Public health officials nervous about plan to move HHS agencies

The jockeying over the proposed Department of Homeland Security has sometimes resembled a tense game of musical chairs, as federal agencies nervously wonder whether they'll have as good a seat when the music stops as the one they started out with. That's particularly true for agencies involved in bioterrorism-one of the few areas in which a new department could splinter programs rather than consolidate them.

Currently, public health functions, including defenses against bioterrorism, exist almost exclusively within the Department of Health and Human Services. HHS houses the National Institutes of Health (which is the federal government's premier medical research entity), the Centers for Disease Control and Prevention (the expert agency on infectious disease), the Food and Drug Administration (the regulator of vaccines, drugs and food safety), the national pharmaceutical stockpile (home of the smallpox vaccine and the anthrax drug Cipro), and the Office of Emergency Preparedness (the coordinating agency for responding to public health emergencies).

Under just about any scenario, a Homeland Security Department would peel off some of HHS's bioterrorism responsibilities. And the questions of who goes and who stays, which leaders make which decisions, and who controls the pocketbook have scientists and public health experts feeling a bit uneasy.

"It's possible that the establishment of a Department of Homeland Security will overall improve our biodefense initiative," said Thomas Inglesby, deputy director of the Johns Hopkins Center for Civilian Biodefense Strategies. "But we have to be mindful of uprooting programs that are having early successes. It could lead us down a path of slowdown or decreases in efficiency."

Indeed, the Health and Human Services Department has generally gotten good marks this year for its focus on bioterrorism. HHS has put new money into bioterrorism research at NIH, developed grant programs to help state and local public health offices beef up their labs and communication systems, and updated the pharmaceutical stockpile to include important bioterrorism remedies.

Some officials and scientists steeped in bioterrorism defense fear that moving bioterror experts away from the public health community at HHS could hamper their ability to make informed decisions quickly during an emergency. They say that the Homeland Security Department would have to re-create some HHS functions in order to develop that bioterrorism expertise, and they doubt that the president or Congress would be willing to spend enough to make that happen.

The medical community has been complaining for years about the federal government's lack of attention to public health issues. Now health experts fear that some of the proposed changes could make public health even more of a stepchild. Having two sets of decision makers (at HHS and at Homeland Security) could create an unhealthy competition for money for medical research and first responders, they say, and they predict that terrorism-related diseases such as anthrax and smallpox would always win out over, say, West Nile virus.

"It's not a perfect fit," said one congressional Republican aide. "You've got a bunch of jigsaw puzzle pieces that don't fit well when you move them from one side to the other." But then, the aide said, the status quo is not ideal, either. In the present setup, "you just don't have the kind of coordination that's necessary to fight bioterrorism," the aide said. "How can the public health community work with the FBI? It's critical that we do, but otherwise it's a joke. The FBI isn't that capable on its own" of making decisions about bioterrorism.

President Bush kicked off the debate earlier this year with a series of far-reaching public health proposals, including recommendations to move several hundred staff members and more than $1 billion in funding from Health and Human Services to Homeland Security. Among those to be transferred would be scientists at NIH, and disease investigators and first responders at the CDC.

But Bush's proposals met with sharp criticism from the public health community, with many arguing that his plan went too far. Members of Congress on both sides of the aisle agreed with the critics, and the House-passed legislation and the Senate bill under consideration would each uproot far fewer programs and people. Nevertheless, the medical community continues to fear that two Cabinet-level decision makers with similar responsibilities could muddle priorities for public health and bioterrorism and could force a duplication of effort. At the very least, the two-headed chain of command would make effective liaisons and communications essential.

Part of the rationale behind forming the new department is to consolidate similar functions within a single agency. For example, Homeland Security would bring border control, customs services and immigration policy together in one department. The goals are to foster cooperation and collaboration, and to improve operational effectiveness. But moving bioterrorism programs from Health and Human Services doesn't accomplish these goals, according to Tara O'Toole, director of the Center for Civilian Biodefense Strategies at Johns Hopkins University. Testifying at a House Energy and Commerce subcommittee hearing in June, she said, "Ideally, one would design bioterrorism response systems that also serve routine organizational purposes."

Even the congressional proposals could jeopardize opportunities to work concurrently on bioterrorism and on general public health, said Jeffrey Koplan, a former CDC director and now vice president for academic health affairs at Emory University in Atlanta. "Epidemiologists, public health specialists, continuing to work together and dealing with problems on a daily basis, are the best defense against bioterrorism."

Who's Packing?

Both the House-passed bill and the Senate's committee-passed bill modified President Bush's original proposal by cutting back the number of HHS positions to be transferred to the Department of Homeland Security. Still, medical professionals worry that even these proposals could do more harm than good.

All three of the plans currently under debate-House, Senate, and White House-address five areas within HHS's purview.

