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My open letter to Professor Amy Gutmann
University of Pennsylvania President and
Christopher H. Browne Distinguished Professor
of Political Science &
Chair of the
Presidential Commission for the Study of
Bioethical Issues
From:
Peter Aleff <prevent at retinopathyofprematurity.org>
Subject:
Recent patient abuses in US medical research on premature babies
Date:
Sat,
27 Nov 2010
16:25:34
-0500
To: <info@bioethics.gov>
Dear Dr. Gutmann,
Following recent headlines such as CNN's "Obama requests review of
U.S. research regulations", and President Obama's request to your
commission to form a panel this coming January to review existing
regulations for the protection of patients in medical research, I
want to bring to your attention that the abuses of inflicting
deliberate harm on unsuspecting and defenseless patients are not
safely limited to long past studies, like the recently revealed
syphilis study in Guatemala, or the equally infamous Tuskegee study
of that disease's evolution in untreated black men.
There is at least one much more recent example in
US
pediatric research that followed a protocol of deliberately exposing
research subjects to intentional harm very similar to that used in
Guatemala.
In the LIGHT-ROP
study of baby-blinding by excess light, published in the
May 28, 1998,
issue of the New England
Journal of Medicine, US medical researchers financed by the
National Eye Institute
exposed premature babies knowingly to the blue-violet spikes in
fluorescent nursery light which they themselves had described as
eye-damaging and as a potential cause of the baby-blinding
retinopathy of prematurity
epidemic.
Even worse, these inhumane researchers intentionally maximized the
babies' exposure to this potentially dangerous irradiation by
forbidding the nursery staff in the three study hospitals to grant
the babies the customary protection from the overly bright
fluorescent light which caring nurses and parents usually arrange by
shading the babies from the harsh illumination with blankets spread
over their isolettes. The reason the trial designers gave in their
Manual of Procedures for
this cruel mistreatment of human babies was that they wanted to
"increase the stratification and contrast of the test results", as
if those babies were disposable guinea pigs.
You will find a description of this abuse at
http://retinopathyofprematurity.org/Re-Tuskegee.htm
where I posted my open
letter to Professor Reverby, the Historian who had discovered the
documents describing the abuses in
Guatemala.
In that letter, I further describe the indifference of the relevant
US
government agencies to this blatant and overt abuse, and I show
that,
incredible as this may seem to lay observers after the prominent
official condemnations of the Tuskegee Study and of the
Human Radiation Experiments, the
U.S.
medical research rules still do not require the protection of
research subjects from known existing dangers. Despite the revision
of the Helsinki Declarations forbidding the use of placebos when
real treatments exist, US researchers still have to protect their
patients only from those dangers that are created by the research
itself. Indeed, the "Criteria for IRB approval of research" state
explicitly in Section 45
CFR
46.111 (2):
"In evaluating risks and benefits, the IRB should consider only
those risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subjects would
receive even if not participating in the research)".
http://cfr.vlex.com/vid/46-111-criteria-irb-approval-research-19931875
Just like the doctors running the textbook-unethical Tuskegee Study
who did not introduce new risks to their subjects, the LIGHT-ROP
authors failed to protect their patients from the well known danger
that they pretended to study. Even worse, they strove
Guatemala-style to maximize the harmful exposure of the unprotected
babies to enhance the "contrast" and thus credibility of their
study results, casually sacrificing those babies' eyesight to their
pretended "science". Yet, they did
not introduce a new risk, they only maintained and increased an
existing one.
Accordingly, despite this obvious violation of common-sense ethics,
their study protocol met the rather low standard of IRB-grade
"medical research ethics" and was fully approved at all the layers
of alleged safeguards against such violations of patients rights and
of common ethics.
The details of this abuse are documented in the study authors' own
words in their Manual of Procedures from which I posted
extensive excerpts in the series of pages that begins at
http://retinopathyofprematurity.org/LIGHT_ROP_Manual01.htm
Moreover, this study was thoroughly unethical on yet another level
because it was intentionally designed to falsely deny the role of
the current nursery lighting in the
ROP
baby- blinding epidemic. That epidemic began in the
US
with the introduction of fluorescent lamps, and started a few years
later also in other
countries as these lamps became available there. The pre-arranged
false-negative finding of the LIGHT-ROP
study now prolongs the baby-blinding which continues the steady
stream of customers for the pediatric retinal surgeons
among its authors. It also protects many other members of the
medical profession from having to admit their liability for the
continued blinding and
other permanent harm to the babies.
