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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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