• Bioterrorism research at the National Institutes of Health. Bush would transfer funding for bioterrorism research to Homeland Security, whose secretary would then determine priorities and set regulations for those programs. But the research scientists would still be under the supervision of HHS-Homeland Security would contract with HHS to do the bioterrorism research. The goal would be to bring bioterrorism experts into closer contact with the intelligence community, so that better decisions could be made about which bio-agents the scientists should research. At the same time, scientists could give intelligence experts a better scientific understanding of what bioterrorists are capable of brewing.

  The House-passed bill, like the president's plan, would authorize Homeland Security to set policy and strategy for research. But there's one important difference: The House bill wouldn't transfer NIH funding to the new department. The Department of Homeland Security would set homeland security priorities, and HHS would carry out its research based on those determinations.

  The Senate legislation, which was approved by the Governmental Affairs Committee and is being debated on the Senate floor, would move both funding and authority for bioterrorism research from NIH to Homeland Security. But pressure from the American Society for Microbiology and other scientific groups could spur the Senate to move closer to the House language, say congressional aides.

• Centers for Disease Control and the Health Resources and Services Administration. Bush would transfer funding for bioterrorism work currently performed by these agencies to the Department of Homeland Security, which would determine priorities and set regulations for those programs. The president's proposal included few details about how to split off the CDC's bioterrorism functions, and filling in those blanks would have been difficult had Congress chosen to follow Bush's plan. The CDC is responsible for investigating and containing any unusual or significant disease outbreak, and its work on bioterrorism has increased dramatically in the past year. The CDC provides funding and technical support to state, and some local, health departments to help them improve their detection and response capabilities for bioterrorism, and to upgrade communications systems and public health laboratories.

  HRSA, a division of HHS that works to improve access to health care through funding community health centers and other facilities, has played a significant role in delivering terrorism grants since September 11. The agency has handed out a total of $45 million in emergency grants to health centers and other medical entities to help them provide support services in the wake of the 9/11 attacks. It also gives grants to help hospitals improve their preparedness and their trauma/emergency medical services.

  Under the House and Senate bills, HHS would retain full funding for bioterrorism programs, although Homeland Security would establish priorities for grant-making.

• Pharmaceutical stockpile. The president's proposal and the House bill would move custody of the national pharmaceutical stockpile to the Homeland Security Department, although HHS would continue to determine the contents. Bush's idea would maintain the authority of HHS scientists to decide which vaccines and antibiotics are placed into the stockpile, but charge Homeland Security with guarding it. Some critics say HHS has been lax in its protection of the stockpile. Indeed, confusion abounds about what's actually in the pharmaceutical stockpile and who has access to it.

  Under the Senate bill, HHS would maintain the stockpile and determine its contents.

• Bioterrorism priorities. Bush proposes removing from CDC the responsibility for identifying which bioterrorism agents pose the greatest threat and keeping track of who possesses them. Again, the idea is that bioterrorism experts currently housed at HHS would benefit from working more closely with the intelligence community, within the Homeland Security Department. The House bill would keep the office within HHS, while the Senate bill would transfer the office to Homeland Security.
• Office of Emergency Preparedness. Under the president's plan, the entire Office of Emergency Preparedness would move from HHS to the new department, along with the Federal Emergency Management Agency. The goal is to improve the day-to-day coordination among the nation's first responders by consolidating them within one department.

  The president's proposal would shift Jerry Hauer, the assistant HHS secretary for public health emergency preparedness, plus 51 staff positions, about half of which are now filled. Both congressional bills would move the functions and staff of the office to Homeland Security, but keep the assistant secretary's position at HHS.

Calling the Shots

As Congress well knows from its own turf battles, when two leaders share power, jurisdictional disputes are sure to arise. So, who would have the final say when two Cabinet secretaries share control over the nation's response to bioterrorism? And how many of the answers must be spelled out in statute?

When it comes to research, for example, both congressional bills say that Homeland Security would set priorities for bioterrorism research, and NIH would decide how to accomplish those goals. It's a similar story for the Centers for Disease Control and Prevention. Under both congressional bills, CDC personnel would remain within HHS, but Homeland Security would set the priorities for bioterrorism research and have some decision-making power over some grant-making.

Splits like these may lead to competing demands, said Ronald Atlas, president of the American Society for Microbiology. "For example, NIH may be developing a better-quality vaccine [to replace] something with limited safety now. A security department may say, `We don't care about safety, but we want a vaccine in the stockpile now.' If the decision on how to spend the money is made by those who don't understand the science," Atlas said, "then you don't get good science."

And what happens if a natural disease outbreak such as West Nile virus, or a natural disaster such as an earthquake, occurs simultaneously with an anthrax or smallpox attack? The same public laboratories test for both bioterrorism toxins and natural diseases, and the same national responders would be on the line for both emergencies (activated through the Office of Emergency Preparedness and the CDC). If Homeland Security were doing the deploying, would the priority go to the bioterrorism threat?

The Office of Emergency Preparedness, which would move all 51 of its staff positions to Homeland Security under all three proposals, mobilizes the 5,000 members of the Public Health Service Commissioned Corps. These people are public health professionals who, when mobilized, become federal employees. They responded to the hantavirus outbreak in the Southwest in the 1980s, Hurricane Andrew in Southern Florida and Louisiana in 1992, the Northridge earthquake in California in 1994.