You will find more background information about this epidemic at
http://retinopathyofprematurity.org/01summary.htm,
including a discussion of an earlier bogus study in the mid-1950s
that deliberately killed many of the babies by withholding the
life-saving oxygen breathing help so that there would be less cases
of blindness among the survivors of this Draconian mistreatment.
Others and I have tried for over three decades to bring these abuses
to the attention of the relevant medical authorities but have so far
not penetrated the stonewalling and wagon-circling with which these
protect the medical profession against any hint of such consistent
wrongdoing.
I hope therefore that your panel for the study of patient abuses in
medical research will be more serious about its task than, for
instance, the 1994-1995
Advisory Committee on Human Radiation Experiments
which issued a lengthy
report volume brimming with the mandatory "never again" rhetoric but
changed nothing in the system that had allowed these abuses and
continues to allow
them.
I am asking you for your kind permission to share your reaction to
this alert with others around the world who are also interested in
ending this epidemic as well as other patient abuses, and I thank
you in advance for your reply.
Sincerely,
Peter Aleff
Reply received from the Commission:
My follow-up email of
March 14, 2011,
to the earlier correspondence posted above:
To the Presidential Commission for the Study of Bioethical Issues
On November 27, 2010, I alerted your Commission to the
patient abuses and scientific fraud in the 1998 LIGHT-ROP
clinical study of blinding premature American babies, as
posted at
http://retinopathyofprematurity.org/BioethicsLIGHT-ROP.htm.
In that study, the researchers knowingly patched the eyes of
their allegedly light-protected group much too late to make any
difference in the babies' exposure to the excess blue-light hazard
from the fluorescent nursery lighting which damages their retinae in
much shorter exposure times. This fraud exonerated the nursery
doctors from having to admit their responsibility for inflicting the
eye damage with the lamps their Academy of Pediatrics specified, and
it kept those baby-blinding fluorescent nursery lamps shining.
This bogus result also allowed the nursery doctors to continue their
lethal as well as brain-damaging oxygen rationing that accounts for
a significant portion of the costs and profits in an
intensive care nursery and that leads to knowingly baby-killing
oxygen-withholding trials like the recent SUPPORT study I
described to you in my email of February 22, as posted at
http://retinopathyofprematurity.org/BioethicsSUPPORT.htm and at
http://retinopathyofprematurity.org/Bioethics1955oxygen.htm.
In that 11/27/2010 email and in the more detailed pages linked to it
I had documented to your Commission that the continued overexposure
of the preemies' still developing and therefore most vulnerable eyes
to the intense energy spike of those fluorescent nursery lamps in
the most retina-damaging wavelength is clearly the obvious cause for
the continuing world-wide epidemic of baby-blinding retinopathy of
prematurity, or ROP.
For instance, the ROP epidemic started here with the introduction of
fluorescent lamps in the US in 1938/39 and began a few years later
in Europe and other industrial countries as these lamps became
available there after the second World War. Also, the typical
intensive care nursery lighting exposes fragile preemie eyes in a
few minutes to more damage-weighted retinal irradiance than the US
Industrial Safety Guidelines have established as the danger limit
for adult workers in an eight-hour work shift. More evidence is
listed on the series of pages that begins with
http://retinopathyofprematurity.org/Babyblindinglights01.htm
Meanwhile, the ROP epidemic still ravages intensive care
nurseries around the world today and is one of the major causes of
childhood blindness in most developed and developing countries.
Valerie H. Bonham, your Commission's Executive Director,
thanked me on December 20 for my comments and said you
would welcome my continued engagement and feedback, so
here it is:
My material showed to your Commission that you could end that
ROP-blinding virtually overnight by exposing the blatant
research fraud in the LIGHT-ROP study which now prevents
nursery doctors around the world from using common sense to
protect the eyes of all preemies from the clearly hazardous
fluorescent irradiation.
The above facts are unrefuted and undisputed by honest scientists.
