The modern pandemic known as AIDS continues to spread at an alarming rate, with approximately 5,000 people becoming infected with HIV daily.[1] The World Health Organization estimated in 1995 that 20 million people worldwide were HIV infected, and that there were more than 4 million cases of AIDS.[1]
Among the international population of HIV-positive adults, approximately 5% have been infected through blood and blood products, which provide the most efficient mode of HIV transmission.[1]
The majority of HIV infection through blood and blood products occurred in the early to mid-1980s, reflecting a period in which international bureaucracy and national attitudes of protectionism caused unconscionable delays in the implementation of measures such as donor screening and viral inactivation that could have prevented the spread of HIV to thousands of individuals.
Infections in Hemophiliacs
The worldwide hemophiliac population, in particular, was devastated by the use of contaminated blood products. Although rates vary significantly by country, more than half of the hemophiliac populations of many countries, including the US, France, Denmark, and Japan, were infected with HIV in the 1980s.[2,3]
The US Centers for Disease Control and Prevention published its first reports of AIDS in homosexual men in June, 1981.[4] In January, 1982, the AIDS death of a hemophiliac was reported. As more cases of hemophiliacs with AIDS began to surface in 1982, the safety of the US blood supply was called into question.
Of particular concern was the use of plasma pooled from thousands of donors in the manufacture of clotting factor concentrates used by hemophiliacs. This created the means by which one infected donor could contaminate an entire supply of blood products and infect hundreds of individuals.
In the January 13, 1983, issue of The New England Journal of Medicine, associate editor Jane Desforges addressed this potential hazard, urging that therapy with clotting factor concentrates for hemophiliacs be replaced with the more cumbersome, outdated therapy using cryopre-cipitate, which is manufactured from a single donor.[5]
At the time, there was no conclusive evidence for AIDS transmission through blood, and HIV had yet to be discovered. An article in the April 2, 1983, Lancet responded to Desforges' claim that hemophiliacs were being infected through blood products, stating that "the recognition of disease in a few hemophiliacs does not necessarily reflect the tip of an iceberg . . . Whilst careful surveillance must continue, the reported cases do not constitute a strong argument for a change in treatment policy."[6]
Acknowledging the Risk
As research progressed and more AIDS cases were documented, it became apparent that there was a risk of infection from blood and blood products. By the end of 1983, most countries had officially acknowledged that risk and had begun to examine ways of increasing the safety of their blood supply.
The screening of donors was begun in most countries; however, many policies were premised on donor self-deferral based on questions about health status rather than on questions regard-ing the known high-risk factors.[7] Homosexuals were the highest risk group, but questions regarding sexual orientation were omitted from donor screening for fear of civil claims for human or civil rights violations or invasions of privacy.
There was also the notion that much of the risk of HIV blood contamination could be avoided by relying solely on voluntary donors; however, many countries, including the United States, relied heavily on paid donors, and the need to keep up with the demand for blood products precluded the adoption of an exclusively voluntary donor system.
The risk of using paid donors was propagated throughout the world by countries that imported blood products from the United States, where 80% of blood plasma donors were remunerated.[8] Countries using large quantities of American blood products reported high rates of HIV infection in hemophilia patients, a trend seen in Canada (40% of hemophiliacs infected), the United Kingdom (39%), France (50%), Germany (53%), and the US (50%).[9,10]
In contrast, countries that manufactured blood products from local donors through a voluntary system, such as Belgium (7%), Norway (8%), the Netherlands (17%), and Finland (1%), all showed much lower HIV infection rates among their hemophilic populations.[9]
The development of virally inactivated blood products played the greatest role in curbing the spread of HIV. As early as 1980, Behringwerke, a German pharmaceutical company, showed that factor VIII, a blood product for hemophiliacs, could be safely heat treated to kill the hepatitis B virus.[11] Similar heat treatment methods were later found to inactivate HIV, and the FDA began licensing heat-treated products in March, 1983.
At the time, it was not known that heat-treated products could prevent the spread of AIDS; however, it was known that many viruses were susceptible to the heating process.
In retrospect, it may seem like the most prudent move by government agencies at that time would have been to recall any non-heat-treated products and then to distribute products that had been heat treated. However, financial and political considerations delayed the distribution of heat-treated products for years in some countries.
A protectionist attitude prevailed in countries that sought to preserve their own markets for heat-treated products. France was offered heat-treated factor VIII(Drug information on factor viii) by an American company as early as May, 1983. France's National Center for Blood Transfusions was in the process of constructing a new fractionation plant, and in the interest of preserving a national market, heat-treated products were not imported from the United States, despite the fact that France's central fractionation plant did not acquire heat treatment technology until November, 1985.
In March, 1985, the French government was unequivocally informed that its blood products were contaminated with HIV, but unheated products were not withdrawn from the French market until October, 1985, when the Social Securities Office stopped reimbursing blood transfusion centers for their expenses in manufacturing non-heat-treated blood products. It is estimated that this 7-month delay in action by the government resulted in the HIV-infection of 1,500 French hemophiliacs.[7,12]
Canada is another example of a country whose decisions regarding the blood supply were influenced by a protectionist attitude. In the 1980s, the Canadian Blood Committee, responsible for directing the Canadian blood collection, processing, and distribution system, attempted to preserve its markets by developing Canadian self-sufficiency in blood products through several fractionation plants.
None of these proposed plants, however, produced any of the major categories of fractionated products, and in 1987 the fractionation industry was abandoned in Canada, despite the expenditure of millions of dollars of government subsidies.
In November, 1984, Cutter Biologic in North Carolina was licensed to heat treat Canada's blood products; however, Connaught Laboratories, still in operation producing non-heat-treated products in Toronto, continued to distribute its product in Canada until the end of March, 1985, under the terms of an existing contract. In July, 1985, a voluntary withdrawal and exchange of all non-heat-treated products was undertaken by the Canadian Red Cross Society.[13]
Perhaps the worst example of blood product mismanagement occurred in the 1980s in Japan. Heat-treated blood products were available to Japan from the United States as early as March, 1983, but they were not approved for sale in Japan until July, 1985. During that time, Japan increased imports of non-heat-treated US products, and US companies were only too happy to comply.
The price of concentrates was much higher in Japan than in the United States, and when the United States began withdrawing untreated products in 1984, companies were faced with the dilemma of cleaning out their old stocks, which conveniently could be exported to Japan.
Within Japan, the move toward heat-treated products was extremely slow. One company, Midori Juji, left non-heat-treated products on the market until 1988, two years after the company had reported to the Ministry of Health and Welfare that withdrawal had been completed.[14-16]
