Imperfect test fuels alternative treatments for Lyme disease

August 17, 2015 byMatthew Perrone
Imperfect test fuels alternative treatments for Lyme disease
This March 2002 file photo shows a deer tick under a microscope in the entomology lab at the University of Rhode Island in South Kingstown, R.I. Far from a summertime nuisance, Lyme Disease is a potentially debilitating disease that has been subject to vigorous medical debate for more than two decades. At issue is both how to test for the tick-borne disease and how to treat it, especially in patients suffering long-term symptoms like fatigue, arthritis and cognitive problems with memory and concentration. (AP Photo/Victoria Arocho, File)

Lyme disease conjures memories of checking for ticks at camp and fretting over bug bites after hikes in the woods. But far from a summertime nuisance, Lyme is a potentially debilitating disease - and the subject of a vigorous debate in modern medicine.

Doctors not only debate how to treat the , which starts with fever and rash but also can develop into long-term problems such as fatigue, arthritis and concentration problems. After decades, they still argue over the standard test for Lyme, which is subject to severe limitations. The conflict has given rise to a cottage industry of alternative Lyme physicians, laboratories, medical guidelines and even research centers at universities.

Here's a look at the debate surrounding Lyme disease, which infects an estimated 300,000 people in the U.S. annually.

Q: How does the blood test work?

Lyme disease is caused by a strain of bacteria carried by certain ticks, primarily found in Northeast and Midwestern U.S. and parts of Europe. But the only U.S.-recommended Lyme test doesn't detect the bacteria. Instead, it measures the immune system's response to Lyme in the form of antibodies, proteins that help fight infections. While it's the best approach available, experts acknowledge it is fraught with problems of accuracy and interpretation: The test usually comes back negative even several weeks after infection. Yet the test also can show a positive result years after infection, even after successful antibiotic treatment.

"We don't have a way of telling, once we put you on therapy, how successful that has been," says Dr. John Branda, of Harvard Medical School.

The test's inability to detect early-stage Lyme isn't a problem for patients who display the signature bull's eye rash caused by disease-carrying ticks - guidelines instruct doctors to skip the test and treat those patients with antibiotics. But as many as 30 percent of those infected never get the rash, leaving doctors to diagnose the disease based on symptoms and patients' recollections of possible exposure.

Q: Is there really no other way to test?

A host of independent laboratories, such as Advanced Laboratory Services in Sharon Hill, Pennsylvania, sell alternative tests claiming to be able to detect the bacteria directly.

But scientists at the Centers for Disease Control and Prevention have been unable to reproduce their results. And a CDC paper published last year suggested the company's findings may have been marred by laboratory contamination.

Mainstream experts say inaccurate alternative Lyme tests lead to over diagnosis and costs hundreds of dollars, since insurance doesn't pay for them. Yet patients request them.

"Patients are so convinced they have Lyme disease that there's a demand for tests that will prove they have it," says Dr. Paul Lantos, an infectious disease specialist at Duke University Medical Center.

Laboratories that develop alternative tests for Lyme are not regulated by the Food and Drug Administration, unlike traditional manufacturers. But last year the FDA said the growing number of so-called "home brew" tests - estimated at 11,000 for all sorts of diseases - demanded closer attention.

"We have concerns that people can be misled and act on information that may or may not have validity," says Katherine Serrano, an FDA deputy division director.

Under a 2014 proposal, FDA would require labs to begin demonstrating the accuracy of their tests, including those for Lyme disease. The proposal has not yet been finalized. Serrano says the FDA would take a risk-based approach to reviewing tests, meaning tests for diseases like cancer would likely come before conditions like Lyme. She estimates it could be more than five years before FDA begins reviewing alternative Lyme tests.

Explore further: Quick, affordable and accurate test to diagnose debilitating Lyme disease

Related Stories

Quick, affordable and accurate test to diagnose debilitating Lyme disease

July 20, 2015
Focus On Lyme, an initiative sponsored by the Leadership Children's Foundation of Gilbert, Ariz., has donated $75,000 to the Translational Genomics Research Institute (TGen) to support research into the development of a quick, ...

Researchers closer to ending debate around Lyme disease and ticks in Australia

June 29, 2015
As debate surrounding whether Lyme disease is associated with tick bites in Australia continues to rage, a team of Murdoch University researchers, together with colleagues at the University of Sydney and Curtin University, ...

New Lyme disease estimate: 300,000 cases a year

August 19, 2013
Health officials say Lyme disease is about 10 times more common than previously reported.

Study shows high-risk areas for Lyme disease growing

July 16, 2015
The geographic areas where Lyme disease is a bigger danger have grown dramatically, according to a new government study published Wednesday

Lyme disease subverts immune system, prevents future protection

July 3, 2015
The bacteria that cause Lyme disease are able to trick an animal's immune system into not launching a full-blown immune response or developing lasting immunity to the disease, report researchers at the University of California, ...

Lyme disease in US is under-reported, CDC says

August 12, 2015
(HealthDay)—Lyme disease may be grossly under-reported in the United States. Government researchers say the tick-borne infection affects about 10 times as many Americans as previously indicated by confirmed case reports.

Recommended for you

PET scans to optimize tuberculosis meningitis treatments and personalize care, study finds

December 6, 2018
Although relatively rare in the United States, and accounting for fewer than 5 percent of tuberculosis cases worldwide, TB of the brain—or tuberculosis meningitis (TBM)—is often deadly, always hard to treat, and a particular ...

Silicosis is on the rise, but is there a therapeutic target?

December 6, 2018
Researchers from the CNRS, the University of Orléans, and the company Artimmune, in collaboration with Turkish clinicians from Atatürk University, have identified a key mechanism of lung inflammation induced by silica exposure, ...

Infectivity of different HIV-1 strains may depend on which cell receptors they target

December 6, 2018
Distinct HIV-1 strains may differ in the nature of the CCR5 molecules to which they bind, affecting which cells they can infect and their ability to enter cells, according to a study published December 6 in the open-access ...

Protecting cell powerhouse paves way to better treatment of acute kidney injury

December 6, 2018
For the first time, scientists have described the body's natural mechanism for temporarily protecting the powerhouses of kidney cells when injury or disease means they aren't getting enough blood or oxygen.

New study uncovers why Rift Valley fever is catastrophic to developing fetuses

December 5, 2018
Like Zika, infection with Rift Valley fever virus can go unnoticed during pregnancy, all the while doing irreparable—often lethal—harm to the fetus. The results of a new study, led by researchers at the University of ...

Study highlights potential role of bioaerosol sampling to address airborne biological threats

December 5, 2018
As a leading global city with a high population density, Singapore is vulnerable to the introduction of biological threats. Initiating an early emergency response to such threats calls for the rapid identification of the ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.