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Science Policy Around the Web August 20th, 2019

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By Mohor Sengupta PhD

Image by Ryan McGuire from Pixabay 

FDA makes new push for graphic warning labels on cigarettes

According to government records, the percentage of smokers in the U.S. has reduced from 40% of the population in the 1960’s to 14%. Despite this dramatic decrease, approximately 480,000 people in the U.S. die each year from diseases directly related to smoking. In an attempt to educate smokers about the dangerous medical consequences of smoking, in 2009 the FDA proposed 9 graphic labels to be printed on cigarette packets. However the FDA’s plan didn’t see the light of day when five tobacco companies challenged the FDA’s decision in court and in 2012 won on grounds of free speech. The judges who ruled in favor of the tobacco companies said that “[the images were] crafted to evoke a strong emotional response,” rather than educating consumers. 

The FDA then backed out saying that it will work on introducing new images and it was soon to announce new proposed labels. In 2016, a lawsuit was filed by health groups against the FDA for not proposing a new plan soon enough. Last Thursday, the FDA announced 13 new graphic labels to be displayed on cigarette packets that would show cancerous tumors, diseased lungs, and feet with amputated toes. The FDA’s tobacco director Mitch Zeller said that these new labels had been designed while keeping in mind the limited public awareness of lesser-known diseases caused by smoking. 

For 35 years, everything that the USA’s cigarette packets have told consumers about the harmfulness of smoking has been contained in a warning statement so tiny that it is missed by most consumers. Research has shown that graphic label inclusion on cigarette packets discourages smokers, and Canada was the first country to adopt this measure in 2000. 

Since then, more data have come to light identifying graphic images as an effect anti-smoking measure. A 2013 study showed that participants tended to respond to graphic labels rather than warning statements on cigarette packets. Another 2013 study estimated that if the FDA had adopted graphic labels in 2012, 5.3 to 8.6 million adults would have quit smoking in a year. They based their results on similar data from Canada where graphic labels are in use. 

It is anticipated that Big Tobacco will challenge the FDA’s move once again. Some of them are already citing the First Amendment as their defense. It is now time to see what is decided if the matter is taken to the courts once again. While thousands of people continue to die because of smoking habits in the USA, and graphic label inclusion on cigarette packets are repeatedly challenged by the tobacco industry, nearly 120 countries across the world have already adopted this measure and are reaping its benefits. 

(Matthew Perrone, STAT)

Experimental Ebola Drugs Saved Lives In Congo Outbreak

Ebola is raging in the Democratic Republic of Congo (DRC). However, a climate of distrust around Ebola clinics compounded with political upheavals in DRC has discouraged patients in the early stages of infection from leaving their community and seeking help in designated Ebola clinics. In this way, the virus has rapidly spread across communities and now threatens people outside of DRC as well. 

Despite these issues, efforts are underway to combat Ebola and develop more effective treatment strategies. A NIAID-funded study that compared four drugs against the Ebola virus recently concluded that two of them showed better results in combating the disease. The study, called ‘Pamoja Tulinde Maisha’ (PALM), is a randomized controlled trial of the four drugs and started on November 2018 as part of the emergency response in DRC.

The four investigational agents were Remdesivir, a commonly used antiviral drug, ZMapp, which showed effectiveness in previous Ebola outbreaks, REGN-EB3, developed by Regeneron and mAb114, a monoclonal antibody jointly developed by NIAID and INRB (in the DRC). 

Having reached a definite conclusion about the effectiveness of the four drugs, the PALM trial stopped earlier than originally scheduled. Preliminary results released on August 9, 2019 show only 30% of Ebola Virus Disease (EVD) patients treated with REGN-EB3 or mAb114 succumbed to the infection, compared to half of those treated with ZMapp or Remdesivir. When analysis was restricted to the relatively healthier patients receiving the more potent treatments, 6% and 11% died on REGN-EB3 and mAb114 treatment regimes respectively. 

With these preliminary results, patients on Remdesivir and ZMapp will now be switched to one of the more effective drugs based on their physician’s discretion. The study will continue to measure the effects of the two drugs from now on. The final analysis of the study data is likely to be made available later this year. 

