Expert says $2 test kits could have prevented HIV

Three out of four cases of HIV infection caused by the transfusion of blood products or plasma from 1983 onwards would have been avoided if a donor test which cost "just a couple of dollars" had been introduced at the time, the Lindsay tribunal heard yesterday.

Dr Donald Francis, a former senior US public health official, said blood banks and product manufacturers were reluctant to spend money on the "surrogate" test, which identified blood donors with AIDS by picking up "markers" for hepatitis B in donated plasma.

He said in January 1983, when he recommended the introduction of the test along with other safeguards, there was "remarkably little concern" about the public health implications of AIDS. Producers and transfusion services, he said, had "a remarkable ability to stare at the data in the face and do as little as possible for the longest period of time".

Dr Francis, who worked for 21 years at the Centers for Disease Control and Prevention (CDC), said producers not only obstructed the introduction of new safety measures but also used plasma from high-risk donors for the manufacturing of factor concentrates for haemophiliacs without the knowledge of the regulatory authorities.

He said producers in the early 1980s had deliberately recruited homosexual men, who were known to be at high risk of hepatitis B infection, to donate blood for the production of vaccines. Dr Francis said the plasma component not used in such production should have been "thrown into the sewer". Instead, he said, it was dumped into plasma pools for manufacturing into concentrates.

This, he said, was probably the main reason why there was such a high concentration of HIV in products used by haemophiliacs.

The practice, he added, was only revealed in the past two years in the course of litigation. Had anyone known at the time, there would have been "a total outcry" and the material would have been taken off the market.

Asked to characterise the use of this high-risk material, along with plasma from prisoners in America, in the manufacturing process, Dr Francis said "it almost was a design for infecting them (haemophiliacs) with HIV."

He said he did not believe producers were trying to kill people. Rather, he said, he believed they did not think through what was an "incredible mistake".

Dr Francis said it was known from an early stage that hepatitis B was closely associated with AIDS. The surrogate test which he recommended in 1983 used the strain of hepatitis as an identifier for AIDS. The test was of "great benefit", he said, as a specific test for HIV had yet to be developed. It was also cheap with kits costing just $2 each.

Despite this, however, surrogate testing was only introduced at a minority of blood centres - in San Francisco and "spottily" elsewhere in the US, he said. Had it been introduced universally he believed three quarters of subsequent post-transfusion AIDS cases would have been eliminated.

The tribunal has heard that the Blood Transfusion Service Board declined to introduce the test and waited instead for a HIV test to come on stream in October 1985. Describing the attitude of US blood transfusion centres at the time, Dr Francis said he could recall a meeting at which "I actually pounded the table and asked how many deaths they needed before they would respond."

He said the producers succeeded in watering down the safety recommendations from the CDC, including that on surrogate testing. An unfortunate consequence of this was that other countries like Ireland were looking to the US for leadership and, thus, were influenced by recommendations which were "very inadequate".

In other evidence, Dr Francis said blood banks had an ethical responsibility in 1986 "at the latest" to introduce a look-back scheme, under which product-recipients are traced from donors who tested positive for HIV. The BTSB only initiated such a programme in September 1996.

Dr Francis said the absence of complete medical records was no justification for a delay. The tribunal was adjourned until next week.