Trigger Warnings

Semester is just about to start at the University of Massachusetts, Lowell (UML), where I’ll be teaching Engineering Ethics.* I won’t be teaching military ethics this semester. If I was, there would be trigger warnings all over that class.**

Why?

Because—among any other reason to add trigger warnings to a class—Lowell is home to the second largest Cambodian diaspora in the United States. One of the largest in the world. And I know that UML takes a lot of local students.

So when I talk about genocide, about war crimes, about intrastate violence, you can bet I need to be aware that there are most likely students in my class who fled, or whose parents fled the Khmer Rouge.

That won’t stop me talking about those issues. Not at all. But people need to be prepared for some things—hell, people’s families might need preparation. That doesn’t infringe on my academic freedom one iota.

I’m not a clinical psychologist, so it’s not my job to judge just how much exposure people can or should receive around their trauma. Moreover, not one person in my class consented to treatment—education isn’t therapy.

So if you can’t wrap your imagination around why trigger warnings might be necessary, why don’t you start thinking about people who are victims of genocide.

*I’ll be including trigger warnings in Engineering Ethics as well, because I’ll be talking about rape and sexual assault in the profession of engineering.

**And you should get trigger warnings anyway in military ethics, because just about everything we discuss in that class is the worst things you can do to people, individually or in groups.

Treating like cases alike: bioethics edition

Crash course in philosophy—treat like cases alike.[1]

That means that if you think a much-hyped article on the health benefits of chocolate is unethical, your reasons for this conclusion ought to apply consistently across other similar cases. Put another way, if you think John Bohannon acted unethically in publishing a study that claimed to show a relationship between the success of weight-loss diets and chocolate consumption, fooling the science journalism world; and if your reasons for thinking this bear on relevantly similar cases, you ought to arrive at similar conclusions about the ethics of those cases as you do about Bohannon.

1) For example, you might think—as I do—that whether or not the study was intended as a hoax, some human subjects protection ought to be enforced. You might worry that there’s no mention of research ethics review or informed consent in the journal article that caused the furor, or any of Bohannon’s writings since. Kelly asked Bohannon on io9 what kind of approval he got for the study, if any. I’ll update if anything comes of that.

But if you do have this concern, then such reasoning should lead you to treat this study conducted by Facebook with similar suspicion. We know that no IRB approved the protocol for that study. We know that people didn’t give meaningful consent.[2]

2) Say you are worried about the consequences of a false study being reported widely by the media. It is true that when studies are overhyped, or falsely reported, all kinds of harm can result.[3] One could easily imagine vulnerable people deceived by the hype.

But if you think that, consider that in 2013, 23andMe was marketing a set of diagnostics for the genetic markers of disease in the absence of any demonstrated analytic or clinical validity. They were selling test kits with no proof that the tests could be interpreted in a meaningful way.

I think that the impact of the latter is actually much greater than the former. One is a journalist with a penchant and reputation for playing tricks on scientific journals. The other is a billion-dollar, Google “we eat DARPA projects for breakfast” backed, industry leader.

But if Bohannon’s actions do meet your threshold for what constitutes an unacceptable risk to others, you are committed to concerns about any and all studies that could harm distant others that reach that threshold.

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If you think Bohannon was out of line, that Facebook was unethical in avoiding oversight, and it was inappropriate for 23andMe to flaunt FDA regulations and market their genetic test kits without demonstrating their validity, then you are consistent.

If you don’t, that’s not necessarily a problem. The burden of proof, though, is now on you to show either a) that you hold one of the above reasons, but the cases are necessarily different; or b) that the reasons you think Bohannon is out of line are sufficiently unique that they don’t apply in the other cases.

Personally? I think the underlying motivation behind a lot of the anger I see online is that scientists, and science communicators, don’t like being made out as fools. That’s understandable. But if that’s the reason, then I don’t think Bohannon is at fault. Journals have an obligation to thoroughly review articles, and Bohannon is notorious for demonstrating just how many predatory journals there are in the scientific landscape today. Journalists have a responsibility to do their jobs and critically examine the work on which they report.

Treat like cases alike, and use this moment for what it should be: a chance to reflect on our reasons for making moral judgement, and our commitment to promoting ethical science.

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1. Like anything in philosophy, there are subtleties to this.  ↩
2. Don’t you even try to tell me that a EULA is adequate consent for scientific research. Yes, you. You know who you are. I’m watching you.  ↩
3. Fun fact: that was the subject of my first ever article!  ↩

Comments on the NSABB Meeting on Gain of Function

On May 5, 2015, the National Science Advisory Board for Biosecurity held a meeting to review the gain-of-function deliberative process, and solicit feedback on their draft framework on the process (published April 6).

As part of that meeting, I am presenting public comment on the ethics of the deliberative process. A copy of the handout I provided to the members of the NSABB—updated to correct a couple of typographical errors—is available here.

You can also view the webcast of my comments live. I am not sure when I’ll be speaking—the public comment sessions are planned for 2:00pm-2:30pm, and again at 3:30pm-3:50pm. However, if you want to watch me give comment (or the rest of the meeting) the webcast is available here.

PLoS: Revolution, or Mere Brand?

Late last week I spoke with Dr. Danielle N. Lee about having a paper rejected from a scientific journal—from the policy section of a scientific journal—on the grounds that it wasn’t considered sufficiently interesting. The topic was a US government process examining the risks and benefits of “gain-of-function research resulting in the creation of potential pandemic pathogens.” My paper was an examination of the ethical issues associated with the process, including the issue of representation in the governing bodies that framed, pursued, and answered the policy process.