It is therefore your Commission's ethical duty to stop this
unnecessary blinding and to save the eyesight of many thousand
children a year, or several hundred every month. This is in your
Commission's power because all you need to do is to alert the public
to the scientific facts, and the nursery doctors will have no choice
but to quickly protect the preemies' eyes.
Nursery doctors all around the world have traditionally accepted and
followed US research results and intensive care nursery routines, as
they did with the bogus recommendations for oxygen withholding to
allegedly prevent blinding. You have now the chance to replace those
disastrously harmful American teachings with a simple way to end the
entire ROP epidemic.
You could thereby make up to the rest of the world, at least in
part, for some of the damage the oxygen withholding doctrine has
done in all the other countries where doctors misled by yet another
unethical US study had blindly accepted that falsely promoted
eugenics-inspired baby-eliminating doctrine.
Yet, your Commission has kept this well documented information for
now over three months locked up in its ivory tower and has so far
done nothing to protect preemies from the continuing abuse of their
vulnerable eyes in today's overbright intensive care nurseries.
I realize that your Commission's assignment is not to stop research
abuses but only to study them and the possibility of their still
occurring today, and then to write a report on your findings. This
narrow view may allow your members to try and use the Nuremberg
defense that they only did what they were told to do, but this
unethical refusal to prevent an imminent harm may not be deemed
acceptable from bioethicists who keep condemning the very similar
ethics violations in Tuskegee.
Indeed, if your Bioethics Commission's failed to protect a
vulnerable population against a known hazard that you could easily
stop and prevent from harming more children, then how, pray tell,
would this failure be different from the infamous failure of the
Tuskegee doctors to stop the syphilis of their study subjects when
they could easily cure it?
If anything, should your Commission omit to quickly end the
baby-blinding then it would rank even worse on that scale because
the Tuskegee doctors were at least not responsible for injuring
additional people beyond those who did already have the disease.
Your Bioethics Commission, by contrast, knowingly lets several more
babies' eyes be destroyed every day that you further delay your
already long overdue epidemic-ending intervention, and it exposes
several more preemies a day to the risks of death and brain damage
from the misled oxygen withholding.
Since one of your Commission's tasks is to compare US laws and
regulations about patient protection in medical research to those of
other countries, I want to draw your attention to the so-called
"Good Samaritan" or "abstain from helping" laws that are popular in
Europe and possibly elsewhere, too.
One of these is the French legal concept of "abstention volontaire
de porter assistance à une personne en péril". Under article 223-6
of the French penal code, each of your Commission's members could be
sued by any parent or other agent of a preemie born in France and
blinded by ROP during your Commission's inaction to stop the
world-wide blinding although it was able to do so. They would be
criminally liable if they knew about the preemies' imminent peril of
bodily harm and if they could have prevented that harm without risk
to themselves. In France, this crime of omission is punishable with
five years in jail plus a fine of 75,000 Euros
http://fr.wikipedia.org/wiki/Non-assistance_%C3%A0_personne_en_danger
.
Germany has equivalent laws about "Unterlassene Hilfeleistung", and
so do Albania, Austria, Belgium, Bulgaria, Croatia, Czech Republic,
Denmark, Finland, Greece, Hungary, Iceland, Italy, the Netherlands,
Norway, Portugal, Russia, Serbia, Spain, and Switzerland, plus
possibly some other countries not mentioned in this Eurocentric list
from
http://en.wikipedia.org/wiki/Duty_to_rescue .
You might therefore need to advise your members to be cautious about
the risk of getting arrested during future travels to those
countries unless your Commission stops the international
baby-blinding with due diligence to prevent more harm.
I further suggest that you consider how you could explain any
continued Tuskegee-style inaction on your Commission's part to the
parents of the American preemies getting blinded now when these
facts become public knowledge. Ultimately, the truth is bound to
come out, as it did for some of the initially secret medical
atrocities committed by others that your Commission now studies.
I ask you therefore to please protect the preemies of the world now
from retina-destroying nursery lamps and from lethal or
brain-damaging oxygen-withholding. You would thereby help to redeem
the moral liability of American medical research for some of its
past ethics breaches that harmed not only its research subjects but
that also keep harming many innocent preemies around the world.
Respectfully submitted,
Peter Aleff
prevent@retinopathyofprematurity.org
Continue
here to the complaint about the 2010 SUPPORT study
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