Discliplinary Proceedings against
Eleazar M. Kadile, M.D.

Part I: Complaint


In December 2001, the Wisconsin Medical Examining Board charged Eleazar M. Kadile, M.D., of Green Bay, Wisconsin, with ten counts of unprofessional conduct. The charges, which are detailed in the document below, include false advertising; failure to give adequate informed consent; failure to keep adequate medical records; obtaining payment by fraud and deceit; and falsely representing that patients were suffering from toxic conditions. Proceedings in front of an Administrative Law Judge began in October 2002. In November 2003, the case was settled with a consent agreement that requires Kadile to (a) implement a strict mandatory disclosure procedure for patients contemplating chelation therapy; (b) undergo an evaluation to determine his fitness to continue practicing medicine, (c) fulfill certain educational requirements; (d) have his practice monitored for at least two years by an independent expert approved by the Board; and (e) pay costs related to the disciplinary process for an amount determined by the Board.


STATE OF WISCONSIN
BEFORE THE MEDICAL EXAMINING BOARD

IN THE MATTER OF THE DISCIPLINARY
PROCEEDINGS AGAINST

ELEAZAR M. KADILE, M.D.,

RESPONDENT.

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COMPLAINT

LS-0112061-MED

I am an employee of the State of Wisconsin Department of Regulation and Licensing, Division of Enforcement. I have read this complaint and know the contents thereof; I have reviewed the investigation file 94 MED 94 in this matter; and based on that information, I believe that the allegations of this complaint are true.

1. The respondent is Eleazar deMira Kadile (D.O.B. 1/26/39) who is licensed and currently registered as a physician and surgeon in the State of Wisconsin, license #20408, first granted on 10/1/76. Respondent's most recent address on file with the Department of Regulation and Licensing is 1538 Belleview St., Green Bay, WI 54311. Respondent is listed in the Board's records as specializing in psychiatry. He resides at 5613 County Hwy T, Whitelaw, Manitowoc County, WI 54247.

2. Respondent is not certified by any board recognized by the American Board of Medical Specialties.

3. Respondent trained as a psychiatrist and engaged in that practice specialty for many years. He has changed his practice and now practices what he describes as chelation therapy, environmental medicine, and general medicine, and a small amount of psychiatry. He, on information and belief, has obtained recognition from three groups not recognized by the American Board of Medical Specialties: the "American Academy of Environmental Medicine," the "American Board of Chelation Therapy," and the "American College for the Advancement of Medicine."

COUNT I

4. During the year 1995, and in subsequent years, respondent caused to be distributed and published to the public a brochure advertising his services as a physician, which brochure stated: "Relentless study of allergy and the environment led to his board certification in Environmental Medicine. In 1992, he received a Fellowship from that same organization." There is no other description of the "board" or "organization" which purported to certify respondent or award him a "Fellowship." By failing to state the full name of the board which certified him in "environmental medicine," respondent violated § Med 10.02(2)(w), Wis. Adm. Code, and committed unprofessional conduct.

COUNT II

5. In the same brochure, respondent advertises as follows: "Our Certified Clinical Nutritionist is available to discuss nutritional needs with you." In fact, respondent had no person on his staff or associated with his practice who is certified under §§448.70 to 448.94, Wis. Stats. A representation that such person is a "Certified Clinical Nutritionist" tends to represent the person as certified in a nutrition-related field, and is therefore prohibited by §448.76, Stats. The brochure statement constitutes a violation of § Med 10.02(2)(o), Wis. Adm. Code, in that it is misleading, deceptive, and prohibited by law; respondent's violation constitutes unprofessional conduct.

COUNT III

6. Respondent caused or authorized to be published in the August 17, 1996 (Sunday) Green Bay Press-Gazette, a general circulation newspaper, an advertisement which stated that a "typical" patient treated with chelation therapy reported that his coronary artery blockage was halved by respondent's chelation therapy, and that "chelation therapy is an effective way to not only combat, but reverse some of the effects of atherosclerosis." Such advertising is false, misleading or deceptive contrary to § Med 10.02(2)(o), Wis. Adm. Code and constitutes unprofessional conduct.

COUNT IV

7. At all times relevant hereto respondent treated patient Roy P., a male born in 1939 with a history of stroke, mild diabetes, herniated lumbar disc L-4-L5, and angioplasty. He had cholesterol levels of 250, with LDL of 173, and was taking cholestyramine.

8. On 11/7/91, Respondent diagnosed the patient as suffering from hypothyroidism, adrenal insufficiency, lead and mercury toxicity, and scleroderma.

9. The patient's TSH, T3 uptake, and FTI laboratory test results were within normal limits, while the T4 was 4.5 (the normal range is 4.9 to 9.5), based on the first laboratory test results in the patient's chart, which bear the date of 11/11/91.

10. The laboratory test results set forth in the previous paragraph do not support a diagnosis of hypothyroidism made by respondent, nor is there any other recorded information in the chart which would support such a diagnosis.

11. Respondent failed to perform a gland stimulation or a ACTH measurement to confirm a diagnosis of adrenal insufficiency; notwithstanding this fact respondent prescribed cortisol for the patient.

12. Respondent performed no tests to confirm the presence of scleroderma.

13. Respondent prescribed 300 mg desiccated thyroid per day, beginning 11/21/91, for treatment of alleged hypothyroidism.