The publication that rejected this paper was PLoS Medicine.

The editorial committee of that journal noted that my article:

provides useful insight into topics, such as competing interests and how they might be managed…Unfortunately, we do feel that your article will be of most interest to those currently involved in debates around [dual-use research of concern] and not the wider audience that reads PLOS Medicine.

The abstract of my article, which included mention of competing interests, and explicitly noted the ethical focus of the paper, received a favorable presubmission inquiry. I was faithful to the limits the editor assigned to my paper provided, but at the end of the day it was decided that the article simply wasn’t relevant to the PLoS audience.

I’m not terribly upset about the rejection: it is part of the business of writing for journals. And I have no problem with a journal’s disinterest in my topic—that happens all the time. The issue, however, is that PLoS has, and does publish articles on this topic, written by scientists, (not bioethicists, or policy analysts) just this month. So it isn’t the topic that is uninteresting. Rather, it is a close examination of the topic, from a perspective that isn’t already enmeshed in the dominant narrative of science, that isn’t interesting. Scientists, according to PLoS, aren’t interested in a critique of representation and ethics in science and science policy—especially, I gather, if that critique comes from outside the scientific establishment.

This presents a conflict of interest for scientific publications. Journals have very little incentive to challenge the government and funding agencies that are responsible for the research that fills their pages. They have even less incentive to publish work that challenges the commitments of their readership. It is a more or less heroic act for a journal to publish an article that takes its readership to task; the first example that comes to mind is the New England Journal of Medicine publication authored by Henry Beecher (paywall), calling out unethical medical expeiriments that occured in the twenty years following World War Two.

Instead, the bioethics and health policy articles that reach the scientific community are largely situated as op-eds (reinforcing the opinion that bioethics and health policy are “mere opinion”), privilege scientists and physicians as authors, are limited in their scope, and are likely to be conservative relative to the values of the scientific community. Everything else is likely to be relegated to journals that the scientific community don’t read. That’s not exactly a recipe for progress.

PLoS has the capacity to change that, but I fear that it won’t. For all that it is marketed as a revolution, open access doesn’t change scientists, and thus is unlikely to change science. Changing an access barrier doesn’t mean that the culture embedded within that system must necessarily change.

I wasn’t planning on publishing this until I’d finished a couple of other projects, but today it was revealed that a peer reviewer—a single peer reviewer—caused a paper under review in the PLoS family to be rejected on sexist and inappropriate grounds. The article, authored by Fiona Ingleby (University of Sussex) and Megan Head (Australian National University) , investigated gender differences in Ph.D.-to-postdoctoral transitions. The charming review had this to say:

Reviewer’s conclusion: we should get a man’s name on MS to improve it (male colleagues had already read it) (2/4) pic.twitter.com/fhiyzNG0R8

— Fiona Ingleby (@FionaIngleby) April 29, 2015

It seems that more than just having a problem with ethics and ethicists, PLoS isn’t capable of holding a sustained conversation about the social, ethical, and political structure of science. Its editorial process allowed a paper to be rejected, under peer review, because there weren’t enough male authors. In many ways, PLoS’ open-access policy allows those historically excluded from science to see what is going on. Getting in and providing a substantive critique of that exclusion, however, faces significantly higher access barriers than a paywall.

That’s a blow to an organization whose authors—and, I presume, readership—describe its business model as a revolution. Other journals don’t promote the same image of their efforts changing the way science is done: if you want to call Nature an embodiment of science today—flaws and all—that’s more or less consistent with how Nature purports to operate.  PLoS claims a different status, but I fear it is more a rhetorical device than a substantive change in the way business is really done in science.

One of my doctoral supervisors, Seumas Miller (who I can almost guarantee will never be published in PLoS) noted that for a system to possess integrity, it needs more than simply the right set of top-down regulations. It also needs a commitment to ethics, and it needs to put that front and center. It has to structure its regulatory framework—and peer-review and editorial are both regulatory frameworks—in a way that promotes and reflects the ethical commitments of the institution and its members.

I’m not sure that an editorial-driven, non-anonymised review process can do that. A journal family that doesn’t establish a commitment to the social and ethical issues in its own field, and designs its journals and review processes around that, won’t succeed at generating substantive changes in the way science gets done. PLoS is a political project within science, but it needs to operate on a basis of reform that is more developed than a mere commitment to open access. The revolution won’t be complete until that happens.

I don’t expect a PLoS Ethics and Science Policy to happen any time soon. Researchers in that domain rarely have the $2900 on hand for publication in PLoS, and I don’t expect the journal family will fund such an endeavor at a loss. But if there is room for that kind of venture—and the Eisens still want to talk to me after this—I think it would be truly revolutionary.

Comments on That CRISPR Paper

If you’ve got a pulse and are interested in biology, you’ve probably heard that a team of scientists have reported successfully (well, kinda) conducting germ line editing on human embryos using the CRISPR-Cas9 technique. I started hearing rumors of this study around the time that a moratorium on germ line experiments in humans was being proposed by some Very Big Deals. With confirmation that the study is real, the bioethics and life sciences worlds are all a-twitter (somewhat literally).

