Ebola epidemic reporting and bioethicists in the media limelight

There is a lot that is bizarre about the Ebola epidemic reporting. Journalists don't seem to be able to get the most basic facts of the matter right. Canada's CBC reported in its news program that Canada is sending a 'vital experimental vaccine' to West Africa. Well, obviously, you don't need to be a virologist or public health expert to figure out how nonsensical this claim is. There is nothing vital about an experimental agent that hasn't been tested on a single human soul.

Generally speaking, I am puzzled about the language that is being deployed widely to describe these experimental agents, by journalists, biomedical scientists and bioethicists alike. Why do we call something an 'experimental vaccine' or an 'experimental drug' (the latter I did unwittingly in my doctoral thesis - produced in another lifetime). The more I think about it, the less this makes sense to me. An experimental vaccine isn't a vaccine, an experimental drug isn't a drug. Both, at best, are chemicals hoped to be efficient with regard to a particular preventative or curative purpose. Until they are known to do that, it is manipulative to add the curative or preventative capacity to their name. Perhaps that's why princes are not kings (they're not called formally 'future king', they're called prince or princess, or whatever else, equally, caterpillars aren't called 'future butterfly' either). Yet when it comes to future may be drugs, we are less hesitant. I think this is a problem, because it leads to pseudo debates among the less well informed (i.e. most people). Framing effects are well known and if anything triggers them, this kind of misleading language does.

Example in point, I was unfortunate enough to have myself recruited for a BBC World program (I love the BBC, would never decline an invite from them). I was the 'ethics' guy on the program, there's an MSF operative, the President of Liberia, plus a 'political scientist' and African ex-pat in London whose role it was to berate the President, and a bunch of other folks. The hour-long program was moderated by one of those less well informed people. She tried to get the ethics debate off the ground by telling the world that two Americans received 'that vaccine', and what I thought of that. I was expected to go on about why not Africans etc etc. Instead I explained that the Americans received an experimental agent hoped to be therapeutic, and that today we have neither a vaccine nor a therapeutic drug. We don't even know whether the experimental agent assisted in their recovery, and we don't know whether the same agent was involved in the death of the Spanish missionary. She cut me off right there and moved on to the next panelist. At least I had fixed this minor issue of her coming into the studio not knowing the difference between a vaccine and a therapeutic drug and between experimental somethings and actual medicines.

Of course, I didn't actually get to talk about bioethical issues at all. So, was it my job to teach the basics here? I mean, it takes really half an hour on the web to get this stuff right, except the BBC staffer must have decided that that's why too much by way of preparation for an hour-long special program involving the President of Liberia! Wow.

Anyhow, bioethicists amongst my friends revelled on Facebook and other social media platforms in the number of interview requests they received, and naturally the pecking order of those media (i.e. were they important ones or so-so outfits).  To be fair, the issues raised by most of us were similar, the answers by and large in the same ballpark. It didn't take a genius to figure most of those questions out. I suspect the only disagreement we'd see come into the open would occur when it comes to deciding who should have priority when it comes to access to limited quantities of an actually working therapeutic drug. Anyhow, some got mortality figures somewhat wrong (it makes a different whether it's 55-60% or 80-90%), and so ended up in consequentialist evaluations that were somewhat off the mark due to their mistaken empirical assumptions.

Nobody questioned why this media ho-ha, and why now. One journalists from a Canadian TV news outfit (Bell owned - hint :) asked me what I thought sustained the media interest. I volunteered that 'you' are probably tired of Gaza, ISIS, and Ukraine, and so an exotic African disease ain't a bad deal during the summer lull in the news. That question didn't pop up during the interview :). Fair enough.

Very few of us questioned the utility (and jurisdiction) of the WHO 'ethics expert' panels missives on the use of experimental agents. It was very much a bioethics undergraduate output, nothing wrong with it, the tricky questions were postponed. To be filed and hopefully quickly forgotten under longish WHO URL and file-name. Mission accomplished. - In any case, it isn't within WHO's powers to 'approve' the use of investigational new drugs anywhere. None of their business. That hasn't stopped the crowd over at Nature.com and most other mass media outlets from misrepresenting this lil bit of fact. It's probably the first time that such a motherhood-and-applepie product from a bunch of guys on WHO's rolodex was taken note of by the mass media. Kinda nice for bioethics, bad news that so few ethicists were involved in producing the document, and too bad that it was such an unnecessarily rushed output. Alta Charo among others noted that the panel chose to address the easy questions and managed to come up with obvious answers, while avoiding the difficult ones.

