The trouble with international ethics guidelines

In nearly regular intervals arguments flare up among bioethicists as well as political activists about the substantive guidance proffered in international ethics guidance documents such as the World Medical Association’s (WMA’s) Declaration of Helsinki or the Council for International Organisation of Medical Sciences’ (CIOMS’) research ethics guidance documents. Who doesn’t recall the arguments about standards of care in clinical trials undertaken in developing countries, or the post-trial benefits debate?[1] Monographs, anthologies, as well as an endless stream of graduate student theses focused on particular aspects of these debates. There is nothing wrong with these efforts. As someone who spends significant amounts of time vetting other people’s content, as a journal editor, academic supervisor and external examiner of graduate students’ theses I have read a lot of content dedicated to these debates over the years.

What has always struck me as strange is that virtually nobody seems to question the relevance of these documents. They are usually taken as authoritative statements, not dissimilar to consensus statements clinicians might publish in medical journals. And yet, it is far from clear that anyone should accept these declarations and guidelines as relevant documents of that kind.[2] Take the WMA’s Declaration of Helsinki as a case in point: it is interesting in so far as it has been one of the most bitterly fought over international research ethics guidance documents just a few years ago. It is still being revised in fairly frequent intervals, alas the old battle axes in this dispute have by and large moved on to other issues. There is little professional interest in substantive changes to what once were highly sensitive provisions in the Declaration.

At least the WMA has some claim to represent the world’s doctors. Still, the Declaration offers no justifications for its guidance, so it is unclear why anyone who undertakes biomedical research and isn’t a medical doctor should bother about it. It is also doubtful that the national medical associations debated in any meaningful way proposed revisions to the Declaration and instructed their delegates to the WMA’s General Assembly to vote in particular ways that actually represent the views of the members of these national associations. You might also wonder why a local GP’s views and vote ought to matter a great deal in matters research ethics in the first place. CIOMS remains a fairly smallish operator with even less of a claim to represent meaningfully people involved in biomedical research.[3] Its initial claim to fame was that it put itself forward to interpret the WMA Declaration of Helsinki. Once that – kind of - established its legitimacy this interpretation morphed into its own guidance document. At least CIOMS has a habit of trying to justify its guidance, as opposed to engaging merely in ex cathedra declarations like the WMA is wont to do.

The situation doesn’t get any better when one looks at international institutions such as the World Health Organisation (WHO). While undoubtedly United Nations insiders are clued in with regard to the status of myriad WHO documents, the wider public, and indeed policy makers outside the corridors of WHO offices, almost certainly do not. A case in point: After spectacularly failing in its response to the Ebola outbreaks WHO engaged in what can best be described as wild activism to show that it is doing something. It issued eventually an ethical guidance document that declared that it is OK to use unregistered experimental interventions on Ebola virus disease patients.[4] The authors of this document, celebrated as they were as experts on the subject matter, had mostly never published a word on either Ebola virus disease or, indeed, on the difficult subject of emergency access to experimental drugs in case of patients with catastrophic illnesses. The latter topic has been a matter of intense debate over the last few decades in bioethics. I should know, I have been involved in these debates. The WHO’s experts may have been nice people interested in this topic, who were known somehow to WHO people in charge of inviting someone ‘expert’, alas very few of their experts had any demonstrable expertise when they willingly pontificated publicly on WHO letterhead on this subject matter. Much like CIOMS, the authors of this guidance document ought to be commended for having made the effort to provide justifications for their recommendations.

The results of the WHO meeting were eventually reported the world all over as the WHO ‘approving’ the use of experimental drugs in patients with Ebola virus disease.[5] It turns out that the WHO has no jurisdiction to approve anything of that sort, and, equally as importantly, WHO never actually did approve what it was reported to have approved. The WHO documents produced by the people it invited to pontificate on this subject, state actually in small print that they merely reflect the views of the people who wrote them down, and that they are not the official view of WHO. Their views, in other words, ought to carry no more weight than the views of any other groups of academics who hang out together at conferences and draft papers in their spare time. This hasn’t stopped academics writing about this subject to mention the WHO documents as if they carried any meaningful regulatory or other weight.[6]

