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Securing the International Blood Supply Against HIV

Securing the International Blood Supply Against HIV

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be replaced with the more cumbersome, outdated therapy using cryopre-cipitate,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 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]

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