and a look behind the hollow facade of bioethics proclamations
Greatly fanfared government watchdogs
never meant to do their job
The LIGHT-ROP study's
President Clinton said in his above- mentioned address that "there are local citizens review boards, there are regulations that establish proper informed consent and ensure that experiments are conducted ethically". You are quoted as saying that you wanted to review these procedures and how each agency is complying14.
I want therefore to bring to your attention that the LIGHT-ROP study bypasses not only the informed consent laws and the "first do no harm" rule, as I just showed, but also appears to sovereignly ignore the rules that require review boards and safety monitoring committees for experiments on humans.
I asked the National Eye Institute repeatedly for copies of the approval letters for the LIGHT-ROP study from the Investigational Review Boards that by law must check the ethical aspects of all studies on humans. Dr. Reynolds stated on page 92 of his LIGHT-ROP application to the NEI that he had attached to it the letters from the local IRBs that reviewed and approved the protocol at each center. Yet, the NEI told me it does not have these letters in its file and did therefore not send them to me. There is thus no evidence that outsiders or parents were ever consulted for this study.
I deduce that the NEI neglects its duty to assure compliance with the mandates that prescribe local citizens review boards, and that if these ethics reviews inaccessible to the public were conducted at all, they were conducted in secret and thus defeat the very purpose of such reviews. It seems to me that secret ethics reviews for medical experiments on unsuspecting people are bound to reinforce the cynicism which President Clinton said he wants to eradicate by eliminating the stonewallings and evasions that feed its roots.
The NEI is equally lax about the circumvention of other supposed safeguards. For instance, the Manual of Procedures for the LIGHT-ROP study assigns the responsibility for the ethical conduct of the study and the safety of the test subjects as well as the review of the informed consent procedures to an independent Data and Safety Monitoring Committee15.
However, in his grant application submitted to the NEI on July 1, 1994, Dr. Reynolds said on pages 71 and 72 that the long-term follow-up as well as the Data and Safety Monitoring Committee had been eliminated for the scaled-down version of the LIGHT-ROP study to control costs. This expedient let all the so delegated concerns with ethics and consent procedures fall through the cracks, but the NEI funded the study on this basis on March 21, 1995.
Curiously, the relevant pages in the Manual of Procedures are dated June 7 and August 8, 1995, long after the cancellation of this here so reassuringly described Committee. The Manual is thus likely to mislead its readers into believing that the usual Safety Monitoring Committee is actually on the job and that all the prescribed ethics procedures have been followed. Yet, the NEI has refused to release the names of the alleged Safety Committee's members despite repeated requests under the Freedom of Information Act.
I submit that such displays of medical sovereignty will make the public's cynicism about proper government oversight continue to grow like Kudzu.
The LIGHT-ROP contempt for informed consent is mainstream and routine
The deceptions in this LIGHT-ROP study are not the plot of some lunatic fringe quacks, and I do not want to single out its authors from their equally mainstream and equally ethics-challenged colleagues. Many leading physicians approved of the study and offered to cooperate, or helped otherwise to suppress the long existing evidence against the nursery lights.
If you accept this definition from a medical writer that an academic discipline is "a group of scholars who have agreed not to ask certain embarrassing questions about key assumptions"16, then the neonatology-related medical community qualifies fully.
You can see this in Section 3 of my book from the non-reactions and tobacco-executive-style denials by various physicians and medical officials whom I tried to alert to the safety and ethics violations in the nursery light issue.
You will further find on page 28 of Dr. Spencer's trial planning grant application a list of 20 nurseries from coast to coast where the leading physicians had expressed their interest to participate in the originally proposed larger-scale LIGHT-ROP trial.
Similarly, the National Eye Institute's Council Action Sheet from June 1990 (unpaginated, just past midway through the Spencer tome) says
This enthusiasm among the reviewers, in turn, demonstrates their lack of understanding and sensitivity to the ethical issues posed by the study design.
Their attitude is symptomatic for many intensive care nurseries. Just as a look in the eyes of a patient can often reveal much about their owner's health, so a look at the mainstream neonatologist approach to preemie eyes reveals a deep-seated contempt for patients, truth-telling, and science among many members of that profession.
The sporadic medical lip service to patients' rights cannot hide that many physicians' traditionally uncomprehending attitude towards informed consent has no more changed in the decades since those unethical Cold War radiation experiments than their traditionally inflexible attitude towards, say, health insurance reform.
Take, for instance, Dr. William A. Silverman, a now retired neonatologist who has written much about ROP and medical ethics and who was one of the two pediatricians interviewed for the Ethics Oral History Project of the President's Advisory Committee on Human Radiation Experiments.
He 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 Report quotes him as saying:
The same Report also notes that "he has since become a strong proponent of the parental permission requirement in pediatric research"17.
In real life, however, Saul does not become Paul, and the leopard does not change its spots. Just as Dr. Silverman and his colleagues held those all-justifying views then in plain and casual violation of the already then legally binding Nuremberg Code, so do he and they hold and apply them now in violation of the present laws and regulations.
Like many other pediatricians, Dr. Silverman supports the LIGHT-ROP trial18 in the full knowledge that the researchers can obtain the parental permission for enrollment only through deception: it is self-evident that no parents informed about the long list of known serious dangers and the complete lack of benefit from the proposed exposure would agree to so needlessly incur such a great risk for the irreplaceable eyes of their baby. So much for Dr. Silverman's alleged conversion.