There’s an ugly side to the current furor, and a lot of it has to do with the nationality of the research team. Apparently the fact that Chinese researchers conducted the study has given people cause for alarm. That there is straight up racism, seasoned liberally with some vintage Cold War nonsense; Kelly has gone over this in a lot more detail. I won’t say any more on this, except to remind that people that when I teach about unethical research, Nazi Germany and the United States of America account for the overwhelming majority of my examples. So let’s all keep a bit of perspective.

Risks, Benefits, and Arguments

Instead, I want to talk about this paper in the context of risks and benefits, and proposed regulatory action around CRISPR. Let me be clear: I think we need to proceed very carefully with CRISPR technologies, particularly as we approach clinical applications. There was a worry that a group had used CRISPR on human embryos. That worry was vindicated yesterday.

Well, sort of. Almost. Not really?

From where I sit, the central concern is best expressed in terms of the risks of using CRISPR techniques on potentially viable human embryos. Commentary in Nature News highlights this concern perfectly:

Others say that such work crosses an ethical line: researchers warned in Nature in March that because the genetic changes to embryos, known as germ line modification, are heritable, they could have an unpredictable effect on future generations. 

The central premises are that 1) CRISPR studies on viable human embryos could lead to significant genetic changes to the resulting live humans; 2) these genetic changes could have unpredictable effects on those humans; 3) the changes could be propagated through human reproduction; and 4) this propagation of changes could have an unpredictable effect on future generations. The conclusion is that we shouldn’t be conducting studies on viable human embryos until we’ve done a lot more research, and have a better mechanism for ethically conducting such research. I support this argument.

The conclusion doesn’t obtain in this case, however, because these embryos weren’t viable. As in, they are never going to result in human beings, and never were. They are “potential human beings” to about the same degree that the Miller-Urey experiment is a potential human being.

Above: not a potential human being.

What the study does show—conclusively— is that the clinical applications for germ line editing require substantial research before they are safe and effective, and this research should be approached with incredible care. The sequence the scientists attempted to introduce into the embryos only took hold in a subset of the embryos tested. Those embryos that did take the change, also produced many off-target mutations (unwanted mutations in the wrong places on the genome). And even when the embryos did show the right mutation, it was only in some cells —the resulting embryos were chimeras, in which some cells possessed the mutation, and others didn’t.

This experiment shows that you can use CRISPR-Cas9 on a human embryo. But that isn’t really a revolutionary result. What is important is just how marginal the success was in terms of a clinically relevant outcome. The conclusion we should draw is that even starting in vivo testing with viable embryos is not only hazardous (for reasons Very Big Deals have noted), but totally futile relative to less risky, more basic scientific inquiry.

Rather than an ethical firestorm, I view this research as an opportunity. This study is, more or less, proof that a robust, community-centered deliberative process is needed to determine what the goals of future CRISPR research are, and what science is needed, in what order, to get there safely. A moratorium on in vivo testing in viable embryos is a valuable part of this process.

Ahistorical narratives in a time of science.

[Update: someone at The Atlantic confirmed for me that this was not so much their article, as it was run  “as part of our partnership with the site Defense One.” Defense One is a part of the AtlanticMedia group, which owns both publications. As the science editor for Defense One—where the piece was first published—it isn’t totally clear to me who edited Tucker’s work for content, other than… himself? Transparency and accountability, anyone?]

Patrick Tucker has a piece in The Atlantic titled “The Next Manhattan Project.” It concerns the current dual-use gain-of-function saga—now the so-called deliberative process about biosafety. It is, in short, a piece of ahistorical fiction. Here’s why—or, here is one list of reasons why.

1) “In January 2012, a team of researchers from the Netherlands and the University of Wisconsin published a paper in the journal Science about airborne transmission of H5N1 influenza, or bird flu, in ferrets.”

False. It was two papers: one in Nature by University of Wisconsin-Madision researchers; one in Science by Dutch researchers. When a writer for The Atlantic can’t Google something that happened 3 years ago, you can bet the previous century is going to be a challenge.

2) Eschewing the history behind current events: “[the 2012 paper (should be papers)] changed the way the United States and nations around the world approached manmade biological threats.”

False. The 2011 (it started in 2011, not 2012) controversy was a continuation of a, by then, decade-old debate about what is now called dual-use research of concern. This started in 2001, when a team of Australian researchers published work describing the creation of (in VERY simplistic terms) a super-poxvirus.There was a CIA report, and a NAS committee. Oh, and does anyone remember Amerithrax?

3) “it solved the riddle of how H5N1 became airborne in humans.”

False. Hilariously, the standard defense of the 2012 studies (remember, The Atlantic, plural) is that they don’t show how H5N1 can transmit via aerosolized respiratory droplets. Vincent Racaniello commonly refers to this as “ferrets are not people.” There’s a complexity about animal models that doesn’t lend to those kinds of easy conclusions. It wasn’t the end result of these papers (or the papers that followed), and it certainly wasn’t the intent of the researchers.

4) Eschewing the reasons behind the Manhattan Project.

The Manhattan Project has a complex history. A group of independent, politically minded—largely emigre—scientists; a world on the edge of war; a novel and particular scientific discovery with a potentially catastrophic outcome; and a belligerent power (well, powers—the Japanese and Russians had programs, in addition to the Nazis) the scientists had good reason to suspect was pursuing said technology.

