Welcome Retraction Decision from the Indian Journal of Medical Ethics, and Hopefully Future Policy Revisions to Be Announced

I have posted two times (here and here) about the deeply misguided decision by the editorial management team of the Indian Journal of Medical Ethics not to retract a fraudulent, obviously "antivaxx" propaganda piece, article. On invitation, I have also summarised my opinion on this matter at the Daily Nous philosophy blog. In all of these posts, I have strongly underscored the otherwise very promising track and strong reputation of this journal, the importance of this for the critical place of global health and developing country perspectives in bioethics scholarship, and my strong wish for a revised course by the IJME editorial management. It is therefore with the greatest satisfaction I have been reached by the news that the same management has now revised its judgement, and decided to retract the article in question, inviting publicity also from the widely read Retraction Watch blog.

The retraction note is rather brief, but open and honest, and it speaks well of the integrity of the editorial management that it does not try to hide its own mistakes, or that the retraction occurred only as a result of pressure from the journal's editorial board and external commentators. It signs off by promising further elaborations in coming editorials. My hope is that these will set out clarified policies and routines that ensure that the journal in the future will keep strictly within its own declared area expertise and scholarship of "all aspects of healthcare ethics and the humanities, relevant to and/or from the perspective of India and other developing countries". This simple policy will save the IJME from any further scandals of the sort it has just escaped, and be a pillar for what I hope will be a further positive route of development of this otherwise excellent journal.

However, on one point, I strongly disagree with the position set out by the editorial management, and that is its apparent decision to continue to hide the identity of the proven fraudulent author that used to call him-/herself "Lars Andersson", falsely claiming affiliation to Karolinska Institutet. The editors are hereby promoting further research fraud by this person, undermining both other journals and research institutions from protecting themselves against this person's future activities. It also impedes appropriate disciplinary action to be taken by the academic or other institution to which the person formerly known as "Lars Andersson" is indeed affiliated. Finally, it impedes any analysis into the vested or other conflicts of interests linking to this person's activity to attempt to peddle fraudulent antivaxx articles. The argument by the editors, that it has promised the author to keep his/her identity a secret is not only invalid. The action makes the editors complicit in any further research fraud undertaken by this person. The promise itself is morally void, as the editors had no business making it in the first place, their primary obligation being to the research community, and not to proven research fraudsters. It is my sincere hope that the further elaborations on editorial policy promised, possibly by help of further dialogue with the journal's editorial board, will lead to revision of judgement also regarding this particular point.

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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!

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Pharma Corps put Money Before Swedish Women's Health, But Why Be Surprised?

Today, the Swedish branch of the international pharma corporation GlaxoSmithKlein (GSK) announced that it will appeal the decision of the united health care regions of Sweden to use the vaccine product of their competitor Sanofi Pasteur MFD (SP), Gardasil, over GSK's Cervarix. The decision is another stalling maneuver in a longwinded process following the decision of Swedish public health authorities to provide young girls and women with a publicly run vaccination programme against Human Papillomvirus (HPV) – causing both cervix cancer and STD's, such as condyloma. It is unknown how long the processing of the appeal will take, but the financial director of GSK in an interview alludes to an earlier court process (see below) that took about 18 months. Thus, due to GSK's decision today, during this time-period potentially all Swedish young females will be provided with no protection against HPV. Possibly, some of these will buy a vaccination with their own money, but that can hardly be credited  as an upside to GSK's decision, given that they could instead have received it for free.

However, this is not the first appeal in this story. In fact, the decision that GSK is now appealing is the result of a former appeal that SP made against an earlier decision to purchase Cervarix. Also in that case, the material effect of the appeal was endangerment of many, many young women's health. Both companies of course argue that their product is the best, but that's just smoke. What they do is to repeat their sales pitch, but now publicly rather than in the original business bid. In the case of GSK, they even have the poor judgement and tasteless arrogance of trying to present their bid as objective argumentation in a debate article. Come on! The assessment of these bids is the business of the buyer, and if the buyer makes a bad decision, that's where the responsibility is to be placed. However, the buyer of a large public health policy order has many things to balance. Of these the effectiveness of the product is, of course one. But effectiveness is a complex matter and in the case of HPV very much so, since different strands of HPV link to several different health problems. In addition to that, the expected effect has to balanced against the cost. This since, at the end of the day, every Swedish Crown spent unnecessarily is a crown that could instead have been spent on other important public health undertakings. Given this situation and given that all information from the bid-makers have their basis in the self-interest of a business organisation (which in the case of becoming a part of a large public health undertaking is huge), the argumentation like the one presented by GSK today is simply not credible. Of course, they have to say that they believe in their product, just as SP has to. But so what? Regardless of this, the buyer has to make an assessment and a decision. What the appeals create is only that this procedure has to be done all over again, the first time by the buyer (according to procedures prescribed in Swedish administrative law), and this last time by a court of law. In neither of these cases will the repetition of GSK and SP of the claim that their product is the best one mean anything. The whole process is so absurd, that the responsible politician for the process of buying the vaccine, Stig Nyman, today urges the government to change the regulation around purchase of health products by the public sector, so that the armies of lawyers of the pharma corps are barred from obstructing orderly processes of great benefit of the public to proceed. Similarly, in Sweden's foremost politically conservative news paper, Svenska Dagbladet, otherwise notorious for its overly charitable interpretations of the intentions and doings of private enterprises, the deadly outcome of GSK's decision is underscored and the analysis is made that the pharma area of business is in fact nothing but callous, inconsiderate and deceitful.

