This post is a follow-up on the past two Petition Updates
Below is my reply to the response I received from the Office of Research Integrity; Wanda K. Jones...
---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
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" <oig@nsf.gov>
Cc: (All members of the TBDWG)
Date: 08/30/2022 3:52 PM
Subject: RE: NIH funded study in 2001 ClinicalTrials.gov Identifier: NCT00000938
On 08/29/2022 9:33 AM Jones, Wanda K. (DHHS/OS/OASH) <wanda.jones@hhs.gov> wrote: “ORI has examined your correspondence, and we are unable to discern an allegation of research misconduct within our jurisdiction.”
Office of Research Integrity
Dr. Wanda Jones, Acting Director
Dear Dr. Jones,
So, you don’t think it is highly suspicious that Klempner reported no evidence of Borrelia in 100% of 700 different blood and cerebrospinal fluid samples from the 129 patients in these studies?
Three years prior to Klempner’s study, Professor Oksi and colleagues reported 20% treatment failure with clinical relapse and culture or PCR positivity in those patients:
Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosi
https://www.tandfonline.com/doi/abs/10.3109/07853899909115982
J Oksi 1, M Marjamäki, J Nikoskelainen, M K Viljanen
PMID: 10442678
DOI: 10.3109/07853899909115982
Abstract
A total of 165 patients with disseminated Lyme borreliosis (diagnosed in 1990-94, all seropositive except one culture-positive patient) were followed after antibiotic treatment, and 32 of them [20%] were regarded as having a clinically defined treatment failure. Of the 165 patients, 136 were tested by polymerase chain reaction (PCR) during the follow-up. PCR was positive from the plasma of 14 patients 0-30 months after discontinuation of the treatment, and 12 of these patients had a clinical relapse. In addition, Borrelia burgdorferi was cultured from the blood of three patients during the follow-up. All three patients belonged to the group with relapse, and two of them were also PCR positive. This report focuses on the 13 patients with clinical relapse and culture or PCR positivity. Eight of the patients had culture or PCR-proven initial diagnosis, the diagnosis of the remaining five patients was based on positive serology only. All 13 patients were primarily treated for more than 3 months with intravenous and/or oral antibiotics (11 of them received intravenous ceftriaxone, nine for 2 weeks, one for 3 weeks and one for 7 weeks, followed by oral antibiotics). The treatment caused only temporary relief in the symptoms of the patients. All but one of them had negative PCR results immediately after the first treatment. The patients were retreated usually with intravenous ceftriaxone for 4-6 weeks. None of them was PCR positive after the retreatment. The response to retreatment was considered good in nine patients. We conclude that the treatment of Lyme borreliosis with appropriate antibiotics for even more than 3 months may not always eradicate the spirochete. By using PCR, it is possible to avoid unnecessary retreatment of patients with 'post-Lyme syndrome' and those with 'serological scars' remaining detectable for months or years after infection.
___________________________________
The Klempner antibiotic trials set the stage for long-term treatment denial [i] [ii] and is referenced in the IDSA’s updated treatment guidance so who determined that the 90-day study duration was adequate to treat all stages of Lyme disease and why are government agencies ignoring all other evidence that we are dealing with an antibiotic resistant/tolerant superbug? Per the chart below, there are a number of known infections requiring up to two years or more to resolve.
Chart from the Stricker publication:
Benefit of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease
https://www.dovepress.com/benefit-of-intravenous-antibiotic-therapy-in-patients-referred-for-tre-peer-reviewed-fulltext-article-IJGM
[Please see Table# 4 or download my version submitted in this email] (Personal Dropbox storage area)
https://www.dropbox.com/s/wyjkjf1izdr1yuv/Prolonged%20Antibiotic%20Therapy%202.jpg?dl=0
Once again Dr. Jones, I am stressing that this is a matter of: “Protecting the health and safety of the public” as listed in your agency’s
§ 93.101 Purpose: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.101
let’s stop hiding behind this "6-year misconduct time limitation" because the unimaginable pain and suffering this study has created has no limitation.
Your agency should be stating that the twenty-one-year-old Klempner antibiotic trials for Lyme disease are questionable at best and should prompt new NIH studies by researchers without any conflicts of interest. It just so happens that Klempner is currently chasing his piece of the Lyme vaccine pie:
MassBiologics research into preventive shot for Lyme disease continues to move forward
https://www.umassmed.edu/news/news-archives/2022/05/massbiologics-research-into-preventive-shot-for-lyme-disease-continues-to-move-forward/
On a personal note, it took two years to clear a chronic prostatitis in my early twenties and when symptoms returned no one questioned the need to prescribe additional antibiotics or a different combination. It wasn’t until Bactrim was introduced that I finally obtained relief.
So if you can’t handle the truth Dr. Jones, which agency should I be dealing with here?
A response to this inquiry is requested.
Respectfully Submitted,
Carl Tuttle
Hudson, NH
Cc: All Members of the Tick-Borne Disease Working Group
References:
[i] Analysis: Why Klempner Study is Not Useful to Rule Out Benefits of Long-Term Treatment
Allison DeLong, Brown University
https://lymediseaseassociation.org/lyme-tbd/controversy/idsa-hearing-report/analysis-why-klempner-study-is-not-useful-to-rule-out-benefits-of-long-term-treatment/
[ii] Borreliella burgdorferi Antimicrobial-Tolerant Persistence in Lyme Disease and Posttreatment Lyme Disease Syndromes
Felipe C. Cabello, Monica E. Embers, Stuart A. Newman, Henry P. Godfrey
https://journals.asm.org/doi/10.1128/mbio.03440-21
_____________________________________________
Response received from the Office of Research Integrity...
On 08/29/2022 9:33 AM Jones, Wanda K. (DHHS/OS/OASH) <wanda.jones@hhs.gov> wrote:
Dear Mr. Tuttle,
Thank you for providing (separately) the additional hyperlinks of articles relevant to the NCT00000938 study. We would hope you are aware that the IDSA has published updated treatment guidance at Clinical Practice Guidelines by the Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology: 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease - PubMed (nih.gov). https://pubmed.ncbi.nlm.nih.gov/33257476/
As these are clinical treatment guidelines, ORI has no purview over them.
ORI’s responsibilities under our regulation are limited to research misconduct. Specifically, at 42 C.F.R. Part 93.103, research misconduct means falsification, fabrication, or plagiarism in proposing, performing, or reviewing research, or in reporting research results in studies supported by U.S. Public Health Service Funds. Research misconduct does not include differences of opinion or disagreements about scientific interpretation of results. ORI conducts oversight review of allegations of research misconduct to protect PHS research funds, integrity of the research record, and health and safety of the public.
ORI has examined your correspondence, and we are unable to discern an allegation of research misconduct within our jurisdiction. ORI will take no further action on your complaint. We note that: your 2015 and 2017 contacts to ORI resulted in the same determination.
Sincerely,
Wanda K. Jones, DrPH, MT(ASCP)
Acting Director
Associate Director for Research and Scientific Integrity
Office of Research Integrity