Showing posts with label AVAC. Show all posts
Showing posts with label AVAC. Show all posts

Sunday, November 17, 2013

Could PrEP be in Competition with Mass Male Circumcision Programs?

[Reposted from the Pre-Exposure Prophylaxis (PrEP) Blog]
After years of trying to create a market for pre-exposure prophylaxis (PrEP) pills, such as Truvada, Big Pharma has turned to their favorite mass marketing ploy: dumping their products in African countries that are starved of health funding. Of course, why wouldn't they dump them in Africa, won't they be paid for with donor funding?
An article in Kenya's The Star entitled "Kenya: 'Wonder Pill' for Risky Sex On the Way" takes the unusual step of raising some difficult questions about PrEP, rather than repeating the Big Pharma press release, despite a shaky introduction. The article continues "Kenyans involved in risky sex behaviours will soon get a 'wonder pill' that can prevent HIV infections. Experts say Truvada, which some call the 'new condom', can reduce chances of catching HIV but there are fears the drug may be misused by the youth".
What, exactly, would constitute misuse of the drug? If it can cut the risk of infection by "up to 75 per cent if one faithfully swallows it daily", what could go wrong? Well, as the article eventually reveals, most people don't swallow drugs daily and most people can not expect 'up to 75%' reduction in risk. That figure is not even from a randomized controlled trial, but from a 'sub-group' study, where the best results are used to exaggerate the level of protection people, in (comparatively) strict trial conditions, may expect. Outside of that sub-group, and outside of drug trial conditions, risk reduction is far lower.
It's odd that such reports talk about studies and proofs for something that they then refer to as a 'wonder pill', a 'new condom' and talk of 'up to 75% protection' (although that's a bit weak compared to the term 'invisible condom' used by those marketing mass male circumcision), and the like. These are PR buzzwords, not scientific findings.
It is said that PrEP programs intend identifying those most at risk of being infected, such as sex workers, intravenous drug users and men who have sex with men. This will be a departure from vilifying these already stigmatized and criminalized groups; it remains to be seen how much donor funding will actually be spent on these groups to provide them with PrEP, given that it has been so difficult in the past to provide them with condoms, injecting equipment and even basic sex and sexuality education.
As the article says, Truvada is expensive, and it has made billions of dollars for Gilead. So it's worth their while pushing as much of the stuff as possible in countries with high HIV prevalence while the patent guarantees that their product will face little competition. By the time the patent expires the likes of Bills Clinton and Gates will surely have set up some program whereby the drugs can continue to be purchased at inflated prices.
The article makes the important point that nearly 1 million HIV positive Kenyans currently need antiroviral drugs just to keep them alive. So why would donors want to provide these same drugs to people who are not yet infected with HIV (aside from an obvious desire to enrich big pharma)?
Oddly enough, a cost effectiveness study makes its estimates using existing levels of male circumcision and antiretroviral therapy. This means that the three multi-billion dollar programs will be in direct competition with each other for funding, and each one will be trying to claim that any drop in HIV incidence is a result of their work. The study also seems to assume far higher levels of success than have been achieved so far. But that's big pharma for you.
While Gilead and other pharmaceuticals can gain a lot from any increase in antiretroviral therapy and PrEP programs, they may not stand to gain from mass male circumcision programs. Their assumption that their PrEP programs will be cost effective only in countries where circumcision levels are low suggests that by the time their product may be approved, the circumcision programs will already need to have failed, some time around 2015.
Worries that people may use PrEP as a kind of recreational drug, so they can dispense with the use of condoms when they are engaging in sex with people who may face a high risk of being HIV positive are not very convincingly addressed; nor are worries that overuse and misuse of antiretrovirals, either for HIV positive people or as PrEP, are brushed aside, with remarks about "government policy" and making the drug available "in form of a package that probably includes HIV testing and other prevention methods".
I seem to remember condoms, circumcision, ABC and various other programs being made available in the form of a package, without that leading to extraordinary results. But it will be interesting to see if PrEP will erode some of the funding currently being made available to, or earmarked for, mass male circumcision programs.
Circumcision programs stand to rake in billions for the big providers, but widespread use of PrEP would be worth far more. It's unlikely that a full scale version of both programs could co-exist; they are not mutually exclusive, but their cost effectiveness is predicated on their being the only or the main program in high HIV prevalence countries.
Whether one program displaces another, or whether they all get funded, the losers will be people in high HIV prevalence African countries, which will continue to suffer from under-funded health and education sectors. They will continue to be a mere 'territory' for sales reps, who will continue to carve things up in ways that should be very familiar to us by now.

