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U.S. to pay for disease defense

Area drug makers may reap benefits

- Washington Correspondent

Published: Wed, Dec. 20, 2006 12:00AM

Modified Wed, Dec. 20, 2006 05:43AM

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WASHINGTON -- Desperate to ward off the nation's most-feared biological threats, the government will give drug companies a new incentive: cash up front.

President Bush on Tuesday signed legislation to give tax dollars to private companies and universities to develop vaccines, medicines and treatments.

Scientists would contract with the federal government to take on man-made terrorist threats and naturally occurring epidemics such as Ebola, anthrax and avian flu, along with chemical and radiological threats.

OTHER BILLS SIGNED

President Bush on Tuesday also signed bills to raise federal funding for autism and shift AIDS money to rural areas and the South.

THE AUTISM BILL increases federal funding by 50 percent for the disorder, which afflicts 1.5 million people in the United States.

Congress voted Dec. 7 to significantly increase federal funding to identify the cause of autism, now diagnosed in one in 166 children. The Senate, acting a day after House passage, approved on a voice vote legislation that authorizes $945 million over five years for autism research, screening and treatment.

The legislation provides the National Institutes of Health with a list of possible research areas related to autism spectrum disorder, including an examination of whether the increase in autism diagnoses is caused by environmental factors.

THE AIDS LEGISLATION will shift care and treatment money to rural areas and the South.

The House on Dec. 9 agreed by voice vote to renew the $2.1 billion-annual Ryan White CARE Act. The Senate passed the bill earlier after senators from New York and New Jersey dropped their opposition, accepting a compromise that settled months of dispute just as Congress adjourned for the year.

AIDS began as a big-city epidemic affecting mainly gay white men. The updates, the first since 2000, aim to spread money more equally around the country. Previous law had counted only patients with full-blown AIDS. The revision also counts patients with HIV who have not developed AIDS. That change favors the South and rural areas, where the disease is a newer phenomenon.

The Associated Press

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The public-private partnership -- akin to the way the U.S. Department of Defense buys fighter jets -- could be a boon for the growing number of biotechnology companies, including several in the Triangle.

But some of the program's work also would be shielded from public scrutiny, a veil that critics say could inhibit oversight and give the false impression abroad that the United States is developing biological weapons.

The bill was shepherded through Congress by Sen. Richard Burr, a Republican from Winston-Salem, who spent two years fending off critics and trying to shape a program acceptable to both biotechnology companies and U.S. Secretary of Health and Human Services Michael Leavitt.

"I think this may be one of the most significant things I do while I'm in Washington," Burr said.

The law creates the Biomedical Advanced Research and Development Authority, known as BARDA. Its director, reporting to Leavitt, would have control of 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, the 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 as the "Valley of Death."

It 'makes a lot of sense'

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

Smith said his company could immediately seek funding to further its work on vaccines for Marburg and Ebola. The vaccines protect non-human primates against infection, he said, and could next 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 who advised members of Congress on the bill.

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

Burr said that in the Triangle, pharmaceutical companies such as GlaxoSmithKline, Merck and Novartis are deepening their work on vaccines, building plants or conducting early research that could be further supported by the new federal authority.

"Given that we have some of the leading research in the country, this could be a huge impact on North Carolina," Burr said.

Washington correspondent Barbara Barrett can be reached at (202) 383-0012 or bbarrett@mcclatchydc.com.

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