The 2010 study of withholding needed oxygen breathing help from preemies
was even more unethical than the syphilis studies in Guatemala and Tuskegee
Dear Professor Wagner:
Re: Current lethal medical baby-suffocating experiments conducted without parental consent at Emory University and with collaboration from University of Pennsylvania
You said during meetings 4 and 5 of the Bioethics Commission that the essential requirement in any medical experiment on humans is the informed consent of the research subjects, and that there is no possibility that abuses like those in the 1940s Guatemala syphilis study could happen here and now. You also said that you would answer the President’s question with a definite “no”, which I take to mean that you would assure him “that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally”.
I want therefore to draw your attention to a group of unethical medical experiments on premature babies in the U.S. where researchers reduced the oxygen breathing help for half the babies enrolled to see whether this would help to reduce the combined incidence of death and blinding eye damage from retinopathy of prematurity, as if these conditions were of comparable severity or could be traded against each other. They withheld this life-saving gas with the knowledge that this would greatly increase the risk of death for the preemies in the low-oxygen group, and despite the mandate in all declarations of medical ethics, from the Nuremberg Code on, that “the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment”, as Article 6 of that Code puts it.
In the most recent of these experiments in the U.S., the researchers reported in the May 16, 2010, online issue of the New England Journal of Medicine that 23 “extra” infants had died in their low-oxygen group, with a probability of 96 per cent that their deaths were correlated with the oxygen rationing. You will find at http://retinopathyofprematurity.org/BioethicsSUPPORT.htm a detailed description of this SUPPORT experiment in which Emory University prominently participated, and of the umbrella study NeOProM that launched several similar experiments in Australia, New Zealand, England, and Canada. That umbrella plan for this human suffocation experiment is listed as having among its collaborators the University of Pennsylvania of which your Commission’s Chair is the President. See http://clinicaltrials.gov/ct2/show/NCT01124331?cond=%22Retinopathy+of+Prematurity%22&rank=33
I had emailed my above description of that suffocation experiment on February 22 to email@example.com since your Commission asked for public input in writing to be sent to this address. I have also repeatedly posted responses on your Commission’s blog in which I referred to this story and included links to it. However, I received no reaction from anyone there to these emails and documentations of ongoing medical ethics breaches. I deduce that this invitation for comments from the public was just for show because if anyone from your Commission had read about the deliberate asphyxiation of human preemies here and now they would have had to react to this medical suffocation experiment just as they did to the revelations about the Guatemala syphilis experiments, or more urgently because the harm to the preemies is still going on.
It seems the cynic was right who posted last December in a discussion forum after an article about your Commission’s current assignment:
“Point out a recent problem, if you can, and look into it. But going after a 60-year old study is a safe way to appear concerned. No one to hold accountable except dead researchers. Again, just window dressing that does nothing to rock the boat of present-day offenders and crimes.”
It also seems that the custodians of the above mailbox did not forward any of my information about the ongoing harm to preemies to you since you still stated publicly that such abuses were impossible long after your Commission had a detailed and unrefuted documentation of the contrary in its possession.
The SUPPORT researchers appear to have conducted their cruel and lethal asphyxiation experiment without any informed consent from the parents, without even telling them that they had enrolled their child in this experiment. This was easy to do since the electronic displays of the oxygen monitoring equipment were adjusted to all show the same range of values to mask the group-assignment of each baby, so the parents had no way to tell that anything was different.
The Freedom of Information Office at the National Institutes of Health cannot find the model consent forms that would have been required for the grant approvers to evaluate the ethical compliance of that experiment, nor can their FOIA Appeals Department. You can read their replies at http://retinopathyofprematurity.org/BioethicsConsent.htm.
Indeed, if the researchers had attempted to obtain this consent, and if they had honestly told the parents about the well known risk of a painful death by asphyxiation to which they wanted to expose their child, just to try and protect his or her eyes with a 50-year old but never proven theory about oxygen, no parent could legally have consented to offer up their baby because this grotesque and potentially lethal experiment was clearly not in the best interest of their baby. Even intact eyes are of no use to a dead child.
You can also see from the NIH replies that the NICHD department which funded the experiment allegedly “does not require grantees to provide consent forms”, that “these forms are not required to be submitted to the NIH as part of the grant application or management process”, and that therefore, they “do not constitute agency records subject to the FOIA process”. If that were true, and the model consent forms were not accessible for public inspection, then this unwarranted secrecy would defeat the purpose of informed consent which must be open and transparent and not dependent on trickery like this hair-splitting evasion.
