Do Family Health International Care About Women or Funding?

A quick look at the HIV/AIDS and Malaria Indicator Survey for Tanzania (or any other African country) will show that 'HIV' always means 'sexually transmitted HIV'. The so called 'ABC' strategy (Abstain from sex, Be faithful to one sexual partner, use a Condom) is still about as far as the global HIV industry has got in terms of HIV prevention. Over 50%, often over 80% of people between the ages of 15 and 49 know about at least one of these methods of reducing the risk of sexually transmitted HIV.

It would be more comforting if a higher percentage of people knew about all the ways of preventing HIV, but that would need to include non-sexual transmission, as well. People answering questions about ABC are prompted but it takes a lot more prompting to get people to suggest non-sexual modes of HIV transmission. Such modes are deemed not to be important enough to include in the Survey. Some people know about them, rather surprisingly, but how many know how to avoid or prevent non-sexual HIV transmission?

PrEP and a handful of other interventions are also aimed at sexual transmission of HIV. While some drugs may also reduce non-sexual transmission, this is not their aim. And telling people they could take antiretroviral drugs to avoid being infected with HIV when they pay a visit to a health facility, a dentist's surgery or the hairdresser might not be the best way of selling the technology.

So gushing about vaginal microbicides "giving women a new tool to protect themselves from HIV infection" sounds like humbug when it comes from FHI's Ward Cates. If FHI gave a damn about women being able to protect themselves from HIV, why do they not take so much interest in non-sexual transmission? After all, they have received hundreds of millions of dollars to try to influence women's behavior, in relation to sex, reproduction and health in general. If they are not in a position to warn about non-sexual transmission, who is?

Of course, there is a set of questions about medical injections and about whether the equipment used was taken out of a sealed packet. But these matters do not usually make up part of HIV prevention programs and few programs mention either the risks from medical injections or the steps people can take to reduce the risks of infection with HIV or any other blood-borne viruses. None of the Aids Indicator Survey questions aim to establish how HIV positive people might have become infected.

The company that produces the drug used in the microbicide gel, Gilead, is one of the many multinational drug companies that sponsors FHI. It wouldn't do Gilead, or anyone else betting on sexual transmission of HIV, any good if non-sexual transmission were to play a significant role in the epidemic in African countries. But luckily, there's a whole pack of companies and even funders who have similar interests, which don't include nosocomial or iatrogenic HIV transmission. Who are they? Just take a look at FHI's list of funders.

Big Pharma Predicts PrEP Will Be Great, For Them

There's always a lot of talking up programs that cost heaps of money, never so much reflection on why throwing money at a problem (or at an industry) doesn't have the predicted effect. So it's surprising that an article by the BBC admits that the target to provide everyone who needs antiretroviral drugs (ARV) with them by 2010 has been missed. Only a third of those who need the drugs are receiving them, according to official figures (WHO, UNAIDS, etc).

There's a bit of hedging because WHO guidelines concerning the stage at which people need ARVs has changed, so the overall figure has gone up. But the target would have been missed, regardless. The figures sound very impressive, but it's hard to find a clear statement of how many people have received ARVs and whose supply has, for some reason, been cut off, how many are lost to follow up, how many have died or are not responding to treatment, how many are in need of second line drugs because they have developed resistance to first line treatment, how many are receiving second line drugs, etc.

For instance, some countries highlight incidents where money or drugs are going missing, but it's rarely made clear what impact that has on treatment or HIV transmission. And while articles constantly make statements such as "virtual elimination of mother-to-child transmission of the virus by 2015 is possible", other articles make it quite clear that there is a huge gap between optimistic press releases and what's happening on the ground. Only 24% of Ugandan children who need them are receiving ARVs, 150,000 are living with HIV, nearly 15,000 are born with the virus every year and 16,000 dye of AIDS every year. And Uganda has received far more money, and far more attention, than most other African countries.

It's good to hear that some pressure is being applied to countries with high HIV prevalence to make some of their own revenue available for the epidemic, and perhaps for health as a whole. So far, most of the money for ARV programs has come from external donors, but their funds are drying up. However, given the progress of attempting to put millions of sick people on drugs, how would a program that aims to put far higher numbers of healthy people on drugs fare?

