Did you know that about 300,000 Americans are diagnosed with Lyme disease every year, according to the Centers for Disease Control and Prevention? That number makes Lyme disease more common than breast cancer, of which about 230,000 people are diagnosed annually, and more than five times more prevalent than HIV. With staggering numbers like that, why is it that so little is known about preventing, diagnosing and effectively treating Lyme disease?
The answer to that question has been muddled in politics and controversy, but the real reason comes down to a lack of information, particularly in the form of patient studies and data. The few randomized controlled trials by the National Institutes of Health (NIH) that shape the way patients with chronic Lyme disease have been diagnosed and treated only studied 37 to 129 people, too few a number to get real, meaningful results.
Lorraine Johnson, JD, MBA and CEO of LymeDisease.org explains that you need large sample sizes of a thousand people or more to be able to perform the analysis necessary to be able to actually tell why some patients respond to treatment while others don’t.
“It’s crazy to think that only 55 patients completed the treatment arm of the largest National Institute of Health funded trial — and that was over 15 years ago,” says Johnson.
Traditional medical research has failed to understand why some chronic Lyme disease sufferers undergoing treatment fail to show improvement, while the number of cases of Lyme disease keep rising. For patients with Lyme, different factors can affect treatment response (factors such as how early a diagnosis was made or whether other tick-borne pathogens were present at the time of infection) so subgroup analysis of large data sets can really prove useful, Johnson explains.
A New Way of Conducting Research
In late 2015, LymeDisease.org, a non-profit patient advocacy organization based in California, sponsored and launched MyLymeData, a large scale, patient-powered big data project geared at producing vast amounts of data through a secure online platform. Conceived of and run by patients to address the issues that they personally care about, MyLymeData is the first national patient-powered registry that aims to accelerate research for chronic Lyme disease. The registry has already enrolled many thousands of patients since its launch.
“For Lyme patients, getting a diagnosis and subsequent treatment is very difficult. To increase an understanding of chronic Lyme disease so that real change in diagnosis and treatment methods can be made, it’s going to take a lot of individual patients coming together,’ says Johnson. “Data must be pooled to answer the questions that make a difference to the quality of patient’s lives.”
And because the technology to collect huge data sets exists, patients don’t have to wait for data to be collected by the NIH or another party, she explains. Instead, they can actively provide data on their symptoms, diagnosis and course of treatment.
How MyLymeData Is Changing the Research Game
In traditional research studies, patients have been screened to fit a restrictive criteria, Johnson explains. “Since the criteria doesn’t represent the average patient, the treatments that are then developed off of that data may not be as effective for the typical patient.”
In addition, traditional medical research studies are expensive and take long periods of time to conduct. (The lag time between research findings becoming practice is about 17 years, studies show.) Not to mention that the government has only allocated a finite amount of money for research into Lyme disease.
“MyLymeData on the other hand can quickly generate research results for a fraction of the cost of traditional studies,” says Johnson. “With such high volumes of enrolled patients, MyLymeData can produce meaningful and accurate results.”
Not only does a patient-powered research network like MyLymeData allow for diverse patient populations to be studied, but further analysis of the data can allow for evaluation of complex treatment regimens used in the real world.
Collecting Big Data on Lyme Disease: How Does It Work?
With MyLymeData, real patients enroll into an online computer database and provide backend researchers with valuable medical information regarding their symptoms, diagnosis, treatment plans and results, Johnson explains. The registry has been vetted by the National Institutes of Health and accepts patients that have either acute or chronic Lyme disease.
According to Johnson, patients can then share their experiences of living with Lyme disease and provide periodic updates. What’s especially unique is that there is an option to upload blood test results and other diagnostic tests that the patient may choose to submit.
Using the collected patient submitted data, researchers then gather massive amounts of information to analyze and identify patterns in how well a person reacts to their recommended treatment. This may lead to developing better treatments since other factors can be taken into account about how Lyme disease is transmitted, how it progresses for patients, the most effective treatment options and the effect co-infections, genetics and coexisting conditions may have on the course of the disease.
Right now the goal for enrollment is set at 10,000 participants, with over 5,000 already enrolled.
“When it comes to diagnosing and treating chronic Lyme disease, patients have much more at stake than anyone else in healthcare,” says Johnson, “Isn’t it time patients pushed research forward using their own data?”