Medical experimentation in Africa

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African countries have been sites for clinical trials by large pharmaceutical companies, raising human rights concerns. [1] Incidents of unethical experimentation, clinical trials lacking properly informed consent, and forced medical procedures have been claimed and prosecuted.

Contents

Specific incidents by date

Meningitis testing in Nigeria: 1990s

The American corporation Pfizer used the drug Trovan in a clinical trial in Kano, Nigeria. The trial compared the new antibiotic (Trovan) against the best treatment available at the time (intravenous ceftriaxone). Eleven children died in the trial: five after taking Trovan and six after taking an older antibiotic used for comparison in the clinical trial. Others suffered blindness, deafness and brain damage, the cause of which is difficult to determine because these disabilities are relatively common outcomes of the disease itself. A panel of medical experts later implicated Pfizer in the incident, concluding the drug had been administered as part of an illegal clinical trial without authorization from the Nigerian government or consent from the children's parents. This led to a lawsuit from the Nigerian government over informed consent. [2] [3] Pfizer countered that it met all the necessary regulations. [2] The drug was approved for general use in the US but eventually withdrawn due to hepatotoxicity.

HIV/AIDS testing in Zimbabwe: 1990s

AZT trials conducted on HIV-positive African subjects by U.S. physicians and the University of Zimbabwe were performed without proper informed consent. [4] The United States began testing AZT treatments in Africa in 1994, through projects funded by the Centers for Disease Control (CDC), the World Health Organization (WHO) 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 subjects did not fully understand the testing methods, the effectiveness, the possible dangers, or the nature of a placebo in testing situations. [4] They were also told about the trials under duress. [4] Half of these women received a placebo that has no effect, making transmission likely. As a result, an estimated 1000 babies contracted HIV/AIDS although a proven life-saving regimen already existed. [4] The CDC ended the short course testing in 1998 after they announced they had enough information from Thailand trials. [4]

Forced sexual reassignment in South Africa: 1970s–1980s

In a project headed by Aubrey Levin during the 1970s to 1980s, the South African Defence Force forced lesbian and gay military personnel to undergo "sex-change" operations. This was part of a secret program to purge homosexuality in the army.[ citation needed ] It included psychological coercion, chemical castration, electric shock, and other unethical medical experiments. An estimated 900 forced sexual reassignment operations may have been performed between 1971 and 1989 at military hospitals.[ citation needed ] Most of the victims were males, young 16 to 24-year-old white men who were drafted into the army during the South African Border War. Women were also subject to the experimentation.[ citation needed ]

Forced contraception in Rhodesia (now Zimbabwe): 1970s

Depo-Provera was clinically tested on black Rhodesian (now Zimbabwean) women in the 1970s. [1] Once approved, the drug was used as a birth control measure. Women on white-run commercial farms were coerced into accepting Depo-Provera. [5] In 1981, the drug was banned in what was by then Zimbabwe. [5]

Sterilisation experiments in German South-West Africa (now part of Namibia): Late 1800s–1910s

Eugen Fischer conducted sterilisation experiments on Herero women in German South-West Africa (now Namibia, less Walvis Bay etc.) in the early 1900s. [1] [6] His experimentation was largely done on mixed-race offspring in order to provide justification to ban mixed-race marriages. [7] He joined the Nazi party thereafter where he did similar experiments in the Jewish concentration camps. Late stage studies were later continued by Doctor Hans Harmsen  [ de ], founder of the German branch of International Planned Parenthood Federation (IPPF) who is also associated with the compulsory sterilisation in Nazi Germany.[ citation needed ]

Effects on legitimate medicine

Unethical medical experimentation that has occurred for over a century may be the cause of the documented fear and mistrust of doctors and medicine in Africa. [8] For example, polio has been on the rise in Nigeria, Chad, and Burkina Faso because many people there avoid vaccinations because they believe that the vaccines are contaminated with HIV or sterilization agents. [8] Due to the meningitis testing incident in Kano, many Nigerians now refuse to participate in clinical trials. [2]

The role of poverty

Many African nations cannot afford to offer medicine for their citizens without subsidies from multinational pharmaceutical corporations. [4] To court these pharmaceutical corporations, some African nations minimize legal regulations on the conduct of medical research, which prevents potential legal battles from arising. [4] This forces some Africans to make a Hobson's choice: "experimental medicine or no medicine at all". [9] People living in the rural or slum area are also more vulnerable to experimentation because they are more likely to be illiterate and to misunderstand the effects of the experimentation. [10]

Codes of ethics

Several national and international bodies have devised codes of ethics for conducting experiments and clinical trials. These include the Nuremberg Code and Helsinki Declaration [4] and the Protocol to the African Charter on Human and Peoples' Rights on the Rights of Women in Africa, which seeks to prohibit all medical and scientific experiments on women without their prior informed consent. [11]

The book and movie The Constant Gardener highlighted the dynamics of conduct in clinical trials in Africa in the slum areas. This was based on the real-life meningitis incident in Kano, Nigeria. New York Times best seller book Medical Apartheid by Harriet A. Washington, provides a historical account of experimentation on African Americans, but also includes the links to African experimentation. [2]

See also

Related Research Articles

The Nuremberg Code is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.

