Dr Howard Mann[1] discusses the "intense controversy about the
scientific and ethical validity" that followed the publication of a
government sponsored lung ventilation experiment conducted on 861
critically ill patients suffering from acute respiratory distress syndrome
(ARDS) or acute lung injury. However, he does not address the violation of
the first and foremost tenet of acceptable research involvin...
Dr Howard Mann[1] discusses the "intense controversy about the
scientific and ethical validity" that followed the publication of a
government sponsored lung ventilation experiment conducted on 861
critically ill patients suffering from acute respiratory distress syndrome
(ARDS) or acute lung injury. However, he does not address the violation of
the first and foremost tenet of acceptable research involving human
subjects: "the voluntary, informed consent of the human subject is
absolutely essential." (Nuremberg Code).
In their published report in The New England Journal of Medicine
(2000) the ARDS Network[2] investigators stated: "informed consent was
obtained from the patients or surrogates at all but one hospital, where
this requirement was waived. " [p. 1302]
However, an investigation by the federal Office of Human Research
Protection (OHRP) [3] determined that "at nearly all" the prestigious
ARDS Network sites informed consent standards had been violated. And OHRP
found that most of these patients were enrolled without legally effective
consent by a legally authorized surrogate. Some patients were enrolled
without anyone's consent. For example, at the University of Washington[4]
(Seattle), 71 subjects 'were unable to provide legally effective informed
consent, and consent for 55 of these subjects was obtained and documented
from another individual." And, OHRP acknowledged that for 16 of the 71
subjects, the IRB waived consent altogether.
OHRP found that ARDS Network sites had not only failed to obtain
informed consent but when consent was obtained it violated essential
requirements:
"at nearly all study sites the informed consent documents failed to
adequately describe the purpose of the research... failed to adequately
describe the nature of the experimental design...failed to include death
as one of the risks of the research." In particular, there was no
statement that the subject could have a higher risk of death depending on
which of the experimental groups he or she was assigned to, in comparison
to not entering the trial and thereby receiving individualized care based
upon the best clinical judgment of the subject?s physicians. " And "
subjects in each experimental group" of the trial "may have been
disadvantaged compared to patients treated according to concurrent routine
clinical practice." [3]
The ARDS Network IRBs approved informed consent documents that "failed to describe the reasonably foreseeable risks and discomforts."
Patients and families were misled with false reassurances. For example,
the University of Utah consent document made unsubstantiated claims:
?risks will be minimized by close monitoring and by a computer protocol."
The computer protocols which will be used to standardize care in both
treatment groups have been extensively tested and been associated with a
four-fold increase in survival for patients with severe lung disease."[5]
The most disturbing aspect of this is that the exact opposite was shown to
be true.[6] Who should bear responsibility for such violations?
An article co-authored by a principle ARDS investigator from the
University of Utah, Dr. Alan Morrison,[7] and two pediatric critical
care physicians affiliated with Harvard (the site of the ARDSNet
statistics analysis) argued in 1999, in the NEJM that explicit informed
consent for research should not be required in experiments such as the
ARDS trial:
"We believe that as with clinical care, in the case of many
randomized, controlled trials, the patient's participation can and should
be considered to be authorized by his or her general consent for treatment
and that specific consent should not be required...In addition, there is a
price that is paid when one insists on specific informed consent for all
randomized, controlled trials. Many worthwhile studies will not be
conducted if investigators are required to obtain specific informed
consent."
Although their utilitarian argument was roundly criticized by federal
officials, physicians and ethicists,[8] it is most disturbing that OHRP?s
investigation revealed that the ARDS Network had, in fact, largely
dispensed with federal informed consent requirements.
The controversial design of this multi-site experiment, in which
patients were withdrawn from the individualized ventilation settings
prescribed by a critical care specialist (i.e. following standard
practice), then randomly assigned to one of two fixed ventilator settings-
-a low 6 ml/kg vs. a high 12 ml/kg--is being heatedly debated. The
American Journal of Respiratory Critical Care Medicine and Critical Care
Medicine, have seen fit to give equal opportunity to both sides of the
debate--but not The New England Journal of Medicine.
In this contested trial design, the investigators substituted
individualized standard treatment with a randomly assigned, fixed
ventilation setting, while failing to include a control group against
which the two tested methods could be compared. But what is the value (or
justification) for conducting an experiment that puts human beings at
increased risk if the findings will not answer the important clinical
question: Which of the two tested methods of ventilation is better than
current practice?
The appropriate control group for ARDS patients would have been a
group of patients receiving standard care which allows physician to select
a tidal volume setting from a range of possible settings, depending upon
the severity of injury to the lung and condition of the patient. At the
time of the ARDS experiment that range in standard care was between 6.5
ml/kg and 14.5 ml/kg. [See: Mann, Fig 1]
Prior to being randomized to either fixed tidal volume, most patients
in the ARDS Network were receiving 9.5 ml/kg to 11.5 ml/kg tidal volume.
