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and a documentation of   patient-harming frauds in medical research

 

 

 
Footnotes:

 

35 L. Dalrymple: "Berman's 'Blue Sky Gazing'" in Astronomy, February 1998, page 14. See also pages 77 and 78 in the same issue for more such warnings about risking near-instant blindness in a mere fraction of a second.

 

 

 

36 per Dr. Reynolds' LIGHT-ROP grant application dated 7-1-94, page 1 middle, left for the $497,078 study cost (not including Dr. Spencer's prior $73,150 trial planning grant), page 8 middle for the projected number of babies with goggles -- 45 in Buffalo and 43 in Dallas -- as well as for the $9.60/pair price of the goggles and the $20.00 per baby in paper supply expenses [which buys about five 500-sheet reams].

 

 

 

37 In Title 45, Part 46, as revised June 18, 1991, 46.115.

 


 


 

  

 

  

  Rigged studies in preemie treatment

 

and their continuing cover-up 

 
 

Davidpreem01.jpg (20108 bytes)

Frauds, cover-ups, and other ethics violations in medical studies of preemies 
by H. Peter Aleff
 

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My letter to Dr. Feinstein, continued from page 6
Incompetence in the LIGHT-ROP trial set-up:

A defender of the LIGHT-ROP authors might try to argue that their flagrant flaw in the timing is not fraud but mere incompetence, and s/he could cite as support for that excuse their doubly bungled set-up for recording the light level data from the trial:

First: they programmed their monitoring data-loggers to make measurements every 8 seconds but to store only averages of every 75 measurements (Item 5.9.2. on MOP page 5-7). This deletes all peak values, such as, for instance, a stray sunbeam temporarily reflected from the ubiquitous glass and chrome in the nursery hitting the eyes of the baby.

A direct exposure like that could seriously damage an adult retina in less than 8 seconds. When it is optically concentrated, it can permanently blind an adult in a split-second. See, for instance, the repeated and insistent warnings in the last few issues of Astronomy Magazine preparing its readers for the upcoming solar eclipse on February 26, 1998, such as:

"There is no "iffyness" about it whatsoever. Any direct exposure of the eye to the sun via an unfiltered telescope or binoculars, even be it for an instant, is very likely to cause permanent serious damage to the retina at the least and, more likely, blindness to the eye or eyes used."35

The small diameter and short focal length of the preemie eye concentrate the light that shines through its proportionally much larger aperture onto a much smaller patch of retina than in the larger adult eye where the light gets distributed over a larger area of much more resistant retinal tissue.

Any such exposure to that stray sunbeam would therefore wreak its retinal havoc much faster in the optically concentrating and biologically more vulnerable eyes of a preemie who can moreover not turn her head away as any adult almost automatically would.

Yet, the ten-minute average in the study records would merely show a faint blip: if the monitor catches, say, a 1000 foot-candle sunbeam reflection during one of those measurements, this one value added to the 74 more typical 60 ftc would change the average only to 72.5 ftc, hardly a meaningful difference.

And if someone happens to stand between the monitor and the nearest lamp for only four of those ten averaged minutes and to so reduce the light intensity on its sensor by, say, half, this shading will cancel out every trace of that potentially damaging sunbeam and bring the average back down to 60.5 ftc.

Darker moments during the varying light exposure can certainly not be blamed for any of the correlation between light exposure and harm the study is alleged to test, so the measurements to be preserved would need to include the peaks as the most important data. Without these peaks, the LIGHT-ROP measurements are useless and potentially misleading, and it does not take an Einstein to figure this out.

Secondly, the LIGHT-ROP authors arranged for the visible display of the light monitors to show only arbitrary numbers (Item 5.9.2.2. on MOP page 5-8) so that no one could see at a glance whether the values measured were in the right range, or whether the gadget had gone haywire, as fancy instruments often do.  Even the much less complex electronic fever thermometers are known to fail occasionally when they start showing patient temperatures far beyond any compatible with life as we know it.

You warn on pages 47 and 48 against the danger of errors in computerized data when these are stored without confirmation and verification, and any engineering apprentice or moderately experienced factory foreman could have told the trial authors that such unseen recording without checkable and frequently checked feedback is an infallible guarantee of wrong data.

