Project BioShield: The first line of biological defense

Billions of dollars back this initiative to spur development of bioterrorism countermeasures. But new vaccines and treatments are only one aspect of readiness.

By — Posted Aug. 16, 2004

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National leaders have always dreamed of the creation of an impenetrable shield or barrier to protect against foreign assaults on American soil. Think fortresses, defense build-ups, interceptor missiles and even the Star Wars program.

But the threat of bioterrorism requires an updated vision, one involving a protective bubble that wards off bugs instead of bombs. The bugs, of course, are viruses and bacteria in weaponized form -- plague, tularemia, anthrax, smallpox, hemorrhagic fevers and an array of other deadly pathogens limited only by laboratory sophistication.

Safeguarding the public from these threats involves a distinct to-do list closely linked to the biomedical research enterprise.

"Ultimately, the hope is to develop a vaccine, or even beyond a vaccine, that can be given to people to prevent organisms from becoming pathogenic, to stump the process before harm is done to human bodies," said Jerome Hauer, executive director of the George Washington University Response to Emergencies and Disasters Institute in Ashburn, Va. "The protective bubble does not need to be a physical barrier anymore. And that's where we've got to look down the road."

Thus, enter Project BioShield.

President Bush first proposed this initiative during his 2003 State of the Union Address. It was approved by Congress earlier this summer and signed into law July 21.

Motivation for it stems from the 2001 anthrax attacks, which highlighted the nation's vulnerability. Five people were killed, and most experts say the toll would have been higher had the disease strain not responded to available antibiotics.

The fact that there was a treatment was a lucky break, lucky because effective vaccines, drugs and other countermeasures simply do not exist for many of the most likely biological threats. A White House fact sheet points out that medicines available for these agents have improved little in decades. Specifically, existing smallpox vaccines are not much different than those last used by the public in the 1960s. And some treatments for radiation and chemical exposure have not changed since the 1970s.

With its $5.6 billion investment over the next decade, Project BioShield has the potential to turn this situation around. It sets out to offer inducements for pharmaceutical and biotech firms to roll up their sleeves and commit to developing medicines to counter possible biological or chemical attacks.

"The goal is to create incentives for private industry to do this sort of research and development -- work that does not make sense under current market forces," said Gerald Epstein, PhD, senior fellow for science and security at the Washington, D.C.-based Center for Strategic and International Studies.

In other words, the federal government is now positioned as a guaranteed buyer. It would select countermeasures deemed necessary that otherwise lack a significant commercial market on the front end of the process, which could last as long as eight years. The actual purchase will be contingent upon data supporting the product's effectiveness.

The BioShield law also increases authorities and flexibility at the National Institutes of Health to expedite work on these specific types of vaccines, drugs and other countermeasures and gives the Food and Drug Administration tightly controlled emergency powers to make promising treatment quickly available to patients in crisis situations.

Still, the key element is the money.

"[It] provides a light at the end of the tunnel," said Hauer, formerly New York City's director of emergency preparedness. "If [the companies] come up with something, ... if they develop a product, they will have a customer. That historically has not been the case, and it chilled innovation."

And what tops the shopping list? A smallpox vaccine. An anthrax vaccine. The possibilities become far less endless when one considers what the dollar amount can actually buy.

"It's not a lot of money," Hauer said. For instance, the Congressional Budget Office estimated that $1.4 billion could be spent on a new anthrax vaccine alone. And that's also why BioShield is generally viewed as only a first step -- albeit a positive one.

"It is a lot for Congress to commit right off the bat," Dr. Epstein said. "But it will be enough to see if the concept is working."

Public health and readiness experts also predict that once BioShield gets up and running, decision-making about specific remedies will be front and center.

"You have to look at it from a threat base," said Hauer, also a former public health preparedness adviser at the Dept. of Health and Human Services. "We have to use BioShield to manage current threats."

But, he added, it also must address future threats. "We can't continue to buy the same old thing. I think the focus now is on better countermeasures, newer countermeasures. We have to have a broad horizon as we look down the road."

With this long view, more issues emerge. For instance, what about the government's role in spurring development of new antibiotics and antiviral agents that have applications beyond bioterrorism?

"I don't want to say there will be no antibiotics developed under BioShield -- it may happen," said Robert Guidos, the Infectious Diseases Society of America's director of public policy and government relations. IDSA has been involved in a push for Congress to create incentives similar to those contained in Project BioShield to urge pharmaceutical companies to develop new antibiotics in response to the growing public health problem of resistance. But the bugs his organization is concerned about, he said, are not likely to be weaponized -- which is BioShield's current focus.

"What we have heard from the administration when we have asked ... is that the pool of money under BioShield is likely to be focused primarily on category A agents," he said. This is a worry for IDSA, because antibiotic resistance is not just a threat, but already a major public health problem.

Meanwhile, additional questions involve the point at which the overlap between public health and national security ends. "One thing that I don't think has become clear is how infectious outbreaks fit into this planning," Hauer said. "If we have a flu outbreak, a flu pandemic or a SARS epidemic, does that become a threat to national security? Some have made the argument that it is. Some have said it's not because it is not a terrorist event."

Beyond BioShield

Some aspects of Project BioShield will take time to shake out.

