Unlike the United States, the UK has bothered to track HIV infection among large, representative samples of drug injectors (both current injectors and those in methadone and other treatment programmes) since close to the start of the epidemic. Part of this effort involved testing anonymous samples of left over blood for HIV — the samples were usually taken from treatment or diagnostic purposes and are stripped of all but the most basic demographic and risk information (age, sex, length of time injecting, recent needle sharing) before being tested with HIV. The results, shown separately for London and the rest of England and Wales are shown below.

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Yes, prevalence for the whole of England and Wales (including London — Scotland has its own system and reports separately) has risen by over 77% in the last decade. But still, fewer than one injector in 60 is infected with HIV. If you draw the graph using a normal percentage scale, you’ll see something close to the true level of infection — still too high, of course, but not exactly an overwhelming prevention failure when compared with data from any city or country that doesn’t have needle exchanges. The graph compares what happened in the UK with what happened in Jakarta, just because I happened to have the Indonesian data handy. But it would look just the same with data from Bangkok or Moscow or even New York in the years before the city (with no help from the federal government) began to hand out needles.

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Since I’m just a numbers nerd and obviously don’t have a great visual imagination, perhaps someone could help me out here: how can you conclude from these pictures that safe injecting programmes fail to prevent HIV?

Does this signal a new wave of common sense in HIV prevention in the United States? That’s certainly what we expected when Obama was elected. During his campaign, for example, he recognised that sterile needle programmes cut HIV infection among injectors, saving lives and money, and pledged to end a ban on funding those programmes from federal coffers. So cities such as his home town of Chicago, pictured in the map below, will now be able to use central money to provide clean needles to the inner city injectors that need them most. As long as they set up in one of the grey spaces. In the cemetary, in other words.

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On this fantastic map, which comes from Yale University’s Dr. Russell Barbour by way of Stop the Drug War, the red areas are the parts of town where it would be illegal to operate a federally funded needle exchange under new rules proposed by Congress. The Drug War Chronicle provides an interesting history of the needle exchange shenannigans. Essentially, Obama did not remove the ban from a budget bill because he thinks policy shouldn’t be made through sub-clauses in budget bills. Democrats on the committee discussing the bill disagreed, and dropped the ban. Then Republicans, not willing to give up the idea that the availability of clean needles would have us all racing to start shooting up smack, decided to protect the innocent by forbidding needle programmes within 1,000 feet of “a public or private day care centre, elementary school, vocational school, secondary school, college, junior college, or university, or any public swimming pool, park, playground, video arcade, or youth centre, or an event sponsored by any such entity”. That’s the red bits on the map of Chicago above. Here’s Dr, Barbour’s map of needle exchange exclusion zones in San Francisco:

This is clearly just a way of pulling the rug from under any effort to increase access to clean needles. We’ve come to expect this kind of implaccable opposition from conservative Drug Warriors in the United States. We used to expect the Brits to be more rational about their drug policy, and the UK has, thank God, held on to its policy of providing clean fits for anyone that needs them. But with the sacking of the government’s independent advisor on drugs David Nutt for repeating his independent advice after the government chose to ignore it, I’m not so sure.

I’m not even going to wade in here about whether or not idependent scientific advisers to government should shut up after their advice is ignored, but I will commend to you a wonderful paper by Dr Nutt on the dangers of Equasy, (pdf) an irrational addiction to horse riding. This has been seized on by many who have not read it as an example of his inappropriate analyses. Irony, where art thou?

The US Drug Warriors also joyously seized on the latest round of anonymous surveillance of HIV among drug injectors in Britain, sending out an e-mail crowing about rising rates of HIV and drawing a link between that and the fact that the UK was the first country in the world to have national injection safety programmes. My next post will put those rather one-eyed claims into perspective.

A month ago, the media got very excited about an HIV vaccine. Study results, released in Thailand with a maximum of fuss and a minimum of detail, showed that the two-step vaccine might protect about a third of the people who get the shots against HIV. Then the doom-mongers weighed in: without more information, we might be overestimating the effects of the jabs. So, is the syringe half full or half empty?

