Life as an Extreme Sport

Ebola, Paternalism, and the Need for WHO’s Medical Ethics Review of Experimental Treatments

Bioethics

WHO_Logo_c300The World Health Organization has released a statement (in full, bottom of blog post) that they are going to convene, early next week, a panel of medical ethicists to “explore the use of experimental treatment in the ongoing Ebola outbreak in West Africa.” The statement goes on to say that

[t]he recent treatment of two health workers from Samaritan’s Purse with experimental medicine has raised questions about whether medicine that has never been tested and shown to be safe in people should be used in the outbreak.

It’s probably safe to assume that at least some of this statement was informed by the Wall Street Journal op-ed published by Jeremy Farrar, David Heymann, and Peter Piot.As I said on Twitter last night, when Peter Piot talks about Ebola, I stop and listen. In particular, the authors note that it “is highly likely that if Ebola were now spreading in Western countries, public-health authorities would give at-risk patients access to experimental drugs or vaccines” and that the “African countries where the current outbreaks of Ebola are occurring should have the same opportunity.” Farrar, Heymann, and Piot also noted that ideally, the World Health Organization would assist the involved African countries with protocols for experimental treatment, research, and prevention, while simultaneously assisting with traditional treatment and containment measures.

This, surprisingly, turned out to be a somewhat controversial view, at least on Twitter. But the West is pretty enamored with the Western Cowboy Doctor who swoops in and saves the day, and there is an enmeshed culture of paternalism and rescue when it comes to how America views, or even talks about, the countries of Africa. It’s one of the reasons any effort to combat pandemics needs to be interdisciplinary; the heroic myths of one field can easily end up being the illustrative horror stories in another. In particular, the West has not been kind to African countries during outbreaks, previous Ebola outbreaks included.“First the French and then the Americans came up the river. Each time they took four tubes of blood, even from sick children. They never returned, and we never received the results of the tests.” Local people of Mékouka and Makokou, Gabon, discussing the rivalries between American and French researchers during the 1996 Gabon outbreak of Ebola. Taken from the Hewlett’s book Ebola, Culture, and Politics: The Anthropology of an Emerging Disease. As anthropologists Barry S. Hewlett and Bonnie L. Hewlett note in their book on Ebola, culture, and politics, there is a tendency for outbreaks to only be contextualized through Western biomedical knowledge and technology. While that might have worked when outbreaks were merely local, as everyone and their grandfather has taken to pointing out, we live in a global environment, with global travel. As such, our approach to outbreaks needs to be global, not local.

There is a long and exploitive history of white intrusion into African countries, and that said history has created a culture of mistrust shouldn’t be surprising. And I’m not just talking about colonialism; pharmaceutical companies have used African countries as testing grounds for “clinical trials” that would never get off the ground in America or other developed world countries. (This was helped by the 2008 decision by the FDA to drop the requirementThe Food and Drug Administration should rethink its rejection of the Declaration of Helsinki. Nature 453, 427-428 (22 May 2008) | doi:10.1038/453427b; Published online 21 May 2008. that international clinical trials follow the requirements of the Declaration of Helsinki.Instead of providing the best standard medical care to control groups, placebos can be utilized. Smashing.) Meningitis cure testing in Nigeria, AZT trials and contraception testing in Zimbabwe;Read Harriet A. Washington’s book Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present for more. we’re not talking the distant past, but the past 35 years.

This is why I’m glad to see that WHO has taken Farrar, Heymann and Piot seriously, and, in a step further, that they’re going consult actual ethicists on the ethics of providing experimental, untested treatment to a vulnerable population in need, rather than just allow the status quo to continue. There’s no news yet on just who will be participating in this convention of ethical experts, but here’s hoping WHO has learned from their past mistakes and will be including a diverse range of voices with experience in the research mentioned above, the history of mistrust, culture, and of course ethics. While I’d hope it goes without saying that medical ethical representatives from the affected African countries should be present, past experience has taught me it’s best not to assume people will automatically reach for diversity over expertise. Again, here’s hoping; after all, I’d really hate to have to reach for awful WHO’s on first style jokes next week to highlight poor panel selections.

 

WHO to convene ethical review of experimental treatment for Ebola

WHO statement
6 August 2014

Early next week, the World Health Organization (WHO) will convene a panel of medical ethicists to explore the use of experimental treatment in the ongoing Ebola outbreak in West Africa. Currently there is no registered medicine or vaccine against the virus, but there are several experimental options under development.

The recent treatment of two health workers from Samaritan’s Purse with experimental medicine has raised questions about whether medicine that has never been tested and shown to be safe in people should be used in the outbreak and, given the extremely limited amount of medicine available, if it is used, who should receive it.

“We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,” says Dr Marie-Paule Kieny, Assistant Director-General at the World Health Organization. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

The gold standard for assessing new medicine involves a series of trials in humans, starting small to make sure the medicine is safe to use. Then, the studies are expanded to more people to see how effective it is, and how best to use it.

The guiding principal with use of any new medicine is ‘do no harm’. Safety is always the main concern.

