Keith Epstein

Army misled troops who got vaccine in Bosnia

Pentagon understated risks and improperly used experimental drug

Sunday, January 25, 1998

By KEITH EPSTEIN
PLAIN DEALER REPORTER

The Food and Drug Administration, investigating the use of a research vaccine on thousands of U.S. soldiers in Bosnia in 1996, has formally cited the Pentagon for understating risks and breaking other rules intended to protect Americans from unethical experimentation.

The investigation uncovered “significant deviations,” reminiscent of similar violations by the military during the Persian Gulf War, when it failed to keep vital records, monitor effects, and properly inform troops they were receiving an unlicensed drug and vaccine.

In Bosnia, nearly 4,000 soldiers were told during military briefings that the vaccine, called TBE, was “already known to be very safe and extremely effective.”

In fact, the troops were inoculated as part of a government-sponsored “clinical investigation and research program,” Army documents show. The vaccine to protect against tick-borne encephalitis, while approved for use by some European countries, is not licensed for use in the U.S.

In a warning letter, an official reprimand, the FDA said soldiers should have been told of the uncertainties and risks involving unlicensed drugs.

The FDA said it no longer has “confidence that [the Defense Department] is at present capable of carrying out its obligations [in conducting medical research] to provide potential protection to deployed military personnel.”

The TBE testing was designed at the Army’s biological defense research station at Fort Detrick, Md., to assess the vaccine’s safety and effectiveness.

But the troops in Bosnia had been told the vaccinations were part of a prevention program.

Virginia Stephanakis, spokeswoman for the Army’s surgeon general, said no soldiers had been harmed, and that the FDA’s criticisms stemmed from “a different interpretation of priorities.”

She said that “if we have to choose, the Army’s top priority is protecting soldiers” rather than being “concerned with administrative details.”

Previous transgressions

It isn’t the first time the military has been criticized for mishandling the use of unlicensed medicines on soldiers.

Members of the Presidential Advisory Commission on Gulf War Veterans Illnesses – troubled by the use of investigational drugs during the war against Saddam Hussein – were outraged to learn similar problems had recurred.

In its last official act before closing up shop two months ago, the gulf war commission issued a report condemning the government’s performance in Bosnia with the vaccine.

“An abysmal failure,” the commission concluded.

The panel had struggled for two years to discover if troops in the Persian Gulf suffered ill effects from vaccines, medicines, or possibly Iraqi poison gas. But the commission was hampered by the Gulf war vaccine project

During the gulf war, troops were given two investigational drugs to protect them against chemical and biological weapons. One was a vaccine against botulism and the other was a drug known as “PB” for pre-treatment against poison gas attacks.

But records of who got those drugs are missing. Such records are pivotal in assessing whether a drug or vaccine is safe and effective.

The gulf war panel used “strong language” about Bosnia, said Joyce Lashof, its chairwoman, because the government’s failure to properly control medical experiments on humans echoed the experience and lessons of the earlier conflict.

“They said they had a hard time keeping records in the gulf because it was a war. But Bosnia is a peacekeeping mission, not a war. And they still messed up with the investigational product.”

After the gulf war – with at least 80,000 veterans now reporting illnesses that have have come to be known as Gulf War Syndrome – missing medical and vaccination records have thwarted efforts to trace what may be responsible.

“They need to take a hard look at how the military obtains informed consent from U.S. troops and the role of troops as research subjects,” Lashof said. “It’s clear that the lessons of the gulf war were not implemented in Bosnia.”

Jonathan A. Bernstein, a professor of medicine at the University of Cincinnati, has a federal research contract to study gulf war veterans and their wives who have reported “burning semen” after sexual relations.

“We’re trying to figure out what is causing these symptoms,” Bernstein said. “Was it something the troops were exposed to over there – a vaccination, a chemical, a drug, a weapon? A lot of times the veterans don’t know what they got because there’s not much available from the Defense Department on vaccination data and exposure.”

Transcripts of the gulf war commission’s sessions show the Defense Department’s top medical officers acknowledged the vaccine research project had been botched.

“I’m not here to make an excuse,” said Brig. Gen. John Parker, an Army assistant surgeon general, at a July 29 session in Buffalo, N.Y. “The facts are on the table. We did not do it well.”

Inside the FDA, regulatory officials were aghast at discovering that the military was a repeat offender. Mary Pendergast, who until last month was an associate commissioner of the FDA and now works for an Irish pharmaceutical company, explained to the commission:

“When we saw the same kinds of regulatory deficiencies in Bosnia that we had seen in the Persian Gulf, it caused a great amount of consternation within the agency.” The reason, she said, was that “if you don’t learn from your mistakes you will just keep repeating them” and “that’s simply not acceptable to us.”

The Army said it has consent forms signed by 3,981 soldiers.

But the FDA cited the military for failing to obtain advance approval of informed consent documents by an ethics board, as required by U.S. law.

Within hours of receiving the gulf war commission’s special report last Nov. 8, President Clinton issued orders creating a new Force Health Protection Program.

Clinton said comprehensive medical records of military personnel now will include details about “inoculations and the exposure to different hazards.”

He said, “This will take the lessons we have learned into the future,” according to a White House statement.

TBE’s origins

Developed and made by a drug cine was licensed in parts of Europe in the 1980s, and has been used in Russia, Yugoslavia and Hungary. More than a million Europeans receive it each year.

The vaccine’s known side effects include lumps, pain and local allergic reactions.

In 1983, the U.S. military gave TBE to operatives in covert operations in Afghanistan, and in 1987 to 200 American inspectors of nuclear missile sites in Russia.

No data have been submitted seeking FDA licensure as a marketable drug in the United States.

The Pentagon abandoned all research on the TBE vaccine last September. It stopped using the vaccine in Bosnia in 1996.

Paul Sullivan, executive director of the National Gulf War Resource Center operated by the Vietnam Veterans of America, was familiar with the vaccine research conducted in Bosnia.

“They did a very sloppy job,” Sullivan said. “With something that’s an investigational new drug, the government has a responsibility to make sure the records are properly maintained. We don’t know the long-term effects of that investigational drug on such a large population of soldiers.”

Sullivan, who served as a cavalry scout with the 1st Armored Division during the gulf war, said the Pentagon was in a tough spot in its dispute with the FDA.

“Admittedly, the Defense Department is a war-fighting agency not a medical agency. But if they want to conduct research, they should follow the rules that every other entity using investigtional drugs has to follow,” Sullivan said. “Universities and drug companies do it. The military has got to get its act together.”

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