Drug board's response to AIDS crisis 'adequate and timely'

Counsel for the Irish Medicines Board (IMB) yesterday described as "unwarranted and unjust" a claim that it "rubber-stamped" applications for product authorisation which were made by pharmaceutical companies during the AIDS crisis.

In a closing submission to the tribunal, Mr Tony Aston SC rejected the allegations by counsel for the Irish Haemophilia Society that its assessment procedures were "completely ineffective".

Mr Aston said the IMB, as the National Drugs Advisory Board (NDAB) is now known, welcomed the society's recommendation for the establishment of a product-testing laboratory in the State. However, he said, such testing would not have overcome the problems of HIV and hepatitis C.

He said product assessment had been, and still was, primarily based on documentary analysis rather than laboratory analysis, the repetition of studies or trials.

"Not only did the NDAB not have the facilities to carry out such analysis but we suggest it would not have been appropriate in the circumstances to do so," he said. "To repeat validation studies or laboratory analysis could only have delayed the approval of heat-treatment (a process which can eliminate HIV) and would have been contrary to the interests of the patients in the urgent situation presented by the AIDS crisis."

Characterising the NDAB's response to the AIDS crisis as "responsible, adequate and timely", Mr Aston said the agency moved quickly to introduce a policy in January 1985 stipulating only heat-treated products were to be used.

The tribunal has heard that non-heat-treated Blood Transfusion Service Board (BTSB) factor 9 continued to be used up to February 1986. However, Mr Aston said it was reasonable to infer the NDAB's former medical director, the late Dr Allene Scott, was under the impression no untreated product was used after the introduction of its policy.

Regarding the use of Armour Factorate batch number A28306, which infected a child in Dublin with HIV in February 1986, Mr Aston said any correspondence sent by the manufacturers to Dr Scott was "reassuring" regarding the product's safety.

Dr Scott had written to the company in February 1986 asking when donor-tested products would be available in the Republic. She received a reply on March 15th, 1986, to say the product on the market was already donor-tested, said Mr Aston.

He added that there was no published material likely to have come before Dr Scott which ought to have set alarm bells ringing about the safety of the product.

Regarding the BTSB's failure to obtain authorisation for the manufacture of factor 9, Mr Aston said the NDAB's role in the matter should be seen in the context of the relationship between the two State agencies. Correspondence dating from the founding of the NDAB expressed the view that the BTSB should in no way be subsidiary to the new agency and that controversy should be avoided.

Rightly or wrongly, said Mr Aston, a "hands-off approach" developed which was not overcome for some time. "This approach may seem out of kilter with the thinking of the early 21st century. However, the atmosphere was very different in the Ireland of the 1970s and early 1980s."

Mr Aston described Dr Scott as the "eyes and ears" of the board. She was one of only eight staff within the agency in the period 1981-1987, during which time it had to deal with thousands of product authorisation applications.

He said the chairwoman, if she considered the NDAB fell "somewhat short of the ideal", should take this into account, along with the fact that fewer than 1 per cent of the products assessed by the NDAB were blood products.