In a proposed settlement, the State of Wisconsin ordered a chelation physician to return to medical school, retake and pass the licensing exam for graduating medical students, have all charts under review by a non-chelating physician, desist from ordering any non-standard alternative medical laboratory testing, require a consent form signed by all patients informing them that the alternative therapy is not-FDA approved nor approved by any official medical organization, and desist from any non-label use of drugs or non-FDA approved devices.

Additionally the physician was ordered to pay the State of Wisconsin for their legal expenses in sanctioning the physician. In the course of the trial the State of Wisconsin named Robert S. Baratz a medical expert capable of testifying on the validity of alternative medical treatments including chelation, Broda Barnes’ thyroid treatment, hair analysis, environmental allergy testing, and other treatments.

Although this proposed settlement has not been accepted by Eleazar Kadile, MD, the charged chelation physician, as of this November date, the Wisconsin prosecuting attorney as well as the Wisconsin medical board clearly have laid out enormous sanctions primarily based on the practice of alternative medicine, not harm to patients.

In the document provided below the extent of sanctioning is stipulated. Reading of this document gives ample evidence that medical boards are now seeking emasculation of any physician guilty of practicing alternative medicine. It is probable that the guidelines established earlier this year by the Federation of State Medical Boards on the disciplining of alternative practitioners played an important role in imposing harsh penalties on Dr. Kadile.

State of Wisconsin
Before the Medical Examining Board

In the Matter of :
Disciplinary Proceedings Against : Final Decision and Order
:
Eleazar M. Kadile, MD, : LS-0112061-MED
Respondent : 94 MED 94, 96 MED 287

The parties to this action for the purposes of §227.53, Wis. Stats., are:

Eleazar M. Kadile, MD
1598 Belleview St.
Green Bay, Wisconsin 54311

Wisconsin Medical Examining Board
P.O. Box 8935
Madison, Wisconsin 53708-8935

Department of Regulation and Licensing
Division of Enforcement
P.O. Box 8935
Madison, Wisconsin 53708-8935

The parties in this matter agree to the terms and conditions of the attached Stipulation as the final decision of this matter, subject to the approval of the Board. The Board has reviewed this Stipulation and considers it acceptable.
Accordingly, the Board in this matter adopts the attached Stipulation and makes the following:

Findings of Fact
1. The respondent is Eleazar deMira Kadile (DOB 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.

2. 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.” The brochure did not contain the complete name of the specialty board which conferred the certification.

3. 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 was or is certified under §§448.70 to 448.94, Wis. Stats, although the person had passed a certification test for a national private association in the field of nutrition in 1991.

4. 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.” The Board finds that there is not sufficient data to support these representations.

5. 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.

6. On 11/7/91, respondent first saw this patient and diagnosed the patient as suffering from subclinical hypothyroidism.

7. The patient’s T3 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.

8. The laboratory test results set forth in the previous paragraph do not support a diagnosis of hypothyroidism. Respondent’s statements that he believed the patient to have “subclinical hypothyroidism” based on the laboratory reports, an uncharted low bass] temperature, high cholesterol, the presence of scleroderma (an autoimmune disorder) and diabetes, and a report of feeling fatigued, is not recognized by the Board.

9. Respondent prescribed desiccated thyroid per day, beginning 11/21/91, for treatment of hypothyroidism.

10. Chelation therapy is a treatment which involves the infusion of intravenous EDTA into a patients 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 or digitalis-induced cardiac arrhythmias. 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.

11. Respondent prescribed and administered magnesium disodium EDTA chelation for this patient, 60 such chelation treatments were administered in Respondents office between 12/3/91 and 5/12/94.

12. Respondent’s conduct created the following risks to the patient which were not adequately disclosed:
A. The provision of thyroid replacement therapy to a patient who does not have hypothyroidism may lead to hyperthyroidism, including weight loss, hypertension, palpitations, diarrhea, cramps, tachycardia, angina pectoris, arrhythmias, tremors, headache, and in severe cases cardiac decompensation, cardiac failure and death.
B. Board finds that Respondent’s failure to accurately and completely record his findings in the patient’s record, and his failure to document 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.

13. In fact, chelation therapy is not accepted by the Board as an effective treatment for any of the patient’s diagnosed conditions.

14. Respondent signed a letter and sent the letter to an insurance company on 1/11/92, stating that the patient had high level of mercury and lead, and that there was a medical necessity for EDTA chelation for the presence of these substances. In fact, the Board does not find high levels of either of these substances by accepted or established testing methods. The purpose of EDTA chelation therapy was to improve the patient’s cardiovascular functioning, and by failing to state this, a material fact was not conveyed to the insurance company.

15. Respondent has stated that if a patient substantially like Mr. P were to present to him today, he would treat him in substantially the same way as he treated Mr. P.

