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Preemie vulnerabilities
Studies of light and ROP
Frauds in LIGHT-ROP
Cover-up stonewalling

 

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Hypocritical Nature
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Deceptive ROP Research

Article submitted to PLoS Medicine,
and correspondence about its rejection

Peter Aleff, prevent@retinopathyofprematurity.org November, 2014 
    

     
 

This page contains
-- the abstract of my paper Deceptive ROP Research
-- the text of that paper and its illustrations
-- its endnotes
-- my pre-submission cover letter to PLoSMedicine of 11/6/2014
-- email from Dr, Amy Ross, PLosMedicine, on 11/7/2014
-- my reply to Dr. Amy Ross on 11/8/2014
-- email from Dr. Amy Ross, PLoSMedicine, on 11/10/2014
-- my reply to Dr. Amy Ross on 11/12/2014

-- email from Dr. Amy Ross, PLoSMedicine, on 11/12/2014
-- email from Maya Sandler, PLoSMedicine, on 11/12/2014
-- my reply to PLoSMedicine on 11/17/2014

-- email from Dr. Paul Simpson, PLoSMedicine, on 11/18/2014
-- my reply to Dr. Paul Simpson, on 11/21/2014

-- comment by Vera Sharav, President,
   Alliance for Human Research Protection, on 11/21/2014

Patient-harming deceits in medical research about baby-blinding Retinopathy of Prematurity (ROP)   
by Peter Aleff

Short Title: Deceptive ROP Research

Abstract: The recent confirmation by the U.S. Office for Human Research Protection that the high-risk SUPPORT experiment of reducing the oxygen levels for some premature babies was conducted without the informed consent of the parents, and the contrived attempts by many members of the medical community to defend this blatant ethics violation, suggest a long overdue scrutiny of the prior research about ROP that led to this latest perversion. It turns out that the initial 1954/5 show trial which recommended the rationing of this life-saving breathing help was a thinly disguised crypto-eugenic euthanasia program to eliminate the “defective germ plasm” of the babies most at risk for being blinded by ROP. Its knowingly false and never verified dogma killed at least 150,000 infants in its first two decades, but this massacre has neither been stopped nor investigated. When evidence became available that the real reason for the blinding was the bright fluorescent nursery lighting, most doctors denied this inconvenient fact, and some pediatric retinal surgeons rigged another bogus experiment, this one to falsely assert the innocence of this excess irradiation and to continue the baby-blinding epidemic. It is time to introduce real science into this evidence-disdaining and patient-harming area of medicine.

*

On October 20, 2014, the U.S. Office for Human Research Protection (OHRP) confirmed its earlier finding that the researchers responsible for the NIH-funded SUPPORT experiment of reducing the oxygen breathing help for premature babies had failed to inform the parents about the significant risks associated with their study[1]. In their clinical paper about it, these researchers had cited the background information that the first two decades of the oxygen restrictions, introduced in 1955 to prevent the blinding from ROP, had killed 150,000 children, and that many subsequent attempts to establish an optimal level of oxygenation for the infants had remained inconclusive. Although some of these had again shown an increased mortality with lower oxygen saturation levels, they expressed the hope that modern measuring methods of oximetry would allow a better calibration for the administration of oxygen, and that this would somehow reduce the consistently encountered mortality increase from restricting it.

However, the SUPPORT researchers still expected that about four percent of the babies in the low-oxygen group would either die or suffer permanent brain damage from the lack of this life-saving gas[2]. In fact, they recorded 23 “extra” deaths in their low-oxygen group, or 3.5 percent of the babies enrolled in it, close to their expectation and with a probability of 96 percent that these deaths were correlated with the oxygen reduction. They have not yet reported the incidence of severe brain damage to be expected from this regimen and to be added to this toll.

Clearly, if any parents had been informed about these well-known risks they could not have legally consented to offer their child for this dangerous experiment. They are allowed to make decisions on behalf of that child only for his or her benefit. Yet, despite the obvious impossibility to obtain the informed consent of the parents, this knowingly baby-suffocating medical research atrocity was approved by the U.S. National Institutes of Health and by the Institutional Review Boards at all 22 participating hospitals. It exposes the consistent failure of all the alleged safeguards at all levels of the U.S. health system. It also shows that all the solemn “never again” vows about the inhumane Human Radiation Experiments and the official apologies for the equally infamous syphilis studies in Tuskegee and Guatemala were just window dressing.

