Adaptive Ebola vaccine trials

There's a New York Times Room for Debate feature has an excellent discussion of the ethics of trials for Ebola treatments and vaccines. Here's part of the essay by Nancy Kass and Steven Goodman:

Ethics is not just figuring out which side poses better arguments; often it’s best to find a third way. Given the breadth and deadly nature of the current Ebola outbreak, and unknowns about treatments, an "adaptive approach" seems most appropriate. Adaptive approaches allow researchers to plan a sequence of studies, or modify a single study in almost real time, as they learn more about a drug. In West Africa, for example, the first 40 Ebola patients in a trial could all get an experimental treatment, and nobody would take a placebo. If nearly all patients survived, in settings where most others were dying with the same supportive care, then it is possible that placebo testing could be avoided, and subsequent trials could randomize to different doses or treatments.

But if the results of the first trial, without placebos, revealed anything less than an almost certain cure, a design with proper controls would have to be initiated, and explained to those participating in the trial. Patients must be told that the drug is not a guaranteed life-saver, so they can see the point of the control group. (And given the multiple beliefs about Ebola among West Africans, creative approaches to promoting understanding and consent are important as well.) These placebo-controlled trials could themselves be adaptive in design, randomizing more patients to whichever therapy appears most effective, until the verdict is clear. If we are to design trials to minimize suffering and death in a whole population, we must temper our compassion with humility about what we think we know.

Biological warfare: malaria edition

Did you know Germany used malaria as a biological weapon during World War II? I'm a bit of a WWII history buff, but wasn't aware of this at all until I dove into Richard Evans' excellent three-part history of Nazi Germany, which concludes with The Third Reich at War. Here's an excerpt, with paragraph breaks and some explanations and emphasis added:

Meanwhile, Allied troops continued to fight their way slowly up the [Italian] peninsula. In their path lay the Pontine marshes, which Mussolini had drained at huge expense during the 1930s, converting them into farmland, settling them with 100,000 First World War veterans and their families, and building five new towns and eighteen villages on the site. The Germans determined to return them to their earlier state, to slow the Allied advance and at the same time wreak further revenge on the treacherous [for turning against Mussolini and surrendering to the Allies] Italians.

Not long after the Italian surrender, the area was visited by Erich Martini and Ernst Rodenwaldt, two medical specialists in malaria who worked at the Military Medical Academy in Berlin. Both men were backed by Himmler’s Ancestral Heritage research organization in the SS; Martini was on the advisory board of its research institute at Dachau. The two men directed the German army to turn off the pumps that kept the former marshes dry, so that by the end of the winter they were covered in water to a depth of 30 centimetres once more. Then, ignoring the appeals of Italian medical scientists, they put the pumps into reverse, drawing sea-water into the area, and destroyed the tidal gates keeping the sea out at high tide.

On their orders German troops dynamited many of the pumps and carted off the rest to Germany, wrecked the equipment used to keep the drainage channels free of vegetation and mined the area around them, ensuring that the damage they caused would be long-lasting.

The purpose of these measures was above all to reintroduce malaria into the marshes, for Martini himself had discovered in 1931 that only one kind of mosquito could survive and breed equally well in salt, fresh or brackish water, namely anopheles labranchiae, the vector of malaria. As a result of the flooding, the freshwater species of mosquito in the Pontine marshes were destroyed; virtually all of the mosquitoes now breeding furiously in the 98,000 acres of flooded land were carriers of the disease, in contrast to the situation in 1940, when they were on the way to being eradicated.

Just to make sure the disease took hold, Martini and Rodenwaldt’s team had all the available stocks of quinine, the drug used to combat it, confiscated and taken to a secret location in Tuscany, far away from the marshes. In order to minimize the number of eyewitnesses, the Germans had evacuated the entire population of the marshlands, allowing them back only when their work had been completed. With their homes flooded or destroyed, many had to sleep in the open, where they quickly fell victim to the vast swarms of anopheles mosquitoes now breeding in the clogged drainage canals and bomb-craters of the area.

Officially registered cases of malaria spiralled from just over 1,200 in 1943 to nearly 55,000 the following year, and 43,000 in 1945: the true number in the area in 1944 was later reckoned to be nearly double the officially recorded figure. With no quinine available, and medical services in disarray because of the war and the effective collapse of the Italian state, the impoverished inhabitants of the area, now suffering from malnutrition as well because of the destruction of their farmland and food supplies, fell victim to malaria. It had been deliberately reintroduced as an act of biological warfare, directed not only at Allied troops who might pass through the region, but also against the quarter of a million Italians who lived there, people now treated by the Germans no longer as allies but as racial inferiors whose act of treachery in deserting the Axis cause deserved the severest possible punishment.

Our future selves will mock this (I hope)

Smiling people holding hands. Walking on the beach. Inexplicable doves flying through blue skies. Terrible side effects discussed cheerily by a honey-voiced narrator.... That's right, this post is about direct-to-consumer pharmaceutical advertising. Niam Hardimh, writing at Crooked Timber, shares one of the odd things about living in the US -- for those who aren't used to our TV:

One thing that is striking, compared with European TV, is what is advertised and how. In particular,  I don’t think you see ads for prescription medicines in Europe, certainly not in Ireland or the UK. They seem to be all over American TV.

