Universal Access to Water Before Universal Access to PrEP

With the buzz that tends to be drummed up when a clinical trial is not, at least on the surface, a complete failure, it is easy to forget what things are like in countries with high HIV prevalence. IRIN has an article about health systems in Kenya needing an overhaul and the frequency of drug shortages and stock outs. Uganda, Tanzania and other countries have similar problems.

This is not just about drugs. On my other blog yesterday, I cited a systematic review of healthcare associated infections which noted "inadequate environmental hygienic conditions; poor infrastructure; insufficient equipment; understaffing; overcrowding; paucity of knowledge and application of basic infection-control measures; prolonged and inappropriate use of invasive devices and antibiotics; scarcity of local and national guidelines and policies [and] reuse of scarce resources, such as needles and gloves."

This is not just about HIV, either. People suffer from and die from preventable and curable diseases, conditions that are cheap and easy to prevent and cure. Many of these diseases relate to a complete lack of basic scientific, health and hygiene knowledge. Many relate to lack of basic rights, such as clean water and sanitation and a healthy environment.

Many people in East African countries have little or no access to health facilities and it's difficult to know how to view that problem. Because many are infected with various 'hospital acquired infections' (HAI) in health facilities, such as HIV, hepatitis, bacterial infections, urinary infections and numerous others. In fact, high rates of HIV are often correlated with relatively high access to health facilities. The lowest rates are often in places where people don't have access to health services.

Large scale rollout of antiretroviral drugs (ARV) has had mixed results, with many people continuing to die of preventable and treatable conditions, such as TB. The number of people on ARVs is quite a small proportion of those who need them. And countries with big programs are depending on donor funding, which is not guaranteed to get any higher, and may even drop.

So the questions are: will health systems be improved enough to make a better job of supplying the enormous number of people who would be in need of PrEP than has been done with ARVs? Where will all the money come from and will the problem of ARV rollout be solved at the same time? Will health issues other than HIV receive the attention they deserve or will people with needs that can be resolved cheaply and simply continue to be ignored?

PrEP is just a pill, it is not the means for ensuring that people who need it receive it and take it as prescribed for as long as they need it. That's no different from ARV treatment, either. But with ARVs, we know that a sustained program with a wide enough reach is still pretty elusive.

So why are we talking about PrEP as if it is anything more than a theory? Universal access to clean water and other basic rights should have been provided before ARVs, at least people would have something with which to swallow the pills. Otherwise, we're just tinkering with the problem.

Experts More Muted About iPrEx Results Than Media

The iPrEx trial tested truvada as an oral pre-exposure prophylaxis for men who have sex with men (MSM). The results were moderate, showing a 44% efficacy. The result would have been far higher had adherence been higher. But if adherence was something that could be assured, high and consistent rates of condom use would make PrEP irrelevant.

From what I can work out also, the study did not test the partners of those who became infected with HIV during the trial. This makes the claim that those taking the drug were protected from sexual transmission, as opposed to some kind of non-sexual transmission, somewhat tenuous. This question is crucial and is still hanging over the equally hyped CAPRISA 004 trial, which tested the use of 1% tenofovir as a vaginal gel.

As a result of very low adherence to the drugs in the iPrEx trial, it is not possible to claim with any confidence that resistance will not develop where those taking the drug become infected with HIV, but where the infection is not detected in time. Most of those who seroconverted were not following adherence advice. HIV strains resistant to truvada were detected in two participants who entered the trial with HIV infection that was not detected until later.

The issue of how early HIV infection is detected in people taking PrEP is very important. How regular would testing need to be for the threat of resistance to be minimized? Most people never get tested. Some test once in their life. Very few test regularly. Would quarterly, or even yearly testing ever be logistically feasible or affordable?

Resistance is not just a danger for the person taking PrEP; resistant strains of HIV can be transmitted, perhaps even to people taking the same PrEP formulation. Worse still, resistant strains could infect large numbers in certain sexual networks, for example, where MSM are targeted as an especially high risk group.

Whatever about the use of this drug in rich countries, the feasibility of using it in developing countries seems pretty low. Levels of side effects were not high, but that's not so comforting given that adherence was so low. The drug itself is very expensive but the cost of regular testing of millions of people, even the very possibility of such an undertaking, makes it a luxury that few could afford. Dropping the price of the drug will not make the cost of large scale rollout of PrEP any more affordable.

Interestingly, it is reported in the appendix that rates of receptive intercourse dropped sharply in the first 12 weeks and stayed at about half what they were at the start. Use of condoms during receptive intercourse increased to a high level, also during the first 12 weeks, and stayed high for the rest of the trial. Similar patterns of protective behavior were noted in the CAPRISA 004 trial.

These findings suggest that even people thought to be at high risk of contracting HIV are amenable to taking precautions. Sadly, rollout of PrEP is not expected to include rollout of similar levels of support and monitoring found in clinical trials. But most sexually active people in some African countries seem to be at high risk of HIV infection and health facilities are unable to contain the endemic chest and diarrheal conditions that kill so many, let alone HIV.

Dr Joseph Sonnabend has a good critique of iPrEx which is worth reading in its entirety. It seems as if those who want to latch on to anything that can be dressed up as good news are being allowed free rein to do so. But those who treat the issue more thoughtfully, and that includes those involved in the trial, don't seem to be shouting from the rooftops.

Gates Foundation Spends Billions on Potemkin Villages

Bill and Melinda Gates seem to think people have a downer on development aid, if their recent attempts to present us with 'success stories' is anything to go by. One of problems with Gates and Co is that they have a lot of say in how the development agenda is set because they have the money to blow on whatever they feel like. So if they feel like blowing their money on puffing their own projects and interests, they'll do it. And if they feel like hyping PrEP, genetically modified organisms and numerous other purely technical quick fixes, they'll do that.

In recent years, questions have been raised about the way things have been done in development up to now. Perhaps that was going nowhere and things will just continue to benefit the donors more than people living in developing countries. But what the Gates Foundation is doing tends to obscure what is going on, to paint a colorful picture when what we need is an accurate picture. Worse still, because they get to set the agenda, issues that have been ignored in the past will stay in the dark and issues that these over paid bureaucrats like will be even more hyped than before.

Nothing I read about Gates and his cronies makes me think that he understands poverty or any other issue in development. I don't even think he cares very much about such things. I have no idea what motivates him but I don't see him engaging with anything but opportunities to force unneeded and possibly harmful technologies on people who are too disempowered to object. The foundation's work risks undermining other work that is going on in development and unless they can learn to cooperate and even take their lead from people who know what they are doing, who know what they are talking about, development will be stifled.

For example, PrEP is not going to reduce the risks that HIV negative people face to any great extent. People who face sexual risks can take other measures and if they can't, it's hard to see how some pills with help. For those who face non-sexual risks, the pills may work, but their availability is not a reason for allowing unsafe medical and other practices to continue. PrEP is in danger of sweeping the real problems under the carpet, but without reducing the risks appreciably.

Genetically modified organisms and other technical quick fixes are similarly distracting from the real issues that give rise to poverty, food insecurity, contaminated water and poor sanitation, inequalities of various kinds and any other development problems. Technical solutions are in the hands of technocrats like Gates and they will always remain in the hands of the rich and powerful. People don't die for want of pills for, say, cholera, they die for want of fresh water. Cure cholera and a handful of other water borne diseases and people will die of something else, probably also water borne.

The majority world is not a sand-pit for Gates and recipients of his largesse to play in, it is reality for most of the world's population. Big 'philanthropy' needs to be answerable to the public before it does irreparable damage, if it hasn't done so already.