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African countries have been sites for clinical trials by large pharmaceutical companies[1]. There have been reports of unethical experimentation and unethical clinical trials in Africa and improper informed consent methods.[2]. The African Charter on Human and Peoples' Rights on the Rights of Women in Africa seeks to prohibit all experiments on women without their informed consent during clinical trials[3]. Human rights activists are asking for more accountability in reference to informed patient consent in Medical experimentation in Africa.

International and National Codes of Ethics

African Charter on Human and Peoples

The provision of article 4(2)(h) of the Protocol to the African Charter on Human and Peoples' Rights on the Rights of Women in Africa seeks to prohibit all medical and scientific experiments on women without their prior informed consent[3].

Nuremberg Code and Helsinki Declaration

The Nuremberg Code and Helsinki Declaration both offer protection to subjects in clinical trials and medical experimentation[4].

National codes of Ethics

Many African nations lack any legislative protections for subjects of medical research. In most cases this is because nations cannot afford such research without subsidies from multinational pharmaceutical corporations[5]. To court these pharmaceutical corporations, African nations minimize regulation on the conduct of medical research so that many legal battles do not arise[6].

Poverty and experimentation

People living in the rural areas and slum area are more vulnerable to experimentation since they are largely illiterate and may not understand the effects of the experimentation[2]. They are also forced with making Hobson's choice: "experimental medicine or no medicine at all".[7].

Iatrophobia in Africa

Medical experimentation has been occurring in Africa for a long time in some cases it has led to iatrophobia particularly on new drug clinical trials [8]. Due to medical experimentation in the past, there is a fear and mistrust in some countries and areas in Africa of medical experimentation[8]. For example, polio has been on the rise in Nigeria, Chad and Burkina Faso because many people avoid vaccinations[8]. They believe that the vaccines are contaminated with H.I.V. or sterilization agents[8].

Several science journals, including Nature, suggested that in one case against Bulgaria where Libyan children were infected through the re-use of incompletely cleaned medical instruments, there were accusations of iatrogenic, or healer-transmitted infections. Studies showed that the infections may have been due to needles not washed properly prior to the Bulgarian nurses arrival to Libya [8]. This means that the acts may have been accidental. But given the history of Western medicine trials in Africa that are consciously done, there was heightened mistrust that it was not intentional [8]. Programs for researchers doing research in Africa are being encourage to understand the clinical trial histories to improve informed consent process.[8]

Controversial medical experimentation In Africa

The Aversion Project in South Africa (1970s-1980's)

In a project headed by Dr. Aubrey Levin South Africa’s apartheid army forced white lesbian and gay soldiers to undergo ’sex-change’ operations.It was part of a secret program to purge homosexuality in the army[9]. This was supported by psychological treatment by army psychologists. Many had to undergo to chemical castration, electric shock, and other unethical medical experiments if they could not be 'cured' with drugs. An estimated 900 forced ’sexual reassignment’ operations may have been performed between 1971 and 1989 at military hospitals[9]. Many of these experiments were conducted at the Military Hospital at Voortrekkerhoogte. Many of the victims were young, 16 to 24-year-old white males drafted into the apartheid army although a few women did have to undergo experimentation[9][10].

Dr. Aubrey Levin is now Clinical Professor in the Department of Psychiatry (Forensic Division) at the University of Calgary’s Medical School and a member at the College of Physicians and Surgeons of Alberta[9].

Project Coast in South Africa (1979-1987)

South Africa's Project Coast was conducted by Wouter Basson, a former head of South Africa’s chemical and biological weapons unit under apartheid in South Africa[8]. He was charged with killing hundreds of blacks in South Africa and Namibia via injected poisons. He was never convicted in South African courts, even though his lieutenants testified," in detail and with consistency" about the medical crimes they conducted against blacks[8].

Depo-Provera in Zimbabwe

Depo-Provera for example, was clinically tested on Zimbawean women in spite of being a known carcinogen[11]. Once approved, the drug was then used as a population control measures in the 1970's. There was coercion of women to accept Depovera on white-run commercial farms [12].Population control interests motivated many of the family planning programs. This led to its eventual ban in Zimbabwe [13].

