The ECDC requires detection of the pathogen’s nucleic acid in a clinical specimen and confirmation by DNA sequencing for diagnosis of any emerging infectious diseases, such as Ebola.
According to official publications of the United States, the state of the art in diagnosing infectious diseases is by molecular approaches, in particular by 16S rRNA gene analysis for bacterial infectious diseases, such as anthrax.
Public availabilty of direct diagnostics for LB
Since 2010 this type of direct diagnostics is available for LB as well. Since the CDC’s main mission is to monitor and track outbreaks of public health threats and managing costs effectively, one would assume that they’d be interested in a way to accurately diagnose in the early stage of LB infection. However, this does not seem to be the case.
Milford’s DNA sequencing test is not only able to detect the DNA of the Borrelia in the blood of those with acute infection, but also in the blood of those that have been possibly infected months or even years ago, and even after treatment. The only problem is that with chronic Lyme patients it is hard to predict the timing when the spirochetes are released into the blood in large numbers.
Milford’s DNA sequencing test can detect positive blood with about 10-50 (average 25) spirochetes per mL of blood. The patients reported in the report “DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections” are all chronic Lyme patients.
A letter to the CDC's new director
A valid positive DNA test would not only provide evidence for evaluation of the effectiveness of medical treatment, but also end the discussion with insurers, employers or bureaucratic agencies such as Child Protective Services who now claim far too often that people are not ill - based on negative results based on indirect, unreliable tests. In doing so they violate the human rights of Access to Care options and fundamental right of both children and parents.
On August 28, 2017, Dr. Lee sent a letter via his attorney to Dr. Brenda Fitzgerald, the new director of the CDC. It is made public here, so everybody can understand its significance in addressing the global health concern.
Dear Dr. Fitzgerald:
This letter requests that the Centers for Disease Control and Prevention (CDC) clarify if metabolomics-driven technologies are now officially recommended for clinical laboratory tests for the diagnosis of emerging infectious diseases in general, including Ebola, anthrax and typhoid fever.
Following the publication of a report titled “Metabolic differentiation of early Lyme disease from southern tick-associated rash illness (STARI)” authored by six CDC employees and eight people from various industries, this metabolomics-driven technology has been widely hailed as “New study offers hope for early Lyme disease diagnosis” in the mainstream news media. The promotion of this novel technology for the diagnosis of Lyme disease is further reinforced by a live interview titled “CDC advises you may need multiple Lyme disease tests after a tick bite”, which showed that the lead author of the report from the CDC was openly endorsing this new test for the diagnosis of Lyme disease, an emerging infectious disease in the country.
However, this novel metabolomics technology has deviated from the current CDC-recognized “State of the Art” for the diagnosis of other emerging infectious diseases and is primarily based on a “provisional patent application #US 62/516,824 that covers the use of a metabolic profiling and specific metabolites as a diagnostic method to objectively differentiate early Lyme disease from STARI and healthy controls” listing two individuals from the industry and one CDC employee as the inventors, as disclosed under Competing Interests of the report.
The public needs to know if the CDC has discovered or has recognized this useful new technology for the diagnosis of infectious diseases and is now directing public funds to develop this newly patented indirect test, instead of funding the well-established DNA-based direct tests for the diagnosis of Lyme disease.
Thank you for your reply. Respectfully,
Sin Hang Lee, MD
Director of Milford Molecular Diagnostics Laboratory
Dr. Fitzgerald has not replied to this letter and Dr. Lee is almost certain the CDC will not respond to this letter for the following reasons (apart from being under gag orders.
- If the CDC says it endorses using metabolite profiles in patient samples for diagnosis of infectious diseases now, the CDC would be a laughing stock.
- If the CDC says this approach is only good for Lyme disease and STARI, it would also open a can of worms because it means that they are creating a double standard for borreliosis case definition and they have not published any scientific data on the unique bacterial physiology of various borrelial species, if any.
- If the CDC says the promotion of using this technology to diagnose Lyme disease does not represent the policy or the opinion of the agency, that means that some CDC officers (Molins and Schriefer et al.) at the Lyme division are abusing their power to promote bogus science at public expense.
According to Dr. Lee, Molins is one of the three patentees. The other two are Wormser and another working in the commercial Metabolomics facility of a University. Their work was designed to block development of the well-established diagnostic technology for Lyme disease infections.
How to change this situation?
Dr. Lee: "We will need to form or to retain an independent agency to conduct a proficiency test survey and find out which laboratories can detect 1 to 1000 spirochetes of various species (Bb or relapsing fever borreliae) in blind-coded blood samples correctly. The CDC will not do it for obvious reasons.
Those labs capable of generating correct results will be invited to a meeting to develop a direct method for diagnosis of spirochetemia. It is possible that many good innovative diagnostic methods have been suppressed by the authorities against the public interests. We need to find out. The laboratories of Allen Steere, Gary Wormser, Telford, and those at Yale would be invited to participate. There is no room for tribalism in such a serious matter affecting so many people's health."
Personal grudge or general health concern?
To Dr. Lee his present public conflict with the CDC is not about himself or his business. The main aim of the legal case is to make the Exhibits public for patients to file their own damages claims and to change public health policies.
That is why he intends to donate the $ 57 million, which is about 10% of the annual payment to seven commercial laboratories to perform the useless serology tests, to implement a national DNA-based diagnostic system in Lyme disease endemic areas.
According to Dr. Lee, “anyone who works in the health care field should not have the aim to become rich anyway”.
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