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Science Policy Around the Web – April 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Scientific Awareness

Earth Day and the March for Science

This Saturday, April 22, is Earth Day and the day scientists have chosen to hold demonstrations in the name of science. The March for Science primary demonstration will be held in Washington, D.C., with over 500 satellite events in other locations around the world. According to their website, the goal of the marches, rallies, and teach-ins is to “defend the vital role science plays in our health, safety, economies, and governments.” In a time where there has been increasing disregard and disdain for sound scientific research, scientists and science enthusiasts are passionate about raising awareness of the importance of scientific research and the funding and support of that research. Many scientists are also hoping to clear up commonly held stereotypes and allow people to see the diversity in scientific careers and that careers can be collaborative, interesting, and enjoyable.

There are those, however, who disagree that these demonstrations and events are the way to bolster funding and awareness. The March for Science professes to be non-partisan, but there are some who see it as a chance to protest against President Trump and his controversial views and statements on various scientific matters. Those who oppose the march feel that there could be unintended consequences for speaking out against a political figure or party, and many believe science should remain objective and not politicized in general. There are many supporters of the march who agree that science should remain politically unbiased but are further motivated to march given the recent budget proposals that would significantly cut funding to the National Institutes of Health and the Environmental Protection Agency.

Not surprisingly, there will also be scientists working at the March for Science. Sociologists from the University of Maryland will be conducting surveys of march attendees. Their goal is to learn more about the people who protest in support of science: their motivations, work backgrounds, and political activism levels. They hope to better understand our current political culture and attitudes about science, as well as see what kind of impact these demonstrations have in the future. (Adam Frank, NPR)


California Vaccination Rate Hits New High after Tougher Immunization Law

Following an outbreak of measles in Disneyland in late 2014, California passed a law that abolished the right for parents to refuse to have their children vaccinated based on personal beliefs. The students enrolling in kindergarten for the 2016-2017 academic year were the first that this law applied to. Comparing this year to the previous, vaccination rates increased from 92.8 percent to 95.6 percent, making this California’s highest year for vaccination rates since the new set of requirements was instated fifteen years ago. This rate is considered high enough to prevent measles transmission which, after being eliminated in 2000, has reemerged as a risk due to an increase in parents exempting their children from receiving vaccinations because of personal beliefs.

California still has a number of at-risk students and residents, however. These requirements have only been in place for the current school year, meaning older class years still have many students whose parents opted to not vaccinate them based on personal beliefs. There are even more unvaccinated adults who were already through school before the current set of requirements. California is still being vigilant to protect the unvaccinated. An unvaccinated high school student in Laguna Beach contracted measles earlier this month, and the school quickly moved to identify other unvaccinated students in the school and bar them from returning until it could be assured that transmission would not occur. The Centers for Disease Control and Prevention (CDC) provide a recommended schedule for vaccination of children (and adolescents and adults) who have no health contraindications. To provide the maximum resistance to measles, a highly contagious disease, the CDC recommends vaccinating between 12-15 months and again between 4-6 years of age. It will likely take some time before the long-term effect of the new law can be observed. (Lena H. Sun, The Washington Post)

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The Trans-Pacific Partnership and its Impact on Pharmaceutical Affordability

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By: Shakira M. Nelson, PhD, MPH

        For many, the Trans-Pacific Partnership (TPP) was a point of great debate during the 2016 Presidential primaries and election. As a simplified explanation, the TPP is a free-trade agreement involving the United States, Canada, Australia, Japan, New Zealand, Mexico, Chile, Peru, Brunei, Malaysia, Singapore and Vietnam, intended to “level the trading playing field” through the elimination of tariffs and other laws that create trade barriers. In its final form, the TPP would impact up to one-third of world trade and 40% of the global gross domestic product. Many who debated the ramifications of the TPP did so in the context of foreign policy interests. Although aligned with foreign policy, a major part of the TPP deals with intellectual property protection, and pharmaceutical drug development. If implemented, the effects of the TPP could greatly diminish public access to affordable medicines, both domestically and internationally. Moreover, the stronghold the TPP places on intellectual property could limit the development and marketing of less expensive options.

