[Congressional Record Volume 141, Number 115 (Monday, July 17, 1995)]
[Senate]
[Pages S10136-S10137]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                           HEMOPHILIA AND HIV

  Mr. DeWINE. Mr. President, the Institute of Medicine--or IOM--last 
Thursday released the findings of a major investigation into how 
America's hemophilia community came to be decimated by the HIV virus. 
It is a very sad and compelling story.
  In the early 1980's, America's blood supply was contaminated with 
HIV. Many Americans have become HIV-positive by transfusions of the 
HIV-tainted blood.
  One particular group of Americans has been extremely hard-hit by this 


[[Page S 10137]]
public health disaster. There are approximately 16,000 Americans who 
require lifelong treatment for hemophilia, a genetic condition that 
impairs the ability of blood to clot effectively.
  In the early 1980s, more than 90 percent of the Americans suffering 
from severe hemophilia were infected by the HIV virus--more than 90 
percent, an absolutely unbelievable figure.
  That is a major human tragedy. I believe we should look to the IOM 
report released last Thursday for answers as to the level of Federal 
Government culpability for this disaster.
  Last Wednesday, on this floor, I discussed three questions that I 
believed were going to be addressed in the IOM report.
  First, did the Federal agencies responsible for blood safety show the 
appropriate level of diligence in screening the blood supply?
  Second, did the Federal agencies move as quickly as they should have 
to approve blood products that were potentially safer?
  Third, did the Federal Government warn the hemophilia community, when 
the Government knew--or should have known--that there were legitimate 
concerns that the blood supply might not be safe?
  Mr. President, if the answer to any of these three key questions is 
no, it seems to me it should be clear that the Federal Government had 
not met its responsibilities in this area. As a result, the Federal 
Government would have a clear duty to provide some measure of relief to 
the people with hemophilia who have been infected with the HIV virus.
  Mr. President, today the report is in.
  The answer to each of these questions is, in fact, no.
  Question 1. Did the Federal agencies responsible for blood safety 
show the appropriate level of diligence in screening the blood supply? 
The report's answer is ``No.''
  In January 1983, scientists from the Centers for Disease Control 
recommended that blood banks use donor screening and deferral to 
protect the blood supply. According to this report, ``it was 
reasonable''--based on the scientific evidence available in January 
1983--``to require blood banks to implement these two screening 
procedures.''
  The report says that ``federal authorities consistently chose the 
least aggressive option that was justifiable'' on donor screening and 
deferral.
  The report's conclusion is:

       The FDA's failure to require this is evidence that the 
     agency did not adequately use its regulatory authority and 
     therefore missed opportunities to protect the public 
     health.''

  By January 1983, epidemiological studies by the Centers for Disease 
Control strongly suggested that blood products transmitted HIV. First 
of all, it was becoming clear that blood recipients were getting AIDS--
even though the recipients were not members of a known high-risk group. 
Second, the epidemiological pattern of AIDS was similar to that of 
another blood-borne disease--hepatitis.
  According to the report, these two facts should have been enough of a 
tip-off to the public health authorities. As early as December 1982, 
the report says,

       (p)lasma collection agencies had begun screening potential 
     donors and excluding those in any of the known risk groups.

  The report says that Federal authorities should have required blood 
banks to do the same.
  Question 2: Did the Federal agencies move as quickly as they should 
have to approve blood products that were potentially safer? Again, the 
report's answer is ``No.''
  The report says that certain heat treatment processes--processes that 
could have prevented many cases of AIDS in the hemophilia community--
could have been developed earlier than 1980.

       In the interval between the decisions of early 1983 and the 
     availability of a blood test for HIV in 1985, public health 
     and blood industry officials became more certain that AIDS 
     among hemophiliacs and transfused patients grew. As their 
     knowledge grew, these officials had to decide about recall of 
     contaminated blood products and possible implementation of a 
     surrogate test for HIV. Meetings of the FDA's Blood Product 
     Advisory Committee in January, February, July and December 
     1993 offered major opportunities to discuss, consider, and 
     reconsider the limited tenor of the policies.

  I say again, Mr. President: ``Major opportunities,'' major 
opportunities to change the course of the government's blood-protection 
policies.
  The report continues:

       For a variety of reasons, neither physicians . . . nor the 
     Public Health Service agencies actively encouraged the plasma 
     fractionation companies to develop heat treatment measures 
     earlier.
       Despite these opportunities and others to review new 
     evidence and to reconsider earlier decisions, blood safety 
     policies changed very little during 1983.

  Mr. President, I cannot avoid agreeing with the conclusion of this 
report: ``(T)he unwillingness of the regulatory agencies to take a lead 
role in the crisis'' was one of the key factors that ``resulted in a 
delay of more than 1 year in implementing strategies to screen donors 
for risk factors associated with AIDS.''
  Question 3. Did the Federal Government warn the hemophilia community, 
when the Government knew--or should have known--that there were 
legitimate concerns that the blood supply might not be safe?
  The report's answer is ``No.''
  According to the report, ``a failure of (government) leadership may 
have delayed effective action during the period from 1982 to 1984. This 
failure led to less than effective donor screening, weak regulatory 
actions, and''--this is the key, Mr. President--``insufficient 
communication to patients about the risks of AIDS.''
  As a result, Mr. President, and I am again quoting from the report: 
``individuals with hemophilia and transfusion recipients had little 
information about risks, benefits, and clinical options for their use 
of blood and blood products.'' The response of ``policymakers'' was 
``very cautious and exposed the decision makers and their organizations 
to a minimum of criticism.''
  In effect, Mr. President, the inertial reflex of bureaucratic caution 
led to a serious failure to protect the public health. That really is 
the bottom line.
  The Americans suffering from hemophilia were relying on their 
government to exercise due care about the safety of the blood supply. 
It is my view, in light of the very important report released today, 
that the Government failed to meet its responsibilities to the 
hemophilia community.
  It is therefore my intention to introduce, in the coming days, 
legislation that will offer some measure of relief to those who have 
been seriously harmed by this governmental failure.
  I have had a discussion with my colleague from Florida, Senator 
Graham, who has been a leader in this area, who has been working for a 
long time with the hemophilia community and those who have been 
impacted by this horrible tragedy. And I would expect to be working 
with him in the future in regard to legislation to be introduced.
  Mr. President, at this time, I yield the floor.

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