Monday, January 29, 2018

VW, Mercedes, BMW and those experiments

So, the three largest German car manufacturers are for obvious and for good reasons targets of everyone's scorn these days. VW in particular is known to have manipulated its diesel engine equipped cars so that when they were tested the engines were relatively clean as far as their nitrogen   oxide pollution is concerned. Once on the road these cars actually generated more pollution than many trucks. In 2012 reportedly over 72 000 Europeans died prematurely because of nitrogen oxide pollution caused by these cars. No argument there.

VW, BMW and Mercedes (Daimler) set up a research outfit designed to investigate the impact of this pollution on humans and the environment. As is the case with these sorts of agitprop outlets, they have an impressive name. The European Research Group on Environment and Health in the Transport Sector it was. The cigarette manufacturing industry had a similar research institute, its aim was, of course, to show that cigarettes have not been shown to cause cancer, and to produce citable evidence (ideally published in scientific leading journals) for the industry's lobbyists.

As is usually the case, there was a whole gaggle of university professors more than willing to lend their names to that enterprise, and so were prestigious research institutes, attached to universities. They accepted contracts from the German car industry research outfit. Among their research were two kinds of trials that are widely condemned today, albeit for reasons that are not quite obvious, at least not when it comes to the trial involving human participants.

The first kind of trial include 10 monkeys. They were put in an airtight room  where they watched cartoons. Meanwhile exhausts from a manipulated VW Beetle with a diesel engine were pumped into the room.  That was then compared against the missions of a 1999 Ford engine.  The finding propagated at the time by the industry research outfit: Diesel engine exhausts, even in high concentrations, do not cause lasting damage to monkeys.

The main criticism mounted against this research (apart from the obvious question whether it is ethical to subject monkeys to that kind of research in the first place - a very reasonable criticism that I think is persuasive) seems to be that we knew already that these exhausts are dangerous, so the companies should have better focused on reducing emissions rather than on trying to show that they're not a health risk.

In any case, the research was based on a fraudulent set-up, the monkeys were subjected to nitrogen oxide concentrations far below what VW diesel engines emitted at the time in the real world. It is unlikely that the researchers who were contracted to undertake this research were aware of the manipulation. The research was undertaken at the Lovelace Respiratory Research Institute in the United States.

The main criticism here should be that highly evolved non-human animals were utilised for research purposes that were not even research purposes. The health impact of a 1999 Ford exhaust was compared against that of a non-existent (aka manipulated) 2012 VW diesel engine. These monkeys were subjected to the risk of bodily harm for no scientific reason at all.

Well, it does not end there. The European Research Group on Environment and Health in the Transport Sector commissioned another experiment, this time involving 25 or so health volunteers at a German university hospital. The study received ethics approval, no VW diesel engine was thankfully involved on this occasion, manipulated or otherwise. The researchers aimed to determine what the health implications of different levels of nitrogen oxide concentrations in the workplace environment/air would be on those trial participants. The trial participants were subjected to those nitrogen oxide concentrations for 3 hours. The study concluded that there were no significant health implications. However, the authors of this study were also quite explicit  about the limitations of their findings. Their summary contains a longish list of caveats, including the warning that a 3 hour test tells us nothing about the effects of chronic exposure (ie the real world).

This study received the required ethics approval, the trial participants were healthy volunteers who gave first person informed consent to trial participation. It is unclear to me here why German politicians and board members of VW, BMW and Mercedes are falling over one another to condemn this research. It seems to me that no fraud was committed, and the question seems scientifically sound.