WHO is at the time of writing in the process of developing procedures for the selection and use of such experimental agents in Ebola virus disease patients.[7]  I suspect the status of these documents won’t be of more significant regulatory weight than that of any of its other Ebola crisis triggered documents. That is not to say that they will be bad documents. It appears to be the case that these documents will be an amalgam of best practice guidelines from nations that have many decades of regulatory experience with emergency access to investigational agents in patients with catastrophic illnesses. However, if, for instance, Liberia and the USA decided to establish an emergency access program for a particular therapeutic experimental agent, and they chose to ignore WHO (who is apparently keen to inject itself into these bilateral processes) what exactly would WHO be able to do about that? Nothing that I can think of.

What is the value of these sorts of guidance documents then? I think they are valuable as documents that drive debate among interested parties about the substantive controversial issues that they address. They might also be of value to organisations such as the International Committee of the Red Cross, Doctors without Borders, and others, who want guidelines for their own emergency access plans without spending too much time thinking about ethically defensible operational frameworks themselves. Last but not least, they might be useful to developing nations without the capacity to develop their own regulatory frameworks and who decide to resort to WHO guidance documents and protocols.

However, given these questions about the status and the legitimacy of these documents, if the old adage caveat emptor ever applied anywhere, it should apply to these guidelines, declarations and policies. Anyone choosing to adopt them ought to adopt them because they consider them ethically defensible, and not because they happen to come from WMA, CIOMS or indeed the WHO.

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[1] Schuklenk, U. 1998. Unethical Perinatal HIV Transmission Trials Establish Bad Precedent. Bioethics 12: 311-318.

 

[2] Schuklenk U. 2004. The Standard of Care Debate: Against the Myth of an ‘International Consensus Opinion’. Journal of Medical Ethics 30: 194-197.

[3] Schuklenk U. 2004. Ibid.

[4] WHO. 2014. Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD) Geneva, August 12, 2014. http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en/ [Accessed March 16, 2015.] See also WHO. 2014. Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD) Geneva: Report of an advisory panel to WHO. Geneva, n.d. http://apps.who.int/iris/bitstream/10665/130997/1/WHO_HIS_KER_GHE_14.1_eng.pdf [Accessed March 17, 2015.]

[5] Eg Anonymous. 2015. WHO approves experimental treatment for Ebola. AlJazeera August 12, 2014. http://www.aljazeera.com/news/africa/2014/08/who-approves-experimental-treatment-ebola-2014812122023925143.html, McKay B, Loftus, P. 2014. Ebola Virus: Experimental Drugs Approved for Use in Fighting Outbreak in West Africa. Wall Street Journal August 13, 2014.   http://www.wsj.com/articles/experimental-drugs-are-approved-for-use-in-fighting-ebola-in-west-africa-1407884538 [Accessed March 17, 2015]

 

[6] Hayden EC, Reardon S. 2014. Should experimental drugs be used in the Ebola outbreak? Nature August 12 doi:10.1038/nature.2014.15698.

[7] WHO. 2015. Public consultation on emergency use assessment and listings procedures for medical products during public health emergencies. http://www.who.int/medicines/news/public_consult_med_prods/en/ [Accessed March 18, 2015.]

WHO Ebola ethics panel excluded those most affected

I'm reproducing here a piece I'm having out over at The Conversation. 

The World Health Organisation has been in a rush to deal with the Ebola outbreak in West Africa. Last week it declared it an international health emergency, and after two infected US doctors were given an experimental drug, it also convened an “ethics panel” to address the use of unregistered interventions for Ebola disease.

In a subsequent statement, the WHO said drugs unproven in humans could be used on Ebola patients:

In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.

Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.

Given that ethics is so central to this discussion and that deploying experimental agents in a population is fraught with difficulty, it’s strange that the ethics panel it put together wasn’t really one at all. Only few of the panelists had any professional background in bioethics or medical ethics. Representatives from the countries affected by Ebola were also missing in action; the WHO added panelists from Japan, Australia, Canada and for good measure Saudi Arabia, but no one from the countries actually affected. Women were also under-represented on the panel.

HIV/AIDS activists fought hard in the early days of the AIDS epidemic to ensure that people affected by the disease are today represented on these kinds of panels. WHO saw it fit to do without. A remarkable turn of events.

