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Experts Call for New Approach to Biodefense

By Joe Fiorill
Global Security Newswire

WASHINGTON — Top experts see important gaps in U.S. President George W. Bush’s largest biological-defense initiative and believe a fundamentally different approach is needed, according to a study released today (see GSN, Oct. 4).

Project Bioshield does not address the threat of an attack using biologically engineered pathogens, according to 30 biological-defense leaders in the government, the drug industry and the academic world who were interviewed for the study by University of Pittsburgh and Sarnoff Corp. researchers.

Instead of seeking to spur development of specific drugs to fight existing agents, the experts said, Washington should invest massively in an effort to speed the processes by which new drugs are developed.

“The experts recommend that government, academia and private enterprise unite to create a new system to develop and approve antidotes quickly and affordably,” the authors wrote. “This is a major challenge, requiring interagency cooperation, coordination with dozens of entities and significant resources. It’s an effort on par with our push to put a man on the moon. But study participants believe such an effort is necessary because of the certainty and magnitude of the threat.”

The experts unanimously called a biological attack on the United States “a certainty,” with some expecting a strike using an existing agent and others predicting a new pathogen would be used. The researchers indicate biological engineering of new pathogens is considered “easy,” anonymously quoting one interviewee as saying, “Any high-school student can create genetically engineered organisms, so I think they will come.”

As a result, the experts believe “that an ‘organism-by-organism’ approach is not an effective long-term strategy for countermeasure development,” according to the study.
“The number of potential threat agents (and engineered agents) is much too large to have a ‘one-bug-one-drug’ approach. In the long term, new paradigms for countering infectious disease will be needed, and the overall drug-development process must be shortened,” the researchers wrote.

Development of a new drug currently takes more than a decade and costs $800 million, according to the study. The researchers did not specifically ask the experts how much time and cost could be trimmed from those figures, but one of the study’s authors, Sarnoff Senior Vice President for Government Operations Mark Lister, said yesterday in an interview that a reduction of “one to two orders of magnitude” is possible.

In calling for a program to shorten “bug-to-drug” times, the experts echoed the views of some House of Representatives Democrats, who in May introduced legislation to create such a program (see GSN, May 5). The Senate is contemplating legislation known as Bioshield II that would also address some of the weaknesses identified in today’s study.

According to the study, “many” of the interviewees favor a “one-stop shop,” either wholly or partly within the government, to implement their recommendations. The entity would coordinate the new strategy and serve as a clearly defined, single interlocutor for the industry.

Lister said the first step should be a “system analysis” of the current drug-development process, with an eye to speeding the process. Because of its experience in conducting such analyses and its familiarity with biological defense, he added, the Defense Department should take the lead.

Bioshield Has “No Impact,” Says Industry Figure

The interviewees not only faulted Bioshield’s lack of focus on overarching processes, but also said the program would do little to spur drug development anyway. Bioshield is intended to promote new development by creating a government-supported market for otherwise unprofitable countermeasures.

“Frankly, I don’t see a whole lot of support” for Bioshield among drug makers, Lister said. “Government doesn’t completely understand the market drivers that confront people in industry.”

The experts said drug makers would be dissuaded from responding to Bioshield by uncertain profits and the potential for huge lawsuits.

“Bioshield has no impact on us as an industry,” the authors quote one industry leader as saying. “What? Are they going to help us with purchasing? What would drive me to put a team on antibiotics when my commercial people are saying, ‘Don’t do it, there is no return on investment on it’?”

Some interviewees recommended more government incentives to drug makers, potentially including direct government funding of companies’ research and stronger market and price guarantees, to spur new countermeasure development.

The experts also identified potential liability for harm caused by new drugs as an obstacle to drug-maker interest in countermeasure development. “That’s first and foremost on the minds of people in industry,” Lister said.

Since testing for countermeasures developed under Bioshield will probably be done on animals, the researchers wrote, “It is possible that the first time that a countermeasure is used in humans — possibly on thousands or even millions of people —would be during a crisis. This scenario has the potential to expose the developer to a significant level of liability because of side effects or lack of efficacy in humans, and many firms are unwilling to shoulder that liability exposure on their own.”

The 30 experts interviewed were listed in the study, and direct quotations from them were included without attribution by name. The experts included the director of the Johns Hopkins Bloomberg School of Public Health’s Center for Immunization Research, Donald Burke; GE Healthcare Technologies President Joe Hogan; the acting deputy assistant to the defense secretary for chemical and biological defense, Klaus Shafer, and a former occupant of the post, Anna Johnson-Winegar; Science Editor-in-Chief Donald Kennedy; former Merck Chief Executive Officer Roy Vagelos; and acting Food and Drug Administration Deputy for Operations Janet Woodcock.