Laurie Kelley and Paul Clement
A Viewer’s Guide:
New Documentary about
Hemophilia HIV History
A new film about hemophilia
during the HIV crisis of the 1980s has energized our
community. Bad Blood documents events that caused the
mass contamination of factor products. Community advocates
cheer the movie’s release and hope it will bring more
attention to the hemophilia community—for funds, for
continued blood safety, and for preserving memories of our
fallen heroes. But will Bad Blood needlessly raise
fears about plasma-derived products? Most Americans with
hemophilia use recombinant products, and most don’t fully
understand the difference between product safety and purity.
Many of us aren’t aware of the complex production of
products, or the fact that all US products are now
considered safe. Use of plasma-derived products is on the
rise as a treatment for inhibitors—and parents are worried.
Now, along comes a film that taps into a parent’s deepest
fear: what am I injecting into my child? Will this new
documentary reinforce that fear, preventing parents from
making good product choices?
Flashback
It was November 2008, the
opening event of National Hemophilia Foundation’s annual
meeting in Denver. The audience of hemophilia families and
hemophilia chapter representatives filed into a large,
festive room decorated with red and blue balloons. Seating
sections were marked with state names, just like a national
political convention.
An empty stage awaited Val
Bias, new CEO of NHF. With President Obama just elected, it
seemed that NHF was ready to celebrate, too.
But then, without warning, the
lights went out. People hushed. Two screens on either side
of the stage lit up, and a movie trailer was unveiled. The
music was somber, haunting.
The scenes were disturbing:
Technicians poured gallons of plasma into vats.
Scruffy-looking men donated plasma. Young children were
tethered to bleak hospital beds by IVs dripping
cryoprecipitate. People with hemophilia unknowingly
injected themselves with contaminated factor. The festive
mood of the opening ceremony vaporized. The six-minute
trailer caused a huge stir. A small group of older patients
enthusiastically applauded. But other attendees were
perplexed, and some pharmaceutical reps were angered. What
was the point of showing the dramatic film trailer? Wasn’t
the community past all this by now? Some worried: Had
something new happened to the blood supply? Or would the
documentary promoted by the trailer shed new light on this
devastating tragedy?
The feature-length documentary
Bad Blood premiered on July 28, 2010, in New York
City for a select group of people in the hemophilia
community. Now, NHF is encouraging chapters to show the
film to its members. But is this documentary appropriate and
educational? Or is it the shocker that the trailer led us to
expect? Should you see it? In short, yes. You should
see Bad Blood. It’s a powerful and remarkable movie.
More than just documenting the human immunodeficiency virus
(HIV)contamination of the 1980s, the film also portrays the
birth of advocacy in the hemophilia community. But before
you watch the film, read our analysis. We hope to prepare
you with a balanced look at the documentary, and present
some key points to help you betterunderstand the history of
factor product development and blood safety today.
From A Friendship, A Promise
The origins of Bad Blood
are personal. This film wasn’t made because of a sudden,
new threat to the nation’s blood supply. Nor because of new
evidence about contamination during the late 1970s and early
1980s. Originally, this was a documentary by award-winning
filmmaker Marilyn Ness, who wanted to tell the story of a
friend who contracted HIV. But Ness’s film eventually
developed into much, much more. “The project started in
1999,”
Ness recalls. “when my friend
Matthew Kleiner, who had hemophilia, told me how he became
HIV positive. It blew me away. He told me how
[HIV-infectedfactor products] had happened, and we both
knew, the full scope had not yet
been understood.”
But, explains Ness, “in 2000
many people couldn’t speak to me, as litigation was still
ongoing. I had to stop the project.” A class action lawsuit
had been filed against pharmaceutical manufacturers on
behalf of the estimated 10,000 patientswith hemophilia
infected by contaminated factor concentrates. Following the
lawsuit’s settlement, the film’s scope grew. “People were
desperate to talk to me,” Marilyn reveals. “I picked up the
project again later in 2006. I knew this story was relevant
even beyond the bleeding disorder community—there was a lot
to learn about FDA [US Food and Drug Administration] reform;
how do you weigh safety against profit?”
