[Congressional Record Volume 140, Number 36 (Friday, March 25, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: March 25, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
THE RAY FAMILY, HEMOPHILIA, AND THE AIDS EPIDEMIC
Mr. GRAHAM. Mr. President, on December 13, 1992, Ricky Ray, a
teenage boy in east Orange County, FL, died at home after his 6-year
battle against AIDS and 15-year or lifelong battle with hemophilia. I
attended Ricky's funeral later that week and read a letter from then
President-elect Bill Clinton who, like I, was profoundly affected by
this incredible human being and his family.
This tragic story begins over 10 years earlier when the first case of
immune deficiency linked to blood products was reported in a Floridian
with hemophilia in January 1982. As documented in Randy Shilt's book
``And the Band Played On: Politics, People, and the AIDS Epidemic,''
evidence grew over the year that others with hemophilia were being
infected and at least two transfusion-related AIDS cases were also
reported. In June 1982, the first warning was issued by the Centers for
Disease Control [CDC] to clotting-concentrate manufacturers, other
Federal health agencies and the National Hemophilia Foundation.
According to Harvey M. Sapolsky and Stephen L. Boswell in ``The
History of Transfusion AIDS: Practice and Policy Alternatives'',
Weighing this evidence, the CDC epidemiologists began
warning representatives of the several blood-banking
organizations that the blood supply was possibly being
contaminated with AIDS. These discussions culminated in a
meeting in Atlanta in early January 1983, at which proposals
were presented to screen out from the blood donor pool
members of high-risk groups.
Sapolsky and Boswell add,
The opposition of the whole-blood collectors delayed
governmental action intended to reduce the risks of AIDS
transmission through transfusions. It was not until March
1983 that the Centers for Disease Control made public the
recommendations for widespread screening.
Moreover, it was not until even February 1984 that manufacturers
included warnings about AIDS on their blood products--over 18 months
after CDC's original warning.
Calls for blood testing for evidence of hepatitis B with a core
antibody test were also being made during the period. According to
Sapolsky and Boswell,
The Food and Drug Administration's Blood Products Advisory
Committee studied the issues pertaining to screening the
blood supply in early 1984, concluding that surrogate
testing, and most specifically the hepatitis B core antibody
test, was not appropriate as a means of identifying those at
high risk for developing AIDS because it screened out too
much of the blood supply.
While some testing did occur like that at Standord University Blood
Bank, it was far from pervasive.
In March 1985, the FDA licensed and put into place the first blood
test for HIV antibodies. Meanwhile, due to the fact that clotting
factors are made from pooled plasma lots composed of thousands of
donors, approximately one-half of the estimated 20,000 Americans with
hemophilia contracted AIDS. The result was, as Michael McLeod reports
in his article ``Bad Blood'' which was printed in the Orlando Sentinel
on December 19, 1993, ``a quite death march, caused by one of the worst
medically induced calamities in history--one that has claimed more than
1,600 Americans already, with at least 8,000 more sure to follow.''
Ricky Ray tested positive for HIV in 1986.
In remembering Ricky, words such as perseverance and wisdom come to
mind. Ricky and his family have, since that revelation in 1986, lived
with the pain and questions caused by this horrible virus called AIDS.
If that is not enough, there was also the pain of being banned from
school in 1987, having their home burned down by an arsonist shortly
thereafter, and spending a tremendous amount of time in court fighting
with the DeSoto County School District and the pharmaceutical companies
that sold the Ray family the contaminated blood products.
Despite it all, Ricky was committed to teach others about his
disease. His mother, Louise Ray, said of Ricky in a recent article
written by Monica Davey at the St. Petersburg Times, ``He believed that
his track in life was to educate people about a disease that nobody
know about. He believed that was his purpose.'' His father Clifford
added, ``Ricky was a very old soul. He had a wisdom about him.''
Like others with hemophilia and AIDS, Ricky was interested in answers
to the questions of why. Why did this happen and why was not more done
to prevent this tragedy? If nothing else, we certainly owe it to the
hemophilia community to find answers to these questions and to do
everything possible to prevent further recurrences.
As a result, I joined Senator Edward M. Kennedy and Congressman
Porter Goss in requesting from Secretary Donna Shalala of the
Department of Health and Human Services a thorough review of the
transmission of HIV through blood products to approximately half of
this Nation's hemophilia population and up to 90 percent among those
with the most severe form of hemophilia. As Congressman Goss and I
wrote in a letter to House Energy and Commerce Committee Chairman John
Dingell, ``Our mission is twofold: first, it is critical to make sure
the Nation's blood-supply and our supply of lifesaving blood clotting
factors are now free on HIV contamination; second, we believe we owe it
to those who were infected and their families to find out what went
wrong.''
Secretary Shalala requested the study to be conducted by the National
Academy of Sciences. We are all hopeful for a thorough, yet speedy,
review of these issues. However, with a person in the hemophilia
community dying every day from AIDS, we cannot just patiently wait for
their conclusions. We must continue to seek answers and move to protect
others from similar fates.
First, and foremost, we must ensure that our Nation's blood supply is
truly safe for both the hemophilia community and all Americans who face
the possibility that they may need a blood transfusion at some point in
their lifetime.
For example, the FDA has a catalog of Red Cross violations since 1988
that is 500 pages long and has more than 3000 violations. In addition,
according to a ``Dateline NBC'' report, there have been ``more than
1,700 cases in the past 5 years in which blood had to be recalled from
Red Cross and non-Red Cross blood banks across the country.'' The FDA,
as a result, has resorted to suing the Red Cross, which is responsible
for nearly half of the Nation's blood supply.
Second, we should ensure that we assist those 10,000 HIV-infected
people and their families with their primary needs. Whether this is
addressed by Congress this year through the provision of universal
health care coverage or not, we must adequately address the health and
human needs of this population and others affected by AIDS.
Third, as Harold L. Dalton, and editor of ``AIDS Law Today: A New
Guide for the Public,'' writes:
* * * we should remember that just as the law frames
society's response to the AIDS epidemic, the society as a
whole shapes the law. Like it or not, we must decide what
kind of society we will be: mean-spirited, shortsighted, and
judgmental or compassionate, clearheaded, and accepting. In
the end, society will determine where the burden of AIDS--
social, financial, and emotional--will fall. We can make the
choice consciously and purposely, or we can make it by
indirection or default, but make it we will.
When Ricky saw the headline that ``Ryan White loses battle with
AIDS'', he was very upset. As quoted by McLeod, he said to his mother,
``If I die, don't let them write that about me. Don't let them say that
I lost. Just because you die, that doesn't mean you gave up. That
doesn't mean you lost.'' Ricky is right because his call for answers,
help for those with AIDS and fight for the safety of the blood supply
lives on.
Mr. President, I ask that additional information concerning this
matter be printed in the Record.
The material follows:
[From the Philadelphia Inquirer, Feb. 4, 1994]
AIDS A Big Factor In Deaths of Hemophiliacs
(By Gilbert M. Gaul)
A new federal study documents the devastating effect of
AIDS on America's hemophiliacs.
The death rate among hemophiliacs with the most common form
of the hereditary bleeding disorder, hemophilia A, tripled
between 1979-1989, chiefly because of AIDS, according to a
report in the February issue of the American Journal of
Hematology.
During the same period, the median age at death for people
with hemophilia A plummeted from 57 years to 40 years,
researchers from the U.S. Centers for Disease Control
reported.
The study found that 470 people with hemophilia A who died
between 1987 and 1989 had AIDS or HIV infection listed as the
cause of death. The 470 accounted for more than half of all
those with hemophilia A who died during that period.
The president of the National Hemophilia Foundation, a New
York advocacy group, said the findings confirmed what
hemophiliacs and their families already knew.
``We have known that this devastation has been going on for
years.'' said Alan Brownstein. ``But for people who want to
see the numbers, their study displays the dramatic reversal
of all of the progress that had been made in the lifespan of
hemophiliacs in the 1970.''
According to the foundation, about 17,000 Americans have
hemophilia A. More than 80 percent of people with severe
hemophilia A are believed to have been infected with AIDS in
the early to mid-1980s through the use of tainted blood-
clotting medicine, called Factor VIII. The first case of AIDS
in hemophiliacs was reported in 1981.
To date, about 4,000 people with hemophilia A are
officially listed as having been infected with AIDS according
to the CDC.
``It's safe to say that more than 2,000 people with
hemophilia A have died of AIDS.'' Brownstein said. Currently,
about 30 more people per month are dying, he said.
The lifespan of hemophiliacs increased in the 1970s, but
then dropped dramatically in the late 1980s as hemophiliacs
started to die from AIDS. After peaking in 1983 to a median
lifespan of 64 years, the median age at death in hemophiliacs
fell to 40 in 1989, the study found. The lifespan of
hemophiliacs today now resembles what it was 20 years ago,
before modern treatments were available.
According to the researchers, the risk of getting AIDS from
tainted blood products has been virtually eliminated since
1985 because of new screening procedures and safer clotting
medicines.
In a related development, Brownstein yesterday said
foundation officials were competing draft legislation to
compensate AIDS-infected hemophiliacs and their families.
They hope to present it to Congress in March.
Under the foundation's proposal, those hemophiliacs would
be eligible for financial help for medical bills and family
support from Medicare and Social Security. The legislation
would also create a special trust fund to meet the needs of
people who have been financially devastated by AIDS,
Brownstein said.
``We're pursuing this on the basis that the federal
government had a major responsibility in monitoring the
safety of the blood supply. We're not casting blame. We're
saying the system didn't work.''
____
[``Dateline NBC,'' Oct. 5, 1993]
Safety of America's Blood Supply
Jane Pauley. A ten-year old in California. A carpenter in
Montana. They have something in common. Both acquired AIDS
from blood transfusions.
Bob Jones. AIDS was the last thing on the face of this
Earth that I was worried about.
Pauley. It happened long after blood screening began.
Elizabeth Dole. American Red Cross blood is the safest it's
ever been. It's the safest in the world.
Pauley. It's not always safe enough. Tonight, a Dateline
investigation into laboratories and blood banks.
Stone Phillips. What does that say about the safety of the
blood supply?
Dr. David Kessler. The risks are rare but they're real.
Pauley. Do you know what you need to know about blood?
Whether it's a surgical procedure or an accident, any one
of us could need a blood transfusion. That's why our first
story is so important: the safety of America's blood supply.
The vast majority of blood transfusions are safe. And
nothing of what follows should cause you to reject blood if
you face a medical emergency. But what you're about to hear
is the untold story of the problems the Federal Government's
been finding at too many of the nation's blood banks.
Stone Phillips. Problems so serious, the government took
the unprecedented step of suing the American Red Cross
earlier this year.
Tonight, the results of a six-month Dateline investigation.
And for the first time on television, we'll show you the
scope of what the Food and Drug Administration described as a
continuing pattern of violations, violations that call into
question whether the blood supply is as safe as it can be. As
FDA Commissioner David Kessler told us, the risks are rare
but real.
