Letters to the Editor
To the Editor:
The article published as a Rapid Communication, “Micronutrient Supplementation Increases CD4 Count in HIV-Infected Individuals on Highly Active Antiretroviral Therapy: A Prospective, Double-Blinded, Placebo-Controlled Trial,”1 from the August 15 issue of this journal raised a number of concerns for me. The major concern is a conflict of interest issue that arises from the reason that I had been looking forward to its publication.
A few months ago, a patient in my HIV primary care practice told me about a vitamin supplement, K-Pax Vitamins (Mill Valley, CA); he had heard about them in a public forum that he had attended. He was interested in getting this supplement, because it was said in the forum that these vitamins boost CD4 cell counts. He dropped off a brochure in response to my questions. The brochure included a figure stating that it was “the only nutritional supplement shown to raise CD4 lymphocyte counts an average of 26%” and that “publication in a peer-reviewed medical journal is pending.” I told the patient that I was looking forward to reviewing the study when it came out but that I could not recommend using the supplement without more information.
I then saw the article in the August 15 issue of this journal, which seemed to be the one referenced in the brochure. The ingredients of the micronutrient supplement in the article are almost identical to those in K-Pax Vitamins, and the percentage increase in CD4 counts is similar (24% in the article) to that in the brochure. The figure in the brochure is referenced on the Web site for K-Pax Vitamins, and the article is also referenced on the product's Web site.2 Most disturbingly, the first author on the paper, Jon D. Kaiser, MD, seems to be the same person mentioned in the brochure as the developer of K-Pax Vitamins. The address for reprints in the article is the same address as the one given in the brochure and on the Web site for K-PAX, Inc. It is also the same address given on Dr. Kaiser's Web page3 for Integrative Health Consulting; the link on this page about the company indicates that he is its medical director.4 No mention of these apparent conflicts of interest appears in the published article.
There are other concerns I have about the methodology of the study, but the conflict of interest issue overshadows them. All the information I mentioned previously (except the brochure itself) can be obtained by an Internet search of the name of the first author. Given the recent controversies at other medical journals about the failure of authors to disclose potential conflicts of interest, I am sure that this article would not have been published without disclosure (or at all) if the Editors had been aware of the conflicts of interest in this case. More attention to methods to detect undisclosed conflicts of interest would be of benefit to those of us who must weigh potential bias in our review of the medical literature for medical decision making.
Duane M. Smith, MD
Weill Medical College of Cornell University, New York, NY
1. Kaiser JD, Campa AM, Ondercin JP, et al. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr