I believe that the practical framework produced by Sofaer, Lewis and
Davies, is the best document available for research ethics committees on
post- trial obligations and responsible transition of research
participants from the last visit of a study to the appropriate healthcare.
This document should be taken into account for future discussion of the
Declaration of Helsinki 2013 draft paragraph on post-trial obligations
(...
I believe that the practical framework produced by Sofaer, Lewis and
Davies, is the best document available for research ethics committees on
post- trial obligations and responsible transition of research
participants from the last visit of a study to the appropriate healthcare.
This document should be taken into account for future discussion of the
Declaration of Helsinki 2013 draft paragraph on post-trial obligations
(see DoH, paragraph 34).
I've written my PhD dissertation on the topic of these guidelines. And
I've attended the seventh consultation at the Brocher Foundation in Geneva
and translated into Spanish an advanced draft of "Care After Research"
Guidelines, that it's available open access to download here:
http://philpapers.org/rec/SOFADD
I hope these materials reach the suitable audience in time.
Javier Hidalgo's response[1] to my commentary[2] was unsatisfactory and
is likely to mislead the readership of JME. First, biomedical journals often discourage authors from citing unpublished studies. After reading
Hidalgo's response, one can see the wisdom of that rule. He quotes several
incorrect assertions made by Michael Clemens in 2007 in an unpublished
paper[3] about my article with Frederic Docquier.[4]
Javier Hidalgo's response[1] to my commentary[2] was unsatisfactory and
is likely to mislead the readership of JME. First, biomedical journals often discourage authors from citing unpublished studies. After reading
Hidalgo's response, one can see the wisdom of that rule. He quotes several
incorrect assertions made by Michael Clemens in 2007 in an unpublished
paper[3] about my article with Frederic Docquier.[4]
Second, Hidalgo repeats the misleading quote from page 6 of Clemens[3]
in his response:
"Bhargava and Docquier note that the fraction of physicians abroad has a
positive and significant effect on the number of adult deaths due to AIDS
in general, while - interestingly--- it has a negative and significant
effect on AIDS deaths in countries where HIV prevalence is low."
In fact, I had spelled out how the net effect of physician emigration rate
on adult deaths due to AIDS is computed in non-linear models[2] and stated
that:
"Thus, the net effect at the sample midpoint was positive; net effect was
very close to 0 (-0.005) when computed at the start of the sample in
1991."
Thus, Clemens is wrong about the negative effect being significant-- it is
not statistically different from zero at the start of the sample. In fact,
to show that the negative net effect is statistically significant for
countries with low HIV prevalence rates, one would have to evaluate its
standard error that in turn depends on standard errors of two other
estimated coefficients and their sample covariance.[2] Such computations
could not have been performed by Clemens since the covariance between the
estimated coefficients was not reported by Bhargava and Docquier.[4]
Further, the net effect was positive at the sample midpoint where the
expectation should be evaluated in such models. This is because the net
effect is a function of the random variable HIV prevalence rates that
varies across countries and over time. Thus, evaluating the net effect at
the sample midpoint is a reasonable approximation for its mathematical
expectation.
Third, I had made several points about the importance of micro data
that are essential for "integrating the epidemiological evidence from
developing countries with the results from analyses of country-level
data". One of the problems in policy oriented research is that some
authors may not be familiar with quantitative analyses necessary for
extracting information from longitudinal data sets covering heterogeneous
individuals over time. While it is easy to base one's claims on analyses
of country-level data, the ethical quandary is whether to incorporate the
findings from elaborate micro studies that may support or contradict the
assertions. For example, I had cited our study in South Africa[5] showing
the benefits of uptake of healthcare services for AIDS patients' CD4 cell
counts and quality of life indicators. There are numerous vacancies for
nurses and physicians in South African clinics because many staff members
have left for more lucrative venues in OECD countries. For a policy debate
to be constructive, it is essential that the available evidence be
examined. It would have been helpful if the micro evidence especially from
sub-Saharan African countries received greater prominence in this
discussion.
Finally, Clemens has claimed that our definition of emigrating
physicians is "problematic"- a claim that Hidalgo repeats. Because the
data agencies in OECD countries use three definitions, we compared the
alternative definitions of emigrating physicians in a subsequent paper[6]
and found this issue to be unimportant. In fact, correlations between
bilateral stocks of emigrating physicians on the basis of countries of
birth and countries of training were very high for countries such as the
U.S. (0.98), France (0.97), and Canada (0.94). Moreover, developing
countries are justified in recovering the investments made in educating
the emigrating physicians.
In summary, policy debates surrounding the emigration of physicians
need to be conducted in a scholarly manner. This can be achieved to some
degree by conducting several empirical or analytical studies and
summarizing the findings for a policy readership. As I had noted
previously, "the policy of regularly recruiting physicians from developing
countries runs contrary to the ethos of technology transfer". Hidalgo's
response avoids addressing many issues that are important from a policy
viewpoint.
REFERENCES
1. Hidalgo, J. Defending the active recruitment of health workers: a
response to commentators. J. Med Ethics. Published online first: 31 may 2013. doi: 10.1136/medethics-2013-101325
2. Bhargava, A. Physician emigration, population health and public
policies. J Med Ethics. Published online first: 26 January 2013.
doi:10.1136/medethics-2012-101235.
3. Clemens, M. Do visas kill? Health effects of African health
professional emigration. Center for Global Development Working Paper
Number 114 2007:1-47.
4. Bhargava, A., Docquier, F. HIV pandemic, medical brain drain and
economic development. World Bank Econ Rev 2008: 22:345-66.
5. Bhargava, A., Booysen, F. Healthcare infrastructure and emotional
support are predictors of CD4 cell counts and quality of life indices of
patients on anti-retroviral treatment in Free State Province, South
Africa. AIDS Care 2010:22: 1-9.
6. Bhargava, A., Docquier, F., Moullan, Y. Modeling the effects of
physician emigration on human development. Econ Human Biol 2011:9: 172-83.
The Health Research Authority (HRA) is fully supportive of, and
strongly encourages, the involvement of patients and the public as active
partners in all aspects of the research process. Such involvement produces
high quality ethical research consistent with the HRA's mission to
'protect and promote the interests of patients and the public in health
research'. The HRA will shortly launch a three-month consultation on its...
