RetinopathyOfPrematurity.org  

Home   

Abstract & Summary

Table of Contents
ROP description
Eugenics against oxygen
Slandering oxygen
Oxygen study frauds  
Alleged study results
Later deaths
Futility and harm
Fluorescent ROP lamps
Damaging irradiance
Preemie vulnerabilities
Studies of light and ROP
Frauds in LIGHT-ROP
Cover-up stonewalling

 

Related items

Protect your baby

Baby-blinding lights
LIGHT-ROP Manual
Macular degeneration
Preemie Pain
Parent Concerns

 Skeptics' Test

 Help for Victims?

Re-Tuskegee

Bioethics LIGHT-ROP

Bioethics SUPPORT

Bioethics own violations

Bioethics Consent

Bioethics 1955 Oxygen

Unethical Bioethics 1

Unethical Bioethics 2

Unethical Bioethics 3

Unethical Bioethics 4

Hypocritical Nature
False Medical Denials

Pre-Nuremberg Bioethics

Protect Humans in Research

Australian Denial Cult >>>

Avaaz Petition to WHO


TV transcripts
on baby-blinding

Good Morning America
CBC Market Place
USA Today

 

Print coverage
The New York Times
Newsweek
Parade Magazine
Aesclepius

About us

 

 

 


 


 

  

 

  

 

Protect Human Subjects in Medical Research
Peter Aleff, prevent@retinopathyofprematurity.org   July 10, 2013 
    

     
 

 

Cult-like denial of Australian preemie suffocation experiments

Since the SUPPORT experiment was conducted under the umbrella of the NeOProM group of trials administered by the University of Sydney in Australia, I also posted a comment in response to a discussion on 8/16/2013 about breaches of medical ethics regulations in Australia, as offered online at  https://theconversation.com/what-australia-should-do-to-ensure-research-integrity-17091#comments. This comment led to the following thread:

Peter Aleff, Independent researcher, posted on August 16, 2013

The authors say correctly that "The importance of adequate regulation for maintaining the integrity of medical research cannot be overstated." However, although regulations such as those based on the Nuremberg Code are very clear, they have been disregarded not only in the example of cancer research cited in the article but even more blatantly in the recent Australian-led NeOProM international experiments of suffocating premature babies without parental consent, as posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf.
 
These knowingly fatal experiments of restricting the life-saving oxygen breathing help for premature babies were conducted in the lopsided hope of maybe preventing some eye damage. They were coordinated by the University of Sydney and included the BOOST II experiment in Australia, in parallel to BOOST II UK and BOOST NZ. The combined results of these three trials were published on May 5, 2013, at NEJM.org under the title "Oxygen Saturation and Outcomes in Preterm Infants" and predictably reported a significantly higher rate of death in the low-oxygen groups.

No parents informed about the well-known risks from these unethical experiments could have legally consented on behalf of their baby because risking death to maybe prevent blindness is clearly not in the interest of their child.
 
In the U.S., the parallel experiment under the NeOProM umbrella was called SUPPORT and killed 23 "extra" babies in the low oxygen group. The U.S. Office for Human Research Protections will hold a public hearing on August 28 to examine why none of the alleged consent forms mentioned the well-known risks created by the research, and how all the Institutional Review Boards involved could have approved this pre-meditated killing of the most vulnerable babies. For details on this hearing see http://retinopathyofprematurity.org/ProtectHumanResearchSubjects.htm
If the Australian regulators are serious about enforcing basic ethics codes in their country, they should conduct a similar inquiry about how these pre-Nuremberg-style medical abuses were allowed without parental consent for the equally deceptive BOOST II experiments."

It will be instructive to observe which of these countries will act to enforce its regulations about ethics in medical research, instead of just pontificating about the importance of the Nuremberg Code and later declarations of medical ethics in research on human subjects.
 

Mark Amey  posted on August 17, 2013,

in reply to Peter Aleff
'international experiments of suffocating premature babies without parental consent...' No, I think you will probably find, if you look a bit further, that BOOST II was an oxygen saturation targeting trial for preterm babies, given that, at that stage, no one knew what the appropriate saturation targets for these infants should be.

'These knowingly fatal experiments of restricting the life-saving oxygen breathing help for premature babies were conducted in the lopsided hope of maybe preventing some eye damage. ' No infant who required supplemental oxygen during the trial had such treatment withheld. There was no 'lop-sided hope' to prevent eye damage.

