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‘Dhammika paniya’ : Expert warns against unethical research under the guise of scientific benefit
As the controversy around the ‘Dhammika paniya’ concoction that took the country by storm recently does the rounds across the country, there were strong protests from experts about the events surrounding the issue.
The Commissioner of Ayurveda, Chatura Kumaratunga, told the Sunday Times that tests were being carried out on COVID-19 patients in a government (western) hospital on the ‘Dhammika paniya‘, a syrup, some of the ingredients of which are a secret only known to the manufacturer, Kegalla resident Dhammika Bandara.
When asked to name the hospital, the Commissioner said that he did not know himself, as he had not received any information following the submission of reports by the Department of Ayurveda to the expert committee appointed by the Health Ministry.
“By Wednesday (December 23), we submitted all the reports with regard to the paniya to this committee. The clinical trials are happening and it should be in a western medicine hospital as the investigations are under a panel of western medicine doctors. It is the responsibility of the committee from there on, with regard to other procedures,” said Mr. Kumaratunga.
Attempts by the Sunday Times to find out at which hospital the paniya was reportedly being tested failed.
Even attempts to check out whether the paniya was originally tested at the Wathupitiwela Hospital, long before the expert committee was set up, hit a
blind wall.
Giving this paniya to people is not equivalent to giving ayurvedic medicine to people, stressed the Director of the Institute for Research and Development (IRD), Prof. Athula Sumathipala, pointing out that ayurveda medicine has the weight of several thousand years of documented administration, results and modifications – this paniya has no origin or history in ayurveda medicine, to his knowledge.
“There is a process of questioning the provenance of new treatment modalities and medicines and the proponent of such a new treatment is required to provide evidence of how he/she devised that treatment to a group of peers, specifically to prevent abuse of patients,” said Prof. Sumathipala who is also Professor of Psychiatry, School of Medicine, Faculty of Medicine & Health Sciences, Keele University, Staffordshire, United Kingdom. Prof. Sumathipala has earned international recognition from WHO and UNESCO as an expert in research ethics .
He was adamant that permitting this type of untested medicines to be given to people is dangerous as it can pave the way for unethical testing/distribution of untested medicines and vaccines in Sri Lanka.
“Don’t open the floodgates to untested medicines/vaccines,” said Prof. Sumathipala.
Referring to the fact that the “issue lies in the process”, he quotes the New England Journal of Medicine which states that though the need for health and mental health research in low and middle-income countries is enormous and it is currently en vogue as it is considered a ‘popular need of the hour’, the attempt to strengthen research capacity in these countries should not result in a repetition of the historical injustice of exploitation of resource-poor settings for easy and cheap research.
Prof. Sumathipala says that it would be irrelevant whether it concerns traditional or western medicine – when the boundary is crossed, it is crossed.
Reverting to the paniya, Prof. Sumathipala speaks of what makes giving it to the people unethical:
- If it has been administered to patients at the Wathupitiwala Hospital, it has been done without following the required procedures like securing ethical approval from a recognized institution
- The scientific validity of the trial seems to be questionable, based on details reported in the media
- The study has not been carried out by experts in ayurveda – expertise in the subject matter is a basic requirement for an investigator conducting the study
- There is doubt whether due ‘informed consent’ was obtained from patients who were participants in the so-called study
- There should be a favourable risk-benefit ratio to the participants in the test project
Prof. Sumathipala reiterates that if there are any moves to test the paniya on prisoners in the future, it would be “particularly unethical”, as they are a vulnerable group who lack the power to refuse to participate if requested by figures of authority. This is a fundamental principle which resulted from the Nuremberg trials in the late 1940s where seven doctors were sentenced to death for carrying out unethical research under the disguise of scientific benefit during the Nazi regime.