Apr
17

BioError, BioTerror Update

The following excerpt is from our first book, Unready, published in 2010. The format of the text was based on a discussion of Myths and Realities regarding the state of Healthcare Emergency Readiness. Many of the issues have yet to be addressed and it could be argued that the situation is even more dangerous. This is discussed in the 2014 Update Section below.

“Myth: U.S. hospitals are prepared for bioterrorism.

Reality: Three years and billions spent on federal initiatives to prepare for pandemic flu had a limited impact on the nation’s readiness to deal with H1N1 (novel flu) pandemic. The disease had spread from Central Mexico to the United States before it was identified and effective cross-border defensive/protective measures came into play. Lack of robust border security and a weak surveillance tracking system made for a chaotic response. Results from two hospital surveys which coincided with the first wave notification of the novel flu found that almost 200 surveyed hospitals did not have written pandemic flu response plans. Reports of the limited availability of personal protective equipment, protective masks, and other required supplies filled daily media accounts.

Bio Hazard

Availability of medical countermeasures, medications and the severe shortage of mechanical ventilators to treat advanced cases of the disease created a need for public guidance in the use of scarce medical supplies and equipment. Early H1N1 cases among caregivers threatened the surge capabilities of health care organizations.

Morbidity and mortality reports identified age-related cohorts at increased risk. Certain prison populations are among these groups (because) commonly accepted methods for prevention and control of endemic and pandemic diseases are difficult to implement within incarceration environments. Social distancing, limited isolation capacity, restrictions on items which may be introduced into the system, and a poor compliance place the group at high risk. High levels of chronic health care conditions, HIV, TB, etc., will increase the need for advanced treatment in these locations. Local hospitals that have prison contract agreements, emergency care beyond the capability of prison health care facilities, and all-hazards arrangements to support these populations during health related disasters are realistic planning concerns for all health care organizations.

Another unidentified group at high risk – infants and children – poses its own set of challenges. General acute hospitals do not serve large pediatric populations and have limited capacity for expansion of care to this group. Community-based facilities have limited supplies of critical resources, such as pharmaceuticals in pediatric doses and appropriately sized equipment, e.g., mechanical ventilators and other respiratory equipment (Ambu Mask). Too often, planners forget that kids are not miniature adults.

Pandemic

Federal guidance for “priority care and later priority vaccine recipients” from limited supplies were of great concern for authorities and made for some strange decision making; a case in point, parents asking authorities why the local prison received their H1N1 vaccines before the local school system.

The H1N1 second wave caught the nation flat-footed, unprepared for that event. Many have been highly critical of today’s response to a known biological threat and an obvious breakdown in our ability to cope with and account for infectious events as they transpire. Serious problems with the reliability of available tests and false-positive findings are disruptive and lead to waste of limited resources; while false-negative findings place whole populations at risk.

The consequences of failure to recognize and measure the extent of H1N1 pandemic does not bode well for the future and has eroded public confidence in the system.

H1N1 versus bioterrorism. The new report from the 2009 WMD Commission Grant/Talent Report surfaces new concerns over old threats, bioterrorism. They posit – “that the national attention to preparedness for bioterrorism has lost its vigor.”

We have expressed our concern with the national movement away from bioterrorism preparedness to pandemic flu. The opportunity lost to achieve the dual benefits of being prepared for bioterrorism and create a solid defense against evolving infectious diseases is incalculable. The news release, Chicago, March 13, 2003, by the American College of Health Care Executives (ACHE), “Hospital CEOs say bioterrorism plans are in place,” may have been premature.

RiskBiological hazards for hospitals come from a number of sources. We have discussed the self-inflicted category in our discussion of hospital-acquired infections (HAI). Endemic and pandemic infections may penetrate hospitals’ defenses from the local community. Unexpected biological agents introduced intentionally or by accident (bioterror/error) into the environment are fraught with unimagined consequences. Some speculate that the greatest national biological danger comes from the unbridled proliferation of bio laboratories across the country. There are an estimated 15,000 individuals working with these deadly agents. Proper vetting of these employees is an administrative challenge, and there is a fear that the potential gaps in disciplined background checks could result in serious “insider threats.” Hospital authorities must recognize the threat posed by these activities in their vicinities and develop a means to identify and respond to agent-specific events. The next bio-threat is one which is intentionally introduced into the hospital environment. Terrorists may well take advantage of endemic and pandemic events to introduce a different agent into the mix.”