Jones. I was just totally shocked, stunned. You know, I
couldn't say a word, I couldn't think, I couldn't do
anything. AIDS was the last thing on the face of this Earth
that I was worried about.
Phillips. Bob Jones is a 60-year-old carpenter living with
his wife, Shirley, in the mountains near Bozeman, Montana,
far removed from the urban neighborhoods that have become the
killing grounds of the AIDS epidemic.
It's hard to imagine anybody being much further from the
highrisk groups for HIV infection than you.
Shirley Jones. Right. That's what we thought. Absolutely.
Jones. Well, apparently our high risk was accepting blood
from the blood bank.
Phillips. Doctors say Bob Jones is slowly dying of AIDS.
What's surprising about his story is how he got it: through a
blood transfusion, a transfusion he received more than four
years after the government had approved a new test that was
supposed to screen blood for AIDS.
In the early years of the AIDS epidemic, before scientists
knew much about it, thousands of people contracted AIDS from
blood transfusions, including celebrities like tennis star
Arthur Ashe.
Woman. Today we are licensing a blood test . . .
Phillips. But that changed in 1985 when officials announced
a new test that would screen the blood.
There's no doubt the new test did dramatically improve
blood safety. Food and Drug Commissioner David Kessler says
today your chances of getting AIDS from a blood transfusion
are about the same as dying from an allergic reaction to
penicillin.
Dr. Kessler. If you need blood tonight, I mean if you have
to be transfused, I can sit here and say that if you need
that transfusion, have that transfusion, because the benefits
outweigh that risk.
Phillips. Even so, Kessler says the nation's blood system
is not as safe as it could be.
Dr. Kessler. The risks are rare but they're real. And
unless it's your own blood, then the risks are out there.
Phillips. Bob Jones says his case is evidence that the
risks are greater than most people realize. And as you'll
see, our own investigation points to the same disturbing
conclusion.
Do you feel that you and your family were misled about the
safety of the blood supply?
Jones. I feel not only my family, us and our family, I
think the whole world has been misled by it. You see these
advertisements on television, ``Blood is safer than it ever
was.'' Well, right. It is. They don't tell you how safe it
never was.
Phillips. It was November 1989 when Bob Jones was rushed to
this hospital near Portland, Oregon. A blood vessel had
burst, causing severe internal bleeding. Surgery saved Bob's
life. But four months later he got a phone call from the head
of the Red Cross blood bank in Portland.
Jones. He told me, he says, ``I hate to be the bearer of
bad news. But,'' he said, ``one of the donors has turned up
positive for HIV.''
Phillips. What in the world went through your mind when you
heard that?
Jones. I hate to see my family have to go through the next,
oh, three, four or five years, whatever it takes. I would
have much rather gone out right on the table.
Phillips. You would have rather died in surgery than gone
through this.
Jones. That's right.
Phillips. How can contaminated blood get through the
screening process? And is it still happening today?
When we started asking those questions, we found a blood
safety net which government officials say has potentially
dangerous holes. From big-city blood banks, where government
records show some critical testing and labeling violations
going on year after year, right into 1993; to government
computer files that document blood recalls, something we'd
never heard of, hundreds of them nationwide during the last
five years; and finally, to the headquarters of an
organization responsible for nearly half of the nation's
blood supply, whose record of repeated safety violations
recently landed it in federal court.
When you took this job, did you ever imagine that your
biggest enforcement nightmare would be coming from an
organization called the American Red Cross?
Dr. Kessler. It's the hardest thing that I have done. And
it had to be done in a way that got the job done and still
not scare the public.
Phillips. In order to understand why FDA Commissioner David
Kessler has taken the Red Cross to court and how people as
unlikely as Bob Jones are still getting AIDS from blood
transfusions, we wanted to find out more about how blood is
tested for safety.
Dr. Ed Engleman. This is the laboratory in which the blood
is tested.
Phillips. Ed Engleman is a medical doctor, research
scientist, and director of the blood bank at Stanford
University. He's also testified as a paid expert in court
cases against the Red Cross. He says all blood must pass a
series of sophisticated tests, screening everything from
hepatitis to syphilis to the AIDS virus.
Dr. Engleman. Each virus is different.
Phillips. But even if every stop in the AIDS test is
followed to the letter, contaminated blood still can slip
through because the test has an inherent weakness, something
blood banks know but you may have heard little about The
problem is that the test doesn't actually look for the AIDS
virus itself, but for the immune system's response to it, the
antibodies.
Dr. Engleman. And once a person is infected with the virus,
it takes time for the antibodies to form. It may take a few
weeks, it may take four or five months.
Phillips. If a donor is recently infected, it may not show
up.
Dr. Engleman. That's correct.
Phillips. That means the test has a built-in blind spot.
And since each unit of blood usually is split into different
components, each component going to a different patient, one
bad unit could infect several people.
In the case of Bob Jones, it turns out the donor had been
recently infected with the AIDS virus and the blood test
didn't catch it. But in a lawsuit, Bob Jones's attorney,
Monte Back, claimed the Red Cross in Portland overlooked what
should have been a clear warning.
Each number on this computer printout represents a blood
sample taken and tested for AIDS. On the list, one stands
out. It's the blood that went to Bob Jones. Although not
above the cutoff that would have prevented its release, this
blood tested far higher than the other samples in the batch.
Monte Beck. If you see an unusual test result that's five
times higher than anybody else on that test that day, that's
telling you something.
Phillips. But if I'm the lab technician and I know what my
cutoff point is, I might not flag it.
Beck. Well, you might not flag it, but you should.
Phillips. Dr. Engleman agrees. He says although blood-
testing equipment is better than ever, all lab technicians
need to be encouraged to use their judgment in close calls.
Often that's not the case, even in his own lab.
Dr. Engleman. So if somebody comes up with a test that is
just below the cutoff, you've trained that individual to
ignore it.
Phillips. This past March, just one day after these opening
arguments began in court, the Red Cross settled the Bob Jones
case, agreeing to pay him an undisclosed amount of money but
admitting no mistakes.
Fred Kyle. We shouldn't imply that this was the fault of
the American Red Cross, because it was not.
Phillips. Fred Kyle is in charge of Red Cross blood banks
nationwide.
Kyle. The American Red Cross, in the case of the Jones
incident, followed every single procedure that we have to the
letter and every single procedure that the Food and Drug
Administration requires to the letter.
Phillips. While the FDA did not find fault with the Red
Cross's handling of the Jones case, these government
inspection reports, obtained by Dateline through the Freedom
of Information Act, show the Red Cross does have a record of
repeatedly failing to follow blood test procedures, not only
for AIDS but for other potentially fatal diseases as well.
In Portland, government inspectors reported in 1991 that
the Red Cross failed to properly calibrate its testing
equipment, failed to follow proper test procedures. And
record-keeping was so sloppy that during one inspection the
government found blood which had failed an AIDS test about to
be shipped out.
Dr. Kessler. There was a great deal of concern.
Phillips. And Kessler says the problems weren't just in
Portland, but at Red Cross blood banks all across the
country.
In Waco, Texas, the Red Cross allowed blood to be
transfused from a donor with a history of failing AIDS tests.
In Farmington, Connecticut, the Red Cross mistakenly released
blood taken from known IV drug users. In Washington, D.C.,
the blood bank failed to follow up on hundreds of cases in
which donors gave blood but later tested positive for AIDS.
Dr. Kessler. It wasn't any one individual violation. What
it was was going in year-in and year-out and seeing the same
violations. That's what concerned us most.
Elizabeth Dole [May 20, 1991]. There can be no higher trust
than the blood of life we distribute.
Dr. Kessler. The government's findings came in spite of
repeated pledges, in 1988 and again in 1991, that the Red
Cross would upgrade its blood system.
Dole. The key here is that we're going to make it as safe
as it can be made, or we're not going to collect blood.
Phillips. Did you talk to Elizabeth Dole about this, head
of the Red Cross?
Dr. Kessler. I spoke to the entire leadership of the
American Red Cross.
Phillips. Unpersuaded their voluntary transformation
program to overhaul equipment and training would address the
problems quickly enough, Commissioner Kessler made what he
calls his most difficult and most important decision. In May
of this year, he took the American Red Cross to court, where
both sides agreed that if the improvements weren't made by
specific deadlines, the Red Cross would answer to a federal
judge.
Kyle. I don't accept the fact or the allegation that the
American Red Cross has dragged its feet at all on maintaining
absolute safety in our operations.
Phillips. Absolute safety?
Kyle. Absolute confidence that we have maximum safety.
Phillips. This is the FDA's catalog of Red Cross violations
since 1988. It's 500 pages, more than 3000 violations. I mean
that's a pretty sizable document.
Kyle. It certainly is.
Stone, I think that if we have rigorous regulatory
enforcement, which absolutely is necessary and we welcome it,
we are always going to have observations of how we can
improve our operations. But that's a different thing than
saying that there is a problem with the safety of the blood
supply, or the efficiency or safety of our operations. That's
two different things.
Kessler. We were seeing too many units that were released
where there was just a breach in one of the levels of
protection. There were just too many unsuitable units being
shipped.
Phillips. When we come back, blood recalls, trying to get
some of those unsuitable units back after they've been
shipped out. And more blood banks cited by the FDA. We'll
tell you which ones, why they got in trouble, and how in some
cases the government threatened to shut them down.
Phillips. As we just heard, there is a blind spot in the
test used to screen blood for the AIDS virus, making it
inevitable that blood from some recently infected donors will
slip through. That's a problem both for Red Cross blood banks
and for private ones as well. But the question is, given
that, how should blood banks respond once they've learned
that one of their donors has tested positive for the virus?
What responsibilities do they have to notify patients who may
have received tainted blood? As we discovered, that's another
problem area for the FDA.
Jessie Lee Fagan was hardly the picture of a child
struggling with cancer, perhaps because she beat it.
Roger Fagan [father]. When we heard the word ``remission,''
that was just the best news I've ever heard.
Phillips. So why is Jessie in a California hospital bed
today? Well, it turns out in overcoming leukemia she received
dozens of blood transfusions. And somewhere along the way,
long after AIDS screening began, she apparently got blood
contaminated with the AIDS virus.
Denise Fagan [mother]. I just thought, ``Oh, my God. How
did it happen.'' I thought this blood was safe.
Phillips. Now, more than two years after she was diagnosed
with AIDS, doctors still don't know the source of the
contaminated blood, leaving open the possibility that an
infected donor may have given more tainted blood that slipped
through. And yet when local health officials tried to find
the donor, they say their efforts were actually thwarted by
the Los Angeles Chapter of the American Red Cross, which
provided much of Jessie's blood.
This March 1992 letter about Jessie's case was sent by the
public health director in Kern County, California to the L.A.
Chapter of the Red Cross. It said, ``Your agency has refused
to provide us important information that would solve the
missing link and prevent further blood contamination and the
spread of AIDS.''
