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Reforms Seen Failing to Rescue U.S. Biodefense Drug Efforts

(Oct. 26) -A VaxGen laboratory technician holds a syringe of experimental anthrax vaccine in 2006. Organizational and funding issues have ensnared U.S. efforts to develop medical countermeasures against potential biological terrorism threats, according to officials (AP Photo/Benjamin Sklar). (Oct. 26) -A VaxGen laboratory technician holds a syringe of experimental anthrax vaccine in 2006. Organizational and funding issues have ensnared U.S. efforts to develop medical countermeasures against potential biological terrorism threats, according to officials (AP Photo/Benjamin Sklar).

Organizational problems and funding shortfalls continue to hinder U.S. efforts to develop and produce vaccines and other treatments for use following a potential act of bioterrorism, despite three attempts to overhaul the system since the 1990s, the New York Times reported on Wednesday (see GSN, Sept. 27).

The nation's preparations for a biological strike face numerous challenges, according to more than 100 interviews with high-level officials at participating federal entities such the National Institutes of Health and the White House, as well as the Health and Human Services, Defense and Homeland Security departments.

Industry specialists have pointed to possible political motivations behind the 2006 cancellation of a deal for development of a new anthrax vaccine, shortly after the creation of a new Health and Human Services Department office intended to facilitate the creation of such treatments. In addition, the National Strategic Stockpile of medical countermeasures still lacks vaccinations for any potential biological "material threats" beyond anthrax and smallpox, and production of no such vaccine is slated to begin in the near future.

The National Biodefense Science Board in a 2010 report said a "lack of U.S. capability to rapidly recognize, respond and recover from a biological attack is the most significant failure" found during the assessment. “Especially troubling is the lack of priority given to the development of medical countermeasures -- the vaccines and medicines that would be required to mitigate the consequences of an attack.”

Health and Human Services Secretary Kathleen Sebelius earlier this year said the countermeasure program was “full of leaks, choke points and dead ends."

A high-level Obama administration source added: “We need a new model. This is never going to work.”

The 2001 anthrax mailings prompted an increase in biological defense funding from $633 million to $4 billion the following year, with a focus on adding to a medical countermeasure cache established in the late 1990s that comprised primarily of 15 million smallpox vaccinations as of mid-2001.

The National Institutes of Health and numerous independent scientific groups in the United States pushed from 2001 until 2004 to refine new manufacturing procedures and expand the stockpile of vaccine for smallpox, a disease eradicated from nature that is known to spread readily and result in death for roughly every third person infected. The United States now holds in excess of 300 courses of smallpox countermeasures in the Strategic National Stockpile.

Still, a $5.6 billion funding tranche unveiled by the Bush administration in 2003 for the development of new biological-weapon countermeasures was insufficient for initiating development of a next-generation anthrax vaccine by the following year, officials said.

“The belief was: Fund it and they will come,” said Senator Richard Burr (R-N.C.), a lawmaker active on biological threat issues. “Well, they didn’t come.”

National Institute of Allergy and Infectious Diseases Director Anthony Fauci agreed that the $5.6 billion funding level was insufficient. “The Mercks and the GlaxoSmithKlines and others looked at it and said, ‘Forget it,’” he said.

Burr responded in mid-2006 by introducing legislation that would establish the Biomedical Advanced Research and Development Authority, a Health and Human Services Department office to fund the refinement of biodefense drugs and help their developers through the process of testing the products and winning approval by the Food and Drug Administration.

“What we saw,” the lawmaker said, “was that we had to become more than a procurer. We had to become a partner.”

Later that year, though, the Health and Human Services Department indicated it would terminate a deal with the biotechnology firm VaxGen for development of a new anthrax vaccine. Issue experts have continued to dispute what prompted the move. One target of blame has been Maryland-based Emergent BioSolutions, which produces the only anthrax vaccine now licensed by the Food and Drug Administration.

“It was [Emergent BioSolutions] lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen,” said Philip Russell, a one-time head of the Army Medical Research and Development Command. “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying.”

“They bought the technology and buried it,” Russell added. “We are five or six years behind where we should be. We should be working on a third-generation vaccine.”

“Should we have kept it? I think there’s a long debate,” BARDA head Robin Robinson said in reference to the canceled vaccine project. “They had brought in some really top-flight people in there, and [former VaxGen head] Lance Gordon was really good at judging talent. Unfortunately, there was a lot of political pressure.”

Countered Emergent President Daniel Abdun-Nabi: "Our issue was not with respect to VaxGen. It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country."

Meanwhile, the BARDA office has only received small portions of its intended $1 billion yearly budget.