Parallel studies with the same protocol were launched in Australia, New Zealand, and the UK under the names BOOST II, BOOST NZ, and BOOST UK, plus a Canadian version called COT which was conducted not only in several Canadian hospitals but also recruited study sites in Argentina, Finland, Germany, Israel, and the U.S.[3]. In none of these countries did any of the many involved officials object to this premeditated abuse and asphyxiating of extremely vulnerable research subjects. Even the OHRP did not react to the planning or conduct of the study but had to be alerted to the blatant ethics violations by an outsider a year after its publication[4]. Then it took two years to send a “letter of determination” to the lead researcher to complain about the lack of informed parental consent. It never addressed the even more serious violation that the researchers had intentionally exposed their subjects to an increased risk of death for their research to prevent blindness which is a non-fatal condition and does in no way justify such a risk. The OHRP did not object to their having thereby killed 23 “extra” children although this premeditated homicide for medical research is no different from the medical atrocities that led to the Nuremberg Code.

Moreover, the OHRP suspended any penalty for the researchers or for the rubberstamping IRB reviewers when it encountered a flurry of objections against its no-consent “determination” not only from the researchers themselves but also from many bioethicists and the editor of the New England Journal of Medicine as well as from top officials at the NIH. All these apologists claimed against all evidence that there had been no foreseeable risks although the researchers had described those risks, and the entire US$20million study had been conducted to quantify those very risks.

Even worse, the Directors of the NIH and two of its Departments not only defended this plainly unethical protocol but also offered the irresponsibly misleading and potentially lethal assertion that oxygen saturation levels as low as 70 percent were safe[5]. However, the authors of the study they cited had specifically stated that the infants in their trial were virtually never at this merely nominal low level[6]. Also, three of the SUPPORT researchers had written in a letter to the editor at the NEJM: “Infants who died spent a higher proportion of time (p < 0.001) with saturations below 80 percent.”[7] Yet, these leaders of the U.S. Health system misrepresented the known facts with a new and recklessly patient-endangering lie to cover up the earlier crime they had approved and funded.

And while the Presidential Commission for the Study of Bioethical Issues assured the U.S. President and the American people that subjects of medical research were now adequately protected against abuses like those in the Tuskegee and Guatemala syphilis studies it ritually condemned, the Universities led by the Chair and Vice-Chair of that Commission actively participated in the deceptive and knowingly lethal and therefore even worse abuses of the SUPPORT experiment[8].  

Besides killing some of their subjects for their research and concealing that well-known risk from the parents, the SUPPORT researchers also ignored their obligation to base their experiment on a thorough knowledge of the scientific background and a careful assessment of the risks and benefits, as required by the Nuremberg Code and the Helsinki Declarations of Medical Ethics for Human Experimentation. Their goal was to prevent or reduce the blinding of the infants from ROP which they gullibly assumed, against historical evidence, to be caused by excess oxygen.

The first babies ever to suffer from ROP were born in 1940. By then, nursery doctors had administered oxygen supplements to premature babies routinely and generously for many decades[9]. Although some current writers on ROP try to contrive scenarios of a change in oxygen practices at that time, these are transparent ad hoc inventions to retroactively blame oxygen, and there neither was nor is any rational reason to link the new and quickly epidemic form of blinding to this long established and consistently life-saving treatment. However, blindness had been a favorite target of eugenicists[10] whose pseudo-science dominated medical thinking to the point that most U.S. states passed medically inspired sterilization laws to keep the “undesirables” from contaminating the gene pool. And some of the most influential American ophthalmologists at the time believed that ROP was caused by “defective germ plasm”.

One of them, Dr. Algernon B. Reese, wrote a series of learned-looking papers to assert the allegedly prenatal origin of the eye damage. He presented the latest of these at the June 23, 1948, meeting of the American Medical Association’s Section on Ophthalmology where he and his like-minded colleagues recommended that the best way to deal with the epidemic was to “not be so zealous in preserving defective persons, of which the world has a sufficient quantity already”[11].

The most effective way to preserve the lives of premature babies was and is to help their still immature lungs with supplemental oxygen, so this group of doctors began a smear campaign against this “undeserved subsidy”[12] and then launched in 1953 the multi-hospital Cooperative Study to blame ROP on that oxygen breathing help[13].

That study was a flagrant research fraud. Its designers withheld the oxygen from virtually all babies for the first two days and then only enrolled the survivors of this brutal weeding in their study. By that time, 45 percent of the babies had died[14], as compared with 32 percent of similar babies who had died in the first seven days in one of the study hospitals during the immediately preceding two years[15].

However, the designers of this Cooperative Study concealed this better-dead-than-blind carnage and deceptively claimed that they had practically wiped out the blinding without affecting the survival rate. Instead, they had killed the babies who would otherwise have grown up blind, but their authoritative lie and welcome prevention message instantly led nursery doctors around the world to severely restrict the breathing help for all preemies although they must have known that oxygen could not suddenly have become the culprit after so many decades of life-saving without blinding. As the SUPPORT authors stated in their paper, this Draconian suffocation policy killed in the U.S. alone an estimated 150,000 infants during its first two decades. The lack of oxygen also inflicted severe brain damage, such as cerebral palsy, on many of the survivors. Yet, no one has held the medical community accountable for this massive massacre and maiming which cannot be explained away as mere error or ignorance.

