T H E   N I H    C A T A L Y S T      J U L Y  –  A U G U S T   2002

Proposed Homeland Security Department Would Work with DHHS

by Fran Pollner

Barely three weeks into his tenure as NIH director, Elias Zerhouni presided over his first meeting of the Advisory Committee to the Director (ACD) June 6, where he heard a report on the NIAID "Strategic Plan for Counter-Bioterrorism Research." That evening, President George W. Bush went on national television to propose a new cabinet-level Department of Homeland Security—a department that, as proposed, would assume authority over the biodefense-related research of NIH.

An inkling of what was to come was contained in a small news release handed to Zerhouni just as Jack Killen, NIAID assistant director for biodefense research, was to brief the new NIH director and the ACD on the status and scope of NIAID’s biodefense research agenda. Zerhouni read the one-sentence news release on the proposed new department, which did not overtly suggest that NIH might be affected, and that possibility was not discussed at the ACD meeting.

The NIAID "strategic plan" was also addressed in the kickoff speech of the NIH Health and Safety Expo a few days later—when the implications of the administration proposal could only be guessed at.

The president’s proposal was later sent to Congress as H.R. 5005; hearings before relevant House and Senate committees, held in June and July, were peppered with the testimony of non-NIH witnesses advising the legislators that the president’s objectives would best be served by retaining control over NIH biodefense-related research within the Department of Health and Human Services, with the proposed Department of Homeland Security having overall guidance and coordinating functions. In early July, at his first press conference with the print media, Zerhouni addressed the issue.

NIAID Strategies

The NIAID biodefense focus, Killen told the ACD, is on infectious diseases and toxins unleashed on a civilian population, a cohort considerably more vast and diverse than the military population. Unlike the military situation, civilian attacks would be unexpected and require rapid diagnostic and therapeutic responses in many different settings.

Targeted for immediate intensive research are those organisms designated Category A by the Centers for Disease Control—organisms deemed to pose the greatest bioterror threat by virtue of their infectiousness and lethality: anthrax, smallpox, botulism, plague, tularemia, and viral hemorrhagic fevers.

The NIAID plan covers intensive study of these agents, including genome sequencing, and of specific and nonspecific host defenses against them, as well as expansion of research capacity—training new investigators in the field, establishing a reagent repository, and building BSL-3/4 facilities at intramural and extramural sites. The extramural sites, Killen said, will be chosen competitively to form regional Centers of Excellence for Bioterrorism and Emerging Diseases Research.

He emphasized that the NIAID bioterror defense program "is based on the concept that bioterror is a subset of the greater problem of emerging and re-emerging diseases." He noted that over the last decade or so, about 30 different organisms have reared their problematic heads around the world.

He also provided a rundown of the president’s FY2003 budget request—delivered at the beginning of the year—that includes $37.7 billion for homeland security, of which $5.9 billion would go toward defending against bioterrorism. The NIH biodefense budget, he said, would increase from $274.5 million this year to $1.75 billion in 2003. The construction of research facilities would account for about $520 million; about $440 million would go toward basic research on agents of bioterrorism; and about $590 million would fund development and testing of therapeutic drugs, vaccines, and diagnostics. The request projects out to 2006, with construction money falling over the years as clinical research and development outlays grow.

Questions having largely to do with the security aspects of the NIAID program dominated the discussion after Killen’s presentation. Would the bio-safety features of the new laboratory facilities serve to keep people out as well as keep pathogens in? Would there be a special vetting process for both intramural and extramural investigators involved in the program? Would there be restrictions on publishing the results of research?

NIH philosophy, Killen noted, has always been that information should be placed in the public realm in as complete and timely a manner as possible. "That said," he continued, "there probably will be some things that are better not placed in the public realm. We have to feel our way into this, beginning from a position of openness." As for the vetting of investigators, he guessed that there "would need to be some restrictions on those with direct access to [potential bioterror] agents—probably related to a security clearance process. Standards are being developed—and quickly," he said.

That night, President Bush made his announcement, and the following day, it was reported that among those operations that would be "absorbed" by the proposed Department of Homeland Security were "HHS civilian biodefense research programs" involving 150 full-time employees and $1.9 billion. NIAID spokespersons contacted by the Catalyst said they did not know how or whether the president’s reorganization plan would affect the NIAID biodefense research program but that they’d "continue doing what we’re doing."

