http://washingtonpost.com/wp-dyn/articles/A61149-2000Jul17.html

Anthrax Shots' Effect Challenged
Army Disputes Expert Who Reviewed Vaccine Tests By Thomas E. Ricks
Washington Post Staff Writer
Tuesday, July 18, 2000; Page A21

The controversial anthrax vaccine that the Pentagon is trying to inject into 2.4 million troops does not provide complete immunity to an anthrax attack, according to an outside expert who has examined Defense Department records of laboratory tests.

Soldiers who are exposed to anthrax may become quite sick and be incapacitated for up to two weeks, even if they have received the full set of six inoculations, said George A. Robertson, a molecular biologist specializing in pharmaceuticals.

But officials at the Army's Medical Research Institute of Infectious Diseases at Fort Detrick, near Frederick, disagreed with Robertson's interpretation of the data. They said he was exaggerating the extent of illness in monkeys that were vaccinated and then exposed to anthrax under laboratory conditions.

The dispute over the degree of immunity conferred by the anthrax vaccine is just the latest in a heap of problems encountered by the 2 1/2-year-old inoculation program.

Last week, the Pentagon announced that a looming shortage of the vaccine will force the military to cut the number of doses it administers from 75,000 to 14,000 a month. Blaming production problems at the sole maker of the vaccine, Bioport Corp. of Lansing, Mich., the Defense Department said that for the remainder of the year it will give up trying to vaccinate all troops and focus on those serving in Korea and the Persian Gulf, where the military sees the highest risk of germ warfare.

The Pentagon has expended millions of dollars and a huge amount of energy on the mass inoculations, which defense officials portray as an unfortunate but necessary response to a rising threat. The program was spurred by U.N. weapons inspectors' discovery in the mid-1990s that Iraq had tried to develop germ weapons and had stockpiled 8,000 liters of anthrax spores before the 1991 Gulf War.

So far, 450,000 members of the U.S. military have received a total of about 1.8 million anthrax vaccinations. But the program has provoked controversy within the armed forces, with about 350 service members refusing to take the vaccine out of concern about its possible side effects. Several dozen have been court-martialed, and others have been allowed to leave the military.

Robertson, an expert in biological warfare, has been analyzing Defense Department test records obtained by Mark Zaid, executive director of the James Madison Project, which seeks to reduce government secrecy. Zaid is also an attorney representing several service members who are resisting the anthrax vaccinations.

Zaid and Robertson conceded that being ill for as long as two weeks is better than dying, the likely fate of those who aren't inoculated or treated quickly with antibiotics after exposure to anthrax. But they said the Pentagon has failed to disclose publicly that the vaccine doesn't confer full immunity to the disease.

"The Defense Department is telling people that anthrax vaccination will protect them 99 percent," said Robertson, a retired Army Reserve colonel who formerly worked at the Army's Infectious Diseases Institute and is now an executive at BioReliance Corp. in Rockville. "It doesn't tell them they will be incapacitated for two weeks."

Anthrax is an acute infectious disease carried by spore-forming bacteria. It usually occurs in farm animals but can be contracted by humans through tainted meat or, more rarely, inhalation of the spores. When inhaled, it first causes cold-like symptoms and is almost always fatal within a week unless treated immediately by antibiotics.

The Pentagon's main Web site on anthrax (www.anthrax.osd.mil) seeks to reassure service members about the safety of the vaccinations but does not provide many details about the vaccine's effectiveness.

Tests on monkeys "lead us to expect that anthrax vaccine would be quite effective in preventing inhaled anthrax," it says. What it doesn't say is that some of the monkeys became very ill.

Zaid and Robertson analyzed the laboratory notebooks from one of the tests conducted on 10 immunized rhesus monkeys and a control group of five animals at the Army's infectious diseases institute. After being fully vaccinated, the monkeys were exposed to a highly lethal dose of aerosol spray of anthrax on June 13, 1991.

"Although all vaccinated monkeys survived, they appeared to be sick over the course of two weeks," the lab report states.

Robertson noted that the monkeys sickened even though they had been given significantly larger doses of vaccine than humans receive, relative to their weight.

Col. Arthur Friedlander, a senior scientist at the institute, rejected Robertson's interpretation of the data.

"It would be a misstatement to take away from the lab notebook that immunized animals when challenged with anthrax are uniformly incapacitated," Friedlander said. "That is a gross overstatement."

He and other officials at the institute said they don't know for sure whether every animal in the 1991 test fell ill and don't think any were sick for two full weeks. In another test last year, they said, 18 of 20 immunized monkeys survived exposure, and none were sickened.

"We don't think that incapacitation of large numbers of troops would occur," said Col. Edward Eitzen, the institute's commander.

But if it turns out that even fully inoculated soldiers would be unable to fight after exposure to anthrax, the implications for U.S. military operations are enormous, said Chris Seiple, a former Marine officer who serves on a panel studying chemical and biological warfare issues at the Center for Strategic and International Studies.

In addition to the military issues of how to protect troops and respond to such an attack, Seiple said he worries about the effect on public opinion. "People have been led to believe that you can be hit with this stuff and still be mission-ready," he said. "If you had a bunch of people taken prisoner because they were sick, you'd have a loss of public confidence."


2000 The Washington Post Company
 
Review:

The monkeys were vaccinated, were given time to develop immunity, then were exposed to anthrax in an efficacy trial.

With normal vaccines, you then have enough immunity that you do not get sick at all.

However, these monkeys got the disease, got sick (meaning the vaccine was NOT highly effective) and furthermore, they got anthrax by inhalation. What do we know about anthrax by inhalation? Of the seven people who survived it in 2001, only one has ever been able to go back to work. So if humans act like monkeys, then the vaccine might save us from death after an anthrax exposure but turn us into physical wrecks, forever.

That is very important. Because right now the millitary says that unvaccinated, sick soldiers would put their buddies at risk to get them evacuated, etc.

DOD knows the vaccine will not work like vaccines should (no illnesses at all) after an exposure--that is why DOD policy requires that vaccinated soldiers be given antibiotics immediately following exposure.

By the way, Friedlander is the person who conducted the 1991 experiment.

Meryl