Sunday, January 21, 2018

The trouble with Public Health: HIV/AIDS in Canada as a case in point

It has been known among HIV/AIDS specialists for many years that infected people are for all practical intent and purposes unable to transmit the virus on to their sex partners, provided they consistently take anti-HIV medicines that render the amount of the virus in their bloodstream undetectable. Common sense would have suggested that Public Health authorities should have acted on this knowledge and ensured that it is deployed in such a way that it contributes toward the maximisation of desirable public health objectives, in this case, obviously the reduction in number of new infections. Public Health agencies should have revamped existing policies demanding that infected people disclose their HIV status to their sex partners to no disclosure required where ‘your viral load is undetectable for 12 months’ or some such figure. This would have dramatically increased the attractiveness of getting tested, of getting infected people discovered in a more timely fashion, getting them treated in a more timely fashion, and ultimately getting their viral load to undetectable in a more timely fashion. The predictable result of this policy change: A significant reduction in new HIV infections. Common sense and Public Health are sadly all too often residing in different realities.
Nothing of this sort occurred during the last few years. HIV infected people with undetectable viral loads were prosecuted for not disclosing their status. Public Health agencies, when given a chance, would disclose their HIV status to their sex partners. The contact tracing Public Health surveillance machine remained in overdrive in countries such as Canada. About 200 carriers of the virus were prosecuted over the years in that country alone. None of this served the public health objective just outlined, and none of this was evidence driven. Rather, it was driven by views on HIV/AIDS that may have had a place in the 1980s to early 1990s when AIDS was considered as a serious public health concern. Today, with negligibly low new infections rates, it is worth asking why HIV remains high on the agenda of Public Health agencies. HIV is clearly not a public health concern in Canada and most other countries of the global north. My suspicion is that the threat of prosecution serves purposes unrelated to HIV, they serve to control consenting adults’ sexual behaviours.
Much is made of the fact that an estimated 1:5 Canadians who are infected with the virus are unaware of their infection. What is typically not mentioned by the same Public Health officials is that they have gone out of their way to make it difficult for Canadians who are HIV infected to find out about their infection. Because the contact tracing government Public Health agencies want to know about each infected Canadian, by name and address, they cannot permit people at risk to test themselves with tests they can conveniently buy down south in the United States in every pharmacy. Unsurprisingly, a different government agency, the drug approval regulator Health Canada, has swung into action and threatened people with prosecution who import and resell reliable, US FDA approved, HIV self-tests into Canada, lest they would find out whether they are infected and Public Health not having their names and addresses on their records. You might not be surprised to learn that while STI testing and treatment is ostensibly free and anonymous at the country's Public Health agencies, in reality patients must show their provincial health insurance cards or else they are out of luck if they carry an STI but fail to provide the said card. The UK's NHS unsurprisingly manages public health in a manner somewhat more focused on infection control than administration.
It is no surprise then that in a country where government surveillance has been prioritised over and at the same time conflated with public health, people at risk of HIV infections remain reluctant to get tested. They have no reason to trust Public Health to act in a timely fashion in response to evidence.
In late 2017, Canada's federal government noticed after much studying what has been known for years about HIV transmission risk and undetectable viral loads. Both federal and provincial justice ministers appear to be finally acting in response to the existing evidence. Prosecutions of HIV infected people with undetectable viral loads who do not disclose their status to their sex partners are likely to be a thing of the past in that country.1
The main lesson I am suggesting we take away from this episode of HIV/AIDS prevention in Canada is to ask that Public Health agencies' policies should be held to public health outcomes, otherwise they serve no purpose. The cavalier approach to civil liberties taken not only by Canada's Public Health agencies, one that was not evidence based for many years, must be replaced by a policy approach based transparently on the latest scientific evidence. A golden rule in most public health ethics documents is that limitations on civil rights (in this case ownership of one's confidential health information) must be justified by significant benefits in public health outcomes, i.e., the public interest. HIV disclosure policies executed by Public Health agencies have failed this test for a very long time. Public Health agencies in Canada in particular have lost trust and support among people at risk of HIV infection because they lost sight of public health outcomes while focusing on Public Health administration and control. A paradigmatic case of how not to implement efficient infection control policies.

Footnote

  1. 1
    Harris, K. (2017, December 1). Liberals want to limit prosecutions of people who do not reveal status to sex partners. CBC NEWS. Retrieved from http://www.cbc.ca/news/politics/liberals-hiv-criminalization-1.4428395

Monday, January 15, 2018

How can we ensure that the global south benefits from and contributes to the field of bioethics?



There has been a legitimate debate going on for many years about the question of how we can ensure that colleagues in the global south can both benefit from bioethics journals such as this, as well as contribute constructively to them.


The issue of access to subscription- based journals has been litigated ad nauseam and I do think global publishers have done by and large a decent job in terms of implementing with WHO and other agencies myriad access themes available to those countries too resource- constrained to afford regular subscriptions.[1]

Some authors disagree, insisting that only Open Access journals, a supposedly superior business model, can address the access problem adequately. And they are right, Open Access journals, by definition, pose no access problems of the kind subscription- based journals pose. Sadly, having your cake and eating it too rarely works in the real world, and so these authors, having resolved the access to academic research problem, are faced with a different problem they did not have before. Open Access journals can only survive as viable enterprises if a sufficiently high number of authors pay what are often expensive article processing charges, or APCs. These journals often offer their equivalent to the access schemes subscription- based journals have put in place, namely differential fees or fee waivers for those who absolutely cannot afford to pay.

Short of asking academics to exploit themselves by volunteering to produce and disseminate academic journals and their content, reliably, over decades, someone will have to pay for the resource intensive production of journals and to ensure the reliable availability of their content.

I have yet to see from those complaining about access problems realistic solutions to this challenge. They mostly, and typically correctly identify the problem, but beyond grandstanding they offer no answers. They expect someone else to sort things out for them.