(Richard Harris, NPR)

 

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August 20, 2019 at 4:56 pm

Science Policy Around the Web – May 31st, 2019

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By: Silvia Preite, Ph.D.

Image by rawpixel from Pixabay 

Common drink and food sweetener – High-Fructose Corn Syrup – accelerates colon cancer growth in mouse models: what about in humans?

Increased consumption of sugar-sweetened drinks has been associated with higher risk of obesity and intestinal cancers. However, whether sugar directly contributes to tumor development, independently from obesity, is less clear. A common sweetner of sodas, fruit-flavored drinks and processed foods is high-fructose corn syrup (HFCS). A recent study published in Science revealed that consumption of HFCS accelerated colon cancers in predisposed mice bearing a mutation in a tumor-suppressor gene commonly found in human colorectal colon cancers. Strikingly, the human diet equivalent amount of HFCS required to see such effects in mice corresponds to 12 ounces of a sweetened drink – one can of soda per day!

Mice fed with HFCS did not become obese or developed metabolic syndrome, however, developed larger and more advanced tumors, compared to water-treated animals. Mechanistically, HFCS leads to increased levels of fructose and glucose in the intestinal lumen and serum, that can be transported and utilized inside the tumor to generate energy and support its growth. The identification of these events opens new possibilities for the development of therapeutic strategies aimed at controlling tumor growth; in particular, targeting of fructose metabolism may selectively slow tumor progression without affecting survival of normal cells. 

Further studies are needed to assess if similar tumorigenic mechanisms take place in humans. Moreover, whether prolonged and extensive consumption of HFCS has a greater detrimental effect on human health compared to other types of sugar remains to be determined. Regardless, this study could contribute to increase public awareness about the potential deleterious effects on physical health and tumor development due to sweetened drinks and processed food whose comsumption is globally rising. 

(Source: Goncalves et al., Science, 2019)

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May 31, 2019 at 3:08 pm

Science Policy Around the Web – May 14th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Rural areas drive increases in global obesity

While past studies have found that the increase in global obesity is largely driven by urban regions, a newly published paper argues that this rise is actually being led by those in rural areas. 

Global increases in BMI (body mass index) have been observed for decades, but no one had evaluated differences in urban and rural regions on a large-scale across many countries. The new Nature study evaluated BMI values in 200 countries from 1985-2017, finding that rural areas are responsible for more than 55% of the global rise in the average BMI and more than 80% of the rise in some low- and middle-income countries (LMICs). 

Previous theories argued that urbanization caused rising BMI largely because of the availability of cheap, ultra-processed foods, a lifestyle that provides more transportation options, and greater access to non-physical leisure activities (smartphones, cable television). In contrast, rural areas were thought more likely to consume more local produce, have less access to ultra-processed and packaged food, and participate in high energy expending activities. However, rural areas, even in LMICs, have now begun to resemble urban areas because of access to ultra-processed foods and cheap mechanized devices that reduce transport and farming energy expenditure.

Obesity results in higher health care costs, lower life expectancy, and reduced quality of life. Thus, prevention strategies are vital but currently, most preventative measures are targeted towards urban areas. Given this new data, funding priorities and strategies need to adjust to address this growing issue. 

(Barry M. Popkin, Nature)

After outcry, USDA will no longer require scientists to label research as ‘preliminary’

After protests, the US Department of Agriculture (USDA) has stopped requiring their staff scientists to label all published peer-reviewed research as “preliminary.” Released last week, the revised USDA guidelines now require the following language when disclaimers are necessary: “The findings and conclusions in this [publication/presentation/blog/report] are those of the author(s) and should not be construed to represent any official USDA or U.S. Government determination or policy.” Not all publications will be obliged to contain this statement. 

Previous USDA guidelines, implemented last July, required publications to carry the label: “The findings and conclusions in this preliminary publication have not been formally disseminated by the [USDA] and should not be construed to represent any agency determination or policy.”  This disclaimer caused concern over claims that it was confusing and possibly misleading. Scientific publications are peer-reviewed (evaluated by professionals in the field for quality and accuracy) and considered completed work, not preliminary. Some among the scientific community feared the disclaimer might reduce the impact of the published research conclusions or be used to diminish findings that conflict with views of the current administration. 

