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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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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. (

Obesity

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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March 14, 2017 at 10:00 am

Science Policy Around the Web – March 7, 2017

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By: Allison Dennis, BS

Synthetic opiates

Opioid Crisis

Keeping up With the Synthetic Opioids

At the center of the opioid crisis is an ever-expanding class of would-be-regulated drugs, exploited for their ability to produce morphine-like effects. Opioids, including morphine, heroin, and oxycodone interact with the opioid receptors found on the surface of our nerve cells to trigger feelings of euphoria, and block pain. Unfortunately, these substances can adversely affect the respiratory rhythm generating area of the central nervous system, resulting in respiratory depression, effectively disrupting the body’s instincts to breathe.

In 2013, the U.S. Drug Enforcement Agency began to detect in confiscated supplies of heroin the synthetic compound, Fentanyl, which is 50 to 100 times more potent and carries a much higher risk of respiratory depression. The supply was traced to illicit online pharmacies in China, prompting Chinese officials to implement an export ban on fentanyl. Just as medical drug makers audition new compounds through structure-based drug design, illicit drug makers quickly modified the structure of fentanyl to produce furanyl fentanyl, temporarily circumventing the ban. This was followed by the production of the elephant tranquilizer, carfentanil. As of March 1, 2017, China has placed a ban on the sale and manufacture of these compounds along with acrylfentanyl and valeryl fentanyl.

However the dynamic that has emerged is a global game of whack-a-mole. Cutting off the global supply of fentanyl-derived compounds will require negotiations with individual governments to cooperate in their ban. Willing chemists in Mexico may already be setting up to fill the gap left by the ban in China. As each substance is entering the U.S. Drug Enforcement Agency’s radar, the list of designer fentanyls is expanding. The rotating portfolio of synthetic opioids has left local law-enforcement and coroners stumped as to how to test for drugs not-yet-known to their screens, leaving a critical lag in identifying local suppliers. (Eric Niler, Wired Magazine)

Influenza

Keeping up with the Neuraminidases

The H7N9 strain of bird flu may be gaining ground as a global threat to human health. On Monday, the U.S. Department of Agriculture confirmed the presence of a highly pathogenic H7 avian influenza strain in a flock of chickens in Lincoln County, Tennessee. The agency is hurrying to establish the neuraminidase protein type, or “n-type” of the virus. In combination with the H7 hemagglutinin type, an N9 would consign this virus to the class of influenza the WHO has described as “definitely one of the most lethal influenza viruses we have seen so far.”

First detected in China in 2013, the H7N9 strain has been the source of yearly epidemics of human infections. These infections are characterized by severe respiratory illness, which has lead to death in 40% of cases. Over 5 flu seasons, 1222 human cases of H7N9 flu have been confirmed. Most infections have been tied to direct exposure to poultry where the avian strain circulates, indicating that the virus is not currently suited for sustained person-to-person spread. However, the ability of these viruses to recombine, gaining new specificities, keeps public health officials watchful.

Following the first reports of H7N9 infections in humans in 2013, the U.S. Department of Health and Human Services amassed a 12 million-dose stockpile of H7N9 specific vaccines. However, the strains selected as the seeds for these vaccines may not adequately protect against the particular H7N9 virus circulating now.  The U.S. CDC is currently evaluating the need to update its vaccine stockpiles in addition to recommending inclusion of H7N9 in next year’s seasonal flu vaccine. Many researchers are hoping to circumvent these concerns with the development of a universal vaccine, protective against all known flu strains. (Helen Branswell, STATnews)

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March 7, 2017 at 9:02 am

Science Policy Around the Web – March 06, 2017

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By: Liu-Ya Tang, PhD

Source: pixabay

Technology and Health

Is That Smartphone Making Your Teenager’s Shyness Worse?

The development of new technologies, especially computers and smartphones, has greatly changed people’s lifestyles. People can telework without going to offices, and shop online without wandering in stores. While this has brought about convenience, it has also generated many adverse effects. People tend to spend more time with their devices than with their peers. Parents of shy teenagers ask, “Is that smartphone making my teenager’s shyness worse?”

