254 Indian women die in US-funded clinical trial women who died were part control group

254 Indian women die in US-funded clinical trial

7:40 AM, 21st April 2014
US-funded clinical trial
The three-cluster randomized controlled trials looked for a cheap screening treatment for cervical cancer for introduction into the public health programme.

NEW DELHI, INDIA: A 15-year US-funded clinical trial has led to death of 254 women in India. 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. 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.

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).

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.

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 an article published in Indian Journal of Medical Ethics (IJME), by Dr Eric Suba, a San Francisco-based pathologist.

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.

 

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