Concerns over alleged cancer-fighting product developed by Colombo Uni
The Consumer Affairs Authority (CAA) is scheduled to call a meeting in the first week of April of all those involved over an issue concerning ‘Vernolac’, a product which claims to “help control & eliminate cancer stem cells”.
A CAA official said that the decision to hold the meeting was taken when the CAA was copied on a letter dated February 5, 2024, sent to the Vice Chancellor (VC) of the University of Colombo about this product, by several professional medical associations. The CAA discussed the matter when its Expert Committee met end-February.
The letter to the VC which also mentions several other products has been sent by the Sri Lanka Medical Association (SLMA), the Ceylon College of Physicians (CCP), the Sri Lanka Association of Clinical Pharmacology and Therapeutics (SLACPT) and the Sri Lanka College of Internal Medicine.
Expressing concern and requesting scientific evidence to support the therapeutic claims of anti-cancer properties with regard to ‘Vernolac’, the letter points out that the promotional material carries the University of Colombo name and logo.
“Any product that is reported or marketed with such clinical therapeutic claims should be backed by robust clinical trial evidence of efficacy and safety with appropriate registrations and approvals in order to protect the well-being and interests of the consumers,” the letter states.
The Sunday Times checked out ‘Vernolac’ with the Ayurvedic Registration No. AyuTech/02/01/ PB/22/1412 being marketed by FADNA Life Science.
The company’s website states that it is sold at the discounted price of Rs. 8,250 (earlier it had been Rs. 8,400) and describes it as a “nontoxic herbal formulation developed as a therapeutic relief for cancer, enriched with immense potentials
required to open up new avenues for a healthy life”. The ingredients are given as: “ernonia zeylanica, Nigella sativa, Leucas zeylanica, Hemidesmus indica, Gynura pseudochina.” (sic)
“Well researched and developed by the Institute of Biochemistry, Molecular Biology and Biotechnology (IBMBB) of the University of Colombo, this trailblazing nutraceutical capsule contains anti-cancer properties that help controlling and eliminating cancer stem cells,” the website states.
It further states that the herbs used “provide anti-proliferative, pro-apoptolic, autophagic and antioxidant properties to arrest abnormal growth of cells”. The dosage is given as 2 capsules twice a day
before meals, half an hour before breakfast and dinner.
When the Sunday Times contacted IBMBB’s Director Prof. B.P. Galhena on email (also copying the Vice Chancellor of the University of Colombo), he firstly stated that his institution is a “leading” postgraduate institute primarily committed to research and development focusing on commercialization.
“Such product development and commercialization are carried out as per the given protocols by the University of Colombo by assigning the responsibilities to the PI (Principal Investigator) for a given project,” he said, requesting that PI Prof. Sameera Samarakoon be contacted.
However, in a follow-up email when the Sunday Times asked whether there was no
oversight over whether those given protocols were adhered to, there was no answer from Prof. Galhena.
When contacted, Prof. Samarakoon said it was a “nutraceutical” based on a traditional herbal formulation. A literature review including in traditional texts on this formulation had been carried out by the late Prof. Ira Thabrew. Both Prof. Thabrew and he also studied other research done worldwide and practices of traditional and ayurvedic practitioners.
When Prof. Samarakoon referred to “evidence-based medicine” in this product development, the Sunday Times sought a specific answer whether it was evidencebased western medicine or any other. He replied that it was not western medicine but “traditional and ayurveda medicine”.
When requested to give a step-by-step account of the research processes that were followed, as the ‘Vernolac’ blurbs claim “extensive research”, he said that for about 14 years he had conducted laboratory testing on different cancer cells. Later animal testing – with rats taken from the Medical Research Institute (MRI) – with regard to toxicity studies were carried out according to WHO (World Health Organization) guidelines.
“These animals were healthy animals,” he said, when asked by the Sunday Times. To the query whether the animal testing data were published, he answered in the negative.
When asked about Clinical Trials with human participation before the marketing of ‘Vernolac’, Prof. Samarakoon said that when they received registration from the Department of Ayurveda, they could market the products. They were given a period of three years to conduct human testing.
“We are in the process of doing so now,” he said, while the Sunday Times also found that the sales of the product had begun in July 2023.
Prof. Samarakoon added that they had submitted their proposal to conduct Clinical Trials to the Ethics Review Committee (ERC) of the Faculty of Indigenous Medicine, University of Colombo, in February 2024 (this year) and it was being processed.