A 61-year-old woman sits pensively in a treatment room at a clinical research unit. She is part of cancer patients being treated with experimental drugs, a first in Kenya.
It is at the Clinical Research Unit at the Aga Khan University Hospital in Nairobi, where volunteer patients are testing potential cancer treatments.
There are about six beds in the room, a pharmacy where the trial drugs are kept, a laboratory where tests are done or prepared for dispatch to labs abroad, exam rooms, and the doctor’s offices.
Lucy Ben, not her real name, who was diagnosed with breast cancer four years ago has been on experimental drugs for one month now.
She says her cancer diagnosis started with a sharp pain in her right armpit.
“I wouldn’t have thought much of it until I went to the hospital the next morning and a test showed I had a cyst. It was deep in the breast so I couldn’t feel it. The doctor ordered a biopsy which showed that I had early-stage cancer, a type called invasive ductal carcinoma. I was told the cancer was about nine to 12 months old,” she says.
She did the surgery, not total removal of the breast, but a small incision to get rid of the cyst.
“I was lucky the disease had not spread. After the surgery, I did 20 radiotherapy sessions,” she says.
A month ago, she was approached to do a clinical trial for an oral pill by Roche, a Swiss pharmaceutical group.
Every day at 3:16 pm, she takes one tablet. If the experimental cancer drug proves successful in a substantial number of patients on trial around the world, then it will find its way into the market.
The launch of cancer clinical trials in Kenya is a big deal.
For the first time, big drug makers have involved Kenyans in finding out if new treatments are effective and precise in curing cancer.
For years, new drugs have been tested on white people, meaning that Kenyan patients who have different genes have a lesser fighting chance because the drug may not work as well as it would on their white counterparts.
“Drugs approved by FDA [Food and Drug Administration] were coming our way but we didn’t know how safe, efficient and tolerable they are on Kenyans, because we were not represented in the clinical trials. This is the first time clinical trials are happening in the history of cancer in Kenya,” says Prof Mansoor Saleh, the chair of the Department of Hematology-Oncology and the director of the Clinical Research Unit at Aga Khan University Hospital.
In some cancer patients, the locally-available drugs have failed to completely clear the disease. Oncologists are also seeing fast-growing and chemo-resistant cancers, among a younger population, which is uncommon in countries like the US. Doctors have realised that cancer drugs work differently in people of various ages, races, ethnicity, and gender.
Nothing to lose
Although the clinical trials are considered game-changing, not many Kenyans are aware of them and whether they are eligible to take part. Also, cancer doctors—especially those working in hospitals without research departments—fail to tell their patients about drug trials or have no idea that the options exist in Kenya.
There is also fear. Ms Ben, who also has type 2 diabetes, says part of her fear was that the drug would have adverse side effects. But she has experienced mild side effects, just a burning sensation in the feet which disappeared.
“I realised I have nothing to lose. It is a supremely hopeful moment for me. What if the drug works? It will also benefit future people with breast cancer,” she says.
The cost of the drugs and tests, which would cost millions of shillings if a patient pays out of pocket, is covered. Transport is also reimbursed.
“The pharma pays, and in return, the patient’s information is added to that of others across the world. If the patient was to pay out of pocket, it would cost about $100,000 (Sh11.9 million) a year,” Prof Mansoor says.
In Kenya, currently, there are ongoing clinical trials for breast, lung, and oesophagus cancers.
“We're also looking at prostate cancer trials,” Prof Mansoor says.
Research shows of the 2.7 million clinical trials conducted globally, less than one percent is done in Africa, yet the continent bears the greatest burden of non-communicable diseases like cancer.
Only 736 clinical trials were done in Africa, and only 26 were cancer-related. Only six trials were done in predominately black patients, with the drugs tested on South Africans and Egyptians.
Game-changer
The number of new cancer cases and deaths in Africa is rising faster than in developed countries, which have managed to tame the tide with new-cutting-age therapies, thanks to clinical trials.
In Kenya, cancer is the third leading cause of death. In three years, the World Health Organisation data projects new annual cases will jump to 82,620 from 42,116. For pharmas, this signals a growing market.
Prof Mansoor says clinical trials offer hope. So far, they are working on 17 clinical trials. Some are complete, others are ongoing. He cites yet another game-changer set to start next month.
“If a patient has a specific gene mutation, which causes cancer, we will have a pill that blocks that mutation. That is something new that has never been done on an African patient,’’ he says, adding “In the US, for instance, clinical trials have allowed patients to access new, better drugs that Africans have no access to.”
Not everyone with cancer is a good candidate for a clinical trial.
“When I came here, I realised I was alone. I asked the doctor why the over 40 patients that I used to meet at the radiotherapy clinic were not part of the clinical trial. He told me most of them had failed the screening tests. I went through a myriad of screening to see if I meet the trial’s criteria; scans, blood, chest, kidney tests…,” says Ms Ben.
Trials challenges
However, as more pharmas find a new market in Kenya, the clinical trial field still has challenges. Kenya lacks adequate physicians and nurses keen on research to man the clinical trial units. Aga Khan and the International Cancer Institute in Eldoret are among the few doing cancer drug trials.
There are also few labs to do the tests, tissues and blood samples have to be sent out of the country. Then there is the long process involved in approving clinical trials by the Ministry of Health's Pharmacy and Poisons Board.
The board says since 2008, a total of 378 clinical trial applications have been received and reviewed, with 326 getting approval.
"Out of the applications received over the period, 20 are for cancer-related studies," says Dr Fred Siyoi, the PPB chief executive.
Part of the challenge that cancer researchers and pharmas say they face is the long processes involved in approving clinical trials in Kenya. Application costs $1,000 (Sh121,260) and it takes about 100 days.
"Clinical trials have multi-sector involvement, including the Pharmacy and Poisons Board, Institutional Ethics committees, and the National Commission for Science Technology and Innovation (Nacosti)," said Dr Siyoi.