Intellectual property can be divided into two categories: industrial property and copyright. Patents, trademarks, and industrial design fall under industrial property. Patent development is a large part of scientists’ work, seen as almost a necessity to incentivizing innovation. Many argue that, without the ability to patent inventions and significant findings, scientists would not be able to generate profits used to sustain research and development; within the pharmaceutical industry, patents are the proverbial bread-and-butter. When in place, patents create a stronghold around the release of new chemical drugs, which prevents competition by generic brands. The standard length of time of a patent for a chemical drug is 20 years, which starts from the time the drug is invented.

Many new medicines under development today fall under the category of ‘biologics’. As the name suggests, biologics are treatments made from biological sources, and are very different from chemical drugs. Created to treat a multitude of diseases, including Ebola and cancer, biological sources include vaccines, anti-toxins, proteins, and monoclonal antibodies. Given their structural complexity compared to traditional drugs, and use of recombinant DNA technology, biologics are more difficult, and costlier to make. Moreover, manufacturers have a greater burden in ensuring product consistency, quality, and purity over time. This is done through certifying that the manufacturing process remains the same over time. Because of this, it is estimated that the price to manufacture biologics cost on average more than 22 times the price of chemical drugs. Current laws state that generic biologic development, known as biosimilars, cannot be approved until 12 years after the branded product has been approved – this is known as an exclusivity period. This was enacted under the Biologics Price Competition and Innovation Act of 2009, by the Food & Drug Administration (FDA).

The challenge with current policies is establishing a period-of-time that balances the need for companies to generate profits and cash flows, which will incentive them to conduct more research and compensate them for the extensive manufacturing processes, with the need to provide greater access through launching generic drugs and biosimilars. The trouble with the proposed policies of the TPP agreement is that they seem to embolden the pharmaceutical companies by introducing changes that would prevent competition from generics and biosimilars for longer periods of time than the current basic terms. The implications of this are far-reaching, as it may lead to a significant increase in the current costs of pharmaceutical drugs and biologics, hindering the health of the patients who rely upon these treatments.

Critics of the current system of patent length and biologic exclusivity periods fear that rather than incentivizing innovation, companies are being rewarded through their ability to charge higher amounts for drugs without the fear of competition on the market. Health policy experts concur, identifying policies such as the Hatch-Waxman Act of 1984 in allowing for the creation of drug monopolies, and “going too far in compensating the pharmaceutical industry at the public’s expense”. A report released in 2009 by the Federal Trade Commission stated that biosimilar development was more difficult to achieve than traditional generic drugs. For example, development requires comparisons to the original biologic, to prove efficacy and equivalence. Biosimilars must share the same mechanism of action, with no clinically significant differences in terms of safety or potency for the approved condition of use. The steps necessary to achieve this are significant, and therefore imposing a 12-year exclusivity period on biologics may be unnecessary. US Congressmen have pushed to compromise, floating an amendment to the TPP that would lower the exclusivity period to 8 years. However, critics and patients who rely upon drug competition to lower market prices, have protested this amendment stating that costs of new drugs and biologics are too high, and 8 years is too long of a length of time to wait for affordable generics and biosimilars to come on to the market.

The impact of decreasing the length of time it takes for biosimilars to come onto the market can be seen with Neupogen, a leukemia drug that was first approved by the FDA in 1991. Delivered via injection, Neupogen costs patients $3,000 for 10 injections. With injections needed daily, this drug could carry a price tag of well over $100,000 per year. It wasn’t until recently, however, that the first biosimilar was approved on the US market. The biosimilar, Zarxio, was approved as a leukemia drug and is priced at more than $1000 less than Neupogen. This pricing has the potential to decrease the yearly costs of this drug from $100,000 with Neupogen to $55,000-$75,000. Further evidence of these financial savings was provided by the Rand Corporation, which predicted a savings of over $44 billion over 10 years with an increased approval of biosimilars, for patients who rely upon these specific cancer treatments.

Internationally, the policies of the TPP also have far reaching effects on the availability and costs of pharmaceuticals. The 12-year exclusivity period would be imposed upon the other countries involved in the TPP, where currently for some, such as Brunei, there is no current exclusivity protection. By imposing the 12-year period, global competition could become restricted. Additionally, the TPP proposes other key patent protections that play a bigger role on the international market. One protection, known as evergreening, allows drug companies to request patent extensions for new uses of old drugs. The immediate effect of this is an extension of monopolies on drug sales for minor reasons. The second protection allows pharmaceutical companies to request patent extensions if it takes “more than 5 years for an application to be granted or rejected.” Advocacy groups fear that the price of drugs would undermine the efforts of health initiatives, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria. These initiatives rely upon price competition to manage costs, with the availability of cheap generics helping drive costs down.

