U.S. Response:  Pentagon Urges Fourfold Increase in Biotechnology Funds

By Bryan Bender
Global Security Newswire

WASHINGTON — The U.S. Defense Department should quadruple its overall annual investments in biological science and technology research from $250 million to $1 billion a year, according to a new Pentagon study that says the military has failed to exploit developments in the life sciences.

The Defense Science Board, an internal Pentagon advisory group, completed a report this month recommending that the military immediately undertake a 20-year effort to dramatically reduce the time it takes to make viable drug treatments available once a new pathogen has been identified.

“A credible defense to deter biological warfare will require [the Defense Department] to tap promptly and effectively into the vast and expanding expertise in biotechnology,” says the report, Defense Science and Technology.  “Currently, [Defense Department] relationships with industry and academia are weak in this area, with limited expertise within the military.”

The study was headed by Anita Jones, a former Pentagon director of defense research and engineering, and Larry Lynn, a former director of the Defense Advanced Research Projects Agency and assistant secretary of defense for advanced technology.

Catch-Up With Biotechnology Industry

The study concludes that the Pentagon is poorly prepared for the threat of biological warfare — terrorists can already choose from a menu of more than 100 naturally occurring microorganisms — because it has not taken advantage of commercial advances in the life sciences over the past two decades.

“The department has largely failed to exploit the rapid developments in the life sciences, and as a result is behind in its ability to combat the threat posed by these advances and to attract the necessary talent to develop the needed capability,” it says.

In 1980, venture capitalists invested $500 million in healthcare, but in 2000 those investments totaled $5 billion, according to the report.  The military, by substantially increasing its annual expenditures on biological science and technology research, can help reorient parts of the biotechnology community away from civilian lifesaving and commercial opportunities — its primary focus — toward military biological defense concerns, the report says.

According to the science board, the military’s biotechnology interests cover a variety of areas including agent-defeat weapons and technology for indications and warning, characterization and response, detection, prediction and protection.  These capabilities, however, must address both known and unknown biological agents, according to the report.

“The nature of the agents used might be very different than expected and thus could defeat warning and response systems,” the report says.

Bug-to-Drug in 24 Hours

Rapid identification of biological agents and their appropriate treatments is a major challenge, according to the study.

“Biological weapons are weapons of terror because the United States lacks adequate therapeutic responses,” it says.  “The ability to generate a therapeutic response and control of the consequences would be a deterrent.”

Shortening what the science board calls the “bug-to-drug” process of drug development requires a 20-year program at a cost of at least $100 million per year to compress key elements that currently take between 10 and 15 years and cost an estimated $500 million per drug.  Under this program, the Defense Department should set 2005 as a goal for compressing the bug-to-drug process from years to months, the study says.  Meanwhile, researchers should develop therapeutics for the top 50 known biological warfare agents.

By 2010, the report calls for compressing the drug development process to weeks and dramatically shortening toxicity and safety screening for new drugs.  The drug manufacturing process should be compressed by 50 percent and the construction of large manufacturing facilities should be initiated, the study says.

“By 2020, the [Defense Department] should create the capability to compress the overall process from identification of a new pathogen to a viable drug to 24 hours” under emergency conditions, according to the report.  Manufacturing facilities should initiate production, “and the process for emergency manufacture should be brought to within days or weeks.”

The project will require “significant collaborative efforts” between industry, academic and government personnel, according to the report.  “The collateral benefits and implications for world health are staggering.”

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Anthrax:  Field Tests Unreliable, White House Says

The Bush administration has warned that field tests used to detect anthrax when suspicious materials are discovered are too unreliable, the Associated Press reported Saturday (see GSN, May 28).

“This equipment does not pass acceptable standards for effectiveness,” said John Marburger, director of the White House Office of Science and Technology Policy, in a memo to be issued today to local officials, emergency responders and more than 250 federal agencies.  “Field testing ... is not recommended and should not be used.”

Anthrax field tests often issue false positive results or fail to detect trace amounts of anthrax, according to a study conducted jointly by the Centers for Disease Control and Prevention and the FBI.  The White House memo advises officials to stop purchasing the tests and to cancel any outstanding contracts, AP reported (Laura Meckler, Associated Press/Yahoo.com, July 20)

As a “stopgap” measure, the memo advises officials to take samples to a CDC-approved laboratory for testing, said an administration official.  Initial results can be determined within six hours, the official said.

President George W. Bush has noted that the United States is seeking to work with private companies to develop more capable field tests, the official said, adding that one flaw in the currently available field tests is a lack of performance standards.  The National Institute for Standards and Technology is working to develop a set of uniform performance standards for anthrax field tests, the official said (Mike Nartker, GSN, July 22).

The Office of Science and Technology Policy memo also includes guidelines for handling suspicious mail and recommends that U.S. agencies stop testing mailrooms for anthrax, since most mail is now irradiated (Meckler, Associated Press).

FBI Continues Broad Search

Meanwhile, the FBI is continuing to conduct a broad investigation into last fall’s anthrax attacks and has not yet ruled out a foreign source, Time magazine reported in its July 29 issue (see GSN, July 8).

While the FBI has focused its “Amerithrax” investigation on 50 U.S. biological weapons experts, the bureau still maintains a large pool of potential suspects, according to Time.  Investigators are continuing to consider several other biological scientists as well as businesses that could have profited from the attacks, Time reported.  They also have looked for evidence of anthrax in the remains of the hijackers onboard the Sept. 11 aircraft, which crashed in Pennsylvania and the Pentagon.  None was found.

“Remember, it doesn’t have to be a top scientist,” said a U.S. investigator.  “It could just be a good bench technician” (Cooper/Shannon, Time, July 29).

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