Guide to the Players and Plot
Bad Blood
portrays one of the most
extraordinary stories in medical history. Strange symptoms
afflicting primarily gay men in the early 1980s led
researchers to discover a new virus that slowly destroys the
body’s immune system, allowing opportunistic infections to
flourish. The virus was also noted in certain other
populations: drug users; Haitians living in the US; and
people with hemophilia.
Why people with hemophilia? By
the late 1970s, factor was being made from increasingly
larger pools of plasma, each containing 10,000 to 60,000
donations. It took only one donation of plasma
containing HIV to contaminate the entire pool, consequently
contaminating each “lot” of factor concentrate produced from
that pool. As a result of infusing this contaminated factor,
about half of the estimated 20,000 people with hemophilia in
the US became infected with HIV, and even more with
hepatitis C. The epidemic exposed deadly flaws in the
US plasma collection system. As Americans began to realize
that this virus had contaminated the nation’s blood supply,
government reaction was tragically slow, despite urgent
warnings from the US Centers for Disease Control (CDC). Many
believe that because the victims were members of the “4-H
club”— heroin users, homosexuals, hemophiliacs and
Haitians—they commanded little attention and sympathy from
the media and the government. And even NHF recommended that
patients continue using factor concentrates.
Matt Kleiner is the unfortunate
star of Bad Blood. The cast also features the FDA and
CDC, and the four manufacturers of clotting factor
concentrates in the early 1980s: Bayer (Miles/Cutter
Laboratories), Baxter (Hyland Laboratories), Armour
Pharmaceuticals, and Alpha Therapeutic. Also appearing are
national hemophilia organizations like NHF and Committee of
Ten Thousand (COTT). And the supporting cast? The blood
donors and the people with hemophilia.
The film attempts to capture
the perspectives of all these players. “This was a
cautionary tale for all drug companies, patients, and
FDA interactions,”
Ness stresses. “It’s an
emotional and impactful story. It’s about how all these
people felt betrayed—by science, by technology, by those
they trusted—all the way around. There hadn’t really been a
film about this tragic story that put into context the lives
they lived before AIDS emerged, especially now with twenty
years’ hindsight.” How to portray an era in which blame
dominated, lawsuits were launched, and thousands of young
men died? Could a filmmaker touch on so many sensitive
subjects fairly, given that her close friend had died, and
not leave an audience of new families with hemophilia scared
to use their factor products?
Jan Bult, president of Plasma
Protein Therapeutic Association (PPTA), which represents
manufacturers of plasma protein therapies, viewed the
trailer at the 2008 meeting and wondered what the
full-length film would be like. He recalls, “I feared Bad
Blood wouldn’t be balanced, and that it would create a
fear factor for young parents who depend on these life
therapies.”
For Mature Audiences Only
The trailer set the tone for
the documentary’s release, provoking concerns that the film
would not be balanced. Some worried that Ness would use
docudrama techniques like those used by director Michael
Moore in Fahrenheit 9/11, which might scare patients
away from plasma-derived products. The trailer had the
plasma products industry on pins and needles.
“I think people were unprepared
for the powerful images and narrative presented in the
initial trailer,” remarks Chris Healey, vice president,
Government and Public Affairs at Grifols, a manufacturer of
plasma-derived factor. “The 2008 NHF annual meeting in
Denver was an exciting time, full of hope and energy. When
the film trailer was shown at the opening session with
little warning or context for the audience, it seemed as
though that energy and excitement left the room.”
And Ness stresses, “The trailer
was never intended for this [NHF] forum.” She explains, “I’m
usually present, someone from Blood Safety1 is usually
present; it’s carefully handled. Showing it to an auditorium
full of people without the Q&A following was not intended.
When the response was negative
in some quarters, I was disappointed. It was scary for some.