Without a control group, it is not possible to know whether one or the
other tested method of ventilation--i.e., 6 ml/kg or 12 ml/kg--is as good
as, better than, or worse than the setting prescribed in current
practice.. As Dr. Mann correctly points out, "An inappropriate choice may
nullify the clinical value of a trial that otherwise meets the requirement
of internal validity." [p. 550]
Dr. Mann makes three recommendations: first, a systematic review of
the relevant literature. It is hard to believe that the standards of
approval for clinical trial have not yet reached the point at which we can
reasonably expect that IRBs would have ensured 'prior to approval' that
investigators have conducted a systematic review of the relevant
literature to ascertain risk.
Two additional steps recommended prior to IRB approval include a
formal survey of relevant clinical experts to document current practices;
and publication of the trial's protocol to solicit critical appraisal of
its rationale and design. To ensure against bias, flawed trial design, as
well protecting human subjects from unjustified risks in invalid
experiments will require accountability.
The ARDS Network experiment is a disturbing case study revealing
current unethical practices at major US universities, and thereby
demonstrating the ineffectiveness of the regulatory protection system that
is supposed to prevent experiments that unnecessarily expose human
subjects to increased risk of death. Only one IRB in the ARDS Network
raised substantive concerns about the inability of eligible patients to
give informed consent. The University of Washington (Seattle) IRB
questioned the ventilator trial design: "What if a subject assigned to the
lower tidal volume group cannot tolerate this level and needs to go to the
higher tidal volumes? Would such a person be dropped from the study?" Yet,
after raising substantive concerns, the IRB approved the research and
approved a waiver of informed consent. This government sponsored trial
cost taxpayers $48 million.
References
[1] Mann, H. Controversial choice of a control intervention in a
trial of ventilator therapy in ARDS: standard of care arguments in a
randomised controlled trial. Journal of Medical Ethics, 2005; 31:548-553.
[2] The Acute Respiratory Distress Syndrome Network. Ventilation with
lower tidal volumes as compared with traditional tidal volumes for acute
lung injury and the acute respiratory distress syndrome. New Engl J Med
2000;342:1301?8.
[3] See, OHRP Letter of determination to ARDS Network. July 3, 2003.
Online at: http://www.hhs.gov/ohrp/detrm_letrs/YR03/jul03a.pdf
[5] Informed consent documents were obtained by the Alliance for
Human Research Protection (AHRP) under the Freedom of Information Act.
[6] Mechanical ventilation in ARDS: One size does not fit all*,
Editorial by Katherine J. Deans, Peter C. Minneci, Steven M. Banks,
Charles Natanson, Peter Q. Eichacker, Critical Care Medicine, 2005;
33(5):1141.
[7] Truog, RD, Robinson, W., Morris, AH. Is informed consent always
necessary for randomized, controlled trials? The New England Journal of
Medicine, 1999; 340 (10):804-807.
[8] New England Journal of Medicine, 1999; 341:448-450, Aug 5, 1999.
Correspondence
Harris raises important concerns about NICE’s QALY methodology. The
rational for rationing treatments is opportunity cost; the alternative
better uses of scarce resources. If opportunity cost is king, why does
NICE not examine the opportunity cost of drugs, the resources (factor
costs) taken to manufacture them, i.e. the ex patent costs rather than the
supplier price, in its calculations, certainly wit...
Harris raises important concerns about NICE’s QALY methodology. The
rational for rationing treatments is opportunity cost; the alternative
better uses of scarce resources. If opportunity cost is king, why does
NICE not examine the opportunity cost of drugs, the resources (factor
costs) taken to manufacture them, i.e. the ex patent costs rather than the
supplier price, in its calculations, certainly within sensitivity
analysis? NICE economic methodology is entirely static, ignoring the
dynamics of the drug market completely.
The Alzheimer example is pertinent. The appraisal report gives a QALY
range of £40-80,000 for Aricept et al. It will probably become "cost
effective" to treat in 7 years time when the drugs go ex patent and
typically, halves or more. (NB there is much data and experience to
forecast price changes ). It is odd that the NICE Social Value Judgement
paper (SVJ) does not even mention this issue, central though it clearly
is.
Most volume drugs are not expensive to manufacture, and costs come
down with improved techniques, so it is equally strange that there is
apparently no background information on drug cost trends published during
the appraisal process. The Technology Advisory Committee is expected to
use its judgement on the "broad balance of costs and benefits ", but does
not seem to be given this essential factual background. The share of drugs
in the NHS bill is also falling, both absolutely, and relatively, since
the last PPR round. There was a £112 million reduction between January -
May 2005 over 2004, largely the result of major drugs going ex patent.
This does put recent draft negative decisions in perspective.
The patent premium represents society’s way of funding research and
launch costs. The NHS, via NICE, is effectively seeking to avoid
contributing its fair share of global R&D costs through denying some
patients until the post patent price drop. As Harris says, this is
discrimination against those for whom treatment is intrinsically
difficult, and arguably unethical in a more global sense.
