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Legislation would reward drug companies for combating bioterror

WASHINGTON—Desperate for vaccines and medicines to ward off such deadly threats as anthrax, Ebola, smallpox and avian flu, Congress wants to give drug companies a new incentive: cash up front.

President Bush signed legislation Tuesday that creates a somewhat controversial bureaucracy that would give tax dollars to private companies and universities to develop vaccines and treatments.

Scientists would contract with the federal government to take on manmade terrorist threats and naturally occurring pandemics, as well as chemical and radiological threats.

The public-private partnership—akin to the way the Defense Department buys fighter jets—could be a boon for the growing number of biotechnology companies.

But some of the new program's work also would be shielded from public scrutiny, which critics say could stymie necessary oversight and lend the false impression internationally that the United States is developing biological weapons.

The bill was shepherded through Congress by Sen. Richard Burr, R-N.C., who spent two years fending off critics and trying to shape a new program palpable to biotechnology companies and to Secretary of Health and Human Services Michael Leavitt.

The law creates the Biomedical Advanced Research and Development Authority, known as BARDA. Its director, reporting to Leavitt, would control the money to dole out for advanced research on a host of vaccines and countermeasures.

"We're becoming their venture capitalist," Burr said Tuesday of companies that would receive the money. "And the advantage is we get to look at their data every day if we want to."

The law was lauded by biotechnology and drug companies, which worked closely with Congress to write the bill.

"We are very happy with this bill. But this is not the end solution to biodefense," said Chris Colwell, who directs health care and regulatory affairs for BIO, a national biotechnology industry group.

The money, $1.07 billion over two years, would be used to help biotechnology companies make the leap from initial research to ready-to-buy procurement—a gap known now as the "Valley of Death."

"It looks like a pretty exciting possibility," said Jonathan Smith, chief science officer for AlphaVax in Durham, N.C., a biotechnology company working on vaccines for half a dozen exotic killers.

Smith said his company could seek funding immediately to further its work on vaccines for ebola and similar viruses. The vaccines protect nonhuman primates against infection, he said, and could go to first-phase safety trials in humans.

"I think there's a fairly general acceptance among scientists that this is a well-done act," Smith said.

Biotech companies often have little incentive to forge ahead on products in biodefense, in which the federal government is the sole market, said Brad Smith, a senior associate at the Center for Biosecurity at the University of Pittsburgh.

"Drug development is an extremely high-risk process that can take years and years," said Brad Smith, who advised members of Congress on the bill. "Building a partnership where government and industry share risks with each other makes a lot of sense."

The new law has critics, though.

When the legislation was introduced in 2005, some scientists and advocacy groups were outraged that it would exempt the entire authority from the Freedom of Information Act. No other government agency has such a broad veil of secrecy.

The act signed into law Tuesday contains a provision prohibiting disclosure of "technical data or scientific information" that would reveal vulnerabilities of the nation's defenses that aren't publicly known. Defining that trigger is up to the secretary of health and human services.

Lynn C. Klotz, a former Harvard scientist and industry consultant, calls the new, more narrow language better, but still troublesome.

"I'm worried that too much of what they do would still remain secret. I don't think there's going to be much oversight," said Klotz, a senior science fellow at the Center for Arms Control and Non-Proliferation in Washington.

He added that other countries could assume that the United States is doing nefarious work.

"It's the extreme secrecy which makes everybody suspicious of us," Klotz said.

Michael Stebbins of the Federation of American Scientists said that although BARDA is needed to develop new biodefense products, the secrecy could prevent any information from coming out.

"The best way to have oversight is to release it to the public," said Stebbins, the director of biology policy for the federation. "Transparency will always give you better oversight and better bang for your buck."

Burr, though, said it would be irresponsible to reveal any vulnerabilities to the nation's defenses.

"Where it might provide our enemy some advantage, I think we have a right and commitment to withhold that information from the public," he said. "We have an obligation."


(c) 2006, McClatchy-Tribune Information Services.

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