The Health Research Authority (HRA) is fully supportive of, and
strongly encourages, the involvement of patients and the public as active
partners in all aspects of the research process. Such involvement produces
high quality ethical research consistent with the HRA's mission to
'protect and promote the interests of patients and the public in health
research'. The HRA will shortly launch a three-month consultation on its
public involvement strategy which sets out our proposed approach for
involving patients and the public in our work, and how we can support and
enable the research community to involve patients and the public more in
their work.
The HRA agrees that patient involvement (PI) offers real benefits as
described in this article. However, it does take issue with the author's
central thesis that the role of lay members on research ethics committees
(RECs) is to be understood as primarily providing a "patient perspective"
involving "checking the accessibility of written materials" and ensuring
that researchers produce "a summary for a lay audience". The HRA is proud
of, and is grateful to all its volunteer REC members who give up their
valuable time to review health research in the NHS in order to ensure that
the rights, safety, dignity and well-being of research participants are
protected. Whilst checking written materials and lay summaries are
important aspects of that review we do not recognise this somewhat narrow
conception of the lay member's contribution put forward in this article.
Staley correctly states that NRES (a Directorate of the HRA)
identifies one aspect of the lay contribution as "taking a balanced view
of the likely harms and benefits of a research project by bringing a lay
perspective..." but neglects to point out that the Department of Health's
'Governance arrangements for research ethics committees - A harmonised
edition' (updated April 2012), states that:
"4.2.2 RECs are expected to reflect current ethical norms in society
as well as their own ethical judgement. REC members may come from groups
associated with particular interests but they are not representatives of
those groups. REC members are appointed in their own right to participate
in the work of a REC as equal individuals of sound judgement, relevant
experience and adequate training in research ethics and REC review.
4.2.3 A REC should contain a mixture of people who reflect the currency of
public opinion ('lay' members), as well as people who have relevant formal
qualifications or professional experience that can help the REC understand
particular aspects of research proposals ('expert' members)."
The important role of lay members as "equal individuals of sound
judgement" reflecting "the currency of public opinion" is thus an integral
part of an ethics committee's function. Lay members are already charged
with taking the very perspective that Staley argues will be necessary as a
result of increasing levels of patient involvement, namely the
contribution of "their views as a 'member of the public'" as a "general
citizen - or reasonable person".
Staley suggests that "If the patient perspective is incorporated into
research projects through early PI, then the quality of these PI processes
will need to be assessed as part of the REC review". In fact RECs already
assess the level of patient involvement through consideration of the
answer given to question (A14-1) of the current Integrated Research
Application System (IRAS) application form: "In which aspects of the
research process have you actively involved, or will you involve,
patients, service users, or members of the public?". This question draws
the attention of both researchers and RECs to the importance of patient
involvement with researchers being challenged to justify any absence of
patient and/or public involvement to the committee.
The HRA welcomes and actively promotes the involvement of patients
and public in the design of health research but this is, unfortunately, a
long way from becoming standard practice, with some researchers still
taking patient involvement to mean that patients are sufficiently
'involved' by virtue of their simply being research participants. So,
whilst REC members do already assess and promote patient involvement in
health research, reflect public opinion and ensure transparency and public
accountability, the "patient perspective", brought not just by lay members
but expert members too (who we should not forget are also patients and
members of the public), will continue to play an important part in the
ethical review of health research in the UK.
Joan Kirkbride (Director of Operations, Health Research Authority)
& Prof. Andrew George (NREAP Chair)
Conflict of Interest:
Joan Kirkbride is the Health Research Authority's Director of Operations with responsibility for the operation of research ethics committees within the National Research Ethics Service. Prof. Andrew George is the Chair of the Health Research Authority's National Research Ethics Advisors' Panel (NREAP) and an expert member of the West London & GTAC REC
In his eLetter George Hill asserts, of circumcision, that "The
evidence of injury to the child's sexual function is now conclusive".
However, this view is not supported by the literature he cites. He tells
us that Podnar found that the penilo-cavernosus reflex is harder to elicit
in circumcised men (or those with their foreskins retracted)1. So it is
harder to elicit a co...
In his eLetter George Hill asserts, of circumcision, that "The
evidence of injury to the child's sexual function is now conclusive".
However, this view is not supported by the literature he cites. He tells
us that Podnar found that the penilo-cavernosus reflex is harder to elicit
in circumcised men (or those with their foreskins retracted)1. So it is
harder to elicit a contraction of the anal sphincter by squeezing the
glans. What sexual functions are impaired by this?
Mr. Hill's third reference2 is unobtainable, beyond an abstract for a
conference presentation, making it impossible to judge its credibility.
The papers by Frisch3 and by Bronselaer4 that Mr. Hill cites both had
shortcomings. Being based on self-selected convenience samples, with
mediocre response rates, they were compromised by participant bias, in
addition to various other problems pointed out by critics5,6. In reply,
Frisch conceded that his study's findings "suggest, but by no means prove"
that a minority of individuals sometimes experience a few negative effects
from circumcision6. This is anything but "conclusive".
In his reply to his critics8, Bronselaer stated that the circumcision
rate in Belgium is 15 % as opposed to the 22.6 % of participants in his
study, but seemed not to appreciate the significance of this - his sample
cannot have been a representative one. A more recent commentary points
out that 12.1 % of his sample were homosexual9 leaving one wondering just
how unrepresentative this sample was.
For every study Mr. Hill might cite indicating a negative effect from
circumcision there are others finding no difference, or even an
improvement. Rather than list examples I refer readers to the recent meta
-analysis by Tian et al10 which finds no significant adverse consequence
of circumcision on male sexual function.
Mr. Hill also overstates his case when he asserts that the three
famous African HIV prevention trials "have been sharply questioned and
even debunked" and proceeds to cite three articles, one of them his own.
Unfortunately for Mr. Hill, each one of these articles has itself been
"sharply questioned and even debunked" in follow up critiques in the very
journals in which they were published. The one following his own was
particularly detailed and thoroughly rebuts the arguments he and his co-
author put forward11. The WHO, CDC, UNAIDS, and other professional bodies
dealing with this ghastly epidemic, also do not agree with Mr. Hill's
assessment.
