state governments to incorporate as part of their screening programs. RUSP inclusion criteria stipulates a condition be identifiable 24-48 hours following birth, screening tests for the condition are available and validated, and the condition has been shown to benefit from early detection. Conditions included within RUSP are recommended by the Advisory Committee on Heritable Disorders in Newborns and Children along with the HHS Secretary. Despite these recommendations, not all states adhere to RUSP suggestions. 

Orphan drugs are intended to serve the rare disease community but are often commercially underdeveloped owing to their limited profitability. The Orphan Drug Act, passed in 1983, has since served as a legislative springboard set to improve the lives of individuals with rare diseases by incentivizing and accelerating drug discovery. Rare diseases are just that– rare, and because rare diseases are defined as disorders that affect less than 200,000 Americans at one time (with a sizeable proportion belonging to pediatric populations), pharmaceutical companies often expect to incur financial loss developing orphan drugs, which often means a treatment is not pursued. Collectively, however, rare diseases comprise a large healthcare need (an estimated 30 million people in the US are living with a rare disease) and have garnered increased public interest through the work of patient advocacy groupsresearch institutionsgrant funding opportunities, and public events such as Rare Disease Day

So, herein lies the dilemma. Are we essentially running a relay race but missing the handoff? Newborn screening assesses the presence of heritable conditions during a critical development period that otherwise may be missed and parallels an incentivized impetus for drug discovery, yet many states are dropping the proverbial baton regarding panel legislation. Consider, Spinal Muscular Atrophy (SMA) and its recent headlines in the rare disease community. SMA is a debilitating (and deadly), heritable disorder resulting in the loss of motor neurons and subsequent muscle atrophy. In 2016, the Food and Drug Administration approved Spinraza as the first-ever treatment of SMA. The American Academy of Neurology 2019 annual meeting recently reported data from 25 infants diagnosed with SMA at less than six weeks of age who received Spinraza prior to observable symptoms. By 14-34 months, none of these infants required permanent ventilation, all were able to sit and swallow without support, and most of them could walk on their own. However, despite this monumental advancement, not all states include SMA in their newborn screening panel. 

How do we become better for the rare disease community? Admittedly, a loaded question and likely multifaceted in approach. One potential approach would be to federally incentivize universal newborn screening across states. Screening implementation conditions typically vary due to financial constraints, frequency of disorder within state’s population, and treatment availability. California and Pennsylvania are currently the only states that with rare disease legislative caucuses. These bipartisan committees are comprised of individuals dedicated to bridging awareness among policy makers, scientists, patients, and the public. However, there are still discrepancies even among states with caucuses (California tests for 63 conditions, while Pennsylvania tests for 38), attesting to the critical necessity of a universal screening panel. 

Science is making vast strides in the detection and treatment of rare diseases. It is time for public health and policy makers follow suit in an appropriate manner, especially when time may be a crucial factor for our youngest rare disease patients

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Written by sciencepolicyforall

August 2, 2019 at 2:38 pm

Science Policy Around the Web – April 12, 2019

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By: Saurav Seshadri, PhD

Photo by Elijah Hiett on Unsplash

With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure

petition demanding coverage of the cystic fibrosis (CF) drug Orkambi in the UK has now garnered over 100,000 signatures, and must therefore be considered by Parliament for debate.  The milestone is the latest development in the struggle between Orkambi maker Vertex Pharmaceuticals and the British government, which began soon after Orkambi was approved in 2015.  The main point of contention is the price of the drug.  The UK’s National Institute for Health and Care Excellence (NICE) has refused to recommend Orkambi at Vertex’s asking price of £104,000 ($136,000) per patient per year, but Vertex has rejected the UK’s offer of £500 million for 5 years’ access, leaving both parties at an impasse.

The UK is not the first country to clash with Vertex over pricing. Several health agencies have refused to pay for Orkambi on the grounds that it is only marginally effective; some now face lawsuits, as programs like Medicaid are required to provide available drugs for qualifying patients.  While Orkambi is not as effective as Vertex’s first drug Kalydeco, it can be prescribed to more patients (up to 50% of those with CF).  Life expectancy for patients with CF is less than 40 years, and many patients are children, so even small improvements can be life-changing.  However, as with the multiple sclerosis drug Ocrevus, NICE seems unlikely to relent; on the contrary, UK Health Minister Matt Hancock recently accused Vertex of ‘hold[ing] the NHS to ransom’ and ‘profiteering’.  

For its part, Vertex is unlikely to compromise on the price of its best-selling drug, which brought in $1.26 billion in 2018.  CEO Jeffrey Leiden insists that this revenue is critical to the company’s continued investment in CF research.  Ironically, this stance may be pushing the UK closer to a measure that would jeopardize all future medical R&D efforts: invoking ‘Crown’ use, which allows the government to sell a patent without the consent of its owner. While the idea has gained support among some British lawmakers, and has been used in the past (to make Pfizer-owned antibiotic tetracycline available in the 1960s), it would face legal challenges that could render it ineffective.  But with public pressure mounting, especially after Vertex recently admitted to destroying almost 8,000 packs of Orkambi amid the standoff, inaction may not be an option for much longer.