14. Chelation therapy is a treatment which involves the infusion of intravenous EDTA into a patient's bloodstream. There are two kinds of EDTA: calcium EDTA and disodium EDTA. Disodium EDTA is used conventionally to remove calcium from the body, and is well accepted for use in cases where a patient has hypercalcemia and digitalis toxicity. Calcium EDTA is used to remove lead from the body in cases of lead poisoning, and is well-accepted for this use. The patient did not have any of these conditions.

15. Respondent prescribed and administered disodium EDTA chelation for this patient. 60 such chelation treatments were administered in Respondent's office between 12/3/91 and 5/12/94. Respondent represented to the patient's insurance carrier that the chelation was needed for mercury and lead levels in the patient. This statement is not supported by any test results or other charted entries for this patient. The statement was false and known by respondent to be false when made, and such statement constitutes unprofessional conduct under § Med 10.02(2)(m), Wis. Adm. Code.

16. Respondent's conduct in providing care and treatment to patient Roy P. fell below the minimum standards of competence established in the profession in the following respects:

A. Respondent's diagnosis of hypothyroidism was not supported by the clinical findings and/or laboratory test results.

B. Respondent's diagnosis of adrenal insufficiency is not supported by the clinical findings or by any testing by gland stimulation or ACTH measurement.

C. Respondent provided inappropriate treatment for hypothyroidism including the prescribing of desiccated thyroid at an initial dose of 300 mg/day.

D. Chelation therapy is not an indicated treatment for the circulatory problems, or any other conditions which the patient had.

E. Respondent failed to accurately and completely record his findings in the patient's record, and failed to conduct a thorough and competent history and physical examination when the patient commenced treatment with Respondent.

17. Respondent's conduct created the following unacceptable risks to the patient:

A. The provision of thyroid replacement therapy to a patient who does not have the condition may lead to hyperthyroidism, including weight loss, hypertension, palpations, diarrhea, cramps, tachycardia, angina pectoris, arrhythmias, tremors, headache, and in severe cases cardiac decompensation, failure and death.

B. Respondent's inaccurate diagnosis of adrenal insufficiency created the risks of treatment for a non-existent condition with all attendant risks to that therapy. In addition, an inaccurate diagnosis may lead to the failure to diagnosis a correct condition and result in the risk of delayed treatment for the patient. If cortisol treatment is stopped abruptly, the patient will likely suffer an Addisonian Crisis which may be fatal.

C. The prescribing of desiccated thyroid at 300 mg. as an initial dose is excessive and may create any of the unacceptable risks to the patient that are set forth in subparagraph (A) above.

D. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

  • Because it is an intravenous treatment, the process carries the risk of serious to fatal blood infection, pain, and bruising from the insertion of the IV needle; this is a risk common to all IV treatments.
  • Disodium EDTA carries the risk of upsetting the electrolyte balance of the blood in that it removes calcium, magnesium, zinc, and other trace metals, and causes excessive potassium excretion. This effect has the potential to cause cardiac arrhythmias, seizures, and death. Patients frequently report nausea, vomiting, diarrhea, abdominal cramps, and anorexia. Prolonged administration has produced dermatologic lesions. Other complications reported include pain or burning sensation at the infusion site, thrombophlebitis, transient circumoral paraesthesia, numbness, headache, hypotension, fever, chills, anemia, glycosuria, hyperuricemia, erythematous skin eruptions, exfoliative dermatitis, other skin and mucous membrane reactions, lassitude, malaise, thirst, fatigue, back pain, muscle cramps, muscular weakness, and calcium embolization. Nephrotoxicity, nocturia, polyuria, dysuria, oliguria, proteinuria, presence of casts and cells in the urine, renal insufficiency, renal failure, and acute tubular necrosis have occurred.
  • If calcium is removed from the body's fluids, there is also the risk that in order to replace this loss, the body will draw calcium from the bone itself, causing osteoporosis with a concomitant greater risk of bone fracture.
  • When used for diabetic patients treated with insulin, chelation has been shown to lower blood glucose concentrations and reduce insulin requirements; thus an additional risk to such patients is presented unless their insulin dosages are adjusted. This increases the risk of hypoglycemic shock, which can lead to death if not promptly treated.
  • When used for conditions for which it is not indicated or justified, it may mask symptoms of underlying disease and cause a patient to delay obtaining proper medical care for an underlying disease or condition, causing the patient's condition to worsen.
  • Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.
  • Such risks are not justified by any benefits of such therapy in any patient without lead poisoning or other condition for which EDTA is approved by the FDA. Its use by a physician for circulatory problems, arteriosclerosis or for removal of metals other than lead and other heavy metals is an unacceptable risk to the patient, and is unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

E. Respondent's failure to accurately and completely record his findings in the patient's record, and his failure to perform a thorough and competent history and physical examination, creates the risk that the patient's conditions are not being accurately recorded, detected, and monitored thereby creating an additional risk that the patient may be inappropriately treated or there may be a delay in necessary treatment.

18. Respondent's conduct as described herein tended to constitutes a danger to the health, welfare and safety of the patient and therefore constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3) and Wis. Adm. Code § MED l0.02(2)(h).

