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WASHINGTON -- The U.S. public health and national security sectors have not yet developed an effective strategy for preventing terrorists from acquiring potentially lethal materials used to produce everyday pharmaceutical products, according to one issue expert (see GSN, Jan. 25).
(Feb. 26) -
U.S. Marines wait to enter a collapsed building simulator during a biological terrorism response drill in 2001. The United States has not taken adequate measures to prevent terrorists from acquiring dangerous materials used in pharmaceutical products, an expert said (Mark Wilson/Getty Images).
Military, diplomatic and associated security agencies have driven the effort to prevent proliferation of biological weapons, Brian Finlay, a senior associate at the Henry L. Stimson Center, said in a new report. However, those organizations traditionally employ a "guards, guns and gates" strategy that is appropriate for safeguarding government-controlled nuclear materials but less likely to succeed within the rapidly expanding, private-sector biotechnology field, he said.
Meanwhile, the U.S. Health and Human Services Department and its component agencies have been reluctant to make national security a part of their mandate, Finlay argued.
"What we're trying to do is still take national security paradigms and kind of cram it into the public health world. And it's a world, unfortunately, that folks on the national security side don't understand all that well," he told Global Security Newswire earlier this month.
Extremists could exploit this situation to cause havoc, if not a great number of deaths, Finlay said: "You could certainly create a whole lot of panic, and obviously the anthrax incident of 2001 is indicative of what even a small amount of this bad stuff can do to disrupt operations" (see GSN, Feb. 22).
Bioterrorism has been considered a significant threat for years, though actual incidents in the United States have been limited in number and scope. Five people were killed in the anthrax mailings nearly a decade ago, while the toxin ricin was found in 2004 at a Senate mail room in Washington and occasionally turns up elsewhere around the country (see GSN, Nov. 20, 2009).
In warning of the looming potential for an act of WMD terrorism, a congressionally mandated commission led by former Senators Bob Graham and Jim Talent asserted last year that bioterrorism was a greater danger than an attack involving a nuclear weapon.
The U.S. government has taken a number of steps to protect the country against the widespread dispersal of a disease agent such as anthrax, smallpox or plague. Among the initiatives are the Biowatch program for detecting airborne biological agents in major cities and the Project Bioshield effort to promote production of WMD countermeasures.
New legislation sponsored by Senators Joseph Lieberman (I-Conn.) and Susan Collins (R-Maine) would boost security at U.S. biological research sites (see GSN, Nov. 5, 2009).
These measures do not go far enough to address the threat, which must be considered global, according to Finlay.
"As a result of the biotechnology revolution and the very nature of the bioweapons threat, it has become increasingly difficult to distinguish between legitimate pharmaceutical research and offensive bioweapons development. What is a legitimate biotech enterprise one day might easily become an offensive bioweapons research and development facility the next," he said in the new report, "Pharmaceutical Terror: Getting Health Care Reform Right."
Governments are responsible for only a small amount of leading-edge biotechnology and drug development, giving authorities little control over what happens in that field, Finlay said. This is cause for concern as the number of companies using dangerous materials increases "exponentially" and there is no protocol to prevent their diversion, his report states.
"There are companies out there ... [that] will go out and essentially kind of meet the security bar that is created by government. They do the minimal [amount] that sort of is required to comply with legal regulations," according to Finlay. "Unfortunately, we have very few companies -- at least that we can tell in our research -- that have gone the extra mile in ensuring a very rigorous control over their supply chain."
The Stimson report cites a British firm that conducted clinical trials on a product that contained lethal botulinum toxin in Iran, a nation suspected in some quarters of having a biological warfare program. Meanwhile, a recent Washington Post article indicated the possible existence of dozens of illicit facilities in Eastern Europe and beyond producing botulinum for the wrinkle-smoothing cosmetic Botox.
A number of companies use minute amounts of select agents -- materials designated by the Centers for Disease Control and Prevention as posing a significant threat to human health -- for what are intended to be beneficial products, Finlay said. There are at least eight companies around the world producing Botox-like products, and others employing the toxins ricin, conotoxin and tetrodotoxin. The number of products undergoing research and development dwarfs the count of those being produced, the researcher said.
As the number of companies using these materials grows, so does the risk that terrorists might acquire them, Finlay said.
The more than 1,200 companies, research institutions and other organizations represented by the Biotechnology Industry Organization "by and large" do not work with select agents themselves, Phyllis Arthur, the trade group's health care regulatory affairs director, told GSN today. "Most of the time they do a lot of that work with outside labs, many of which are government labs," she said.
"Biotech companies take internal security extremely seriously and do a lot to ensure that these pathogens are secured. But they are not the primary holder of the [materials] most of the time," Arthur said.
While it would be nearly impossible to extract enough of a toxin to conduct a widespread attack, terrorists could collect a sufficient amount to create a "weapon of mass disruption," according to Finlay. "Suddenly you've got four people in the [U.S. Senate] Hart office building that die of botulinum poisoning," he said.
More worrisome is that terrorists could get their hands on the technology used to produce the substances, he said.
The United States is not well prepared to respond to this threat, Finlay added.
The Food and Drug Administration, a branch of Health and Human Services, has no particular assignment for national security, and would make licensing decisions based on the safety and efficacy of a product rather than its proliferation potential, the report says. The agency could consider a license for application for a drug that was produced using foreign research that would be banned in this country, it adds.
Similarly, Homeland Security's Customs and Border Patrol might also not focus on proliferation risks posed by products entering the country, according to the report.
Health and Human Services did not respond to a request for comment. A Homeland Security Department official said the agency would not respond directly to the report, but noted that certain pharmaceutical production facilities are required to conduct security vulnerability assessments and enact safeguards plans.
Anyone bringing biological specimens into the country could also be required to submit a permit from the U.S. Agriculture Department or the Centers for Disease Control and Prevention to border personnel, the official added.
There are a number of strategies for addressing the vulnerabilities addressed in the report, including upgrading the Food and Drug Administration's authority to consider national security in making regulatory decisions and improved monitoring of products to their final destinations, Finlay said.
Health care legislation passed last fall by the House of Representatives includes a clause that would prohibit the Health and Human Services Department from licensing a biological product before being assured by national security and drug enforcement agencies that it would not pose a danger to the public. The Obama administration should keep such measures in mind as it continues to press its health care effort, Finlay argued.
"I believe there needs to be a diminution of the stovepipes between national security and public health so that they work more seamlessly toward a common goal without needlessly stymieing innovation in this country and around the world," he told GSN.
Balance is needed to ensure that any security upgrades do not restrict disease research intended to benefit the public, Arthur asserted.
"Let's make sure we're paying attention to not hampering innovation, so universities and the government labs and companies work together to make these very important medical countermeasures," she said.