CINCINNATI: Intactivists Protest Circumcision "Experiment" at Good Samaritan Hospital

Last week, intactivists gathered at TriHealth Good Samaritan Hospital in Cincinnati, Ohio, to protest a clinical "trial" they are conducting, which aims to compare two circumcision devices commonly used for neonatal circumcisions. The experiment aims to compare the Gomco and Mogen circumcision clamps to see which one causes "less pain."

Bottom-left: Mogen clamp. Top-right: Gomco clamp

Details of the Circumcision "Study"
The claimed purpose of this study is to see which circumcision method is "less painful." Parents are being solicited to enroll their male infants in a study comparing two clamps used for non-medical circumcision.

In addition, the experiment seeks to see which method causes more bleeding, takes more time, which is followed by the most "parental satisfaction" in follow up visits (never mind the satisfaction of the child, on whom the circumcision is being performed) , which one causes more need for revisions within 6 weeks, and which one is more likely to cause infections.

Bleeding is being measured by weight of blood soaked gauzes after the procedure. Other outcome measures include neonatal pain score and a standarized score, including vital signs and facial expression.

The so-called "researchers" are starting from the hypothesis that the Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.

The participants are being euphemistically called "volunteers," and they are male babies 4 days old or less, born healthy from pregnancies without complications.

The experiment, entitled "Gomco Versus Mogen: Which is Best?" is currently "recruiting participants," or rather, persuading parents to enroll their healthy newborn baby boys. More than 200 babies have or will become subjects in the experiment, planned to run through April 2014.

More details on this "study" can be seen here.

Glaringly Obvious Problems

Deliberate Pain
The claimed purpose of this "study" is to decide which clamp "causes less pain." While up until recently, circumcision advocates argued that babies felt "no pain," and some continue to insist circumcision is painless still, the researchers here are not pretending the procedure is painless anymore; they are conceding that pain results regardless of used method. (Actually, it's been known for years that newborns feel pain more acutely than adults, and that circumcision is excruciatingly painful.)

In other words, for the purpose this "study," healthy, non-consenting babies are being enrolled, who will be deliberately made to experience pain. This is inescapably necessary to purportedly track which non-medical surgery method causes "less pain."

Non-medical surgery on healthy, non-consenting minors
The babies being circumcised for this experiment are being called "volunteers," which is a horrible stretch. The "researchers" can get by doing this because they've obtained signed consent from parents, placing on them the onus of responsibility, and circumventing the important question of medical necessity.

A big problem with this is the fact that researchers need "volunteers" for their experiment, and for this reason, parents who are being asked to have their children "participate" may not be being told how much pain circumcision actually causes. They CANNOT know; researchers cannot tell them exactly how much pain their child will endure, for measuring pain is the very purpose of the study. How much information are parents being given to obtain their consent to allow their children to participate in this study? Will they be shown a video of each procedure? Would the parents still consent for their children to "participate" in this experiment if they were truly informed?

But more importantly, consent from parents must be asked only after it has been determined that the child is suffering a medical illness for which there is no other alternative. Without medical or clinical indication, can a doctor even be performing surgical procedures on healthy, non-consenting minors? Let alone be eliciting consent from their parents? Let alone be asking them to let their children "participate" in an experiment, where the researchers cannot deny that the children will be experiencing deliberate pain? 

Short Timeframes for Other Factors
The "researchers" state they will be collecting data for other factors, such as bleeding results, "parental satisfaction" results, botched circumcisions, as well as others. The timeframes for many of these seem inappropriately short, such as measuring bleeding only 10 minutes after the surgery; babies have been known to have bleeding complication for hours, if not days. Additionally, some of these complications, particularly botched results and the need for revision, do not present themselves until the parents have gone home, sometimes even months, years down the line, so these babies will be excluded from this "study."

Note that one of the factors measured is "parental satisfaction," as if that had anything to do with the premise of their "study," which is ostensibly to measure and compare the pain of each device. Excluded here is the satisfaction of the person whose penis is in question.

Medical Ethics and Human Rights Consciously Breached
Not only do the "researchers" know that the procedure is painful, they are also aware that there are risks and complications they expect to see. (Infections and bleeding being the most common complication; not mentioned here are adhesions and the need for surgical revision of botched circumcision jobs.)