As I said, authors in the global south can access bioethics journal content either by means of the access schemes mentioned earlier, or by simply emailing the authors of content they are interested in and by asking those authors for a complimentary electronic copy of their article. Nobody would decline such a request.

I do think that a much greater challenge is to enable scholars from the global south to participate in international conferences and workshops both to share their own knowledge, but also to learn from colleagues and to network with a view to establishing research partnerships and the like.

I suspect you will know Facebook. I posted a photo from a workshop I had organised in the summer of 2017 in the UK, on the most recent version of the Council for International Organizations of Medical Sciences  (CIOMS) research ethics guidelines. Not unexpectedly a colleague, located in an upmarket London- based university, harangued me for the lack of diversity, perhaps most significantly, the evident lack of attendees from the global south. That colleague was right: only two of the 25 or so workshop delegates came from the Caribbean, while everyone else came from countries of the global north. Of course, I had virtually no funding to organise said workshop, and everyone who travelled there paid their own way. Nobody’s flight was covered by me. I did have inquiries from various colleagues in the global south who would have loved to attend, but quickly gave up on the idea due to lack of funds for their travel expenses. The colleague who criticized me quite publicly, naturally, had no funds to offer either. It is always easier to criticize than to contribute meaningfully to change. The same, as I tried to show, holds true for academics who refuse to acknowledge the cost involved in producing academic journals.

Some constructive attempts have been made to have a more globally representative group of conference goers presenting at and attending international bioethics events. A successful example of this is the Global Forum on Bioethics and Research. The GFBR has been around for a longish time. It’s funded mostly by the UK’s Wellcome Trust, the Gates Foundation, the US NIH Fogarty International Center and the UK’s Medical Research Council. I had a quick look at the GFBR’s website, with a view to finding out who governs it, and who decides on the composition of speakers and attendees of its meetings, given that its funders reside essentially in the USA and the UK. It seems to me as if the majority of those people are either staff members of these funding organisations, or are past/current grant recipients.[2] There appear to be very few truly independent scholars from the global south among those in charge of organising these global events.

I don’t think that this is the result of any kind of malicious intent. It’s likely a function of ‘who do we know who could serve on that steering committee who is from Africa, Asia etc’, and who does one know? Well, the answer is likely to be: ‘someone we have funded before’.

However, that alone does not address the question of whether or not the meetings are failures when it comes to the question of participants from the global south. Here are the criteria the GBFR uses to determine who among the applicants will be invited[3]:

·         Country of origin: GFBR would like to ensure a representative distribution of delegates from different regions;

·         Background /current area of expertise: GFBR is aimed at anyone involved or interested in health research ethics, including researchers, policy-makers and community representatives. GFBR seeks representation from many different disciplines;

·         Membership of an IRB/REC: Membership of an Institutional Review Board / Research Ethics Committee is not a prerequisite for attending GFBR, but may be taken into consideration;

·         Experience of ethics: GFBR encourage s a mixture of ‘old’ and ‘new’ faces at each forum so that participants can productively discuss issues of concern to them and gain from the perspectives of others. Applicants need not be experts in ethics;

·         Reasons for attending the meeting: GFBR seeks participants who will be able to actively contribute to the meeting and who expect to impact on research ethics and/or pursue a career in research ethics in their own country.



While there is the inevitable number of people who presumably just have to be at every such meeting (let’s call them ‘old’ faces), the GFBR has succeeded in terms of attracting a fairly wide range of delegates from the global south to its meetings over the last few years.  It’s a small (and expensive) meeting, designed to host about 80 delegates, but it’s probably a meeting as good as they come on the global bioethics scene. I truly wish there were more such events on the global bioethics events’ calendar.



It is fortuitous that the next World Congress of the International Association of Bioethics will be held in New Delhi from 4-7 December 2018 under the theme Health for all in an unequal world: obligations of global bioethics and is locally hosted by SAMA, the resource group for women’s health, the Forum for Medical Ethics Society, and, of course, the IAB.[4] With a bit of luck (and planning) there might be a plenary dedicated to figuring out how to enable more delegates from the global south to attend such events. Why don’t you propose to organise such a plenary to the India- based hosts of the event. They might consider it quite seriously.

















[1]Schuklenk U. 2015. Fighting Imaginary Enemies in Bioethics Publishing. Bioethics 29(8): ii-iii. Schuklenk U, Magnus D. 2017. Justice and Bioethics: Who Should Finance Bioethics Publishing? AJOB 17(10): 1-2.
[2] http://www.gfbr.global/about-the-gfbr/ [Accessed 28 November 2017].
[3] http://www.gfbr.global/forum-meetings/ [Accessed 28 November 2017].
[4] http://www.iab2018.org [Accessed 28 November 2017]