SEPTEMBER 1997 · VOLUME 18 · NUMBER 9
I N T E R V I E W
Elaine DePrince is the author of Cry Bloody Murder: A Tale of Tainted Blood, which details the blood companies' failure to adopt available preventative techniques that could have stopped the spread of AIDS to hemophiliacs. DePrince and her two biological sons were born with von Willebrand disease, a type of hemophilia. She went on to adopt three other boys, who had hemophilia A. The DePrinces did everything they could to assure that their sons would have normal childhoods despite their bleeding disorders. The blood plasma concentrates upon which they relied afforded them a freedom which had been denied earlier generations of hemophiliacs and seemed in many ways a blessing. Three of the DePrince sons, like more than 50 percent of the hemophilia community, became infected with HIV because they believed the assurance of their doctors, industry leaders and others that blood plasma concentrates were safe.
For the last several years, DePrince has been active in lawsuits against the companies which supplied tainted blood products to hemophiliacs.
Elaine DePrince: Hemophilia is a genetically transmitted disease.
Every single day, a person with normal clotting ability breaks a blood vessel somewhere in his or her body. That blood vessel is immediately patched by the formation of a clot. But in the case of a person with a type of hemophilia, the blood vessel will just continue to leak into a joint or into an open space in the body. This can be crippling or life-threatening.
A very mild hemophiliac might hemorrhage once in his entire life time. A severe hemophiliac can hemorrhage every other day.
MM: How many hemophiliacs are there in the United States?
DePrince: One child in every 10,000 male births has hemophilia A. And one child in 100,000 male births has hemophilia B. The incidence of von Willebrand disease -- which is similar to hemophilia but different in that the deficient clotting factor does not always remain at the same level -- is not known. Right now it is estimated that there are 20,000 individuals with hemophilia A and B in the United States.
MM: What was the first medical breakthrough on hemophilia?
DePrince: In the 1800s, it was first discovered that blood transfusions helped hemophiliacs. Over time, it was found that blood could be separated into cellular components and into plasma products -- this is called plasma fractionation. The plasma portion of the blood contains salt, the proteins that enable clotting, antibodies, sugar and water. The cellular portion isn't necessary for hemophiliacs, and always causes a reaction. So, it is better not to receive cellular portions of the blood.
Plasma fractionation was a wonderful development. This began around the late 1930s.
But there was such a small amount of clotting factor in a pint of plasma, that hemophiliacs would need vast amounts of plasma to increase their clotting factor levels.
MM: When was the major treatment breakthrough?
DePrince: In the mid-1960s, there were two nearly simultaneous developments.
Dr. Judith Graham Pool developed cryoprecipitate -- referred to as cryo. Cryoprecipitate is the product made from clotting factors separated from frozen plasma. Cryo made higher doses of clotting factor available to hemophiliacs without overloading their systems. But the downside was, like the blood and plasma transfusions before it, cryo usually required a trip to the emergency room for treatment.
The other development which occurred in the 1960s was the production of a concentrated clotting factor product by the proprietary plasma fractionation industry. This was a great product because you knew exactly how much you were getting in each dose. And instead of being transfused with bags and bags of plasma, you could get just a few ounces of concentrated clotting factor.
This was first licensed and marketed by Baxter in California. They produced the concentrated clotting factor VIII. It looked like powdered milk. It was a freezed dried product, like freezed dried coffee, but it was white. It came in a tiny little bottle. And you turned it into a liquid it by adding sterile water. One or two vials of this product (about 30 cc.) could stop hemorrhaging in a hemophiliac. The real plus was that it didn't need to be frozen. You could travel with it. You could take it to the movies. You could take it to the restaurant. Wherever you had a hemorrhage, you could treat it immediately.
There was a problem with the concentrate back in the 1960s and the manufacturers knew this. The manufacturers knew that in order to produce concentrate, you needed a lot of plasma. It was more plasma that they could possibly get from the voluntary donor population. So they relied on paid donors. And in general, the people who were willing to be paid for their plasma were from the underbelly of society.