Although the current administration has ended the USA’s association with the Trans-Pacific Partnership, it is important to note that other countries may try to implement some of the policies, affecting the availability and affordability of drug treatments. To decrease this burden, the US could work to assist in negotiating exceptions for the poorer and smaller countries, to help them meet any challenges they may come up against. Within the US itself, it is important for policies, laws and any future trade agreements to be modified, with more of a focus on the affordability and regulation of drugs and biologics. Imposing price controls may offer a modest benefit, but may not be a long-term solution. A focus on lowering the patent length for new drugs and biologics can be an immediate step. Although the push back from pharmaceutical lobbyists will be substantial, alleviating the financial burden on families afflicted with cancer and diseases should be the focus.

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Science Policy Around the Web – March 18, 2017

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By: Joel Adu-Brimpong, BS

By James Tourtellotte, CBP Today [Public domain], via Wikimedia Commons

Public Health Policy

Missing the Brush Strokes while Gazing at the Bigger Picture

Last Wednesday, the House Committee on Education and the Workforce approved a little-advertised bill called HR 1313, or the genetic testing bill, with partisan-line voting (all 22 republicans in favor and all 17 democrats opposed). Overshadowed by the highly publicized, contentious debate over the Affordable Care Act repeal-and-replace efforts, this bill has remained largely undetected by the media as it traverses congress. This genetic testing bill would not only enable employers to require their employees to undergo genetic testing but also allow employers access to the genetic information, according to an article by STAT news. Employees refusing such requests could be at risk for thousands of dollars in penalties.

Current legislation, including the Americans with Disabilities Act (ADA) and the 2008 Genetic Information Nondiscrimination Act (GINA), prohibit such authority by employers, preventing requests by employers for “underwriting purposes”, which include “basing insurance deductibles, rebates, rewards, or other financial incentives on completing a health risk assessment or health screenings.” Additionally, genetic information provided to employers must be de-identified and aggregated to protect individual identities.

The HR 1313 bill would circumvent current legislation by nullifying these protections as long as the genetic test requests are part of “workplace wellness programs.” Employers purport that the ADA and GINA are “not consistent with the well-established and employee protective wellness program regulatory framework under HIPAA.” They argue that the House bill will aid in aligning the ADA and GINA with laws about workplace wellness programs. Conversely, experts including Jennifer Mathis, director of policy and legal advocacy at the Bazelon Center for Mental Health Law, and Nancy Cox, president of the American Society of Human Genetics, have come out against the bill. In an opposition letter to chairwoman Representative Virginia Foxx (R-N.C.), and ranking member, Robert Scott, of the U.S. House Committee on Education and the Workforce, critics of the bill state that “Workplace wellness programs are fully able to encourage healthy behaviors within the current legal framework: they need not collect and retain private genetic and medical information to be effective. Individuals ought not to be subject to steep financial pressures by their health plans or employers to disclose their own or their families’ genetic and medical information.” Nonetheless, with the possibility of such infringement, we remain lost in the bigger debate surrounding Affordable Care Act repeal-and-replace efforts with little regard for subtle components like HR 1313. (Sharon Begley, STAT news)

Infectious Diseases

Here We Go Again? The Re-emergence of Yet Again, Another Arbovirus

The recent resurgence of arboviruses, or ARthropod-BOrne viruses, in the Americas is concerning. While the 1990’s saw the reemergence of Dengue and the West Nile, Chikungunya resurfaced in 2013 and, recently, Zika in 2015. With South and Central America and the Caribbean still reeling from the reemergence of these viruses, another arbovirus appears to be making a comeback. Over the past weeks, a fifth arbovirus has been detected. Per a perspective piece co-authored by Dr. Anthony Fauci, infectious disease expert and director of the National Institute of Allergy and Infectious Diseases, there are on-going outbreaks of yellow fever in Brazil.