But people did respond to it and it helped me raise money
for the film. Two people who responded were Shari and
Stephen Bender of New York, whose daughter Rose has
hemophilia. “Stephen and I were moved by the trailer,”
recalls Shari. “It was so powerful that we both decided to
help fundraise to make [the movie] happen. The tragedy of
the HIV crisis fortunately did not affect us—but we need to
remember the past, remain vigilant, and demand a safer blood
system.” She notes, “Many HIV remembrance events are not
well attended. As president of the New York City Hemophilia
Chapter, I think many new parents are forgetting the past,
and they need to know.”
Kendra Baker is a young mother
of two sons with hemophilia. Both Wyatt and Gavin were born
many years after the HIV contamination. Despite her sons’
good health, Baker lost five relatives with hemophilia to
HIV. The question of blood product safety weighs on her now:
Wyatt has an inhibitor, and recently her HTC suggested
trying a plasma-derived product for Immune Tolerance
Induction (ITI), to lower the inhibitor. “I’m concerned
about switching to plasma products, because I know my
family’s history,” says Baker. “I know that plasma products
are safer now; other people say they use them every day and
they work. But I asked my hematologist, who I love and
trust, ‘Can you guarantee me five years from now we will not
have problems?’ She said that while we know more now than
then, she still can’t guarantee anything.” Baker notes,
“That’s the same story we heard back then. I just am not
comfortable using plasma-derived.”
Baker would gain no comfort
from the first 47 seconds of Bad Blood, which aims
for shock value, as the audience hears or sees these words:
hemophilia holocaust, lawsuit, lawyers, tainted
blood, pharmaceutical industry. The film begins with a
lawyer—who specializes in suing pharmaceutical
companies—blaming pharma for putting profits above safety.
With an opening like this, community members, especially
those new to hemophilia, need some guidance. Ideally,
viewers could avoid unnecessary fears when they see Bad
Blood if informed and experienced blood industry experts
are available. “I don’t think families living with a
bleeding disorder who are unaware of this history are
prepared to see this [film] without some conversation
beforehand,” says Mark Zatyrka, who contracted HIV and
hepatitis C from a transfusion to treat his hemophilia, and
who is a founder of the Connecticut Hemophilia Society.
“It’s important that some discussion happen before showing
the film, and it’s important to have follow-up afterwards.
You can expect there will be lots of questions.”
In any case, before you see
Bad Blood, you should know what the film gets right, and
what it omits.
What the Film Got Right
Bad Blood
is a powerful testimony to the
suffering of people with hemophilia. Rare archival footage
accurately portrays life for them in the 1950s and 1960s,
before factor concentrates: patients receiving plasma or
cryoprecipitate; hemophilic children walking in their
backyards or being admitted to the hospital. Parents of
young children today will be emotionally touched by the
scenes of suffering and frequent hospital stays of children
with hemophilia. This glimpse into history paves the way
for us to understand the intense gratitude of families and
physicians for the advent of clotting factor concentrates,
which ended much pain, reduced long hospital stays, and made
life more normal.
Ness gives us an excellent
overview of hemophilia: what it is, how it’s transmitted,
how untreated bleeding eventually cripples. Accurate
diagrams and animated graphics enhance the information.
Bad Blood also reviews the history of treatment: from
nothing at all to whole blood, from fresh frozen plasma to
cryo, and eventually to factor concentrates. The
outstanding historical review is complete with photos and
testimonials from patients today who recall the pain they
endured as a result of ineffective treatments.
We learn how factor products
were made in the 1970s: how blood plasma was collected,
pooled and processed. At first, factor seems a miracle
product, but the film exposes the reality. By today’s
standards, this early era of blood processing can look grim
and even unsanitary. Images of impoverished or
sickly-looking people donating plasma remind us of
government and industry’s low standards for plasma
collection thirty years ago.
Bad Blood
accurately portrays how poor
oversight of the plasma collection industry set the stage
for widespread viral contamination. The medical community
and government already knew that hepatitis was in clotting
factor. But everyone—government, physicians, patients,
industry—tolerated it, because they considered these viral
infections
largely benign, and they
believed that a greatly increased quality of life outweighed
the risk of viral infection. The stage was set for disaster.
