HIV Drugs: Expert Opinion Trumps Randomized Controlled Trial

One of the biggest HIV industry funded junkets on the calendar, the International Aids/Antiviral Society's (IAS) AIDS 2012 Conference, is currently underway in Washington DC, the area with the highest HIV prevalence in the Western world. Conspicuously, despite an avowed commitment to fighting stigma, many of the most prominent victims of HIV related stigma will not be attending the conference as sex workers and other stigmatized groups are unable to get a visa to visit 'the most democratic nation on earth'. They have been relegated to a small and less well funded conference in India.

The IAS is said to be the "world's leading independent association of HIV professionals". But my attention has been drawn to their new guidelines on 'treatment as prevention', hailed as a 'game changer' in the press. This is the use of antiretroviral drugs as soon as the patient has tested positive for HIV, as opposed to waiting until they have reached a particular clinical stage, which is what happens at the moment.

The authors of the guidelines disclose conflicts of interest that read like a who's who (or should it be 'whose') of Big Pharma. In addition, it appears that treatment as prevention is being adopted as a strategy before the results of a randomized controlled trial have been reported, a trial designed to answer questions such as when is the best time to start taking antiretroviral drugs.

As well as casting doubt on their independence, the use of expert opinion to trump evidence based medicine also raises a serious question about their professionalism; if the results of the trial are preempted by these experts' recommendations, what is the point of the trial? What if the trial results, due some time in 2016, contradict their conclusions? The possible risks of early antiretroviral treatment include various short and long term side effects, the development of resistance to these and similar drugs and, presumably, other possible risks that can not be listed until the trial has finished.

One of the objections raised to treatment as prevention is that many people who are already in urgent need of ARVs, especially in high prevalence countries, are unable to get the drugs. So would it be acceptable to start doling out these extremely expensive drugs to the potential millions of people who may be HIV positive, but are not currently judged to be in need by their physicians?

Much of the demand for early treatment, treatment as prevention and pre-exposure prophylaxis arises in wealthy countries, where HIV prevalence is relatively low. This demand is actively encouraged by the pharmaceutical companies who produce the drugs; so it's a match made in heaven for some. Even if resistance does develop, many people in wealthier countries can still afford (or their insurance company can still afford) the much more expensive second round drugs that must be used. But if first round drugs are unavailable to many in developing countries, second round drugs will be unavailable to almost everyone there.

Despite hearty reassurances that adherence to complex drug regimes was not a problem in poor countries in the early days of mass treatment, research has shown otherwise (perhaps demonstrating the difference between expert opinion and evidence based medicine). The BBC cites research that the most rapid increase in ARV resistance occurred in East Africa, where HIV prevalence is medium rather than high. Resistance was found to have occurred at 29% a year there and at 14% in Southern Africa, where prevalence is high.

The BBC article goes on to say that adherence can be improved by measures such as access to food and clean water. This is a reminder that many Africans receiving 'treatment' for HIV get little more than a bottle of pills and a bit of finger wagging. They may swallow the pills with contaminated water and eat little food to help them tolerate medication which can be toxic to people who are suffering from poor nutrition. Numbers on treatment seems to be a lot more important than the precise impact the mass treatment strategy is having on the epidemic.

The real 'game changer' in the HIV industry would be to put HIV in perspective; it is one disease out of many health issues and it is no more independent of people's overall health than any other disease. Could there be a more poignant signal of how out of perspective HIV is than the realization that many infections over the last 20 years could have been averted if more attention had been paid to prevention through improving health and other social conditions? And even HIV positive people often die of easily preventable and treatable diseases, such as water borne diseases, respiratory infections and the like.

Treatment as prevention is depicted as an effort to treat every HIV positive person in order to decrease onward transmission of HIV, but it is, in reality, a strategy to sell overpriced drugs to as many people as possible. It goes hand in hand with early treatment and pre-exposure prophylaxis, which all together should increase the market for ARVs from less than 10 million people to many tens of millions of people. And spending ever increasing billions on this one disease means that less is spent on the sort of things that really improve the lives of people in the poorest countries, such as health, education, infrastructure, employment and social services.

It is worth reflecting on the 'risks' that those taking part in the randomized controlled trial of early ARV treatment face: side effects are an opportunity to try different drugs and different combinations of drugs, even more expensive drugs. The risk is to those receiving the drugs, not to the pharmaceutical company. And resistance, of course, represents an even more significant opportunity because the response is far more expensive drugs. People, once on these drugs, will need to take them for life. What could be better for Big Pharma? So why wait for an irritatingly long trial when you can just pay experts to tell the world what you would like them to hear?

[For more about non-sexual HIV transmission and mass male circumcision, see the Don't Get Stuck With HIV site.]