'and predictably reported a significantly higher rate of death in the low-oxygen groups. ', no not predictably. These preterm infants still had MUCH higher saturations than they would have in utero, and higher saturations than many infants with cardiac anomalies.

It seems to me that you are ingenuous towards the intentions of the trial authors, and the participating institutions.

 

Peter Aleff  posted on August 17, 2013,

in reply to Mark Amey
The BOOST II researchers restricted the oxygen supplementation of half the babies to values between 85 and 89 percent arterial saturation, as opposed to the standard of care which was 85 to 95 or even 98 percent. They knew that the lower oxygen levels were strongly associated with higher mortality, as documented again and again over more than 50 years of fumbling around with restricting this breathing help.
The oxygen saturations in utero are irrelevant once the babies are breathing through their lungs.

The experiment designers knew beforehand that they could not tell the parents about the known risks from their restricting the oxygen. They had advocated beforehand that this "defensive documentation" would reduce the number of enrolled babies. In the US branch of this same parallel experiment it turned out that none of the participating hospitals had informed the parents about the risks, and I suggest you check the actual consent forms that the parents were given in Australia.
If these had described the known actual risks, no parent could legally have agreed to expose their child to the increased risk of death just for the unconfirmed hope of preventing some eye damage. Knowingly exposing the children to the increased risk of death from low oxygen levels is a violation of the Nuremberg Code and other declarations of medical ethics, no matter how anyone may try to cover up this undeniable fact.

The difference is that in the US there was a complaint about this violation which is being investigated whereas in Australia it appears that no one raised any questions.
 

Mark Amey posted on August 18, 2013

in reply to Peter Aleff
'standard of care which was 85 to 95 or even 98 percent' No, the standard of care for these infants wasn't 98 % saturations at this time.

'They knew that the lower oxygen levels were strongly associated with higher mortality, as documented again and again over more than 50 years of fumbling around with restricting this breathing help. ' Yes, restriction of supplemental oxygen, without measurement of oxygen saturation, was experimented with in the 60s, and resulted in increased death in preterms (bear in mind that the pulse oximeter hadn't been invented at that stage, but, saturations in the mid-80s had not been associated with a higher risk of death (otherwise the BOOST II trial wouldn't have been conducted: http://www.nejm.org/doi/full/10.1056/NEJMc1304827

The BOOST II trial consent form does not mention a higher risk of death in the lower target oxygenation group (but this hadn't been demonstrated at this time). This is very similar to the SUPPORT trial (http://www.nejm.org/doi/full/10.1056/NEJMe1304996) you mentioned above.

The researchers involved in the BOOST II trial demonstrate a great deal of integrity in that, the safety of the trial assessed through pooled analysis mid-way through the trial, and the trial discontinued. The authors made these results public very quickly through a number of journals.

Peter, do you really believe that clinicians enroll patients in clinical trials where the risk of death, or severe outcome is not disclosed??

 

  • Peter Aleff posted on August 18, 2013,

    Iin reply to Mark Amey
    The "standard of care" of 85 to 95 percent oxygen is an arbitrary definition since some hospitals in the informal pre-trial survey and earlier studies had aimed for up to 98 percent arterial oxygen saturation.

    The researchers' alleged ignorance of the risks from oxygen restricting does not withstand scrutiny since the NeOProM proposal had already stated that

    " none [of these five trials] individually will be able to exclude the possibility that the expected valuable short term benefits associated with giving babies less oxygen are not associated with a small but significant 4 per cent increase in death or serious neurosensory disability in survivors.

    Similarly, the SUPPORT researchers had written that "the safety of the infants in the low-oxygen group remains a concern." However, none of this concern and expectation of increases in death and brain damage were conveyed in the SUPPORT consent forms. They also cannot have been mentioned in those for the BOOST II experiments either because no parent could have volunteered to expose their child to those risks.

    The higher risks of death and brain damage in the low-oxygen group had thus been predicted, and it took a significant number of actual deaths to make the BOOST researchers at long last discontinue their fatal experiment.

