A pharmaceutical firm was in possession of three studies casting doubt on the safety of one of its blood products two months before a shipment was sent to the BTSB, the Lindsay tribunal heard yesterday. Dr Alfred Prince, an international virology expert who conducted the first of the studies, said the US multinational company Armour would have had the findings of all three about October 1985.
The results suggested the heat-treatment protocol used by Armour for its Factorate product was ineffective against HIV and AIDS.
The tribunal has already heard that Armour issued 350 vials of the product to the Blood Transfusion Service Board in December 1985. The BTSB sent them back because it had started to stock what it believed was a safer product made from Irish plasma.
However, some of the same batch, numbered A28306, was subsequently reissued to St James's Hospital, Dublin, infecting - it is believed - one haemophiliac with HIV in February 1986.
Dr Prince, a virologist with the New York Blood Centre, told the tribunal that Armour refused to allow him publish the findings of his study, conducted on behalf of the company between January and August 1985. Initially, he said, the company reacted to his report with disbelief. "They thought we had screwed up in some way," he said.
However, he said, subsequent studies by Dr J.S. McDougal, of the Centre for Disease Control, and Armour itself reproduced his findings.
Despite this, Armour issued a circular in March 1986 to treating doctors, including Prof Ian Temperley at St James's, reassuring them that its protocol of heat-treating at 60C for 30 hours was effective in killing viruses.
Dr Prince agreed that the circular conflicted with his findings and that there was nothing in the letter which would have raised concern about the product.
He was asked by Mr Raymond Bradley, solicitor for the Irish Haemophilia Society, whether he thought his findings should have been included in the circular.
Dr Prince was prevented from answering, however, after an objection by Mr John Finlay SC, for the tribunal. The chairwoman, Judge Alison Lindsay, said she did not think it was a fair question to put to the witness.
Under cross-examination, Dr Prince did agree, however, that Armour should have informed the appropriate regulatory authorities of his findings.
Asked why Armour had refused him permission to publish his results, he replied: "They said that this would have been extremely distressing to the haemophilia community to cast doubt about the safety of the product."
He said he felt that as a scientist he had "a responsibility to the field" to make the findings public and, as a result, he repeated the tests using Factor 8 that was sourced elsewhere.
The results were published in a letter to the Lancet in May 1986. While Armour was not mentioned by name, its heat-treatment protocol was identified as producing "surprisingly modest" results, suggesting a need for caution among doctors and blood transfusion centres.
The letter was published after two reports, in March and April 1986, of haemophiliacs becoming infected with HIV through heat-treated products. Both were caused by Factorate heat-treated under the Armour protocol.
Dr Prince will continue his evidence today.