I do wonder to what extent bioethicists should contribute to maintaining media interest in a story that shouldn't be that big. More Africans have died of other diseases in the countries in question, apparently nobody cares about this. Should we in bioethics not focus on this during interviews to put the hype into perspective? Should we really entertain journalists trying hard to 'bring this back to Canada', including fantasies about an Ebola epidemic in the country? I don't think so.

*Steps of soapbox.*

WHO Ebola ethics panel excluded those most affected

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What's wrong with you WHO?

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

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

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

Ted Hsu not standing for re-election in Kingston and the Islands riding

Ted Hsu, Liberal MP for Kingston and the Islands declared today that he won't be seeking re-election. In characteristic honesty he explained in his farewell note that it's just too much work to represent our riding in federal parliament. He'll stick around for the remainder of this parliament probably while he's looking for a new job.

I've made no secret out of my strong opposition to Hsu. This guy was never a liberal to begin with. So, I am glad to see soon the back of him. Other than a bizarre pro-life foray in federal parliament, his other claim to fame was to defend science against the Conservative's onslaught. He deserves credit for the latter.

Hsu bet on every candidate other than Trudeau in the federal leadership race. Call him principled or incompetent, as far as his political judgment is concerned, Hsu must have realized that he wouldn't be finding himself in any position of actual influence in the likely up-coming Trudeau administration. Worse, Trudeau made clear that he doesn't want pro-life activists in his caucus. There wasn't really anywhere to go for Ted Hsu. He succeeded remarkably well in terms of isolating himself in the federal Liberal Party and its parliamentary caucus.

Personally I hope Hsu will move to his actual political home, the Green Party of Canada. It's run by fellow Christian Elizabeth May. She is also known to lack political judgment and so engages in political support for racist, homophobic, misogynist sects like Falun Gong.

After Sophie Kiwala's selection for our provincial government I hold little hope that the local Liberal riding association will be able to find a competitive replacement for Mr Hsu, but apparently that doesn't quite matter. Kingston seems to elect whoever the Liberals decide to put up. Interesting times ahead.

Could Canadian patients be prevented from accessing experimental Ebola drugs, too? You bet they could!

Ok, so I'm a tad bit lazy. Sections of the post below are actually a few months old and I'm re-posting them here, because of the current debate about access to the experimental drug deployed in the case of the two Ebola missionaries in the United States. 

First things first though, on the current debate: There has been a bit of a storm in a teacup about the question of whether or not it is just to provide an experimental treatment for Ebola to two sick missionaries who returned home to the United States from West Africa while denying it to dying Africans. Art Caplan has provided a reasonable analysis of the issues in a Washington Post OpEd. I disagree with him on the reasons for why the agent cannot be produced now in larger quantities and shipped to West Africa (poor start-up company and all that jazz). There is no reason to accept an artificial scarcity (i.e. human regulation made) as a kind of natural law, inevitable and beyond our control. Still, Caplan is right, it would be difficult to provide the medication locally in West Africa where it's needed, due to the relatively fragile nature of the experimental agent (it needs special handling, be kept in a freezer and whatnot). And yes, imagine the drug actually was a dud, potentially doing more harm then good. The same professional do-gooders shouting now racism and demanding delivery of the medication to Africa would turn around before you can say 'ouch' and excitedly shout 'exploitation' and 'African guinea pigs' and, yes, 'racism', because that charge usually sticks. 

From the published reports about the experimental agent it's unclear - to me - at what stage in the R&D process it is. It seems to me - I might be mistaken here - that the drug hasn't undergone phase 1 clinical trials (i.e. how dangerous to human health is it?). From the experience with the two missionaries it seems at least as if it ain't too toxic. Still, two folks count for all scientific intent and purposes as an anecdote. Not a big surprise though, that proper trials have not been undertaken, given how quick people die, and in what locations they usually die. Doing placebo-controlled studies - no doubt the methodological gold standard under the circumstances - also seems a dicey proposition seeing the high mortality rate among infected people. 

Fundamentally though, the question is whether knowledgable patients suffering from catastrophic illnesses should be permitted to access experimental drugs. Ebola is just the latest disease triggering this debate. It turns out, the situation the African patients find themselves in isn't that different to the situation faced by Canadians suffering from other catastrophic diseases.  It's here where my mentioned older post kicks in...

Imagine you suffer from a catastrophic kind of illness, an illness that’s invariably going to kill you in the near future. Everything that you and your doctor know about the illness suggests that your death will be anything but peaceful. Doctors can deal with some of your symptoms and palliative care can address some of the pain you are experiencing. But that’s about it.

Sadly this scenario isn’t unrealistic. Many Canadians face this sort of situation today.