I am particularly struck by the way these ads are made. The visuals  typically show someone having a happy and trouble-free life while using these drugs, overlaid with soothing music and a reassuringly bland voice-over. But clearly the US FDA requires advertisers to include all the small print in their ads as well.

Do you read all the known downsides of the medicines you take? Don’t...

It's easy to become habituated to these since they're everywhere, but it hasn't always been that way, and in most places it still isn't -- the US and New Zealand are the only two countries that allow direct advertising of drugs. Here's an exemplary ad for Vioxx, which was pulled off the market because it caused health problems (which Merck systematically lied about):

Ice skating. A minor celebrity. Inspiring music. They even note that "Vioxx specifically targets the Cox2 enzyme." How many Americans can even define what an enzyme is? I'm sure consumers are more likely to remember that than the mentioned side effects ("bleeding can occur without warning")... Other lovely examples include this other ad for Vioxx, and one for Zocor.

For more examples and some background on how the ads came to be, check out "Sick of pharmaceutical ads: here's why they won't go away" on io9.

Rights bleg

bleg: (Internet slang) An entry in a blog requesting information or contributions. (from Wiktionary)

This entry was prompted by an interesting post on religion and human rights by Kate Cronin-Furman over at Wronging Rights. My question here has little to do with the contents of that particular post other than having been prompted by it in my impossibly tangential brain, but I think it's a great post that you should all read regardless. Now on to my question:

I'm not sure I believe in human rights. Don't get me wrong; I'm not a monster, and I'm really more agnostic on them than a certain skeptic. I also happen to value very highly pretty much all the widely-believed human rights and most everything to which the title of a human right has been expanded. I'm not convinced that my personal normative valuation or preference is the same as actually believing in human rights (their existence and universality), or whether the rights framework is the most true or helpful one. The work I want to do overlaps a lot with rights practitioners and language -- again with the valuation of those ends. I've also read quite a few things written by human rights activists, but mostly on the level of "we were trying to document or stop this atrocity" or otherwise using the language of rights towards an end which I support, but usually assuming from the beginning that the reader believed in human rights. It also seems that a lot of things that just seem good to many people, independent of a rights-based framework, are touted in that language because it is simply what is done. I also get the impression that there are a fair number of people working within the 'human rights establishment' who see the construct as more useful than true (or don't distinguish between the two) but I have no way to verify that.

None of these hesitations are final, of course -- this may simply be a shortcoming in my education that I need to rectify. I grew up very religious and went to a very conservative college that only employs professors who belong to a particular conservative evangelical denomination. I missed out on formal coursework or guided readings in secular philosophy or ethics, or at least any presentation of that material by people who actually believed it. Some of what I learned was heavily filtered through that strain of fundamentalist thought that looks at everything that is not itself and decries it as an un-moored, baseless fantasy. (Amongst others, blame Francis Schaeffer -- one his books recounts the truly atrocious evangelistic technique of trying to convince a confused young person that there are only two intellectually honest ways to reconcile hopelessness resulting from the perceived failure of secular philosophy to find meaning; believe in God or commit suicide.)

There were certainly others who were more gentle in approach but the underlying thought was always there, that there can be no absolute statements -- whether about morality or rights -- without theistic belief. However, in college I took a skeptical turn and eventually came to disbelieve my theist roots altogether. My graduate work has been more technically-focused (which is what I wanted), for example considering how to achieve improvements in health rather than deep thinking about the foundational assumption that there is a right to health. Many of my peers who attended liberal arts schools or research universities have obviously focused on the study of human rights to a much greater extent, whereas my education bypassed it altogether. To some extent I want to believe in human rights because it seems to be the dominant framework and language and things would just be simpler if I did. But wanting to believe something because it's helpful is not enough to me. It seems like it would be easier to believe in human rights if one did believe in a higher power, which may be one reason why liberal religious groups seem well-represented in human rights circles.

So finally, my bleg: what should I read? Is there a single primer on or defense of the foundations of human rights that you would recommend to a secular/skeptical person like me? This could be a book, an essay, a journal article --  whatever you think might be the most convincing case. I think this line of thinking deserves more than a simple read of a Wikipedia page; I'm hoping that you can distill the arguments that you've found most useful in thinking about rights into a few recommendations. Likewise, if you're in the doubter camp or think there is a better secular alternative out there I'd be happy to hear counter-suggestions as well.

Timing

This week in one of my classes we were scheduled to discuss humanitarian intervention and the "responsibility to protect" principle. Our case study is on Libya, and especially on the initial decision to intervene. Not coincidentally, one of the professors for the course is Anne-Marie Slaughter (see her NYT editorial in support of action, just days before UN Resolution 1973). The news of Gadhafi's death broke just before class. Then, after a session touching on these topics in the context of broader theories of international relations, I found myself in a computer lab with several of my classmates. We were mostly checking our email or printing assignments, but the conversation turned to Libya. Someone mentioned that a video had been posted of Gadhafi still alive when he was captured (see here), and we started pulling up different videos and trying to piece together what happened. What order, who did what, how we should react, and so forth.

