| Baby-harming medical research frauds | |||||
about retinopathy of prematurity by H. Peter Aleff, 2005 | ||||||
2.3: Launching the big bogus study of oxygen In the early 1950s, as the first large cohort of children blinded in American nurseries reached the age to go to school, the nursery doctors came under pressure to end the intensive care nursery epidemic which the overwhelmed providers of services to blind people had begun to perceive as an urgent national problem [1]. Ending the stream of blinded survivors by throttling their oxygen “subsidies” was still the convenient solution for a profession which had just demonstrated how little the public interest meant to its members.Although the initial trial by Patz and Hoeck showed less blinding in the low-oxygen group, it was useless for convincing the skeptics. Despite the grant reviewers’ initial strong concerns about the risk of babies dying from insufficient oxygen, the study authors had conspicuously omitted to report the respective mortality rates in the routine versus low oxygen groups [2]. This information was, of course, essential for judging the risks of the “wild idea” they had proposed to test, and some readers may have wondered why they had withheld it.A new and more authoritative study was needed, and here is Silverman’s eyewitness account about the relevant meeting in which he took part:
To be fair, not all of those in the meeting joined the bandwagon. Silverman noted also that
However, the result of this meeting illustrates how easily political pressure can lead to the omission of all ordinary scientific precautions. The outcome of this little discussed agreement was the 18-hospital Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Its designers made no provisions to check in the aftermath of their hit-and-run trial for the mortality their oxygen withholding was bound to create, or for the less immediately visible damage which they knew would afflict the brains of those whom they had deprived of oxygen. In addition, that study was a blatant scientific fraud, and it also violated many of the then officially promoted standards of medical ethics.
2.4: Scientific frauds in the bogus oxygen study The designers of that Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen rigged the study procedures to hide and falsely deny the fatal danger of oxygen withholding. They knew that the preemies most at risk for ROP were the most immature ones with the lowest birth weights and the most immature eyes, and that these had also the most immature lungs, as documented in some of their statements:
These authors were further fully aware that babies with immature lungs who need help with breathing need this help right away, particularly during the first 12 to 24 hours, or else they will succumb quickly to their respiratory problems. This is evident from pediatric textbooks of their time:
Knowing all this, the trial designers delayed the enrollment and the beginning of most oxygen administration until the babies were 48 hours old. By that time, 634 had died, and 786 survived to be enrolled. Only 52 of these survivors had received any supplementary oxygen at all during their first two days [10], presumably from nurses like those at the Gallinger hospital cited above who had preferred helping the babies instead of blindly obeying doctors’ orders.The 45% of the babies who had died in those two days included, predictably, most of those who would otherwise have survived to grow up blind. For comparison, the death rate among the 437 preemies born at less than 2000 gram in one of the participating hospitals during the immediately preceding years 1950 and 1951 had been 32% within the first seven days [11].However, that protocol of killing the patients most at risk for blindness before their deaths would be counted concealed the sharp rise in mortality which the perpetrators of this grotesque experiment knew their cure worse than the disease would produce. This deceptive trick allowed the kangaroo-court of show-trial judges to announce its knowingly false verdict that the oxygen withholding had virtually ended the blinding but had not affected the mortality rate. Other signs that this study had been planned as a deliberate fraud are numerous. For instance, long before any data from the study came in Reese had expressed his hope that oxygen would be “successfully incriminated” [12], a bias in favor of this outcome that ruled out any objectivity in his evaluation. And when the preliminary results did arrive, he led the meeting in September 1954 where he introduced as well as closed the prolonged presentation of the pre-arranged outcome from that study[13].Yet, Reese's own writings on ROP show that he could not have believed a word of his accusations against the oxygen scapegoat because he had consistently maintained until then that the blinding was “without doubt” due to prenatal causes. As late as 1952, he had written another long paper in which he claimed again to have found ROP in the eyes of stillborn infants. He concluded again that the disease could be present at birth although demonstrable evidence for it at this early age was the exception:
Although Reese’s “if it can be assumed ... then we know” style of thinking may have allowed him to bypass some rules of conventional logic, he still could not honestly have blamed postnatal oxygen administration for a condition he so firmly believed to exist often already at birth and to have prenatal causes. Moreover, Reese and his like-minded colleagues knew quite well that preemies had received ample oxygen for many decades without ever suffering a single case of ROP, and that this long-proven remedy could therefore not suddenly have begun to cause the never previously encountered blinding. The scientific flaws in that trial included also statistical slight-of-hand that alleged to separate the babies' need for oxygen from their immaturity although one is clearly a function of the other. A correlation between the pulmonary immaturity which makes the babies need oxygen and the ocular immaturity which predisposes them to ROP must be expected but is meaningless, as "The Oxford Textbook of Medicine" explains in more general terms, translated here in parentheses to match the case at hand:
