ABSTRACT
Dr Eric Suba has been distorting facts and persistently disseminating biased and misleading views and statements regarding our studies over the past several years. His article in the Indian Journal of Medical Ethics fails to mention the facts that seem unfavourable to his arguments, and the ethical concerns are unsubstantiated by the evidence. In this context, we present the following clarifications for the attention of your readers, notably with regard to: (i) the study design and inclusion of a control group; (ii) the informed consent of the women participating in the study; (iii) the conformity with international ethical standards and guidelines, and (iv) the provision of screening to women in the control arm of the studies. We also highlight the benefits that are flowing from this research and the risk that misinformation may further delay access for women to life-saving cervical cancer screening.
ABSTRACT
We read with interest the recent editorial in the IJME on the ethics of standard care in screening trials for cervical cancer in India. The author takes exception to the fact that three cervical cancer screening studies in India used no screening as the control arm, in spite of evidence that the Pap smear is an effective screening tool. The author argues that the Pap smear should have been the standard arm in these trials, and that it was unethical to “withhold” this screening method from participants in the control arm of the trial. At the outset, we wish to declare a conflict of interest in our response by virtue of being investigators of one of the aforesaid trials, but feel it necessary to clarify certain facts that have been overlooked
ABSTRACT
The study in Osmanabad district, India , was organised to measure the effect of a single round of screening by HPV testing, or quality assured cytology, or visual inspection with acetic acid (VIA) on cervical cancer incidence and mortality, whereas reductions in disease have followed repeated rounds of high-intensity screening in developed countries.
Subject(s)
Adolescent , Aged , Child , Female , Humans , India , Mass Screening , Mass Vaccination , Papillomavirus Vaccines , Pilot Projects , Uterine Cervical Neoplasms/prevention & controlABSTRACT
Cervical cancer is the second most common cancer in the women worldwide and the most frequent in developing countries, including India. Human papilloma virus (HPV) is the major etiological factor in cervical cancer patients. Host factors are also critical in regulating tumor growth and cytokines that modulate immunologic control may be of particular importance. In the present study, we investigated the correlation between the presence of HPV and type of cytokines expressed in cervical carcinomas and attempted to elucidate the possible reasons for the immune suppression. Cytokines investigated were type-1 cytokine IFN-gamma (shows immunostimulatory function and capable of limiting tumor growth) and type-2 cytokines IL-4, IL-10 and IL-6 (show immunosuppressive function and capable of stimulating tumor growth). Our data demonstrated the presence of HPV sub-types 16 and 18 in 86% and 13.8% of cervical tumor biopsies, respectively. The cervical tumor biopsies showed increased presence for mRNA for IL-10 and IL-1alpha, while none of the biopsies showed expression for IFN-gamma. A correlation was observed between the presence of HPV in cervical tumor biopsies and mRNA for IL-10. Increased percentages of CD4+CD25+ regulatory T cells (Tregs) were observed in circulation in cervical cancer patients, providing evidence for increased immune suppression. IL-10 may play a key role in maintenance of Tregs and explains the immunosuppressive state of cervical cancer patients.