It is worrisome that circumcision opponents overstate their case so
much. Telling circumcised males that they are sexually damaged can only
cause them anxiety and distress. And to tell them it when the evidence
does not support this view makes the distress entirely needless. And
claiming that the African trials are "debunked" when this is clearly not
so, whilst failing to acknowledge detailed rebuttals of the very articles
one cites in support of this claim, only invites accusations of denialism.
Finally, Mr. Hill writes as Vice-President of an activist
organization, "Doctors Opposing Circumcision", so has a clear interest in
promoting his organization's agenda. Fair enough, that is what a Vice-
President should do. However, this agenda extends to denying the
established benefit of circumcision in the context of African AIDS,
pitting it against major professional bodies and a large volume of peer-
reviewed research. It does not reflect mainstream medical opinion on this
matter. Furthermore, only two of its five officers are medically
qualified (Mr. Hill is not) which is a little surprising, given its name.
All this could easily tempt cynics to express doubts about its
credibility. Perhaps Mr. Hill could kindly allay such doubts please by
telling readers how many members this campaigning group has, and how many
are medical doctors?
References.
1. Podnar, S. Clinical elicitation of the penilo-cavernosus reflex in
circumcised men.BJU Int. 2011;209:582-5.
2. Solinis, I., Yiannaki, A. Does circumcision improve couple's sex
life? J Mens Health Gend. 2007;4(3):361.
3. Frisch, M., Lindholm, M., Gr?nb?k, M. Male circumcision and sexual
function in men and women: a survey-based, cross-sectional study in
Denmark. Int J Epidemiol. 2011;40(5):1367-81.
4. Bronselaer, G.A., Schober, J.M., Meyer-Bahlburg, H.F.L., et al.
Male circumcision decreases penile sensitivity as measured in a large
cohort. BJU Int. 2013;111(5):820-27.
5. Morris, B.J., Waskett, J.H., Gray, R.H. Does sexual function
survey in Denmark offer any support for male circumcision having an
adverse effect? Int J Epidemiol. 2012;41(1):310-2.
6. Morris, B.J., Kreiger, J.N., Kigozi, G. Male circumcision
decreases penile sensitivity as measured in a large cohort. BJU Int.
2013;111(5):E269-70.
7. Frisch, M. Author's Response to: Brian Morris et al, Does sexual
function survey in Denmark offer any support for male circumcision having
an adverse effect? Int J Epidemiol. 2012;41(1):312-4.
8. Bronselaer, G. Reply. BJU Int. 2013;111(5):E270-1.
9. Wang, K., Tian, Y., Wazir, R. Male circumcision decreases penile
sensitivity as measured in a large cohort. BJU Int. 2013;112(1);E2-3.
10. Tian, Y., Liu, W., Wang, J-Z., et al. Effects of circumcision on
male sexual functions: a systematic review and meta-analysis. Asian J
Androl. 2013:1-5.
11. Wamai, R.G., Morris, B.J., Waskett, J.H. et al. Criticisms of
African trials fail to withstand scrutiny: Male circumcision does prevent
HIV infection. J Law Med. 2012;20(1):93-123.
Whilst it is right and proper that the circumcision issue be debated,
it is disturbing that many of those who oppose circumcision rely heavily
upon selective literature citations, untested speculations about foreskin
function, fear-mongering aimed at making circumcised males feel they have
been sexually damaged, and denialism about the proven benefits of the
procedure, while ignoring pub...
Whilst it is right and proper that the circumcision issue be debated,
it is disturbing that many of those who oppose circumcision rely heavily
upon selective literature citations, untested speculations about foreskin
function, fear-mongering aimed at making circumcised males feel they have
been sexually damaged, and denialism about the proven benefits of the
procedure, while ignoring published criticisms of their arguments.
Predictably all these academic sins are committed by circumcision
opponents in the current issue of the Journal of Medical Ethics. Rather
than rebut each author in turn, which would be tedious, I will concentrate
on just one, the article by David Lang, "Circumcision, sexual dysfunction
and the child's best interests: why the anatomical details matter"1. Most
of the usual academic sins are repeated in his opinion piece, making it a
good example of anti-circumcision polemic.
Part of the reason Lang's piece is so bad is his use of popular, non-
peer-reviewed, or biased sources. Lang is heavily reliant on an opinion-
piece by Fleiss in a popular magazine called "Mothering: the Magazine of
Natural Family Living"2. To anyone familiar with popular but unscientific
views, the word "natural" always sets alarm bells ringing, as it is so
often associated with the appeal to nature fallacy. Lang's reference list
also reads like a "Who's Who" of the anti-circumcision movement: Fleiss,
Cold, Taylor, Bollinger, Van Howe, Darby, Svoboda ... all well known to be
passionately anti-circumcision and therefore, it may be argued, not
impartial, and some of whom have clocked up impressive tallies of
rebuttals and critiques in the medical literature.
Proceeding now to the technical points, citing Fleiss2 Lang tells us
that the foreskin contains "more than 20000 nerve endings". Fleiss gives
no experimental data in support of this, but instead refers to an old
paper3 which does not give the 20000 figure, directly. It has to be
inferred by extrapolation, and exaggeration, from a single square
centimetre of a single foreskin which contained 212 nerve endings. It is
not clear where on the foreskin the sample came, which is important as the
distribution of nerve endings may vary. Nor is it stated how old the donor
was, which matters as nerve ending density may decline with age. It
includes nerve endings of any kind, including temperature receptors, but
there were only two of the touch receptors (Meissner's corpuscles) that
circumcision opponents harp on about. There is no indication of how
typical this particular sample was, nor any comparison with other body
parts to provide a control. And to arrive at 20000 one has to multiply by
94.3 square centimetres, which is a very generous foreskin, even assuming
both inner and outer surfaces are being counted. None of this mattered for
the purposes of the original study, but Fleiss' extrapolation is absurd
and, without a control, worthless.
Copying another of Fleiss's errors, Lang complains about,
"desensitisation of the glans ... due to successive layers of
keratinisation from constant exposure and abrasion". As before this is not
backed up by peer-reviewed science. Like the oft-repeated 20000 figure, it
is an urban myth. What scant evidence there is indicates no difference
between circumcised and uncircumcised members4.
