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Bad Blood: A Cautionary Tale Viral Contamination Transcript

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Viral Contamination Transcript

Speakers: Donna Shaw, Terry MacNeill, Mathew Kleiner, Eric Weinberg, Jenny Kleiner, Sidney Kleiner, Narrator, Shelby Dietrich, Robert Massie Jr., Mary Lou Murphy, Regina Butler, Glenn Pierce, Susan Resnik, Doctor, Bruce Evatt, David Castaldi, Announcer, Announcer 2, Announcer 3, Dana Kuhn, Announcer 4, Announcer 5, Alan Brownstein, John Finlayson, Announcer 6, Margaret Heckler, Announcer 7, Announcer 8, Student, Announcer 9, Doctor, Official, Protestor 1, Protestor 2, Protestor 3, All Protestors, Corey Dubin, Lisa Smith, Donna Shalala

(Music)

DONNA SHAW: I was a reporter for the Philadelphia Inquirer at the time that I first learned of this story. In particular, I wrote about the pharmaceutical industry, and I came across this little story about a lawsuit that was being brought by hemophiliacs against the blood products industry. And so I called one of the lawyers and within minutes, I knew it was going to be a great story. And he told me, he said, “If you stick with this – if you really dig into this, it’s going to be like nothing else you’ve ever covered.”

(Crowd chanting)

Someone should have said that there is a danger here. This was one of the largest medically induced epidemics in the history of this country. How could that have happened?

TERRY MACNEILL: The pharmaceutical companies, the doctors, the FDA, the government, they had the knowledge. I don’t know what their intent was but they had the knowledge. They failed to warn us. They failed to warn us.

MATHEW KLEINER: The blood product companies and our government need to take responsibility and say, “This happened on our watch.”

ERIC WEINBERG: And the pharmaceutical company’s profit drives research. It’s a wonderful thing, but never at the expense of safety. That’s kind of what gets – got lost here and it can get lost again. It’s too easy to get lost.

(Music)

JENNY KLEINER: The thing that makes me most angry – angry or sad, I mean I guess it’s sort of a combination. But I’m always afraid something’s going to happen to you, and you shouldn’t have to think that at this age. You know?

MATHEW KLEINER: It’s easier for me because I know how I feel, and I know if I feel strong or if I don’t feel strong and I know –

JENNY KLEINER: That’s why I have to ask you every day because you don’t always tell me.

MATHEW KLEINER: Right.

JENNY KLEINER: No one can guarantee anything but I feel like I want someone to just – I want someone to tell me it will be okay.

(Music)

MATHEW KLEINER: When they came to my parents and they said, “One of your children has hemophilia and one of your children does not,” they said, “Well we knew it was you because you were always bruised and battered by doing nothing.”


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SIDNEY KLEINER: We would always have to rush him to emergency rooms. We got to know almost every hospital emergency room in New York City.

SUZANNE KELINER: I remember when he was about eight and he hurt his leg. His leg looked like a watermelon and it was just – no matter where he put himself it was just the pain because of the pressure of it. It was a lot of pressure on this little person. It had to be excruciating.

NARRATOR: Born in 1971, Mathew Kleiner escaped hemophilia’s darkest era, a time when no treatment was available and patients rarely lived past their teens. By the 1950s, crude treatments meant children survived but it was a very difficult life.

(Child speaking in background)

SHELBY DIETRICH: I wanted to do what all the children around them were doing, to run, to play, to play on playground equipment. It has hazardous even though it didn’t look hazardous and brought on bleeds.

(Car engine revving)

Hemophilia is a blood clotting disorder. It’s a very large misunderstanding that if you have a little cut on your finger, you’re just going to bleed to death on the spot. That is not true at all. The major problem in hemophilia, bleeding, is internally. That’s where the crippling manifestations of hemophilia make themselves felt, bleeding in the knees, the ankles, and other big joints. So life was really hell.

(Music)

ROBERT MASSIE JR.: When you have hemophilia, you’re more likely to bruise. And so I would have these big purple and black bruises on different parts of my body and when my mother took me to the store, she would get very angry looks from other people, especially other mothers because they drew the conclusion that she was hitting me.

NARRATOR: Families could not escape the impact of hemophilia. Ordinary activities or even a child’s growth causes blood vessels to break. Normally, the body’s clotting process repairs them but with hemophilia, this process fails and internal bleeding begins.

ROBERT MASSIE JR.: Sometimes slowly, sometimes very quickly, the pain goes from dull to acute to – and in its worst form it’s really, kind of a torture, and it can go on for hours and hours, even days. Your mind shrinks to a very tiny space where all you can think about is how to get to the next second and then from that second, to the next second after that.

(Teakettle whistling)

(Music)

NARRATOR: Hemophilia is caused by a genetic mutation and is usually passed from a mother to one or more of her sons. Daughters may inherit and pass on the mutation but rarely have the disease. People with hemophilia have low levels of one of two clotting proteins found in blood called factor eight and factor nine. The degree to which this protein is absent determines whether a case is mild, moderate, or severe.

(Music)

MARY LOU MURPHY: I had two boys with hemophilia. It’s very upsetting when you find out that your child has hemophilia. Leo was born in fifty-eight. He did have quite a number of bleeds, which eventually destroyed a lot of the bone. The blood just eats away at the joints and he went through the first years of his life getting whole blood as a treatment and it had very little impact on a bleed and it meant laying for hours and hours and hours while your blood dripped one drip at a time. And then in the end, there wasn’t


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a very positive result and then so he’d have to start all over again the next day and he was hospitalized for long periods of time.

NARRATOR: To replace the missing proteins, doctors gave transfusions of whole blood with little effect. Then they tried using plasma, the liquid part of blood, but it still did not contain enough clotting factor to quickly manage a bleed. Each passing hour brought greater risk of permanent damage and prolonged, excruciating pain.

SHELBY DIETRICH: I sometimes wondered why I kept treating these patients because it was so frustrating. One never had a patient who got well. Even as minor a thing as a bleeding lip or a loose baby tooth occurred and they had to go to the hospital.

NARRATOR: Unable to offer effective treatment, Dr. Shelby Dietrich sought to ease patient pain through counseling and physical therapy. Though her California clinic became the model for hemophilia care around the country, the children still suffered.

SHELBY DIETRICH: The old-fashioned medicine, which is what we were certainly practicing then, is to be with parents and families through the worst episodes of their lives and to stand with them. I guess that’s what we did a lot of.

