Research
We believe very strongly in properly
conducted medical research. Because of the responses to this off-label treatment that we continue to see in our patients,
we hope to eventually initiate formal clinical trials to scientifically evaluate this treatment as applied to several of the
malignancies where we've seen best results. We are an independent medical practice without government or industry funding,
and so at the present time we are unable to have the very substantial financial resources and personnel to initiate a formal
research arm. At some point collaborative efforts or other developments may make this possible. (Some may notice
that a preliminary research submission with the National Institutes of Health was temporarily withdrawn at our own initiative.
This is because IRB approval will require resources not currently available to us.)
We wish to make sure potential patients understand
that the program offered is off-label treatment in a medical practice and not a formal clinical trial. (Of course,
FDA regulations specifically allow off-label treatment and it is done all day every day in cancer clinics across the nation.)
While we continue to see very gratifying results in our patients, they do not constitute controlled clinical data and we do
not represent them as such. You can read more about our results by clicking on the "Results" page on this
web site. Please be assured that we adhere strictly to FDA regulations and voluntarily keep them informed of our status
and outcomes.
If
formal clinical trials are instituted at some point, one thing will not change. The care of our patients, including
those who don't qualify for clinical trials, will always be our highest priority and the only reason for our existence.