Professor Joe Moran, in his article in the Washington Post, says that the parents’ concern is reasonable. The Stanford Shyness Survey, which was started by Professor Philip Zimbardo in the 1970s, found that “the number of people who said they were shy had risen from 40 percent to 60 percent” in about 20 years. He attributed this to new technology like email, cell phones and even ATMs. He even described such phenomena of non-communication as the arrival of “a new ice age”.

Contrary to Professor Zimbardo’s claims, other findings showed that the new technology provided a different social method. As an example, teenagers often use texting to express their love without running into awkward situations. Texting actually gives them time and space to digest and ponder a response. Further, Professor Moran said that the claim of Professor Zimardo was made before the rise of social networks;  shy teenagers can share their personal life online even if they don’t talk in public. He also talks about the paradox of shyness, where shyness is caused by “our strange capacity for self-attention”, while “we are also social animals that crave the support and approval of the tribe.” Therefore, new technologies are not making the shyness worse, in contrast social networks and smartphones can help shy teenagers find new ways to express that contradiction. (Joe Moran, Washington Post)

Genomics

Biologists Propose to Sequence the DNA of All Life on Earth

You may think that it is impossible to sequence the DNA of all life on Earth, but at a meeting organized by the Smithsonian Initiative on Biodiversity Genomics and the Shenzhen, China-based sequencing powerhouse BGI, researchers announced their intent to start the Earth BioGenome Project (EBP). The news was reported in Science. There are other ongoing big sequencing projects such as the UK Biobank, which aims to sequence the genomes of 500,000 individuals.

The significance of the EBP will greatly help “understand how life evolves”, says Oliver Ryder, a conservation biologist at the San Diego Zoo Institute for Conservation Research in California. Though the EBP researchers are still working on many details, they propose to carry out this project in three steps. Firstly, they plan to sequence the genome of a member of each eukaryotic family (about 9000 in all) in great detail as reference genomes. Secondly, they would sequence species from each of the 150,000 to 200,000 genera to a lesser degree. Finally, the sequencing task will be expanded to the 1.5 million remaining known eukaryotic species with a lower resolution, which can be improved if needed. As suggested by EBP researchers, the eukaryotic work might be completed in a decade.

There are many challenges to starting this project. One significant challenge is sampling, which requires international efforts from developing countries, particularly those with high biodiversity. The Global Genome Biodiversity Network could supply much of the DNA needed, as it is compiling lists and images of specimens at museums and other biorepositories around the world. As not all DNA samples in museum specimens are good enough for high-quality genomes, getting samples from the wild would be the biggest challenge and the highest cost. The EBP researchers also need to develop standards to ensure high-quality genome sequences and to record associated information for each species sequenced. (Elizabeth Pennisi, ScienceInsider)

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March 6, 2017 at 8:41 am

Science Policy Around the Web – February 24, 2017

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By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

An article published in Science discusses a lawsuit filed on February 13 against the U.S. Department of Agriculture (USDA) by an animal law expert at Harvard University. According to the plaintiffs, USDA violated the federal Freedom of Information Act (FOIA) when it removed thousands of animal welfare inspection reports and other records from a publicly accessible website. USDA generated records that document animal facility inspections, enforcement actions, animal censuses, and other information collected by the agency in the course of enforcing the federal Animal Welfare Act.  The law covers animals in more than 7800 facilities, including zoos, roadside circuses, and research laboratories at government agencies and academic medical centers.

The decision to remove the public access to these records may have been a response to a lawsuit involving another law, the Horse Protection Act. The plaintiffs in a 2016 Texas lawsuit accused USDA of violating their rights under the Privacy Act by posting inspection documents required by the Horse Protection Act. A resulting USDA review of all its public postings led the agency to scrub from its website documents generated under both the Horse Protection Act and the Animal Welfare Act.  In the future, the agency announced, people who want access to those records will need to file a FOIA request. The agency’s most recent FOIA report states that it takes an average of 94 days for the agency to respond to a simple FOIA request and 234 days on average for more complicated requests.