2.5: “Better dead than blind” ethics violations in the bogus oxygen study Like many of the grossly unethical Human Radiation Experiments which other U.S. doctors conducted around that time on other unsuspecting victims, the design of that oxygen withholding study also failed to meet the ethical standards that the medical community had proclaimed by then with much ado as its own alleged guidelines. Those flunked standards include several of the mandates in the Nuremberg Code of medical ethics which American physicians and judges had established just a few years earlier[16] to reassure the public that medical doctors would never again conduct unethical medical experiments on unconsenting subjects. Nuremberg Article 1 says the voluntary consent of the test subject is absolutely essential, and that this consent must be based on full disclosure of all the hazards reasonably to be expected. Similarly, the United States' laws about informed consent had long said that physicians have a duty to fully disclose all the facts which will allow a patient to balance the probable risks against the probable benefits[17]. However, the doctors who ran that oxygen study cannot have informed the parents about the study's stated purpose of risking death to maybe prevent blindness. Nor could they have told those parents about the brain damage which they knew to expect for their babies as highly probable side-effects from oxygen deprivation. Most sane parents would no doubt have refused to enroll their baby if they had been informed honestly that s/he would be exposed to a high risk of dying from easily avoided breathing problems, or else of growing up retarded and/or crippled, all in the tenuous hope that s/he or some other preemie might perhaps not lose their sight. On that subject, Articles 5 to 7 of the Nuremberg Code explicitly state:
Each one of these Articles alone should have ruled out any tinkering with the life-saving oxygen. The concept of intentionally withholding the needed breathing help to observe how many of the oxygen-deprived babies would die from its lack is similar to the concept of the then ongoing and now rightly discredited Tuskegee syphilis study in which American doctors knowingly withheld easily available life-saving treatment from patients for decades, until 1972, to observe the natural course of the disease [18].All the rules of ethics, medical or real, insist that exposing unconsenting people to a risk of death or any other possible harm is wrong, whether in the interest of science or any other. It is also wrong whether the victims are put in harm's way by coercion, as in the concentration camps which inspired the Nuremberg Code, or by deceit, as in the Tuskegee The risk of death clearly exceeds the importance of avoiding blindness as the whole exceeds the part. Doctors killing or maiming patients to maybe save the sight of some among them is even more absurd than religious Inquisitioners killing and torturing heretics to maybe save their souls. The soul, at least, was deemed an essential part of a person. Sight is not. Most non-suicidal blind or sighted people, including physicians, would probably not want to risk their own life just to gain or maintain sight. Many blind people say blindness is not a major handicap but only an inconvenience; it certainly does not prevent them from leading independent lives as satisfying and productive as those of their sighted counterparts [19],[20].For instance, the National Hero of Bohemia, Jan Zizka, a statesman and general whose innovative tactics and strategies saved his country six hundred years ago from much superior forces, was blind in both eyes [21]. There is also at least one case of a boy totally blinded in childhood who became a successful physician and wrote a useful book about the special obstacles he encountered, describing the solutions that helped him and that may now help others[22].Blind people count among them artists and athletes and barbers and engineers and entrepreneurs and fathers and mothers and more; with only minor exceptions, such as car driving, they fill about as many roles as sighted people do. And each of them is a person and entitled to life and respect, no less than you or I. But some medical doctors deny blind people this basic respect and demonize blindness. Bad images often hurt good people, as many victims of discrimination against stereotypes can testify. This is why organizations such as the National Federation of the Blind have long been campaigning against damaging images of blindness. Typically, when they alert offending individuals that their portrayals of blind persons are negative and harmful, those responsible usually soon recognize their error, apologize, and withdraw the offending statement. However, some doctors are less civilized. Marc Maurer, President of that Federation, is a lawyer blind from ROP who was born just in time before the oxygen withholding doctrine would otherwise have suffocated him. He has for many years exposed the unscientific and irresponsible behavior of physicians who falsely portray blindness as a hindrance to thinking and as leading to demented behavior [23],[24].Yet, some disease-mongering [25] medical organizations continue to promote and exploit their “better dead than blind” myth that life without sight is without value. At the time of the oxygen withholding trial, this medical myth helped to spread the idea that blindness would be worse for preemies than brain damage or death, and the same myth still lingers behind today's oxygen curtailment.Some comments from the Associate Director of the New York State Department of Health's Division of Medical Services, made shortly before the 1953/54 bogus oxygen withholding trial, illustrate the then medical perception of blindness. He justified his and his colleagues' pessimism about the futility of "salvaging" babies below 1500 grams on the grounds that 5.6% among them would have gross visual defects due to retrolental fibroplasia, and some others would suffer from cerebral palsy [26]. In other words, better twenty children dead than one of them blind and maybe a few in wheelchairs.More recent examples of this same damaging attitude include, for instance, the fundraising magazine of the Schepens Eye Research Institute, an Affiliate of Harvard Medical School. Several articles in its Spring 1993 issue, including one by that Institute's much celebrated founder, suggest that without visual function a person has no autonomy, that early loss of sight may impair all aspects of physical and mental development, and that more eye research will reward society with healthy, independent, contributing individuals – implying that blind people are excluded from that category. Here are some excerpts:
Even Silverman, one of the very few physicians who appears to have cared about the later fate of some ROP victims and who had long raised critical questions about the consequences of oxygen withholding -- even he conveyed the message that blind babies should not be helped to live. He offered repeatedly an anecdote about a man blind from ROP who visited an intensive care nursery "to 'see' the babies":
The emotions such anecdotes stir up have an even greater impact on the life and death of preemies when medical experts yield to them and rule that blindness is a worse problem for blind people than most blind people think it is. Many societies have long agreed that doctors have no right to decide whether some people's risk of blindness or other disabilities makes them unworthy of life. Yet, in intensive care nurseries all over America and in many other countries that follow the American model of preemie care, otherwise humane but doctrine-duped nursery doctors still make this decision daily, each time they restrict a preemie's oxygen supply to “protect” her from ROP.
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