Democrats propose plan to boost biological defenses

Seeking to plug what they called a gap in President George W. Bush's plan to strengthen U.S. biological defenses, House Democrats Tuesday introduced legislation intended to shorten the time required to develop drugs to counter new varieties of infectious agents.

Led by Jim Turner of Texas, the top Democrat on the House Select Committee on Homeland Security, the lawmakers emphasized the danger that could be posed by new pathogens resulting from biotechnological advances.

"The RAPID [Rapid Pathogen Identification to Delivery] Cures Act is a wake-up call for America. … The question is, will the president lead?" Rep. Sheila Jackson Lee, also a Texas Democrat, said at a ceremony launching the bill and a related report by Turner.

"We went many miles to seek out weapons of mass destruction. We looked far and wide, yet here we are in a nation where the wake-up call has not yet been heeded," Jackson Lee said.

According to the report, Bush's Project Bioshield, whose legislative incarnation has passed the House but not the Senate, would not promote development of "protections for tomorrow's biological weapons threat."

"Bioshield is targeted at addressing classical agents, not the laboratory-altered pathogens of the future. In addition, it relies on the current process of drug and vaccine development, which takes an average of 14 years before a new medicine is available. As a consequence, our protective biodefenses are essentially static and unmoving in the face of a threat that is highly variable and unpredictable. As illustrated by SARS [severe acute respiratory syndrome], we lack effective countermeasures and a nimble way to develop and field them," Turner wrote.

As a result, Turner introduced the RAPID Cures Act, intended primarily to promote technological advances that would speed development of countermeasures against new threats. The bill envisions technological measures such as rapid screening of existing drug libraries during an outbreak, as well as efforts to overcome what the Democrats called pharmaceutical companies' current preference for developing lucrative "lifestyle drugs" ? medicines that combat impotence or baldness, for example ? rather than antibiotics and vaccines.

At yesterday's gathering, Turner claimed bipartisan support for the measure in the homeland panel and the Armed Services Committee. Lee and Del. Donna Christensen, D-V.I., who is a medical doctor and former public health official, joined Turner at the event.

According to the text of the bill, it typically costs $800 million and takes at least 10 years to discover, develop and secure approval of a new drug. Although Congress has approved shortened testing and approval processes in emergencies, the bill indicates, "it will likely still take years for even an experimental treatment or vaccine to become available."

"There is no coordinated, focused research and development program or overall national strategy to achieve significant and dramatic reductions in the time frame from the identification of a pathogen to the development and emergency approval for human use of reasonably safe and effective new biodefense medical countermeasures against a previously unknown or engineered pathogen or toxin," the bill reads.

"Even utilizing existing technologies," it continues, "there is no organized capability in the public or private sector to rapidly screen drug candidates for potential therapeutic activity against pathogens; develop and manufacture drug, biological or medical device products; or test already approved treatments for efficacy against a previously unknown or engineered biological threat that puts our deployed armed forces or the homeland at risk."

Biosecurity expert Brad Smith called Project Bioshield an "important first step" toward improving U.S. defenses but echoed Turner's view that the administration plan would not promote development of new countermeasures the United States is likely to need.

Smith, a fellow at the University of Pittsburgh Medical Center's Center for Biosecurity, stressed the need for new research tools, a different approach to science and technology and possibly changes in business development processes. The U.S. drug development pipeline, he said, is short on antibiotics, antivirals, vaccines and rapid diagnostics, while the potential of existing-drug libraries at the National Institutes of Health and elsewhere is being insufficiently tapped.

"The kind of approach that is advocated in the bill introduced by Representative Turner is on the right path," Smith said. "If you have something like SARS sweeping across the country," he said, "you don't necessarily have 10 to 15 years" to develop a new drug.

Asked about the potential for drastically shorter "bug-to-drug" time frames, he said, "The important thing is that, right now, we need to look at things that probably do seem amazing."

A bioterrorism strategy introduced last week by the heads of the Health and Human Services, Homeland Security and Defense departments indicates the Bush administration is working to accelerate the development of countermeasures. The abridged, public version of the document does not specifically address the concerns raised by the Homeland Security Committee Democrats.

"The proliferation of biological materials, technologies and expertise," the administration said in the document, "increases the potential to evade our existing medical and nonmedical countermeasures. To address this challenge, we are taking advantage of these same technologies to ensure that we can anticipate and prepare for the emergence of this threat. We are building the flexibility and speed to characterize such agents, assess existing defenses and rapidly develop safe and effective countermeasures."

By passing Turner's bill, Congress would declare a U.S. policy of promoting technological advances to reduce countermeasure development time and would amend laws including the Homeland Security Act to reflect the policy. Congress would authorize $10 million to implement the plan in fiscal 2005 and would require the three department heads to submit a strategy for achieving the bill's goals within six months of passage.

The Turner bill would also require Health and Human Services within six months to set up a system for rapidly establishing programs to study the safety and effectiveness of new and existing drugs that could be used against new threats.