While reaction towards the disclaimer change has been generally positive, some non-USDA researchers are still concerned that the latest guidelines have the potential to jeopardize scientific integrity. The new guidelines say that the USDA can request “corrections” or “changes” to research papers if they pertain to a “prominent issue,” a significant scientific advancement, or could influence trade/policy decisions. Rebecca Boehm, an economist at the Union of Concerned Scientists, stated that “removing ‘preliminary’ from the disclaimer is a step in the right direction, but there still may be unnecessary obstacles preventing agency researchers from publishing their work in peer-reviewed journals.” 

(Ben Guarino, Washington Post)

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May 14, 2019 at 4:56 pm

Science Policy Around the Web – April 26, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

World’s first malaria vaccine to go to 360,000 African children

On Tuesday, the World Health Organization (WHO) announced the launch of a large-scale pilot of the first malaria vaccine ever developed. 360,000 children under 2 years old will be vaccinated per year across three African countries (Malawi started vaccinating this week and Ghana and Kenya will began in the next couple weeks). The combined effort could immunize up to one million children by 2023. Children under five years old are at the most risk for life-threatening complications from malaria and more than 250,000 children in Africa die from the disease every year. 

The vaccine was developed by GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI) with support from the Gates Foundation. Data from clinical trials indicates it only provides partial protection, preventing around 40% of malaria cases. Thus, the vaccine is meant to complement existing solutions to preventing malaria ( e.g.bed nets, insecticide, and rapid diagnosis and treatment of the disease).  

Malaria is a parasitic infection that is transmitted via a bite from the female Anopheles mosquito. While the disease is preventable and treatable, an estimated 435,000 people die from it each year. The newly developed vaccine protects against P. falciparum, the most prevalent malaria strain found in sub-Saharan Africa.

The vaccine, known as RTS,S or Mosquirix, has taken decades to develop. It is given in four doses: 3 doses provided between the first five and nine months of age and the last delivered around the 2ndbirthday. While this is a big step, some malaria researchers are questioning the implementation of this vaccine when other, more effective vaccines are currently in clinical trials. However, even 40% efficacy will be very helpful in combating this devastating disease.

(Katie Hunt, CNN)

Drug Distributor And Former Execs Face First Criminal Charges In Opioid Crisis

For the first time, federal criminal charges were brought against a pharmaceutical distributer for its role in perpetuating the US’s deadly opioid crisis. Rochester Drug Co-Operative (RDC), the 6th largest distributor in the US, was charged with conspiring to distribute controlled narcotics (fentanyl and oxycodone), defrauding the United States government, and willingly failing to file suspicious order reports. Separate individual charges were also brought against two of their former executives.

Distributors connect drug makers to pharmacies and they are charged with monitoring drug distribution to ensure there is no abuse. However, this monitoring seems ineffectual at best. In one extreme example, an investigation by the Charleston Gazette Mail reported that a single pharmacy in the small town of Kermit, West Virginia (population 392) received 9 million hydrocodone pills over a two year period from out of state drug companies. 

In the RDC case, the US attorney in Manhattan, Geoffrey S. Berman, argues that greed has been the primary motivator for this abuse. Prosecutors said that RDC’s executives ignored warning signs and distributed tens of millions of fentanyl products and oxycodone pills to pharmacies they knew were distributing drugs illegally, resulting in massive profits. RDC has effectively admitted to violating federal narcotics laws and has agreed to pay a $20 million fine and will be supervised by an independent monitor over the next five years.

More than 700,000 people have died from drug overdoses over the last 20 years, the majority of which have been attributed to opioids, and some estimates predict hundreds of thousands more could die in the next decade due to opioid overdoses alone. 

Addiction treatment is underfunded in the US and the White House Council of Economic Advisers estimated that the crisis cost $500 billion in economic losses in 2015 alone. Hundreds of lawsuits across the country have been filed against opioid makers, producers, and distributors in hopes of holding them accountable, preventing misbehavior in the future, and receiving money to offset the costs of the crisis on the public. 