The 2012 story has almost no parallel with these contexts—much less has an organizational, clearly defined set of ends, or unilateral mandate with which to achieve those ends. The existential threat in the background of the Manhattan Project is absent here—there is no Nazi power. If we truly considered H5N1 highly pathogenic avian influenza to be an existential threat, our public health systems and scientific endeavors would look totally different.

5) Misrepresenting the classified complex.

Despite it being the single comparison Tucker draws between the 2012 studies (plural) and the Manhattan Project, Tucker doesn’t discuss the classified complex as any more than a passing comment. He boils the entire conversation down to “but now the Internet makes classifying things hard.”

Never mind that the classified community was remarkably successful at its job, to the point where it invented ways to create information sharing within an environment of total secrecy. The classified community continues to do its work today—just because we don’t pay much attention to Los Alamos, Oak Ridge, or Lawrence Livermore don’t mean they don’t exist.

Tucker also misses some of the human factors that would actually make his claims interesting. Between Fuchs and the Rosenbergs, ye olde security could be compromised in much the same way as it is today: too much trust of the wrong people, and a bit of carelessness inside the confines of a community that thinks itself insulated. If anything, the current debate about dual-use is more about misplaced trust and overconfidence than it is about nukes.

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These are only five of a variety of problems with Tucker’s article. What bothers me most is that the headline grants a legitimacy to one perspective on the current debate that simply isn’t warranted. These scientists aren’t racing against the clock to avert a catastrophe—and if they are, their methods are questionable at best. The current debate is far more nuanced, and far less certain than the conversation that went down in Long Island in 1939. And that’s saying something, because the debate then was pretty damned nuanced.

What would the Next Manhattan Project really look like? Lock the best minds in biology in a series of laboratories across the country—or world, that’s cool too. Give them at least $26 billion. And give them charge of creating a cheap, easily deployable, universal flu vaccine.

That’d be great. Or, at least, it’d be much better than The Atlantic’s piece from yesterday.

Book Interest: A Straw Poll

A question for readers of this blog, and followers on Twitter. If I and two co-editors were to release an interdisciplinary edited collection on the 2013-2015 Ebola Virus Disease Outbreak, would you read it? This collection would cover topics including:

• Virology;
• Clinical Medicine;
• Epidemiology;
• Ecology;
• Political Science;
• Anthropology;
• Journalism;
• Health Law;
• Bioethics.

If this is something that interests you, leave a comment, reply to me on Twitter, or drop me an email at neva9257 [at] Gmail dot com. If you can, please note your country of residence, field that you work in (research discipline, teaching/policy/research/public health, etc.) , and what you’d use such a volume for (reference, scholarship, teaching, general interest, coffee table, doorstop, etc.)

This is a project I’ve had in the works for some time, and my colleagues and I are almost at a contract. Demonstrating some interest will get us over that line.

#shirtstorm: men hurting science.

Or “why the signs and symbols that create the Leaky Pipeline are unethical, and compromise the integrity of science itself.” This post because Katie Hinde asked, and this is just as important as the other writing I’m doing.

If you float through my sector of the Internet, you’ve probably heard or seen something about #shirtstorm: the clown in the Rosetta project—which just landed a robot on a comet—who decided it’d be the height of taste to be interviewed wearing this:

https://twitter.com/roseveleth/status/532538957490561024

Yes, that’s Rosetta scientist Matt Taylor in a shirt depicting a range of mostly-naked women. The sexist, completely unprofessional character of this fashion choice is pretty obvious. Taylor also doubled down by saying of the mission “she is sexy, but I never said she is easy.”

Way to represent your field, mate.

Better people than me have talked about why the shirt is sexist, why it marginalizes women, why the response is horrid, and why the shirt—as a sign—is bad news. I’ve also seen a lot of defenders of Taylor responding in ways that can be boiled down to “woah, man [because really, it is always “man”], I just came here for the science.”

But the pointy end of that is that this does hurt science. Taylor, and his defenders, are hurting science—the knowledge base—with their actions.

As a set of claims about the world, science is pretty fabulous for the way that claims can be subjected to the scrutiny of testing, replication, and review. Science advances because cross-checking new findings is a function of the institution of science. It’s a system that has accomplished also sorts of amazing things—including putting a robot on a comet.

Image courtesy Randall Munroe under the Creative Commons Attribution-NonCommercial 2.5 License

Yet science advances only as far, and as fast, as its membership. This has actually been a problem for science all the way back to before it was routinely called “science,” when STEM was more or less just “natural philosophy” (“you’re welcome”—Philosophers). When American science—particularly American physics—was getting started in the 19th century, it went through an awful lot of growing pains trying to institutionalize and make sure the technically sweetest ideas made it to the top of the pile. It is the reason the American university research system exists, the American Association for the Advancement of Science exists, and why the American PhD system evolved the way it did (and yes, at the time it was basically about competing with Europe).

Every country has their own history, but the message is clear—you only get science to progress by getting people to ask the right questions, answer those questions, and then subject those questions to a robust critique.

The problem is that without a widely diverse group of practitioners, you aren’t going to get the best set of questions, or the best set of critiques. And asking questions and framing critiques is highly dependent on the context and character of the questioners.

The history of science abounds stories in which the person is a key part of asking the question, even as the theory lives on when they die (or move on to another question). Lise Meitner in the snow, elucidating the liquid drop model of atomic fusion. Léo Szilard crossing the street, enlightened by the progression of traffic lights into the thought of the nuclear chain reaction. Darwin and his finches. Goodall and her chimpanzees. Bose and his famous lecture that led him to his theories of quantum mechanics.