TERRY MACNEILL: Both of my sons were severe hemophiliacs. I was young. I was in my twenties. I didn’t really know what hemophilia was and I did sort of like a crash course on trying to find out what it was going to do to my sons. Brian was in the hospital maybe three hundred times before his third birthday. He was in the hospital almost every holiday and missed a lot of school so it was quite an adjustment.

REGINA BUTLER: I started in 1973 in hemophilia care and got to know a lot of young adolescents at that time who had lived with hemophilia their whole lives, and these boys tell me that their entire childhood was really focused around hemophilia. Sometimes they actually looked forward to coming to the hospital because that’s where their friends were.

ROBERT MASSIE JR.: I was home for long periods of time recuperating from these different bleedings. Very, very few friends came to see me. It was a lonely existence for somebody who’s extremely extroverted. I was very focused on the future. “Well, things are hard now. Well, I’m losing the ability to walk now but this is America. We’re going to experience technological change the like we’ve never seen. Maybe I won’t even have this in a few years. Who knows what will happen.”

(Music)

NARRATOR: In fact, a more effective treatment for hemophilia was in the works. In 1964, Dr. Judith Graham Pool was working in a lab at Stanford University when she noticed a residue at the bottom of a bag of thawed plasma. For years, it had been discarded as useless. She tested it, and discovered that it was rich in factor proteins. The concentrated substance had ten times the clotting power of plasma alone. By 1965, blood banks were making cryoprecipitate, or just cryo, available to patients.

GLENN PIERCE: I spent about a third of my childhood in the hospital. One of the first times that I got cryo, I was probably eleven or twelve and I went in because I had a cut on my tonsils, probably from some food that I ate. Previously that might have meant a prolonged hospitalization where I would get fresh frozen plasma for a period of one, two, or three weeks. But this time I went in, I got cryo, and as soon as the infusion was done, I can remember looking in the mirror with a flashlight and the bleeding had stopped. And it was truly a miracle.

NARRATOR: Pool’s discovery was a major leap forward, but researchers weren’t satisfied. It took as many as fifteen bags of cryo to stop a bleed and an infusion time of up to half a day. If patients were to lead normal lives, a more concentrated treatment was needed. Working with cryo, researchers found a way to extract just the factor proteins. These isolated proteins could often control bleeds in a single dose.


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This breakthrough was licensed to the pharmaceutical industry, whose manufacturing and marketing capabilities promised treatment for all.

In 1966, the U.S. government approved anti-hemophilic factor concentrate for patient use. To grateful patients, it was known simply as factor.

SHELBY DIETRICH: It was a revolutionary transforming advance in medical treatment. If your knee tingles or you fell down or you bit your lip, something like that, then treat.

NARRATOR: Unlike cryo, which was frozen and cumbersome, factor was reduced to a powder. It was then mixed with saline for infusion. In time, the product was even marketed for home use to be stored and infused by the families themselves.

ROBERT MASSIE JR.: Every aspect of my freedom was defined by access to factor eight. I could mix up the factor and infuse it in a matter of minutes, and I took it to every conceivable kind of place and I did shots in every conceivable kind of place, including the bathroom of airborne planes. So I could go anywhere.

TERRY MACNEILL: It was almost like a miracle drug where you said “Oh my God. It might cut down on at least Brian’s, at least half of his hospitalizations.” Sure and heck, Shawn never went into the hospital for anything. It was totally controlled at home.

MARY LOU MURPHY: I could see the impact because I had Leo who was about twelve or thirteen before it became available and was wearing braces as a result of many bleeds. And then Matt came and he just went right on to factor eight and it was a different story. And they were living normal lives, definitely.

MATHEW KLEINER: It changed everything because I could bring the product home and I could just, you know, use it whenever I wanted and this time, if I twisted my knee in first period playing in gym and I went and gave myself a shot, I could just put ice on my knee and go back to class.

SUSAN RESNIK: This was considered, quote, “A good-news disease.” Hemophilia was called the chronic illness success story of the decade. The benefits of the factor enabling these little boys who had been in pain and who couldn’t walk and who couldn’t go to school and who couldn’t play sports, to suddenly be able to go to camp, to play games. Patients were thriving and growing up and beginning to be able to be in school full time, go to college, graduate school, get married.

(Music)

NARRATOR: Four companies soon dominated the U.S. market for factor concentrates. The patient population was small, about fifteen thousand individuals in the U.S., and about four hundred thousand worldwide. But seven out of ten cases required frequent infusions, costing thousands of dollars per year.

DONNA SHAW: I think it quickly became apparent that the clotting factor concentrates were going to be enormously profitable. Today, that’s about a six-billion-dollar-a-year industry globally. That was such a revolution for the patients, but it also meant that their well-being was no longer something just between them and doctors. It suddenly became something that was very much the business of business and that changed the complexion of their treatment in really dramatic ways.

(Mathew Kleiner saying ah while being examined by a doctor)

MATHEW KLEINER: I mean my hepatitis level is probably pretty high.

DOCTOR: Does that hurt?

MATHEW KLEINER: Yeah.


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BRUCE EVATT: Almost universally, all of the patients became infected with hepatitis B who took these products within the first two or three doses.

MATHEW KELINER: Our relationship with the doctors was such that you really didn’t question what you were being told. As a ten year old, my parents were sitting there saying, “How can we make our kid better?” You know, this is a product that’s going to make my kid better. Okay.

(Music)

NARRATOR: Hepatitis is a virus that attacks the liver. It was present in nearly every vial of factor. Concerns over viral contamination led Dr. Judith Graham Pool and a few others to warn against factor use. Problems were built into its production, they said, beginning with the collection of blood.

DONNA SHAW: Most of us, when we think of blood donors, we think of the company that gets together the blood drive it’s seen as this outpouring of community goodwill. That is not where most of the blood comes from for commercial blood clotting products.

NARRATOR: In the 1960s, for-profit blood banks began to offer cash for plasma.

ERIC WEINBERG: The plasma centers were owned by the pharmaceutical companies. These centers were licensed by the FDA. There were centers located in parts of the cities that would be described as skid row locations, and the donors were typically transient, poor. Going to pay donors has always been understood to be a high-risk venture because when you pay someone for their plasma, they have a motive to lie about their health because they need the money.