Overall, the film is a detailed
timeline of one of the worst medical disasters in history.
It’s told through photos, and through the narratives of
several people involved: physicians Dr. Shelby Dietrich and
Dr. Bruce Evatt; patients Bob Massie, Matt Kleiner, and
Glenn Pierce; journalist Donna Shaw; lawyer Eric Weinberg;
and a single pharmaceutical representative, David Castaldi,
president of Baxter/Hyland from 1977 to 1987. Ness adeptly
weaves the timeline with many personal stories and
perspectives. Bad Blood is heart-wrenching, sad,
impressive, and educational.
And it’s backed by a plethora
of documents, collected from the pharmaceutical companies,
FDA and NHF, chronicling the impending disaster. These
documents reveal that some companies engaged in cover-ups
and scandalous practices—including one that shipped product
overseas, knowing it was likely contaminated, when the
company could no longer sell it in the US.
Ness considers her film a
balanced portrayal of viewpoints. “It was a challenge,” she
says. “My goal was to let each person tell the story from
their perspective. We struggled hard and long someone from
the drug companies, and the caregivers, and the FDA, and the
families allows people a firsthand glimpse into how a crisis
unfolds. I think we fairly portrayed everyone’s point of
view.”
What the Film Missed
Ness believes she did her
homework well, noting, “We needed three sources for every
statement of fact in the film.” Renowned physician Dr.
Bruce Evatt of the CDC, who was one of the first to sound
the alarm that HIV was spreading through the blood supply,
reviewed the film for accuracy.
But the film is not without
bias and several omissions. The AIDS epidemic is presented
mostly from the viewpoint of people with hemophilia who have
HIV or who lost loved ones, and not from the viewpoint of
pharmaceutical companies, scientists, or the FDA. The
context in which decisions were made regarding hepatitis,
HIV, and product treatments is incomplete. For example, the
film offers no explanation of the difficulties of developing
a heat-treatment viral inactivation process for factor
concentrates, and later, a solvent-detergent treatment. And
when these topics are mentioned, around 50 minutes into the
film, the FDA is cast as inept, and the drug companies as
profit-driven, heartless villains.
Ness admits that no
pharmaceutical company representative would consent to be
interviewed, save Castaldi. Yet Bult, who represents the
plasma product producers, was interviewed—and then cut from
the film. Bult described various measures in place today
that provide greater product safety—film footage that could
allay fears of new parents. But Ness laments that in an
82-minute film, she had to choose “only the most salient
issues for the lay audience to comprehend.”
Given its length, Bad Blood
is a stunning compilation of the history of hemophilia
treatment and the unfolding of the HIV crisis. Yet it
interprets 30-year-old, complex events in 20/20 hindsight,
creating a black-and-white, simplistic story.
We’ve identified three key
areas where viewers need a deeper understanding to
supplement what is shown in the film:
1. How the American political
climate impacted the FDA and other federal health agencies
at the beginning of the AIDS crisis.
2. Basic science about viruses
and viral inactivation methods, and the timeline of events,
including efforts by pharmaceutical companies.
3. Advances in the safety of
plasma-derived products since the 1980s.
1. How Politics Impacted the US
and FDA
First, let’s look at the
political climate surrounding the AIDS era. In 1981, newly
elected President Ronald Reagan vowed to reduce the size of
government and decrease government oversight of private
industry. Subsequent cuts resulted in the loss of almost 10%
of the FDA’s workforce of 7,500 employees in 1981. The day
after Reagan took office, the FDA commissioner was fired.
Over the next few years, the directors of the CDC and
National Institutes of Health (NIH), and the Assistant
Secretary for Health and Human Services (HHS) all changed,
often with substantial intervals before a new appointee.