The Red Cross says it was only trying to protect donor
confidentiality. But other documents obtained by Dateline
show that the Los Angeles Red Cross, in a number of cases,
has been slow to notify patients who may have received
contaminated blood.
An AIDS transfusion case reported in October of 1991. The
blood donor isn't contacted until February of '92. And as of
May `92, more than six months later, the blood recipients
hadn't been contacted.
Dr. Engleman. I think that's--I think that's criminal. I
think it's absolutely irresponsible. Because not only do you
have the blood donor who hasn't been contacted immediately,
now you have the recipients who are infected and capable of
infecting other people.
Dr. Kessler. Was it sloppy? Was it the result of not
realizing that they had to adhere to rigid standards? Sure.
Kyle. The L.A. center did not move as fast in the past as
we insist they move now.
Phillips. And in fact, there was a failure to promptly try
to contact people who might have received contaminated blood.
Kyle. In the past, they weren't moving as fast as we wanted
them to. Yeah.
Phillips. The implications there are pretty serious. I mean
if people don't know that they may have been contaminated,
what's going to happen? They're going to go out and
contaminate others, potentially, with the virus.
Dr. Kessler. It is very serious. And that's why we've taken
the actions that we've taken.
Phillips. Although the Red Cross has been the focus of the
government's enforcement effort, Dateline discovered the
problems haven't been limited to that organization. Records
show that within the past year the government shut down a
non-Red Cross blood bank in Putnam County, Florida, and
one in Spokane, Washington, which was allowed to reopen
only after a management shakeup. And the FDA has
threatened to close down other blood banks, as well, for
AIDS and non-AIDS-related violations, including Life
Source, the largest blood bank in the Chicago area, cited
for failing to perform blood tests properly and not
keeping an accurate list of ineligible donors. The Irwin
Memorial Blood Center, the largest in San Francisco, cited
for failing to test blood correctly and failing to
properly investigate cases of possible AIDS-contaminated
transfusions. The Wobley (?) Blood Bank, the largest in
Dallas, cited for mistakenly allowing people who fail the
AIDS test to keep donating blood, some of it actually
distributed for transfusion.
Dateline has learned that federal inspectors thought those
violations in Dallas were so serious, they considered
pursuing criminal charges because of the repeated release of
unsuitable blood, blood that wasn't adequately screened.
All these blood centers were ultimately allowed to remain
open after convincing the FDA they were upgrading their
equipment and procedures.
Dr. Kessler. What we're saying is that if there's not
immediate correction, we're going to close down and stop
allowing you to ship blood. I mean it's as serious as you
get.
Phillips. And there's more. A Dateline analysis of
government computer records uncovered more than 1700 cases in
the past five years in which blood had to be recalled from
Red Cross and non-Red Cross blood banks across the country.
In more than 500 of those cases, records show the recalls
were because the blood had failed at least one of the safety
checks meant to screen out AIDS.
This map shows the states, 36 of them plus the District of
Columbia, in which blood banks have reported AIDS-related
recalls since 1991.
Now, a recall doesn't mean the blood was necessarily
infected, but it does mean there was a mistake in the safety
screening.
What does that say about the safety of the blood supply?
Dr. Kessler. It doesn't allow me to sleep very well at
night, knowing that, you know, that we have to recall blood.
Phillips. Your staff has told us that only a very small
fraction of the blood that's recalled is actually recovered.
Dr. Kessler. That's correct.
Phillips. Well, doesn't that leave a very big unresolved
medical issue out there, blood that you don't know whether
it's contaminated or not contaminated?
Dr. Kessler. Certainly, if there is a breach in a layer of
protection, there is no question that the blood poses risks.
Kyle. I think we are doing a disservice, I truly do, if we
imply that the blood supply in this country is not safe.
Because it is safe.
Phillips. In spite of the problems, the Red Cross and other
blood banks point to the following statistic as evidence that
the blood supply is extraordinary safe.
Kyle. Since there was testing for the HIV virus in 1985,
there have, I believe, been in the United States 21
identified cases of transfusion-related HIV.
Phillips. That figure comes from the Centers for Disease
Control, the CDC, and it's been repeated year after year to
reassure the public that the risk of getting AIDS from blood
transfusions is very low. The most recent CDC statistic is
actually 25 cases in the past eight years. That's an average
of just three a year out of millions of transfusions. But
Dateline discovered that number may not tell the whole story.
Remember Bob Jones? His blood transfusion was in November
1989, but Dateline discovered that his case hasn't been
included yet in the CDC's numbers.
Jones. I don't think they're telling us the truth on that,
because of my not being listed.
Phillips. The government says it doesn't count cases like
Jone's until the patient develops full-blown AIDS. Experts
say that can take years, even after patients have tested
positive for the AIDS virus.
How many uncounted cases are there? Nobody knows for sure.
But Commissioner Kessler told Dateline that instead of three
transfusion AIDS cases each year, the real number today could
range from 70 to several hundred.
Dr. Kessler. You're dealing with, at most, I think, several
hundred cases a year. And when you recognize that there are
somewhere between 12 and 18 million units a year that are
transfused, the risk is small.
Phillips. Several hundred per year is a lot more than 25
since 1985.
Dr. Kessler. That's--Stone, that's the best estimate that I
have. That's the best number that I can give you today.
Phillips. In the end, for people like Jessie Lee Fagan and
Bob Jones, it's no longer about estimates or numbers. It's
about doing everything possible to make an imperfect system
safer.
Jones. I'd like to see them fix this up so's that my
grandkids and your grandkids aren't fighting this 20-30 years
from now, if there's anybody left.
Phillips. The American Red Cross told us just last week
that instead of two or three cases, it now estimates there
may be as many as 89 cases each year of HIV contracted
through blood transfusions.
So, what should you do?
Well, first, you cannot get AIDS by donating. So don't be
afraid to give blood.
Second, and we repeat, nothing you've heard tonight should
prevent you from accepting blood in a medical emergency. But
if you need surgery and it is not an emergency, FDA
Commissioner David Kessler urges everyone, if at all
possible, to set aside their own blood.
____
[Dateline NBC, Dec. 14, 1993]
Hemophiliacs Not Told of Clotting Factor's AIDS Risk
Jane Pauley. If only we knew then what we do now. But back
when the magnitude of the AIDS crises was only beginning to
be understood, one group of people at high risk slipped
between the cracks of what we knew and what we didn't yet
know. Thousands are dead or dying.
Was this tragedy preventable?
Stone Phillips. Our story goes back to the early 1980s,
when people with hemophilia began using a blood-clotting
agent known as factor. It was convenient and effective, but
it was often transmitting the AIDS virus.
Tonight a six-month Dateline investigation shows that there
were people in authority who knew about the risks. So why
didn't their warnings reach more people?
Here's Lea Thompson.
[Clip of demonstration]
Woman: Ten thousand people infected.
Louise Ray: They should have at least given these people
word that every time you put that needle in your arm, you are
playing Russian roulette. I don't appreciate it that they
played God with my children's lives.
Lea Thompson. Louise Ray's three sons are among the
thousands of hemophiliacs who got the AIDS virus by injecting
a blood product that was supposed to help them, not kill
them.
This is Ricky, Robert and Randy Ray in 1987. They were all
born with hemophilia, a bleeding disorder among males that
prevents blood from clotting. Like most hemophiliacs, they
were treated with infusions of clotting factor, a concentrate
made from the blood of up to 20,000 donors.
Mrs. Ray. The only thing that I knew about factor, that it
was this miracle drug that made it easier for hemophiliacs.
Thompson. It was a miracle. Beginning in the '70s, instead
of having to go to the hospital for treatment, hemophiliacs
could finally treat themselves at home. And if swelling or
bleeding did occur, patients started using it even when it
wasn't absolutely necessary.
Mrs. Ray. So we thought it was great, and we never
questioned it because we didn't know that we could.
Thompson. The Rays say they never would have used factor
had they known the risks: that in the early '80s, just one
donor with AIDS could contaminate thousands of bottles of
clotting factor.
Once they were infected, the Ray brothers paid a heavy
price. They were barred from school. Their house was burned
to the ground. Today one son, Ricky, is already dead. And
Louise knows that inevitably she will lose two more.
Mrs. Ray. I have to wonder every morning when I get up, you
know, is this the day that they're going to get sick? Is this
the day that we're going to go down that road that I went
with with Ricky?
Thompson. There were 20,000 hemophiliacs in the United
States in the early '80s. By 1985 drug companies had found a
way to heat factor to make it safe. But by then it was too
late. We now know over 12,000 people were infected with the
AIDS virus, nearly two out of every three hemophiliacs.
Almost an entire generation wiped out.
Today hemophiliacs are outraged because they have
discovered most of those people didn't have to die, that it
could have been prevented.
Man. Facts don't lie.
[Applause]
Thompson. Once silent, hemophiliacs are looking to place
blame.
Man. Nail that son of a bitch.
Thompson. In a strange twist, they're not only suing the
companies that made the factor, but the very organization
that claims to protect their interests, the National
Hemophilia Foundation, the NHF, which doctors and patients
trusted for information, not only about hemophilia but also
about AIDS.
Man. They should have decided in favor of safety, and they
didn't.
[Applause]
Mrs. Ray. The National Hemophilia Foundation was supposed
to have been there as an advocate for us. They took away our
choice and our right to make a medically informed decision
for our children. And that's wrong.
Thompson. Do you ever step back from this and say, ``Almost
everybody I represent is going to die?
Alan Brownstein. I can't believe it. I can't believe it.
Thompson. And this is the man that many hemophiliacs blame
the most. Alan Brownstein, the Executive Director of the NHF
since 1981.
Hemophiliacs charge that because of the NHF's close ties to
drug companies, Brownstein and his former medical advisers
failed to adequately warn them.
There are many people who say you just didn't do your job
in the early '80s, and as a result they're dying.
Brownstein. We did all that we could. And I just wish we
had more information so that we could have made decisions
that could have saved more lives.
Thompson. But as the nation's chief consumer advocate for
hemophiliacs, the NHF had plenty of information. What it did
with it was another matter.
A six-month Dateline investigation has uncovered disturbing
evidence that at a time when factor was known to be
contaminated, the NHF continually downplayed the danger of
using it.
In July of 1982, when little was known about AIDS, the
government Centers for Disease Control alerted the NHF that
for the first time three hemophiliacs had been discovered
with AIDS, and the CDC indicated all signs pointed to
clotting factor as the cause.
Brownstein. We thought, first of all, that we had to get
the information out.
Thompson. And several days later, the NHF did send out the
first of a series of newsletters. While it advised patients
to consult their doctors, it emphasized the risk of AIDS was
only minimal and that CDC was not advising a change in
treatment. In other words, keep using the factor.
Dr. Donald Francis. The newsletter says that CDC does not
recommend changing treatment. That was just not true.
