Ghosts of (colonial) vaccines past: Why East Africans shun clinical trials

Wednesday May 20 2020

A researcher at the University of Pittsburgh

A researcher at the University of Pittsburgh works on a Covid-19 vaccine candidate, a fingertip-sized patch with dissolvable microscopic needles, in Pittsburgh, Pennsylvania, US on March 28, 2020.  PHOTO | UPMC | REUTERS 

VERAH OKEYO
By VERAH OKEYO
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In a count kept by the journal Nature, more than 115 vaccine trials for Covid-19 are going on in the world but none in Africa despite the region recording over 88,000 confirmed cases of the virus and more than 2,853 associated deaths.

According to the data, 46 per cent of the vaccines are in North America, 18 per cent in China, and 18 per cent in Asia, excluding China, Australia and Europe.

These are regions that have recorded many deaths, and the need for a vaccine seemed urgent.

Back home in East Africa, however, the numbers are rising. As of Tuesday, the World Health Organisation reported that Kenya had the highest number with 963 positive Covid-19 and 50 deaths, closely followed by Tanzania with 509 cases and 21 deaths. Uganda and Rwanda, with 260 and 308 cases respectively, have not registered any deaths. Burundi has recorded a death and 42 cases

The first discussions on the possibility of a vaccine tried on Kenyans attracted condemnation, a collision of colonial histories and modern medicine, and experts fear that it would deny the region of the vaccine when it is finally found.

There was an uproar when Kenyans learnt through an interview aired on BBC that the University of Oxford was recruiting 1,100 healthy volunteers for ChAdOx1 nCoV-19 vaccine trial in the UK and would move to the country when phase 1 was over.

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It did not help that in early April, two French said on TV that scientists should test a well-known BCG vaccine for Tuberculosis on Africans.

Dr John Nkengassong, director of Africa Centres for Disease Prevention and Control, took to his Twitter account to comment: “AfricaCDC strongly condemns the very unfortunate remarks made...AfricaCDC and WHO will work closely to ensure that clinical trials on Covid19 in Africa are carried out using the most ethical and scientific principles.”

However, not everyone shared these sentiments, with Dr Catherine Kyobutungi, director of the Kenya based African Population and Health Research Centre, dismissing the uproar as unwarranted.

“Clinical trials are one of the most closely monitored and regulated fields in research to protect people,” she said, adding, “It is important for the African continent to participate in the trials so that we are not left out of this scramble for the cure.”

Dr Kyobutungi said that vaccines, particularly targeting viruses, should be universal.

“These viruses constantly mutate and have different strains in different locations, and you can only know whether a vaccine is effective or not if you conduct trials on it.”

Missing out, yet again

Africa being left out of a vaccine has happened before.

The vaccine developed for Rotavirus, a disease that nearly every child develops between the age of three and five, was effective in Europe and North America but not in Africa because it was developed for strains in those regions.

The Rotavirus problem was due to genome sequencing, a scientific procedure where researchers multiply the DNA of a virus so that they are able to study the behaviour of that virus.

According to Prof Thumbi Ndung’u, a Kenyan researcher based in South Africa, genome sequencing is an expensive process that few labs in Africa can conduct.

“The freezers should be kept at a certain temperature and that means a steady supply of electricity, special computers, specialised expertise to analyse the sequences... these cost a lot of money,” he said.

“By April 18, 2019, Africa only had 90 sequences out of the more than 7,700 done globally to date,” he added.

It is no wonder, that according to the Pan African Clinical Trials Registry run by the WHO, there are only 12 vaccine and drug trials going on in Kenya, Uganda and Tanzania.

However, vaccine development using the traditional method of following the first, second and third phases is slow.

But as the scale of the pandemic becomes clearer, scientists have shaved many months off the timeline through controlled human challenge studies: They give healthy people an experimental vaccine and then deliberately infect them.

Speaking to Science, vaccine researcher Stanley Plotkin from the University of Pennsylvania said a carefully designed “human challenge could take away two or three months.”

Although controlled, to East Africans the human challenge triggers painful memories of the colonial times when vaccines and drug trials were guided by the mantra “it is injurious but at least we are doing something”

In her book Africa as a Living Laboratory: Empire, Development, and the Problem of Scientific Knowledge, Dr Hellen Tiller chronicles the repulsion that East Africa has to vaccines and horror that the continent has endured in the name of vaccine and drug trials.

The angst stems from the blame that Europe brought some of the diseases that they are trying to eliminate now to Africa.

Vaccine and drug trials were surfacing in East Africa between 1880 and 1910, a key time when the colonial governments invaded the continent and the germ theory of diseases which attributed diseases to microorganisms was also becoming widely accepted.

Medicine became part of the conquering of East Africa—or, as the Europeans saw it, one of the ways to "civilise and develop" a "backward continent."

The late Patrick Manson, the founder of the London School of Tropical Medicine, said in 1902 that the conquest was a violent pathological revolution that brought diseases like sleeping sickness into the Lake Victoria area in Kenya and Uganda.