As of February 2017, there have been 234 reported cases and 80 confirmed deaths, with many other infections pending investigation. In context, the number of reported cases currently exceeds previously observed rates of infection for this time of the year. Regionally, the reported cases appear localized to rural areas in southeastern Brazil, chiefly Sao Paulo, Espirito Santo and Minas Gerais. According to the article, current cases appear to be “sylvatic” or jungle cases, with transmission occurring primarily between forest mosquitoes and non-human primates. Thus far, there is no evidence to suggest human-to-human transmission via the infamous Aedes aeqypti mosquito. Humans currently serve as “incidental hosts.” However, the propinquity of the affected areas to major urban centers in Brazil, where routine coverage of yellow fever vaccination is low, is alarming.

Experts posit that the likelihood of spread to the continental United States is low. However, they caution, “In an era of frequent international travel, any marked increase in domestic cases in Brazil raises the possibility of travel-related cases [anywhere].” A particularly poignant example in the article is the December 2015 large urban yellow fever outbreak in Angola and subsequent spread to the Congo. This led to an exhaustion of the world’s emergency supply of vaccines for epidemic response, “prompting health authorities to immunize inhabitants in some areas using one fifth of the standard does in order to extend vaccine supply.” Amidst these critical times of global health crises, threatened cuts to U.S. global health support will likely be catastrophic for developing nations. (Madison Park, CNN)

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Written by sciencepolicyforall

March 18, 2017 at 9:31 pm

Science Policy Around the Web – March 14, 2017

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By: Liz Spehalski, PhD

Affordable Care Act

ACA Replacement Bill Released by House

Last Monday, House Republicans released their plan to repeal and replace former President Obama’s Patient Protection and Affordable Care Act (ACA), also known as Obamacare. The American Health Care Act (AHCA), a more conservative vision for the nation’s health care system, was created as a collaboration between the White House and the Senate Republicans. The Republican Party has been critical of the ACA because of the large role that it created for the federal government in health care, such as the need for the IRS to verify eligible people for financial help and federally mandating the public to have health insurance.

The AHCA will maintain some of the popular features of the ACA, such as allowing young adults to stay on their parent’s health care plans until the age of 26, banning lifetime coverage caps, and maintaining the ban on discrimination against people with pre-existing conditions. It also temporarily maintains the expansion of Medicaid to cover millions of low income Americans through January 1, 2020.

Instead of the individual mandate, a fine penalizing Americans for failing to have health insurance, the new bill would try to encourage people to sustain coverage by allowing insurers to impose a 30 % fine to those who have a gap between plans. The AHCA also changes the structure of tax credits given to those who want to buy insurance. Under the ACA, people who earn less than 200 percent of the poverty line get the highest subsidies. The Republican plan would instead give tax credits based mostly on age. The AHCA will also cut off federal funds to Planned Parenthood through Medicaid and other government programs for one year.

While Republicans did not offer any estimate of how much their plan would cost, or how many people would gain or lose insurance coverage, the Congressional Budget Office released its estimate yesterday, raising concerns. Two key House committees swiftly approved the bill, but uncertainty surrounds how this bill will fare in Congress, as some conservatives are concerned that it does not go far enough to remove government from health care, while others are concerned about their constituents losing coverage due to the loss of Medicaid expansion. No Democrats are expected to support the bill. (


Fewer Overweight Americans Trying to Lose Weight

A study published in the Journal of the American Medical Association this week found that the percentage of Americans trying to lose weight is declining. In 1990, when researchers asked overweight Americans if they were trying to lose weight, 56% responded yes, while that number decreased to 49% in 2014. Researchers analyzed US government health surveys from 1988 through 2014 which involved in-person physical exams and health- related questions including whether the participants had tried to lose weight within the last year. The study included over 27,000 adults ages 20-59, and weight status was determined using body mass index (BMI).

The explanation behind this trend seems to be the shift in public perception over dieting and overweight people. “Socially accepted normal body weight is shifting toward heavier weight. As more people around us are getting heavier, we simply believe we are fine, and no need to do anything with it,” said lead author Dr. Jian Zhang, a public health researcher at Georgia Southern University. The authors of the study also discuss other possible reasons for this data, such as primary care physicians not discussing weight issues with their patients.

