Drop Everything, A Vaginal Gel Has Been Developed

Chi Mgbako writes an article entitled "International donors must fund female-controlled HIV prevention gel", but this raises a number of issues.


Is a vaginal gel, as Mgbako and others argue, female controlled? One would think that if it is, so are oral contraceptives. Yet, the majority of women in many developing countries opt for injectible contraceptives. They say their husbands object to them taking contraceptives, so they get an injection every three months, possibly running the risk of picking up some blood-borne infection at the clinic, perhaps even HIV. Will the same husbands that object to oral contraceptives ignore vaginal gels? Has this even been tested?

Also, this article mentions a number of things that are in need of change, such as domestic violence and gender inequality. These are in need of change regardless of HIV transmission. Is the author advocating that these and other social problems be ignored as long as vaginal gel is paid for by international donors and some (rather small) percentage of HIV infections are possible prevented?

I don't think the author is making the argument that these other social problems are insignificant or that HIV reduction should be chosen over other social problems. Rather, it needs to be made clear that that is something international donors do.

Numerous social problems have been alluded to as causing HIV transmission, allowing HIV transmission, assisting HIV transmission, etc. But most of these problems are independent of HIV, they existed before HIV and they won't just go away on their own.

But HIV programs have a tendency to ignore contexts to the extent that HIV testing clinics are set up in areas where people are dying of contaminated water related diseases, respiratory infections, intestinal parasites and other treatable and preventable conditions. HIV programs are, no matter how much those in the HIV industry would like to argue otherwise, deflecting attention from real and preventable problems.

And to what end? That we might be able to reduce HIV transmission by 39% (in ideal, trial related scenarios)?

Finally, if the gel is so good, why have funders not come up with the funding? Is there something they know that we are not allowed to know? Other HIV related drugs have made billions, why are international funders drawing back from this one?

Some Disturbing Considerations Relating to PrEP Trials

I’m not sure why Aegis have an article about PrEP entitled ‘hope and excitement greet first successful microbicide’ so soon after worries being raised that the money to do further required tests has not been forthcoming. These refer to the CAPRISA 004 trial, which received the most hype during the Vienna AIDS Conference only a few months ago.

Anyhow, the article notes that “Behavioural messages that encourage abstinence, monogamy and use of condoms have had […] only a limited long-term impact on the spread of HIV in that region.” The article calls for HIV prevention strategies to be made relevant, though they are not talking about making them relevant to the possibility that some HIV is not sexually transmitted.

A popular claim about PrEP (and other technological fixes) is that they can be applied by women and are “under their control”. There may be some truth in this. Yet, oral contraception has long been available without most women choosing to avail of it. Many instead opt for injectable versions, thus putting themselves at higher risk of being infected with HIV and other viruses as a result of unhygienic health practices.

Injectable versions of contraception are very popular with married women and sex workers, though perhaps for different reasons. Married women say they are not willing to risk having their husband interfere if they keep oral contraceptives at home, which they have to take regularly. It remains to be seen whether attitudes towards PrEP gel are any different. Is it really ‘under the control of women’?

The question is pertinent because unsafe health care practices are not under any clients control, whether male or female. People might be able to take precautions but they have to know that such practices could lead to infection and they have to know what they can do to protect themselves. The HIV/AIDS industry, in this instance, doesn’t seem to be interested in the strategy being under the control of those who face the risks.

The CAPRISA 004 trial, despite widely repeated claims, did not establish what risks were reduced among those taking part. Was it just the risk of sexual transmission that was reduced or was it also the risk of non-sexual transmission? The difference is crucial.

The article notes that the trial results were not affected by frequency of sex. But sexual activity was not very high during the trial and it decreased over time, as did use of the Tenofovir gel. However, HIV transmission over the course of the trial was extremely high, even among the intervention group.

It is also noted that “average viral load was not significantly different” between the intervention and control groups. The ‘Test and Treat’ strategy, which was being hyped as much as PrEP two years ago, claims that placing every HIV positive person on antiretroviral drugs will reduce viral load and therefore reduce transmission. But there is now evidence that low viral load may not be so closely related to rates of HIV transmission, something I have recently discussed on my other blog, HIV in Kenya.

The Aegis article warns that the results need to be viewed with caution; this can not be stressed enough. These trials, CAPRISA 004 in particular, seem to take little notice of how HIV might be transmitted among the populations taking part in their research. If HIV is not all transmitted sexually, such trials will continue to produce invalid results and people will continue to be exposed unnecessarily to the risk of infection with HIV and other blood-borne viruses.

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?

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.