An example from Scotland demonstrates rather clearly why it is
seriously misguided to use QALY’s to select patients, rather than compare
treatment paths. The SMC, NICE Scottish counterpart, has provisionally
rejected pegvisomant as the 3rd line treatment for acromegaly. This is a
rare endocrine disease, usually diagnosed in early adulthood but across a
wide range of ages. Pegvisomant appears to be a very effective but very
expensive drug, approximately £18,000 p.a. – but these patients will have
exhausted the wide range of cheaper treatments for this condition. The
best evidence is that ineffectively treated acromegalics lose around 9.5
years of good quality life expectancy, dying at typically 65 rather than
75. This suggests the additional life expectancy should be QALY valued at
up to £300,000. SMC did not do a detailed study, but clearly, using basic
NICE principles, a patient diagnosed at 25 (50 years at £18,000) has no
hope, one at 58 is at the margin, (£306,000) and older patients would be
"profitable". There are just 31 such patients in Scotland, but these,
unlike the children with vastly expensive metabolic disease removed by
NICE from its SVJ, itself a breathtakingly arbitrary value judgement,
won’t make headlines. The bias against low profile disease is only too
clear.
NICE controversies would disappear if, like other administrations, it
adopted an inclusive principle," at least one" effective treatment, where
it exists. It is time that NICE methodology is independently reviewed.
Such a review might also seek to commission a QALY estimate of the loss of
welfare and stress caused to patients and carers by its periodic ill-
judged negative and delayed decisions.
Dr. Mann's 20/20 hindsight discloses the availability of some of the
alternative research designs that might have answered the question
addressed by the ARDSNET researchers. However, the choice among
alternatives in face of uncertainty is not itself controversial. What is
and should be controversial in all such cases is the failure to disclose
to the unknowing patients or their surrogates the nature o...
Dr. Mann's 20/20 hindsight discloses the availability of some of the
alternative research designs that might have answered the question
addressed by the ARDSNET researchers. However, the choice among
alternatives in face of uncertainty is not itself controversial. What is
and should be controversial in all such cases is the failure to disclose
to the unknowing patients or their surrogates the nature of the risk into
which the researchers would put them. Interestingly, Dr. Mann's focus and
survey of the expert clinicians to establish the "probative" value of an
experimental design lacking representation of the applicable, albeit
putative, standard of care in the situation entirely misses the point that
the ARDSNET researchers failed to satisfy the ethical and legal
requirement pursuant to 45 CFR 46 of obtaining the informed consent of the
patients or their surrogate decision-makers.
The Alliance for Human Research Protection (AHRP) that Dr. Mann cites
as one of the critics of the ARDSNET trial complained to the Office of
Human Research Protection (OHRP) about the lack of informed consent for a
substantial number of the human subjects, which the OHRP itself had drawn
to the attention of the ARDSNET researchers.
The ordinary "standard of care" requires the physician to explain the
benefits and risks of the intended treatment before undertaking it. This
essential step makes the difference at law between authorized treatment
and a battery committed on the person of the patient.
The question that remains to be addressed in all of this is "If the
researchers were so muddled and uncertain about what they were doing, how
could they have possibly conveyed the possible benefits and risks to their
patients or surrogate decision-makers?" That this should have been done is
uncontroversial, and fixing this deficiency was one of the stipulations in
the OHRP permission for the ARDSNET researchers to resume the suspended
trial in question.
Fox and Thomson[1] have injected a note of rationality into debate
over male circumcision with their conclusion that there is no compelling
legal authority for the view that the practice is lawful. They have
presented a thorough critique of the BMA's 2003 guidance document.[2] It
is however instructive to examine the statement from the BMA guidance that
"Male circumcision in cases where there is a clea...
Fox and Thomson[1] have injected a note of rationality into debate
over male circumcision with their conclusion that there is no compelling
legal authority for the view that the practice is lawful. They have
presented a thorough critique of the BMA's 2003 guidance document.[2] It
is however instructive to examine the statement from the BMA guidance that
"Male circumcision in cases where there is a clear clinical need is not
normally controversial" against the advice "to circumcise for therapeutic
reasons where medical research has shown other techniques to be at least
as effective and less invasive would be unethical and inappropriate".
The evidence for the efficacy of conservative treatment is, in most
cases presently treated by circumcision, overwhelming. As this deviates
from the standard teaching of the medical curriculum, it is appropriate to
outline the evidence in respect of what have recently been considered the
main clinical indications for male circumcision.
Uncomplicated phimosis can be treated by potent topical steroids or
by simple conservative surgery.[3-5] Clearly it is inappropriate to
remove histologically normal tissue since this is amenable to plastic
correction. Paraphimosis too can be treated by an overwhelming array of
conservative treatments.[6] Balanitis should be treated in accordance
with clinical guidelines.[7] Recurrent balanitis can be managed by
restriction of washing with soap.[8]
Current medical teaching has it that preputial lichen sclerosus,
otherwise known as "BXO",[9] is an "absolute" indication for circumcision.