DAVID CASTALDI: It was already illegal by this time to collect whole blood from paid donors, but because the products that were made from plasma could not be supplied out of the volunteer blood community, and still can’t to this day, paid donors were permitted for commercial companies like Highland and its competitors. There was blood collected in foreign countries. There was also plasma collected in prisons that certainly gave the industry a very poor image.

DONNA SHAW: It’s not as though the FDA didn’t realize that these were the kinds of donors that were being used. But the regulators were told, “If you put any more restrictions on us, you’re going to make it impossible for us to treat these patients – these hemophiliacs.” So the government was under enormous pressure to let these products be sold.

BRUCE EVATT: It requires a great deal of plasma in order to manufacture concentrates efficiently and effectively.

ANNOUNCER: Each bottle represents the plasma sold by one man for five dollars.

BRUCE EVATT: Companies initially were using plasma collected from forty to sixty thousand donors, putting them into a vat and then processing it so then they collected the clotting factor from all of those donors. The risk of that is that one or two or three infected donors, which would be expected in a donor pool of sixty thousand, who had a blood-born disease, would then suddenly infect the whole pool and thus infect all of the patients who received that material.

NARRATOR: But companies insisted this was the only practical way to meet patient demand, and the regulators allowed it.

JOHN FINLAYSON: This was a long time coming, because they could never get the factor eight molecule to hold still long enough to let anybody put it in a bottle and dry it. This was a breakthrough that was like flight, and I think that nobody would make the judgment “Oh, we must wait until it’s safe.”

DAVID CASTALDI: Everyone knew that factor eight concentrates could transmit hepatitis because it was just assumed that this was one of the disadvantages of any product made from blood.


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BRUCE EVATT: At the time, hepatitis seemed such a small issue as compared to dying from hemophilia. It was considered an acceptable risk by not only physicians but by government and by the commercial companies.

ERIC WEINBERG: A severe hemophiliac who would infuse clotting factor concentrate maybe once a week, so, say fifty times a year, would easily be exposed over the course of a year to the blood plasma of literally millions of donors. And I’m not sure that the patients really understood the implications of using these clotting factor concentrates the way the companies did.

DONNA SHAW: One would think the logical next question, given the fact that it was widely accepted that there was hepatitis in these products, if hepatitis was in there, what else was there?

(Clock ticking)

ANNOUNCER: The disease seems to begin with recurrent fevers, swollen lymph glands, loss of weight and appetite, and a general rundown feeling.

NARRATOR: Acquired immune deficiency syndrome, or AIDS, was first identified in 1981. No one knew what caused it.

BRUCE EVATT: I first heard of the possibility of this new disease in a patient with hemophilia in early 1982.

NARRATOR: Within months, the diagnosis of two more hemophiliacs raised concern. Was AIDS in the blood supply?

BRUCE EVATT: The hemophilia patients were clearly the population that made everyone begin to think if this were a new-blood borne illness, then the magnitude was tremendous not only for patients with hemophilia but for the U.S. population because at that point in time, ten million units of blood were transfused each year in the United States. And so it was a moment that had to be dealt with, we thought, very quickly.

NARRATOR: Scientists at the Centers for Disease Control set out to stop what they feared would be a pandemic. They urgently needed to convince leaders of government, industry, and medicine to take action and save lives.

BRUCE EVATT: During a period of time, we were working sixteen; seventeen, eighteen-hour days and sometimes we would be on the road for a week or two at a time, trying to identify what was going on. Information was accumulating so quickly, and so we had many, many nightmares. It was an extremely stressful situation.

REGINA BUTLER: Bruce Evatt from the CDC came and talked about individuals who had hemophilia, who had developed pneumocystis pneumonia. It is a moment I will never forget because I had a lightning bolt go off that, in my heart, really, that I thought “Oh my goodness. All of our patients are going to die.”

(Music)

SUZANNE KLEINER: You know, you heard in the beginning that homosexuals were getting sick and they didn’t know why and they were trying to blame it on different things and then there was a smattering of “Gee, maybe it went through the blood products.” And I had like a –

(Suzanne Kleiner making gasping noise)

In my stomach and I said, “Wait a second. If it’s in their blood, it’s going to be in Mathew’s system soon.


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(Clock ticking)

NARRATOR: Not everyone saw the threat. In New York, leaders of the National Hemophilia Foundation, the patients’ only advocacy group, remained skeptical.

GLENN PIERCE: Although it seemed to me that this could be blood borne, nobody could really conceive of the fact that it might kill the majority of individuals that it had infected. There was no precedent at all for that in the hemophiliac community.

NARRATOR: There was no precedent anywhere for the kind of epidemic Evatt and his colleagues were warning about in 1982. Some accused the CDC of created a crisis just to keep their agency open. Desperate, they looked for definitive proof that AIDS could be transmitted through blood.

ANNOUNCER 2: Recently a baby who received a blood transfusion at this San Francisco hospital developed symptoms of AIDS. It was discovered that the blood donor had the disease.

BRUCE EVATT: We finally identified a case that everyone would accept as a transfusion case in an infant. We thought that this was the nail in the coffin that – that clearly the evidence existed now, that this was a blood borne agent.

NARRATOR: Surely, now the FDA, which regulated blood and blood products, would take action. But it was the CDC that called an emergency meeting weeks later in January 1983. They gathered together leaders from FDA, activist groups, and the blood industry.

SHELBY DIETRICH: After a red-eye flight, I went to the CDC meeting and I thought, “Maybe there is something going on that is going to be pretty big here.” And I really – my instinct was “I need to know this, whatever there is to know so I can tell the people at home.”

ANNOUNCER 3: When doctors and scientists are finished here, they still will not know the cause of AIDS, but they are hoping to come away from this meeting with one thing and that is a list of preventative measures.

NARRATOR: It was an unprecedented opportunity, a room full of decision makers. Dr. Bruce Evatt, an epidemiologist, described the disease patterns he saw. AIDS had already been diagnosed in eight hundred people. Eight of those were hemophiliacs. But up to fifty percent of the hemophilia population showed symptoms.

SUSAN RESNIK: I think very few of the physicians had the kind of background or knowledge base to understand and appreciate what the epidemiologists were saying, and if we don’t see how our data and the kind of data we understand, we better do nothing different. I think they really didn’t get it.

NARRATOR: No one knew yet what caused AIDS or how it was spread. To change national blood policy based on just eight confirmed hemophilia cases, many felt was premature.

