FEATURE ARTICLE

August 2005

Congress Poised to Act on Weak Bio-Preparedness

by Joe Pappalardo

Flaws in the U.S.’ current defenses against dangerous diseases are numerous and institutional, according to experts. In response to these shortcomings, key congressional leaders are vowing action to fix the problems.

Speakers at a recent bioterrorism and infectious disease conference, hosted by Georgetown University, generally agreed that the United States lagged in many areas of bio-defense, including the quality of detection equipment, the readiness of hospitals to accept mass casualties, the ability of state and local governments to distribute vaccines and the willingness of the private sector to develop countermeasures to probable biological weapons.

“For the next 20 years we are going to have gaps that a willful terrorist will be able to walk through,” said Michael McDonald, president Global Health Initiatives, a medical information and technology company.

Also troubling were assertions that efforts to thwart naturally-occurring diseases, which pose an equal or greater threat, were not given as much attention as deliberate releases.

High on the list of worrisome emerging diseases is avian flu. Because all influenza viruses have the ability to change, scientists are concerned that the virus could one day be communicable between humans and become a pandemic, according to the Centers for Disease Control. Human immune systems have little protection against influenza strains starting in animal populations.

The threat from avian flu “exceeds by an order of magnitude” a biological al-Queda attack, said Richard Falkenrath, a senior fellow at the Brookings Institution, who until May 2004 served in the White House as deputy assistant to the president and deputy homeland security advisor. “I do not think our response is commensurate with the risk.”

Even worse, if a treatment or vaccine existed, “not a single city or state is able to distribute it from the tarmac in a significant time frame,” Falkenrath said.

He added that if a manmade, mass-casualty attack had been identified and the only unknown aspect was the timing, the government would show a more robust response. However, in the case of a strain of avian flu, he said the response has been sluggish.

Key politicians agree, and legislative action is high on the list of some influential agenda-setters.

“In essence, we have no vaccine for avian flu. Nor do we have enough of the anti-viral agent Tamiflu to treat more than one percent of our population for avian flu,” said U.S. Senate Majority Leader Bill Frist, R-Tenn., during a speech at Harvard University. “Though not as initially dramatic as a nuclear blast, biological warfare is potentially far more destructive … (and) distressingly easy to wage.”

Frist called for a “Manhattan Project for the 21st Century” to protect the nation and the world from infectious disease.

Legislative efforts come with the understanding that the initial post-9/11 response, a bipartisan law called Bioshield, has not worked. One of its key sponsors, Sen. Joe Lieberman, D-Conn., told conference attendees that many key aspects of that law have not performed as he wanted. Perhaps most critically, Lieberman said, “the bio-pharmaceutical industry yawned” at the government incentives to promote protective research.

The 109th Congress is moving on this issue, and members of both political parties are signaling out the issue as a priority.

Frist is one sponsor of the “Protecting America in the War on Terror Act of 2005,” designated by him (as majority leader) as Senate Bill 3. The bill’s low number indicates its importance in the order of issues to be tackled by Congress.

Lieberman, along with Republican Senators Orrin Hatch of Utah, and Sam Brownback of Kansas, also offered a bill, S.975, dubbed Bioshield II. The bills share several main points, several of which are sources of heated debate.

Among them is the level of legal protection offered to those who develop, distribute, prescribe and administer countermeasures in the event of an epidemic. Congress could do this by broadening the Safety Act to include liability protection prior to an epidemic, a move Lieberman conceded is “controversial.”

Other “business friendly” measures include waiving anti-trust laws to allow companies to dominate vaccine markets and providing tax incentives to domestic companies to develop and manufacture vaccines and countermeasures.

Lieberman’s bill also puts forward a “wild card patent,” which grants a two-year extension to a drug maker’s exclusive patent for a product that combats a known biological threat. Also, the patent holder could apply those new rules to any drug in its inventory, even if it has nothing to do with thwarting an epidemic. The rule could add up to millions or billions of dollars in profits for the patent holder, at the possible expense of generic drug makers.

For Bioshield or any similar legislation to work, Lieberman said, rewards must be given only to products that have proven themselves to be effective. He advocated “setting up rewards at the goal-lines.”

“We’re not following a defense contractor model because we don’t believe it will work,” he said.

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