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

     
 

 

Keep medical researchers from using children as disposable guinea pigs, as they did in recent preemie suffocation experiments

 

The U.S. Office of Human Research Protections (OHRP) is inviting all who register to a public meeting for which it requests comments about the consent and protection of human subjects in medical research, particularly of children in what they call "standard of care interventions". The meeting will be held on August 28, 2013, from 9AM to 5PM, at the Department of Health and Human Services in Washington, DC, and its details are posted at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-15160.pdf.   

This meeting is important for anyone who wants to protect children from being abused, behind their parents' backs, in clinical experiments so dangerous and unethical that the researchers know they could not get parental consent if they honestly explained the foreseeable risks from their project for the children they try to enroll. The expected results of some such actually conducted dubious experiments include death and severe permanent brain damage -- risks that no parent would or could knowingly accept for their child.

The call for this meeting is a defensive reaction by the OHRP to the stir it had created among some medical researchers and bioethicists by sending a "letter of determination" to the leader of the recent lethal multi-hospital SUPPORT experiment. The designers of that ill-conceived experiment had restricted oxygen breathing help for premature babies without informing the parents about the known risks from that throttling of the life-saving gas. These predicted risks included higher rates of death and severe brain damage in the low-oxygen group, and the researchers wanted to compare these with an allegedly greater risk of blindness in the group with more normal oxygen levels.

Blindness is a non-fatal condition and therefore in no way justifies exposing anyone to the risk of dying for its potential prevention. From the Nuremberg Code on, all declarations of medical ethics insist that no experiment should risk the death or permanent injury of any subject, and also that the welfare of the subject should be more important than the goals of the investigation. Yet, the SUPPORT experimenters predictably killed 23 "extra" babies in that low-oxygen group and likely caused severe permanent brain damage to a still unknown number of the survivors, all this merely to try and maybe prevent some cases of blindness. [See the description of that SUPPORT experiment "Target Ranges of Oxygen Saturation in Extremely Preterm Infants" at  http://www.nejm.org/doi/full/10.1056/NEJMoa0911781].

Despite these blatant violations of all medical ethics codes and of several U.S. Federal regulations, some of the SUPPORT researchers and their bioethicist apologists protested strongly against the criticism from the OHRP and falsely claimed that there was no need to inform the parents because the intervention fell within the limits of the "standard of care" and did not add any risk.

The designation "standard of care intervention" is a red herring because each  intervention to be tested differs by definition from the prevailing standard of care and carries different risks. The entire SUPPORT experiment had been conducted to compare the risks of death and brain damage with those of mostly blindness in the low- and high-oxygen groups, with arterial blood oxygen saturations of 85 to 89 percent in the low group and 91 to 95 percent in the other. The current "standard of care" includes the entire range from 85 to 95 or even 98 percent, so the treatments in both of these separate groups were clear deviations from that standard. Moreover, each of these narrower ranges was associated with different specific risks -- risks of death, brain damage, and blindness which the researchers themselves had described and discussed.

On July 11, 2013, a self-described "group of physicians, bioethicists, and scholars in allied fields" agreed with the OHRP 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]

However, the proponents of that questionable SUPPORT experiment try to gloss over those differences and to falsely represent their intervention as just the same care the subjects would have received anyway even if they had not been enrolled in the experimental treatment groups. Their false claim that there was no difference in risk is another blatant lie unworthy of people who pretend to be scientists. This lie contradicts the very purpose of the experiment as well as the researchers' explicit statements about their goals, and it destroys any scientific credibility they may have had because no one can trust anything said by a person who lies so blatantly about matters of life and death. [For a detailed discussion of the lies offered in defense of the SUPPORT experiment, see http://www.ahrp.org/cms/content/view/925/9/ by Vera Sharav, President of the Alliance for Human Research Protection. This Alliance is a non-governmental organization that tries to fill some of the gap left by the U.S. Government's timid and overly deferential Office of Human Research Protections.]

