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ON THE MORNING of December 17, 1998, Ronda Wilson, a supremely fit, strikingly beautiful American helicopter gunship pilot, was heading for military stardom. Just 21 and the only woman in her squadron, she had recently defeated her 63 male fellow pilots to earn the coveted Top Gun award in her first gunnery flight test. She was without peer in her cavalry unit, so skilled at handling the OH-58 Delta Warrior, armed with Hellfire missiles and .50-calibre machine guns, that she was described by her commanding officer as “one of the most outstanding pilots of her generation”.
On that morning, at Fort Stewart, Georgia, she received a routine order that was ultimately to destroy her faith in the military family and American government which she loved beyond question, and which she says “I was willing to die for”. She was told to “go get your jabs”.
She was never told what the injection was for, and felt no need to ask. It was, she later discovered, the first in a six-dose course of anthrax vaccination. It was the moment she became part of the US government’s compulsory, highly ambitious anthrax vaccination programme for all 2.4 million of its military personnel; the project was authorised by President Clinton himself, it had begun eight months before, and it was halted 18 months later amid damning congressional verdicts, lawsuits and accusations of a top-level cover-up.
There were many things Wilson was not told about the 0.5ml phial of milky liquid that was being injected into her arm. It was manufactured by a company that today, after a new lease of life for the vaccination programme, has begun to distribute millions of doses to immunise “high-risk” US troops heading to the Persian Gulf for an attack on Iraq. (British soldiers will not be immunised with this vaccine, but with a home-grown version, produced at Porton Down).
Critics of the vaccine, who include congressmen, senior military officers and more than 450 American servicemen who have been court-martialled or forced to leave the military for refusing to take it, say its ability to combat inhalation anthrax has never been proven and it has never been tested on humans; it has never been licensed to combat inhalation anthrax; and its long term effects have never been known. Those claims are supported by a congressional committee which issued a scathing and alarming report into the efficacy and supervision of the vaccine, and the immunisation programme, in April 2000.
Its critics also claim it is being forced on the country’s soldiers as part of a politically-inspired attempt to persuade the American public that an effective vaccine against an anthrax terror attack exists, and that its soldiers are safe from Saddam Hussein’s chemical and biological arsenal.
The Pentagon, and BioPort, the manufacturer, together with the Food and Drug Administration, which licenses US drugs, fiercely deny these claims. The Times has looked at thousands of pages of government, FDA, Army, congressional and medical reports stretching back 30 years. The extraordinary story of this anthrax vaccine, suddenly thrust on to centre stage in a new age of global terror, is one of high-level politics, furious scientific dispute, big business and great controversy.
One thing is certain — this vaccine has a history. Questions persist on two levels: the ability of the company that manufactures it to produce it safely, and the safety and effectiveness of the vaccine itself. There is testimony and documentation that raise the question of why the American military establishment and successive White House administrations have persisted with a company and a vaccine that by their own admission have suffered problems. It is a history that the hundreds of thousands of US troops about to receive the compulsory immunisation, and who have no right to refuse it, are not being told about.
Of all the things Wilson was not told about her first jab, perhaps the most crucial was this: that 10 months earlier, in February 1998, after an inspection of the Michigan laboratory that manufactures the vaccine, the plant had its authority to make the vaccine suspended by the FDA.
The inspection followed five years of warning letters citing concerns over the plant’s record-keeping and violations in safety, potency consistency and sterility. The February 1998 FDA report, which effectively prevented the plant from manufacturing fresh supplies of the vaccine for three years, and a copy of which has been obtained by The Times, is damning.
The 95-page report found lots of the vaccine contaminated, a filtration process not authorised by the FDA, problems with cleanliness and the sterility of equipment and a failure to ensure a uniform potency of the drug.
“The firm routinely redates Anthrax Vaccine lots that have reached their labelled expiration date,” the report says. And it states: “Lot FAV036 was at room temperature for 20 hours, the filling operation was aborted, it was placed back in the refrigerator.” According to military records it was a dose from Lot FAV036 that was given to Wilson that December morning, eight months after the FDA report had been sent to BioPort.
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