Cervical cancer: US expert raises doubts over clinical trial on 2.24 lakh women

With the visual inspection with acetic acid procedure for screening sanctioned in 15 states in India, arguments over the ethical side of the clinical trial continue

| Mumbai | Published: February 5, 2016 1:10:37 am

It was a fiery one-on-one session between San Francisco-based pathologist Dr Eric Suba and a team of medical oncologists from Tata Memorial Hospital with allegations and counter-allegations over a 13-year-long clinical trial the hospital conducted on 2.24 lakh women for understanding cervical cancer-related mortality through different screening methods.

Suba, the director of clinical laboratories at the Kaiser Permanante Medical Center who heads an NGO for prevention of cervical cancer, has come to Mumbai to discuss three clinical trials on cervical cancer in India, with which he had raised ethical issues and subsequently forced the Centre and the state government to look into the trial reports. While the trial has been approved and cleared by the government, with the visual inspection with acetic acid (VIA) procedure for screening sanctioned in 15 states in India, arguments over the ethical side of the clinical trial continue till date.

The United States Office for Human Research Protections (OHRP) had also investigated into the trials in which 1.38 lakh women were offered no screening for cervical cancer while another lakh were offered cervical screening at Tata Memorial Hospital.

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According to Suba, the three trials held with participants from Mumbai in first, villages in Osmanabad in second and Dindigul in Tamil Nadu in third did not ensure an informed consent from women and followed “unethical practice” of keeping one group in controlled group with no screening. The end result was to check mortality between no screening group, group with VIA screening, group with pap smear screening and group with human papillomavirus. At Tata hospital, the trial ran from 1997 to 2015. Suba gave a presentation for an hour at KEM hospital. He levelled direct charges of not getting informed consent from women and of violating human right norms as per Helsinki Declaration’s guidelines.

Soon after his presentation, Tata Memorial Centre director Dr Rajendra Badwe explained that 22,000 women had benefited with the economical screening intervention (VIA), which cost Rs 30 per women as opposed to Rs 700-800 for pap smear, which is the adopted screening in the West.

“No ethical violations have been committed. Informed consent was taken,” Badwe said.

Badwe was supported by a team of oncologists who supported the trial’s findings. Dr S Shastri, trial’s principal investigator, said, “The women who were given no screening were monitored and could get access to hospital services any time. Their health was not ignored,” he said. A packed auditorium roared with opinions from doctors, activists and oncologists. Suba now plans to pay a visit to a village near Pune to check for himself how well the VIA screening is working for the rural population.

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