New momentum for biodefense

SUN JOURNAL

Attacks: One of the things that changed Sept. 11 was the government's attitude toward preparing for a biological terrorism incident.

October 14, 2001|By Frank D. Roylance | Frank D. Roylance,SUN STAFF

Before Sept. 11, smallpox had been conquered, plague was a chapter in medieval history and anthrax was a heavy-metal band.

In government, military and academic labs, a few scientists were studying these and other rare or Third World scourges that might be used in warfare or terror attacks.

But the big pharmaceutical companies were focused instead on diseases with bigger markets - such as HIV, influenza, meningitis, chicken pox or pneumonia.

So, when the terrorism of Sept. 11 put fear of bioterrorism on the front page, America opened its medicine chest to find that its defenses against the most likely bioterror agents were wanting.

Dr. Tara O'Toole of the Johns Hopkins Civilian Biodefense Studies Center told Congress that the United States had effective vaccines or drug treatment for just 12 of the 50 most serious pathogens thought to be likely bioweapon agents.

Developing and producing new vaccines to defend Americans against even the most likely bioterror agents could take a decade and hundreds of millions of dollars - each, experts say. It will not always be easy, or even desirable.

But there is now new momentum.

"There is, every day, more and more marshaling of resources and thoughts to try and become prepared," says Dr. Myron Levine, director of the University of Maryland Center for Vaccine Development.

Last year's federal budget included about $350 million in public health spending related to bioterrorism defense preparations. Democratic Sen. Edward M. Kennedy of Massachusetts and others have proposed spending more than $1.4 billion in the current year. The Bush administration has discussed an $800 million figure.

U.S. Health and Human Services Secretary Tommy G. Thompson has ordered the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration to join hands and work with private industry in the United States and abroad.

"He knows the urgency of it and is getting personally involved to make sure we don't have any insurmountable barriers," says Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases.

Under normal circumstances, Levine says, the government labs, academia, biotech companies and drug makers constitute a vaccine research and development machine that is "by far the most productive in the world."

But the system breaks down in the developing world, where the sick are also poor. It fails to serve in solely military applications, where the market is small, and in bioterror, where it is hypothetical.

"The system is flawed," Levine says. "There has to be another way to move products forward."

In this new, post-attack world, the government has its best head start with smallpox - one of mankind's most feared, deadly and disfiguring diseases until it was eradicated in the wild in the 1970s.

Routine immunization of U.S. children halted in 1972, and the immunity of those vaccinated before then has largely worn off.

Experts see no need to develop a new vaccine. The old one worked well. The problem is supply.

The CDC has 12 million to 15 million doses of the old vaccine stored in warehouses. That seemed like plenty before Sept. 11. But "that certainly is not enough to contain pockets of deliberately started epidemic disease in this country," Fauci said.

To boost its stockpiles, last year the federal government hired the British firm Acambis PLC to produce 40 million doses of a purer, safer vaccine by 2004 - at a cost of $343 million. That schedule has since been accelerated to 2002.

"Forty million would be a very good start on being able to curtail an epidemic," Fauci says.

In the interim, the CDC has launched a study at the University of Maryland and three other centers to find out whether the 25-year-old vaccines still work, and whether they would work even if diluted to one-fifth or one-tenth of full strength.

Dilution "would automatically increase the existing stock by five to 10 times," said Dr. Carol O. Tacket, chief of adult clinical studies at the UM Center for Vaccine Development and principal investigator in the study.

Universal vaccination is rejected by most experts because the vaccine itself carries small but significant risks, including encephalitis. If all 285 million Americans were vaccinated, more than 500 could be expected to die from it.

The anthrax vaccine in America's arsenal is far more problematic. Approved only for the military, it is in such short supply that it has been given to fewer than a quarter of the 2.3 million soldiers scheduled for inoculation.

It requires six shots over 18 months, with annual boosters. And it is slow to confer immunity.

Worse, the government's only supplier, BioPort of Lansing, Mich., has been shut down since 1998. It has failed two inspections by the U.S. Food and Drug Administration in its bid to start up its production line. It awaits a third.

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