| Hi Lloyd,
This article makes me sick to my stomach. It says in
1981 the Red Cross knew HCV was being spread through the blood
supply, had a test to screen for it but decided to delay testing
for six years!
It's absolutely irresponsible. You should see if that
lawyer on your message board could start a class action suit
against them for anyone receiving a blood transfusion between
1981 and 1987. I wonder what there not telling us about
right now!
Take care,
Bill
Disease Spread as Blood Test was Delayed
By KAREN DILLON
2003 The Kansas City Star
WARNING SIGNS: In the 1970s, about 1,500
hospital patients participated in the Transfusion-Transmitted
Viruses Study. Researchers concluded that ALT testing
could slow the spread of hepatitis C. However, the blood
testing was delayed for years. The infected blood from
the study is stored at BBI Biotech in Gaithersburg, Md., for
future research.
WASHINGTON, D.C. - Guardians
of the nation's blood supply gathered in 1981 at American
Red Cross headquarters to consider a way to prevent Hepatitis
C from spreading through transfusions.
For more than four hours they talked about using a test that
was available and could help screen out blood carrying the
virus.
The so-called ALT test was far from perfect. But evidence
that it would slow a disease infecting hundreds of thousands
of patients each year seemed so persuasive that the blood
industry needed to act.
The group concluded:
"Blood collection agencies in the U.S. should prepare
to test ALT levels of all blood units."
But that didn't happen. In fact, the blood industry would
delay testing for another six years.
It's impossible to know how many hepatitis C infections could
have been prevented by the ALT test during those years.
But that figure might be more than 300,000 people, based on
data from some studies.
Arguments made in January 1981 to use the ALT test, revealed
in reports and documents obtained by The Kansas City Star,
surprise some of those who were trying to contain the virus.
"I did not know this (report) existed," said Ron
Gilcher, head of the Oklahoma Blood Institute. "I
was really shocked."
In 1983, Gilcher's blood center broke from the industry to
become one of the first to use the ALT test, but he now wishes
he had known two years before that the report existed.
"Certainly if I had seen this information I would have
had the test in place in 1981," Gilcher said. "What
amazed me was the results of this were not communicated to
the transfusion community."
Instead, the blood industry reversed course.
Five months after the 1981 meeting, industry groups began
recommending a delay in testing, and the government never
forced the issue.
Blood leaders who opposed the test said it did a poor job
of detecting hepatitis C. More study was needed to show
it would actually reduce the number of cases. It would
cost blood banks too much, especially to replace donors who
would be barred from giving blood. And it would be difficult
to implement.
Besides, the disease didn't seem that deadly.
Today, many blood bank officials say they shouldn't be blamed
for the decision to delay ALT testing.
"Nobody did anything wrong as far as I'm concerned,"
said Paul Holland, who in 1981 was chairman of a blood industry
committee on hepatitis testing.
"In hindsight, maybe we could have done differently,
but that's hindsight."
A researcher who backed the ALT test said he nonetheless understood
how hard it was for blood bankers to make decisions at the
time.
Armchair quarterbacking is easy 20 years later, said F. Blaine
Hollinger, director of an HCV and HIV research center at Baylor
College of Medicine.
"When you are going through it, it doesn't quite hit
you," he said.
But after the January 1981 meeting, some blood officials clearly
felt heavy responsibility.
In fact, one of the participants wrote a week later that some
at the meeting "were talking about preventing a disease
that we in fact help create through blood transfusion."
Another participant, Johanna Pindyck, began using the test
at her blood bank.
"This was a serious disease, and it was a preventable
disease," says Pindyck, who was director of the Greater
New York Blood program.
The Canadian Red Cross also was concerned about hepatitis
C and sent a representative to monitor American discussions
in 1981. But Canada waited even longer than the United
States to test, and that decision resulted in criminal charges
last November against the Canadian Red Cross.
Back in the United States, up to 450,000 people who got hepatitis
C through transfusions before 1992 are believed to be alive
today. Many of them still don't know they have the disease,
which has been called the Silent Epidemic.
There is no way to tell how many of those cases occurred in
the early 1980s and could have been prevented by ALT testing.
Need for a test
By the mid-1970s, early studies indicated hepatitis C was
infecting 10 percent of all transfusion patients, or about
300,000 a year.
A test for hepatitis B, licensed in 1972, had screened most
of that virus out of the blood supply, but there was no test
for hepatitis C, or non-A, non-B hepatitis, as it was known
then.
One test, ALT -- which stands for alanine aminotransferase,
a liver enzyme -- had been used by physicians since at least
the 1950s to find damage to the liver. Blood banks in
Germany and Austria, but not the United States, had used it
since at least 1970 to screen blood for hepatitis.
A study began in 1974, in part to determine the link between
transfusions and hepatitis, said Richard D. Aach, principal
author of the study and now an associate dean at Case Western
Reserve University's medical school.
