Could PrEP be in Competition with Mass Male Circumcision Programs?

17 Nov

[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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