On Call

Infectious disease expert Anthony Fauci lands front and center in the nation's biodefense program.

Dr. Anthony Fauci can tell you exactly where he was on June 5, 1981. It was on the same National Institutes of Health campus in Bethesda, Md., where he still works.

"I was sitting in my office across the lawn in Building 10 . . . when I got the first morbidity and mortality weekly report of five cases of pneumocystis carinii pneumonia in gay men in Los Angeles," he recalls.

Those cases were the first signs of what would become an HIV pandemic. After similar reports a month later, Fauci, who headed one of the NIH laboratories focused on the immune system, decided to redirect his research to the mysterious new disease. The move would place him at the center of the fight against HIV and AIDS, as a researcher, clinician and administrator, for the next two decades.

Twenty-five years later, as director of NIH's infectious diseases branch, Fauci is once again at the core of a nascent federal effort: this time, biodefense.

He recalls with similar clarity the fall of 2001, when the Sept. 11 terrorist attacks and anthrax mailings suddenly made developing drugs to fight biological warfare agents a federal priority. In conversations with federal leaders as high as President Bush, Fauci says, the simple recurring question was, "Can this be done?"

"Will you be able to take the responsibility of developing a robust research program to help us understand these microbes enough . . . to efficiently develop counter- measures?" Fauci recalls them asking. "And the answer was, 'Yes, we'll meet the challenge.' "

That response seems to sum up the Brooklyn native, an amicable but no-nonsense figure who reels off succinct sentences in a staccato New York accent. Fauci works tirelessly, routinely clocking 14-hour days and still visiting HIV patients on Wednesdays and Fridays. He works most of Saturday and a few hours on Sunday when "things get tight."

Things were extremely tight in 2001, when Fauci found himself in charge of an enormous federal initiative nearly overnight: funding basic research to pave the way for the development of bioterror counter- measures. NIH's National Institute of Allergy and Infectious Diseases was tapped as the lead agency, he says, because its history of preparing for naturally occurring diseases parallels the type of research needed on man-made microbes.

But since 2001, the agency's work has expanded from basic research to advanced development, provoking critics from industry and Capitol Hill, who say NIAID is overstepping its bounds. This alleged "mission creep" has Fauci's agency in an area beyond its expertise, they charge, putting taxpayer-funded projects in competition with the private sector.

"How are we not competing with the private sector [firms] that, for free market reasons, are pursuing these projects?" Rep. Todd Platts, R-Pa., asked Fauci at a House Government Reform subcommittee hearing in June 2005.

Fauci says his agency is trying to partner-not compete-with industry by helping biodefense firms reach a point in development where they can "take the ball and run" toward a successful countermeasure drug and procurement under Project BioShield. The $5.6 billion federal program is aimed at buying biodefense products and luring private firms to develop them.

Fauci says congressional revisions to BioShield, which omitted funding for the costly advanced drug development stage, created a gap that NIAID had to fill-biodefense being too risky for most firms to invest in otherwise.

"You can say, 'Well, the companies should be doing it and why should the federal taxpayer money go into any aspect of it?' And the answer is, you could think about that all you want, it's not going to happen," Fauci says.

Industry representatives blame the government for the tepid biotech response. It failed to set the market, they argue, stating clearly how many and what kinds of products it intends to buy, so that companies and investors could gauge the risk involved in developing them.

Many observers agree with Fauci's view that his agency is filling a gap. They say it makes sense in the incipient stages of the federal biodefense effort that leaders would turn to someone of his stature. The Cornell University Medical College graduate came to NIH in 1968 and has pioneered the field of immunoregulation and made seminal contributions to understanding how the AIDS virus destroys the body's defenses, among other achievements. He has headed NIAID since 1984, managing a research portfolio that ballooned from about $1 billion when he arrived to $4.4 billion in fiscal 2006.

Still, Fauci's involvement in BioShield has created the perception among some that he is the gatekeeper to biodefense procurements and that companies funded through NIH go on to lucrative awards while others are shut out. "There's no other mechanism to enter into the pipeline," says a Senate staffer who follows the issue and asked to remain anonymous.

Fauci forcefully rejects that accusation. "The NIH can be helpful by clarifying and developing concepts [to] show that a particular concept will work as a vaccine or as a countermeasure," he says. "But I think there's been this false impression that if you don't go through the NIH system, you'll never get a BioShield contract. That's just not correct."

Even if there is never another bioterror attack, Fauci says the work and concepts advanced in biodefense will pay off in other areas of infectious diseases, just as the development of bioterror counter-measures has been aided by research into diseases such as HIV.

That disease marks its 25th year in June, an anniversary that stirs reflection for the NIAID director.

"I have found myself, just on where I've been over the last 20-plus years, right in the middle, in the hub, of some of the most important transformations in our society centered around the arena of health," he says. "It's been an extraordinary experience."

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