Archive for April 2017
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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By: Thaddeus Davenport, PhD
The election of Donald Trump to the Oval Office and the early actions of his administration have sparked a wave of protests in support of women’s rights and immigration, among other issues. Like other citizens, scientists have some cause to be concerned about the administration’s early actions that reveal a general disregard for facts and scientific evidence. In response, organizers have planned the March for Science for this Saturday, April 22nd, as an opportunity for people to gather in cities around the world to voice their support for factual information and scientific research. And while it is important to denounce the actions of the Trump administration that are harmful to science and health, it may be even more critical to acknowledge the underlying partisan divisions that created a niche for his rhetoric and to begin the difficult work of bridging the divide. For example, a Pew Research Center poll from 2015 indicates that 89% of liberal Democrats believe government investment in basic science pays off in the long-run, while only 61% of conservative Republicans feel the same way. Additionally, American adults with less knowledge of scientific topics are more likely to believe that government funding of basic science does not pay off. This suggests that improved science education and outreach will be important in building public support for scientific research. However, scientists often lead very busy lives and have little time outside of their professional activities to devote to valuable pursuits like science outreach. How, then, might scientists work towards building a better relationship with the public?
The products of science – knowledge, medicines, technology – are the clearest evidence of the value of research, and they are the best arguments for continued research funding. Efficiency in science is good not only for scientists hoping to make a name for themselves, but also for the public, who as the primary benefactors of academic research, must benefit from the products of that research. If taxpayers’ demand for scientific inquiry dissipates because of a perceived poor return on their investment, then the government, which supposedly represents these taxpayers, will limit its investment in science. Therefore, in addition to communicating science more clearly to the public, scientists and funding agencies should ensure that science is working efficiently and working for the public.
Information is the primary output of research, and it is arguably the most essential input for innovation. Not all research will lead to a new product that benefits the public, but most research will yield a publication that may be useful to other scientists. Science journals play a critical role in coordinating peer review and disseminating new research findings, and as the primary gatekeepers to this information, they are in the difficult position of balancing accessibility to the content of their journals with the viability of their business. This position deserves some sympathy in the case of journals published by scientific societies, which are typically non-profit organizations that perform valuable functions including scientific outreach, education and lobbying. However, for-profit journals are less justified in making a significant profit out of restricting access to information that was, in most cases, obtained through publicly-funded research.
Restricting access to information gathered in the course of research risks obscuring the value of research to a public that is already skeptical about investing in basic science, and it slows down and increases the cost of innovation. In light of this, there is growing pressure on publishers to provide options for open-access publishing. In 2008, the National Institutes of Health adopted a public access policy, which requires that “investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, that the NIH shall implement the public access policy in a manner consistent with copyright law.” This policy was extended through an executive order from the Obama Administration in 2013 to include all federal agencies with research budgets greater than $100 million, with additional requirements to improve accessibility.
These requirements are changing scientific publishing and will improve access to information, but they remain limited relative to the demand for access, as evidenced by the existence of paper pirating websites, and the success of open access journals like PLoS and eLife. Additionally, other funding agencies like the Bill and Melinda Gates Foundation and the Wellcome Trust have imposed even more stringent requirements for open access. Indeed, researchers will find a spectrum of open-access policies among the available journals, with the most rapid access to information allowed by so-called ‘preprint’ publishers like biorxiv.org. Given that many research manuscripts require months or years of revision and re-revision during submission to (usually multiple) journals, preprint servers accelerate the dissemination of information that is potentially valuable for innovation, by allowing researchers to post manuscripts prior to acceptance in a peer-reviewed journal. Many journals have now adopted explicit policies for handling manuscripts that have been previously submitted to bioRxiv, with many of them treating these manuscripts favorably.
Given that most journals accept manuscripts that have been previously published on bioRxiv, and some journals even look to bioRxiv for content, there is little incentive to submit to journals without also submitting to bioRxiv. If the goal is, as stated above, to improve the transparency and the efficiency of research in order to make science work for the public, then scientists should take every opportunity to make their data as accessible as possible, and as quickly as possible. Similarly, funding agencies should continue to push for increased access by validating preprint publications as acceptable evidence of productivity in progress reports and grant applications, and incentivizing grant recipients to simultaneously submit manuscripts to preprint servers and peer-reviewed journals. Scientists have many options when they publish, and by voting for good open-access practices with their manuscripts, they have the opportunity to guide the direction of the future of scientific publishing. These small, but important, actions may improve the vitality of research and increase the rate at which discoveries tangibly benefit taxpayers, and, in combination with science outreach and education, may ultimately strengthen the relationship between scientists and the public.
March for Science this Saturday, if it feels like the right thing to do, and then strive to make science work better for everyone by sharing the fruits of research.
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By: Emily Petrus, PhD
There’s no question that the US spends too much on healthcare – in 2015 it cost 18% of its GDP, equivalent to $3.2 trillion dollars. In fact, we spend more on healthcare to cover just 34% of our population via Medicare and Medicaid than other countries who cover their entire population with universal healthcare. Most people assume that this higher spending equals better health, but unfortunately this isn’t the case.
According to a 2015 Commonwealth Fund survey, the US has the highest infant mortality and obesity rates and the lowest life expectancy of the top 13 Organisation for Economic Co-operation and Development (OECD) countries. In addition, we have the highest rates of prescription drug use, amputation due to diabetes mismanagement, and the second highest death rate from ischemic heart disease. Our relatively small percentage (14.1%) of people over age 65 also have the highest rate of at least two chronic illnesses per person. These numbers are estimated to increase as baby boomers age, so the outlook isn’t good when considering how many elderly people we can expect to suffer from chronic health issues.
