Posts Tagged ‘biomedical research’
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: Aparna Kishor, MD, PhD
To an outside observer, the scientific enterprise in the US appears to be thriving. The 2016 budget of the National Institutes of Health (NIH) was $31.3 billion. Of this, about 80% was distributed to research projects performed extramurally, pointing to the fact that hundreds of thousands of researchers nationwide, established scientists as well as trainees, benefit from the funding. Although the numbers are somewhat murky, it is likely that over 50% of graduate students and postdoctoral researchers (postdocs) receive some federal funds.
A more granular view of the reality of modern scientific training reveals its true complexity. In The Postdoctoral Experience Revisited, a report on postdoctoral training in the US, the National Academies argue that there are serious issues in the way we train our young scientists today, including those having to do with recognition and compensation, mentorship, and career advising. Fundamentally, although the US has more postdocs than ever before, does this serve the individuals involved?
First some context. For those committed to a career in the biological sciences, the first stage of training is graduate study to acquire technical and field-specific skills, culminating in a PhD. Traditionally, the second is the postdoctoral stage, which provides additional technical experience and preparation for a future career, ideally culminating in a research position. In the US, approximately 65% of those with graduate degrees in the life sciences continue on to a postdoc which is the field with the highest rate of entry. The second highest is in the physical sciences, with only 50%. Although the quotidian experiences of the two may be similar, the graduate and postdoctoral stages are actually quite different, particularly since graduate training tends to have formal requirements and expectations while postdoctoral training, does not. This framework also has distinct benefits for the principle investigators (PIs). A major one is economic: junior scientists are a willing, and in the case of postdocs, highly trained, source of cheap labor (more on this below). On occasion, the work may be done at no cost to the PI if the trainee has funding from another source, although this is becoming proportionally less common.
When the postdoctoral arrangement was established in the early part of the 20th century, the training periods were typically 1-2 year stints in a lab to learn additional skills and consolidate connections in the field. After this, the young researcher would generally transition into an academic position. In the 1970’s, close to 55% of postdocs held tenure or tenure track faculty positions 6 years after completion of their graduate studies. Now, when a postdoc plans for his or her next career move, the situation is not so simple and this has aroused the concern of the National Academies. Partly, the difficulty is due to the number of available academic positions being outstripped by the number of postdocs in the pipeline. Data from 2006 show that only 33% of postdocs had faculty positions 6 years after graduate school and only half of those were tenured or tenure-track. The rest of the explanation lies in the fact that the landscape of the scientific enterprise has evolved.
Most obviously, the demographics of the postdoc community are markedly different from those in the early 20th century resulting in different needs for trainees. As of 2014, women were receiving close to 50% of all life science doctorates awarded in the US. Gender parity at graduation has not carried through to the faculty level (where only approximately 25% of tenured faculty are women). Among the many potential causes for this decline, one is that many women leave the academic track due to the challenges in balancing a career with raising a family. Nonetheless, there are more women at all levels in the sciences than before, indicating that retention may be increased by supporting women during the time that their children are young. Holders of temporary visas comprise another important population, but there are very few concrete data pertaining to them. They obtain close to 25% of all doctorates in the biological sciences, and 80% of those who have jobs after graduation stay in the US. With this, there is significant flux into the system at the postdoc level. As a result, upwards of a third of all biomedical postdocs in the US are foreign nationals primarily from India and China. Since these people have never been counted, the best way to help them meet their goals and the role they play in the US scientific arena are undefined.
Another important change is that postdoctoral training periods have lengthened from 1-2 years to around 4 years. For those who want the training, this timeline extension is believed to be a necessary sacrifice in order to gain entry into the competitive world of academia. Unsurprisingly, the percentage of PIs under 36 has fallen from 18% from 1980 to 3% in 2010. For established investigators, the longer training times are advantageous. Postdoc salaries at research institutions generally amount to less than the combined tuition-plus-stipend package offered to graduate students. After a few years, a postdoc may conduct research at a level equivalent to that of permanent scientific staff but at a fraction of the cost – postdocs pull in anywhere from $40,000 to $49,000 a year, while staff will have full benefits and a salary closer to $80,000 a year. Given this, the challenge is to make a prolonged training period valuable, feasible, and non-exploitative for all who choose it.
Finally, there is growing evidence that a postdoc may not be the right choice for everyone. Most junior scientists feel limited by the now-classic dichotomy between pursuing research in academia and industry. The reality is that many other career options exist, although some are a step or two removed from pure research. These are in areas like consulting, intellectual property, and science policy. Some jobs will provide entry-level incomes greater than a postdoc, and may even lead to career prospects that are more secure than that in research. Entry level salaries for some careers in industry begin at $70,000 and mean salaries in industry can be $40,000 more than that in academia, and the age at first non-academic job is lower than that for academics. Critically, for those wishing to optimize some of these other aspects of their professional advancement, a postdoc may be unnecessary.
Taken together, these developments indicate a need to change the culture surrounding the postdoc. The essence of the National Academies’ recommendation to improve the postdoctoral experience is that the entire scientific community must treat it as a valuable training opportunity instead of basic employment. To this end, the minimum postdoctoral salary should be increased, even beyond the current $47,484. The improved economics for trainees will have a number of benefits: it will place more value on these individuals, limit the number of postdocs an investigator may hire, perhaps encourage more women to stay in research, and make positions more competitive, lessening their use as a default employment option. Postdocs should also be encouraged to receive individual funds as proof of independence. There is some evidence that postdocs on their own fellowships are more satisfied than those funded by their lab, although it seems likely that people more committed to a career as a researcher are the ones most likely to apply for fellowships. Additionally, those who receive early career grants are more likely to receive independent investigator grants and faculty appointments. Finally, there is an argument for more staff positions as a measure to keep postdoctoral opportunities as dedicated training experiences.
For now, it is important for each researcher to decide whether it is in his or her best interest to embark on the postdoctoral route. Fortunately, career advising is increasingly available to trainees at all levels and the NIH and other groups have issued mentorship guidelines for postdocs. Overall, the entire scientific community must assist in returning value to a postdoc and in meaningful career development for all trainees.
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