In February 13’s lawsuit, the plaintiffs invoke a section of FOIA that requires agencies to make publicly available electronically all records that it has released under FOIA which “because of the nature of the subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” (Meredith Wadman, ScienceInsider)

Science and Immigration

Grad Students, Postdocs with U.S. Visas Face Uncertainty

While U.S. courts are busy handling President Donald Trump’s travel ban on immigration from seven majority-Muslim countries, the temporary shut down of the executive order, the appeal to reinstate the travel ban, the rejection of the immediate restoration of the ban, and more appeals and rulings, graduates and postdoctoral students already in the United States are weighing their options and trying to plan rationally in an unpredictable and fluid situation.

Many scientists in the U.S. are on student or other working visas. All these visas may not be renewable, depending on future executive orders and regulations. The dilemma “simply ruins their future. It’s a catastrophe,” says a Yemeni biologist who is on a university faculty on an H-1B, a 3-year visa for professionals. For years, lawmakers in Washington have tried to reform abuses of visa regulations by companies using visas to bring workers to the U.S. to learn the ropes, and then send the trained workers to other countries where the job can be done cheaply. The H-1B system is contentious: on one side labor advocates want the exploitation of the H-1B system to stop supporting an outsourcing business model. On the other hand, tech companies like Google and Facebook say they can’t get enough visas for top foreign talent, as the cap on the number of H-1Bs issued every year means that sometimes foreign graduates from top U.S. universities, places like the Massachusetts Institute of Technology and the University of California, Berkeley, can’t get one. The travel ban already has harmed the top universities in the U.S., stranding students, faculty and scholars abroad, and making foreign schools more attractive to some of the world’s brightest students.

In papers filed in Brooklyn federal court, the schools (that include Columbia, Duke, Harvard, Johns Hopkins, Princeton, Stanford, Yale, Massachusetts Institute of Technology and several more) said that the order blocking travel from seven predominantly Muslim countries threatens their abilities to educate future leaders from every continent. They said the executive order has “serious and chilling implications” and that the ban “casts doubt on the prospect and value of studying and working here for everyone,” the papers said. (Meredith Wadman, Richard Stone, Science)

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

“Scientists should be permitted to modify human embryos destined for implantation in the womb to eliminate devastating genetic diseases such as sickle-cell anaemia or cystic fibrosis — once gene-editing techniques advance sufficiently for use in people and proper restrictions are in place. That’s the conclusion of a 14 February report from the US National Academies of Science, Engineering, and Medicine.”

The report follows a 2015 National Academies summit between scientists, ethicists, legal experts and patient groups from around the world. At the time of the meeting, given the outstanding scientific, ethical and legal questions surrounding the issue, the organizers concluded that scientists shouldn’t yet perform germline editing on embryos intended for establishing a pregnancy. However, the organizers also stated that altering human embryos for basic research was acceptable.

The latest iteration of this ongoing CRISPR debate moves the bar a little further. The report recommends restricting the technique to severe medical conditions for which no other treatment exists. Eric Lander, president of the Broad Institute of MIT and Harvard, said, “It’s a very careful, conservative position that’s just a little bit beyond an absolute bar.” In the report, the committee also called for international cooperation, strict regulatory and oversight framework, public input into decisions and long-term follow-ups of children who have edited genomes. The report adds that for now, genome editing should not be used for human enhancement, such as improving a person’s intelligence or giving them super-strength.

The report drew immediate criticism from a California-based non-profit organization called the Center for Genetics and Society. “This report is a dramatic departure from the widespread global agreement that human germline modification should remain off limits,” said Marcy Darnovsky, executive director of the center. “It acknowledges many of the widely recognized risks, including stigmatizing people with disabilities, exacerbating existing inequalities, and introducing new eugenic abuses. Strangely, there’s no apparent connection between those dire risks and the recommendation to move ahead.” (Sara Reardon, Nature)

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February 24, 2017 at 11:23 am

Science Policy Around the Web – February 21, 2017

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By: Rachel Smallwood, PhD

Obesity

Should We Treat Obesity Like a Contagious Disease?

Researchers are modeling obesity from a public health perspective as a contagious disease. There are many factors associated with obesity, including genetics, low levels of physical activity, and high caloric intake. An earlier study examined the effects of different social factors on an individual’s risk of being obese; it found that people with obese friends and family were at an increased risk for obesity, and this trend was influenced by how close the relationships were.

