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False claims and assumptions

Posted by Baker on 09 Mar 2012 at 17:58 GMT

Publication of the findings of Embers et al. has generated much excitement in the Lyme disease activist community. However, it also has generated many false claims and accusations, namely, that the NIH and I have suppressed the publicizing the results of this work for more than 12 years and, in so doing, have contributed to the pain and suffering of those afflicted with Lyme disease. Nothing could be further from the truth.

Everyone knows that the results of all research supported by an NIH grant are the sole intellectual property of the principal investigator on that research grant. He/she is completely free -- at any time-- to publish the results of his/her work, without advanced approval or permission by either the NIH or the Program Officer. The grantee is not even required to submit copies of the paper to either the NIH or the Program Officer, prior to submission to a scientific journal for publication -- or even before making an oral presentation at a scientific meeting.

If some believe that publication of the findings of Embers et al. have been delayed unreasonably, they should ask Drs. Philipp and Barthold for an explanation as to why the results of their work were not published earlier. I regret that they did not see fit to utter a single word to counter the false accusations made against me and the NIH, accusations that they know are not true. Shame on both of them.

No competing interests declared.

RE: False claims and assumptions

NathanielZiering replied to Baker on 03 Sep 2012 at 18:39 GMT

Dear Mr Baker,

Daniel Patrick Moynihan once said "Everyone is entitled to his own opinion, but not his own facts".

As such, if the science purported here by Embers, et al. is solid it will be reproduced in the lab by research peers and stand on its own merits.

I find no need for blame or shame. This is an egotistical matter, not an empiric one and really has no place here. In fact, I don't know why you even felt the need to make this comment when you already submitted an empirical argument in this thread.

On the empiric prong, I find your argument - Critical Analysis of Treatment Trials of Rhesus Macaques Infected with Borrelia burgdorferi Reveals Important Flaws in Experimental Design - to be lacking in sincerity.

Your critique states

"...it is not justifiable to assume that reliable information about human Lyme disease or PTLDS can be inferred from the methodologically flawed study of Embers and colleagues (2012) on the use of ceftriaxone and/or doxycycline for the treatment of latent B. burgdorferi infection in rhesus macaques.

It is essential that future studies on the treatment of animals infected with B. burgdorferi address standard PK/PD parameters, and provide sufficient documentation of the consistency of antibiotic blood levels over time and among different animals."

My first argument is that short of infecting humans, inference from Rhesus Monkeys are perhaps the most reliable in vivo source of information we can put in our data set. If studies on Rhesus Monkeys are illegitimate for Lyme Disease, they must be abandoned in the medical community as a whole.

My second argument is the call for PK/PD parameters. I feel they are being used in this critique as a pre-condition to disregard the merits of the whole study.

The PK/PD parameters for the antibiotics employed in this study are well documented in both Rhesus Monkeys and in conjunction with Borrelia and therefore not are strong enough to warrant the study as methodologically flawed study.

Lastly, I feel you are failing prey to a false dichotomy that exists in Borreliosis studies that portends that Late stage or chronic disease is either -

1) the cause of persistent spirochete infection or
2) a post-infectious inflammatory disease.

Given the variable matrix of borrelia species, spirochete ability to change it's OSP in vivo, potentiality for biofilm production, signal transduction leading to an autoimmune like state, and individual immune response, it's an oversimplification to state it is an either/or issue.

It may be half of one (1) and half of the other (2), and on an case by case basis.

Until we approach these studies without taking an either/or position, which is tantamount to taking "sides", the issue will continue to be politicized. In this scenario everyone loses; doctors, researchers and patients.

Sincerely,
Nathaniel Ziering

No competing interests declared.