Dear CAPRISA 004, You've Been Dumped

The most hyped issue by far at the hype-laden Vienna Aids Conference a few months ago was the CAPRISA 004 microbicide trials, which is said to be "at least 39% effective in preventing HIV infection" when applied before and after sex. There were calls for the technology to be made widely available as soon as possible, though the trial results are not impressive and several more years, at a minimum, are required before a viable product results.

On the strength of the hype, attempts were made to raise $100 million to carry out further trials. But only $58 million has been raised so far. What has happened to all the enthusiasm of a few months ago? Given his endorsement of technological fixes, especially pharmaceutical ones, why hasn't Gates coughed up the shortfall yet? And why is so much of the money coming from donors? Big Pharma constantly bleats about how much money they invest in products as an excuse for extorting enormous profits out of what is often publicly funded research. Where are they now?

Many African countries are finding just how quickly donors pull out when it suits them, although these countries were heroes in the fight against HIV only a short time ago. Far fewer people receive antiretroviral drugs than need them, many of them are lost to follow up, develop resistance, die of something curable or simply cease to be important now that HIV treatment on its own is no longer flavor of the month.

What could explain this sudden lack of interest? Will PrEP experience similar fluctuations?

Pharmaceutical Research; Blink and You've Missed it

Only last year, a Cochrane Review of PrEP concluded that "there is no reliable evidence to support the use of any antiretroviral agent for HIV chemoprophylaxis". At the time the study was carried out, only one study met their inclusion criteria and the result of it was not statistically significant.

But it's amazing how much can be achieved in a short time by a multi-billion dollar multinational pharmaceutical industry with ample funding and a high probability of huge profits. Ever since the HIV industry has changed its tune from 'The news is bad, we need more money' to 'The news is good, we need more money', there has been lots of favorable writing about PrEP and related uses of HIV drugs.

The Cochrane Review listed the following implications:

"We advocate well-conducted trials with the statistical power to answer questions about the value of PrEP in preventing HIV infection in various populations and risk groups. Ongoing and future trials should evaluate other important issues, such as behavioural disinhibition and drug resistance, which are some of the major concerns about the use of chemoprophylaxis for HIV."

And already there have been trials which are being interpreted in the most generous terms possible; there have been papers about how disinhibition is not likely to be such a big problem; and even drug resistance is being written about as if it is a mere challenge, not a danger, like drug resistance in relation to other diseases.

This is amazing progress, truly amazing. I'm simply amazed.

Good Cop, Bad Cop, No Cop, No Problem

A recent article on PrEP notes, among other things, the problem of 'addressing informal markets'. The article is entitled 'Implementation Science of Pre-exposure Prophylaxis: Preparing for Public Use' and it lists many of the 'challenges' of PrEP, which is useful. But because there are so many challenges, informal markets only get a brief paragraph.

If people are getting drugs for free, they could easily sell them on. If PrEP is intended to be sold to people, the drugs that are currently free can be sold, instead. This is an informal market.

This development of informal markets has occurred at various times in various places. There is evidence that it still occurs, which is not really a problem for the pharmaceutical industry, as long as they are getting paid. But it is a problem that people could end up taking unprescribed drugs and using them for purposes for which they were not intended.

There is also a danger that, as the drug taking will not be monitored, if the person becomes infected with HIV, resistance could develop. Again, this is not a problem for the pharmaceutical industry because they have other, more expensive drugs that they can sell. But the person selling on the drugs could be failing to adhere to their own regime and those receiving the drugs are in danger of developing resistance and even passing that on to others.

If PrEP is to be rolled out as a possible means of preventing HIV transmission, it would want to be very well controlled. The numbers of people involved would be far higher than the numbers currently on antiretroviral drugs (ARV) and this program is not very well controlled. As much as 25-40% of people on ARVs in countries such as Kenya could be lost to follow-up. They just don't have the record keeping capacity in their health services to administrate current levels of ARV roll out, let alone an even bigger roll out of PrEP.