NIAID in Action

Carole Heilman (right) answers more questions following her talk on the NIAID biodefense research program

Several days later, on June 11, Carole Heilman, director of the NIAID Microbiology and Infectious Diseases Division, gave her scheduled talk on "NIAID BioDefense: The Response and Role of NIH" to keynote the NIH Health and Safety Expo held that day.

She presented an overview much like Killen had, but when she delineated the spokes of the overall HHS biodefense program—CDC surveillance and stockpiling of vaccines and antimicrobials; NIH basic research and medical interventions; FDA regulatory approval of vaccines, therapeutics, and diagnostics; and OEP (Office of Emergency Preparedness) resource mobilization and local-federal coordination—she issued a caveat: "This is how we look today. Indeed, I’m not sure if this is how we’ll look in a little while."

Heilman proceeded to summarize the sorts of biodefense activities in which various NIH institutes are currently engaged: NIGMS epidemic modeling, NIEHS environmental assessment of contamination, and NINR and NIMH examination of post-traumatic stress sequelae, in addition to the NIAID focus on pathogens and immune response.

Thus far, she said, the NIH response to the precipitous bioterror threat unleashed in the fall of 2001 has yielded a "remarkable [array of] accomplishments in record time." Among the activities she noted were the following:

Smallpox vaccine dilution studies: A clinical trial involving 680 healthy adults established that existing stocks of smallpox vaccine are effective at 1:5 and 1:10 dilutions.

Smallpox vaccine development: In the face of insufficient stores of vaccinia immunoglobulin to protect immuno-compromised populations at risk of disseminated vaccinia, testing is underway of a less reactogenic smallpox vaccine based on modified vaccinia Ankara.

Antiviral drug development: In testing the repertoire of antiviral drugs against both vaccinia and smallpox, cidofovir has emerged as a base from which to develop effective therapies.

Anthrax pathogenesis studies: Three linked mechanisms of cell entry, any one of which can be modified to block infection, have been discovered.

In collaboration with the Navy, genomic sequencing of Bacillus anthracis has been accelerated.

In collaboration with the National Science Foundation and The Institute for Genomic Research, studies have yielded possible forensic markers to identify sources of B. anthracis.

In collaboration with the military, studies are underway to develop a civilian alternative to the military’s anthrax vaccine, which requires six injections over 18 months, a regimen that would not work in a bioterror setting.

Ongoing VRC studies are untangling the complexities of the Ebola virus’ life cycle, leading to the development of candidate vaccines.

Along the biodefense product pipeline, NIAID is geared up to travel from pathogen to product through the stages of basic research, target identification, preclinical development, and clinical evaluation. RO1 and PO1 grants are going out in FY2003 for basic research in pathogen replication and pathogenesis, animal models of infection, and host and innate immune response.

Industry collaborations are being sought for preclinical development and to expand GMP/GLP facilities for manufacturing vaccines and drugs. HHS has asked for speed in developing one particular anti-anthrax product–recombinant protective antigen, or rPA.

NIAID has also expanded clinical studies to examine mucosal immunity, food- and water-borne infections, and respiratory infections; international sites are being developed.

In addition to the newly conceived Regional Centers of Excellence for Biodefense and Emerging Infectious Disease Research, FY2003 money is also targeted to the establishment of Centers of Human Immunology to explore how to manipulate the immune response to selectively and specifically respond to unknown pathogens.

From the Homeland Security Act of 2002


The following is part of the text of "Title III–Chemical, Biological, Radiological, and Nuclear Countermeasures. Sec. 303: Conduct of Certain Public Health-Related Activities."

(a)(1) Except as the President may otherwise direct, the Secretary [of Homeland Security] shall carry out his civilian human health-related biological, biomedical, and infectious disease defense research and development (including vaccine research and development) responsibilities through the Department of Health and Human Services (including the Public Health Service), under agreements with the Secretary of Health and Human Services, and may transfer funds to him in connection with such agreements.

(2) With respect to any responsibilities carried out through the Department of Health and Human Services under this subsection, the Secretary, in consultation with the Secretary of Health and Human Services, shall have the authority to establish the research and development program, including the setting of priorities.

The following is part of the "Analysis" of "Section 303: Conduct of Certain Public Health-Related Activities."

