inmacdonald wrote:Dear Camp,
You raise a fair question.
If you have a copy of the Embers Application for funding to th NIH
which should be available via the freedom of inLiformation act, or
through Dr Monica Embers, I will read it -Line by Line.
By way of the hypothetical;
If a primate study was funded to confirm or to refute
the issue of Chronic Lyme in Humans, then the
disclaimer at the end of her article would not have been written
Thanks, I don't need a line by line reading. I read the disclaimer at the end of the article.
It's just that when the Embers study was discussed on lymedisease.org, I recall one of the responses was about how this study was commissioned.
See: http://lymedisease.org/news/lymepolicyw ... years.html
Here is the important excerpt taken from Phyllis Mervine from this page:
"Dr. Baker, when Carl Brenner and I were on the NIH Advisory Panel for the Klempner treatment trials, and you were the NIH Lyme Program Officer, we asked for longer treatment, but you said it would be too expensive. We were afraid the chosen protocol would prove not to be enough for such sick patients, but you assured us that Klempner would only prove that this particular treatment worked or didn’t work – and that it was just the first treatment trial of a series. We believed you.
We were concerned that the study used only subjective methods to evaluate the patients, so we pushed for a parallel monkey trial to give us objective evidence to balance the scale. You funded Philipp’s study but we never saw the results – until now."
So I get the impression from this passage that the study was requested for by Lyme disease patient advocacy organizations with the idea that this would be an analogous study that provided reports on how treatment affected Rhesus macaques in order to somehow demonstrate whether or not the human data was valid and reproducible.
I asked the question I did in part because my thoughts are if people knew that the PK/PD of the antibiotics given these Rhesus macaques was different than it is in humans - that researchers would know this and adjust the dosing and duration of antibiotics accordingly to mirror that which is found in human hosts.
If they are among the best academic veterinary physicians in the world and if the NIH reviewers thought there was a problem before any NIH dollars were released - then all the methods and materials that were supposed to have been used would have already been approved.
But here, at the end of the study statement, you're pointing out the disclaimer about the study not intending to mimic a study on human subjects - when that is exactly what it sounds like the study was intended to be.
If the macaques' dosing and duration - their PK and PD was not intended to match that of what humans would have received (adjusted for macaques) - then does this confirm that this study (which it sounds like it was requested by organizations to do just that) was never intended by the researchers in the first place to be "a parallel monkey trial to give us objective evidence to balance the scale"?
I would like an explanation.