Tsetse flies which normally fed on cows, were brought closer to mankind and further from their source of food, and so they turned to mankind.

Dr Tiller records that the Germans and the French developed drugs laced with arsenic that even killed some of the patients who were treated, but the British cordoned off affected areas, and sometimes used coercive tactics, like quarantine.

In 1951, Dr Tiller wrote, philanthropies such as the Rockefeller spent only 3 per cent of their grants on Africa.

This left Africa exposed. In 1955, a senior physician from Oxford University Honor Smith pointed out that “it is an almost unlimited field that Africa offers for clinical research”, and that Africans were passive, unproblematic and would not question whatever is done on them.

One would imagine that most of these challenges had been dealt with, but a 2016 study of clinical trials in Sub Saharan Africa by the University of Glasgow published in the journal Contemporary Clinical Trials Communications found several reasons why human studies in Africa were still far below the ones taking place in the developed world.

Among these were lack of money, inappropriate mechanisms for getting informed consent, and fear of being considered exploitative particularly with the conduct of randomised placebo-controlled studies, as well as other considerations around continued access to medicines once the trials are complete.

Ills on trials

In 2017, the Swiss NGO Public Eye published a report on the ills of clinical trials in East Africa, including an account of the Development of Antiretroviral Therapy in Africa (DART) trial which recruited 3,300 volunteers. Patients in the sexually transmitted infections arm of the trial were switched to continuous therapy and 14 died.

Ever since, the world has learnt from its follies and forced the ever secretive pharmaceutical industry to be transparent on the studies they conduct in methodology, the number of those participating, analysis and conclusions.

Organisations such as the Coalition for Epidemic Preparedness Innovations work with authorities and vaccine developers to ensure that every detail is attended to.

East Africa has also instituted its own ethical review bodies: Tanzania Medicines and Medical Devices Authority watches over clinical trials but only after getting approvals from various bodies such as the National Institute for Medical Research, in addition to eight other requirements. Similar standards are set for Uganda and Kenyan researchers.

These bodies ensure that the participants are taken care of.  For example, participants who get the intravenous injection of the vaccine in the Antibody Mediated Prevention (AMP) study taking place in Kenya, Tanzania and 13 other countries, that started in 2017 and will end this year are entitled to healthcare.

In the interruption of Covid-19, the researchers wrote to the study participants: "We remain committed to the safety and wellbeing of all study participants and study teams...we require those with a scheduled appointment to contact the site beforehand if they feel unwell."

The AMP study, like many clinical trials, benefitted the participating countries' health systems through raising research standards. The clinicians in the Mbeya Medical Research Centre (MMRC) which is based in the Mbeya Referral Hospital also learnt new diagnostics and treatment modalities.

Due to the monies needed for research, Africa has been reduced to suppliers of specimens and when the vaccine is met they are left out or they have to buy it at an outrageous price.

Despite the millions of dollars involved, studies have shown that only 10 per cent of phase 1 studies are approved, and with cash-strapped health systems, African governments focus on immediate needs such as medications.

This leaves East Africa to rely on donors for money for these studies.  Dr Fredros Okumu, the director for health at Ifakara Health Institute in Tanzania, told The EastAfrican researchers in Africa will become even more cognisant of the “colonial” biases that have been perpetuated and in some cases “normalised.”

"I hope that new normal starts to emerge regarding decision making, resource allocation and accountability and this will require that our scientists to take greater control of the agenda," said Dr Okumu.

He wants African governments and the private sector to invest in research, so they can be apportioned to their rightful segment of the international “cake” “commensurate to its contribution to the global growth” and produce the proverbial “critical mass of researchers” that the continent needs.

In the search for Covid-19 vaccine and drugs, seven researchers from East Africa have been incorporated into a global coalition of researchers called the Covid-19 Clinical Research Coalition to ensure Africans ethically participate in the studies.

Kenya is represented by Prof Yeri Kombe who is the Director-General of the Kenya Medical Research Institute (KEMRI); Philip Bejon, executive director of the KEMRI-Wellcome Trust Research Programme; Anastasia Guantai, from the University of Nairobi; and Fred Siyoi from the Pharmacy and Poisons Board.

Tanzania has Hassan Mshinda from Botnar Foundation and Dr Honorati Masanja, who is the director of Ifakara Health Institute while Uganda has Barnabas Nawangwe from Makerere University.

The other countries from Africa are Malawi, Ethiopia, Ghana, Democratic Republic of Congo, South Africa and Nigeria. Europe has the majority of members at 31 including major research funders such as the Wellcome Trust (United Kingdom), Pasteur Institute (France), Drugs for Neglected Diseases initiative (Switzerland) and others.

Dr Masanja told The EastAfrican that Covid-19 has presented a unique position of conducting research in the middle of an epidemic and it is important that East Africa ensure that there are ethical standards.

"We must protect patients at all costs," Dr Masanja said.