Lichen sclerosus should however be treated according to clinical
guidelines.[10] At least one controlled trial has confirmed that topical
steroids will effectively treat "BXO" in a percentage of cases.[11] A
greater number of less rigorous studies have shown that potent topical
steroids are effective for phimosis involving lichen sclerosus.[12-17]
The percentage effectiveness appears to be directly related to the potency
of the steroid used. A success rate of 70% has been reported by Jorgensen
for clobetasol diproprionate.[12]
Three recent studies undermine the Law Commission's argument for
stating that circumcision is not, by their definition based on reducing
sexual pleasure, a mutilation.[18-20] Decreased sexual satisfaction
secondary to circumcision has been demonstrated in 17%,[18] 27%[19] and
38%[20] of patients. Moreover, since it comprises a wound under section
20 of the Offences against the Person Act, 1861, male circumcision's
lawfulness must be in serious doubt. Indeed it may arguably constitute
grievous bodily harm.
Male circumcision would be ethical and appropriate only in cases of
severe preputial lichen sclerosus which do not respond to conservative
treatment; or in rare cases where the prepuce is irredeemably damaged due
to necrosis or malignancy. The time has come for medical associations to
caution their members that the removal of normal tissue from normal
unconsenting children is always unethical. The medical school curriculum
must urgently be updated to remove spurious clinical indications for this
outmoded form of treatment.
References
1. Fox M, Thomson M. A covenant with the status quo? Male
circumcision and the new BMA guidance to doctors. J Med Eth. 2005;
31(8):4639.
2. British Medical Association. The law and ethics of male
circumcision: guidance for doctors. London: BMA, 2003.
3. Dewan PA, Tieu HC, and Chieng BS. Phimosis: is circumcision
necessary? J Paediatr Child Health. 1996;32(4):2859.
4. Berdeu D, Sauze L, Ha-Vinh P and Blum-Boisgard C. Cost-
effectiveness of treatments for phimosis: a comparison of surgical and
medicinal approaches and their economic effect. BJU Int.
2001;87:239244.
5. Van Howe RS. Cost-effective treatment of phimosis. Pediatrics.
1998;102:E43.
6. Little B, White M. Treatment options for paraphimosis. Int J Clin
Pract. 2005; 55(9):5913.
7. No author identified. National guideline for the management of
balanitis. Sex Transm Infect. 1999; 75(Suppl 1):S85-8.
8. Birley HDL, Walker MM, Luzzi GA, Bell R, Taylor-Robinson D, Byrne
M, Renton AM. Clinical Features and Management of Recurrent Balanitis;
Association with Atopy and Genital Washing. Genitourin Med. 1993; 69:400-
3.
9. Hinchliffe SA, Ciftci AO, Khine MM, Rickwood AMK, Ashwood J,
McGill F, Clapham EM, van Velzen D. Composition of the inflammatory
infiltrate in pediatric penile lichen sclerosus et atrophicus (balanitis
xerotica obliterans): a prospective, comparative immunophenotyping study.
Pediatr Pathol. 1994; 14:223-233.
10. Neill SM, Tatnall FM, Cox NH. Guidelines for the management of
lichen sclerosus. Br J Dermatol. 2002; 147:640-9.
11. Kiss A, Csontai A, Pirot L, Nyirady P, Merksz M, Kiraly L. The
response of balanitis xerotica obliterans to local steroid application
compared with placebo in children. J Urol. 2001; 165(1):219-20.
12. Jorgensen ET, Svensson A. The Treatment of Phimosis in Boys, with
A Potent Topical Steroid (Clobetasol propionate 0.05%) Cream. Acta Derm
Venerol (stockh). 1993; 73(1):5556.
13. Pasieczny TAH. The treatment of balanitis xerotica obliterans
with testosterone propionate ointment. Acta Derm Venerol (stockh). 1977;
57:275-7.
14. Dahlman-Ghozlan K, Hedbald MA, Von Krogh G. Penile lichen
sclerosus et atrophicus treated with clobetasol diproprionate 0:05% cream:
a retrospective clinical and histopathalogical study. J Am Acad Dermatol.
1999; 40(3):451-7.
15. Neuhaus IM, Skidmore RA. Balanitis Xerotica Obliterans and Its
Differential Diagnosis. J Am Board Fam Pract. 1999; 12(6):473-6.
16. Poynter JH, Levy J. Balanitis xerotica obliterans: effective
treatment with topical and sublesional corticosteroids. Br J Urol. 1967;
39:420-5.
17. Vincent MV, MacKinnon E. The response of clinical balanitis
xerotica obliterans to the application of topical steroidbased
creams. J Pediatr Surg. 2005; 40(4):709-12.
18. Masood S, Patel HR, Himpson RC, Palmer JH, Mufti GR, Sheriff MK.
Penile sensitivity and sexual satisfaction after circumcision: are we
informing men correctly? Urol Int. 2005; 75(1):62-6.
