title: US-funded measurements of cervical cancer death rates in India: scientific and ethical concerns.
abstract: BACKGROUND
  Since 1998, randomised trials in India funded by the US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation have compared cervical cancer death rates among 224,929 women offered cervical screening to those among 138,624 women offered no screening whatsoever. To date, at least 254 women in unscreened control groups have died of cervical cancer. The United States Office for Human Research Protections (OHRP) determined that the subjects in the studies were not given adequate information for the purpose of providing informed consent. The determinations of the OHRP contradict assurances given by other American medical and bioethical leaders. CONCERNS: Defective scientific design required inadequate informed consent. US-funded measurements of death rates may have needlessly delayed development of indispensable, life-saving public health infrastructure. US-funded measurements of incidence and death rates proved to be scientifically irreproducible and unreliable. Predictably, nothing was learned from these measurements that was not already known. Statistical bias embedded in measurement of death rates yielded the absurd conclusion that Papanicolaou screening does not prevent cervical cancer, leading to a marketing campaign for a proprietary human papillomavirus (HPV) screening test unaffordable for the women among whom death rates had been measured. Inexplicably, measurements of death rates among unscreened women were continued even after the mortality benefit of screening had been confirmed. Quality management of NCI fundedvisual screening (VIA) in Mumbai failed catastrophically, with unsettling implications for VIA conducted by those with less expertise.
  
  
  CONCLUSIONS
  High-quality screening must be provided to all surviving unscreened women without further delay. US-based global health organisations should institutionalise a commitment to “improving health outcomes as rapidly as possible among as many people as possible.” Those who suffered avoidable harm and death, as well as their families, should be promptly and fairly compensated. As another critic of these unfortunate studies concluded, “You can’t let people die to show something you already know.”
authors.affiliation: Director, Clinical Laboratories, Kaiser Permanente Medical Center, 350 Saint Joseph Avenue, San Francisco, California 94115. eric.suba@gmail.com.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Suba
mesh_terms: D005260:Female; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007258:Informed Consent; D008403:Mass Screening / Q000191:economics* / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012109:Research Support as Topic; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000401:mortality* / Q000517:prevention & control*; D014626:Vaginal Smears