Yet, apparently the LIGHT-ROP researchers verified none of their dataloggers' measurements until their two-year study was almost over. Shortly before its initially projected end, they discovered that their fancy on-line light monitoring system had "a significant flaw, rendering that data false and unfortunately useless" (See Dr. Reynolds' attached Progress Report of February 1, 1997).

The cover-up
of the fraud in the LIGHT-ROP study:

However, even if said devil's advocate for the LIGHT-ROP authors could allege that their demonstrated amateurishness in their data recording set-up showed they were also too incompetent to understand the literature they are citing, s/he could still not argue that they overlooked this matter of initial exposure time by ignorance or accident.

I had sent to Dr. Rand Spencer, one of the original LIGHT-ROP proposal's co-authors, the clinical article that forms my Section 1 and that documents in detail how typical nursery lighting exposes the vulnerable eyes of the preemies in 15 minutes or less to the dose of retinal irradiance which the Occupational Safety guidelines warn against as the danger limit for healthy adult workers, and he acknowledged receipt of my letter (see pages 157 to 160 in my book).

Similarly, Mr. Bill Sardi at Eye Communications Inc. had alerted Dr. Spencer to the same danger, and Dr. Spencer reassured him in his attached reply of October 23, 1989:

"One of our major objectives is to design a study which would stand the least possible chance of ruling out light as a factor in the development of significant ROP if it indeed does truly have an effect."

The LIGHT-ROP authors were thus aware of these warnings and have not refuted them or shown that they can be safely ignored. Yet, they and their sponsors avoid all discussion of the short exposure periods that they know to have produced retinal damage in the different experiments they cite.  They also ignore the mountain of similar experiments on which the industrial safety data are based. Instead, they knowingly delay protecting the babies for up to 24 hours, as in most of the previous studies. Why?

The official explanations that the LIGHT-ROP authors and their sponsors give for the reason behind this crucial delay vary according to the intended audience. For the general readers of PARADE magazine, Dr. Karl Kupfer, the Director of the National Eye Institute, conjures up a dramatic but exceptional situation and says, as quoted by Bernard Gavzer in the above cited June 1 issue:

"Expectant mothers going into labor well before their due date usually come into the hospital under emergency conditions. The doctor's goal is to stop the contractions and prevent a premature birth; there is little, if any, time to ask the mother or father for consent to a study." (...) [Once the baby is born] "it would not be ethical to approach the mother for consent until she is physically and psychologically able to provide it. The mother is not only under the effect of sedation but also mental exertion, and she is unable to understand immediately what is being proposed. Both parents need time to cope with the possibility that their child will die or have serious health complications before they can be approached about the study."

This misleading scenario of breathless haste and instant plop-out birth is as wrong as Dr. Kupfer's patronizing presumption to know what a mother is able to understand.

Such emergency births upon arrival at the hospital may happen occasionally, but if you look at the obstetric literature or ask parents of preemies, you find the much more common case is reflected in Mrs. Margie Watson's comment in that same article: that she was in the hospital many hours before giving birth to her preemie daughter and would have had plenty of time to consider the proposal of a study.

This publicly alleged excuse for the delay in protecting the babies would appear so transparently false to the intended readers of the LIGHT-ROP Manual of Procedures -- professionals who work in hospitals -- that the Manual does not even mention it. These more experienced readers are given a less easily verified reason for not requesting the parental consent during labor:

"While not impossible, this approach would introduce considerable logistic and cost constraints into the study." (MOP page 3-6, bottom)

However, this pretext does not bear scrutiny either. In the many trials for testing lung surfactant in preemies unable to breathe by themselves, the investigators typically had to administer this potentially lung-enabling medication almost immediately after the baby's birth, so the parents must routinely have given their consent to these experiments during labor.

Furthermore, to ignore such a crucial parameter of the investigation for reasons of cost and logistics is acting like a maker of fake sailing charts who shows everywhere safe depths and knowingly leaves out the sunken reefs and rocks because showing these hazards -- the ostensible purpose of the chart -- would take too much drafting time.

The initial $497,078 budget of this explicitly cost-conscious LIGHT-ROP study, before it was increased to its now more than a million dollars, granted the researchers $5,649 for each of the babies to be provided with up to six $9.60/pair goggles, leaving $5,591 per goggled baby for her and her controls' couple of extra eye examinations each and for the overhead expense of recording their results36.