Continuing with his theme of copying uncritically from Fleiss, Lang
lectures about drying of the glans and interruption of "the normal
circulation of blood". Without wishing to sound facetious one may retort,
"So what?" In the absence of evidence that these things matter, they are
irrelevant, although it could be argued that drying creates an environment
less conducive to pathogens.
The doctrine of the gliding motion is next. Circumcision immobilises
the remaining skin and thereby "destroys the mechanism by which the glans
is normally stimulated", Lang parrots Fleiss. It may be countered that
circumcision enhances the actual mechanism by which the glans is
stimulated - direct contact with the vaginal wall. Many men do find their
foreskins gliding back and forth during coitus, but others have short
foreskins that retract behind the glans upon erection. Where is the
research indicating how many men experience gliding, what they (and their
partners) think about it, and whether the greater contact with the vaginal
wall experienced by a bare glans compensates for its loss? What would a
condom do to it?
Finally breaking from echoing Fleiss, Lang begins copying
unquestioningly from Cold & Taylor5. Meatal stenosis, we are told,
occurs in "in 5-10% of circumcised males" citing these two circumcision
opponents, but theirs' is a secondary source, which in turn cites five
others. The first is an author (Van Howe) whose later more detailed study
on this topic was discredited6. Three others were studies of children
circumcised because of foreskin pathology, which may be associated with
meatal stenosis. The remaining study found an 8 % incidence but had no
control.
Some recent studies find dramatically lower figures. 0.55 % and 0.9
% in Iran7,8 and 0.01 % for English boys9. Another Iranian study found 6.6
%, but none at all when petroleum jelly was applied for 6 months post-
op10. Meatal stenosis has long been regarded as subjective and tricky to
define and diagnose consistently, with differences of opinion even as to
its significance11.
"The prepuce is primary, erogenous tissue necessary for normal sexual
function. The complex interaction between the protopathic sensitivity of
the corpuscular receptor-deficient glans penis and the corpuscular
receptor rich ridged band of the male prepuce is required for normal
copulatory behavior" Lang cuts and pastes from Cold & Taylor. But
others dismiss this as unproven speculation12. Although the sample size
was small, when men were asked to rank the different parts of their penis
with respect to sexual sensation, the glans was first, the prepuce last13.
Sexual sensation is mediated by genital corpuscles, which are absent from
the prepuce14.
In the recent African HIV prevention trials, thousands of men were
circumcised and compared to controls. These studies included sexual
function. In the Ugandan trial, 98 - 99 % of both the intervention and the
control groups reported satisfaction with their sexual function after two
years15. In the Kenyan trial, 64 % of men found that sensitivity improved
after circumcision, and 54.5 % reported greater ease of achieving
orgasm16. The most recent meta-analysis on the subject found that
circumcision has no adverse effect on male sexual function17. Circumcision
opponents greatly overstate the alleged erogenous merits of the foreskin.
Lang switches to a study by two other prominent, anti-circumcision
figures, Bollinger & Van Howe18 to claim that "circumcised men are 4.5
times more likely to use an erectile dysfunction drug than intact men."
Unfortunately, Lang ignores the subsequent criticism of this study19. Its
self-selected sample was recruited through advertisements on two websites
with strongly anti-circumcision content. It is hard to imagine a more
effective way of ensuring a biased sample, short of advertising
specifically for circumcision opponents. Indeed the loaded title of the
advertisement, "Male circumcision trauma survey" comes close to doing
exactly that. In their reply, Bollinger & Van Howe concede the
potential for bias, and that their results are "unconfirmed"20.
When Lang gets to his next point, "18% of adult American men (of whom
approximately three-fourths are circumcised) have erectile dysfunction" he
finally cites a credible source21. But it is a source that linked erectile
dysfunction to cardiovascular problems, diabetes, lack of exercise and
age, not to circumcision. The aforementioned meta-analysis found no
association between circumcision and erectile dysfunction17.
Lang concludes his section on the alleged harm of circumcision with
an extraordinary combination of speculation and barrel-scraping. The USA,
he tells us, "accounts for 46% of Viagra sales" and, whilst conceding that
this "could be explained by any number of factors unrelated to
circumcision", speculates that this is due to truncation of the perineal
nerve.
In the absence of any credible evidence that circumcision causes
erectile dysfunction, speculations about the perineal nerve are moot. And
the popularity of Viagra, which can be a recreational drug, in the
wealthiest country on earth, with a high consumption of all manner of
pharmaceuticals, can indeed be explained without recourse to baseless fear
-mongering about circumcision.
Done properly, circumcision does not damage sexual function. But
misleading claims put about by its opponents do damage the self-esteem of
circumcised males by needlessly making them feel they are damaged, and are
missing an important part of their anatomy. And they distress parents by
deceiving them into believing they have harmed their sons. This is
certainly an effective way to draw angry and motivated new recruits into
the anti-circumcision movement, and into "surveys" on "circumcision
trauma", but it is misleading and unethical.
Whether or not to circumcise should be decided on quality peer-
reviewed evidence that withstands scrutiny. Not urban myths, untested
speculations, and discredited "surveys" on biased samples by biased
authors. But that is all Lang offers us. It is ironic that the title of
Lang's opinion piece should state that "the anatomical details matter" and
he then proceeds to get them wrong, or to exaggerate their importance. His
details do not matter. The facts do, and they do not support the anti-
circumcision crusaders' claims about impairment of sexual function.
References.
1. Lang, D.P. "Circumcision, sexual dysfunction and the child's best
interests: why the anatomical details matter". J Med Ethics, 2013;39:429-
31.
2. Fleiss, P. The case against circumcision. Mothering: the Magazine
of Natural Family Living. 1997;Winter:36-45.
3. Bazett, H.C., McGlone, B., Williams, R.G., Lufkin, H.M., Depth,
Distribution and Probable Identification in the Prepuce of Sensory End-
Organs Concerned in Sensations of Temperature and Touch; Thermometric
Conductivity. Archives of Neurology and Psychiatry, 1932;27:489-517.
4. Szabo, R., Short,R.V., How does male circumcision protect against
HIV infection? BMJ, 2000;320:1592-4.
