Regulatory Actions against
Juergen G. Winkler, M.D.

Stephen Barrett, M.D.


Juergen Winkler, M.D., who operates Quantum Functional Medicine in Carlsbad, California, has been disciplined twice by California's medical licensing board. In 1999, he was accused of aiding and abetting an unlicensed practitioner (Ravi Devgan, M.D.) treat six patients with advanced cancer and failing to maintain adequate records of what he did. The charges were settled with a stipulation under which Winkler was reprimanded and ordered to complete a course in medical record-keeping and to pay $2,907 for the cost of the proceedings. (Devgan, who practiced mainly in Canada, was disciplined several times and in 2003 had his license revoked for exploiting and inappropriately treating cancer patients.)

In 2011, as shown below, Winkler was accused of misleading advertising, dishonesty, negligence, and failure to maintain adequate records in connection with inappropriately treating five cancer patient with insulin potentiation therapy (IPT). The accusation stated that Winkler had described IPT as a way to administer standard chemotherapeutic drugs at much lower doses so that patients do not suffer severe side effects. However, IPT has not been proven safe or effective, and the board concluded that Winkler's choices of drugs and dosages were inappropriate. The charges were settled with a stipulated agreement and order under which Winkler was placed on probation for three years and required to enroll in an ethics course and a clinical evaluation and training program. He was also prohibited from making or disseminating false or misleading statements about IPT.


KAMALA D. HARRIS
Attorney General of California
THOMAS S..LAZAR
Supervising Deputy Attorney General
DAVID P. CHAN
Deputy Attorney General
State Bar No. 159343
110 West "A" Street, Suite 1100
San Diego, CA 92101
P.O. Box 85266
San Diego, CA 92186-5266
Telephone: (619) 645~2600
Facsimile: (619) 645-2061
Attorneys for Complainant

BEFORE THE
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA

In the Matter of the Accusation Against:

JUERGEN G. WINKLER, M.D.
2204 El Camino Real, Suite 104
Oceanside, CA 92054

Physician's and Surgeon's Certificate
No. G67075

Respondent.


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Case No.1 0-2009-200762

ACCUSATION

FILED JUNE 8, 2011

Complainant alleges:

PARTIES

1. Linda K. Whitney (hereinafter "Complainant") brings this Accusation solely in her official capacity as the Executive Director of the Medical Board of California, Department of Consumer Affairs.

2. On or about September 18, 1989, the Medical Board of California issued Physician's and Surgeon's Certificate Number 067075 to Juergen G. Winkler, M.D. (hereinafter "Respondent"). The Physician's and Surgeon's Certificate was in full force and effect at all times relevant to the charges brought herein and will expire on November 30, 2012, unless renewed.

PRIOR DISCIPLINARY ACTION

3. On June 8, 2000, in a disciplinary action entitled "In the Matter of Accusation Against Juergen Winkler, M.D.," Case No. 10-1998-91.390,·the Medical Board of California, issued an order in which respondent, Physician's and Surgeon's Certificate No. 067075, was publicly reprimanded and he was ordered to successfully complete a course in medical record keeping.

JURISDICTION

4. This Accusation is brought before the Medical Board of California (Board), Department of Consumer Affairs, under the authority of the following laws. All section references are to the Business and Professions Code (Code) unless otherwise indicated.

5. Section 2227 of the Code provides that a licensee who is found guilty under the Medical Practice Act may have his or her license revoked, suspended for a period not to exceed one year, placed on probation and required to pay the costs of probation monitoring, or such other action taken in relation to discipline as the Division deems proper.

6. Section 2234 of the Code states:

"The Division of Medical Quality1 shall take action against any licensee who is charged-with unprofessional conduct. In addition to other provision's of this article, unprofessional conduct includes, but is not limited to, the following:

"(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the violation of, or conspiring to violate any provision of this chapter [Chapter 5, the Medical Practice Act].

"(b) Gross negligence.

"(c) Repeated negligent acts. To be repeated, there must be two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.

"(1) An initial negligent diagnosis followed by an act or omission medically appropriate for that negligent diagnosis of the patient.shall.constitute a single negligent act.

"(2) When the standard of care requires a change in the diagnosis, act, or omission that constitutes the negligent act described in paragraph (1), including, but not limited to, a reevaluation of the diagnosis or a change in treatment, and the licensee's conduct departs from the applicable standard of care, each departure constitutes a separate and distinct breach of the standard of care.

