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Posts Tagged ‘global health

Science Policy Around the Web November 29th, 2019

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By Maria Disotuar, PhD

Source: Pixneo

To Drive Down Insulin Prices, W.H.O. Will Certify Generic Versions

Without insulin, a person with type 1 diabetes cannot survive, and the cost and accessibility to insulin continues to be a problem for individuals suffering from this incurable autoimmune disease. Diabetes mellitus is a chronic metabolic disease characterized by high blood glucose levels. There are two types of diabetes, Type 1 diabetes results from the loss of pancreatic β-cell function, resulting in an inability to produce insulin, a peptide-based hormone. On the other hand, Type 2 diabetes patients are resistant to insulin. Those suffering from Type 1 diabetes require daily insulin therapy to stay alive, and patients with type 2 diabetes require insulin therapy to maintain a healthy lifestyle. Currently, more than 400 million people worldwide have diabetes and this number is expected to increase in the coming years. The main problem being that there are no generic forms of insulin and the price for current insulin analogs has gone from approximately $20 per vial to $250 per vial depending on the type of insulin. This price increase over the past 20 years has made insulin unaffordable for many individuals particularly for younger generations of Americans struggling to pay student loans. For these individuals, seeing the price of insulin jump from $4.34 to $12. 92 per milliliter has meant rationing the lifesaving drug to the bare minimum – a deadly decision for some.

As a response to the growing demand for insulin and skyrocketing prices, the World Health Organization (WHO) has proposed a two year prequalification pilot project, which will allow pharmaceutical companies to produce generic insulin to be evaluated by WHO for efficacy and affordability. These types of pilot projects have been previously deployed to improve the accessibility of life saving drugs for malaria, HIV, and tuberculosis. These efforts have led to an increase in production and market competition leading to reduced costs for individuals.

Currently, the major producers of insulin, Eli Lilly, Novo Nordisk, and Sanofi have welcomed the prequalification program, vowing to be a part of the solution not the problem. According to WHO, companies in several countries, including China and India, have already expressed interest in the pilot project. This shift in insulin production would allow companies producing insulin domestically to enter the global market. As WHO-certified suppliers, these new competitors could dramatically drive down the price of insulin and improve accessibility on a global scale. Despite this positive global outlook, there are still some hurdles to cross for Americans to obtain these generic insulin products. The main one being that the pharmaceutical market is regulated by the FDA and the review process can be expensive for smaller companies. Nonetheless, Americans are fighting back to reduce the cost of insulin and other life savingdrugs, prompting lawmakers, presidential candidates, and the President to prioritize reduced drug prices for Americans. These mounting pressures will hopefully lead to a faster solution for this life or death situation.

(Donald G. McNeil Jr., The New York Times)

Will Microneedle Patches Be the Future of Birth Control?

In 2018, the The Lancet reported that between 2010 and 2014 44% of all pregnancies in the world were unplanned. Despite medical advances in sexual and reproductive health, new contraceptive methods are needed to expand accessibility and improve reliability for women. In the United States, the establishment of the Affordable Care Act (ACA) and health policies such as the Federal Contraceptive Coverage Guarantee, which requires private health plans to include coverage for contraceptives and sexual health services, has improved family planning for women of reproductive age. Despite the social and economic benefits of improved family planning and enhanced accessibility, conservatives continue to challenge these beneficial health policies. Unfavorable changes to these policies could result in major barriers for women to access some of the most effective, yet pricier forms of contraceptives such as intrauterine devices (IUDs) and implants. Studies show these long-acting forms of birth control are up to 20 times more effective in preventing unintended pregnancies than shorter-acting methods such as the pill or ring. Thus, new long-term contraceptives with reduced cost barriers would be essential in reducing unintended pregnancies and enhancing economic benefits on a global scale.

To address this issue, researchers at the Georgia Institute of Technology and University of Michigan in partnership with Family Health International (FHI) – a non profit human development organization, have developed a long-acting contraceptive administered by a patch containing biodegradable microneedles. The patch is placed on the surface of the skin and the microneedles painlessly come into contact withinterstitial fluid resulting in the formation of carbon dioxide bubbles, which allow the microneedles to detach from the patch within 1 minute of application. The needles themselves do not introduce a new contraceptive hormone, rather they provide levonorgestrel (LNG), which is regularly used in IUDs and has been deemed as safe and efficacious. After dissociation from the patch the needles slowly release LNG into the bloodstream. 