19. Respondent's patient chart is below minimum standards for the profession, in that it does not provide a clear and legible record of his differential diagnosis of the patient and do not provide to a subsequent treating practitioner a reasonably clear statement as to what the patient's condition and prognosis are. Such records place the patient at risk of increased harm because if they are needed in an emergency and respondent is not personally available because of travel, illness, or death, there is no way a subsequent treating physician can know what the patient's history, medications, and past treatment are. A minimally competent physician would keep a chart which legibly states the patients signs and symptoms, the diagnosis, and the plan for further testing (including rationale) or treating the patient. Respondent's charting practices are unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

20. The above described treatments were not, in fact, preceded by an explanation of the alternative viable medical modes of treatment and the risks and benefits of these treatments, and thus they were provided without adequate informed consent of the patient, all in violation of § Med 10.02(2)(u), Wis. Adm. Code. Such conduct constitutes unprofessional conduct under the Code and statutes.

COUNT V

21. Complainant realleges all of the paragraphs of Count IV above.

22. Respondent represented to the patient that chelation therapy would provide effective treatment for circulatory problems or another condition which the patient had.

23. In fact, chelation therapy is not an effective treatment for any of the patient's conditions.

24. Respondent knew or should have known that chelation therapy would not provide the treatment results represented by Respondent for circulatory problems (or any other condition which the patient had) or Respondent did not have sufficient knowledge of the truth or falsity of these representations and therefore made them without attempting to determine their validity.

25. The patient, in good faith and without the ability to ascertain the truth of the representations by the exercise of reasonable care, relied upon the Respondent's representations in accepting the treatment recommendations.

26. Respondent attempted to obtain and did in fact obtain professional fees by fraud and deceit by billing the patient and by receiving payments for said treatment from the patient, and by representing to the patient's insurance company that the patient had high levels of mercury and lead, when such was not the case, in an effort to obtain payment from the insurance company.

27. Obtaining or attempting to obtain any professional fee or compensation in any form by fraud or deceit constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3) and Wis. Adm. Code § MED l0.02(2)(m).

COUNT VI

28. On and between 2/4/92 and his death on 10/31/93, respondent provided services to patient W.L.H. Mr. H. was born in 1940 and had a myocardial infarction about 17 months before consulting respondent. The patient's diagnoses included severe atherosclerotic disease, and conventional testing shows that he had severe and permanent damage to his heart from his heart attack.

29. Respondent conducted lead tests which showed the patient to have a lead level within normal limits. Respondent then wrote a letter to "to whom it may concern" stating that the patient was "toxic" with lead. Respondent knew that this letter would be used in an attempt to obtain insurance benefits, and knew that the statement was incorrect. Such conduct is unprofessional under § Med 10.02(2)(m), Wis. Adm. Code.

30. Respondent ordered hair analysis which is of no medical value for this patient. Respondent ordered "whole blood analysis" which is also of no medical value in atherosclerosis and most other medical conditions and had no value for this patient. All of these tests showed no meaningful excess in any metals.

31. In 1/92, evidence of an enlarged heart was present when the patient was examined elsewhere. Respondent examined the patient on 3/4/92, and scheduled the patient for chelation; respondent failed to observe or note this obvious physical finding of severe illness.

32. Respondent prescribed thyroid medication for the patient. There is no discussion in the chart of any review of the dangers of such medications for patients with hypertensive disease, such as this patient. Further, there is no evidence in the chart that the patient had any condition requiring such medication.

33. Respondent administered chelation therapy to this patient, and informed the patient's cardiologist that he was doing so. However, in so informing the cardiologist, respondent stated, among other things, that he would be following the protocol of the "American College of Advancement in Medicine." Further, respondent stated that he wanted the cardiologist to know that "Chelation diminishes platelet aggregation" [i.e. that it makes red blood cells "slippery" (this is often referred to as "thinning" the blood, and the agents which do this are popularly known as blood thinners)]. Respondent requested that the cardiologist be prepared to adjust the patient's medication, particularly the Coumadin® (warfarin) which the cardiologist had prescribed and which has the same effect upon red blood cells. Respondent failed to state in his letter that the ACAM protocol also calls for the addition of heparin to the chelation mixture, also a blood "thinner" (and to state how much would be administered to the patient); respondent also failed to state or otherwise inform the cardiologist of all of the ingredients of the chelation infusion. Such failure created the unacceptable risk of allowing the patient's blood to become too "thin," thus increasing the risk of internal bleeding or of stroke. Respondent also failed to monitor tests for blood clotting times closely in the patient, in violation of the ACAM protocol. All of this was unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

34. The patient died of a massive heart attack on 10/31/93.

35. Respondent's conduct also created the following unacceptable risks to the patient:

A. The provision of thyroid replacement therapy to a patient who does not have the condition may lead to hyperthyroidism, including weight loss, hypertension, palpations, diarrhea, cramps, tachycardia, angina pectoris, arrhythmias, tremors, headache, and in severe cases cardiac decompensation, failure and death; such risk is exacerbated in patients with hypertensive disease such as this patient.

B. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

  • Because it is an intravenous treatment, the process carries the risk of serious to fatal blood infection, pain, and bruising from the insertion of the IV needle; this is a risk common to all IV treatments.
  • Disodium EDTA carries the risk of upsetting the electrolyte balance of the blood in that it removes calcium, magnesium, zinc, and other trace metals, and causes potassium excretion. This effect has the potential to cause cardiac arrhythmias, seizures, and death. Patients frequently report nausea, vomiting, diarrhea, abdominal cramps, and anorexia. Prolonged administration has produced dermatologic lesions. Other complications reported include pain or burning sensation at the infusion site, thrombophlebitis, transient circumoral paraesthesia, numbness, headache, hypotension, fever, chills, anemia, glycosuria, hyperuricemia, erythematous skin eruptions, exfoliative dermatitis, other skin and mucous membrane reactions, lassitude, malaise, thirst, fatigue, back pain, muscle cramps, muscular weakness, and calcium embolization. Nephrotoxicity, nocturia, polyuria, dysuria, oliguria, proteinuria, presence of casts and cells in the urine, renal insufficiency, renal failure, and acute tubular necrosis have occurred.
  • If calcium is removed from the body's fluids, there is also the risk that in order to replace this loss, the body will draw calcium from the bone itself, causing osteoporosis with a concomitant greater risk of bone fracture.
  • When used for conditions for which it is not indicated or justified, it may mask symptoms of underlying disease and cause a patient to delay obtaining proper medical care for an underlying disease or condition, causing the patient's condition to worsen.
  • Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.
  • Such risks are not justified by any benefits of such therapy in any patient without lead poisoning or other condition for which EDTA is approved by the FDA. Its use by a physician for circulatory problems, arteriosclerosis or for removal of metals other than lead and other heavy metals is an unacceptable risk to the patient, and is unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

C. Respondent's failure to accurately and completely record his findings in the patient's record, and his failure to perform a thorough and competent history and physical examination, creates the risk that the patient's conditions are not being accurately recorded, detected, and monitored thereby creating an additional risk that the patient may be inappropriately treated or there may be a delay in necessary treatment.

36. Respondent's conduct as described herein tended to constitutes a danger to the health, welfare and safety of the patient and therefore constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3) and Wis. Adm. Code § MED l0.02(2)(h).

37. Respondent's records indicate that he did not add heparin to the patient's chelation infusion until late in the patient's treatment. Respondent's statement to the cardiologist were thus false and constituted unprofessional conduct pursuant to § Med 10.02(2)(m), Wis. Adm. Code. Respondent's records contain no justification for either omitting, or for later adding, heparin to the chelation mixture.

38. Chelation is ineffective for the treatment of arteriosclerosis, and respondent's use of this treatment for this condition constituted an attempt to gain a fee by fraud or deceit contrary to § Med 10.02(2)(m), Wis. Adm. Code.

39. Respondent diagnosed excessive amounts of certain metal and trace elements in the patient by means of a "urine EDTA challenge" test. There is no such test which is accepted in medicine. The use of such a test was an attempt to obtain a professional fee by fraud or deceit, contrary to § Med 10.02(2)(m), Wis. Adm. Code. The use of such an ineffective test also violated § Med 10.02(2)(h), Wis. Adm. Code, in that it created the unacceptable risk of suggesting that the patient had conditions which he did not, in fact, have, and that the patient would thus undergo unnecessary treatment which could mask or aggravate other disease states.

40. Respondent's patient chart is below minimum standards for the profession, in that it does not provide a clear and legible record of his differential diagnosis of the patient and do not provide to a subsequent treating practitioner a reasonably clear statement as to what the patient's condition and prognosis are. Such records place the patient at risk of increased harm because if they are needed in an emergency and respondent is not personally available because of travel, illness, or death, there is no way a subsequent treating physician can know what the patient's history, medications, and past treatment are. A minimally competent physician would keep a chart which legibly states the patients signs and symptoms, the diagnosis, and the plan for further testing (including rationale) or treating the patient. Respondent's charting practices are unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code. Additionally, this chart contains entries which are clearly out of order, appears to have missing pages, and appears to have been altered after the fact, apparently for purposes of either obtaining third party payment, or obstructing the Board's investigation of this matter. Such conduct is also unprofessional conduct under § Med 10.02(2)(m), Wis. Adm. Code.

41. The above described treatments were not, in fact, preceded by an explanation of the alternative viable medical modes of treatment and the risks and benefits of these treatments, and thus they were provided without adequate informed consent of the patient, all in violation of § Med 10.02(2)(u), Wis. Adm. Code. Such conduct constitutes unprofessional conduct under the Code and statutes.

COUNT VII

42. On or about 9/5/90, Respondent began seeing Louis W., an unmarried retired farmer who was born in 1920, as a patient. The patient's initial complaints were general fatigue, sinus drainage and congestion, shortness of breath, and a ringing in his ears. Respondent diagnosed the patient as having diabetes mellitus, circulatory blockage, and chronic fatigue syndrome, together with multiple allergies, allergic asthma, and hypothyroidism.

43. Respondent did not chart any information concerning the patient's diabetes history: whether type I or II, what was being done to manage it, what its course had been, etc. The chart also notes that the patient was treated for hypertension, and his blood pressure was noted to be 152/90 with a heart rate of 80, but does not detail what the treatments may have been or why they may have stopped. The chart states that the patient was on no medication; this is a very unusual statement for a 70 year old man with diabetes and hypertension, but respondent says nothing to explain it, nor is there any comment upon the patient's heart rate or blood pressure.

44. Respondent's diagnoses of diabetes and circulatory blockage are not justified by anything in the chart. There was no indication that respondent looked for or noted diminished pulses or bruits, or that respondent performed a cardiac exam, or noted the patient's respiratory rate.

45. At later times, respondent reports that the patient is taking Humulin 70/30 40cc qam and 25cc qpm. This is an impossible dosage, and would likely be fatal. This notation is repeated several times.

