The New England Center for Investigative Reporting has discovered that thousands of people are receiving non-FDA approved tests for Lyme disease, which may be giving unreliable results. The report includes a graphic showing the spread of Lyme disease over time — including to Wisconsin, which is one of the hotspots for the tick-borne disease. One of the testing companies is in Osceola, Wisconsin.
According to the New England Center:
As Lyme disease becomes an increasingly challenging public health threat across the Northeast, a growing number of tests for the vexing ailment may be misdiagnosing patients when telling them that they have – or don’t have – the tick-borne illness.
An exemption in federal regulations allows many labs to offer Lyme tests without proof that they accurately identify the disease, leaving anxious patients and their doctors to decide which tests to believe.
“There are desperately ill people looking for an answer. But there are so many companies using (unproven tests) … you can’t trust them,’’ said Andrew Onderdonk, a professor of pathology at Harvard Medical School who was diagnosed with Lyme disease in 2012 using a federally recommended test.
While the loophole in US Food and Drug Administration regulations affects a wide variety of tests, it has particular significance with Lyme disease because controversy exists over its diagnosis, treatment and how long the illness can last. Thousands of sick people believe they have a chronic form of the illness that can evade antibiotics and last years, but medical establishment doctors often dismiss this idea of long-term Lyme.