Please see the response below from Alexander Runko, Ph.D. Office of Research Integrity and my additional replies.
This is an ongoing dialog into my inquiry regarding the Klempner Antibiotic Trials” for Lyme disease.
Initial inquiry posted Aug 26, 2022 found here:
Inquiry to the Inspector General for Scientific Integrity (Klempner antibiotic trials)
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/30864725
Additional email to the Acting Director of the Office of Research Integrity asking for acknowledgement for my inquiry:
From: CARL TUTTLE <runagain@comcast.net>
Sent: Thursday, August 25, 2022 9:40 AM
To: Jones, Wanda K. (DHHS/OS/OASH) <Wanda.Jones@hhs.gov>; Runko, Alexander (HHS/OASH) <Alexander.Runko@hhs.gov>; Wehner, Karen (HHS/OASH) <Karen.Wehner@hhs.gov>; oig@nsf.gov
Cc: (All members of the Tick-Borne Disease Working Group)
Subject: Fwd: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
U.S. Department of Health and Human Services
Office of Research Integrity
1101 Wootton Parkway Suite 240
Rockville MD 20852
Attn: Dr. Wanda Jones, Acting Director
Dear Dr. Jones,
In reference to ClinicalTrials.gov Identifier: NCT00000938, which set the stage for unimaginable pain and suffering, you were carbon copied on August 22, 2022. I received acknowledgement from the National Science Foundation Office of Inspector General but I have yet to hear from your office.
I want to be perfectly clear; this inquiry is serious and affects hundreds of thousands of horribly ill patients across America who have been gaslighted by the CDC and Infectious Diseases Society of America for three decades frequently referring to ONE clinical trial: NCT00000938
while ignoring the mountain of evidence refuting those trial results; “no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from the 129 patients in these studies.”
It would be irresponsible for the Director of Research Integrity to ignore this inquiry.
I have carbon copied all members of the Federal Tick-Borne Disease Working Group while I await your response.
Respectfully Submitted,
Carl Tuttle
Hudson, NH
Cc:
Alexander Runko, Ph.D. Director, Division of Investigative Oversight
Karen Wehner, Ph.D. Director, Division of Education and Integrity
___________________________________________________
Acknowledgement from Dr. Runko:
---------- Original Message ----------
From: "Runko, Alexander (HHS/OASH)" <Alexander.Runko@hhs.gov>
To: CARL TUTTLE <runagain@comcast.net>
Cc: "Jones, Wanda K. (DHHS/OS/OASH)" <Wanda.Jones@hhs.gov>, "Wehner, Karen (HHS/OASH)" <Karen.Wehner@hhs.gov>
Date: 08/25/2022 10:04 AM
Subject: RE: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
Dear Mr. Tuttle,
Thank you for your message regarding the study. ORI will review and take appropriate actions in accordance with federal regulations at 42 C.F.R. Part 93.
Best,
Alexander Runko, Ph.D.
Director, Division of Investigative Oversight
Office of Research Integrity
ori.hhs.gov/
____________________________________________
Carl Tuttle's 1st reply:
---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: "Runko, Alexander (HHS/OASH)" <Alexander.Runko@hhs.gov>
Cc: "Jones, Wanda K. (DHHS/OS/OASH)" <Wanda.Jones@hhs.gov>, "Wehner, Karen (HHS/OASH)" <Karen.Wehner@hhs.gov>
Date: 08/25/2022 10:23 AM
Subject: RE: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
Dear Dr. Runko,
Thank you for responding to my email.
As mentioned in my inquiry, I’m not claiming misconduct here so please do not respond with an expiration of a "6-year time limitation."
Something is drastically wrong with Klempner's methods when 360 other studies are finding the exact opposite.
This is a matter of: "Protecting the health and safety of the public" as listed in § 93.101 Purpose
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.101
Respectfully Submitted,
Carl Tuttle
Hudson, NH
_____________________________________________
Carl Tuttle's 2nd reply: (Cc: All members of the TBDWG)
---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: "Runko, Alexander (HHS/OASH)" <Alexander.Runko@hhs.gov>
Cc: "Jones, Wanda K. (DHHS/OS/OASH)" <Wanda.Jones@hhs.gov>, "Wehner, Karen (HHS/OASH)" <Karen.Wehner@hhs.gov>
Date: 08/25/2022 11:57 AM
Subject: RE: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
Dear Dr. Runko,
As a follow-up to my inquiry I would like to submit the following article written by Lorraine Johnson, JD, MBA regarding the serious implications of the Klempner study funded by the NIH under the direction of Philip Baker. There was a companion study that concluded the direct opposite to Klempner's findings and yet the CDC and IDSA continue to this day to propagate the Klempner results.
Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0029914
"Monica Embers, Stephen Barthold and colleagues has found that the bacteria that cause Lyme disease, Borrelia burgdorferi (Bb) persist in monkeys after antibiotic treatment. It is the latest in a number of studies that have demonstrated persistent infection in animal models despite treatment." Feb 10, 2012
Lorraine Johnson's article; communication with Dr. Phil Baker who controlled Lyme disease funding at the NIH:
LYMEPOLICYWONK: Was the Last Decade of Lyme Research a Cover-Up? Baker and the Embers Study Revisited.
https://www.lymedisease.org/lymepolicywonk-was-the-last-decade-of-lyme-research-a-cover-up-baker-and-the-embers-study-revisited-2
Respectfully Submitted,
Carl Tuttle
Hudson, NH
_____________________________________________
Carl Tuttle's 3rd reply: (Cc: All members of the TBDWG)
---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: "Runko, Alexander (HHS/OASH)" <Alexander.Runko@hhs.gov>
Cc: "Jones, Wanda K. (DHHS/OS/OASH)" <Wanda.Jones@hhs.gov>, "Wehner, Karen (HHS/OASH)" <Karen.Wehner@hhs.gov>
Date: 08/26/2022 9:31 AM
Subject: RE: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
Dear Dr. Runko,
You might want to take a moment to read the following independent evaluation of the NIH funded Klempner study:
The Lyme Klempner Study Given a "D" in Quality By Independent Research Company
https://www.personalconsult.com/articles/lymeklempnerstudy.html
If you talk to a physician who believes all labs are equal in quality for testing Lyme disease and that 30 days of antibiotics always cures even severe chronic and advanced Lyme, you might hear them quote as "proof" of their good reasoning the Klempner study on Lyme disease. It is supposed to show Lyme is quickly and easily dispatched no matter how long you have missed diagnosing it.
An independent consulting company, www.verimresearch.com/samples.htm actually gave the study a "D." And it is used as an example of the poorest of the poor in terms of research quality.
Excerpt:
The authors attempted to attribute significance to the fact that none of the participants had positive cultures or PCR (genetic) tests for Bb. The original paper stated that subjects testing positive in these tests were excluded from the study, making their absence less than surprising. When later challenged on this point, the authors stated in a response that they conducted over 1800 cultures and PCR tests, both for participant selection and for assessment during the study, and all results were negative [13]. This calls into question the researchers’ techniques in performing these tests, which were not specifically described in the case of the PCR and poorly described for the culture. Performing 1800 tests on participants from locales highly endemic for Lyme disease would be expected to produce some positives, however few, from new or reinfections, if nothing else. Additionally, there was no statement that positive controls were used to validate test procedures.
Carl Tuttle