46. Respondent ordered a "whole blood analysis" which has no medical value for this patient, on several occasions, each time with normal results. No rationale for this test is stated, or exists.

47. A "hair mineral analysis" report was received by Respondent concerning this patient on or about 12/5/91. That report stated that the patient's mineral levels for all minerals and metals was within normal limits, except for molybdenum which was at .45 (reference range .21 to .44). Hair mineral analysis is of no medical value except for detecting materials not normally found in the body. A test of the patient's blood was performed on or about 12/28/91, and showed all minerals and metals to be within the reference ranges for each, except that the patient had 62 ppm calcium (reference range 68-74). There are no earlier mineral and metal tests in the patient's chart, except for iron, calcium, and magnesium levels on 9/6/90, 8/28/91, and 12/3/91, which were all within normal limits.

48. On or about 3/26/92, respondent received the results of laboratory tests showing that respondent's cholesterol was worse, in that it had increased to 240, with triglycerides at 446 and glucose of 142. Although the patient's condition was worsening, respondent failed to note this fact and failed to act.

49. Pulmonary function tests on 9/5/90 show severe restrictive disease, but respondent failed to comment or react to these grossly abnormal results. On 9/10/91, respondent signed a note that chest x-ray revealed that the patient had a pleural effusion on his right lung. This could be caused by several things, most of which are severe illnesses; the patient's condition required close monitoring. At no time does respondent comment on this condition or act upon it.

50. The patient was prescribed and administered chelation therapy between 9/16/91 and 5/28/92 (34 treatments), for which respondent charged and collected a fee, ostensibly for a diagnosis of excess zinc, iron, molybdenum, phosphorus, platinum, and tin.

51. In fact, these diagnoses were not justified by the tests performed.

52. On or about 5/4/92, respondent signed a letter addressed "to whom it may concern" stating that the patient had high levels of zinc, iron, molybdenum, phosphorus, platinum and tin." There is nothing in the patient's chart to support this statement. Respondent knew that the letter would be used to attempt to obtain payment or reimbursement from Medicare. Respondent's conduct constitutes making a false statement in practice with fraudulent intent, or was an attempt to obtain a professional fee by fraud or deceit, in either event it was unprofessional conduct pursuant to § Med 10.02(2)(m), Wis. Adm. Code.

53. Nothing in the patient's chart justified a diagnosis of hypothyroidism or the prescribing of thyroid replacement, but respondent prescribed such medication.

54. At a later time, respondent also prescribed Seldane-D® for this patient, although Seldane-D contains 120mg of pseudoephedrine, and is therefore contraindicated in patients on thyroid replacement, in that in combination these drugs act synergistically and can cause the heart to go into supraventricular tachycardia, a potentially fatal condition.

55. Respondent also conducted a purported test for candida, and prescribed nystatin for the patient. The patient had no symptoms or signs of candidiasis, and there was no need for either this test or the prescription for nystatin.

56. Respondent's conduct created the following unacceptable risks to the patient:

A. The provision of thyroid replacement therapy to a patient who does not have the condition may lead to hyperthyroidism, including weight loss, hypertension, palpations, diarrhea, cramps, tachycardia, angina pectoris, arrhythmias, tremors, headache, and in severe cases cardiac decompensation, failure and death.

B. Failing to act upon the patient's excessive cholesterol levels, high blood pressure, pulmonary disease, and pleural effusion, all increased the risk of the patient's death or severe illness by heart attack, stroke, pneumonia, pleurisy, or other complications of these conditions.

C. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

  • Because it is an intravenous treatment, the process carries the risk of serious to fatal blood infection, pain, and bruising from the insertion of the IV needle; this is a risk common to all IV treatments.
  • Disodium EDTA carries the risk of upsetting the electrolyte balance of the blood in that it removes calcium, magnesium, zinc, and other trace metals, and causes potassium excretion. This effect has the potential to cause cardiac arrhythmias, seizures, and death. Patients frequently report nausea, vomiting, diarrhea, abdominal cramps, and anorexia. Prolonged administration has produced dermatologic lesions. Other complications reported include pain or burning sensation at the infusion site, thrombophlebitis, transient circumoral paraesthesia, numbness, headache, hypotension, fever, chills, anemia, glycosuria, hyperuricemia, erythematous skin eruptions, exfoliative dermatitis, other skin and mucous membrane reactions, lassitude, malaise, thirst, fatigue, back pain, muscle cramps, muscular weakness, and calcium embolization. Nephrotoxicity, nocturia, polyuria, dysuria, oliguria, proteinuria, presence of casts and cells in the urine, renal insufficiency, renal failure, and acute tubular necrosis have occurred.
  • If calcium is removed from the body's fluids, there is also the risk that in order to replace this loss, the body will draw calcium from the bone itself, causing osteoporosis with a concomitant greater risk of bone fracture.
  • When used for diabetic patients treated with insulin, chelation has been shown to lower blood glucose concentrations and reduce insulin requirements; thus an additional risk to such patients is presented unless their insulin dosages are adjusted. This increases the risk to the patient of hypoglycemic shock, which can be fatal if not promptly treated.
  • When used for conditions for which it is not indicated or justified, it may mask symptoms of underlying disease and cause a patient to delay obtaining proper medical care for an underlying disease or condition, causing the patient's condition to worsen.
  • Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.