In other words, they are running a medical experiment on human babies, knowing that they are going to suffer pain, and that some are going to need additional surgeries, and/or may suffer even more severe complications.

The Use of the Mogen Clamp
An important fact that is not being acknowledged, or deliberately omitted here, is the fact that one of the clamps being "compared," the Mogen clamp, has a bad track record and is notorious for circumcision mishaps, even when used by professionals.

The "Manual for early infant male circumcision under local anaesthesia,"published by the World Health organization in 2010, details that both the Mogen clamp and the Gomco clamp have a risk for penile laceration and amputation, but extends to say that "penile amputation can occur even under ideal circumstances" with the Mogen clamp.

In a 2013 study in Botswana, the Mogen clamp and the Plastibell were compared. The adverse events with the Mogen clamp were considered to be more frequent but "minor" (removal of too little skin and development of skin bridges and adhesions). Bleeding was more frequent with the Mogen clamp as well.

Circumcision botches are so common with the Mogen clamp, that its manufacturer has been put out of business by numerous lawsuits involving partial or complete amputations of the glans penis. In a very recent case, a judge approved a $4.6 million settlement on a behalf of a boy who lost the head of his penis in a botched circumcision attempt. In the $11 million dollar lawsuit that finally put the Mogen company out of business, a mohel severed the end of another baby's glans using one of their clamps.

Data from Attorneys for the Rights of the Child, ARCLaw, show over 80 million dollars paid on settlements over botched circumcisions since 1985. Beyond the economic value (when compared to a billion dollar a year industry), those numbers represent children whose lives will have been impacted for the rest of their lives due to a non-medical elective surgery.

The peculiar thing about Mogen is that until the very end, they claimed that injury was impossible with the use of their clamp, even after other glans amputations were reported. The injury behind a prior lawsuit at Fulton County Superior Court had already put Mogen on notice about the danger of the device. In a different case, at South Fulton Medical Center, another law suit was won in 2009. In that case, a child lost a third of his glans, and the plaintiffs were awarded 2.3 million dollars.

While Mogen is out of business, their clamps have not been recalled, and they continue to be in use, as we observe here. Some doctors continue to market the Mogen technique as "bloodless, painless" and "state of the art."

Given the history of the Mogen clamp, it is beyond me how the "researchers" in this so-called "study" can begin with the hypothesis that the Mogen clamp is "better." It's almost as if the actual purpose of this "study" is to vindicate the Mogen clamp. Perhaps researchers hope that by publishing their study, they could blot out the Mogen clamp's history and clear its record?

So long story short, "researchers" at TriHealth Good Samaritan Hospital in Cincinnati, Ohio, are conducting an experiment on healthy, non-consenting minors, where they will be deliberately made to experience pain, with obsolete and dangerous equipment. Without any medical or clinical indication, they will be eliciting "consent" from parents for surgery, and their permission to include their children for this experiment.


Problems with the Good Samaritan Hospital Statement:
According to WLWT, TriHealth Good Samaritan released the following statement in their defense:

"At Good Samaritan Hospital it is understood that patient care, education and research respect and support the total good of the patient and uphold the sanctity of human life and the principles of Catholic teaching.

The circumcision study compares two medically accepted circumcision processes. Only after the parent or guardian requests and consents to circumcision for their infant, is informed consent sought for this study; they are free to decline their child’s participation in this study. Steps to ensure pain relief are integral to the study protocol.

Male infant circumcision has been practiced for centuries and is not among the procedures prohibited in the Ethical and Religious Directives for Catholic Health Care Services."

The statement is problematic from the get-go; healthy newborn males are not patients. The children on which these "researchers" will be experimenting are not sick. In fact, that the children are in good health is a requirement of this repulsive "study." Nevermind the complete disregard and disrespect for the child's basic human rights, and nevermind the first dictum of medicine "First do no harm," circumcising a healthy, non-consenting minor contradicts the principles of Catholic and Christian teaching.

In the second paragraph, the hospital conveniently fails to mention Mogen's history, and they conveniently circumvent the fact that the children involved will not be suffering any kind of illness for which circumcision is the only method of treatment by placing the onus of responsibility on parents, who, because of the nature of the study (it is to deliberately cause and measure pain), may not be given full information as the truth may discourage them.