Some of those on the panel may have expertise on Ebola, but with a large body of academic literature out there on the two relevant issues, namely ethics of access to experimental drugs in case of catastrophic illness and the ethics of resource allocation, the top names in bioethics and medical ethics that deal pretty much only with these issues, weren’t included on the panel. As Greg Moorlock has argued previously on The Conversation, this happens all too often when big decisions are being made.

It may well be, as some have argued, that getting African panelists at such short notice to Geneva might have been impossible due to visa constraints and similar unfortunate matters. But with some panellists participating virtually via Skype or some other video conferencing tools, it would no doubt have been possible to include some West African representatives from countries affected by Ebola.

The problem with haphazard activism such as that displayed by WHO is that it destroys credibility and trust. There is already a high degree of distrust of foreign aid workers in the countries affected. Talkfests, where others in Switzerland discuss what should or should not happen with access to experimental agents for people in countries of the global south but who are not at the table, is the last thing needed now.

One could counter that the WHO has been responding, however imperfectly, to a health emergency and that it needed to press ahead. But actually at this point in time, there isn’t an experimental agent to be distributed: the company that produced ZMapp, the drug used on the two US health workers (who have since recovered) and a Spanish missionary (who died), has said it is out of stock.

The Nigerian government also recently said that Nigerians wouldn’t be able to access the drug for at least a few months because the drug existed only in such small amounts.

In other words, there was no need for such a rush as far as assembling this panel was concerned.

Experimental agents may be used under certain ethical circumstances, which the WHO knows. And the ethics and regulatory frameworks guiding access in many countries are more sophisticated than the statement of good things the WHO panel produced. Decisions about the how and when should be the responsibility of national jurisdictions and negotiations between nation states. If there wasn’t this exotic thing called Ebola that has triggered a worldwide moral panic, demanding “action”, no doubt we would have been spared this expert statement.

Considering that Ebola constitutes an international public health emergency, other ethical issues such as compulsory confinement of infected people or the professional obligations of medical personnel to patients would have been more appropriate issues for a WHO ethics panel to discuss but weren’t.

I suspect that the WHO wanted to be seen to be doing something. To its credit it put ethics at the forefront of its thinking about the crisis. Alas, it chose the wrong topic at the wrong point in time and arguably, by and large, the wrong people to do so.

What's wrong with you WHO?

I'm sure you've heard about the Ebola epidemic going on in West Africa.WHO has recently declared it an international health emergency (quite unlike other diseases in the region that likely kill more people). Of course, once one has jumped on to the panic generating band wagon, one also needs to demonstrate that one is doing 'something'.WHO decided to convene a meeting of medical ethics folks to discuss the distribution of (non-existent in any meaningful quantities) experimental therapeutic agents and (non-existent in any meaningful quantities) experimental preventive vaccines. Turns out, most attendees of the meeting had no ethics background at all.

Given the urgency to hold the meeting (in the absence of any goods to be resource allocated there's zero urgency to organize this event) WHO seems to have decided to stab randomly at its ethics rolodex, because the list of delegates is quite remarkable. Most of them are not known to have any public health ethics competence. None of the folks attending the meeting have published on ethical issues involved in access to experimental drugs in case of catastrophic illness. A look in recent issues of academic journals might have helped WHO to pick folks familiar with these sorts of issues. Alas, the rolodex clearly had to do.Women are virtually absent. Delegates from the region most affected (actually only affected) are pretty much absent, too. However, there's a Canadian chap, a Japanese chap, and importantly, a bloke from Australia as well as a guy from Saudi Arabia - all places desperately waiting for the first Ebola case to pop up on a flight, so the local media hype can be sustained for awhile longer, and the list goes on.

What on earth were you thinking, WHO, if anything?

Grinding my gears - Truvada marketing

I don't know whether you watch Family Guy, but if you do you will recall Peter going on to become a minor TV celebrity in an episode where he goes on rants about whatever it is that's grinding his gears, as he puts it so succinctly.

Take this commentary in that spirit - I may have missed relevant information (aka Peter …). I know that HIV prevention/Tx folks check on this blog every now and then. Consider yourselves invited to enlighten me if I missed a beat.

