Regulatory Action against
Ted L. Edwards, M.D.

Stephen Barrett, M.D.


In 2017, the Texas Medical Board charged Ted Leroy Edwards, Jr., M.D. with "failing to meet the standard of care and nontherapeutically prescribing pancreatic cancer treatment for one patient." The complaint (shown below) states that the treatments included intravenous vitamin C, oxidative therapy, pulse therapy, and a regimen of oral supplements that included Biomulsion D, Poly MVA, Argaricu Blazei Murill, curcumin, indol 3 carbinol, genistein, protease, and Apex water, none of which met the generally accepted standard of care for patients with metastatic pancreatic cancer. Edwards practices as part of the Hills Medical Group at the Center for Health and Healing in Austin, Texas.

In 2018, the complaint was settled with an agreed order under which the board found that Edwards had failed to keep adequate records of the patient and required him to (a) pass the board's Medical Jurisprudence Examination, (b) complete at least 16 hours of continuing medical education in risk management and medical recordkeeping, and (c) submit his consent forms to the board for review. The agreement noted that Edwards is 82 years old.


HEARING CONDUCTED BY THE
STATE OFFICE OF ADMINISTRATIVE HEARINGS
SOAH DOCKET NO. 503-17-5862-MD
TEXAS MEDICAL LICENSE NO. C-8269

IN THE MATTER OF THE
THE COMPLAINT AGAINST
TED LEROY EDWARDS, JR., MD.
 

BEFORE THE

TEXAS MEDICAL BOARD

COMPLAINT

TO THE HONORABLE TEXAS MEDICAL BOARD AND THE HONORABLE ADMINISTRATIVE LAW JUDGE TO BE ASSIGNED:

The Staff of the Texas Medical Board (the Board) files this Complaint against Ted Leroy Edwards, .lr., M.D. (Respondent), for alleged violations of the Medical Practice Act (the Act), Texas Occupations Code, Title 3, Subtitle B, Chapters 151 to 165 and would show the following:

I. SUMMARY OF FACTUAL ALLEGATIONS

Respondent failed to meet the standard of care by inappropriately treating one patient's pancreatic cancer using non-therapeutic treatments. Respondent failed to adhere to the established standards for physicians practicing complementary and alternative medicine.

II. LEGAL AUTHORITY AND JURISDICTION

1. Respondent is a Texas Physician and holds Texas Medical License No. 08269, that was originally issued on August 20, 1960. Respondent's license was in full force and effect at all times material and relevant to this Complaint.

2. Respondent received notice of one or more Informal Settlement Conferences (ISC), The Board complied with all procedural rules, including but not limited to, Board Rules 182 and 187, as applicable.

3. No agreement to settle this matter has been reached by the parties.

4. All jurisdictional requirements have been satisfied,

5. The filing of this Complaint and the relief requested are necessary to protect the health and public interest of the citizens of the State of Texas.

III. APPLICABLE STATUTES AND STATUTORY VIOLATIONS

The following statutes, rules, and agency policy are applicable to the procedures for conduct of the hearing this matter:

General Statutes and Rules:

1. Section 164.007(a) of the Act requires that the Board adopt procedures governing formal disposition of a contested case before the State Office of Administrative Hearings.

2. 22 TEX, ADMIN CODE, CHAPTER 187 sets forth the procedures adopted by the Board under the requirement of Section 164.007(a) of the Act.

3. 22 TEX. ADMIN. CODE, CHAPTER 190 sets forth aggravating factors that warrant more severe or restrictive action by the Board,

4. 1 TEX. ADMIN, CODE, CHAPTER 155 sets forth the rules of procedure adopted by SOAH for contested case proceedings.

5, 1 TEX. ADMIN. CODE, CHAPTER 155.507, requires the issuance of a Proposal for Decision (PFD) containing Findings of Fact and Conclusions of Law.

6, Section 164.007(a) of the Act, Board Rule 187.37(d)(2) and Board Rule 190, provide the Board with the sole and exclusive authority to determine the charges on the merits, to impose sanctions for violation of the Act or a Board rule, and to issue a Final Order.