Also, the phrase 'implementation science' in the article title smacks of 'scientists' doing more than a little work to help pharmaceutical companies push their wares on populations who may be very reluctant to buy them if they actually get to know anything about them. Implementation science may or may not be related to the practice of 'medical ghostwriting', where pharmaceutical companies (or people acting for them) write up their 'research' and then get some bona fide scientists to put their name to the paper. How much this happens with regard to PrEP, I couldn't say.

Opportunity and Opportunism in the HIV Industry

There's an article in the July edition of the Journal of the International AIDS Society entitled "Planning for pre-exposure prophylaxis to prevent HIV transmission: challenges and opportunities". The list of 13 authors and their respective institutions reads like a page from a Who's Who of the HIV/AIDS industry. The tone of the article suggests that there is more interest in the opportunities presented by pre-exposure prophylaxis (PrEP); the challenges are made seem quite irrelevant, or at least surmountable. The paper emanated from a meeting sponsored by the Gates Foundation.

In addition to the apparent irrationality of trying to eradicate HIV by putting most sexually active HIV negative people on antiretroviral drugs (ARV), PrEP would seem to be in tension with another, slightly less irrational strategy: 'treatment as prevention'. Treatment as prevention involves treating everyone found to be HIV positive with ARVs, regardless of their disease stage. According to this theory, people who are on ARVs are not very infectious, so they are unlikely enough to transmit HIV for the epidemic to eventually be eradicated.

But a successful treatment as prevention program would obviate the need for PrEP. And a successful PrEP program would make treatment as prevention a serious case of overkill. Perhaps the industry, in its great wisdom, is not advocating for both programs to be implemented in the one place. But both strategies seem to be about maximizing drug use without having much likelihood of effecting substantial reductions in HIV transmission.

PrEP would target HIV negative people and treatment as prevention would target HIV positive people, so the latter would seem to be the more tractable aim. Even in the highest prevalence countries, there are more HIV negative people than HIV positive. But then you have to make the decision, assuming your resources are limited, as to whether you distribute drugs among those who are already sick, to allow them to live longer and to enjoy good health; or distribute drugs among those who are not sick, but who may become infected.

PrEP and treatment as prevention are not complementary strategies, they are clearly in tension. But the tension is not irresolvable. Healthy people don't need drugs. There are other prevention strategies available that PrEP can only overlap with, such as condoms and possibly others. There is also prevention of non-sexual HIV transmission, which has been totally ignored in developing countries so far. But the aim to treat everyone infected, no matter how desirable, will not guarantee the protection of people as yet uninfected.

The article concludes "It is an ethical imperative that we act now to prepare the path to timely implementation [of PrEP]". The only ethical imperative is that we find appropriate treatments and prevention interventions. The imperative to exploit the HIV pandemic to make huge profits is not ethical, whatever else it may be.

Betting on Sex

The behavioral paradigm, which claims that most HIV transmission in African countries is a result of unsafe heterosexual intercourse, is vitally important to the pharmaceutical companies competing to develop HIV drugs. Some HIV transmission is due to heterosexual intercourse, but it is not clear what proportion. Some transmission is also due to unsafe medical and cosmetic practices. But, according to those defending the orthodox view, sex is the problem and only a tiny proportion of the virus is transmitted through any non-sexual route.

Betting on the behavioral paradigm being true, the pharmaceutical industry has been working to widen their markets. They are not only targeting people who are HIV positive but also the far bigger, and more lucrative market, of those who are HIV negative. It is hoped that they can be scared into believing that they are vulnerable, and more to the point, that they need to take some form of drug to protect themselves.

Four of the main means of widening the market for HIV drugs are vaccines, microbicides, pre-exposure prophylaxis (PrEP) and a strategy called 'treatment as prevention'. A maximum of about five million HIV positive people in the world are currently on antiretroviral drugs (ARV). But tens of millions, perhaps hundreds of millions could be potential customers for vaccines, microbicides and PrEP. Even just one of these could increase ARV consumption by tens or hundreds of times.

Treatment as prevention, testing everyone regularly and putting anyone found to be HIV positive on ARVs to reduce their transmission rate, would create a smaller market, but it could still be about ten times the current market.

To help out the pharmaceutical industry a bit more, because they are clearly struggling to make ends meet, there are two further phenomena. The first is the new WHO Guidelines on HIV treatment, which recommend putting HIV positive people on treatment at an earlier stage of disease progression. This could double the current market. The second is the enormous levels of ARV drug resistance that will inevitably develop as a result of all the previous considerations.