16. The Board finds that the state’s expert, Robert S. Baratz, is qualified to give admissible testimony on all aspects of this matter.

Conclusions of Law
A. The Wisconsin Medical Examining Board has jurisdiction to act in this matter pursuant to §448.02(3), Wis. Stats. and is authorized to enter into the attached Stipulation pursuant to §227.44(5), Wis. Stats.
B. Failing to state the full name of the board which certified him in “environmental medicine,” as described in”2, above, violated § Med 10.02(2)(w), Wis, Adm. Code.
C. Representing that a person is a “Certified Clinical Nutritionist,” as described in”3, above, tends to represent the person as certified in a nutrition-related field, and is therefore prohibited by §448.76, Wis. Stats. The brochure statement constitutes a violation of § Med 10.02(2)(o), Wis. Adm. Code.
D. The advertising described in 4, above, is contrary to § Med 10.02(2)(o), Wis, Adm. Code.
E. Respondent’s conduct as described in 5-15, above, violated § Med 10.O2(2)(u), Wis. Adm. Code.
F. Respondent’s conduct as described in 14, above, violated Wis. Adm. Code § MED 10.02(2)(m).
G. The above conduct constitutes unprofessional conduct within the meaning of Wis. Stats. §448.02(3).

Order
Now, therefore, it is hereby ordered, that the attached Stipulation is accepted.
It is further ordered, that Eleazar M. Kadile, MD, is reprimanded for his unprofessional conduct in this matter.

It is further ordered, that the license to practice medicine and surgery of respondent is limited as provided in §448.O2(3)(e), Wis. Stats., and as follows:

1) Respondent shall, for all patients, record in the chart the names and contact information for all other physicians the patient is seeing or is likely to see on a continuing basis, and shall inform one primary care physician’s office, in writing, of his diagnosis and proposed treatment of the patient. If a patient refuses consent for respondent to provide such information to the other physician, respondent shall not treat that patient.

2) Respondent shall not engage or participate in any research project on human subjects without the specific approval of the Board.

3) Respondent shall not prescribe, dispense, or administer any drug product or device which is not FDA approved, nor for any use or indication for which such drug product or device is not labeled in the United States, nor may respondent order, dispense, or administer any compounded drug or drug product, except as permitted in this Order. Off-label or compounded prescribing shall be pursuant to the form attached as required disclosure for experimental/unconventional diagnosis and treatment. The Board or its designee may grant exceptions to this requirement for written informed consent for “off-label” prescribing, upon petition, either as to an individual case or product or as to a category of patients or products. Respondent may offer chelation therapy only if the patient signs the form which is attached to this Order as required disclosure for ethylenediaminetetraacetic acid (EDTA) chelation therapy. Respondent shall not alter, preface, supplement or in any way attempt to defeat or minimize the message of the approved disclosure forms with other documents or oral statements; respondent shall comply with cb. Med 18, Wis. Adm. Code. The form shall be preserved in the patient’s chart, and a copy given to the patient at the time of signing.

4) Respondent shall not order or recommend any established test for unestablished reasons, or any unestablished test (including but not limited to whole blood analysis, hair analysis, any test offered by facilities which are not commonly used by physicians practicing conventional medicine) unless the patient signs the attached required disclosure for experimental/unconventional diagnosis and treatment. All testing shall be performed by CLIA regulated laboratory which is authorized to do the test performed.

5) Respondent shall not sell any good or article to any patient at other than his actual cost (including shipping) without written notice (approved by the Board or its designee) by respondent that such goods or articles are being sold on a for-profit basis, and with acknowledgment from the patient that he/she is purchasing the good or article voluntarily, of his/her own free will, and that he/she may purchase the items elsewhere.

6) Respondent shall make no statement concerning a patient’s condition, orally or in writing, to any third party payor or a patient (or patient’s caregiver) which is not clearly supportable by the patient’s health care record. Respondent shall not make any statement to a third party payor or a patient (or patient’s caregiver) that a patient has abnormal levels of any substance without enclosing the laboratory report which supports that statement.

7) Respondent shall, at his own expense, retain a physician who is board certified in a specialty recognized by the American Board of Medical Specialties in a field providing primary care to patients, who is acceptable to the Board, such acceptance not to be unreasonably withheld. The retained physician shall, on behalf of the Board, review respondent’s patient charts no less often than every three months, or as the retained physician shall determine is necessary to timely review the records, and shall report to the Board any conduct which may violate this Order or be negligent, unprofessional, in violation of any state or federal law or rule, or outside the standard of care. The retained physician’s sole duty is to the Board and not to any patient or third party. Respondent shall cooperate at all times with the retained physician including by timely paying any fees in full, answering questions, and providing supplemental information promptly when requested. All of respondent’s personal clinical notes resulting from office visits shall be typed.

