Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Lisa Capaldini, M.D.
Internal Medicine
The standard way to evaluate HIV treatments is to review documents submitted to regulatory agencies, like the FDA. In the case of treatments deemed to be actual pharmaceuticals, this is an non-negotiable requirement: Claims cannot be made about pharmaceuticals until the FDA endorses the accuracy of the claims.
When it comes to nonpharmaceutical treatments such as supplements, herbs, and foods, there is very little monitoring of or substantiation of claims. Part of the reason for this is economic and legal: Studies to substantiate claims are very costly, and, many "natural" treatments are not patentable, hence these treatments are not "ownable." Another reason these treatments aren't formally studied, though, is that studies could demonstrate that the treatment is ineffective. Before the advent of effective HAART therapies, people with HIV and their medical caregivers were willing to try many unsubstantiated therapies because we had nothing else to fall back on. Now, most treaters and people with HIV are using so-called supplements to either delay needing to take HAART therapies, to treat the side-effects of HAART (e.g. diarrhea), or to address complications of HIV infection that are not reliably reversed by HAART alone (e.g. wasting, cognitive dysfunction).
Some of these therapies ARE being formally evaluated: A doctor at my institution, for example, is studying the role of a novel anti-oxidant in the treatment of mild HIV cognitive dysfunction. I've strongly encouraged my patients to enroll in this well-conducted study. On the other hand, some products, while they certainly MAY be quite useful, have been promoted with no data to demonstrate either safety or efficacy (a doctor colleague called me to endorse a HIV vitamin line she was behind -- when I told her that I didn't feel I had the nutritional expertise to reliably endorse a nutrient supplement, she responded that that was OK, she simply wanted to use my name as a well-known HIV treater.....)
So when it comes to claims of nonpublished studies, or products with no studies at all, there isn't much recourse. As a clinician I look at a variety of factors when my patients inquire about non-FDA products: Has the product been used safely in other disease states? Is the use of the product biologically plausible? Who will profit from the sale/distribution of the product? Have drug-interaction studies been done? I don't want to sound unsupportive of supplements: Many of my patients seem to have derived benefit from them. The difficulty with assessing these treatments, and getting information about them is that most of these products have NOT been evaluated in the way the medical community is used to evaluating medical treatments. And some of these treatments are scams: how to tell is a matter of good networking within the HIV treatment community and time.
I hope this information will help you look at Immune 26 with a fine-tuned perspective.
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