Separate from the implications of Gadhafi's death for the future of Libya, there's a question of how quickly media has changed how we interact with world events, and how participants in those events seek to portray them. A century ago radio brought real-time news, followed a few decades later by TV. The last decade has seen the proliferation of digital video cameras and the rise of sites like YouTube where anyone can disseminate footage to the entire world, at first side-stepping the old media and then being amplified by it.

I don't know how this situation would have played out a few decades ago, but here we were watching videos taken earlier the same day by rebel forces in Libya. Has there ever been faster turnaround between the fall of a despot, the spread of imagery to shape the narrative of what happened? As viewers and discussants we were participating in the immediate struggle to claim responsibility.

Famine

I want to write something about Somalia, but I don't feel qualified to add much to the discussion. Many smart people have already said much (read here, here, and here). One theme is that it's important to recognize that famine is a human political and economic phenomenon, not a natural one. But others are making those arguments better than I can. The more you know, the more you want to help, and the harder that can seem to do. I think the work I've done this summer in NYC with their Dept of Health has been valuable, but I also feel constrained by my imminent return to the classroom. My emotions say it would be great to assuage my feelings of helplessness now by going somewhere awful and doing whatever needs to be done, right now. But I'm in school because I believe that technical skills are really important when it comes to choosing the right things to do (and measuring their impact) ... so for now I have to wait and let others do the doing.

By all accounts, the situation in Somalia is truly horrific and likely to get worse. Honestly, I've been avoiding reading too much about it because it makes me sad, and it makes me angry. If you're looking for something to do too, the One campaign has compiled a list of organizations working on famine relief. I just made a donation to my charity of choice and hope you will too. My only recommendation is to make your donation to an organization's main donation link, rather than one specific to famine response. Most of the best organizations were likely poised to respond precisely because they had unrestricted, non-earmarked funds from previous donors. They will likely spend as much as they can on these efforts, so your donation will go to Somalia if needed. Or it will go, alas, to the next calamity.

The battle for hearts and minds

A major difference between the public health approach and the beliefs and strategies underlying fields such as human rights or medicine is that public health concerns the prioritization of limited resources. There is a limited pie. Even if you believe that pie can be expanded (it can, at times), it cannot be expanded infinitely, and so at some point in the policy process someone has to make a decision about how to prioritize the resources at hand. This traditional public health approach overlaps with and gets blurred into human rights and medicine and politics such that the value judgments underlying different claims aren't always apparent. We have a certain number of interventions that are known to work -- they save lives and reduce suffering -- but we don't have enough resources to do all of those things in every place that needs them. If we choose option A, some people will be saved or helped, and some will die. If we choose option B, a different number of people will be saved or helped, and some other group of people will die. The discussion of who will be saved is often explicit, while the discussion of the opportunity cost, those who will not be saved is almost always lacking. Both groups are abstract, but the opportunity cost group is usually more abstract than the people you're trying to help. These are generalities of course, and in reality there is uncertainty built into the claims about just how many lives could be saved or improved with any one approach.

The problem is this: pretty much everything we do in global health is good. Sure, we can argue specifics and there are glaring examples to the contrary, but for the most part we all want to save lives, prevent suffering, and improve health. No one is seriously against successful interventions when they stand alone: no one thinks people with HIV shouldn't get antiretrovirals, or children with diarrhea shouldn't get oral rehydration therapy. Rather, they may oppose spending money on HIV instead of on childhood diarrhea (or in reality, vice versa). Who is comfortable with making an argument against preventing childhood burns? Being against treating horrific cancers? Any takers? So we all argue for something that is good, and avoid the messy discussions of trade-offs.

Thus, much of the conflict in the global health fields is about spending money on X intervention versus intervention or approach Y. Or, better yet, traditional and known intervention A versus new and sexy and unproven-at-scale approach B. I don't think I'd want to live in a world where all health decisions are made entirely by cost-benefit analysis, nor would I want to live in a world where all decisions on care and policy are made from a rights-based approach -- both approaches result in absurdities when taken to their extremes and to the neglect of each other. My impression is that most professionals in global health draw insight from both poles, so that individuals fall somewhere on a continuum and disagree more with others who are furthest away. The tension exists not just between differing camps but within all of us who feel torn by hard choices.

So the differences between the mostly utilitarian public health old-guard and the more recent crop of rights-driven global health advocates aren't always clear-cut, and they often talk right past each other ... or they just work at different organizations, teach at different schools and attend different conferences so they won't have to talk to each other. To some extent they're fundraising from different audiences, but they also end up advocating that the same resources -- often a slice of the US global health budget -- get spent on their priorities. These tensions usually simmer under the surface or get coated in academic-speak, but sometimes they come out. Which brings me to an anecdote to leaven my generalities:

A few months ago I was having a private conversation with a professor, one who leans a bit towards the cost-benefit side of the continuum with a dose of contrarianism thrown in for good measure. Paul Farmer came up -- I don't remember how. I paraphrase:

Resource allocation is the central dilemma in public health. Period. If people don't get that, they're not public health. Paul Farmer? Fuck Paul Farmer. He just doesn't get it.

