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Pharmaceuticals: Partial Immunity

U.S. Incentives Made the Bioterror Defense Business a Work in Progress

Batches of letters that were sent to at least five news organizations and then to a pair of senators in the fall of 2001 fundamentally changed the nation’s arsenal of defenses against bioterrorism. For the multibillion-dollar vaccine industry, those envelopes are the most important legacy of the moment in history remembered as Sept. 11 — although they were mailed a week after that and have never been credibly linked to fundamentalist Islamic terrorists.

The letters, which were suffused with extremely deadly anthrax spores, killed five people, sickened at least 22 others, and deeply disrupted and disturbed a congressional community already rocked by the belief that the hijackers of United Flight 93, which ended up crashing in a rural field, had the Capitol in their sights. The Senate’s Hart Building was cordoned off for three months; all the other lawmaker office buildings were closed for a time; mail delivery was subjected to intense new security; and hundreds of congressional aides were prescribed the antibiotic Cipro in case they’d been exposed.

The Justice Department ultimately concluded that circumstantial evidence pointed conclusively to Bruce Ivins, a government scientist at the Fort Detrick biodefense lab in Maryland, as the sole perpetrator; he committed suicide three years ago, just before he was to be arrested. But no matter who did it — and conspiracy theories abound to this day — the underlying message contained in those envelopes was clearly received: Biological agents are a real threat to everyone in America.

And that message prompted Congress to write a quartet of laws to help the government defeat any effort to use biology as a weapon of terror. The first, enacted in 2002, required additional tracking of food and drugs. A 2004 law guaranteed that $5.6 billion would be spent in the next decade to develop and stockpile vaccines and other countermeasures. A 2006 statute created a new bureaucracy to finance and support research into those new countermeasures, and another law enacted that year granted the manufacturers of those measures liability protections.

All those efforts have resulted in some clear successes, and the nation is far better prepared than it was a decade ago. But those achievements have also been marred by missteps. Lawmakers have complained about the slow pace of development for new drugs and next-generation vaccines, the lack of interest from the industry’s biggest players, and the fact that — for some threats — there still is no reliable antidote.

“We’ve done quite well in a number of areas and done poorly in other areas,” said D.A. Henderson, one of the nation’s most experienced bioterrorism experts, who was tapped by the Bush administration to help lead its efforts in 2001 to prevent a biological or chemical attack. “It’s a mixed bag.”

Obama administration officials acknowledge that the public still is not fully protected. Last month, when Homeland Security Secretary Janet Napolitano addressed the Organization for Security and Co-operation in Europe, the world’s largest regional security organization, she said that “of the many challenges” facing the security of the world, “none are more pressing than the evolving transnational threats that we confront,” including “the proliferation of chemical, biological, radiological or nuclear weapons.”

And two weeks ago, when John Dingell, the senior Democrat on the House Energy and Commerce Committee, asked Nicole Lurie, the assistant secretary of Health and Human Services for preparedness and response, whether the nation has stockpiled the necessary medical countermeasures to respond to bioterrorism, her answer was short and candid: “Not completely.”

Bumps for BioShield

The most prominent symbol of the efforts against biological, chemical and radiological weapons is Project BioShield, created seven years ago. The law guaranteed the biochemical industry a $5.6 billion market by promising to purchase that much in drugs, vaccines and other countermeasures to protect against attacks. The law also permitted HHS to temporarily allow the emergency use of drugs or countermeasures that haven’t gone through the full approval process at the Food and Drug Administration.

Under the program, HHS and Homeland Security are allowed to promise to buy products as many as eight years before they are supposed to be delivered — a crucial way for the government to give the drug companies incentives to make products that might never be commercially viable because they protect against a type of attack that might never occur.

The authors of the law hoped the lure of secure funding would entice the big biopharmaceutical companies to compete in a market that otherwise might not offer enough return on investment.

But that didn’t happen. And the first big BioShield contract — with VaxGen Inc., for a new anthrax vaccine — was canceled in 2006, two years after it was signed, because federal officials said the company wasn’t hitting its milestones for progress. Lawmakers had grown frustrated that work under BioShield was not proceeding as quickly as hoped. In 2004 and 2005, Congress rescinded a total of $25 million in appropriations that had not been spent.

Lawmakers were concerned that the smaller companies that did show interest in doing BioShield work often ran out of money as they moved from basic research into the more advanced development of treatments or vaccines, including clinical trials. These companies also had less experience with drug development. As a result, HHS and FDA officials have had to provide more regulatory and scientific guidance to these companies than they would for bigger and more experienced pharmaceutical companies.

These concerns convinced Congress to create the Biomedical Advanced Research and Development Authority — known by its acronym, Barda — in a law enacted five years ago in an attempt to correct some of the problems in the BioShield program.

The authority was designed to execute contracts more quickly than under the original BioShield program, and to provide funding in stages, so that companies would have enough funds to complete their development of the new countermeasures. Barda now administers all of the BioShield contracts, as well as some others funded outside the BioShield program.

Through the years, BioShield money often has been shifted to address other public health needs. About $1.5 billion from the $5.6 billion account has been rescinded or moved to other health programs, according to the Congressional Research Service.

Some money went to fight global influenza, a disease that cast a shadow over the world two years ago after an outbreak of a particular strain of the flu in Mexico spread to the United States. The outbreak followed earlier concerns that a different type, known as avian flu, might become a pandemic.

Worry about pandemic flu and other public health crises has led officials to pursue programs that have both a biodefense and a public health purpose. An analysis of this year’s federal budget by the Center for Biosecurity of the University of Pittsburgh found that 91 percent of money being spent on biodefense is going to programs that have  other goals as well.

A System Still Vulnerable

The Obama administration has acknowledged that BioShield hasn’t worked as well as intended. An HHS report last year concluded that using government to spur the development of new products “has been slower and more costly than anticipated, as has been maintaining and sustaining the federal stockpile.”

The Government Accountability Office noted in April that, while some chemical, biological, radiological and nuclear countermeasures “can be immediately acquired, most have not yet been developed.” For example, of the threats prioritized by Homeland Security, only one — anthrax — has a rapid diagnostic test. GAO expert Cynthia Bascetta also said that there are not yet any available drugs or other countermeasures to protect someone who has been exposed to the Ebola or Marburg viruses.

This fall, Congress is preparing to begin the process of reauthorizing the law that gave birth to Barda, with improving the attention to chemical and radiological risks being a main goal. The legislation is also expected to further encourage drug and countermeasure developers to move away from creating treatments specifically for one disease — an approach dubbed the “one bug, one drug” strategy — to those that could provide protection from a variety of threats.

Lawmakers say they expect to change the procedures to emergency-use authorization so that FDA officials could give pre-approval to some drugs or countermeasures that they believe are safe and likely to be effective against public health threats, even though the products have not yet gone through the full FDA review process.

And both the administration and Republicans deeply involved in the debate want to set up a “strategic investor” nonprofit that will act in a way similar to a venture capital fund to support the development of new countermeasures.

“We’ve made tremendous strides in prioritizing the threats,” Richard Burr, a North Carolina Republican who helped write the 2005 law as a freshman senator, said in an interview.

“We’ve had some limited successes in acquiring all of the countermeasures we need,” Burr said. “Hopefully in the reauthorization this fall we’ll put in place the mechanisms to really carry us where we need to go.”

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