Unfortunately, some pediatricians and bioethicists use lying as an acceptable medical tool. Consider, for instance, these earlier comments from John D. Lantos, M.D., a prominent pediatrician and vocal defender of the SUPPORT deceptions:

"In medicine, of course, there is a long and distinguished tradition of lying. (...) The age-old medical adage to do no harm has become essentially obsolete in modern medicine. We do harm all the time, generally in hope of achieving a greater good. (...) As with most modern bioethic paradigms, all bets are off when it comes to pediatrics. (...) Sometimes, perhaps, even in America, the best medicine might still be a comforting lie." [John D. Lantos, Perspectives in Biology and Medicine, University of Chicago Press, Autumn 1996, pages 78-92, quotes on pages 80, 81, 84, 87, and 91.]

The idea that physicians are allowed to lie "for a greater good" invites the sort of hubris that justifies deception for purposes which only the medical Übermensch can judge. It allows these self-declared superior judges to forget their unctuously proclaimed Declarations of Medical Ethics and to ignore the horrible lessons that had led to their modern model, the Nuremberg Code.

The sporadic medical lip service to patients' rights cannot hide that many physicians traditionally had a disdaining attitude towards informed consent, and that this has not changed in the decades since the establishment of that Code. This continuity among U.S. doctors' mindsets is attested by a long list of already then expressly forbidden medical crimes, such as the infamous patient-infecting and treatment-withholding syphilis studies in Guatemala and Tuskegee, or the Cold War radiation experiments of exposing unsuspecting soldiers as well as civilians to sickening irradiation. These are just some of the better known among many other medical research atrocities, and they were revealed only decades later with contrite Presidential apologies. But right to the sound of those solemn "never again" promises, some contemporary doctors were committing new and sometimes even worse abuses.

The knowingly baby-killing SUPPORT experiment was still going on when President Obama apologized to the people and government of Guatemala for the then recently discovered patient-infecting medical abuses there in the late 1940s which had not even included premeditated killing, and during President Clinton's condemnations of the Tuskegee and Radiation abuses, doctors in his country conducted the parent-deceiving and preemie-abusing LIGHT-ROP research fraud described at http://retinopathyofprematurity.org/40fraudsinLIGHTROP.htm.

That fake LIGHT-ROP experiment was rigged to falsely exonerate the role of the fluorescent nursery light in the ROP epidemic, and it revealed, for instance, the attitude of the late William A. Silverman, M.D., a once prominent neonatologist who wrote much about the alleged baby-blinding from oxygen and about medical ethics and who was one of the two pediatricians interviewed under President Clinton for the Ethics Oral History Project of the President's Advisory Committee on Human Radiation Experiments.

Dr. Silverman told said Committee that in the 1950s, he and many other pediatricians believed it was not necessary to obtain the permission of parents before using a pediatric patient as a subject in research. The Oral History Report quoted him as saying:

"Performing non-therapeutic experiments on children without authorization from parents was part of a broader 'ethos of the time' in which 'everyone was a draftee' in a national war on disease."

The same Report also noted that "he has since become a strong proponent of the parental permission requirement in pediatric research". ["The Human Radiation Experiments - Final Report of the President's Advisory Committee", Oxford University Press, New York, 1996, page 201 right.]

In real life, however, Saul does not become Paul, and the leopard does not change its spots. Just as Dr. Silverman and his colleagues had earlier held those all-justifying beliefs in plain violation of the already then legally binding Nuremberg Code, so did he and they continue to hold and apply these views in violation of all the relevant laws and regulations, and the SUPPORT apologists clearly still do.

Like many other pediatricians around the time of that interview, Dr. Silverman supported the fraudulent LIGHT-ROP experiment of blinding babies with nursery light. He did so in the full knowledge that the researchers could not obtain the parents' permission for enrolling their children unless they hid from them the by then well-known dangers of those lights to preemie eyes as well as their cruel intention to maximize the irradiation of the unprotected preemies "to increase the contrast between the groups". So much for Dr. Silverman's alleged conversion into an advocate of parental permission which appears to parallel the just as deeply rooted aversion to such honesty among many of his colleagues. [See Dr. Silverman's letter of support and offer to help on page 75 of Dr. Spencer's LIGHT-ROP Planning Grant Application, and a description of the frauds in that experiment in the Manual of Procedures posted on the pages beginning at http://retinopathyofprematurity.org/LIGHT_ROP_Manual01.htm.]

