Roy Page, M.D. Surrenders Medical License

Stephen Barrett, M.D.


In January 2008, Roy C. Page, M.D. of Memphis Tennessee, settled charges against him by permanently surrendering his medical license. The agreed order (shown below) states that between 1997 and 2003, Page treated at least 74 cancer patients with what he referred to as “Gene Activated Therapy” or “Theracine"—a vaccine said to be developed from blood and tumor samples taken from the patient. Page represented that he was conducting research, but he did not file an Investigational New Drug Application with the FDA or collect any data for analysis. In 2003, after the FDA notified him that it would seek to disqualify him as a clinical investigator, Page signed a consent agreement in which he agreed to permanent disqualification. In 2004, he pleaded guilty in federal court to a felony drug misbranding charge, for which he was fined $2,000 and sentenced to one year of probation.


STATE OF TENNESSEE
DEPARTMENT OF HEALTH


IN THE MATTER OF:

ROY C. PAGE, M.D.
RESPONDENT

MEMPHIS, TENNESSEE
TENNESSEE LICENSE # 2608

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BEFORE THE TENNESSEE BOARD
OF MEDICAL EXAMINERS

DOCKET NO. 17.18-094627A


AMENDED AGREED ORDER


This matter came to be heard before the Tennessee Board of Medical Examiners (hereinafter “the Board”) on the 23rd day of January, 2008, pursuant to a Notice of Charges issued against the Respondent by the Division of Health Related Boards of the Tennessee Department of Health (hereinafter “the State”). The State was represented by Andrea Huddleston, Assistant General Counsel. The Respondent was not present but was represented by counsel, Dan Warlick, Esquire. After consideration of the Notice of Charges and presentation of counsel, the Board finds as follows:

1. The Respondent agrees that presentation to and consideration of this Agreed Order by the Board for ratification and all matters divulged during that process shall not constitute unfair disclosure such that the Board or any of its members shall be prejudiced to the extent that requires their disqualification from hearing this matter should this order not be ratified.

2. The Respondent understands the nature of the charges herein alleged and that if proved at hearing, such charges and allegations would constitute cause for imposing discipline upon Respondent’s license issued by the Board.

3. The Respondent is aware of each of Respondent’s rights, including the right to a hearing on the charges and allegations, the right to appear personally and by counsel, the right to confront and cross-examine witnesses who would testify against Respondent, the right to testify and present evidence on Respondent’s own behalf, as well as to the issuance of subpoenas to compel the attendance of witnesses and the production of documents, the right to contest the charges and allegations, and other rights which are accorded Respondent pursuant to the Administrative Procedures Act and other applicable laws, including the right to seek reconsideration, review by the Chancery Court and appellate review.

4. In order to avoid the expense and uncertainty of a hearing, Respondent freely and voluntarily waives each and every one of these rights set forth above and admits the truth of the allegations herein contained. Respondent agrees that cause exists to discipline his license.

5. The Respondent understands that by signing this Agreed Order, Respondent is enabling the Board to issue its order without further process. In the event that the Board rejects this Agreed Order for any reason, it will be of no force or effect for either party.


FINDINGS OF FACT


6. Respondent has been at all times pertinent hereto licensed by the Board as a medical doctor in the State of Tennessee, having been granted license number 2608 by the Board, on January 1, 1956.

7. Between 1997 and 2003, the Respondent treated at least seventy-four cancer patients with what he referred to as “Gene Activated Therapy” or “Theracine”. This “therapy” consisted of a vaccine developed from blood and tumor samples taken from the patient. The Respondent represented to these patients that he was conducting a study of this therapy working with Dr. George Kindness of Amscot Labs. Patients were charged for the treatment by Dr. George Kindness and Amscot Labs. Dr. Page charged for surgery and office visits.

8. The Respondent represented to patients that the “vaccine” was manufactured at Amscot Labs by a Dr. George Kindness of Ohio, using blood and tumor samples taken from the patients. Although George Kindness has a PhD in immunology, the Mr. Kindness identified by Respondent has no license to practice medicine in either Ohio or Tennessee.

9. Respondent never filed an Investigational New Drug Application or a protocol with the F.D.A, nor had he received approval for the study from the Methodist Hospital Investigational Review Board (IRB). A subsequent search warrant executed by the F.D.A. upon the Respondent’s offices in Memphis and the Cincinnati offices of Amscot Labs and Mr. Kindness failed to discover any evidence of research data being collected or analyzed for purposes of studying “Gene Activated Therapy” or “Theracine”.

10. On February 13, 2004, subsequent to the F.D.A.’s investigation, the Respondent pleaded guilty in the United States District Court for West Tennessee to a felony count of Introduction and Delivery for Introduction into Interstate Commerce a Misbranded Drug.

11. As a result of the F.D.A. investigation, Methodist Hospital summarily suspended Respondent’s privileges and the Medical Executive Committee ultimately recommended termination of Respondent’s privileges.