The point is that the ideas of great scientists, and the methods they use, depend on the person. Where they came from; how they experience the world. In order to find the best science, we need to start with the most robust starting sample of scientists we can.

When people are marginalized out of science—women, people of color, LGBQTI people, people with disabilities, people of other religions—the sample size decreases. Possible new perspectives and research projects vanish from science, because a bunch of straight white dudes just can’t think of it. That’s bad science. That’s bad society.

This has real, concrete implications for science and medicine. Susan Dodds, a philosopher and bioethicist at the University of Tasmania, has a wonderful paper called “Inclusion and exclusion in women’s access to health and medicine” (You can find the paper here). Dodds notes that the way our institutions are set up, access to healthcare and medical research is limited by the role of gender. Women’s health issues—again, in care and research—tend to be sidelined unless it has something to do with reproduction. This is to the point that research ostensibly designed to be sensitive to sex and gender often asks questions and uses methodology that limit the validity of experimental results to women, individually or as a group. The scientific community quite literally can’t answer questions properly for lack of diversity, and asks questions badly from an excess of sexism.

You can imagine how that translates across fields, and between different groups that STEM has traditionally marginalized.

So when you defend Matt Taylor, allow people to threaten Rose Eveleth, and tolerate the vitriol that goes on against women—in STEM and out of STEM—you limit the kinds of questions that can be asked of science, and the ways we have of answering those questions.

You corrupt science. You maim it. You warp it.

I realize this shouldn’t be a deciding factor—Matt Taylor’s actions are blameworthy even if he wasn’t engaged in a practice that contributes to the maiming of science. But for those who can’t be convinced by that, who “just want to be about the science,” take a good, long hard look at yourself.  If the litany of women scientists who never got credit for their efforts wasn’t bad enough, there are generations of women scientists—Curies, Meitners, Lovelaces, and Bourkes—that never were. We’re all poorer for that.

So next time you want to be “just about the science,” tell Matt Taylor to stick to the black polo.

Fetishizing science in a time of Ebola

It didn’t matter to me – I was in it for the science. –GLaDOS.

Science provides us knowledge. But—for most—science and the knowledge it brings isn’t the only or most important thing out there. Modern biomedical ethics is built upon, among other seminal statements, the Declaration of Helsinki, which states that:

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

That’s one of the reasons it was so concerning to stumble across a new article on Scientia Salon, brainchild of CUNY Professor of Philosophy Massimo Pigliucci, in which it was argued that anyone who wants to receive an experimental treatment for the Ebola virus must enroll in a placebo-controlled, randomized clinical trial. The author, evolutionary biologist Joanna Monti-Masel, claims that

The unethical behavior here…is not doing an experiment, but doing an experiment without using a control group. There should be no compassionate use exceptions. Everybody who wants these treatments should have to enter a randomized trial to have a chance of getting them.

…At least five patients have received a potentially effective treatment, but nobody has yet been assigned to a control group. This is the ethical travesty, and it needs to stop.

For those catching up, the Ebola outbreak that is believed to have started in December of 2013 has infected 1,975 people, and killed 1,069. Last week, the WHO declared that the outbreak constituted an Public Health Emergency of International Concern; this week, a WHO ethics advisory committee released a statement approving the use of unregistered interventions for Ebola. Kelly Hills and I have written on the ethics of latter part here.

Monti-Masel, however, thinks that the WHO is acting unethically by allowing for “compassionate use,” which the WHO is defining here as access to an unapproved drug outside of a clinical trial. Rather, she argues, anyone who wants access to these new drugs must be part of a clinical trial.

And not just any trial. Monti-Masel believes that the only way we ought to collect data about these experimental interventions is by setting up a double-blind, randomized clinical trial in the middle of an epidemic in West Africa. That is, we offer those suffering from Ebola—which is primarily killing vulnerable members of the nations of Sierra Leone, Guinea, Liberia, and Nigeria—something, which may or may not be a drug that may or may not work, or might be a sugar pill. We don’t tell them which one it is, because we won’t know which it was until after the fact. We then determine who gets better, and which ones get worse. And if that isn’t what the patient wants, then they get nothing.

Science for the sake of science

It is worth noting, first up, that Monti-Masel is reacting to a hypothetical storm in a nonexistent teacup. Aside from the WHO ethics committee’s general recommendations that data collection is necessary, but must be collected and shared ethically and equitably, there’s nothing else to suggest what types of data collection, and study design, might be permissible. Moving immediately to the need for control groups and randomized trials presumes a lot about the WHO’s mild statement, and jumps the gun on a lot of serious ethics that has to happen before—and has to involve the countries that are actually in the middle of this outbreak.

But more importantly, Monti-Masel fetishizes data collection above and beyond any other consideration. The main benefits she cites is the power of the studies that could be achieved through a randomized trial. All other concerns are secondary, it seems, to the possibility of doing accurate—not good—science.

But that’s wrongheaded; more, it is paternalistic and racist—to say nothing of deeply myopic—to presume that the central purpose of these interventions ought to be to collect data. Collecting data is necessary; collecting data is good. But the ways in which collect that data, and the quality of data we should aim for, must be subject to the central aim of these interventions: “to try to save the lives of patients and to curb the epidemic.”

