A Model List of Essential Diagnostics Needs to Include Tick-Borne Diseases

Prior to the advent of laboratory testing medical decisions were based on the interpretation of a patient's symptoms. Today the majority of medical decisions are based upon diagnostic tests. Tests have become an essential part of modern healthcare.

"Without diagnostics, medicine is blind." ~ Alain Merieux

In 1977, the World Health Organization (WHO) developed a Model List of Essential Medicines (EML).  The list is updated every two years making 2015 the 19th EML Publication. In 2007, the WHO created an EML list for Children which is currently on it's 5th publication. [1] The purpose of the list is as follows:

The core list presents a list of minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost–effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment. [2]

While the WHO has painstakingly maintained a list of 409 priority medicines for common illnesses, they did not create a corresponding list of priority diagnostic tests. In an era when the World is focused on reducing antibiotic resistance, it would seem prudent to have diagnostic tools which would allow Doctors to more precisely prescribe lifesaving medication. This technology is available today. See President Obama's 2016 Precision Medicine Initiative (PMI). [3]

It's Time for a Model of Essential Diagnostics

A June 2016 article published in The New England Journal of Medicine entitled "Time for a Model of Essential Diagnostics" called for the WHO to establish an influential Model List of Essential Diagnostics (EDL). This new EDL would compliment the current EML.[4]

In my prior post, I pointed out how in 2011 the WHO called for an end to the use of blood tests for Tuberculosis because the tests are so inaccurate.

In 2011 The World Health Organization (WHO) released a policy statement calling for an end to the use of commercial serodiagnostic blood tests for Tuberculosis because the tests are "inconsistent, imprecise and put patients lives in danger." (WHO Statement on TB Testing) The following year the Ministry of Health in India passed a law banning the use of these inaccurate TB tests. [5]

Lyme disease is the fastest growing vector-borne disease in North America, with more than 300,000 people being diagnosed annually. In 2016, it is estimated somewhere between 375,000 and 425,000 will be infected. This number does not include other tick-borne infections like Anaplasma, Babesia, Ehrlichia, Powassan Virus, Rocky Mountain Spotted Fever, or any of the Relapsing Fever species of Borrelia like Miyamotoi or the newly discovered Mayonii. Currently, the CDC lists 15 different tick-borne diseases found within the United States (see below). [6] Unfortunately, for many of these illnesses there are no commercially available lab tests. The CDC states these blood "tests are under development and not widely commercially available but can be ordered from a limited number of CLIA-approved laboratories."

For Many of These Diseases There is No Commercially Available Lab Test

Source: CDC

Diagnosis of Lyme Disease is Delayed Due to Lack of Adequate Testing

 A 2015 nationwide survey indicated only 7% of patients are diagnosed and treated within the first month of contracting Lyme Disease. Early administration of antibiotics is absolutely critical to treatment success. Unfortunately, a majority of patients (62%) reported it took more than two years for them to receive a proper diagnosis. During this 2 year period of time the chronic infection spreads through out the body causing a multitude of symptoms including, Pain, Lyme Arthritis, Neuralgia, Bells Palsy, Myalgic Encephalomyelitis, POTS, or Lyme Carditis (a potentially deadly infection of the heart).[7] Even with an early diagnosis, 10-30% of patients will go on to develop chronic symptoms of Lyme Disease (possibly due to persistent Lyme infection or an untreated co-infection from the same tick bite).

There are two factors contributing to late and misdiagnosis of Lyme Disease:

1. The test for Lyme disease is 50% accurate. (this is precisely the reason the WHO banned the blood test for TB as noted above) 
2. Physicians, even in endemic regions of the U.S., are unaware of the prevalence of Tick-borne Diseases in their County. In fact, the CDC states "Lyme Disease cases have been reported in nearly every state." 

Every day there are nearly 1,000 people infected with Lyme Disease in the U.S. Every day there are patients given a wrong diagnosis of Mood disorders, Chronic Fatigue, Fibromyalgia, Lupus, Multiple Sclerosis, ALS, or Alzheimers amongst other things.

Famous Lyme Disease Cases

The list of celebrities who have contracted Lyme Disease includes Amy Tan, Ashley Olsen, Alec Baldwin, Yoland Foster, Rebecca Wells, Ben Stiller, Richard Gere, Avril Lavigne, Daryl Hall and even former President George W. Bush. Two recently publicized stories are Ally Hilfiger who did not receive a diagnosis of Lyme Disease until after being admitted to a psychiatric hospital; and Kris Kristofferson who suffered years of Alzheimer's-like Dementia until getting a positive test and treatment for Lyme Disease. Both of these celebrities suffered over a decade of misdiagnosis, and both report slowly returning to normal life after treatment with long term antibiotics.

The most famous case is of Dr. Neil Spector a Duke cancer researcher, who received multiple false-negative Lyme tests until finally receiving the proper diagnosis of Lyme Disease. Unfortunately, even after IV antibiotics the damage to his heart was too great, eventually requiring a total heart transplant for him survive. Dr. Spector continues to be an outspoken advocate for better diagnostics and improved treatment for Lyme Disease. You can read his Letter to Charlie Baker, the Governor of Massachusetts here.  The fact is we have no idea how extensive Deaths from Lyme Disease are in this country. As pointed out here, it's likely that Lyme-related heart deaths are much worse than public health officials thought.

These are just a few of the thousands of Chronic Lyme stories being told every day. Many of these patients are bounced from one doctor to the next and given dozens of the wrong medications until finally getting the right diagnosis and proper treatment. Until the scientific and medical community understands the utmost importance of accurate diagnostic tests, patients will continue to suffer needlessly.

Proper Diagnostic Tests are Essential to Timely and Proper Treatment

The U.S. Centers for Disease Control and the World Health Organization set the standard for World health. We need the CDC and the WHO to embrace the cutting edge technology available, which will allow Medicine to rapidly identify illnesses within a timely manner. This is the goal of Precision Medicine. This should be the goal of all Healthcare.