The Transfusion-Transmitted Viruses Study enrolled 1,500 elective
surgery patients who received blood that was measured for
ALT levels. They were followed to see whether they developed
non-A, non-B hepatitis.
By 1978 the study had reached a preliminary conclusion: The
ALT test could reduce cases of hepatitis if used to screen
blood donated for transfusions, removing the blood that had
high levels of the liver enzyme.
"It became clear after several years, a few years into
this study, 1976 or 1978, that ALT was an excellent marker,"
said Hollinger, an investigator for the virus study and a
former chairman of a Food and Drug Administration advisory
committee.
James W. Mosley, the study's principal investigator, said
he encouraged blood banks to use the ALT test but they remained
skeptical.
"We probably should have called more attention to it,"
he said.
By January 1981, though, government and blood bank officials
were ready to talk about ALT testing. The American Red
Cross invited a group of blood experts to its Washington headquarters.
The group included a top FDA blood expert, a pioneering HCV
researcher at the National Institutes of Health, and representatives
of the American Association of Blood Banks, the Red Cross
and the Council of Community Blood Centers.
Documents from the meeting show the 1981 group reached
several conclusions:
| .
ALT testing would decrease the number
of patients who got infected, based on at least two studies.
The participants "agreed that there was evidence
that the introduction of ALT testing would reduce the
incidence of post-transfusion non-A, non-B hepatitis." |
| .
Evidence for the test was so strong, in fact, that it
would no longer be possible to conduct studies in which
patients received blood known to have high ALT levels.
Participants at the meeting agreed that such studies would
no longer be ethical. |
| .
Much needed to be done before testing could begin.
The group appointed a working committee to sort through
such issues as how to make testing consistent and what
to tell donors who have high-ALT blood. |
The blood industry would also have to address the loss of
up to 3 percent of donors, including many who weren't actually
infected but tested positive nonetheless. But that shouldn't
stand in the way of testing, said Alfred J Katz, a blood center
director who soon would become executive director of the Red
Cross Blood Services.
A week after the January 1981 meeting Katz wrote to
a colleague:
"This concern did not outweigh the medical, scientific,
ethical, legal, and public relations judgment that it was
incumbent upon us to prepare to implement ALT as a donor screening
procedure, in order to decrease NANB (non-A, non-B) hepatitis
in recipients."
But within five months the industry changed direction based
on recommendations of at least two advisory committees.
"The Committee concluded that the available data are
insufficient for a decision on introduction of routine ALT
testing of blood donors at this time," one blood group
wrote in June 1981.
Some of those who met in January 1981 won't talk about the
dramatic change, including Katz and Roger Dodd, who wrote
the report of the meeting and today is still with the Red
Cross.
But a spokesman for the blood banks association describes
the rapid turnabout as an evolution, not a reversal.
"Although some of the initial documents could be read
to indicate the way is clear and this is what we are going
to do, I think the environment in which that conclusion was
reached was one of change," said James P. AuBuchon, medical
director of the blood bank at Dartmouth-Hitchcock Medical
Center and former member of a federal blood advisory committee.
"Additional concerns were raised."
Joseph P. O'Malley, who attended the January 1981 meeting,
said a few persuasive people seized control of it and influenced
the recommendation to implement ALT testing. The decisions
the group reached didn't reflect the thinking of the blood
industry, said O'Malley, who retired after 32 years with the
Red Cross and FDA.
Indeed, Thomas Zuck was surprised to discover the true thinking
of blood bankers in the months following the meeting.
"I think we left that '81 meeting with the expectation
that this was going to happen within a year," said Zuck,
who at the time worked for the blood banks association. "I
don't think we realized the resentment there was in some quarters.
They really didn't want to do it."
In fact, Zuck thinks, the Red Cross put the meeting together
actually expecting that the group would reject ALT testing.
"The Red Cross was leading the band mainly because they
wanted a blockade," said Zuck, who remains a consultant
to foreign countries investigating blood contamination.
The Red Cross has refused to talk about the meeting, but it
has characterized the conclusions as only preliminary in documents
it filed in response to a lawsuit.
Obstacles
For the next five years, the industry debated using the ALT
test but left it on hold.
Among the reasons it offered:
.
Lack of evidence
Despite the January 1981 conclusion, it wasn't clear, after
all, that ALT screening would reduce hepatitis C cases, blood
leaders said.
The major studies only predicted that ALT testing would decrease
hepatitis but did not confirm it, some researchers said. In
fact, ALT testing might even have minimal impact.
As a result, instead of being unethical, another study on
humans was needed, some top blood officials said in meetings
and articles. It could take up to six years and involve thousands
of patients and donors.
But Hollinger and some other experts said another study was
senseless.
"That was just a bunch of crap," he said.
Indeed, the study was never performed in the United States.
Some say the proposed study wasn't the real point -- the point
was to delay the ALT test.