12. Subsequent to the summary suspension of Respondent’s privileges at Methodist Hospital, Respondent completed an application for re-appointment at Baptist Memorial Hospital but did not reveal on that application either the investigation by the F.D.A or his summary suspension by Methodist Hospital. As a result of this incorrect application for re-appointment, the Baptist Hospital Medical Executive Committee recommended that Respondent’s clinical privileges be revoked. During the subsequent fair hearing process, Respondent voluntarily surrendered his clinical privileges at Baptist Memorial Hospital.

13. In addition to and concomitant with the “Theracine” treatment, Respondent administered to numerous patients other unconventional and F.D.A. unapproved treatments such as the “Holt/Spall treatment” and the “Taliberg treatment”.


CONCLUSIONS OF LAW


The facts as found in the Findings of Fact are sufficient to establish that the Respondent has violated the following statutes or rules which are part of the Medical Examiners Practice Act, (TENN. CODE ANN. § 63-6-101, et seq.) for which disciplinary action before and by the Board of Medical Examiners is authorized:

14. The facts contained in paragraphs 6 through 13, supra, constitute grounds for disciplinary action against Respondent’s license to practice medicine in the State of Tennessee pursuant to the Tennessee Medical Practice Act which authorizes disciplinary action against a Respondent who has engaged in unprofessional, dishonorable or unethical conduct. TENN. CODE ANN. § 63-6-214(b)(1).

15. The facts contained in paragraphs 6 through 13, supra, constitute grounds for disciplinary action against Respondent’s license to practice medicine in the State of Tennessee pursuant to the Tennessee Medical Practice Act which authorizes disciplinary action against a Respondent who is convicted of a felony, or any offense under state or federal drug laws, or convicted of any offense involving moral turpitude. TENN. CODE ANN. § 63-6-214(b)(10).


REASONS FOR DECISION


The Tennessee Board of Medical Examiners takes this action in order to protect the health, safety and welfare of the citizens of the State of Tennessee.


ORDER


The facts as found in the Findings of Fact are sufficient to establish that the Respondent has violated the following statutes or rules which are part of the Medical Examiners Practice Act, (TENN. CODE ANN. § 63-6-101, et seq.) for which disciplinary action before and by the Board of Medical Examiners is authorized:

16. The Tennessee medical license of Roy C. Page, M.D., license number 2608, is hereby PERMANENTLY SURRENDERED, commencing the date of entry of this Order.

17. Respondent hereby acknowledges that the surrender of his medical license shall have and be considered to have the same effect as a revocation.

18. The Respondent must pay, pursuant to T.C.A. § 63-6-214(k) and Rule 0880-2-.12(1)(j) of the Official Compilation Rules and Regulations of the State of Tennessee, the actual and reasonable costs of prosecuting this case to the extent allowed by law, including all costs assessed by the Secretary of State, Administrative Procedures Division as well as the Office of General Counsel. Costs related to the Bureau of Investigations are waived. These costs will be established by an Affidavit of Costs prepared and filed by counsel for the Department. The maximum amount for the assessment of costs shall be seven thousand five-hundred dollars ($7,500.00).

19. Respondent understands that this is a formal disciplinary action and will be reported to the Health Integrity and Protection Data Bank (H.I.P.D.B.) and/or similar agency.


NOTICE


20. Any and all costs shall be paid in full within thirty (30) days from the issuance of the Affidavit of Costs by submitting a certified check, cashier’s check, or money order payable to the State of Tennessee, which shall be mailed or delivered to: Disciplinary Coordinator, The Division of Health Related Boards, Tennessee Department of Health, 227 French Landing, Suite 300, Heritage Place Metro Center, Nashville, Tennessee 37243. A notation shall be placed on said check that it is payable for the costs of Roy C. Page, M.D.

This AGREED ORDER was approved by a majority of a quorum of the Tennessee Board of Medical Examiners at a public meeting of the Board and signed this  day of , 2008.

Chairperson
Tennessee Board of Medical Examiners

APPROVED FOR ENTRY:

Roy C. Page, M.D. DATE
Respondent
Tennessee License Number 2608
3960 Knight Arnold Road, Suite 322
Memphis, TN 38118

Dan Warlick, Esq. DATE
611 Commerce Street
Suite 2712, The Tower
Nashville, Tennessee 37203
Attorney for Respondent

Andrea Huddleston, B.P.R. 016155 DATE
Assistant General Counsel
Office of General Counsel
Tennessee Department of Health
Plaza 1, Suite 210
220 Athens Way
Nashville, Tennessee 37243
(615) 741-1611

CERTIFICATE OF FILING

This Order was received for filing in the Office of the Tennessee Secretary of State, Administrative Procedures Division, and became effective on the 24th day of January, 2008.

_____________________________
Thomas G. Stovall, Director
Administrative Procedures Division

This page was posted on March 24, 2008.

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