Now more details have been released, we’re still looking at half a glass. Hurrah! said some reports. The vaccine really is protective. Boo hoo, said others. Unless you torture the statistics, they don’t confess to much of an impact. I finally got around to combing through the full report of the trial in the New England Journal of Medicine. Both the optimists and the pessimists are right. It really depends on what your hopes and expectations were. If you are a basic scientist (as most of the people involved in the study were) you’d be pretty thrilled by the results, because they show that vaccines might one day work. If you are a public health boffin such as myself, you’d be pretty disappointed, because the study suggests that that this vaccine doesn’t work for the people who really need it — a point much underplayed in the official reports.

In their full paper the research team reported three sets of results for this study among young men and women in Northern Thailand; only the most optimistic of these was reported to the press in the initial release of results a month ago. Keith Alcorn of Aidsmap has produced a typically sound and balanced summary of the paper if you want more details. But here’s my more opinionated take.

Analysis 1: Real World.
This is technically known as an “intention to treat analysis”. The final analysis includes everyone who was enrolled in the study, regardless of whether or not they followed all the procedures correctly. This is the analysis which is most interesting to public health boffins, because it comes closest to showing how things might happen in the messy reality of life, where people forget to show up for appointments, get given the wrong dose by mistake, etc. In this analysis, people in the vaccinated group were 26.4% less likely than those in the unvaccinated group to get infected with HIV. There was a 92% probability that this difference was not due simply to chance; that means that the difference would not be considered “significant” by those who cleave to the mystical figure of 95% to dictate what is or is not worth considering. Taking into account random differences between the people assigned to the vaccine and the placebo groups, the researchers were 95% sure that the real effect of the vaccine did something between making you 48 percent less likely to contract HIV, and making you four percent more likely to get infected.

Analysis 2: Ideal World.
Known as the “per protocol analysis”, this looks only at the people who got all their shots on time, in the right doses. This is more or less the human equivalent of doing things in lab conditions, and is the sort of analysis that is most useful for basic scientists. Only three quarters of all the study subjects qualified. That in itself is worrying to people like me; if we can’t deliver four doses of vaccine to a quarter of the participants in an incredibly well-organised, well-funded study with hugely well-motivated study staff, how the hell are we going to do it in the real world? More worrying to the basic scientists, I would have thought, is the fact that in this sub-population of people who did everything exactly comme il faut, the vaccine did not have a more pronounced effect (26.2%, with an 16% chance that the effect was due to chance). Because numbers were smaller there was an even wider range that might have reflected the “true” outcome, from increasing infections by 13.3 percent to cutting them by 51.9 percent.

Analysis 3: Tidied-up World
Not a common convention, the “modified intention to treat analysis” essentially reflected the real world with the messiest bits knocked off. In this analysis, the researchers included everyone in the study, except the seven people who it turned out were already infected before their first jab. These people were missed in the initial screening test because they were still in the “window period” during which a person has the virus, but not yet the antibodies which cause a test to show up positive. They were discovered because they had turned positive by their last jab; the team then went back and used a (much more expensive) test for the virus itself on the original screening sample and found that they had already been infected. From a basic science point of view, it makes perfect sense to excluse these people from the analysis; obviously, a vaccine can’t protect people who are already infected. From a public health point of view, it’s debatable whether we should tidy up the data like this. If we put huge national vaccine programmes in place, we’re going to be vaccinating people who are in the window period, especially in the early years, and in groups at highest risk. I’d say we want to take that into account when estimating the potential effect of a vaccine. it was this “tidy” analysis that hit the headlines a month ago, and gave the study its only “significant” result — a 31.2% reduction in HIV infection, with a 96% probability that the effect was not a statistical fluke. This time, we could be 95% sure that the vaccine didn’t make things worse, that it reduced infection by at least 1.1%, and perhaps by as much as 51.2%.

As a public health nerd, I’m most interested in the Real World Analysis. But I’m even more interested in something that’s buried down at the bottom of Table 2.

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Here, the research team looks at the effect of the vaccine on people with different levels of risk behaviour. In a shockingly poor piece of paper writing/ editing, it is not actually possible to tell from the Methods section of this paper how the different levels of risk are defined. But the definition for high risk does seem to include at least some of the usual suspects: needle sharing during drug injection, same sex partners for men, commercial sex etc. And what Table 2 shows is that the vaccine makes no difference at all for those at highest risk. It might cut infection rates by nearly half in that group, or it might increase the chance of getting HIV by nearly three quarters. The best-guess estimate is that it cuts infection rates by under 4% among the people who are most likely to be exposed to the virus. Four percent is as good (or bad) as nothing.