It is self-evident that no parents informed about the long list of known serious dangers and the complete lack of benefit to their child from the proposed maximized irradiation in that fake LIGHT-ROP experiment would have agreed to so needlessly incur such a great risk to the irreplaceable eyes of their baby.

Similarly, none of the parents deceived by the researchers in the lethal SUPPORT experiment would have knowingly agreed to expose their newborn child to the great and potentially fatal risks from enrolling in that dangerous and non-beneficial project. However, none of the Institutional Review Boards or of the government agencies that are supposed to prevent such subject abuses and intentionally misleading research frauds saw anything wrong with these blatant violations of medical ethics and Federal regulations, or with the deceptive omissions of all the predictable dangers from the proposed research on the parental consent forms.

Even the Directors of the National Institutes of Health and two of its relevant departments joined the dishonest chorus of those who defend the egregious violations of all ethics, medical or otherwise, in the SUPPORT experiment.

As documented at http://retinopathyofprematurity.org/RelapseToPreNurembergCodeBioethics.htm these NIH Directors dangerously misrepresented the clinical literature they cited. In their effort to cover up the SUPPORT crimes, they falsely claimed oxygen saturations as low as 70 percent were safe for preemies, thereby knowingly misleading nursery doctors to throttle the oxygen faucets down to these lethal and brain-damaging levels and so to kill and maim even more babies. And they gave this criminal advice to help cover up the earlier crime.

Many of these throwbacks to Pre-Nuremberg bioethics also claim the consent requirement in all the current Codes of Medical Ethics is a well-meaning but inconvenient and counterproductive hindrance against research projects where a full disclosure of the risks would likely dissuade many or all potential subjects from participating. Those proponents of unfettered medical experimenting complained that obtaining consent was a bothersome, expensive, and counterproductive "defensive documentation" that would reduce the number of babies enrolled or could even prevent some experiments from ever starting. One went even as far as asserting that the consent requirement could be as deadly as a "python's embrace" in that it strangled potentially life-saving research and kept it from being conducted. [Simon N. Whitney, MD, JD. The Python's Embrace: Clinical Research Regulation by Institutional Review Boards, Pediatrics 129 (2012). http://pediatrics.aappublications.org/content/129/3/576.full?sid=395f53b6-259b-4654-97b4-3a5c96e2b893]

Although the SUPPORT researchers had clearly violated all relevant U.S. regulations and international codes of medical ethics, the OHRP backed off from even the mild slap on the wrist it had issued to the knowingly preemie-suffocating experimenters. It now withholds its criticism and reaction to the 23 "extra" deaths of babies in the predictably lethal low-oxygen group until the issues can be discussed and clarified in the proposed public meeting. Here is the headline from an article by Bob Grant in the June 10, 2013, issue of "The Scientist" about this failure to even ever so feebly attempt to enforce the Federal regulations:

"Leaders of Infant Trial Will Not Yet Face Sanctions: US watchdog suspends plans to discipline researchers who failed to disclose the full risks of an experimental trial conducted with premature infants."

The upcoming public meeting about the SUPPORT experiment will therefore be a revealing test whether the Office of Human Research Protections will continue to cave to the rogue group of pediatricians and bioethicists and Directors at the National Institutes of Health who try to cover up and ignore the premeditated murders in the SUPPORT experiment, or whether that OHRP will belatedly begin to do its assigned job and hold the violators accountable.

 

Science funding depends on public support for science, and this support requires the public perception that science is conducted in responsible and transparent ways. Condoning research crimes is therefore not in the interest of any scientist.

 

 

*

Here is a slightly edited and updated version of the reply I sent to the OHRP in response to their announcement of the meeting. Dr. Irene Stith-Coleman, Director, Division of Policy & Assurances at the Office for Human Research Protections, confirmed to me on 6/26/2013 that "we will  put [this reply] into the Public Docket HHS-OPHS-2013-0004". However, as of 7/15, that Docket was still listed as containing zero comments, so I reposted this note at http://www.regulations.gov and added a link to this web page plus this page itself as an attachment: 

I was told that you are planning to hold a public meeting on August 28 in Washington, D.C., about informed consent for experiments on humans in medical research.