8) Respondent shall forthwith ensure that none of his staff uses the title “certified clinical nutritionist” or any other title which violates § 448.76, Wis. Stats.

9) Respondent shall forthwith cease to use any advertising which includes testimonials, and shall not advertise any medical practice or course of treatment which would include any particular or specific off-label use of drug products or devices, nor shall he advertise that he is board-certified unless he is either certified by a board recognized by the American Board of Medical Specialties, or discloses the full name of the Board which has certified him.. However, Respondent continues to have the right to advertise his complementary and alternative medicine practice.

10) Respondent shall, at his own expense, participate in and successfully complete within 12 months of the date of this Order, an educational program established through the University of Wisconsin Continuing Medical Education Program (which may conduct any program through the Medical College of Wisconsin or another CME provider) in medical recordkeeping approved by the Board or its designee. Alternatively, respondent shall complete another recordkeeping course pre-approved by the Board or its designee, which is substantially equivalent.
a) Under tutelage of a mentor selected by the program, Respondent shall review a selected text on medical recordkeeping, and shall introduce the mentor’s recommendations into his system in both clinic and hospital records. All of Respondent’s records may be reviewed and discussed periodically as the mentor shall determine. Reviews may include not only the adequacy of documentation but any quality of care or related issue.
b) The mentor shall agree to report any matter which may constitute a danger to the health, safety or welfare of patient or public, or any violation of law to the Board whenever it comes to the mentor’s attention.
c) Respondent’s progress and the outcome of the program shall be reported directly to the Department Monitor who may discuss Respondent’s progress with the mentor. The UW-CME shall certify the results of the program upon completion to the Board.
d) If Respondent does not successfully complete the program or achieve the program objectives, the matter shall be referred to the Board to determine any additional appropriate discipline for the conduct set forth in the Findings of Fact.

It is further ordered, that respondent’s license is limited in the following additional respect: If respondent renews his registration after October 31, 2005, respondent shall either have taken and passed the SPEX with a score of 75 (respondent may not attempt the test more than twice without Board approval), or have undergone an assessment to evaluate respondents current abilities to practice medicine at his current practice, given his current patient population and the facts of this case. The assessment shall be performed under the direction of the University of Wisconsin Continuing Medical Education Program (UW-CME), and may include a cognitive screening assessment, peer interview, and/or physical examination. Respondent shall have completed all portions of the process for which be is responsible (including payment of all required fees), as requested by UW-CME, before October 31, 2005.

If the results of this assessment process show a deficiency in respondent’s abilities, respondent shall participate in and successfully complete an educational program established through the UW-CME and based upon on the results of the assessment. The educational program shall include a post-intervention assessment which may be 6-18 months following the completion of the didactic portion of the program. Respondent shall complete this program within the time parameters established by the UW-CME, but no later than two years from the date of the report to the Board of the results of the assessment process.

In the event that UW-CME states that it is unable to develop an educational program which adequately addresses the issues identified in the assessment, the program shall notify the Board of this fact, and the matter shall be returned to the Division of Enforcement for further action. The results of the assessment shall be admissible as evidence in any subsequent proceedings in this action.

Respondent shall be responsible for all costs incurred for the SPEX or the assessment and training under the terms of this Order, and shall timely pay all fees when due.

The UW-CME shall certify to the Board the results of the assessment and educational program upon their completion, and may certify separately the didactic portion of the program and the post-intervention assessment. Upon receipt of certification of completion of the terms and conditions set forth above, the Medical Examining Board shall inform respondent that his obligations under this portion of this order have been satisfied and that his license is no longer limited in this respect.

If respondent does not successfully complete the program or does not successfully achieve the objectives of the program, and does not pass SPEX, this matter shall be referred to the Board to determine any other appropriate discipline for the conduct set out in the Findings of Fact. Respondent and the Division will have the opportunity to present argument to the Board on that issue. The Board and respondent will receive the results of the assessment and respondents performance in the program, including the post-intervention assessment as evidence in determining appropriate discipline.

If respondent has diligently pursued the assessment option in a timely manner, and has promptly started the recommended educational program (if any), but is unable to fully complete the educational program recommended, by October 31, 2005, he may petition the Board for a reasonable extension to finish the educational program. The granting of such extension is within the discretion of the Board, and may include conditions or additional limitations for the period of such extension, based on the assessment and respondent’s progress in the educational program as known at that time.

It is further ordered, that respondent shall pay partial costs of investigating and prosecuting this matter in the amount of $15,000, together with statutory interest from the date of this Order, by October 31, 2003.

It is further ordered, that pursuant to §448.02(4), Wis. Stats., if the Board determines that there is probable cause to believe that respondent has violated any term of this Final Decision and Order, the Board may order that the license of respondent be summarily suspended pending investigation of the alleged violation.