The money earmarked for copying paper supplies buys about ten times the weight of each baby in reams of paper to note whether s/he has ROP or not, so the trial administrators could certainly have spared a few extra consent forms for the mothers in labor across the hall, or even across town.

The reluctance of the medical establishment to address the problem honestly is further illustrated by the non-response to my complaint from the doctor-staffed government agencies that are ostensibly charged with acting on complaints about misbehavior among doctors, such as the one I had sent last March to the National Bioethics Advisory Commission.

President Clinton had created this Commission specifically to protect the American public from such medical transgressions, but when I asked it to protect the babies in the LIGHT-ROP experiment, this protector-of-the-public declared itself not charged with examining individual cases (see my page 248 for a copy of their reply).

It seems that its members can ponder some abstract generic abuse without looking at actual cases, like a judge who condemned the concept of crime to jail instead of the robbers and killers who committed the crimes, or like a pre-Sydenham medical doctor who prescribed his purgings and potions to drive out generic disease instead of treating a patient who suffered from measles or epilepsy or scarlet fever.

The Commission passed my complaint on across the hall to the Office for Protection from Research Risks, and that Office ignored it until an article on this subject appeared in the June 1, 1997, issue of the Sunday newspaper supplement PARADE Magazine.

Two days after PARADE told its 90 million readers from Coast to Coast that I had filed said complaint, the Office wanted to know if I allowed them to keep my name on the complaint documents or if I desired to remain anonymous. Kafka could not have done better.

Two months later, they acknowledged the receipt of my letter, but despite several follow-up calls from a member of Congress they have not responded further. Whatever that so-called "Bioethics" may have been, the Santayana Syndrome epidemic has clearly wiped it out.

Similarly, the National Eye Institute refuses to comply with the Freedom of Information Act and to release the letters from the Institutional Review Boards that are supposed to have approved the LIGHT-ROP study.

The Code of Federal Regulations on Protection of Human Subjects mandates37 that the institution engaged in the research must maintain these records accessible for inspection and copying, but the National Eye Institute circumvents this Federal mandate simply by saying that "LIGHT-ROP is an investigator-initiated study which is supported, but not conducted, by the NEI."

That means the NEI can keep from the public the essential documents about any study it funds, simply by paying someone outside its walls to make the initial proposal. It also means that the public's alleged protections against medical transgressions like the inhuman Human Radiation Experiments or the Tuskeegee Study are only an illusion.

Never mind the President's highly publicized apologies for these past transgressions and his solemn promises to prevent their repetition -- the medical establishment is sovereign and does not let him or anyone interfere with its public-deceiving traditions.

Can one escape the conclusion that LIGHT-ROP is knowingly designed to deny and cover up the hazards from routine nursery lighting to the eyes of premature babies?

Cui bono? Can the indefensible delay in protecting these babies during the most crucial time of highest risk have any other plausible purpose than a short-sighted attempt to cover up the all-to-embarrassing past and present blunders and crimes in the medical approach to ROP?

Some may argue an additional purpose could be to continue the ROP epidemic and thereby maintain the steady stream of cryotherapy operations and other lucrative medical interventions that this most frequent cause of childhood blindness guarantees for the many pediatric retinal surgeons and other physicians who sell their services to the victims.

This claim would be hard to either prove or disprove, but I trust you must agree the evidence is unequivocal that the LIGHT-ROP trial is intentionally rigged to obtain the "extremely useful" negative result of no significant difference in blinding between the unprotected babies and those who were only allegedly protected.

See Dr. Reynolds' attached letter of September 26, 1994, to Dr. Andrew Mariani at the National Eye Institute: "But even a negative result would be extremely useful in ending a long scientific and public debate." 

It would of course be useful for the medical authorities to thus falsely assert the harmlessness of the nursery lighting and to  avoid responsibility for the severe damage this iatrogenic agent has caused over the last fifty years to tens and possibly hundreds of thousands of patients. 

This lie would also divert attention from the harmful medical maligning and rationing of the life-saving oxygen.   Admitting this routine medical euthanasia program would cause great damage to the medical profession's most valuable asset which is the image it projects.

On the other hand, the patient-harming cover-up is bound to blemish that image even more in the long run -- yet another case of a medical quick-fix "cure" worse than the disease, and yet another manifestation of the Santayana Syndrome.

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