Consequently, the plasma came from Third World countries, or areas in the United States that were economically depressed or had high concentrations of homeless people or intravenous drug users. So, we are talking about getting plasma that came from paid, high-risk donors.
By contrast, the cryoprecipitate was processed in a non-profit blood bank and came from volunteer donors. It was less convenient, but it was cleaner.
MM: Did the hemophiliac population know that it was cleaner?
DePrince: No. The patients really didn't understand the differences between the two.
There were some patients who were warned by their doctors that concentrate was a dirty product. Some physicians didn't want their patients to use the concentrate. Some physicians even refused to treat their patients with it. If their patients wanted to use the new concentrate, they would refer them, in some cases, to another physician for treatment. These doctors were seeing an increased incidence of liver disease in hemophiliacs who were using the concentrate.
But the physicians and patients who refused the concentrate were the minority.
MM: What companies make up the blood industry?
DePrince: I'm talking primarily about the plasma fractionation industry. There are four major fractionators in the United States -- Alpha, Armour, Bayer and Baxter. However, the blood-banking industry is guilty for this disaster also because the blood-banking industry lobbied for laws that would exempt blood products, including clotting factor concentrate, from strict product liability. Forty-seven states now have these blood shield laws.
The majority of these laws state that blood is to be considered a service, not a sale. Therefore, blood products are exempt from strict product liability.
MM: When was the first indication that there was a serious problem in the United States?
DePrince: In 1982, when three hemophiliacs were diagnosed with AIDS. This was reported in the Center for Disease Control's (CDC) Mortality and Morbidity Weekly Report.
The National Hemophilia Foundation reported the diagnosis, but hemophiliacs were told by the Foundation that this was nothing to worry about, that this was an exceptional incident. The Foundation stated that the CDC had not recommended a change from current treatment methods.
It is true that the CDC hadn't recommended a change, but that was because it wasn't the CDC's job to recommend a change unless asked. CDC researchers have since testified that they were never even asked if they would recommend hemophiliacs continue using clotting factor. They testified that, at the time, they had said to each other -- and I paraphrase -- "If we had children who were hemophiliacs, we would not allow them to use clotting factor concentrate."
MM: Is it correct that it only takes one person with AIDS to contaminate the whole supply?
DePrince: The blood companies took the plasma, collected from up to 100,000 or more paid high-risk donors, and put it into one large vat. And if only one person were infected, the entire vat was infected. And they would take that vat, and from it they would manufacture anywhere from 500 to 2,500 vials of clotting factor, depending on the potency of the product.
But every single one of those vials coming out of such a vat would contain HIV.
MM: But the companies weren't aware at the time of the risk of HIV transmission, were they?
DePrince: In the mid-1970s, studies were conducted and it was determined that liver disease had become the second leading cause of death among hemophiliacs -- second only to internal hemorrhaging. The manufacturers knew as early as the mid-to-late 1960s that there was a major problem with the product. Not only were the patients developing hepatitis, but workers in the industry were also developing hepatitis.
The companies realized in the 1960s that there had to be more than one kind of hepatitis. They should have at that point done something to destroy the hepatitis viruses. In the 1970s, one German company -- Behringwerke AG -- developed a process to virally inactivate the product. In destroying the hepatitis viruses, they had also destroyed any HIV, even though they didn't realize it. HIV was discovered to be far more sensitive than hepatitis viruses.
So, if the U.S. companies had done the right thing and protected their consumers from hepatitis, this problem could have been avoided.
Hepatitis was no simple problem. My children's AIDS treatment was vastly complicated by hepatitis. Even before AIDS became a problem for them, hepatitis was a problem for them.
MM: So the companies could have prevented this disaster with Behringwerke's heat treatment?
DePrince: Yes. They didn't because it would have been expensive. In some experiments, the destruction rate of the clotting factor from the heat treatment ranged from 18 percent to 95 percent, depending on where the study was being conducted. Behringwerke admitted that there was a 50 percent factor VIII loss in producing this product. But in retrospect, the hepatitis was expensive.