Vaccines, microbicides, PrEP and treatment as prevention are all predicated on the behavioral paradigm. While any treatment with ARV drugs may give some protection against any kind of HIV transmission, no one is going to vaccinate against something that they could catch from unsafe medical or cosmetic practices. They will just insist on safe medical or cosmetic practices. No one would put a topical microbicide on their genitals to protect themselves from accidental exposure to contaminated medical equipment during an operation. And people certainly won't be taking PrEP before going to the doctor, dentist, hairdresser or tattoo artist.

If a significant proportion of HIV transmission is as a result of unsafe medical or cosmetic practices, that would really cut into the markets that Big Pharma have been trying to secure for so long. The whole HIV industry and the hoards of academics, consultants, bureaucrats and countless others that work so hard to claim that sex is the problem would have to find other approaches to cutting transmission.

True, it would be far easier to cut transmission if a lot of it turned out to be non-sexual. But easier for whom? Topical microbicides and the like can't be used for much else aside from preventing sexually transmitted HIV. I'm sure there'll still be vast markets for HIV related pharmaceutical products. But without sex, will anyone even care any more? It's hard to imagine who will want to be involved in HIV prevention campaigns without the current emphasis on sex, whether they come from a moral, population control, religious, political, salacious, commercial or almost any other angle.

I don't wish to exaggerate, I'm sure sex plays a big part in HIV transmission. But the world needs to know just how big that part is. And that means investigating the part that non-sexual HIV transmission plays in high prevalence countries. Simply guessing, which is what UNAIDS currently do, is not good enough. People are entitled to know how HIV is being transmitted so that they can protect themselves and others.

The HIV industry, if it is ever to have an impact on the pandemic, also needs to know. They need to let Big Pharma fend for themselves, they'll probably be OK. But many people are being infected with HIV, suffering disease and stigma and passing the virus on to others because they don't know that they can be infected through non-sexual routes and so they don't know how to protect themselves. It's time for the industry to admit they got it wrong, that it's not all about sex, and to start doing something about it.

Beware of What We Don't Know About PrEP

It might be thought that if HIV were one day, not just preventable, but also curable, that prevalence in most countries would go down very quickly and anyone infected in the future would be cured, sooner or later.

But are all preventable diseases prevented, where possible? And are all curable diseases cured? Cholera, malaria, polio and a huge range of other diseases can all be prevented by provision of clean water and good sanitation and most of them are curable (although clean water is also required for this, not just drugs). Yet water-borne diseases are endemic in many countries and kill vast numbers of people. And polio, despite considerable efforts, some successful, just keeps coming back, to a large extent because people keep drinking water contaminated with sewage.

So why should pre-exposure prophylaxis (PrEP) for HIV be any different? Perhaps HIV is seen as politically important. Well, it certainly is politicized. But then, a massive cholera outbreak in Zimbabwe last year was also politicized. It received a lot of attention, one suspects, because Zimbabwe and Mugabe were receiving a lot of attention.

Cholera outbreaks are a reflection of very poor water and sanitation provision. The failure to deal with such an outbreak efficiently reflects badly on the strength of the country's administration and on the strength of their health services.

However, the cholera epidemic ceased to interest the world's media, perhaps because it eventually petered out, as epidemics sometimes do. Water and sanitation provision are unlikely to have been improved much, the same probably applies to health services. As for the administration, all that can be said is that the medial has gone off to ogle at something else.

How long will it take the world's media to focus on the current cholera outbreak in Nigeria? Perhaps the political situation is not considered interesting enough at the moment, but as a health story, it doesn't seem to have got around yet. Ok, the story is getting around now, but mostly among the African and NGO press. It has even appeared, briefly, in the mainstream media, but it has not been very widely covered, given the implications of such an epidemic.

When the media does get around to covering the outbreak, it will probably concentrate on the sheer magnitude, rather than the conditions that allowed the outbreak to become an epidemic. The media may even reflect on the irony of such an epidemic occurring when it's so easily predicted and prevented.