I have in the past received copies of “informed consent” forms from the NIH for other inquiries, so the NIH does not appear to tell the truth here. Moreover, according to §46.122 of the Federal Regulations on "Use of Federal funds" they are not allowed to disburse funds for any research involving human subjects “unless the requirements of this policy have been satisfied." The policy referred to dealt mostly with the importance of informed consent, and there is no way how the NIH can check the grant applicants’ compliance with those rules unless they have seen that the consent form accurately describes all the risks of the proposed experiment. Therefore, if that form existed, then it would have to be found with the grant application, at least if the NIH followed its own rules.
The NIH rather seems here to be trying to hide a crime against these children that is even worse than the infamous syphilis experiments in Guatemala and Tuskegee since the SUPPORT experiment knowingly and deliberately exposed humans to a well known risk of death, with no corresponding benefit to them that would outweigh this risk.
Professor Gutmann offered this admonition about the syphilis experiments in Guatemala during your Commission’s 8-30 meeting:
“We must look to, and learn from, the past so that we can assure the public that scientific and medical research today is conducted in an ethical manner,” said Gutmann. “Research with human subjects is a sacred trust. Without public confidence, participation will decline and critical research will be stopped. It is imperative that we get this right.”
The refusal by the NIH to honor this sacred trust and to come clean about its human suffocation experiments does not deserve this desired public confidence. And Professor Gutmann’s words, as well as your assurances about the alleged present impossibility of such abuses, may appear highly questionable to many people when members of her University state coldly in the NeOProM paper that they cannot rule out a “small but significant 4% increase in death or serious neurosensory disability in survivors” of their proposed low-oxygen groups.
Who do these “researchers” think they are? They seem to believe that their research interests trump all human rights, including even the preemies’ right to live, and they seem to feel free to casually expose fellow humans without their or their parents’ knowledge to an increased risk of death. Don’t they know that they have an ethical and legal obligation to protect their subjects from any intentionally increased risk of death or disability, particularly the most vulnerable children? How can Professor Gutmann tolerate such callous and unsupervised arrogation of power over life and death by members of her faculty, and how can you let members of your faculty participate in the predictable and deliberate suffocation of those 23 “extra” preemies?
How can she or you or anyone explain to the public that this intentional exposure of babies to a significantly increased risk of death is not premeditated medical murder? What is the difference between this painful and lethal suffocation experiment and the horrible hypothermia and hypobaric experiments in which Nazi doctors tried to find out the limits of human resistance to cold and lack of breathing air? Those crimes led to the Nuremberg Code and several executions of its retroactive violators, but when today’s doctors cruelly throttle the gasping preemies’ life-saving oxygen to coldly observe how many of them will die, in clear violation of well established codes and laws but with Federal funds from the NIH, they get to add another paper in a prestigious medical journal to their resume.
As Dr. Anita Allen from your Commission said about Dr. Cutler’s Guatemala experiments,
"the researchers put their own medical advancement first and human decency a far second".
Obviously, nothing has changed, even though the recent Executive Summary of your Commission’s International Research Panel assures its readers that
“over the past five decades, the United States has made significant progress in developing rules, standards and practices for protecting human research subjects in research”.
This may be the prevailing view in the self-centered medical community and in the insulated ivory towers of your Commission members who keep reassuring each other in their public speeches that all is for the best in this best of all possible worlds. However, as long as these rules and standards are as cavalierly disregarded as in the baby-asphyxiating experiments, they are only Potemkin progress.
All the declarations of “medical ethics” mandate extra care, precautions, and protections for all experiments on vulnerable populations, such as children. Yet, the extremely vulnerable preemies in those asphyxiating experiments are treated as disposable guinea pigs.
And if neither you nor Professor Gutmann can prevent such heinous and fatal crimes against defenseless research subjects from occurring in your own Universities, then how will you be able to assure President Obama that current participants in medical experiments are now protected against gross abuses like those in Guatemala and Tuskegee? The SUPPORT and NeOProM experiments are also intentionally exposing subjects to increased risk, as in Guatemala, and also withholding an available and effective treatment, as in Tuskegee. However, here the risk is not just infection but death, and the withholding of the immediately needed oxygen breathing help is even more lethal than withholding syphilis medication.
I had also asked the NIH FOIA Appeals Department to inform me about their procedures for verifying whether any consent form submitted to them was actually the one used in the experiment. For instance, a Kenyan official was recently quoted in the 7-15 issue of Capital News of Kenya as saying:
“’After you approve a research, nothing stops a dishonest researcher from designing a different consent form and administering it to participants. We usually do random checks on researchers to curb this,’ he says. He anticipates that based on the complaints they get, at least ten per cent of researchers could be sidestepping some of the procedures.”
It turns out the U.S. NIH does not do any such verification. They will only certify the authenticity of a copy as being a true reproduction of an original, but they do not check whether the original itself is genuine. They rely entirely on the honor system in trusting blindly that all grantees will do the right thing and obediently follow the rules although many researchers keep grumbling publicly that these rules are too cumbersome. Glaring gaps like this in the basic supervision of research paid for by Federal funds are not likely to help restore the public confidence in the medical research industry that Professor Gutmann considers necessary.