D. Such risks are not justified by any benefits of such therapy in any patient without lead poisoning or other condition for which EDTA is approved by the FDA. Its use by a physician for circulatory problems, arteriosclerosis or for removal of metals other than lead and other heavy metals is an unacceptable risk to the patient, and is unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

E. Respondent's failure to accurately and completely record his findings in the patient's record, and his failure to perform a thorough and competent history and physical examination, creates the risk that the patient's conditions are not being accurately recorded, detected, and monitored thereby creating an additional risk that the patient may be inappropriately treated or there may be a delay in necessary treatment.

57. Respondent's conduct as described herein tended to constitutes a danger to the health, welfare and safety of the patient and therefore constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3) and Wis. Adm. Code § MED l0.02(2)(h).

58. Respondent's patient chart is below minimum standards for the profession, in that it does not provide a clear and legible record of his differential diagnosis of the patient and do not provide to a subsequent treating practitioner a reasonably clear statement as to what the patient's condition and prognosis are. Such records place the patient at risk of increased harm because if they are needed in an emergency and respondent is not personally available because of travel, illness, or death, there is no way a subsequent treating physician can know what the patient's history, medications, and past treatment are. A minimally competent physician would keep a chart which legibly states the patients signs and symptoms, the diagnosis, and the plan for further testing (including rationale) or treating the patient. Respondent's charting practices are unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

59. The above described treatments were not, in fact, preceded by an explanation of the alternative viable medical modes of treatment and the risks and benefits of these treatments, and thus they were provided without adequate informed consent of the patient, all in violation of § Med 10.02(2)(u), Wis. Adm. Code. Such conduct constitutes unprofessional conduct under the Code and statutes.

COUNT VIII

60. In March, 1993, respondent began to see Nancy K., born in 1932, as a patient. The patient had a history of cardiac ischemia and AMI. Ms. K. was diagnosed as having hypothyroidism.

61. In fact, her laboratory tests and/or signs and symptoms did not support any such diagnosis. Respondent prescribed Synthroid® and Armour Thyroid for this supposed condition. Respondent also ordered an RA-I uptake test, which uses radioactive iodine. This test was not indicated, as the patient's TSH was normal, and it put the patient at unnecessary risk of exposure to radioactivity. Additionally, respondent had previously prescribed iodine for the patient, thus making the test invalid, even if it were clinically appropriate.

62. The patient had an EKG which showed that she had a myocardial infarction, and a positive stress test. Respondent had in this patient's chart a cholesterol lab test result of 361, with weight of 220 lbs (height 5'3"), plus a very high LDL reading, and her parents both had heart conditions, but there is nothing in the chart which demonstrated any effort to deal with these data, which clearly make the patient a high risk for future additional coronary disease. Respondent did not prescribe cholesterol-lowering medications, nor did he conduct a competent examination of the patient's heart, which would have noted heart rate, sounds, murmurs, thrills, and exact heart position.

63. Respondent's treatment of this patient constituted a danger to the patient in that failure to treat the patient's cholesterol created an unacceptable risk of heart attack for the patient. A minimally competent practitioner would have placed the patient on a low cholesterol diet and cholesterol-reducing medication immediately. Respondent's conduct was unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

64. The patient's lead level as measured in her urine was very slightly elevated, and respondent prescribed and used chelation therapy, ostensibly for this condition. In fact, urine testing is not medically valid for such a diagnosis.

65. The lead level did not justify chelation therapy, and respondent did not use calcium EDTA for the therapy, which would have been the correct form of EDTA to use if the patient had lead poisoning, but instead used disodium EDTA. Further, his order for chelation therapy did not specify the content of the solution to be infused, and thus was invalid as a physician's order. Notwithstanding this, the patient received 38 chelation infusions between 3/22/93 and 1/12/94.

66. On 1/26/94, the patient suffered a heart attack.

67. Respondent's conduct created the following unacceptable risks to the patient:

A. The provision of thyroid replacement therapy to a patient who does not have the condition may lead to hyperthyroidism, including weight loss, hypertension, palpations, diarrhea, cramps, tachycardia, angina pectoris, arrhythmias, tremors, headache, and in severe cases cardiac decompensation, failure and death.

B. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

  • Because it is an intravenous treatment, the process carries the risk of serious to fatal blood infection, pain, and bruising from the insertion of the IV needle; this is a risk common to all IV treatments. \
  • Disodium EDTA carries the risk of upsetting the electrolyte balance of the blood in that it removes calcium, magnesium, zinc, and other trace metals, and causes potassium excretion. This effect has the potential to cause cardiac arrhythmias, seizures, and death. Patients frequently report nausea, vomiting, diarrhea, abdominal cramps, and anorexia. Prolonged administration has produced dermatologic lesions. Other complications reported include pain or burning sensation at the infusion site, thrombophlebitis, transient circumoral paraesthesia, numbness, headache, hypotension, fever, chills, anemia, glycosuria, hyperuricemia, erythematous skin eruptions, exfoliative dermatitis, other skin and mucous membrane reactions, lassitude, malaise, thirst, fatigue, back pain, muscle cramps, muscular weakness, and calcium embolization. Nephrotoxicity, nocturia, polyuria, dysuria, oliguria, proteinuria, presence of casts and cells in the urine, renal insufficiency, renal failure, and acute tubular necrosis have occurred.
  • If calcium is removed from the body's fluids, there is also the risk that in order to replace this loss, the body will draw calcium from the bone itself, causing osteoporosis with a concomitant greater risk of bone fracture.
  • When used for conditions for which it is not indicated or justified, it may mask symptoms of underlying disease and cause a patient to delay obtaining proper medical care for an underlying disease or condition, causing the patient's condition to worsen.
  • Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.
  • Such risks are not justified by any benefits of such therapy in any patient without lead poisoning or other condition for which EDTA is approved by the FDA. Its use by a physician for circulatory problems, arteriosclerosis or for removal of metals other than lead and other heavy metals is an unacceptable risk to the patient, and is unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

C. Respondent's failure to accurately and completely record his findings in the patient's record, and his failure to perform a thorough and competent history and physical examination, creates the risk that the patient's conditions are not being accurately recorded, detected, and monitored thereby creating an additional risk that the patient may be inappropriately treated or there may be a delay in necessary treatment.

