( 2,528 words)
A herd of black swans disproves
Meanwhile, the Bioethics
Commission’s “Moral Science” report offers the requested
assurances about allegedly adequate safeguards even though the very
existence of the lethal NeOProM and SUPPORT experiments and the
fraud as well as the continuing lethal legacy of the 1955
Cooperative Study of oxygen withholding plainly disprove all
those assurances. The Commission cannot plead ignorance about
these well documented counter-examples because it had been
repeatedly alerted to their patient abuses and ethics violations in
the emails posted at the links below, and also in excerpts from
these, with links to them, submitted as answers to entries on the
Commission’s blog. See these emails:
Moreover, this herd of black swans that all disprove the Commission’s rosy-colored assurances turned up in the only small sliver of medical practice I investigated, the clinical approach to ROP. This narrow field may have played a significant role in shaping the modern practices of neonatology but is only one aspect in this multi-faceted subspecialty of pediatrics, and pediatrics itself is a relatively small part within all of medicine. Finding so many misleading major research frauds and patient-harming ethics violations in just this one area of a small sub-sub-specialty raises the suspicion that others could also be lurking in other areas of the art. Until the Commission’s rosy picture gets examined for more of those black spots and thoroughly scrubbed, it is dangerously misleading to assure the President and the public that it is clean.
Bioethics Commission admits it cannot support its assurances
Even if none of these black swans existed, the Commission’s report would still not support those soothing but false assurances about adequate safeguards because it refutes its own assertions and undermines these in the text even more than its qualifications mentioned in the conclusions suggest.
The Commission explains that it can give no such assurances whatsoever because it had neither enough time nor resources to investigate the more than 55,386 studies involving human subjects which the Federal Government acknowledged to have funded in 2010. In many cases, the Commission could obtain only incomplete or even no information, including the studies run by the CIA which refused to reveal anything about them to the Commission.
Moreover, the information which the Commission had requested from the various government departments and agencies conducting research on humans covered only
The report does not mention whether that questionnaire also included any questions about the ethical aspects of any project. But even if it did, the sheer quantity of those projects and the lack of time to look at even a sizeable portion of them would have made any aggregate conclusions about them impossible. Nor could the Commission even attempt any check of their overall compliance with the Common Rule of ethics for research on human subjects that governs such projects for most of the agencies involved.
The report admits this lack of data on which to base any assurances about those studies:
Listing these data and counting the studies are indeed among the first steps needed before anyone can evaluate this huge number of federally funded studies for risks to their subjects and the protections provided against those risks, and the Commission is to be commended for having taken these initial steps. However, these preparations for making the examination feasible are not the examination itself, and they allow no statement about the adequacy of the assumed safeguards in all those unexamined study protocols.
The Commission describes on page 41 how to begin with their examination:
Then it lists some of some of these methods, such as a project-by-project assessment using a sample of studies, reviews of agency IRB records, structured interviews with research team members, and site visits, but it adds on page 42:
After so explaining that it had not gathered any of the evidence it would have needed for its requested assessment of current practices and safeguards, the Commission continues in the next sentence with this conclusion:
There is nothing in the report that is consistent with these assurances, but the many limiting qualifications quoted above negate them entirely.
Lack of informed consent in eight percent of HHS studies sampled
The only time the Commission actually examines ethics violations is when it looks at recent reviews of enforcement actions by the Office for Human Research Protections. This OHRP works only for the Department of Health and Human Services which accounted for 26,651 studies, or 48 per cent of the above total. According to the Commission’s report, the cases of non-compliance found there in unstated numbers often involved violations of the review process by the Institutional Review Boards and their approvals of informed consent documents. The problems identified with these were
The Commission concluded from this uncounted sample of studies flagged for OHRP attention that “the incidence of serious harm or unethical treatment is fairly low”.
However, the requirement for informed consent is the cornerstone of all the alleged protections for human research subjects. Experimenting on an unconsenting subject is a serious violation. As in the SUPPORT suffocation experiment, this breach is likely to hide some underhanded scheme that keeps the researchers from telling their subjects about their potentially harmful intentions.
Because the OHRP has no systematic way of detecting cases of non-compliance, those brought to its attention are close to a random sampling from the total number of studies in its jurisdiction. This suggests that up to around eight per cent of the studies in that total, or over 2,000 of the HHS experiments on humans, may have been carried out without the informed consent of the subjects whereas the above assurances would require an actively monitored zero-tolerance policy against such abuses, not just the Commission’s shrug. The high percentage of these serious violations in the sample provided by the OHRP is incompatible with any honest assurances about the adequacy of current safeguards.
The victims of these many experiments conducted without their consent or even knowledge may want to differ with the Commission’s attempt to so casually dismiss the absence of this most important safeguard against research abuses in large or even small numbers of cases.
