Kenyan patients being used as guinea pigs by researchers

By PETER ORENGO

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 university researchers 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 researchers participate, either knowingly or through orders of their superiors, in administering unapproved drugs on patients,” 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.

Samples

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.

Immune

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 motivate researchers, 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.

Experts worry that research guidelines that exists are being overlooked.

“Good science should be able to protect the public from a drug’s potentially dangerous side effects.  What we are seeing in Kenya is a lot of abuse by researchers who sometimes give patients toxic drugs with serious side effects. This should not be happening,” said Dr Orege.

In an incident dubbed “Cellphone data mining breakthrough technology,” researchers at the Harvard School of Public Health and Kemri admitted they used unauthorised data to conduct a survey on how malaria spreads in Kenya without informing the participants, which is unethical going by international research protocols. 

A statement posted on the university’s website says between June 2008 and June 2009, the researchers mapped every call or text made by each of 14,816,521 Kenyan mobile phone subscribers to one of 11,920 cell towers located in 692 different settlements.

The other incident is the Asembo Bay Cohort Project where pregnant women in a 15-village study area were enrolled without their knowledge, and monitored at monthly intervals until the final month of gestation when weekly visits were conducted. It recorded an abnormally high neonatal mortality which researchers equated to high HIV prevalence.

And it does not end there. In 2001, a bitter row erupted between the owners of a Nairobi HIV and Aids orphanage and a researcher at Kenya’s Institute of Primate Research over blood samples which were allegedly collected from the minors and siphoned off to Oxford University in the UK.

A researcher who exposed the scandal said the director of the home had been bleeding HIV-positive children with the help of interns from the UK in exchange for money for the institution.

Another study published in the journal Emerging Infectious Diseases, which reportedly involved the Kenya Medical Research Institute, was later disowned by the Kemri director who said the institution was not aware of such a study.

The study had revealed the discovery of   new malaria-transmitting mosquito species in the western areas of Kenya by scientists from London and Kemri. 

Since the authors of the study included those from Kemri, we can only deduce that the Kenyan researchers in the project participated without the authority of their bosses.

In Kenya, the National Council for Science and Technology (NCST) is responsible for coordinating all research and advising the government on research-related matters. Two other national bodies involved in ethical review are the Kenya HIV and Aids Vaccine Subcommittee, and the Pharmacy and Poisons Board, both of which are affiliated with the Ministry of Health.

The country has three fundamental documents regulating human subjects research. They include the NCST-promulgated Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya, pursuant to the Science and Technology Act of 1979, which set forth a framework for determining if a research proposal is ethical.

The other one is a 2005 Ministry of Health-enacted National Guidelines for Research and Development of HIV/Aids Vaccines. These guidelines specifically address human subjects research proposals relating to the effort to identify HIV and Aids vaccines.

Kemri also has guidelines for research that is conducted through that institution. The institution, established under the 1979 Science and Technology (Amendment) Act,  is responsible for carrying out health science research.

“While researchers typically must seek final approval from NCST, certain institutions have final approval power themselves. Two institutions with committees that can grant final approval are Kemri and Kenyatta National Hospital, which are responsible for reviewing all research proposals from Ministry of Health researchers,” said Dr Kizito Lubano, a data analyst at Kemri.

For HIV/Aids vaccine research, investigators must submit a concept paper to the Kenya HIV/Aids Vaccine sub-committee, which will respond with advice. The investigators must next submit a proposal simultaneously to the Pharmacy and Poisons Board and to NCST or another designated ethical review committee. Both of these bodies must approve the research plan.

Unfortunately, these guidelines have not been reviewed since the 1970s and 1980s when they came into force, making the current level of research approvals porous.

It is estimated that some 3,000 doctors each year are paid by drug firms to sign up their patients to tests and on average 15 patients are needed for each trial, according to ProPublica’s Dollars for Docs database. With doctors picking up Sh140,000 per patient, drug companies are spending over Sh3.8 billion, on getting doctors onside. There is no suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.  Medical fraud experts from the US Food and Drug Administration estimate that one per cent of all new drug trials involve fraud, including failure to get proper consent from patients. This means milions of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.

In a recent document, Steps to Advance the Earliest Phases of Clinical Research in the Development of Innovative Medical Treatments, it was reported that  92 out of every 100 drugs that successfully pass animal trials and go into human clinical testing fail during the human clinical trial phase. The problem is that species differences are so vast that animal results are, at best, a very poor approximation of what will happen in humans or, at worst, dangerously misleading. The alternative is to advance science to the point where preclinical tests are based on human biology, which will better predict what will happen to real human volunteers or patients in the clinical trials.

In Kenya, it is the hands-off approach that is the source of concern. 

“People have the right to make their own informed decisions as to whether they want to participate in any research. They must, therefore, be informed about the background of the study, what benefits and risks are involved, how long the study will go on, and they must be able to comprehend the information given,” says former director of medical services Dr James Nyikal in a report, Kenya National Guidelines for Research and Development of HIV/Aids Vaccines.