You won't hear that in a lecture or in a public speech, but it's there. I've heard similar sentiments from the other side of the spectrum, those who see the number-crunching cost-benefiteers as soulless automatons who block the poor from getting the care they need.

These dilemmas are not going away any time soon. But I think being conscious of them and striving to be explicit about how our own values and biases shape our research and advocacy will help us to collectively reach a balance of heart and mind that makes more sense to everyone.

HIV/AIDS is one of the areas of global health where the raw passion of the heart most conflicts with the terrible dearth of resources we have to fight the demon. Decisions have ugly consequences either way you choose, and, rightly or wrongly, dispassionate research is often anything but. The recent news that pre-exposure prophylaxis (PrEP) can prevent HIV acquisition in sero-discordant heterosexual couples is huge in the news right now. Elizabeth Pisani (epidemiologist and author of The Wisdom of Whores) hits the nail on the head in this recent blog post. She notes that there are voices clamoring for widespread scale-up of PrEP -- treating the HIV negative partner -- but that PrEP prevents infection in 60% of cases while treating the HIV-positive partner cuts infection by 96%. Continuing:

That leaves us with the question: who should get PReP? Right now, there are not enough antiretrovirals to go around to treat all the sick people who need treatment. If we’re going to use them selectively for prevention, we should start with the most effective use, which appears to be early treatment of the infected partner in discordant couples. We could also give them to people who aren’t in a couple but who know that they’re likely to get around a bit and might want to stay safe without using condoms. That’s potentially a lot of people; it will stretch our purses. But more than that, it will stretch our political will.

So who is PReP for? We’ve got a better option for discordant couples. We’re not going to want to give it to randy adolescents. We know it works for gay men, but some of the countries where the trials took place would rather thump or jail gay men than protect their sexual health.[...] But I think we would be unwise to rush around talking about massive roll-out of PReP before we actually figure out who it works for in the real world.

Treating people with HIV is good. Preventing infection via treatment is good. Prevention infection via PrEP is good (assuming it doesn't breed more drug resistant strains and make it harder to treat everyone... but that's another story). But most voices in the debate have an agenda and are pushing for one thing above the rest. One of them -- or a balance of them -- is right, but you have to understand their values before that can be discerned. And I think many people in global health don't even think explicitly about their own values, such as the mix of cost-benefit and rights-based approaches they find most appealing. Rather, we all want to promote whatever we're working on that the moment. After all, it's all good.

CIA's despicable Pakistan vaccination ploy

Via Conflict Health, The Guardian reports that the "CIA organised fake vaccination drive to get Osama bin Laden's family DNA":

In March health workers administered the vaccine in a poor neighborhood on the edge of Abbottabad called Nawa Sher. The hepatitis B vaccine is usually given in three doses, the second a month after the first. But in April, instead of administering the second dose in Nawa Sher, the doctor returned to Abbottabad and moved the nurses on to Bilal Town, the suburb where Bin Laden lived.

Christopher Albon of Conflict Health writes:

If true, the CIA’s actions are irresponsible and utterly reprehensible. The quote above implies that the patients never received their second or third doses of the hepatitis B vaccine. And even if they did, there is absolutely no guarantee that the vaccines were real. The simple fact is that the health of the children of Abbottabad has been put at risk through a deceptive medical operations by the Central Intelligence Agency. Furthermore, the operation undermines future vaccination campaigns and Pakistani health workers by fueling conspiracy theories about their true purpose.

Albon notes that the Guardian's source is Pakistan's ISI... but this McClatchy story seems to confirm it via US sources:

The doctor's role was to help American officials know with certainty that bin Laden was in the compound, according to security officials and residents here, all of whom spoke only on the condition of anonymity because they feared government retribution. U.S. officials in Washington confirmed the general outlines of the effort. They asked not to be identified because of the sensitivity of the topic.

The sensitivity of the topic? No kidding. This is absolutely terrible, and not just because the kids originally involved might not have gotten the second round of vaccine (which is bad) or because it will make the work of legitimate public health officials in Pakistan even harder (which is very bad). Vaccines are amazing innovations that save millions of lives, and they are so widely respected that combatants have gone to extraordinary lengths to allow vaccination campaigns to proceed in the midst of war. For instance, UNICEF has brokered ceasefires in Afghanistan and Pakistan for polio vaccine campaigns which are essential since those are two of the four countries where polio transmission has never been interrupted.

I hope I'm not overreacting, but I'm afraid this news may be bad for the kids of Pakistan, Afghanistan, and the rest of the world. Assuming the early reports are confirmed, this plot should be condemned by everyone. If US officials who support global vaccination efforts are going to control the damage as much as possible -- though it's likely much of it has already been done -- then there need to be some very public repercussions for whoever authorized this or had any foreknowledge. What tragic stupidity: a few branches of the US government are spending millions and millions to promote vaccines, while another branch is doing this. The CIA is out of control. Sadly, I'm not optimistic that there will be any accountability, and I'm fuming that my own country breached this critical, neutral tool of peace and health. How incredibly short-sighted.

