Bio-defense Standoff

Sidelined: Major pharmaceutical firms spurn investing in bio-defense research because there's relatively little money in it. Meanwhile, the U.S. has countermeasures for only 13 of the world's top 50 pathogens, experts say.

March 02, 2003|By Julie Bell | Julie Bell,SUN STAFF

As a series of anthrax attacks terrorized the United States in October 2001, Health and Human Services Secretary Tommy G. Thompson launched a showdown with Bayer Corp. that would reverberate through an industry.

Unhappy with the discount the pharmaceutical giant had offered the government on Cipro, the first approved treatment for inhalation anthrax, Thompson told a congressional panel he was ready to seek a waiver of Cipro's patent and open the market to generic drug makers - an extraordinary move that potentially could cost Bayer hundreds of millions of dollars.

"Are you prepared, if Bayer does not cooperate with you, to do that?" Rep. Bernard Sanders, the Vermont Independent, asked pointedly.

"Yes, I am," Thompson said.

The threat pushed Bayer to slash its government price for Cipro. It also laid bare an inherent conflict between government and the only industry capable of developing new vaccines and medicines to protect Americans against biological attack.

Government, the sole potential purchaser of most bio-defense products, wants to buy them cheaply. But drug companies won't make a product unless they believe it will pay.

The result, critics say, is a virtual stalemate that has the world's largest, most accomplished pharmaceutical companies sitting on the sidelines and the national bio-defense effort in disarray.

It persists, even as citizens are warned to get ready for more bio-terror attacks and as U.S. troops prepare for war against Iraq, a country accused of stockpiling biological weapons.

"There is no guarantee that `If we build it, they will come,' " said venture capitalist J. Leighton Read. "There really is no reason to play for a rational, economic player."

Aventis Pasteur Inc., a leading vaccine maker, is among companies waiting for the federal government to say what new vaccines it wants to stockpile in what order, and for what price, before deciding whether to launch major efforts to develop them.

"In the case of our company, given the extraordinary sense of urgency and emergency, it seems most efficient to us to let the U.S. government and other governments take the lead in identifying the priorities," said Chris Grant, Aventis Pasteur's vice president of public policy and government relations.

Compounding the problem is a government-sponsored scientific research system that often begets more research rather than new products; government bungling of a previous bio-defense manufacturing contract, and a government contracting process that critics see as disorganized and disjointed.

What's more, industry representatives and consultants said Thompson's Cipro ploy has drug companies worrying the government will hammer down prices if they do succeed in developing a new drug or vaccine - a lengthy, expensive process fraught with risk of failure.

"Coercion just isn't an environment where science flourishes," said Dr. Michael Friedman, a Pharmacia Corp. executive who works on biomedical preparedness issues for the trade group Pharmaceutical Research and Manufacturers of America.

To be sure, the government has made fitful progress: The Health and Human Services Department has contracted to make enough smallpox vaccine to inoculate every American. The Department of Defense has hired DynPort Vaccine Co. of Frederick to research up to 17 vaccines, including a next-generation anthrax one. And BioPort Corp. of Lansing, Mich., is at work manufacturing a first-generation anthrax vaccine for the Pentagon after years of problems.

Few countermeasures

Still, a Defense Department advisory panel of experts recently estimated the country has countermeasures for only 13 of the world's top 50 pathogens, according to congressional testimony.

"I don't think the country has yet created a plan for what's needed," said Dr. Tara J. O'Toole, director of the Johns Hopkins University Center for Civilian Biodefense Strategies and a former U.S. assistant secretary of energy for environment safety and health.

President Bush's pledge in his recent State of the Union address to seek up to $6 billion over 10 years for bio-defense countermeasures isn't enough, she said.

"The future of bio-terrorism," she said, "is much scarier than what we are facing now."

Just what level of immediate threat citizens and the military face from biological weapons is a matter of debate. But what is undeniable is that the world's understanding of the inner workings of living substances is advancing at warp speed, increasing the potential to do both tremendous good and unprecedented evil.

In experiments at GenVec Inc. of Rockville, for example, tiny genetic payloads are encapsulated in viral envelopes that act like biological suitcases, carrying genes deep in the body where they direct the making of proteins with healing powers.

What if, scientists worry, similar processes were used to direct the making of harmful substances? Could they be designed to be contagious? Could an entire city be brought to its knees?

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