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Re: Re: "Question About Magic Johnson"
Mar 25, 2004

Dear Dr. Pierone, Thank you for your kind and detailed answer to my not-quite-as-broad-as-it-appears-to-be question. I realize that dual-drug regimens, and as you point out many HAART regimens, fail in advanced HIV+ patients. But, I didn't mean to frame my long, and admittedly wandering, question in the context of advanced (progressed) HIV+ patient populations whose adaptive and innate immune systems have already sustained considerable irreparable damage. The cohort in the Aquitaine 1996-1998 (sub?)study had CD4+ T cell nadirs of >350 Cells/mml and viral load <33,000 copies/mml. The majority of those patients had pretty good (though not perfect) viralogic responses to dual-drug (NRTI) regimens at 52 weeks. Common sense indicates that the same dual-drug regimens would do even better in HIV+ patients whose immune systems were fully intact.

With respect to the cost of a clinical trial of the substances I listed, I submitted the example of our frugal AACTG clinical trials network, which runs several dozen trials a year for around $100M dollars, and contrasted that against the many Billions of dollars of profits that AZT has generated for the patent holder/wholesalers/retailers, to indicate that there is ZERO financial justification for NOT testing the substances I mentioned in multiple combinations in small controlled phase-I, II & III clinical trials. It simply isn't that expensive compared to the fleecing that American pharmaceutical customers receive day-in and day-out. The substances I mentioned produce MORE than enough profits, over the course of a few years, to pay for a miserly AACTG clinical trial.

Cheaper and less toxic anti-HIV substances, that have proven anti-HIV properties, appear to be purposefully ignored in favor of greater profit producing substances to the apparent detriment of 1 million to 3 million HIV+ Americans, and to the certain detriment to 14,000 HIV+ Americans (who die) per year.

I'm all for reasonable profits. But, not at the expense of progress. And certainly not at the cost of lives. The cost of anti-HIV drug development in America appears to be grossly over-stated. And the AACTG appears to be in-bed with the greedy pharmaceutical industry when it ignores testing multiple substances that have proven anti-HIV properties in HEALTHY, RECENTLY INFECTED HIV+ populations.

Kind regards,

Tom

Response from Dr. Pierone

I agree that antiretroviral therapy does not need to produce complete viral suppression to be beneficial, and dual nuke therapy has considerable activity in low viral load patients. We have a few patients that have been on dual nukes for many years with undetectable or very low level viremia. But the bar has been raised for therapy. The risk of viral resistance, and especially cross-resistance, argues against such intermediate approaches. One can certainly suppress viremia in early HIV infection with dual nukes, but at the cost of resistance that would limit future treatment options.

The bar has also been raised for potential antiretroviral compounds. When we had nothing available, it was understandable to get excited about selenium, licorice root (Glycyrrhiza glabra), coconut oil, aspirin, and NAC. But unless a compound can be purified for mass production, demonstrate high level in vitro activity, be shown to be non-toxic in animals and humans at doses necessary for activity, it really has no future. We are way past the era of squeezing coconuts to produce antiretrovirals. Even countries with relatively poor economies (by Western standards) have the ability to mass produce generic antiretrovirals that have been proven effective. Although about 15,000 people in the United States die of AIDS yearly, 8000 people die DAILY worldwide.

The focus should be on improving access to proven and effective treatments for the millions of people dying needlessly of AIDS in poorer countries. I would have no objection to taking the 100 million dollar budget away from the hopelessly ossified ACTG, not to study licorice root, but give it to the global fund and have them spend it to build infrastructure in underdeveloped countries and buy generic antiretrovirals and save some lives. Let's not hold our breath on this one.



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