Shades of Tuskegee in Indian cancer studies

How do we know whether screening for something like cervical cancer is effective at saving women's lives? Two ongoing studies conducted in India (one funded by the National Cancer Institute and the other by The Gates Foundation) are aimed at answering that question — but their methods are under fire by critics.

It works like this. Say you want to test the effectiveness of a new screening method. You recruit a large group of women and you split them into two groups. One group gets the screening regularly. The other, the control group, doesn't get the screening. Then you follow them over time and track how many women in both groups died of cancer. That's a pretty basic scientific method. It's also something that prompts big questions about the treatment of women in the control group.

The people conducting the study say women in the control group were told they could seek out screening on their own. Critics argue that point (and the way the study worked) wasn't clearly explained, and that those alterante options weren't as available to the women as researchers imply. The majority of the women participating in the studies are poor and have very little formal education.

There are some important differences between this and the infamous Tuskegee syphilis experiment. In that case, researchers identified men with syphilis and neither told them about their disease nor offered them treatment — just monitored the deadly disease's progress. Here, there's clearly an attempt (however poorly executed) at being open with the women about what the study is and what is being done. And nobody is intentionally trying to prevent sick women from being treated. But the study definitely exists in an uncomfortable space and could reasonably be called unethical. Is it ever okay to not screen people for a disease that are pretty sure some of them have? If not, how do we figure out whether potentially life-saving screening methods are actually useful? How do you do statistics ethically when people are the numbers? I don't have good answers for these questions.

Here's what we do know. There are 76,000 women enrolled in the National Cancer Institute study, and another 31,000 in The Gates Foundation study. So far, they've been tracked for 12 years and at least 79 of the women in the control groups have died of cervical cancer.

Read Bob Ortega's full story at The Arizona Republic


  1. Why couldn’t each patient be screened both ways to see which screening had better results? It seems like that method would still yield valuable data.

  2. There is nothing unethical in the basis of these studies.
    *one group of people are treated in the way they currently would be if the study did not exist. They may or may not get screening by another approach which will tell you how good the present practice towards them is.
    *the second group will be screened a process that is far from non-invasive. This will after sufficient numbers of people and sufficient time has passed tell you what difference if any the screening offers.

    This is extremely simple no one is being treated any worse than they normally would be, but some people are being asked to take a not very pleasant test that might be of help to them if there are sufficient health resources to treat any abnormality found in a timely fashion. If you treat everyone then you are simply giving all of them an untested treatment which is ethically far more unjustifiable.

    Flagging up phantom menaces of Tuskegee is hyperbole and you should perhaps think reflect on what your own motives as a ‘science writer’ may be for doing that.

    I would also caution against the view that all screening is good. In the case of breast cancer and prostate cancer there are good reasons to think poor quality tests which cannot distinguish between dangerously malignant and low risk disease may have led to many thousands of people being exposed to unnecessary and painful and disfiguring treatments. This raises questions about how you should structure trials to try and detect such problems but that will of course require a realistic approach to clinical trials and their funding.

    Lastly if there is one important thing to do regards clinical trials it is to support the release of all the hidden trial data locked in pharma Co.s databases so that it can be used to benefit people and make realistic decisions on the value of treatments. Not doing so diminishes the value of those who agreed to take part in the tests whichever arm of the trial they were in and is really unethical! so please go visit the excellent science blog by Ben Goldacre and sign up to Alltrials!

    1. Typically, if the screen proved wildly effective then the study would be stopped and the screen would be offered to the control group. I can’t imagine there aren’t multiple medical ethicists monitoring the course of this study.

  3. So… this is nothing like Tuskegee where the subjects were suffering from the disease and were not informed of the available and effective treatment.

    This sensationalism really detracts from the horror that took place at Tuskegee.

    1. But it’s not trivial, either.  The standard of care in the USA for gynecological consults is to be screened for cervical abnormalities, whether via the vinegar method or a PAP smear, or both.  The standard of care in India is “no care,” so the ethical logic was that a control group of no screening doesn’t conflict with the (lack of a) standard of care where the trials were being conducted. 

      But really, the known standard of care in the developed world should have been applied and all of the women who were recruited into a gyno consult should have had the screening.

      This is the same kind of thing as Star Trek’s “Prime Directive.”  Do you intervene or not when entering a foreign land? 

      Do you withhold your first-world knowledge from a people who could clearly benefit, just so you can conduct your little clinical trial with a  wrongheaded adherence to some study design standard that you think you need to uphold?  Or do you modify your study to look at a deeper, finer level of detail that you’d be looking for in a first-world country?

      My heart tells me you intervene every time you make contact with a woman, because you have knowledge and she and her country do not.