So, Truvada marketing by WHO and other assorted HIV prevention folks is grinding my gears in a big way these days. WHO reportedly advises that sexually active HIV negative gay men in sero-discordant relationships should go on Truvada. What grinds my gears is that to date there is not a single documented case of HIV transmission from an HIV positive guy on HAART whose viral load is undetectable, courtesy of that medication, to his sex partner. For the sake of the argument, assume that there are in fact a (very) small number of such transmissions happening. How can that be a good reason for advising every HIV negative gay man in such a relationship to initiate a regime of - frankly - fairly toxic drugs for ever (i.e. while he is sexually active)? Unlike Gilead's information on its Truvada website, the UK NHS provides a clearer picture of what you HIV negative gay guys can expect if you choose to join the Truvada train. These ain't sugar pills.

What grinds my gears it that we have zero clinical evidence that folks who take Truvada prophylactically, and say, successfully, throughout their sexually active lives, fare any better than those who wait with going on HAART until they sero-convert. What one would want to know, obviously, is whether folks who wait for a possible infection and then get treated, fare any worse in terms of mortality/morbidity than those who have boarded the Truvada train at gigantic cost to the health care system or their insurance company or to themselves. The truth is, we don't know that. This hasn't stopped WHO from marketing Truvada busily on behalf of Gilead, the drug's manufacturer.

Some have argued that folks would typically only need to use Truvada for a few weeks prior to an unsafe sexual encounter and then possibly use post-exposure prophylaxis afterwards. So, the argument continues, they'd be better off than those who'd sero-convert and have to take HAART for the rest of their biological lives. I'm sure Gilead's sales executives quietly laugh at this logic, because none of us plan for an unsafe sexual encounter (you know, in the real world nobody will say, hey, I'm going to have unsafe sex in six weeks time, lemme go on Truvada now, when unsafe sex done, I'll stop it again - sex doesn't quite work like that). In any case, post-exposure prophylaxis works in around 92-95% of cases, so why not stick to such a regime if you had unsafe sex with someone who's HIV positive and doesn't have an undetectable viral load.

Now, this was what I consider the strongest rationale for advising sexually active men to go on Truvada as a means of HIV prevention. Apparently, WHO hasn't quite left it there and went all out, it recommends that all 'men who have sex with men consider taking antiretroviral medicines as an additional method of preventing HIV infection'. This quote is from WHO's own press statement on the release of its report.

Talking about grinding my gears, this definitely does. For starters, the majority of sexually active gay men do not become HIV infected. And yet, WHO thinks they all should go permanently on highly expensive  - prices admittedly vary, in Canada they're at 1100 $ p/month, in South Africa at a more palatable 9$/month - and fairly toxic drugs. At this point in time we do not even know what the impact on their health would be 20 years down the track. As mentioned earlier, even for those who might become infected we do not know whether they might not be better off beginning treatment after they got infected than using comparable drugs throughout their lives to prevent an infection.

Let me cut thru the chase here: If WHO was an honest organization, it would concede that the only sound motive for advising all sexually active gay men to begin taking Truvada is a public health rationale, and not the health of those who take those drugs. Incidentally, that makes sense, WHO does mostly public health stuff anyway. If all or most sexually active gay men would take Truvada, we'd probably be able to get rid of the bug over a generation or two. This would come at a medium to potentially high price paid by the majority of gay men who would take this drug even though they'd not have caught the bug anyway.

That being said, I'm not trying to persuade anyone not to go on Truvada, I don't know whether it's a good or a bad idea, what grinds my gears is that in the absence of crucial clinical questions being settled, sweeping recommendations are made by WHO with a view to putting perfectly healthy gay men throughout their sexually active lives on seriously heavy medication with a side-effects list as long as your weekend shopping list. This is dangerous, because the absence of vital clinical evidence suggests there ought not to be consensus advice of this sort.

I can't wait for NICE to step in here and call this nonsense for what it is, a marketing exercise.

Should we get used to an age of compulsory confinement?

Here's my column from the Kingston Whig Standard of May 02/03 2014.

Yes, I know, Rob Ford went again on a drug-induced binge and blurted out his usual slew of racist, sexist, anti-gay views. He promised to disappear for four weeks and then return to save Torontonians tax monies, or something like that. I don’t live in that town, so whatever.

