In 1981, concern was growing about an unidentified disease associated with the collapse of the immune system and increased susceptibility to infectious diseases. Surveys from the United States revealed that the unknown disease was found mostly in homosexual men and users of intravenous drugs. However, in France, surveys revealed that the disease was found in a more diverse group of patients.
The U.S. Centers for Disease Control and Prevention or CDC reported on 16 July 1982 that three patients suffering from haemophilia had acquired the disease. Epidemiologists suggested that the disease might be spreading through blood-derived products and haemophiliacs were at high risk. Furthermore, they believed that the contaminated products were obtained from individuals who were already suffering from the then unknown immune disease.
Researchers eventually determined that the mysterious disease was not isolated in the homosexual community and it was becoming common in people suffering from haemophilia. In July 1982, the disease was identified as acquired immunodeficiency syndrome or AIDS. Further research revealed AIDS was caused by the human immunodeficiency virus or HIV.
What is haemophilia and Factor VIII?
Haemophilia is a class of incurable life-threatening genetic disorders chiefly characterised by the inability of the body to control blood clotting, thus resulting in uncontrollable bleeding. For individuals suffering from this disease, a damaged blood vessel due to external wounds or trauma could be life threatening. But medical breakthroughs have considerably extended the life expectancy of haemophilic patients through appropriate treatments and healthcare management.
Pharmaceutical companies have developed and distributed a class of injectable blood product intended to manage haemophilia A—a type of haemophilia caused by deficiency in the blood clotting protein Factor VIII or anti-haemophilic factor. This product is a concentrated form of Factor VIII obtained from donor blood plasma, particularly through a process called plasmapheresis.
To obtain blood plasma, plasmapheresis would involve removing the blood from the body, separating the blood cells and plasma centrifugation or plasma filtration, and collecting and freezing the plasma for storage.
Access to Factor VIII has drastically improved the quality of life of individuals with haemophilia A while also facilitating their preparation for possible surgeries and homecare. By injecting the product, patients are provided with the missing protein needed to stop bleeding or prevent bleeds from starting. The drug has helped the individuals with haemophilia A to lead normal lives. However, Factor VIII had a troubling history.
Haemophilia blood product contamination
During the 1980s, the Cutter Biological division of German multinational chemical and pharmaceutical company Bayer developed and sold millions of Factor VIII product in the global market. Several companies had also developed and distributed the same blood product to compete with Bayer.
Several sources revealed that pharmaceutical companies had acquire blood plasma from various risky donor populations in the U.S., including homosexuals, intravenous drug users, prisoners, and former inmates. In his exploratory book, Andreas Moritz mentioned that Bayer, in an attempt to haste acquisition of blood plasma and produce more supply of Factor VIII, broke American federal laws that required the company to screen out donors from infectious diseases, including viral hepatitis. The company drew out blood from around 10,000 high-risk donors who were paid for their service during the 1980s.
However, it is also important to consider the fact that in the early years of the AIDS epidemic, there was still no screening test for HIV. Obtaining blood from a small number of HIV-positive individuals could contaminate the entire donor blood plasma pool. But after the identification of HIV and AIDS, the CDC went as far as to warn the public in March 1983 that blood products might be responsible for HIV incidents among haemophilia patients.
The CDC warning meant Bayer could lose the U.S. market. Furthermore, because the company had a large stock of Factor VIII, it would certainly suffer financial losses if the inventory remained unsold.
More problems were brewing. France had decided to temporarily halt all imports of blood-derivative products until it could figure out what to do. In addition, another pharmaceutical company had began making heated plasma concentrate that effectively eliminated possible viral and other pathological contamination.
A report by Walt Bogdanich and Eric Koli of The New York Times cited several company documents—including internal memorandums, minutes of company marketing meetings, and telex to foreign distributors—that exposed the apparent deliberate attempt of Bayer to sell HIV-contaminated Factor VIII. A revealing information from one of the documents mentioned that the manager of plasma procurement at Cutter Biological division had acknowledged in a letter that there was a strong evidence indicating the culpability of blood plasma products in spreading HIV.
Selling the HIV contaminated Factor VIII
Despite the warning and awareness, Bayer decided to conceive a marketing plan to improve the sales of its Factors VIII product. The plan included developing a heated version of Factor VIII. The Cutter Biological division of Bayer finally received a U.S. approval for selling the heated Factor VIII on 29 February 1984. However, the plan also included an attempt to sell the unheated and possibly contaminated Factor VIII inventory. A letter to distributors rolled out in June 1983 in 21 countries argued there was no substantial basis pinning down the spread of HIV through blood products. Thus, the company continued selling the unheated Factor VIII product in other countries.
The Bogdanich and Koli report mentioned that more than 100 haemophiliacs in Hong Kong and Taiwan acquired HIV after using the unheated Factor VIII products of Bayer. The company had also continued selling the old version after February 1984 in Malaysia, Singapore, Indonesia, and Argentina. There were 300,000 units sold in Argentina alone and the Far East market had ordered 400,000 more units.
To justify the sales of unheated Factor VIII product, Bayer argued some customers still wanted the old version because they deemed it more effective. Accordingly, these customers believed that heating the blood plasma concentrate could render it less effective and possibly dangerous. The company also argued that some countries such as Japan and Taiwan were slow to approve the newer version, thereby prompting the Japanese and Taiwanese customers to resort to purchasing the older version. There was also an alleged plasma shortage in 1985 that kept Bayer from producing a large inventory of heated Factor VIII product.
But documents suggested that Bayer was focusing more on profitability. The heated Factor VIII was selling briskly leaving the company with an excess inventory of unheated Factor VIII. The decline in sales performance compelled the company to sell the old version of the blood product, hoping that it could preserve the profit margin from several large fixed-price contracts.
The study of Leemon McHenry and Mellad Khoshnood revealed Bayer has remained guilty of research misconduct and violations of basic ethical principles of medical and business ethics. The investment in producing the old version of Factor III product was simply too high to destroy the entire inventory. As a result, the company misrepresented the results of its own research and continued selling the HIV-contaminated product in Asia and Latin America, thus infecting haemophiliacs with the dreaded disease.
To date, there are still no solid court case and court resolution that would implicate the culpability of Bayer. While admitting to no accountability, the report of Bogdanich and Koli mentioned that Bayer and three other companies have paid haemophilia patients around $600 million to settle more than 15 years of lawsuit. It is important to note that apart from Bayer, other pharmaceutical companies including Alpha Therapeutic Corporation, Institut Mérieux, and Baxter International have been accused of selling blood products contaminated with HIV and hepatitis virus.
Further details of the report of Moritz are in his book Vaccine Nation: Poisoning the Population, One Shot at a Time published in 2011. More details of the report of Bogdanich and Koli are in the article “2 paths of Bayer drug in 80’s: Riskier one steered overseas” published in 2003 in the New York Times. More details of the McHenry and Khoshnood study are in the article “Blood money: Bayer’s inventory of HIV-contaminated blood products and third world haemophiliacs” published in 2014 in the journal Accountability in Research: Policies and Quality Assurance.