68. Respondent's conduct as described herein tended to constitutes a danger to the health, welfare and safety of the patient and therefore constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3) and Wis. Adm. Code § MED l0.02(2)(h).

69. Additionally, respondent's treatment of the patient by use of chelation therapy, which had no effect upon her cholesterol, constituted excessive and ineffective treatment, and for respondent to continue this treatment even after it failed to reduce her cholesterol constituted an effort to obtain a fee by fraud or deceit, and was unprofessional conduct pursuant to § Med 10.02(2)(m), Wis. Adm. Code.

70. Respondent's physical examinations of the patient were also below minimum standards. For example, respondent's examination records indicate "n/a" in a space provided for breast examinations. Failure to do such an examination puts the patient at unacceptable risk for having a tumor go undiscovered, or for failing to detect edema which could indicate any number of serious conditions. A minimally competent physician routinely and regularly examines the breasts of female patients during physical examinations of the patient. Such omissions were unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

71. Respondent diagnosed the patient as having food allergies, but then failed to do standard testing for such allergies such as elimination diet. The patient's complaints of itchy feet and rhinitis were attributed by respondent to food allergies, with no data to support such a conclusion. In fact, the patient was taking a large number of substances including bee pollen, creekweed and other herbs, and other substances which can cause allergic reactions such as itchy skin and rhinitis. The patient was also taking niacin, which is well known to cause itchy skin. A minimally competent practitioner would have had the patient cease taking these substances to see if that improved her condition. Further, a minimally competent practitioner would have advised the patient to stop taking unnecessary supplements and substances because of their potential to mask symptoms of disease, and to cause disease or other conditions adverse to health. Respondent's conduct was unprofessional conduct pursuant to § Med 10.02(2)(h) and (m), Wis. Adm. Code.

72. Respondent's patient chart is below minimum standards for the profession, in that it does not provide a clear and legible record of his differential diagnosis of the patient and do not provide to a subsequent treating practitioner a reasonably clear statement as to what the patient's condition and prognosis are. Such records place the patient at risk of increased harm because if they are needed in an emergency and respondent is not personally available because of travel, illness, or death, there is no way a subsequent treating physician can know what the patient's history, medications, and past treatment are. A minimally competent physician would keep a chart which legibly states the patients signs and symptoms, the diagnosis, and the plan for further testing (including rationale) or treating the patient. Respondent's charting practices are unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

73. The above described treatments were not, in fact, preceded by an explanation of the alternative viable medical modes of treatment and the risks and benefits of these treatments, and thus they were provided without adequate informed consent of the patient, all in violation of § Med 10.02(2)(u), Wis. Adm. Code. Such conduct constitutes unprofessional conduct under the Code and statutes.

COUNT IX

74. On 6/7/00, respondent began treating Andrew E., a child who was born in 1995. The mother's chief complaint was that the patient had multiple allergies and asthma. Respondent's chart reveals the following history: the child was prescribed Defendol (echinacea, cat's claw, and astragalus) _ capsule/day, and a Proventil® inhaler which was said to be needed "not very often." The mother stated that the child was allergic to "milk, cats, dogs, horses, horsebarns, cefzil, prelone." An "environmental survey" refers to allergies of 2 years duration, wheezing, and the desire of the mother to control asthma without steroids. The mother's written responses to the "environmental survey" are that in the fall of 1995 the patient had "milk sensitivity" and in the winter of 1997 or spring of 1998 he developed asthma, resulting from an exposure at a relative's house. A recent flare-up was noted as having occurred in May, 2000. The mother stated that the patient had been diagnosed with asthma by a Dr. Hayes and prescribed Proventil; both diagnosis and prescription had been affirmed later by a Dr. Loewen. The mother wrote that the Proventil did help ease the wheezing, but was "not a satisfactory long-term solution." The child was said to experience wheezing, fever/cold symptoms for 1 _ weeks following exposures, behavioral problems with food allergies, nose rubbing, and cough, and that these were caused by pet hair and dander, milk, dairy products, and food colors. However, he could go weeks without symptoms. The patient was noted to have been breast fed to 8 months, to have spit up often but not been colicky or ever had severe diaper rash, and to have had eczema and rashes. The child's diet was reviewed, as were a number of common irritants such as tobacco smoke and household products. The survey notes that the patient's family has dogs and a cat, said to be outside animals, and that the neighbors have horses. "Allergy" without further elaboration was noted in the father, brother, aunt, and grandparent, and the father, aunt, and grandparent were noted to have a food or drug allergy but there was no mention of what that allergy might be. There is no detailed discussion of the events leading up to the patient's reactions, and no discussion of the eczema.