People elect the leaders they deserve. Also in Toronto, our premier was introducing her budget as I wrote this. Given that we live in a more or less bankrupt province, it is only mildly amusing that she reportedly found money to pay for infertile couples’ IVF procedures. Well, she didn’t quite “find” money, she decided to spend money that we don’t actually have. Her objective is to help those prospective parents who are unwilling to pay for IVF procedures themselves, but who seem wealthy enough to cough up the cash to raise children. Good going. We also learned this week, courtesy of the Supreme Court of Canada, that Prime Minister Stephen Harper and his friends in federal government seem to have only a very limited understanding of our constitutional arrangements, because they were yet again told off by the court.

Plenty to write a weekly column about, you might think. And yet, there are actually bigger fish to fry.The World Health Organization reported this week, in a disturbing document, the state of antimicrobial resistance across the world. We all have heard on and off about problems with the state of antibiotics research and development. A “race” was reportedly taking place. We were barely “ahead” of those nasty bugs. Typically, these problems seem to occur in faraway places like India and sub-Saharan Africa where tuberculosis is reportedly making a big comeback. Now comes the World Health Organization, telling us that the end is nigh. Well, not quite like that, but let this statement from the report’s foreword sink in for a moment: “Increasingly, governments around the world are beginning to pay attention to a problem so serious that it threatens the achievements of modern medicine. A post-antibiotic era — in which common infections and minor injuries can kill — far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century.” The signs are that we are losing the race, and it actually is a real race to stay ahead of bacteria that would — in the absence of antibiotics — kill us in very large numbers. Not just the poor in faraway places.

The World Health Organization report notes that multi-drug-resistant tuberculosis is probably significantly underreported, thereby undermining control efforts. It also warns that antibiotics-resistant bacteria causing common infections such as those of the urinary tract and pneumonia are becoming increasingly common across the world, not just in the tropics. You will be pleased to learn that just when the world is warming up and malaria-carrying mosquitoes are spreading into areas where they have not been seen before, artemisinin, the main component used to treat malaria sufferers, is not working well any longer in a number of countries. If the mosquitoes carrying the drug-resistant infection spread into other countries due to the changing climate, the malaria-related death toll could quickly rise. Even HIV drugs aren’t what they once were. At least one drug (of a limited number available) is failing between 10% to 17% of newly infected people because the virus has successfully developed resistance to that particular drug. Seemingly, like everything, even the things killing us evolve to get stronger and survive. The cost of treating people who have developed antimicrobial resistance to a whole host of bacteria, viruses, parasites and fungi is increasing rapidly. The side-effects of ever more complex treatment regimes mounted to preserve their lives are frequently significant. Resistance to anti-flu drugs is also increasing. This is a by and large unnecessary development, given that we could simply get vaccinated and so keep the number of flu infections down.

The really big problem, though, is antibacterial resistance and the lack of new treatments in our research and development pipeline. While the situation on the HIV frontiers might not be great, it thankfully takes a lot more effort to transmit HIV than it does to transmit tuberculosis or gonorrhea, for instance.

Talking about transmission, tuberculosis is fairly easily transmissible. You can pick it up without doing much about it, not much different from picking up the flu virus. You talk to someone with an active infection and that person might sneeze or cough, and voila, the odds aren’t terrible that you will become infected. Going forward, we will probably see more life-threatening illnesses that are easily transmissible and cannot be effectively treated any longer. The question arises how we should try to contain the spread of such illnesses.

We know already that many people who are aware of their infection and who understand that they carry an easily transmissible virus, tend to drag themselves into workplaces. More often than not, they aim to show that delivering at work while sick shows how professional they really are. The company comes first. Well, in the process, they pass their bug on to many other people who do the same, eventually a very large number of people are sick, some will die of an entirely avoidable infection. We are pretty good at being irresponsible in relation to our fellow citizens, especially when it comes to these sorts of infectious illnesses. Given that in the foreseeable future we will not be able to treat an increasing number of easily transmissible infections efficiently, if at all, I wonder whether it is time to begin a new conversation about our rules of conduct toward each other. Should we compel people with such infections to check into specialized facilities where they will be isolated and well cared for? It seems to me that would be a small price to pay to protect our public health. That is, assuming such a strategy could achieve its objective and prevent a significant number of new infections.