We know the conditions under which cholera outbreaks become epidemics, the determinants of such large scale health emergencies. We know how to substantially reduce the probability of such an outbreak and how to prevent it from escalating. You will find the perfect conditions for outbreaks of cholera and other water-borne diseases in most countries in Africa, right now.

'Emergencies' are not always unforeseen events. We might not know when and where they will occur but we always know the sort of places where they might occur, the conditions under which they will occur, given time. We usually have (or could easily obtain) a good idea of how many people are vulnerable to injury and death if they do occur and how to improve the conditions to the extent that an outbreak can be contained and people treated until their health is restored.

People needn't suffer from and die from many of the preventable and curable diseases that they do suffer and die from. But we also have the capability to provide HIV positive people with palliative care so they don't have to suffer unnecessarily, yet many don't receive such care. Many people who need antiretroviral drugs (ARV) either don't receive them or fail to keep on taking the drugs. In other words, many people suffer from and die from Aids, unnecessarily.

Even if HIV PrEP were a reality, and it is far from that, why should we believe that the practicalities of distributing such drugs to the people who need them, when they need them, for as long as they need them, will ever be part of the intention of those who keep screaming about how important PrEP is? Being able to do something is not the same as doing it, or having any intention of doing it.

If PrEP advocates would be a little honest and balanced in their arguments, I might give them some credence. But it is the very absoluteness of their pronouncements, the purity of their stated intentions, the apparent goodness and even the applicability of PrEP to the world that makes me think that the whole thing is part of a broader aim to vastly increase sales of relatively useless pharmaceutical products to people; any people at all.

One of the most worrying aspects of PrEP and HIV is that, unlike water-borne diseases, we don't know why such huge numbers of Africans become infected with HIV. We know that people who are members of some demographic groups in some countries are more likely to be infected than people from other demographic groups and countries. But we are not certain, despite assurances to the contrary, why this is so.

Everyone drinks water and most people have sex. Only some people drink contaminated water and only some are likely to have sex with a person who is HIV positive. But in most demographic groups in most countries, the likelihood of becoming infected with HIV, despite having regular, unprotected sex with someone who is HIV positive, is very low. Until we understand why this is so, PrEP will be of little use, if any, in high HIV prevalence countries.

The Opposition is Real, it's the Defense that is Fabricated

In an article entitled "The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?", Singh and Mills make the very assumption about PrEP that they are not in a position to make: that it may be useful for women involved in commercial sex work. As is clear from a number of studies, high prevalence of HIV is not very closely related to sexual behavior nor to 'high risk' groups, such as commercial sex workers.

Therefore, we are still in the dark about how PrEP should be used. Making PrEP available to low risk groups would be ridiculous, but I think that is what the pharmaceutical companies involved would like; to put lots of healthy people on drugs that they need to take in large quantities for much of their adult life.

The authors of the paper try to use seemingly reasonable arguments and suggest that the industry needs to be 'proactive' in its dealings with those who oppose the creation of markets for useless pharmaceutical products, taking advantage of cheap research subjects in developing countries. But by 'proactive', they seem to be recommending that the industry get in quickly and preempt any potential opposition.

They talk approvingly and rather naively about the involvement of the Bill and Melinda Gates Foundation in getting both sides together, as if the foundation is anything other than a major part of the HIV industry that stands to profit handsomely from its investments in Big Pharma.

Differences between activists and the HIV industry are not mere 'ideology'. Activists are not convinced that PrEP has anything to offer anyone but the pharmaceutical industry. Yes, the goal is combating Aids and the target is people who are HIV positive (and those who are at risk of becoming infected). But PrEP is irrelevant to both of those. So activists will continue to oppose it.

Drugs for the Healthy, Drugs for the Sick, Drugs for those In Between

Joep M A Lange expresses his frustration about protesters 'derailing' trials of PrEP a few years ago, referring to the halting of the trials in Cambodia, Cameroon and Nigeria. He wishes that protesters would all operate under some kind of umbrella, presumably so they can all be bought off all at once, like himself. But there is a good reason why protesters do not operate under an umbrella organization: they often have very different agenda.

And there are many reasons for questioning the use of PrEP as an ostensible means of reducing HIV transmission in developing countries. Some would argue that health is not purely a matter of disease eradication and they object to the medicalization of health, where people dying of water borne diseases are given drugs which they swallow using contaminated water.