B. Specific Violations Cited:

Respondent has violated the following provisions of the Act and Board Rules

1. Section 164.051(a)(1) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's commission of an act prohibited under Section 164.052 of the Act.

2. Section 164.051(a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on violation of Board Rules 165.1(a) failure to maintain an adequate medical record and 200.3(1), (2), and (3), failure to adhere to those established standards for physicians practicing complementary and alternative medicine

3. Section 164.051(a)(o) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by Board Rule 190.8(1)(A), failure to treat patient according to the generally accepted standard of care, (B), negligence in performing medical services, (C), failure to use proper diligence in one's professional practice, (D), failure to safeguard against potential complications, (G), failure to disclose reasonably foreseeable side effects of a procedure or treatment; (1-1), failure to disclose reasonable alternative treatments to a proposed procedure or treatment; and (K), prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine).

4. Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public.

5. Section 164.053(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutie in the manner the drug or treatment is administered or prescribed.

IV. FACTUAL ALLEGATIONS

Based on information and belief, Board Staff alleges:

A. Respondent violated the Act by failing to meet the standard of care and nontherapeutically prescribing pancreatic cancer treatment for one patient.

1. Respondent specializes in Internal Medicine with a sub-specialty in Gastroenterology, and is not board certified.

2. Respondent's practice offers complementary, conventional and holistic healthcare, and alternative health medicine.

3. On March 10, 2016, Respondent saw the patient for a new patient evaluation. A pancreatic mass had been detected and she was scheduled for biopsy; the working diagnosis was pancreatic cancer.

4. On March 14, 2016, Respondent saw the patient for a follow-up visit. The diagnosis of pancreatic cancer with liver metastases had been confirmed by biopsy. Respondent and the patient discussed a plan of care involving oxidative IV, U131 (ultraviolet blood irradiation), and triple oxidative therapy which included hydrogen peroxide, ozone, and Koch's catalyst,

5. On March 17, 2016, the patient signed a consent form for complementary and supportive treatments for cancer patients which states in part, "these therapies are not considered treatment of malignancy, nor are they represented to be treatments for cancer but are rather complementary to and supportive of primary cancer treatments"

6. On March 17, 2016, Respondent was aware that the patient was not undergoing any primary cancer treatment; therefore, he was directing his treatment primarily towards the pancreatic cancer and not as supportive or complimentary treatment.

7. On March 24, 2016, Respondent ordered infusion therapy of 50g ascorbic acid with nutrients and oxidative and pulse therapy, and prescribed Genistein.

8. On April 7, 2016, Respondent recommended starting a six month treatment regimen of oral supplements including: Biomulsion D, Poly MVA, Argaricu Blazei Murill, curcumin, indol 3 carbinol, genistein, protease, and Apex water.

9. On April 19, 2016, the patient saw Respondent for back pain and abdominal pain. Respondent's plan of care included naltrexone for pain and ivermectin ("associated with having pancreatic healing qualities").

10. On May 12, 2016, Respondent ordered an Iron infusion (4cc).

11. On May 16, 2016, the patient signed a consent form for vaginal ozone,

12. The above mentioned treatments that Respondent provided the patient are not accepted forms of treatment for metastatic pancreatic cancer and were not being offered as complimentary treatment to primary cancer treatment.

13. Respondent's failure to meet the standard of care and non-therapeutic treatment of the patient's metastatic pancreatic cancer violates the following provisions of the Act and Board Rules:

Section l64.051(a)(l) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's commission of an act prohibited under Section 164.052 of the Act.

Section 164.051(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by Board Rule 190,8(1) (A), failure to treat patient according to the generally accepted standard of care, (B), negligence in performing medical services, (C), failure to use proper diligence in one's professional practice, and (D), failure to safeguard against potential complications, (G), failure to disclose reasonably foreseeable side effects of a procedure or treatment; (H), failure to disclose reasonable alternative treatments to a proposed procedure or treatment; and K), prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine).

Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public.

