The (warning: very large PDF file) of John Lentz, MD, who operated Lentz Lyme Clinic in Destin, on November 4, 2016, . In doing so, it (ALJ), issued in July of this year, following a 4-day hearing in January. The Board voted against the ALJ’s recommended imposition of a $30,000 fine.
The very presence of a “Lyme clinic” in Florida is an anomaly indicating something might be amiss. As noted by the ALJ, while it is not impossible to contract Lyme disease in Florida, it is not prevalent in the state. , in 2015, Florida had 0.6 confirmed cases per 100,000 population, a total of only 116 cases. Most people diagnosed in Florida were likely infected elsewhere while traveling.
But a Lyme clinic makes perfect sense, economically at least, when one understands the transmogrification of real Lyme disease into “chronic” Lyme disease and of the real specialty of infectious diseases into the “specialty” of “Lyme literate” doctors.
go through internal medicine residencies, followed by infectious disease fellowships, take the American Board of Internal Medicine certification exam in infectious diseases, and are members of the (IDSA). “Lyme literate” doctors do residencies in any area and gain their Lyme “literacy” through seminars where no actual patient care may be involved. They are members of the International Lyme and Associated Diseases Society (ILADS), an organization that advocates very different standards than the IDSA for the diagnosis and treatment of Lyme disease and whose guidelines are based on “very low quality evidence.”
Without getting into the weeds (where ticks may be hiding) too much, real Lyme disease is an infectious disease transmitted by a tick bite. Its symptoms are a rash, fever, headache and fatigue, although not all symptoms may appear. It is diagnosed by medical history, physical exam and sometimes a blood test. It can take 4 to 6 weeks for the immune system to make antibodies against Borrelia burgdorferi, the organism responsible for the disease, and show up on a blood test. Anyone who has symptoms for longer than 6 weeks and who hasn’t been treated with antibiotics is unlikely to have Lyme disease if the blood test is negative, according to the IDSA.
A diagnosis of “chronic” Lyme, which is not recognized by medical science, is based on a collection of vague, non-specific symptoms that could be attributed to any number of things (or nothing):
Lyme is a multi-systemic illness, and may affect every part of the body causing fatigue, stiff neck, headaches, light and sound sensitivity, tinnitus (ringing in the ears), anemia, dizziness, joint and muscle pain, brain fog, tingling, numbness and burning sensations of the extremities, memory and concentration problems, difficulties with sleep (both falling asleep and frequent awakening), chest pain and palpitations and/or psychiatric symptoms like depression and anxiety.
Non-standardized and unvalidated tests are thrown into the diagnostic mix, presumably to add credibility to the diagnosis, while evidence-based testing is rejected. Standard treatment for “chronic” Lyme includes long-term antibiotics, which is both and . describe the ill-effects of long-term antibiotics.
A “specialty” based on a few seminars
Lentz did a family practice residency and was board-certified in family practice until 2009, but currently holds no board certification. He graduated from medical school in 1975 and practiced in South Carolina, but moved to Florida in 2001, where he worked in a variety of practice settings, including working as an emergency room doctor in several hospitals. In 2007, he opened the Lentz Lyme Clinic. His education and training for this enterprise, according to his hearing testimony, was attendance at four courses, each lasting three to four days. He testified that the first course he took, put on by ILADS, was not until 2009. Another, also put on by ILADS, was in 2010. It featured Eva Sapi, PhD. , Sapi’s
recent research shows that Borrelia burgdorferi is capable forming a protective layer around itself ??” [sic] called biofilm ??” [sic] which could render it to be very resistant to antibiotics and provide a logical explanation as to why extensive antibiotic treatment for patients with a tick-bite history could fail.
This research has been by dubious medical clinics.
The two remaining courses were taught by Dr. Carol Ann Ryser, a pediatrician whose Kansas City clinic treated, among other things, “chronic” Lyme disease. Ryser as part of a plea agreement with the feds over fraud and tax evasion charges in 2013. She was also the subject of numerous malpractice actions, her as a devotee of the idea that “bugs” could hide in one’s “biofilm,” necessitating lengthy antibiotic treatment.
The Department of Health’s case against Lentz involved his treatment of seven patients, as alleged in three administrative complaints consolidated for hearing. Lentz’s courses in “chronic” Lyme diagnosis and treatment were well-reflected in his practice. According to the ALJ’s Recommended Order, Lentz’s falling below the standard of care included the following:
Diagnosed Lyme disease without objective laboratory tests results from ELISA or Western blot tests.
Lentz testified he based his Lyme diagnoses on clinical presentation and CD57 blood panels. As the ALJ noted, the CD57 panel itself carries a disclaimer stating it is for investigational purposes only and should not be used as a diagnostic procedure without confirmation of the diagnosis by a medically established diagnostic product or procedure. He also used other unvalidated tests, even though at least one other had a disclaimer stating it was for research use only.
While the ALJ found that performing other tests in conjunction with the ELISA and Western blot tests is not a per se departure,
the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing these tests previously obtained by the patient
where the exposure to the disease occurred four weeks or more in the past. In other words, just what the IDSA says. She rejected the testimony of , Lentz’s infectious disease expert, who testified that the ELISA and Western blot tests had “little value” as “not credible.” that ELISA is “unreliable” and that the Western blot test is too narrow in its reporting.
Diagnosed babesiosis and bartonellosis without appropriate testing.
This is another popular “Lyme literate” diagnosis, rejected by IDSA but given support by ILADS. The ALJ noted that both are uncommon infections and that even an infectious disease specialist might never see a case in his or her entire career, yet Lentz diagnosed several patients with these infections and treated them.
Prescribed inappropriate and excessive antibiotic therapy without medical justification.
