In 1982, a crisis was beginning to unfold. Gay men were dying of an unknown cause, which years later was shown to be the Human Immunodeficiency Virus (HIV). At that time, I was not involved with the gay community, with acquired immunodeficiency syndrome (AIDS), or with HIV. But federal funding of my research on blood products helped us prevent the transmission of HIV and hepatitis to tens of thousands of Americans.
I led a small team of research scientists at the New York Blood Center (NYBC) interested in developing new therapeutic products from plasma, the fluid portion of blood. What was known in 1982 was that a plasma product called AHF used in the treatment of hemophilia occasionally transmitted hepatitis B virus and transmitted another virus eventually to be known as hepatitis C. The risk of hepatitis C in this patient group was accepted because the infection was believed to be mild and the benefit of treating the patient with the plasma product was great.
The challenge
If we were going to succeed in developing new plasma products useful to large numbers of patients, such as ones that accelerate wound healing, we had to eliminate viral risk. The only way of doing this with certainty was the use of viral killing methods. The challenge was to find methods that would kill large quantities of virus without damaging the therapeutic protein.
Finding a solution
Supported by the virology laboratories and others at NYBC and based on preliminary studies demonstrating virus kill, in 1983 we received an award from the National Institutes of Health (NIH) totaling just over $750,000 for the “Detection and inactivation of non-A, non-B hepatitis agents in blood”. This award enabled us to greatly accelerate our work which, by that time, included exploring the use of organic solvents and detergents such as had been used in the preparation of viral vaccines. The idea was to disrupt viral structures by stripping away essential fatty acids with the hope that the proteins of interest would be unaffected. Our hopes were fully realized.
We showed that the method we developed, commonly referred to solvent/detergent or SD treatment, completely inactivated hepatitis B and C viruses in a chimpanzee model, and, in collaboration with Dr. Gallo at the NIH, we showed that HIV was rapidly and completely inactivated. As importantly, the valuable proteins such as AHF appeared to be unaffected.
Based on these results, the Food and Drug Administration (FDA) licensed the NYBC’s plasma product for the treatment of hemophilia in 1985. More complete clinical studies run cooperatively by NYBC and the FDA showed that the AHF protein was undamaged and HIV and hepatitis viruses were not transmitted.
Impact
For the next fifteen years, over 60 organizations worldwide adopted SD technology and applied it to a wide variety of products including AHF, intravenous immune globulin used in the treatment of immune deficiency disorders, and even monoclonal antibodies and other recombinant technology derived proteins. Hundreds of millions doses of SD-treated products have been infused in people; countless transmissions of Hepatitis B, Hepatitis C, and HIV were eliminated; and the lives of tens of thousands of patients were saved or improved.
The importance of federal support
Success stories like these are not guaranteed. Without federal support, I am reasonably certain that our findings would have made for a nice publication or two and little else. Additional federal grant support that I received resulted in improving the consistency and viral safety of transfusion plasma, now available broadly, and spawned efforts leading to red cells and platelet products with enhanced viral and bacterial safety.
I am forever grateful for the grant support that I received, and the granting agencies and the nation should take pride in the initiatives they foster. My, no really our story, demonstrates the impact of federal funding and the degree to which the scientific enterprise is a collaborative effort, bringing together many diligent minds from research institutes, private organizations and multiple federal agencies. We should all hope that this continues unabated. Our population deserves it.