Though the decline of 7% may seem low, this number could represent up to seven million Americans, as more than two thirds of adults are considered to be overweight or obese, according to recent NIH statistics. Scientists say this is concerning because obesity increases the risk of a host of diseases such as heart disease, diabetes, cancer, liver disease, osteoarthritis, and stroke. However, “There’s a possible good news story in this,” says Janet Tomiyama, a psychologist at UCLA who studies eating behavior and weight stigma. “We’re not going to shame people into health,” Tomiyama says, “a lot of research shows that having a healthy body image is what leads to better health outcomes. Maybe people are taking the focus off the number on the scale, and going more towards focusing on their health.” The CDC’s current  obesity prevention efforts focus on policy and environmental strategies that target the affordability of healthy eating and active living, noting that fad diets can be unhealthy and tend to fail over the long term. (Allison Aubrey, NPR)

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Written by sciencepolicyforall

March 14, 2017 at 10:00 am

Zika and Ebola: two different viruses with shared lessons

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By: Rachel Zamoiski, Ph.D., MPH

Photo source: An Ebola isolation unit via

Zika virus has been all over the news lately, but it hasn’t been that long since a different virus was making headlines all over the world: Ebola. The Ebola epidemic of Western Africa, which began in 2014 and ended in January 2016, has resulted in over 28,000 Ebola diagnoses and over 11,000 deaths. While the seemingly near-constant news updates on Zika may remind us of the media coverage of Ebola, the two diseases are very different from each other. However, there are still lessons to be learned from the Ebola outbreak that can be applied to how we deal with this potential Zika epidemic.

The illnesses caused by Ebola and Zika are very different from each other. With Ebola, the main concern is the disease itself. Ebola is often fatal, especially in settings without good infrastructure or advanced medicine. The symptoms of Ebola are severe and can involve severe vomiting and diarrhea, as well as uncontrolled bleeding. Ebola is transmitted by contact with the body fluids of an infected person, even after the patient has died. In contrast, the symptoms of Zika are mild. It’s uncertain exactly how Zika is spread, but the primary route of transmission of Zika appears to be via mosquitoes and not direct contact with infected individuals, although other routes of transmission may be possible, as limited reports have emerged of sexual transmission. In addition, recent reports state that scientists have found active virus in saliva and urine, although it is not known if those fluids could transmit the virus. The actual symptoms caused by Zika virus is not particularly concerning when compared to Ebola. While the symptoms of the disease caused by Ebola and its high case-fatality rate were the main concerns of the Ebola outbreak, the greatest concern with Zika is the possible effect on fetuses when pregnant women are infected.

An article in Morbidity and Mortality Weekly Report from January 29, 2016 describes a “possible association” between Zika and microcephaly in babies born to mothers infected during pregnancy. The authors report an increase in cases of microcephaly, defined as a head circumference greater than two standard deviations below the mean, adjusted for gestational age and sex. The babies with microcephaly were born to mothers who either lived in or had visited areas with current Zika outbreaks. The article states that pregnant women should try to avoid contact with mosquitoes, while also noting that “further studies are needed to confirm the association of microcephaly with Zika virus infection.” While the link between Zika and microcephaly is still not well understood, it still seems prudent to advise pregnant women to avoid contact with the virus, out of an abundance of caution.

While it is important to be cautious and not expose people to unnecessary risk, even when the risk is uncertain, it’s also true that an overabundance of caution is not always a good idea. With Ebola, there were efforts to quarantine health workers returning from West Africa even when they posed no threat to public health. These efforts were made largely by politicians, and not by people with medical or scientific expertise, who instead recommended routine monitoring but not quarantine in asymptomatic individuals, as patients needed to be symptomatic in order to transmit the virus to others. This is in contrast with the well-known case of Typhoid Mary, a woman working as a cook who was forcibly quarantined because she was infecting people with typhoid even though she was not sick herself, and was unwilling to stop working as a cook. In situations like that of Ebola, not only does forced quarantine punish people for performing work that should be celebrated and honored, but it also potentially discourages healthcare workers from traveling to disease-ridden areas by stigmatizing them and treating them like prisoners unwelcome in their own country.

Less is known about Zika than about Ebola. With Zika, we don’t really know how infectious it is, or exactly how it’s transmitted. But what lessons are there to be learned from Ebola, to guide our response to Zika?

It’s important to take emerging infectious diseases seriously. One of the downsides of having such effective vaccines against formerly-common illnesses like measles and mumps is that we can forget how powerful and widespread viruses can be. The Ebola outbreak reminded us that viruses still have the potential to infect and kill many thousands of people, both far away and close to home.

