Nightline: Hemophiliacs Assail Drug Firms Tainted Blood

ByJoe O’Connor and Kristen Rassiger

W A S H I N G T O N,  Dec. 27, 2000 -- Think of them as “canaries in the coal mine.” Like the fragile birds sent down into the mines to detect the first whiffs of toxic gas, hemophiliacs represent a first line of defense against any infectious threat to the nation’s blood supply.

If groups of hemophiliacs suddenly become sick, their misfortune may very well alert the rest of us to the dangers of bad blood.

For hemophiliacs, regular infusions of a blood-clotting agent made from donated plasma have become essential to life. This agent, known as Factor VIII, reduces their blood-clotting time from hours to just minutes. It has been received by hemophiliacs and their families as a miracle drug that permits children to play without fear of uncontrolled bleeding from a simple scrape and allows adults to live twice as long as they might have a generation ago.

But Factor VIII, which was synthesized from the plasma of 20,000 to 100,000 donors, also carried a significant downside: If one of these donors is infected with a blood-born virus, the miraculous factor would also be contaminated. Many hemophiliacs were exposed to the hepatitis virus in the 1970s and to AIDS in the early 1980s — experiences that suggest how a miracle can become a nightmare.

Tainted TransfusionsThousands of hemophiliacs died from AIDS when they became infected via HIV-infected Factor VIII. Official numbers from the Centers for Disease Control and Prevention report that 3,511 hemophiliacs died; but of the approximately 20,000 hemophiliacs living in the United States in 1980, as many as 8,500 were infected by the disease through tainted transfusions.

These CDC figures are contested by many in the hemophiliac community, who claim that as many as 10,000 hemophiliacs died as a result of HIV-infected Factor VIII. And many families of hemophiliacs blame the manufacturers of Factor VIII, which they believe could have done more to spare hemophiliacs exposure to this deadly disease.

At the beginning of the epidemic, representatives of the drug companies point out, they were forced to make decisions based on a lack of scientific knowledge of what caused AIDS and are thus not to blame for the hemophiliacs’ deaths. They also allege that the Food and Drug Administration had failed to properly regulate blood products early enough in the AIDS crisis.

But victims and their families accuse the pharmaceutical companies of failing to perform a heat-treatment process that might have prevented HIV contamination of the factor.

The companies emphatically deny these charges and state that their production methods “met or exceeded the world’s most stringent safety standards.” In 1984, the blood-product companies did develop heat treatments to eliminate HIV in Factor VIII and began using the process once the FDA gave its approval. This was also the year in which HIV was determined to be the cause of AIDS.

By 1985, it was possible to test Factor VIII for HIV, but the industry continued to make and distribute non-heated product that it knew was probably contaminated with HIV because, according to the industry, physicians were still asking for it. And heat treatment also posed risks: The process reduced the amount of clotting factor in each dose reducing its effectiveness. But more importantly, there was a higher potential for the body to reject Factor VIII totally, leaving hemophiliacs with no effective treatment.

Even after 20 years, allegations and recriminations keep families and the pharmaceutical companies tangled in court over the distribution and sale of Factor VIII. And the families have lost all of those cases that have gone to trial. We may never know for certain whether or not the Factor VIII-related deaths could have been prevented.

Questioning the Safety of the Blood SupplyTwo decades of vital questions about the safety of the blood supply remain unanswered. Were most hemophiliacs infected even before HIV was discovered? Were male homosexuals and other individuals at high risk of carrying HIV screened early enough from the donor pool to protect hemophiliacs? Should hemophiliacs have been urged to use slower, thus riskier, clotting treatments as soon as government researchers began to suspect Factor VIII was a likely source of HIV infection? If drug companies knew about the risks, why didn’t they put warning labels on Factor VIII? And why was non-heat-treated Factor VIII sold abroad even after it was found the heating process greatly reduced the risk of contamination?

Nightline producers have interviewed infected hemophiliacs and their families, attorneys for hemophiliacs, industry spokesmen and epidemiologists in an attempt to answer these questions. The FDA declined to comment. The four U.S. manufacturers of Factor VIII refused repeated requests from Nightline to address this question on camera, although an off-camera background briefing was provided.

Can this type of tragedy happen again? Could the commercialization of new drugs and treatments overshadow crucial public-health concerns in the future?

Thomas Drees, former president of Alpha Therapeutic, says such concerns are valid: “This will happen again,” he told Nightline. Drees claims that the plasma industry will continue to fight against testing for emerging blood-born diseases.

Always a RiskHemophiliacs who rely on plasma-derived clotting factors are assured by organizations like the Plasma Protein Therapeutics Association that the plasma industry now takes precautions to ensure that HIV and other blood-borne infections will be detected and removed from their products. As the primary advocate for the leading producers of plasma-based and recombinant biological therapeutics, the PPTA and its members have developed sensitive screening tests that can potentially detect some viruses even before a donor displays symptoms or develops antibodies.

To date, there are high levels of regulatory oversight on blood products including a recent suit filed by the FDA against the American Red Cross. The FDA charges the nation’s largest blood supplier with not properly ensuring the safety of its blood through sloppy processing and storage which puts the public at risk.

But in spite of FDA enforced regulations and new forms of testing, Dr. Michael Busch of the University of California at San Francisco says that “of the nation’s 12 million units of donated blood, about 10 units of HIV-infected blood go undetected each year.” This figure may seem insignificant when compared with the blood crises of the 1980s, they represent about two or three new HIV-infections annually among factor-dependent hemophiliacs.

Dr. Don Francis, who worked for the CDC during the height of the AIDS epidemic in the 1980s, says such risk cannot be completely eliminated from any product or treatment, however.

“We do have to be prepared for new things in the future,” says Francis. “And some of these things may be slow-moving things.” One of our best hopes for the future, he claims, is that companies will better evaluate risk vs. predicted benefit.

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