A drug to treat hemophilia was polluted with hepatitis viruses and HIV

An excerpt from Doctor Guilt?

by Everett Winslow Lovrien, MD

This is the story of a boy who had hemophilia, a bleeding disorder that resulted in pain, disability and death before adulthood. A new medicine was developed which brought an end to suffering and increased longevity in persons with hemophilia.  The effect of the new medicine was like magic. It was a remarkable revolutionary advancement in the treatment of hemophilia, a medical disorder that had caused suffering for many previous centuries.

The medicine was manufactured from the plasma of paid blood donors.  Unexpectedly, a dark cloud descended when persons infusing the medicine became ill. It was discovered that the new medicine was polluted with hepatitis viruses and HIV.  By the time of discovery it was too late to prevent infection. The boy and 10,000 others in the USA became infected with HIV the virus that causes AIDS. He died from AIDS at age seventeen rather than have a prolonged life that was intended with the new medicine.  The medicine was sold to other countries resulting in thousands of deaths from AIDS all over the world.

In addition to the boy, others like him that received medical care at the same clinic he attended also became infected with HIV and hepatitis viruses. One hundred persons at the treatment center where he received his care died from AIDS or liver failure. A dozen other families who lost a son or father or husband were contacted or interviewed in their homes and asked if they blamed the doctors who prescribed the medicine that resulted in death. Doctors are supposed to provide treatment without causing harm to their patients. The doctors didn’t know that HIV, a new virus that causes AIDS, existed. But could they have known or should they have known?  Do the families view the doctors as guilty of causing harm and death?

The families believe the doctors were incorrect when they told the families to take the medicine and their loved one would live to become an old man and have a near normal life. But they do not believe the doctors are guilty.  They were using the best knowledge available at the time.

However, the families do believe the pharmaceutical manufacturers of the medicine are accountable for the deaths from AIDS in persons who infused their medicine to treat hemophilia. If there was suspicion that the medicine was polluted, why didn’t the producers of the medicine purify it by removing the viruses from the donor plasma?  The manufacturers replied that they didn’t know how to purify the medicine or that the methods of viral depletion were too expensive. But since then, reviews have revealed that although the drug companies didn’t know how to remove the hepatitis viruses and HIV, it was known but not by them. It has been known since World War II that heating plasma inactivates hepatitis viruses. If Hepatitis would have been destroyed in plasma by heating, HIV would have also been eliminated even though its existence was not known. AIDS could have been prevented in hemophilia.

In the USA the system of free marketing and capitalism leads to entrepreneurship resulting in the development of new beneficial medicines by pharmaceutical manufacturers. Remarkable and beneficial new medicines have been developed in the USA using genetic engineering methods with recombinant techniques as a result of capitalism.   The force that drives new development is profitability. But when safety is sacrificed for profitability, in a society without cost controls, greed prevails. The manufacture of medicine to treat hemophilia is a multi-billion dollar industry with intense competition.  Because of human nature regulations are necessary to prevent greed.  The families who lost a loved one from AIDS or liver failure from hepatitis regard the drug companies that made the new medicine for hemophilia as bringing great advancement but guilty of greed.

AIDS is not a mysterious disease. It is the result of HIV infection in humans when the natural occurring virus in simians in Africa, SIV, jumped a species to become HIV in humans.  This came about as the result of the production of the human hepatitis B vaccine. As the result of human behavior, the HIV virus infected intravenous drug users who sold their plasma to pharmaceutical manufacturers of the medicine to treat hemophilia.

The use of a medical treatment requires judgment by the prescribing doctor and the patient recipient.  The benefits of treatment must be compared with the hazards, a trade off. The impact of an activity, a medical treatment or a pharmaceutical innovation, may not be apparent at the time of an action. The risk of harm from a possible but unknown substance in the medicine was judged to be a less threat than the threat of death from bleeding into the brain if medicine was withheld. That turned out to be incorrect.

Sometimes good intentions result in bad things happening.  The intent to prevent hepatitis infection in Africa was a good intention. But the process led to the jumping of a species when SIV of monkeys and chimpanzees mutated to become HIV in humans.

For a balanced society, critical thinking is necessary.  Doctors are closest to their patients and should make treatment decisions, with input from their patients, without influence from pharmaceutical manufacturers and commercial and publicity organizations.

We should not forget the great tragedy that happened in hemophilia when thousands of persons all over the world died from AIDS and liver failure.  AIDS is a man-made disease and could have been avoided. Their families want their story to be told. They should be remembered so that this tragedy does not recur.   They are part of our society and all of us should care what happened to them.

Everett Winslow Lovrien is former medical director of Hemophilia Center at the Oregon Health Sciences University and the author of Doctor Guilt?

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