This section requires the secretary of Homeland Security to carry out his civilian human health-related biological, biomedical, and infectious disease defense research and development responsibilities through agreements with the Department of Health and Human Services unless the President otherwise directs, and gives the Secretary specific transfer authority to fund such agreements. In carrying out these responsibilities, however, the Secretary retains full authority to establish the research and development program, including the setting of priorities. The section also gives the Secretary specific authority to fund other research and development projects that he elects to carry out through the Department of Health and Human Services or other federal agencies.

The entire text of the Homeland Security Act of 2002 can be found here. An analysis of the act can be found at this site.


Congress Gets Into the (Homeland Security) Act

Introduced into the House on June 24, the Administration’s proposal to establish the Department of Homeland Security, was referred to a dozen different congressional committees with jurisdiction. Several held hearings the last week in June and in early July; those conducted in the House Energy and Commerce Subcommittee on Oversight and Investigation and the Senate Governmental Affairs Committee focused particularly on those sections of the proposal dealing with the transfer of programs or authority over programs from the Department of Health and Human Services to the Department of Homeland Security. Sen. Joe Lieberman (D-Conn.), the chairman of the Senate panel, had authored an earlier bill to create a national homeland security department that calls for many of the changes adopted in the Administration proposal but does not alter HHS authorities. It is his committee that will prepare and shepherd the Senate version of the Administration bill through the legislative process. "I want to explore the wisdom of [the Administration] approach—how and if it would work," he said.

Witnesses addressing the NIH civilian biodefense research program cautioned that shifting control to the new department might compromise scientific expertise and public health objectives. Gail Cassell, vice president of scientific affairs and Distinguished Lilly Research Scholar for Infectious Diseases of Eli Lilly and Company, Indianapolis, emphasized the need for "excellent science based upon peer review and merit" and advised that "NIH/NIAID is uniquely positioned" to lead a biodefense effort that aligns government, academia, and industry.

Ronald Atlas, president-elect of the American Society for Microbiology (ASM), detailed the "accelerated basic and clinical research related to bioterrorism" already undertaken by NIH, in particular NIAID. "This acceleration has occurred across the spectrum of scientific activities from basic research in microbial biology to the development of vaccines and therapeutics to research related to diagnostic systems. It is critical that this work continue to develop rapidly and efficiently . . ." To best achieve the Administration’s goal of civilian biodefense, he said, the "ASM suggests reversing the responsibilities identified in Section 303(a)(2) of the Administration’s Bill [see box below]."

In marking up the bill July 11, the full Energy and Commerce Committee, chaired by W. J. "Billy" Tauzin (R-La.), amended the language of the relevant sections to conform to Atlas’ suggestion. More hearings before a specially convened House Select Committee on Homeland Security were scheduled at Catalyst press time. Members of both houses vowed to complete their versions of the legislation before the August recess. For full text of witness testimony before House and Senate committees and for access to videocasts of hearings, visit the House Energy and Commerce and Senate Governmental Affairs committee sites.

To track the activities of the House Select Committee on Homeland Security, go to its website.




Zerhouni: NIAID's Momentum To Continue


Asked where the Administration blueprint to establish a Department of Homeland Security would place the decision-making authority in awarding NIH biodefense-related research, NIH Director Elias Zerhouni responded, "We’ve already implemented a strategic plan [the NIAID Strategic Plan for Counter-Bioterrorism Research], and we will continue [to award grants]. We will also continue to implement the construction of needed facilities."

In his first press conference with the print media, held in his NIH office July 2, Zerhouni emphasized the need to "continue the momentum" generated by NIAID. Asked what it means for NIH to be a contractor to a homeland defense agency, Zerhouni noted that deciding how best to implement a biodefense research program requires an analysis that has yet to be undertaken. Until that has been achieved, he said, the "mechanism to have NIH continue" on its current path by having the new department coordinate policy and "contract back" the funds to NIAID to execute the program is "probably the best strategy" given the current state of knowledge.

He noted that biodefense "is not necessarily driven just by bioterrorism. We need to defend against naturally occurring organisms and to establish an infrastructure responsive to the emergence of new threats, whether man-made or not, and to re-emerging infections." That model, he said, is not easily achieved. He did note, however, that "NIAID has developed quite an infrastructure."





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