Update: In addition to the Guardian story, Conflict Health, and McClatchy stories linked above, this NYTimes article offers further confirmation and the CNN piece has some additional details. Tom Paulson at Humanosphere, Mark Leon Goldberg of UN Dispatch, Charles Kenny of CGD, and Seth Mnookin all offer commentary.

History refresh: AZT and ethics

A professor pointed me to this online history and ethics lesson from the Harvard Kennedy School's Program on Ethical Issues in International Research: The Debate Over Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations. It's surprisingly readable, and the issues debated are surprisingly current.

In 1994, researchers in the US and France announced stunning news of a rare victory in the battle against the AIDS pandemic. Studies conducted in both countries had shown conclusively that a regimen of the drug AZT, administered prenatally to HIV-positive pregnant women and then to their babies after birth, reduced the rate of mother-to-infant transmission of HIV by fully two-thirds. The results of the clinical trials constituted "one of the most dramatic discoveries of the AIDS epidemic," the New York Times declared, and one of the most heartening as well.

The new regimen--known by its study name, AIDS Clinical Trials Group (ACTG) 076 or, often, simply "076"--offered the epidemic's most vulnerable targets, newborns, their best hope thus far of a healthy childhood and a normal life span. The number of infants who might benefit from this research was significant: according to World Health Organization (WHO) figures, as many as five to ten million children born between 1990-2000 would be infected with HIV. In the mid-1990s, it was estimated that HIV-infected infants were being born at the rate of 1,000 a day worldwide.

So impressive were the findings of ACTG 076--and so substantial the difference in the transmission rate between subjects given AZT and those given a placebo (eight percent versus 25 percent)--that the clinical trials, which were still ongoing, were stopped early, and all participants in the studies were treated with AZT. In June 1994, after reviewing the study results, the US Public Health Service recommended that the 076 regimen be administered to HIV-infected pregnant women in the US as standard treatment to prevent transmission of the virus.

But while 076 was hailed as a major breakthrough, the celebration was somewhat muted. For a variety of reasons, the new treatment regimen would not likely reach those who most desperately needed it: pregnant women in the developing nations of the world and, most particularly, sub-Saharan Africa, where AIDS was wreaking devastation on a scale unimagined in the West.

I think one reason why graduate school can be so overwhelming is that you're trying to learn the basic technical skills of a field or subfield, and also playing catch-up on everything that's been written on your field, ever. True, some of it's outdated, and there are reviews that bring you up to speed on questions that are basically settled. But there's a lot of history that gets lost in the shuttle, and it's easy to forget that something was once controversial. Something as universally agreed upon today as using antiretrovirals to prevent mother-to-child transmission of HIV was once the subject of massive, heart-wrenching debate. I tend to wax pessimistic and think we're doomed to repeat the mistakes of the past regardless of whether we know our history, because we either can't agree on what the mistakes of the past were, or because past conflicts represent unavoidable differences of opinion, certainty, and power. But getting a quick refresher on the history of a is valuable because it puts current debates in perspective.

Gates and Media Funding

You may or may not have heard of this controversy: the Gates Foundation -- a huge funding source in global health -- has been paying various media sources to ramp up their coverage of global health and development issues. It seems to me that various voices in global health have tended to respond to this as you might expect them to, based on their more general reactions to the Gates Foundation. If you like most of Gates does, you probably see this as a boon, since global health and development (especially if you exclude disaster/aid stories) aren't the hottest issues in the media landscape. If you're skeptical of the typical Gates Foundation solutions (technological fixes, for example) then you might think this is more problematic.

I started off writing some lengthy thoughts on this, and realized Tom Paulson at Humanosphere has already said some of what I want to say. So I'll quote from him a bit, and then finish with a few more of my own thoughts. First, here is an interview Paulson did with Kate James, head of communications at the Gates Foundation. An excerpt:

Q Why does the Gates Foundation fund media?

Kate James: It’s driven by our recognition of the changing media landscape. We’ve seen this big drop-off in the amount of coverage of global health and development issues. Even before that, there was a problem with a lack of quality, in-depth reporting on many of these issues so we don’t see this as being internally driven by any agenda on our part. We’re responding to a need.

Q Isn’t there a risk that by paying media to do these stories the Gates Foundation’s agenda will be favored, drowning out the dissenting voices and critics of your agenda?

KJ: When we establish these partnerships, everyone is very clear that there is total editorial independence. How these organizations choose to cover issues is completely up to them.

The most recent wave of controversy seems to stem from Gates funding going to an ABC documentary on global health that featured clips of Bill and Melinda Gates, among other things. Paulson writes about that as well. Reacting to a segment on Guatemala, Paulson writes:

For example, many would argue that part of the reason for Guatemala’s problem with malnutrition and poverty stems from a long history of inequitable international trade policies and American political interference (as well as corporate influence) in Central America.

The Gates Foundation steers clear of such hot-button political issues and we’ll see if ABC News does as well. Another example of a potential “blind spot” is the Seattle philanthropy’s tendency to favor technological solutions — such as vaccines or fortified foods — as opposed to messier issues involving governance, industry and economics.