Already the discoverer of ROP had written early-on that the most logical cause for this damage to the most light-sensitive organ was the babies’ premature exposure to light. Although he did not yet connect these dots, he was right because 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.

Reese and a few other doctors pretended to test the effect of light during their campaign of blaming oxygen, but they all patched the eyes of the allegedly protected infants only up to 24 hours after birth[16]. They knew that thermal eye damage from intense light, such as staring at the sun or at a welding arc, accumulates within a few seconds. Lesser intensities act just slightly slower through a photochemical process.

Systematic research from the 1960s on to prevent eye damage from industrial lasers showed indeed that bright light inflicted its latent damage in a matter of minutes, not multiple hours. It also established that the most retina-damaging light is in the “blue-light-hazard” wavelength region from 430 to 440 nanometers. Fluorescent lamps emit a major part of their energy at 435.8 nm. Adult eyes are somewhat protected from that hazard because our lens and vitreous become yellow as they age and so do not let all this blue-violet penetrate to the retina. By contrast, the eyes of babies are still very transparent and lack this protection, and those of preemies are even more vulnerable because their retinal vessels are still developing and are therefore extremely sensitive to any irradiation. Yet, 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 established as the danger limit for adult workers over an eight-hour shift[17].

Bluelightbarrier

 

Fluorescent lamp spectrum
 
The yellow curve shows the spectrum emitted by the Deluxe Cool White lamp from Sylvania which is similar to that from other makers of the same model. The horizontal axis gives the wavelength in nanometers and the vertical axis the intensity of the irradiation in Watts per ten nanometers. The tallest spike is at 435.8 nanometer in all fluorescent lamps. It is actually higher than shown on this graph which averages the energies over bands 10 nm wide. This wavelength is right in the middle of the area of greatest vulnerability to blue-light damage for all mammalian retinae which ranges from about 430 to 440 nanometers and is here represented by the gap in the red “retinal protection barrier”.

(Graph by the author: Bluelightbarrier.tif)

 

EyePatchedPreem02

 

Blinding preemies with nursery lamps

The eyes of this premature baby are patched to protect them from the bright fluorescent lamps used to reduce the bilirubin level in his bloodstream.  These bilirubin lamps are only three to five times brighter than the typical intensive care nursery lighting to which the babies' unprotected retinae are exposed 24 hours a day. They are well-known to cause eye damage, but the only slightly less intense regular ceiling lamps are somehow deemed safe, without any evidence.

(Image: EyePatchedPreemie02.tif, photo by author)

 

To test the role of light, researchers in three D.C. area hospitals covered in 1982 all the incubators with gray filters to reduce the irradiation of the babies from 60 foot-candles to 25 ftc. This drastically reduced the incidence as well as severity of ROP in all the birth weight groups, with a chance of only one in a hundred for the smallest babies that this might be a fluke. However, some doctors quibbled that this study was of the before-and-after type, and this gave them a pretext to reject these embarrassing findings[18].

This flimsy excuse did not convince the public, so two pediatric retinal surgeons rigged another bogus experiment to silence the critics of the nursery lighting. Although many of the references these surgeons cited described light damage from short exposures, they again delayed the eye patching in their allegedly protected group and so again “proved” the innocence of the fluorescent lamps[19]. Their knowingly false result is now enshrined as the reigning dogma. This as well as the oxygen fraud need to be exposed and corrected before any progress can be made to end the ROP epidemic.


Endnotes:


[1] See the Federal Register for the OHRP draft about which research risks need to be disclosed: Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care, posted at http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2014-0005-00. This is hair-splitting sophistry, as if the Nuremberg Code’s mandate to disclose “all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment” were not clear enough.

[2]  Support Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network: “Target Ranges of Oxygen Saturation in Extremely Preterm Infants”, posted in the May 16, 2010, online issue of the New England Journal of Medicine, at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781

[3] All these experiments were conducted in parallel as part of the international NeOPrOM study, headquartered in Sydney, Australia. It is posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf. See Askie LM, Brocklehurst P, Darlow BA, et al.: “NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol”, BMC Pediatrics, January 17, 2011, see page 10 for the description of the founding group, and Table 1 on pages 28 to 30 for a comparison of these five parallel studies. The combined results of the three BOOST 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. The results of the COT trials are discussed at Eduardo Bancalari, MD; Nelson Claure, MSc, PhD: "Oxygenation Targets and Outcomes in Premature Infants", JAMA. 2013;309(20):2161-2162. doi:10.1001/jama.2013.5831, http://jama.jamanetwork.com/article.aspx?articleid=1684964. That discussion includes this gem of trying to explain away the fatal effect of oxygen restriction: “Data from infants enrolled in COT after the pulse oximeter software update showed 2.7 percent higher mortality in the lower compared with the higher saturation target group. However, this difference was due to a decrease in mortality in the higher saturation group rather than a change in the lower group with the new software.”