(Music)

SHELBY DIETRICH: And I listened to all of that discussion over hours and I heard all sides of this. Nothing really emerged. I mean, there were no public health policies and no change in blood banking.

DONNA SHAW: It was a great exercise in mass denial, and the enormous tragedy of all of those really smart people being in the same room was that AIDS was firmly into the blood supply. It was in these products. Thousands of people were going to die, and nothing was going to be done.

BRUCE EVATT: This meeting was probably the most depressing meeting I think, of all of this period of time, that we at CDC experienced. They didn’t want to make any decisions. They just wanted to see more


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data, and it was putting these patients in the abstract of numbers rather than human beings that were being lost to this condition.

DANA KUHN: I was first diagnosed with a mild case of hemophilia when I was about seventeen years old. In 1983 I was an ordained Presbyterian minister just newly graduated from seminary, had a wife, had a son, and the day after graduation I had my daughter. And at that time, I was playing basketball and I landed the wrong way on someone’s foot and broke my ankle. So I thought, “Well, I better go to the emergency room because I have this thing called hemophilia.”

NARRATOR: A mild hemophiliac, twenty-nine year old Dana Kuhn had never been treated. Two months after the CDC meeting, with no changes in blood policy, he was infused with his first-ever dose of factor concentrate. No one mentioned AIDS.

DANA KUHN: I probably got about three treatments in all and throughout the course of two days. And about four or five days later, I started to come down with flu-like symptoms.

ANNOUNCER 4: Since the AIDS epidemic began, doctors have found the disease in at least twelve hemophiliacs and what may be symptoms in many others. The unaffected are beginning to worry.

(Music)

MARY LOU MURPHY: It was alarming and I would call one of the clinicians. I can remember these times. “Don’t worry. Nobody’s getting infected.” You know. “Don’t worry about it. There’s nobody getting infected.” So then I would relax for a while until I read something else again and then I’d call again and get the same answer.

ANNOUNCER 5: But it was learned today that at least one hemophiliac patient here in Southern California was given blood plasma from a donor who died of AIDS. As many as two hundred hemophiliacs across the country could have received transfusions from that infected plasma.

REGINA BUTLER: It was a very chaotic time. It was a time of high emotion, information coming and going quickly, and while all of the other information kept changing, one thing that didn’t change was that our patients still had hemophilia and they were still bleeding.

ALAN BROWNSTEIN: It is extremely important that hemophiliacs continue to use their much-needed blood clotting factor products because the risk of not using it is greater than the risk of AIDS itself.

NARRATOR: Some countries, fearing AIDS, sought to ban the importation and use of American blood products, but in the U.S., even as the epidemic grew, little changed.

SHELBY DIETRICH: I was trying to be reassuring because, truly, there wasn’t scientific data. It was all sort of circumstantial and put the pieces together. So kind of, what’s a poor person to do? The answer to that was keep on doing what you’re doing.

MATHEW KLEINER: Because we weren’t told to stop, we just figured hey, rumors are rumors and it can’t be that bad.

ANNOUNCER 6: As a precaution, all of the plasma in question is being removed from the shelves as quickly as possible.

NARRATOR: When a donor was found to have AIDS, companies might recall effected plasma or specific batches of factor, but these recalls were never required by the FDA and products remained on shelves, in patients’ homes, and doctors’ offices.

TERRY MACNEILL: One night, the doctor called and asked me if I had used certain lot numbers for Brian and for Shawn. No one had ever questioned that. So I just told him we used it and he said, “Oh don’t


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worry. Just keep doing what you’re doing. I want you to keep doing what you’re doing.” I said, “Well is there a problem?” He said “No.” And that was that.

NARRATOR: In rare cases, clinics gave patients the choice to switch from factor to the older therapy, cryoprecipitate. Treatment with cryo exposed patients to many fewer donors, reducing the risk of AIDS.

REGINA BUTLER: Most of our families did choose to go back to cryoprecipitate at that time. We were fortunate to be able to do that because the Red Cross had agreed to process the donations into cryoprecipitate for us. Using cryo at home is not as easy as using concentrate at home but it will stop the bleeding.

NARRATOR: Dr. Oscar Ratnoff had tried to keep his patients away from factor since it was brought to market, for fear of hepatitis. Now, it appeared this precaution had also reduced the risk of AIDS.

GLENN PIERCE: Dr. Ratnoff suggested that I would die of AIDS if I didn’t switch back to cryo. I simply didn’t believe him, and I wasn’t willing to give up my lifestyle. I was in medical school, working one hundred and twenty hours a week and there was no way I could see taking time out, going down to the blood bank, and mixing up some cryo.

NARRATOR: The vast majority of hemophiliacs had no choice.

SHELBY DIETRICH: Cryo is locally produced. It’s not a commercial product. It is produced or rather it is prepared from the local blood bank. And the local Red Cross here in Los Angeles was not willing, either back then or now, to furnish us with nearly enough cryo to treat the large number of patients we had. And it was logistically not feasible.

MARY LOU MURPHY: Never in my family – my family was never given the option. I definitely regret not being able to because we had been through that period with cryo with my older son and we were able to ask friends and relatives to donate and it was a very comforting thing and it was simple enough to do. I know that we could have done it.

NARRATOR: Federal action was needed to stop the unfolding crisis. But the FDA, which oversees blood and blood products, continued to pursue what critics would later call the least aggressive option when it came to regulation.

DONNA SHAW: I would think that the average person would look at what happened in those years and say, “Where was the FDA? Were they asleep at the switch?” These were the people – these are the people who are charged with protecting all of us from this kind of product, from this kind of issue.

JOHN FINLAYSON: I was not involved in the regulation of factor eight and factor nine but certainly if the FDA had convincing evidence that a product was lethal, the FDA would rise and stop it. I don’t think there’s any question about that, but the major question is when something is going on and it’s adverse but we don’t understand it, how hard should we push to get it off the market?

ERIC WEINBERG: THE FDA tended to view their relationship with industry as a coequal relationship. In other words, we’re going to work together with industry and they weren’t professional regulators. They weren’t cops. They were scientists, and so there was little pressure brought to bear on industry.

NARRATOR: The National Hemophilia Foundation, the patients’ primary advocacy group, also came under fire. Why had they not demanded cleaner products? And why had they advised treatment as usual for so long?