For example, without proper testing, Lentz diagnosed one young woman who had multiple orthopedic problems (and therefore pain) with Lyme and babesiosis. He referred her for venous port placement for administration of IV antibiotics. He prescribed at one visit alone:
- Acetaminophen-oxycodone 300 mg – 7.5 mg oral tablets, three times a day
- Cymbalta 30 mg orally, once a day
- Flagyl 500 mg oral tablets, 3 weeks on, 1 week off
- Heparin, 5,000 units/ml injectable solution, once a day
- Omnicef 300 mg oral capsules, once a day
- Interfase Plus Prothera, a supplement
- Boluoke lumbrokinase, a supplement
At a subsequent visit, he ordered a Fry test for bartonellosis and prescribed IV vancomycin for bartonellosis, even though she had yet to be diagnosed with that disease. Fortunately, this patient saw a real infectious diseases doctor at some point, who advised her to immediately stop the therapy prescribed by Lentz because it “was unsafe.”
If you are a medical professional, you are likely saying to yourself at this point: Heparin? Why heparin? Read on.
Prescribed the anticoagulant heparin in the treatment of Lyme, babesiosis and bartonellosis, without medical justification.
Lentz prescribed heparin for several patients. He testified that heparin was “very therapeutic for biofilm” and that it “coats the babesia so when the babesia protozoan enters the red blood cell” it “protects the red blood cells from actually allowing babesis to enter them,” a bit of pseudoscience one imagines he learned in the courses he attended.
The ALJ had a different view. She concluded that not only was its prescription in these cases a departure from the standard of care, it
was a dangerous choice for this or any other patient who did not have a need for a blood thinner.
Failed to obtain complete medical histories, failed to perform adequate physical examinations and failed to keep adequate medical records.
On some patients, he performed no history and physical, but ordered non-standard tests for Lyme disease based on e-mails sent to him by people he’d never seen in person. Reading between the lines, it appears some of his correspondents were actively seeking “Lyme literate” doctors based on information on the internet or recommendations from friends. With others, his history and physical were inadequate. For instance, he did not inquire about travel history, to see if the patients had been to Lyme-infested areas. As the ALJ said, Lentz
seems so focused on Lyme disease and its possible co-infections that he seems to pay no attention to other symptoms or complaints the patient may have.
The ALJ also found Lentz prescribed antiparasitic medication, antimalarial medication, antacids, laxatives, enzyme formulations, and supplements, without medical justification. In addition, he failed to comply with a state law requiring the immediate reporting of “diseases of public health significance,” including Lyme disease, to the Department of Health.
The ALJ did not agree with the Department of Health that Lentz’s failure to refer patients to an infectious disease specialist was below the standard of care:
the evidence was not clear and convincing that a primary care physician could not diagnose Lyme disease or babesiosis, assuming that he or she took an appropriate history, conducted a thorough physical examination, and, where warranted, ordered the appropriate objective laboratory tests.
Based on her finding that Lentz was guilty of “repeated malpractice,” the ALJ recommended revocation of his license and the fine. Because the Board of Medicine agreed with the ALJ’s findings of repeated malpractice, it had no discretion to impose a lesser penalty than revocation. In 2004, Floridians overwhelmingly approved a proposed amendment to the state constitution, subsequently enacted into Florida law via enabling legislation, dubbed the “.” The law prohibits physicians with three or more incidents of medical malpractice, proven by clear and convincing evidence, from being licensed to practice medicine. Because Board proceedings require proof by “clear and convincing evidence,” the adjudication in this case met the statutory requirements. According to the audiotape of the Board proceedings, this is the first “three strikes” case the Board has considered, although I could not confirm this. Of course, one hopes the Board would reach the same conclusion even without the Three Strikes Rule if presented with this egregious case.
What happens next?
Lentz had 30 days to appeal the Board’s revocation to the state court of appeals. As of yesterday, I could not find that a notice of appeal had been docketed on the court’s website, but that isn’t conclusive as to whether one has been filed. If he appeals, he has a right to a stay of his license revocation “upon such conditions as are reasonable” unless the Department of Health can convince the court of appeals that a stay “would constitute a probably danger to the health, safety, or welfare of the state.”
Should he appeal, the appellate court cannot substitute its judgment for that of the Board (which is based on the ALJ’s decision) as to the weight of the evidence on any disputed finding of fact. It can, however, determine that a particular finding is “not supported by competent, substantial evidence in the record.” In this case, the ALJ repeatedly rejected the testimony of Lentz’s expert as not credible on issues such as appropriate testing and use of antibiotics. The Department of Health, on the other hand, presented the testimony of an expert in infectious diseases and family practice in support of its case. Several ID doctors who treated patients after Lentz also testified as to how they rejected Lentz’s diagnoses and took patients off his regimens. This should give Lentz little hope of overturning the Board’s decision.
In sum, starting in 2007, Lentz, an older, peripatetic family practice physician, opened a clinic specializing in diagnosing and treating certain infectious diseases, based on his having taken a few seminars. As a consequence, his patients were diagnosed with diseases they did not have by any credible assessment of their symptoms, using unvalidated tests that plainly stated they were not for diagnostic purposes, and subjected to expensive, ineffective, painful, and possibly dangerous treatments. This went on for almost a decade before the state medical board revoked his license, thus assuring (barring overturning the Board’s decision on appeal) that he will never have this opportunity again.
Yet, because of pressure from misinformed advocacy groups and physicians who eschew science, these appalling practices are being put beyond the reach of the authorities. Had Florida a law like, for example, New York’s, which greatly inhibits the medical board from taking action against “Lyme literate” physicians, Lentz might well be exonerated. Something is wrong with this system.