Viral Contamination Transcript / 1
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.”
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 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-fashionedmedicine, 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. 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.
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.”