(Richard Gonzales, NPR)


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April 26, 2019 at 9:30 am

The worst humanitarian crisis in the world: war, disease outbreaks and famine in Yemen

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By: Silvia Preite, Ph.D.

Source: Wikimedia

War and natural emergencies in low and middle-income countries often result in the weakening of health systems and relaxation of disease surveillance and prevention, leading to increased risk of infectious disease outbreaks. The over four-year civil war in Yemen continues today and, according to the United Nations (UN), has resulted in the worst on-going humanitarian crisis in the world. Hunger and the spread of communicable diseases affects the vast majority of the Yemeni population.

Overview of the ongoing war in Yemen

Before the start of the conflict in 2015, Yemen was already the poorest country in the Middle East, with debilitated health care systems and poor infrastructures. In March 2015, the Houthi movement took over the government in Sana’a (the capital). In response, a Saudi Arabia and United Arab Emirates-led coalition (supported by several other nations including the United States, the United Kingdom and France) started a military intervention in Yemen, with the intention of restoring the Yemeni government. Overall, this conflict resulted in devastation of agriculture, services, and industry in Yemen. Moreover, in more than four years of air strikes, over 50% of Yemeni hospitals, clinics, water treatment plants and sewage have been continuously bombed. The situation is further worsened by restrictions on food and medicines and limited access to fuel, leaving many essential facilities non-functional, including water sanitation centers. These conditions have led to extreme famine and spreading of diseases, including massive cholera outbreaks among the population. 

Cholera outbreaks

Cholera is a bacterial disease leading to severe diarrhea and dehydration, usually caused by the consumption of contaminated water or food. World-wide, an estimated 2.9 million cases and 95,000 deaths occur each year. It has been estimated that cholera has affected more than 1 million people in Yemen, with more than 2000 deaths, becoming the worst cholera outbreak in the world. According to Médecins sans Frontières (MSF) (known in English as Doctors Without Border) and Physicians for Human Rights, hospitals, mobile clinics, ambulances, and cholera treatment centers continue to be bombed, despite the fact that they have been marked as medical centers and the GPS coordinates have been communicated to the Saudi coalition. In addition to cholera, as a consequence of dropping immunization rates, more than 3000 cases of measles have been reported. Cholera and measles can be prevented by vaccinations and proper health infrastructure. Global eradication efforts have been adopted over the years to eliminate these infections, making the spreading of these diseases in Yemen a significant setback. 

Humanitarian violations

The Fourth Geneva Convention concerns the protection of civilians during conflicts, and has been ratified by 196 states, including parties involved and supporting the war in Yemen. The air strikes on medical centers violate the principles of medical neutrality established by the convention that protects hospitals and health care workers from being attacked. Within the standards of this international law, there is also the right of free mobility of medical personnel within a conflict zone. In contrast, during the civil war in Yemen restrictions have been applied by all involved parties on the activity of medical staff, delivery of health care equipment, essential medicines and vaccines. 

Latest UN report on the Yemen crisis

According to the UN, an estimated 24.1 million people (80% of the total population) need assistance and protection in Yemen, and of those, 14.3 million are in acute need (need help to survive). More than 3 million people are currently internally displaced (IDP), living in desperate conditions in Yemen or elsewhere in the region. It is estimated that 20.1 million people need food assistance, 19.7 million people need basic health care services, and 17.8 million people lack potable water, sanitation and hygiene (WASH). 

Children

An estimated 7.4 million children are in need of humanitarian assistance. Severe children’s rights violations are taking place in Yemen, affecting more than 4000 children and including the risk of being armed and recruited in the war for the boys and child marriage for girls. An estimate of 2 million children are deprived of an education, with around 2,000 schools made unusable by air strikes or occupied by IDPs or armed groups. Upwards of 85.000 children under the age of 5 may have died from severe hunger or other diseases. Overall, according to the UN, at least one child dies every ten minutes in Yemen because of diseases that could be normally prevented, hunger and respiratory infections. 

