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Written Comments- TBD Working Group June 21, 2018 Meeting
Vaccine & Therapeutics Subcommittee
Putting The Cart in Front of the Horse Are We?
In 2005, Johns Hopkins published a study indicating lab tests for Lyme disease missed approximately 75% of the people who were infected. (1)
Over a decade later, a study by Michael Cook, et. al. determined 74.9% of those infected had false-negative Lyme test results. (2)
Obviously, Lyme tests are NOT any more accurate today than in the past.
In fact, many medical professionals on the front lines treating the growing number of chronically ill patients believe the percentages of missed Lyme cases are much higher- up to 90%.
When conclusions in scientific studies are based on results of inaccurate Lyme tests, the study's conclusions will be flawed.
When the same flawed studies and same flawed tests are used in the development of a Lyme vaccine, the vaccine can't help but be seriously flawed.
Stakeholders who have vehemently pushed to keep the failed Lyme tests on the market to the exclusion of others (3) are also involved with and are dependent on the success of the vaccine. (4)
This new (recycled) Lyme vaccine currently in clinical trials is projected by Valneva to be worth approximately $900,000,000 (U.S. dollars) annually.(5) Its review and subsequent approval is being determined by the same stakeholders who continue to promote and profit from the failed Lyme tests.
Although the promise of nearly one billion dollars a year is inviting, there should be no Lyme vaccines approved, mandated or distributed until there are accurate Lyme tests on the market.
It’s that simple.
Lucy Barnes
631 Railroad Avenue
Centreville, MD 21617
References
(1.) https://www.ncbi.nlm.nih.gov/pubmed/16207966
(2.) https://www.ncbi.nlm.nih.gov/pubmed/28435311
(3.) https://www.ncbi.nlm.nih.gov/pubmed/19407031
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