The researchers point out that the study was not designed to look at these differences, but call the results “intriguing”. To an immunologist, they must be. Perhaps the immunity conferred by the vaccine is not strong enough to withstand the repeated assaults suffered by someone who shares needles daily or turns tricks three times a week — I have no idea. But to public health workers, it is not intriguing, it is devastating. If a vaccine doesn’t work for the people who need it most, what’s the point? It depends on costs, of course. But would we really develop something that we could give to people who have a very low probability of exposure, while leaving those who are likely to be at risk for HIV unprotected?

It’s a false dichotomy, of course. This trial is a triumph for basic science, because it gives us something positive to work with. It is very far from being a triumph for public health, and it is not helpful that in the early rush of euphoria it was presented as such. I’d even be wary of the language used by the authors of the NEJM paper: in their headline result, they reported quite wrongly that the study showed that “there was a trend toward the prevention of HIV-1 infection among the vaccine recipients”. A trend is something that develops over time. If anything, the data suggest that the effect of the vaccine was weakened over time, so the trend was away from protection, not towards it. But I’m splitting hairs. With vaccines, the basic science has to be right before we even think about the public health questions. This study will send the immunologists back to the drawing board. They need to figure out how we have a possibly succesful vaccine that makes no difference to viral loads in those who do get infected. They need to understand why people who are most exposed to HIV are least likely to be protected. They need to parse out the mechanism by which these two sets of shots, each of which has failed on its own, might be working together. If (and it is still only an if) they can do all of that, then develop something that really does work, the public health nerds can start worrying about how to deliver it, and to whom.

The fact that raids on over 800 brothels didn’t net any traffickers doesn’t mean that there isn’t anyone in the UK selling sex against their will. But (I’ve said it before and in today’s Guardian I say it again) trying to wipe out the sex trade completely only makes things worse for the minority who are forced into it.

There is little one can do to change the minds of those who object, viscerally, to the commodification of sex. And the numbers will always be open to dispute, as they are with any illegal activity. But a lot of good researchers have spent a lot of time and effort trying to get a handle on trafficking in the sex trade — you can find excellent references here and here, and there’s a pretty good discussion thread over at Badscience. It’s like the massive, hidden HIV epidemic in the Middle East — if we haven’t found it after two decades of looking, maybe it really isn’t so massive after all.

For those who don’t have time to read the whole Guardian article, I’ll pull one key quote from a cop:

The head of the UK Human Trafficking Centre, Grahame Maxwell, who is chief constable of North Yorkshire, acknowledged the importance of the figures: “The facts speak for themselves. I’m not trying to argue with them in any shape or form,” he said.
He said he had commissioned fresh research from regional intelligence units to try to get a clearer picture of the scale of sex trafficking. “What we’re trying to do is to get it gently back to some reality here,” he said.
“It’s not where you go down on every street corner in every street in Britain, and there’s a trafficked individual.
“There are more people trafficked for labour exploitation than there are for sexual exploitation. We need to redress the balance here. People just seem to grab figures from the air.”

**UPDATE** The Guardian has published more interesting contributions to the debate, including the opinions of people who sell sex for a living.

With Halloween coming up, and in contrast to the hysteria around migrant sex workers, I offer this seasonal celebration of migrant pumpkin pickers in Canada, courtesy of Ickaprick.

It’s like this. Ms Harman, who is Deputy Leader of the UK’s ruling Labour Party, wants whats best for working girls. Punternet does too. (For those who use the term “john”, a punter is a man who buys sex). Ms. Harman wants to reduce trafiicking of women into sex work. Punternet does too — that’s why it provides links to allow men using the site to report women that they suspect might be under age or working against their will. Is that why Ms Harman decided to give the site such good publicity, more than doubling its hits to an eye-watering 2.7 million a day according to the Financial Times? From the vote of thanks she’s had from sex workers working on both sides of the Atlantic. you might think so. But no, the good democrat was actually appealing to California Governor Arnold Schwarzenegger to shut the site down (the server is, apparently situated in the land of free speech).

No surprise to regular readers of this site; it is all part of Nanny Labour’s ongoing campaign to wipe out consensual trade in sex which, the views of sex workers themselves notwithstanding (see comments), always amounts to exploitation. But it did bring the idiocy of this policy to the notice of mainstream commentators such as the FT’s Matthwe Engel, which can only be a good thing.