[4] See the second half of my page “Alleged Parental Consent Forms” for the relevant correspondence with OHRP, as posted at http://retinopathyofprematurity.org/48BioethicsConsent.htm. The OHRP’s inertia raises the question: what is the value of a watchdog whom you have to wake up and then ask to please bark?

[5] Kathy L. Hudson, Ph.D., Alan E. Guttmacher, M.D., and Francis S. Collins, M.D., Ph.D.: “In Support of SUPPORT — A View from the NIH”, N Engl J Med 2013; 368:2349-2351, June 20, 2013 DOI: 10.1056/NEJMp1306986, as posted at http://www.nejm.org/doi/full/10.1056/NEJMp1306986rss=searchAndBrowse

[6] Tin W, Milligan DW, Pennefather P, Hey E. "Pulse oximetry, severe retinopathy, and outcome at one year in babies of less than 28 weeks gestation", (Arch Dis Child Fetal Neonatal Ed 2001;84:F106-F110).

[7] Waldemar A. Carlo, M.D., Neil N. Finer, M.D., Marie G. Gantz, Ph.D., reply to “Letter to the Editor”, n engl j med 363;13 nejm.org september 23, 2010, as posted at http://www.nejm.org/doi/pdf/10.1056/NEJMc1007912

[9]  See, for instance, Hess JH. “Oxygen Unit for Premature and Very Young Infants”.  American Journal of Diseases of Children, April 1934, 47: 916-917, see page 917 for birth weights. For more examples dating back as far as 1893, go to http://retinopathyofprematurity.org/22oxygenslander.htm

[11]Abstract of Discussion” after Algernon B. Reese, M.D., New York: “Persistence and Hyperplasia of Primary Vitreous; Retrolental Fibroplasia -- Two Entities”; in Archives of Ophthalmology, Vol. 41, Nr. 5, May 1949, paper on pages 527-549, quote on page 550 top, as also cited in http://retinopathyofprematurity.org/01Summary.htm .

[13] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543.

[14] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see Table 8A on last, unnumbered, page of  Appendix.

[15] Silverman WA, Blodi FC, Locke JC, Day RL, Reese AB: “Incidence of retrolental fibroplasia in a New York nursery”, Archives of Ophthalmology, 1952, 48:698-711, see page 698 for admissions, birth weight, and mortality.

[16] LOCKE JC, REESE AB. Retrolental fibroplasia - the negative role of light, mydriatics, and the ophthalmoscopic examination in its etiology. Arch Ophthalmol 1952: 48: 44 47 (see page 44), as discussed at  http://retinopathyofprematurity.org/37studiesoflightandROP.htm

[17] See my peer-reviewed report “Baby-blinding retinopathy of prematurity and intensive care nursery lighting”, Iatrogenics  (The Official Journal of the International Society for the Prevention of Iatrogenic Complications--ISPIC) Volume 1, Issue 2, dated April-June 1991: 2: 68-85 but distributed in Summer 1992. It is posted at http://retinopathyofprematurity.org/Babyblindinglights01.htm

[18] GLASS P, AVERY GB, SLUBRAMIANIAN KNS, KEYS MP, SOSTEK AM, FRIENDLY DS. Effects of bright light in the hospital nursery on the incidence of retinopathy of prematurity. New Engl J Med 1985: 313: 401-4, as discussed at http://retinopathyofprematurity.org/37studiesoflightandROP.htm

[19] Reynolds JD, Hardy RJ, Kennedy KA, Spencer R, van Heuven WAJ, Fielder AR for the LIGHT-ROP Cooperative Group: Lack of Efficacy of Light Reduction in Preventing Retinopathy of Prematurity, NEJM May 28, 1998, 338 (22):1572–6. See the discussion of the frauds in this experiment at http://retinopathyofprematurity.org/40fraudsinLIGHTROP.htm. Also, some of the most incriminating portions from the Manual of Procedures for that rigged LIGHT-ROP trial are posted on the pages beginning at http://retinopathyofprematurity.org/LIGHT_ROP_Manual01.htm 

 

My Cover letter to PLoS Medicine of November 6, 2014

From: Peter Aleff, 2097 Cottonwood Drive, Vineland, NJ 08361 USA    
prevent@retinopathyofprematurity.org

To the PLOS Editor:

Please find in the next file my pre-submission article “Patient-harming deceits in medical research about baby-blinding Retinopathy of Prematurity (ROP)” which can also be described with the short title “Deceptive ROP Research”.