Media contact:
Tarik Jasarevic
WHO Department of Communications
Telephone: +41 22 791 50 99
Mobile: +41 79 367 62 14
E-mail: jasarevict@who.int

Virtually Speaking Science: Megalodons, Mermaids, & More with David Shiffman

Virtually Speaking Science

Image Credit: APL/DCL
Image Credit: APL/DCL
Tonight on Virtually Speaking Science, I have a treat for biology and science fiction lovers: David Shiffman, a PhD student in shark biology and conservation at the University of Miami, known to many by his Twitter name WhySharksMatter, will be joining me to talk about his research and social media outreach efforts, including shark week and Sharknado II. (And yes, megalodons, mermaids, Discovery Channel, and all that jazz.)

We’ll start at 5pm PT/8pm ET over at BlogTalk Radio, or you can join us in Second Life! If you’d like to ask David a question, feel free to tweet me the question ahead of time, and use the hashtag #VSpeak or #AskVS. During the show, definitely use the hashtags and either tweet me or my producer, Sherry. Talk to you tonight!

Attempting to Incite Trans Panic Requires More than a Nonpology

...and everything else

You always hear that covers are an art, but I’m not sure how much anyone really realizes that until they’ve worked on a cover (copy or art). Sure, you learn really fast when you publish something that shouldn’t have made it out of concept, but there’s a strange blindness that sometimes comes over you when you work on something too closely. If this seems strangely sympathetic to you, well, I am. I’ve been on the receiving end of the letters and calls that happen when cover art goes wrong, and I’ve made the point of trying very hard to learn what readers say when something does go wrong—which, thankfully, hasn’t happened to me in a very, very long time.But boy was that first time a doozy. I hadn’t even technically been around when the issue was released, but I sure as hell heard about it from Every Single Nurse who was tired of being portrayed as a sexpot in a tiny white dress. Safety note: NEVER picture a nurse like that on your cover. NEVER.

July11CoverWhich is why, when I saw the July 11, 2014 cover of Science Magazine, I winced in sympathy. They were going to catch hell for it, that much was obvious, and it seemed obvious that it was just a matter of thoughtlessness that led to a sexist, reductionist image of lovely headless female bodies on a cover discussing means of reducing HIV in the Southern Hemisphere.See, occasionally I am still an optimist. TEACHES ME.

I tweeted some vague comment of oh, bad cover, suck it up and admit it was a mistake, it happens in publishing, don’t repeat it, etc and platitude, and then went on about the Internet. Surely the CDC had done something else worth mocking, and I didn’t want to miss it.

That is when I saw Dr. Jacquelyn Gill‘s engagement with Science Magazine’s career editor, Jim Austin. Rather than attempt to summarize the conversation, I’ll just show it to you:
AustinTweets
Needless to say, the notion that Austin was defending the idea of inciting trans panic because it would be “interesting” didn’t go over terribly well. You should read Kate Forbes’ explanation of why this is emblematic of the problem with science (rather than Science Magazine alone) at this Shakesville post. You could also read what Andrew David Thaler and Emily Finke had to say at Southern Fried Science or Mad Art Lab, respectively.

Rather than repeat their excellent points, what I want to focus on is the apology from Science Magazine’s Editor-in-Chief, Marcia McNutt. Or, really, her classic nonpology.You can read the full apology without my commentary at this link. I’ll be using my primer on apologies as reference for how to apologize, since once again, we apparently need to go over this every couple of months.

The letter begins:

From Science Editor-in-Chief Marcia McNutt:
Science has heard from many readers expressing their opinions and concerns with the recent [11 July 2014] cover choice.

The cover showing transgender sex workers in Jakarta was selected after much discussion by a large group and was not intended to offend anyone, but rather to highlight the fact that there are solutions for the AIDS crisis for this forgotten but at-risk group.

Apparently this is an incredibly forgotten at-risk group, since the number of times the word “transgender” appears in this oh-so-special Strategies Against HIV/AIDS issue of Science Magazine? Three times.It’s possible I missed one or two; I did your basic “open the open access articles, search on “trans” and see what comes up. Transmission was very popular. That said, to be technical, it was only two times, if you consider the fact that at one point they use the word “transgenders,” which, per GLAAD Media guidelines on writing about transgender folks, is problematic. Transgender is an adjective, not a noun.

And just to clarify, McNutt: I was willing to give you a pass for a bad idea when I thought you were just attempting to sell Science via marginalizing and sexualizing women’s bodies. It’s nothing new, it’s just aggravating. The minute I had that context you seem to think I needed to find the cover okay, that the image was of transgender women in Jakarta who are also sex workers? That is when I became appalled, both that there is apparently not a single person in the entire editorial process at Science Magazine who has the ability to call stop on such a bad idea (either because no one saw it or no one felt safe in calling it out), and because your staff feel gotcha! trans panic is an appropriate artistic intent behind a cover.

Said apology continues:

A few have indicated to me that the cover did exactly that, but more have indicated the opposite reaction: that the cover was offensive because they did not have the context of the story prior to viewing it, an important piece of information that was available to those choosing the cover.

