“Egregious safety failures at Army lab led to anthrax mistakes” (USA Today)

An investigation into the Army labs at Dugway Proving Ground in Utah, responsible for chemical and biological defensive testing, was launched last year after it was discovered to be accidentally shipping live anthrax to laboratories across the country for over a decade. The report reveals gaps that go far beyond that of poor leadership, and include a dozen personnel that are being held accountable and could face disciplinary action as a result. To read more about the findings of the Army investigation report, visit USA Today:  http://www.usatoday.com/story/news/nation/2016/01/15/military-bioterrorism-lab-safety/78752876/

Dual Use Research: Is it Possible to Protect the Public Without Encroaching Rights?

For decades, scientists have had reasonable freedom and control over their research and experiments and able to publish and share their work without much inconvenience. The freedom of creativity in the field of science is much like that of an artist – often fueled by an inspiration from other sources, a passion for a unique realm of art (in this case, science), and a natural curiosity. Within reasonable limits, artists and scientists had the world at their fingertips; as long as they weren’t causing a societal disruption or engaging in illegal activity, their work was unregulated and not subject to state interference. With the continued growth of scientific knowledge and technological development, awareness of the risks associated with the misuse of scientific knowledge and new technology has continued to increase significantly – especially in microbiological research.

Microbiological research threats emerged on the public radar when anthrax strains used in the 2001 mailings to several United States government officials and citizens were found to have originated from the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Maryland. While senior biodefense researcher Dr. Bruce Ivins was the primary suspect for the anthrax mailings (mainly due to his unauthorized decontamination of several areas of USAMRIID), his involvement is still unresolved today. Since then, scientists have been scrutinized for working on certain research topics and published research literature labeled as “sensitive.” Ron Fouchier, a scientist at Erasmus Medical Center in Rotterdam, Netherlands, completed research and wrote a research paper in 2011 on laboratory-created strains of H5N1 avian influenza.During the course of his research he faced pressure from the Dutch government over the content of the paper that contained potentially dangerous information that might essentially teach someone how to create synthetic H5N1. In 2012 the U.S. magazine Science was to publish the paper until the U.S. government stepped in to block the paper from being published. Eventually Fouchier and the National Science Advisory Board for Biosecurity (NSABB), an advisory committee for the United States government, came to a compromise about the publication –it could only be published if sensitive information were removed from the article. After that decision came proposals to create a system only accessible to “responsible scientists” where the removed sensitive information could be viewed. But who is responsible for deciding which scientists are responsible? And what makes one scientist more responsible than another? Which qualities would one use to measure how reliable a scientist is: Credentials? Previous research? Educational background?  Possession of a criminal record? While it is an interesting point to consider, society can’t make these decisions based on arbitrary methods of identification. There is no way to know if the Harvard educated, award-winning, highly skilled professor with a spotless criminal and driving record is going to be more trustworthy than the man who hasn’t published any major papers, committed a misdemeanor in his freshman year of college, and has not yet been able to contribute anything to the scientific community. In a radio interview for Science Friday, Dr. D.A. Henderson, a distinguished scientist and epidemiologist at the University of Pittsburgh Medical Center’s Center for Biosecurity, pondered what this would mean for the scientific community.Scientists might be turned down for grants or jobs arbitrarily, which would prove to be disruptive to the fundamental tenets of scientific inquiry as well as to the basic rights of those individuals who would not understand why they weren’t chosen for access to the exclusive system.

Upon realization of the possible dangers on publishing certain components of scientific research, the United States government assembled the NSABB, a panel of voting members with expertise in medicine, life sciences, national security, and other related fields. The NSABB previously assisted in addressing issues related to biosecurity and dual use research in 2004. Decisions made by the NSABB have no legal authority and their findings are strictly advisory. As the majority of scientific work in the United States is funded by a government entity, refusal to comply with NSABB’s advice could result in the reduction or loss of funding. An NSABB decision, while in the best interest of national security and the safety of our citizens, could have a chilling effect on research and advancement. Knowing that one’s research may be abridged to omit sensitive details, or blocked from publication, could discourage scientists from publishing – or even attempting – certain types of research. History has shown that general open access to scientific research publication contributes to many advancements and scientific breakthroughs. Science is a field in which breakthroughs are built upon past innovations and discoveries. Restricting the publication of research could negatively impact such scientific progress in the long run.

