Saturday, 16 December 2017

On the "One State Solution" to the Israel-Palestine Conflict

Since the Oslo Accords of 1993 and 1995 initiated what has become known as the "Oslo Process", the recognised vision of how to resolve the longstanding violent conflict between the state of Israel and Palestinian representatives, organisations and people have been the so-called  Two State Solution, where the state of Israel is to mostly withdraw to its original 1947 borders, and a state of Palestine reign over the remaining territory of what used to be the British colonial "protectorate" of Palestine. This resulted in the creation of the Palestinian Authority reign over the Westbank and Gaza territories, pending final negotiations about nation state borders, which have never so far taken place. In the meantime Israeli seizure of Palestinian property and land, and colonial settlements in occupied territory have continued, as have violent rhetoric and activities both within the Palestinian territories (since the militant islamist Hamas movement seized power over Gaza and effectively put a stop to democracy there), and between the Israeli army and various militias and activists from the Palestinian side. Of course, mostly with the result of massive domination and show of force from the Israeli side, to the repeated disbenefit of people living in the areas, especially the blockaded Gaza strip. Very recently, some initiatives from Hamas has signaled attempts to overcome the infighting with the Palestinian Authority, but so far with no notable political result. Even more recently, US president Donald Trump stumbled into the conflict in the rogue elephant manner he has made himself known for and designated Jerusalem from now on to be the recognised capital of Israel, albeit the US (or the UN) does not recognise the territory where Jerusalem is located as part of Israeli territory, but as occupied land. Not surprisingly, this gave rise to a new wave of violence from military, militants and activists on both sides. The idea of the two state solution seems less politically realistic than it has ever done.

Against this background, a number of debaters have suggested an alternative idea, The One State Solution, which to a lot of people makes a lot more sense than the fiasco and resulting mayhem that has been going on since the creation of the state of Israel in 1947. This idea, simply put, is that all of the territory currently contested is made into one single state, that this state is made ethnically unaligned (abolishing ideas about a Jewish or Palestinian homeland), democratic, and secular, and that a deal is struck on the question of how people in various forms of exile may return (or not return) to the area to settle. One idea would here be to allow Palestinians housed in refugee camps, e.g., in Syria and Lebanon, since generations a "law of return", just as the present state of Israel allows a "law of return" for Jews who can prove appropriate lineage. Another notion is to stop the current Israeli practice, and to instate normal migration laws based on ethnically and religiously neutral criteria. All who discuss this idea recognise that no such deal will be satisfying chauvinists and extremists on either side, as it means abolishing the notions of a "Jewish", a "Muslim" or "Islamic", a "Palestinian", an "Arab", etc. state. Nevertheless, having one state, with one administration, one judicial apparatus, one police force and one military, will be in a better position to control such elements than in the current state of a nasty mix of virtual anarchy and martial law, where extremist on both sides continue to perpetuate a state of chaos and violence to no benefit for most people on either side. Some examples of proponents and critics of this idea can be found here, here, here, here.

However, the practical way towards a one state solution is making a lot of people uneasy, as it necessitates breaking with some cherished ideas and longstanding practical solutions. The most obvious way to instigate the one state solution is for the current state of Israel to simply annex the territory it presently illegally occupies; the West Bank, Gaza and Jerusalem. Thereby, these areas are declared to be parts of the state of Israel, its settlers are recognised as Israeli citizens, with the same rights and obligations as any other current Israeli citizen. Those who want to hold on to ethnic or religious chauvinist political ideas don't like this, of course. Besides the obvious dissatisfaction from islamist camps (such as Hamas), there is also a lot of Israeli orthodox chauvinists and rightwing politicians, who quite like the present situation of occupation, as it allows the military to rule with martial law style arbitrary discretion. The whole Jewish settlement and land grabbing operation pretty much rests on this situation of (lack of) law enforcement. That, by itself, should be excellent reason for reasonable people to like the one state solution. But also many people of this sort I have talked to hesitate to support the one state road ahead, and I have heard two reasons for this: First, the fear of enlarged interstate military conflict though having surrounding countries interpret the move as hostile and react accordingly. This is an important point, but this risk is present also – if not more – with the current two state debacle. Whatever solution for the Israel-Palestine conflict is reached needs to contain agreements with neighbouring countries in the region that guarantee sustainable, stable and peaceful conditions for all.

The second reason for hesitation is a distrust of the current state of Israel's ability to maintain itself as the kind of democratic, ethnically neutral and secular state, committed to rule of law and equal treatment, that is necessary for the one state solution to function. This reason, in contrast to the first one, is a game changer issue. This since it will force the state of Israel – and its present government – to finally put down its foot with regard to its political identity. With the one state solution, either Israel takes the consequences, and abolishes all notions of ethnic or religious identity as its basis, or it will have to abolish its often held out liberal democratic aura and turn itself into a bona fide apartheid state within its own lawful borders (in contrast to the virtual apartheid currently practiced via the partition into "real" Israel and occupied territories). Likewise, should citizens of Palestinian origin reach political power in the new one state of Israel/Palestine, they will face a similar choice between maintaining the ethnically neutral and secular democratic solution of a one state Israel/Palestine, or pursuing the islamist/Palestinianchauvinist agenda lurking within the notion of this territory "belonging to" a certain "people", thereby promoting their own apartheid solution. That is, the very same basic notion that drives the Jewish chauvinist notion of present day Israel, only with another "people" as the supposedly chosen one. Both, of course, can only lead to genocide, should they prevail.

This, I suggest, is what makes the one state solution both very scary for many people, and at the same time immensely attractive. It is the best solution under ideal conditions, but given the still apparently strong commitment of dominant parties involved to ethnic/religious chauvinism, and the infantile notion of a possibility to "win" over the opposing side, it may seem politically infeasible. At the same time, the alternatives of continued anarchy and war or one or the other version of genocide are hardly more appealing. I'm torn.


Monday, 21 August 2017

Increasing Critical Questions Amid Mexican Mitochondrial Replacement Therapy Experiment

Mitchondrial Replacement Therapy (MRT) – sometimes referred to with its headline name "Three Parent Babies" – is an innovative, in humans yet unproven, reproductive genetic technology, by which it is hoped that a more effective avoidance of having children with severe mitochondrial hereditary disease (as a rule extremely severe, untreatable and lethal). MRT is controversial both as assisted reproductive technologies are controversial, primarily among certain religious groups, and because it is the first example of hereditary genetic modification of human beings – so-called germline genetic modification – that has been seriously contemplated. A nice summary of the scientific and ethical complexities involved can be found here.  The last couple of years, ethical, legal and scientific debate about whether or not human trials of this experimental technique should be allowed has surged, and special legal provisions have been created for this purpose in the U.K., as well as some US states. However, the leading reproductive researchers in the UK and US just stepping up to make an opportunity out of this new legal room were quickly overtaken by the less prominent colleague of Dr. John Zhang, from a US private fertility clinic, who almost a year ago reported a human MRT experiment conducted at a Mexican clinic in order to duck US regulatory oversight.