(Eric Sagonowsky, FiercePharma)


Why some low-income neighborhoods are better than others

A recent study, published in PNAS, builds upon a body of evidence that while race can influence upward mobility (with white children having a 4-fold higher chance of moving from the lowest to highest income brackets than their black peers), environmental factors also play a major role.  Previous work demonstrated that the neighborhood in which a child grows up has a large effect on their future success, with better outcomes for children raised in low-poverty neighborhoods, regardless of race.  However, black children are significantly less likely to live in such neighborhoods.  To combat racial inequality, it is critical to understand which aspects of poverty impact long-term socioeconomic progress. 

The new study is based on the Opportunity Atlas, and pulls together data from tax returns, Census surveys, police reports, prison admission records, and blood tests conducted by the health department. The data tracks a cohort of children born in 1978-1983 (age 31-37 in 2014), living in 754 Census tracts in Chicago.  The authors report that even after controlling for other variables, a large proportion of the racial disparity observed in adults can be explained by three factors: violence, incarceration, and lead exposure during adolescence.  Since these factors were highly correlated with each other, the authors combined them into a single ‘neighborhood harshness/toxicity’ factor; this variable proved to be a much stronger predictor of income, incarceration, and teen pregnancy than more traditional factors, such as poverty or college education rates.   

That these elements impair social mobility is perhaps not surprising, as exposure to both violence in the community and high levels of lead have both been linked to cognitive impairment. But the magnitude of the effect is striking: for example, according to their model, toxicity exposure could account for 60% of the difference in incarceration rates between black and white men in their sample, and a 10% increase in teen births among black women.  While the authors acknowledge they cannot establish causality, they conclude that ‘Chicago’s residential segregation is disproportionately exposing its black children to neighborhoods that are hazardous to their development’.  Recently elected mayor Lori Lightfoot ran on a platform that includes stopping violence, expanding affordable housing, and ‘investing in our neighborhoods’.  Insight into the mechanisms that perpetuate inequality can only enhance these policies’ power to improve the trajectories of vulnerable kids.      

(Sujata Gupta, Science News


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April 12, 2019 at 5:21 pm

Science Policy Around the Web – January 11, 2019

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By: Mary Weston, Ph.D.

1600px-aedes_albopictus

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 – April 13, 2018

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By: Maryam Zaringhalam, Ph.D.

20180413_Linkpost

source: pixabay

Public Health

Flint school children to be screened for effects of lead after agreement

April 25th will mark four years since Flint, Michigan had clean drinking water. In that time, the water has been contaminated with lead at levels above hazardous waste and with pathogens like Legionnaires’, which resulted in an outbreak that left 12 dead. The mishandling of Flint’s water crisis has resulted in a number of lawsuits and several felony convictions, with charges ranging from conspiracy to involuntary manslaughter.

Most recently, a judge approved a $4 million legal agreement on Thursday to screen children for exposure to lead poisoning and evaluate their cognitive development, memory, and learning. The lawsuit was first filed in 2016 by a coalition of local and national groups sued the Michigan Department of Education and school districts in Flint. Exposure to lead — a neurotoxin — during childhood can have long-term adverse health effects on cognitive and physical development. As a result, children exposed to lead may require special education services. The results of these evaluations, which will begin in September, will be used to better provide services to the children affected by lead exposure. Dr. Mona Hanna-Attisha, director of the Michigan State University-Hurley Children’s Hospital Pediatric Health Initiative and an early advocate for the Flint community, will oversee the program. The lawsuit will continue in Michigan federal court to increase special education services and reforms with representation by the ACLU of Michigan.

The Flint water crisis began in 2014 when the city switched its water supply from Lake Huron to the Flint River, which had long been polluted by industrial byproducts. Flint residents immediately reported poor-tasting water, however, their complaints were ignored by government officials despite robust community advocacy efforts. Finally, in September 2015 scientists at Virginia Tech published an extensive report (made possible by collaboration with members of the Flint community) documenting dangerous levels of lead in Flint residences, followed by a report from the Environmental Protection Agency (EPA). Pollution in the river had created a fertile breeding ground for bacteria, so the river was treated with chlorine, making the water acidic, in turn leaching lead from Flint residents’ plumbing. The crisis could have been prevented if appropriate corrosion control measures were taken.

On April 6, Michigan Governor Rick Snyder announced Flint’s water is once again safe for drinking, terminating the free bottled water program designed to give Flint residents safe water as part of a $450 million state and federal aid package. Nevertheless, mistrust remains.