In this model of the prevalence of obesity, the researchers included a factor to represent obesity as a “social contagion”, reflecting those previous findings and indicating a potential increased risk and increased prevalence due to transmission from one person to another. This mechanism is assumed to be related to people adopting the behaviors of those close to them; notably, activity levels and type and quantity of food consumed. The model predicts obesity rates in populations with terms associated with the genetic contribution to obesity, the mother’s non-genetic contribution to her offspring, and the prevalence of obesity. Essentially, the more obese individuals there are in a society, the more likely it is for someone to know and interact with an obese person.

The models indicate that obesity prevalence plateaus around 35-40% without an intervention. The model is still fairly primitive, but the researchers hope that in future it could provide insight into the effects of potential interventions. For example, is it better to target an intervention to individuals who are already obese, or should the reach of the intervention be more broad and target the population as a whole? When the models reach a level of complexity comparable to the existing factors for obesity, they can be a powerful tool in preventing and addressing the epidemic. (Kelly Servick, Science Magazine)

Autism

Brain Scans Spot Early Signs of Autism in High-Risk Babies

A study recently published in Nature showed that alterations in brain development in children who go on to be diagnosed with autism precede behavioral symptoms. High-risk infants’ brains were scanned with MRI at 6, 12, and 24 months. It was determined that the infants who were subsequently diagnosed with autism had a faster rate of brain volume growth between 12 and 24 months. Additionally, between 6 and 12 months, these infants had a faster rate of growth in the surface area of folds on the brain, called the cortical surface.

Taking these findings, the research team used a machine learning approach called a deep-learning neural network to make a model to predict whether an infant would be diagnosed with autism based on their MRIs from 6 and 12 months. This model was tested in a larger set of infants, and the model correctly predicted 30 out of 37 infants who went on to be diagnosed (true positives), and it incorrectly predicted that 4 infants would be diagnosed with autism out of the 142 who were not later diagnosed (false positives). These results are much more robust than behavior-based predictions from this same age range.

More work needs to be done to replicate the results in a larger sample. Additionally, all of the participants were high-risk infants, meaning they had a sibling who was diagnosed with autism, so the results are not necessarily generalizable to the rest of the population. Further studies need to be done in the general population to determine if these same patterns are observable, but that would require an even larger sample due to the lower risk. However, the early detection of symptoms and prediction of diagnosis are potentially valuable tools, especially considering another recent publication showed that early intervention in children with autism affects the severity of symptoms years down the road. (Ewen Callaway, Nature News)

Science Funding

Ebola Funding Surge Hides Falling Investment in Other Neglected Diseases

Funding totals from 2015 reveal a trending decrease in funding for neglected diseases, excluding Ebola and other viral hemorrhagic fevers. Neglected diseases are diseases that primarily affect developing companies, thus providing little incentive for private research and development by commercial entities; the other diseases include malaria, tuberculosis, and HIV/AIDS. Given the recent surge of funding for Ebola research, the analysis firm, Policy Cures Research, decided to separate it from the other neglected diseases in its analysis to observe funding patterns independent from the epidemic that dominated the news and international concerns. Funding was tracked from private, public, and philanthropic sources.

The funding for Ebola research has primarily gone to development of a vaccine, and over a third of the funds were provided by industry. For the other diseases, the decline in overall funding is mostly represented by a decline in funding from public entities, primarily comprised of the governments of large, developed countries. Those countries accounted for 97% of the research funding for neglected diseases in 2015, so any significant change in that funding category would affect the overall funding amounts. However, there was also a slight decline in philanthropic funding. When including Ebola with the others, funding of neglected diseases was actually at its highest in the past ten years. It is not known whether money was funneled from the other diseases to Ebola research, or if this decline is indicative of less research spending in general. (Erin Ross, Nature News)

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February 21, 2017 at 10:03 am

Science Policy Around the Web – February 17, 2017

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By: Thaddeus Davenport, PhD

Source: pixabay

CRISPR

Decision in the CRISPR-Cas9 Patent Dispute

This week, Heidi Wedford from Nature News reported that the United States Patent and Trademark Office (USPTO) made a decision on the disputed patents for the gene editing technology known as CRISPR-Cas9 in favor of the Broad Institute of MIT and Harvard. The CRISPR-Cas9 system has been widely publicized, and this publicity is arguably not out of proportion with the potential of this technology to simplify and accelerate the manipulation of DNA of both microbial (prokaryotic) and higher order (eukaryotic) cells for research and therapy. A simplified, programmable version of CRISPR-Cas9 for use in gene editing was initially described by Charpentier and Doudna, and it was rapidly translated for use in eukaryotic cells by Zhang and colleagues at the Broad Institute in parallel with Doudna, Charpentier, and others.

