Biodefense Spending

Imagine this journey: a highly infectious influenza virus is cultured in a laboratory in Virginia and then purchased by another lab in Ohio, where it is stored frozen for some time. Eventually, the virus makes its way to a medical company in Texas, where it is incorporated into proficiency test kits that are shipped to thousands of clinical labs around the world.

You don't have to imagine this scary scenario because it actually occurred. Only a Canadian lab technician's error in March brought it to light.

The virus in question, H2N2, caused the Asian flu pandemic of 1957 that killed more than 1 million people worldwide. By 1968, H2N2 mysteriously disappeared, and a new virus strain, H3N2, surfaced. With H3N2's appearance, H2N2 was no longer incorporated into vaccines, and people born after 1968 have little or no immunity to it.

When it was discovered that H2N2 had mistakenly been sent to about 6,000 low-containment labs in 19 countries, World Health Organization (WHO) officials panicked. They feared the possibility of a lab technician becoming infected and triggering another pandemic.

The likelihood of H2N2 sparking another epidemic is small. Still, the slim possibility of widespread infection remained, and WHO asked all recipient labs--most in the U.S.--to destroy the virus. Both WHO and the U.S. Centers for Disease Control & Prevention (CDC) have said that all labs have complied, and neither organization has reported a single infection. But tracking down the thousands of kits was not easy.

CDC tracks only pathogens that are considered "select" agents, and flu viruses are not among these potential bioterror weapons, even though the Department of Homeland Security assesses pandemic flu as the most likely of 12 potential disasters to occur. After the H2N2 incident, however, CDC is drawing up new, voluntary guidelines on proficiency tests to help prevent the types of errors that occurred in this saga. CDC has no authority to enforce these guidelines, however.

Pathogens are routinely transported by such courier services as FedEx and UPS. On crowded highways, accidents happen. This March, a FedEx truck hauling boxes of anthrax, flu virus, salmonella, and Escherichia coli collided with a car in Ontario. Fortunately, none of the organisms escaped.

The H2N2 incident, on the heels of the March crash, has raised many questions about safeguards for routine shipments of sometimes-deadly organisms. Such shipments are likely to increase in the future. With the construction of more high-containment BSL-3 and BSL-4 "hot" labs on the drawing boards, more dangerous pathogens will likely be shipped through or to densely populated areas.

In response to the terrorist attacks of Sept. 11, 2001, and the anthrax letters that followed in October, the U.S. began pouring money into biodefense research. Most of it is going to build a stockpile of vaccines and drugs (Bioshield funding) and a network of biosafety hot labs. The National Institute of Allergy & Infectious Diseases (NIAID) is funding research on a select group of potential bioterror agents.

Some scientists contend that the NIAID-funded research has little scientific or public health relevance. They believe--and NIAID officials deny--that this funding is being diverted from nonbiodefense research that would better serve the public and the economy.

These scientists also argue that the biodefense money is attracting scientists and institutions that have little or no experience in working safely with deadly pathogens. The critics paint the NIAID biodefense effort as a training program that will increase the pool of people with expertise in and access to bioweapons. They contend that the program is making the nation less safe and less able to deal with emerging infectious diseases.

Today, scientists in the U.S. and U.K. are inserting genes from the 1918 flu virus--the most deadly ever--into ordinary human flu viruses to learn how the 1918 virus killed. Many scientists insist this research is necessary to help protect us from future killer viruses, but many are also concerned that it is not being carried out under the highest biosafety level, BSL-4. This chimera virus is lethal, and if it ever escaped the lab, the significance of what the H2N2 virus might have wrought would pale by comparison.

U.S. researchers have sequenced and published five of eight genes of the 1918 flu genome. When the remaining genes are sequenced and published, anyone, working anywhere, with expertise and funding will be able to reconstruct the 1918 virus. What a terror weapon that would be.

The only weapon in our antiviral arsenal is oseltamivir, marketed as Tamiflu. Wide use of Tamiflu as a prophylactic could build up resistance in deadly viral strains--and then the cupboard could be bare, as bare as the flu vaccine cabinet last winter. Shouldn't some of the $5.6 billion in Bioshield money be spent on developing DNA-based vaccines that would relieve current production problems?

With WHO and CDC officials raising the specter of a possible imminent flu pandemic, why, as a nation, aren't we spending more on public health issues like new and emerging infectious diseases? Saying, as government officials have, that research on esoteric pathogens now being supported may also spill over to the public health arena isn't sufficient.

With accidents like the H2N2 saga, transportation of scary organisms on public highways, flu vaccine shortages, and killer infectious diseases on the horizon, it's time to rethink--and possibly redirect--biodefense spending. Because the biodefense program was ramped up so quickly after 9/11, too much money is being spent too quickly with too little planning.