The recent baby-asphyxiating experiments described above, and the original oxygen rationing fraud in the 1950s posted at http://retinopathyofprematurity.org/Bioethics1955oxygen.htm, are not the only transgressions at the NIH against premature babies. There is a mountain of evidence that the entire epidemic of baby-blinding retinopathy of prematurity has nothing to do at all with oxygen levels but is entirely caused by the excessive retinal irradiation with the blue-hazard component of the standard fluorescent nursery lighting. Yet, the NIH tried to deny this with a bogus trial.
Fluorescent lamps were introduced into intensive care nurseries precisely at the beginnings of this blinding epidemic, first here in the U.S. in 1939/40, and after World War 2 again in Europe and other industrial countries when these lamps became available there and the same blinding epidemic punctually burst on the scene. By that time, oxygen supplements had been administered to preemies for many decades without ever causing any case of blindness or other eye damage. However, the lip-service promoters of so-called “evidence-based” medicine reflexively and irrationally deny the role of this well recognized and never refuted light hazard which they keep inflicting on defenseless babies. Instead, nursery doctors around the world insist on throttling the life-saving oxygen because of a rigged and eugenics-motivated baby-asphyxiating U.S. trial from 1955/6. That fraudulent show trial introduced the worldwide oxygen withholding to eliminate the “defective germ plasm” of the preemies most vulnerable to the blinding, as described at the above link and at http://retinopathyofprematurity.org/01summary.htm.
The much acclaimed results of that bogus trial killed 150,000 babies in the first 20 years, as the NeOProM paper cites, and the reckless rigging of that trial itself should be the object of your intense attention if your Commission really wanted to expose ancient wrongs not only in Guatemala. The more recent baby-asphyxiating experiments in which your and Professor Gutmann’s Universities participate are now likely to impose a similar death toll. Although the U.S. part of those experiments reported 23 “extra” deaths in the low-oxygen group and reduced the rate of blindness among the survivors for the most part again only by killing the babies with the most vulnerable eyes, exactly as that 1955/6 experiment had done, there is now a new trend to further reduce the oxygen levels to the low level which had so increased the mortality.
The San Luis Obisco News quoted on August 6 the Medical Director of the local NICU as saying that
"newer guidelines just coming out lower the amount of oxygen given to preemies even further."
Similarly, an article by Laura Landro in the Wall Street Journal of July 19, 2011, stated
"Some neonatal intensive care units are cutting back on the high levels of oxygen traditionally given to premature babies. (...) Nurses used to be taught that babies should have a blood oxygen saturation level of 99 per cent and appear glowing pink and healthy", Ms. Rikli says. "It was hard for some nurses to accept reducing blood oxygen levels to the 85 per cent range, despite research linking higher levels to blindness. It takes constant vigilance and persistence to show nurses the data and to hold them accountable," she says. "A visit from parents of a baby who is now blind because he got too much oxygen in the NICU was effective," she says. "Sometimes you have to bring the human element in, too."
However, these patronizing advocates of tighter restrictions on breathing help don't explain how the existence of a blind child proves anything about the cause of his or her blindness. They simply assume the nurses are gullible enough to accept their mere assertion as "proof" against oxygen. Even worse, they also omit to say that the medical experiment behind these new guidelines for lower oxygen levels had killed 23 "extra" babies in the low-oxygen group, and that the SUPPORT researchers had announced as their result:
There is no version of “medical ethics” or real ethics that would consider such a skewed trade-off acceptable, but those “newer guidelines” based on the criminal SUPPORT experiment now advise nursery doctors that it is better to kill preemies than to let them grow up blind, confirming the widespread medical attitude of “better dead than living blind”. Actually, from the narrow and cynical perspective of some doctors this is true because parents are less likely to sue their baby’s doctor over that baby’s death than over his or her blindness so it is in the doctors’ interest to just kill off the most vulnerable babies. This may not be abuse of research subjects but is abuse of patients based on crooked research and intentionally baby-killing guidelines. This new threat to preemies is therefore also among the flaws in the current medical research system that your Commission should expose and end if it followed the intention of President Obama’s instructions and not just their unfortunately more narrow wording.
The researchers involved in the SUPPORT and/or NeOProM experiments are also violating the rule of “medical ethics” which says that they should be familiar with the scientific literature relevant to the condition they plan to study with their experiment. Scientist working in the fields of Occupational Safety and Laser Safety have accumulated over the last five to six decades a vast literature about accidental and experimental light-damage to the mammalian retina from various exposure times and intensities as well as wavelengths. It turns out that fluorescent lamps emit their highest energy spike in the by far highest-hazard blue-violet wavelength of 435.8 nanometers, and preemies have none of our adult defenses against the retinal damage from this harsh irradiation. The typical nursery lighting accumulates on their retinae in less than fifteen minutes an overdose of blue-light damage that exceeds the danger limit set by the U.S. Occupational Safety Guidelines for adult workers -- see my clinical article “Baby-blinding retinopathy of prematurity and intensive care nursery lighting” at http://retinopathyofprematurity.org/Babyblindinglights01.htm.