". . ."

"(e) The commission of any act involving dishonesty or corruption which is substantially related to the qualifications, functions, or duties of a physician and surgeon. "(f) Any action or conduct which would have warranted the denial of a certificate.

“. . . “

1California Business and Professions Code section 2002, as amended and effective January 1, 2008, provides that, unless otherwise expressly provided, the term "board" as used in the State Medical Practice Act (Cal. Bus. & Prof. Code, §§2000, et. seq.) means the "Medical Board of California," and references to the "Division of Medical Quality" and "Division of Licensing" in the Act or any other provision of law shall be deemed to refer to the Board.

7. Section 2266 of the Code states: "The failure of a physician and surgeon to maintain adequate and accurate records relating to the provision of services to their patients constitutes unprofessional conduct.”

8. Section of the Code 2271 states:

“Any advertising in violation of Section 17500, relating to false or misleading advertising, constitutes unprofessional conduct."

9. Section of the Code 17500 states:

"It is unlawful for any person, firm, corporation or association, or any employee thereof with intent directly or indirectly to dispose of real or personal property or to perform services, professional or otherwise, or anything of any nature whatsoever or to induce the public to enter into any obligation relating thereto, to make or disseminate or cause to be made or disseminated before the public in this state, or to make or disseminate or cause to be made or disseminated from this state before the public in any state, in any newspaper or other publication, or any advertising device, or by public outcry or proclamation, or in any other manner or means whatever, including over the Internet, any statement, concerning that real or personal property or those services, professional or otherwise, or concerning any circumstance or matter or tact connected with the proposed performance or disposition thereof, which is untrue or misleading, and which is known, or which by the exercise of reasonable care should be known, to be untrue or misleading, or for any person, firm, or corporation to so make or disseminate or cause to be so made or disseminated any such statement as part of a plan or scheme with the intent not to sell that personal property or those' services, professional or otherwise, so advertised at the price stated therein, or as so advertised. Any violation of the provisions of this section is a misdemeanor punishable by imprisonment in the county jail not exceeding six months, or by a fine not exceeding two thousand five hundred dollars ($2,500), or by both that imprisonment and fine."

10. Unprofessional conduct under California Business and Professions Code section 7234 is conduct which breaches the rules or ethical code of the medical profession, or conduct which is unbecoming to a member in good standing of the medical profession, and which demonstrates an unfitness to practice medicine.2

2Shea v. Board of Medical Examiners (1978) 81 Ca1.App.3d 564, 575.

FIRST CAUSE FOR DISCIPLINE
(Gross Negligence)

11. Respondent is subject to disciplinary action under sections 2227 and 2234, as defined by section 2234, subdivision (b), of the Code, in that respondent was grossly negligent in his care and treatment of patients J.J., J.C., J.K., W.P., and R.F., as more particularly alleged hereinafter:

12. At all times relevant herein, respondent specialized in providing Insulin Potentiation Therapy (IPT), a form of low dose chemotherapy. On his website, respondent references a "Kinder & Gentler Chemotherapy" and describes IPT .as follows:

"Insulin Potentiation Therapy is a protocol for administering traditional chemotherapeutic drugs using Insulin to transport the chemotherapeutic drugs across the cell membrane into the cancer cells. A much lower dose of the highly toxic drugs is required, because IPT treatment targets only the cancer cells. sparing the good cells, The cancer cells get the chemotherapeutic drugs, not the normal-cells. Therefore, the patient does not suffer the severe side effects so common with conventional chemotherapy—no hair loss, vomiting, or fevers. The quality of life remains high during treatment."

Patient J.J.

A. In or about early 2002, patient J.J. then a 56 year old male, was diagnosed with Grade I follicular lymphoma3 for which he received treatment consisting of "enzymes" from an alternative medicine practitioner in Texas. Patient J.J. subsequently moved to California and was seen by an oncologist in Glendale who. evaluated him and elected "watchful waiting" without any treatment. In or about 2006, patient J.J. developed a right testicular mass which was not malignant, and several months later, developed a right inguinal mass. In or about earl y 2007, patient J.J. underwent an excision of the right inguinal mass and other nodes in the right inguinal region. The mass and nodes were tested and determined to be Grade II follicular lymphoma. On or about July 2, 2008, a PET scan showed significant progression of patient J.J.'s disease when compared to the previous PET3 scan that was done in or about April, 2008. Conventional treatment was scheduled for patient J.J., however, he never presented for the scheduled treatment but, instead, sought the services of respondent.