By cutting budgets and
personnel, the Reagan administration crippled the
enforcement power of the FDA and other health agencies. Many
FDA initiatives to inform consumers about the ingredients
and side effects of drugs were stopped cold. FDA regulatory
inspections dropped by 88%. At the beginning of the AIDS
epidemic around 1982, the FDA was shorthanded, demoralized,
and in disarray, which greatly compromised its ability to
react to the emerging health crisis.
At the same time, the religious
right and newly minted “moral majority,” both significant
constituents of Reagan’s electorate, used HIV infection to
rally against homosexuals. AIDS conspiracy theories
abounded, and AIDS hysteria engulfed the country. Bad
Blood skillfully portrays the discrimination and hatred
experienced by the families of Ricky Ray and Ryan White.
2. Heat Treatment: Not So
Simple
Bad Blood
might make you wonder, why
didn’t companies implement plasma safety procedures earlier?
But the science isn’t so simple. The film implies that a
heat treatment to kill hepatitis could have been implemented
as early as 1980. In hindsight, this could have saved lives
by preventing infection with yet-to-be discovered HIV. But
companies didn’t implement this safety method for many
reasons beyond just profit margin concerns.
Since the 1940s, medical
science has known that blood products can transmit
hepatitis, a liver disease. By the 1970s, two types of
hepatitis had been identified: hepatitis A (HAV) and
hepatitis B (HBV). Mandatory testing was initiated in 1971
to screen plasma donors for HBV. A test for HAV became
available in 1978. By the late 1970s, it was apparent that
factor concentrates were also infected with another, yet
unknown virus, then called non-A, non-B hepatitis; it slowly
attacked the liver, often with no early symptoms. The virus
was finally identified in 1989 and named hepatitis C (HCV).
Heat treatment had been used
for decades to inactivate hepatitis viruses in blood
products such as albumin. But early experiments with heat
treating factor concentrates in the mid-1970s were
disappointing—the factor was destroyed along with the
viruses. In Bad Blood, Dr. Evatt remarks that heat
treatment was “simple in the end.” But the development of a
heat-treatment process for factor VIII was far from simple.
In fact, it would become a difficult challenge: the large,
very fragile factor VIII protein is easily destroyed by
heat. Time-consuming, expensive research involved testing
dozens of variables, one at a time, and injecting the
product into chimpanzees to see if they developed signs of
liver disease.
Research into heat treatment of
factor concentrates was a low priority in the late 1970s.
Infection with hepatitis rarely resulted in serious disease.
Patients and hematologists believed that treating people
with hemophilia rapidly and more effectively at home, which
improved quality of life, more than offset the risk of
hepatitis. And at the time, no
one knew that HCV was in the
factor—and would eventually become a killer. Hematologists
also argued that heat treatment could cause an immune
response in patients, resulting in higher incidence of
inhibitors, which did occur with two European products a
decade later.
Research picked up pace in 1980
after scientists working for the small German company
Behringwerke published a report suggesting that their heat
treatment removed the risk of HBV. Contrary to statements in
BadBlood, the Behringwerke report did not
prove previous US and European drug company experiments
wrong. Nor was the German product hepatitis free—it still
transmitted HAV and HCV. Also omitted from the film was the
fact that the Behringwerke process resulted in a loss of 75%
to over 90% of the factor, and the product cost ten times as
much as unheated product.
Perhaps the key point
overlooked in Bad Blood is that implementing any heat
treatment process in 1980 would have required doubling the
size of the plasma collection industry, retooling production
facilities, and relicensing products—impossible in a short
time. If these changes had been implemented, perhaps as many
as 90% of people with hemophilia would have been unable to
purchase clotting factor concentrate or cryoprecipitate,
leaving them with no treatment at all.
By 1980, cryo was no longer
available as a backup for the vast majority of people with
hemophilia. In Bad Blood, Dr. Dietrich notes that
trying to return to cryo would have been impossible: the
American Red Cross had lost the workforce and infrastructure
needed to process large volumes of cryo, and blood centers
were unwilling or
unable to process the huge
amount of plasma needed.