19. Coursey JW, Morey AF, McAninch JW, Summerton DJ, Secrest C, White
P, Miller K, Pieczonka C, Hochberg D, Armenakas N. Erectile function after
anterior urethroplasty. J Urol. 2001; 166(6):2273-6.
20. Fink KS, Carson CC, DeVellis RF. Adult Circumcision Outcomes
Study: Effect on Erectile Function, Penile Sensitivity, Sexual Activity
and Satisfaction. J Urol. 2002; 167(5):2113-6.
Although Fox and Thomson make interesting comments on the BMA
guidance on male circumcision, their proposal to make it unlawful is
unwise.
First, there is room for doubt about the objectivity of views on this
matter. They declare no interests, but can this be true of any male
writer? They point out that fathers want their sons to resemble
themselves, and to a degree we may all wish others of...
Although Fox and Thomson make interesting comments on the BMA
guidance on male circumcision, their proposal to make it unlawful is
unwise.
First, there is room for doubt about the objectivity of views on this
matter. They declare no interests, but can this be true of any male
writer? They point out that fathers want their sons to resemble
themselves, and to a degree we may all wish others of our sex to resmble
us. Therefore male authors should state whether they are bereft of, or are
proud possessors of a prepuce. If most opponents of circumcision are
intact, and most defenders are mutilated, we may wonder to what extent
papers are rationalisations of emotional attitudes. As Ayer might have
said "boo to circumcision". Of course arguments must still be countered.
If my guess is wrong, it will be reassuring. Accordingly I must confess to
dispossession, and having no memory of my brief time intact on this earth,
perhaps do not know what I am missing, figuratively speaking.
Next they assume that the medical case against circumcision is beyond
doubt. But there is a substantial body of contrary opinion. The truth is
probably that some suffer, some benefit, and most are little affected: it
is hard to know the balance.
They wish to protect the human rights of the infant, but surely there
must be some bold spirits among the circumcised, articulate enough to
protest about the violation of their own rights in childhood. Yet no sound
is heard. Indeed many give retrospective approval by circumcising their
own sons. Among them are doctors, who might not allow social pressure to
make them harm their children. So is it not a shade patronising of the
authors to defend those, who will later deny any need for defence?
The BMA rightly says that there is no medical need for circumcision,
and doctors are not obliged to perform it. The law sensibly avoids taking
sides in medical disputes, but it does require the consent of both parents
to an intervention with doubtful medical justification. What more can Fox
and Thomson want? To proscribe all circumcision would be intensely
resented as religious persecution. And perhaps a vestige of unconscious
prejudice motivates some of the hostility. To permit circumcision only to
specified faith groups would be invidious. To forbid doctors alone to
circumcise would be ridiculous. Perhaps the status quo is best.
Michael Benatar's defense of his "narrow point" linking circumcision
with "breast reduction, liposuction and rhinoplasty" does not address the
issue of what constitutes "mutilation" in the case of infant circumcision.
Where an adult may not feel deprived of his or her prepuce when amputated
with his or her personal consent, an infant never has that choice. An
infant's screams of protest make the depr...
Michael Benatar's defense of his "narrow point" linking circumcision
with "breast reduction, liposuction and rhinoplasty" does not address the
issue of what constitutes "mutilation" in the case of infant circumcision.
Where an adult may not feel deprived of his or her prepuce when amputated
with his or her personal consent, an infant never has that choice. An
infant's screams of protest make the deprivation an absolute and can never
be anything other than a mutilation by definition when done for non-
therapeutic reasons. It has everything to do with the consent issue and
simply cannot be separated from it. It should also be noted that proxy
consent in most Western countries is invalid in the case of female
circumcision and is, by logical extension, invalid in the case of infant
male circumcision as well. For a myriad of social, political, and
religious reasons, the law is not being applied equally.
Further, Mr. Benatar asserts that "appearance-altering removal of
healthy tissue is not a sufficient condition for mutilation." While this
may possibly be true in the case of an adult making a free choice, it is
not true in a case where the amputation is forced upon an minor child
without medical necessity. Nor is the circumcision of a child merely an
appearance-altering ablation, but is, as the ground-breaking research of
Taylor, Lockwood, Cold and others clearly shows, the forced excision of a
highly innervated, functional structure indispensable to normal sexual
function.[1-8]
These researchers show that the prepuce
is a unique, complex structure composed of thousands of specialized nerves
working in concert with Meissner’s corpuscles, vascular systems, and
stimuli receptors that have evolved over millions of years to maximize
human sexual experience. Such an amputation deprives an individual of a
normal penis and of the full range and depth of sexual pleasure it
provides. It would be analogous to cutting off an index finger or big toe
to the functioning of hand or foot. This, by any definition found in any
standard English dictionary is a mutilation when done for no therapeutic
reason and against the victim's will. To permanently amputate any body
part from the non-consenting for non-therapeutic reasons is an ethical
lapse of significant gravity and has no place in a modern medical context.
Fox and Thompson and many others in the legal and ethical fields have
taken note of this and are now in the process of making this outmoded,
medical and cultural relic accountable to law and ethics [9-19].