There is no question that sensitive scientific information needs to be watched closely, but there does not seem to be a plausible solution to the problem at this time. The new restrictions and regulations on scientific research are meant for national security, but at what point does national security encroach on the right of free speech? At what point do we allow national security concerns to impede the scientific process upon which so many societal advancements are based? This debate not only has technical implications, but is an ethical quandary as well.

As is the case with many ethical debates, there is no perfect solution. A sound strategy begins with the heavy involvement of the scientific community in the discussion; fortunately members of the community are engaging on this topic. A 2007 study analyzed literature centered around the ethics of biodefense and dual-use research of concern from the Medical Literature Analysis and Retrieval System (MEDLINE) database, which holds bibliographical information for academic science journals. Ten articles met their inclusion criteria, and the study concluded that self-regulation within the scientific community, international cooperation, and increased security were the top three suggestions for minimizing the risks presented by dual-use research. Conscientious self-regulation would allow scientists to oversee their own research and associated literature without concerns of compromising the quality of their publications. Additionally, international cooperation would unify a larger group of scientists who may possess similar concerns against the problem. Finally, better cooperation establishes stronger safety and security measures through focused peer review. Combined, these three measures can increase security and make the misuse of sensitive scientific information more difficult for people with access to it, and with increased safety education and clarity of dual use definitions, could further decrease the risks from misusing science.

Herfst, S., Schrauwen, E. J., Linster, M., Chutinimitkul, S., de Wit, E., Munster, V. J., & Fouchier, R. A. (2012). “Airborne transmission of influenza A/H5N1 virus between ferrets.” Science, 336(6088), 1534-1541.

Anand, N.S. (Producer). (2012, January 06). Debate persists over publishing bird flu studies [Audio podcast]. Retrieved from http://www.sciencefriday.com/segment/01/06/2012/debate-persists-over-publishing-bird-flu-studies.html

Dolgitser, M. (2007). “Minimization of the Risks Posed by Dual-Use Research: A Structured Literature Review.” Journal of the American Biological Safety Association12(3), 175. Retrieved from http://www.absa.org/abj/abj/071203dolgitser.pdf

Tosin Fadeyi is currently a graduate student at the University of Maryland University College, pursuing a Master of Science in Biotechnology and specializing in Biosecurity and Biodefense. She is a biosecurity intern at the Federation of American Scientists, overseeing the Virtual Biosecurity Center (VBC). She is also a peer review associate handling clinical trials and medical science journals for PLoS One, a peer-reviewed science publication.

Misconceptions and the Spread of Infectious Disease

New and improved medical treatments for infectious diseases are vital to improving global health security; however, public education is equally important. Myths and misperceptions regarding infectious diseases have detrimental effects on global health when a disease outbreak occurs. While it may seem that this problem is isolated to remote regions of the developing world, neither infectious diseases nor misconceptions regarding them are explicitly confined to certain areas.

Outbreaks can be highly disruptive to the movement of people and goods, often leading to increased regulations and restrictions on travel and trade to reduce the potential for further spread of disease. The Severe Acute Respiratory Syndrome (SARS) epidemic in 2003 was but one of the numerous examples in which international travel was disrupted. The disease quickly infected thousands of people around the world and disrupted national economies. Due to the rapid transmissibility of SARS, the World Health Organization (WHO) issued a travel advisory in effort to reduce the international public threat. In 2001, the United Kingdom experienced a detrimental hit to the agricultural sector as foot-and-mouth disease spread throughout livestock. Because of the highly transmissible nature of the disease (which affected cattle, pigs, sheep, and goats), the government banned all exports of live animals, meat, and dairy products in an effort to mitigate the spread of the disease and on February 24, mass slaughtering of pigs and cattle began. Later that same year, the tourist industry estimated that businesses lost nearly £250 million ($421 million U.S. dollars).