Actually, the Commission cannot say this about even just the well identified HHS experiments unless it qualifies that assertion as an opinion about what it has not examined. The multiple disavowals of its report’s up-front assurances and the undeniable counter-examples so completely undermine its core conclusion about the adequacy of current research safeguards that the Commission should retract that dangerously misleading central part of its report if it has any sense of scientific integrity or of common decency towards the deceived research subjects and recipients of its report.
Meanwhile, the Commission denounces long past patient-infecting abuses in Guatemala and so projects a stern image of caring about such ethics violations while avoiding to criticize the present crimes and loopholes on their own watch and under their own noses. This is in keeping with the traditional purpose of bioethics, as described by medical anthropologists who deconstructed several codes of medical ethics from various countries and periods and found that these were invariably
[See ref. 40 at www.retinopathyofprematurity.org/01summary.htm] The aim of these Potemkin codes is thus not to assure responsible behavior by medical practitioners but only its appearance.
The “Moral Science” report complies with this basic purpose of bioethics of projecting a trustworthy image. It promises on pages 42 and 46, despite its admitted lack of evidence about the current status of subject protections, that if its few proposed tweaks to the current research system are implemented, then
The Commission’s respect for society must be very low if it believes that this transparently self-contradicting cover-up report can so easily trick that society into again trusting bioethics and its promises of future protections against a still continuing pattern of harmful research abuses.
Criminal charges for crimes against research subjects
The willful killing of another person, as in these child suffocation experiments, is an act which the FBI defines as murder. The use of this charged term may shock some readers accustomed to the euphemisms of professional decorum required in the clinical literature. However, if they are unwilling to admit that a crime is a crime even when committed by academics, the recent child sex abuse scandal at Penn State University and the domino-like toppling of the abuser’s enablers up the chain of command should remind them that not treating an abuser’s crime as a crime is also a crime. There are times when justified outrage is more appropriate than the usual polite silence which easily becomes complicity. The intentional killing of children is even worse than their sexual abuse, and helping to whitewash or cover up this ongoing carnage serves only to prolong it.
I tried to alert the FBI to the ongoing nationwide medical child abuses and killings but received no reaction. It appears that the U.S. Department of Justice has long granted sovereign immunity to all medical doctors, even those involved in the willful killing and maiming of humans, as in the Human Radiation Experiments and in the mass asphyxiating of preemies by oxygen withholding, in the deliberately epidemic-prolonging LIGHT-ROP research fraud, and most recently in the knowingly lethal SUPPORT experiment. It has so far neglected its duty to conduct criminal investigations of these peer-reviewed medical murders and patient-harming research frauds, and it has not objected to the latest intentionally lethal oxygen withholding guidelines for premature babies.
The above examples show that the medical community and medical officials appear unable and/or unwilling to police clinical experiments for their scientific quality and for the proper use of informed consent forms. There should be an independent review board, recruited from outside the medical echo chamber, that checks the study design for its scientific value and logic as well as the accuracy of the risk descriptions on the consent forms.
Posting these designs and descriptions on a science-oriented forum, such as http://precedings.nature.com/ or http://f1000research.com/, for public comments would add to the transparency and exposure to different perspectives from outside the small guild of peer reviewers which can resemble a hall of mirrors. Offering an incentive to anyone who documents the omission or misrepresentation of a risk on a consent form might invite widespread participation in this public scrutiny.
The Code of Federal Regulations states in its §46.122 on the “Use of Federal funds" that these may not be expended for research involving human subjects unless the requirements of the policy on informed consent listed in its preceding paragraphs have been satisfied. This regulation is currently not enforced at the National Institutes of Health. For instance, the funds for the SUPPORT suffocation experiment were approved without any verification of the mandated but not submitted consent forms.
The failure to obtain documented informed consent from research subjects in eight percent of the sampling examined by the Office for Human Research Protections should be unacceptable instead of being considered “fairly low” by a problem-belittling and falsely reassuring Bioethics Commission. Each such absence of consent should trigger a criminal investigation because the informed consent of participants in clinical experiments to the honestly and completely disclosed risks they face is a cornerstone of modern medical research, and it is confirmed as a human right in international codes of medical ethics.
Suggestions to dismiss this mandate as “well intentioned guidelines” that interfere with the enrollment of study subjects should not be tolerated, particularly not in peer reviewed clinical journals. Yet, they were published in the American Academy of Pediatrics’ flagship journal as an integral part of the proposal for the SUPPORT experiment which clearly could not disclose the full risks to the parents of the victims or else never start enrolling. This shows that these pre-Nuremberg-style attitudes towards abusing research subjects are not some rogue researcher’s slip-up but are still widely shared within the profession. The tacitly implied expectation is that the law will wink again, as it usually does, and that no one will be held accountable.
I ask therefore that the U.S. Government begin to apply its laws also to medical researchers and their enablers when they knowingly injure their research subjects or patients or fail to protect them from known harm.
Return to these earlier parts:
Bioethics Part 1:
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