A few additional thoughts:

Would this fly in another industry? Can you imagine a Citibank-financed investigative series on the financial industry? That's probably a bad example for several reasons, including the Citibank-Gates comparison and the fact that the financial industry is not underreported. I'm having a hard time thinking of a comparable example: an industry that doesn't get much news coverage, where a big actor funded the media -- if you can think of an example, please let me know.

Obviously this induces a bias in the coverage. To say otherwise is pretty much indefensible to me. Think of it this way: if Noam Chomsky had a multi-billion dollar foundation that gave grants to the media to increase news coverage of international development, but did not have specific editorial control, would that not still bias the resulting coverage? Would an organization a) get those grants if it were not already likely to do the cover the subject with at last a gentle, overall bias towards Chomsky's point of view, or b) continue to get grants for new projects if they widely ridiculed Chomsky's approach? It doesn't have to be Chomsky -- take your pick of someone with clearly identifiable positions on international issues, and you get the same picture. Do the communications staffers at the Gates Foundation need to personally review the story lines for this sort of bias to creep in? Of course not.

Which matters more: the bias or the increased coverage? For now I lean towards increased coverage, but this is up for debate. It's really important that the funding be disclosed (as I understand it has been). It would also be nice if there was enough public demand for coverage of international development that the media covered it in all its complexity and difficulty and nuance without needing support from a foundation, but that's not the world we live in for now. And maybe the funded coverage will ultimately result in more discussion of the structural and systemic roots of international inequality, rather than just "quick fixes."

[Other thoughts on Gates and media funding by Paul Fortner, the Chronicle of Philanthropy, and (older) LA Times.]

Randomizing in the USA, ctd

[Update: There's quite a bit of new material on this controversy if you're interested. Here's a PDF of Seth Diamond's testimony in support of (and extensive description of) the evaluation at a recent hearing, along with letters of support from a number of social scientists and public health researchers. Also, here's a separate article on the City Council hearing at which Diamond testified, and an NPR story that basically rehashes the Times one. Michael Gechter argues that the testing is wrong because there isn't doubt about whether the program works, but, as noted in the comments there, doesn't note that denial-of-service was already part of the program because it was underfunded.] A couple weeks ago I posted a link to this NYTimes article on a program of assistance for the homeless that's currently being evaluated by a randomized trial. The Poverty Action Lab blog had some discussion on the subject that you should check out too.

The short version is that New York City has a housing assistance program that is supposed to keep people from becoming homeless, but they never gave it a truly rigorous evaluation. It would have been better to evaluate it up front (before the full program was rolled out) but they didn't do that, and now they are.  The policy isn't proven to work, and they don't have resources to give it to everyone anyway, so instead of using a waiting list (arguably a fair system) they're randomizing people into receiving the assistance or not, and then tracking whether they end up homeless. If that makes you a little uncomfortable, that's probably a good thing -- it's a sticky issue, and one that might wrongly be easier to brush aside when working in a different culture. But I think on balance it's still a good idea to evaluate programs when we don't know if they actually do what they're supposed to do.

The thing I want to highlight for now is the impact that the tone and presentation of the article impacts your reactions to the issue being discussed. There's obviously an effect, but I thought this would be a good example because I noticed that the Times article contains both valid criticisms of the program and a good defense of why it makes sense to test it.

I reworked the article by rearranging the presentation of those sections. Mostly I just shifted paragraphs, but in a few cases I rearranged some clauses as well. I changed the headline, but otherwise I didn't change a single word, other than clarifying some names when they were introduced in a different order than in the original. And by leading with the rationale for the policy instead of with the emotional appeal against it, I think the article gives a much different impression. Let me know what you think:

City Department Innovates to Test Policy Solutions

By CARA BUCKLEY with some unauthorized edits by BRETT KELLER

It has long been the standard practice in medical testing: Give drug treatment to one group while another, the control group, goes without.

Now, New York City is applying the same methodology to assess one of its programs to prevent homelessness. Half of the test subjects — people who are behind on rent and in danger of being evicted — are being denied assistance from the program for two years, with researchers tracking them to see if they end up homeless.

New York City is among a number of governments, philanthropies and research groups turning to so-called randomized controlled trials to evaluate social welfare programs.

The federal Department of Housing and Urban Development recently started an 18-month study in 10 cities and counties to track up to 3,000 families who land in homeless shelters. Families will be randomly assigned to programs that put them in homes, give them housing subsidies or allow them to stay in shelters. The goal, a HUD spokesman, Brian Sullivan, said, is to find out which approach most effectively ushered people into permanent homes.

The New York study involves monitoring 400 households that sought Homebase help between June and August. Two hundred were given the program’s services, and 200 were not. Those denied help by Homebase were given the names of other agencies — among them H.R.A. Job Centers, Housing Court Answers and Eviction Intervention Services — from which they could seek assistance.

The city’s Department of Homeless Services said the study was necessary to determine whether the $23 million program, called Homebase, helped the people for whom it was intended. Homebase, begun in 2004, offers job training, counseling services and emergency money to help people stay in their homes.