During a scheduled visit to your specialist doctor you learn that there’s a brand-new drug currently being tested that might just save your life, if it worked that is. The doctor has already inquired with the researchers testing the drug in a phase-three clinical trial and you would be eligible to participate in that trial.

Phase-three clinical trials are trials at which stage in the drug research and development process we know what its safety profile looks like and we have pretty good evidence to think that it’s effective to some extent. That is so because during earlier trials, involving initially animals and eventually other patients, sufficient evidence has been accumulated to justify letting the phase-three trial go ahead. Now the doctors are trying to recruit a fairly large number of patients in order to establish whether the drug is as good as they thought it is. The nature of your disease is such though that there is no standard therapy around to assist your struggle for survival. The trial design in such cases demands that the experimental agent is tested against a placebo control, a dummy pill. That’s done because we need to know, before doctors can confidently prescribe the drug to patients like yourself, that the drug is doing better than what is the status quo – ie no drug. It’s always possible that an experimental drug actually does worse than the dummy pill.

Now, ask yourself, if you were that patient: Would you be willing to participate in a last-chance clinical trial where you’d have a 50:50 chance of getting a dummy pill? You know already what the dummy pill would achieve: your death. Would you trust the investigators to pull the plug quickly enough for you to survive if they discovered that the experimental drug actually works? In case you want to get a better handle on how it feels to be faced with this sort of decision, check out this blog (adriennes.blog.com) by a Toronto-based melanoma patient.

Many people suffering catastrophic illnesses flat-out refuse to participate in research that’s designed as I have described it. Their argument is not about the trial methodology, it is sound. Their argument is about the ethics of providing dying people with a coercive offer: join my clinical research project on my conditions or die a predictably horrible death.

The good news is that the story doesn’t end here. It has been recognized by regulators both in Canada and elsewhere that such coercive offers to people fighting for their very survival are incompatible with the fundamental values of liberal democracies. We must not reduce patients suffering catastrophic illnesses to mere means to achieve our research objectives. While that’s nothing much other than an honorable principle, there’s also a more pragmatic reason for this. I’ll get to that in a moment.

Health Canada actually permits people who suffer catastrophic illnesses to access drugs that are in the clinical trials system, and they can do so without actually participating in the clinical trials I mentioned earlier. The agency runs a Special Access Program for these sorts of patients. The program permits patients to access the experimental agent without trial participation. In return they promise to have their doctors monitor the impact of the drug carefully and report it back to the manufacturer or whoever runs the clinical trial. One of the ethical reasons for this I have just mentioned. The pragmatic reason for this solution is this: it was discovered during the early days of the AIDS epidemic, when no life-preserving medication existed, that patients who are coerced into placebo controlled trials will simply cheat in order to get access to the actual experimental drug. HIV-infected people enrolled in ostensibly placebo-controlled trials and then took their drugs to chemists to find out who did and who didn’t get the active agent. They then started sharing the actual drug and dumped the placebo. That, of course, rendered the trial pretty useless. True volunteers would have accepted the uncertainties and volunteered to test whether the experimental agent is any better than the placebo control.

The problem patients with catastrophic disease who wish to access experimental drugs through our Special Access Program face today in Canada is two-fold: Health Canada leaves it up to pharmaceutical companies to decide whether or not they provide drugs to eligible patients. Manufacturers who have trouble recruiting sufficient numbers of patients into their trials could deny patients access to the experimental drug to encourage them to join the trial on their conditions. They might also have other reasons for refusing to provide catastrophically-ill patients with access to an experimental drug. Either way, we are back to square one: a coercive situation. This problem occurs more frequently in Canada than you might think. Here is a heart wrenching appeal (http://www.youtube.com/watch?v=olwDT7NPSsM) from one such patient, who has since died. A Toronto paper contacted me about another case recently, both cases interestingly involved pharmaceutical multinational Bristol Myers Squibb refusing to provide an experimental drug that the company is testing in a phase-three clinical trial right now. This issue should be addressed by Health Canada as a matter of urgency. The other problem is that manufacturers are permitted to charge for their experimental drug. That is unreasonable. It costs typically cents to produce such medicines – I am not talking research and development costs but actual production costs. There is no reason whatsoever why pharmaceutical companies should profit from experimental drugs. They should be compelled by Health Canada to provide such agents to clinically eligible patients, while the clinical trials are ongoing and the drug isn’t formally approved as a for-pay prescription medication. If Health Canada were to address these shortcomings of the present Special Access Program it would ensure that catastrophically ill patients are given a fairer shot at actually accessing these experimental drugs.

Udo Schuklenk holds the Ontario Research Chair in Bioethics and Public Policy at Queen’s University, he tweets @schuklenk