Newsweek Article Does Not Pertain to NEIDL
Newsweek recently published an article that raises concerns about biosafety laboratories. The article did not mention the NEIDL, but we have nonetheless received a number of questions about whether the article and the concerns it raised have any relevance to the BU biosafety lab. The short answer to that question is: not in the least. We cannot speak to Newsweek’s accuracy as it relates to other labs and events which are front and center in its article, such as incidents which took place in Russia forty years ago. But we do know that any comparison to the NEIDL is false, and that the BU lab represents a safe, regulated, transparent, and best-in-class example of how to plan, build and operate a biosafety facility that is dedicated to finding cures for emerging infectious diseases. To that end, we want to share just a few points of difference between what Newsweek claims and the reality here in Boston.
Newsweek: The primary focus of this article is Project BioShield, a federal government program established in the aftermath of 9/11 to fund the development and stockpiling of drugs that would counter the effects of an attack on the US using chemical, biological, nuclear or radiological agents.
Fact: Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL) BSL-4 facility has nothing to do with Project BioShield. The NEIDL is joining a network of 10 other biocontainment facilities located around the country that will safely identify new ways to diagnose, treat and cure emerging infectious diseases.
Newsweek: By using two examples of Russian military experiments purportedly gone wrong from the 1970s, the article would have the reader fear that “there are hundreds of laboratories across the country working on the exact same type of bioweapons research.” It also states that in weaponizing these pathogens, researchers are devising “a delivery system that infects as many initial hosts as possible, and mutates the agent so it spreads from person to person even more quickly than nature intended.”
Fact: It is illegal to develop weapons of mass destruction. The NEIDL will neither weaponize BSL-4 organisms nor will it conduct classified research on them. In addition, the NEIDL is not researching fast-acting delivery systems for bioweapons but rather is finding cures for diseases through the development of vaccines, diagnostics, and therapeutics to treat people who are infected with these agents, or who are at risk of infection.
Newsweek: The article would have the reader believe that “there are no national standards” governing the safety of the labs.
Fact: This is incorrect. To cite three national standards: Boston University followed the National Institutes of Health (NIH) federal guidelines for the design and construction of its lab. The Department of Justice (DOJ) mandates background checks on any scientist working with Select Agents. The Centers for Disease Control and Prevention (CDC) is the primary regulatory body for all BSL-3 and BSL-4 labs dealing with Select Agents. It is also in charge of the inspection process for these labs, conducting regular and spot inspections of labs and inventory. All persons working at the NEIDL must undergo a background clearance process which includes criminal background checks, an academic credential check, license and credential check, and past employment check. In addition to the initial background checks, persons working with Select Agents will also undergo a Department of Justice clearance process, including a fingerprint-based background check conducted by the FBI. Furthermore, people who work with select agents must register with the CDC.
Boston University also follows the regulations of other international, federal, state, and local authorities including the Department of Transportation, CDC, International Air Transportation Authority, and World Health Organization on the transportation of select agents.
Newsweek: A critic cited in the article says many institutional biosafety committees (IBCs) “exist on paper only.”
Fact: That assertion is simply not true at Boston University. Boston University has a robust and active Institutional Biosafety Committee that is responsible for approval of research projects. It is comprised of BU faculty and investigators with expertise in areas such as microbiology, hospital epidemiology, biological and laboratory safety, along with Environmental Health and Safety specialists and community representatives. The IBC meets monthly to review research applications. The IBC does its work in compliance with the regulations of federal, state and local government agencies. Members of the public can follow the work through the minutes of its meetings on the NEIDL website.
BU has also established a NEIDL Community Liaison Committee (CLC) to promote public participation and transparency. The nine members of the CLC, who are members of the public and unaffiliated with Boston University, play a critical role in facilitating communication and information flow between the NEIDL and the community. They too are part of the process, ensuring that any and all BSL-4 research will be publicly discussed and vetted before it can proceed. Anyone interested in its work can find minutes of the CLC’s monthly meetings on the NEIDL website.
Newsweek: The article attempts to cast doubt on the shipping of Select Agents, even suggesting some can be shipped in the mail.
Fact: Boston University follows the regulations of international, federal, state, and local authorities on the transportation of Select Agents and in some areas has gone beyond the regulations to ensure pathogens are safely shipped to and from the lab. The transportation of Select Agents is governed by a number of regulations and agencies.