For another pediatric view of deception as an acceptable medical tool, consider, for instance, these comments from John D. Lantos, M.D., a prominent currently active pediatrician and speaker at a medical ethics conference:
"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. (...) Bioethics never kept anybody out of the rain. (...) Sometimes, perhaps, even in America, the best medicine might still be a comforting lie."19
An outsider might see that even if bioethics never kept anybody out of the rain, it would certainly have kept many people out of the grave or kept their eyes and brains intact if bioethics was just ethics.
The idea that ethics might be different for physicians than for us common mortals invites the sort of hubris that justifies deception for purposes which only the medical Übermensch can discern. Those who accept it replace the obsolete "first do no harm" adage with "eritis sicut deus, scientes bonum et malum", the original harmful message of the same serpent that is now entwined around the caduceus, the medical emblem. Can you expect such haloed healers to respect the laws of mere humans?
The harm caused by this elitist medical disregard of common ethics is so enormous in terms of children killed, or brain damaged, and/or blinded, that it is difficult to reconcile this carnage with the traditional image of doctors concerned about their patients.
Like any other large group of people, the medical profession may include some criminals, but it is hard to imagine that so many leading physicians could be as crassly cynical as the evidence implies.
I prefer to think that many of them are not aware of the harm they cause and suffer instead from professional hubris, a conviction they can do no wrong that has long been a hallmark of medical doctors. It is this overconfident mindset that allowed them in the past to inflict the many useless and dangerous treatments for which the history of medicine is known, and that allows them now to continue.
It is a pity that the English-language literature has produced no equivalent to the French playwright Molière because that keen observer's skewering of medical pomposity is needed here, too. He documented this same medical mindset when he had the Imaginary Invalid's brother describe that hypochondriac's physician:
"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."20
If you replace "purging and bleeding" with "asphyxiating, blinding, and vivisecting"21, this clinical description from over three centuries ago still applies equally well to many modern nursery doctors who display an equally blind faith in their often equally damaging doctrine.
And if you want to protect the American people from the harm caused by this mindset, as President Clinton asked your Commission to do, then I suggest you subject the medical profession to an effective outside review not only for its compliance with mandated research procedures but even more for the scientific soundness of its practices.
The President's Advisory Committee on Human Radiation Experiments stated in its Recommendations that
"In research involving human subjects, good ethics begins with good science. (...) If the science is poor, it is unethical to impose even minimal risk or inconvenience on human subjects. (...) IRBs must be situated to assure themselves that the science they approve to go forward with human subjects satisfies some minimal threshold of scientific merit.22
I submit that the everyday treatment of human patients, too, should be based on scientific merit, and that the evaluation of medical practices and research proposals should not be left to physicians. Or can economists, for instance, decide among themselves the values of their theories without reality checks and input from outside their small circle?
You are said to be a champion of diversity and to advocate "Voyages of discovery in a pluralistic society"23. I hope therefore you will agree that the traditional and parochial medical thinking, too, must be challenged with a diversity of views. Outsiders offer other perspectives, or, in words which an art critic said in a different context but which apply equally well to the medical prejudices in the case at hand:
" ... the basic intuitional assumptions of any group of people must be sought among the things they take so much for granted that they are unaware of them. The easiest way to discover such unphrased basic assumptions is by approach from the point of view of a very different group of people with very different habits and ideas."24
An open evaluation of the LIGHT-ROP trial proposal by independent outsiders who do not share the neonatologist assumptions and biases would probably have picked up the absurdity of evaluating the light reduction as if it were the administration of a new and potentially dangerous treatment that must pass stringent significance hurdles before it can be approved.
The treatment here is instead the unnatural and unnecessary exposure to hazardous bright light itself, as I discuss on pages 121 and 122 of my book. The safety of this thoughtlessly inflicted routine treatment has never been demonstrated, but a mountain of evidence, some of it cited in the grant application itself, attests its hazards.
Any outsider familiar with risk management, and any informed parent of a baby to be subjected to such irradiation, would insist that the slightest association of this benefit-less treatment with even the suspicion of a risk to the babies should trigger the immediate removal of that suspected hazard.
President Clinton called for vigilance in overseeing medical research, and his Advisory Committee on Human Radiation Experiments takes past governments to task because they did not have a system in place to ensure that individuals were not wronged by their use as research subjects without their adequate consent when that use resulted in harm25.
The LIGHT-ROP study demonstrates that there is still no such system in place, and I hope that you and your Commission can install one that works.
Until honesty in dealing with patients as well as in study design is not just mandated but also enforced, and thereby inherently prevents abuses and deceptions like those I describe, I submit that the laws about informed consent and the President's Executive Order to review the consent procedures resemble the famous Code of Hammurabi.
This set of laws, one of the first surviving to include detailed regulations on medical practice and malpractice, was proclaimed and engraved in granite, and clay copies of it were distributed throughout that king's Babylonian empire. However, hundreds of legal tablets from when and where it was in force show that the court proceedings and judgments often paid no attention whatsoever to those official edicts26.
Clearly, the more things change, the more they remain the same27.
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