African meds: Time for drugs tested on black people to tackle diseases

Pharmaceutical companies in Kenya import about 80 per cent of the medicine used here. Most comprise generics and originals. For a drug to be safe for human use it has to go through clinical trials, testing and approvals from various bodies. However, majority of the clinical trials are conducted in foreign countries with very few Africans.

Consider the drug trials that took part in 2019 before the corona pandemic: 48 drugs were put for trial and 46,391 patients from various ethnic groups participated. Of the number, 72 per cent were whites and 18 per cent Hispanics. Only nine per cent were of Black African American descent, the same percentage as Asians. Up to 72 per cent were women.

If a cancer drug is tested, then how is its efficacy when administered to a Kenyan woman, considering the low number of Africans in drug trials in foreign countries where the drugs are developed?

In Kenya, 40.3 women per 100,000 are affected by breast cancer, which later on accounts for a high number of deaths, positioning it as the high killer in women.

Mansoor Saleh, the chair, Department of Hematology-Oncology and the founding Director of the AKU Cancer Centre in Nairobi, says it is important to understand the different pathways of how cancer spreads in a body in order to come up with a drug that follows the path to kill cancer cells.

Toxicity one gets

Dr Mansoor explains that about 4 per cent of minorities are involved in clinical trials in the West, like in North America, and that “the drugs that the white man gets or the toxicity he or she gets may not be applicable to the African American population.”

Mansoor says there is need to study the genomic profile of the population for answers on whether the drug applies to it since “we get all these drugs from America, Europe, that we use here in Africa, but they may or may not apply to the African genetic make-up. That is why we Africans need to study these drugs on how they work on us.”

The World Health Organisation groups clinical trials into four groups. Phase 1 comprises of testing new drugs for the first time among very few people to evaluate a safe dosage range and to identify side effects.

Phase two looks at successful treatments from Phase 1 in a larger group of humans to determine any adverse effects while Phase 3 brings in people from different regions and countries at a larger capacity.

Phase 4 is usually done after a country approves the treatment which is now done in a wider population and over a longer time frame.

Maina Mwea a trained pharmacist turned herbalist says that Kenya is long overdue in utilising our own drugs instead of relying on imported products. He however has a different opinion on clinical trials.

“The problem with us Africans is that we believe so much in others than in ourselves. If someone came from the western world today with a certain drug for a certain disease, we will take it to be the gospel truth but if one of us proposed a drug we will not go for it,” says the pharmacist.

According to Dr Mwea, clinical trials do not provide a clear picture of what can work for a population.

“If an agency here in the country has a drug and they test it on 100 people or 1000 and say that the drug is okay for use it beats logic. A look at traditional medicines will tell you that they have been around and have been in communities for over millions of people meaning if they were to be classified as clinical trials that would makes sense,” Mwea argues.

“I have no issue if you want to do clinical trials, but you cannot tell me it is better than what the traditional communities have been using. We need to validate our own traditional drugs,” he further adds.

According to Atlant Clinical a contract research organisation, a country must meet certain criteria for it to be able to conduct a clinical trial.

A country needs to have willing patients, medical staff, ease of importing drugs needed in the trials, availability of resources and acceptance of the study in regards to integrity and consistency of data.

Atlant argues that well developed countries have advantages over developing nations when it comes to clinical trials. According to the research organisation, their medical staff is more motivated because they are eager to increase their credentials by participating in the trial and they have fewer conflicting obligations to hospitals, universities or other research organisations.

The cancer centre at AKU seeks to change this trend by having the first centre for clinical trials for cancer. There are rules and regulations on how these treatments are to be administered.

Mansoor says a patient diagnosed with triple-negative breast cancer and has never gone for chemotherapy can qualify. Those who have exhausted all drug therapies also qualify to take part in such studies.

“You must have had no progress from cryotherapy to say that you have a disease that is not responding to it, but if the drug is working then you don’t qualify,” says Mansoor.

Breast cancer trial drugs

He says there are certain breast cancer trial drugs that seem to work for lung cancer by blocking a certain pathway. If a discovery is made that the same drugs can treat lung cancer, then a study has to be done to ensure it is effective before approval for use.

“If you fail to do so and re-purpose a drug, the FDA or Nacosti or even NHIF might say that they will not pay for that drug since it was only tested for breast cancer and not lung cancer,” explains Mansoor.

In Kenya, the trajectory map of diseases shows that infectious diseases are going down while new diseases, as well as resistant forms, are cropping up.

Over a long period, the question of Africans being used as guinea pigs has acted as a big barrier to conducting trials. Mansoor says to find a solution we need to test how something works.

“The beauty of research is the patient does not pay. It is investigation and it is paid for by the sponsor. We do not coerce patients to take part, that is why there is a consent form. There’s nothing like guinea pigs for something to be proved to be working. One volunteers. Even the first man to go to the moon volunteered. All the other people benefit as a result,” says Mansoor.

The first patient for the vaccine is set to come in around December, while the first breast cancer patient will come in 2021 and will be promoted by Roche.

Mansoor shares that experimental therapy is not just a hobby on the side it is a calling, you have to believe in the drug and be compassionate.