In the developing world, pneumonia, diarrhea, malaria, measles, and HIV/AIDS are some of the primary causes of death, especially among children. This is in part attributable to socioeconomic factors that prevent people from having access to routine health services and immunizations. Poor nutrition and unsanitary living conditions also place people at-risk. In Africa, the death rate among children from measles, a viral respiratory disease, has reached an average rate of one per minute. Measles weakens the child’s immune system, rendering them susceptible to further fatal complications such as diarrhea, pneumonia, and malnutrition. Yet, in the developed regions of the world, measles is commonly treated through immunizations.

Tetanus, an infection caused by the bacteria Clostridium tetani (which is ubiquitous in the soil), is common in developing areas that continue to practice unsanitary medical techniques during procedures such as child birth, circumcision, and use of contaminated medical bandages during such procedures. While proper sanitary resources are scarce in these regions, it is evident that the lack of supplies is not the only cause of disease transmission as proper sanitation techniques could have mitigated transmission. Due to the lack of education and misinformation regarding public health, sanitation, and the mechanisms of disease transmission, the spread of infectious diseases like tetanus continues.

Developed countries are also susceptible to infectious disease outbreaks despite modern medical advances and technology. Disease outbreaks in developed regions have been due in part to the misconceptions of vaccines and anti-bacterial drugs that have been used to deter the spread of infectious diseases. While some individuals have the perception that antibiotics are a “cure-all” drug, their effectiveness is only on infections caused by bacteria, not viruses. When improperly used (for example- taking when they are not needed, ingesting the wrong type of antibiotic or one that is not of the proper dose), the bacterial cells that survive can result in reinfection or the emergence of an antibiotic-resistant strain of the bacteria. This was evident in the recent reemergence of pertussis, also known as “Whooping Cough,” in the mid-1970s when Great Britain, Sweden and Japan reduced their usage of the pertussis vaccine as there was a common fear of vaccinations. The effect was immediate and drastic- there were over 100,000 cases and 36 deaths in Great Britain, 13,000 cases and 41 deaths in Japan, and 3,200 cases in Sweden. The United States witnessed a similar outbreak in the northwest region of the country in 2012, when over 17,000 cases emerged shortly after an increased rate of vaccine refusals for pertussis. While no vaccine is 100% effective, it is evident that popular misconceptions regarding infectious diseases and their spread can have detrimental repercussions on the populace and need to be addressed head-on.

Education, early detection, and access to are all essential in containing and preventing the spread of disease in a globalized society. Myths and misconceptions have hindered the effectiveness of vaccinations, as individuals have become skeptical of their effectiveness. However, vaccinations can drastically reduce the chances of contracting many diseases. Additionally, developing and utilizing programs that educate the public regarding the implications of infectious diseases and treatments pertaining to them, the spread of disease is likely to be significantly reduced.

Infectious disease outbreaks are a significant threat to global health security and thus have the potential to impact nearly every facet of daily life. Even in an era of medical advancements, increased sanitary practices, and knowledge of microbes, infectious diseases are still prevalent throughout the world. While having better medical practices and medicines available is beneficial in combating the transmission of infectious diseases, there is no substitute for better public health education.

U.S. National Library of Medicine. “Severe Acute Respiratory Syndrome (SARS).” Last Modified Jan. 28, 2013. Accessed March 20, 2014. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004460/

Eco Health  Alliance. “7 Common Myths About Pandemics and New Diseases.” Last modified June 27, 2013. Accessed on March 19, 2014. http://www.ecohealthalliance.org/blog/99-7_common_myths_about_pandemics_and_new_diseases

BBC. “Foot-and-Mouth Crisis Remembered.” Last modified February 17, 2011. Accessed on May 13, 2014. http://www.bbc.com/news/uk-england-12483017

UNICEF. “Immunization: Why Children Are Dying.” Accessed on March 19, 2014. http://www.unicef.org/immunization/index_why.html

Medical News Today. “What is Tetanus? What Causes Tetanus?” Last modified Sept. 4, 2009. Accessed on March 19, 2014. http://www.medicalnewstoday.com/articles/163063.php