    Yes, Mark, the clinicians in the SUPPORT experiment enrolled patients without disclosing the known risks of death and severe brain damage, and only two of 22 consent forms mentioned a potential risk of blindness. See the several comments submitted by medical professionals in the US for the upcoming public meeting about these ethics violations at http://www.regulations.gov under the docket number HHS-OPHS-2013-0004.

    It is likely that the BOOST II researchers also hid those risks, or else they could not have enrolled anyone informed about those risks.

    Unfortunately, these ethics violations in experiments on premature babies are not exceptional but have been frequent in the tinkering with the oxygen breathing help, beginning with the unethical 1950s suffocation studies that led to the belatedly acknowledged mass asphyxiations of at least 150,000 babies in the US alone during the first two decades of oxygen rationing.

    Premature babies are even more helpless than inmates of concentration camps, and their freshly minted parents, parachuted into the alien environment of intensive care nurseries, are in no position to defend them against cruel medical research abuses like those that led to the Nuremberg Code to begin with.

    Moreover, all those lethal attempts to prevent blinding from excess oxygen are entirely misguided because they willfully ignore a vast body of scientific literature about retinal damage from the blue light emitted in high doses by the fluorescent nursery lamps. A preemie in a typical intensive care nursery receives in less than fifteen minutes the overdose of blue-light hazard which the US industrial safety guidelines have set as the danger limit for adult industrial workers.

    The entire epidemic of baby-blinding from retinopathy of prematurity started in the US the year after the commercial introduction of fluorescent lamps, and a few years later in other industrial countries as these lamps became available there. For details, see http://retinopathyofprematurity.org/01summary.htm and the full documentation on the pages linked to that one.

    To answer the original question in the title of the present article, if Australia wants to ensure research integrity, it should first make sure that researchers are familiar with the scientific literature on their topic instead of only what they find in their narrow echo chamber.
     

  • Response by Mark Amey to Peter Aleff

    On Monday, August 19, 2013 at 3:25 AM, The Conversation <support@theconversation.com> wrote:
    "Thanks for that reference, ! didn't understand that i was part of a eugenics cult by working in neonatal intensive care for the last 25 years. I'll file that link with 'UFO's abducted my in my sleep'!!"

     

    Peter Aleff posted on August 19, 2013

    Thank you, Mark, for suggesting the word that had eluded me in my attempts to describe the proponents of oxygen restrictions for premature babies. Their designation as "cult" conveys properly their uncritical acceptance of a bogus dogma and their unwillingness to accept evidence from outside their hermetic bubble, regardless how well that evidence is documented with conventional sources.

    The members of this cult like to forget that their lethal practice of oxygen rationing originated from some diehard eugenicists' desire to "not preserve the lives of those defectives". They keep blaming life-saving oxygen for the epidemic of baby-blinding that started with the introduction of fluorescent lamps, and they try to divert attention from the fact that by then, oxygen breathing help had been safely and generously administered for many decades without ever causing any eye damage.

    Until the members of this cult accept these historical facts, they will continue their misguided and patient-harming practice, and there will be more attempts to justify the knowingly fatal oxygen-restricting with unethical experiments like the recent BOOST II that have to be conducted without informed parental consent.

    You asserted earlier that the increased risk of death from low oxygen was unknown at the time the BOOST II experiment started. Yet, you have not retracted that patently false assertion after I documented to you that the researchers themselves had anticipated the higher rate of death in their low-oxygen group and had even expressed concern about the safety of the babies in it.

    There will be no integrity in clinical research on premature babies as long as researchers and their defenders are allowed to follow this pattern of cult behavior and to continue treating human babies as disposable guinea pigs, as in BOOST II.

    The US Office of Human Research Protection is now reacting to this violation of basic medical ethics, and if there is an Australian counterpart that is serious about enforcing research integrity, it will have to do the same.

