THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Saturday, August 12, 1995 TAG: 9508100013
SECTION: FRONT PAGE: A12 EDITION: FINAL
TYPE: Another View
SOURCE: By COREY DUBIN
LENGTH: Medium: 97 lines
The regulatory-rollback proposal introduced by Senate Majority Leader Bob Dole 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 and blood products each year.
In a lethal irony, the Senate was debating the bill just when the National Academy of Science was releasing its long-awaited report, ``HIV & the Blood Supply: An Analysis of Crisis Decision Making,'' which examined 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 study calls for a ``tougher regulatory approach by the Food and Drug Administration'' in the face of emergent medical threats. However, the Dole bill 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 bloodborne AIDS epidemic. The agency relied heavily on the advice of 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.
The manufacturers of these blood-clotting products, vital to people with hemophilia, were able to influence the rule-making, due to their control of information. ``It was the manufacturers . . . and their industry organization'' notes the report, ``that had the important data related to availability and production,'' and ``those data seem to have been highly influential in molding the BPAC position'' in favor of inaction. The report further observed 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 Food and Drug Administration is charged with protecting health and safety. However, the Dole bill requires the agency to do so when the benefits ``justify'' the costs. But, 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 self-regulate 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 Science 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 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 to not 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 NAS report, he asked for the resignations of most of the members of the committee with ties to the blood-bank industry.
Viruses such as Hepatitis C, Parvo B-19 and others continue to threaten the blood supply. Recently a special FDA advisory panel voted unanimously to withdraw any products produced from donors who were found to have contracted Cruetzfeldt Jacob 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 due to a theoretical risk. However, the Dole bill would have forced the FDA to choose a less-costly alternative, thereby thwarting this ground-breaking precautionary action.
Commissioner Kessler's efforts will be for naught if the Dole bill passes. This regulatory rollback will handicap efforts to choose the best means of combating future threats. 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. MEMO: Mr. Dubin, a resident of Santa Barbara, Calif., is vice president of the
Committee of Ten Thousand, the nation's largest grass-roots hemophilia
organization. He is also a voting consultant to the FDA's Blood
Products Advisory Committee.
by CNB