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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking

Statement of

Michael A. Stoto, Ph.D.
Senior Staff Officer
Division of Health Promotion and Disease Prevention
Institute of Medicine
National Academy of Sciences
2101Constitution Ave. NW
Washington, DC 20418
(202) 334-2383
MSTOTO@NAS.EDU

representing the Committee to Study HIV Transmission through Blood and Blood Products Institute of Medicine

before the Committee on Labor and Human Resources
United States Senate

October 30, 1997

Good morning, Mr. Chairman and members of the Committee. My name is Dr. Michael Stoto. I am a senior staff officer in the division of Health Promotion and Disease Prevention of the Institute of Medicine (IOM) and I am a co-editor of HIV and the Blood Supply: An Analysis of Crisis Decisionmaking, the report of the IOM Committee to Study HIV Transmission through Blood and Blood Products. This committee was organized under the auspices of the Institute of Medicine, a private, non-profit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences. On behalf of Dr. Harold Sox, who chaired the committee, I have a copy of the summary of the report which I would like to submit for the record. The complete report is also available on the Internet at WWW.NAP.EDU/BOOKSTORE/

In April 1993, in response to concerns voiced by the hemophiliac community, Representative Porter Goss and Senators Edward Kennedy and Robert Graham requested that Secretary of Health and Human Services Donna Shalala open an investigation into the events leading to the transmission of HIV to individuals with hemophilia from contaminated blood products. Secretary Shalala agreed that it would be useful to gain a more complete understanding of the use of blood and blood products for the treatment of individuals with hemophilia and those who received transfusions in the early years of the AIDS epidemic. Thus, with the intention of preparing for future threats to the blood supply, the Department of Health and Human Services requested that the IOM study the transmission of HIV through the blood supply. To carry out this work, the IOM established the IOM Committee to Study HIV Transmission through Blood and Blood Products.

The committee was asked to examine the decisions made from 1982 through 1986 to safeguard blood and blood products, and to evaluate the actions taken to contain the AIDS epidemic. In its report, the committee attempted to provide both a comprehensive account of the events hat led to the contamination of the U.S. blood supply and a critical assessment of the difficult decisions that were made in the context of the uncertainty of this period. At the request of the Department of Health and Human Services, the report does not seek to determine liability or affix blame for any individual or collective decisions regarding HIV transmission through blood or blood products.

Committee Conclusions

During the early years of the AIDS epidemic, as you know, thousands of Americans became infected with HIV through the nation's blood supply. The committee was asked to draw lessons from decisionmaking between 1982 and 1986 and suggest how those lessons can help the nation prepare for future threats to the safety of blood and blood products. The committee concluded that a failure of leadership in the government and the blood industry led to several missed opportunities to help protect the public from the threat of AIDS. Preventing a similar outcome from a future threat, the committee concluded, will require mechanisms to ensure strong leadership and coordinated, systematic decisionmaking.

The committee found that the events of the early 1980s underscore the difficulty of personal and institutional decisionmaking when the stakes are high, when knowledge is imprecise and incomplete, and when decision

makers have personal or institutional biases.

Although epidemiologic evidence strongly suggested by January 1983

that AIDS was transmitted through blood and blood products, the magnitude

of the risk for recipients was not yet known. Policymakers quickly

developed a list of clinical and public health options to reduce the risk

of AIDS, but because of substantial scientific uncertainty about their

harms and benefits, they adopted the least aggressive options consistent

with the available scientific information.

The committee also found, for example, that despite epidemiologic

evidence showing that several groups had an increased risk of developing

AIDS, organizations implemented donor questioning to determine a person's

high-risk status in different ways at different times, and most blood

banks refused to screen donors for homosexuality. Most blood and plasma

collection agencies also rejected CDC scientists' suggestion that they

employ a surrogate test for AIDS (hepatitis B core antigen). Earlier

implementation of either measure probably would have reduced the number of

individuals infected with HIV through blood and blood products.

Weaknesses in the FDA's collaborative regulatory approach to blood

safety issues, in the composition and operations of the Blood Products

Advisory Committee (BPAC), and in the agency's ability to analyze

independently its advisors' recommendations also became apparent to the

committee. For instance, a series of letters from agency to blood supply

organizations in March 1983 may not have specified with sufficient clarity

that the agency required industry to implement the FDA's recommendations.

Similarly, the agency's handling of its decision in July 1983 to recall

suspect lots of factor concentrate on a case-by-case basis suggested that

the agency lacked both the capacity to structure its advisory process

adequately and to analyze independently the advisors' recommendations.

These and other events indicate the need for a more systematic approach to

blood safety regulation when there is uncertainty and danger to the

public.

Fewer individuals with hemophilia might have been infected with HIV

if the plasma products industry has placed a higher priority on developing

a technology to inactivate hepatitis B virus in antihemophilic factor

concentrate (AHF). When this technology became available it proved

effective against HIV as well as hepatitis B. Hepatitis had been viewed as

an "acceptable risk" of AHF concentrate, and neither physicians nor

patients nor the Public Health Service actively encouraged the plasma

fractionation companies to develop viral inactivation measures.

