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Last Updated

28 Jun 2002

Source: New York Times, June 29, 2002.

'90 Study Aided Experts in Stockpile Decision


WASHINGTON, June 28 -- It was the fall of 1990, a month after Saddam Hussein's army invaded Kuwait. Amid fears that Iraq would wage biological war using anthrax, a team of government scientists was commissioned to answer an urgent question: Could a prolonged course of antibiotics, anthrax vaccine, or a combination of the two keep people exposed to anthrax from getting sick?

The experiment, involving 68 rhesus monkeys and nearly as many researchers, suggested that monkeys who received both antibiotics and vaccine would fare better than those who received either vaccine or antibiotics alone. But the research, led by Arthur M. Friedlander, a senior scientist at the government's bioterrorism defense laboratory in Fort Detrick, Md., was far from definitive.

Definitive or not, Dr. Friedlander's wartime work provides the scientific underpinning for the government's announcement today that it is creating the first stockpile of anthrax vaccine for civilian use. Government officials were vague today about how the vaccine stockpile, along with an existing stockpile of antibiotics, would be used, except to say it would be offered in an emergency.

"Stockpiling the vaccine is the most prudent course for protecting our citizens' health and well-being," said Claude Allen, deputy secretary of health and human services.

Despite the paucity of evidence, most experts agree.

"There's no way in the world you could do a clinical trial of this in humans," said Dr. Philip Brachman, an anthrax expert at Emory University. "We use the best scientific judgments we have."

The anthrax vaccine has long been plagued by questions about its safety, with some soldiers who had been inoculated complaining of a range of illnesses. In March, an independent panel of experts at the Institute of Medicine issued a report saying the vaccine was safe and effective, even against genetically engineered strains of anthrax. Still, skeptics remained.

"It never hurts to have a stockpile," said Dr. Meryl Nass, an internist in Freeport, Me., who has been highly critical of the vaccine.

But Dr. Nass said she would offer it only as a last resort.

The vaccine has, in fact, already been offered to civilians. After the anthrax attacks last fall, the Centers for Disease Control and Prevention made it available to thousands of postal employees and Capitol Hill workers who had been exposed. But only 192 people took the government up on its offer.

David Ashford, an anthrax expert at the disease control centers, said he would like to see additional animal research to help public health officials better understand how to use the vaccine for "post-exposure prophylaxis."

Dr. Friedlander agreed.

In the monkey study, he said, researchers exposed the animals to anthrax, and gave them treatment of antibiotics, vaccine or a combination of the two. A handful of the treated animals died. After three months, the survivors were again exposed to anthrax. This time, there were deaths in each group, Dr. Friedlander said, with one exception: the animals given both antibiotics and vaccine.

The experiment, Dr. Friedlander said, began less than a month after Iraq invaded Kuwait, and lasted five months start to finish.

"I must tell you," he said. "this was a wartime footing. There was an urgency like never before."