Dark vision: Medical countermeasures against the next wave of bioterror
Stakeholders gather to thwart the unthinkable
Five years after 9/11 and the anthrax attacks that followed, stakeholders in public health, medicine, and private industry are forging a partnership that anticipates the next generation of deadly challenges to the nation's biodefense. A draft of a strategic medical countermeasures planning document under stakeholder review warns that "ongoing advances in biotechnology are believed to enable the engineering of novel organisms that could be targeted to completely bypass our countermeasures and might even be mistaken as naturally occurring emerging agents."
The draft document — Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats — outlines the future implementation of the nation's defense plan, Project BioShield.1 It was discussed at a first-of-its-kind stakeholder's workshop recently in Washington, DC.
"Advanced agents are genetically modified so that they are deliberately designed to evade our existing countermeasures," said Rajeev Venkayya, MD, special assistant to the president for biodefense and a member of the Homeland Security Council. "These are next-generation threats. While these may have seemed way off in the distance in the 1990s, one need only look at the rapidly accelerating pace of the biotechnology revolution to realize that it won't be long [until this is possible]. In the average moderately equipped lab, an individual who has average brightness might be able to produce an advanced biological agent. The threat that we believe we need to be prepared for in the long term is a novel agent that is communicable against which we do not have a countermeasure."
In addition to advanced agents, biodefense planners are looking at three other categories of agents:
- Traditional: Naturally occurring microorganisms or toxin products with the potential to be weaponized and disseminated to cause mass casualties (e.g., anthrax, smallpox, etc.).
- Enhanced: Traditional agents that have been modified or selected to circumvent current countermeasures. For example, an enhanced agent could be a bacterial pathogen that is modified to confer resistance to an antibiotic.
- Emerging: Naturally occurring organisms that are newly recognized or anticipated to present a public health threat. Recent examples of emerging agents include severe acute respiratory syndrome (SARS) and West Nile Virus.
'Low-hanging fruit'
"The large body of our efforts to date have focused on the traditional and the enhanced agents, and appropriately so," Venkayya said. "These are the low-hanging fruit of our medical countermeasure enterprise. These are the very real and present dangers that we need to develop a strategy and stockpiles to address now. As we go forward though, we know we are going to face the emerging threats [and advanced agents]. We need to think of the emerging and advanced categories differently. We need to integrate discovery and development efforts. We need to establish a favorable environment for developing new platform technologies for countermeasures and diagnostic purposes."
For example, there are new microchip-based technologies that could allow investigators to quickly identify a novel agent and rapidly develop candidate countermeasures, he said. Such technologies are being fast-tracked through regulatory oversight, with $160 million earmarked in the current fiscal year for advanced development of novel countermeasures.
Nevertheless, the anthrax attacks showed that just because there is a medical countermeasure it does not mean that it is going to be effectively utilized. "We learned a lot about counter measures," said Georges Benjamin, MD, executive director of the American Public Health Association. "We learned that Cipro goes away pretty quickly when everybody wants some. There was hoarding it, people prescribing and taking it, and the supply line for a common pharmaceutical was very fragile. We have to learn that lesson for anything we do in the future in terms of BioShield. We have to understand how we are going to implement these marvelous discoveries in the real world. We have not even begun to fund that effort yet. We know we need to deal with public and medical surge capacity. Bottom line, we need to build a comprehensive health system — which we have not yet done — to respond to a broad range of public health threats [from] killer spinach, anthrax, or new emerging infectious diseases either done by Mother Nature or intentionally."
Indeed, the future level of biodefense funding hinges on planners ability to fold it into a general public health response, Venkayya said. "If we are going to continue to build out the infrastructure necessary to address the bioterrorism threat and to enable further our broader biodefense efforts we need to be able to prove to Congress that biodefense belongs in the broader medical and public health arena," he said.
