Monday, 21 May 2018

Highly Problematic Stance on Fake "Antivaxx" Authorship By the Indian Journal of Medical Ethics


It is a recognised challenge of my research field, bioethics, to include and empower researchers and institutions from low- and midlle-resource settings. Since a few years, the leading journal of Bioethics, runs the side journal Developing World Bioethics to address this issue, and over the past few years a number of journals have appeared, based at institutions outside of the most affluent parts of the world with a natural focus on bioethical issue of relevance to such settings, as well as global health related issues. One of these is the Indian Journal of Medical Ethics, that has quickly been rising in the ranks and attracting respect for its consistent work.

However, very recently the IJME has been dragged into potential scandal. First, the editor, Amar Jesani, decided to publish an article by a fake author, claiming fake credentials and affiliations, of an obvious antivaxx junk article of the sort that antivaxxers – just like tobacco-industry sponsored scientists used to do regarding the dangers of smoking – are constantly trying to peddle to various journals to create an image of "scientific controversy" around the use of vaccines to fight infectious disease and build public health. The fakes were all very easy to detect, and already the fact that the "author" was not using the email-domain of, and has no profile at the webpages of, the institution (Karolinska Institutet) to which he claimed affiliation should have rung immediate alarm-bells. But then, when this is pointed out, and the journal is alerted to this research fraud, the editor Amar Jesani decides not to retract the article! Instead, the editor appears to have decided to trust the author's obviously bogus explanations for his (?) fraud, and to attempt to counter a, to my mind, quite sound statement on the matter from the Karolinska Institutet president, Ole-Petter Ottersen.

The bogus explanations and Jesani's expression of sympathy with them, and Ottersen's stringent response, is to be found here. This very surprising and ill-conceived action of Jesani is potentially extremely damaging for the IJME, and in effect risks to soil the reputation of the entire field of bioethics. The fake author's attempt at justifying the fraud is that he/she has to be anonymous to protect him-/herself from persecution for unpopular views. This, of course, is not even worth the scrap of paper it was scribbled on. The real role of the fraud is to block any investigation into conflicts of interests (the antivaxx movement is nowadays a flourishing industry of quackery), other activities of the author that would undermine confidence in the article's content, and the fact the author lied to the editor, and offered the explanation only in retrospect when the scam had been uncovered should, of course, mean that the editor should have no trust in what the author is claiming. This is a proven fraudster, and should be treated as such. Just as authors lying about ethics approval should have their papers taken out, authors who lie about other things of relevance to the evaluation and assessment of the research have their papers removed. As Ottersen says in his second blog post: an editor of an ethics journal should know this. The editorial board of the journal should immediately and strongly recommend its editor, who has obviously let his personal prestige lead him astray in this matter, to revise his position and act according to the high publication ethical standards expected of a bioethics journal that aspires to be well regarded.

Let me, lastly, comment on the possible need for author anonymity for research articles. The afterconstructed reason brough forward by the fake author and that Jesani surprisingly buys, is the idea that is often practices within news reporting. Where, eg., a newspaper may protect sources by keeping them confidential. However, that also means that whatever story is built on this, needs to present suffient additional public evidence, that is open for scrutiny, in order to compensate for the loss of control following source anonymity. This has not taken place in the case of the fraudulent article. Also, the whole spinn about author/source confidentiality is obviously a lie in the present case: Had the author had any such plan, he/she would have honestly and openly contacted the IJME editor about it, and Jesani could have pondered - bringing in the editorial board - the issue. Had they decided to approve such a request, this would have brought with it extraordinarily strong obligations to check the author credibility, CoI, etc. This is not what occurred, however. What occurred is that a con-man defrauded the journal, and the journal editor then decides, against any common sense, to trust said con-man. Unbelievable!

****

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. ***