“What does it take in the pharmaceutical industry?” Health and Human Services Assistant Secretary Nicole Lurie asked in 2009. “A billion dollars per product! The advanced development part of that might be about $350 million, so that’s the part that we should be funded for.”

The office has received additional funding since 2009, but some firms have described organizational complications created when Lurie asked contractors to coordinate with her rather than Robinson.

“Now you really have two bosses,” said Eric Richman, chief executive offerer of PharmAthene, one of four firms working on a potential successor to the anthrax vaccine. “We actually spend as much time managing our contracts as we do developing our drugs. It’s a real burden.”

“This becomes very frustrating for [Robinson],” one HHS official added. “What does he tell the companies -- ‘Now I have to go ask for permission?’”

Lurie and Robinson also provided diverging explanations for the agency's move way from vaccine development in favor of drugs that are potentially usable against multiple agents.

Lurie described said the move was prompted by budgetary concerns. “You’d like to have vaccines further along in the pipeline for all the threats we have, and you’d like to have a way to manufacture them quickly,” Lurie said. “But I don’t think there’s anywhere near enough money in the system.”

Robinson, though, said the changing emphasis was motivated by the questionable medical feasibility of vaccines for additional agents. “There are only two biothreats -- smallpox and anthrax -- that we feel vaccination is the appropriate way to go,” the official said.

“I don’t think there’s a case to be made for" vaccines for other bioterror threats, he said. "What we’re doing is therapeutics.”

That position was questioned by Tara O’Toole, who heads the Homeland Security Department's Science and Technology Directorate. “Vaccines are essential. If there’s a bioattack, people are going to want their children vaccinated. It’s the only defense against reload.”

Former Navy Secretary Richard Danzig elaborated on the "reload" idea: “When we talk about terrorists’ acquiring a nuclear weapon, we’re talking about just that -- they’re acquiring a weapon. With biological weapons, we’re talking about acquiring the ability to produce weapons. So if you acquire the ability to produce 100 grams of anthrax, you can keep doing that. You really have to think about biology as potentially the subject of a campaign, where somebody keeps attacking, rather than a one-shot incident.”

“You can reassure people that there will be antibiotics available for them, and you can keep producing ever greater numbers of antibiotics. But you can see that if you had the ability to vaccinate people and protect them, it would provide a larger degree of protection. So to the extent that these things come to pass, I think there will be more pressure to develop vaccines,” Danzig said.

Brett Giroir, a former head of the Defense Sciences Office at the Pentagon's Defense Advanced Research Projects Agency, also endorsed the development of vaccines for a wider range of threats.

“Vaccines are critical components of a biodefense posture, and anybody who thinks they’re not isn’t thinking seriously about how we approach this,” Giroir said. “If we got sprayed with tularemia in College Station [Texas] and a biodefense sensor went off, that would be an ideal opportunity for vaccine.”

Fauci questioned the practicality of the "material-threat" list.

“It’s less of a priority to say, ‘OK, now here’s our menu for the Strategic National Stockpile,’” he said. “We call that the military model.”

“Do we have this little thing in the stockpile or not? I don’t judge the safety of the country on that basis. To me, the idea of a naturally occurring threat is infinitely greater,” he said.

The official described the list as a remnant of Cold War-era planning for a biological strike by the Soviet Union.

“So when the decision was made to make an investment into developing countermeasures,” Fauci said, “that was essentially their matrix from the beginning: these are what we know the Soviets had. We know they have stockpiles. This is what we’re going to protect against.”

“I think the unknown threat of a mutant microbe is infinitely greater than someone coming and dropping a glanders on us,” he said. “I mean, seriously. Get real about that.”

O'Toole said Fauci's remarks were "completely wrong" regarding the list.

“We use current intelligence as an integral part of every material-threat determination,” the official said. “I’m surprised anyone in NIH would think otherwise, particularly since the details of the material-threat determination process are briefed at the White House. It does raise a troubling question about how seriously NIH is engaged in the biodefense mission.”

The absence of one person at the White House who would work solely on biological readiness matters is another concern, according to past and present officials. Currently, four top White House staffers have some level of involvement on the issue while also dealing with other matters, according to the Times (see GSN, Oct. 19).

“The only way that you can get all of those people in the room is to call them into the White House, and to have a coordinating group under a single person,” said Kenneth Bernard, a health security specialist for the Clinton and Bush administrations.

Randall Larsen, chief executive officer of the WMD Center, described a lack of a central coordination as a problem.

“Today, there are more than two dozen Senate-confirmed individuals with some responsibility for biodefense. Not one person has it for a full-time job, and no one is in charge” (Wil Hylton, New York Times, Oct. 26).

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