"Was that a ruse for the blood bankers?" said Mosley,
a professor emeritus at the University of California-Los Angeles
medical school. "Did they say, `Oh my God, we need to
study this some more and then we can just prolong everything'?
Oh yes."
. Difficulty in Testing
Because ALT levels in the population tended to vary from region
to region, blood banks would have a hard time setting a nationwide
rate that would signal dangerous donations.
But the working group that was appointed at the January 1981
meeting to write those guidelines never met. A national conference
on ALT screening was scheduled by the government for June
1981, but it never happened either.
. Donors
The numbers of lost donors would not be worth the infections
that would be prevented. Of the donors who tested positive
in the ALT test, for example, only a third might have hepatitis
C.
The loss of so many other donors who weren't really infected
would unnecessarily alarm the donors and also create a dangerous
shortage of blood, leaders said.
Two extensive studies had estimated, however, that only 1.5
percent to 3 percent of all donors would be excluded.
. Partial Solution
Many thought a better test -- one actually triggered by the
virus, not just by a liver enzyme -- would be worth waiting
for because studies predicted the ALT test would prevent only
a third of the infections.
But the January 1981 group knew a better test could be years
away -- and, in fact, it was. Besides, said Pindyck, the former
New York blood director, that debate just didn't make sense:
"If a group of firemen were outside a burning building
and they could only save 30 percent of the people in the building,
and they sat around and debated and said, `It's not worth
our effort to do it,' what would happen?"
Voluntary Testing
Only a few blood banks, including Pindyck's, bucked the industry.
After the January 1981 meeting, the Greater New York Blood
Center, which had been part of the TTV study, decided to use
the test. An independent committee of doctors, business leaders
and others studied data for the blood center and concluded
unanimously that the $2.77 cost of each test -- to cover the
test itself and loss of donors -- was worth the drawbacks.
In fact, by 1983, Pindyck and a colleague had published an
article that confronted some of the industry's objections.
The ALT test was not difficult to conduct, and the center
easily absorbed the loss of donors, Pindyck said.
The report's impact? "Nobody paid any attention,"
Pindyck said.
Ironically, even though the federal government didn't require
the ALT test anywhere in the nation, it wanted to protect
its own blood. The National Institutes of Health ordered ALT
screening at its largest research hospital.
The FDA also took no position on another screening test, known
as the hepatitis B core antibody test, which was available
by 1983. Used together, it appeared, both tests could flag
hepatitis C in more than 40 percent of the cases.
At the time, the value of the tests still seemed unproven
and the costs in donors too high, said Jay Epstein, director
of the FDA's Office of Blood Research and Review. And a better
test still seemed near.
"On the other hand, the FDA did not discourage blood
banks that elected voluntarily to implement those tests,"
Epstein said.
Indeed, blood banks finally did decide in 1986 to use the
tests following an FDA blood advisory committee meeting. The
committee heard about increasing reports that hepatitis C
patients were dying.
"If we were the ones that caused their death with transfusion,
I think that is something we should try to prevent,"
Harvey Alter, an NIH scientist credited as perhaps the nation's
pre-eminent hepatitis C researcher, told the committee.
The Red Cross and other blood associations asked blood banks
in 1986 to use the ALT test and the hepatitis B core antibody
test. By 1987, most did, including the Community Blood Center
in Kansas City.
As for the FDA, it never set guidelines or required the ALT
test to be used.
As a result, some infected blood that would have been detected
was used for transfusions, Mosley said.
Action in Canada
The years of delay have attracted little notice in the United
States.
But in some countries, such as Canada and Australia, delays
in hepatitis C testing have created a scandal, prompting public
protests.
In fact, the Canadian Red Cross and its former top blood official
were charged last year for not using available screening tests
between 1986 and 1990, and for not warning the public that
blood was unscreened. The charges are pending.
"This is a crime," said Mike McCarthy, a hepatitis
C patient and until recently senior policy adviser to the
ministry of health in the province of Ontario.
"People were harmed and people suffered egregious injuries
and many people died."
Canada has paid millions of dollars in compensation to people
infected with hepatitis C through transfusions. In fact, in
1994 Canada began searching for those people to make sure
they knew they had received infected blood.
In the United States, however, hundreds of thousands of infected
patients have never been notified.
And there is no compensation, despite prodding by a congressional
committee and others. No strong lobby has ever formed around
the disease to force the government to set up a fund.
And one American blood official doesn't believe there should
be a fund. A lot of medical procedures are risky, and the
blood industry did the best it could with hepatitis C, said
Holland, former head of a government blood bank and now director
of a Sacramento blood bank.
"It was really nobody's fault," Holland said. "Life
is full of risks."
To reach Karen Dillon, projects reporter, call (816) 234-4430
or send e-mail to kdillon@kcstar.com. Database editor Gregory
S. Reeves contributed to this report.
|