Thompson. Dr. Donald Francis was one of the leading
scientists at the CDC during the outbreak of the AIDS
epidemic. Francis and his colleagues repeatedly warned the
NHF about the danger of injecting factor, and by the end of
1982, he says, the NHF should have seen what was going.
Dr. Francis. We were already expressing at that time our
fear that half the hemophiliacs might die of this disease.
Thompson. If half their members were doing to die of AIDS,
that fear did not seem to be reflected by the NHF.
Dana Kuhn. They're the watchdog. And I felt like if there
was any problem with the product, they would make sure that
everybody knew about it.
Thompson. On March 25th, 1983, Dana Kuhn, a minister and a
hemophiliac, broke his foot playing in a church basketball
game. At the hospital, even though his injury was not
serious, as a precaution they injected him with clotting
factor. It was his first and only injection.
Is there a word that can explain how you feel?
Kuhn. Betrayed.
Thompson. And the reality is, is that you're living with a
disease that has no cure.
Kuhn. Right. And my children are living with a nightmare,
that they don't know when their dad is going to develop
symptoms and die of AIDS.
Thompson. What Dana Kuhn never knew was three weeks before
he received what would be his fatal injection, the CDC issued
an even stronger statement: that blood product appeared to be
the cause of AIDS in hemophiliacs. But the NHF newsletter
five days later failed to mention that.
Kuhn. Why weren't we getting warned when you had all this
information? That is when we should have been totally warned,
and it should have gone over the wire and people should have
had a choice.
Thompson. It would be three years before Kuhn would
discover he had contracted the HIV virus. By then, he had
unknowingly passed it to his wife. Patricia Kuhn died 21 days
after she was diagnosed with AIDS.
Did you ever dream that she would be the first to go?
Kuhn. It just totally destroyed my life when she died. And
the toughest part was to tell my children. They didn't
understand why their mom died and they would say ``It's not
fair. It's not fair. Why did God let my mother die?''
Thompson. And what's even harder to understand is why,
nearly a year after the CDC's first warning, the NHF sent out
this May 1983 bulletin with a headline, ``NHF Urges Clotting
Factor Use Be Maintained.'' By then, the death toll was
rising, and thousands who weren't already infected were still
at risk.
Dr. Francis. Clotting factor was not an essential to the
survival of a hemophiliac. There were other options for
treatment. To say that NHF urges clotting factor use, at
least I feel at times, was a death sentence to lots of
people.
Thompson. Mr. Brownstein, what does the headline say?
Brownstein. Oh. ``NHF Urges Clotting Factor Use Be
Maintained,'' because at that time the risk was minimal, from
what we knew. And keep in mind that the leading cause of
death in people with hemophilia was bleeding that was not
treated with clotting factor.
Dr. Francis. He's clearly in error. It was clear that the
leading cause of death in hemophiliacs was not bleeding, but
already in January of 1983 the leading cause of death was
AIDS.
Thompson. And Francis and others charge the NHF never
placed enough emphasis on the link between factor and AIDS.
Dateline reviewed all of NHF's newsletters from 1982 to
1985. And although there were some references to potential
risks, not once could we find any clear warning not to use
factor because it could lead to AIDS.
Tom Drees. And nobody, including my own company, issued a
warning.
Thompson. Tom Drees is the former head of one of the
companies that makes factor. In the early '80s, Drees says,
he was fired for trying to make the factor safer. He claims
that while the companies put profits ahead of lives, the NHF
looked the other way.
Why would the National Hemophilia Foundation side with the
pharmaceutical companies in an issue that it knew was killing
its very own people.
Drees. Because it got a substantial amount of its income
from the pharmaceutical companies. And over the years, they
were always after us to make more contributions.
Brownstein. They funded a project here and there, but the
actual operation of the foundation--zero.
Thompson. They were doing things for you that wouldn't have
been done if they hadn't paid for them.
Brownstein. That is correct. That is correct. And those--
that is quite typical to get support, but it's also--we are
honor-bound to make sure that this support is done without
any strings whatsoever.
Thompson. There was no conflict of interests.. . .
Brownstein. Zero.
Thompson. . . .in the early '80s with these pharmaceutical
companies.
Brownstein. Zero.
Thompson. But the drug companies certainly took advantage
of NHF newsletters.
On May 11th of 1983, you put out this bulletin saying ``NHF
Urges Clotting Factor Use Be Maintained.''
Brownstein. Un-huh.
Thompson. Do you have any idea how the pharmaceutical
companies used this bulletin?
Brownstein. No. I know how we use it and I know how we send
it to our physicians and to members of our community.
Thompson. Here are two memos sent to sales forces.
Dateline has obtained these two 1983 drug company memos
with that NHF newsletter attached urging patients to inject
factor. Doctors confirm that NHF information was used to push
sales.
They took your bulletin and they took it to hospitals and
to doctors and said, ``This is what the NHF wants to go on.
Now please buy my product.''
____
Bad Blood--Every Day, a Hemophiliac Dies of AIDS. It Didn't Have to
Happen
(By Michael McLeod)
There's a pool on the third floor of the hotel, but Johnny
Kellar hasn't bothered to bring his swimsuit.
At 13, he still has the face of a child, with curly brown
hair and a poutish over-bite. But he steers away from the
other kids at the convention, staying with the adults
instead--sitting in on their meetings, taking part in their
protest marches, wearing one of the buttons they've been
passing out.
``Cry Bloody Murder,'' it says.
Johnny, of Clearwater, is wearing the button when he
accosts an executive from the National Hemophilia Foundation
in the lobby of the Indianapolis hotel.
``You thought I'd be dead by now, didn't you?'' Johnny
shouts. ``Well . . . I'm back!''
Johnny's mother doesn't scold him after the outburst. Nor
do any of the other adults. No one even appears surprised.
The annual convention of the hemophilia foundation is the one
place Johnny Kellar and his anger fit right in.
Like Johnny, many of the people at this convention are
dying. Like him, they are intent on speaking their minds,
knowing how slim the chances are that they will be back next
year to elaborate.
Theirs is not a photogenic catastrophe, no space shuttle
blown to bits while millions watched. Until now it has been a
quiet death march, caused by one of the worst medically
induced calamities in history--one that has claimed more than
1,600 Americans already, with at least 8,000 more sure to
follow.
They are among the more than 10,000 hemophiliacs in the
United States who contracted AIDS in the early 1980s from a
blood based clotting agent that pharmaceutical companies and
the National Hemophilia Foundation told them to continue
using even after government warnings that it was dangerous.
Fearful of the stigma of AIDS, most hemophiliacs suffered
quietly as their numbers diminished. The only hemophiliacs
with AIDS who generated publicity were children who were
forced into confrontations--Ryan White in Indiana, the three
Ray brothers in Florida. Thousands of other hemophiliacs,
young and old, fought solitary battles--for hope, for legal
redress, for details about how their medicine had been
contaminated and why they were not warned.
Lately that has begun to change. Hemophiliacs have banded
together, with their strongest bond not commiseration but
camaraderie.
Motivated by the Ray family, they have sparked a
congressional inquiry into the catastrophe. The Rays, who
live in east Orlando, helped persuade U.S. Sens. Bob Graham
of Flordia and Edward M. Kennedy of Massachusetts to
spearhead the federal investigation soon after the death last
year of 15-year-old Ricky Ray, Ricky was the eldest of
Clifford and Louis Ray's three hemophiliac sons, all of whom
contracted the AIDS virus from the contaminated, blood-based
medicine.
The 18-month inquiry by the National Academy of Sciences
will focus on the response of federal agencies and private
industry to the contamination.
Hemophiliacs also have filed suit against four drug
companies and the National Hemophilia Foundation, asserting
that because of its close ties to industry the nonprofit
consumer group played down the danger of the medicine when it
should have been warning them about it.
In that class-action suit filed in October, the drug
companies are accused on continuing to sell infected
medication even after top scientists, bureaucrats and company
executives knew or should have known that it was contaminated
with the AIDS virus.
Whatever the results of the congressional inquiry and
related legal action, this much is clear following an
examination by Florida magazine of internal corporate
memorandums, transcripts of public health meetings, lawsuits,
government documents and more than 100 interviews with
victims and industry leaders:
The imminent death from AIDS of more than half of the
hemophiliacs in the United States and thousands more abroad
could have been avoided. Questions about the safety of blood-
based products emerged in the mid-1970s, long before the AIDS
crisis. And as early as 1980 the pharmaceutical industry
rejected proven cleansing processes that could have
eliminated viruses such as AIDS from the medicine.
In 1982, people responsible for ensuring the safety of the
hemophiliac community were officially warned by the federal
Centers for Disease Control and Prevention that the blood-
based medication was dangerous and probably fatal. Those
warnings, however, were not relayed in their entirety to
hemophiliacs and their doctors for a year and a half.
Along with the CDC's warnings came two major safety
recommendations by the federal health agency that were
ignored by all but one of the pharmaceuticals. A 1983 memo
shows that three of the companies went further, suggesting
``delaying tactics'' to evade those recommendations.
Meanwhile, the federal Food and Drug Administration, which
oversees the safety of blood products, deferred many critical
decisions to the industry by exercising little regulatory
control.
By the time the drug companies issued warnings and
perfected measures to purify the medicine, thousands in the
United States had been infected.
Scientists such as Dr. Donald Francis look back with horror
on their futile attempts to persuade industry and government
leaders to take emergency action. To Francis, the
contamination of the hemophiliac community was a human-
wrought catastrophe with all the classic trademarks: the
pressure of money, the illusion of invulnerability, the
warning voices that go unheard, the chances to change course
that slip by unheeded.
``It was like we were standing at a bend in the railroad
tracks, and you could hear the sound of an engine and you
could feel the tracks vibrating. And everyone was saying,
`No, you're wrong. There's no train coming,''' recalls
Francis, an epidemics specialist with the CDC in the 1980s.
To Chicago lawyer Leonard Ring, one of the attorneys in the
class-action suit, the tragedy is nothing short of ``the
largest scandal in U.S. medical history.''
Its boundaries actually extend even farther. The same
medicine that infected hemophiliacs in the United States was
exported to England, Canada, Japan and other countries.
Similar scandals involving blood concentrate took place in
Germany and in France, where it reached the level of a
Watergate, toppling a political party and sending two high-
ranking government scientists to jail.
And in Costa Rica, at least 15 hemophiliacs are infected
with AIDS because an American company, now called Miles Inc.,
sent a tainted shipment of the medicine there in 1985, when
Miles already had crated an AIDS-free product through heat
treatment.
To Miles and the other drug companies that produce the
blood concentrate--Rhone-Poulenc Rorer/Armour
Pharmaceuticals, Baxter Healthcare Corp. and Alpha
Therapeutic Corp.--the contamination of their product was
simply a terrible tragedy that was no one's fault.
``The villain here is not any person or company,'' says Don
Hyman, director of corporate communications for Miles Inc. in
New Haven, Conn. ``Isn't it possible that no one is to blame?