      Say, instead of looking at vinegar or no-vinegar for 15 years, you perform a stratified random sampling that moves around the country.  You simultaneously track cervical cancer in the general population with a registry and improved data-collection as a separate action.  The screeners and the data-collectors are blinded from one another and are not allowed to make contact.   So then you have a natural experiment going.  You screen as many women as you can, and you have a retrospective control group that you are collecting data on.  15 years later, you compare cervical cancer rates in your treatment and control arms.  Then you have a similarly robust answer, and you did the right thing by screening and treating as many women as your funding would allow.

      That would be harder to implement, and not as straight up as a treatment/no-treatment RCT, but at least it would be ethical and best-effort.

      Shame on the NCI and Gates Foundation for not treating as many women as they possibly could.

  4. Yes, there is something troublesome happening here.  About 100,000 women are being subjected to intimate and invasive testing processes without proof that there is any actual benefit in mortality to them in undergoing these testing processes.  Why are we allowing these researchers to violate the dignity of and risk harm to these poor, ill-informed women?

    1. Can’t tell if trolling or actually believe that attempting to detect cervical cancer is worthless. N.B. AFAIK, nobody is forced to undergo any screening, so if not trolling, you’re argument is not particularly compelling.

      1. Stumptown is ironically making an equally valid counterargument by pretending outrage that people are exposed to an untested treatment. That is the whole point of the clinical trial–we don’t know if it works. If it doesn’t work, then you are better off in the control group. The test group would have to go through all those procedures and get no benefit at all. MKB seems to be starting with the assumption that we already know that screening works.

          1. The total of the women in the study between both groups was over 250K, there were 106K+ in the control arms.  The endpoint of the NCI study was “Death” ….. It’s well established that the screening and with early detection, treatment is both minimal and curative. That’s where my outrage lies. The logic that the standard of care in India is “do nothing” with regard to screening was a horribly designed using rationale that was unethical.  Why?  These 250K+ women showed up which is a clear indication they were looking to “do something.”  Researchers funded by US dollars failed miserably and not to get all melodramatic but the blood of the 79 deaths (only through 2009 as the researchers won’t give the info for the last three plus years as to how many more died until required-later this year).. that blood is on the hands of anyone who had anything to do with this study.  Again, just my two cents understanding a bit about cancer research and a lot about cervical cancer — it’s causes, the effectiveness of treatment and the curability of this disease.

  5. I am very glad to see this post.  I’m going to name drop because I am going to post a link to a blog post I wrote about these very same studies.  I’m a virtual friend of Xeni… I don’t think she will mind if I blab my piece in this space.

    I have plenty to say about what was done to these women with US gov’t funding and the private funding of the Gates Foundation who has done so much for developing nations.  Setting other unethical issues aside for a moment, the biggest issue is “informed consent” …. As someone who has participated in a few studies (I am a breast cancer patient, 6 yrs post treatment), it is unethical to enroll any participant in a study without informed consent.  The total number of women enrolled in these two studies is in excess of 250,000 (the 76K and 31K were the “controls”).  They live in the slums in poverty.  They are uneducated and they could not read the forms.  The signatures were in the form of thumbprints.  It’s likely that fewer than 1000 women could read the forms.  

    Even if they could read, it wouldn’t matter.  When the study was submitted for grant consideration, the researchers attached the consent form they would be using to the grant application.  The consent form that NCI was given contained language that PAP tests are the proper method of screening for cervical cancer and that there are centers in India where they could have PAP tests done.  Sounds great, right?  EXCEPT, when the consent form was translated, that whole section was omitted from the form.

    The lead researcher on the Gates study was on the review panel for the NCI study.  Seems a bit odd to me.  The NCI questioned the need to continue with no screening in 2009 but allowed it to continue.  

    The 79 deaths are as of 2009.  Both studies would not release any further death rates.  Those will be reported later this year.  I’d hazard a guess that number is going to climb when they add three plus more years of “follow up” of “controls” …

    Both studies are under investigation as there appear to have been violations by both researchers.  No one is giving any official comment.  Kudos to Bob Ortega for spending six months doing his research to bring this to light.

    Bottom line:  Research studies save lives.  These women all showed up thinking they were doing something to help themselves (and to help others).  THEY may not have known better but the researchers did.  When you knowingly place humans in a control arm of a study that you KNOW is going to result in death because the science has already been proven (including in developing nations), that is highly unethical.

    Thanks for letting me share some of the rest of the story.

  6. In this case they do know the screening works.  That’s not called into question.  The screening methods found cancers at very early treatable & curable stages.  NCI wanted the control group to be moved to the screening group in 2009 but the researcher argued because that wasn’t her “endpoint” …   Her endpoint was, “would unscreened women die”  HELL… they knew they would die.  The whistle blower doctor who reported these researchers led to the opening of investigations by the agencies that oversee publicly and privately funded research.  The women in the control group were “expendable” “lab rats”  ….. AFTER his complaint was lodged, the researcher in the NCI study notified the investigating agency (in November) that they would screen the 76K controls.  The Gates group began screening their controls in Jan of 2011.  

    1. Interesting. Thank you for filling in more of the story. I agree that informed consent is always key to any study.

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