     

    Added in my email confirmation of this post: So much for my public response to your post. And just among us, I suggest you chain yourself to your bed to prevent being abducted by those UFOs. 
    Best wishes, Peter Aleff

    Mia Masters, pensioner, posted on August 20, 2013,

    in reply to Mark Amey
    BMJ 2013 online 9 July

    N Engl J Med 2013; 368:2094-104

    N Engl J Med 2010;362:1959-69

     

    Peter Aleff posted on August 20, 2013, in response to Mia Masters

    Mia, the links you offered lead to the official reports by the researchers themselves. To put these in perspective, see also the comments about these reports cited below:

    On July 11, 2013, a self-described "group of physicians, bioethicists, and scholars in allied fields" agreed with the Office of Human Research Protections and stated that the consent forms for the SUPPORT experiment failed in each of the elements required by the U.S. Federal Regulations. These critics said clearly that the oxygen interventions for the two groups in that experiment had been different from standard care, and that the potential difference in the risks was "reasonably foreseeable since determining differential risk was the very purpose of the study." [Macklin R., Shepherd L., Dreger A., and Asch A.: "The OHRP and SUPPORT -- Another View", New England Journal of Medicine, http://www.nejm.org/doi/full/10.1056/NEJMc1308015]

    What these authors say about the SUPPORT experiment applies equally to BOOST II which was a parallel trial and could not have disclosed the well-known risks either because no parent could legally have consented to volunteer their child for this potentially lethal medical experiment.

    For more about the flaws in this entire series of NeOProM baby-suffocation experiments, see my page http://retinopathyofprematurity.org/ProtectHumanResearchSubjects.htm.

    See also an analysis of the lies offered by the U.S. medical community in defense of the SUPPORT experiment posted at http://www.ahrp.org/cms/content/view/925/9/  by Vera Sharav, President of the Alliance for Human Research Protection.

    On 8-21-2013 I sent the following email with the subject line
    "Unethical BOOST suffocation experiment on premature babies"
    to minister.plibersek@health.gov.au
     

    To the Honorable Tanya Plibersek, Minister of Health, Commonwealth of Australia
     
    Dear Minister Plibersek,
     
    I want to draw your attention to an unethical and lethal clinical experiment of restricting oxygen breathing help for premature babies that was conducted recently both in Australia and in several other countries under Australian supervision and direction. The umbrella study protocol was published in BMC Pediatrics (2011) 11:6 under the title NeOProM (Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol) by the NHMRC Clinical Trials Centre, University of Sydney, at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf .
     
    The experiment components in the UK, Australia, and New Zealand were conducted under the names BOOST II UK, BOOST II AU, and BOOST NZ. They were funded by the Australian National Health and Medical Research Council and others, with the BOOST II Current Controlled Trials number ISRCTN00842661, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606 and ACTRN12605000253606.  Their combined results were reported on May 30, 2013, in the New England Journal of Medicine 2013; 368:2094-2104, as posted at http://www.nejm.org/doi/pdf/10.1056/NEJMoa1302298.
     
    I live in the U.S. and complained to the U.S. Office of Human Research Protection (OHRP) about the U.S. parallel to this experiment which had the acronym SUPPORT and was published in the May 16, 2010, online issue of the NEJM under the title "Target Ranges of Oxygen Saturation in Extremely Preterm Infants" at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781.
     
    In my complaint, which applies equally to the BOOST protocols, I drew the attention of the OHRP to the fact that the SUPPORT researchers had deliberately exposed the infants enrolled in their low-oxygen groups to an increased risk of death in their attempt to see whether the lower arterial oxygen saturation in that group would reduce the rate of blinding from retinopathy of prematurity. They predictably killed 23 "extra" babies in that group, with a 96 percent probability that these deaths were correlated with their reduced oxygenation. I also pointed out that this must have been done without the informed consent of the parents because no parent would have had the right of volunteering their child for this cruel asphyxiation experiment which was not at all in the interest of that child and exposed it to fatal risks without any corresponding benefit.
     
    Both this pre-meditated killing of many babies as well as the deception of the parents about the known risks are of course gross violations of the Nuremberg Code and of the various subsequent declarations of medical ethics for research on human subjects. After almost two years of investigation, the OHRP agreed that the consent forms had failed to state any of the reasonably foreseeable risks, and they issued a "letter of determination" to the leader of the SUPPORT experiment.
     
    A month later, the consumer protection organizations Public Citizen and Alliance for Human Research Protection alerted the press to these violations and triggered a wave of denials from the researchers and other members of the U.S. medical community who all claimed that the risks had not been foreseeable. They made these denials despite clear documentation that the researchers themselves had expected an increase of four percent in the rate of death and severe disabilities, and that they had expressed "concern about the safety of the infants in the low-oxygen groups". They, and assorted "bioethicists", also claimed that the intervention of separating the babies into groups with 85 to 89 percent and 91 to 95 percent oxygen saturations fell within the "standard of care" which they defined as the entire range from 85 to 95 percent.
     