Sterlisation experiments in Namibia

In the case for sterlisation experiments were initially conducted on Herero women in German-occupied South West Africa (Namibia) by Dr. Eugen Fischer.[14][15]. His experimentation was largely done on mixed-race offspring in order to provide justification to ban mixed-race marriages.[16] He joined the Nazi party thereafter where he did similar experiments in the Jewish concentration camps. Late stage studies were later continued by Doctor Hams Harmsen, founder of the German branch of International Planned Parenthood Federation (IPPF) whose name is also associated with the compulsory sterilisation in Nazi Germany.

Meningitis testing in Kano, Nigeria

Pfizer drug, Trovan was used in a clinical trial in Nigeria. By the time the trial ended, 200 children were disabled and 11 were dead. This led to a lawsuit from the Nigerian government over informed consent in Kano, Nigeria[17][18]. Pfizer countered that it met all the necessary regulations[17]. This has led to a mistrust in medical vaccines in Nigeria, particularly in Kano where they refuse to participate in many trials now[17].

HIV/AIDS Short-Course AZT Testing in Zimbabwe (1994-1998)

AZT trials conducted on HIV-positive African subjects by U.S. physicians and the University of Zimbabwe were not performed without proper informed consent. [19]. The United States began testing AZT treatments in Africa in 1994, through projects fundeded by Centers for Disease Control (CDC) and the National Institutes of Health (NIH). It included testing of over 17,000 women for a medication that prevents mother to child transmission of HIV/AIDS. The subject did not fully understand the testing methods, the effectiveness, possible dangers, or the nature of a placebo in testing situations[20]. They were also told about the trials under duress[21]. Half of these women received a placebo that has no effect which means transmission was likely and a result an estimated 1000 babies contracted HIV/AIDS when a proven life-saving regimen already existed[22]. The CDC ended the short course testing in 1998 after they announced they had enouh information from Thailand trials[23].

Pop culture references

The movie 'The Constant Gardener' highlighted the dynamics of conduct in clinical trials in Africa in the slum areas. This was based on a real-life case in Kano, Nigeria. New York Times best seller Harriet A Washington's book Medical Apartheid, provides a historical account of experimentation on African Americans, but also includes the links to African experimentation[17].

Legal suits

Nigeria sued Pfizer over the meningitis experiemnets conducted in Kano, Nigeria[18].

See also

References

  1. Washington,Harriet A. Medical Apathied, Anchor Books 2006 p390
  2. 2.0 2.1 "Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa — Clincal Trials". Ctj.sagepub.com. 2006-06-01. http://ctj.sagepub.com/content/3/3/306.abstract. Retrieved 2010-11-12.
  3. 3.0 3.1 http://allafrica.com/stories/200805290720.html
  4. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  5. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  6. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  7. Washington,Harriet A. Medical Apathied, Anchor Books 2006 p394
  8. 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 http://www.nytimes.com/2007/07/31/opinion/31washington.html
  9. 9.0 9.1 9.2 9.3 http://www.mindpowernews.com/UnethicalExperiments.htm
  10. http://www.mrc.ac.za/healthsystems/aversion.pdf
  11. Washington, Harriet A, Medical apartheid, Anchor books p390
  12. Kaler, Amy. 1998. A Threat to the Nation and a Threat to the Men: the Banning of Depo-Provera in Zimbabwe, 1981. Journal of Southern African Studies 24(2):p 347
  13. Kaler, Amy. 1998. A Threat to the Nation and a Threat to the Men: the Banning of Depo-Provera in Zimbabwe, 1981. Journal of Southern African Studies 24(2):p 347
  14. Washington, Harriet A, Medical apartheid, anchor books p390
  15. http://www.ezakwantu.com/Gallery%20Herero%20and%20Namaqua%20Genocide.htm
  16. http://en.wikipedia.org/wiki/Eugen_Fischer
  17. 17.0 17.1 17.2 17.3 Washington,Harriet A. Medical Apartheid, Anchor Books 2006 p392-393
  18. 18.0 18.1 "Africa | Nigeria sues drugs giant Pfizer". BBC News. 2007-06-05. http://news.bbc.co.uk/2/hi/africa/6719141.stm. Retrieved 2010-11-12.
  19. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  20. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  21. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  22. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
  23. Meier,Benjamin Mason: International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent, Berkeley journal of international law [1085-5718] Meier yr:2002 vol:20 iss:3 pg:513 -554
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