Kenyan patients being used as guinea pigs by researchers
Thousands of desperate Kenyan patients are being used as guinea pigs in a thriving multibillion-drug industry with some trials contravening the country’s laws and the international drugs-trial protocols.
A Dutch NGO, Somo, has released a report, Clinical Trials in Kenya, which says some of this research is conducted by individuals, especially universityresearchers working on their theses. The experiments conducted often raise ethical issues, especially when safety protocals are ignored.
The specialists say the problem is being compounded when desperate Kenyans diagnosed with cancer or HIV volunteer for trials solely to gain access to medicine and treatment.
Those carrying out the trials include poorly-paid university researchers and doctors who willingly use new drugs on patients upon being promised money, or an agreement for further studies in elite institutions outside the country.
The major risk factor here is bio-terrorism where the country could be exposed to harmful substances or even diseases worse than Aids. Those involved include renowned Kenyan professionals, who apart from working for drug companies, authorise the smuggling of medical samples such as blood and body part organs for study outside the country. The cartel is said to include high-level government officials.
“I know that a lot of our doctors and researchersparticipate, either knowingly or through orders of their superiors, in administering unapproved drugs onpatients,” said a lead researcher who accepted to talk so long as he was not named.
“Also, Kenyans, especially those with HIV, are signing up for clinical trials because they think they may somehow end up being cured. Research is big business in this country.”
Moses Otsyula, now head of virology at Kenya’s Institute of Primate Research, raised the red flag a few years ago when he filed a lawsuit against Oxford University and eight British scientists, alleging fraud and theft of samples and research materials, which were ferried outside the country.
Otsyula was reported in a UK newspaper as saying British researchers “stole” samples of blood and computer data from Kenya’s Nyumbani orphanage where some HIV-positive children had defied expectations by surviving for many years without medication.
Lead researcher Rowland-Jones refuted the claims, saying her team had the necessary permissions for their research, and that any confusion about the status of ethical approval was accidental.
Currently, tens of trials are ongoing in Kenya, mostly by public research institutes with donor funding and a smaller number by multi-national pharmaceutical corporations with local counterparts. These are agencies and institutions working in HIV and Aids vaccine research and development, including IAVI, the NIH-sponsored HIV and Aids Vaccine Trials Network, the US Centres for Disease Control and Prevention, the Walter Reed Project, the Medical Research Council UK, Wellcome Trust, the French Agency for Research on Aids, the Harvard Aids Institute and the European Union. Due to limited transparency, a complete overview of the trials has not been established.
Research procedures in the developed world are complex, elaborate and stringent, as they should be, if it involves bringing in new drugs to help people in need. Unfortunately, this is not happening in Kenya, says Johannes Odhiambo, a lecturer at the University of Nairobi.
“Although in theory, the application and clearance process in research is clear, there is limited coordination and communication among the national regulators, individual research institutes, so relevant ministries might cause substantial variation in review procedures.”
The country continues to experience a number of controversial issues over drug development for HIV, some concerning the ethical conduct of trials and some revolving around issues of ownership of intellectual property. A number of recent incidences have been exposed, while many other cases go unnoticed.
The first major ethical issue involved the Majengo case. In this incident, the University of Nairobi and University of Manitoba in Canada researchers followed a group of prostitutes in this area of Nairobi, who remained HIV-negative despite long exposure to HIV-positive men. They were hoping to discover what has kept the women HIV-negative and use their findings to develop a HIV vaccine.
The researchers worked with the Majengo prostitutes for more than 15 years, but later, some of these women, thought to be immune to HIV became infected. It was later reported that a specific cell mechanism in their bodies had kept these women free from infection.
The biggest complaint that came out of the Majengo case study and published in Canadian newspapers was that the prostitutes used in the study were exploited by researchers and had little to show for their contribution to science.
So while science is used as the bait, it is the desire to proft from these experiments that motivateresearchers, experts say.
“It’s true, drug companies and donors in the past used some researchers to do their dirty work due to our lop-sided process. Today, every institution has a regulatory guideline. But others may still want to participate in an illegality for money,” said Odhiambo. “They also don’t have any ownership of material.”
In another recent example, a lead researcher warned Kenyans against being duped by experts who claimed he had found a cure for Aids after two patients allegedly turned negative when the doctor administered methotrexate — an anti-cancer treatment drug — and a cocktail of other drugs.
Dr Patrick Orege of the Kenya Medical Research Institute (Kemri) in Kisumu and also a former director of the National Aids Control Council says methotrexate has known serious side effects on those who use it. Furthermore, it is not clear how many patients had used the drug before the two claimed they were cured of HIV. There is no evidence to suggest that it was put through scientific clinical trials and the findings published in peer-reviewed medical journals.
By PETER ORENGO