Already from the start, ethical and regulatory questionmarks have surrounded this experiment. First, objections have been raised about the ethics of Dr. Zhang to create MRT embryos in the US to then be moved to foreign soil in order to circumvent US regulatory frameworks and scientific guidelines for MRT. Second, while Dr. Zhang had described why Mexico was chosen as the country to host the experiment by claiming that “there are no rules” regarding MRT there, subsequent legal analysis by my bioethics scholarly colleagues César Palacios Gonzalez and María de Jesús Medina Arellano has revealed that the experiment very likely breached a number of Mexican legal statutes related to research and reproductive medicine. A popular presentation of this finding can be accessed here.

In the meantime, the US Food and Drug Administration, yes, the mighty FDA, has apparently been silently probing the matter with regard to Dr. Zangh's relationship to US federal law. For just a few days ago, Mary A. Malarkey, Director of the FDA's Office of Compliance and Biologics Quality, sent a briskly phrased (to say the least) official letter to Dr. Zhang, enumerating a number of US federal legal violations allegedly involved in the Mexico MRT adventure. I have uploaded the letter to to Google and made it available for anyone to view and share, here. Among the allegations made in this letter are the following:

  1. ... you are using MRT to form a genetically modified embryo, which is subject to FDA’s regulations with respect to human cells, tissues, or cellular or tissue based products (HCT/Ps) under 21 CFR Part 1271, issued under authority of section 361 of the Public Health Service Act (PHS Act [42 U.S.C. 264]). HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and do not qualify for any exceptions in section 1271.15, are subject to additional regulation, including appropriate premarket review.
    The genetically modified embryo that you formed using MRT does not meet all the criteria in 21 CFR 1271.10(a) and does not qualify for any exceptions. /... /
    [The HCT/P is] also regulated as a drug as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)], and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i). Specifically, your processing constitutes more than minimal manipulation of cells or nonstructural tissues, as defined in 21 CFR 1271(f)(2)
    To lawfully market a drug that is also a biologic, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a demonstration of safety, purity, and potency. While in the development stage, such biological drugs may be distributed for clinical use in humans only if the sponsor has an IND application in effect as specified by FDA regulations (21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312). The MRT-produced HCT/P is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. / ... /

    Nor is exportation permitted unless it meets the requirements of an applicable export exemption.
     / ... / your export at issue here did not meet the requirements of any of these export exemptions. / ... /
    The Director signs off by noting:

    This letter is not intended to be an all-inclusive list of violations. It is your responsibility to ensure full compliance with the FD&C Act and the PHS Act and their implementing regulations. 

    We request that you notify this office, in writing, of the steps you have taken or will take to address the violation noted above and to prevent recurrence.

    While I am cautiously positive to having well-regulated legal room for MRT trials, I have to say I found Dr. Zhang's maverick action very ill-conceived from the start. While the experiment has been subsequently reported scientifically, it is not part of any controlled and planned experimental series that could contribute to the formation of a solid body of scientific evidence to either substantiate or rebut the hypothesis that MRT is a viable medical procedure. Nor was it done in response to any sort of dire medical need, but solely as an attempt to overcome efficiency problems in IVF, thereby lacking any of the ethical justification usually cited as the main reason to allow for human MRT trials. Moreover, as there was no research ethical review, no check has been applied to the consent procedure, making it very likely that the couple who were the patients have been exposed to what is known as the therapeutic misconception. Therefore, the experiment brings to mind  the sorry tale of what has become of the once red-hot scientific field of stem cell therapy, nowadays mostly ruined and disreputed by gung-ho experimenters and unchecked, semi-fraudulent commercial operations preying on vulnerable people's desperation in a hunt for money and personal glory. If germ-line gene therapy is to be allowed and able to develop out of MRT experiments, it has to proceed within a very rigid and tight oversight, both scientifically and ethically. Stunts like the one of Dr. Zhang constitute a threat to that. Therefore, I'm very pleased to see FDA yank whatever legal leash it has as hard as it can, and I hope the scientific community will do the same. As a first step, a retraction of the article in Reproductive Biomedicine Online due to false statements regarding ethical and legal status of the reported trial may be in order?

  2. ***

Sunday, 4 June 2017

Registration Open for Our Free of Charge Symposium on Ethics and Antibiotic Resistance!

As I reported before, the Centre for Antibiotic Resistance Research, CARe, at the University of Gothenburg, is organising a free of charge symposium this fall on the theme of Ethics and Value Challenges in Antibiotic Resistance Management, Policy and Research.

Participation is free and open to professionals, officials, policy makers, researchers and interested members of the public, but requires pre-registration. Get more information and sign up here.

Taking place November 15-16, this is a unique opportunity for anyone interested in the topic of antibiotic resistance to learn from and interact with world-leading researchers in this area, representing disciplines such as bioethics, law, medicine, philosophy and public health, including Michael Selgelid, Clare Chandler, Marcel Verweij, Alena Buyx, Jonathan Anomaly, Steven J. Hoffman, Julian Savulescu, Otto Cars, and others.

Below is a flyer for the event - please share it as much as you like!

Wednesday, 8 March 2017

Save the date! Symposium on Ethics and Value Challenges in Antibiotic Resistance Management, Policy and Research, November 15-16, 2017

Ethics and Value Challenges in Antibiotic Resistance Management, Policy and Research, symposium in Gothenburg, November 15-16, 2017. Save the date!

The World Health Organization identifies antibiotic resistance as a global challenge so serious that it threatens the fundamental achievement of modern medicine. Ethics and value conflicts are at the centre of this challenge: understanding its nature and stakes, identifying adequate social responses, understanding why policies and actions can be more or less accepted by stakeholders. Underlying issues regard conflict between individual interests and long term interests of society; as well as national as opposed to global societal interests in the short- and long term, how to manage the distribution of benefits and burdens coming out of efforts to mitigate further resistance development and managing consequences of established resistance, and responsibly balancing uncertainty in the face of major public health threats. 

The Centre for Antibiotic Resistance Research (CARe) at the University of Gothenburg started in 2016 as a cross disciplinary hub for research, education and public outreach across six faculties, including collaboration with societal and private actors. More information about CARe is found here:

The original CARe team at its inaugural conference in April 12016

 Now CARe presents a 2 day symposium on the theme of Ethics and Value Challenges in Antibiotic Resistance Management, Policy and Research, November 15-16, 2017. This symposium will house up to 300 participants, and assemble internationally excellent keynote presenters in ethics, law, public health and related areas engaged on this topic – including leaders of recently started major research projects– from Australia, Canada, the Netherlands, Germany, Sweden, the United Kingdom, and the USA (see program below). The conference is open and free of charge, but will require pre-registration, details of how to register will follow.