And by 1982, when it was recognized that HIV was going to be a problem in the product, the companies could have instituted surrogate testing. This refers to the hepatitis B core antibody test.
In the 1970s, the bloodbanking industry began using the hepatitis B surface antigen test to eliminate donors with hepatitis B. But this only eliminated a small number of donors. There were many people who were still donating who had hepatitis B or who were carriers of hepatitis B, but they weren't testing positive for the hepatitis B surface antigen.
The hepatitis B core antibody test was a much more sensitive test that would have eliminated a huge number of hepatitis B patients -- and indirectly many HIV positive patients. In its hepatitis study on gay men, the CDC had determined that approximately 90 percent of the men who had been identified with hepatitis were also being diagnosed with AIDS.
MM: Is clotting factor clean today?
DePrince: It is relatively clean. It no longer carries HIV unless there is a lab error. Incidents of HIV transmission have been extremely rare since 1987.
MM: What changed in 1987 to make this problem virtually go away?
DePrince: By 1987, all of the U.S. companies and international manufacturers of clotting factor were using effective heat treatment processes, or they used a solvent detergent process which was very effective.
MM: What forced the change?
DePrince: In 1983, the CDC and National Institutes of Health conducted a nationwide surveillance of hemophiliacs. It was determined that probably one-third to one-half of hemophiliacs in the study would go on to develop AIDS. And that was only in 1983. Hemophiliacs continued to be infected after that for another few years.
The manufacturers then realized they were going to be killing off their consumers.
MM: The manufacturers did nothing until they saw their patient population was being killed off?
DePrince: To be fair, the manufacturers claim that they were working on viral inactivation in the 1980s. But they should have been working on viral inactivation from the very first day that the product was licensed in the mid-1960s, because they knew from clinical trials that it was transmitting hepatitis.
MM: How many hemophiliacs died from AIDS?
DePrince: Nearly 5,000 have died in the United States and I believe that another 5,000 to 7,000 are HIV-infected. Anywhere between 50 percent and 78 percent of the hemophiliac population alive in 1982 was infected with HIV.
There were 12,000 people who did not have hemophilia who contracted HIV in the 1980s, because there was no surrogate testing of donor blood. If surrogate testing had been instituted, probably 90 percent of those infected would not have been infected. These are people who needed plasma or blood transfusions in the emergency room.
MM: If there is a smoking gun document here, it comes from a gentleman named Thomas Drees.
DePrince: Thomas Drees is the former CEO of Alpha. He has testified that there was a conspiracy among the manufacturers to delay surrogate testing. That's the use of the hepatitis B core antibody test to determine the probability that the donor is also HIV infected.
Drees says the companies knew of this test but failed to use it because it cost an additional five dollars a unit. Every time they drew a unit of blood from a donor, it would cost five dollars to do the test. So for every donor, there would be an additional five dollar charge. But they could have passed the cost onto the consumers. I don't know anyone within the hemophilia community who would not have paid extra for clotting factor.
Thomas Drees is saddened about what has happened. He has testified for the plaintiffs in these cases. He was kind enough to proofread my manuscript.
MM: What would these tests have done to the price of clotting factor?
DePrince: It could have doubled the price of the clotting factor. But that eventually happened anyway.
The clotting factor is very expensive. It cost me $4,000 for one recent treatment. And it was my fourth treatment in three days.
MM: There have been hundreds of lawsuits against blood companies. In a nutshell, what is going on there?
DePrince: Only one case out of 13 that have gone to court has been successful. The one successful plaintiff, in Florida, recovered $2 million.
A federal class action was filed in Chicago and subsequently decertified. The class represented 6,200 hemophiliacs. Recently it settled for what I consider a puny amount -- $100,000 per person.
MM: Even after decertification, the individuals settled?
DePrince: Yes, because the majority of hemophiliacs nationwide were outside the statute of limitations and they live in blood shield law states.
However, a recent Supreme Court decision, Amchem v. Windsor, covering the asbestos class action settlement, may affect the hemophiliac class action. Two appeals were filed challenging the class action settlement, and the Amchem decision may weigh in favor of those challenging the settlement.