DONNA SHAW: Most of the people at that time on the board of the NHF were people with hemophilia or family members had hemophilia, so they had as much to lose as any other patient. But they were not strong advocates for that community. If they had gone to the FDA and said, “This is simply not acceptable for our members. You have to do something about this.” But they didn’t do that.


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GLENN PIERCE: The NHF was run by men with hemophilia who had the pain and crippling of childhood. They remembered what it was like before there was effective treatment. They had no desire to go back there, and they didn’t have any desire to see the community go back to those ages. In retrospect, they shouldn’t have provided advice. They should have simply stated the facts and let patients come to their own conclusions.

(Snapping pictures)

MARGARET HECKLER: The probable cause of AIDS has been found. We now have a blood test for AIDS, which we hope, can be widely available within about six months.

(Speaking in background)

NARRATOR: Three years into the epidemic, the cause of AIDS, the human immune deficiency virus or HIV had been identified. Soon it was possible to test for HIV infection.

ROBERT MASSIE JR.: I went into my doctor’s office. She said, “We’ve run the HIV tests. Would you like to know your result?” I said “Yes.” She took down one book and she looked up my code number from my testing number and she put that down and then she opened up another book of loose leaf, full of results, and she found my testing number and she said, “You’re positive.” And I said “Do we know what this means?” And she said “Not yet.” I said “Thank you.” And I got up and I left.

MARY LOU MURPHY: I remember that they went out to be tested.

NARRATOR: By now, Leo Murphy was working in the film industry in Los Angeles. Matt was in high school.

MARY LOU MURPHY: Leo called me on the phone and said “You know, we’re both positive.” I thought “Oh positive that means that’s good.” That, you know, must mean that everything’s going to be okay, that they aren’t infected. And then I clarified that with him and it was – it was just a horrible moment, horrible. At that point, you know, to have your son say that both he and his brother were infected with AIDS.

DANA KUHN: I knew that I had been treated at least once, well, that one time. And I said, “I just want to eliminate that thought of a risk. I have a family and I’m concerned about that.” So they took the sample of blood and that came back and it was positive. It took three weeks for it to come back at that time. And so they told me that from now on, any sexual intimacy that you have with your wife, it needs to be with protection.

MATHEW KLEINER: We found out eighty percent, up to ninety-five percent of the hemophiliacs in my age group that were using product regularly had been infected. When my dad and I were going to sit down and learn what the results were I was like “So what do you think the odds are that I was in the lucky five percent?” And both of us were like “No way.” You know? We were like yeah this is not going to be a good – this is not going to be a good chat. But I have to say that Dr. Helgartner’s (ph) response was encouraging. She basically said, “It is your job to live until the time you are thirty because by the time you are thirty, we’ll make this chronic condition rather than a terminal one.”

REGINA BUTLER: Fortunately, I do believe that using single donor cryo for our children with hemophilia in our center did save some people and many children because we have a twenty percent rate of HIV rather than a much higher rate, close to eighty percent.

(Music)

BRUCE EVATT: Treating with cryoprecipitate, a severe hemophilia patient may get exposed to a few hundred donors as opposed to sixty thousand donors in a single dose of factor. Switching to


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cryoprecipitate for a short period of time, I think, would have made a difference in the hemophilia community.

NARRATOR: THE CDC had been storing samples of hemophiliacs’ blood since the 1970s to monitor blood safety. Now, those samples provided a timeline of AIDS infection.

GLENN PIERCE: I asked Dr. Ratnoff to go back to my frozen stored plasma samples and find out first if I was infected, and second, when I became infected. It turned out that I became infected in 1982. It was a great-unknown period of time. I can remember personally thinking, “Would death come next month? Would it come next year?” and that was tough. It was very tough.

(Music)

NARRATOR: As people learned they were infected with HIV, many faced public ostracism.

I remember being in a supermarket and seeing a Life magazine or something like that. I could read the cover from thirty feet away and it said in huge red letters “AIDS: Now No One Is Safe.” So I thought, “That could go badly for everyone.”

ANNOUNCER 7: Ryan White, a fourteen-year-old Kokomo, Indiana boy was banned from school last July after he contracted AIDS from a blood transfusion for hemophilia.

ANNOUNCER 8: Those most frightened by the deadly disease, forty-three percent of Ryan’s schoolmate’s boycotted class today.

STUDENT: I ain’t got nothing against Ryan or anything. I just don’t want AIDS in our school.

REGINA BUTLER: All of a sudden, hemophilia became a dirty word. It’s like, now people no longer wanted anyone to know that they had hemophilia because hemophilia meant AIDS.

NARRATOR: In Florida, another young hemophiliac, Ricky Ray, also faced intense hostility.

ANNOUNCER 9: A week of death threats, bomb scares, and school boycotts ended in a weekend tragedy for the Ray family when a suspicious fire destroyed their home, forcing them to flee and vowing never to return to Arcadia.

ANNOUNCER 10: A new school day in a new town for Ricky, Robert, and Randy Ray. The three brothers are hemophiliacs who have been exposed to the AIDS virus. And the entire Ray family has been exposed to AIDS hysteria.

REGINA BUTLER: People had to become very secretive, and it caused tremendous consternation for families. All of a sudden the whole family is just sort of shutting down and closing in among themselves, not having the opportunity to really get social support because they didn’t want anybody to know now that their child had hemophilia.

MATHEW KLEINER: I definitely knew that I had this big secret that I couldn’t tell anyone. At that point, basically, there wasn’t any change. I mean, I didn’t feel sick and I didn’t look sick and everything was fine. I wound up not telling anyone in high school that I was positive unless I was dating them so I ended up telling two people.

NARRATOR: When Mathew went on to Cornell University, he decided to confront the stigma of AIDS.

MATHEW KLEINER: (Speaking to an audience) Living with HIV is that you have to balance–


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At that point, I decided to let everyone know that I was HIV positive and so I went out and I started doing safer sex workshops and it wound up being a great experience. I wound up doing over two hundred workshops. It was in the newspaper and all this other stuff.

(Speaking in footage from a 1993 interview with MTV) Relationships for me had to be that much more serious, you know. It couldn’t be a random hookup or if it was going to be a random hookup, it had to be someone I could trust completely.

I do think about getting sick and I do think about losing everything. It’s a motivator for me to do more now. You know, when your mortality is like right in your face, all of a sudden, like, doing more becomes like, an inviting thing. I’d rather try to make a difference.