3Follicular lymphoma is a common type of non-Hodgkin Lymphoma. It is a slow­growing lymphoma that arises from B-cells, a type of white blood cell.

çA positron emission tomography (PET) scan is an imaging test that uses a radioactive substance (called a tracer) to look for disease in the body.

B. On or about September 8, 2008, patient J.J. presented to respondent for consultation and possible treatment. Laboratory tests were ordered and patient J.J.. was given supplements.

C. On or about November 3, 2009, patient J.J. began receiving Insulin Potentiation Therapy/Low Dose Chemotherapy (IPT/LDC) from respondent. Patient J.J.'s treatment consisted of the following chemotherapy drugs: Adriamycin5 10 mg.; Vincristine,6 0.5 mg to 1.0 mg: Cyclophosphamide7 12.5 mg: and Methotrexate.8 50 mg. and continued until on or about April 29, 2009, at intervals varying from 3 to 7 days; Before the chemotherapy, patient J.J. received Kutapressin (an amino acid complex derived from bovine liver) and insulin. The insulin dose ranged from 15 and 32 units. In addition, patient J.J. was given vitamins, calcium, zinc and magnesium before chemotherapy. Patient J.J. received approximately 29 sessions of IPT/LDC over a 6-month period.

5Adriamycin (Doxorubicin) is an antineoplastic antibiotic. It works by kil1ing cancer cells.

6Vincristine is in a class of drugs known as vinca alkaloids. It slows or stops the growth of cancer cells in the. body.

7Cyclophosphamide (Cytoxan) is in a class of drugs known as alkylating agents; it slows or 'stops the growth of cancer cells in the body.

8Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells. It is used treat certain' . types of cancer of the breast, skin, head and neck, or lung. It is also used to treat severe psoriasis and rheumatoid arthritis.

D. On or about May 31, 2009, patient J.J. was seen by Dr. F.R., an oncologist, who noted that patient J.1. had an initial response to the therapy, but minimal improvement was noted in the most recent PET scan done on or about April 29, 2009. On or about June 10, 2009, Dr. F.R. placed patient J.J. on the standard conventional chemotherapy regimen of Rituxan,9 375 mg.; Cyclophosphamide 750 mg; Doxyrubicin (Adriamycin) 50 mg; Vincristine 1.4 mg; and Prednisone10 100 mg.

9Rituxan (rituximab) is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

10Prednisone is in a class of drugs called corticosteroids. Prednisone prevents the release of substances in the body that cause inflammation.

E. On or about July 27, 2009, patient J.C. underwent a follow up PET scan which showed "normal PET scan with no evidence of focal areas of increased activity."

Patient J.C.

F. On or about December 4, 2007, patient then a 64 year old female, was diagnosed with infiltrating ductal carcinoma of the left breast. The estrogen receptors were positive, progesterone receptors were negative and so was the Her2Neu.11

11Her2Neu is the acronym for human epidermal growth factor receptor 2. Knowing the Her2Neu status is an important part of the diagnosis.

G, On or about December 13, 2007. patient J.C. underwent a lumpectomy12 of the left breast with axillary lymph node biopsy. The pathology of the left breast showed infiltrating ductal carcinoma, 4.7 cm in size, with lymphovascular invasion. The pathology of the nodal specimen showed metastatic mammary carcinoma in two of two nodes without capsular invasion. A PET scan taken on or about January 3, 2008, showed mild increased uptake within the lateral left breast. Her estrogen receptors were positive, progesterone receptors were negative and the Her2Neu was over expressed (amplified).

12Lumpectomy is a surgical procedure that involves removing a suspected malignant (cancerous) turnor, or lump, and a small portion of the surrounding tissue from a woman's breast.

H. On or about February 18, 2008, patient J.C. was seen by respondent for consultation and possible neoadjuvant13 chemotherapy treatment. On or about February 25, 2008, patient J.C. started IPT/LDC treatment with respondent. Patient J.C. received approximately seven weekly treatment sessions which ended on or about April 7, 2008. Approximately two of the seven treatment sessions were administered by respondent, and five of the treatments were administered by Dr. L.B., respondent's partner.

13The administration of therapeutic agents before the main treatment of definitive surgery,

I. The chemotherapeutic agents used by respondent and his partner in treating patient J.C. were Adriamycin, 10mg.; Taxol,14 30 mg.; Methotrexate, 50 mg.; Cytoxan, 125 mg.; and Carboplatin,15 50 mg. Before chemotherapy patient. J.C. was given insulin, in addition to vitamins and minerals. The dose of insulin ranged from 21 and 22 units.