A key component of the evolving approach is an inevitable blend of clinical medicine and public health. "Prior to 9/11, there was a divergence, a drifting apart of medicine and public health," said James J. James, MD, director of disaster preparedness at the American Medical Association. "I really feel since 9/11 that both fields have recognized that in support of national health security, there is a tremendous interdependence between medicine and public health. There is an increasing acceptance of the thought that all physicians have a secondary specialty — public health."
Major education efforts are under way to bring this about, but eventually there is a need to go beyond the continuing education mode and get training into the curriculum of medical schools, he said. Likewise, the AMA is trying to create a data base of health care workers who can be "notified, deployed and validated on site."
Of course, that cadre must include nurses, who have not always seen themselves as fully informed members in the emerging partnership. Nurses must be confident that bioterrorism planners will provide adequate personal protective equipment and clearly communicate the risk of any medicines or antidotes that are brought into the response, emphasized Nancy L. Hughes, RN, director of the center for occupational and environmental health at the American Nurses Association.
"It's important for nurses to have the full understanding," she said. "They like to know the rationale about what is happening and what are the expectations and actions to be taken. It's critical that nurses are at the table."
There are 2.9 million registered nurses in the United States, making them the largest single health care group and the backbone of any medical response, she reminded workshop attendees. "Nurses are concerned about protection and security," Hughes said. "They are very concerned about whether they can receive prophylaxis pre-event, post-event, and vaccines if they are available. It's important that nurses are confident that there has been strategic preparation and that there will be follow-up and monitoring of any problems that should develop. Unless there is assurance that there is protection from undue harm and a sense of security for the nurse — including liability protection and funded injury compensation — there is a risk that nurse response will not be as great as it [could] be."
Beyond physicians and nurses, there is an urgent need to better prepare a "resilient" citizenry for the scale and devastation that might result from the type of attacks being discussed, James added. "The things we are talking about are war," he said. "We are going to have casualties. I think the American public needs to be better prepared for that type of event. We need to better define what we are preparing for, and it's not a two-car collision or even a jet airplane crash. It's an event that is going to overpower the community where it occurs."
Deliver meds or people die
Indeed, the effects of emergencies are "excruciatingly local," added Mike Leavitt, U.S. Secretary of Health and Human Services (HHS), recalling an anthrax scare he had to deal with personally at the 2002 Winter Olympics. However, in somewhat different tone then has been taken with a pandemic flu response, he stressed that localities will not be left on their own in a bioterrorism scenario. "In a moment of crisis, if we are not able to deliver medicines to people over wide areas in short time frames, people die," he said.
In that regard, funding for the Strategic National Stockpile of medicines has grown from $52 million in 2001 to $530 million this year. But the critical adjunct must come from the private sector, thus Project BioShield was created to nurture markets where none previously existed and provide incentives for the development of new medicines, he said. As a result, eight contracts for countermeasure development and acquisition have been awarded, representing nearly $1.9 billion in investment. Treatments are being developed for anthrax, and an antitoxin is in advanced development for botulism toxin, he said. In addition, the National Institute of Allergy and Infectious Diseases has issued five awards totaling $4 million to fund the development of products that eliminate radioactive materials from the human body following radiological or nuclear exposure.
"These are important steps," Leavitt said. "But much, much more must be done. We need to get better at this. I've observed at least two places that we can improve: The first is the internal challenge of speed. In this case, speed is life. The second is the external challenge of private sector participation, including transparency, liability, and funding."
The first stakeholder's workshop was evidence of the emphasis on transparency and it will likely become a regular meeting, he noted. "Your thoughts and your comments will be used in crafting the next step, the HHS implementation plan," Leavitt said. "That plan will be published and made publicly available early next year. It will detail which medical countermeasure should be developed next and in which quantities in the near-, the mid-, and the long-term timelines — all the way out to 2023. The plan stretches out for many years to allow those of you doing research and development to devote the resources that might be necessary to develop the countermeasures."
Reference
- Department of Health and Human Services. Office of Public Health Emergency Preparedness; Draft HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats. Fed Reg Sept. 8, 2006; 71[174]:53,097-53,102.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content