Its supporters agree that the devil will be in the details -- how it is implemented, how many dollars actually get to where they are needed, and whether the initiative will avoid getting bogged down in bureaucracy.

There is also speculation that the new law might not go far enough to entice pharmaceutical industry activity. Already, some members of the Senate are working on a next-generation BioShield bill that would likely strengthen the liability protections provided for drugmakers and advance additional tax and intellectual property incentives.

But there is also an awareness that the real power of any advances triggered by Project BioShield will be closely tied to variables untouched by the legislation.

"Having stockpiles of effective medicines or vaccines will not protect us without a functional public health system that includes disease-tracking systems to quickly detect an attack, labs that can identify the biological or chemical agent, and a trained public health work force that can rapidly respond," said Shelley Hearne, PhD, executive director of the Trust for America's Health, during congressional testimony earlier this spring.

Other fundamental systemic challenges also come to mind -- concerns about vaccine production capacity, which many say does not match current war-time emphasis, and hospital surge capacity.

"I think [that's] the biggest obstacle right now at the state and local level. I don't think our medical care system is anywhere near prepared to deal with the massive onslaught of patients in the event of a big terrorist event either using bombs, dirty bombs, biologics or chemicals," Hauer said.

Nor is it ready for other kinds of mass casualty events, catastrophes such as a pandemic flu or a major earthquake, explained Christi L. Koenig, MD, a former director of the Veterans Administration emergency preparedness program.

For now, the funding is focused on developing response capacity for bioterrorist threats. But the idea is to use this momentum to prepare for these other things, too. After all, preparedness is a multifactorial issue, and BioShield is just one aspect of it.

There is another side: "Beds don't take care of patients," said Dr. Koenig, a spokeswoman for the American College of Emergency Physicians. "We need trained staff and community planning -- connectivity from local to state to federal level." She calls it an "all-hazards approach."

And this kind of approach requires big-picture thinking. "The problem is ... there are all of these different bits and pieces of investment in biosecurity," Dr. Hearne said in a separate interview. "You need this comprehensive, connecting of the dots. ... That's the part that's been missing. There is currently no big picture bio game plan making sure all these different investments are working together to fill our security gaps.

In the end, though, the awareness of the health infrastructure's needs do not overwhelm the optimism about what Project BioShield might achieve in terms of protecting Americans from the biothreats and, therefore, operating as a deterrent.

"The reality is BioShield does a good job as a first step," Hauer said. "Is it the end all? No. But it is a good first step. And yes, a lot more still needs to be done."

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Ironing out the details

It took lawmakers a year and a half to negotiate ways to create incentives for research and development of vaccines, drugs and diagnostics for use against weaponized biological agents.

October 2001 A letter laced with anthrax was delivered to Capitol Hill, underscoring the nation's vulnerability to bioterrorism.

January 2003 In his State of the Union address, President Bush announced Project BioShield, a comprehensive effort to make available new and innovative drugs and vaccines to better protect against biologic attack.

March 2003 Legislation to implement Project BioShield was introduced in Congress.

July 2003 The House of Representatives approved 421-2 a version of the legislation; however, consideration slowed in the Senate because of funding authorization and appropriation questions.

May 19, 2004 The Senate approved 99-0 its version of Project BioShield.

July 14, 2004 The House approved 414-2 the Senate-passed bill.

July 21, 2004 The president signed Project BioShield into law.

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Are we prepared?

It's a question that Centers for Disease Control and Prevention Director Julie Gerberding, MD, MPH, is frequently asked regarding the ability of the United States to respond to a health emergency -- whether related to bioterrorism or a pandemic influenza.

"The answer is that it is the wrong question," said Dr. Gerberding, speaking July 20 at the First National Congress on Public Health Readiness in Washington, D.C. "Preparedness is not a black-or-white event. [It] is an ongoing process of improvement."

The goal of the meeting, co-sponsored by the CDC and the American Medical Association, was to bring together leaders from both medicine and public health to discuss strategies to confront terrorist and naturally occurring threats.

"Globalization, connectivity and speed are the hallmarks of the preparedness that we are trying to achieve," Dr. Gerberding said. Central to it are the links between local health departments, local health care organizations and local clinicians. "But they can't do this alone." Thus, the CDC is working to support "connectivity" through its E-CDC BioSense Project, which collects health information from existing resources to detect and interpret trends.

"Right now we're getting about 500,000 laboratory reports every day from national sources," she said. The system also takes in clinical information from the Dept. of Defense and from Veterans Affairs medical centers. It tracks some over-the-counter drug sales and nurse hotline calls. In addition, several other evolving national data sources come together in CDC's biointelligence center.

Under the agency's proposed budget, Dr. Gerberding hopes to extend this national data acquisition program to the local level so that these health agencies are better connected to the clinical enterprise. In the meantime, BioSense has been shown to detect events such as foodborne illness or influenza outbreaks earlier than the usual reporting methods.

"We are beginning to see progress, and as the system evolves we believe it will be one more tool for helping to identify early threats," Dr. Gerberding said.

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External links

Thomas, the federal legislative information service, for bill summary, status and full text of "The Project BioShield Act of 2004" (S 15) (link)

AMA Center for Disaster Preparedness and Emergency Preparedness (link)

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