Preliminary program (all speakers confirmed):
Otto Cars (Uppsala University): Global political response to the antiobiotic resistance challenge 
Michael J. Selgelid (Monash University and WHO): Ethics and value challenges created by antibiotic resistance: a roadmap
Marcel Verweij (Wagenigen University): What is responsible care for ABR carriers?
Clare Chandler (London School of Hygiene & Tropical Medicine): What is care in the wake of antibiotics? Experiences of global health in low resource settings.
Michael Millar (Queen Mary University of London): Antibiotic resistance: a threat to capability security
Jonathan Anomaly (UNC Chapel Hill & Duke University): Antibiotic resistance is a public goods problem
Julian Savulescu (University of Oxford): Collective responsibility and its ethical implication related to ABR
Steven J. Hoffman (University of Ottawa): What is required of effective legal mechanisms in the ABR area?
Jasper Littmann (Robert Koch Institute): Institutional ethics when responding to global security threats, such as ABR
Alena Buyx (Christian-Albrechts University of Kiel): How should policy makers, business and professional practitioners think about the ethical aspects of ABR management?
Christian Munthe (University of Gothenburg): Do we have reason to adjust standard precautionary rules for introduction of new interventions and methods in ABR policy and other public health emergency settings?
Sverker Jagers (University of Gothenburg): The role of public trust to balance ethics and effectiveness in the implementation of global political action 

Organizers: Joakim Larsson (director of CARe), Christian Munthe (PI for ethics in CARe), and the CARe steering committee.

Tuesday, 28 February 2017

Independent Science Journalist Who Exposes Research Fraud, Ethics Breaches & Corruption Threatened by Lawsuits: Here's How You Can support Him!

As I have been reporting before, no holds barred independent German science journalist Leonid Schneider, who runs the blog For Better Science to expose and call out science fraud, ethics breaches and general scientific hype and institutional corruption, particularly in the life and medical sciences, has recently been hit by civil lawsuits to silence his reporting. Besides the couple of Thorsten and Heike Walles, another exposed former Paolo Macchiarini associate and likely co-fraudster and ethics villain, Philipp Jungebluth, is now also suing Schneider for libel. In both cases, court injunction have already been made threatening Schneider with massive monetary fines or prison time, and he is now facing the substantive economic cost of defending himself in two separate proceedings and, if the court so decides, pay the fines and the legal costs of the plaintiffs. Note that what Schneider has been reporting is only already publicly available and proven facts, so he is not in any way slandering these people, but rather providing an important information service to universities, hospitals, research funders, and potential patients (and possible guinea pigs) of the dear doctors. Of course, the whole thing is a so-called SLAPP operation, to shut Schneider up by scaring him with the financial consequences of continuing his reporting.

To help Schneider manage through this challenge, you may first of all sign this letter of support of his reporting. If you're in such a position, you may also engage Schneider professionally. But he has also set up this crowd funding page, to help everyone who dislike science fraudsters and unethical researchers, as well as the practice of silencing important public reporting by abusing civil law, to pitch in financially. I've become a monthly "patron", but there are many options and you may chose your contribution freely, with more generous amounts providing you with a steady stream of Schneider's homemade satirical science cartoons, such as this one:

Saturday, 18 February 2017

The Leadership Moral Qualities of President Donald "So-called POTUS" Trump

Holders of political positions of high office, such as presidents or prime ministers, always attract controversies due to the content of rivaling political aims, agendas and visions. But one thing you would expect of any holder of such a position is that this person possess the ability to lead. For this is what such offices are ultimately about. The new US president, Donald Trump, has now been in office for some – very brief – time. Mostly these beginning days of a new US presidency – or a new cabinet in a parliamentary democracy – are ones of relative calm and ease; of settling in and attending to the formalities necessary to, thereafter, be able to rule for real and do one's best to realise whatever political program one has been elected on. Not so this time. Donald Trump has in a very short time managed to (I'm not giving any specific links here – all you need to do is to do a bit of Googling):

a) ... issue an unlawful (according to some court decisions even unconstitutional) executive order on one of his central deliveries to those who elected him: the so-called travel ban, aka Muslim ban, in spite of the fact that his closest legal adviser, the acting attorney general, had advised him against the design of the order;

b) ... fire said acting Attorney General for having done her job and extended said advise, before being forced by the legal system to back down;

c) ... attacking the federal courts that decided said order is unlawful for doing their constitutional job and applying and interpreting the law – openly mocking them as "so-called" judiciary, earning himself the epiteth of the "so-called POTUS" – rather than realising that said order needs to be redesigned to achieve legal compliance;

d) ... appointing a personal security adviser, Michael Flynn, who already from the start was heavily in question from a national security standpoint due to dodgy Russian contacts, and who then lied about that to his own administration, making himself into an even worse threat to national security, before being exposed as a liar and finally fired just a few days after his appointment, but apparently as long as two weeks after the President had been briefed about the question marks hanging over him;

e) ... apparently openly lying about this documented foreknowledge when asked by a reporter;

f) ... fire the acting Attorney General (same as b above), who – again! – had done her job, and advised the President about the national security threat posed by Flynn;

g) ... trying to surpress the unsurpressable and increasingly credible information about his campaign staff having had potentially illegal contacts with Russian intelligence agents and officer prior to his inauguration;

h) ... failing to have one of his central ministerial appointments confirmed by Congress, in spite of having a secure GOP majority in both houses;

i) ... making a number of apparently unplanned and ill thought-through international political attempts (Mexico, Russia, China, Europe, Israel, Nato, Yemen ...), which so far have only weakened the international standing of the USA due to their apparent lack of systematic strategy, and their confusing lack of grounding in the US diplomatic and international affairs ministry;

j) ... appoint a press secretary, Sean Spicer, of such questionable competence and skill that he has already managed to antagonise more or less the entire news media corps and made himself the laughing stock of the world;

k) ... apparently for this reason elevated his former campaign manager, Kellyanne Conway, to some form of unspecified advisory capacity, whose role now seems to be to second guess Spicer when he seems to be botching up 8which happens frequently), but who has already herself been caught with open lying and fabrication of facts, all of which just serves to deepen the confusion and lack of credibility of the new administration; 

l) ... himself, personally!, as well antagonising and attacking the same media for criticising his actions, via Twitter or actual press conference, rather than learn from his obvious mistakes and take action to bring them onto his side. His first solo press conference is, in this respect, a stuff of legends in its exhibit of confusion, lies and complete lack of judgement – even the formerly good media dog of the GOP and alt-right, Fox News is decrying the spectacle, and counting the lies;

m) ... apparently also antagonising, rather than allying, large parts of the very federal administration that is meant to help him execute his policies, e.g., by derailing or ignoring its expert opinion and intelligence, among other things regarding all of the items above;

n) ... continued to openly and blatantly lie, and antagonise all that point this out for doing so.

Ok, so all of this in just a few weeks, and long before any real policy making has begun. Everybody know that several of Trump's central promises that got him elected will run into severe trouble in the process of making actual law, confirm the federal budget, et cetera. For a large portion of his GOP majority of course sees that several of his ideas will not be of benefit to either the American people or the Republican party – such as starting trade wars, or radically increase the federal financial deficit and lending to be able to realise the combination of the promised infrastructure and industry projects, the increased military spending in combination with decreased federal taxes. One would have supposed that the Trump inner circle knew about this, and therefore would take some care to prepare to ground well for the very real political battles that lie ahead, especially as this would mean using a period of relative calm, when new administrations are usually left comparably alone in terms of critical scrutiny. If they don't €#%+ up, that is. Which is what Donald Trump has apparently been doing from day one. But this is already clearly set out in any number of reports and commentaries available all over, and not any kind of original point of mine.