That article for your “Health in Action” magazine is meant to help researchers in the area of ROP to break free from the current dead-end of blaming oxygen for the continued epidemic of baby-blinding and to address at long last its real cause which is the excessive irradiation of premature babies with the concentrated “blue-light-hazard” of fluorescent lamps. Past medical investigations about this condition have been marred not only by blatant research frauds which I document in detail but also by a blind adherence of well-meaning but uncritical practitioners to the medical dogma created by these misleading frauds.

I hope therefore that your audience includes some real scientists who are able to question a prevailing opinion and to replace it with documented facts, and that you will present these facts to them. You will thereby help save many premature babies around the world from the blinding ignorance of their doctors about the role of nursery lighting in the eye damage they keep inflicting on these most vulnerable of all patients.   

My interest in this area of medicine was triggered 30 years ago by the premature birth of my son David who is blind from retinopathy of prematurity and brain-damaged from the lack of oxygen that his doctors and nurses throttled in the mistaken belief that this would prevent the eye damage he incurred anyway. Shortly after the last of his many unsuccessful eye operations I accepted a position as manager of a factory that cured inks with ultraviolet light, and I familiarized myself with the industrial safety aspects of using such irradiation.

While studying the relevant literature about light damage to the eye I discovered that this damage was not limited to the very short wavelengths used in the ink curing processes but can also be caused by visible light in the nearby blue-violet range. This includes the prominent “mercury-line emission” of all fluorescent lamps at the 435.8 nanometer wavelength that shines precisely into the retinal protection gap of greatest vulnerability for all mammalian eyes which industrial researchers have located in the 430 to 440 nm wavelength range. Not surprisingly, the previously unknown blinding from retinopathy of prematurity started the year after the introduction of those lamps.

There is a mountain of scientific literature about this kind of photochemical eye damage from light that acts on a continuum with the thermal damage from staring at the sun or at welding arcs, but the many nursery doctors whom I tried to alert to this obvious reason for the baby-blinding epidemic refused to listen. To them, the question had been solved in the 1950s by a trial that blamed oxygen for the blinding. However, a close reading of that report shows that the researchers back then reduced the incidence of blinding simply by suffocating the babies most likely to suffer from the eye damage and then lying about those extra deaths they had caused. They had even stated publicly a few years earlier that the condition was pre-natal and due to “defective germ plasm”, and that nursery doctors should “not be so zealous in preserving these defective persons”.

I submit that it is time to undo the damage those crypto-eugenicist asphyxiators of the “defective” babies caused with their hidden but still ongoing euthanasia doctrine, and I hope that your audience will look at the facts in a scientific manner.

Among the many additional medical institutions that refused so far to act against the research frauds I documented are the American Academy of Pediatrics as well as the U.S. Office of Research Integrity which did not respond either to my repeated alerts, and the World Health Organization which has also not replied to my warning. I did not mention these in the text because I have already reached exactly the limit of 2000 words. I would appreciate your permission to add these to the text, as well as a mention of the two illustrations with captions I propose. Also, I can provide additional photos for an attractive header.

Over the more than a quarter century that I campaigned for a more rational approach to treating premature babies, I have published two articles on the same general topic that I have cited among the references for the present article. I have also posted them with much other related material on my website at http://retinopathyofprematurity.org/01Summary.htm and at http://retinopathyofprematurity.org/Babyblindinglights01.htm.

I ask you to please waive or reduce your publication fee. I have self-financed all my research for this topic and do not have the deep pockets of a sponsoring organization. I do not have any financial or professional interest in the publication of my article, and no conflict of interest.

Thank you in advance for anything you can do to help end this continued iatrogenic epidemic of baby-blinding and brain-damaging.

Sincerely,

Peter Aleff


Reply from Dr. Amy Ross, PLoSMedicine, on November 7, 2014:

Dear Mr. Aleff,   
   
Thank you very much for your presubmission inquiry regarding the manuscript entitled "Patient-harming deceits in medical research about baby-blinding Retinopathy of Prematurity (ROP)" (PMEDICINE-D-14-03455). We are delighted that you are considering PLOS Medicine for publication of your work.

As with all inquiries submitted to the journal, yours was considered in light of other papers that we receive, and our aims for the journal. We are looking for papers of wide general interest which provide a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance in management or public health policy.  Within these criteria, we prioritize research on conditions that contribute to a substantial proportion of the global burden of disease. I am sorry to say that we do not think your manuscript would be best suited to PLOS Medicine.

While we agree that these findings will be of interest to specialists in this area, without more robust implications for clinical approaches or health policy we do not think that they would be of the wide general interest that we are seeking for PLOS Medicine's general audience.

I am sorry that I cannot be more positive on this occasion.
I hope you appreciate the reasons for this decision, and will consider PLOS Medicine for other submissions in the future.

Thank you for giving us the opportunity to consider your work.