75. A blood sample was taken and analyzed which found allergen specific IgE for cat, dog, and dust mite, but found none for milk. This test is not a clinically useful test for allergies under these circumstances.

76. Respondent ordered an increase in the Defendol to _ capsule twice a day, a nutritional supplement "Meta-Essent," and diagnosed the patient as having multiple allergies.

77. On 6/7/00, the patient's mother consented to treatment in writing, but the written consent contains no statement of what the treatment might be, or for what condition it is recommended.

78. At the patient's next visit on 6/29/00, respondent ordered additional testing called RAST and a treatment called "sublingual immunotherapy" plus diet modification. There is no indication of what the modification of the diet should be.

79. Over the next year, respondent ordered a series of such RAST tests and "sublingual immunotherapy" treatments for a variety of foods, plants, microorganisms, chemicals, and other common allergens, all of which were billed to an insurance company and the patient's parents. Treatments were provided covering several allergens at a time. Respondent billed for approximately $2800 for services rendered over this 1 year period.

80. In fact, RAST and sublingual immunotherapy are not accepted medical procedures and have no clinical value.

81. By billing for RAST and sublingual immunotherapy, respondent violated § Med 10.02(2)(m), Wis. Adm. Code; such conduct constitutes unprofessional conduct.

82. Respondent's entire treatment of this patient fell below the minimal standards of competence for a physician in the following respects:

A. The history taken was inadequate in that it failed to obtain any details regarding the onset of wheezing or other symptoms later diagnosed as asthma.

B. Respondent failed to recommend that the family pets be removed from the patient's residential premises.

C. Respondent failed to note that it would be unusual for a child to develop a milk allergy at 6 months, in that most children are not fed cow's milk until they are 1 year of age, and this child was said to have been breast fed until 8 months. While a 6 month old child might react to cow's milk, this is not likely to be an allergy.

D. Respondent failed to refer the patient to a pediatric allergist for appropriate diagnosis and management.

E. Respondent failed to inquire further into the eczema that the patient's parent reported, which could have revealed other important information about the child's medical condition.

F. The mother's statement that the child was allergic to dairy products and food coloring is not supported by her report of symptoms; food allergies typically result in violent and immediate reactions in the stomach and intestines within an hour of eating the food, or a swollen tongue and closure of the airway. Behavioral problems are not allergies at all.

G. The mother's statement that weeks could go by without symptoms was not further explored by respondent: this statement indicates that the child's problems are not allergies as the things that she reports the child as being allergic to are part of the child's everyday environment and thus the child was exposed to them every day.

83. Respondent's conduct in diagnosing the child with asthma and allergies and prescribing RAST and sublingual immunotherapy were an unjustifiable increase in risk to the patient in the following respects:

A. Respondent's failure to recommend removal of possible allergens from the environment could, if the patient really had asthma or allergies, cause additional asthmatic attacks or reactions, which can have serious and even fatal results.

B. Respondent's failure to take a proper history and to inquire about eczema and the details of the onset of the patient's symptoms increase the risk of his missing another medical condition which would go untreated, or result in an incorrect diagnosis and unnecessary or inappropriate treatment which carries all the risks associated with that treatment.

84. The minimally competent physician would have avoided these risks by:

A. Referring the child to a pediatric allergist for testing, diagnosis, and treatment.

B. Taking a detailed and careful history including all events leading up to any symptoms observed by the parent.

C. Refraining from unproved procedures such as RAST and sublingual immunotherapy.

D. Recommended preventive actions such as the removal of common allergens such as pets from the patient's environment, before commencing more extensive and expensive treatments.

85. The above acts and omissions violate § Med 10.02(2)(h), Wis. Adm. Code, and constitute unprofessional conduct under the Code and statutes.

86. Respondent's patient chart is below minimum standards for the profession, in that it does not provide a clear and legible record of his differential diagnosis of the patient and does not provide to a subsequent treating practitioner a reasonably clear statement as to what the patient's condition and prognosis are. Such a record places the patient at risk of increased harm in that if it is needed in an emergency and respondent is not personally available because of travel, illness, or death, there is no way a subsequent treating physician can know what the patient's history, medications, and past treatment are. A minimally competent physician would keep a chart which legibly states the patients signs and symptoms, the diagnosis, and the plan for further testing (including rationale) or treating the patient. Respondent's charting practices are unprofessional conduct pursuant to § Med 10.02(2)(h), Wis. Adm. Code.

87. The above described treatments were not, in fact, preceded by an explanation of the alternative viable medical modes of treatment and the risks and benefits of these treatments, and thus they were provided without adequate informed consent of the patient, all in violation of § Med 10.02(2)(u), Wis. Adm. Code. Such conduct constitutes unprofessional conduct under the Code and statutes.

COUNT X

88. During the past ten years, respondent has engaged in the following practices for which he has billed patients for professional fees:

all of which constitute obtaining or attempts to obtain compensation by fraud or deceit, contrary to § Med 10.02(2)(m), Wis. Adm. Code.

WHEREFORE the complainant demands that the disciplinary authority hear evidence relevant to matters alleged in this complaint, determine and impose the discipline warranted, and assess the costs of the proceeding against the respondent.

Dated this December 3, 2001.

__________________________________
Arthur Thexton, Prosecuting Attorney
Division of Enforcement
Department of Regulation and Licensing
P.O. Box 8935
Madison, WI 53708-8935

This page was revised on December 1, 2003.

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