Unlike the film’s portrayal of
hematologists at the January 1983 CDC meeting, most
hematologists did “get it.” They knew that people with
hemophilia were between a rock and a hard place. The film
also never mentions that the FDA was expediting approval of
virally inactivated clotting factor concentrates: the Baxter
heat treated product was approved in just eight months
instead of the typical three to six years, and debuted in
March 1983.
3. Where the Film Left Off:
Improved Blood Safety
Viewers of Bad Blood
will be less fearful if they know what has happened since
the 1980s to improve blood safety. Ness addressed this
after the movie premiere on July 28, with a panel discussion
that included NHF CEO Val Bias, PPTA’s Jan Bult, and the
president of Gay Men’s Health Crisis. “Someone asked what’s
changed and what’s different now,” recalls Mark Zatyrka,
“and Jan made clear how industry has changed and what
additional safeguards exist now. It was very courageous for
him to be there.”
Bult says, “Matt Kleiner’s
family was at the premiere. After the movie, Matt’s father
came to me and said, ‘Thank you for coming; it made us feel
good to see what changes have been made.’”
Bult continues, “Bad Blood
accurately depicts the tragic events that occurred in
the hemophilia community in the 1980s.” But, he adds, “Not
noted in the film is the safety record of current therapies;
there have been no viral transmissions for decades. The
movie provides no information on the number of safety and
quality initiatives that have been put in place since that
time.”
And what initiatives have been
taken since that time? Hemophilia patients became activists,
and forever changed the way blood and blood products are
processed and approved in this country—for all citizens.
Patient activists like Glenn Pierce, Dana Kuhn, Corey Dubin,
and Val Bias were directly responsible for the restructuring
of FDA’s Blood Products Advisory Committee and the
establishment of a consumer position as one of the
committee’s 17 voting members. The hemophilia community was
also instrumental in establishing the Advisory Committee on
Blood Safety and Availability (ACBSA) in 1997, part of HHS.
The committee has 20 members, including at least one
consumer member—usually from the hemophilia community.
Industry also took initiatives.
Pharmaceutical manufacturers listened to consumers and
developed recombinant products, which most US hemophilia
patients now use, eliminating the use of blood plasma.
Pharmaceutical manufacturers also implemented extensive
safety measures in collecting and producing plasma products.
Gone are the days when plasma was collected from prisoners
or people with high-risk behaviors. All donors today are
carefully screened, and all plasma-derived products are
virally inactivated.
Some products even use a double
viral-inactivation procedure. Changes in the plasma
collection business implemented since the mid-1980s center
on three equally important measures: (1) donor selection,
(2) testing for pathogens, and (3) inactivation and removal
of pathogens. Industry standards now include:
• Qualified Donor Standard.
At plasma collection centers, each donor has a physical exam
and regular follow-up exams to create a comprehensive health
history. The donor must return for a second donation and
pass all health and blood tests again before his or her
plasma can be used.
• 60-Day Inventory Hold
Standard. Source plasma is frozen and held in inventory
for a minimum of 60 days. This allows any suspect donations
to be retrieved and discarded before being considered for
use in fractionated blood products.
• Implementation of more
sensitive viral blood tests. One example is the Nucleic
Acid Tests (NAT). Since the late 1990s, NAT has allowed
contaminated donations to be detected earlier and removed
from the plasma pool.
The best news of all? There has
been no known transmission of HIV since 1986, and of HCV
since 1989. But despite these advances, fear lingers. Baker
says, “My HTC told me there hasn’t been a viral transmission
in over twenty years using plasma-derived…yet my heart sinks
when I hear they might put Wyatt on human product.
1. The Advisory Committee on
Blood Safety and Availability of the US Department of Health
and Human Services (HHS).
2. The Blood Products Advisory
Committee (BPAC) reviews and evaluates data concerning the
safety, effectiveness, and appropriate use of blood, and of
products derived from blood and serum or from biotechnology.
8 Parent Empowerment Newsletter |
November 201