Unfortunately, the single-minded oxygen withholders not only ignore or somehow dismiss this entire body of scientific literature on light damage to the eye, including several papers in relevant medical journals such as Pediatrics or the NEJM. Two pediatric retinal surgeons even rigged in the mid 1990s another fake and patient-abusing experiment in three hospitals, called LIGHT-ROP, to falsely affirm the safety of the nursery lighting and so to deny all medical liability for the permanent severe eye damage it causes to many children.
Knowing that the blue-light damage from the nursery lighting which they pretended to study can accumulate to damaging levels in just a few minutes, these authors had the nursery staffs patch the eyes of their allegedly “protected” groups only as late as up to 24 hours after birth, to equally and grossly overdose them all. Then they reported that they had found no difference in blinding rates, and their knowingly false and dangerously misleading result is now enshrined on the ROP web page of the National Eye Institute as the guiding doctrine on nursery lighting that assures a steady stream of customers for pediatric retinal surgeries.
I had emailed to firstname.lastname@example.org in November 2010 detailed information about this irresponsible experiment the authors of which also lied to the parents about its risks. See the lower half of my page http://retinopathyofprematurity.org/BioethicsLIGHT-ROP.htm for that email, and http://retinopathyofprematurity.org/40fraudsinLIGHTROP.htm for a discussion of the many other violations against ethics and science in that highly unethical and intentionally misleading experiment which now has the status of medical Gospel.
So far, however, your Commission has not reacted to these urgent and fully documented warnings against the nursery lighting. It has the information how to stop the ongoing epidemic of baby-blinding and cannot refute any of that material. It can also not claim that this material is too technical and hard to understand or needs further study since most of your members are supposed to be scientists and should be able to grasp that actually rather simple information.
Yet, your Commission allows the baby-blinding to continue unabated, just like the Tuskegee doctors who knew the remedy for their patients’ disease but let it continue unabated. How much trust do you think this callous inaction on your part will inspire the public to have in “bioethics” when even your Commission for the Study of Bioethical Issues so blatantly disdains the most basic rules of both medical and real ethics today while unctuously denouncing some of those who did the same but long ago?
Professor Gutmann said above: “It is imperative that we get this right”. I hope that you and she both have the serious intention of getting this right and that you will therefore help to protect those hapless preemies who are now being blinded and suffocated to the point of death or severe brain damage. I also hope that you and Professor Gutmann will investigate the unethical baby-suffocating experiments in which members of your respective faculties are involved, and that you will then take appropriate actions to teach them and the other participants about real ethics instead of just the distorted medical kind.
I thank you in advance for any help you will provide to protect premature babies from the willful ignorance of ethics-challenged nursery doctors, and I look forward with interest to hearing from you.
H. Peter Aleff
My public comment submitted on October 24, 2011, to the Federal eRulemaking Portal at www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-0001 in response to the HHS request for comment on its proposed rules concerning "Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators":
I support your aim of improving the current protections for research subjects but fear that your new rules will be futile if they are as poorly enforced as the current ones, and if the Offices for Human Research Protections and for Research Integrity keep ignoring alerts as now. To make you aware of the current gap, please find below a partial list of routine violations in major clinical experiments on premature babies, with links to full documentations.
1) Two current multi-hospital clinical trials of withholding oxygen from preemies are knowingly increasing their risks of death and severe brain damage, to try and protect them from blinding, but without a benefit worth these much greater risks. One of these suffocation experiments had 23 “extra” deaths in the low-oxygen group, with only 4 percent chance that this was a fluke. This open disregard of basic respect for the humans so sacrificed to research as collateral damage, and of NIH regulations §46.111, passed all levels of grant review. See www.retinopathyofprematurity.org/BioethicsOwnViolations.htm.
The NIH cannot locate the consent
forms for this experiment although
forbids them to fund any research on humans
unless the policy on informed consent has
been satisfied. This clearly requires
checking that the consent forms truly
describe the proposed risks and then
auditing that these are used.
§46.122 anticipates your proposed
consolidation of IRB approvals for
multi-site trials but it is not enforced.
3) The biased researchers willfully ignore a large body of scientific work on light damage to the eye which is a more likely cause of the baby-blinding than excess oxygen. They also read uncritically their own specialty’s papers and blindly accept several obvious research frauds in their doctrine. See www.retinopathyofprematurity.org/40fraudsinLIGHTROP.htm and www.retinopathyofprematurity.org/BioethicsOxygen.htm.
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