The general requirements are issued by the US Department of Transportation, which sets down strict requirements for packaging, labeling, and documentation of the materials, and requires training for employees involved in shipping. All transportation will involve Department of Transportation (DOT) compliant triple packaging and will be placed in a non-crushable, liquid-tight, solid container for an added layer of safety. These packages will be transported via exclusive-use vehicles and will be secured in the transport vehicle away from potential impact on outer walls. In addition, shippers will adhere to pre-determined travel routes and strictly defined schedules for pick-ups and deliveries, and both package and vehicle will be monitored by BU and local emergency responders using GPS.
The CDC also plays a critical role in regulating the shipment of Select Agents. Qualified carriers must meet all federal, state and local regulations to transport these materials. There will be notification to the Boston Public Health Commission, Boston Police and Fire Departments, and Boston Emergency Medical Services in advance of shipments and GPS monitoring of the vehicle and package. The transportation of BSL-4 organisms is tightly controlled, and BU has worked closely with city, state, and federal authorities to ensure that our transportation plan complies with all regulations. The transportation plan, in fact, was developed largely to address public concern over routes, monitoring and packaging. Boston University’s transportation plan significantly exceeds requirements and standards in place.
Newsweek: This same critic says, “No one is doing due diligence on any of the labs so we don’t really know if they’re well run.”
Fact: Not so. From oversight at the federal, state, and local level, to the public’s access to information about research through the lab’s website, there are many eyes on the NEIDL. The Boston Public Health Commission (BPHC) is the primary regulatory agency at the local level and reviews all BSL-3 and BSL-4 work. BU is required under BPHC regulations to file an application for each proposed BSL-3 and BSL-4 project. BPHC approval requires a satisfactory review of all 22 sections of the permit application followed by Institutional Biosafety Committee (IBC) approval and confirmation that the IBC approval addressed safety issues, space, and procedures of concern to the BPHC. Additionally, the BPHC will inspect the space and equipment and may require a review of work practices or project specific standard operating procedures. BPHC oversight also includes strict reporting requirements for notification on incidents, submission of an annual report, requirements for city emergency response training and involvement in drills and exercises, and reserves the right to perform unannounced inspections and to stop work if BPHC deems it necessary.
At the federal level, government regulators include NIH, DOJ, and CDC. A team from the Department of Homeland Security has conducted an onsite NEIDL security assessment to review the lab’s security plan and operations, including our infrastructure, public safety personnel, and technology.
At the state level, the Massachusetts Departments of Environmental Protection, Public Health, and Public Safety have oversight or responsibilities related to the safe operations of the NEIDL as does the Massachusetts Water Resources Authority and the Massachusetts Emergency Management Agency. Clearly, the work at the NEIDL remains heavily regulated and scrutinized.
Newsweek: Newsweek suggests, “There’s a clash of ideas between scientists and regulators, and that when it comes down to it, the lab’s scientific goals prevail—even if it means putting lives on the line.”
Fact: No scientist working in Boston University’s labs has the discretion to put aside requirements established by the myriad federal, state, and local agencies overseeing the lab. The bottom line is, if a regulator says to stop or do something differently, all researchers must do so. In fact, at the NEIDL there is a daily meeting of Emergency Health Services, facilities, security, and administrative representatives to review the protocols and spaces, and any one of these individuals has veto rights over the use of the space.
Newsweek: The article states that it is difficult to guarantee or even assess safety within biosafety labs in the United States and that those safeguards that do exist are minimal.
Fact: BU’s lab meets and by many measures exceeds existing safety standards. From its design, to its construction and plans for operation, comprehensive biosafety and biosecurity safeguards are in place. And safety does not rely solely on armed guards 24/7. Outside the building is a hardened perimeter and controlled access points, while inside the facility sophisticated biometrics limit access. Inside the building are primary and secondary back-up systems for all critical equipment and redundancy in decontamination and filtration systems. Laboratory space is configured for working safely from air circulation to staff circulation reinforcing the use of personal protective equipment. These are just a few of the state-of-the-art tools incorporated into the NEIDL to address strict access control to only those people authorized to be in specific spaces so that work is performed as safely as possible. In addition, Boston University in general and the NEIDL in particular embrace a culture of safety in which each person is responsible to ensure the safety of our researchers and our neighbors.
Newsweek: The article suggests through an account of an incident in Russia 43 years ago that smallpox research today “lives on in research labs.” The article creates the impression that labs are experimenting or have in their possession substantial quantities of pathogens such as smallpox and that these pathogens can easily be dispersed.
Fact: It is illegal to conduct smallpox research in the US with the exception of the CDC lab in Atlanta. The NEIDL will not be studying smallpox. Indeed it cannot. In the case of other Select Agents, the NEIDL will only be in possession of minute quantities of pathogens. The transmissibility of this quantity is extremely slight, as BSL-4 organisms can only be transmitted by contact. To “catch” these diseases, a person normally has to be exposed to the bodily fluids of a patient who is in a later stage of the disease.