J. On or about April 7, 2008, a PET scan of patient J.C. showed a single new hypermetabolic left axillary node consistent with malignancy. On or about July 15, 2008, a CT scan of patient J.C.'s chest, abdomen, and pelvis showed a 27 mm left axillary lymph node consistent with recurrent neoplasm and a 12 mm stellate density at the right lower lobe of undetermined significance:

14Taxol is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body. It is used to treat breast cancer, lung cancer, and ovarian cancer.

15Carboplatin is in a class of drugs known as platinum-containing compounds; it slows or stops the growth of cancer cells in the body.

K. On or about May 5, 2008, patient J.C.'s husband sent Dr. L.B. a letter stating that they were having trouble with reimbursement from their insurance carrier and that patient J.C. was receiving treatment somewhere else.

Patient J.K.

L. On or about May 3, 2007, patient J.K., then a 54 year old female chiropractor, was diagnosed by a core biopsy with invasive ductal carcinoma of the left breast. On or about June 5, 2007, a biopsy of a sentinel left axillary lymph node revealed metastasis. Her estrogen and progesterone receptors were positive and Her2Neu was 2+.

M. On or about June 14, 2007, patient J.K. was seen by respondent for consultation and possible treatment, and she begun IPT/LDC treatment on that day.

N. Between on or about June 14, 2007 and November 13, 2007, patient J.K. received approximately eighteen IPT/LDC treatment sessions. The chemotherapeutic agents used by respondent in treating patient J.K. during this time were as follows: 5-FU,16 100 mg.; Adriamycin, 10 mg.; Cytoxan, 125 mg.; and Taxol, 30 mg. Before chemotherapy patient J.K. was given insulin, in addition to various vitamins and minerals. The dose of insulin ranged from 13 and 20 units. The treatment sessions continued twice a week for 2. weeks then weekly for eleven sessions, one 10 day break followed by twice weekly during one week, then one last treatment 3 weeks later. Additionally, patient J.K. received . Diflucan and Flagyl for presumptive infections on sessions seven through fifteen. Patient J .K. remained so fatigued during her treatment course that she was unable to maintain regular hours at her chiropractic practice.

15FU (Fluorouracil) belongs to a group of drugs known as antimetabolites. It resembles a normal cell nutrient needed by cancer cells to grow. The cancer cells take up fluorouracil, which then interferes with their growth.

O. On or about September 15, 2008, patient J.K. underwent a PET scan which showed interval development of a focal area of increased uptake in the upper outer quadrant of the left breast. On or about September 22, 2008, a core biopsy of a mass in patient J.K. 's left breast showed a recurrence of her invasive ductal carcinoma. Both estrogen and progesterone receptors were positive and Her2Neu was negative.

P. On or about September 26, 2008 patient J.K. again started with the IPT/LDC treatments and continued until on or about January 2, 2009, ranging from 3 days to a couple of weeks intervals. The chemotherapeutic agents used in treating patient J .K. were as follows: 5-FU, 100-125 mg.; Adriamycin, 10 mg.; Cytoxan, 100-125 mg.; Taxol, 30 mg.; Methotrexate, 50-75 mg.; and Carboplatin 50 mg. Before chemotherapy patient J.K. was given insulin, in addition to various vitamins and minerals. The dose of insulin ranged from 14 and 17 units.

Patient W.P.

Q. In or about January, 2008, patient W.P., then a 73 year old male, was diagnosed with inoperable Stage N gastric adenocarcinoma. Patient W.P. subsequently received chemotherapy' and radiation therapy, and was evaluated by a surgeon at UCLA who determined he was not a candidate for surgery. In or about August, 2008, patient W.P. underwent a PET scan which revealed persistent metabolic' activity at the gastroesophageal junction consistent with malignancy, new lung lesions, and new retroperitoneal lymph node. On or about September 15, 2008, patient W.P. underwent an endoscopy that showed inflammation in one area near the gastroesophageal junction that indicated a high grade dysplasia suspicious for deeper residual malignancy.

R. On or about September 5, 2008, patient W.P. was seen by respondent in consultation. On or about September 23, 2008, patient W.P. received his first IPT/LDC treatment. Between on or about September 23, 2008 and April 27, 2009, patient W.P. received approximately twenty one IPT/LDC treatment sessions at various intervals ranging from 3 days to a few weeks.

