Unethical US Government-Funded Cervical Screening Study in India: US Freedom of Information Act Disclosures.

Abstract

Documents obtained through the US Freedom of Information Act show that, in 1997, the US National Cancer Institute (NCI) funded an 18-year randomized controlled trial in Mumbai that used mortality endpoints to compare a discredited cervical screening test to no screening. The Mumbai trial required Indian and global health leaders to assume "no screening" would remain "standard care" throughout India for the duration of the trial, and thereby delayed the implementation of routine cervical screening among the general population of India for 18 years. During those 18 years, more than one million women died from cervical cancer in India, while Pap screening became "standard care" in other developing countries. Incorrect beliefs that Pap screening is not feasible in developing countries provide false justification for opportunity costs associated with the Mumbai trial and hinder cervical cancer prevention efforts in developing countries, where 90% of global cervical cancer deaths occur. Those incorrect beliefs also undermine World Health Organization policy guidelines, which should be corrected to acknowledge that good-quality Pap screening can be implemented in developing countries with reasonable investment. Tata Memorial Hospital and the US Office for Human Research Protections (OHRP) determined the Mumbai trial was unethical. That determination has been effectively covered up by false and misleading statements from US medical leaders. All surviving Mumbai trial participants, from both intervention and control arms, should finally receive good-quality cervical screening tests. NCI leaders should accept OHRP determinations, acknowledge the Mumbai trial was unethical, and apologize to trial participants.