The department, added commissioner Seth Diamond, had to cut $20 million from its budget in November, and federal stimulus money for Homebase will end in July 2012.

Such trials, while not new, are becoming especially popular in developing countries. In India, for example, researchers using a controlled trial found that installing cameras in classrooms reduced teacher absenteeism at rural schools. Children given deworming treatment in Kenya ended up having better attendance at school and growing taller.

“It’s a very effective way to find out what works and what doesn’t,” said Esther Duflo, an economist at the Massachusetts Institute of Technology who has advanced the testing of social programs in the third world. “Everybody, every country, has a limited budget and wants to find out what programs are effective.”

The department is paying $577,000 for the study, which is being administered by the City University of New York along with the research firm Abt Associates, based in Cambridge, Mass. The firm’s institutional review board concluded that the study was ethical for several reasons, said Mary Maguire, a spokeswoman for Abt: because it was not an entitlement, meaning it was not available to everyone; because it could not serve all of the people who applied for it; and because the control group had access to other services.

The firm also believed, she said, that such tests offered the “most compelling evidence” about how well a program worked.

Dennis P. Culhane, a professor of social welfare policy at the University of Pennsylvania, said the New York test was particularly valuable because there was widespread doubt about whether eviction-prevention programs really worked.

Professor Culhane, who is working as a consultant on both the New York and HUD studies, added that people were routinely denied Homebase help anyway, and that the study was merely reorganizing who ended up in that pool. According to the city, 5,500 households receive full Homebase help each year, and an additional 1,500 are denied case management and rental assistance because money runs out.

But some public officials and legal aid groups have denounced the study as unethical and cruel, and have called on the city to stop the study and to grant help to all the test subjects who had been denied assistance.

“They should immediately stop this experiment,” said the Manhattan borough president, Scott M. Stringer. “The city shouldn’t be making guinea pigs out of its most vulnerable.”

But, as controversial as the experiment has become, Mr. Diamond said that just because 90 percent of the families helped by Homebase stayed out of shelters did not mean it was Homebase that kept families in their homes. People who sought out Homebase might be resourceful to begin with, he said, and adept at patching together various means of housing help.

Advocates for the homeless said they were puzzled about why the trial was necessary, since the city proclaimed the Homebase program as “highly successful” in the September 2010 Mayor’s Management Report, saying that over 90 percent of families that received help from Homebase did not end up in homeless shelters. One critic of the trial, Councilwoman Annabel Palma, is holding a General Welfare Committee hearing about the program on Thursday.

“I don’t think homeless people in our time, or in any time, should be treated like lab rats,” Ms. Palma said.

“This is about putting emotions aside,” [Mr. Diamond] said. “When you’re making decisions about millions of dollars and thousands of people’s lives, you have to do this on data, and that is what this is about.”

Still, legal aid lawyers in New York said that apart from their opposition to the study’s ethics, its timing was troubling because nowadays, there were fewer resources to go around.

Ian Davie, a lawyer with Legal Services NYC in the Bronx, said Homebase was often a family’s last resort before eviction. One of his clients, Angie Almodovar, 27, a single mother who is pregnant with her third child, ended up in the study group denied Homebase assistance. “I wanted to cry, honestly speaking,” Ms. Almodovar said. “Homebase at the time was my only hope.”

Ms. Almodovar said she was told when she sought help from Homebase that in order to apply, she had to enter a lottery that could result in her being denied assistance. She said she signed a letter indicating she understood. Five minutes after a caseworker typed her information into a computer, she learned she would not receive assistance from the program.

With Mr. Davie’s help, she cobbled together money from the Coalition for the Homeless and a public-assistance grant to stay in her apartment. But Mr. Davie wondered what would become of those less able to navigate the system. “She was the person who didn’t fall through the cracks,” Mr. Davie said of Ms. Almodovar. “It’s the people who don’t have assistance that are the ones we really worry about.”

Professor Culhane said, “There’s no doubt you can find poor people in need, but there’s no evidence that people who get this program’s help would end up homeless without it.”

Randomizing in the USA

The NYTimes posted this article about a randomized trial in New York City:

It has long been the standard practice in medical testing: Give drug treatment to one group while another, the control group, goes without.

Now, New York City is applying the same methodology to assess one of its programs to prevent homelessness. Half of the test subjects — people who are behind on rent and in danger of being evicted — are being denied assistance from the program for two years, with researchers tracking them to see if they end up homeless.

Dean Karlan at Innovations for Policy Action responds:

It always amazes me when people think resources are unlimited. Why is "scarce resource" such a hard concept to understand?

I think two of the most important points here are that a) there weren't enough resources for everyone to get the services anyway, so they're just changing the decision-making process for who gets the service from first-come-first-served (presumably) to randomized, and b) studies like this can be ethical when there is reasonable doubt about whether a program actually helps or not. If it were firmly established that the program is beneficial, then it's unethical to test it, which is why you can't keep testing a proven drug against placebo.