Isn't it possible that the villain here is simply a virus?''
Several high-ranking hematologists support the position of
these drug companies that the infection of their product with
AIDS was no one's fault.
``Hindsight is great, but we had to make logical decisions
based on the information we had at the time,'' says Dr. Louis
Aledort, a key figure in the controversy as medical adviser
to the National Hemophilia Foundation when the AIDS crisis
began. ``People have short memories. They forget all the good
things we did for hemophiliacs before this happened.''
Gainesville hematologist Craig Kitchens, who has testified
on behalf of the drug companies in lawsuits brought by
hemophiliacs, also feels that blame is being misplaced.
Kitchens says the scientists who voiced early warnings were
essentially just lucky.
``If you put 30 guys in a room, one of them is going to
predict who is going to win the World Series,'' he says.
Yet it wasn't just a game of random numbers that doomed
thousands of hemophiliacs. Nor was it a single, viral
villain.
It was a system of government and private enterprise that
failed them precisely when they needed its protection the
most.
``They lied to us,'' says Johnny Kellar. ``Do they think
we're stupid? It's so obvious. The whole thing was money,
money. Money was more important to them than our lives.''
Johnny became friends with both Ricky Ray and Jason
Christopher, an 11-year-old Tampa hemophiliac who died of
AIDS two years ago. Last year, a jury awarded Jason's parents
$2 million in their milestone negligence lawsuit against
Armour. The jury decided that Armour knew enough in 1982 and
1983 to warn users of the AIDS risk--and that if such a
warning had come, Jason's doctor would have changed to a
safer treatment. Attorneys for Armour, who are appealing,
described the outcome as a ``sympathy verdict.''
Dave Houston of Palm Harbor was the foreman of that jury.
``There was no emotion involved'' in the decision, he said.
``We just felt that a company as big as that, a company
that supplies anything--food, medicine, whatever--if they
ever had the slightest doubt about the safety of anything,
they need to take it off the shelf. You may lose a few
million, but in the long run you'll save yourself money--and
you'll save people's lives.''
The jury award was small consolation to Johnny Kellar, who
says he now has to fight ``the companies'' not only for
himself but for friends like Jason and Rickey.
``The way I see it, I don't have any chokce,'' he says.
``They killed my friends. They gave me AIDS. And if I let
them get by with it, they're just going to do it again.''
It was a golden age. It was a miracle cure.
In Miami, Maxine Segal's two teenage boys, Doug and Scott,
had been in and out of the hospital so often that all their
crushes were on candy stripers. Now, instead of spending
their weekends hooked up to intravenous lines, they were
water-skiing and going to band practice.
In Hershey, Pa., a retired night watchman named Gino
Cailone was able at last to take his dream trip to the old
country--to a rustic mountain village where indoor plumbing
was still a novelty. He came back home beaming, showing off
pictures of long-lost cousins pointing at their sinks.
In Fort Pierce, a cattleman named Merlin Dawson had been
passing up chances to expand his business because of his
health. Now he was establishing herds in South America.
And in Clearwater, the parents of Jason Christopher were
relieved that their infant son would grow up like a normal
boy.
It was all because of a new, blood-based medicine that had
been developed to treat their illness, hemophilia.
The standard misconception about hemophilia is that its
victims can bleed to death from a tiny scratch. That's not
true. But for many years, the reality was nearly as bad.
Because of a single missing gene, the blood hemophiliacs
fails to clot properly. The main problem for hemophiliacs is
``spontaneous'' internal bleeds that can start for no
apparent reason.
Without clotting action, blood can seep into joints
repeatedly, eroding cartilage and even bone, causing painful
swelling and a form of arthritis. Before World War II, a
hemophiliac was usually on crutches or in a wheelchair by the
time he reached his teens.
Transmitted by women, hemophilia causes symptoms almost
exclusively in males. Its hereditary nature helped to make it
a ``closet'' disease--a family secret. Mothers felt guilty
for giving it to their sons. Sons felt like sissies because
they were overprotected.
Probably the most famous and overprotected hemophiliac in
history was Nicholas II of Russia, one of several aristocrats
who inherited the disease from Queen Victoria. But the
cloistered image of hemophilia would continue to haunt its
victims even into modern times.
For years, the only treatment was an infusion of blood
plasma--the translucent, protein-laden part of blood that
remains when red blood cells are taken out. Plasma helped
save lives, but it did little to stop the crippling effect of
bleeds.
Then, in 1964, Stanford University researcher Judith Poole
noticed a sediment, or ``cryoprecipitate,'' that accumulated
at the bottom of frozen plasma. She tested the substance and
discovered that it consisted mostly of the proteins that help
blood to clot. If hemophiliacs could be treated with the
sediment--Poole called it ``cryo'' for short--it would at
least be better than giving them whole plasma, which taxed
the circulatory system and involved long hospital sessions.
Cryo was a turning point for hemophiliacs. Because it could
deliver clotting proteins quickly, there now was a way to
prevent the painful internal bleeds and joint damage.
Yet it was still cumbersome. It had to be kept frozen, and
a doctor was needed to administer it. Then, in 1968,
researchers at the American Red Cross and Hyland Laboratories
developed a new product, which quickly became known as
clotting concentrate.
It was mass-produced by pooling plasma in huge vats, then
drawing off the proteins that make blood clot--either Factor
VIII, the protein lacked by most hemophiliacs, or Factor IX,
another clotting protein. The clotting agent was then
stabilized, freeze-dried and bottled.
Now hemophiliacs could treat themselves, thanks to the
small, vacuum-packed vials of white crystals--ready to be
dissolved in water and injected ``early and often,'' as
manufacturers advised.
Patients were euphoric. Doctors basked in their gratitude.
A Gainesville hematologist remembers a whole family coming to
his office to hug him on their way to the Grand Canyon--the
first time they had dared take their hemophiliac son across
the Alachua County line.
One physician called the mid-1970s ``the golden age of
hemophiliacs.'' A company that distributed clotting
concentrate came up with a cartoon super-hero mascot for it,
a caped crusader called ``Factor Man.'' If it sounded more
like a Saturday morning cartoon character than a medical
advance nobody was about to complain.
Like most medications, clotting concentrate had a side
effect. Although the concentrate was treated to screen out
bacteria, viruses could slip through. Doctors knew that one
in particular was inevitable: viral hepatitis
Because the plasma of an average of 20,000 different donors
was pooled in huge vats to make clotting concentrate, viral
hepatitis became statistically inevitable for hemophiliacs.
And doctors knew that a portion of those who contracted
hepatitis eventually would die from liver damage caused by
the disease.
But it would take decades for viral hepatitis to kill
someone who contracted it from clotting concentrate. And
because concentrate was so convenient and effective, many
doctors, drug manufacturers, the FDA and hemophiliacs
themselves accepted the risk.
Others didn't.
Dr. Oscar Ratnoff had no particular inside track on the
manufacturing of concentrate. But the Cleveland hematologist
had done research into liver diseases. And one of the things
he remembered was the massive outbreak of hepatitis during
World War II, when soldiers were exposed to pooled plasma.
The incident stuck in his mind as an example of just how
volatile plasma from thousands of donors could be. Ratnoff
wasn't so sure the trade-off between the convenience of
clotting concentrate and the risk of hepatitis was such a
good one. Why risk contracting a fatal disease for the sake
of convenience?
Many of his colleagues thought Ratnoff was hopelessly old-
fashioned and conservative. ``Oh,'' one would later say,
``Oscar was always saying things like that.''
But as Ratnoff knew, cryo was produced by local blood banks
with the plasma of only a dozen or so donors. With a pool
that small, chances were excellent that you could avoid
hepatitis altogether.
Like any good doctor, Ratnoff decided to explain the risks
to his patients and give them a choice.
Five patients chose cryo.
Five shrugged of his warnings and kept using clotting
concentrate.
``You're messing with my lifestyle, Doc,'' said one of
them.
There had been no telltale jolt, no sound of massive gears
locking in place. But a doomsday machine had begun churning
forward, and five more hemophiliacs had just taken their
places on board--alongside Jason Christopher, Gino Cialone,
Merlin Dawson, Doug and Scott Segal and 10,000 others.
It was a holiday weekend, July 4, 1991, when Calvin Dawson
drove from Apopka to Fort Pierce to say goodbye to his
brother. By then, Merlin was emaciated. Confined to a
wheelchair, he was resigned to death. ``This thing is going
to kill me,'' he said. They prayed together. Merlin bound his
head, then looked at Calvin and said that he had accepted
Christ as his savior, that he wasn't afraid of death, that it
had to be better than the suffering he was going through.
Then he swore Calvin to a promise.
``This is the damndest thing to happen to a group of
people,'' he said. ``If you do anything, Calvin, find out
what happened and why.''
What happened is that hemophiliacs unknowingly became part
of what Peter Levine, a leading hemophilia researcher, calls
an ``unbelievable experiment.''
That experiment--sanctioned by the FDA and carried out by
the pharmaceutical industry--would involve regular, week-
after-week exposure to a product made from the bodily fluids
of thousands of people. Later, it would be equated to having
unprotected sex with 20,000 strangers every week.
Unlike the plasma that was used in cryo, the plasma in
clotting concentrate came from blood that was bought and
sold--the basis of a loosely regulated, highly competitive $2
billion industry revolving around plasma products.
The foundation of the plasma industry was a system of paid-
donor centers, most of them located in impoverished, inner-
city neighborhoods where people were paid $10 to $20 per
donation.
Two of the companies that produced clotting concentrate for
hemophiliacs also had programs to draw plasma from inmates in
federal prisons. A string of plasma centers that catered to
migrant workers was located along the border between the
United States and Mexico. And between 1972 and 1977, a series
of American-run plasma centers was operating in Central and
South America, from Haiti to Argentina, where they could pay
for less per donation.
Hemophiliacs were suddenly at the receiving end of what was
quite literally an international bloodstream.
Three of the four companies that sold clotting concentrate
would soon become subsidiaries of foreign-owned
conglomerates--German, French and Japanese. In the 1970s, the
United States became the chief exporter of plasma and
clotting concentrate across the world.
It was a profitable system. As everyone would later
realize, it was also ideal for spreading a worldwide
epidemic.
There were two reasons. Plasma-product manufacturers were
now pooling the blood of thousands of people, exponentially
increasing the risk of contamination from disease. And plasma
centers were paying for the blood of high-risk donors--people
who were less likely to be healthy than volunteer donors.
In the midst of the golden age, however, it was difficult
to shift the momentum of a multinational industry once its
course was set.
As medical director for Hyland Pharmaceuticals, Dr. Edward
Shanbrom had overseen the original mass production of
clotting concentrate in 1974. He became concerned when
technicians who worked close to the huge vats of plasma
developed skin rashes and hepatitis.
It was one thing to calculate, on paper, the risk-to-
benefit ratio of clotting concentrate. It was another to see
people catch a serious disease simply because they came into
contact with invisible vapors from the pooling vats.
