Don’t Feed the Bioterrorism Threat

in Program

By Brian Finlay – Residents pour into the subway in rush-hour haste. They are met by five coordinated terrorist releases of sarin, a deadly nerve agent. A dozen people die, fifty more are severely injured, nearly a thousand are temporarily disabled.

This could be an emergency planning drill in any of a dozen large US cities. Except that the attack really happened in Tokyo-fourteen years ago in March. The perpetrators were members of Aum Shinrikyo, a Japanese doomsday cult, and the incident was an early wake up call to the potential for catastrophe when terrorists are armed with weapons of mass destruction.

Today, the threat remains, enhanced by a world in which biological and chemical agents are increasingly available to any interested terrorist. In December, a bi-partisan Congressional Commission declared a 50% or greater chance of a terrorist attack involving a nuclear or biological weapon. Shockingly, these odds represented the probability of an attack over the next five years.

The same Commission concluded that terrorists are more likely to obtain a biological weapon because of the spread of biotechnology around the globe. This is both the good and bad sides of a world in which innovative new medicines are being developed in India, South Africa, Brazil, Cuba, China and dozens of other countries. The spread of biotechnology has yielded unprecedented advances for the human condition. But it has also increased the availability of pathogens and technologies that can be used for sinister purposes.

In a globalized world, bioweapons can be made as easily in a ramshackle hut in the frontiers of Pakistan as in a fully equipped Western laboratory. From the tragedy of 9/11 we learned that government’s primary mode of organization-policy silos across functional areas within distinct departments and agencies-leads to isolation and competition, rather than communication and cooperation.

Yet-and despite the urging of successive Commissions and panels of experts-the United States government provides little structure and often no mandated collaboration among national security, homeland security, and public health agencies. This leaves open wide windows of opportunity for would-be bioterrorists and governments bent on developing biological weapons.

For instance, the US Food and Drug Administration is active on development and approval of vaccines and counter-agents, but has no apparent responsibility to consider homeland and national security when it makes decisions to approve products for the US market. In the case of one product before the agency now, and as reported recently in the Washington Times, its manufacturer has exported the product to Iran despite its containing botulinum toxin-the most deadly substance known to man. This same company initiated a series of clinical trials of this product in Iran. According to government sources, this may well have involved sharing of sensitive information that would advance Iran’s suspected offensive biological weapons program.

Another foreign company is using recombinant DNA technology to generate functional, longer lasting forms of botulinum toxin. While potentially beneficial to patients, such knowledge would be incredibly dangerous in the hands of a would-be bioterrorist. US law forbids such dangerous research in the United States. However, nothing prevents the company from undertaking this research abroad and then seeking US FDA approval for the product that emerges from their forbidden activities. In both cases, the inability of US national security and public health agencies to work together may yield new opportunities for nefarious activity.

Despite these recent failures to properly police activities that feed bioterrorism, new evidence suggests that the Congress and the White House are awakening to the new realities of globalization and terrorism. In legislation introduced this month, Senator Sam Brownback (R-KS) would prohibit FDA from approving a pharmaceutical product that bears or contains potentially dangerous substances, if the applicant marketed or provided those substances to the Islamic Republic of Iran or an institution within the country.

Similarly, in a bill designed to expedite development of “generic” biologic products or “biosimilars,” Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) wisely address problems created by certain dangerous ingredients. These products could only be approved under the shortened biosimilar approval process if FDA consults with national security and other agencies and determines there is no threat to national security or public health.

In another sign of greater consciousness about restraining-and not feeding-the bioterror threat, the President has nominated the brilliant physician and former New York City health commissioner, Dr. Margaret Hamburg, to be the next head of the FDA. Among her many accomplishments, she is a renowned expert in bioterrorism.

These are all positive signs that FDA and other public health agencies may take more seriously their role in cooperating with national security agencies to prevent bioterrorism. We can hope, as well, that they set an example for breaking down the stovepipes throughout government that hinder our efforts to mitigate other terrorist threats. All this may counter and prevent the Commission’s grim finding that we will probably be victimized by a deadly attack before 2013.

Photo Credit: National Institute of General Medical Sciences

 Brian Finlay directs the Managing Across Boundaries Program and co-directs the Cooperative Nonproliferation Program.

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