Rio Cruz, PhD
Executive Co-Director
International Coalition for Genital Integrity
References
1. Winkelmann, R. K. 1956. The cutaneous innervation of human
newborn prepuce. Journal of Investigative Dermatology 26(1):53–
67. 1959
2. Lakshmanan, S., and S. Prakash. 1980. Human prepuce: Some aspects
of structure and function. Indian Journal of Surgery
(44):134–37.
3. Taylor, J. R., A. P. Lockwood, and A. J. Taylor. 1996. The
prepuce:
Specialized mucosa of the penis and its loss to circumcision. British
Journal of Urology 77:291–95.
4. Halata, Z., and A. Spaethe. 1997. Sensory innervation of the human
penis. Advances in Experimental Medicine and Biology
424:265–66.
5. Fleiss, P. M., F. M. Hodges, and R. S. Van Howe. 1998.
Immunological
functions of the human prepuce. Sexually Transmitted Infections
74(5):364–67.
6. Cold, C., and K. McGrath. 1999. Anatomy and histology of the
penile and clitoral prepuce in primates. In Male and female circumcision:
Medical, legal, and ethical considerations in pediatric
practice, ed. G. C. Denniston, F. M. Hodges, and M. F. Milos. New
York: Kluwer Academic/Plenum Publishers.
7. Cold, C. J., and J. R. Taylor. 1999. The prepuce. British Journal
of
Urology International 83 (Suppl. 1):34–44.
8. O'Hara K, O'Hara J. The effect of male circumcision on the sexual
enjoyment of
the female partner. BJU International 1999; 83, Suppl. 1:79-84.
9. Brigman, W. E. 1984. Circumcision as child abuse: The legal and
constitutional issues. University of Louisville School of Law. Journal
of Family Law 23(3):1984–85
10. Dwyer, J. G. 1994. Parents’ religion and children’s welfare:
Debunking
the doctrine of parents’ rights. California Law Review
82(6):1371–1447.
11. Denniston, G. C. 1996. Circumcision and the code of ethics.
Humane
Health International 12(2):78–80.
12. Chessler, A. 1997. Justifying the unjustifiable: Rite v. wrong.
Buffalo
Law Review 45:555–612.
13. Smith, J. 1998. Male circumcision and the rights of the child. In
To
Baehr in our minds: Essays in human rights from the heart of the
Netherlands, ed. M. Bulterman, A. Hendriks, and J. Smith, 465–98.
Utrecht: Netherlands Institute of Human Rights, University of
Utrecht.
14. Price, C. 1999. Male circumcision: An ethical and legal affront.
Bulletin
of Medical Ethics, May, 13–19
15. Povenmire, R. 1999. Do parents have the legal authority to
consent
to the surgical amputation of normal, healthy tissue from their infant
children? The practice of circumcision in the United States.
Journal of Gender, Social Policy and the Law 7(1):87–123, 1998–99.
16. Van Howe, R. 1999. Involuntary circumcision: The legal issues.
BJU International 83(Suppl. 1):63–73.
17. Boyle, G. J., J. S. Svoboda, C. P. Price, and J. N. Turner. 2000.
Circumcision
of healthy boys: Criminal assault? Journal of Law and
Medicine 7:301–10.
18. Somerville, M. A. 2000. Altering baby boys’ bodies: the ethics of
infant male circumcision. In The ethical canary: Science, society
and the human spirit, M. A. Somerville, 202–19. Toronto: Viking.
19. Svoboda, J. S., R. S. Van Howe, and J. G. Dwyer. 2000. Informed
consent for neonatal circumcision: An ethical and legal conundrum.
Journal of Contemporary Health Law Policy 17:61–133.
20. Dritsas, L. S. 2001. Below the belt: Doctors, debate, and the
ongoing
American discussion of routine neonatal male circumcision.
Virginia Polytechnic Institute and State University Bulletin of Science,
Technology and Society 21(4):297–311.
Fox and Thomson's critique of infant male circumcision and the BMA's
updated guidance to doctors rightly focuses on the "harm/benefit
assessment which lies at the heart of the male circumcision debate." A
common error made by circumcision proponents is that the benefits and
harms are so equally balanced that it's a toss up.
This is incorrect. To count a medical intervention as having benefit...
Fox and Thomson's critique of infant male circumcision and the BMA's
updated guidance to doctors rightly focuses on the "harm/benefit
assessment which lies at the heart of the male circumcision debate." A
common error made by circumcision proponents is that the benefits and
harms are so equally balanced that it's a toss up.
This is incorrect. To count a medical intervention as having benefit
or therapeutic value requires that the "benefit" greatly outweighs the
risks and harms necessary to obtain it. Further, that the intervention is
the only rational way to obtain these proffered benefits and that they are
necessary to the overall health of the child. Infant circumcision does
not fill any of these criteria. Neither does it take into consideration
the obvious fact that the prepuce has a valid, beneficial, and
evolutionary purpose and justifiably belongs to the owner, not his
parents, his religion, his peer group, the medical establishment or anyone
else. Under these circumstances, we are no more justified in amputating
an infant's foreskin against his will than we are in cutting off an ear,
nose or limb unless there is clear medical necessity and the amputation is
the least invasive treatment available.