Shaken, Shanbrom decided to develop a detergent-wash
process to make clotting concentrate virus-free. But it took
him five years. And when he tried to sell his cleansing
process to the drug companies in 1980, they turned him down.
A year later, the companies also ignored another kind of
cleansing process by a German company, which had tested its
new product on a group of 155 hemophiliacs. None of them
contracted hepatitis.
Nor was anyone taking note of the warnings of Dr. J.
Garrett Allen, a Stanford University surgeon who had once run
a blood bank at the University of Chicago. Allen waged a long
and unsuccessful campaign to warn people about the dangers of
pooled plasma.
``Large pools are highly profitable, but they are medically
bankrupt,'' Allen said in 1987. ``This is not a recent
consensus. There was no valid reason to not have developed a
heat-treatment protocol . . . in the 1970s.''
Articles in medical journals from that time were
documenting the progression of liver disease caused by
hepatitis, which had become the second-leading killer of
hemophiliacs, after bleeding. And in 1974, a U.S. Senate
subcommittee under Sen. Henry Jackson of Washington began
looking into the blood-plasma industry. The inquiry died
after Jackson lost his bid for the presidential nomination.
Robert Massie Jr. was an investigator for Jackson at the
time. Massie, a hemophiliac with AIDS, is a professor in
business ethics at Harvard Divinity College.
``It was clear to anyone who looked at the system that it
was absolutely perverted, with little concern for safety,
driven by the search for cheap plasma and the desire to
maximize profit,'' he says.
Yet apart from that brief investigation, few questioned the
collection methods of the plasma industry or the danger of
hepatitis.
And fewer still stopped to wonder: If one virus could slip
through, who was to say that another one wouldn't?
Make a wish, they said. The charitable organization that
set up dream trips for children with terminal diseases told
Johnny Kellar he could go anywhere, meet anyone.
``OK,'' said Johnny. ``I want to meet Arnold
Schwarzenegger.''
So Johnny and his mother were flown to Hollywood. But when
he came face to face with Arnold, Johnny was too nervous to
talk. His mother had to relay the boy's request. He didn't
want an autograph. he didn't want a souvenir.
``My son says you're the Terminator, and he has a job for
you,'' Marge Kellar said. ``He says he wants you to terminate
the drug companies for him.''
Dr. Donald Francis had spent years battling communicable
diseases in impoverished countries--from smallpox to exotic
African viruses.
As early as 1981, when the notion still seemed outlandish
to many scientists, he suspected that AIDS was caused by a
new virus with a long incubation period. Independent and
mercurial, the young epidemics specialist was often impatient
with the ponderous CDC bureaucracy. He quickly became known
as a hothead--a reputation he bolstered by pounding on a
table during a key meeting between CDC scientists and balky
blood industry leaders during the early months of the AIDS
crisis, demanding: ``How many deaths do you need?''
It was typical for Francis to get straight to the point, as
he did in a conversation with another CDC scientist, Dr.
Bruce Evatt, in 1982.
``If your children had hemophilia,'' Francis asked, ``would
you let them use clotting concentrate?''
Unlike Francis, Evatt was courtly, soft-spoken. A good
listener and a diplomat, he had been around a federal agency
long enough to choose his words carefully.
In this case, however, his response was unhesitating.
``No,'' he said.
Yet even though the danger was clear to the two
specialists, it would take a year and a half for their
warnings to get through to hemophiliacs.
What stood in the way?
Francis would later come up with a theory about that. He
calls it ``the erroneous consensus spiral,'' and he says he
may some day write a paper about it. His thesis would be that
thousands of Americans weren't killed by the AIDS virus. They
were victims of the status quo.
Time after time, in the key crisis years of 1982 to 1984,
people and institutions who could have saved lives refused to
listen to the warnings of specialists.
``I had worked around the world in a variety of government
settings, including dictatorships and military regimes, and I
have never seen the sort of repression of the truth that I
was dealing with then,'' says Francis, who retired from the
CDC two years ago and in now working on an AIDS vaccine for a
private biotechnology firm. ``We told them what the danger
was. We told them what to do about it. And they ignored us.''
Evatt, who is still with the CDC, says:
``You have to remember that, at the time, infectious
diseases weren't supposed to happen. We thought we had
conquered infectious diseases forever. They were supposed to
be a thing of the past.
``What happened--the disbelief, the way people reacted--
that was just human nature. It's the sort of thing that
happens every day. Nobody wants to believe bad news. It's
just that in this case, the consequences were so immense.''
It was in the spring of 1982 that Evatt, a divisional
director at the CDC, began seeing evidence that hemophiliacs
were falling ill from the same immune system collapse that
was killing gay men. Haitians and intravenous drug users.
Evatt and other CDC scientists had feared it would happen.
Hemophiliacs were the canaries in the coal mine--harbingers
of a deadly infiltration. The thing--whatever it was--had
gotten into the blood supply, into blood plasma, into
clotting concentrates. One infected blood donor could taint
tens of thousands of units of clotting factor because of the
lethal exponentials of the pooling vats.
Eventually, more than half of the nation's 20,000
hemophiliacs would contract a fatal disease through the
medicine they had thought of as their salvation. By the time
hemophiliacs understood the implications of the infection and
the nature of the disease, hundreds of their sexual partners
were also infected.
But all those horrors still lay in the future when Evatt's
staff, in July 1982, presented evidence of three cases of the
mysterious new disease in hemophiliacs.
Evatt knew that for many hemophiliacs, it already might be
too late. Thousands more were at grave risk.
He and his staff quickly started working on a plan to alert
the blood industry, the FDA and other federal agencies.
Though CDC scientists saw the danger in clotting
concentrate--and also in routine blood transfusions--they
could only make recommendations about how to deal with it.
The CDC wanted blood banks and plasma centers to begin
screening donors--that is, to stop taking blood and plasma
from homosexuals. That suggestion drew the ire of gay
activists, which helped to delay the screening.
CDC doctors also wanted to test blood and plasma for
hepatitis and to discard all samples that came out positive.
Doing so would make blood products much safer, the CDC
reasoned, because eight out of 10 donors with AIDS also had
hepatitis.
However, the agency had no authority to enforce those
recommendations. That action would have had to come from the
FDA or the drug companies themselves. Nor did CDC directly
warn hemophiliacs: That responsibility was assumed by the
National Hemophilia Foundation.
So for CDC scientists, the critical first years of the AIDS
crisis would be like a macabre version of the parlor game in
which a whispered message, relayed through several people,
becomes muddled by the time it reaches the last in line.
In July 1982, the CDC issued its first official warning
about hemophiliacs and AIDS, when Evatt wrote a letter to
other federal health agencies, blood banks, the four
pharmaceutical companies and Dr. Louis Aledort, the National
Hemophilia Foundation's medical director.
``We have been suspicious that it may be transmitted in a
manner similar to hepatitis, and thus creates a problem for
the users of blood products,'' Evatt wrote. ``Hemophiliacs
would be prime candidates to develop this syndrome.''
Internal memos from the early months of the AIDS crisis, in
1982 and '83 show that the drug companies understood the
danger to hemophiliacs.
In a 1982 memo, a doctor with Amour Pharmaceutical wrote:
``Deficiency Syndrome [AIDS] is now a major issue. The cases
are doubling every six months, it is probably a transmissible
disease and may be found in all blood products. High risk
groups for Hepatitis B (which includes hemophiliacs) are also
high risk for AIDS.''
In a deposition for Maryland hemophiliacs's lawsuit, Milton
Mozen, medical research director of Miles Inc., said his
company knew in October 1983 that the blood concentrate could
cause AIDS and that the entire supply of clotting concentrate
was contaminated.
Even earlier, the company was aware of its responsibility
to warn consumers. In an internal memo sent to top
executives, dated Dec. 29, 1982, an attorney for a division
of Miles Inc. called Cutter Biological, sent this warning:
``It appears to me to be advisable to include an AIDS
warning in our literature . . . litigation is inevitable, and
we must demonstrate diligence in passing along whatever we do
know to the physicians who prescribe the product.''
The company, however, did not issue those warnings for
another year and a half.
Meanwhile, doctors and consumers were told the danger was
minimal.
Three months after the internal Cutter memo, an article
appeared in a Cutter magazine for hemophiliacs.
The article, titled ``What is Cutter Biological Doing to
Minimize the Risk of AIDS?'' claimed that Cutter was
``launching an all-out campaign that includes strict
precautionary measures to make clotting concentrate safer.''
Then it listed Cutter's blood-plasma collecting centers,
noting: ``There are no Cutter centers in New York, San
Francisco, Los Angeles or Miami, where the vast majority of
AIDS cases to date have been reported.''
The prison where Cutter drew blood was not listed. And
anyone familiar with the West Coast might have paused at the
very first California city on Cutter's list: Berkeley.
Besides being just a 10-minute subway ride from San
Francisco, Berkely is a college town with substantial
communities of gays and drug users--the population that
doctors knew was most at risk.
And although it was true that Cutter has no plasma center
in Miami, it did have one in a run-down section of Fort
Lauderdale--a center that had been criticized for safety
violations by the FDA.
``That, to me--playing that game of misleading little
geographical games with your patients--that was just plain
callous,'' says Dr. Thomas Drees. ``That shows you the mind-
set of some of these companies.''
From 1973 to 1984, Drees was the president of Alpha
Therapeutics in Los Angeles, one of the companies that
produced clotting concentrate. He now works as a consultant
and is one of a few members of the plasma industry who is an
outspoken critic of the drug companies.
Drees says he was aggressive in applying safety standards--
and was fired specifically for that reason, when the company
was taken over by a Japanese conglomerate, Green Cross.
An Alpha spokesperson declined comment.
``My attitude was, if you thought you had a problem, you
had a problem,'' says Drees. ``In terms of our safety
standards, we always tried to stay a step ahead of whatever
the FDA advised. Ethically, morally, that was the way I
thought we should do business.''
That attitude was not necessarily shared by other clotting-
concentrate manufacturers.
One internal memo, dated December 1983, indicates that some
of the manufacturers--not including Cutter--were trying to
delay a recommendation to initiate plasma-screening measures
that the CDC had suggested a year earlier.
``Mike Rodell of Armour proposed a task force to deliberate
the details of the recommendation and provide further
information in three months,'' the memo reads. ``. . . The
general thrust of the task force is to provide a delaying
tactic for the implementation of further testings.''
The FDA agreed to the formation of the task force, which
consisted of drug industry representatives. The task force
eventually recommended against the testing that the CDC
wanted.
Instead, the drug companies began experimenting with heat-
treated clotting concentrate, assuming that heat would kill
any fatal virus. By 1984, scientists had finally identified
the AIDS virus that destroys the immune system and confirmed
it was transmitted through blood products and bodily fluids.
They eventually would learn that a combination of blood-
donor screening and heat treating would eliminate the virus
from their blood product. By 1985, the clotting concentrate
was considered safe--three years after the CDC issued its
warning and recommended blood screening.