Unfortunately, I will not be able to attend that meeting. I am the primary caretaker of my now 28-year-old prematurely born son who is blind from retinopathy of prematurity (ROP) and severely brain damaged from restrictions in his oxygen breathing help. These restrictions were similar to the oxygen restrictions the SUPPORT experimenters inflicted on half their subjects without telling the parents about the well-known risks from the withholding of this life-saving and brain-sustaining gas. I cannot leave my disabled and incapacitated son alone for even a few hours, so I have to submit my comments to you in writing as electronic comments, hereby identified with docket number HHS-OPHS-2013-0004.

As you may know from my initial alert to your office about the ethical lapses in the SUPPORT experiment, I have long been very interested in this issue. I have tried since 1987 to draw the attention of many medical doctors and academies to the fact that the baby-blinding ROP epidemic is directly caused by the excessive blue-light-hazard from the fluorescent nursery lamps which grossly overexpose the still developing retinae of premature babies in just a few minutes to more damage-weighted retinal irradiance than the dose which the U.S. Occupational Safety Guidelines have set as the danger limit for adult industrial workers during an eight-hour shift. Moreover, I documented that the first victims of this then new form of blinding were born the year after the commercial introduction of fluorescent lamps, and that the same parallel was repeated after World War 2 in other industrial countries as these lamps become available there and the sudden start of the ROP epidemic followed them closely.

I also showed a few years later that the entire theory of blinding by excess oxygen is based on a blatant research fraud and has no scientific merit, as documented on my website http://retinopathyofprematurity.org which I am including as part of this submission. Please note that no one has ever refuted any part of my documentation or argument there, but that most physicians have so far preferred to ignore or categorically deny these verifiable facts. They act like Flat-Earthers and willfully misrepresent the clinical record so that they don't have to admit those inconvenient and embarrassing proofs that they are stubbornly barking up the wrong tree. 

The SUPPORT researchers also blatantly violate the medical ethics requirement that they should be familiar with the relevant literature, such as the mountain of scientific studies about retinal damage from light which I discuss in my series of pages that begins with http://retinopathyofprematurity.org/Babyblindinglights01.htm. They further appear to be ignorant of the obvious flaws and even frauds in some of the experiments about oxygen levels for premature babies. They do not even acknowledge the medical discovery in the 1920s that the retina regulates its own oxygen supply which is independent from the arterial saturation which the researchers measured. Even if the current convoluted theory about excess oxygen in the still developing retinal blood vessels causing these to become tortuous and so to lead to retinal detachment was correct, it would still not make any sense to study the effects of oxygen in the retinal vessels by measuring the oxygen in the arterial blood, just because that latter measuring is easier to do. This attempt is like the proverbial searching under a street light for the wallet lost in the dark alley.

Yet, the SUPPORT researchers killed 23 "extra" babies in their pre-doomed pursuit of this alleged relationship between oxygen and blinding, and they hid the risks of their experiment from the parents because these could never have agreed to expose their child to potentially fatal or brain-damaging levels of asphyxiation.

As posted on the page http://retinopathyofprematurity.org/Bioethicsconsent.htm of that site, I filed with your Office on May 24, 2011, my complaint about  the impossibility of informed parental consent to the knowingly lethal SUPPORT baby-suffocation experiment and about the researchers' crime of exposing human subjects to that increased risk of death merely to try and prevent eye damage which is a non-fatal condition. Dr. Kristina C. Borror replied to me on May 31, 2011, to acknowledge my complaint, and on July 18, 2011, to promise an investigation.

Even though your Office never replied to me directly regarding this complaint I had filed almost two years earlier, I learned indirectly about your having sent recently a "letter of determination" to the University of Alabama at Birmingham to criticize the lack of information about the SUPPORT risks on the parental "informed consent" forms. However, your Office apparently never noticed the crime of deliberately killing for research the 23 "extra" babies who predictably died in the low-oxygen group. If your Office condones that these 23 lives were preventably sacrificed to medical science, then what does the "Human Research Protection" in its name mean? Please address my entire complaint.

