HISTORY: The Failed Trovan Drug Trial by Pfizer in Kano that killed and maimed Nigerians/Pfizer unethical drug testing in Nigeria in 1996/unethical clinical trials in Africa.
The article was prompted by the highly controversial plan by some French scientists/doctors to start the unethical clinical trial of the COVID-19 vaccine in Africa.
Though this suggestion has been vehemently rejected by Africans including the World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus who without mincing words rejected the idea saying:”Africa can’t and won’t be a testing ground for any vaccine.”
I want to take us down memory lane concerning a failed clinical trial on the cure for meningitis in Kano State, Northern Nigeria, carried out by pharmaceutical giant Pfizer 24 years ago in 1996 and how it killed and permanently incapacitated its victims. The name of the drug used for clinical trial was called Trovan.
This sad history of clinical is better told with facts by no other person than @ojayfemi, a Nigerian medical now based in Australia..
I was reading an article analysing the Tuskegee Alabama syphilis experiment and its interplay with “Hobson’s choice” and how poverty dictates what you get from cruel opportunist. You would think thats where the story ends until i found semblance in the Trovan Kano case.
In 1996, there was an outbreak of Meningitis in lots of states in Northern Nigeria at the time with >10,000 deaths. The most serious epidemic of meningitis till date in Nigeria.
Pfizer was looking to test a new drug (Trovan) which had not yet been used on similar cases.
During this drug development, there where concerns in guinea pigs on its noted side effect. Interestingly at same time, there was already a proven solid therapy for meningitis at the time (Ceftriaxone) and so this drug was meant to probably be a second best or perhaps new best.
So Pfizer travelled down to “help”, they gave 100 patients the new drug and 100 patients underdosage of Ceftriaxone. 5 patients in the Trovan arm died while 6 in the underdosed Ceftriaxone arm died. These aside the several hundreds with permanent neurological deficits.
Pfizer neglected to acquire informed consent from the parents of the patients, who were, anyway, too stressed to make rational decisions.
As its always the case, there was a Nigerian investigator doctor (Dr. Abdulhamid Isa Dutse) employed to be the face of this trial. No proper consent taken from patients or ethical concerns where raised and the anyhowism was in full display. A year later it was found out that the ethical letter of approval from Nigerian government was forged/falsified. The Nigerian government described the clinical trial as “an illegal trial of an unregistered drug.”
Pfizer packed its bags and left after 2 weeks of wrecking havoc with no proper completion of its trial or follow up of the patients they “treated”. interestingly while this was going on, in the same building, (doctors without borders) where treating patients better and rightly.
After the bubble burst in the US of A, there was legal wrangling for years (i’m not a laywer so i won’t dwell much) suffice it to say though that there was a settlement out of court to a tune of $75million in 2009. Pfizer made an initial deposit of $10 million to Kano state government and $175,000 to the parents of five of the children who had died during the outbreak and clinical trials after a 15 year legal battle.
Although Pfizer argued in its legal defence that the children had been killed by the disease and not their drugs, the out-of-court settlement robbed us of an opportunity to have the medical facts established before a court of law.
1. Why was Nigeria chosen as the guinea pig to test this? no other developed country had this tested on its people in same scenario. Several crazy experiments like this abound in poor countries with poor non chalant leaders.
2. What where the Nigerian health officials thinking? there was no way this would be a success without their active participation.
3. No punishment that i could see was meted out to the doctor who was the face of this, even after acknowledging a forged ethics document.
4. There is always a sellout in any group or gathering, you just need to pay the asking price partly or in full.
CAVEAT: This article does not in any way portray vaccination or clinical trials on drugs or vaccines as bad or unnecessary. It is just a lesson down the part of history on the need of ethical and legal clinical trials. Human clinical or drug trials will continually be debated and reviewed based on ethical grounds in centuries to come.
This article should never be shared as propaganda against vaccination. Vaccines remain the cheapest, easiest and safest way of preventing deadly diseases.
Edited by Dr Udomoh