AIDS@30: 4—Civil advocacy and changes in clinical research; the successes of biological science

09 Nov 2011 10:00

Many community-based organisations lead the way in promoting ethics and efficacy in both clinical and public health science. What falls under the broad rubric of treatment-advocacy has included what is researched, the ethics of research, the development of clinical research methodology, and the social utility of technical solutions to social problems such as HIV-exposure in occupational injury and unprotected sex.

Identifiable advances include the end of placebo-controlled trials when people are otherwise facing certain death; the diversification of end-points (e.g., moving from death as an end-point to the use of clinical biomarkers such as CD4 cell counts and viral load); the inclusion of diverse patients groups, for the simple fact that AIDS expresses itself differently in men and women, Whites and non-Whites, adults and children, so it’s important to see how a treatment works in all these groups rather than just in white men; and also compassionate-use protocols, in which those ineligible for the proper clinical trial can still gain access to the experimental drug and community-based researchers can use a more natural-history approach to the efficacy of a drug and its toxicities.

These are all highly significant triumphs in the history of civil advocacy in clinical science. I’m not aware of historical or policy research that has focused on the intersection of civil empowerment with the history of scientific practice, but given the great potential for this to expand in the future, I think this would be a fruitful topic for inquiry in relation to AIDS.

So, let’s step back and do a very brief review of the primary scientific triumphs. They are of paramount importance to the successful control of HIV, but many of them are obvious and already well celebrated.

If we look at the triumphs of biological science, we can identify the discovery of HIV at the Institut Pasteur in Paris; the understanding of the molecular structure and function of the virus, leading to the discovery of what are now several classes of antiretroviral drugs—an advance comparable to the discovery of antibiotics. We also have the success of the prevention of HIV-transmission from mother to fetus through medication.

This was not a simple process, and there were many dead-ends and acts of scientific desperation: I remember most of the early trials of drugs such as Peptide T, Foscarnet, AL721, dextran sulfate, hpa-23, ribavirin, suramin, cytokines such as interferons alpha and gamma, interleukin-2, and GM-CSF, not to mention a myriad of phytochemical and herbal decoctions, and I used some of them myself, particularly Chinese herbs and interleukin-2.

It’s worth looking for a moment at the reality of the development of highly active antiretroviral therapy—also know by the acronym of HAART—which became available in 1996.

As we can see from the red line here, 1996 showed a radical downturn in deaths from AIDS and this was due to the availability of protease inhibitors.

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These inhibit a crucial enzyme produced by HIV that is necessary for it to reproduce the components to create new virus particles. With a crippled protease, HIV is unable to reproduce and spread itself within the body. This biotechnical success in developing protease inhibitors obviously left the public at the mercy of pharmaceutical companies and there was very clear profiteering and price-gouging by them. This utterly indefensible practice was successfully challenged by treatment-advocates over the next several years and around 2000, generics became available. One of the levers was the PR disaster that this profiteering created for the pharmaceutical companies involved and Glaxo Smith Kline was particularly accused.

The effects of enabling the production of generics is worth looking at. Within one year, the prices of proprietary anti-HIV medications, as we can see here, were forced to drop to less than 10% of their original.

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