Mayo Clinic. “Antibiotics: Misuse Puts You and Others at Greater Risk.” Last  Modified 2014. Accessed March 20, 2014. http://www.mayoclinic.org/healthy-living/consumer-health/in-depth/antibiotics/art-20045720

Koo, Ingrid. About.com, “The Truth About Antibiotics.” 6 Nov. 2008. 6 Apr. 2014. http://infectiousdiseases.about.com/od/treatment/a/antibiotic_myth.htm

Center for Disease Control. “Some Common Misconceptions About Vaccination and How to Respond to Them.” Last modified Feb. 18, 2011. Accessed on March 19, 2014. http://www.cdc.gov/vaccines/vac-gen/6mishome.htm

Forbes. “Anti-Vaccine Movement Causes The Worst Whooping Cough Epidemic in 70 Years.” Last Modified July 23, 2012. Accessed on March 19, 2014. http://www.forbes.com/sites/stevensalzberg/2012/07/23/anti-vaccine-movement-causes-the-worst-whooping-cough-epidemic-in-70-years/

Mayo Clinic. “Infectious Diseases.” Last modified    Jan. 23, 2013. Accessed on May 23, 2014. http://www.mayoclinic.org/diseases-conditions/infectious-diseases/basics/prevention/con-20033534

Brittany Linkous is a graduate of King University with a double major in Cellular and Molecular Biology and Political Science and History, and a minor in Security and Intelligence Studies. While at King, she served as Executive Officer of the King Security and Intelligence Studies Group and Executive Editor of the Security and Intelligence Studies Journal. She also interned in Washington, DC, at the William J. Perry Center for Hemispheric Defense Studies at the National Defense University, and the Federation of American Scientists. In the fall of 2014, Brittany will be entering the Biodefense Program at George Mason University.

Examining Global Biosecurity Engagement Programs

Global biosecurity engagement programs are designed to prevent the harmful use of biological agents and pathogens. It is difficult to measure the effectiveness of these programs in improving biosecurity given that there have been relatively few attempts to misuse the life sciences. Metrics that focus on outputs (what was done) as opposed to outcomes (the impact of what was done) have not been helpful in determining how these efforts might be improved in the future. As a result, the goals of the programs have traditionally been more quantitative in nature – for example, increasing the number of agents secured and number of scientists engaged. Broadening the scope of biosecurity engagement metrics can help align program goals with a more qualitative approach that prioritizes the international partners’ global health security.

To understand how biosecurity engagement is conducted and evaluated, Michelle Rozo, Ph.D. candidate at Johns Hopkins University, interviewed more than 35 individuals in the United States and abroad (including government officials and their non-governmental partners) regarding current and future programs that can be used to create a cohesive, global health system approach to biosecurity. The results from the interviews are complied in an issue brief which also provides a strategy for policymakers to focus more on qualitative public health outcomes instead of quantitative security outputs. With this strategy, programs will cost less and be more effective in reducing global threats.

View Full Brief

New Bioethics Council to Advise the White House

It was reported this week that the Presidents Council on Bioethics was disbanded. The Council, appointed by the Bush Administration, was often accused of taking a more ideological than scientific perspective in its reports and advice. In its place, President Obama will convene a new bioethics commission.

Science Magazine Biodefense News – Army Bans Pathogen Work

Today Science Magazine is reporting that the Army has banned all pathogen research at one of its labs at the Armed Forced Institute of Pathology (AFIP) in Washington, DC. This decision was made December 2, 2008 as a result of an earlier failed Biological Surety Inspection, and not made public.

Science reports that “officials found that lab managers ignored information about certain employees that could have disqualified them from having access to dangerous pathogens. The redacted version of the IG’s [Inspector General’s] report released to Science does not divulge the nature of this so-called potentially disqualifying information, but it could be anything from alcoholism to mental instability.”

On October 28, 2008 AR 50-1 came into effect, stipulating a strict Biological Personnel Reliability Program for DOD employees as part of their Biological Surety Program. It includes and intense background investigation and interviews  of employees as well as regulations regarding substance abuse and mental health.

In early February the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) also suspended its research on biological select agents and toxins when it was realized that there were problems with the system of accounting for high risk microbes and biological materials in the laboratories at Fort Detrick, MD.