Requiring participation in a randomized, placebo-controlled clinical trial in order to access these drugs is deeply paternalistic. It presumes that the priorities defined by Monti-Masel’s hypothetical study are not only the best for the scientist, but the best for everyone. It doesn’t even consider that the people of a country embroiled in an Ebola epidemic might not want to participate in a placebo-controlled trial. Indeed, Monti-Masel claims that compassionate use outside of a clinical trial would be “an ethical travesty” because it would give us lower quality data for lack of a suitable (placebo) control group.

That reduces the patient to a mere data point. Considering the lengthy history of drug testing in African countries that leave the communities in which they are tested worse off, it is not hard to detect the racism implicit in such an extreme study design. History is rife with contributions “to the legacy of black bodies being manipulated and violated for ‘the benefit of all.’” To be ethical, research—even in small samples such as must occur with the limited experimental agents present for this outbreak of Ebola—must take into account practices that respect the agency and priorities of the participant. People are not simply data points; vulnerable populations are not simply a convenient supply of test subjects.

Finally, advocating placebo controls simply misses the ethical forest for the trees. Monti-Masel claims:

One final concern is that many Africans are suspicious of Western doctors and experiments, and that their fears will keep them away. That’s fine, at least for now. That’s what the ethical principle of autonomy is about, crystallized in the notion of informed consent.

Rather, we should simply let those prospective patients know that if they want a chance at accessing an intervention, they have to enroll. If not, they are just out of luck—a move that is, as already discussed, paternalistic and racist. This doesn’t concern Monti-Masel, however:

Plenty of infected Africans will probably refuse to take part in the trial. That’s okay, because we don’t have enough treatments to go around anyway.

This completely misses the point of the “suspicion of Western doctors” about which people are concerned. To know why, ask this question instead: what happens when it becomes clear that Western doctors are only offering the hope of drugs if you’ll sign up to their trials? In an outbreak in which people are already avoiding reporting cases, or hiding loved ones that are infected with the virus; for a disease that, historically, has generated mistrust in Western interventions; what does Monti-Masel think the impact of a placebo-controlled trial will be for the outbreak as a whole? I know there are no RCTs on that topic, but any student of history would be able to tell you that things will go downhill fast. Trust is a vital element in a public health intervention. Jeopardizing that trust in the name of a small trial values the data above the lives of everyone in the outbreak.

This is a disappointing article in Scientia Salon. The submission itself is problematic; the comments are horrific. One hopes that in the future the site will look closely at submissions, in light of the enthusiastic endorsement of enforced autopsies that has resulted from this post. There is power in the platform, and in the middle of an outbreak this is not a productive contribution.

Doing better means asking, not telling

Hills and I have already argued, at length, about the ethics of distributing these drugs. We’ve advocated that those “who have traditionally and unjustly held power over African nations, step back and accept our role as people to provide assistance, rather than determine it.” It isn’t surprising that Monti-Masel’s reply has struck the worst possible chord.

Moreover, there is still good science that we should be doing, in partnership with the countries that are the site of this outbreak. Giving up the fetish of the placebo control group doesn’t mean giving up on trials, or good research. It just recognizes that certain kinds of study are unethical to pursue in the context of a dangerous disease outbreak, among a vulnerable population that are prone to exploitation by Western powers.

At the end of the day, we want science to be commensurate with other important values. Making science—one type of science—the be-all and end-all of our ethical considerations takes the very important role of knowledge in promoting human health, wealth, and security, and perverts it. We do not want to be like GLaDOS, the super-intelligent, passive aggressive antagonist of the Portal franchise.

Our motto should never be:

I’ve experiments to run,

There is research to be done;

On the people who are still alive.

Paternalism, Procedure, Precedent: The Ethics of Using Unproven Therapies in an Ebola Outbreak

The World Health Organization convened an ethics panel on Monday to discuss the ethics of using experimental treatments in the current Ebola outbreak in—so far—Guinea, Liberia, Sierra Leone, and Nigeria. The panel has, thankfully, concluded that “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”

Nonetheless, the reasons for this decision aren’t necessarily clear; statements like the one issued today are typically light on the details. My own experience on social media is that there isn’t a lot of clarity on the range of decisions we might take into account in coming to such a decision, and how we decide what’s important. And—believing, as I do, that ethics is as much a conversation as it is a set of decisions—that leaves open significant potential for misunderstanding and misrepresentation.

Kelly and I wrote the following over the weekend, but were sidetracked in posting it by pesky things like scientific accuracy, and the controversy that followed the announcement that a Spanish priest had also received the Zmapp treatment. We post this, as Kelly so beautifully put it, in the hope that it will be “is useful for answering the questions people who don’t have much background in ethics may have, as well as getting into the cultural zeitgeist for discussions not only about future pandemic situations but also discussions about disparate treatment of people from the Developed vs Developing World.”

[Cross-posted at Life as an Extreme Sport]

A “secret serum.” A vaccine. A cure. A miracle. With the announcement of the use of ZMapp to treat two Americans sick with the Ebola virus with apparently no ill effect, the hum and buzz on social media, commentary websites, and even the 24/7 news cycle, has become one of “should the serum be given to Africa? Will it?” The question has dominated for more than a week, and become something that the World Health Organization feels it needs to address by convening a panel of medical ethics experts to offer an analysis of what should be done.