Others might worry about the side effects of taking drugs, especially for healthy people. Then there's resistance, where people taking PrEP might be or become infected with HIV and resistance would develop. They would have a difficult and expensive to treat strain of HIV, which they could easily transmit to others. The 'cure' would have made things a lot worse.

These are all legitimate worries and they all need to be on the drug companies' agenda, whether they like it or not. They can't be relegated to any other business, crowded under an 'umbrella', to be treated with the same contempt that the pharmaceutical industry treats people in high HIV prevalence countries, HIV positive and HIV negative alike.

But there are two other worries I'd like to highlight here: firstly, Joep raises the issue of 'female-controlled' prevention techniques (though he says technologies because it musth be high tech, right?). The drug industry likes to point out how terrible the plight of women and children is and how men are so unreliable and badly behaved and that they are making PrEP available to help the most vulnerable people in high HIV prevalence countries.

But this is an argument for researching the issue of disempowerment and ways of alleviating it. Of course, drug companies may not have a big part to play, you certainly can't cure those problems with a drug. But I suspect that's how they want to push their products. They should consider how decades of availability of contraceptive drugs haven't done anything for the disempowered, nor much for fertility, either.

A second important issue around PrEP is that the HIV industry as a whole, that vast 'umbrella' of people and institutions who are doing very well out of the HIV pandemic and want to do a whole lot better, doesn't know a great deal about how HIV is transmitted. Or rather, much of their 'technology' is aimed at sexual transmission of HIV when non-sexual transmission of HIV is not talked about.

Joep and the string of competing interests he lists in his article have been trying to set the agenda for years, they are still trying. Opposition should come from anywhere there is a legitimate worry about the agenda for every international HIV/Aids conference, because the worries are many. Whereas the agenda of Big Pharma is always the same: how to get bigger.

Healthy people don't need medicine and sick people don't need useless, potentially harmful medicine. As long as there is Big Pharma, stupid ideas like PrEP and hyenas like Joep, I hope there will also be protests and protesters, shouting all the louder because they don't have access to the high platforms and the influential ears enjoyed by the HIV industry.

Welcome to Pre-Exposure Prophylaxis or PrEP

Preventing a disease may seem preferable to waiting until someone becomes infected and then treating them. But HIV pre-exposure prophylaxis (PrEP) is a bit different. In countries with high HIV prevalence, such as Swaziland, Lesotho, South Africa, Botswana, Zimbabwe and a number of others, so many people are at risk of being infected, the cost of providing medication for them all would be prohibitive. After all, PrEP is not a once off inoculation; it is something you need to take for as long as you are sexually active.

So why write a blog about that? Well, I have searched the web a good deal for information about PrEP and it is overwhelmingly positive and overwhelmingly shaped by the very people who stand to gain from promoting it, namely the pharmaceutical industries, Big Pharma. I would expect to find at least some articles that criticize or question or even try to analyze PrEP. But I only came across one. So I'll be on the lookout for others.

HIV is a virus spread by contaminated bodily fluids, such as blood, semen, vaginal fluid and others. It is relatively difficult to spread through sexual contact, especially penile-vaginal contact, though anal sex is especially dangerous. But some of the most common routes of infection could be non-sexual. In which case, it would be a waste of effort and money to target people on the basis of their assumed sexual behavior with PrEP. Unless you wanted to waste money; unless it isn't your money; unless it is development money.

If you want to hear cheers for PrEP, just have a look at the Aids Vaccine Advocacy Coalition (AVAC), a pharmaceutical poodle that yaps a lot but, ultimately, protects nothing but Big Pharma profits. It claims not to be supported by Big Pharma, but they do get money and support from institutions that cheer for little else: UNAIDS, CDC and IAVI. And then there's the Bill Gates Foundation, which makes a lot of money from Big Pharma and other, equally admirable, multinational interests.

I have written about PrEP elsewhere, especially on my HIV in Kenya blog (just search for 'PrEP' in the search box) and briefly in the blog, Kwa Sababu, now sadly defunct. But I think the field of PrEP is in serious need of analysis and discussion. I hope others feel the same way.