I hereby resubmit that part of my complaint which your Office neglected. I am also refuting the allegations by the SUPPORT defenders that both the low- and high-oxygen groups received the current "standard of care", and that the risks from restricting the oxygen supplements were not foreseeable. The "standard of care" for oxygen administration to premature babies covered the entire range from 85 percent to 95 and even 98 percent arterial saturation. Separating this range into a high and low part is not the same as using the entire range in the "standard of care", particularly since the researchers themselves had discussed the added risks from low-oxygen saturations and merely wanted to find the presumably narrower optimal range that balanced the risk of blinding against those of death and maiming, as if these were on the same level.

The very purpose of the SUPPORT experiment was to compare the main risks of blinding in the high-oxygen group with those of death and severe brain damage in the low-oxygen group and to evaluate the "composite outcomes", as if blindness could be compared in severity with death. That intention alone is a violation of all "medical ethics" from the Nuremberg Code on. They all forbid to expose research subjects to even a remote risk of death. A vague and rather unsupported hope of maybe preventing some eye damage does not justify exposing anyone to such a fatal risk, and doing so deliberately meets the definition of premeditated murder. The researchers had expressed concern for the safety of the infants in the low-oxygen group but they did not convey this concern to the parents, nor did they acknowledge that the very existence of their justified concern should have prevented their entire experiment in the first place. Even intact eyes would be of no use to a dead child.

Despite their and their "bioethicist" colleagues' belated denials of any difference in risk introduced by that ethically impossible experiment, the SUPPORT researchers knew beforehand that they could not honestly obtain the informed consent to those very real and predictable risks from any parent. Already in their initial proposal for their experiment they had disparaged this need as "defensive documentation" that might keep their research from ever starting, so their hiding of these risks was a deliberate non-compliance with the Federal disclosure requirements. They clearly considered their research to be more important than the welfare of their research subjects -- yet another violation of all relevant codes and regulations, and another relapse into the infamous pre-Nuremberg "bioethics".

See my page http://retinopathyofprematurity.org/RelapseToPreNurembergCodeBioethics.htm for the sourcing of this information, and also for the researchers' prior knowledge of the risks they tried to hide from the parents. With the careless and maybe ignorant complicity of the individual rubber-stamping IRBs, they committed a medical atrocity that is even worse than the now infamous syphilis studies in Guatemala and Tuskegee. The researchers in those "only" infected their subjects or withheld known treatment, but the designers of the SUPPORT experiment deliberately killed many of their subjects. They did this escalation of harm right while President Obama and Secretary of State Hillary Clinton apologized to the government and people of Guatemala for the past medical atrocities U.S. medical researchers had committed there.

Moreover, in the last third of that page I quote the Director of the National Institutes of Health and two of his department heads who deliberately tried to cover up the baby-killing crime by dangerously misrepresenting the premature infants' need for oxygen, as posted at http://www.nejm.org/doi/full/10.1056/NEJMp1306986rss=searchAndBrowse.

They stated misleadingly that "studies" had shown the safety of reducing the arterial oxygen saturation to as low as 70 percent. However, the one paper they cited to allegedly support this treacherously false assertion said nothing of the sort. It described a group with a nominal range of 70 to 90 percent but specified explicitly that the nursery staff always maintained the actual saturation in the upper part of the nominal range. In other words, none of the babies in that group were exposed to that merely theoretical low end of the nominal range which these NIH leaders falsely declared safe without any evidence that it had ever been used.

In addition, these NIH leaders blatantly ignored an earlier written statement from three of the SUPPORT authors that in their experiment episodes of saturations below 80 percent were strongly correlated with the deaths of the so deprived infants. See http://www.nejm.org/doi/pdf/10.1056/NEJMc1007912

To distort this clearly stated information to the point of falsely describing oxygen levels of 70 percent as safe is irresponsible because this misleading allegation by such highly placed authorities is likely to lead authority-influenced and -trusting care providers to throttle this life-saving gas to levels that are unsafe. This false assurance of safety is therefore likely to make them kill further babies or to severely damage their brains. 

