PRAISE FOR QUESTIONABLE RESEARCH @ASCO #ASCO13

ASCO, the American Society of Clinical Oncology, is winding down their annual meeting.  I caught a tweet from a doctor about the findings of a cervical cancer study in India.  Have you been around since February?  If not, I would strongly suggest reading this post I wrote because I was so outraged at the design of the study.

The LEAD doctor got to share his findings at the ASCO meeting.  Thumbprints as acceptable informed consent?  Information included in the application completely omitted from the paperwork once the grant was approved for funding by the US government?  The study was (is?) under the investigation of the Office of Human Research Protection--a committee that is tasked with making sure there is no unethical use of humans in research.......  

What went on in India was unethical.  The endpoint of a study was DEATH.  Cervical cancer is highly curable and women in India were used as lab rats.  One of the first discussions at the ASCO 13 meeting was about the need to fill clinical trials.  I agree.  Clinical trials save lives.  Unless they are poorly designed and despite the poor design, they are allowed to proceed until a whistle blower finds out and questions the whole thing.

Forbes has an article on their website:  How Vinegar Could Save 73,000 Women A Year From Cancer.  Yes.  It's true.  But the problem?  Women did not have to DIE in the control arm of this study in order to make this determination.  Before everyone applauds this doctor for his innovative idea, I think we all need to question how this was allowed to proceed as designed.  When justification for the study is defended by words like, "They have no screening anyway, so there is no standard of care (for cervical cancer screening in India)" or "Death is often the endpoint of randomized studies (but when we have curative treatments, should that be allowed)," I am troubled.  THEY may not have known better.  Quite simply, WE DO and that's a big part of why I am so troubled.

I'm as disgusted today as I was in February when I first learned about the study.  I wonder if anyone at the meeting got up to ask the doctor about the investigation and the ethics of true informed consent and setting up a control group of women who were treated as expendable objects rather than human beings.  I'm pretty sure we take more precautions with the mice used in experiments in this country than the measures used to protect the women in India.

Here's the link to the overview of the findings which appear as follows:

Background: Cervical cancer is the most common cancer among women in developing countries and is the leading cause of cancer death in Indian women. Since cytology-based screening is not easily implementable in India, there is a need to evolve simpler alternatives. Methods: We initiated a cluster-randomized controlled trial in 1998 to investigate the efficacy of VIA screening by primary health workers (PHWs) in reducing cervical cancer mortality. Women aged 35-64 years with no prior history of cancer were included. The study was designed to include 20 clusters with an average of 7,500 eligible women per cluster. Four rounds of cancer education and VIA screening were conducted by PHWs at 24-month intervals in the screening group, while cancer education was offered once at recruitment to the control group. Recruitment was completed in March 31, 2002. Although the study was planned for 16 years, we analysed the results on the advice of the DSMC at 12 years. Results: We recruited 75,360 women from 10 clusters in the screening group and 76,178 women from 10 comparable clusters in the control group. The analysis is on an intention-to-treat basis. In the screening group, we achieved 89% participation for screening and 79% compliance for post-screening diagnostic confirmation. The quality of screening by PHWs was comparable to that of an expert gynecologist (κ=0.84). The incidence of invasive cervical cancer was 26.74 per 100,000 (95%CI: 23.41-30.74) in the screening group and 27.49 per 100,000 (95%CI: 23.66-32.09) in the control group. Compliance to treatment for invasive cancer was 86.34% in screening group and 72.29% in the control group. The screening group showed a 31% reduction in cervical cancer mortality (mortality rate ratio RR=0.69; 95%CI: 0.54-0.88; p=0.003) compared to the control group. A 7% reduction was also observed in all-cause mortality (mortality rate ratio RR=0.93; 95%CI: 0.79–1.10; p=0.41). Conclusions: VIA screening conducted by PHWs significantly reduced cervical cancer mortality. VIA screening is easily implementable and could prevent 22,000 cervical cancer deaths in India and 72,600 deaths in resource poor countries annually. Clinical trial information: NCT00632047.

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