By Gatonye Gathura
Local and foreign scientists want their Kenyan colleagues who with two Dutch doctors put Kenyans on unethical HIV treatment be punished.
The scientists are also angry that the Dutchmen have been let off the hook back home with only a simple warning which does not even amount to a reprimand.
In a complaint early this month (March 17) scientists from the Kenya Medical Research Institute (Kemri) and The Netherlands say the punishment does not go far enough.
The foreigners Dr Leo van Gelder and Dr Jan Scholten with Kenyans Dr James H. Ombaka and nurse Linnet Omole had in 2006 put 228 HIV patients through what Dutch authorities now say were unethical drug trials.
The group had put the HIV positive patients on a homeopathic substance called Iquilai, in a process the Dutch authorities, after investigations say contravened international regulations on human drug trials.
Returning a guilty verdict on the two Dutchmen on July 25, 2017, The Netherlands health disciplinary tribunal said the researchers did not follow the proper protocol and failed to do a proper risk assessment.
The tribunal also found that the study did not get the required ethics approval for clinical trials on human subjects while the published data was inconsistent.
For this, the tribunal only warned the two doctors on the basis that despite the established malpractices they never intended to cause any harm.
But the complaining scientists argue that good intentions do not replace ethical conduct in research.
“We strongly believe the burden to comply with ethical principles is on the researcher, whether foreign or local, all good intentions aside,” they complain in the journal The Lancet.
“The local research collaborators should also be held accountable,” demand the complainants who include Prof Elizabeth Bukusi, a senior researcher at Kemri.
The matter cropped up in 2006 when the team had put the patients on the substance Iquilai, a mineral supplement which thy claimed could treat HIV/Aids patients.
The study findings were published online in 2008 by the sponsoring NGO, Aids Remedy Fund, registered in The Netherlands.
According to the study: Iquilai: Homeopathic Therapy for HIV/Aids, the work was carried out in two locations.
One was in Yala which was coordinated by Dr Ombaka the lead investigator and also a director at the Ganjoni Medical Centre in Mombasa. Dr Ombaka is yet to respond to our enquiries on the matter. The other site in Ndhiwa, the study says was conducted by Mrs Omole.
A major conclusion of the study was that more than 90 per cent of the study patients put on Iquilai had responded positively to the treatment.
But following complaints from this newspaper (Standard) in 2011, The Independent of UK and Netherlands media over Iquilai the matter was raised in the Dutch Parliament.
The then health minister Edith Schippers had ordered the health inspection unit to investigate whether Scholten and Van Gelder had violated any medical regulations.
In 2016 the two were brought before the health tribunal but acquitted of any wrong doing. The tribunal had ruled that the Kenyan doctor involved should be considered the person with final responsibility for organising the experiments.
However the health inspection unit had appealed the ruling in a process that led to the July 2017 guilty verdict and a warning.
In their correspondence in The Lancet, Bukusi and Francis Angira of Kemri, Joyce L Browne, Rieke van der Graaf and Menno R Smit of the University Medical Center Utrecht, The Netherlands, say despite their disappointment the ruling is a milestone for research in poor countries.
“We appreciate the tribunal’s recognition that their mandate in oversight of Dutch doctors extends beyond the country’s borders.”
This acknowledgment, they say is important because it shows foreign doctors working in poor countries such as Kenya can be held accountable for their actions.