The promise of new therapies gives us hope— hope that we can battle the diseases that cause human suffering. Yes, there are risks, but it is hope that is the source of our courage to introduce these new therapies into our arsenal of medicines; for the risks are certainly outweighed by the rewards. For most of the scientific miracles that have become medicines today, the development of such therapies was not paired with unfortunate sacrifices. Unfortunately, for others, sacrifices were made so we can have the medicinal marvels that we have today. As we stand in the midst of the promise of cellular therapy and the hope of regenerative medicine, we should learn from the risks that we took in the past so we can reap the rewards without harsh sacrifices.
In 1965, plasma derived Factor VIII provided hope for patients suffering from hemophilia. However, from 1979 to 1985, many of these patients who were treated for their hemophilia, contracted the deadly human immunodeficiency virus instead. And in 1989, when Hepatitis C virus was discovered, an even higher percentage of hemophilia patients fell ill with chronic liver disease. Because of the risk of human pathogens in plasma derived therapeutics and the inconsistency and lack of reliability of blood supply, the biopharmaceutical industry began the trend of avoiding plasma derived ingredients in the manufacture of recombinant biologics. Recombinant Factor VIII is now given to patients and has a much-improved safety profile.
Fast-forward 46 years after the discovery of Factor VIII and we are now investigating the use of cellular therapy to treat diseases such as diabetes, heart disease, cancer and other neurodegenerative diseases. It is surprising then that in development of these therapies, plasma derived human albumin is still widely used. Yes, regulatory controls are in place to ensure safety of the plasma derived preparations. However, we can only test for viruses that we already know exist. Almost fifty years ago, they did not test for the virus that causes AIDS because they did not know it existed. Over 20 years ago, they did not test for Hepatitis C virus because they did not know it existed.
We are in the 21st century and we are 100% sure that viruses can be found in the preparations of human blood. Drug information online (Drugs.com) lists the following risks of transmissible reagents in plasma derived preparations in their website:
- Despite screening for certain viruses (HIV, Hep B, Hep C) and a pasteurization procedure to reduce viral infections potentially associated with plasma protein fraction, a risk for transmission of infectious agents still remains.
- Transmission of non-enveloped viruses, including Hepatitis HAV and parvovirus B19 has been documented following administration of plasma derived coagulation factors
- May carry a risk of transmitting the causative agent of Creutzfeldt-Jacob Disease (CJD) or variant CJD
The surest way to avoid human pathogens is the use of recombinant products such as recombinant human albumin in place of the plasma derived alternative. Biologic therapies are now being manufactured animal free and plasma derived ingredients free. There are too many risks associated with either animal or plasma derived sources. Recombinant media ingredients are available and cost effective. Let us charge ahead with the ambitious, yet attainable technology of cellular therapy and regenerative medicine. However, let us proceed with safety and the most minimal risk. Let us not relive the events of the 20th century, but instead learn from them.