Niverapine Drug Trial in Africa

Similarly to the colonialism Africa experienced historically, where the natural resources like gold and copper (among many others) were extracted, many argue that today, big pharmaceutical companies exploit the poor of Africa through the extraction of data from drug trials. As yet another example of re-colonization in Africa, this refers to the drug companies who are conducting their trials in various parts of the continent, in order to see the new drugs approved by the American based FDA (Food and Drug Administration) so they can be granted a licence to market them to the wider Western community. Companies often run their trials in poverty- stricken countries because of the usual outsourcing motives, it is cheaper (in comparison to what Westerns get paid for participating in trials), and evidently from the following case study, it is easier to hide unfavourable evidence that might effect the drug’s approval by the FDA or the National Institutes of Health (NIH). From the film, the Constant Gardener (2005), this form of ‘neocolonialism’ can be described as one that “carelessly expends the lives of innocent citizens in the Third World in the quest for billion-dollar medicines to sell to the first world (Independent 2005).” In this particular case study, the trial drug Niverapine is considered in reference to the ‘neocolonial’ atrocities that taint the pharmaceutical industry.




Viramune (Nevirapine)
NIH Image



Niverapine is an anti-HIV drug, manufactured by the U.S. subsidiary of German- based Boehringer Ingelheim in the state of Connecticut. It has been trialed to decrease the spread of mother-to-child HIV (Burcher 2005). The U.S. funded trials of the drug in parts of Africa came under scrutiny when a ‘whistleblower’ came forward to expose a cover up in relation to evidence of Nevirapine having toxic effects upon HIV positive African women and their newborns, who were part of the trial. A published document written by South African lawyer and journalist Anthony Brink discloses the official dangers of the drug that was granted approval to be used and trialed on people in Africa -when it was had been denied approval for America. He argues that this “[implies] an indefensible double standard, one for the First World and one for the Third (Brink 2008, p xiv).”


Following this statement, Brink’s report also identifies that the FDA requires that the drug manufacturers must provide doctors who will be prescribing the drug, any warnings that are attached. The information about the dangers of Nevirapine, are exactly as follows:


“WARNING: SEVERE LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE [ALSO CALLED NEVIRAPINE]. THESE HAVE INCLUDED CASES OF STEVEN-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE. SEVERE AND LIFE-THREATENING HEPATOTOXICITY, INCLUDING FATAL HEPATIC NECROSIS, HAS OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. RESISTANT VIRUS EMERGES RAPIDLY AND UNIFORMLY WHEN VIRAMUNE IS ADMINISTERED AS MONOTHERAPY, THEREFORE, VIRAMUNE SHOULD ALWAYS BE ADMINISTERED IN COMBINATION WITH ANTIRETROVIRAL AGENTS (Brink 2008, p 6).”



Ironically, data revealing the negative outcomes of the Ugandan trials went missing and therefore, the FDA was unable to audit the American National Institutes of Health’s (NIH) trial, which was necessary for a licence to market in America (ref). This ‘information’ above, warning doctors of the negative side effects, strongly reveals the reason for the cover up. In 2004, seven years after the trials first began, government scientist and ‘whistleblower’, Dr. Jonathan Fishbein, took allegations to Congress reporting of poor government research practices and substandard patient protections within the NIH Uganda trials (Hartford Courant 2004). Eventually the chief of the NIH AIDS division, Dr. Edmund Tramont, admitted that he deleted the information that negatively effected the trials and he had, in fact, changed the conclusions (Scheff, 2004; Hartford Courant 2004).


The Ugandan trial results that were deleted contained evidence of thousands of toxic reactions, and in some cases death (ref). Sources reveal that “thirty-eight babies died… mostly in the Nevirapine group”, however the drug gained administrational approval “because the rate of viral infection measured [non-diagnostically] was 13.1 percent in newborns,” which was some degree of success (Burcher 2005).

Image from liamscheff.com

The Neveriapine tirals in Africa were not only conducted in Uganda, Brink’s report also discusses, Professor Coovadia, from Mandela Medical School, South Africa, and reports he was paid a foreign ‘award’ of R50 million to trial Nevirapine. While the professor argued to the media in South Africa that it was something to do to ‘help the poor’, really was argued to be “for the rich”, like Professor Coovadia (Brink 2008, pp xvi-xvii). The drug was approved much to the dismay of many, and put to trial, which has led to further deaths and outrage. Former South African President Thabo Mbeki at the time, accused the U.S. of using Africans as “guinea pigs” (Scheff 2004), and he has lashed out against drug companies, accusing them of putting profits ahead of patients (UN Wire 2000).


Unfortunately, this is not the first example of pharmaceutical exploitation in Africa. The high profile case surrounding Pfizer Ltd., another pharmaceutical giant, also contributes to Western corporate disgraces, when medical trials for children with meningitis were conducted without informed consent in Nigeria, also causing death from the drug Trovan’s toxicities (ADIGUN, n.d.). Therefore, after considering the discrepancies of Nevirapine’s trials in Africa, it is understood that this is another example of neo-colonialism, as it impedes upon the lives of African people, and in this case, newborn African babies, by putting their lives in jeopardy during drug trials when the same drug has been banned for use in America, all the while misleading some to believe that it is ‘charity for the poor’. Clearly, there is something very questionable about this. Perhaps it is best described again, as the expenditure of African lives “in the quest for billion-dollar medicines to sell to the first world (Independent 2005).”

Image from filmcatcher.com

Reference List

Adigun, B (n.d), ‘Nigeria files new lawsuit against Pfizer’, Loyola University of Chicago website, viewed 5 June 2009, .

Brink, A. 2008, ‘The Trouble with Nevirapine’, (Treatment Information Group) viewed 5 June 2009, .

Burcher, S 2005, ‘NIH-Sponsored AIDS Drugs Tests on Mothers and Babies’, Institute of Science in Society website, viewed 5 June 2009, .

Hartford Courant 2004 (n.a), ‘An AIDS Coverup at NIH’, Hartford Courant Editorial, Dec. 27 2004, p. A10, Retrieved June 5, 2009, (Hartford Courant database).

Scheff, L. 2004, ‘The Truth About Nevirapine’, (Guerrilla News Network), viewed 25 May, 2009, .

The Constant Gardener 2005, Motion Picture, Focus Features, United Kingdom.

The Independent 2005, ‘The true story of how multinational drug companies took liberties with African lives‘, The Independent website, 26 September 2005, viewed 18 May 2009, .

UN Wire 2000, ‘South Africa Says Drug Testing Caused Deaths,’ United Nations Wire website, viewed 5 June, 2009, .