Dated this November 20, 2002.
Wisconsin Medical Examining Board by a member of the Board.

Required Disclosure for Ethylenediaminetetraacetic Acid (EDTA) Chelation Therapy

Patient name and full address:
Age and sex:
Malignancies, diseases, illnesses or physical conditions diagnosed for medical treatment by EDTA chelation therapy (list all):

My physician has explained to me and I fully understand:
(a) that the use of ethylenediaminetetraacetic acid (EDTA) has been approved by the federal Food and Drug Administration (FDA) only for the use of removing heavy metals from the body (or, in the calcium disodium form, for treating hypercalcemia or digitalis intoxication);
(b) that the FDA has not approved the drug EDTA for treatment of diseases or conditions other than heavy metals poisoning (or, in the calcium disodium form, for treating hypercalcemia or digitalis intoxication);
(c) that it has not been established through controlled trials that EDTA chelation therapy is effective for the treatment of circulatory diseases, specifically including atherosclerosis, hardening of the arteries, vascular insufficiency, or diabetes;
(d) that three small controlled trials were completed in 1992, l994 and 2001, which trials found that EDTA chelation therapy was not effective in the treatment of vascular diseases;
(e) that the federal government and most insurance companies do not pay for or reimburse for treatment with EDTA chelation therapy for vascular conditions;
(f) that the Wisconsin Medical Examining Board has monitored the development of the scientific literature on EDTA chelation therapy and has concluded that EDTA chelation therapy has been demonstrated to be ineffective in the treatment of vascular diseases;
(g) that the Wisconsin Medical Examining Board has determined that the use of EDTA chelation therapy by Wisconsin citizens may be harmful to their health in that that such patients may forego the use of medical treatments and drugs of proven usefulness in the treatment of vascular disease;
(h) that neither the American Medical Association, the American Osteopathic Association, the American College of Cardiology, the American Heart Association, nor any other recognized independent conventional medical association recommends the use of EDTA chelation therapy for the treatment of any human disease, illness, malady or physical condition other than heavy metals poisoning (or, in the calcium disodium form, for treating hypercalcemia or digitalis intoxication);
(i) that the Wisconsin Medical Examining Board strongly recommends that Wisconsin citizens not undergo EDTA chelation therapy for the treatment of any human disease, illness, malady or physical condition other than heavy metals poisoning (or in the calcium disodium form, for treating hypercalcemia or digitalis intoxication)
(j) that therapy with EDTA chelation may not be begun until three days have expired after the date of my execution of this informed consent form.
I have read and understand the above. Notwithstanding having read and understood the above, I hereby elect to undergo treatment with EDTA chelation therapy.

Patient signature and date:

Physician Certification:
I certify that the above patient signed this form on the date stated, that three days have elapsed after the patient’s signature, and that I have complied with the terms of this Disclosure Consent.

Physician signature and date:

Physician printed name as shown on state registration card:

Required Disclosure for Experimental/Unconventional Diagnosis and Treatment

Patient name and full address:
Age and sex:
Diseases, illnesses or physical conditions diagnosed or to be diagnosed:
My physician has explained to me and I fully understand:
(a) that the use of the proposed diagnostic test and/or therapy (describe fully): is experimental and not part of conventional medical diagnosis or treatment for any condition I have or which I might have.
(b) that the FDA has not approved the labeling of the drug(s), device(s), or tests proposed to be used for the purpose of diagnosing or treating my condition;
(c) that it has not been established through controlled trials accepted by the Wisconsin Medical Examining Board that the proposed diagnostic method or therapy will properly diagnose or have any effect upon my condition;
(d) that the federal government and most insurance companies do not pay for or reimburse for the test or treatment as proposed;
(e) that the Wisconsin Medical Examining Board has not approved, and does not approve this proposed test or therapy;
(f) that the Wisconsin Medical Examining Board has determined that the use of this test or therapy by Wisconsin citizens may be harmful to their health in that that such patients may forego the use of other medical tests, treatments, and/or drugs of proven usefulness in the treatment of my disease or condition;
(g) that the Wisconsin Medical Examining Board recommends that Wisconsin citizens not undergo such improved tests or therapy, but that citizens should seek medical diagnosis and care with proven accuracy and effectiveness;
(h) that therapy may not be begun until three days have expired after the date of my execution of this informed consent form.

I have read and understand the above. Notwithstanding having read and understood the above, I hereby elect to undergo the testing and/or treatment as described above.

Patient signature and date:

Physician Certification:
I certify that the above patient signed this form on the date stated, that three business days have elapsed after the patient’s signature, and that I have complied with the terms of this Disclosure.

Physician signature and date:

Physician
printed name as shown on state registration card:

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