Udo Schuklenk teaches bioethics at Queen’s University, he tweets @schuklenk.

Against male circumcision on religious or cultural grounds

There is something surreal about the current debates that are taking place in some European countries about male circumcision. Well, it is not so much male circumcision as such, but the circumcision of very young Jewish and Muslim boys in Germany and the Netherlands. In Germany a court has recently declared circumcision on non-medical grounds illegal – much like female genital mutilation is illegal in the country. The court’s rationale was, essentially, that male circumcision for religious or cultural purposes is akin to assault or battery. If there is no overriding clinical benefit to the child undergoing the surgery, it is not justifiable to proceed with it.

In the Netherlands the Royal Dutch Medical Association has recently come forward arguing that male circumcision should be discouraged. The association notes in a report that a large number of complications resulting from circumcision are known, including ‘infections, bleeding, sepsis, necrosis, fibrosis of the skin, urinary tract infections, meningitis, herpes infections, meatisis, meatal stenosis, necrosis and necrotising complications, all of which have led to the complete amputation of the penis.’ Even deaths have been reported. There is also some evidence that circumcision diminishes pleasure during sexual intercourse and generally has a negative impact on the enjoyment of sex. The results of a large cross-sectional study in Denmark, published in 2011, reveal that ‘circumcision was associated with frequent orgasm difficulties in Danish men and with a range of frequent sexual difficulties in women, notably orgasm difficulties, dyspareunia and a sense of incomplete sexual needs fulfilment.’ It appears to be the case that that male circumcision is not a cost neutral, risk-free activity.

On the other side of the equation is what the World Health Organisation describes as ‘compelling evidence’ that circumcision reduces the HIV infection risk of adult males to a significant extent. This has led some to suggest population level circumcision of males in sub-Saharan African countries. A public health argument might plausibly be made for such a policy in areas with high HIV prevalence. However, neither Germany nor the Netherlands are located in sub-Saharan Africa. The prevalence of HIV/AIDS is thankfully quite low in those countries, and there is no reason to suggest that this is going to change any time soon.

Male as well as female genital mutilation are predominantly religiously or culturally motivated practices. Remarkably, the two world religions that tend to be so often at loggerheads, namely Islam and Judaism, both fervently support male mutilation while supporters of female genital mutilation will only be able to find support among Islamic scholars. I am not an expert in world religions and I have little doubt that theological arguments over what Judaism’s and Islam’s holy documents prescribe are likely possible, even among well-intentioned experts. Leaving theological arguments aside, however, there is a strong cultural consensus in Jewish and Muslim communities that male circumcision is something good.

Both in Germany and in the Netherlands representatives of the Islamic and Jewish faiths respectively charged those arguing against male circumcision with unfair discrimination. Indeed, one Rabbi reportedly went on the record claiming that the German court’s decision was ‘perhaps the most serious attack on Jewish life in Europe since the Holocaust.’ As has been noted by bioethics scholars quite a few times, we should be very suspicious if the holocaust argument is deployed in support or against something. Quite likely there is no reasonable argument to be had, hence the Nazi argument is wheeled in in order to discredit whatever it is that someone has a bone to pick with.

Of course, it is always possible that the motives of some of those arguing against circumcision are driven by ulterior intentions. You would have reason, for instance, to be suspicious if a Christian intelligent design organization hired an ex-Muslim atheist to campaign against Islam. However, it is surprising that it did not occur to these religious lobbyists that child welfare and fundamentally the child’s right to her bodily integrity are of paramount importance. In liberal Western democracies they rightly trump parental religious beliefs. The only issue that should matter in these debates is the affected children’s welfare. Religion or other cultural convictions, no matter how strongly felt, should not even enter into the equation. We do not permit Jehovah’s witnesses to prevent their off-spring from receiving blood transfusions when this is medically indicated. Why not? Simply put: we apply a child’s best interest standard. Best interest, when considered in a medical context, by necessity refers to health related concerns. It’s a legal standard applied, for instance in Canada. There is no good reason to deviate from this standard to accommodate the religious traditions of Muslims or Jews. It is also worth noting that we usually give parents significant room to make parental decisions on behalf of their children, precisely because we believe that they usually know what is in their children’s best interest. That might even explain why the paternalism-in-medicine doctrine has its roots in the idea of a good parent (well, father) doing what is in his child’s best interest, even if the child disagrees. In the case under consideration, however, it is clear that the motives driving the parents derive their strength from religious or cultural convictions rather than from empirical evidence in support of the need for a surgical intervention in every male child.  

