SUPPORT: Tuskegee-Style Medical Deceit Still Overrules Human Research Protections

Peter Aleff, our guest contributor whose scathing, detailed insightful critique of unethical experiments, in particular, the contentious government sponsored SUPPORT experiment that put premature babies lives and well-being at increased risk without disclosing the true nature of the experiment to the parents.

Tuskegee-Style Medical Deceit Still Overrules Human Research Protections: The recent baby-suffocating SUPPORT experiment and its context by Peter Aleff

Table of Contents with Summaries:

1.) Smokescreens of “medical ethics”
A judge in Alabama asserted recently that medical researchers have the right to expose their human subjects to knowingly harmful and even fatal experiments without their or their parents’ informed consent. This gives official approval to the many violations of its much proclaimed ethics codes that the medical profession routinely committed, including the infamous Tuskegee Study of syphilis that had long been condemned as a textbook example for those same abuses.

2.) Disposable babies maimed and killed in the SUPPORT suffocation experiment
Medical researchers in 23 U.S. hospitals, led by the University of Alabama Birmingham Hospital, not far from Tuskegee, deliberately restricted from 2005 to 2009 the oxygen breathing help for half of the 1316 premature babies enrolled in their SUPPORT suffocation experiment; they thereby predictably killed 23 “extra” babies in their low-oxygen group. The Universities headed by the Chair and Vice Chair of President Obama’s Bioethics Commission actively participated in this blatant violation of all medical ethics codes but that Commission then falsely reassured the President and the American public that the current regulations offered sufficient protection against such abuses. The researchers had lied to the parents about the risks because obtaining their mandatory informed consent would have been a bothersome, expensive, and counterproductive “defensive documentation” that would have interfered with their research. Many so-called “bioethicists” as well as the Director of the National Institutes of Health defended this deliberate crime of the researchers although their experiment design amounted to premeditated harm for the babies and even murder.

3.) The failure of the legal system to address the SUPPORT abuses
The parents of three babies harmed during the SUPPORT experiment brought a malpractice suit against the lead researcher at the University of Alabama Birmingham and the members of the Institutional Review Board who had rubberstamped the openly patient-abusing research protocol. However, the U.S. District Judge for this case accepted at face value the dishonest disclaimers of the defendants and their medical experts who falsely blamed the injuries of the plaintiffs on only their prematurity. They omitted to tell the Judge that the defendants’ own team had published the clinical report about the SUPPORT experiment which attributed the 23 “extra” deaths in the low-oxygen group to the oxygen restriction with a probability of 96 percent, and that the lower rate of retinopathy of prematurity (ROP) incidence in that group compared with the high-oxygen group had a probability of 99.9 percent of being due to the experiment conditions. The Judge, in turn, ignored the legal rule about “preponderance of evidence” which requires a plaintiff’s claim to be only “more likely than not”, and she dismissed the plaintiffs’ case as “mere possibility” despite the high probabilities that clearly met the legal standard for attributing the injuries to the experiment. One of the mercenary “bioethicists” who had previously defended the SUPPORT experiment then crowed in the NEJM that the study had followed “high ethical standards” and had proved that the system worked.

4.) “Truthiness” in the pediatric doctrine
The Judge also repeated uncritically in her account of the background to the SUPPORT experiment that blood oxygen levels as low as 70 percent were still safe for premature babies. This number was based on a deliberate misreading of a study cited by the Director of the National Institutes of Health. That study had included a group with a nominal oxygen level that low, yet its text made clear that the babies rarely if ever were at that low level but were generally kept near the top of their group’s range. The Director of the NIH and two of his Department Directors had chosen to cite this low number to make the 85 to 89 percent level in the SUPPORT low-oxygen group sound safer than it actually was, despite a letter to the NEJM editor from some of the SUPPORT researchers themselves, including the defendant Dr. Carlo, that levels below 80 percent were strongly correlated with death. Such misrepresentations and refusals to accept facts are common in medical research, and the doctrine about ROP has even more than its fair share of these as well as of outright research frauds.

