In 1995, a committee of the Institute of Medicine (IOM), released a report called, HIV and the Blood Supply: An Analysis of Crisis Decision Making. This report is a turning point for the hemophilia community.
Blood Safety Changes Ordered
They Include a Blood-safety Director and Less Influence By The Industry
The Philadelphia Inquirer
By: Donna Shaw, Staff writer
Date: October 13, 1995
WASHINGTON, D.C. – Vowing that government would never again allow an AIDS-style tragedy to kill thousands of transfusion recipients, Secretary of Health and Human Services Donna Shalala yesterday ordered sweeping changes in the way the nation regulates blood safety.
Shalala announced she had appointed a blood-safety director to oversee and coordinate all Public Health Service programs on blood. The lack of a single administrator with authority to make decisions was a key factor in the government’s slow response to suspicions in the early 1980s that the AIDS virus had infected the blood supply, she said.
She also announced that the Food and Drug Administration’s Blood Products Advisory Committee no longer would have any voting members from industry or even members with “the appearance of a conflict of interest resulting from their connection to the blood industry.” Industry members will be nonvoting advisers to the committee, Shalala said. “Blood safety must never again be handled as a secondary issue,” she said in testimony before a House subcommittee. “I am elevating it to the highest level of the department.”
Shalala named Dr. Philip Lee, the HHS assistant secretary for health, as her blood-safety director.
She also created a blood-safety committee to assist Lee; it will include the heads of the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention.
Shalala’s moves received cautious praise from hemophilia activists and doctors who also testified at the hearing, which was held by a subcommittee of the House Committee on Government Reform and Oversight. But they cautioned that the new measures would be effective only if industry was not permitted to dominate Lee’s safety panel. “Our big concern is if we’re going to set up a council that mimics what we’ve seen in the past,” said Corey Dubin, a California hemophilia activist who contracted the AIDS virus and hepatitis from blood-clotting products.
In the late 1970s and early 1980s, between 8,000 and 10,000 hemophiliacs were infected with the AIDS virus from tainted blood products. An additional 12,000 people received HIV-infected blood transfusions.
An unknown additional number – so poorly defined and studied that officials could put it only at somewhere between 100,000 and 200,000 – are believed infected with Hepatitis C from blood and plasma products. There is little that doctors can do to treat or cure such patients, and treatments intended to inactivate viruses don’t always work, the officials said.
Shalala’s moves were the latest in a series of reforms in response to a July report by the Institute of Medicine (IOM) blaming government regulators for not taking stronger action in the early 1980s to prevent thousands of deaths from HIV-tainted blood products. The report also was sharply critical of the plasma-products industry, which makes hemophilia-clotting medicines and other plasma products.
Echoing the findings of that report, Shalala said a “lack of leadership” in the early 1980s contributed to the problems and that “some key political leaders were openly hostile” to intervention because the first victims were gay. “It is clear that the history is a sorry history that we do not want to repeat,” she said.
The American Blood Resources Association, which represents the plasma- products industry, said in a statement yesterday that it supported “in principle” many of the institute’s recommendations. “At the same time, we must make clear that many of IOM’s ‘findings and conclusions’ are incorrect and without foundation,” the group said in a prepared statement.
The FDA Blood Products Advisory Committee, long dominated by experts with industry ties, has been a particular target of criticism from hemophilia activists. For example, at its last meeting, held in June, the panel agreed unanimously that a new HIV blood-screening test was more effective than previous versions. But in a subsequent vote after heated debate, it refused to recommend that the test be required to screen blood donors at blood and plasma collection centers, deciding that the public-health benefit did not justify the expense.
The committee was disbanded soon afterward and, in August, FDA Commissioner David A. Kessler rejected its advice on the screening test. He also overruled it on another issue, saying the FDA would recommend the recall of any blood products that might contain the rare, but fatal, Creutzfeldt-Jakob disease.
Shalala said that when the committee is re-formed, it will have more consumer representation and a permanent member from the Centers for Disease Control, the agency that was ignored when it sounded the first alarm on AIDS and blood in the early 1980s.
Lee said his blood-safety committee would look at broader ethical and social-policy issues involved in maintaining an adequate blood supply and, thus, not conflict with the FDA advisory panel, whose function is to advise regulators.
Asked if she endorsed the Ricky Ray Hemophilia Relief Fund Act, a bill that would provide financial compensation to HIV-infected hemophiliacs, Shalala said HHS officials “have not reviewed that issue.” But she and Lee said they would be willing to talk to Congress about it.
In Philadelphia last night, at the opening of the National Hemophilia Foundation’s annual meeting, the crowd applauded noisily when told that the Ricky Ray bill had gained 135 co-sponsors in the House. It needs 218 to be brought to the floor for a vote.