Lyme patient and advocate Carl Tuttle tuned into the Tick-borne Disease Working Group Meeting on March 3 & 4 and listened with dismay as Chief of the Bacteriology and Mycology Branch NIAID, NIH – Dr. Dixon referenced the unscientific Klempner Trial that has been used for decades against using further treatment for Lyme/MSIDS patients with remaining symptoms.
He sent the following to Dixon: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/25847056?
700 articles LYME Evidence of Persistence
The most disturbing reference for persistent infection originates from the Centers for Disease Control in Fort Collins, Colorado where Borrelia burgdorferi, was grown from the cerebrospinal fluid of Lyme patient Vicki Logan despite prior treatment with intravenous antibiotics. Her case made the front page of the New York Times Science Times in August of 1993.
Logan’s positive culture and autopsy report were forwarded to past CDC Director Brenda Fitzgerald, MD.
Letter to Brenda Fitzgerald, MD
In contrast, the Klempner antibiotic trials found no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from 129 patients. That’s not statistically possible Dr. Dixon!
I reached out to Dr. Klempner in 2018 and of course there was no response.
Letter written by Tuttle in 2018 to Dr. Klempner:
I would like to call attention to the attached study recently identifying chronic Lyme disease in twelve patients from Canada.
Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease
All of these patients were culture positive for infection (genital secretions, skin “Morgellons” and blood) even after multiple years on antibiotics so there was no relief from current antimicrobials. Some of these patients had taken as many as eleven different types of antibiotics.
In contrast, your 2001 antibiotic treatment study found; “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.”
Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease
Not a single positive Dr. Klempner? Doesn’t this statistically prove that your methodology was fatally flawed?
Did you culture skin and genital secretions as the Middelveen paper reports? It would appear that you conveniently stopped looking after your results supported the existing thirty year dogma; chronic Lyme does not exist.
Persistent Lyme disease is not new and has been intentionally/deceitfully suppressed for decades as described in the Vicki Logan case identified in the following letter to past CDC Director Barbara Fitzgerald:
In 1991 B. burgdorferi had been isolated in culture from Vicki Logan’s CSF (CDC’s laboratory in Fort Collins CO.) despite prior treatment with 21 days of IV cefotaxime and 4 months of oral minocycline.
The dishonest science here in the U.S. has denied chronic Lyme which stifled research to find a curative approach. Now the rest of the world is suffering.
We have lost nearly four decades to this 21st century plague due to the racketeering scheme identified in the RICO lawsuit filed by SHRADER & ASSOCIATES, LLP against the Infectious Disease Society of America, seven IDSA Panelists and eight insurance companies. The U.S. Centers for Disease Control has aligned itself with the seven IDSA Panelists identified in this lawsuit.
Lyme is an incurable disease when not treated immediately which is spreading across North America and deceitfully misclassified as a low-risk and non-urgent health issue. Patient experience is describing a disease that is destroying lives, ending careers, causing death and disability while leaving victims in financial ruin. Current antimicrobials are ineffective for eradicating all forms of the Borrelia spirochete.
Public outcry has been ignored for decades while the Centers for Disease Control sat on evidence that this infection was not easily treated with a one size fits all treatment approach as dictated by the Infectious Diseases Society of America.
Once again your studies were fatally flawed while supporting the controlling dogma leaving hundreds of thousands if not millions worldwide with a persistent infection and absolutely no relief. We have another AIDS on our hands.
Lyme Endemic Hudson, NH
Cc: Michael F. Collins, Chancellor
Some of you may be wondering about the Klempner trial, which can be found here: https://www.ncbi.nlm.nih.gov/pubmed/11450676
Countering the Klempner Trial, here is a 2012 Study showing retreatment can be beneficial: https://www.sciencedirect.com/science/article/pii/S1551714412002030
Article explaining flaws in the Klempner Trial: https://www.lymedisease.org/lymepolicywonk-new-study-reveals-fatal-flaws-in-nih-klempner-trial-statistical-analysis-is-this-error-human-incompetence-or-worse/
Clinical trials usually require that patients improve, but not that they return to perfect health. DeLong found that the Klempner trial set the level for determining treatment success excessively high. For instance, in the seronegative arm of the trial, treatment success required that patients not simply return to the norm for the general population, but instead surpass the norm by essentially one full standard deviation. That type of success is unheard of in clinical trials.
Many researchers say that small sample size trials are unethical because they can literally steer scientists down the wrong path. That’s what the Klempner study did. It was a waste of money, a waste of time, and it has led research down the wrong path for the last 10 years.
Second, the Klempner team could have avoided “overstating” its findings and highlighted the potential for error. The ethical implications of exaggeration in science are understood by other scientific societies. For example, the code of conduct for the American Chemical Society states: “Public comments on scientific matters should be made with care and accuracy, without unsubstantiated, exaggerated, or premature statements.”
Instead, the Klempner study concluded flatly that retreatment was ineffective.
Also, Embers et al. found 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
For fun, I did a little sleuthing on Dr. Klempner (who is behind the new Lyme vaccine)
- Klempner directed the National Emerging Infectious Disease Laboratories at BU that has a “clear biodefense mandate”:http://archive.boston.com/news/globe/magazine/articles/2004/08/08/when_bioterror_moves_next_door?pg=full
- Klempner sat on the 2006 IDSA Lyme guidelines panel https://www.lymedisease.org/lymepolicywonk-new-study-reveals-fatal-flaws-in-nih-klempner-trial-statistical-analysis-is-this-error-human-incompetence-or-worse/
- Klempner leads MassBiologics, the publicly funded non-profit behind Lyme PrEP, a Lyme pre-exposure prophylaxis shot. https://www.statnews.com/2019/08/22/lyme-disease-vaccine-market/ (It STILL targets Osp A, the same outer surface protein targeted by Lymerix, a vaccine that maimed thousands of people and dogs and gave them Lyme-like symptoms which most authorities deny). Important quote:
Klempner was optimistic. “We’ve learned some very important lessons from the LYMErix debacle, as I think some people would categorize it,” he said. “It certainly remains the only safe and effective vaccine that’s been pulled from the market.”
During LYMErix’s brief stint on the market, Clarke was among the recipients. Having had Lyme disease twice, she decided to try the vaccine. Even after receiving the final LYMErix shot, Clarke said she got Lyme disease for a third time.
So Dr. Klempner, a man with rife conflicts of interest, states emphatically that LYMErix was “safe and effective” despite the plethora of people & dogs who developed Lyme-like symptoms.