S. The chemotherapeutic agents used by respondent in treating patient W.P. and given in various combinations (at times doses are not mentioned) were as follows:

Adriamycin: Taxotere.17 5 mg.: Oxaliplatinr18 5-FU. 100 rng.: Epirubicin;19 Innotecan2040 mg.; Carboplatin, 50 mg.; Mitomycin.,21 2.5-80 mg.; Cisplatin, 15-50 mg.; Topotecan;22 Alimta,23 50 mg.; Methotrexate, 50 mg.; Erbitux24 35 mg.; and Taxol, 30 mg. Before chemotherapy, patient W.P. was given insulin ranging from 35 to 38 units, in addition to vitamins and minerals.

17Taxotere (docetaxel) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

18Oxaliplatin belongs to the group of medicines called antineoplastics. Oxaliplatin interferes with the growth of cancer cells, which are eventually destroyed.

19Epirubicin is in a class of drugs known as anthracyclines. It slows or stops the growth of cancer cells in the body.

20lrinotecan is a cancer medication that interfere's with the growth and spread of cancer cells in the body.

21Mitomycin is an anti-cancer chemotherapy drug. It is classified as an antitumor antibiotic.

22Topotecan is. a cancer medication that interferes with the growth and spread of cancer cells in the body.

23Alimta (pemetrexed) is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

24Erbitux is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body. Erbitux is used to treat cancers of the colon and rectum.

T.. On or about May 12, 2009, patient W.P. underwent a CT scan of the chest which showed an 8 mm nodule in the right lower lobe. On May 13, 2009, a PET scan showed moderate size hypermetabolic mass in the proximal stomach extending to the esophagealgastric junction which was consistent with his primary gastric neoplasm. Patient W.P. died on or about October 1, 2009.

Patient R.F.

U. In or about May, 2006, patient R.F., then a 42 year old female, was diagnosed with high-grade infiltrating ductal carcinoma of the right breast, and underwent a right modified radical mastectomy. Her marker status was negative for all three prognostic markers: estrogen, progesterone, and Her2Neu, indicating a poor prognosis and limiting her potentially successful treatment options. She received four cycles of Adriamycin and Cytoxan chemotherapy and was thought to be in remission which lasted several months. In or about early 2007) patient R.F. developed a right axillary mass and received a second course of chemotherapy, followed by surgical axillary lymph node dissection.

V. In or about July, 2008, patient R.F. was noted to have a large loculated mass in the right hemithorax with sternal destruction and extension to the mediastinum along with pulmonary metastasis. In or about August, 2008, patient R.F. was noted to have mental status changes, and after an evaluation, an MRI revealed severe metastases some in the left cerebellum and in the left frontal-parietal region of the brain. On or about August 13, 2008, patient R.F. underwent brain surgery to resect the brain lesion.

W. On or about August 18, 2008, patient R.F. was seen by respondent in consultation and possible treatment. The chemotherapy regimen was discussed and patient R.F. began IPT/LDC treatment on that day. Between on or about August 18, 2008 and January 19, 2009, patient R.F. received approximately thirty one IPT/LDC treatment sessions at various intervals ranging from 3 days to a couple of weeks.

X. The chemotherapeutic agents used by respondent in treating patient R.F. (at times doses are not mentioned) were as follows: Adriamycin, 10 rng.; Taxol, 30 mg.; Cytoxan; Carboplatin, 50 mg.; 5-FU, 100 mg.; Doxil25 2 mg.; Vinorelbine,26 10 mg.; Ifosfamide,27 200 mg.; Gemzar28 200 mg.; Cisplatin, 15 mg.; and lrinotecan, 40 mg. Before chemotherapy, patient R.F. was given insulin ranging from 20 to 21 units, in addition to vitamins and minerals.

25Doxil is an anti-cancer ("antineoplastic" or "cytotoxic"). chemotherapy drug. it IS the drug doxorubicin encapsulated in a closed lipid sphere (liposome) .. Doxil is classified as an “anthracycline antibiotic."

26Vinorelbine belongs to the general group of medicines known as antineoplastics.

27Ifosfamide belongs to the group of medicines caned alkylating agents. It is used to treat cancer of the testicles as well as some other kinds of cancer. Ifosfamide interferes with the growth of cancer cells, which are eventually destroyed.

