Row over clinical trial as 254 Indian women die.

The three-cluster randomized controlled trials looked for a cheap screening treatment for cervical cancer for introduction into the public health programme

NEW DELHI: The death of 254 Indian women from modest backgrounds in the course of a 15-year US-funded clinical trial has triggered a raging debate about its ethicality. The trial was for a cervical cancer screening method and the women who died were part of a control group kept without screening to study death rates in unscreened populations. 

It is a well established fact that any kind of cervical screening reduces the incidence of the cancer. Yet, almost 140,000 women in the control arm of the trial were not screened. After a complaint made to it, the United States Office for Human Research Protections (OHRP) determined that the women were not given adequate information to give informed consent. 

Those arguing that the trial was unethical also say it violated the international ethical guidelines on medical research, the Helsinki Declaration's guidelines, which clearly state that "the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention". 

Even Indian Council of Medical Research (ICMR) guidelines stipulate that a placebo can be used only if the disease is self-limiting or when no proven preventive, diagnostic or therapeutic method exists. 

"Clearly these trials violated both international and national guidelines," said Sandhya Srinivasan of the Indian Journal of Medical Ethics (IJME), who in her editorial on the subject in April last year pointed out that "these studies would not have been permitted in the country of the funding organizations (US National Cancer Institute and the Bill and Melinda Gates Foundation (BMGF)." 

An article in the latest issue of the IJME by Dr Eric Suba, a San Francisco-based pathologist, who had filed a complaint in the US in May 2011 against the trial, has demanded compensation for the families of the women who died and immediate screening and treatment, where necessary, of the women in the unscreened group. 

The three-cluster randomized controlled trials looked for a cheap screening treatment for cervical cancer for introduction into the public health programme. The screening treatments being examined were Visual Inspection with Acetic Acid (VIA) screening, Pap smear — which is the standard of care in the west — and HPV screening. 

The trials were conducted among Indian women of the lowest socioeconomic status in Mumbai slums, villages in Osmanabad in Maharashtra and in Dindigul in Tamil Nadu. These studies compared the cervical cancer death rate among 224,929 women who were offered the different types of cervical screening to that among 138,624 women who were offered no screening at all. 

In the IJME article, Dr Suba asked what purpose was to be served by keeping 140,000 women without screening when the effectiveness of cervical screening is well accepted. "...people should not be used to demonstrate exactly how much death results from lack of medical care," stated Dr Suba.

 

Trial researchers claimed that having unscreened control groups is ethically justified in India because no-screening is considered "standard care". So all that the unscreened women got were health education information on cervical cancer, the importance of screening and where it was available. 

Since at the time of the trial there were no doubts about the benefits of cervical screening, the creation and maintenance of unscreened control groups in the US-funded studies in India required inadequate informed consent, pointed out Dr Suba's article, something that the OHRP also had determined. 

If, at any time during the past 15 years, the women in the unscreened control groups had been told the simple truth that cervical screening would lower their risk of death from cancer, they would have left the control groups and sought screening on their own, thereby nullifying a scientifically defective experimental design, Dr Suba argued. The OHRP determined that it was thus difficult to presume that the BMGF-funded studies are not compromised by the inadequate informed consent, wrote Dr Suba.

Bhavnagar model: Muslim buys house, can’t move in

Police outside the bungalow in Bhavnagar on Tuesday. express

In a section of Krishna Nagar, a posh area of Bhavnagar city, a signboard declares the address as “Hindu Sanatorium”. It is a predominantly Hindu area — till recently, only three of the 150-odd bungalows belonged to Muslims. A fourth bungalow was purchased by a Bohra Muslim, Ali Asghar Zaveri, in January this year, but he has not been able to move in due to protests by Hindu residents.

For the last two months, the Hindu residents have been holding “Ram Darbars” outside Zaveri’s bungalow every evening, gathering there and playing recordings of “Hanuman Chalisa” and bhajans.

VHP leader Pravin Togadia visited the area during the darbar on Saturday. Addressing the gathering, he reportedly warned Zaveri to vacate the premises within 48 hours and asked residents to forcibly occupy the bungalow. An FIR has been filed against him.

When The Indian Express visited the area on Tuesday, two policemen were standing guard outside the bungalow. Zaveri, who deals in scrap from the Alang ship breaking yard, was not around. When contacted on the phone, Zaveri said, “I am out for some personal work and shall call you back when I get free.” At his house in the Muslim-dominated Haluriya Chowk area, his mother said he was not home. His office in Bhadevani Street also remained closed throughout the day.

The bungalow next to Zaveri’s belongs to the family of Razak Lakhani. While Lakhani is dead, his family continues to live there. Both the Muslim families that owned the other two adjoining bungalows shifted out after the 2002 riots. The remaining residents are mostly Patels, Sonis and Brahmins. The Swadhyay Parivar, followers of the late Pandurang Shastri, also owns a bungalow in the area.

Zaveri bought the bungalow from Kishoresinh Gohil, a hotelier and real estate developer. According to records availble with the deputy registrar’s office, the sale of property was registerd on January 10 this year.

“Three years back, I bought the property for my sons for Rs 45 lakh. They did not like it so I put it on sale. I offered to sell it to residents of the area at a lower rate, but nobody came forward. Some months back, I issued a public notice in local dailies announcing sale of the property to Ali. Nobody raised any objection, so we finalised the deal,” said Gohil, who is also a local Congress leader and chairman of the Bhavnagar district land development bank.

“Gohil showed the bungalow to many people but got no buyers as it is believed to be unlucky,” said a resident. Neighbours said they came to know that the property, spread over 657 square metres, had been sold to Zaveri when he turned up at the bungalow about two months back.

“We asked him not to buy the bungalow for the sake of peace in the area, but he said he had already bought it and would live in it. There are many religious places in the surrounding area and we thought their food habits may offend us. So we decided to protest and hold ‘Ram Darbars’ outside the gate of his bungalow,” said a garment trader who lives in the area.

“As a matter of principle, I am not opposed to Muslims living in our area. A family has been living among us for the past four decades. But we fear their food habits can offend us, and it may lead to other Muslims buying properties here. That is why I am protesting,” said another Hindu resident on condition of anonymity.

“The residents told us they are opposed to a minority community member buying residential property in their locality. This is the reason why they have been holding ‘Ram Darbars’ outside the bungalow,” said Police Inspector Chandubha Dodiya.

Source: http://indianexpress.com/article/india/politics/bhavnagar-model-muslim-buys-house-cant-move-in/99/