However, it’s not all doom and gloom – we are in the top 3rd for surviving cancer, boast the lowest smoking rates, and have the highest access to diagnostic imaging services (such as MRI and CT scans). In this light, it makes sense that we spend more, have better access to expensive technology, and use more expensive prescription drugs. Another way to slice the data paints a different picture. The sickest 5% of the population accounts for 50% of medical spending, and accounts for 60% of spending on prescription drugs. Together these data indicate that the US could be in better shape if we had a healthier population.
How could we make the population healthier? Let’s consider that the determinants for health are 30% genetics, 70% behavior, environment and social factors, only 10% is mediated by healthcare. Other OECD countries spend significantly more on social services such as supportive housing, employment programs, retirement and disability programs. Social services are especially beneficial for people in lower income brackets, who incidentally have the poorest health in the US. The life expectancy for the poorest Americans is about 13 years less than the wealthiest. Racial disparities also contribute to gaps in healthcare outcomes for Black, Hispanic, Asian and American Indians/Alaskan Native Americans, all of whom experience worse medical care. The parameters measured included access to care, effective communication with medical staff, and a specific source of ongoing medical care, such as a primary care physician. It is estimated that these disparities amount to billions of dollars in economic loss – $35 billion in excess health care expenditures – for example, a trip to the emergency room for something that could be treated by better access to a primary care physician. Expanding Medicaid would increase medical access to poor and disadvantaged minority groups, for example, Blacks in the south. However, many states thatch have high at-risk populations decided not to expand Medicaid. Spending more on social services aimed at improving people’s health seems to be working in other OECD countries, and the National Academy of Medicine recommends the US increase spending in these areas.
Social services are unlikely to gain support from conservatives, so spending in this area is unlikely to be supported by the current administration. However, there are other areas in healthcare that can gain bipartisan support. 30% of medical expenses are considered wasteful – meaning they are for unnecessary services, fraud, and sky high pharmaceutical or administrative costs. Medicare has already saved billions of dollars by reducing overpayments to private insurers and tying medical provider payments to quality of care. Overall a goal of those involved in healthcare reform should seek to follow this example of prioritizing value over volume of care, which will translate to better outcomes at lower costs for patients and taxpayers.
So what did the Affordable Care Act (ACA, also known as Obamacare) achieve since it was passed in 2010? In the time leading up to the ACA, 82% of the American public wanted healthcare reform. Private insurance premiums were rising 10% per year, and insurance didn’t have to cover expensive benefits, so many plans came without services like mental health or maternity care. Maternity care is not just a women’s issue, healthier pregnancies result in healthier babies who become part of our population. Before the ACA, 50 million (17%) of the population was uninsured; by 2016 20 million people had gained health insurance, leaving only 10% of our population uninsured. Women and people with pre-existing conditions can’t be denied coverage or charged more by insurance companies. Lifetime spending caps were removed, meaning if you were a sick baby in the ICU you can’t be denied coverage for the remainder of your life. The most popular part of the bill allows young adults to stay on their parents’ insurance until age 26, which reduced the uninsured rate for young adults by 47%. Finally, tax credits made health insurance through exchanges more affordable for those at or below 400% of the federal poverty line.
Those are the good parts about the ACA – here’s the bad news. High deductible plans have increased from 10% of plans offered in 2010 to 51% of plans in 2016, meaning people buying insurance can expect to pay at least the first $1,000 per year out of pocket. If it seems that premiums are jumping, they are: they rose 20% from 2011 to 2016. It’s easy to blame the ACA for rising premiums, but if we consider that premiums rose 10% per year before the ACA, 20% in 5 years doesn’t sound so bad. Some specific states are expecting huge increases, for example Oklahoma will see a 42% increase in 2016. Part of the reason premiums are rising is because healthcare gets more expensive each year – it outpaces inflation and wages. Insurance companies are also losing money because they have enrolled more sick, expensive people than they expected to when they set prices. The ACA attempted to mediate the sticker shock for insurance companies by setting up “risk corridors” to help shoulder the burden, but that part of the bill was scuttled for political reasons, and now insurance companies are passing the buck to consumers. Regarding taxes, under the ACA, those without insurance will face a penalty fee double that of the 2015 amounts.
A central campaign promise of Trump and Republicans was to repeal the ACA and provide better and more affordable coverage for all. The American Health Care Act (AHCA) proposed several weeks ago by Republicans was a repeal and replace bill which was unpopular from the start. The AHCA was unpopular with conservatives for not going far enough to repeal the ACA, while moderates worried about the 20 million people, including their constituents, being denied or outpriced from insurance due to some elements of the bill. The AHCA removed the mandates requiring insurance companies to provide essential health benefits. This could lower premiums but insurers could also reduce services, leading to “junk plans”. Additionally, tax credits for people buying insurance would be significantly lower than current levels, making insurance too expensive for many middle-income people. Medicaid coverage was also proposed to shrink, resulting in less coverage for poor Americans. Finally, eliminating the community rating of the ACA would enable insurance companies to charge older and sicker people higher premiums, essentially pricing those who need insurance the most out of the market. The AHCA proposed to ameliorate this problem by providing larger tax credits to older individuals and setting up pools of high risk people subsidized by the government.
It is safe to assume that the Republican controlled House, Senate and the White House will try again to present bills that modify the ACA. However, it remains to be seen if they will try a bipartisan effort to fix certain parts of the bill that are flawed, or repeal and replace the ACA with something completely new.
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