Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy

Saturday, March 9, 2013

Ethics of 2 cancer studies questioned

India studies funded by Gates Foundation, National Cancer Institute draw scrutiny

By Bob Ortega
The Republic
Originally posted February 15, 2013

For more than 12 years, as part of two massive U.S-funded studies in India, researchers tracked a large group of women for cervical cancer but didn’t screen them, instead monitoring them as their cancers progressed. At least 79 of the women died.

One study, funded by the National Cancer Institute, did not adequately inform more than 76,000 women taking part about their alternatives for getting cervical-cancer screening; and those women did not give adequate informed consent, according to the Office of Human Research Protection, part of the U.S. Department of Health and Human Services.

The other study, funded by the Gates Foundation, is under review by the Food and Drug Administration, according to Kristina Borror, the OHRP’s director of compliance oversight. That study has raised similar concerns regarding 31,000 women who were tracked but not routinely screened or treated for cervical cancer.

Both studies continue today, though researchers for both told The Arizona Republic they have begun to offer screening to the women.

While the two studies differ in important respects, both included large numbers of women placed in “control groups” who were offered free visits with health-care workers, but who, until recently,were not screened for cervical cancer. Instead, researchers met with and tracked these women to monitor how many would develop cervical cancer and die, so their death rates could be compared with those of women who were being screened and treated for free.

The entire story is here.