AIDS prevention research has hit a major road block. More than 150 recent prevention trials including vaccine and microbicide candidates failed to protect trial participants against HIV infection. It is inevitable that the question is asked: Is there ever a point in time where we should concede defeat and abandon any further HIV vaccine and HIV microbicide trials?
With the death toll standing at 25 million lives lost prematurely to AIDS, and 33 million people worldwide currently living with HIV, the unpleasant truth is we have no choice other than to press ahead with further trials. I am not a great fan of Winston Churchill, but his famous remark, ‘Never give in. Never give in. Never, never, never’ seems to be the only appropriate response to the vaccine/microbicide trial question in the age of AIDS.
AIDS drugs have become more sophisticated, and no one knows for sure how long people will be able to cope with the side effects of such powerful agents. Truth be told, while new drugs are being developed continuously, we are barely ahead of the ever-mutating virus. Are we ahead at all, or are we falling further behind? For every one person bring treated in the developing world, roughly five new people become infected. It is far from clear that we can win the numbers game.
Even though significant inroads have been made, it remains that the vast majority of people in developing countries who could clinically benefit from AIDS drugs have no access to the life preserving medications that continue to be brought to the market.
While AIDS vaccine trials continue unabated, so do the equally unsuccessful microbicide trials. Microbicide trials are described by some as the politically correct brother of the better funded AIDS vaccine trials. Their scientific rationale seems as shaky, if not shakier than those of vaccine candidates, yet they continue because they are seen as the last best hope for women in developing countries to protect themselves against infection. The trouble is that so far all these trials have achieved so far is an increase in the number of women who have become more susceptible to an HIV infection as a result of their trial participation.
Proponents of the defeatist stance, including Homayoon Khanlou and Michael Weinstein of the AIDS Healthcare Foundation, the largest provider of HIV/AIDS medical care in the USA, argue that instead of continuing to squander hundreds of millions of dollars on a futile quest for an HIV vaccine, the focus should shift to spending on the prevention, testing and treatment of AIDS.
But we will only ever know after a trial whether or not it has been futile. At this point in time there is no real reason to assume such trials will necessarily fail. What we should be focusing on instead are other ethical concerns such as the provision of care to people who seroconvert during trials, or people who become more susceptible to an infection due to their trial participation. We have to ensure that no trial participant is left without adequate clinical care at the very minimum. The talk about pulling the plug on HIV vaccine and microbicide trials needs to end sooner rather than later.