A second hurdle has appeared in the path to treatment of hemophilia. After the introduction of commercially available Antihemophilia Factor for treating hemophilia with Factor VIII and Factor IX in the early 1970s, life completely changed for those boys and men who suffered pain and agony, becoming disabled ending with a short life expectancy prior to the new AHF concentrates. For 10 years life for persons with hemophilia was sailing along almost equal in quality to a person without hemophilia.
The first hurdle that interrupted the treatment was the contamination of the new medicine with HIV and hepatitis viruses. Many persons died of AIDS or liver failure as the result of the viruses in the medicine. By 2008, in person with hemophilia, 13,083 developed AIDS. Those days are past as the result of the entrepreneurship of the pharmaceutical manufacturers who have produced safe medicines utilizing advanced methods including genetic engineering resulting in a recombinant AHF. Plasma derived AHF has been deviralized and made safe.
The second hurdle in the path of treatment for hemophilia is cost. The comprehensive study of Factor VIII use around the world by Stonebraker and colleagues ( 2010) revealed that medicine to treat hemophilia is used primarily in countries with high incomes. One-half or more of the hemophilia persons in the world receive inadequate or no treatment. Most low income countries have other conditions that receive a higher priority such as infectious disease, malaria, violence, natural disasters and inadequate economic development.
The population of the United States, 310 million compared to the world population, 7 billion, is only 4.7%. The annual world production of Factor VIII totals 6.9 billion units (2008). However 12,000 persons in the USA use 2.06 billion units amounting to 30% of the world production. The infusion of Factor VIII per person in the USA averages 171,670 units annually. When recombinant Factor VIII is used at $.90 -$.95 per unit the cost per person annually equals or exceeds $150,000.
Selling Factor VIII in the USA is possible despite the high costs because there is a way to pay for it. In countries of low income, no method of payment exists. Should there be a needed medicine that is available but not affordable? The United States is a country of high consumerism. But it is also a country of high pollution. As a result of the contribution to global warming and pollution of the ocean with plastic debris by the USA, an economic effect has been felt in poor countries as their fishing has declined. Citizens have been deprived of an income and cannot pay taxes. There is no way to buy expensive medicines.
A solution might include transferring the modern technological methods of Factor VIII production to countries of low incomes while retaining domestic production of the medicine for use in the U.S.A. The U.S.A. has an obligation to assist in the world economics. There are cars in the world and they cannot all be made in America. Similarly, the world’s production of Factor VIII cannot all be made in America. The production of Factor VIII by U.S. pharmaceutical manufacturers of medicine to treat hemophilia would not be threatened by assisting low income countries to produce their own medicine, for presently there are almost no sales of medicine to the countries of low income. The establishment of facilities to produce the medicine in other counties must be completed by the pharmaceutical industry, not the federal government.
Just as Nike makes shoes in Malaysia, Wyeth, Pfizer etc could make Factor VIII in Pakistan or Somalia. The drug companies would monitor and supervise and assist in production. Rather than selling poor countries AHF medicine, let’s show them how to make their own. Such an action would create employment, relieve suffering and contribute to a better world.
-Everett Winslow Lovrien, M.D.