<span class="mw-page-title-main">Informed consent</span> Need and process for obtaining subject approval prior to treatment or research

Informed consent is a principle in medical ethics, medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.

<span class="mw-page-title-main">Zidovudine</span> Antiretroviral medication

Zidovudine (ZDV), also known as azidothymidine (AZT), was the first antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use in combination with other antiretrovirals. It may be used to prevent mother-to-child spread during birth or after a needlestick injury or other potential exposure. It is sold both by itself and together as lamivudine/zidovudine and abacavir/lamivudine/zidovudine. It can be used by mouth or by slow injection into a vein.

<span class="mw-page-title-main">Human subject research</span> Systematic, scientific investigation that involves human beings as research subjects

Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.

<span class="mw-page-title-main">Trovafloxacin</span> Antibiotic

Trovafloxacin is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV. It was withdrawn from the market due to the risk of hepatotoxicity. It had better Gram-positive bacterial coverage but less Gram-negative coverage than the previous fluoroquinolones.

<span class="mw-page-title-main">Henry K. Beecher</span> American medical academic

Henry Knowles Beecher was a pioneering American anesthesiologist, medical ethicist, and investigator of the placebo effect at Harvard Medical School.

Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms.

The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone, a cephalosporin antibiotic. Pfizer gave the children a substantially reduced dose of the ceftriaxone relative to that described on the US FDA-approved prescribing information. The allegation is that this was done to skew the test in favor of its own drug. Pfizer claimed that the dose used was sufficient even though a clinical trial performed by Médecins Sans Frontières recommends a dose of 50–100 mg/kg.

An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.

<span class="mw-page-title-main">Nazi human experimentation</span> Unethical experiments on human subjects

Nazi human experimentation was a series of medical experiments on prisoners by Nazi Germany in its concentration camps mainly between 1942 and 1945. There were 15,754 documented victims, of various nationalities and age groups, although the true number is believed to be more extensive. Many survived, with a quarter of documented victims being killed. Survivors generally experienced severe permanent injuries.

<i>Medical Apartheid</i> 2007 nonfiction book by Harriet A. Washington

Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present is a 2007 book by Harriet A. Washington. It is a history of medical experimentation on African Americans. From the era of slavery to the present day, this book presents the first detailed account of black Americans' abuse as unwitting subjects of medical experimentation.

<span class="mw-page-title-main">Medroxyprogesterone acetate</span> Injectable form of birth control

Medroxyprogesterone acetate (MPA), also known as depot medroxyprogesterone acetate (DMPA) in injectable form and sold under the brand name Depo-Provera among others, is a hormonal medication of the progestin type. It is used as a method of birth control and as a part of menopausal hormone therapy. It is also used to treat endometriosis, abnormal uterine bleeding, paraphilia, and certain types of cancer. The medication is available both alone and in combination with an estrogen. It is taken by mouth, used under the tongue, or by injection into a muscle or fat.

<span class="mw-page-title-main">Claus Schilling</span> German tropical medicine specialist, war criminal

Claus Karl Schilling, also recorded as Klaus Schilling, was a German tropical medicine specialist who participated in the Nazi human experiments at the Dachau concentration camp during World War II.

Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.

The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.

Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.

<span class="mw-page-title-main">Harriet A. Washington</span> American journalist and historian

Harriet A. Washington is an American writer and medical ethicist. She is the author of the book Medical Apartheid, which won the 2007 National Book Critics Circle Award for Nonfiction. She has also written books on environmental racism and the erosion of informed consent in medicine.

Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics.

References

  1. 1 2 3 Washington, Harriet A. Medical Apartheid , Anchor Books 2006 p390
  2. 1 2 3 4 Washington, Harriet A. Medical Apartheid , Anchor Books 2006 p392-393
  3. ↑ "Africa | Nigeria sues drugs giant Pfizer". BBC News . 2007-06-05. Retrieved 2010-11-12.
  4. 1 2 3 4 5 6 7 8 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. 1 2 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
  6. ↑ "Herero and Namaqua Genocide - Herero Genocide Nama Genocide". Archived from the original on 2011-12-09. Retrieved 2011-11-28.
  7. ↑ Eugen Fischer
  8. 1 2 Washington, Harriet A. (2007-07-31). "Why Africa Fears Western Medicine". The New York Times.
  9. ↑ Washington, Harriet A. Medical Apartheid , Anchor Books 2006 p394
  10. ↑ Krosin, Michael T.; Klitzman, Robert; Levin, Bruce; Cheng, Jianfeng; Ranney, Megan L. (2006-06-01). "Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa — Clinical Trials". Clinical Trials. 3 (3). Ctj.sagepub.com: 306–313. doi:10.1191/1740774506cn150oa. PMID   16895047. S2CID   24491268 . Retrieved 2010-11-12.
  11. ↑ "allAfrica.com: Africa: Women And Scientific Experiments - Is Informed Consent Enough? (Page 1 of 3)". Archived from the original on 2008-05-31.
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