Section l64.053(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutie in the manner the drug or treatment is administered or prescribed,

B. Respondent violated the Act by failing to adhere to the established standards for physicians practicing complementary and alternative medicine.

1. Respondent's medical records failed to include the following documentation of the patient assessment required under Board Rule 200.3(1): conventional medical treatment options; and whether the complementary health care therapy could interfere with any other recommended or ongoing treatment the patient assessment

2. Respondent's medical records failed to include the following documentation of disclosure required under Board Rule 200.3(2): the objectives, expected outcomes, or goals of the proposed treatment; the risks and benefits of the proposed treatment; the extent the proposed treatment could interfere with any ongoing or recommended medical care; and a description of the underlying therapeutic basis or mechanism of action of the proposed treatment purporting to have a reasonable potential for therapeutic gain that is written in a manner understandable to the patient disclosure.

3, Respondent's medical records failed to include the following documentation of the treatment plan required under Board Rule 200.3(3): a favorable risk/benefit ratio compared to other treatments for the same condition; be based upon a reasonable expectation that it will result in a favorable patient outcome, including preventive practices; and be based upon the expectation that a greater benefit for the same condition will be achieved than what can be expected with no treatment.

4. Respondent's failure to adhere to the established standards for physicians practicing complementary and alternative medicine violates the following provisions of the Act and Board Rules:

Section 164.051(a)(l) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's commission of an act prohibited under Section 164.052 of the Act.

Section 164.051(a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on violation of Board Rules 165.1(3) failure to maintain an adequate medical record and 200.3(1), (2), and (3), failure to adhere to those established standards for physicians practicing complementary and alternative medicine.

Section 164.051(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by Board Rule 190.8(1)(K), prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine).

Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public Section 164i053(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutie in the manner the drug or treatment is administered or prescribed.

V. AGGRAVATING AND MITIGATING FACTORS

Board Rule 190.14 provides that the Board may impose more restrictive sanctions when there are multiple violations of the Act.

Board Rule 190.15 provides that the Board may consider aggravating factors that warrant more severe or restrictive disciplinary action This case includes the following aggravating factors: increased potential for harm to the public; intentional act constituting a violation; and other relevant circumstances increasing the severity of the misconduct

Board staff is not aware of any mitigating factors that apply and demands that Respondent submit proof to substantiate any alleged mitigating factors.

VI. NOTICE TO RESPONDENT

IF YOU DO NOT FILE A WRITTEN ANSWER TO THIS COMPLAINT WITH THE STATE OFFICE OF ADMINISTRATIVE HEARINGS WITHIN 20 DAYS AFTER THE DATE OF RECEIPT, A DEFAULT ORDER MAY BE ENTERED AGAINST YOU, WHICH MAY INCLUDE THE DENIAL OF LICENSURE OR ANY OR ALL OF THE REQUESTED SANCTIONS, INCLUDING THE REVOCATION OF YOUR LICENSE. A COPY OF ANY ANSWER YOU FILE WITH THE STATE OFFICE OF ADMINISTRATIVE HEARINGS SHALL ALSO BE PROVIDED TO THE HEARINGS COORDINATOR OF THE TEXAS MEDICAL BOARD.

VII. PRAYER

Board Staff requests that an administrative law judge employed by the State Office of Administrative Hearings conduct a contested case hearing on the merits of the Complaint, and issue a Proposal for Decision containing Findings of Fact and Conclusions of Law necessary to support a determination that Respondent violated the Act and Board Rules as set forth in this Complaint.

Respectfully submitted,
TEXAS MEDICAL BOARD

CHRISTOPHER PALAZOLA
Litigation Manager

SUSAN RODRIGUEZ
Supervising Attorney

________________________
Jerry Bergman, Staff Attorney
State Bar No. 24081694
jerrybergman@TMB.state.tx.us
Telephone: (512) 305-7072
Fax: (512) 305-7007 333
Guadalupe, Tower 3, Suite 610
Austin, Texas 78701

Filed with the Texas Medical Board on August 21, 2017.


________________________
Scott Freshour, J.D.
Interim Executive Director
Texas Medical Board  

This article was posted on JUly 4, 2018.

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