Mr. Shaw discusses gov sponsored human experiment–important stuff

The discussion requires amplification. Because the human exposure experiments are on our mind for sure.

We at Junk Science are concerned about human exposure to air pollutants experiments sponsored and funded by EPA at 10 domestic and 6 foreign medical schools.

Thanks for your post, Mr. Shaw. You are always enlightening and stimulating.

Mr. Shaw discusses the problem of the Support study on more than 1000 severely premature babies to evaluate effect of oxygen concentration administered on development of a retinopathy (back of the eye disease) that causes blindness. NIH sponsored a multi institutional study with two levels of oxygen therapy as the arms of the study.

Oxygen was supplemented to achieve target pulse oximetry, the % of Hemoglobin saturation in the capillary blood. Normal is above 95 %. below 90% in persons with some cardio-respiratory compromise. Does not measure amount of hemoglobin carrying the oxygen, just the percentage of oxy hemoglobin–the hemoglobin with oxygen attached to deoxy hemoglobin, no oxygen on board. Hemoglobin is very large 4 subunit protein molecule with an iron atom in the center.

Addressing some points made by Mr. Shaw.

I don’t have a problem with the blinding of nurse and Peds ICU providers–it prevents cheating, provided there is no known risk to the arm of the study with the lower pulse oximeter parameters.

Older children and adult humans normally have pulse ox above 95% oxygen saturation in the capillary blood as measured by the pulse ox sensor on the finger or the foot. 90% is low range and problematic. 80s are not good, dangerous, 70s incompatible with life. Babies/newborns have fetal hemoglobin that works at lower partial pressures, so they are not as affected by low oxygen tension as regular blood cells with mature hemoglobin A.

The issue of retinopathy in preemies is a tough one and consents may have been inadequate for sure. How can a proper warning be composed when people had no idea what might happen if a child, with fetal hemoglobin that operates at lower partial pressures of oxygen,, is subjected to lower than 90 % pulse oximeter ranges for therapy. .

However, That is clearly not the kind of violation of ethics that the exposure of human subject to small particles in excess of EPA safety limits would be, since the EPA asserts that small particles are lethal,, carcinogenic, and toxic at any level. Now that’ll get you going.

So, Mr. Shaw, let’s add this one, and continue to try to expose unethical human experiments. I note that Vera Sharav, President, Alliance for Human Research Protection was bent out of shape by the study and its consents and methodology. Noting your concerns, Mr. Shaw, the air pollution exposure experiments are much worse, blinding nurses and providers to the pulse ox ranges, and the informed consent issues are, in fact issues that are arguably handled by the protocols, for example, since we don’t know that the higher ranges are essential to preventing brain damage or other problems, a slightly lower pulse ox may be a legitimate inquiry, when the high pulse ox is considered a toxic level and there is no evidence that a lower pulse ox is toxic.

There is a legitimate inquiry on a very serious problem–for a long time high oxygen levels were considered to be the cause of a proliferative vascular change that caused the blindness. So the downside risk of lower pulse ox was easily dealt with in that for other age groups high 80s is not considered toxic.

So we have a legitimate basis for saying–low level, no known risk, high level considered a seriously toxic risk.

Then the consents have to be written based on things known. Blinding the providers prevents interferences. Too many nurses or providers always taught that pulse ox must be above 95 in normals and above 90 in those that are in trouble, and you have cheating that screws up the protocol.

I Am gonna put this up as a separate post, it deserves more discussion.

Thanks Mr. Shaw, your contributions are always extremely helpful and valuable.

2 responses to “Mr. Shaw discusses gov sponsored human experiment–important stuff

  1. @john1282–

    Thanks for your posting. As to..

    “I don’t have a problem with the blinding of nurse and Peds ICU providers–it prevents cheating, provided there is no known risk to the arm of the study with the lower pulse oximeter parameters.”

    There is a significant risk with low oxygen, including brain damage. In fact, the researchers had predicted an increase of four percent for death and severe brain damage in their low-oxygen group. The result they reported was 23 “extra” babies killed in that group, or 3.5 percent. The numbers with brain damage have not been reported and probably never will be.

    Also, the “science” behind higher oxygen causing the retinopathy is not quite as “settled” as you might think. [I could have addressed this in more detial, but the piece was getting too long as it was.]

    Moreover, based on litigation documents, it is quite likely that the tweaking of the oximeters was FAR more than what was admitted in the NEJM article.

    The worst part of this was the utter whitewashing by NIH, if not the purposeful targeting of black babies born to single mothers.

    As to Ms. Sharav being “bent out of shape,” she has access to other information that puts SUPPORT into the Mengele category. No kidding.

  2. Mr. Shaw, thanks for your comments. The effect of pulse ox in the low level arm was not specified or known to me. Theoretically a low pulse ox maintained would not be lethal. Kids who die in the low ox arm might have died from whatever. Preemies have many problems.

    I would also say that the study is not so helpful, given that retinopathy is probably multifactorial and the previous history includes a period of time that my pediatric friends tell me was dominated by 100 percent oxygen,, which is not what they do now.

    For more than 25 years the idea has been aim for a pulse ox of mid 90s. 92-96 93-97.

    That was because such a level was normal range oxygenation.

    However, understand that is ideal, It does not remove the question, well what if you have to use 100% Oxygen to keep a baby in the target range?

    As for my commitment to the high oxygen causes proliferative retinopathy, I knew that was controversial then and now, and not resolved. .

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