Urgent need for plans and resolutions

Both famine and disease outbreaks are threatening the Yemeni population and their survival currently relies only on international aid. In February 2019, the United Nations and the Governments of Sweden and Switzerland converged in Geneva to face and discuss the “High-Level Pledging Event for the Humanitarian Crisis in Yemen”. The aim of this meeting was to request international support to alleviate the suffering of the Yemeni people, and they requested $4 billion to provide life-saving assistance. Up to now, 6.3% of the requested budget has been funded; it is encouraging to note that last year UN was able to raise almost 100% of what was initially requested through multiple world-wide donations. 

Along with new funding, the OCHA (UN Office for the Coordination of Humanitarian Affairs), argues that urgent action is needed to prevent any exacerbation of the crisis. The most urgent action to resolve this unprecedented, man-made, medical and humanitarian emergency should come from all the parties involved to end the war and allow the re-establishment of food imports and adequate health services.

As the world barely watches, with only intermittent attention given by the international media, the conflicts and emergency remain. Non-profit and humanitarian organizations (UNICEFMSFWFPSave the Children) have greatly aided the Yemeni population, despite challenging operational environments and the import and circulation restrictions. Moreover, when millions of people, including children, die from hunger and preventable diseases every day, the ethical responsibility of this disaster becomes global and concerns all of us. 

Global implications and future perspectives 

The on-going conflict in Yemen, illustrates how the support of research into innovative global-health solutions is highly needed. When the traditional healthcare system has collapsed and human rights are suspended, we need technologies which further support the victims of war-torn countries to achieve basic sanitary and health standards, beside disease monitoring and vaccination strategies.

We live in an increasingly interconnected world where outbreaks of neglected or re-emerging infectious diseases know no boundaries. Therefore, the consequences of conflicts and disasters in low-middle income countries pose a significant global threat and may affect even stable healthcare systems. Proper evaluation of the causes and consequences of infection outbreaks during the Yemeni conflict is therefore critical for two reasons: devise new strategies to more effectively control and prevent the spread in war-torn areas, and proactively encourage and support countries in regions of conflict to take the necessary measures to minimize the risk of similar humanitarian disasters in the future.

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April 11, 2019 at 4:29 pm

Science Policy Around the Web – February 26, 2019

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By: Jennifer Patterson-West, Ph.D.

Source: Ellsworth Airforce Base

Scientists Release Controversial Genetically Modified Mosquitoes In High-Security Lab

Malaria is a parasitic disease that affects more than 200 million people each year.  Symptoms can range from mild to severe, and include high fever, chills, and flu-like symptoms.  These symptoms are more dangerous to children under the age of 5, which account for 77% of related deaths.

The life cycle of malaria requires two hosts: humans and female Anopheles mosquitoes.  It is important to note that not all species of Anopheles mosquitoes are good vectors, in fact, only 30-40 of the approximately 430 species transmit malaria in nature. The life cycle of malaria is also dependent on additional environmental factors including ambient temperature and humidity. Together these factors account for the geographic distribution of malaria. Although malaria is found more than 100 countries, transmission is most prevalent in Sub-Saharan Africa and in parts of Oceania including Papua New Guinea. 

In the past decade, major gains have been made to control the disease in developing nations thanks to increased funding. Current preventative measures include insecticide-treated netsindoor residual spraying, and intermittent preventative treatment for individuals at increased risk including pregnant women and infants.

In early February, a high-security laboratory in Terni, Italy launched a study to evaluate a new powerful weapon against the mosquito vector.  This new weapon is a genetically modified mosquitothat can spread a genetic mutation lethal to its own species. Researchers targeted the gene “doublesex” to producing female mosquitos that are sterile and have mouths resembling male mosquitos, which are unable to bite.  

The goal is to dramatically crash or reduce the local population of the main species of malaria spreading mosquitoes, Anopheles gambiae. To increase heritability of the mutation, researchers utilized CRISPR technology to engineer a “gene drive” into the genetically modified species. Gene drive inheritance ensures that nearly all progeny inherits the mutation.