28Gemzar is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Gemzar is classified as an antimetabolite.

Y. On or about January 29.2009. patient R.F. engaged a new conventional oncologist for considerable increased pain from her mediastinal chest wall mass since the previous several weeks. On or about May 2, 2009, patient R.F. passed away.

13. Respondent committed gross negligence in his care and treatment of patients J.J., J.C., J.K., W.P., and R.F. which included, but was not limited to, the fol1owing:

(a) Respondent's website is intentionally misleading regarding the potential dangers associated with IPT/LDC because it suggests, incorrectly, that it is as effective, but without the hazards, as conventional chemotherapeutic treatment for cancer.

(b) Respondent failed to include Rituximab in patient J.J.'s treatment regimen, an his dosages and frequency for Adriamycin, Vincristine and Cyclophosphamide used in treating patient J.J. were inappropriate.

(c) Respondent added Methotrexate to patient J.1.'s 'chemotherapeutic treatment regimen which is not appropriate in the treatment of non-Hodgkin's lymphoma.

(d) Respondent failed to adequately document the dosages for Vincristine and Cyclophosphamide that were given to patient J.J.

(e) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient J.J. prior to the IPT/LDC treatment.

(f) Respondent's dosages, frequency and combination for chemotherapeutic agents used in treating patient J.C. were inappropriate.

(g) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient J.C. prior to initiating the IPT/LDC treatment.

(h)' Respondent failed to adequately monitor patient J.C.'s blood glucose level during approximately three of the seven IPT/LDC treatment sessions.

(i) Respondent used incorrect dosing, frequency, and combination of chemotherapeutic agents in treating patient J.K.

G) Respondent failed to sign or initial every handwritten note in the progress notes regarding the treatment and care of patient J.K.

(k) Respondent failed to sign multiple treatment sheets for patient J.K.

(l) Respondent failed to adequately document the dosages of chemotherapeutic agents used in multiple treatment sessions of patient J.K.

(m) Respondent failed to adequately monitor patient W.P. 's blood glucose level during multiple IPT/LDC treatment sessions.

(n) Respondent failed to adequately document patient W.J..'s serial blood glucose results, dosages of chemotherapeutic agents, the reasons for his choices and changes in chemotherapeutic agents used in the treatment of patient W.P. Respondent failed to sign or initial patient W.P.'s treatment sheets.

(o) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient W.P. prior to the IPT/LDC treatment.

(p) Respondent used incorrect dosing, frequency, and combination of chemotherapeutic agents in treating patient R.F.

(q) Respondent failed to adequately document the dosages for the chemotherapeutic agents used in several treatment sessions of patient R.F.

(r) Respondent failed to sign or initial hand-written notes regarding the treatment of patient R.F.

(s) Respondent failed to accurately document the treatment, and drugs and/or supplements given to patient R.F. during her treatment session on or about January 19, 2009.

(t) Respondent failed to adequately monitor patient R.F. 's blood glucose level during multiple. IPT/LDC treatment sessions.

(u) Respondent failed to communicate with patient R.F.'s other treating physicians, and failed to adequately document information regarding other treatments she had received. (v) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient R.F. prior to the IPT/LDC treatment.

SECOND CAUSE FOR DISCIPLINE
(Repeated Negligent Acts)

14. Respondent has further subjected his Physician's and Surgeon's Certificate No. G67075 to disciplinary action under sections 2227 and 2234, as defined by section 2234, subdivision (c), of the Code, in that he committed repeated negligent acts in his care and treatment of patients J.J., J.C., J.K., W.P., and R.F., as more particularly alleged hereinafter:

15. Paragraphs 11, 12, and 13, above, are hereby incorporated by reference and re­alleged as if fully set forth herein. .

16. Respondent committed repeated negligent acts in his care and treatment of patients J.J., J.C., J.K., W.P., and R.F. which included, by not limited to, the following:

(a) Respondent's website is intentionally misleading regarding the potential dangers associated with IPT ILDC because it suggests, incorrectly, that it is as effective, but . without the hazards, as conventional chemotherapeutic treatment for cancer.

(b) Respondent failed to include Rituximab in patient J.J.'s treatment regimen, and his dosages and frequency for Adriamycin, Vincristine and Cyclophosphamide used.in treating patient J.J. were inappropriate.

(c) Respondent added Methotrexate to patient J.J.'s chemotherapeutic treatment regimen which is not appropriate in the treatment' of non-Hodgkin's lymphoma.