And the general question about untested cures/vaccines in the event of a disease pandemic is an important one; there are already guidelines for what kind of treatments can and will be made available during a flu pandemic, and it seems quite sensible that a guideline be developed for all potential pandemic pathogens. However, it isn’t a question that is relevant in the current context, because we are already past that.

While people may be stating “should the serum be made available?” that’s not the question being asked.

It isn’t the question being asked, because we already know the answer: yes. In this last week, the serum has been made available—to Kent Brantly and Nancy Writebol. The pair of American health care workers have received the ZMapp serum, which, until this past week, had not been tested on any human subjects. We already know that the answer to whether or not the serum should be made available is “yes”–or at least, “yes, to people like us.” [1]

Instead, more specifically, the implicit (and at times very explicit) question being asked is: “should the serum be made available to the West African countries suffering from the current Ebola outbreak?”

Your instinctive response to this might be “yes! This is clearly a matter of equality and justice; the lives of those people suffering from Ebola in Sierra Leone, Guinea, Liberia, and Nigeria[2] are just as important as the Americans who were given the serum.” If so, good reader, then this essay is not addressed to you. After all, you have clearly reached the same conclusion we have: Why shouldn’t—assuming that Mapp can make good on its claims that it can manufacture sufficient quantities of their serum—those who are suffering have care made available? There are risks, to be sure. But those risks were clearly outweighed by the urgency of the situation in which Brantly and Writebol found themselves, and in which hundreds (if not thousands) of people across the Atlantic find themselves now.

And why not? If it is in our power to help those suffering, we ought to do so. Justice and equality are traditions upon which civilizations are based. Adam Smith, better known for his “invisible hand” of the market, believed that societies are only worthy when they are just. Peter Singer has argued that if we can help those in need at no cost to ourselves, we simply must do so. And Thomas Pogge has, for more then a decade now, argued that the historical injustices faced by countries who were preyed on by the West obligate those living today to assist in supporting the health systems of those countries, and bettering the lives of their citizens.

Indeed, the responses to “why not,” which attempt to justify not sharing a treatment already given to two people, has an uncomfortable relationship to the historical injustices that Pogge references. These objections, often made with good intentions, can be broadly broken down into three categories: paternalism; procedure; and precedent.

Paternalism

With paternalistic objections to proving experimental Ebola treatments to Western African nations in need, it’s common to hear concern about corruption, ability to consent, or even a call-back to previous, unethical testing on vulnerable human subjects. Perhaps the most common of these is the belief that all governments in Africa are corrupt maws that inhale non-governmental organization money and aid to prop up an exclusive elite at the expense of the rest of the country. The history of corruption, from the power voids left by colonial government departures, to the actual problems created by colonialism (complete with unnatural country delineations) are broadly recognized and, importantly, well beyond the scope of a post arguing that it is ethical to allow these countries self-determination.

A more specific ethical concern is that people who are gravely ill are often viewed as being unable to give consent, let alone informed consent. Much of the current outbreak has occurred outside of city areas, in rural and remote areas of the affected countries. There are some valid questions about whether or not people can genuinely understand the risks and benefits of using a completely experimental vaccine if they don’t have anything that easily maps onto the “basic education” system common in the developed world. There is also the fact that when people are gravely ill, they may not be cognizant and aware enough to grant consent, or that their family is so desperate for a cure that they will do anything, regardless of risk.

Neither of these issues, though, means that it is impossible for infected patients or their families to made determinations about what kind of care they would like to receive. An aspect of receiving informed consent is to make sure risk and benefit is described in a way that makes sense and is understandable to the people making the choices; in this, the reverence for autonomy of the individual should be respected, rather than the paternalistic instincts of those in positions of power.

Informed consent also ties into specific and ugly histories involving pharmaceutical testing and African countries. There is a history of many countries in Africa, like Zimbabwe and South Africa, being exploited for AZT trials, experimental hormonal contraceptive, and other drugs and devices. These trials are frequently coercive, and have contributed to the legacy of black bodies being manipulated and violated for “the benefit of all.”

Fears about consent and testing on vulnerable populations are valid; no one is saying to parachute the ZMapp serum down in little chilled coolers for willy-nilly application. Merely that, given the history of testing on vulnerable people and exploiting the populations of African countries, rather than standing in a position of authority saying “let us decide whether or not we will let you make your own decision,” the West should step aside and say “this is your choice.”

The difference here is stark: it’s a matter of forcing an option vs. accepting that the choice is to be made by someone not you (where “you” is “the West”), and that these countries are full-fledged countries who have their own systems and own choices.

Procedure

Others believe that there is an ethical issue in distributing the serum on a broad scale. Some people claim that the outbreak provides the perfect opportunity to conduct a large, randomized control trial (RCT)—the “gold standard” of medical research—of ZMapp. Others believe that such a trial is impossible in the context of a pandemic, and we should thus hold off from making the drug available for lack of ability to monitor the drug’s efficacy.

We believe both positions are false. By fetishizing the gold standard, we—the USA and developed world—miss the point of our role as participants in solving this disease outbreak. Standards of evidence required for drug use are different from country to country, even in the developed world. They are also different in different contexts, and levels of urgency. An RCT would introduce an element of testing to treatment that, given what we know about the justified mistrust that people in developing nations have of the developed world and their experiments, would creating more tensions in countries wary of Western medical interventions. The potential of an RCT to backfire and jeopardize the provision of care makes it unwise—without changing our conclusion that assistance must be rendered.