6. Schoen, E.J. Letter to the editor. Clin Ped., 2007;46(1):86.
7. Simforoosh, N., Tabibi, A., Khalili, S.A.R., Soltani, M.H.,
Afjehi, A., Aalami, F., Bodoohi, H. Neonatal circumcision reduces the
incidence of asymptomatic urinary tract infection: a large prospective
study with long-term follow up using Plastibell. J Ped Urol., 2012;8:320-
3.
8. Yegane, R-A., Salehi, N-A., Koshdel, J-A. Late complications of
circumcision in Iran. Pediatr Surg Int., 2006;22:442-5.
9. Cathcart, P., Nuttall, M., Meulen, J., Emberton, M., Kenny, S.E.
Trends in paediatric circumcision and its complications in England between
1997 and 2003. Brit J Surg. 2006;93:885-90.
10. Bazmamoun, H., Ghorbanpour, M., Mousavi-Bahar, S.H., Lubrication
of circumcision site for prevention of meatal stenosis in children younger
than 2 years old. Urol J., 2008;5(4):233-6.
12. Alanis, M.C., Lucidi, R.S., Neonatal circumcision: A review of
the world's oldest and most controversial operation. Obstet Gynecol Surv.,
2004;59(5):379-95.
13. Schober, J.M., Meyer-Bahlburg, H.F., Dolezal,C. Self-ratings of
genital anatomy, sexual sensitivity and function in men using the 'Self-
assessment of genital anatomy and sexual function, Male' questionnaire.
BJU Int., 2009;103:1096-1103.
14. Rhodin, J.A.G. Histology. 1974. Oxford University Press, London.
15. Kigozi, G., Watya, S., Polis, C.B., Buwembo, D., Kiggundu, V.,
Wawer, M.J., Serwadda, D., Nalugoda, F., N., Bacon, M.C., Ssempijja, V.,
Makumbi, F., Gray, R.H., The effect of male circumcision on sexual
satisfaction and function, results from a randomized trial of male
circumcision for human immunodeficiency virus prevention, Rakia, Uganda.
BJU Int., 2008;101:65-70.
16. Krieger, J.N., Mehta S.D., Bailey R.C., Agot, K., Ndinya-Achola,
J.O., Parker, C., Moses, S. Adult male circumcision: Effects on sexual
function and sexual satisfaction in Kisumu, Kenya. J Sex Med., 2008;5:2610
-22.
17. Tian, Y., Liu, W., Wang, J.Z., Wazir, R., Yue, X. & Wang,K.J.
Effects of circumcision on male sexual functions: a systematic review and
meta-analysis. Asian J Androl., 2013; in press.
18. Bollinger, D., Van Howe, R.S. Alexythmia and circumcision trauma:
a preliminary investigation. Int J Men's Health, 2011;10:184-95.
19. Morris, B.J., Waskett, J.H., Claims that circumcision increases
alexithymia and erectile dysfunction are unfounded: a critique of
Bollinger and Van Howe's "Alexithymia and circumcision trauma: a
preliminary investigation". Int J Men's Health. 2012;11:177-81.
20. Bollinger, D., Van Howe, R.S. Preliminary results are
preliminary, not "unfounded": reply to Morris and Waskett. Int J Men's
Health. 2012;11:181-4.
21. Selvin, E., Burnett, A.L., Platz, E.A. Prevalence and risk
factors for erectile dysfunction in the US. Amer J Med., 2007;120:151-7.
The paper by Hooper & Spicer and some of the responses to it raise an important debate about the hazards of safety legislation. It is wrong to assume that safety legislation will cause no harm and in line with principles of medical ethics public health professionals are obliged to take such harm into account.
The first level of harm may arise when the legislation actually mandates an unsafe act because all the consequences of...
The paper by Hooper & Spicer and some of the responses to it raise an important debate about the hazards of safety legislation. It is wrong to assume that safety legislation will cause no harm and in line with principles of medical ethics public health professionals are obliged to take such harm into account.
The first level of harm may arise when the legislation actually mandates an unsafe act because all the consequences of the act have not been taken into account. Although it is self evidently true that cycle helmets have a protective function in certain accidents the benefit that would be expected from the physics of the situation has not been demonstrated in population studies. What is offsetting it? Is it an increased risk of neck injuries? Is it that car drivers drive closer to cyclists who look less vulnerable? We need to know this before legislation could be regarded as ethical.
The second level of harm may arise when the legislation creates a false sense of security resulting in risk compensation. Cycle helmets do not offer anything like the degree of protection that is sometimes assumed so this is a serious potential problem. It is unethical to mislead.
The third level of harm may arise when people act in a dangerous or unhealthy way in response to legislation. This is an issue with cycle helmets because the evidence shows that the introduction of legislation will lead to a fall in cycling rates resulting in deaths from diabetes, heart disease, osteoporosis and mental illness. Excessive rail safety requirements can have the effect of reducing rail travel and substituting less safe road travel. For young men, who are safer cycling than driving, this issue arises with cycle helmets as well. It is unethical to create a situation which leads people to harmn themselves.
The fourth level of harm arises when we lose a sense of proportion in safety legislation so that people lose the capacity to weigh risks. In the Paddington rail disaster a large number of people were killed in a head on collision between two trains one of which had passed a signal at danger. This signal was badly sited and had been passed at danger a number of times previously but nothing was done. Nobody had convened a meeting of the Signal Sighting Committee. At this time the rail network was engaged in a major campaign to reduce deaths to zero and as part of this was developing safety cases about risks like passengers falling off the edge of station platforms. THSG asks a simple question - in the course of this process did the system lose sight of what is important, lose the capacity to prioritise and as a consequence of that neglect a major risk. The case for cycle helmets is weaker than the case for helmets when playing football and on a par with the case for helmets when driving. The added risks of cycling rather than driving on a local journey for a middle aged adult are comparable to the added risks of taking the car instead of the train or driving on an all purpose road instead of a motorway. If society attempts legislative control of risks of this order it will fail, and in doing so its failure will impact on much more significant issues as well. It is unethical to set up systems which will fail in such a way as to damage lifesaving activities.