At this point it needs to be asked; without medical or clinical indication, can doctors be performing surgery on healthy, non-consenting minors? Let alone be giving parents any kind of "choice?" Let alone be asking parents to "volunteer" their children for an experiment whose stated purpose is to deliberately cause and measure pain? Using a clamp with a negative track record for circumcision mishaps?

The last sentence in the second paragraph is conflicting with the stated purpose of the so-called "study."

 Steps to ensure pain relief are integral to the study protocol.

This seems counter-intuitive to the purpose of the "study," which aims to determine which circumcision method is "less painful," as ensuring pain relief will make it difficult to measure pain adequately.

The last paragraph offers the logical fallacy of appeal to antiquity, and offers a disingenuous reference to the Ethical and Religious Directives for Catholic Health Care Services.

As pointed out by Guggie Daily in her blog, it is true only in that the Ethical and Religious Directives doesn't mention infant circumcision as a separate topic at all in the entire document. The statement made by Trihealth seems to imply it's not prohibited, versus not being mentioned directly.

Furthermore, here is what the Ethical and Religious Directives for Catholic Health Care Services does say, regarding situations where non-consenting minors are being signed up for non-therapeutic experiments with risks:

"31. No one should be the subject of medical or genetic experimentation, even if it is therapeutic, unless the person or surrogate first has given free and informed consent. In instances of nontherapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person’s well-being. Moreover, the greater the person’s incompetency and vulnerability, the greater the reasons must be to perform any medical experimentation, especially nontherapeutic."

"51. Nontherapeutic experiments on a living embryo or fetus are not permitted, even with the consent of the parents. Therapeutic experiments are permitted for a proportionate reason with the free and informed consent of the parents or, if the father cannot be contacted, at least of the mother. Medical research that will not harm the life or physical integrity of an unborn child is permitted with parental consent."

The directive doesn't explicitly have a statement on non-therapeutic circumcision of infants, male nor female. In fact, since nothing is said about female infant circumcision, if we are to follow the logic of the above conflicting statement, female circumcision, and perhaps other non-therapeutic surgery is approved as well.

At any rate, the related statements clearly show that non-therapeutic circumcision experimentation on baby boys is prohibited, but Catholic hospitals should already know this. There's certainly no confusion when it comes to Catholic teaching on unnecessary medical procedures, forced medical procedures and amputations.

The U.S. Conference of Catholic Bishops asserts:

"All persons served by Catholic health care have the right and duty to protect and preserve their bodily and functional integrity. The functional integrity of the person may be sacrificed to maintain the health or life of the person when no other morally permissible means is available. (Ethical and Religious Directives for Catholic Health Care Services (Fifth Edition, 2009), n. 29.)

The Catechism of the Catholic Church states:

"Except when performed for strictly therapeutic medical reasons, directly intended amputations, mutilations and sterilizations performed on innocent persons are against moral law." (CCC, n. 2297)

What is infant circumcision?

Or, more appropriately, what is the foreskin?

The foreskin is not a birth defect. Neither is it a congenital deformity or genetic anomaly akin to a 6th finger or a cleft. Neither is it a medical condition like a ruptured appendix or diseased gall bladder. Neither is it a dead part of the body, like the umbilical cord, hair, or fingernails.

The foreskin is not "extra skin." The foreskin is normal, natural, healthy, functioning tissue, with which all boys are born; it is as intrinsic to male genitalia as labia are to female genitalia.

Circumcision is the surgical removal of the foreskin from the penis, which leaves the glans, or head of the penis, permanently exposed. After circumcision, the head of the penis, and surrounding mucosal tissue, dries out and becomes tough and calloused in a process called "keratinization." The appearance and mechanics of the penis are changed for the rest of a man's life.

What is the medical definition of amputation?

The Free Dictionary by Farlex gives the following definition:

"Amputation is the intentional surgical removal of a limb or body part. It is performed to remove diseased tissue or relieve pain."

Even the medical definition of amputation clearly states that removal of a body part is done to address disease and relieve pain, neither of which are present in a healthy newborns. As the very premise of this so-called "study" concedes, circumcision causes pain, which the "researchers" no longer deny, and which they are set to measure by deliberately causing it.