At this point, the United States is the only Western country that has not settled with its hemophiliacs.
A number of hemophiliacs opted out of the settlement; their suits are ongoing. Some of them have strong stand-alone cases and some do not. I have three cases here in New Jersey, which is a non-blood shield law state.
MM: These matters affected your family directly. What happened to your sons?
DePrince: My five boys names are Adam, Erik, Michael, Teddy and Cubby. My two oldest, Adam and Erik, are my biological sons. The three youngest children were Michael, Teddy and Cubby -- they were adopted. By 1987, Cubby and Michael were symptomatic for AIDS. They were six and eight at the time. There was no drug available for pediatric patients with AIDS.
By 1990, Cubby had a deadly opportunistic infection. Michael's health was failing rapidly and Teddy was also symptomatic. Teddy responded to the drugs. Michael did not respond to the drugs. Cubby had no T-cells by the time AZT was available for him. He had no immune system left.
From 1988 to the present has been a nightmare for my family. We tried to live a normal life.
It was painful for me to watch my children suffering and dying. It was difficult for my husband and I to maintain some equilibrium in the home so that our surviving children wouldn't be total basket cases. It is indescribable. I don't know how you can describe having to tell an eight-year-old that he is going to die young.
Cubby died first, in June 1993. Michael died nine months later. Michael had a 10-hour convulsion. I promised him he wouldn't have to go to the hospital. His three surviving brothers so desperately didn't want him to be sent to the hospital that they laid across his body so that I could put an IV into him, so that we could give him the morphine drip he needed to stop his convulsions. His brothers so desperately didn't want to see their brother die in a hospital. He was afraid of hospitals.
MM: Your activism caused your husband to lose his job?
DePrince: There is no direct evidence on this. There is nothing in the file anywhere. I'm sure that any decisions that were made were probably made on a golf green somewhere.
In 1996, we were successful in getting the state of New Jersey to waive the statute of limitations for hemophiliacs with AIDS. This appeared to have a direct impact on my husband's job.
My husband had worked for a manufacturer of pharmaceutical excipients, the inactive ingredients in pharmaceuticals. The company's largest customer was Bayer. I had tussled with Bayer's lobbyist in New Jersey over the issue of the statute of limitations. He had testified before a New Jersey Senate Committee and I had testified following him and pointed out flaws in his testimony. Consequently, the Senate Committee voted to pass the bill out of committee.
In January 1996, the four manufacturers discovered that I had provided the Hemophilia Association of New Jersey with documents upon which the Association based its testimony in the legislative hearing. After that, my husband was threatened with probation on his job. He had been there for almost 21 years. He was the director of operations for several plants. Recently, a vice president of his corporation, in an interview with Bob Massie, who wrote an article for The New Yorker, stated that my husband's performance was extraordinary.
My husband was fired the day after I accepted Random House's bid on my book.
He's now working for the industry as a consultant. He seems to be successful in dealing with Japanese companies -- which makes sense: the Japanese responded to this tragedy much more strongly than the United States has.
MM: Have there been criminal prosecutions of blood companies anywhere in the world over this contamination?
DePrince: Yes. There have been prosecutions in Germany and France. There is ongoing criminal prosecution in Japan.
The Japanese companies and the government made apologies. There was acknowledgement of wrongdoing and guilt. In the United States, no one wants to admit guilt. They want to claim that this was an accident of circumstance.
This is the position of the companies and the U.S. government. We have tried to pass a bill through Congress to give compassionate relief to hemophiliacs with HIV and their survivors in the United States. It is sponsored by Porter Goss of Florida and Michael DeWine of Ohio. It was originally introduced in 1995. It didn't pass. It has been reintroduced in this session. We have 240 Congressional sponsors. But we are lacking support in the Senate.
Currently, Congressman Rob Andrews of New Jersey is preparing to introduce a bill which would roll back the statutes of limitations for HIV-infected members of the hemophilia community. If it succeeds, it will enable these individuals to file stand-alone cases throughout the nation.