Apparently I should have said “said so sensible explanation continues,” as this isn’t an apology. This is a “well, SOME PEOPLE got it” defense. Oh sure, more people didn’t get it, but some people still did, so see? See? It’s not only Science Magazine that understood. Other people did, too.Gosh, why do you have to be so sensitive? Okay, okay, wait, the next paragraph! Surely the apology is there, and one merely needed to establish context for what was being apologized for, if somewhat clumsily.

I am truly sorry for any discomfort that this cover may have caused anyone, and promise that we will strive to do much better in the future to be sensitive to all groups and not assume that context and intent will speak for themselves.

— Marcia McNutt, Editor-in-Chief, the Science family of journals

Well damn. It looks like we’ve got ourselves a genuine nonpology here! We have:

  • apologies for how you feel, which shifts the focus on to you and implies that this is an obligatory response because of how you feel, rather than any actual belief in having made a mistake;
  • a “may have caused” variation on the “if I offended anyone” nonpology that is frequently found falling out of politicians’ mouths;She kept the nonpology short and sweet and classic over on Twitter: “we apologize to those offended.”
  • a nebulous promise of doing better without any indication that they’ve absorbed what the problem was to begin with.

To reiterate, an apology needs to do four things. It should: articulate and clearly recognize what the problem is; accept responsibility, without blaming anyone else (including the “if you felt” defense); express remorse in a clear, concise manner; and explain the remedy that will prevent this mistake from ever occurring again.

In particular, McNutt’s choice to completely ignore Austin’s “gazey” comments and subsequent comment that moral indignation is boring is problematic, because without addressing how Science will pull in the reins of this editor, there is absolutely no reason for anyone who is aware of the numerous problems in this cover to believe that there is any remedy that can happen. While Austin can defend his Twitter account as “personal” all he wants, he identifies who he is, who he works for, and does work representing Science Magazine on that account. He cannot then decide to offend numerous people and skip away from his affiliation as “nope nope all mine, not them.”

Science may have an image problem, but right now, the problem at Science Magazine clearly goes well beyond image—or cover.

Ziploc: There’s No Better Way to Protect Your Select Agent Investment

...and everything else, Bioethics, BioScary, Politics

A lot of interesting testimony came out of yesterday’s House Energy and Commerce Oversight and Investigations Subcommittee hearing, which was titled “Review of CDC Anthrax Lab Incident,” but broadly covered the numerous slapstick-‘cept-it-ain’t-funny errors around dangerous pathogens research at the Centers for Disease Control and Prevention.

I don't know about you, but I feel safer already.
I don’t know about you, but I feel safer already.
For those just joining the conversation, these hilarious mishaps have included leaving activated anthrax in unlocked, unsecured refrigerators; mixing high pathogenicity avian influenza with low pathogenicity avian influenza and then shipping it over to the US Department of Agriculture in the worst version of novelty surprise in a can ever; and using ziploc bags to transport petri dishes between labs. And as an added bonus, there was some discussion about the broader issues of the proliferation of biosafety laboratories working on select agents.

In particular, the statement of Nancy Kingsbury, PhD, the Managing Director, Applied Research and Methods, at the Government Accountability office, is worth a read. The statement pulls no punches, saying:

No federal entity is responsible for strategic planning and oversight of high-containment laboratories. … No one agency is responsible for determining the aggregate or cumulative risks associated with the continued expansion of high-containment laboratories; according to experts and federal officials GAO interviewed for prior work, the oversight of these laboratories is fragmented and largely self-policing.

In fact, since 2001, the proliferation of biosafety laboratories has resulted in nearly 1500 laboratories in the United States alone that handle and do research on dangerous pathogens.

If only there were some sort of national advisory board for biosecuri-oh wait!

Except, as has already been noted, the NSABB hasn’t met in nearly two years. But that’s okay, you see; the current chair of the NSABB1 wants you to know that this is intentional! Samuel L. Stanley Jr., MD, says that the NSABB has “been waiting essentially for the new federal guidelines to come out on institutional implementation of DURC policy. We wanted to have a look at what the federal agencies would come up with.”2

PicardOneJob-200One job.

You guys had one job.

Well, wait. Okay. This can easily be clarified by looking at the NSABB charter, which was recently revised, so clearly it is timely and up-to-date and will clarif-

The NSABB will provide advice on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration both national security concerns and the needs of the research community to foster continued rapid progress in public health and agricultural research.3

Damnit.4

In Stanley’s defense, he argues that these recent “issues” at the CDC are surely concerning as a scientist, but they’re really not about dual-use or gain of function research, so they don’t involve the NSABB. It wasn’t, you see, created to be about biosafety.

It’s really such a bitch when the first bulleted item on the list of “description of duties” on your charter contradicts the interviews you give: Recommend strategies and guidance for enhancing personnel reliability among individuals with access to biological select agents and toxins.5

Funny thing. The last time I looked, anthrax sure as hell was a select agent. Oh look! So is H5N1.

Your move, Stanley. I suggest it involve picking up a phone and dialing 11 different numbers.