What I would like to comment on is what moral qualities of President Donald "So-called POTUS" Trump are revealed by how he has chosen to handle these early challenges, troubles and setbacks. For such qualities are, of course, central to any leader's prospect of success, both regarding central projects one is set to realise (whatever these are), and regarding one's ability of holding together whatever organisation one is set to lead in order to effect that realisation. I am thus not reviewing the moral quality of his political aims, vision or agenda, but rather how well is is equipped to lead an attempt to realise those aims, that vision and agenda.

1. Carefulness
This quality is about a leader's ability of preparing actions well – its antonym is carelessness. As related above Donald "So-called POTUS" Trump scores very low in this dimension of leadership. many of the chaotic blunders during these first few weeks could have been easily avoided by better preparation. The ability of exhibiting carefulness depends on several of the qualities listed below.

2. Wisdom
This quality is about several things, bounded together by the importance for a leader to be able to learn from mistakes, revise opinion in view of misjudgement, and design his or her administrative support to secure this ability. Well-known obstacles to the achievement of wise leadership is for a leader to surround him-/herself with advisers that are "yesmen" and/or loyal rather than competent, to be prone to assume people who object to one's propsals are conspiring, rather than carefully considering the content of criticism. So far, Donald "So-called POTUS" Trump has demonstrated very little on this front. Possibly the only sign so far is the final, at great pains, forcing out of Flynn, and the final, again at great pains, grumbling contention that, possibly, the travelban order will have to be entirely redrafted and rule of law respected after all. A wise leader would, of course, never have hired Flynn in the first place, or acted immediately on the incriminating information, and would immediately have accepted the court decision regarding the travelban, and gone back to work to do better, rather than firing the foremost adviser who had told him how the land lay and mock the same constitution that gives him the power he is so amateurishly attempting to execute.

3. Responsibility
This is about two things. First, to accept the link between power and accountability for the consequences of its wielding. Second to communicate this sense of responsibility to the surrounding world. This means not, e.g., blaming underlings for one's own mistakes (e.g., of appointing them) or ignoring their advise, or others for their predictable reactions to what one does. Again, Donald "So-called POTUS" Trump has a long way to go to even approach the minimal standard of a half-decent leader.

4. Perspective
This is the ability to assume and see the reason of the points of views of others, as well as be able to think strategically and long-term, acknowledging the complexities of an heterogeneous world. This could, for instance, imply accepting some adaption to opponents' and critics' points of view in order to realise larger objectives further on, or to think once or twice about how other around you might respond when you threaten them. As a case in point on both fronts, while Trump may very well chose to tax Mexican imports to pay for the so-called border wall that Trump has promised to build (as he has hinted that he plans), this will, of course, have an effect on the consumption of said goods, undermining the revenue in question, while at the same time it is predictable that Mexico can easily offset the damage by taxing US imports to a similar degree to offset the damage. As there's a more or less 50/50 import/export trade relationship between the two countries, the netto effect would mainly be a shrunken economy on both sides, and it would seem that the Trump threat has pretty much nothing going for it, unless one fails to think two or three steps ahead. Donald "So-called POTUS" Trump once again fails to exhibit such qualities,

5. Restraint
This is basically about keeping one's cool in the face of opposition and complications. To keep a clear mind in order to be able to realise one's plans, to forestall opposition to read one's hand, to avoid unnecessarily antagonising those with which one may in the future be forced to attempt negotiation and compromise, and to secure a basic understanding and respect also of those who have a critical stance to one's attempts (such as the press). Above,  I didn't even mentioned specifically the Twitter activity that Donald "So-called POTUS" Trump, I may add that now, to underscore how magnificently he is failing also on this point.

6. Effectiveness
Now, a leader who is lacking in any of the qualities 1-5, may be excused if he/she, as the saying goes, gets the job done. The problem is that Donald "So-called POTUS" Trump is not, and to a great extent due to his very lack of the moral qualities needed for great leadership. As mentioned, so far, all of the circus created has been far from any real policy making challenge – it's been about the elementary preparations for those. And Donald "So-called POTUS" Trump isn't even able to pull that off. Partly because of this failure, partly because of the lack of qualities 1-5 so far demonstrated, it is highly unlikely that he will be able to realise any of his rather ambitious campaign promises, although there will, of course, be an expected policy swing to the right – with known negative consequences for the core supporter groups of Trump. Where that will leave US politics four years from now is not an entirely comfortable thought.


Thursday, 5 January 2017

Attend our summer school on the Ethics of Family in Health- and Social Care!

One of my commitments is as active member and member of the steering group of an international network on family ethics research, headed by Marian Verkerk, Professor Ethics of Care of the University Medical Centre Groningen. The network has a forthcoming volume (to which I contribute two sections), edited by Marian, Hilde Lindemann and Janice McLaughlin, on Oxford University Press, with the preliminary title Where Families and Health Care Meet.

Another output is a new summer school, organised by the UMCG, on the broad topic of ethical complications and issues in health and social care due to various aspects of family and how patients and clients, as well as professionals, are inescapably embedded in webs of close personal relationships and the fact that society and institutions are all built on assumptions of such webs being in existence. The course is open to masters as well as PhD students and goes under the heading of What About the Family? Besides myself and Marian, the featured speakers/tutors include Ulrik Kihlbom (Uppsala University), Hilde Lindemann, Jamie Nelson (both Michigan State University), Veerle Provoost (University of Ghent), Jackie Leach Scully, Simon Woods (both Newcastle University) and Kristin Zeiler (Linköping University), and others yet to be confirmed members of our network from the universities of Göttingen and Lübeck.

Here is the course webpage. Below is a 2 page flyer that you are more than welcome to share in your networks and with whoever you think maybe interested. Hope to see you in Groningen in August!


Remembering Derek Parfit

Unexpectedly, Derek Parfit died on new year's day 2017, an event sending shock-waves throughout the global philosophy community, as he was no more than 74 years old. For you who don't know who he was, it can be summed up in terms of the most important moral philosopher of the 20th and, so far, the 21th century. With his book Reasons and Persons (Oxford UP, 1984), he single-handedly redrew the intellectual maps of normative ethics, philosophy of action and rationality, value theory and existential philosophy, partly by making intriguing revelations of how they interconnect, and demonstrating puzzles and challenges coming out of that, which a lion's share of the philosophy world is still grappling with in one way or the other. He followed that up with the monumental On What Matters, of which two volumes have been published and a third is rumoured to be on its way later this year. In 2014 Parfit was awarded the Rolf Schock Prize in Logic and Philosophy, which I celebrated with this little parody piece of his distinctive writing style.

There's already a fair portion of good in memoriam pieces out there, featuring personal reminiscence, summaries of his life and works, as well as links to videos of his lectures. A nice listing can be found on Harvard University's (one of the top institutions to which Parfit was linked) memorial webpage.