NARRATOR: Three years later, Mathew developed a weakness in his arm and leg. He was diagnosed with PML, an AIDS-related lesion on his brain.

SUZANNE KLEINER: After having all of these years of nothing, boom. And he deteriorated really very fast.

MATHEW KLEINER: I was paralyzed in a wheelchair for like six months.

DOCTOR: Oh, wow you were really – you couldn’t move.

MATHEW KLEINER: No. The only thing that was working was basically my biceps.

So I still have like fifty percent use of my arm and fifty percent use of my leg, if not less than that. And that part is hard.

I’m walking at hyperextension in my knee so that hurts and my shoulder. I’ve worked it back but the middle delt – I think this is what it is. It doesn’t work really well, so it hurts too.

DOCTOR: Okay.

SUZANNE KLEINER: Being Mathew, he pulled through. He went home from the hospital. He had to learn how to write, learn how to dress himself. He graduated law school in a wheelchair. He could hardly sit up. He had a life. He had a girlfriend, and he just continued on. So out of horror, he was making a life for himself.

(Music)

He wanted to get married. She was brave enough to marry him.

(Crowd murmuring during footage of Mathew Kleiner’s wedding)

They were looking forward.

(Applause)

(Music)

NARRATOR: The means to kill HIV in factor may have existed all along. When factor first won FDA approval in the 1960s, scientists knew that heat would kill some viruses found in plasma. But manufacturers had argued that heat would damage the fragile clotting proteins. In 1979, a small German company proved them wrong. Behringwerke entered the market with an effective product they said was free of hepatitis, killed by heat. The American companies took notice.


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ERIC WEINBERG: Some poster boards were put up by the Behringwerke scientist and suddenly Baxter and the other companies knew that they were in trouble. That’s when the dollars got committed to the project.

DAVID CASTALDI: Behringwerke’s breakthrough in Europe was the stimulus that led us to initiate a project at Highland. So the free market system works as it’s supposed to work in terms of encouraging people to take initiatives that will benefit, in this case, patients with hemophilia.

ERIC WEINBERG: So I looked for memos that would say things like “We are very concerned about our patients.” You know? “We want to fix this problem because the patients are getting hepatitis,” but there’s none of that. Basically, what you see in the memos is we better get to work because we’re going to lose our market share.

DAVID CASTALDI: We put tremendous efforts behind it and made it the number one project priority within our company, and were delighted when we were the first ones to reach the market in the United States with such a product.

OFFICIAL: This process that we’re watching is our heat treatment or viral inactivation step for our factory concentrate. Once it is filled, we then heat the water to sixty degrees centigrade and then start the timer.

DONNA SHAW: One of the company scientists is asked, “Was there any reason scientifically that you could not have done that kind of viral inactivation earlier?” And his response was “Of course we could have done it earlier.” You know? “We could have done it years earlier but we had to wait until the marketing people said we could have the money.”

NARRATOR: For more than a decade, manufacturers had argued that it couldn’t be done. Now it took just three years for Highland Baxter to bring a heat-treated product to market and within a year, all three of its competitors had done the same. Heat treatment reduced but did not eliminate the risk of hepatitis infection. In 1984, Dr. Bruce Evatt and colleagues at the CDC wondered if heat would be effective against HIV.

BRUCE EVATT: If it did destroy HIV, then they have means at hand to stop the epidemic immediately. And we found that the virus was extremely heat sensitive. Heat treatment was quite simple in the end.

ERIC WEINBERG: Had these companies aggressively pursued sterilizing their product, cleaning up their product, from the time that they knew that patients were being exposed to hepatitis in these products, and had they done it, most hemophiliacs would not have been infected with HIV.

NARRATOR: Immediately after the CDC released its findings, the National Hemophilia Foundation urged doctors to switch to heat-treated factor. But the untreated, contaminated product also continued to be sold.

ERIC WEINBERG: The companies don’t recall their unheated product so there is product that is in pharmacies, in hospitals, in doctor’s offices, in patients’ homes, that is deadly and there is nothing on the label to tell the doctor or the patient that it is deadly. The companies know it is deadly, and they don’t recall it.

TERRY MACNEILL: And you kept on giving your kids this medicine that was supposed to help them and cure them for hemophilia, and you kept on reinfecting them every time you opened your fridge and you injected them with AIDS.

MARY LOU MURPHY: It was a big business – continues to be a big business, and I think that was a big factor in why it wasn’t ever recalled. It just numbs your mind that people would do that to other people.


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ERIC WEINBERG: The chief regulator of clotting factor companies in this country contacts the companies in 1985 and says, “We want you to quietly recall your unheated product so that Congress and the media and the doctors don’t know that we, the government, have been lax in making you do this.”

(Music)

SHELBY DIETRICH: I believe in was 1985. We had something like five patients die within a week. They all have AIDS infection and they were all men and young men I had taken care of through thick and thin for years and years. One can’t help but feel “What have I done?” Or “What have I not done?” Sins of omission and commission. But to see so many lives snuffed out at once, lives still unfolding, is just devastating.

NARRATOR: In 1986, Dana Kuhn’s wife Patty was diagnosed with AIDS, unknowingly infected by Dana years earlier.

DANA KUHN: She took a turn for the worse and she started to go downhill and they had to take her to intensive care to intubate her because she couldn’t breathe. By the time I got there, she couldn’t talk anymore. During, the doctor said, “She’s not going to make it.” That just – it just tore me up and so I had to communicate with her through squeezing of hands and I just told her, you know, that I loved her, and then she would squeeze back that she loved me. And I told her, you know, “I’m going to take good care of those kids.” And I remember she just squeezed my hand and “Yes, I know you are.”

(Music)

NARRATOR: Across the country, the death toll from AIDS was rising. In the hemophilia community, families turned to each other for support and began to discover a profound and disturbing truth.

DONNA SHAW: They began to band together. They began to talk to one another. They compared notes. They got lawyers and those lawyers in turn got them documents that began to show the extent to which they had been victimized.

NARRATOR: They learned about the plasma donors, the pooling practices, the possibility of returning to cryoprecipitate, the ignored warnings of the CDC. Over time, the documents were compiled into a volume they named “The Trail of AIDS.”

DANA KUHN: The one that really got my attention, CDC came out with their mortality morbidity report and I remember it said, “We are highly suspicious that it is in the blood supply.” And I received my infusion of factor March 26, 1983. This communication came out in March of eighty-three and I thought “Wow.” Right then and there, someone should have said to this community, there is a danger here. So I became a man with a mission, and I was going to try to show people that there was negligence here.

