US doctor was unaware of high-risk plasma sources

Cost was the overwhelming consideration for the second-largest user of blood products for the treatment of haemophiliacs in the…

Cost was the overwhelming consideration for the second-largest user of blood products for the treatment of haemophiliacs in the US, its director told the Lindsay tribunal yesterday.

Dr Shelby Dietrich, who has 40 years' experience as director of two centres, the Orthopaedic Hospital, Los Angeles, and the Huntington Memorial Hospital, Pasadena, California, also said the source of blood plasma was not a particular concern in the early 1980s and her centres relied on producers and the fact that products had been licensed by the Food and Drug Administration (FDA).

She also noted that as the second-largest user of blood concentrates in the US, in the early 1980s she was not aware of allegations that some manufacturers had sourced blood plasma from prisons and other high-risk areas.

Dr Dietrich was also chair of the medical board of the World Federation of Haemophilia between 1979 and 1985. Speaking about the federation's recommendations amid "uncertainty" at the spread of the HIV virus in 1983, she said: "We had to come out with meaningless recommendations for lack of information."

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The period between 1983 and 1984 were the most difficult of her career as a physician. "Those years remain in my memory as very black years," she said.

"Uncertainty became the name of the game. We no longer knew that we were doing the best for the patient, and as the months went on the uncertainty simply grew." She said it eased only after the autumn of 1984, when heat-treated blood concentrate was proven to be effective against "spiked" concentrate.

Such was the rate of HIV infection of haemophiliacs that by that time hepatitis C "seemed like a bad cold at times to us".

Earlier, Dr Dietrich had told Mr John Finlay SC, for the tribunal, that the basis of treatment was "concentrate on demand".

She said alternative treatments such as cryoprecipitate were not viable for her centres, one reason being that at the time, the local pool, Los Angeles, represented the fourth-highest risk area for HIV infection in the US.

The centres did not have a choice of blood concentrates, but purchased what was available and licensed by the FDA. "It would have been the product du jour, so to speak," she said. "Whatever we were using at the time, they got it."

Dr Dietrich said that in January 1983, one manufacturer announced it was excluding male donors who acknowledged having sex with other men, and other manufacturers quickly followed.

At a time of unease about whether serious efforts were being made to exclude high-risk groups, she visited one manufacturer's donor clinic near the Mexican border to carry out an "unannounced inspection" but was pleasantly surprised by what she saw.

But as the years went by she read "numerous allegations that some of the manufacturers took plasma from prisons and high-risk areas of San Francisco".

She told the tribunal she avoided contact with the drug companies, as doctors were targets for salesmen. But she said that in choosing concentrates "our criteria was strongly influenced by the bid price", and in the treatment of haemophilia "cost was the overwhelming consideration". The tribunal is expected to hear the evidence of its next witness on Thursday week.