I never had the pleasure of meeting Derek Parfit in person (and many bear witness of that this would indeed have been a pleasure), but his philosophical work has had a large impact on my own philosophical explorations, for what they're worth. When I started to attend the "higher seminar" in practical philosophy at Stockholm University in 1985, Reasons and Persons was on the reading list for a full term, and the seniors took turns introducing the different parts, sucking me and the other "youngsters" into sophisticated philosophical reasoning and argument on a level way above what we had ever experienced before. I choose, as a consequence, to write my B.A. thesis on a few pages of part 2 of the book, where Parfit defends what he calls the "Critical present aim theory" of practical reason or rational action, according to which certain individual desires may be irrational in themselves due to their very content. I was critical of Parfit's way of supporting "CP", as I found it putting the cart before the horse by invoking what to me looked like a fundamental moral conviction (that it's not justified to prefer suffering just because it occurs on certain weekdays) as its basis, which would be problematic in a question begging manner given Parfit's aim of using CP to support the idea of objective moral truths. But this was more importantly a formative experience of how well made philosophy will always be open to questioning if only you work hard enough on understanding its details – gaps for criticism are only absent when the work is marked by obscurity and ambiguity, and therefore you should never fear obvious openings for disagreement in your own work, they are unavoidable. Later, I wrote my Ph.D. thesis on the morality of abortion (in Swedish), and there both the discussion of personal identity over time, and (more importantly) the moral importance of future people came to provide very important input. These aspects of his work then continued to have an impact of my later work in bioethics, e.g., on embryo research, reproductive ethics and gene technology. Later, Parfit's musings over problems of collective action, value aggregation and the pragmatics of applying ethical theories in practice (part 1 of Reasons and Persons) added important context and basis for my contributions to public health ethics and the ethics of risk and precaution.

Now, it should be underlined, that Parfit's influence has never been that of a prophet – someone's whose teachings one accepts and then spends one's life as a follower of, working out the details with the assumption that the master's words must never be doubted. Parfit's strength was never the thesis, but the argument and its analysis – often leading to initially apparently clear positions falling apart into zillion variants, each of which in need of their own little set of arguments. When he pursued a substantive thesis, I often disagreed with him, albeit acknowledging much of the analytical landscape created to reach it. Parfit was a philosopher who ingeniously created intellectual context and complication for others to freely move about within. In that way, much of whatever I have ever managed to contribute to my own little corners of the vast world of philosophy wouldn't have been there for the picking, had it not been for the context of problematisation and complexity provided through Parfit's prior achievements. This, I'm convinced, is true of a great many other currently active philosophers as well. And I believe that this will continue to be the case for a fair amount of time ahead.


Wednesday, 4 January 2017

German Macchiarini-linked researchers Thorsten and Heike Walles bully blogger with libel threats to surpress information about their apparently irregular experimental transplant surgery

As you may imagine, the research ethical and misconduct scandal around Paolo Macchiarini's surgical experiments at the Karolinska Institutet (a radio summary is here, text ones are here and here) has been a big deal for anyone engaged in bio- and research ethics in Sweden the past year. But not only here, as Macchiarini has had many international links and seemingly hopped between employers and affiliations all over the place for many years, where he has inspired others to work with similar techniques as himself.

Now, some of these people and institutions apparently do all they can to wash their hands free of any Macchiarini-stains, attempting to suppress and silence any public mention of the past associations and stall potential inquiries, especially to impede them to stimulate big news media to take an interest. Possibly for short-sighted reasons of protecting reputation, but possibly also for the reason of preventing more in-depth investigations of research ethical breach, possible scientific misconduct or, as has happened in the Macchiarini case, violent crime. Actions taken usually include unwillingness to share relevant documentation with external inquirers, or refusal to answer their queries, thus undermining the basis for objective public reporting. Lately, however, some have escalated to aggressive legal actions against inquirers, in order to threat them with financial damage to have them stop reporting and even to withdraw already published material. The rationale of such actions is, of course, not to establish wrongdoing or actual libel (that would take years of legal procedure all the way up to the European court of human rights), but to strategically use the law to construct a financial threat that already at the preliminary investigation and  hearing phase undermines the practical possibility of further critical inquiry, as the very economic cost of the legal process itself (regardless of its outcome) will often be impossible to bear for independent inquirers. This, of course, adds to the reason of the tainted researcher to have the tooth paste back into the tube before Big Media gets a whiff, as those would have the financial muscle not to be liable to these kinds of bullying tactics.

Photo source:

A recent example is the German team of Thorsten Walles and Heike Walles (formerly Mertsching) at the university hospital of Wurzbürg, who have recently taken action against critical science blogger Leonid Schneider, who runs the blog For Better Science. Citing their fundamental legal right to be able to freely use their talents ( ≈ pursuit of happiness) – in this case meaning, having successful scientific careers, being able to have better salary, accrue research funds, get new jobs, etc. – they have demanded that Schneider stops reporting about their past experimental trachea transplants, and also won an emergency court injunction that threatens Schneider with jail unless he removes a section of a Macchiarini-report, where the link to the Walles-team is made explicit, and to pay the legal fees for the process leading up to this result. The court order has been made without any hearing of Schneider's side of things, and this is apparently (possibly) OK under German civil law, as he has the right to appeal (provided he can raise the money to pay a lawyer). Schneider has, of course, accepted the injunction and removed the paragraph awaiting an appeal, as can be viewed in this updated version of the original post (linked above), with the relevant section as screenshot here (double click to enlarge):

The original section (cashed here) looked like this (the removed paragraph highlighted by me):

The action has been discussed extensively in a Twitter thread, to be found here. There, among other things, it is made clear that the Walles trachea surgery experiments – like those of Macchiarini – have been retrospectively found to be against European regulation. Moreover, it seems that the information that the Walles so desperately want to be removed from public view is essentially already available for any curious German, through the book Patient meines Lebens – Von Ärzten, die alles wagen by prized journalist Bernard Albrecht, cited by Schneider in his blog post.

I can, of course, acknowledge the vested self-interest of the Walles to suppress publicity around their past Macchiarini-association, and the fact that they apparently have performed very similar type of irregular trachea surgery experiments as he did at the Karolinska. However, it is clear that there is an overwhelming public interest of having this information publicly available – not only in Germany, but internationally; for potential employers, funders and – not least – patients, who have every right to avoid the risk of consulting a doctor that may make them into guinea pigs in irregular experiments.

Had the Walles acted out of honest and honourabe scientific and medical professional motives, they would, of course, have seen to this themselves long ago, initiating and welcoming transparent inquiries and press reporting the very minute that the Macchiarini scandal emerged. Instead, they have done their best to blinker the public and has, ultimately, resorted to petty threats against those trying to make public the professional actions for which they are, without doubt, responsible and which there is an overwhelming public interest in having open to public view. This course of action, especially the court order to Schneider to censor his past posts, makes it highly likely that this is the path they will continue to thread. Leonid Schneider will undoubtedly do his best to fight back, but as the basis here is financial muscle, not moral or legal righteousness, it is unlikely that he will be able to (afford to) prevail, and the Walles of course know this. Here are the actions those who disapprove of this development can take to make their dishonourable actions moot:

1. Continuously report in social media about the Walles' legal bullying of Schneider (and others), taking every piece of news about the processes as a reason to recite the details of their Macchiarini-association, their experimental surgeries, etc., thus keeping this information in the public domain.

2. Link to existing cashed versions of the original reports. However, it is likely that the Walles will take action to have these scrubbed, so therefore it is also desirable to:

3. Reposting the original, uncensured blog posts on public Google+ and other pages, blogs, etc. I have done so here (uncensured Macchiarini post), and here (detailed post on the Walles history of human experimentation).