John W. Travis, MD, MPH
President
Wellness Associates
POB 8422
Asheville, NC 28814
jwtravis{at}atlc.org
The Benatar brothers once again attempt to “justify the unjustifiable”, as Chessler so aptly put it.1 One has to admire their dogged defence of their position, even after the American Journal of Bioethics published devastating criticism of their earlier paper.2
The Benatar brothers once again attempt to “justify the unjustifiable”, as Chessler so aptly put it.1 One has to admire their dogged defence of their position, even after the American Journal of Bioethics published devastating criticism of their earlier paper.2
Mutilation
They still fail to understand the nature of mutilation. Mutilation is the destruction of appearance or function. Circumcision does both. In addition to altering appearance by replacing normal tissue with scar tissue, circumcision alters function in the following ways:
Protective functions. The foreskin protects the glans penis throughout life. The amputation of the foreskin of infants is well documented to cause meatal ulceration and meatal stenosis.3-5 The protective foreskin keeps the surface of the glans penis clean, free of infection, smooth, moist, supple, and sensitive.6
Gliding action. The looseness of the foreskin allows it to glide back and forth during sexual intercourse.7 The gliding action provides effortless penetration8 and reduction of friction and chafing.9 Circumcision tightens the penile skin and destroys the gliding action, causing difficult insertion10 and abrasive intercourse.9
Sensation. Anatomic investigation shows the foreskin to be highly innervated tissue.11 Excision of the foreskin and its nerves causes weakened erectile function,12 decreased penile sensitivity,12 loss of erectile confidence,10 delayed ejaculation,13 and prolonged intercourse,10 all of which are indicative of diminished sensory input.
Circumcision, therefore, readily qualifies as mutilation.
Surrogate Consent
The Benatars also fail to grasp the distinction between personal consent and surrogate consent.2 They cite breast reduction, liposuction, and rhinoplasty as examples of ethical procedures that remove healthy tissue. These procedures are commonly performed on adults who have very broad powers to consent, while non-therapeutic circumcisions usually are performed on children who are legally unable to consent, so the consent can only be granted by a surrogate, usually a parent, who has very limited powers to consent.2
The Benatars improperly attempt to validate parental surrogate consent for non-therapeutic consent by comparing non-therapeutic circumcision to vaccination.2 The comparison is inapposite because vaccination enjoys medical approval,14 while non-therapeutic circumcision does not.
It is well established that surrogate consent must be exercised only in the best interests of the child and no one else.15 Surrogates and doctors have a duty to protect the child’s rights.15,16 Parental rights do not override child rights.16 The attending physician must provide the medical care the child needs, not what someone else wants.17 Parental consent is not valid unless it is preceded by a physician’s diagnosis of disease and a recommendation for treatment thereof. Parental cultural or ethnic views, family traditions, and the like are not interests of the child and simply do not qualify as excuses to violate his body.18
Conclusion
The Benatars’ humanitarian efforts would be better directed toward ending circumcision in their native South Africa where numerous youths die from its complications every year.19
M. Fox and M. Thomson [1] say that we [2] draw analogies between male
circumcision and other surgical procedures such as breast reduction,
liposuction and rhinoplasty. They argue that such analogies are "seriously
flawed" because, unlike circumcision, these other procedures "involve adult patients capable of consenting" to them.
This criticism, as we have explained elsewhere [3], takes our a...
M. Fox and M. Thomson [1] say that we [2] draw analogies between male
circumcision and other surgical procedures such as breast reduction,
liposuction and rhinoplasty. They argue that such analogies are "seriously
flawed" because, unlike circumcision, these other procedures "involve adult patients capable of consenting" to them.
This criticism, as we have explained elsewhere [3], takes our analogy out of context. We never claimed that circumcision is analogous to these
other procedures in every way. Instead, we used the analogy to make one
very limited point – that appearance-altering removal of healthy tissue is
not a sufficient condition for mutilation. We illustrated this by noting
that although breast reduction, liposuction and rhinoplasty involve the
removal of healthy tissue they are plausibly not thought of as mutilation.
This has nothing to do with the consent issue, which we examined
separately.
References
1) M. Fox, M Thomson, "A covenant with the status quo? Male
circumcision and the new BMA guidance to doctors" J Med Ethics 2005; 31:
463-469.
2) M Benatar, D Benatar, "Between prophylaxis and child abuse: the
ethics of neonatal male circumcision" Am J Bioeth 2003; 3(2): 35-48.
Having read your article on the ethics of male circumcision, I can
totally agree that no lawful reason can be justified to excise healthy
sexual tissue (or any other for that matter) from non-consenting minors.
International law makes clear that it is unlawful to force someone
into a religion without their free and non-coerced consent, yet sexual
mutilation in the name of religion does ex...