Will your Office censor the authors of this willful and potentially lethal misrepresentation that they made to cover up a premeditated medical mass murder by recklessly causing more deaths? And will your Office of Human Research Protection at least try to protect humans not only from direct medical research but also from the consequences of misleading results or of misinformation spread about them? 

Regarding the risks to be disclosed for informed consent, I want to point out a puzzling discrepancy in your Notice of Meeting and Request for Comment: On page 1 you are asking for input about "what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process" whereas on page 6 you cite the current regulation which states that the subjects must be provided “a description of any reasonably foreseeable risks or discomforts to the subject.” What part of "any" is unclear to you? Or are the initiators of this public meeting trying to roll back the meaning of this simple word and thereby to weaken the disclosure requirements?

As to the "Issues for Discussion" on pages 9 to 11 where you invite comments about how an IRB should evaluate risks from medical research, these issues must be evaluated for each individual experiment based on a thorough knowledge of the relevant clinical and other related literature. There is no generic one-answer-fits-all rule for separating the risks created by research as opposed to the risks inherent in standard treatment. This separation is different in each case, and so are the changes in risks caused by changes in applying only parts from the standard of care. The only general rule one can apply is a variation of the Golden Rule that asks whether the IRB members would accept the risks from a proposed experiment for themselves or for their family. 

But even that Golden Rule is not enough because some well-meaning but uninformed IRB judge may ignore or underestimate the risks, like the medical doctor of Molière's time whose closed mind that playwright described. This traditional medical mindset evokes the unshakeable convictions which still appear to guide some modern members of that profession, including some proponents of the oxygen-blinding theory and some unconditional defenders of the SUPPORT design:

"He's a doctor through and through, a man with more faith in his rules than anything capable of mathematical proof. He would think it a crime to even question them. Medicine has no obscurities for him, no doubts, no difficulties. Full of headlong prejudice, unshakable self-confidence, and no more common sense and reasoning than a brute beast he goes on his way purging and bleeding at random and hesitates at nothing. It's no good bearing him ill will for the harm that he does you -- he'll send you into the next world with the best of intentions and in killing you off do no more for you than he would do for his own wife and children or, if need arose, for himself."  [Molière: "The Imaginary Invalid", Paris, 1673, Act 3; translation by John Wood, Penguin Books, 1959, page 258.]

This is why the members of IRBs must be familiar with the context of the research proposals they evaluate and use informed judgment which cannot be replaced by generic rules or blind faith. Or else you might as well replace the IRBs with an algorithm. For all they have done with the SUPPORT approvals, no one would notice a difference. Actually, a well designed algorithm would likely have done a better job of identifying the lack of risk disclosure.

In the case of the SUPPORT experiment, the changes in risk between the high and low partial ranges of that standard were well known to the researchers who merely wanted to refine their quantifications. These long documented risks were also known to their colleagues throughout the field, and they should have been disclosed to the parents, as clearly required by the regulations. But then, of course, the parents would not and legally could not have consented.

Questions such as "What criteria should be used by the IRB to evaluate whether the risks to subjects are reasonably foreseeable?" boil down again to the requirement for knowledge of the clinical and other relevant literature which are already covered by the Nuremberg Code and Helsinki Declarations of Medical Ethics for research on humans as well as the relevant Federal Regulations. Presenting such questions as new and still needing answers looks merely like an attempt to obfuscate the breaches and to imply a lack of clarity where the answers are already well defined. 

Raising these issues as new questions is similar to the attempts by some industry groups to artificially create doubts about scientifically settled issues such as lung damage from tobacco smoking or climate change from emissions of greenhouse gases. The tactics of moving the goal posts by raising such bogus questions may be effective in diverting attention from the actual violations of the regulations so attacked, but such doubt-implying maneuvers should be beneath your Office which is supposed to impartially follow the methods of science. 

Respectfully submitted,

Peter Aleff
2097 Cottonwood Drive
Vineland, NJ 08361

phone (removed for web posting)
prevent@retinopathyofprematurity.org 

See also the discussion about the BOOST II experiment in Australia posted here at http://retinopathyofprematurity.org/AustralianDenialCult.htm

 

 
 

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