CROSSPOST: Untangling forgotten tracheal transplants of Heike and Thorsten Walles, who set a lawyer upon me

This is a crosspost of the original, uncensored version of a post relating facts and developments related to past surgical human experiments by the German researchers Thorsten Walles and Heike Walles, linked to scandal surgeon Paolo Macchiarini, from the For Better Science blog. The crosspost has been prompted by legal threats having forced Leonid Schneider to remove relevant details regarding the German researcher team from another post, making it likely that such claims will be extended also to the article here crossposted. More details and background on how I view this development can be found here.

A similar crosspost has been made of the For Better Science post on Macchiarini that the Walles have already managed to bully Schneider into censoring, and is available here.

*** BEGINNING OF CROSSPOST (All of this is citation, of the original version of this post by Leonid Schneider):

This is the story of three tracheal transplants, performed by the husband and wife team Thorsten Walles and Heike Mertsching (now Walles), former collaborators of Paolo Macchiarini. My investigation quickly led to the Walles couple setting their lawyer on me, demanding almost €3000 immediately and up to €100,000 later. All because of a single short paragraph from this Macchiarini story, which mentioned their earlier activities. None of their current or former employers nor their lawyer chose to share any specific information about the 3 tracheal transplants, and the fate of these 3 patients.
Macchiarini and the Walleses started their tracheal transplant activities at the Medical University Hannover (MHH), under the regenerative medicine enthusiast Axel Haverich. Together, the team implanted in 2003 a tracheal patch into a cancer patient using a piece of pig intestine, and moved their separate ways soon afterwards.  Macchiarini went in 2004 to Barcelona, where he had his famous trachea transplant breakthrough in 2008 (see my report here). The Walles couple went in the same year to Stuttgart in southern Germany. The thorax surgeon Thorsten to the Robert Bosch Hospital, Clinic Schillerhöhe, the regenerative medicine-specialising biologist Heike (back then carrying the name of her previous husband, Mertsching) became professor at the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB). There, the husband and wife team transplanted between 2007 and 2009 two more patients with tracheal replacements made from pig intestine. The clinical success and the actual performance of these transplants is unclear, it is also not helpful that authors chose to omit certain key aspects when the two cases were eventually published.

Heike Walles developed at her Fraunhofer Institute a technology to grow any kind of tissues and even organs in her high-tech safety bioreactors: skin, liver, intestine, bone and of course the trachea, all according to this scientist and her husband, with its own bioreactor-grown vasculature. This is how the technology works, according to Thorsten Walles as posted on ResearchGate:
“We developed a bioartificial tissue (TraVaSc-TERM ®) for the surgical reconstruction of extensive tracheo-bronchial defects including circumferent airway replacement. The tissue is generated from a xenogene biological scaffold [pig intestine, -LS] that is decellularized, preserving the structure of the vascular network. For transplant generation, these vascular structures are reseeded with autologous endothelial precursor cells of the recipient. Two more autologous cell types are needed to generate a functional airway substitute. Our approach results in a vascularized autologous transplant tissue that can be connected to the recipient’s blood supply at time of implantation to guarantee transplant survival. Tissue generation takes about five weeks. The TraVaSc-TERM ® was applied successfully in three patients between 2006 and 2009 [actually, it seems one patient was counted as two, -LS]. As a result of the ATMP-legislation in Europe the TraVaSc-TERM ®-generation process had to be transferred from an F&E environment into GMP. This task was finished in 2015 and we wait for regulatory approval”.
After her 3 allegedly successful tracheal transplants, Heike Walles became a member of the German Ethics Council (Ethikrat) In June 2010 and served the nation by safeguarding patient protection and medical ethics in Germany until September 2012. Mightily impressed by her research achievements, the federal state of Bavaria dumped in 2014 €10 Million over Heike Walles and invited her to head the new translational centre for “Regenerative Therapies for Oncology and Musculoskeletal Diseases” in Würzburg. The new director remained affiliated with her Fraunhofer institute, but additionally became in August 2009 professor at the University Clinic Würzburg. Her husband Thorsten received a professorship at the same place in January 2012. There, the couple began to collaborate with the technology giant Siemens and are apparently almost ready to churn out tissues and organs to save hundreds of patients, based on their previous success stories. As Walles’ co-worker Jan Hansmann from Fraunhofer declared in Siemens-magazine article from September 2016:
“Hansmann describes one of the major successes of tissue engineering in Würzburg: “Working with the University Hospital and the Robert Bosch Hospital, we recently produced a complete section of a human windpipe in the bioreactor and successfully implanted it into a very seriously ill patient as part of a ‘compassionate use’ program.” In fact, no other research group in the world has to date produced such a complex biological implant”.

Silent night

The case of that and other two tracheal transplants was very tangled. At points, my perception was that the publicly owned German research institutions deliberately wanted me to follow false leads I picked up on internet, in order to discredit my reporting. Indeed, the fact that the Walleses used their official University Clinic Würzburg affiliations in the lawyer’s letter suggests an involvement of their employer, who received (but never really answered) my questions 2 weeks before my previous article appeared. That would be indeed an interesting new way for a German university to react to a blogger’s inquiry.
The current Walles employers, University of Würzburg and the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB) chose not to share any useful information with me. Würzburg categorically denied their University Clinic’s involvement in the operation described by Hansmann above, Siemens magazine refused to explain and Hansmann never replied to my email. Thorsten Walles’ former boss, head of thorax surgery at Schillerhöhe Clinic in Stuttgart, Godehard Friedel, who co-developed the technology, forwarded my email to his PR spokesperson, who refused to share any information citing protection of patient privacy. Thus, no thanks at all go to them. In the end however, I think I could reconstruct the three trachea transplants made by the Walles couple quite truthfully.
It got that bad that the press relations offices of the Fraunhofer IGB, whose job it is to promote the institute’s research and publications, repeatedly refused to name me the papers where Walles’ three trachea transplant patients had been described. I found those anyway, and I also found out that some very important aspects have been omitted from the publications. Small issues like the suspected failure of the transplants, or these patients being long dead at the time when the papers were published.
The same Fraunhofer PR officer Claudia Vorbeck who denied me any information whatsoever, also by insisting that the federally-sponsored public research institution is exempt from Freedom of Information inquiries, authored in 2009 a press release hailing one of these Walles trachea transplants (see 3rd patient  below). All I was made understand was that the Fraunhofer Institute takes enormous pride in the research of their professor Heike Walles:
“Prof. Walles develops and uses methods of tissue engineering to produce the most diverse, complex human tissues that are used for risk assessment in chemical and pharmaceutical research as well as in regenerative medicine. Prof. Walles and her team use biological carrier materials for the production of these human tissues. In the course of her research at the Fraunhofer IGB, Prof. Walles has developed a biological matrix consisting of a decellularized pig intestine as a scaffolding structure for a potential trachea implant”.
Vorbeck then added:
“The research work of Prof. Walles for the development and production of trachea grafts on a biological matrix was carried out at the Fraunhofer Institute IGB according to the requirements of the German medicinal product ( The authorities responsible in this context were always involved in accordance with legal requirements. These authorities also have all the necessary documents on good scientific practice, such as ethics or animal welfare applications”.
The University of Würzburg refuse to comment on anything which happened before Walleses became their professors. At least I managed to get this out, after some yanking:
“The professors Walles declare that the cooperation with Mr. P. Macchiarini ended already in early 2005. The last common publications stems from the year 2006“.