(Alex Dobuzinskis, Reuters)

Healthcare

Trump administration rewrites ACA insurance rules to give more power to states

After several unsuccessful Congressional attempts to repeal the Affordable Care Act (ACA) last year, the Trump administration has taken steps to roll back ACA regulations with 523 pages worth of new and revised rules. The new regulations will take effect for ACA health plans sold this fall for 2019 coverage.

Perhaps the most significant change comes from a new rule aimed at shrinking the authority of the individual mandate — the ACA provision that every individual must have healthcare or face a penalty. Individuals can seek exemption from that requirement through one of two broad channels. On Monday, April 9, the Centers for Medicare & Medicaid Services issued a final notice that individuals living in counties with only one or no ACA insurers qualify for a “hardship exemption” because the marketplace is not competitive in their region. Notably, in 2018, around half of US counties had only one or ACA insurers. Individuals opposing abortion can also qualify for exemption if their only ACA provider options cover abortion. In November, the Congressional Budget Office projected that a straight repeal of the individual mandate would increase premiums by ten percent; so even a partial effective repeal could lead to increased premiums for customers opting to stay on ACA plans.

The new rules also grant states much more authority and flexibility when determining whether healthcare plans meet ACA standards. The old ACA rules required insurers provide a standard set of ten essential health benefits to ensure customers had access to the same core set of benefits and allow them to comparison shop. Before, states were required to base these ten categories on the same benchmark plan within state borders. The rule has now been changed so that states can select different benchmark standards across state lines a la carte (i.e. a maternity care standard from New Jersey paired with a laboratory services standard from Arkansas).

CMS Administrator Seema Verma told reporters: “Ultimately the law needs congressional action to repeal.” But in the meantime, the above examples are only two of several changes that will reign in the ACA’s powers.

(Amy Goldstein, The Washington Post)

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April 13, 2018 at 4:02 pm

Science Policy Around the Web – January 12, 2018

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By: Maryam Zaringhalam, Ph.D.

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source: pixabay

Emergency Preparedness/ Public Health

CDC plans session on ‘preparing for the unthinkable’: a nuclear detonation

On January 4, the Centers for Disease Control and Prevention (CDC) announced a grand rounds — or training session — entitled “Public Health Response to a Nuclear Detonation.” The event’s web page notes: “While a nuclear detonation is unlikely, it would have devastating results and there would be limited time to take critical protection steps. Despite the fear surrounding such an event, planning and preparation can lessen deaths and illness.” While the announcement followed a Twitter exchange between North Korean leader Kim Jong Un and President Donald Trump, CDC officials maintain that planning for the grand rounds has been underway for months. The Tweet also triggered an uptick in sales for potassium iodide, a drug that can be taken to prevent the absorption of radioactive iodine in the thyroid. The last CDC training focused on radiological and nuclear disaster preparedness was offered by the CDC in 2010, so this session will be an opportunity to share what public health programs at the federal, state, and local level have done to prepare in the intervening years. The session will be webcast live on January 16 and is geared towards research and public health professionals, but can also be viewed by interested members of the public.

(Helen Branswell, STAT News)

Public Health

Hospitals In States That Expanded Medicaid Less Likely To Close

The Affordable Care Act included a provision for expanding Medicaid programs to cover all people with household incomes up to 138 percent of the federal poverty level. In 2012, the Supreme Court left individual states to decide whether or not they would opt into Medicaid expansion. For the 31 states and the District of Columbia that chose to expand Medicaid, the federal government pledged to cover 100 percent of the cost for newly eligible enrollees in the first few years, with a provision that the share would eventually decrease to 90 percent. According to a new study, hospitals in Medicaid-expansion states were six times less likely to close than hospitals in the 19 states that did not expand.

Researchers at the University of Colorado tracked hospital closures and financial performance in the period between 2008 (four years before the ACA went into effect) and 2016. They attributed the favorable performance of hospitals in expansion states to the increased population of lower income people with insurance. As a result, Medicaid payments to hospitals increased and less hospital care went uncompensated because an uninsured patient could not afford to pay their bills.

The effect was most pronounced in rural hospitals, which often struggle to stay open. Hospital closure in rural communities can have large economic consequences. Mark Holmes, director of the Rural Health Research Program at UNC, told STAT: “Hospitals are usually the largest, or the second-largest, employer in a community… Losing an employer of 150 people with good jobs is like losing a manufacturing plant.”

While ACA repeal failed last year, Republican members of Congress are still pressing to roll back Medicaid expansion. Some lawmakers have suggested a block grant system, which would cap state spending on Medicaid at a set cost and allow states to spend the money however they would like. On Thursday, January 11, 2018, the Center for Medicare & Medicaid Services (CMS) issued a letter to state Medicaid directors that opens the door for states to require adults to be actively employed as a condition for coverage. The findings of this report, published Monday in the journal Health Affairs, therefore remain salient in the ongoing debate around health care.

(John Daley, NPR)

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Written by sciencepolicyforall

January 12, 2018 at 5:39 pm