GOTTA LOVE ANONYMOUS COMMENTS

You Ms. Ciccarella, are the epitome of arm-chair activism. Your allegations are completely baseless and myopic. You fail to understand the significance of this study. I guess you have no exposure to the reality of cancer in India. You live in your air conditioned home, work on your 'iMac' and drive a luxury sedan and that's why it's easy to call this research as unethical. But if you actually visit India and see the situation in front of your eyes, not over the internet, you would then understand that this study is the stepping stone to making cervical cancer screening with acetic acid mandatory not just in India but in other countries as well. I feel sorry for your childish views because you cannot grasp even a modicum of the reality in India. I would suggest instead of creating an uproar over the internet, visit Mumbai and volunteer at Tata Memorial Hospital. Then, maybe you would not feel the same.


That was addressed to me on my original blog post about the shoddy informed consent and the fact that papers were missing and the now brought to light thanks to Dr. Eric Suba.

I have plenty to say about people who hide behind the cloak of anonymity.  If what I do is "arm chair activism" then I wear that badge with pride.  I know I spoke on behalf of the REST of the women when I used my "iMac" to question the ethics of informed consent.

As far as the rest of the moronic commentary about my inability to grasp even a modicum of reality, what I do grasp is that we do not deliberately harm controls in clinical studies.  I might suggest reading the letter from the Office for Human Research Protections which determined the study funding by this government was NON-COMPLIANT with regulations in place to protect human research subjects.

My views are not childish.  The end does not always justify the means.  This is the global reach of social media.  This is a way of seeing that all are protected.  I did not create an uproar on the internet.  I merely spoke the truth.  And, for what it's worth, my luxury sedan is actually a coupe.  If you wish to see my reply, click on over to the post.  I don't want to copy it here.

Instead, I'm going to set the pettiness aside and let Dr. Eric Suba speak to the nonsense in this comment.    According to something he addressed to me on Facebook, this is where he stands.  Take note of the very last phrase:

Thanks. I've got a better sense now of how this story's being perceived apart from the ethical issues. People, perhaps yourself included, seem to be inferring from news reports that the NCI-funded research has somehow "invented" or validated the vinegar test so that the world can now start saving lives with it. Unfortunately, the whole truth is that the vinegar test has been in routine clinical use since the 1930s and that, scientifically, we've learned utterly nothing from the the India studies that we didn't already know.

In addition, I am most grateful to Dr. Suba for sharing this email which he sent to the NIH regarding the ethical questions surrounding this study.  He gets the last word in today's post.  Let the arm chair comments fly:

Edward L. Trimble MD MPH
Director
Center for Global Health
U.S. National Cancer Institute

Dear Dr. Trimble:

In response to allegations I had submitted, the U.S. Office for Human Research Protections determined that the NCI-funded study of cervical screening in Mumbai was noncompliant with U.S. Department of Health and Human Services regulations for the protection of human research subjects. Following the OHRP determination, I was invited to submit a manuscript about U.S.-funded cervical screening studies in India to a peer-reviewed Indian medical journal based in Mumbai. In light of recent media publicity surrounding the NCI-funded study, I would appreciate your responses to the four questions below, which I'll include in the publication. I have cc'd Congressional representatives who may wish to consider whether this study constitutes an appropriate use of taxpayer dollars.

1. What have we learned from the ethically controversial NCI-funded Mumbai study that we did not already know?

2. Why did the NCI require unscreened control groups and mortality endpoints for the Mumbai study, but not for cervical screening studies in any other settings?

3. Is it plausible that widely-publicized reductions of cervical cancer mortality reported from Mumbai were not caused by NCI-funded VIA screening, but by factors that had nothing to do with VIA screening?

4. Did NCI leaders advise Indian medical leaders to delay widespread implementation of cervical screening in India until after completion of the NCI-funded Mumbai study?

I've included a data table below to assist your consideration of these questions. Please note that:
-- VIA disease detection rates during Mumbai Screening Round 2 were lower than disease detection rates for no-screening during Mumbai Screening Round 2. 
-- VIA disease detection rates during all NCI-funded Mumbai screening rounds were dramatically lower than VIA disease detection rates reported by the Gates Foundation-funded study of VIA in Mumbai.
-- VIA disease detection rates during all NCI-funded Mumbai screening rounds were dramatically lower than disease detection rates reported for no-screening in Osmanabad and Dindigul.
-- A single round of VIA screening caused 25% reductions of cervical cancer incidence in Dindigul.(6)
-- Four rounds of NCI-funded VIA screening caused no reductions of cervical cancer incidence in Mumbai.(ASCO abstract) 

Thank you for your consideration.

Sincerely yours,

Eric J. Suba MD
President and Executive Director
The Viet/American Cervical Cancer Prevention Project

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