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Thursday, December 16, 2010

Circumcision Could Increase HIV Transmission But Strategy Will Continue

With all the publicity about mass male circumcision (MMC) and the great part it could play in reducing HIV transmission in high prevalence countries, little is said about the likely effect of such a strategy on women. After all, it is women who are most likely to be infected, women who are most susceptible, women who are said to have the least power in relationships, etc.

Well, something like a report, but without the balance you might expect, has been published on MMC and women. The fact that AVAC (a pharmaceutical industry front) and the Gates Foundation are involved means that, whatever the report finds, it will be used to support MMC. It certainly won't be used to slow things down and consider whether this is the right way to go about it.

The report finds that women lack detailed factual information about how MMC is supposed to play a part in HIV prevention. This is not surprising, considering the heavily biased reporting on the technique. The average of '60% protection' claimed on the basis of three brief trials involving small numbers of people doesn't stand up to scrutiny.

The fact is, it is not clear how circumcision protects men against being infected with HIV, if it really does protect them. What is clear is that HIV prevalence is only lower among circumcised men in some countries. In other countries, HIV prevalence is higher among circumcised men. How that problem will be resolved is not clear.

Also, MMC does not directly protect women at all. It could be argued that if fewer men are HIV positive, fewer women will become infected, so they are indirectly protected. But, in addition to the lack of clarity about how much it protects men, it is not clear than most women are infected with HIV through sexual intercourse.

Many HIV positive women have a HIV negative husband, yet many of these women only have one partner. Even if their husband is as sexually promiscuous as African men are said to be, something there is no evidence for, their husband didn't infect them if they are not themselves infected. If some people are not being infected sexually, circumcision will have no benefit for them.

But are circumcised men who are HIV positive less likely to transmit HIV to women, or more likely? There is evidence that they are more likely. Many HIV positive men are circumcised and many more will become infected. It needs to be clear whether MMC will also reduce transmission by men who are already infected or who have yet to become infected.

The 'report' finds that many women think they are directly protected from HIV transmission if their partner is circumcised. But many men also believe that they are protected and they will argue that they don't need to use other precautions, such as condoms. Even the circumcision trials advised those taking part to use condoms. Circumcision, even according to its most ardent advocates, does not guarantee against infection and the 60% figure refers to circumcision in conjunction with consistent and correct condom use.

When it comes to negotiating 'safe' sex, it will be even harder for women to negotiate for condom use if the man, and perhaps even the woman, think that circumcision obviates the need for condoms. And even if the man doesn't believe that he can safely have unprotected sex, he could still use the claim to support his case, if he wished to. If people associate circumcision with a lower likelihood of being infected with HIV, the operation could put women in more danger from unprotected sex, rather than less.

There is also the problem of circumcision performed in a non-clinical setting, which carries high risks of various kinds of infection, including HIV. Many men have been and many will continue to be circumcised outside of clinical settings, where the may not be tested, before or after, and the risk of transmission under such circumstances may be increased as a result of circumcision.

Some have even conflated male circumcision with female genital mutilation(FGM), whether inadvertently or otherwise. Even the promoters of MMC have not tried to promote FGM, but there are those who believe, or wish to believe, that it also reduces HIV transmission.

This is where things become more mystifying. Areas with high rates of FGM tend to have low HIV prevalence (such as the Kuria and Kisii tribes in Nyanza province). And some areas with low FGM rates have high HIV prevalence (such as the Luo tribe, also in Nyanza).

This is not because FGM reduces transmission, although the reason for the correlation is not clear. In other words, even if there is a correlation between high rates of FGM and low HIV prevalence, most people wouldn't claim that there is a causal connection between the two phenomena.

But then, advocating MMC on the basis of similar correlations seems particularly foolish. There is speculation about why removing the foreskin could possibly give some protection but there has been no explanation of exactly how this might work. And the assumed process is not just unclear, it is not even consistent if circumcised men in some areas show higher prevalence rates than uncircumcised men.

This report makes it clear that, despite evidence against the claimed benefits of MMC, including the finding that it will increase the vulnerability of women, MMC will go ahead. The findings of the report are profound, but not as profound as the stupidity of continuing with MMC under the guise of reducing HIV transmission. It is difficult to comprehend, but advocates of MMC have always intended to procede with the intervention, regardless of the consequences. Amazingly, this report confirms that intention, without explaining what advocates, or anyone else, has to gain.

This report claims to be opposed to stigma and advocates dispelling myths that support stigmatizing attitudes. But an MMC strategy ony lends support to the common belief that 'promiscuous' women spread HIV. The conflation of FGM with MMC also goes back a long way and is also being used to justify this and other violent acts against women. But the almost guaranteed failure of HIV prevention strageties has never put the HIV industry off in the past, so why should it do so now?

[AVAC and the Gates Foundation are also deeply involved in the CAPRISA 004 vaginal gel trial; more on my other blog]

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