Best wishes,
Amy Ross, PhD
Senior Editor

My reply to Dr. Amy Ross, PLoSMedicine, on November 8, 2014

Thank you, Dr. Amy Ross,
 
for your reply to my pre-submission of my paper about the baby-blinding epidemic retinopathy of prematurity and how to end it by re-examining the false premises for the current medical approach to it. This iatrogenic disaster is a major cause of childhood blinding in developed countries around the world and has recently also been singled out by the World Health Organization as a major threat in developing nations. I provide a simple prescription for a clinical application to prevent the continued blinding by ending the over-irradiation of the babies retinae with fluorescent light that exposes them in just a few minutes to more damage-weighted retinal irradiance than what the U.S. Industrial Safety Guidelines allow for adult workers during an eight-hour shift.  
 
I also pointed out that the recent SUPPORT experiment violated the Nuremberg Code as well as the various Helsinki Declarations of Medical Ethics for Research on Humans and the U.S. Federal Regulations, and that the callous decision of the researchers to go ahead with their oxygen-reducing, despite the knowledge that this would result in death or severe brain damage for about four percent in their suffocation group, amounted to pre-meditated homicide of the infamous type that led to the Nuremberg Code.
 
Yet, you are telling me that my fully documented analysis of the causes for this eye damage and brain deprivation are not providing "a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance in management or public health policy". You are thereby joining the many medical practitioners who prefer to deny scientific evidence just so that they will not have to admit having been wrong for so long, regardless of the continued damage that their wrong approach causes to many thousands of children every year. 
 
The editor of Scientific American wrote in her introduction to the November 2014 issue that practitioners of science "are unafraid to examine evidence and, if the facts point the way, revise previous notions, even if they have been widely held".
 
If you don't examine the evidence that I presented to you for ending this severely patient-harming and world-wide epidemic, and if you cannot refute that evidence but join the stonewalling and wagon-circling common among medical practitioners, then you become an accomplice to the criminal ethics violators who knowingly prefer continuing this epidemic to admitting a wrong committed by the medical guild.
 
Before I publicise your refusal to act as a scientist while representing PLOS Medicine I ask you to please confirm that this is your considered position so that I will not wrongly accuse you and your organization.
 
Thank you in advance for clarifying your decision and the reasons for it.
Sincerely
Peter Aleff

Reply from PLoSMedicine on November 10, 2014 

Dear Peter Aleff,

If you feel we have misunderstood the presubmission the easiest thing is if you submit the full paper as an appeal. An appeal can be made on the grounds specified in our “appeal of decisions” section of our author guidelines: http://www.plosmedicine.org/static/guidelines.action.

The procedure moving forward is that we will assess the paper carefully before deciding whether or not to proceed further with full peer review. Please check our guidelines for submission of new papers at http://journals.plos.org/plosmedicine/checklist.php.

For your information, an appeal counts as a full submission to PLOS Medicine, so please do not submit your manuscript elsewhere whilst your appeal is under consideration in PLOS Medicine.

If you wish to submit your full paper, please let us know. I have copied in the journal staff at plosmedicine@plos.org who will send you instructions for how and where to upload your full paper in the system. Please note that appeals are given second priority as compared to new manuscripts undergoing their first round of evaluation so we cannot promise rapid review

Best wishes,
Amy

PLOS I OPEN FOR DISCOVERY
Amy Ross, PhD I Senior Editor, PLOS Medicine
1160 Battery Street, Suite 100, San Francisco, CA 94111
aross@plos.org I Main +1 415-624-1200 I Direct +1 415-590-3479 I Fax +1 415-546-4090

My reply to Dr. Amy Ross at PLoSMedicine on November 12, 2014

Thank you, Dr. Amy Ross,
 
for your reply. As you would have noticed if you had actually looked at my original submission, I had already included the full paper under the rubric "manuscript with images". You would also have seen that my paper is "of wide general interest [and] provides a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application", and that it "would lead to a substantial advance in management or public health policy." I am attaching another copy of that submission.
 
The wide general interest may be evidenced by the fact that the U.S. National Institutes of Health just spent $20 million for the SUPPORT experiment from 2005 to 2009, and the other four parallel trials run by the other four countries listed in my paper are likely to have spent similar amounts, for a combined total near US$100 million. It seems unlikely that all these countries spent that much on a topic that is not of general interest.
 
My paper also provides clear insight into the pathogenesis of retinopathy of prematurity, a major cause of childhood blindness around the world. This insight has so far eluded the clueless researchers who willfully ignore not only the Nuremberg Code of medical ethics in research on humans but also a mountain of scientific literature about light damage to the eye. Instead of doing their homework, or accepting my verifiable professional advice with its precise calculations of the damage-weighted retinal irradiance for premature babies, they keep barking up the wrong tree with their fraud-based and never confirmed oxygen theory just as their predecessors have done for 60 years with their longest-running euthanasia program so far. The SUPPORT researchers knowingly killed 23 "extra" babies in their low-oxygen group for their research and came up with the same old inconclusive result that is of no clinical use at all whereas I provide a clear path toward clinical application for ending the ongoing epidemic. I thereby provide a substantial advance in the management of this public health problem which blinds and maims thousands of infants each year around the world and which would be easy to end with the application of the scientific thinking and data that I offer.
 
