Full Disclosure: Did Government’s Experiment on Preemies Hide Risks? – IOTW Report

Full Disclosure: Did Government’s Experiment on Preemies Hide Risks?

The Daily Signal

The government-backed study is called SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” The experiment was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health, part of the Department of Health and Human Services.

All three women now say they never would have agreed to take part if they had known the NIH-funded study’s true nature—to randomly manipulate preemie oxygen levels. They discovered that just last year.

Just 24 weeks into her pregnancy, Sharrissa Cook gave birth to a critically ill baby boy. Dreshan weighed in at a fragile 1 pound, 11 ounces. He lay motionless in the incubator, connected to tubes and monitors in the neonatal intensive care unit at the University of Alabama at Birmingham Hospital.

“He was so tiny,” Cook recalls. “I was a first-time mom. I didn’t have a clue. I didn’t know what to expect.”

It was Oct. 11, 2006. Medical personnel asked Cook, then a 26-year-old single mother, to enroll little Dreshan in a study. She says they described it as a program offering assistance and encouragement to preemies—premature babies—and their families. She readily signed the consent form.

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4 Comments on Full Disclosure: Did Government’s Experiment on Preemies Hide Risks?

  1. The Kennedy’s lost a premature boy in the early 50’s. I arrived in that same era, a month and a half early. Infants were given a 50/50 chance to live back then but the resulting issues were the same. I found the article interesting because it gives more information about lung and vision problems. Docs then made their best guesses as they manipulated oxygen. It is surprising they haven’t nailed this one down more exactly but children are surviving at incredibly younger ages now.
    I must say that in the final analysis, the Physicians have a responsibility to do THE BEST THEY CAN given their knowledge at the time and the unique circumstances surrounding each birth, the rest as they say is in God’s hands. I do not believe a parent should be given an abundance of choices, that’s why we have Doctors. If Goobermint is going to get involved and experiment with human futures then they have a responsibility to pay for what that person needs throughout life to make up any deficits they subjected the person to – anything that deviates from “normal”.
    I’m satisfied knowing the Doctors who helped me did the best they could, if I knew I was an experimental subject – well, the lamp shades in my house would all have names.

  2. This link was posted on the Ace of Spades Yahoo group. The following is my researched response. I can’t post the cited articles on this comment page, but if you them, just ask.

    *****

    Research skills…activated. See attached articles.

    The basic gist: Because high levels of oxygen cause damage to eyes of infants, they wanted to see if they could lower the level of oxygenation such that it would prevent this eye damage, without significantly impacting mortality.

    They could not. The study conclusion was that the lower levels of oxygen had a negligible decrease in eye damage (a much lower level of oxygen would therefore seem necessary to have any effect) but a significant increase in infant mortality. So, lesson learned, there, because Standard of Care had been trending toward lower levels of oxygen. This study changed that, and will save more preemies in the future. The article titled Target ranges…etc. is the initial study data dump. (I guess you can argue whether an increase in mortality from 20% to 24% is significant in any practical way. I was referring to the data being statistically significant.)

    The two study groups were set at 85-90% O2 (the low-O2 group) and 91-95% O2 (the high-O2 group). It is important to emphasize here that at the time the study was done, both of these oxygenation ranges were considered as Standard of Care. This is all perfectly fine.

    Now, in order to maintain the double-blind nature of the study, they had to alter the PulseOx monitors on both the high-O2 and low-O2 groups, by lowering the high-O2 group by 3% and raising the low-O2 group by 3%. Otherwise it would have been obvious to the medical staff which baby was in which group, thus destroying the double-blind nature of the study and ruining the entire project. Again, this is all perfectly fine. A double-blind study prevents your study data from being skewed by researcher bias.

    The problems are these: Fiddling with those monitors meant that the individual babies (are they are still PATIENTS, not research animals) might not be getting the best individualized care needed in each particular case. One of the principles of using human research subjects is that if adhering strictly to your experimental protocol will cause adverse effects in your subject AND those effects would either not occur or be significantly reduced by removing them from the study, then you REMOVE THEM FROM THE FUCKING STUDY. Like, yesterday. Altering the monitors makes that call more difficult to make than it would otherwise be.

    Secondly, there is the eternal argument that a layman is, in a lot of highly involved situations such as this, simply incapable of making an actual informed consent. It’s not that the parents were stupid…but they weren’t doctors. They lack the training to really understand what’s going on. When my auto mechanic explains what he has to do to my car to get it running, I just smile, nod, and sign the credit card receipt, because I don’t have the slightest fucking clue what he just said to me. Because I’m a Doctor. And I don’t know shit about cars. I put gas in, and it goes. I can change a tire. That’s about as far as it goes.

    (If the number on that receipt is exceptionally large, I show it to Evil Misogynistic Wife. She knows about things like that. Anyway…)

    These questions are discussed in the next article, Learning the right lessons…etc.

    The final article (Ethical support…etc.) also discusses these issues, but re-emphasizes the point that when this study was actually completed (2005-2009), nothing in their study protocol was outside the normal Standard of Care. Which means that the question whether or not to pull a particular child from the study would have required a judgment on the infant receiving “appropriate care”, when no established standard for determining “appropriate care” existed at the time.

    My judgement? The study was valid. The group that seems to be spearheading the original complaint is cherry-picking what actually happened to support their argument.

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