However, this is good food for thought for those who are interested in doing randomized trials of development initiatives in other countries. It shows the impact (and reactions) from individuals to being treated as "test subjects" here in the US -- and why should we expect people in other countries to feel differently? That said, a lot of randomized trials don't get this sort of pushback. I'm not familiar with this program beyond what I read in this article, but it's possible that more could have been done to communicate the purpose of the trial to the community, activists, and the media.

There are some interesting questions raised in the IPA blog comments as well.

Afraid

Here are two semi-related articles: one by William Easterly about how aid to Ethiopia is propping up an oppressive regime, and another by Rory Carroll on the pernicious but well-intentioned effects of aid tourism in Haiti. Basically, it's really hard to do things right, because international aid and development are not simple. Good intentions are not enough. You can mess up by funneling all your money through a central regime, or by having an uncoordinated, paternalistic mess.

A couple confessions. First, I'm a former "aid tourist." In high school and college I went on short-term trips to Mexico, Guyana, and Zambia (and slightly different experiences elsewhere). My church youth group went to Torreon, Mexico and helped build a church (problematize that). In Guyana and Zambia I was part of medical groups that ostensibly aimed to improve the health of the local people; in hindsight neither project could have possibly had any lasting effects on health, and likely fostered dependency.

Second, I'm an aspiring public health / development professional, and I'm afraid. I don't want to be the short-term, uncoordinated, reinventing-the-wheel, well-intention aid vacationer -- and I think given my education (and the experience I hope to continually gain) I'm more likely to avoid at least some of those shortcomings. But I'm scared that my work might prop up nasty regimes, or satiate a bloated aid industry that justifies its projects to sustain itself, or give me the false impression of doing good while actually doing harm.

I think the first step to doing better is being afraid of these things, but I'm still learning where to go from here.

Tuskegee in Guatemala

The news that a US government study in the 1940s involved injecting Guatemalans with syphilis has been circulating, and it makes my stomach turn. Susan Reverby -- the Wellesley historian who uncovered the fiasco -- has made the draft paper available on her website: "'Normal Exposure' and Inoculation Syphilis: A PHS 'Tuskegee' Doctor in Guatemala, 1946-48," which will be published in the Journal of Policy History in January.

From the introduction:

Policy is often made based on historical understandings of particular events, and the story of the “Tuskegee” Syphilis Study (the Study) has, more than any other medical research experiment, shaped policy surrounding human subjects. The forty-year study of “untreated syphilis in the male Negro” sparked outrage in 1972 after it became widely known, and inspired requirements for informed consent, the protection of vulnerable subjects, and oversight by institutional review boards.

When the story of the Study circulates, however, it often becomes mythical. In truth the United States Public Health Service (PHS) doctors who ran the Study observed the course of the already acquired and untreated late latent disease in hundreds of African American men in Macon County, Alabama. They provided a little treatment in the first few months in 1932 and then neither extensive heavy metals treatment nor penicillin after it proved a cure for the late latent stage of the disease in the 1950s. Yet much folklore asserts that the doctors went beyond this neglect, and that they secretly infected the men by injecting them with the bacteria that causes syphilis. This virally spread belief about the PHS’s intentional infecting appears almost daily in books, articles, talks, letters, websites, tweets, news broadcasts, political rhetoric, and above all in whispers and conversations. It is reinforced when photographs of the Study’s blood draws circulate, especially when they are cropped to show prominently a black arm and a white hand on a syringe that could, to an unknowing eye, be seen as an injection.

Historians of the Study have spent decades now trying to correct the misunderstandings in the public and the academy, and to make the facts as knowable as possible. The story is horrific enough, it is argued, without perpetuating misunderstanding over what really did happen and how many knew about it. What if, however, the PHS did conduct a somewhat secret study whose subjects were infected with syphilis by one of the PHS doctors who also worked in “Tuskegee?” How should this be acknowledged and affect how we discuss historical understandings that drive the need for human subject protection?

(Emphasis added.) And later:

Ironically, though, the mythic version of the “Tuskegee” Study may offer a better picture of mid-century PHS ethics than the seemingly more informed accounts. For Public Health Service researchers did, in fact, deliberately infect poor and vulnerable men and women with syphilis in order to study the disease. The mistake of the myth is to set that story in Alabama, when it took place further south, in Guatemala.

Interestingly, the episode happened during a period of hope in Guatemalan history -- one of elections and land reforms, before decades of civil war that followed our overthrow of the democratically elected government:

The United Fruit Company owned and controlled much of Guatemala, the quintessential “banana republic,” in the first half of the 20th century. When the PHS looked to Guatemala for its research in the immediate post-World War II years, it came into the country during the period known for its relative freedoms; between 1944 and the U.S. led CIA coup of the elected government in 1954, there were efforts made at labor protection laws, land reform, and democratic elections. The PHS was part of the effort to use Guatemala for scientific research as they presumed to transfer laboratory materials, skills, and knowledge to Guatemalan public health elite.

And one last tidbit:

In reporting to Cutler after he returned to the States, he explained that he had brought Surgeon General Thomas Parran up to date and that with a “merry twinkle [that] came into his eye…[he] said ‘You know, we couldn’t do such an experiment in this country.’”60

Read the whole thing.