Your instant rejection of my paper and my science-based solution to the epidemic, suggests that there may be truth to the accusation made about the rigged LIGHT-ROP trial that the medical profession has no interest in ending this epidemic which maintains a steady stream of customers for costly pediatric retinal surgery and keeps the infants for several additional days in the intensive care nursery which is said to be the most profitable department of many hospitals. The continuation of the blinding epidemic is also a boon to the makers of the expensive oximeter instruments which would be unnecessary if nursery doctors could be made to acknowledge the long documented role of the fluorescent nursery lighting in the continued blinding.
 
I am therefore suggesting that you examine my pre-submission which included already the submission of my paper with all the relevant references that prove my point. This would help to dispel the suspicion that you may want to help continue the blinding by suppressing my simple solution for ending it.
 
I look forward with interest to your reply.
 
Sincerely,  
Peter Aleff

Reply from Dr. Amy Ross, PLoSMedicine, on November 12, 2014:

Dear Peter Aleff,

Thanks for your email. You will need to resubmit the paper as we do not read full submissions at the presubmission stage and we need more information from you to go along with your submission (e.g. competing interests)

I’ve cc’d our journal staff who can help you with this process.

Best,
Amy

Reply from Maya Sandler, PLoSMedicine, on November 12, 2014:


Dear Mr. Aleff,

Thank you for your letter asking us to reconsider our decision on your manuscript "Patient-harming deceits in medical research about baby-blinding Retinopathy of Prematurity (ROP)" (PMEDICINE-D-14-03455). I am writing on behalf of the PLOS Medicine editorial team.

When an author queries the decision on a presubmission inquiry, our standard procedure is to allow submission of the full manuscript. We have brought forward the files from your presubmission inquiry, alongside your appeal letter, and they are now in the 'Submissions Needing Revision' folder.

Use the link below to login to the system:

http://www.editorialmanager.com/pmedicine
Your username is: Peter Aleff
Your password is: aleff286.

Please go to "Submissions Needing Revision" folder and revise your Presubmission Inquiry into a full Research Article, uploading any extra files.

Please make sure that you include competing interests, financial disclosure and an ethics statement in the article file as well as in the submissions form.

We hope you will understand that, given their responsibility for new submissions and manuscripts currently under review, the editors are not able to make appeals an immediate priority. After receiving an appeal the editors aim to respond within two weeks with a decision on whether or not they will proceed with further evaluation of the manuscript for PLOS Medicine. Should they decide to seek input from an academic editor in this decision, additional time may be necessary. There is no guarantee an appeal will be successful.
   
Please contact us at plosmedicine@plos.org if you have any questions or concerns about this process or if you require an update on your appeal's progress after submission.

Sincerely,
Maya Sandler
Publications Assistant, PLOS Medicine

My reply to PLoSMedicine on November 17, 2014:

Dear Lady or Sir,
 
I resubmitted my article unchanged because the rejection notice was simply the same text as in the form letter email Dr. Amy Ross had sent me and which I debunked point by point -- yet the same bogus claims against my submission re-appear there unchanged. I am therefore re-sending you my article again and hope that someone will actually read it instead of sending me again the rote denial Dr. Ross had sent me.
 
I am also re-sending you attached my original cover letter in which I had already answered the questions about conflict of interest and personal or professional gain from the article -- again in the hope that this time someone at your organization will read my submission and comments.
 
As I told Dr. Ross repeatedly, I am exposing a routine medical malpractice that is based on several research frauds and severely harms many thousands of premature babies around the world every year during which this reckless overexposure of premature babies to the blue-light-hazard from fluorescent nursery lamps continues as well as the eugenicist "remedy" of suffocating the babies at risk by withholding their oxygen breathing help and so to reduce the number of blind survivors. I hope that at least someone among your staff is scientifically literate enough to understand the documentation I provide and ethical enough to feel compelled to act on it.
 
If you don't want to expose the malpractices I describe and document, then I suggest you replace the word "Science" in the title of your PLoS journal with "Coverup Complicity".
 
Thank you in advance for helping me to expose this hidden euthanasia program conducted in intensive care nurseries around the world behind the backs of the parents of premature babies, based on blatantly fraudulent medical research.
 
Sincerely,
Peter Aleff

Reply from Dr. Paul Simpson, PLoSMedicine on November 18, 2014

Dear Mr Aleff and colleagues,

Your email has been forwarded to me to assess in light of you concerns. After reading your cover letter, manuscript and the email chain, I’m afraid the that our decision remains the same and we won’t be moving forward with your manuscript.