TERRY MACNEILL: It took parents, not only myself, it took a lot of people in this community a long time to put this in your head that doctors, clinics, American Red Cross, the FDA, the government—you sound crazy when you say that, that everybody knew but you.

NARRATOR: In 1992, Glenn Pierce became president of the National Hemophilia Foundation. In search of answers, he began poring through old documents. Corporate memos revealed that when companies could no longer sell unheated factor in the U.S., they gathered up unsold stock for export and sale overseas.

GLENN PIERCE: It was shocking that they shipped product overseas that they knew was contaminated with a lethal virus. It was becoming clear to me that the NHF, in many ways, was very naïve in respect to industry. It told me that industry didn’t necessarily have all of the best interests at heart. It told me that the FDA didn’t necessarily maintain a good watchdog role over industry and that the system really needed to change.


15

DONNA SHAW: The hemophiliac community changed a lot in the 1980s and 1990s from a fairly quiet, docile group of individuals to a really strong and vocal organization.

PROTESTOR 1: My husband will die of AIDS because they did not want to spend the money to clean this product up.

PROTESTOR 2: My husband was sold out for a dollar. He was murdered.

PROTESTOR 3: Needlessly murdered.

(Protestors speaking in background)

NARRATOR: In 1992, a decade after the first case of AIDS in their community, hemophiliacs formed the Committee of Ten Thousand. It was named for the number of men believed to have been infected.

ALL PROTESTORS: We want the truth. We want the truth. We want the truth.

COREY DUBIN: I’m putting everybody on notice from NHF and anybody that cares to listen. We’re not going to be gone. We’re not dying quietly. I have no intention of dying quietly. My friends aren’t dying quietly and it’s time that we looked at this organization and made some honest assessments and decisions about where we need to go so NHF represents hemophiliacs and not the big five drug companies in the medical establishment.

LISA SMITH: This is just a small sample of the documentation I have that proves beyond a doubt that they knew this product was much more risky than what we were told.

(Music)

NARRATOR: Their evidence reached the new U.S. Secretary of Health and Human Services, Donna Shalala. She asked the Institute of Medicine, an independent group of scientists, to study how HIV had so thoroughly breached the nation’s blood supply. Dana Kuhn went to Washington and led the Institute of Medicine through the Trail of AIDS.

DANA KUHN: This was day in, day out, our passion. This was what we had to do. We knew the truth and we had to make the truth known.

NARRATOR: In its 1995 report, the Institute of Medicine confirmed that the system had failed the hemophilia community and all of those reliant on the U.S. blood supply.

DONNA SHALALA: I believe the IOM report shows that our entire public health system missed opportunities to intervene and to save lives. Blood safety must never again be handled as a secondary issue. I am elevating it to the highest level of the department.

NARRATOR: Dana Kuhn, Glenn Pierce, and other hemophiliacs were appointed to a cabinet level advisory committee charged with protecting the nation’s blood supply. They were the first patients ever to serve in such a role. Today, the committee continues to evaluate the risks posed to the nation’s blood supply by emerging health threats, such as swine flu and mad cow disease.

ALL PROTESTORS: Stop the red tape.

(Protestors chanting in background)

NARRATOR: In the 1990s, the parents, children, and wives of hemophiliacs infected with HIV –

(Protestors singing)


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– demanded that congress pass the Ricky Ray Relief Act, restitution for the nation’s failure to protect them.

ALL PROTESTORS: Hey, hey, Ricky Ray. Hey, hey, Ricky Ray.

DANA KUHN: Now over half of our infected population is dead, our government should look with shame upon its delay in acting on this bill.

(Protestors chanting)

NARRATOR: The bill was named after Ricky Ray, the young hemophiliac whose family home was burned to the ground.


In 1992, Ricky Ray died of AIDS. He was fourteen. Throughout the early 1990s, AIDS claimed the lives of hemophiliacs at a rate of one per day.

(Music)

MARY LOU MURPHY: It’s a very helpless feeling when you watch your children become ill and can’t do too much about it, can’t do really anything about it. Matt became ill first and he was tied to doctors really and treatments and medication, and it was just an unbelievably tough existence. It was very hard to see them just go down, you know. They loved life so much, so it was difficult, very difficult.

TERRY MACNEILL: I felt like I had poured all of my energy into hemophilia for them to be able to be teenagers and young men and be able to survive hemophilia, and then AIDS comes along and you felt like so what do I do now? Because I can’t fix this, I cannot fix this. I can’t help you anymore. I can’t sit on the bed and have talks with my son, at maybe fifteen and sixteen years old, was going to ask me “How much longer do I have Mom? Do you think I’m going to make it through high school? Do you think I’m going to make it through college?”

(Music)

NARRATOR: It took six years for Congress to release payments under the Ricky Ray Relief Act, one hundred thousand dollars to each hemophiliac infected with HIV. Soon after, the four U.S. drug companies settled a lawsuit brought by families. They admitted no wrongdoing, but, like the government, offered each plaintiff a payment of one hundred thousand dollars. It was roughly, what they earned from one child’s treatment for a year.

ROBERT MASSIE JR.: I did receive the payment, but one hundred thousand dollars is nothing to people who have lost members of their family and I still think that there was – that justice was not served.

NARRATOR: Mathew Kleiner was among those who refused to settle, wanting the drug companies to answer for their actions in court.

MATHEW KLEINER: We have a pretty good idea that some things were done that were done wrong and they should be rectified and I shouldn’t have to bankrupt my family to rectify their mistake. And that’s why I’m bringing a lawsuit.

TERRY MACNEILL: We’ve got a compassionate payment, a Ricky Ray Bill, HR 1023 that we worked six years on that Clinton signed which we’re thankful for. But we have a compassionate payment. They did not acknowledge they did anything wrong. It was compassionately done. Canada is having criminal trials. France put two doctors in prison. The Japanese made them bow down to the moms and apologize.

(Mothers speaking Japanese)


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Do you know of any country that gives a compassionate payment of one hundred thousand dollars to seventy-five hundred people if they didn’t do anything wrong?

DONNA SHAW: A lot of the people in the blood-products industry were devastated by what happened to that community. I would never say that these were decisions that were made by evil people, but they were made by people with a bottom line in mind. And that was ultimately the failure of the entire system.