But the lack of wisdom in conducting an RCT doesn’t mean we should just throw up our hands and not assist. If the countries responsible for managing the outbreak thought it opportune, a large cohort study could be done where everyone who is able receives treatment, and the results are compared to the history of the virus over time. This might not allow researchers to control every factor, but it would go a long way to showing the efficacy of ZMapp the next time Ebola surfaces.

Talk of trials, however, misses the point of our role in participation in a more fundamental way. If you aid someone, you do so for their benefit on their terms. We don’t want to mandate data collection “for the good of West Africa.” We should ask the decision makers inside Guinea, Sierra Leone, Nigeria, and Liberia how we can best collect data with them, for them and their benefit as they see it.

The WHO has developed frameworks for this in other disease contexts, such as pandemic influenza.[3] While these need not define the scope of cooperation, the past can serve to guide deliberation on how best to assist. The WHO’s policies, by virtue of being reached through international consensus, gives extra weight to the global nature of this cooperation.

Precedent

The WHO can play an extra role in countering the paternalism of intervention by developed nations, while beginning the process to set a good precedent for future outbreaks. Jeremy Farrar, David Heynmann, and Peter Piot have argued that:

“The [WHO] could assist African countries with developing rigorous protocols for the use and study of experimental approaches to treatment and prevention, while coordinating more traditional containment measures. As the only body with the necessary international authority, it must take on this greater leadership role.” [5; emphasis added]

The capacity of the WHO to provide oversight, while still enabling African countries to enact their own protocols and treatment plans, is our best chance to address concerns over oversight of the outbreak. There is no denying that this outbreak is international, and without proper management more countries could see cases of Ebola arise. An international body is better equipped to do this with legitimacy, and without paternalism, than any one country alone. The recent declaration by the WHO that the Ebola outbreak is a Public Health Emergency of International Concern, and their accompanying recommendations, is the perfect backdrop for this type of action.

Compassion, or Colonialism

We have to ask ourselves if we want to continue inflicting the wounds of colonialism on African nations. Insisting that Americans are a “special case” when it comes to a disease with a current CFR of 56% only underscores a persistent mistrust: that people in the West get better treatment and care, because those lives are valued more than the lives in developing parts of the world. This fear can be seen in previous Ebola outbreaks: During the 2000-2001 Ugandan outbreak of Sudan ebolavirus, an existing pervasive belief that Euro-Americans visit Central Africa to harvest body parts for profit was amplified by infectious disease control efforts, resulting in infected individuals and their family running and hiding from medical treatment, magnifying the extent of the outbreak. Many local people during the 2002 outbreak of Zaire ebolavirus in the border areas of Gabon and the Republic of Congo believed that Ebola was a disease invented by the French to eliminate African populations (allowing the French unfettered access to their lands and materials).[4] Currently, people in Liberia are already asking why, if there is no cure for Ebola (the standard response on the ground), the Americans are being cured. [5]

The choice to use the experimental vaccine was already made; that genie is well and truly out of the bottle. The question you have to ask yourself is this: can you live with supporting the idea that the lives of Brantly and Writebol are more important than the life of Shiekh Umarr Kahn, the only virologist in Sierra Leone? What about Dr. Samuel Brisbane, the chief medical officer of one of Liberia’s medical centers? How about the other approximately 800 people spread between Nigeria, Sierra Leone, Guinea, and Liberia, all of whom are certainly valued by the people within their lives.

Is this an appeal to emotion? Certainly. Sometimes decisions about what is moral, ethical, right, requires seeing the people you’re talking about as people, rather than numbers and statistics on the other side of an ocean. But that emotion can and should build into our conception of ethics and justice. Returning to the legacy of Adam Smith, “the relief of misery for its own sake is an impulse whose justification is a core intuition…of any plausible theory of moral thought.”[6]

We know that Ebola is a disease of missing infrastructure, poverty, and minimal health care systems. No one is suggesting that these countries not be given the help that they are asking for, in containing the disease, in implementing public health strategies, or in having access to any experimental cures and vaccines available. No one denies that there are ethical issues at stake. Nor are we stating a belief that ZMapp–or Tekmira, or any other unproven intervention–will stop the current outbreak. What we are advocating is merely that we, who have traditionally and unjustly held power over African nations, step back and accept our role as people to provide assistance, rather than determine it.

— Kelly Hills and Nicholas Evans

[1]: While some light debate may have questioned whether or not Brantly and Writebol had the ability to consent, there has never been a serious question here in the USA of not giving them the serum.

[2]: Not “Africa.”

[3]: World Health Organization. Pandemic influenza preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits. Geneva, 2011. http://www.who.int/influenza/resources/pip_framework/en/ Accessed 8 August 2014.

[4] Hewlett BS, Hewlett BL. “Ebola, Culture and Politics: The Anthropology of an Emerging Disease,” pp 57;77. Thomson Wadsworth; Belmont, California; 2008.

[5] Farrar J, Heymann D, Piot P. Experimental Medicine in a Time of Ebola. Published 6 August 2014: http://online.wsj.com/articles/experimental-medicine-and-african-ebola-1407258551 Accessed 7 August 2014.

[6] Campbell, T. “Poverty as a Violation of Human Rights: Inhumanity, or Injustice?” in Pogge, T., Freedom from Poverty as a Human Right: Who Owes What to the Very Poor? (Oxford, UK: Oxford University Press, 2007)