We assessed your article based on our criteria for magazine pieces published in PLOS Medicine and, unfortunately, we don’t feel your article is best suited to our audience. The article has two strands, firstly it aims to highlight the controversies around the SUPPORT study and secondly it aims to highlight a potential association between exposure to fluorescent lights and ROP. While we agree that the SUPPORT trial was controversial and should be discussed in the medical literature, we feel that it has been covered at length in the major medical journals, in particular in the New England Journal of Medicine which published the original trial. Your narrative that describes the association between fluorescent lights and ROP has also been described by yourself on a number of occasions (for example in Iatrogenics in 1992) and we don’t feel your current manuscript furthers the discussion or provides stronger evidence for the association compared to your earlier work. While we’re sure that there is an audience for your work, we don’t feel your article is best suited to PLOS Medicine.

The tone of your correspondence around your appeal is not acceptable. We have an appeals process because we understand that there are occasions when an author feels we’ve misunderstood their work. However, we don’t expect authors to respond in an impolite or non-collegial manner, as you have regrettably chosen to do. I expect that any future correspondence will adopt the professional tone that is in keeping with the seriousness of the subject matter of your article.

I’m sorry that I can’t be more positive on this occasion but I hope you understand the reasons for our decision.

With best wishes

Dr. Paul Simpson

PLOS I OPEN FOR DISCOVERY
Paul J. Simpson, PhD I Deputy Editor, PLOS Medicine
Carlyle House, Carlyle Road, Cambridge, CB4 3DN, United Kingdom

My reply to Dr. Paul Simpson, PLoSMedicine, on November 21, 2014

Thank you, Dr. Simpson.
 
for your reply and for the wealth of quotable material you supplied that will help me to illustrate your and your journal's lack of interest in ethics and patient welfare.
 
Whereas you claim that the controvery around the SUPPORT trial has been covered at length, you fail to mention that this coverage dealt so far with only one of its several major ethics violations, that is, the failure to obtain the informed consent from the parents of the babies enrolled in that cruel experiment. It omitted entirely to address the researchers' predictably killing 23 "extra" babies for their research, which is premeditated homicide, or their obligation under the Nuremberg Code and Helsinki Declarations of medical ethics for research on humans to familiarize themselves first with the relevant literature about the blinding they wanted to study. Instead of including the most obvious cause of the blinding which is the overdose of retinal irradiance with blue-light-hazard fluorescent nursery light, they limited themselves to the deadly and dead-end approach of tinkering with the oxygen breathing help. Your trying to stifle the discussion of these abuses amounts to complicity in their cover-up.
 
You are also claiming that I should have provided "stronger evidence" for the role of the nursery light in the continued epidemic of baby-blinding, but you fail entirely to point out any weakness in the solid and never refuted evidence I present. Your dismissing this evidence without being able to refute any of it demonstrates again your complicity in the cover-up of the iatrogenic cause for the current baby-blinding. You protect this profitable malpractice by not helping to expose it and by trying to belittle evidence against it which you cannot counter.  
 
The tone I have adopted in denouncing your complicity with the criminal continuation of the epidemic matches the seriousness of the subject matter to the defenseless babies who continue to be recklessly blinded or killed by their doctors. You don't appear to understand your ethical obligation to speak up against this continued abuse once it has been brought to your attention. Instead, you prefer to participate in the nursery doctors' defensive wagon-circling, despite your journal's hypocritical slogan "Open for Discovery".
 
Thank you again for having so clearly exposed the reasons for your decision to not denounce the crimes in the SUPPORT experiment and in the routine intensive care nursery blinding its researchers pretended to study by suffocating babies.
 
Sincerely,
Peter Aleff


Comment by Vera Sharav,
President, Alliance for Human Research Protection,
on November 21, 2014, about PLoSMedicine's reply from Dr. Simpson: 

Peter,
It is also most telling that the deputy editor, Paul Simpson, PhD, mentioned ONLY the articles by the promoters of the "Research Über Alles" brigade in The NEJM!

That should tell us all we need to know about where PLoS Medicine  now stands!!

It is a matter of public record that the NEJM under the editorial leadership of Dr. Jeffrey Drazen has without exception given its strong support to unethical medical experiments. Indeed, the editors were even complicit in concealing clinical trial data, as in the VIOXX VIGOR trial. (Richard Smith. Lapses at the NEJM, Journal of the Royal Society of Medicine, 2006, pp. 380-382.)

PLoS Medicine it appears, would like to have nothing to do with inconvenient evidence of experimental abuse of human subjects.
 
Best to you and your efforts to bring attention to one of the current unethical medical experiments.

Vera Sharav
President, ALLIANCE FOR HUMAN RESEARCH PROTECTION

 
 

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