It was July 2003 that I set out on a journey to Cape Girardeau, Missouri, to visit Edwin J. Masters, the doctor involved in hand-to-hand combat with the Centers for Disease Control and Prevention over the existence of Lyme disease in the Southern United States. Working with a few intrepid colleagues, Dr. Masters managed to generate powerful evidence for Southern Lyme, though his evidence was continually undermined.
For two days straight I sat with Dr. Masters in his oversized basement, reviewing document after document showing how data had been filtered to shed doubt on the disease. Ed Masters' story sheds light not only on Lyme disease but also the dangers we all face when medicine is politicized and studies skewed. His great persistence finally led to recognition of Masters' disease, the Lyme of the south.
The heroic Dr. Masters died on June 21 2009. In his honor, I'll spend several days retelling his sprawling, riveting, and most important tale.
By 1990, Ed Masters was regularly diagnosing Missouri patients with Lyme disease based on presentation with the EM rash (which CDC called diagnostic) and other objective signs.After sending his patients to specialists to rule out other health problems, he treated them with antibiotics, generally amoxicillin or doxycycline.
Masters knew the Yale scientists were reporting a treatment failure rate between 10 and 15 percent for early Lyme disease and “deemed that unacceptable. If I had an 85-90 percent success rate treating strep throat I would be drawn and quartered. So I treated patients at the longer end of the recommended scale --for about three or four weeks-- assuming that I would then be at the higher end of the success curve as well.” Intuitively he’d hit upon the treatment that scientists at Stony Brook would soon recommend for early Lyme disease, and his patients got well. “It was a new thing, but I was getting enough success that I was enormously encouraged,” Masters states.
Masters’ credibility was bolstered not just by the quantity of his data and his treatment success, but also by the work of the preeminent Missouri entomologist Dorothy Fier, a specialist in Rocky Mountain spotted fever at St. Louis University. Fier had visited Masters’ personal tree farm and collected samples of the common lone star tick (species name Amblyomma americanum) notable for the distinctive white dot, or “lone star,” on the backs of females, found not just in Missouri but throughout the Midwest, the Northeast all the way to Maine, and the South. A force to be reckoned with, the influential Fier found some kind of borrelia in two percent of the lone star ticks she sampled, and came out in support of Masters’ Missouri Lyme.
With the support of Fier and data on about 125 patients, 30 with well-documented erythema migrans rashes, Masters was publishing his findings and taking his show on the road. His reports garnered so much interest he was invited, in July 1990, to present his findings at the prestigious IV International Conference on Lyme Borreliosis in Stockholm, Sweden, where experts from the US and Europe, alike, studied his pictures and case histories and agreed they could see no difference between his patients and those with classic Lyme disease. Ben Luft of Stony Brook was so impressed he invited Masters to enter his patients in an upcoming NIH study on antibiotics.
By 1991, Masters had made such a stir that the New York Times was prompted to run a story about the “mystery” Lyme disease cases along the Mississippi River in Cape Girardeau. That’s when the CDC really took note. The CDC had long told doctors that the EM rash alone was diagnostic for the disease. Yet now they insisted the rule did not hold for Missouri, where neither Ixodes dammini (the specific tick northern scientists erroneously said was needed to transmit Lyme in the northeast and midwest) nor Ixodes pacificus (the Western tick found to transmit Lyme disease) could be found.
Without the expected tick, CDC scientists said, they wanted a higher level of evidence: Namely, Lyme spirochetes of the species Borrelia burgdorferi would need to be cultured from biopsies of human rashes, from ticks, or from animal hosts, and that had not been done.
“I was living in two worlds,” Masters said. “I would go to conferences and present to academic experts, and they would say, “Hmmm, that’s Lyme disease. Then I would go back home to Missouri and the people from the CDC would tell me I was misdiagnosing all these patients. Diagnosis of Lyme disease based on the erythema migrans rash was controversial only in Missouri, and nowhere else in the world.”
Through 1991, as Masters’ differences with the CDC became increasingly heated, he traveled to conferences equipped with a poster of his patients’ erythema migrans rashes and a quote from William Harvey, the 17th century physician and father of physiology, who had been ostracized for years for daring to suggest that blood circulated. “I appeal to your own eyes as my witness and judge,” William Harvey had said in 1651, just as Ed Masters appealed to his colleagues now.
The EM rashes on Masters’ poster were powerful visual evidence for some sort of borreliosis, Lyme disease proper or not. Missouri rashes had been found to contain spirochetes by the pathologists Paul Duray and J. DeKoning, widely recognized as the two top experts on such issues. Blood from Masters’ patients had by now tested positive for Lyme disease by ELISA at numerous labs, including the University of Connecticut, the University of Minnesota, and the CDC itself. Things came to a head during one of Masters’ presentations, when a CDC representative declared that none of it proved the phenomenon in question was Lyme disease.
“Why can’t you accept this,” Masters countered. “The evidence is overwhelming.”
“Because you haven’t proven it’s Borrelia burgdorferi,” the CDC official said.
“Excuse me!” Masters bellowed in front of a crowd. “You’re the CDC, the federally-funded, taxpayer-supported research institute that’s supposed to check this out, and you are telling me, a solo family physician finding these patients, that I haven’t proven it’s Borrelia burgdorferi? I think we need a little job clarification here. It’s not my job to prove it or disprove it, it’s yours!”
That’s when the CDC invited Masters and a few of his colleagues, including Dorothy Fier and Missouri state epidemiologist Denny Donnell, to apply for a grant to study the matter. The group wrote a proposal for studying Masters’ patients along with ticks captured in the vicinities where infection had likely occurred. Then Masters heard through the grapevine that the proposal had been rejected. Some time later the CDC called to say that while it lacked funds to outsource the study, they could conduct it with in-house researchers, in other words, scientists employed by the CDC itself. Masters could provide the patients and the ticks.
To be continued, Adapted from Cure Unknown, Inside the Lyme Epidemic.(St. Martins Press, 2008)