The regulatory rollback proposal introduced by Senate Majority Leader Bob Dole - and still pending - has grave implications for the safety of this nation's blood supply.
The legislation would undermine the Food and Drug Administration's ability to protect the health and safety of the 3.5 million Americans who use blood products each year.In a lethal irony, the Senate was debating the bill just when the National Academy of Science was issuing its long-awaited report, "HIV & The Blood Supply: an Analysis of Crisis Decision Making." It examines the response to the contamination of America's blood supply, by the virus that causes AIDS, during the 1980s.
The report details how 90 percent of the nation's people with severe hemophilia, as well as 29,000 other Americans, were infected with HIV due to a breakdown in the federal regulatory system.
The academy's study calls for a "tougher regulatory approach by the Food and Drug Administration" in the face of emergent medical threats.
However, Dole's Senate Bill 343 would make a tougher approach almost impossible by codifying the very economic standards that consigned nearly 40,000 Americans to the nightmare of HIV infection.
According to the report, "The FDA consistently chose the least aggressive options available" in responding to the accelerating blood-borne AIDS epidemic.
The agency relied heavily on its Blood Products Advisory Committee in determining whether to recall blood products, including anti-hemophilic factor, manufactured from pools containing the plasma of known high-risk donors.
Unfortunately, this critical advisory committee was dominated by the blood banking industry, which had a strong interest in avoiding costly new tests and screening procedures.
Manufacturers of these blood-clotting products, vital to persons with hemophilia, influenced the rule-making with their control of information.
The report further observes that a recall of blood products might have destroyed an important market, and the producers "had very strong economic concerns in seeking to avoid that result."
The FDA is charged with protecting health and safety. However, the Dole bill requires the agency to do so only when the benefits "justify" the costs. In a bizarre Catch-22, the agency relies almost exclusively on the regulated industry for cost data.
Worse, the bill allows the blood industry to continue to regulate itself by establishing "peer review" panels to oversee agency analyses. Amazingly, FDA scientists may be excluded from the panel, but industry-paid scientists are explicitly permitted to be members.
Both provisions clearly stand the National Academy of Sciences report on its head, contradicting the authors' findings that federal "agencies should not rely upon the entities they regulate for analysis of data and modeling of decision problems."
It would be a terrible mistake to think of viral contamination of the blood supply as ancient history or a tragedy from which we've learned our lessons. The FDA reports that between 1987 and 1994, there were an average of 300 cases of transfusion-associated HIV per year.
We have learned there is a window of time between when a person is infected and the point at which existing HIV antibody tests will detect that infection.
That window can be shut by instituting p-24 antigen testing of blood donors. But on June 23, the industry-dominated advisory committee voted not to adopt this important protection for the users of blood.
The decisive factor was a cost-benefit analysis presented by the director of the Irwin Memorial Blood Bank.
Once again, industry's bottom line prevailed over public health.
To his credit, FDA Commissioner David Kessler recently began to take some positive steps toward change. In response to the National Academy of Sciences report, he asked for the resignations of most committee members with ties to the blood bank industry.
Viruses such as Hepatitis C and Parvo B-19 continue to threaten the blood supply. A special FDA advisory panel recently voted unanimously to withdraw any products from donors found to have contracted Creutzfeldt-Jakob disease, a fatal brain disorder about which little is known.
Since the transmission of this illness through blood products is unconfirmed, the panel's decision represents the first time a product recall was instituted because of a theoretical risk. However, the Dole bill would have forced the FDA to choose "a less costly alternative," thereby thwarting this groundbreaking precautionary action.
Kessler's efforts will be for naught if the Dole bill passes.
The language virtually guarantees a replay of the previous hemophilia holocaust the next time a lethal blood-borne virus, whose scientific characteristics are not well known, surfaces in the blood supply.