Other issues of cultural politics I had to try and explain: why I am addicted to a radio soap opera that has been running for nearly 60 years. That’s right, The Archers, originally billed as “the everyday story of country folk”, now rebranded appallingly as “contermporary drama in a rural setting”. I tried to explain that bracketed between the unchanging theme tune “Tum ti tum ti tum ti tum…” came all the burning issues of the day. My mate rolled his eyes and went back to blogging about really burning issues, like rectal gonnorhea. Then, on Friday, he apologised. He “just happened” to turn on the radio when The Archers was on (that’s how I started too — a slippery slope to a lifelong struggle with Archers addiciton). And bingo: Ian gets beaten up because he’s gay. You could argue that Ian gets beaten up because he tries politely to get a bunch of drunken football louts to shut up. But they called him a “bender”, which is surely enough to blow the homophobia flag up the pole. (You can listen to the episode until 16/10/09.) The question that is not exactly burning up the message boards is: why did Ian not want to report the assault to the police? Might he suspect that the cops in a rural setting might have rather uncontemporary views about anal sex between men? You’ll just have to tune in to find out…

So we’ll have more pregnant teenagers, more ill-equppied child-mothers, more kids being poorly raised by resentful single parents whose own opportunities in life were cut short for lack of a pill or a condom. None of which leads to great health outcomes for either mother or child. Is it any wonder that the world’s wealthiest country trails the likes of Cypress, Morrocco and the Dominican Republic in health care?

If this depresses you, this gem from Paul Hipp might cheer you up.

Thanks to Txema and Kim Thomas.

There a couple of things that no-one much has mentioned. The first is that the vaccine was designed to produce a response to sub-types E and B. Subtype E (and an AE recombinant) is a form of HIV-1 that is very common in heterosexual HIV infections in Thailand, but much less common in other parts of the world. In most Western epidemics (and among gay men in other parts of the world, including Thailand) subtype B is most common. But as you can see on the map, in east and southern Africa, where around half of people with HIV in the world live, subtype C has the upper hand.

So even if we improve the efficacy of the combination that was tried in Thailand, there’s no telling whether it will be useable in Africa, where it is most needed.

Second, those who got the real vaccine combination but went on to get infected with HIV anyway had just the same amount of virus in their blood, on average, as those who got the placebo injections. This was a surprise; researchers had hoped that people who had been vaccinated would at least have lower concentrations of virus. It was also a disappointment, because lower viral loads generally mean less damage to the immune system (which in turn means it takes longer to get sick from other things, or to develop AIDS). Lower viral loads also mean that an infected person is less likely to pass HIV on to other people.

Some of the better scientific analyses (such as this report from IAVI) raise questions about just how robust the results will turn out to be once they are analysed more carefully. Interestingly to epi-nerds, none of the press releases or official fact sheets about the trial gave a p-value — a measure of the probablility that the difference between the two groups was due to chance. It fell the the ever-reliable Jon Cohen at Science to dig that out (and to Roger to find it for me at a bleary-eyed hour; thanks.)

It’s always easier to pick holes in these trials than to do them; whatever the results, the Thai Ministry of Public Health and the US Army deserve credit for having had the balls to push ahead with this difficult and much criticised piece of research.

Note the rueful way the Canadian researchers lament the absence of US participation in the North American Opiate Medicate Initiative. In their excellent paper in the New England Journal of Medicine researchers from Vancouver and Montreal thank “the many U.S. scientists who contributed to the early design discussions but ultimately were unable to participate in the trial” because of what they ellipitcally call “financial and logistic barriers”.

This trial was being planned at the same time that the Traditional Values Coalition, defender of all that is Right and Good in America, were sticking the Republican Rottweilers on the National Institutes for Health for funding studies of sexual and drug-taking behaviour. No surprise, then, that US scientists had to drop out of the study. There is no reason in the world to believe that heroin prescription wouldn’t work as well in the US as it does in Canada, the UK or any other country at reducing consumption of street heroin, keeping people in treatment and cutting crime among that hard core of users that have tried and failed to get off smack by using methadone or just saying no. But in the current climate (yes, even with the Obama administration in occupation) there’s really not much point in doing studies in the States — no amount of evidence will lead to a policy change. As Virginia Berridge points out in an interesting editorial in the same issue of NEJM, drug policy is more a matter of history and culture than it is of science. America, founded on puritanism, has always been less tolerant of opiates than the Brits, who used them to fuel an unequal trade with China and some properly great literature.