Newsweek: The article states that due to a “lack of counting and registration standards,” there is no accurate estimate of the number of biosafety labs in the United States.
Fact: The Boston Public Health Commission and Boston Fire Department strictly regulate the number and registration of all biosafety labs within the city of Boston. As of 2006, anyone operating or planning to operate a BSL-3 or BSL-4 lab in the City of Boston is required to apply for and receive a permit to operate from the BPHC. This process includes submitting detailed documentation including but not limited to risk management plans, transportation and waste plans, decontamination plans, and chemical hygiene plans. These lab plans must then undergo a number of reviews in addition to the BPHC’s, including a review by Boston Inspectional Services. Labs must also be physically inspected in order to receive a permit and are subject to inspection at any time. Once they receive a permit, all BSL-3 and BSL-4 research to be undertaken must again be approved by the BPHC. In addition to BSL-3 and BSL-4 labs, the Boston Fire Department oversees registration for all research labs in general. Exhaustive documentation ensures the BPHC and Boston Fire Department constantly have a clear count of labs within city limits. Currently there are nine laboratories working at BSL-3 in Boston operated by five different institutions. The sole BSL-4 facility would be the NEIDL.
Newsweek: The article would suggest that there have been any number of incidents or accidents involving BSL-4 pathogens being exposed to the community.
Fact: This claim is completely false. Currently, there are 10 BSL-4 facilities in operation in the United States. With over 100 years of cumulative operation and hundreds of thousands of man-hours of research, there has never been any laboratory-acquired infection or community infection by such organisms.
Newsweek: The article suggests the government has little knowledge of what occurs in the nation’s biosafety labs and that much of the labs’ operation remains hidden from both regulators and the public.
Fact: At the NEIDL, all information regarding research proposals and grants is public information available to anyone who wishes to view it. In addition, the NEIDL is regulated by the CDC and Boston Public Health Commission, ensuring widespread knowledge of the operations occurring within the lab. The NEIDL must operate under the BPHC’s strict standard operating procedures and is subject to spot inspections. The lab is also required to report any issues or problems that occur during the course of work, whether accidents in the lab or small maintenance glitches, with all reports involving real or potential exposures posted publicly on the NEIDL website.
Newsweek: In citing an example from 2008 in which a bird hit a power transformer knocking out power to the CDC’s Emerging Infectious Diseases Laboratory in Atlanta, the article suggests that power failures are unpreventable and can easily allow viral agents to spread.
Fact: Such an accident would not knock the BSL-4 lab in Boston offline. If the lab were to lose the primary line delivering electrical power, secondary lines are there for backup. Another level of redundancy consists of two generators in place if the secondary line were to fail, either one of which is sufficient to operate the building at full load. Fuel for these generators is stored on-site providing power for normal building operations for more than two days, and much longer if non-essential systems are shut down, allowing for extended operations of critical systems. The NEIDL also provides redundancy in all critical safety and utility systems such as steam, decontamination, and fire suppression.
When you look at the facts, then, it is clear that the Newsweek story has nothing to do with Boston University’s NEIDL and our research to find cures for emerging infectious diseases. Beyond that, however, it is also worth noting that the Newsweek story contains a number of general inaccuracies which should be considered in assessing the article’s impact and credibility. Here are just a few notes of our own.
1. Newsweek says that what became known as the “biological Chernobyl” should have taught the world a lesson. But in the United States today, there are hundreds of laboratories sprinkled across the country working on the exact same type of bioweapon research…”
This statement is blatantly false. In November of 1969, President Nixon ordered the United States to unilaterally discontinue its biological weapons program. In 1975, the Biological Weapons Convention also prohibited development of biological weapons. For decades, then, it has been illegal to work on biological weapons development. See http://www.presidency.ucsb.edu/ws/?pid=2343
2. Newsweek claims that, in great secrecy, the United States has spent billions on the Project BioShield Act… Despite these good intentions, Newsweek says, the program may have put the nation at greater risk of a homegrown disease escaping from a lab and quickly infecting millions.
The Project BioShield Act was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the act was to stockpile and distribute vaccines that had not been tested for safety or efficacy in humans, due to ethical concerns. In September of 2012, the Biomedical Advanced Research and Development Authority (BARDA) reported the stockpiling of the following:
- 107,000 doses of antitoxin for Clostridium botulinum
- 57,102 doses of monoclonal antibody raxibacumab—treats anthrax
- 10,000 doses of anthrax immune globulin
- 28.75 million doses of anthrax vaccine BioThrax
- 107,560 doses of Botulinum antitoxin.
Clearly, then, the release of vaccines and other countermeasures is of absolutely no risk to the public.
For a link to the BARDA reports, see https://www.medicalcountermeasures.gov/barda/cbrn/project-bioshield-overview/project-bioshield-annual-report.aspx
3. Newsweek says that in order to speed up its acquisition of rare drugs, BioShield has set up what amounts to an FDA fast-track review process resulting in shortcuts being taken. The article implies that these labs are taking unnecessary and unsafe risks and putting untested drugs in the hands of consumers.
Contrary to Newsweek’s implications, emergency countermeasures are subject to the same regulations by the FDA as other drugs and vaccines approved in the United States. In addition, drugs and vaccines developed under BioShield have not used this “fast track” process. In terms of shortcuts, in times of emergency, and with no approved alternatives available, Congress has granted the FDA the power to authorize the use of an unapproved drug or use of approved products in new ways to prevent serious or life-threatening conditions. Even in these cases, however, there must be scientific evidence of the drug’s efficacy (which may come from animal studies in extreme circumstances as allowed in the Animal Efficacy Rule) and proof that potential benefits outweigh potential risks. Even with an emergency use authorization, the instances when a drug or product can be used are clearly specified and regulated. Therefore, untested drugs are never put in consumers’ hands—rather, those that have yet to gain approval may be used in extreme emergency circumstances. Furthermore, there is no “shortcut”—the Animal Efficacy Rule covers development of vaccines and therapeutics where traditional clinical evaluation protocols would violate ethical standards. Since these countermeasures would only be used in case of an emergency, the normal rules of marketplace corrections simply do not apply.
4. Newsweek claims that the BioShield Act may have undermined some of the essential protections against labs leaking deadly biological agents into the environment.
There is no evidence to support the notion that deadly biological agents have been “leaked” into the environment—to the contrary: the regulations for the study of these biological agents fall under the Select Agent Rules. It is a federal crime to release these agents from any laboratory—period. (See 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) published in the Federal Register on October 05, 2012.
5. Newsweek says that “along with funding the cures, the HHS (Department of Health and Human Services) is also funding the creation of new bio-weapons, to be used to preemptively develop cures and vaccines for diseases that might break out.”
This is pure fiction and conspiracy theory. HHS cannot fund the development of new bio-weapons because it is illegal to do so. In fact, over the last decade, there is a new emerging infectious disease that appears every 12–18 months. These diseases are naturally occurring events mostly due to spillover of animal pathogens to humans—not lab-created weapons as the article suggests.
6. Newsweek states that “researchers must know how to create a weaponized virus, devise a delivery system that infects as many initial hosts as possible, and mutate the agent so it spreads from person to person even more quickly than nature intended.
The specter of creating new killer viruses has been raised continuously, and research that touches on these areas is now carefully reviewed under “dual use research of concern” policies of institutions. An early and frightening example of modifying viruses was stumbled upon accidently by a group of Australian scientists (see http://www.newscientist.com/article/dn311-killer-mousepox-virus-raises-bioterror-fears.html#.UytZrF7Q_FI for a report on this). This report generated much discussion among scientists, and to our knowledge has not been repeated.
More recently, “gain of function” experiments have been used to try to understand what types of mutations would be required for avian influenza viruses to allow person-to-person spread. Gain of function experiments introduce or enhance a gene product with the intent to increase the transmissibility or impact of pathogens. Understandably, these experiments again generated significant discourse in the scientific community and, in addition to institutional review of such experiments before they can begin, now also require special oversight and approval at the federal level before they can be funded. See http://osp.od.nih.gov/sites/default/files/resources/HHS%20H5N1%20Framework%20-%20Final%202-21-2013.pdf
However, it is essential to recognize that this “evolution” occurs all the time in nature. This process can impact how emerging infectious diseases can spread between humans, and influence the severity of disease.
7. Newsweek blatantly questions the ethics of biodefense and what they call “dual-use” (the premise that in order to create a drug or vaccine the researcher must use the bacteria or viruses that cause the illness in question.)
The idea of “dual-use” is not unique to biodefense research. In fact, every drug and vaccine—from those used to treat HIV to everyday antibiotics—is developed using bacteria or viruses that cause the illness. These same techniques that are used for antibiotic development are used to develop vaccines for emergency use. In addition, Boston University has led the nation in the “dual use” debate and has been a leader in instructing researchers in their consideration of “dual use”. All IBC protocols that may have the potential for dual use are sent to a special subcommittee for review before approval/disapproval.
As an FYI, if you Google “DURC”, the top hit remains Boston University’s policy. http://www.bu.edu/orc/initiatives/durc/