(d) Respondent failed to adequately document the dosages for Vincristine and Cyclophosphamide that were given to patient J.J.

(e) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient J.J. prior to the IPTILDC treatment.

(f) Respondent's dosages, frequency and combination for chemotherapeutic agents used in treating patient 1.C. were inappropriate.

(g) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient J.C. prior to initiating the IPT/LDC treatment.

(h) Respondent failed to adequately monitor patient J.C.'s blood glucose level during approximately three of the seven IPT/LDC treatment sessions.

(i) Respondent used incorrect dosing, frequency, and combination of chemotherapeutic agents in treating patient J.K.

(j) Respondent failed to sign or initial every handwritten note in the progress notes regarding the treatment and care of patient J.K.

(k) Respondent failed to sign multiple treatment sheets for patient J.K.

(1) Respondent failed to adequately document the dosages of chemotherapeutic agents used in mu1tiple treatment sessions of patient J.K.

(m) Respondent failed to adequately monitor patient W.P. 's blood glucose level during multiple IPT/LDC treatment sessions.

(n) Respondent failed to adequately document patient W.P.'s serial blood glucose results, dosages of chemotherapeutic agents, the reasons for his choices and changes in chemotherapeutic agents used in the treatment of patient W.P. Respondent failed to sign or initial patient W.P.'s treatment sheets.

(o) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient W.P. prior-to the IPT/LDC treatment.

(p) Respondent used incorrect dosing, frequency, and combination of chemotherapeutic agents in treating patient R.F.

(q) Respondent failed to adequately document the dosages for the chemotherapeutic agents used in several treatment sessions of patient R.F.

(r) Respondent failed to sign or initial hand-written notes regarding the treatment of patient R.F.

(s) Respondent failed to accurately document the treatment, and drugs 'and/or supplements given to patient R.F. during her treatment session on or about January 19, 2009.

(t) Respondent failed to adequately monitor patient R.F.'s blood glucose level during multiple IPT/LDC treatment sessions.

(u) Respondent failed to communicate with patient R.F. 's other treating physicians; and failed to adequately document information regarding other treatments she had received.

(v) Respondent failed to obtain a baseline physical examination as part of his initial evaluation of patient R.F. prior to the IPT/LDC treatment.

(w) Respondent failed to document the dosages for the chemotherapy agents used to treat patient J.C. on or about February 25, 2008.

(x) Respondent failed to adequately document a history and physical examination, and treatment status regarding patient J.K.

THIRD CAUSE FOR DISCIPLINE
(Failure to Maintain Adequate and Accurate Medical Records)

17. Respondent has further subjected his Physician's and Surgeon's Certificate No G 67075 to disciplinary action under sections 2227 and 2234, as defined by section 2266, of the Code, in that respondent failed to maintain adequate and accurate records in regards to his care and treatment of patients J.J., J .C., J .K., W.P., and R.F., as more particularly alleged hereinafter.

18. Paragraphs 11 through 16, above, are hereby incorporated by reference and realleged as if fully set-forth herein.

FOURTH CAUSE FOR DISCIPLINE
(False and/or Misleading Advertising)

19. Respondent has further subjected his Physician's and Surgeon's Certificate No. G67075 to disciplinary action under Code sections 2227 and 2234, as defined by Code section 2271 in that he disseminated false and/or misleading representations through his website, in violation of section 17500 of the Code. The circumstances are set forth below.

20. Paragraphs 11 through 13, above, are hereby incorporated by reference as if fully set forth herein.

A. Respondent's website, at all times relevant herein, stated that, "What cancers respond to IPT? IPT treatment has been reported to work well for many different types of cancers. There are also reports of IPT bringing responses and remissions to patients with some very difficult cancers, even cancers in late stages." In fact, this representation is untrue and/or misleading, lacks substantiation and is based solely on respondent's personal experience rather than peer reviewed studies or other valid scientific analysis.

B. Respondent's website, at all times relevant herein, stated that. "Is IPT just as effective as the chemotherapy my oncologist would prescribe? It does appear that the percentages for remission and survival are at least as good as with conventional chemotherapy, and probably much better." In fact, this representation is untrue and/or misleading, lacks substantiation and is based solely on respondent's personal experience rather than peer reviewed studies or other valid scientific analysis.

