The FDA is drafting guidance for Lyme Disease Drug Development. Not surprisingly they have completely mischaracterized the disease and target patient population. It looks like we have an important opportunity to educate them before sick patients aren't included in the cohorts eligible to receive treatment. Similar to the vaccine, working with the wrong population will make treatments look effective even if they are not. It also prevents drug developers from being able to address what the real disease is and does. April 3 at 11:59 pm is the deadline for comments. Please consider commenting and/or sharing with others.
Announcement:
https://www.raps.org/news-and-articles/news-articles/2023/2/fda-draft-guidance-addresses-clinical-development
Draft Guidance:
https://www.fda.gov/media/164949/download
Comment Here
https://www.regulations.gov/commenton/FDA-2022-D-2315-0002
Carl Tuttle's Submitted comment...
___________________________________________________________________________
Office of Communications,
Division of Drug Information Center for Drug Evaluation and Research
Food and Drug Administration
Focusing on the early stage of Lyme disease with bulls-eye rash is the root cause of this failed Public Health Response. Less than 50% of Lyme patients developed that rash as recorded by Epidemiologists in the State of Maine.
2011, 42% developed the rash:
2012, 49% developed the rash:
2013, 51% developed the rash:
2014, 57% developed the rash:
Lyme was pigeonholed into the category of “Hard to Catch and Easily Treated” through an elaborate scheme focusing on the acute stage of disease with bulls-eye rash and early treatment while avoiding the horribly disabled Lyme patient population. [i] The Centers for Disease Control financed the dishonest science using taxpayer dollars [ii] under grant# RO1 CK 000152 [iii] which has misguided a nation of intelligent physicians through the deliberate suppression of evidence of persistent Borrelia infection after aggressive antibiotic treatment. [iv]
This well-orchestrated scheme has misclassified Lyme as a low-risk and non-urgent health threat which actually belongs in the same health threat category as AIDS, Zika, cancer etc. and requires a Manhattan Project to understand how the infection it disables its victim just like untreated strep throat leads to rheumatic fever causing irreversible heart damage, untreated HIV leads to AIDS with substantial disability and death and untreated syphilis leads to progressive disability and dementia. Patients with a prolonged exposure to the Lyme disease pathogen are almost always incapacitated. Many these patients are often diagnosed with the chronic diseases of our time with no known etiology as exposed in the “Under our Skin” extended trailer:
Under Our Skin - Extended Trailer (please watch)
https://www.youtube.com/watch?v=sxWgS0XLVqw
There are no guidelines for treating the late stage disabled Lyme patient (who ends up bedridden or in a wheelchair) listed in the recently revised IDSA Lyme Treatment Guideline because that class of patient has been deliberately avoided at all costs so as not to expose the truth while keeping the current paradigm intact.
In fact, the IDSA does not want clinicians to rule out Lyme in patients who have been diagnosed with the chronic diseases of our time:
June article in Medscape by past IDSA president Paul Auwaerter
A Quick Tour of the New Lyme Disease Guideline
https://www.medscape.com/viewarticle/951589
Paul G. Auwaerter, MD
June 14, 2021
Excerpt:
“Of importance, the guideline goes out of its way to cite the lack of evidence for performing Lyme disease tests, specifically routine testing in cases where there's no evidence or link to Lyme disease. Examples include someone who is asymptomatic after a tick bite, even when they have a neurologic condition such as amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, dementia, or any kind of new-onset seizures or psychiatric illness. In children, behavioral and developmental disorders don't warrant assessing a Lyme disease serology.”
____________________________________
I sent an email to Dr. Auwaerter pointing out that a recent study identified tick-borne infections in nine out of ten institutionalized adolescents: [v] [vi]
Study detects tick-borne illness in teens hospitalized for depression
https://www.lymedisease.org/hospitalized-teens-lyme-depression/
-Ten patients were diagnosed with DSM-5 Major Depressive Disorder, seven were additionally diagnosed with Generalized Anxiety Disorder, and three had made serious suicide attempts.
-Ten adolescents picked at random with mental illness severe enough that they required institutionalization— nine of them had evidence of tick-borne infections and nine had evidence of autoimmune encephalitis.
__________________________________________
Instead of playing along with the dishonesty by avoiding the truth/evidence that Lyme is a disabling disease, our public health officials responsible for this travesty should be thoroughly investigated and held accountable to ensure this atrocity will never repeat itself.
Summary:
Stop focusing on the early stage of Lyme disease with bulls-eye rash and find a cure for all stages of the disease. Include patients in this study who are horribly disabled by an infection capable of destroying lives, ending careers while leaving its victims in financial ruin as reported by the Lyme patient population for the past thirty years!
Respectfully submitted,
Carl Tuttle
Hudson, NH
References (please read them!)
[i] NEWS: Former patient who testified as a child about Lyme disease recalls encounter with Sen. Ted Kennedy
https://www.lymedisease.org/186/
Evan White testified from his wheelchair in 1993 at Senator Ted Kennedy’s Hearing, Washington DC
Excerpt:
“No one could hear or feel the moment of that child and not be moved,” Kennedy explained to the [Boston] Globe at the time. Anyone who wasn’t moved, he said, “hasn’t got a heart.”
[ii] Feb 4, 2020 complaint regarding the misuse of taxpayer dollars
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/25876147
[iii] Subjective Symptoms after Treatment of Lyme Disease
https://reporter.nih.gov/search/14E9C8084784C1D47598B8961CAA4A01A2FFCEB861BF/projects?shared=true&legacy=1
[iv] Lyme borreliosis: diagnosis and management
https://www.bmj.com/content/369/bmj.m1041/rr-1
[v] A Quick Tour of the New (IDSA) Lyme Disease Guideline
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/29231613
[vi] A Quick Tour of the New (IDSA) Lyme Disease Guideline #2
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/29263852