FEATURE ARTICLE

March 2005

Pentagon Redirects Priorities In Chemical-Biological Defense

by Sandra I. Erwin

The Pentagon will broaden the scope of its chemical and biological defense programs, in an effort to prepare for future domestic emergencies, officials say.

Major concerns are the Defense Department’s inability to respond to a mass-casualty biological attack and to keep adequate supplies of vaccines and medicines to treat a wide array of potentially deadly bugs—ranging from bacterial anthrax to botulinum toxin and the smallpox virus.

Despite false alarms about biological weapons in Iraq before U.S. forces toppled Saddam Hussein’s regime two years ago, U.S. officials express certainty that an enemy country or terrorist organization one day will strike a major metropolitan area in the United States with deadly pathogens. Even if the attack caused a relatively small number of casualties, experts agree, the ensuing chaos and panic likely would cripple that city.

The Defense Department gradually has recognized the need to boost resources in the medical field to help counter bioterrorism, says Klaus O. Schafer, deputy assistant secretary of defense for chemical and biological defense.

Schafer oversees a more than a billion-dollar yearly operation that is focused primarily on developing technologies for military use. In recent months, however, the course of the program has changed. The military is directing more emphasis to homeland defense.

“We are taking a more holistic approach,” he says in an interview. “This program has been focused too much on individual products.” The Pentagon, he says, wants to work more closely with the “first-responder community” and ensure that the money spent actually leads to useful capabilities.

The Defense Department has tried to define its role in homeland security since 9/11, but has not been successful yet, Schafer adds. The upshot is that “the people on the ground,” meaning the first responders and medical emergency personnel at the state and local levels, do not have a clear line of communication with the Pentagon. This makes it difficult for them to convey their equipment needs.

Schafer says his office intends to help fill existing gaps in U.S. defenses against bioterrorism, particularly the shortage of vaccines and drugs to help treat victims. “The biggest area I have focused on in the past months is the medical side,” he says.

Despite billions of dollars spent on homeland defense, experts warn, the United States has yet to figure out how to deal with biowarfare. “Terrorist groups could use pathogens to attack people, livestock or crops,” writes Dennis Pirages, a professor of international politics at the University of Maryland. He notes that bacteria and viruses are not usually viewed as “military threats,” but probably should be, given that naturally occurring infectious diseases have killed, on average, 14 times more people than military conflicts.

“Although pathogens have claimed far larger numbers of human casualties, relatively few resources from public treasuries have been devoted to dealing with them,” Pirages writes in “State of the World 2005.”

The Defense Department plans to step up research-and-development efforts in the medical field, Schafer says, and encourage more companies to team up with the government in pursuing sophisticated new drugs that can treat multiple pathogens.

“We are moving away from the ‘one-bug to one-drug’ concept. That’s the way we’ve approached the problem in the past,” he says.

Medical technology has advanced to the point that it’s possible to develop drugs that can work against more than one agent. A single treatment, for example, could neutralize both the Ebola and smallpox viruses.

“It’s a little premature to say, but there are things out there that look very promising,” says Schafer.

Although the Bush administration already has launched a high-profile project called Bioshield, the government needs to go even further in bringing more innovative technology to the biodefense market, he notes. Bioshield authorizes the Department of Homeland Security to spend up to $5.6 billion during 10 years to stockpile vaccines and medicines.

Of particular concern to the industry is that Bioshield does not protect suppliers from liability in case of a terrorist attack, Schafer says. “Industry will tell you there are still major problems … There is still enough concern on the liability issue that big industry remains skittish about participation.”

Small, innovative companies in the biotech industry also tend to refrain from working with the Defense Department, according to Schafer, because they fear the government won’t protect their intellectual property, and investors tend to view defense contracts as too risky.

Schafer says he’ll work to change that perception. “I’m trying to be aggressive about going after ideas that exist in the biotech world … To get these companies to come into our space is somewhat difficult. Investors don’t like it. Contracting procedures are slow. We tend to not move very quickly.”

In reality, Schafer says, the industry stands to make healthy profits if the products pass the required tests. “The government takes a lot of risks. We are willing to put money into some harebrained ideas,” he says. “Often, the Defense Department will fund some of the risky business to get us down the road a little way and will help companies build some of their portfolio in the infectious disease treatment area … We take the big risks. They get paid.”

Biological and chemical defense efforts could benefit from growing budgets during the next six years, if Congress approves the administration’s latest funding request. The Defense Department is seeking a $2.1 billion increase spread over five years. The budget for 2006 would rise to $1.6 billion, for a total of $9.9 billion for the 2006-2011 period.

Even with additional funding, many programs may not progress as fast as Pentagon officials would like, because suppliers can’t meet the stringent technical requirements. “This science is pretty complex,” says Schafer. In addition, any vaccine or medicine the Defense Department buys has to be approved by the Food and Drug Administration. That process can take years and hundreds of millions of dollars.

One example of an emerging “super drug” that potentially could help treat victims of radiation and bioagents is Homspera, made by ImmuneRegen BioSciences Inc. The FDA will be testing this drug in the near future, says Mark Witten, research professor at the University of Arizona and co-founder and acting head researcher of ImmuneRegen, a biotechnology company in Scottsdale, Ariz.

The company recently signed a “letter of intent” with Canada’s Department of National Defense that could lead to the development of a “universal protector” drug for multiple applications, Witten says in an interview. “We know our drug works against radiation. We think it may have applications against anthrax, ricin and mustard gas.”

ImmugeRegen shareholders hailed the agreement with Canada, he says, because it commits the government to put up two-thirds of the research costs, while the company only has to pay one-third.

Witten suggests that the U.S. Defense Department would benefit from similar arrangements. The reason why biodefense technology is not moving swiftly in the United States, he adds, is because there is no “sense of urgency.” Nearly four years after 9/11, Witten says, complacency has set in.

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