The first patient, or Macchiarini-led kick-off in Hannover

I reported previously about this Macchiarini operation in my article about his patients. As the local newspaper, Hannoversche Allgemeine Zeitung (HAZ) reported on September 6th 2003, Macchiarini and the Walles couple transplanted the cancer patient Ernst Fromhage with a tracheal patch of decellurised pig intestine seeded with patient’s own muscle cells. The intervention was published as MacChiarini (sic!) et al 2004 and the method as Walles et al, 2004. Macchiarini is corresponding author on both publications and thus the principal investigator chiefly responsible for the development of that technology. However, Thorsten Walles claimed the credit in a 2009 interview for himself and his wife:
„In 2003, I specialized in thoracic surgery for my surgical training. Here, I first met patients with tracheal injuries that could not be treated anymore. I was able to convince my then-boss Paolo Macchiarini of the concept of treating such injuries with bioartificial tissues. Together we modified the procedures for the production of human bioartificial tissues for trachea transplants, originally developed by Prof. Mertsching and myself. Already in 2004 we were able to successfully treat the first patient”.
Not everyone was impressed. The famous late thorax surgery specialist Hermes Grillo took an issue with this method (Grillo, 2005):
“One must also question placement of a free graft of any tissue over an area that is still contaminated, even if not grossly infected, by the bacteria that necessarily are present in such a situation, despite all cleanup treatment before repair. More to the point, however, is the fact that defects of this sort have long been closed by vascularized pedicled autogenous tissues (omentum, pericardium, intercostal muscle, and other muscle flaps). Addition of an engineered tissue graft seems superfluous”.
Yet according to Walles, the 2003 operation on the patient Fromhage in Hannover was a success for regenerative medicine:
“The implant healed easily into the airway and there were no problems. The patient lived for 16 months a self-determined life. Unfortunately, his cancer caught up with him and he died”.
Now it makes sense why back in spring 2016 the Hannover hospital refused to share with me any information about the fate of that patient, claiming that his medical records were not available.

The second patient and his half-story

Of the second patient, a 63-year old man, we do not know the name, and we do not know exactly what kind of transplant he received. This is what the 2013 book by the German journalist Bernhard Albrecht, “Patient of My Life” in its chapter “Breathing” (see Google-Books version), tells us about Walles’ tracheal transplants:
“Twice they operated patients whose windpipes were corroded by cancer. Both did not live long after the operation. The first patient [Fromhage, operated together with Macchiarini in 2003, -LS] died on his main disease, but the second one began to question all their efforts. The artificial trachea rotted namely inside his body. The fault lied with the absence of own blood supply in the artificial tissue”.
As Walles lawyer made clear, the artificial material was not plastic, where “the blood supply does not function”, but based on a biological scaffold. But the lawyer did not specify how the capillary blood supply inside dead decellurised scaffold is supposed to succeed. Macchiarini and his partners in Spain, Italy and UK transplanted many patients with such, using decellurised donor tracheas. It seems all these transplants either rotted and collapsed or were overgrown with scar tissue, unless you trust those authors’ own claims of vascularisation and full regeneration. It would be nice to know more about Walles’ pig intestine transplant and how it fared inside that 63-year old man’s throat, but alas, this is none of public’s business apparently. There was however this very informative interview from 2009 with Thorsten Walles with the German magazine The Stem Cell (Die Stammzelle):
“Dr. Walles: The technology was ready for operation from 2007 onwards. In the same year a patient with a combined injury from the trachea and esophagus was arrived to us from another clinic. The 63-year-old has been unable to eat, drink or speak for three years. He therefore had a tracheostomy and took his food through a stomach probe, which was introduced through his nose. In the 3 years, a total of 14 surgeries were performed by the various clinics on the patient in order to close the defect. Unfortunately, all unsuccessful. A surgeon who treated this patient had heard of our new procedure and referred the patient to us.
The stem cell: And you implanted a piece of the air tube?
Dr. Walles: Not immediatedly. Due to the large defect, it was necessary to use an implant with its own vascular supply. We had never done this before in a human being and we were honestly afraid to use these new implants in the chest and risk that they would fail and cause serious complications.
The stem cell: So what did they do then?
Dr. Walles: We grew a bioartificial tissue as we needed it for the repair of the airway defect and implanted it into the left upper arm of the patient.
The stem cell: Why exactly there?
Dr. Walles: The blood vessels in the upper arm are easy to reach and do not require any major surgery. We have connected the graft to the upper arm vessels with two microsurgical vascular anastomoses. After one week we removed the transplant again and it was examined by the researchers in the Fraunhofer IGB.
The stem cell: Why?
Dr. Walles: We wanted to make sure that the artificially produced vessels work in the implant and that the transplant does not die. We have therefore clinically checked whether our implant has the function we expect at all. We also wanted to ascertain whether there were any side effects, such as, for example, inflammatory reactions occurring after rejection. We had prepared a second implant for the reconstruction of the airway and esophageal end defect, which would be ready for use 1 week after explantation of the arm implant. So we had 1 week to prove how well our technology works in humans. For this the researchers at the Fraunhofer IGB had to do night shifts. The studies showed that the transplant was fully functional even after one week. The results have now been published in the scientific journal Transplantation”.
The paper appeared as Mertsching et al 2009, but it never mentions that the one-week in-arm experiment was followed up by the actual trachea transplant into the throat. Surely that bit would have been most interesting for the worldwide community of thorax surgeons and stem cell researchers? According to Heike Walles presentation to the German Ethics Council, the transplant was “fully functional over a short period of time”.
When the Mertsching et al 2009 paper was published and when Thorsten Walles gave that interview to “The Stem Cell”, the patient had been dead for almost 2 years already. This was indirectly suggested by Heike Walles’ Ethics Council presentation, confirmed by the 2013 dissertation of her PhD student Iris Dally (page 126), as well as by a press release of the state of Baden-Württemberg from October 2008 which quoted Thorsten Walles:
“Walles does not want to rush: “We want to approach the clinical application of this method slowly.” Despite all the initial successes, transplantations are still an experimental and risky intervention. There will always be setbacks. The last patient implanted with a piece of bioartificial tissue died a few weeks after surgery as a result of unexpected complications”.
Whatever their reasons to be modest, the ground-breaking tracheal replacement operation and the ensuing unexpected demise of the patient were omitted in the Mertsching et al 2009 article. What lead to his death? In his available interviews, Thorsten Walles never mentioned anything about cancer (but the Albrecht book did, see above), only a physical injury to the trachea and oesophagus, and everyone involved refused to divulge any information. It is not clear therefore why the patient died so soon after a piece of pig intestine was inserted into his chest as his new breathing tube.

