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Twenty-five years of HIV/AIDS
September 2006
by Randall C. Willis  |  Email the author

The world came to my backyard (literally) last month as Toronto hosted the XVI International AIDS Conference and it was quite an eye-open­ing experience for this jaded editor. Rather than try to encapsulate the entire conference in a brief commentary, however, I wanted to offer a couple of thoughts.
One of the things I noticed was that hearing about a clinical trial is a very different experi­ence when one or more participants are sitting in the room next to you. Drug companies and regulatory agencies go to great lengths to ensure that every trial yields statistically relevant data, unbiased by anecdotal information. And yet, in hearing the reflections of trial participants, one quickly realizes that life is anecdotal; that human lives, no matter how well planned, are not ruled by statistics.
What do you do when a small subset of a pop­ulation do better on a particular drug regimen or formulation than the more "popular" one?
A friend of mine suffered from severe asthma that she could only control using one brand of inhalant. Unfortunately, at some point, the manufacturer changed the formulation of the therapeutic to one that was no longer effective for my friend, leaving her to hoard as much of the original formulation as she could.
While I am confident that the company changed the formulation to improve the drug's efficacy in the majority of patients, my friend was part of that small population who suffered by the decision. As far as I know, she continues to experience difficulties.
What do we do for these people?
It is ironic that the industry (editors includ­ed) fills the pages of magazines, newspapers and web sites with discussions of personalized medicine, but no one asks how this concept bal­ances against the fact that we largely offer some people substandard treatment because their market was too small to warrant further devel­opment of the drugs that are most efficacious for them.
Just how "personal­ized" can we realistical­ly expect personalized medicine to be?
In some sense, drug companies are facing similar dilemmas when it comes to providing drugs for the underpriv­ileged or the developing world. In this case, however, the problem is not one of biological response but rather financial capability. The physical market is large enough, but the finan­cial returns are too small. Drug companies face the unenviable challenge of walking the razor's edge between market calls for profitability and social calls for accountability. There has to be a middle ground.
In a session entitled "People before Trade", I listened to a panel of speakers from India, Brazil, Malaysia and South Africa decry the patent pro­cess and demonize the pharmaceutical industry and their respective governments for inaction. Each person called for remedies from the aboli­tion of patents to compulsory licensing to gov­ernment-use authorization. One speaker put it succinctly: "Your prices are killing people."
In listening to this revivalist meeting, how­ever, I noted that few of the speakers offered any sense that they understood how and why companies functioned—to make money. Or if they did understand, it simply did not mat­ter to them. Even allowing for a "reasonable" profit—which they did not define—they argue that prices remain too high.
Even if all of the drugs went off patent tomor­row, however, are any of these groups ready to manufacture them? Jonathan Berger, senior researcher at South Africa's AIDS Law Project, sadly admitted that even though Bristol-Myers Squibb's Amphotericin B (Fungizone) was off patent, no one had stood up to manufacture a generic version.
It seems that rather than quench the fire, efforts by pharmaceutical companies to lower prices in the developing world or to out-license drugs to generics firms for strict distribution within these regions simply fuels the fire of activists who want more; who see these actions as proof that companies' knew they were "goug­ing" the world.
As seems to be the case with organiza­tions like the International Partnership for Microbicides and The Population Coalition, when NGOs develop the infrastructure to deal with drug development and manufacture, they will find willing partners in a pharmaceutical industry with shelves full of potential drugs. But until the shrill rhetoric dies down, I don't know that there will be too many winners in this dispute.



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