The fifth level of harm comes when the legislation conveys a false message and as a result people make poor decisions. Cycling is a safe activity which benefits health. Yet the commonest reason given for not cycling is safety. If we compel cyclists to wear helmets we give out the message that it is on a par with riding a motorcycle or with working on a building site. It is unethical to mislead people into making harmful choices.
We must understand that safety legislation is not a free good. We can only handle so much of it and we must prioritise. We must reach out for a safe society, in which people who climb mountains use the right equipment, check the weather and tell people what route they are taking, not a risk averse society where people do not climb mountains. A morbid preoccupation with the dangers of normal safe activities limits lives and can kill people.
STEPHEN J. WATKINS
Chair, Transport and Health Study Group.
Conflict of Interest:
THSG has a policy of opposition to compulsory cycle helmets based on its understanding of the scientific evidence
The otherwise excellent paper by German law professors Merkel and Putze1 fails to sufficiently emphasize the prohibition against using Wisconsin v. Yoder (1972) to support physical injury to a child in the name of religion.
Then Chief Justice Burger wrote the majority opinion for the court and specifically exempted the case from application to physical harm. In his opinio...
The otherwise excellent paper by German law professors Merkel and Putze1 fails to sufficiently emphasize the prohibition against using Wisconsin v. Yoder (1972) to support physical injury to a child in the name of religion.
Then Chief Justice Burger wrote the majority opinion for the court and specifically exempted the case from application to physical harm. In his opinion, he wrote:
"This case, of course, is not one in which any harm to the physical or mental health of the child or to the public safety, peace, order, or welfare has been demonstrated or may be properly inferred."2
The court reaffirmed the earlier case of
Prince v. Massachusetts (1944) as the controlling case in situations in which a child is put at risk in the name of religion: 3
"To be sure, the power of the parent, even when linked to a free exercise claim, may be subject to limitation under Prince if it appears that parental decisions will jeopardize the health or safety of the child, or have a potential for significant social burdens."2
In the case of Prince v. Massachusetts, Justice Rutledge delivered the opinion of the court. The court said:
"The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death. People v. Pierson, 176 N.Y. 201, 68 N.E. 243. The catalogue need not be lengthened. It is sufficient to show what indeed appellant hardly disputes, that the state has a wide range of power for limiting parental freedom and authority in things affecting the child's welfare, and that this includes, to some extent, matters of conscience and religious conviction."4
The court then famously stated:
"Other harmful possibilities could be stated, of emotional excitement and psychological or physical injury. Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves."4
Therefore, the free exercise clause of the First Amendment to the United States Constitution cannot be used to support putting a child at risk in the name of religion.
Free exercise of religion is not only an adult right. Children also have a right to freely exercise their religious views when they reach "the age of reason."3 With particular application to the physical injury of circumcision, the child may make that decision for himself when he reaches the age of legal capacity, however neither the free exercise clause nor Yoder offers any support whatsoever for any alleged parental "right to circumcise."
References
Merkel R, Putze H. After Cologne: male circumcision and the law. Parental right, religious liberty or criminal assault? J Med Ethics Published Online First 22 May 2013. doi: 10:1136/medethics-2012-11284.
Wisconsin v. Yoder, 406 U.S. 205 (1972).
Adler PW. Is circumcision legal. 16 Rich. J.L. & Pub. Int. 2013;16: 439. Available at http://rjolpi.richmond.edu/archive/Adler_Formatted.pdf Accessed 9 June 2013.
"If circumcision is a net benefit to a child, parents do not violate his rights to bodily integrity or self-determination by circumcising him. Careful attention to (the evidence for) the costs and benefits of circumcision to the child himself is thus essential."1
The evidence of injury to the child's sexual func...
"If circumcision is a net benefit to a child, parents do not violate his rights to bodily integrity or self-determination by circumcising him. Careful attention to (the evidence for) the costs and benefits of circumcision to the child himself is thus essential."1
The evidence of injury to the child's sexual function is now conclusive. Podnar has demonstrated the adverse effect of circumcision upon the penilo-cavernosus reflex.2 Furthermore, several international studies demonstrate the injury of male circumcision to the sexual relations of both male and female.3-5
Benetar relies on "three major studies" as evidence of the efficacy of male circumcision in reducing HIV infection; however, those studies have been sharply questioned and even debunked.6-8
Therefore, the evidence against circumcision is conclusive, while the alleged evidence for circumcision has collapsed.
By Benetar's own standards, circumcision is not a benefit, but instead is a malefit; thus the circumcision of male children is an unethical operation.
References
Benetar D. Evaluations of circumcision should be circumscribed by the evidence. J Med Eth. 2013; published online first 31 May 2013.
Podnar S. Clinical elicitation of the penilo-cavernosus reflex in circumcised men.BJU Int. 2011;209:582-5. doi:10.1111/j.1464-410X.2011.10364.x
Solinis I, Yiannaki A. Does circumcision improve couple's sex life? J Mens Health Gend. 2007;4(3):361.
Frisch M, Lindholm, Grønbæk M. Male circumcision and sexual function in men and women: a survey-based, cross-sectional study in Denmark. Int J Epidemiol. 2011;40(5):1367-81.
Bronselaer GA, Schober JM, Meyer-Bahlburg HFL, et al. Male circumcision decreases penile sensitivity as measured in a large cohort. BJU Int. 2013;111(5):820-27. doi:10.1111/j.1464-410X.2012.11761.x
Van Howe, Storms MS. How the circumcision solution in Africa will increase HIV infections. Journal of Public Health in Africa 2011; 2:e4 doi:10.4081/jphia.2011.e4
Ncayiyana DJ. The illusive promise of circumcision to prevent female-to-male HIV infection - not the way to go for South Africa. SAMJ 2011;101(11):775-6.
Boyle GJ, Hill G. Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: Methodological, ethical and legal concerns. J Law Med (Melbourne) 2011;19:316-34.
We read with great interest Daoust and Racine's contribution to the
ongoing debate about brain death and its ethical and medical implications
[1]. The authors argue that little is known about how the public
understands the concept of death determined by neurological criteria
(DNC). They set out to trace common sources of public confusion about DNC
and seek to "better define the relationship between expert and lay views...