(Music)

NARRATOR: Hemophilia advocates now turned their attention to factor production. They began meeting regularly with the FDA and insisted on more stringent regulation. The FDA began sending trained manufacturing inspectors into plants, closing some for violations and imposing fines. Manufacturers responded with their own industry wide safety standards that, today, exceed FDA guidelines.

GLENN PIERCE: These changes would not have occurred without patient advocacy by the NHF and the other advocacy groups. It’s only when people start raising questions and demanding answers and then asking for change and if they don’t get it, demanding change, that change happens.

NARRATOR: Hemophilia advocates had forever changed the nations handling of blood and blood products.

(Protestors chanting)

But the weight of past decisions would continue to have devastating consequences.

ROBERT MASSIE JR.: I had a very exciting job. I was travelling a lot, having a big impact on the world. I finally felt I was in a place where I could bring all of my skills together. And then six years ago, I felt like I had Clorox in my veins and I was sick in some very deep way. It took a little while for the doctors to tell me but they suddenly realized, wow, he’s not getting sick with HIV but he is getting sick from hepatitis.

NARRATOR: Several forms of hepatitis had been present in factor from the beginning. Hepatitis B had been manageable and Hepatitis C had been mild. But now, years later, Hepatitis C was proving to be deadly.

ROBERT MASSIE JR.: The sclerosis was slowing down all of my systems. I was starting to become overwhelmingly tired and experiencing brain fog. And then I just have drifted steadily downward in terms of my capacity since then.

BRUCE EVATT: Well it turns out now that the major killer of patients with hemophilia will be Hepatitis C. And it was only within the last few years that we’ve begun to understand the long-term complications.

NARRATOR: Heat does not kill Hepatitis C, but a detergent process that removes it was patented in 1980 and offered to the drug companies. Twelve years later in 1992, they adopted it. The delay meant that for nearly a decade, patients no longer exposed to HIV, including children newly diagnosed with hemophilia, were still being infected with Hepatitis C.

GLENN PIERCE: Hepatitis C began to take its toll on me and every year in the 2000s became a little worse. I first started trying treatment for it in the 1990s, but I was surprised last October to receive a call telling me that they had a liver for me so I was transplanted. It was a major operation. The absolutely amazing thing is that within twenty-four hours of this liver transplant, I no longer had hemophilia, I was cured because factor eight is made in the liver, therefore liver transplants will be curative. That was awesome and really weird.



18

NARRATOR: Mathew Kleiner had settled with the drug companies and was moving on.

JENNY KLEINER: Did you already have your dinner pills or –

MATHEW KLEINER: I already had my dinner pills.

JENNY KLEINER: You did?

MATHEW KLEINER: Yeah.

NARRATOR: Now with his AIDS under control, he and his wife Jenny were exploring a new procedure that would allow them to safely start a family.

SUZANNE KLEINER: He was always told you’ll live to thirty, take your cocktail. Live to thirty you’ll be home free. Hepatitis was never mentioned, never. It was never discussed. It was always AIDS, AIDS, AIDS, AIDS, AIDS, AIDS. It was never hepatitis. And he really got sick at the worst possible time. His wife was pregnant. He made sure they had a great apartment. He found her a nanny. He was so excited about having kids.

SIDNEY KLEINER: January 1, 2003, they became parents to two girls and a boy. By the third week of January, he was jaundiced. His liver was really getting bad.

SUZANNE KLEINER: And he got sicker and sicker and sicker, and one doctor said, “Don’t worry. We can give him a transplant.” So that was – we were holding onto that for dear life.

SIDNEY KLEINER: One day the doctor came over and said, “I’d like to speak to you Mr. Kleiner. This is very serious.” And he told us that the problem was that if he had a liver transplant, they’d have to reduce his immune system so he wouldn’t reject the liver. Then his PML and his HIV would kill him anyhow, so he was not a good risk. The doctor left the room and for the first time ever, something no parent should ever try to have to deal with, my son cried out that he was going to die and that he wanted to know who was going to take care of his wife and children.

SUZANNE KLEINER: And then we just knew that was it. And even then, he hung on longer than they thought he would. You know, but he died I guess the best way, in the arms of his wife so he had the most, I guess, perfect death. So I was very grateful to her that she gave my son –

(Music. The following text is shown onscreen: For nearly two decades, Factor medicines have been free of both HIV and hepatitis C. An estimated 10,000 US hemophiliacs were infected with HIV and 15,000 were infected with hepatitis. Thousands more were infected worldwide.)

ROBERT MASSIE JR.: That’s a rare tragedy and a rare irony that people could have come so close to being home free and then, because of a decision made about money, they were denied that and people died. (Text shown onscreen: Robert Massie, Jr. had a successful liver transplant in July 2009. He is now cured of hemophilia.)

(Music)

BRUCE EVATT: I think the hardest thing for me personally was not being able to convince, you know, people what was happening when it was happening. And I think that was very difficult. (Text shown onscreen: Dr. Bruce Evatt spent the rest of his career lecturing about epidemiology and the need to act quickly when confronting new infectious diseases.)

DANA KUHN: I think every American citizen should be active in their health care and learn and see that our government isn’t perfect and they do make mistakes, but do you want to become one of their mistakes? (Text shown onscreen: It has taken years of grueling treatment but Dana has been symptom-


19

free of hepatitis C since 1996. Today he heads a non-profit that helps families pay the costly medical expenses associated with chronic illness.)

ERIC WEINBERG: If we’re not vigilant, then this will happen again. If the corporate mindset is profit, if it’s shortsighted, if it’s market share rather than safety, it’ll happen again for sure. It’ll happen to you or me or to our children or to our friends and that’s what concerns me. (Text shown onscreen: Eric Weinberg continues to litigate in cases where people have been injured by pharmaceuticals.)

DONNA SHAW: More and more of our products, our pharmaceutical products, our medicines, are being made overseas in factories that are rarely if ever inspected by the Food and Drug Administration. There isn’t the money. There isn’t the will and it becomes so much more urgent and difficult to regulate and based on what I see from this case, you know, I really wonder if our system is up to it. I really think it might not be. (Text shown onscreen: Donna Shaw continued to write about the impact of business and politics on the pharmaceutical industry. Today she is a journalism professor. She teaches this story to every class.)

(Music)

[End of Audio]

From “Bad Blood: A Cautionary Tale.” Copyright 2010 by Media Group. Adapted with permission.

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