By Renae Merle
Washington Post Staff Writer
Tuesday, January 16, 2007; D01
When President Bush goes before Congress later this month, it will mark four years since he used his State of the Union address to launch Project BioShield, an ambitious effort to counter bioterrorism attacks with vast new stockpiles of vaccines and treatments.
Progress, however, has been slow.
The $5.6 billion program is still struggling to define its priorities, and officials have spent less than a quarter of their budget. Last month, the project endured the collapse of its largest program, an effort to produce enough advanced anthrax vaccine for roughly the population of Washington and New York. And still unresolved is how the government will address threats like acute radiation sickness or treat the estimated 10 million people with impaired immune systems who cannot take advantage of current stockpiles of smallpox vaccines. In his speech, Bush listed the Ebola virus and plague as among the threats the program would address, but little significant action has been taken on those, either.
The government has yet to release a plan outlining what drugs it will buy and in what quantities, though it says it will do so in the next few months.
Congress passed legislation late last year revamping BioShield, allowing the Department of Health and Human Services to pour more money into the small companies spearheading the effort more quickly and reorganizing the program's management. But HHS officials acknowledge that tougher challenges lie ahead.
"BioShield is still a young program," said Gerald Parker, the principal deputy assistant secretary for preparedness and response at HHS.
The first phase of the program "was low-hanging fruit, taking things that were already in development" and putting them in the stockpile, Parker said. "Now we're getting into the harder phase of this."
Here is a look at BioShield's fitful progress on some of government's top priorities, those bioterror agents that have been labeled national security threats by the Department of Homeland Security:
AnthraxAnthrax is best known for the October 2001 attack in which envelopes containing anthrax spores were sent through the mail, killing five people and sickening others. The attack prompted worries that an antibiotic-restraint strain of anthrax could be developed, moving the threat to the top of federal health officials' priority list.
As the result of an effort that began before BioShield, there are enough antibiotics in the national stockpile to treat 40 million people for more than 60 days, HHS says. Stockpiles also include 9 million doses of an anthrax vaccine produced by Emergent BioSolutions of Gaithersburg, with another 1 million to be delivered by the first quarter of this year. In an emergency, the usual six doses of the vaccine necessary for immunity could be cut to three and used with an antibiotic, HHS says. That should be enough to treat 1.3 million patients.
Rockville-based Human Genome Sciences and Cangene of Winnipeg, Canada, are scheduled to deliver 30,000 doses of an anthrax antitoxin. HGS is scheduled to begin delivery in 2009 and Cangene is scheduled to begin delivery later this year, according to HHS.
The agency is struggling to develop a more modern anthrax vaccine that could be administered in fewer doses and with fewer side effects. In 2004, the agency tapped a small California firm, VaxGen, for an $877 million contract to deliver 75 million doses of an anthrax vaccine. VaxGen encountered delays and technical problems, and HHS canceled the contract in December after the firm failed to begin human testing on time. HHS officials are examining ways to get the effort back on track.
BotulismBotulism is a concern because the natural toxin can be easily produced and transported, making it a major threat. The Japanese cult Aum Shinrikyo tried and failed to disperse the botulinum toxin in the 1990s in downtown Tokyo and at U.S. military installations.
A far more serious threat would be if someone managed to get the toxin in the food supply, said Gerald L. Epstein, a senior fellow at the Center for Strategic and International Studies. An attack using botulinum toxin could cause hundreds of thousands of causalities, according to DHS.
Cangene has begun delivering the first of 200,000 doses of an antitoxin, which would have to be delivered shortly after patients show symptoms to counteract the effects of the toxin. There are currently no plans to pursue a vaccine, according to HHS.
SmallpoxSmallpox was eradicated in the 1970s, and there are only two official repositories of the disease, in the United States and Russia. But before the Soviet Union collapsed it adapted large quantities of smallpox for use in bombs and missiles, according to the Center for Biosecurity of the University of Pittsburgh Medical Center.
That has spurred concerns that stocks may fall into the hands of terrorists or countries considered rogue states by the United States. Since standard smallpox vaccination ended in the United States more than 30 years ago, the population could be vulnerable to attack, according to the biosecurity center.
There is a stockpile of more than 300 million doses of smallpox vaccine, enough for everyone in the United States, according to HHS. That effort began before BioShield.
The agency is also pursuing another version of the smallpox vaccine that could be used by people with impaired immune systems, a growing population of cancer survivors, organ transplant recipients and HIV-infected patients. A BioShield competition began in 2005, but no winner has been announced. HHS officials said a contract could come sometime this year.
Radiation, 'Dirty Bomb'Authorities worry that people could become exposed to radiation either through a direct nuclear attack or the use of a "dirty bomb," which would employ conventional explosives or other means to spread radioactive materials.
Enough potassium iodide to treat 1 million people is already in the national stockpile, according to HHS. Potassium iodide doesn't treat most aspects of radiation exposure, but scientists believe it can protect the thyroid gland from cancer in such an attack.
Fleming & Co. Pharmaceuticals received two BioShield contracts to deliver 4.8 million bottles of a liquid form of potassium iodide for children. It has delivered 1.9 million bottles so far. Akorn Inc. has begun delivering 450,000 doses of an anti-radiation drug therapy that would adhere to radioactive particles in the blood stream and flush them out of the body.
To address acute radiation sickness, HHS launched a competition in 2005 for 100,000 doses of a drug treatment that would address the infections and uncontrolled bleeding caused by exposure. After several delays, HHS officials said they expect to announce a contract this year.
Plague, EbolaPlague is blamed for killing a third of Europe's population in the 14th and 15th centuries. The pneumonic form of the disease could be caused by releasing plague bacteria in an aerosol attack. The disease is considered nearly always fatal unless antibiotic treatment is started with 24 hours of infection, according to HHS.
Another potential bioterror threat, Ebola, is a hemorrhagic fever caused by a virus that first appeared in Africa in the 1970s. The virus can spread from person to person and kills most of the people it infects, causing massive hemorrhaging that dissolves their insides and sends blood oozing from the orifices of their bodies. Experts believe Ebola is a threat in the hands of terrorists, and the Soviet Union is believed to have created Ebola weapons before it collapsed. Aum Shinrikyo, the Japanese religious cult that released sarin nerve gas in the Tokyo subway system in 1995, went to Zaire to learn more about Ebola.
Despite President Bush's mention of plague and Ebola in his State of the Union speech, the government has yet to contract with any company to produce a defense. HHS officials say the implementation plan to be issued in the next few months will include a roadmap to address both threats.
Meanwhile, the National Institutes of Health is pursuing research on vaccines for both. NIH has completed the first phase of human testing for the Ebola version and is seeking volunteers for the second, according to an NIH official, who said it would be several years before it could be stockpiled.