Category: Archive

U.S. drugs firms may face probe over tainted blood

February 16, 2011

By Staff Reporter

The inquiry, set up by the Oireachtas and headed by High Court judge Alison Lindsay, has been sitting since 1999 and has heard evidence from 148 witnesses, including harrowing testimony from surviving hemophiliacs and their relatives.

The judge makes eight recommendations involving improvements in medical procedures surrounding the treatment of hemophiliacs.

Health Minister Michael Martin has indicated that a further statutory inquiry — the third to probe blood scandals — will investigate multinational pharmaceutical companies that supplied most of the contaminated blood products.

A senior lawyer has already reported to the minister after having traveled to the U.S. to investigate what evidence is available there in a Florida repository about the drug companies and to consult with legal experts involved in U.S. litigation involving HIV-infected hemophiliacs.

Contaminated blood-clotting products led to 80 percent of the 400-strong hemophiliac community being infected. So far, 78 have died, six of them since the tribunal was established.

Hemophilia is an hereditary blood disease characterized by the inability of blood to clot, leading to excessive bleeding, even from minor injuries.

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Lindsay criticizes the transfusion service for a “serious failure” in the mid-1980s for not moving earlier to withdraw a contaminated blood-clotting product that led to HIV infections.

It was “clearly inappropriate” for the service to continue to supply the product, Factor 9, until December 1985, when heat-treated supplies were available.

It infected seven hemophiliacs with HIV and five have since died. One infected a partner with the virus.

She also found supervision by the Department of Health was “lacking” in a number of respects.

The judge said the number of specialist blood doctors had been “grossly inadequate” until recently, medical record-keeping was “unsatisfactory and incomplete” and there was “somewhat haphazard” communication between doctors and hospitals treating hemophiliacs.

The report concludes that blood products for hemophiliacs are now of the highest standard and the safest nature and “this must continue to be the case.”

A recurring theme during the 196 days of evidence was about the “upset and distress” in the way hemophiliacs had been told of infections, a lack of counseling and the delay in getting tests results.

Judge Lindsay turned down a submission from the Irish Hemophilia Society to formally submit a copy of her 239-page report plus appendices to the Director of Public Prosecutions.

“It is not the function of a Tribunal of Inquiry to decide issues of criminal or civil liability,” Lindsay said. “The Tribunal is of the view that it is not appropriate in these circumstances to send a copy of the report to the Director.”

She said it was also inappropriate for her to comment on the possibility of a further tribunal of inquiry into international drug companies whose products are held responsible for infecting most of the hemophiliacs.

However, the minister told RTE he would be meeting the IHS to discuss the recommendations and he was committed to “advancing” the question of a further inquiry.

“I think there will be another inquiry,” he said. “The precise form of it is open for discussion. It should be borne in mind that the vast majority of the infection stems from the commercial products produced by these companies as opposed to products produced by the blood bank.”

Rosemary Daly, IHS administrator, welcomed the report and said the statistics could not convey “the human misery, pain and loss” that had befallen the hemophiliac community.

The IHS walked out of a previous tribunal probing contaminated blood products, particularly the infection of about 1,500 women with Hepatitis C. It said it was not giving adequate attention to its problems.

In 1997, that inquiry found a “catalogue of failures, neglect and inadequacies” in the operation of the Irish Blood Transfusion Board from the late 1970s to early ’90s.

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