JAIDS Journal of Acquired Immune Deficiency Syndromes:
Letters to the Editor
This letter is in response to Dr. Smith's concerns regarding “Micronutrient Supplementation Increases CD4 Count in HIV-Infected Individuals on Highly Active Antiviral Therapy: A Prospective, Double-Blinded, Placebo-Controlled Trial.”
The origins of this research date back to the promising improvements I observed in my clinic patients in 2000 and 2001 after they began to take a generic version of the micronutrient formula tested in the research trial. Enrollment took place at clinical sites and by clinical investigators not connected to my clinic between January 2002 and May 2003, and the final data analysis report was received in December 2003. The data were analyzed by a third-party data analysis company (The Ovation Research Group) contracted directly to Bristol-Myers Squibb, who contributed 100% of the funding for the study.
After reporting the improved immune reconstitution of patients taking the micronutrients plus highly active antiretroviral therapy (HAART) to the Bristol-Myers Squibb team, I anticipated that they would show interest in pursuing the development of a therapy that had the potential to act as a safe and beneficial immune modulator.
On learning that they had no interest in pursuing the development of this compound, I chose to form a company, K-PAX, Inc., to keep the micronutrient supplement in production and make it available for sale while I worked to get the study results published.
I neglected to inform the Editors of this journal of this conflict of interest and any potential bias that existed during the paper's submission and publication process. Nor did I inform the other authors on the paper of my financial interest in the company. They received no personal compensation for their efforts.
Jon D. Kaiser, MD
Clinical Faculty University of California San Francisco Medical School San Francisco, CA