2014 Bio-Error/Bio-Terror Update

In a scathing report in 2009, GAO-09-1036T, found that there was a serious lack of oversight in the biological testing laboratories that proliferated in the wake of the Anthrax terror event in 2001. Among the findings:

  • “Because no federal agency has the mission to track the expansion of BSL-3 and BSL-4 laboratories in the United States, no federal agency knows how many such laboratories exist in the United States. While there is a consensus among federal agency officials and experts that some degree of risk is always associated with high-containment laboratories, no one agency is responsible for determining, or able to determine, the aggregate or cumulative risks associated with the expansion of these high-containment laboratories.”
  • “Four highly publicized incidents in high-containment laboratories, as well as evidence in the scientific literature, demonstrate that:

(1) While laboratory accidents are rare, they do occur, primarily because of human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures;

(2) Insiders can pose a risk; and

(3) It is difficult to control inventories of biological agents with currently available technologies. It has been suggested that personnel reliability programs would mitigate the insider risk. The National Science Advisory Board for Biosecurity reported that there is little evidence that personnel reliability measures are effective or have predictive value in identifying individuals who may pose an insider risk.

(4) Continuity of electrical power is vital for the safe functioning of high-containment laboratories; in particular since maintenance of essential pressure differentials using electrically driven fans provides an important barrier for preventing the uncontrolled release of agents. 65 Lapses in electrical power that occurred at a CDC laboratory raise concerns about standards in high-containment laboratory facility design, management of construction, and operations.”

ebolavirus

Despite the report, very little was done to address the safety concerns, and in 2011 there were public protests in Boston by concerned citizens, as reported by ABC News.

The GAO released a second report, GAO-13-844R, again raising a red flag in February 2013, expressing concern that none of the recommendations in the original report had been acted upon, and the number of unregulated labs had increased significantly during the interim. This finally got the attention of the Department of Homeland Security in a news story in April of 2013.

Why this Matters Now More than Ever

We are in an increasingly dangerous environment due to several factors:

  • Profiteers in the national drug distribution system have created a Grey Market based on “purchasing” drugs (without physically taking possession) and reselling them several times, in some cases driving the price up 8,000% between factory and end user organization, and creating false shortages in supply. This in combination with having a large percentage of medicines, including basic vaccines, manufactured offshore (China) puts the nation in a strategically weak position to ensure availability, authenticity, and quality of imported drugs. Theft within the distribution channel has also increased dramatically, particularly among the opioids, which have helped drive an epidemic of addiction to Oxycontin and Oxycodone; which is in turn part of a larger, broad-based heroin explosion across the country.

Recent Large-Scale Bio Events

SARS: This week over 2,000 vials of the deadly SARS virus disappeared from the Pasteur Institute Laboratory in France.

EBOLA: There was an Ebola Outbreak in West Africa that appears to have been caused by a new strain of the disease; it has killed over 100 in Guinea and Liberia.

EBOLA

AVIAN FLU: Japanese Self Defense forces were enlisted to cull over 100,000 chickens on  Tuesday after a hundred birds died last weekend.

MERS: We predicted that the pilgrims coming into Saudi Arabia and then returning to their home countries by air would be a vector for the disease.   This seems to be the case for at least one death in Malaysia, as reported by the Wall Street Journal.

TB and Diabetes Comorbidity: According to the World Health Organization website: “Along the US-Mexico border, the incidence of TB is 7.9 per 100,000 population in US border states and 26.3 per 100,000 population in Mexican border states, both of which are higher than the national averages in the US and Mexico, respectively. Diabetes is a major problem along the US-Mexico border. In 2003, diabetes was the third leading cause of death on the Mexican side of the border and the sixth on the US side. Recent prevalence estimates indicate that approximately 16% of the people living along the border have diabetes, and another 14% of adults on the US side have pre-diabetes. Recent evidence found that TB-diabetes comorbidity exceeded that of comorbidity with HIV/AIDS”.

Location of Biolabs: Some major Bio-containment and Biosecurity Level-3 (BSL-3) and Biosecurity Level-4 (BSL-4) labs are in dangerous locations. For example, prior to Hurricane Katrina, Tulane National Primate Research Center had over 5,000 monkeys and apes in a cluster of BSL-3 facilities; mostly in outdoor cages. As evidenced by the exploding population of Burmese Pythons in the Everglades, animals have a way of escaping when the buildings are destroyed in a hurricane.

Ike surges

Galveston Texas houses a BSL-4 facility, one of the two National Laboratories, and serves as the Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases. Galveston is also the location of the deadliest weather disaster in United States history, the Hurricane of 1900 that took between 6,000 and 12,000 lives, with 12-foot low-tide surges flooding 6–10 miles inland. Since 1983 Galveston has suffered three billion-dollar hurricanes, Alicia in 1983 with $2B, Allison in 2001 with $5B, and Hurricane Ike in 2008 with $29.5B in US damage. The UT labs have been completely devastated due to flooding several times. It would be hard to choose a more dangerous location.

Hospitals and other providers responsible for offering care in a biological event should have minimum levels of information about what specific bio agents “select agents” are being studied in the area in order to provide an earlier diagnosis if a patient presents with flu-like or agent-specific symptoms.

We realize this post seems very pessimistic. Our objective is only to draw attention to what appears to be an increasing and unchecked threat from biological events, the danger posed by accidental exposure in an unregulated environment or intentional public release from an insider who should not have access to these materials is truly a cause for concern. At a minimum, the Federal government needs to get serious about the thousands of unregulated labs.