"At the time of natural disasters, for example, the local morgue is typically overrun. There are all sorts of responses that don't fall under terrorist activities," said one public health analyst. "The Office of Emergency Preparedness coordinates all of that." What if the hantavirus outbreak had occurred at the same time as a terrorist threat? "What if someone says it's a code red day" for terrorism, the analyst asked, "and they can't release these [public health officers] because they're expecting something big?"

Uncertainty also surrounds the role of Surgeon General Richard Carmona, who was recently sworn into office. As a medical school professor at the University of Arizona, Carmona was responsible for developing and implementing plans for the university and the Arizona community at large for responding to attacks using weapons of mass destruction. But despite Carmona's expertise in terrorism preparedness, his new role might be limited. Under all three proposals, the Office of Emergency Preparedness, now to be part of Homeland Security, might have the authority to activate the commissioned corps.

"If they brought in a new surgeon general with an eye toward being more effective on terrorism, but they take away the responsibility for the corps-it's kind of a contradictory message," the analyst said. "What will his role be, if they take away his power to coordinate? Just a spokesman?"

Getting Results

Regardless of who's calling the shots, the most important question is how best to protect the public from bioterrorism without compromising the overall public health mission. Many experts, including members of Congress in both parties, gave the president's original proposal bad marks on answering that question.

Stephen D. Prior, research director of the National Security Health Policy Center at the Potomac Institute for Policy Studies, said he saw little merit in moving scientists from NIH, for example. "Any of us is only as good as the support team around us," he said. "It's the peer group, the collegiate element. It's being able to throw out ideas and have several people bat them around."

Leaving the scientists at NIH, but setting their priorities at Homeland Security, he said, may provide the best of both worlds. Homeland Security would work with its intelligence experts to determine which bio-agents pose the greatest threats, then charge NIH with the responsibility of conducting the research on those priorities, whether smallpox, tularemia, or Ebola, for example. NIH scientists could move toward those goals with great flexibility, bolstered by the support of a research environment.

Indeed, while a consensus is growing that this kind of shared responsibility might be beneficial, the biggest question now appears to be how to build in adequate coordination between the two departments. "This is a concern," said one aide to a congressional Democrat, although "there's some level of coordination required even if there's no [Homeland Security] Department." Members of Congress are now deciding how best to ensure effective communication between the two departments. One possibility is to create a liaison office.

Then there's the question of red tape. Susan Polan, director of government relations for the Trust for America's Health, a nonprofit public health advocacy organization, says she's concerned that the new department will create more bureaucratic hoops for local and state offices to jump through to get financial assistance in emergencies. Polan doesn't like the idea of moving FEMA into Homeland Security. "It will be a more convoluted process for getting money out to the states," she said.

But allowing the status quo to persist is also dangerous, according to Prior. In essence, he said, the traditional role of public health in disease management, and the primary capabilities of the Centers for Disease Control and Prevention simply don't match the requirements for defense against the threat of bioterrorism.

"The very nature of a bioterrorist incident-i.e., the deliberate release of a biological agent for the purposes of disruption and destruction-begins with the terrorist ensuring that the choice of agent, the method of dissemination, the effect on the target population, etc., can overcome the routine methods of disease control that are employed." Terrorists, Prior said, can readily circumvent the "normal" means of disease control by choosing an "exotic" agent, by attacking with large quantities of an agent, or by delivering the agent in an unexpected way.

Moreover, some fear that leaving bioterrorism responsibilities within HHS could allow complacency to set in. "If biodefense activities do not reside in the Homeland Defense Department, there is some peril that these crucial functions will be neglected," O'Toole said at the June Energy and Commerce subcommittee hearing.

Prior recommends creating a "red team" within Homeland Security, to be composed of independent, private-sector bioterrorism experts. The red team would collaboratively examine the emerging strategies, critique them, and develop a coherent defense capability. The goal would be to test existing and proposed capabilities continually, to pinpoint weaknesses, and to offer solutions.

All in all, it's a delicate balance, according to public health and bioterrorism experts. That was the message from Margaret Hamburg, vice president of biological programs at the Nuclear Threat Initiative, a private group funded by CNN founder Ted Turner to reduce the risks of nuclear, biological, and chemical weapons.

At the June subcommittee hearing, she said, "A new Cabinet-level Department of Homeland Security can potentially improve coordination of U.S. government activities such as border security, customs procedures, and aspects of emergency response." She warned, however, that "improving coordination of activities related to bioterrorism prevention, preparedness, and response is a greater challenge."

Julie Gerberding, director of the CDC, supports the new department, but says she's pleased that most of her team will stay put. "We have to create government organization capacity to respond to the fact that it wasn't just something that happened last fall," and it could happen again, she said. At the same time, she added, "I'm very pleased that as the implementation of the proposals goes forward and the details are being worked out, the responsibilities for the public health piece are remaining with Health and Human Services."