Despite the need for new methods for reducing malaria, activists and other scientists warn that the technology can have unforeseen effects on the environment.  The environmental group, Friends of the Earth, is part of international coalition protesting the use of these new genetically modified organisms. Jim Thomas of the ETC group, has noted concern that gene drive technologies can also be used to develop biological weapons.  

To reduce the risk associated with releasing the gene-drive mosquitoes, the project plans years of additional study that will methodically and cautiously evaluate the mosquitoes and their potential environmental impacts with close consultation from other scientists, government officials, and local residents in Africa.

(Rob Stein, NPR)

With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling

Bacillus Calmette-Guerin (BCG) is a potent immunotherapy for the treatment of fast-growing bladder cancer.  BCG was initially used in 1921 as a tuberculosis vaccine.  In the 1970s, BCG was shown to stimulate the immune system to attack tumor cells when administered through a catheter into the bladder of cancer patients. Since then, BCG has become a potent treatment for intermediate and high-risk non-muscle invasive (NMI) urothelial cancer (UC) of the bladder.

Bladder cancer is the nation’s sixth most prevalent cancer with approximately 80,000 new cases each year.  About 20% of these patients are diagnosed with a type of bladder cancer that can be treated with BCG.  Although BCG doesn’t work for all eligible patients, the response rate is more than 70%.

Despite the established potency of BCG, there is a critical national shortage.  Supplies of BCG have been erratic since 2011, when the United States Food and Drug Administration (FDA) promptly shut down the Sanofi manufacturing lab after a failed inspection.  After continued regulatory issues, Sanofi stopped production of BCG in 2016. Merck is now the only manufacturer of BCG for the Unite States and European markets.

Merck has acknowledged short supplies and indicated that they are currently working at capacity.  Tyrone Brewer, the vice president of global oncology marketing at Merck, has indicated that the company intends to continue producing BCG for “the foreseeable future.”

During shortages, chemotherapies, such as mitomycin, can be used as alternative therapies.  However, they have lower efficacy and a higher price tag than BCG. During the 2014 BCG shortage, the cost of mitomycin increased by 99% further exacerbating the financial burden of these alternative therapies. 

In response to erratic supply of BCG, the Southwest Oncology Group has launched a clinical trial (S1602) to compare the TICE BCG strain currently used in the United States to the Tokyo Strain.  The FDA will consider the results of this trial as critical information for approving the Tokyo strain for use in the United States. 

In the meantime, urologists have begun to divide dosages into thirds to prolong supplies.  However, a recent literature review indicated that a large scale, well-designed, prospective study is need to establish a standard dose and maintenance instillation for reducing recurrence rate since the efficacy of lower dosage is unclear from existing data.

The University of Utah Drug information Service reported that in 2015 approximately 265 generic drugs were in short supply in the United States.  Of potentially greater concern than the current shortage of BCG are generic drugs that can have immediate life and death consequences. For instance, a retrospective study of the norepinephrine shortage in 2011 indicated a 10% higher mortality rate during hospitalization when the alternative vasopressor, phenylephrine was used.

A recent perspective from Davies et al. argues that current policy efforts have not sufficiently prevented supply disruptions of important generic drugs.  A major consideration for dealing with generic drug shortages are the unintended consequences of current policies. For instance, the 2003 Medicare Modernization Act, which sought to protect consumers by limiting the cost increase for generic drugs to 6% above the Medicare average sale price (ASP). This restriction may not provide manufactures with sufficient proficient to invest in production facilities.  

Further compounded these issues is the fact that manufacturers face few negative consequences during shortages, whereas an excess in supply cuts in to profit margins. To provide additional incentive for maintaining reliable supplies of generic-drugs, Davies et al. suggested that the FDA prioritize the review of future generic-drug applications from companies that “maintain generic drug production without quality-control problems”.  In November, the FDA issued a news release about efforts to address drug shortages, which included remedying the underlying problems when a shortage arise within their current authorities.  In today’s political climate, any policy reform or expanse to FDA’s authority to mitigate future shortages and provide incentives for the production of generic medications will require cross-party support. 

(Meghana Keshavan, STAT news)

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February 26, 2019 at 1:44 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