    These false claims were debunked in several analytical letters by Public Citizen and also by a self-described "group of physicians, bioethicists, and scholars in allied fields" who agreed with the OHRP. They stated that
     
    "... the consent forms for the SUPPORT experiment failed in each of the elements required by the U.S. Federal Regulations. These critics said clearly that the oxygen interventions for the two groups in that experiment had been different from standard care, and that the potential difference in the risks was "reasonably foreseeable since determining differential risk was the very purpose of the study." [Macklin R., Shepherd L., Dreger A., and Asch A.: "The OHRP and SUPPORT -- Another View", New England Journal of Medicine, http://www.nejm.org/doi/full/10.1056/NEJMc1308015]
    In addition, Vera Sharav, President of the Alliance for Human Research Protection, wrote a detailed rebuttal of the blatant lies offered in defense of the SUPPORT experiment, see http://www.ahrp.org/cms/content/view/925/9/
     
    In response, the OHRP announced a public meeting, to be held on August 28, to discuss the requirements for informed consent for experiments alleged to be within the "standard of care" and invited comments. The announcement of the meeting is posted at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-15160.pdf, and the written comments are collected at http://www.regulations.gov under the docket number HHS-OPHS-2013-0004.
     
    I had further complained that the researchers had not complied with their obligation to be familiar with the scientific literature on the subject they proposed to study. The reason for their experiment was to compare the outcomes of death and severe disabilities with the incidence of blinding from retinopathy of prematurity. They stubbornly maintain against all evidence that this blinding is caused by excess oxygen, and they willfully ignore a large body of scientific literature about retinal damage from light, particularly from the well-defined blue-light hazard to which the infants are exposed from the fluorescent lighting in typical intensive care nurseries.
     
    Fluorescent lamps emit a large protion of their radiation in the most retina-damaging wavelengths, with a spike at 435.8 nanometers right in the middle of the area of highest vulnerability which is the range from 430 to 440 nm. The typical nursery lighting exposes the retinae of a preemie in less than fifteen minutes to the dose of damage-weighted retinal irradiance that the U.S. Industrial Safety Guidelines have designated as the danger limit for adult industrial workers, as I documented on the series of web pages that begins with http://retinopathyofprematurity.org/Babyblindinglights01.htm.
     
    The researchers obsessed with oxygen throttling and baby-suffocating also refuse to acknowledge that oxygen had been given routinely and generously to premature babies for many decades before the first one ever developed any retinopathy of prematurity, and that this still continuing epidemic of baby-blinding started in the U.S. in 1940, the year after the commercial introduction of fluorescent lamps. The same parallel repeated itself after World War 2 in other industrial countries as these lamps became available there, but the oxygen-researchers don't want to know about that.
     
    For a typical example of this rote and Flat-Earth-cult-like denial of wrongdoing by oxygen restricting and of blinding by excess light, see, for instance, the online exchange I had recently with an Australian neonatologist, Dr. Mark Amey, who defended the BOOST II experiment against all logic and reason and ethics. You will find this exchange in the last third of the page https://theconversation.com/what-australia-should-do-to-ensure-research-integrity-17091#comments.
     
     
    I am therefore asking you to please investigate how the NeOProM and BOOST II researchers could knowingly expose human babies to an increased risk of death in violation of all medical ethics and also of your country's relevant regulations, why they did so behind the backs of the parents without obtaining their informed consent, and why they launched this risky and expensive series of futile asphyxiation experiments without first checking the most obvious reason for the epidemic of eye damage which is the retina-damaging nursery lighting.
     
    Thank you in advance for anything you can do to protect your country's premature babies from the severe harm inflicted by their doctors, and to thereby end the current epidemic of baby-blinding.
     
    Sincerely,
     
    Peter Aleff
     

     

     

     
     

    Return to navigation bar    Back to top     About us
    Our Privacy Policy     Useful Links    

    Contact us at retinopathyofprematurity.org
    2097 Cottonwood Drive, Vineland, NJ 08361  USA
    All not otherwise credited material on this site is
    1986 to 2014 H. Peter Aleff All rights reserved.
    This site was last updated on January 3, 2015