One finding that surprised the Canadian researchers: while most people in the study obviously knew if they were taking methadone (orally) or heroin (injected) a small number of users were randomly assigned to inject hydromorphone instead of heroin. Neither they nor the study staff knew who was getting the real thing and who was getting the semi-sythetic cough suppressant. Amazingly, not one of the people shooting up cough medicine for a year could tell they weren’t taking smack. As the researchers pointed out in slightly mealy-mouthed research-speak, “the benefits of injectable opiod maintenance might be achievable without the emotional and regulatory barriers often presented by heroin maintenance”. Meaning that we might get away with prescribing drugs to help chronic users stabilise their lives if we could just stay out of the headlines. The “SMACKING UP YOUR TAXES TO SUPPORT JUNKIES!” type headlines.

A finding that didn’t surprise the Canadian researchers: people who were injecting drugs, even on prescription, were much more likely to OD than people on methadone — mostly because the heroin doesn’t mix so well with some of the other drugs they had been taking (crack cocaine use didn’t change for any of the study groups in Canada, although it fell in all groups in the UK). BUT, as the researchers point out, all but one of the overdoses happened in the study clinic, where staff were able to administer nalaxone and provide other support so that users got through the overdose ok. If they’d been out shooting up street smack, the chances are they wouldn’t have been so lucky. Which is one more reason to support supervised injecting facilities such as Vancouver’s impressive Insite.

One thing the Canadian researchers didn’t report was the relative cost of the different approaches. The UK study reported that heroin maintenance cost about £15,000 per person per year, about a third of the cost of a year in jail. But it took a report on the BBC to tell us that we could put three people on methadone for a year for the same amount. The question is: how many of them would still be on treatment at the end of the year?

(The Beeb story has an interesting video interview of one of the users of the programme, but sadly no embed code).

Thanks to IRMA, the bottom line in HIV prevention, for that gem. To balance the utter tastelessness of not just the beer but the ad promoting it, which I piled on yesterday’s horrid Hitler offering, I draw your attention to this South African campaign, which comes courtesy of a Guardian reader. On the soppy side, but with an edge of implicit honesty that verges on the inspiring.

AIDS activists need to change not only their tune but their name. What we need is HIV activism, not AIDS activism. Because with the treatments that are now widely available in Western Europe and North America, AIDS is vanishing fast. While it continues to kill millions of people in Sub-Saharan Africa, where two thirds of people with HIV live, in most industrial countries it now kills a few hundred people a year at most. As long as treatment is available and effective, AIDS will remain largely a thing of the past in the rich world. But if drug-resistant strains develop and spread — and there is a real possibility they will — we’ll be back to the carnage of the late 1980s and early 1990s. Only very much worse, because there are so many more people now living with HIV in the West. And there are more people living with HIV in part because people aren’t dying of AIDS any more (a good thing) and in part because we are doing so very badly at prevention (definitely not a good thing). Brand new HIV infections are on the rise again among gay men in Germany, the US, the UK, Australia, Canada, Spain, Switzerland, the Netherlands — just about everywhere we’ve can measure it. That really is shocking.

Does it seem churlish, then, for me to be criticising the new prevention campaign in Germany? Some respondents to a comment I wrote in The Guardian think so. But I’m critical precisely because we need more good prevention that addresses local realities. The local realities in Germany are:

1) we are already effectively preventing AIDS, through treatment
2) we are failing to prevent HIV
3) the vast majority of the sexual transmission of HIV happens between men in anal sex

What Germany needs is campaigns to encourage gay men to avoid an inconvenient life-long infection (HIV) that is expensive to treat and can be most easily prevented by using condoms in sex. That is not what Malawi or Washington DC or Buenos Aires need, but it IS what Germany needs. What the Das Comitee ad gives the German public is a campaign to encourage heterosexual women to avoid a killer disease that in their local reality barely exists. “Shock value” is all very well, but if you are shocking the wrong people about the wrong things, you’re not going to prevent many HIV infections. And that’s what we need to do, now more than ever.