San Francisco-based pathologist, Dr Eric Suba, who pioneered the pap-smear programme in Vietnam in 1994, and has been a vocal critic of three studies conducted in India, said here on Wednesday that there were multiple flaws and flouting of ethical principles in these US-funded randomised controlled trials.
Speaking to The Hindu , Dr Suba said, of the 3,00,000 women who were recruited as volunteers, 1,40,000 were placed in “non-screening arms” and were deprived of established screening methods. Dr Suba would be speaking on this at the Eighth Krishna Raj memorial lecture at the KEM Hospital in Parel on Thursday.
Talking about one of the major screenings at the Tata Memorial Hospital (TMH), he said adequate informed consent was not taken from those in the unscreened group. At least 254 women in the “no screening” control groups had died.
The TMH study had claimed that cervical cancer — which accounts for about 70,000 deaths among women in India per year — need not be screened by pap smears or Human Papillomavirus (HPV) tests, but a simpler method – VIA – can be used in which vinegar is applied to the cervix to detect pre-cancerous lesions.
“My dialogue with Tata Memorial started when they first published the results of their study in 2010. When I saw their funding was from the US National Cancer Institute, I realised that I could lodge a formal complaint with the US government,” he said. In 2011, Dr Suba lodged a complaint with the US Office of Human Research Protection.
“They launched an investigation which confirmed my allegations. The study was unethical because the participants had not been given enough information to make an informed choice,” he said.
The results of the TMH study were supported by similar studies conducted among women from slum areas in Maharashtra (Osmanabad) and Dindigul in Tamil Nadu, but over the years, several experts have questioned the ethical principles. TMH officials told The Hindu that women in the control arm were under surveillance and Dr Suba’s allegations were unfounded.
“An overview committee had even come down and reviewed all our records and cleared it [the study]. The final clearance too came from them about six months ago ,” said Rajendra Badwe, director, TMH. Dr. Badwe said cervical cancer incidence was reducing in India – without a screening or a vaccine.
“If the incidence in U.S. is 5 per 100,000, as per the Bombay Cancer Registry, it is 8 per 100,000,” said Dr. Badwe.
Dr. Eric Suba alleges multiple flaws and flouting of ethical principles in randomised trials
