Bayer Infected Third-World Countries with HIV
Intro
The origin of the Human Immunodeficiency Virus (HIV) is one of the tantalizing mysteries of the AIDS epidemic. It is believed to have been transferred to humans after they ate chimp meat carrying the Simian Immunodeficiency Virus (SIV). This virus attacks the immune system of monkeys and apes in a similar way that HIV attacks humans.
Another interesting theory postulates that the transmission of SIV and the emergence of the HIV epidemic in Africa and other regions was not due to eating contaminated meat, since SIVs have been in close contact with humans for thousands of years without the emergence of epidemic HIV, but in fact the use of unsterile injections that caused a sudden emergence of the virus in the mid-20th century.
The first recorded evidence of HIV, or patient zero, comes from a plasma sample of an unknown man taken in 1959 in what is now known as the Democratic Republic of the Congo.
Given that the samples were taken from “healthy” individuals, and subsequent experiments in the 1960s, 70s and ’80s showed indications of antibodies related to HIV, it is believed that the distinct cross-species transmission might have occurred much earlier, probably in the 1920s decade.
HIV is spread primarily by unprotected anal and oral sex, contaminated blood transfusions, hypodermic needles, and from mother to child during pregnancy, delivery, or breastfeeding.
Due to a lack of public understanding and resources, HIV became stigmatized and individuals affected by the virus were ostracized and discriminated against. These combined factors led to the AIDS Epidemic of the 1980s.
Haemophilia
Haemophiliacs, individuals with a bleeding disorder, require regular infusions of clotting factors, which were derived from donated blood plasma.
Haemophiliacs lack or have insufficient levels of essential pro-coagulation proteins found in normal human blood. Consequently, when they experience a cut, the bleeding persists for an extended period of time instead of clotting promptly as it would in a healthy individual.
Haemophiliacs frequently encounter spontaneous bleeding in their joints, leading to severe disability, or even life-threatening bleeding in the brain. Severe cuts or internal bleeding can also result in significant blood loss and even death.
Prior to the discovery of anti-haemophiliac factor (AHF), haemophiliacs had to undergo hospitalization and receive blood products like fresh frozen plasma and whole blood to manage severe bleeding. AHF, a transformative breakthrough, enabled haemophiliacs to lead relatively normal lives by providing a combination of various pro-coagulation proteins sourced from blood donated by healthy individuals.
AHF, or anti-haemophiliac factor, is generated by consolidating plasma from numerous individual donations, ranging from 1,000 to 50,000, to form a single “lot.” This pooled plasma undergoes chemical processing to create freeze-dried AHF powder. The resulting powder is then packaged into convenient vials, which are reconstituted with saline solution and administered intravenously to haemophiliacs.
Background
In the early 1980s, the human immunodeficiency virus (HIV) was identified as the causative agent of acquired immunodeficiency syndrome (AIDS). This deadly virus claimed countless lives and brought devastation to the world, leaving an indelible mark on medical history.
The first year of the AIDS epidemic seemed isolated to a few individuals in a few cities, so it received little media attention. However, as cases started to emerge among infants and people with haemophilia, a sense of widespread panic permeated American society.
“In 1985, Ryan White, a teenage haemophiliac living in Indiana, contracted AIDS from a blood transfusion. Parents in his community feared he would expose their children to AIDS, resulting in Ryan being barred from attending school.” – CDC.Gov Museum.
“In 1986, U.S. Surgeon General C. Everett Koop issued the Surgeon General’s Report on AIDS. In it, he called for a comprehensive program of sex and AIDS education, urged the widespread use of condoms, and dispelled myths that HIV could be spread by mosquitoes. In 1987, CDC launched an unprecedented national campaign, America Responds to AIDS (ARTA.)” CDC.Gov Museum.
Among the many stories of anguish and loss, the role played by Bayer, a prominent pharmaceutical company, in the spread of HIV to third-world haemophiliacs in Asia and South America, stands out as a tragic chapter in medical history.
In the late 1970s and 1980s, the US Federal Government passed laws requiring companies to obtain blood for manufacturing their blood products from strictly healthy individuals.
However, unbeknownst to the medical community and patients, some of the plasma used in these products were sourced from high-risk populations and purchased at a much cheaper rate, including drug users, skid row residents and prisoners, who had a higher likelihood of carrying HIV virus. The wanted plasma had a secondary benefit in that it helped companies develop other lucrative blood-based products, such as the production of antigens to fight Hepatitis B.
There were several companies involved in the scandal: Alpha Therapeutic Corporation, Institut Mérieux (which now is part of Sanofi), Bayer Corporation and its Cutter Biological division, and Baxter International and its Hyland Pharmaceutical division.
Cutter Laboratories
Bayer is one of the largest pharmaceutical companies in the world, whose motto is “Science for a better life”. Despite the effectiveness of its PR department, Bayer has a dark history when it comes to medical science.
In 1978, Bayer acquired Cutter Laboratories, a company known for producing clotting factor concentrates used by haemophiliacs, and through this company, it became embroiled in the HIV/AIDS crisis due to its involvement in the manufacturing and distribution of blood clotting products.