5.) The start of the alleged link between oxygen and baby-blinding
ROP began in 1940 in Boston, after oxygen had been given to premature babies for several decades without ever causing any eye damage. However, oxygen was the major means of helping the most vulnerable babies survive, and some eugenicist doctors at that time blamed the blinding on undesirable “defective germ plasm” which they wanted to eliminate by eliminating those babies. So they first started a smear campaign against “liberal” oxygen as an “undeserved subsidy”, then they rigged a multi-hospital trial in which they withheld the breathing help for the first two days, and only then they enrolled the survivors of this brutal weeding. This strategy killed the most vulnerable babies who would have been most likely to develop ROP, and the “researchers” then announced falsely that they had virtually ended the blinding without increasing the mortality.

This greatly touted wrong result immediately caused neonatologists around the world to severely ration oxygen for all preemies although this one study contradicted all previous experience and could never be replicated despite many attempts. It killed at least 150,000 babies in the first two decades of oxygen rationing, but this massacre was never investigated and still continues to some unknown and unadmitted degree.

The latest attempt to clarify this non-existing relationship between blinding and suffocation mortality with the $20-million SUPPORT experiment predictably killed 23 “extra” babies but produced again no new knowledge. However, true to the hidden eugenic agenda, some “better dead than blind” nurseries lowered their oxygen supplementing to reduce the blinding although they knew this would kill more babies. This ongoing routine killing of premature babies without any objection from the “pro-life” embryo defenders highlights the absurdity of the current attacks in Congress on the use of aborted fetal tissues from Planned Parenthood for necessary and legitimate medical research instead of incinerating them as medical waste. If those attackers were really pro-life, they would make efforts to stop the continued killing of born babies.

6.) Medical denials that the blinding is caused by the excessive nursery lighting
The ROP epidemic had started in the U.S. the year after the commercial introduction of fluorescent lamps, and the same parallel repeated itself after World War 2 in other industrial countries as those lamps became available there and the ROP epidemic broke out just as suddenly in their wake. Industrial-safety researchers established that the most retina-damaging light is in the “blue-light-hazard” wavelength region from 430 to 440 nanometers. Virtually all fluorescent lamps emit a major part of their energy precisely in the middle of that most dangerous range, at 435.8 nm. The eyes of preemies are at their most vulnerable stage. The typical intensive care nursery lighting of 60 to 100 foot-candles exposes their retinae in less than 15 minutes to the amount of damage-weighted retinal irradiance that the U.S. Industrial Safety Guidelines have established as the danger limit for adult workers over an eight-hour shift. The presence of oxygen enhances the radiation damage caused by the blue-light-hazard, but oxygen alone does not create that damage.

A study in 1982 reduced the irradiation of the babies from 60 foot-candles to 25 ftc and drastically reduced the incidence as well as severity of ROP. However, critics did not like the result and quibbled with the before-and-after format of the study. To disprove it, they rigged their own experiment by patching the eyes of half the preemies enrolled but applied the patches only up to 24 hours after birth while knowing that it takes only a few minutes to cause the eye damage. Their knowingly false result that the nursery lighting does not affect the blinding is now the reigning dogma and continues the profitable blinding epidemic.

7.) Ending the cover-up of the euthanasia and ROP-blinding against premature babies
The fake LIGHT-ROP trial as well as the Cooperative Study oxygen swindle need to be exposed and retracted before any progress can be made to end the ROP epidemic. Also, all babies need to be protected from the blue-light hazard of the fluorescent nursery lamps, for instance, with yellow filter coatings.

Many nursery doctors and editors of medical journals are strongly opposed to any examination of their blatantly false and fraud-based dogmas about oxygen causing ROP and alleged lack of eye damage from nursery lighting. This defensive wagon-circling attitude must be overcome and replaced by a culture of transparency and error-correction. Outcomes from all intensive care nurseries need to be published and compared to identify the trouble spots. This will give hospitals the now lacking incentive to improve those outcomes.

Read entire detailed critique Peter Aleff_Tuskegee-Style Medical Deceit