Thursday, February 21, 2013

WHY HASN'T THE SH*T HIT THE FAN ???

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
Star Gazette
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.



18 comments:

  1. Despicable, to realize "professionals" supposedly looking for a cure are probably upping someone's chance to die. Ashame how poor people who can't read are treated by a government they have trusted. I feel just as you do, AnneMarie, as I'm sure almost everyone will who reads this blog or the other media leaks putting this out there in front of us. Plain shameful.

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  2. i, too, am outraged at this atrocious neglect of regard for human life and basic ethics. i will read bob orteg's report on az/central and the other resources you've provided - after i finish feeling nauseous and quit shaking with anger and disgust and deep sadness for the victims of this hideous debacle.

    if there is any way to send a letter, make a phone call - whatever, i will certainly do so. thank you so much for letting us know about this sorry chapter and giving us a way to dig deeper into the story.

    love, XOXO

    karen, TC

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  3. This is just plain horrible. Anger and disgust doesn't even scratch the surface.

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  4. This is 19th century science for the 21st century. Old school study structure, with the double-blind placebo-dosed "control" group, which flies in the face of what's possible today, beyond just the ethical concerns. Which are massive. Amy Harmon did a series on melanoma trials (among others) in 2010-2011, the most heartbreaking of which shared the story of identical twins who were in a clinical trial for a new melanoma drug. One was in the control group, with predictable results. It ain't just happening to women in India: http://www.nytimes.com/2010/09/19/health/research/19trial.html?ref=targetcancer

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    1. Casey..... THAT makes me sick, too. Compassionate care use should not be such a hurdle. This is a heartbreaking story. There is much to discuss about "control arms" when a drug looks promising. PD991 (Pfizer) is one such drug for metastatic breast cancer. It's opening phase III trials this month. The phase II data was over the top impressive. PFS 26 months as compared to 7 months????? Stay tuned... The first person denied that medication and I'm right there. I can't sit on the sidelines for some of this stuff....

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  5. My mind is officially blown. Kudos to you for digging into this, AM, and bringing it to our attention. And what's even more infuriating is that there are so many studies conducted everywhere, including here, with very poor study design, and front-loaded bias, that still manage to get published in peer review journals. And then get hyped in the media. And you start digging and find out how the 'bad' results are hidden and the 'good' results are rubbish. Oy...

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  6. I am disgusted by our government and the researchers who performed this research. It is one thing for our government to fund something like this, they are not physically putting these people in harms way. But as a human, how can you seriously support this and physically go through the motions first hand as a researcher. What goes through your mind knowing the direct impact YOU as a researcher has on these women. Why had none of the researchers stepped in and put a stop to this?

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  7. This is so sad that "research" has gone so far as to use these helpless women. I am amazed that this even was allowed to happen. Great investigative article.

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  8. Thank you all for your comments. Rather than reply individually, I'm doing a blanket thank you for making me realize I'm not crazy and this is a disgrace.

    I am not going to let this story go until SOMEONE tells it. I've been googling every combination of words and there is no mention of this story anywhere except in AZCentral where it first appeared and the same links with one additional blog added (with somewhat inaccurate information so I'm not linking for now).

    I'm beginning to wonder if people are afraid to touch anything funded by the Gates Foundation because they have done and continue to do MUCH good in developing countries. I have to wonder if it was just the NCI if people would be resting on their heels for so long. The evidence is compelling. I don't understand WHY this isn't an outrage???

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    1. I have been wondering the same thing! I've sent it to a couple media outlets asking them to pick up the story. Perhaps if we all keep at it, the story will eventually gain some traction.

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    2. If you look closer you will find that the Gates foundation is not about doing good in developing countries. This is an organization that owns 500,000 shares of monsanto. It doesn't take long using google to find lots of stories about Gates and eugenics.

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  9. AnneMarie, great story by Bob Ortega of the Republic. FYI, the only reason USAT did not publish it the same day was because of a miscommunication about when the story was scheduled to run in Arizona. USA Today and the Republic are owned by the same company and normally work in concert when publishing big news stories. I don't know where the rest of the media is on this one.

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  10. This is so ridiculous, it really is. It's so sad when people take advantage of others who cannot defend themselves. The screwed up thing is, they will say that they were helping. They will say that at least some of the women got early detection and were treated, and that this would not happen if not for them. They will also say that in order to make the results of the study legit they had to do it this way. But when it comes to life and death, more than logic should prevail. This is so sad.

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  11. Today, On International Womens Day, I am sending this post into the twitterverse....

    There is still no coverage. WHO swept is under the rug? I'm not happy about this at all....

    Tweets being directed to CNN, Oprah and Urban Zen for starters and that's only because I'm distracted at the moment so I'm haven't compiled a full list....

    Thank you all....

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    1. I also started this petition for International Women's Day. Please sign and share!

      http://www.change.org/petitions/bill-melinda-gates-foundation-support-global-dissemination-of-proven-cervical-cancer-screening?utm_campaign=autopublish&utm_medium=facebook&utm_source=share_petition

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  12. Thank you, T, for starting the petition and I DID share it ... which is how I know your name....

    I've shared it with others, I've begun posting it and I'm going to reblog this post. I'm STILL disgusted and I don't understand where the press is.... I don't understand .... WHERE is the outrage?????

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  13. 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.

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    1. You, Anonymous, are quite a piece of work.

      The OHRP does not think my allegations are baseless or myopic. Indeed, they found the same problems with the study design as I pose here. Informed consent was not in compliance with US gov't standards. Paperwork submitted with the grant application with the "sample" forms to be provided to the controls somehow never made it to the consent packets provided to these women. THAT was a problem for the OHRP, too. IRB records where missing or incomplete. DO NOT dare tell me that I fail to understand the significance of this study. I fully understand the significance and the need for screening. That is not being called into question. The methodology is.

      No, I have not been to India. Yes, I have a comfortable life. I am also literate and the women who showed up for a clinical study, the illiterate, uneducated women who SHOWED UP, deserved better. I speak on their behalf. Funny, I have several people who are very close to me who HAVE been to the slums of Mumbai and they are equally outraged. They were not surprised either. "Women are expendable."

      My views may be childish to you, but for many, they are seen as giving voice to those who don't know better. I have the courage to stand up and state my views without hiding behind a cloak of anonymity. I am sorry you lack the courage to stand up for your beliefs by identifying yourself.

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