We read with great interest Daoust and Racine's contribution to the
ongoing debate about brain death and its ethical and medical implications
[1]. The authors argue that little is known about how the public
understands the concept of death determined by neurological criteria
(DNC). They set out to trace common sources of public confusion about DNC
and seek to "better define the relationship between expert and lay views
of death". We wish to comment on the issue of whether or not public
confusion "reflects public confusion in the media or perhaps a more
profound insight into the nature of academic debates among experts".
Although the authors recognize that "recent critiques have made any clear
meaning of DNC more challenging and even counterintuitive", they position
themselves, with no further explanation, on one side of the debate by
stating that "landmark contributions and guidelines of professional
societies have brought clarity and credence to the standard definition of
DNC". With that, they imply that current determination of death and organ
transplantation practices are rigorous and that media coverage distorts
the actual process of declaring a person dead based on neurological
criteria.
The two premises-- that the standard of DNC has clarity and credence
and that producing a clear meaning of DNC is both challenging and
counterintuitive-- are logically irreconcilable. The authors,
nevertheless, conclude that all discussions in the media and with patient-
families should "reinforce the genuine nature of neurological
determination of death as a criterion to establish death...". Either (a)
the philosophical rationale proposed in the President's Council on
Bioethics "White Paper" [2] seeking to validate the concept of DNC, and
the criteria and tests for determining DNC outlined in the guidelines by
professional societies, definitively settled the issue, or (b) the critics
have been raising legitimate concerns and have successfully challenged the
validity of this concept. Regarding the President's Council of Bioethics'
philosophical validation of DNC, the debate is ongoing and indeed has
intensified [3-5]. In regard to professional societies' guidelines, the
American Academy of Neurology has assigned level "U" (i.e., unknown,
conflicting or insufficient evidence) to several recommendations in the
DNC [6]. Generally, for clinical practice guidelines to be trustworthy,
the Institute of Medicine requires the recommendations to be supported by
a much higher level of evidence than "U" [7].
The authors also mention that some articles refer to the brain-dead
patient as being "kept alive" by artificial methods rather than as being
dead. Yet this brings out the fact that it is odd to declare an individual
with functioning circulation and respiration (in the sense of cellular
exchange of oxygen and carbon dioxide-- ventilator-dependence is
irrelevant to the issue of whether a person is alive or dead) dead as is
done in brain-dead patients. Even though the authors ostensibly
acknowledge the academic debate about the validity of brain-death
criteria, de facto they ignore it, claiming (though not arguing) that both
discussions between the patient's family (note the use of the word
"patient," which does not make sense if the patient is dead) and
information shared with the general public should reflect the view that
brain death criteria are "genuine". Therefore, Daoust and Racine's
recommendation to reinforce the genuine nature of neurological
determination of death is not only premature but, if followed through,
would deprive the public of informed decision making about organ donation
following DNC. More importantly, merely repeating the claim that brain-
death criteria are "genuine" does not make them so.
Maintaining the professional integrity of medicine and public trust
is a responsibility shared by the global medical community. This
responsibility demands honesty, truthfulness and transparency with the
general public regarding healthcare issues (e.g., organ donation at the
end of life). Daoust and Racine report that critics of DNC have argued
that DNC "merely represents a convenient 'redefinition' of death solely
for the purpose of transplant medicine." Many in the medical community
would agree with the critics. After several decades, the cumulative
clinical experience with many kinds of brain-dead patients over decades,
combined with logic has disproved the neurologic criterion of death.
Persistent denial of caveats that donors are not certainly dead may be
leading to grievously unethical medical practice namely: (1) the lack of
truly informed consent in the donation process, (2) the strategic campaign
of rhetoric, partial information, and misinformation designed to induce
people to check the donor box on drivers licenses and to induce families
to authorize donation from a "brain-dead" loved one, (3) the nondisclosure
of financial conflict of interest on the part of organ procurement
representatives whose job is to convince grieving families to donate.
The media have been fulfilling their primary duties of disclosing to
the general public scientific, ethical and cultural controversies about
neurologic criteria [8,9]. The conclusion of Daoust and Racine that
"public discussions should reinforce the genuine nature of neurological
determination of death as a criterion to establish death" and "scholarly
debates need to be contextualized to avoid undue collateral damage to
public confidence in DNC and organ donation practices" can also be
construed as a call for censorship of media and suppression of scholarly
debates. Costas-Lombardia and Castiel have criticized the control of
information in Spain by the transplantation industry: "disinformation of
society is an indispensable condition for the success of the 'Spanish
Model'" [10]. Organ procurement and transplantation practice generate
billions of dollars in a commodified US health care system annually [11].
The call for control of media and scholarly debates to avoid collateral
damage to organ transplantation practice may indeed violate public trust
in the medical profession and the First Amendment of the United States
Constitution.
Michael Potts, Ph.D., Department of Philosophy, Methodist University,
Fayetteville, North Carolina, USA
Joseph L. Verheijde, PhD, MBA, PT, Department Physical Medicine and
Rehabilitation, Mayo Clinic, Phoenix, Arizona, USA
David W. Evans, MA, MD, FRCP, Queens' College, Cambridge, UK
Mohamed Y. Rady, MB BChir MA MD (Cantab), Department of Critical Care
Medicine, Mayo Clinic Hospital, Phoenix, Arizona, USA
D. Alan Shewmon, MD Olive View-UCLA Medical Center, Sylmar, CA, USA
References
1. Daoust A, Racine E. Depictions of 'brain death' in the media:
medical and ethical implications. J Med Ethics.2013:Published Online
First: 12 April 2013 doi:2010.1136/medethics-2012-101260
2. The President's Council on Bioethics. Controversies in the
determination of death. A White Paper of the President's Council on
Bioethics. 2008; http://bioethics.georgetown.edu/pcbe/reports/death/.
Accessed 10 April 2013.
3. Shewmon A. Brain Death: Can It Be Resuscitated? Hastings Cent
Rep.2009; 39(2):18-23.
4. Joffe AR. Brain death is not death: a critique of the concept,
criterion, and tests of brain death. Rev. Neurosci.2009; 20(3-4):187-198.
5. Nair-Collins M. "Brain Death, Paternalism, and the Language of
"Death"." Kennedy Inst Ethics J.2013; 23(1):53-104.
