Anthrax: serious business | Page 3 of 3

Anthrax: serious business

Can we breathe easy yet? An examination of how safe we are as two local firms battle it out to develop a next-generation vaccine

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Complaints about the anthrax vaccine date back to the first Gulf War in 1991. A 2002 study by the National Academy of Sciences’ Institute of Medicine found the BioThrax vaccine to be “acceptably safe”—but added that improvements were needed.

In 2004, a civil lawsuit prompted by reports of side effects such as fatigue and joint pain resulted in a federal court suspending mandatory vaccinations for soldiers serving in Korea, Afghanistan and Iraq. (The requirement was reinstated two years later, after a review by the U.S. Food and Drug Administration affirmed the vaccine to be safe.)

That same year, then-Health and Human Services Secretary Tommy Thompson awarded an $877.5 million contract to a California-based firm called VaxGen to deliver 75 million doses of a second-generation rPA vaccine to the national stockpile beginning in 2006. Two years later, the contract was cancelled—and many attribute that to Emergent.

“Lobbying by Emergent has slowed down anthrax vaccine [development] by five years or more,” says Philip Russell, a former commander of the U.S. Army Medical Research and Development Command who, following the 2001 anthrax attacks, helped lead HHS efforts to stockpile medical countermeasures.

Disclosure forms filed with the U.S. Senate show that Emergent dramatically ramped up its lobbying spending at the time—quadrupling it from less than $400,000 in 2004 to $2 million in 2006. It employed a dozen outside lobbying firms, including one with two former U.S. senators and another with two former aides to then-Vice President Dick Cheney.

Russell, a highly respected figure in biodefense circles, recalls one incident in which an outside lobbyist hired by Emergent “wrote a letter that Sen. [Charles] Grassley [R-Iowa] signed, accusing me of malfeasance.” The letter claimed Russell had had a role in developing the VaxGen vaccine, which he says isn’t true. “So I had to go explain to Grassley’s staff that they were wrong.”

For its part, Emergent says problems with the VaxGen vaccine—rather than lobbying—sealed the company’s fate.  

“The view that we expressed was: ‘Don’t put all your eggs in one basket, you can’t rely on an early-stage product candidate that is yet unproven,’ ” Abdun-Nabi says. “…And yes, we talked to a lot of people. We felt very strongly about that view, and we were not ashamed of it. So I think that is misinterpreted as sharp elbows and heavy-handed. But it was core to our business, and it was core to the safety of the population.”

In 2008, Emergent acquired the rights to the VaxGen vaccine for about $2 million after that company failed. Emergent currently is developing it as a rival to PharmAthene’s rPA vaccine.

In 2009, the federal Biomedical Advanced Research and Development Authority (BARDA) requested proposals for production of a next-generation vaccine such as the one VaxGen had been trying to develop. Originally it asked that such a vaccine be ready within eight years for licensing by the FDA. But later that year it did an about-face, saying that wasn’t realistic.

Russell says BARDA was caving in to pressure from Emergent. BARDA chief Robin Robinson, who was not made available for an interview, previously has denied that.

In early 2010, BARDA offered contracts to both Emergent and PharmAthene totaling $265 million to continue their work in developing a second-generation vaccine. Emergent promptly lodged a protest against the PharmAthene contract. The protest, though ultimately rejected, delayed PharmAthene for three months during the review process, according to Richman.

Weeks after the review, Emergent’s chief in-house lobbyist, Allen Shofe, was quoted in The Wall Street Journal calling PharmAthene “a virtual company run by a bunch of political hacks [operating] out of a warehouse.”

Richman laughs at the characterization. “I don’t know what their strategy is, but I can tell you that the ‘warehouse’ we’re working out of is class A office space that we’re paying too much for,” he says. “And that’s one of the reasons preventing us from moving to Montgomery County: We can’t even sublease it.”

Abdun-Nabi, an attorney by training, deftly sidesteps when asked whether he shares Shofe’s view of PharmAthene. “You know, I don’t think about PharmAthene,” he says. “I haven’t really met the folks over there. They have a product. It is what it is. It will be what it will be. They’re not really front and center for me.”

But later he says: “This isn’t a question of PharmAthene over Emergent. This is a question of whether one of these products—or both of these products—ultimately achieves scientific success. And that’s really the challenge. If both products work, I think the government will buy both. This is an opportunity for both companies to succeed.”

It’s a rare point of consensus between the dueling rivals.

Says Richman: “We have always believed, and still believe, that the market is going to be split between Emergent and PharmAthene, that the government wants two sources of an anthrax vaccine, instead of today, where they are a sole source provider.”

Meanwhile, other measures have been taken to assure public safety against the threat of anthrax.

Following a seven-year federal investigation, a Fort Detrick scientist named Bruce Ivins was identified as the likely source of the anthrax letters. Told by his attorneys that he would be indicted for the five anthrax-related deaths, he committed suicide in 2008. In The Mirage Man: Bruce Ivins, the Anthrax Attacks, and America’s Rush to War (Bantam, 2011), Bethesda writer David Willman depicts Ivins as a deeply disturbed individual who plotted to poison women with whom he was obsessed going back to his college days.

Ironically, Ivins’ top priority as a scientist was developing an anthrax vaccine. Willman, a Pulitzer Prize-winning reporter for the Los Angeles Times, notes that Ivins held a couple of patents as co-inventor of a next-generation vaccine and believed that the Defense Department was not giving the vaccine the support it merited. All indications are that Ivins acted alone in carrying out the 2001 attacks.     

Today, air-monitoring systems have been installed in 282 mail processing facilities that handle incoming items, according to a Postal Service spokeswoman, and handlers are encouraged to watch for suspicious objects, though none has tested positive for anthrax since the 2001 attacks.

Should an anthrax-laden letter make it past those safeguards, there’s the current anthrax vaccine stockpile along with what BARDA says are enough antibiotics to treat up to 40 million people.

Joel McCleary, the onetime political operative who founded PharmAthene six months before 9/11, doesn’t think that’s sufficient. He believes there should be enough vaccine for every U.S. citizen—and there should be a second-generation vaccine. Problem is, he says, “there’s no sense of urgency.”

D.A. Henderson of the University of Pittsburgh’s Baltimore-based Center for Biosecurity would seem to agree. He worked with Russell to develop and stockpile bioterrorism countermeasures after 9/11. And in his recent speech to public health professionals, he noted that federal budget allocations for emergency preparedness are down 40 percent over the past decade.

“I can fathom only one explanation for this: complacency,” he said. “It took the anthrax disaster to capture the attention of policy makers. Must we now have another truly catastrophic epidemic disaster before there is understanding? I’m afraid it is inevitable, based on the record of the past 10 years.”

Bethesda’s Louis Peck has spent much of his 40-year career covering local, state and national politics. He is currently on the faculty of Boston University’s Washington Journalism Program.

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