I'm sharing this story in every arena I can find. I don't understand why this isn't all over the media. This appears on my personal blog:
The story finally has legs. They are wobbly but they won't stay wobbly for long. If I stay on the sidelines, I'm as guilty as those directly involved. As of last night, the story appeared in just one publication. It was posted on February 15th. Bob Ortega wrote the piece for AZCentral.com.
It was no where else on the internet until last night. In a 24 hour news cycle, for a story of this magnitude to take FIVE days to hit other media outlets... what's wrong with this picture?
What happened and where? There were two research studies funded out of THIS country that should be all over the news. The NCI, that would be the National Cancer Institute began their study in 1997 enrolling 151,000 women from the slums of Mumbai, India. The study was for cervical cancer which is highly curable if diagnosed early. Half of the women were screened using vinegar to see if there were white areas in the cervix. When we are called back for a colposcopy, the doctor uses a similar method to locate areas that will be sent for biopsy. In this study, women who had abnormal tissue (in the form of white areas) were treated at no cost to remove the lesions.
What did they do with the OTHER half of the women? The "control group." The women in the control group were provided with health information and were told they could seek screening on their own. First of all, these women were essentially treated like lab rats. Tell a woman who is living in the slums of a third world country she can seek screening on her own??? From whom and with what money?
I'm so outraged over this, I can barely type. In THIS country, control groups are not used as expendable subjects. Controls are provided with proper care if there is a standard of care. In 2009, from the slums of Mumbai, reports were provided to the NCI about the 151K Indian women. There was a significant difference between the two groups. Cancer and pre-cancerous lesions in the women being screened were being found earlier and treated at a much earlier stage. However, the NCI continued the study and the 76K women in the control group were still "controls" and still not being screened. The rationale? They needed to continue to determine if there was a statistical significance in death due to cervical cancer between the screened and the unscreened women.
I WANT TO SCREAM .... You MUST be kidding me? The endpoint of the study was DEATH from a disease that is treatable. I have a serious problem with the way the study was structured. How can this be acceptable to anyone with ANY shred of a sense of ethics or human decency?? At issue as I understand it, is informed consent. For starters, the "sample" of the informed consent submitted with the grant application explained that PAP screening is the usual standard of care and there are facilities in India where PAP tests are performed. That whole part about the PAP tests? Somehow it got lost in translation. Literally. Those words did not make it to the copy provided to all of the women.
At the heart of that issue? How can one provide true informed consent if they can not read? First there is a faulty consent form and then, by their own admission, the researchers state that fewer than 5% of the women in the study can read. My math sucks but that means upward of 145,000 women were in a research study that they likely did not fully understand. Thumbprints are affixed to the consent forms.
Bottom line? As of 2009, only 142 women in the control group went for screening: 50 had full blown cervical cancer and 15 were already dead. I wonder what happened to the rest of the 75K plus women who were not screened. This study was brought to the attention Office of Human Research Protection (OHRP), a committee whose responsibility includes preventing the unethical use of humans in research experiments. After much discussion, the doctors in Mumbai began testing the "controls." They notified OHRP in November that they would be screening the controls. The researcher claims the testing had nothing to do with the investigation of the OHRP and that it was already part of the study protocol. Unimportant since there should never have been a "just go about your merry business and do nothing" control arm. Period. Those are OUR tax dollars. Government funding.
And then, there is another study. Also in India. This one is being performed in poverty stricken rural areas and is funded privately by The Gates Foundation. Those are your computing dollars, your operating systems (I've already switched teams in the computing world). This study recruited just under 132K women and they were divided into four groups. One group received PAP smears, one group received the visual vinegar test, one group had DNA testing for HPV which is the virus that causes cervical cancer and group number four.... ding ding ding... the controls. They got nothing. Except that same shoddy consent thing with the literacy issues and the thumbprints. And instructions about seeking their own screening... in rural areas. Interestingly, if the numbers were reported accurately, a far higher percentage of women in the rural control group sought independent screening. Go figure.
There is a bit less information about the Gates study which is presently being investigated by the FDA. As of 2009, there were 64 deaths in the control group. In January of 2011, the researchers funded by Gates Foundation began screening the nearly 32K women in the control group. They are being tested for HPV (I'm not really sure that's the proper way to "screen" but I'm not a researcher so I'll leave that alone). After over 2 years, they say they have screened "nearly half" of the controls. They expect to have everyone tested by August. Again with the numbers. Let me understand this. It took 25 months to screen (almost) 16K women and it will now take 7 months to screen the OTHER 16K+ women??? Sorry for being a skeptic but that sounds a bit like, "We got caught and we better get our asses in gear on the screening."
The footnotes. These researchers proclaim that NO HARM was done to the women in the control groups because the average low income woman in India is receiving the same standard of care as those assigned to the control group: no routine screening. This is the way we want to help those in developing nations? Instead of bringing them much needed medical assistance, we use them as human lab rats, with the full knowledge and understanding that lives WILL be lost.
Daniel Wilker, a Harvard ethics professor believes there is a bottom line. "When you recruit research subjects, you take on a responsibility that can't be ignored, you have to do the best you can for your controls." The best certainly does not include death from something that is treatable and curable. I call that a dark day and there is blood on plenty of hands. Right now, it's the blood of 79 women who likely did not have to die. And, those are old numbers. We will find out the real numbers later this year. How many more have died over the past three plus years since those 79 deaths were reported?
The rest of the footnotes. The main researcher on the Gates study is on the NCI Review Board for the other study. How does that saying go? Sounds a bit like the fox watching the hen house especially considering the NCI gave the go ahead for the study to continue until death. And the women in the NCI study only JUST began the screening process within the past three months. No verification of any screening is mentioned. Only that the researcher told the NCI in November correspondence that screening would be (was being) done. Besides skewing statistics and numbers, now we have to parse words because some are very carefully constructing their sentences to perhaps sound better than the reality. Yeah.... I'm pretty damn disgusted by all of this in case that got lost in my tone and tenor.
And finally.... The whistleblower. A big nod to Dr. Eric Suba, the San Francisco pathologist who lodged a formal complaint in May of 2011 against both of these studies. And an even bigger nod to Bob Ortega for caring enough to do the investigative work and write what is a stellar piece of journalism.
A bit about Bob Ortega can be found here: He was just presented an award by the Sidney Hillman Foundation.
To those of you thinking Tuskegee, she's got it covered here.
The complete article on AZCentral which I HIGHLY recommend reading in its entirety if you can stomach it....
USA Today Reprinted The Story
Huff Post sends you to USA Today
I wonder why no one else has anything to say about this mess. Where are the major networks? Where is the television coverage? Where is the outrage??
Maybe I'm shooting my big mouth off without proper information and that's why it hasn't been all over the news? The whole thing is a massive mistake on the part of those who shared their information? I get it. Who cares about risking the lives of 107K impoverished women half way around the world? After all, about 77K women died of this very disease in that same country in 2010. In their own twisted minds are these researchers basking in the glow of the 175K women who they treated.
It's all about making a difference. It's about leaving the place a little better than you found it. It's not about this. Just Remember This: The women who died showed up. They stepped up for a research study. THEY wanted to leave their piece of earth better than they found it. They deserved far better and we, who know better, should hang our heads in shame.