6. Wijdicks EF, Varelas PN, Gronseth GS, Greer DM. Evidence-based
guideline update: Determining brain death in adults: Report of the Quality
Standards Subcommittee of the American Academy of Neurology.
Neurology.2010; 74(23):1911-1918.
7. Institute of Medicine (IOM) -National Academy of Sciences.
Clinical Practice Guidelines We Can Trust. 2011;
http://www.nap.edu/openbook.php?record_id=13058. Accessed 10 April, 2013.
8. Rady MY, McGregor JL, Verheijde JL. Mass media campaigns and organ
donation: managing conflicting messages and interests. Med Health Care
Philos.2012; 15(2 ):229-241.
9. Rady M, McGregor J, Verheijde J. Transparency and accountability
in mass media campaigns about organ donation: a response to Morgan and
Feeley. Med Health Care Philos.2013:Published online: 25 January 2013. DOI
2010.1007/s11019-11013-19466-11014.
10. Costas-Lombardia E, Fereres Castiel J. The Easy Success of the
Spanish Model for Organ Transplantation. Artif Organs.2011; 35(9):835-837.
11. Bentley TS, Hanson SG, Hauboldt RH. Milliman Research Report.
2011 U.S. organ and tissue transplant cost estimates and discussion. 2012;
http://publications.milliman.com/research/health-rr/pdfs/2011-us-organ-
tissue.pdf. Accessed April 1, 2013.
We would like to thank Professor Stewart Justman for his thoughtful
paper "Placebo: the lie that comes true", in which he highlights the
often neglected deception in research on placebos and points out the
potential harms related to half-truths or exaggerated claims about the
"power of the placebo" (1). We agree strongly with his conclusion that "it
is necessary to root the placebo effect in the attentive practice of
me...
We would like to thank Professor Stewart Justman for his thoughtful
paper "Placebo: the lie that comes true", in which he highlights the
often neglected deception in research on placebos and points out the
potential harms related to half-truths or exaggerated claims about the
"power of the placebo" (1). We agree strongly with his conclusion that "it
is necessary to root the placebo effect in the attentive practice of
medicine itself". We also agree with his other conclusion that the
"appropriate response to this dilemma is first of all to consider the
placebo effect as a therapeutic benefit arising from the conscientious
performance of the rituals of good medicine, and not as a resource to be
tapped by the use of trickery (with equivocations counting as trickery) or
dispensed in the form of pills."
As Justman also remarks, much of the confusion related to placebos
and placebo effects is related to the ambiguous nature and many
understandings of these concepts. We'd like to develop this point further
and repeat our earlier suggestion to replace the ambiguous "placebo
effect" with a new term "care effect" in the clinical context (2). In the
research context, the term "placebo effect" could be replaced by the
expression "the effect in the control group" when the outcome of the
research is discussed. The equivocal concept "impure placebo" confuses
more than it clarifies and should be abandoned totally. If a method of
treatment is ineffective in its own right, it should be called an
ineffective treatment for a particular patient or problem.
References:
1. Justman S. Placebo: the lie that comes true. J Med Ethics 2013;39:243-
248.
2. Louhiala P, Puustinen R. Rethinking the placebo effect. J Med Ethics;
Medical Humanities 2008;34:107-109.
Authors:
Pekka Louhiala, Hjelt Institute, University of Helsinki, Finland,
pekka.louhiala@helsinki.fi
Raimo Puustinen, Medical School, University of Tampere, Finland,
raimo.puustinen@uta.fi
I believe that the practical framework produced by Sofaer, Lewis and Davies, is the best document available for research ethics committees on post- trial obligations and responsible transition of research participants from the last visit of a study to the appropriate healthcare. This document should be taken into account for future discussion of the Declaration of Helsinki 2013 draft paragraph on post-trial obligations (...
Javier Hidalgo's response[1] to my commentary[2] was unsatisfactory and is likely to mislead the readership of JME. First, biomedical journals often discourage authors from citing unpublished studies. After reading Hidalgo's response, one can see the wisdom of that rule. He quotes several incorrect assertions made by Michael Clemens in 2007 in an unpublished paper[3] about my article with Frederic Docquier.[4]
Se...
The Health Research Authority (HRA) is fully supportive of, and strongly encourages, the involvement of patients and the public as active partners in all aspects of the research process. Such involvement produces high quality ethical research consistent with the HRA's mission to 'protect and promote the interests of patients and the public in health research'. The HRA will shortly launch a three-month consultation on its...
Case against circumcision overstated.
In his eLetter George Hill asserts, of circumcision, that "The evidence of injury to the child's sexual function is now conclusive". However, this view is not supported by the literature he cites. He tells us that Podnar found that the penilo-cavernosus reflex is harder to elicit in circumcised men (or those with their foreskins retracted)1. So it is harder to elicit a co...
By Stephen Moreton Ph.D.
Whilst it is right and proper that the circumcision issue be debated, it is disturbing that many of those who oppose circumcision rely heavily upon selective literature citations, untested speculations about foreskin function, fear-mongering aimed at making circumcised males feel they have been sexually damaged, and denialism about the proven benefits of the procedure, while ignoring pub...
Dear Editor:
The otherwise excellent paper by German law professors Merkel and Putze1 fails to sufficiently emphasize the prohibition against using Wisconsin v. Yoder (1972) to support physical injury to a child in the name of religion.
Then Chief Justice Burger wrote the majority opinion for the court and specifically exempted the case from application to physical harm. In his opinio...
Dear Editor:
Benetar argues:
The evidence of injury to the child's sexual func...
We read with great interest Daoust and Racine's contribution to the ongoing debate about brain death and its ethical and medical implications [1]. The authors argue that little is known about how the public understands the concept of death determined by neurological criteria (DNC). They set out to trace common sources of public confusion about DNC and seek to "better define the relationship between expert and lay views...
We would like to thank Professor Stewart Justman for his thoughtful paper "Placebo: the lie that comes true", in which he highlights the often neglected deception in research on placebos and points out the potential harms related to half-truths or exaggerated claims about the "power of the placebo" (1). We agree strongly with his conclusion that "it is necessary to root the placebo effect in the attentive practice of me...
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