Now, GSK has realised that the decision to appeal yet another time does not put the company's image in a very good light and therefore tries to give an impression of having taken the decision greatly troubled and burdened by ethical considerations. All pharma corps nowadays do their utmost to project such an image of caring about the health of people and minding about ethics, and GSK is no exception. However, is this more than mere branding (a question that applies to SP  just as much, of course)? One of my department's most successful young researchers, Joakim Sandberg, wrote his PhD dissertation Ethical Investing: Making Money or making a Difference? (and numerous papers) on the issue of how much the projected interest of being "ethical" used as a marketing tool by companies in different branches (using the case of investment funds) is grounded in any substantial ethical commitment. The sign of such a commitment is double: (1) that the company has a clear, publicly accessible and plausible idea of the criteria for acting ethically defensible (most of the book is about what that implies) and (2) that this idea at least sometimes is actually motivating the company to make decisions that are less than optimal in business terms. Simply put, if you are not prepared to sacrifice anything for your ideals, you effectively have no ideals. Not surprisingly, perhaps, it appears that the examples of business operations projecting the image of being especially ethical and at the same time meeting condition (2) is a rare species indeed.

In the pharma area, there are numerous examples of this phenomenon. In fact, the list of cases is becoming so long and depressing that the mechanical repetition of the public relations departments of all of the pharma corps around the world that good ethics is a key endpoint of their enterprise is starting to sound like the gibberish of a mad clown who no one think is funny anymore. Just a few years back (before I started this blog, or you would have read about it here), Astra-Zeneca was exposed in a major research ethics scandal,  where they had deliberatly chosen to conduct a clinical trial of psychiatric drug in a country (Russia) that insisted on a placebo arm of the trial, although an existing efficacious treatment was in place. In effect, half of the participants were left with no rather than some treatment and a number of suicides had to occur before A-Z had the sense to abort. What is more, they did this not in order to have a license for the drug in Russia, but to have it in the EU. I and several bioethics colleagues in my country had no problem in harshly criticising A-Z (here, here) and the lame response from A-Z was that they indeed were an ethical company, since they had abided by Russian research ethical regulation - thus pretending that they carried no responsibility for having chosen (obviously for economical reasons) to house the trial in Russia in the first place. This is just one among many, many cases of what in bioethics circles has become known as clinical trial imperialism. Simply put, Western pharma corps systematically try to place their trials of new drugs in countries where the trial will be most cheaply run while still providing results that may get them a license somewhere in the West. As to upholding minimal standards of human subjects protection, reliable oversight and accountability – sod that!

So, to get back to GSK, SP and the HPV vaccination business. What we see happening in this case is just more of the same. Sweden just like all other Western countries are using tax payers money to provide pharma corps with very privileged positions: patent systems, drug subsidises, seed money to ease the establishment of offices and labs, access to the resources of medical schools, university hospitals and public health care systems, close cooperation to smooth the product development process, and support for a market for non-prescription drugs that in most cases actually is detrimental to the health of the population. They do all that because they see no alternative. The development of new pharmaceuticals for serious and widespread disease is a high risk endeavor and very expensive process, and most countries prefer to have it done with the funding accessible through business transactions. But this is no reason to be seduced by their marketing offices. Pharma corps don't care about anyone's health and even less about public health. In fact, the best business sitiuation for a pharma corp is a permanent health problem that never goes away, but where the company can supply a product that slightly mitigate the symptoms. That's far, far better business than anything that cures people or – to name the nightmare of a pharma – that permanently prevents the onset of the problem. Even less do they care about ethics or upholding minimally decent ethical standards. They demonstrate this convincingly by never ever being prepared to sacrifice a buck for adjusting to ethical considerations of any weight. They do, of course, abide by laws, but prefer to place production in countries where efficient industrial operation is combined with the most allowing rules – unless sale efficiency demands otherwise. They do, on homepages and in company prospects, repeat the words "ethics" and "ethical" (as well as "responsible") so often that the cursory reader might mistake them for something out of the Vatican, but, as the Swedish case of GSK and SP regarding HPV vaccination shows, all of this is smoke and bogus. All. That is not a very comforting thought, and in light of our view of pharma corps as necessary, that discomfort may trick us to believe otherwise. But this is, I claim, the sole truth.