Thus far, the pharmacokinetics of the patches has been tested on rats and a placebo version has been tested in humans to test the separation process between the patch and the needles. The in vivo animal studies indicate the patch is able to maintain LNG concentrations at acceptable levels for more than one month and the placebo patch was well tolerated among study participants with only 10% reporting transient pain or redness at the site of patch application. Lastly, the researchers analyzed conceptions and acceptability of this new contraceptive method among American, Indian, and Nigerian women compared to oral contraceptives and monthly contraceptive injections administered by a physician. The results indicate women overwhelmingly preferred the microneedle patch method over the daily pill (90%) or monthly injections (100%). The researchers expect the patch to be simple to mass produce and a low-cost contraceptive option, which will reduce cost barriers and improve accessibility for women. Although the results of the study are promising, additional studies will have to be completed to address some of its limitations. Future studies will have to increase the number of animals used in the study and the number of human participants. Additionally, the release profile for LNG will likely need to be extended beyond 1-month to truly address the need for new long-acting forms of contraceptives. Finally, clinical trials will have to be completed to test the efficacy and general reliability of this method at reducing unintended pregnancies. If the microneedle patch is approved, it would be the first self-administered long-term birth control to enter the market, which could ultimately lead to enhanced accessibility for women with limited access to health care.

(Claire Bugos, Smisothian) 

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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Written by sciencepolicyforall

January 11, 2019 at 4:44 pm

Science Policy Around the Web – April 29, 2017

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By: Saurav Seshadri, PhD

digital forensics 5” by jon crel is licensed under CC BY 2.0

Forsensic Science

Now Who Will Push Ahead on Validating Forensic Science Disciplines?

The realities of forensic science remain far removed from the white-coated wizardry depicted on shows like CSI. Although forensic results often heavily influence criminal trials, there is a substantial gap between the perceived and true reliability of commonly used methods such as fingerprint and bitemark identification. The National Commission on Forensic Science (NCFS) was established in 2013 to help close this gap, by promoting rigorous, independent evaluation of forensic techniques, as well as communication between law enforcement agencies and academic scientists. The NCFS was supported jointly by the Department of Justice (DOJ) and National Institutes of Standards and Technology (NIST), and has published over forty documents reflecting the consensus of scientists, lawyers, law enforcement officers, and other stakeholders.

Recently confirmed Attorney General Jeff Sessions has decided not to renew the NCFS’ charter, which expired on April 23, 2017. Its work will ostensibly be taken over by a new entity, which will be developed by a DOJ Subcommittee on Forensics and spearheaded by an as-yet-unnamed, DOJ-appointed Senior Forensic Advisor. The DOJ is currently seeking input on how best to organize this initiative, but its actions already suggest an unwillingness to follow expert guidance, such as the original recommendations from the National Academy of Sciences that led to the creation of the NCFS. The recommendations include ‘[t]his new entity must be an independent federal agency…[i]t must not be part of a law enforcement agency’ and ‘…no existing or new division or unit within DOJ would be an appropriate location for a new entity governing the forensic science community’.

Despite this setback, some of the NCFS’ contributions, such as promoting acceptance of the need for licensing and accreditation, may have a lasting influence on the field. In the NCFS’ absence, NIST is expected to play a central role in coordinating the forensic science community. Support for these efforts will be critical to improving standards in forensic practice, and ultimately, to providing justice to the American public. (Suzanne Bell, The Conversation)

Infectious Disease

Ghana, Kenya and Malawi to Take Part in WHO Malaria Vaccine Pilot Program

While interventions such as insecticide-treated mosquito nets have dramatically reduced malaria-related deaths, almost half a million people still die annually from the disease, predominantly children in sub-Saharan Africa. Continuing the fight against malaria, the World Health Organization Regional Office for Africa (WHO/AFRO) has announced that a pilot program to test the world’s first malaria vaccine will begin in 2018. The vaccine (RTS,S or MosquirixTM) is the result of over $500 million in investment from GlaxoSmithKline and the Bill & Melinda Gates Foundation. It has shown promising results in Phase 3 trials, reducing rates of malaria by almost half in children treated at 5-17 months old. Following guidance from two independent advisory groups, the WHO will implement the vaccine in three countries that have high malarial burdens despite ongoing, large-scale anti-malaria efforts. The first stage of the program, which is being funded by several international health organizations in addition to WHO and GSK, will span 2018-2020, with final results expected in 2022.

RTS,S has followed an unconventional route to its current stage of development. It was approved by the European Medicines Agency (EMA) under Article 58, a mechanism that allows the EMA’s Committee for Medicinal Products for Human Use (CHMP) to collaborate with the WHO and international regulatory agencies to evaluate drugs intended for use in developing countries. However, in the first ten years after its inception in 2004, just seven drugs received positive opinions from CHMP through Article 58, and among these, the EMA has reported limited commercial success. This track record, combined with the emergence of more attractive incentive programs to develop drugs for tropical diseases (including a priority review voucher system launched by the FDA in 2007), has raised questions about Article 58’s effectiveness. A positive outcome for RTS,S could revitalize the program and lead to more innovative treatments for vulnerable populations worldwide. (WHO/AFRO press release)

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April 29, 2017 at 8:56 pm

How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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Written by sciencepolicyforall

April 21, 2017 at 8:47 am