Is worth noting that Cutter Laboratories had been involved in a vaccine accident in 1955 which caused “40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.”
Much like other pharmaceutical companies, Bayer had been using Third World countries as the dumping grounds for unwanted, obsolete and poor-quality drugs. In particular, infecting haemophiliacs from Asia with HIV-contaminated blood products.
In 1982, the Centre for Disease Control (CDC) made an alarming discovery. It revealed that haemophiliacs treated with AHF (heterosexuals without a history of IV drug abuse) had acquired a rare type of pneumonia called pneumocystis carinii pneumonia, which was commonly diagnosed in individuals with AIDS.
The CDC emphasized that pneumocystis carinii pneumonia had never been observed before in haemophilia patients without underlying diseases or a history of immunosuppressive therapy. Studies in chimpanzees infected with AHF also developed “AIDS-like symptoms”.
In 1983, Cutter’s competitor, Baxter Healthcare, developed a heat-treat process to deactivate virally AHF products in the frozen plasma that prevented proteins from denaturing at room temperature. Their new method was successful, which threatened Cutter’s share of the market.
The same year, Cutter began to develop its own heat-treated AHF product after successful clinical trials with chimpanzees. In fact, Cutter’s own medical experts advised that “once this product is licensed, it would be unethical to place a patient on other therapy.”
Cutter’s Marketing Plan
One of Cutter’s strategies to acquire blood with high levels of antibodies was to purchase plasma from advertisers in gay men’s magazines in which blood donations were solicited for the betterment of hepatitis research and the creation of a vaccine.
By 1984, Cutter’s inventory included both heat-treated and non-heat-treated AHF. The company began the process of reviewing its international markets to determine if excess inventories of non-heat-treated AHF could be sold. It found these willing markets in countries where it predicted, according to the 1985 Far East Region Preliminary Marketing Plan, that “AIDS will not become a major issue amongst Asian haematologists during 1985.”
Heat-treated AHF would be introduced in Asia only “if necessary to defend against the fear of AIDS” A Cutter memo of 1984 unequivocally asserted that the supply of regular AHF would need to be exhausted before the heat-treated product could be introduced in the Far East.
Cutter continued to sell the old medicine overseas, leading a US regulator to accuse the company of reneging on its promise to discontinue its sale. Records indicate that Cutter officials persisted in selling the outdated version to their Asian partners assuring them that AHF was the “same fine product we have supplied for years”, and thus, avoid being burdened with a significant surplus of an increasingly undesirable product in the US and Europe.
Furthermore, even after the introduction of the new medicine, Cutter continued manufacturing the old unheated version for several additional months. A telex exchange between Cutter and a distributor reveals another motive for this decision: the company had fixed-price contracts and believed that producing the old product would be more cost-effective.
Cutter exported its products to Hong Kong, Taiwan, Malaysia, Singapore, Indonesia, Japan, Argentina and France. More than 5 million units were sold. A typical unit might contain 250 vials.
Profit over People
It is unclear how many thousands if not millions of people worldwide were infected with HIV by greedy pharmaceutical corporations such as Cutter Laboratories, Alpha Therapeutic Corporation, Institut Mérieux and Baxter International.
The numbers could potentially be much higher and include people who died and/or never joined any class-action lawsuits due to a lack of information, resources and accessibility. Though millions have been paid to victims and families in compensation. Rough estimates suggest the following number of affected individuals:
US
Estimates range from 6,000 to 10,000 haemophiliacs infected with HIV.
Taiwan and Hong Kong
Hundreds of individuals were affected. The exact number is unknown, but Bayer has paid about $600 million to settle more than 15 years of lawsuits.
Canada
2,000 people were infected with HIV and up to 60,000 with Hepatitis C.
France
An estimated 4,000 people, many haemophiliacs, were given blood infected with HIV.
Iran
Approximately 300 Iranians were infected with the tainted blood.
Iraq
At least 115 Iraqi haemophiliacs had contracted AIDS from clotting agents imported from France and Austria.
Italy
1,300 people, including almost 150 children, had died in Italy from infected blood infusions since 1985.
Japan
Over 1,400 Japanese haemophiliacs were exposed to HIV, and more than 500 were believed to have died by 2001.
Portugal
More than 100 Portuguese haemophiliacs were infected with the AIDS virus after receiving transfusions of contaminated plasma that had been imported and distributed by the public health service.
United Kingdom
8,120 people were chronically infected with Hepatitis C for ten years or more after contaminated blood transfusions. Around 1,250 people with bleeding disorders were infected with HIV in the UK and at least 700 people infected with Hepatitis C had died.
Conclusion
The consequences of Bayer’s actions were devastating. Thousands of haemophiliacs, often living in already disadvantaged circumstances, were unknowingly exposed to HIV through the clotting factors they relied upon for survival. Many of them contracted the virus, resulting in a significant number of deaths and widespread suffering. Families were torn apart, communities were devastated, and trust in the healthcare system was shattered.
This raised ethical concerns about the prioritization of profit over patient well-being and the disparate treatment of vulnerable populations.
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