The 3rd patient and another puzzle around the transplant

The interview in The Stem Cell is from August 2009, yet Walles does not mention his 3rd patient, the Indian Pavninder Singh, whom he and his wife transplanted just half a year before with a “regenerated” piece of pig intestine. Not a single word. Instead, Walles speaks of new European regulations and changes in German medicinal product regulations, which stopped his big plans:
“In July 2009, we received funding from the German Federal Ministry of Education and Research (BMBF) (FKZ 0315575) to fund a clinical trial for the treatment of patients with tracheal and esophageal defects with our bioartificial transplants. First, we must provide the regulatory authorities with the information they need in order to get a manufacturer’s license at the end. Our aim is to obtain a European approval for our bioartificial tissue implants within the framework of the study”.
The trial obviously never happened, lacking approval from authorities. The Walles methodology suffered a major setback when the new German medicinal produce legislation (Arzneimittelgesetz) became officially binding on July 17th 2009, less than three months after Walleses performed the third (and apparently last) trachea transplant. According to Albrecht book, the investigations by the authorities into suspected breach of regulations were therefore aborted.
Singh originally came to Germany illegally, but integrated quickly, married a German wife and learned German language. On December 9th 2008, the young man in his twenties attempted suicide by swallowing oven cleaner fluid. Singh survived, but his oesophagus and trachea were damaged irreparably. He had to be saved by tracheostomy, a permanent hole in his throat. Because of his burned epiglottis, the patient had to keep an erect posture at all times to avoid stomach acid flowing into his airways and lungs. In April 27th 2009, Singh received a tracheal transplant from the Walles couple, fashioned from pig intestine. This is how the University of Würzburg described the breakthrough achievements of their new professors:
“Thorsten Walles and his colleagues carried out the successful transplantation of the replacement trachea at the Schillerhöhe Lung Clinic in Gerlingen near Stuttgart in April 2009. The artificial organ was accepted by the body without rejection and adequately supplied with blood. Unfortunately, after this encouraging world premiere, the further development and dissemination of the procedure has been stalled due to European changes in the drug legislation”.
Now however, the PR person of the University of Würzburg, Esther Knemeyer Pereira replied to my inquiry that all three tracheal transplant operations by Walles took place before 2009, and had nothing to do with the university or its clinic. At the same time, the Würzburg professors Walles operated until 2014 a personal website “Bioartificial organs”, where patients were invited to contact Thorsten Walles at Clinic Schillerhöhe about “bioartificial implants for reconstructive thoracic surgery” (screenshots of the website here). This might explain why my inquiry if further tracheal transplants are intended in Würzburg went unanswered. Meanwhile, a legal action against me was being prepared.
What Walles or their academic employers never ever mentioned: Singh’s trachea transplant most likely did not work. Shortly after the operation, Walles re-opened the tracheostomy, the hole in the throat remained until Singh’s suicide death in December 2011. This information is only available in the Albrecht book (“the hole in his throat was his misery”), because the author met the patient personally in November 2011, shortly before Singh’s accomplished suicide:
“Why does he need the hole [tracheostomy, -LS] still? Dr. Walles initially closed it, told Singh. But then he had always been chocking, food and saliva entered the windpipe. The oven cleaner had also corroded the epiglottis in his throat. Due to heavy scarring, it did not close properly when swallowing.”
We do not know for sure if the transplant integrated as announced, but given the tracheostomy, it was unlikely to be of any use even if it did. Heike Walles declared to the Ethics Council in 2010 that the patient Singh “has no problems whatsoever”. Also her lawyer now sternly told me:
“The patient described in the book by Mr Albrecht lived self-determined life over a long period of time after the operation”.
No mention of tracheostomy, again, but the lawyer did declare that all information in the Albrecht book was correct. Thorsten Walles himself spoke in a 2014 interview (which was recently removed from the BioRegio-Stern website, backup copy here):
“We have used a method for the treatment which we have been researching on since 2000 and where we already had initial successes in the application. Since the patient wanted the treatment and we also had the impression that he can make it, we grew a trachea from the cells of his body and implanted it successfully. Unfortunately, however, this has not improved his private situation and a few years later he then took his own life”.
Asked about Singh’s suicide despite the miracle cure which allegedly restored his health, Walles elaborated:
“In the first moment, this pulled the ground from under our feet. We asked ourselves why we carried out this elaborate treatment in the first place. This experience prevented us so far from publishing our scientific results of the applied technology, because we were questioning the rationale of the treatment in this case”.
The next year however, a paper was published which described a patient case perfectly fitting that of Singh. With one exception: the patient in Steinke et al, Tissue Engineering Part A, 2015, is seemingly alive and well. Where Singh killed himself 2.5 years after the operation, his published doppelgänger was examined just after the same period and was found that he “could eat and drink normally and was also able to play soccer”. No tracheostomy was mentioned, instead:
“The early postoperative course was uneventful and the transplanted airway tissue was integrated into the host. 2.5 years after transplantation, a bronchoscopy confirmed the scar-free reconstruction of the former airway defect. Histological work-up documented respiratory airway mucosa lining the bronchial reconstruction, making it indistinguishable from native airway mucosa. After transplantation, our bioartificial airway tissue provided perfect airway healing.”
Was it indeed a biopsy as the authors report, or possibly an autopsy of a suicide victim? I tried to find out from the paper’s authors if the patient was indeed Singh. Walles’ PhD student Dally (who herself declared Singh as dead in her dissertation), threw down the phone on me, the corresponding author Maria Steinke, Chair of Tissue Engineering and Regenerative Medicine in Würzburg, did the same after telling me she is not entitled to comment. The Fraunhofer PR person Vorbeck declared to me that the responsibility for the content and correctness of the two discussed Walles publications featuring Fraunhofer affiliation lied predominantly with the clinicians who treated these patients. But not with Fraunhofer or their own scientist Heike Walles, who according to Vorbeck never performed any “human experimenting”.
In that Steinke et al, 2015 publication, the authors state that they did not replace a segment of trachea, but introduced a large pig-intestine-made patch of “membranous part of the trachea”. This is strange, all other sources (like this Spiegel magazine article from 2011, or even Fraunhofer own press release) clearly suggest a replacement of the tracheal tube, not a patch. What did the second patient receive then, the one who died so soon after the operation? The corresponding Mertsching et al 2009 paper clearly showed a tubular piece of pig intestine. Yet all information is kept secret by the Fraunhofer Institute, the Clinic Schillerhöhe and the University of Würzburg. Also the Walles lawyer does not speak of that unlucky 63-year old man at all.

Clinical trial cancelled?

A scheduled clinical trial with 5 patients, funded since July 2009 by the German Federal Ministry for Education and Research, and to be carried out at Clinic Schillerhöhe (see 2013 Dally dissertation, page 139) was apparently not approved and never performed (Heike Walles spoke of 15 patients in her Ethics Council presentation in 2010). A tragedy, certainly for the Fraunhofer Institute and their clinic partners, maybe less so for the patients.
After the hype, these alleged successes became almost forgotten. In 2010, Thorsten Walles received a Von-Langenbeck-Award of the German Surgery Society (DGCH). The press release mentions only the first patient from Hannover, the merits are shared with Heike Walles. Paolo Macchiarini, the corresponding author of that publication, is someone whom the Walleses seem to be most reluctant to be associated with, as also the lawyer’s letter made clear.