Having read your article on the ethics of male circumcision, I can
totally agree that no lawful reason can be justified to excise healthy
sexual tissue (or any other for that matter) from non-consenting minors.
International law makes clear that it is unlawful to force someone
into a religion without their free and non-coerced consent, yet sexual
mutilation in the name of religion does exactly that. The right of the
child to body integrity exceeds the right of the parent to impose their
will upon the child.
Your paper seems to agree with the concept that ritual circumcision
is similar to tattooing, ear piercing or violent sports, but to compare
the former to the latter reveals a complete lack of understanding of the
issue of sexual mutilation. The former removes permanently a large
proportion of the sexually erogenous tissue from the male, almost always
from a minor and therefore without the free and legal consent of the
victim. The latter carry no permanent harm or loss, unless one suffers a
debilitating injury during participation in sport, or HIV infection during
tattooing and ear piercing. But most importantly, all of the latter can
safely be presumed to be carried out with consent. Few minors get tattoos
or participate in violent sports.
The greatest error of your paper occurs when you swallow whole the
unsubstantiated fiction that circumcision does not alter or diminish the
enjoyment of sexual intercourse. You are apparently ignorant of the
innervation of the foreskin and ridged band, and of the anatomical studies
that have shown that the ridged band and frenulum contain the vast
majority of erogenous nerve receptors. The ridged band is always removed,
and the frenulum greatly damaged by circumcision when the mutilator does
not specifically attempt to remove it all.
Dr. John Taylor, Chris Cold, and Ken McGrath have shown that the
equivalent fine touch, pressure, temperature and motion sensors are found
in the foreskin/frenulum, and in the female clitoris and clitoral hood.
The removal of either must diminish the sexual experience. To believe
otherwise is to believe that less is more. The great success of those
promoting sexual mutilation has been to focus their opponents attention on
legal and medical issues, obscuring the real and substantial life long
loss suffered by the mutilated.
Dear Editor
Dr Howard Mann[1] discusses the "intense controversy about the scientific and ethical validity" that followed the publication of a government sponsored lung ventilation experiment conducted on 861 critically ill patients suffering from acute respiratory distress syndrome (ARDS) or acute lung injury. However, he does not address the violation of the first and foremost tenet of acceptable research involvin...
Dear Editor,
Harris raises important concerns about NICE’s QALY methodology. The rational for rationing treatments is opportunity cost; the alternative better uses of scarce resources. If opportunity cost is king, why does NICE not examine the opportunity cost of drugs, the resources (factor costs) taken to manufacture them, i.e. the ex patent costs rather than the supplier price, in its calculations, certainly wit...
Dear Editor,
Dr. Mann's 20/20 hindsight discloses the availability of some of the alternative research designs that might have answered the question addressed by the ARDSNET researchers. However, the choice among alternatives in face of uncertainty is not itself controversial. What is and should be controversial in all such cases is the failure to disclose to the unknowing patients or their surrogates the nature o...
Dear Editor,
Fox and Thomson[1] have injected a note of rationality into debate over male circumcision with their conclusion that there is no compelling legal authority for the view that the practice is lawful. They have presented a thorough critique of the BMA's 2003 guidance document.[2] It is however instructive to examine the statement from the BMA guidance that "Male circumcision in cases where there is a clea...
Dear Editor,
Although Fox and Thomson make interesting comments on the BMA guidance on male circumcision, their proposal to make it unlawful is unwise.
First, there is room for doubt about the objectivity of views on this matter. They declare no interests, but can this be true of any male writer? They point out that fathers want their sons to resemble themselves, and to a degree we may all wish others of...
Dear Editor,
Michael Benatar's defense of his "narrow point" linking circumcision with "breast reduction, liposuction and rhinoplasty" does not address the issue of what constitutes "mutilation" in the case of infant circumcision. Where an adult may not feel deprived of his or her prepuce when amputated with his or her personal consent, an infant never has that choice. An infant's screams of protest make the depr...
Dear Editor,
Fox and Thomson's critique of infant male circumcision and the BMA's updated guidance to doctors rightly focuses on the "harm/benefit assessment which lies at the heart of the male circumcision debate." A common error made by circumcision proponents is that the benefits and harms are so equally balanced that it's a toss up.
This is incorrect. To count a medical intervention as having benefit...
Dear Editor,
M. Fox and M. Thomson [1] say that we [2] draw analogies between male circumcision and other surgical procedures such as breast reduction, liposuction and rhinoplasty. They argue that such analogies are "seriously flawed" because, unlike circumcision, these other procedures "involve adult patients capable of consenting" to them.
This criticism, as we have explained elsewhere [3], takes our a...
Dear Editor,
Having read your article on the ethics of male circumcision, I can totally agree that no lawful reason can be justified to excise healthy sexual tissue (or any other for that matter) from non-consenting minors.
International law makes clear that it is unlawful to force someone into a religion without their free and non-coerced consent, yet sexual mutilation in the name of religion does ex...
Pages