HHS, DHS and CDC Webcast on Swine Flu

Today at 1pm EST HHS secretary Kathleen Sebelius, DHS Secretary Janet Napolitano and acting Director of the CDC Richard Besser will be webcast answering questions about Swine Flu from the American people.  The webcast will be available at www.hhs.gov and questions can be emailed to hhsstudio@hhs.gov.

The World Health Oraganization has now raised the Pandemic Alert Level to Phase 5 meaning that they believe there is a “strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.” There currently have been 109 confirmed cases of Swine Flu in the US and one death. Continually updated information on the situation and statistics as well as fact sheets and interim guidance documents can be found on the CDC Swine Flu page at www.cdc.gov/swineflu.

Researchers Worldwide Rally to Help Scientist Exposed to Ebola

SciecneInsider has the details surrounding an Ebola researcher who pricked her finger with a needle during an experiment last week. Virologists around the world are collaborating to try to save their colleagues life. An exposure to Ebola from a needle stick does not often lead to infection with the deadly illness, but a group of scientists immediately got together to discuss a long list of experimental vaccines and treatments that could possibly prevent infection or slow progression of the disease. As a result, the exposed researcher was given a vaccine that has previously been shown to provide protection in monkeys who had been exposed to Ebola. The incubation period of Ebola is typically between 4 and 21 days, and it has only been 6 days since the needle stick incident. Thus far there is no indication that the researcher has contracted an Ebola infection, but virologists are anxiously following her case.

Briefing on Oversight of High-Containment Laboratories

On March 12 AAAS in partnership with the Center for Biosecurity of UPMC hosted a public briefing to discuss the current oversight of high-containment laboratories. The session was held to discuss the elements of H.R. 1225, the recently introduced Select Agent Program and Biosafety Improvement Act of 2009. This bill seeks to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories.
Michael Ehret from the Midwest Research Institute, a private laboratory, Michael St. Clair, from Ohio State University an academic laboratory, and Michael Pentella from the University of Iowa, a public health laboratory discussed the regulatory procedures associated with the operation of each of their facilities. Each spoke about the different agencies and number of inspections or audits that they face each year, the costs of these audits and staff training as well as additional personnel reliability programs in place at their institutions.
All three speakers expressed concern about the number of agencies, each with a unique set of regulations, responsible for oversight of their facilities and suggested that a harmonized approach to regulation was necessary. Each of the represented laboratories also had internal oversight committees to ensure a high level of safety and security.

President Obama Overturns Bush Stem Cell Ban

During a ceremony at the White House today, President Obama signed an Executive Order to overturn President Bush’s 2001 restrictions on using federal funds for research on embryonic stem cells. The Executive Order is focused on stem cell research, but it signals a desire by the Obama Administration to return scientific integrity to its policy decisions. Accompanying the Executive Order will also be a Presidential Memorandum to ensure that the government’s scientific decisions are insulated from political influence. This is a welcome change after 8 years of the Bush Administration ignoring or distorting science to further its political agenda.

Over 30 Nations can deploy biological weapons

Yesterday Interfax news agency reported that experts estimate that over 30 nations have the capability to rapidly deploy biological weapons. The remarks were made by Natalya Kaverina of the Russian Academy of Sciences’ Institute of Global Economy and International Relations during a presentation for the Stockholm International Peace Research Institute on March 3. Kaverina suggested that the tempation to use such weapons had inreased due to global instability and economic uncertainty.

Plague Infected Mice Missing from UMDNJ Lab

This weekend it was reported that 2 mice infected with Yersinia pestis, the causitive agent of plague, were missing from a lab at the University of Medicine and Dentistry of New Jersey (UMDNJ). In September 2005 it was also reported that 3 live mice infected with Y. pestis were missing from UMDNJ a lab. In this case however, the “missing mice” are actually the carcasses of mice who died during an experiment, were bagged and placed in a freezer for storage until the experiment was completed and they could be incinerated. It is believed that the missing bag of mice was accidentally sterilized along with another bag.

In both cases the FBI investigated and determined that there was no public health risk.