Included in the threat of infectious diseases is the widespread fear caused by the perception of a seemingly unstoppable deadly virus. This understandably scared many people and undoubtedly contributed to the unscientific overreaction by many politicians. This underscores the need for good communication in the management and control of infectious diseases. If a politician announced plans to forcibly quarantine cancer patients, there would be widespread outcry and ridicule, because the general public understands cancer well enough to know that quarantine is not an effective method of preventing cancer. The same should be true for new public health concerns as well.

Finally, good data are paramount in understanding and implementing effective methods to prevent and disrupt transmission. Our efforts should focus on collecting good data, clarifying the risks of Zika, and better understanding how it is transmitted, as well as how it’s not transmitted.

With Zika, we should be cautious, and take precautions to avoid the virus even when we don’t fully understand its effects. At the same time, our response to this public health crisis, as well as others in the future, should be based on good data, and not politics or scare tactics.

Written by sciencepolicyforall

February 17, 2016 at 9:00 am

Science Policy Around the Web – June 16, 2015

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By: Danielle Friend, Ph.D.

Health Policy

A Bill to Fight Obesity

A bill titled “Treat and Reduce Obesity Act of 2015” was recently sponsored by Erik Paulsen (R-MN) and would amend title XVIII (Medicare) of the Social Security Act in an attempt to treat and prevent obesity in America. The bills states that “According to the Centers for Disease Control, about 34 percent of adults aged 65 and over were obese in the period of 2009 through 2012, representing almost 15 million people”. The bill also brings up the important point that obesity also “increases the risk for chronic diseases and conditions, including high blood pressure, heart disease, certain cancers, arthritis, mental illness, lipid disorders, sleep apnea, and type 2 diabetes”. Importantly, “the direct and indirect cost of obesity is more than $450 billion annually” and that “a Medicare beneficiary with obesity costs $1,964 more than a normal-weight beneficiary”. The bill would attempt to reduce obesity rates and lower the financial costs to society by allowing the Social Security Act to cover intensive behavioral therapy for obesity. In addition, the amendment will also allow Social Security to cover pharmaceuticals used to treat obesity or for weight loss management.

Data and Biomedical Research

National Library of Medicine urged to take on broader role

Originally established in 1836 as a small collection of medical books and journal housed in the Office of the Surgeon General of the army, the National Library of Medicine (NLM) has now grown into the world’s largest biomedical library. Consisting of an extensive collection of both paper and digital sources, the NLM also runs GenBank, MedlinePlus, and This year, Francis Collins, the director of the National Institutes of Health, organized a working group to determine the new vision of the NLM. Although the working group determined that the current programs run by the NLM should stay in place, the working group also decided that the NLM should expand its role as a leader in sharing biomedical data. The working group suggests that the NLM should coordinate data science programs and run the Big Data to Knowledge (BD2K) initiative at the NIH. Other main points of the report include continuing to serving as a leader through gathering and sharing biomedical research, supporting data sharing, research reproducibility, and transparent analysis. The NLM is also encouraged to support education in biomedical informatics, data science and library science. The complete report on the future vision of NLM can be found here. (Jocelyn Kaiser, ScienceInsider)

Therapies of the Future

Researchers discover genes associated with resistance to spongiform encephalopathies

Authors of a recent paper published in Nature have discovered a human genetic variant that lends resistance to certain individuals against some types of spongiform encephalopathies. Spongiform encephalopathies are currently most visible in the public mind as “mad cow”disease and the human variant Creutzfeldt–Jakob disease (vCJD). These currently incurable encephalopathies are caused when abnormal prion proteins (PrP) spread throughout the brain, damaging tissue and ultimately leading to death. Researchers of the recent paper entitled “A naturally occurring variant of the human prion protein completely prevents prion disease” found that a variant of PrP found in certain individuals gave mice resistance to developing one kind of spongiform encephalopathy, Kuru, when exposed to diseased prions. Researchers have hopes that understanding how this genetic variant prevents the propagation of PrP may lead to future medical treatments possibly through the inhibition PrP during spongiform encephalopathies. (Glen Telling, Nature News and Views)

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June 16, 2015 at 9:00 am