Unless there is a medical or clinical indication, the circumcision of a healthy, non-consenting individual is a deliberate wound; it is the destruction of normal, healthy tissue, the permanent disfigurement of normal, healthy organs, and by very definition, infant genital mutilation, and a violation of the most basic of human rights.

For any surgical procedure, including surgery to modify the genitals, medical ethics requires both necessity and informed consent, both of which cannot be present in healthy, non-consenting newborns. Without medical or clinical indication, doctors have absolutely no business performing surgery in healthy, non-consenting individual, much less be eliciting any kind of "decision" or "participation" from parents.

This "experiment" on human babies in in direct violation of Catholic teaching and ethical health care directives. Trihealth's statement is complete hogwash. 

Closing Statements

Imagine if you will, a "study" that sets out to see what the "least painful" method of female circumcision. Which one causes the least bleeding. Which one causes "less complications." Which one results in less need for revisional surgery later on. Imagine a "study" whose stated purpose implies causing deliberate pain in baby girls. Imagine one of the factors the "study" sets out to measure is whether or not the parents have been satisfied. Would it ever fly?

Would it be called "progress" if so-called "researchers" found a way to perform infant female circumcision in a way that was "bloodless?" "Painless?" "With little to no risk?"

I'm reminded of a 1959 American researcher, W. G. Rathmann MD, who invented a clamp for female circumcision, as a cure for frigidity. At the least he wasn't targeting infants.

Rathmann Clamp for female circumcision

Rathmann clamp in action - clamping the clitoral hood, the female equivalent of the male foreskin

The trend of opinion on routine male circumcision is overwhelmingly negative in industrialized nations. No respected medical board recommends circumcision for infants. All of them, including the AAP in their last statement, say that the "benefits" are not sufficient.

It must be asked how it is that parents are being asked to consider the self-same "benefits" that couldn't convince a single respected medical organization, and somehow come up with a more reasonable conclusion, and how it is doctors are expected to comply a "decision" that goes against the best medical authorities in the West.

It must be asked, WHY are "researchers" conducting "experiments" on a procedure no medical organization recommends, on healthy, non-consenting minors?

Without medical or clinical indication, how is it doctors are performing surgery on healthy, non-consenting minors? How it they're even letting parents make any kind of "choice?" Let alone "volunteer" their children for an experiment to "measure the pain" of a non-therapeutic, non-medical surgical procedure no respected medical organization can bring itself to recommend?

Is it conscionable that an "experiment" involving a procedure that no medical organization in the world can bring itself to recommend in healthy, non-consenting minors is being conducted?

Is it conscionable that "researchers" are conducting an experiment whose very premise admits that the newborns will be deliberately made to experience pain?

And, can it be conscionable that a device that is known for circumcision mishaps (its manufacturer was put out of business by countless lawsuits raised against them) is being tested?

Who in the world approved this experiment? What was running through their minds?

Would an experiment to see "what is the least painful method of female circumcision" ever be aproved in this way?

The only good that can come out of this "research study" is that nobody will be able to pretend that infants cannot feel pain anymore. They say that they are trying to determine which method results in LESS pain and LESS blood loss, in other words, admitting that there is pain and blood loss involved no matter how it's done.

Further Details:
The study itself can be viewed here, and here.

Principal Investigator: Mounira Habli, MD
http://www.cincinnatichildrens.org/bio/h/mounira-habli/        
mounira_habli@trihealth.com

(The principal investigator appears to be wearing a Muslim head covering. No conflict of interest there...)

Contact: Michaela Eschenbacher, MPH
http://www.linkedin.com/in/michaelaeschenbacher   
michaela_eschenbacher@trihealth.com  


Contact: Rachel Sinkey, MD
http://www.trihealth.com/discover-trihealth/education/trihealth-obstetrics-and-gynecology-residency/list-of-current-residents/      
rachel_sinkey@trihealth.com

Sponsors and Collaborators
TriHealth Inc.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726036


Related Posts:

Circumcision Botches and the Elephant in the Room

The Ghost of Mogen

AAP: Around the Bush and Closer to Nowhere

The Circumcision Blame Game

Politically Correct Research: When Science, Morals and Political Agendas Collide

Other takes on the matter:
Guggie Daly

Related Links:

Intact America Press Release

WLWT Coverage

WCPO Coverage

CNN: Circumcision study halted due to trauma