C. Respondent's website, at all times relevant herein, stated: "Are there any side effects of IPT treatment? Almost none. There is certainly no hair loss, no going home to shiver in bed for a day or two, and no severe vomiting. There is occasional constipation, which is easily controlled by simple medications. Some nausea is occasionally encountered for a few hours after the first couple of treatments, but this is also easily managed." In fact, this representation is untrue and/or misleading, lacks substantiation and is also inconsistent with respondent's own observations including his observation of patient J.K. who remained so fatigued during her treatment course that she was unable to maintain regular hours at her chiropractic practice.

D. Respondent's website, at all time relevant herein, stated: "As compared to conventional chemotherapy, there are no severe and debilitating side effects. The patient can easily continue with normal daily activities, enjoying a high quality of life while avoiding severe vomiting, hair loss, or fevers." In fact, this representation is untrue or misleading, lacks substantiation and is also inconsistent with respondent's own observations including his observation of patient J.K. who remained so fatigued during her treatment course that she was unable to maintain regular hours at her chiropractic practice.

E. Respondent's website, at all times relevant herein, stated: "Are there any dangers in IPT treatment? Unlike with conventional chemotherapy, there have been no reported deaths as a result of IPT. In brief, there is no danger. The worst side effect encountered is easily managed constipation. Unlike conventional chemotherapy, anemia and decreased platelet counts are unusual and usually not so severe as to require transfusions." In fact, this representation is untrue or misleading, lacks substantiation, is purportedly based on respondent's personal experience rather than peer reviewed studies or other valid scientific analysis, and is also inconsistent with respondent's own observations at his practice .

F. Respondent's website, at all times relevant herein, stated: "Treatment costs are significantly less than standard chemotherapy, and most insurance carriers do pay a significant portion of the fees." In fact, this representation is untrue or misleading, lacks substantiation and is also inconsistent with respondent's own observations including his observation of patient J.C. who had to seek treatment somewhere else because she was having trouble with reimbursement from her insurance carrier.

G. Respondent's website, at all times relevant herein, generally misrepresented the benefits and dangers of his treatment.

H. Respondent's website, at all times relevant herein, contained material representations that were represented as fact even though they were not based on fact.

SIXTH CAUSE FOR DISCIPLINE
(Dishonesty or Corruption)

21. Respondent is further subject to disciplinary action under sections 2227 and 2234, as defined by section 2234, subdivision (e), of the Code, in that respondent committed an act or acts of dishonesty or corruption, as more particularly described hereinafter:

22. Paragraphs 19 and 20, above, which are hereby incorporated by reference as if fully set forth herein.

SEVENTH CAUSE FOR DISCIPLINE
(General Unprofessional Conduct)

23. Respondent has further subjected his Physician's and Surgeon's Certificate No. G67075 to disciplinary action under sections 2227 and 2234 of the Code in that he has engaged in conduct which breaches the rules or ethical code of the medical profession, or conduct which is unbecoming to a member in good standing of the medical profession, and which demonstrates an unfitness to practice medicine, as more particularly described hereinafter:

24. Paragraphs 19 and 20, above, which are hereby incorporated by reference as if fully set forth herein.

DISCIPLINE CONSIDERATIONS

25. To determine the degree of discipline, if any, to be imposed on respondent, Complainant alleges that on or about June 8, 2000, in a prior disciplinary action entitled "In the Matter of the Accusation Against Juergen Winkler, M.D." before the Medical Board of California; in Case No. 10M1998-91390, respondent, Physician's and Surgeon's Certificate No. .0'67075, was publicly reprimanded for allegations of aiding and abetting unlicensed practice and failure to maintain adequate and accurate medical records. Respondent was ordered to successfully complete a course.in medical record keeping. That decision is now final and is incorporated by reference as if fully set forth herein.

PRAYER

WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Medical Board of California issue a decision:

1. Revoking or suspending Physician's and Surgeon's Certificate Number G67075, heretofore issued to respondent JUERGEN G. WINKLER, M.D.;

2. Revoking, suspending or denying approval of respondent JUERGEN G. WINKLER, M.D.'s authority to supervise physician assistants, pursuant to section 3527 of the Code;

3. Ordering respondent JUERGEN G. WINKLER, M.D. to pay the Board, if placed on probation, the costs of probation monitoring; and

4. Taking such other and further action as deemed necessary and proper.

DATED: June 8, 2011.

LINDA K. WHITNEY
Executive Director .
Medical Board of California
Department of Consumer Affairs
State of California
Complainant

This page was posted on August 29, 2013.

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