The USPTO decision follows a dramatic and ongoing dispute over whether the patent application submitted by the University of California on behalf of Doudna and Charpentier – which was submitted before that of the Broad Institute, and described the technology in broad terms as a method of cutting desired DNA sequences – was sufficient to protect the CRISPR-Cas9 intellectual property when the Broad Institute later filed a fast-tracked patent application describing the use of CRISPR-Cas9 for use in eukaryotic cells. Because the Broad Institute’s application was expedited, it was approved before the University of California’s application. In January of 2016, the University of California filed for an ‘interference’ proceeding, with the goal of demonstrating to the USPTO that Doudna and colleagues were the first to invent CRISPR-Cas9, and that the patent application from the Broad Institute was an ‘ordinary’ extension of the technology described in the University of California application.

On February 15th of this year, the USPTO ruled that the technology described in the Broad Institute’s application was distinct from that of the University of California’s. The importance of this decision is that the patents granted to the Broad Institute for the use of CRISPR-Cas9 in mammalian cells will be upheld for now. It also creates some complexity for companies seeking to license CRISPR-Cas9 technology. Because of the overlapping content of the CRISPR-Cas9 patents held by the University of California and the Broad Institute, it is possible that companies may need to license the technology from both institutions. The University of California may still appeal the USPTO’s decision, but this is a significant victory for the Broad Institute for the time being. For many scientists, this dispute is a dramatic introduction to the inner workings of the patent application process. We would do well to familiarize ourselves with this system and ensure that it works effectively to accurately reward the discoveries of our fellow scientists and to facilitate the transfer of technology to those who need it most, without imposing undue economic burden on companies and consumers. (Heidi Wedford, Nature News)

Scientific Publishing

Open Access to Gates Foundation Funded Research

Also this week, Dalmeet Singh Chawla reported for ScienceInsider that the Bill and Melinda Gates Foundation had reached an agreement with the American Association for the Advancement of Science (AAAS) that will allow researchers funded by the Gates Foundation to publish their research in the AAAS journals Science, Science Translational Medicine, Science Signaling, Science Immunology, and Science Robotics. This agreement follows an announcement in January in which the Gates Foundation decided that research funded by the foundation would no longer be allowed to be published in subscription journals including Nature, Science, and New England Journal of Medicine, among others, because these journals do not meet the open access requirements stipulated by the new Gates open-access policies. The new Gates Foundation policy requires its grant recipients to publish in free, open-access journals and to make data freely available immediately after publication for both commercial and non-commercial uses. A similar policy is being considered by the nascent Chan Zuckerberg Initiative.

In the agreement with AAAS, the Gates Foundation will pay the association $100,000 in order to make Gates-funded published content immediately freely available online. Convincing a journal as prominent as Science to make some of its content open-access is a step in the right direction, but it is perhaps more important as a symbol of a changing attitude toward publishing companies. Michael Eisen, co-founder of the Public Library of Science (PLoS) open-access journals, was interviewed for the ScienceInsider article and noted, “[t]he future is with immediate publication and post-publication peer review, and the sooner we get there the better.” This sentiment seems to be increasingly shared by researchers frustrated with the hegemony of the top-tier journals, their power over researchers’ careers, and the constraints that subscription-based journals impose on the spread of new information. Funding agencies including the Gates Foundation, Howard Hughes Medical Institute, and the National Institutes of Health are in a unique position to be able to dictate where the research they fund may be published. A collective decision by these agencies to push the publishing market towards an improved distribution of knowledge – through open-access publishing and post-publication peer review – and away from the historical and totally imagined importance of validation through high-tier journal publication would enrich the scientific ecosystem and accelerate innovation. In this regard, the efforts by the Gates Foundation are laudable and should be extended further. (Dalmeet Singh Chawla, ScienceInsider)

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February 17, 2017 at 12:44 pm