Even then, hemophiliac activists say, one company continued
to use the old, unheated and unscreened clotting concentrate
rather than destroy it. Dallas attorney Charles Siegel says
he has proof.
Cutter, he says, ``dumped'' unscreened, unheated and AIDS-
tainted clotting concentrate into a foreign market, knowing
that it could be contaminated. Siegel is suing Miles Inc. on
behalf of 15 Costa Rican hemophiliacs who contracted AIDS
from the contaminated concentrate, which was shipped to Costa
Rica by Miles' Cutter subsidiary in March 1985. At the time,
Cutter had an AIDS-free product available.
``It's very difficult for someone outside of the U.S. to
sue a U.S. company,'' Siegel says. ``I honestly think that
Cutter just never believed in a million years that anyone
[from Costa Rica] would ever sue them over this, and that's
why they did it.''
As an example of the company's unwillingness to destroy
products that might be tainted, Siegel points to a series of
Cutter memos recommending the sale of ``unscreened''
product--meaning raw plasma drawn from donors who had not
been screened for AIDs.
``Put unscreened material into finished inventory as soon
as possible,'' reads one such memo, dated March 20, 1986.
``Get word to distribution to move existing unscreened
finished goods inventory before we move screened material. .
. . From a production planning and inventory-control point of
view, this current policy is desired. We need the unscreened
inventory to meet our 1986 sales requirements and want to
avoid large writeoffs.''
Siegel contends that such concern for profit was the reason
that his Costa Rican clients ended up with AIDS.
Clotting concentrate is one of the most expensive medicines
ever made. Someone with severe hemophilia spends roughly
$150,000 a year on the treatment. By one estimate, the
pharmaceutical industry takes in $250 million a year from the
sale of the medicine.
``They had the technology available to make a safer product
and ship it to their customers,'' Siegal says. ``So they had
to make a choice: Do you sell the old stuff or throw it out?
They chose. They decided to just put it in the pipeline.''
Donald Hyman, the spokesman for Miles Inc., calls criticism
such as Siegel's nothing but hyperbole.
``We reject categorically any allegation that we would put
profits over concern for human safety,'' he stated in a
recent news release. ``As in all such cases, tragedies such
as this create an urge in some people to seek a villain. And
the villain here is the AIDS virus.''
Miles acted properly, ``based on the scientific knowledge
of the time, to procure safe and effective bloodclotting
products,'' he wrote. The company ``never sold products that
its scientists believed could transmit the AIDS virus.''
In response to sending nonheat-treated concentrate to Costa
Rica, Hyman stated: ``Although we can now know the tremendous
benefits of heat-treated product, the company, the medical
community and regulatory agencies in the various countries
did not fully understand these benefits when it was first
introduced.''
It was just a charity basketball game, something the church
had put together that spring in 1983. One of the players was
40-year-old Dana Kuhn, a father of two who was working as an
assistant for the church as part of his seminary studies.
He went up for a rebound, came down off balance and wound
up breaking a bone in his foot. At the emergency room, he
told doctors that he was a mild hemophiliac--with such a
faint trace of the disease that he had never had to use
clotting concentrate.
They suggested, just be on the safe side, that he should
get a shot of concentrate to stave off any bleeding problems
that the broken bone might cause.
Kuhn was doubtful. He'd heard rumors that there was a
problem with AIDS in the concentrate. But the doctors, he
says, assured him it was safe.
``They probably have a way of screening the virus out of
this stuff,'' he remembers thinking as they gave him the
injection.
It was the legal responsibility of the drug companies to
warn consumers about any danger caused by their products. But
there were two other lines of defense for hemophiliacs.
One was the Food and Drug Administration, the federal
agency that regulates blood products. The other was the
National Hemophilia Foundation, the group with the most
direct line of communication to hemophiliacs.
Why, then, did neither the FDA nor the foundation make sure
that the pharmaceuticals followed the blood-screening
recommendations and other precautions laid out by the CDC in
the early 1980s?
At the time, both organizations had critical flaws that
hampered their ability to deal with an emergency.
The FDA, during the Reagan deregulation years, left key
posts unfilled for years. Morale was low, with many
scientists shopping around for new jobs. Regulation also was
less than aggressive: In 1983, at the height of the crisis,
the FDA agreed to a blood-industry suggestion to cut down on
the number of its inspections of blood banks--from one per
year to one every other year.
The FDA has been described in court cases as, by nature, a
``passive'' agency--one that relies on manufacturers to stay
abreast of safety issues relating to their products. In a
series of hearings on drug-labeling regulations in 1978, an
FDA commissioner said that it was impossible, given staff and
funding limitations, for the FDA to operate any other way.
Dr. Donald Francis, the CDC epidemics specialist, gives two
reasons why his agency's recommendations were not immediately
adopted: the FDA's complacency and resistance from blood
banks and pharmaceutical companies.
``They never really sat down and listened to us when we
warned them very clearly about what was happening,'' Francis
says. ``And now they all have to live with themselves. So, of
course, they're going to say that it wasn't their fault, that
they did everything they could. But that's simply not true.
The truth is that they killed a lot of people.''
At a series of meetings of blood industry leaders and
federal officials, the CDC warnings and screening
recommendations were downplayed and derided.
Where were their studies? How could they be so sure?
Weren't they exaggerating? Many at the agency, and within the
blood industry, saw the CDC's aggressiveness as the
beginnings of a turf war.
``We also agreed that the CDC was getting increasingly
involved in areas beyond their area of expertise,'' reads an
internal Cutter memo, dated January 1983.
Among the doubters was Dr. Dennis Donahue, head of the
biologics division of the FDA, which was chiefly responsible
for overseeing the clotting-concentrate manufacturers.
Like many FDA officials, Donahue had been in the blood-bank
industry himself. And an internal Cutter memo mentions that,
at the time of the AIDS crisis, Donahue was disillusioned
with the FDA and was looking for another job--in the blood
industry.
Donahue thought the CDC's suggestion for a stopgap
screening test was ``absolute nonsense.'' A Cutter memo,
dated Dec. 27, 1982, notes that Donahue ``requested that we
send him some official notification of our plans so that he
could use this as ammunition that voluntary efforts of the
industry precluded the need for any further regulation.''
In effect, decision making was left to blood bankers, drug
company executives and doctors whose careers revolved around
clotting concentrate--all people who had a vested interest in
the outcome.
Donahue, who is retired, declined to comment, as did an FDA
spokeswoman in Washington, citing pending litigation.
``They were gambling that things wouldn't be as bad as the
CDC said,'' says Judy Kavanaugh, a Sarasota attorney who is
working on the class-action lawsuit against the
pharmaceuticals and the hemophilia foundation. ``The tragedy
is that they were gambling with people's lives.''
Kavanaugh says that a ``revolving door'' was in operation
at the time between FDA officials and the private industry
they regulated.
``If you look at the documents, you see an incredible
chumminess--among the regulatory agency, the so-called
consumer advocacy group for hemophiliacs and the blood
industry,'' she says. ``People just seem to move around
freely from place to place within this inner circle. It's
like a little country club. Everybody has an angle. Everybody
has a reason to be pals with the other guy.''
The foundation occupied a place in that inner circle. The
nonprofit group had come close to bankruptcy in the late
1970s and had discovered a way out: the coattails of the
clotting-concentrate manufacturers. Drug companies sponsored
foundation conventions and financed the foundation's mailings
to members. Internal foundation documents show what the
product manufacturers were getting in return for their
donations: publicity for their product.
Kavanaugh believes that the foundation was hesitant in its
warnings because it didn't want to offend the drug companies.
``They weren't watchdogs,'' she says. ``They were more like
lap dogs.''
Although the foundation did call for screening of blood
donors early in the crisis, its officials continued to
downplay the danger of AIDS.
The foundation's executive director, Allan Brownstein, in a
speech to drug company representatives in 1983, criticized
``scare tactics used by some of the media [that] have created
so much fear that . . . the use of product is down.''
And even though the CDC continued to warn the blood
industry in an escalating series of letters and conferences,
the foundation's medical adviser, Dr. Louis Aledort, all but
scoffed at the notion that hemophiliacs were at risk.
Aledort had been one of the heroes of the golden age--a key
figure in the science, the business and the politics of
hemophilia that evolved around clotting concentrate. He
successfully lobbied for federally funded centers that
offered greatly improved, comprehensive care to hemophiliacs.
Besides acting as medical adviser to the hemophilia
foundation, Aledort frequently worked on research projects
about hemophilia paid for by one or more of the drug
companies that produced clotting concentrate. Drees, the
former Alpha president, says his company gave Aledort roughly
$25,000 a year.
Aledort also was closely aligned with Cutter. He received
money for research from Cutter, helped solicit donations from
Cutter for the foundation and contributed articles to a
monthly newsletter that the company sent out to hemophiliacs.
In the May 1983 edition of that newsletter, Aledort
downplayed the danger of AIDS. By then a dozen hemophiliacs
in the United States were known to have developed symptoms of
the disease.
``Let's put this in perspective,'' Aledort wrote. ``AIDS is
a dreadful, terrible disease that is frightening.
Hemophiliacs are frightened . . . but whether and if and how
it relates to their therapy [meaning clotting concentrate] is
completely unclear.'' The article continued: ``There is no
evidence to support that AIDS is transmitted in either
cryoprecipitate or concentrate, although it is possible.''
Two months earlier, the CDC Morbidity & Mortality Weekly
Report had stated: ``Blood products . . . appear responsible
for AIDS among hemophiliacs who require clotting factor.''
And at a meeting earlier that year, Dr. Ratnoff, the
Cleveland hematologist, had been invited to share his
research, which showed that those of his patients who are
using cryo rather than clotting concentrate were not showing
any symptoms of the immune disorder.
``There was evidence of what was happening. It wasn't just
from me, and it was very clear cut,'' Ratnoff says today.
``But I can assure you it was antithetical to the prevailing
view, and there were very powerful forces aligned against
it.''
Aledort was among the most outspoken of the high-ranking
doctors and blood industry leaders who were convinced that
the CDC was wrong and that Ratnoff's data were insignificant.
Aledort's own theory was that the growing number of
hemophiliacs with the immune disorder were only reacting to
antigens--bits of foreign protein that were known to be
transmitted by blood products.
Aledort's position was that hemophiliacs should continue to
use concentrate, despite its possible danger. Several other
key hematologists agreed with him.
Their oft-repeated logic was that the ``known risk'' of
hemorrhaging was greater than the ``unknown risk'' of
possible AIDS infection. At that time, scientists were still
uncertain whether people who became infected with the AIDS
virus would always develop symptoms of the disease. And they
also knew that a large percentage of hemophiliacs already had
been infected with the virus by the time the CDC issued the
warning about it. For them, it was already too late.
