The site has since surveyed 7,000 people, Johnson reported this month at a conference in the San Francisco Bay Area. The site calls itself “the first national large-scale study of chronic Lyme disease.”
It’s one of the newest large online registries built by patients with rare or understudied conditions. Feeling ignored by academics and Big Pharma, they turn to the internet, where they can pool the collective wisdom of people who might otherwise never enroll in a clinical trial.
Scientists are increasingly relying on apps and websites like this one to conduct research. But as this approach becomes more popular, researchers have questions about its inherent lack of rigor and standardization.
Online surveys typically don’t require proof of a diagnosis, and self-diagnosis is often tricky. For example, the varied symptoms of Lyme disease — arthritis, fever, headaches, shooting pain, and memory problems, among others — crop up in many other conditions, making it difficult to identify conclusively, even for doctors. It’s also tough to keep people engaged in a study when they’re scattered across the country.
“The ability to get big data on large numbers of people fairly easily, that’s a strength,” said Dr. John Aucott, director of the Lyme Disease Clinical Research Center at Johns Hopkins University, who is not involved with MyLymeData. “The advantage is you’re getting patient symptoms — but the disadvantage is you don’t truly know they’re due to Lyme disease.”
Despite these potential issues, self-reported patient data could soon help pharma companies bring drugs to market faster. Under the 21st Century Cures Act, passed in December, companies applying for certain kinds of FDA drug approvals can submit data about how patients are reacting to drugs in the real world, rather than data collected from rigorously controlled clinical trials. Critics say this provision weakens regulatory oversight.
“In terms of generating really good evidence that you’re going to make people better off, [real-world data] is a good starting point, but it’s not the finish line,” said Vinay Prasad, a hematologist-oncologist at Oregon Health and Sciences University.
The federal government has funded only a handful of Lyme disease studies, and one of the larger ones, published in 2001, enrolled just 130 people. All of the studies focused on patients who had symptoms even after taking antibiotics. Patients often call this advanced stage “chronic Lyme disease,” as does MyLymeData, though most doctors argue that this term has come to mean many things to different people and has no accepted definition. They and the CDC instead use “post-treatment Lyme disease syndrome.”
Johnson says that she created MyLymeData to make up for this dearth of research on patients with lingering symptoms. “The problem with Lyme disease is essentially there is no data,” she told BuzzFeed News.
She doesn’t know of any cures or treatments in the works for Lyme patients who don’t respond to antibiotics — but hopes her database will inspire pharmaceutical companies to develop some.
The people who have signed up for MyLymeData, she said, “were just very anxious to push forward research because research had really kind of left them behind,” she said
But experts note that MyLymeData’s database may not accurately reflect Lyme patients, particularly those with persistent symptoms, the hardest stage to diagnose.
For Aucott of Johns Hopkins, making a diagnosis of post-treatment Lyme disease syndrome is a painstaking process. There isn’t one clear biomarker, like a genetic mutation or an X-ray reading, that proves someone has the condition. He and a nurse interview a patient, then review all of their medical records and lab reports, to establish both that they were healthy before getting diagnosed and showed Lyme symptoms after their antibiotic treatment. Aucott also tries to figure out if they might have anemia, thyroid disease, chronic fatigue syndrome, or something else with similar symptoms.
“I’ve seen 500 or 1,000 patients with decades of work,” Aucott told BuzzFeed News. “That’s the level of detail you need to really be convinced you have a uniform population.”
He and other experts told BuzzFeed News that they’re worried that MyLymeData allows, but doesn’t require, people to provide lab readouts and doctors’ notes to prove which stage of disease they’ve had, or even that they ever had the disease. To sign up, participants simply need to check boxes saying they live in the United States and have been diagnosed for Lyme by a health care professional. Then they answer a barrage of questions, such as how many times they’ve been infected, when they were first infected, and which symptoms they’ve had. (To test the service, a Lyme-free BuzzFeed News reporter successfully signed up and filled out responses about her nonexistent condition.)
“I’m not sure this kind of registry would be super helpful other than to tell you a little bit about what patients who have been labeled with ‘chronic Lyme’ complain about or have been treated for it,” said Paul Auwaerter, a professor of medicine and Lyme specialist at Johns Hopkins.
Others question how well the database represents actual patients.
Johnson admitted that MyLymeData relies on the honor system, but pointed out, “I don’t think 7,000 people would take the time to go through and complete the surveys and do the follow-ups if they didn’t have a diagnosis.”
And, she said, the beauty of the database is that if a researcher wanted to study something about biomarkers, they could easily contact people through MyLymeData and ask for their lab reports and other medical records. She says that she and the academic researchers she’s working with, whose names she declined to share, will always be careful to point out the limitations of their research.
It is possible to glean accurate insights about diseases from self-reported data, says Ben Heywood, president and co-founder of PatientsLikeMe, a website where patients go to discuss their conditions. But, he added, it takes “a fair amount of manual curation” to make the data useful for research institutions that team up with the company, such as the FDA. PatientsLikeMe members have reported more than 30,000 treatments and symptoms for various illnesses, which staff then translate into medical terms (such as translating “chemo brain” into the more technical term, “cancer treatment-related cognitive impairment”).
“Doing real-world evidence or patient-generated health data in a rigorous scientific and methodological way, the way we do it, is hard,” Heywood said.