A range of options for the management of hemophilia, available in

1983, offered the possibility of reducing or eliminating dependence on AHF

concentrate and thereby reducing the risk of HIV transmission. Individuals

with hemophilia and transfusion recipients, however, had little

information about the risks and benefits of these options. Under

prevailing conditions of uncertainty and danger, physicians seemed less

willing, rather than more willing, to share responsibility for

decisionmaking with the patient.

After the dramatic successes of treatment with AHF concentrate in the

1970s, physicians were reluctant to tell individuals with severe

hemophilia that they should consider alternative treatments that reduced

the risk of AIDS but increased the chance of bleeding. The National

Hemophilia Foundation (NHF) and physicians, in their effort to find the

right balance between the risks and benefits of continued use of AHF

concentrate, tended to give more weight to the well-established benefits

of AHF concentrate and underestimate the risks of AIDS, which were still

uncertain.

Institutional barriers to patient-physician communications and

relationships between relevant organizations also impeded the flow of

information. A close relationship between the NHF and industry, for

instance, created a conflict of interest that seriously compromised the

perceived independence of the NHF's recommendations. With input from a

wider group of experts it might have disseminated information on a wider

range of clinical options.

Committee Recommendations

In the context of its analysis of the events of the early 1980s, the

committee made several recommendations for protecting the blood supply

from future threats, including:

- The Secretary of Health and Human Services should designate a

blood safety director to head the government's efforts to maintain a safe

blood supply. Because many agencies share responsibility for blood safety,

a single highly placed official to enforce cooperation is critically

important.

- The Department of Health and Human Services should establish a

blood safety council to assess threats to the blood supply and to propose

and coordinate strategies for preventing and controlling them. The council

also would inform public health officials, clinicians, and the public

about the nature of the threats and strategies for dealing with them, and

would alert scientists about research needs.

- In preparation for future threats, the Department should

establish a sequence of steps to protect the blood supply and criteria for

implementing them. Taking steps proportional to the magnitude of the risk

allows for careful consideration - and reconsideration - of options.

- When faced with a clinical decision in which all options carry

risk, especially if the amount of risk is uncertain, physicians and

patients should take extra care to discuss a wide range of options.

- Voluntary organizations that make recommendations about using

commercial products must avoid conflicts of interest, maintain independent

judgment, and otherwise act so as to earn the confidence of the public and

patients.

Compensation Policy

It was not within the committee's mandate to make recommendations

about compensating affected individuals for damages incurred in the past,

the subject of HR1023. Furthermore, it is the IOM's policy not to comment

on specific legislation. However, the committee's analysis did lead to one

recommendation regarding a no-fault compensation system that might be set

up -- for the future, not retrospectively. The committee concluded that if

in the early 1980s had there been a no-fault compensation system like the

one it recommended in its report, this system could have relieved much

financial hardship suffered by many who became infected with HIV through

blood and blood products in the United States. The no-fault principles

outlined in this recommendation might serve to guide policymakers as they

consider whether to implement a compensation system for those infected in

the 1980s.

When a product or service provided for the public good has inherent

risks, the common law tort system fails to protect the rightful interests

of patients who suffer harm resulting from the use of those products or

services. Each claim requires extended, costly, and complex adjudicative

procedures to establish liability. The results are erratic and

unpredictable, and therefore inequitable. The doctrine of strict liability

holds manufacturers accountable for injuries that are incurred from

products that are inherently dangerous because diligence cannot fully

eliminate their risks. The public health imperative of assuring enough

vaccine for widespread use argues for limits on the strict liability

doctrine for vaccine-related injuries. The chief concern is that fear of

liability will discourage manufacturers from producing a vital public

good. To vitiate this concern, a federal compensation system has removed

vaccine-related injuries from the scope of strict liability laws. The

federal government established a mechanism for compensating individuals

suffering harm from vaccine-related complications. Its rationale is that

consent to undergo vaccination confers benefits to the entire community.

Blood-product-related injuries have also been removed from the

scope of strict liability law by blood shield laws, which are in force in

most states, and which protect society's interests in having an adequate

blood supply. The blood shield laws serve to protect providers and

manufacturers of blood and blood products from liability claims in

instances where they take all due care to ensure the safety of the

product. These laws, however, are unique in the manner in which they limit

liability. The shield laws have made it difficult, and often impossible,

to obtain compensation for HIV infection acquired from blood or blood

products. To address this asymmetry between the protection that blood

shield laws offer for manufacturers and adequate protection of individual

rights, the committee recommended that "The federal government should

consider establishing a no-fault compensation system for individuals who

suffer adverse consequences from the use of blood or blood products."

An effective no-fault system requires prospective standards and

procedures to guide its operations. In a no-fault system, individual

plaintiffs would not have to prove that their adverse outcome was a result

of negligence related to manufacture of a blood product. Therefore, there

needs to be an objective, science-based process to establish which

categories of adverse outcomes are caused by blood-borne pathogens and

which individual cases deserve compensation. As with vaccines, a tax or

fee paid by all manufacturers or by the recipients of blood products could

finance a compensation system. Rather than attempt to allocate blame for

HIV infections through blood and blood products, some countries have

established such no-fault compensation programs for individuals infected

with HIV as a result of their use of blood and blood products. Countries

fund these programs in a variety of ways, including direct government

support and joint

public/private resources.

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