But that still left thousands of hemophiliacs who might
have been able to avoid infection--perhaps by switching from
concentrate to cryo. Evatt himself estimates that roughly
half of the hemophiliacs who contracted the AIDS virus were
infected after his warning.
The standard of public health is to err on the side of
caution. And a key principle of medical ethics is the notion
of informed consent: that the patient should be apprised of
any risk from treatment.
That may be why Aledort's point of view so astonished one
FDA scientist that, at a key 1983 meeting, he asked Aledort
to repeat himself, saying, ``I just want to make sure I'm
hearing what I think I'm hearing.''
And the foundation itself became disillusioned with
Aledort. In 1983, its executives decided to seek his
resignation as medical director. the minutes of an executive
committee meeting held in April 1983 spell out the reason:
``Dr. Aledort is not a team player. . . . Dr. Aledort's
medical brilliance is accompanied by personality traits which
take an excessive amount of time and effort to cope with. . .
. There have been isolated but real instances in which Dr.
Aledort has failed to properly implement NHF policies which
he has not agreed with, and, instead, has interposed a
personal position to delay or negate NHF policy.''
Like many doctors who were mistaken about AIDS and
hemophilia, Aledort, now the director of the hemophilia
treatment center and a member of the board of directors at
Mount Sinai Hospital in New York, says that he would still do
the same thing again, given the information he had.
``We were wrong,'' he says. ``We didn't think it was a
virus, and we certainly didn't know it was 100 percent
lethal. There were uncertainties.''
Aledort describes himself as a ``visionary'' and a
``straight shooter'' and says of his dispute with the
hemophilia foundation: ``They expected me to say, `Recall all
Factor' [clotting concentrate]. They wanted me to say things
I disagreed with, and I wouldn't do it.'' He says he feared
that the CDC's warnings would panic hemophiliacs. ``All I was
saying was, let's stop the ticker tape.''
He accuses CDC scientists like Dr. Donald Fancis of
``creative recall.'' He complains bitterly about hemophiliacs
who have picketed banquets in his honor and who refer to him
as ``the Joseph Mengele of the hemophilia holocaust.''
They want somebody's head to roll,'' says Aledort. ``It is
like a mob scene out of the French Revolution--`Let's knock
off everybody who ever treated us.' Well, that won't solve
anything. But this is a fan club country. It's like a
ballplayer who makes one bad play. You're remembered for your
last mistake, not all the good you did before.''
Aledort says he didn't perceive himself as having a
conflict of interest. He says of all the studies that he did,
funded with drug company money: ``Who do you think profits
from all those studies? The hemophiliacs do.''
But to many, Aledort has come to represent what one
hemophiliac advocate calls the ``incestuous relationship''
among the foundation, the drug companies and the FDA.
``He could have blown the whistle and stopped the train,''
says Calvin Dawson, whose brother Merlin died of AIDS from
the medicine a few weeks after his farewell visit.
``Everybody would have listened to Lou Aledort.''
Says Ricky Ray's mother, Louise: ``He played God with a lot
of people's lives. He was in a position to warn us, and he
didn't.''
Jan Hamilton was a key member of the foundation's board of
directors during the early 1980s. She says that the board
simply believed what Aledort told them and went along with
his suggestions.
``I was at some of those meetings. I can remember getting
goose bumps, worrying abut what was going on. but they kept
telling us it was not that serious.
``He was the expert. We never thought he would mislead
us,'' she says.
Last year, Hamilton and her husband, who is a pediatrician,
were shown for the first time some of the early warning
letters to Aledort from the CDC. She says they both began
crying.
``I was crying because I felt so bad and so angry and so
betrayed,'' she says. ``But I think my husband was crying for
a different reason. I think it was because he hates to see
people in his profession going against the Hippocratic
oath.''
The newspaper clipping enraged Ricky Ray. It wasn't the
story. It was the headline:
``Ryan White loses battle with AIDS.''
``Mom,'' Ricky said, ``If I die, don't let them write that
about me. Don't let them say that I lost. Just because you
die, that doesn't mean you gave up. That doesn't mean you
lost.''
In their final moments, the pilots of doomed airliners
rarely express fear.
Instead, just before the crash, they are angry. They wonder
what is wrong with the machine, and they hate it for failing
them. They don't appeal to the hereafter. They curse the here
and now.
It is something akin to that emotion that imbues the 1993
convention of the National Hemophilia Foundation.
The meeting is not just for hemophiliacs but for health
professionals, and some of the seminars and meetings are
about promising developments for hemophiliacs. A cure
involving gene therapy is tantalizingly close. A new Kind of
clotting drug, produced in the lab instead of from human
plasma, is already available.
Neither of those subjects comes up in the meetings--support
groups, legal seminars and town meetings--for hemophiliacs
with AIDS.
Many of them have lost loved ones, and many have only
months to live themselves. But it isn't grief or fear that
drives them. It's a sense of betrayal best expressed by a
woman who stands up at one meeting and compares hemophiliacs
with AIDS to incest victims.
``We've gone through all the same stages,'' she says
through her tears. ``First disbelief and denial. You just
can't believe that someone who was supposed to be protecting
you did this to you. Then rage. And then, finally, what you
want most is just for the truth to come out, so that you can
heal.''
Calvin Dawson is here. Dawson, who lives in Apopka, has
become a firebrand in the hemophiliac community. He keeps his
brother's wheelchair in his office as a reminder of the
deathbed promise he made to him to find out what happened and
why.
Dana Kuhn is here. Kuhn is the minister who used clotting
concentrate just once in his life, after the charity
basketball game. The shot gave him the AIDS virus, which he
unwittingly transmitted to his wife, who died two years
later.
Because his case was so clear-cut, he could have pursued an
individual, multi-million-dollar lawsuit. Instead, he became
one of the lead plaintiffs in the class-action suit, to give
it added credibility.
Michael Druck is here. a 32-year-old Manhattan coin dealer,
he is among the leaders of a small group of hemophiliacs with
AIDS who have staged protests at testimonial dinners for
Aledort and other doctors involved in key decisionmaking
roles during the crisis. Like many men at the convention,
Druck has an immune system that is paper-thin. His T-cell
count--they are the immune cells that the AIDS virus
attacks--is measured in single digits. He jokes darkly about
talking to another AIDS-infected hemophiliac whose T-cell
count was even smaller.
``I offered,'' says Druck, ``to loan him one of mine until
Tuesday.''
Michael Rosenberg is here. A former publisher, he is one of
the elder statesmen of the grass-roots activism among
hemophiliacs with AIDS. Everyone can see the change in
Rosenberg since last year's meeting. They've seen the same
signs before in all the others: the pallor, the way the
clothes no longer fit, the hollows in the face that begin to
show a little more clearly. Rosenberg is an inspired speaker,
but now there is a hesitation. People lean forward in their
seats, trying to finish his sentences for him.
Bruce Evatt is here as well. Though he tells people, again
and again, that he saw his inability to warn them as ``a
personal failure,'' he is considered a hero by many
hemophiliacs. There is always a circle of people around him.
The CDC pays his expenses to come to the convention--unlike
the early years of the crisis when Evatt, traveling to speak
to various groups about the threat of AIDS, often had to
spend his own money or beg other government agencies for
travel funds.
Pharmaceutical company representatives were once a
prominent presence at foundation conventions. They set up
display tables and ``infusion suites'' where people could go
for free injections.
But there are only a few displays at this year's
convention, and those are usually unmanned, with just a
brochure or two and a scattering of free pens on the tables.
At last year's convention, Maxine Segal walked up to one
young man at the Miles Inc. table, took off her glasses and
leaned over within a few inches of him. ``I just wanted you
to see the face of the mother of two boys that your company
murdered,'' she said.
AIDS has taken its fatal course a little more slowly with
hemophiliacs than with other victims, but time is running
out. One hemophiliac per day dies from AIDS in this country.
Those who survive are ``getting close to the far edge of the
curve,'' as one AIDS-infected conventioneer phrases it. A
mimeographed, homemade cartoon is making the rounds at the
convention, depicting a row of gravestones that read ``RIP
hemophiliac.'' A speaker at a lectern is addressing the
gravestones. ``It is with great pleasure we give an award to
the pharmaceutical companies and one to the government for
their never-tiring battle to find a cure for hemophilia,'' he
says.
Johnny Kellar likes that cartoon a lot. He's been passing
it out to people. Though most of the time he stays to himself
or listens quietly, he hasn't always been such a loner.
Like many young hemophiliacs with AIDS, he made friends
with other infected children, meeting them at camps and in
treatment centers--children with no future, drawn together in
a kinship that is difficult for adults to fathom.
That was how he became best friends with Jason Christopher,
the Tampa youth whose parents won a $2 million lawsuit that
helped pave the way for the class-action suit.
Two years ago, Jason and Johnny were being treated in a St.
Petersburg hospital, where they played tricks on the nurses--
their favorite one being to rig a balloon-and-needle booby
trap to explode when the nurses lowered their beds.
Jason was in the final stages of AIDS. But John's problem
was different. The doctors gave it a vague name: ``failure to
thrive.'' In truth, they could offer no particular physical
reason for his listlessness, his loss of appetite, his weight
loss. Though he had the AIDS virus, it was not in its active
stage. But it would be soon, the doctor warned Johnny's
mother, if his tailspin wasn't reversed.
Then, a few months later, Jason died.
And Marge Kellar was surprised when, soon after that,
Johnny perked up.
He started eating again. He began speaking on behalf of an
AIDS awareness group and asking more questions about how his
medicine got contaminated with AIDS.
He adopted a theme song: ``Beat It.'' He liked the lyrics:
They'll kick you and beat you and tell you it's fair . . .
just beat it.
He visited Ricky Ray when Ricky was on his deathbed.
``Give 'em hell when I'm gone,'' Ricky told him.
Like so many others, Johnny Kellar has the paper-thin
immune system, the single-digit T-cell count. Statistically,
he should be dead by now. His mother has come to believe that
the only thing keeping him alive is anger. It's as though the
raw fuel of adolescence has been drained out of him and
replaced by something else. She has begun calling him by a
wry nickname: ``Old Man.''
On this night, the ``old man'' has left the adults meeting
upstairs and has headed for the awards dinner--the social
highlight of the convention.
A jazz band is tuning up on stage. Allan Brownstein,
executive director of the hemophilia foundation, the man at
whom Johnny had shouted earlier, amuses everyone by sitting
down at the piano and playing ``Chopsticks.'' Waitresses
circle with crystal water pitchers while guests in semiformal
wear filter through the ballroom looking for their seats. In
all the refined commotion, nobody notices Johnny slip a
program off the table.
Johnny glides out of the ballroom, stuffing the paper in
his pocket.
``Information,'' he mutters mysteriously. ``I pick up
things, here and there. You never know when it might come in
handy.''
If he notices the slogan at the top of the program, he
doesn't say so. But there it is in black and white, the motto
that the National Hemophilia Foundation selected for this
year's convention: ``Securing our future . . .
together.''
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