American Doctor Claims Research in India was Unethical



February 17, 2016

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An American doctor has claimed that a major study of cervical cancer in India was unethical, leading to at least 254 “pointless deaths.” American pathologist Dr Eric Suba has criticized three major long-term studies of cervical cancer, conducted in India between 1997 and 2012. In a lecture given in Mubai last February, Dr. Suba has claimed:

“In my opinion, these studies are the worst betrayals of science and ethics anywhere in the world in the 21st century.”

 

Dr. Suba may have a point. The three clinical trials in question compared an “experimental” group of low-income women screened with pelvic exams and Pap smears with a “control” group of women who had no such screening. The results were predictable: the experimental groups fared better in terms of cancer rates and survival than the controls. Dr. Suba claims, therefore, that the study was “scientifically pointless,” since it was “contemplating a question that has already been answered.”

There is an important ethical question here. The whole idea of a control and an experimental group in a statistical study depends on a principle of experimental medicine known as clinical equipoise, where we don’t really know which group will fare better. Otherwise, who would agree to take part in a randomized study? We’ve known for years that the Pap smear, invented in the 1920s, clearly detects early cervical cancer and saves lives.

The U.S Office of Human Research Protections has already found violations of informed consent in the India study, and a full investigation continues.

Suba Report Details

BMJ Discussion of Clinical Equipoise

 

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