Posts Tagged ‘biosafety’
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 Adele Blackler
H5N1, the highly pathogenic and deadly avian flu, has been causing panic since it first appeared in Hong Kong in 1997. Though the flu has a high mortality rate, it is very rarely transmissible between humans, and thus there has been no widespread epidemic or pandemic resulting from H5N1[i].
However, the announcement last year by two research groups, from the U.S. and the Netherlands, that they had identified key mutations that made the flu highly transmissible among ferrets, caused an outcry among the public and the scientific community. The U.S. National Science Advisory Board for Biosecurity, NSABB, raised concerns that full publication of the research methods could give potential bioterrorists a new weapon and asked that only redacted methods be published, to make it difficult to duplicate the results[ii].
Recently, a special World Health Organization (WHO) panel convened to discuss the flu research and, after discussion with the research authors and leading scientists in the field, recommended that the current voluntary halt to research should continue until a more thorough analysis of laboratory biosafety could be completed[iii]. However, in the interest of aiding public health efforts and scientific research, the WHO panel recommended that both papers be published with complete methods, meaning that the published methods will be complete enough to be replicated by other labs around the world with access to the starting material. In response, the NSABB has requested a second look at the manuscripts and research and Congressional Representative Jim Sensenbrenner (R-WI) has questioned why this research was funded by the National Institutes of Health (NIH) in the first place[iv].
In an influenza pandemic, early detection and tracking is essential to being able to slow the spread of the virus and mitigate damage by quickly developing a vaccine. Understanding what mutations can make the H5N1 flu transmissible could help with early detection of emerging pandemic-causing strains and could make tracking the flu easier. This research could play a key role in understanding how the avian flu can become transmissible among humans, and that could help with early detection. Ultimately, if the H5N1 flu becomes highly transmissible among humans and turns into a pandemic-causing strain, early detection could save a countless number of lives.
Is the possibility of great public benefit enough to allow the H5N1 research to continue? Supporters of continuing this line of research point to the 1970s, when a new type of experiments involving altering DNA made headlines. Recombinant DNA research was also temporarily halted due to safety concerns, yet today DNA recombination experiments are routinely performed with no risk to health and safety[v].
Or is the risk that the deadly virus could escape the lab simply too great to justify continuation of the research? If research continues, what security measures should be in place? Further complicating the current debate is that many scientists in favor of H5N1 research are disagreeing about the biosafety level (BSL) a lab should have in place while working with the virus. Currently, most infectious disease labs work with the second highest level of biocontainment, BSL3. This is the same biocontainment level that was used for the current H5N1 research. Individuals in favor of raising the required BSL to the highest possible level (BSL4) argue that it is the safest way to work with the virus and minimize exposure. However, few labs in the nation are equipped for BSL4, and requiring such a high level of security might unduly restrict who can perform research on H5N1, effectively putting an end to most of the research on the virus[vi].
Currently, it looks like research on the engineered flu strain will resume at the end of the voluntary moratorium, and the results will most likely be published with full, not redacted, methods. However, the debate on whether or not this research should continue, and if the proposed benefits outweigh the possible risks, will continue for quite some time.