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We thank Ms. Kansky for her expression of concern and interest in our study. The University of Miami Procrit Study is indeed a clinical trial funded by the National Institutes of Health (NIH), National Heart Lung and Blood Institute. The study is a five year study designed to determine whether persons with CFS, who have diminished red blood cell volume, will experience clinical improvement through treatment with Procrit. Procrit is a federally approved medicine that stimulates the body to use its own mechanisms to increase red blood cell production. The treatment intervention lasts about 4 months. Because the red blood cell transports the needed oxygen and blood sugar to the cells, the study hypothesis is that increasing red blood cell volume will act to decrease fatigue and other CFS symptomatology and improve circulatory control. We are assessing the role of the immune and circulatory systems in the treatment outcomes. This study is a placebo controlled design but if those with low red blood cell volume are initially randomized to placebo treatment they will be offered an opportunity to receive the Procrit treatment in a follow-up study phase.
Ms. Kansky points out in her note that there have been two previous pilot studies that have not shown positive results. The problem I have with this statement is that it suggests that these studies were a complete assessment of the value of the Procrit treatment. In fact, Dr. Bell who was an investigator mentioned by Ms. Kansky of one of the pilot studies, was also a coinvestigator with Dr. Streeten in another small but published study that showed very promising effects of Procrit (epoetin alpha) treatment. The fact that the studies to which Ms. Kansky refers were pilot studies indicates that indeed they were not complete. Given that there is other compelling evidence to support the use of Procrit to treat CFS patients with diminished red blood cell volume, a panel of about 20 esteemed scientists at the NIH have reviewed the evidence and have resoundingly agreed that such a study should be conducted. Hence we received funding to do this in the fall of 2000.
Ms. Kansky speculates that someone gave out their mailing lists of CFS patients to us. This is absolutely NOT true. I was interviewed by a local news station and the report was picked up and broadcast nationally. The news report was solicited by the TV station and was not a paid advertisement. The fact that the report was picked up by affiliated stations across the country occurred without our knowledge. We received more than 1000 inquiries from interested persons around the country and from Canada. In order to treat these persons with the respect and dignity that they deserve, we hired additional staff to as promptly and efficiently as possible respond to each and every person who inquired. Contrary to the suggestion of impropriety made by Ms. Kansky, we have not offered the National CFIDS Foundation nor any other organization any money for their lists of patients.
We are doing our level best to try to examine the pathophysiology of this very devastating disease and have made a great deal of progress thanks to the help of a great many persons afflicted with CFS. We thank you for your support. We are midway through the study and hope to have some preliminary findings submitted for publication in the spring.
Barry Hurwitz, Ph.D.
Professor
Behavioral Medicine Research Center
(200 BMRC)
c/o VA Medical Center
1201 NW 16th Street
Miami, FL 33125
Professor
Behavioral Medicine Research Center
(200 BMRC)
c/o VA Medical Center
1201 NW 16th Street
Miami, FL 33125
Below is an updated web link to our web page describing the study.
A brochure and registration forms can be viewed by clinking on the links below
BROCHURE
REGISTRATION FORMS
If you have questions please email me at AlexGonzalez@...
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