Surprisingly, in Germany major political parties from the centre right Christian Democrats to the Liberals as well as the leftish German Labour Party fell over one another promising to introduce legislation aimed at safeguarding purported parental rights to mutilate their children’s genitals for religious reasons. The Greens were expressly more concerned about ‘religious freedom’ than about child welfare. The parliamentarians expressed worries that otherwise Muslim and Jews just could not live any longer in Germany. Strangely the same concern does not seem to apply to Jehovah’s Witnesses who are forced to adapt their religious practices to German law protecting children against parental abuse. The parliament passed a resolution asking the government to create legislation aimed at permitting male circumcision as long as it occurs without ‘unnecessary pain’. The German foreign minister reportedly thought the parliament’s vote demonstrated that Germany is a cosmopolitan and tolerant society, when arguably it demonstrated that the country’s politicians are readily prepared to subjugate child welfare concerns to concerns about alleged religious freedoms. Interestingly enough, the same parliamentarians had no problems protecting women against female genital mutilation with an argument suggesting that it is ‘sittenwidrig’, ie against German customs or morals. This, of course, is question begging. How is female genital mutilation any more sittenwidrig than male genital mutilation? In a historical sense it is arguably against German customs as there is no such tradition in Germany, but history cannot as such provide normative guidance. Female genital mutilation clearly causes more harmful consequences, but these cuts might possibly also be undertaken without causing unnecessary (sic!) pain, and that seems to be the odd yardstick against which male circumcision is held. One cannot help but wonder, what other bodily parts the German parliamentarians might in the future see fit to be removed lawfully as long as the removal does not cause unnecessary (sic!) pain and as long as some religious ritual or other is attached to it.

Germany as well as other countries would be well advised to reconsider permitting religiously or otherwise culturally motivated irreversible surgical body modifications of children that serve no uncontroversial medically beneficial purpose. If a competent adult or a mature minor wanted to go ahead with circumcision, a case could easily be made to respect such wishes. However, in the case of children the child’s –medically understood - welfare should take precedence over parents’ religious convictions. That is how most societies rightly address this problem with respect to Jehovah’s Witnesses’ prohibition of blood transfusions and that is how we should handle it with regard to genital mutilations of the various kinds that are popular among particular religions. Parenthood should not be confused with unrestricted ownership, neither by parents nor by parliamentarians trying to accommodate religious convictions. It is surprising that using children as mere means to satisfy parental religious or cultural needs should be considered acceptable in the 21^st century version of Immanuel Kant’s homeland.

More corruption at UN?

Turns out what most interested observers have been arguing for a long time has been proven correct. The WHO's panic mongering in relation to the swine flu pandemic was just that, panic mongering. The primary beneficiaries were pharmaceutical companies whose products were stockpiled by many countries that responded to WHO recommendations. Finally, in-depth reports accuse WHO of exaggerating the real danger. The reports also note that on the WHO committee writing the report served several scientists who arguably had a conflict of interest (related to their relationships with pharmaceutical companies). The Washington Post wonders whether or not the WHO advert for flu medicines (aka its flu guidance) informed its member countries of these commercial conflicts of interest.

WHO in favour of fair innings based resource allocation justice

WHO, in a recently published report, has come out in favour of an approach to resource allocation justice based on the fair innings argument. That is quite interesting. US authorities, more or less, came out in favour of maximising lives saved instead of maximising life years saved (ie no discrimination in favour of the young). The UK has come up with a draft ethics guideline leaving open the question how scarce life-preserving treatments should be allocated in case of pandemic influenza. So, it's not insignificant that the WHO's experts support an approach aiming to save the maximum number of life years that can be preserved.