William Rea, M.D. Settles Charges
by the Texas Medical Board
Stephen Barrett, M.D.
In August 2010, the Texas Medical Board approved a mediated agreed order (shown below) under which William J. Rea, M.D. must revise the form he uses to obtain consent to treat patients with injections of environmental substances. The order was based upon Rea's failure to obtain informed consent from five patients diagnosed with chemical sensitivity and/or environmental sensitivity. During the investigation, Rea testified that a "car exhaust" solution he used for injections was so dilute that only an "electromagnetic imprint" of the original active substances remained.. The revised consent form, also shown below, must state that (a) his injections contain only the “electromagnetic imprint” of the agents in question, (b) the therapy is not FDA-approved, and (c) the therapeutic value of the therapy is disputed. In addition, he must not start using any formulations that contain any amounts of substances classified as hazardous or carcinogenic by the Environmental Protection Agency or any other federal or state regulatory agency.
The agreed order settled the board's complaint, filed in 2007, which charged that Rea had (a) used pseudoscientific test methods, (b) failed to make accurate diagnoses, (c) provided "nonsensical" treatments, (d) failed to properly inform patients that his approach is unproven, (e) practiced in areas for which he has not been trained, and (f) represented himself as certified by a board that is not recognized by the American Board of Medical Specialties. The charges not related to informed consent were dropped as part of the settlement. Rea is also licensed in Ohio. After learning about the Texas case, the Ohio Board of Medicine ruled that even though Rea was not practicing in Ohio, it would hold him to the same restrictions. Rea appealed this decision, but in 2013, the Franklin County (Ohio) Court of Common Pleas upheld the Ohio Board's ruling.
Rea, who operates the Environmental Health Center in Dallas, Texas, is best known for his promotion of the concept of multiple chemical sensitivity (MCS), a diagnosis not recognized as valid by the scientific community. Quackwatch has a detailed discussion of "MCS."
LICENSE NO. D-2294
IN THE MATTER OF
THE LICENSE OF
William James Rea, M.D.
TEXAS MEDICAL BOARD
MEDIATED AGREED ORDER
On the 27 day of August, 2010. came on to be heard before the Texas Medical Board (the "Board"), duly in session. the matter of the license of William James Rea, M.D. ("Respondent").
On November 16, 2006, Respondent appeared in person, with counsel Stephen A. Coke, at an Informal Show Compliance Proceeding and Settlement Conference (“ISC”) in response to a letter of invitation from the staff of the Board. The Board's representatives were Keith Miller, M.D. and Paulette Southard, members of the Board. Mark Martyn represented Board staff.
Following the ISC a formal complaint was filed at the State Office of Administrative Hearings ("SOAH"). Subsequent to the filing at SOAH a mediation conference was held on August 21, 2008. Respondent appeared with counsel, Algis Augustine. The Board was represented Scott Freshour.
The matter did not settle at mediation. Respondent then retained Jacques Simon as lead counsel. Discovery was undertaken in this matter. After discovery was completed but prior to convening the contested case hearing the parties reached settlement.
Board Staff filed a complaint at the State Office of Administrative Hearings ("SOAH") charging Respondent with violations related to five patients. The charges concerned Respondent's diagnosis and treatment of "chemical sensitivity." After the completion of discovery, it appears that notwithstanding the allegations of the complaint, the primary concern of the Board relates to and focuses on Respondent's use of chemical antigens and the informed consent for such treatment.
Respondent has not previously received a disciplinary order from the Board. Upon the recommendation of the Board's representatives and with the consent of Respondent, the Board makes the following Findings and Conclusions of Law and enters this Agreed Order.
The Board finds that:
1. Respondent received all notice required by law. All jurisdictional requirements have been satisfied. Respondent waives an)' defect in notice and any further right to notice or hearing under the Medical Practice Act, Title 3. Subtitle B, Texas Occupations Code (the “Act") or the Rules of the Board.
2. Respondent currently holds Texas Medical License No. 0·2294. Respondent was originally issued this license to practice medicine in Texas on June 22, 1965. Respondent is also licensed to practice in Ohio, Arkansas, and Illinois.
3. Respondent is primarily engaged in the practice of environmental medicine. Respondent is board certified by the American Boards of Cardiovascular Surgery and General Surgery. members of the American Board of Medical Specialties.
4. Respondent is a member of the American Academy of Environmental Medicine and the Pan American Allergy Society. and practices medicine pursuant to the guidelines of those professional associations and has certifications from those medical professional organizations.
5. Respondent is 75 years of age.
I. The case involves five patients that were diagnosed with chemical sensitivity and/or environmentally sensitivity.
2. Respondent made these determinations based on use of various tests, including but not limited: SPECT brain scan. pupillography. thermography, heart rate variability. and intradermal skin testing for sensitivity to such things as: jet and diesel fuel, natural gas, titanium, and lake algae. The intradermal testing was the primary concern of the Board related to testing because certain injections purported to be extracts of jet fuel and diesel fuel exhaust fumes and other chemicals. Respondent denied that the injections contained any harmful substances.
3. Respondent's treatment of these patients included: environmental controls; heat depuration therapy; intravenous therapies; oxygen treatments, and antigen injections.
The antigen injections were the primary concern of the Board because certain injections purported to be extracts of jet fuel and diesel fuel exhaust fumes and other chemicals. Respondent denied that the antigens contained any harmful substances.
2. Respondent during his deposition of May 21, 2010 stated that there are no active chemicals in any of the chemical antigens, only the "electromagnetic imprint" of the chemical. Respondent testified that he uses in his testing and treatment of patients antigens containing electromagnetic imprint of the following: natural gas; propane gas; ethanol; formaldehyde; phenol; unleaded gasoline and jet fuel. Respondent testified that the antigens are in fact homeopathic remedies rather than substances containing actual chemicals. Respondent testified that none of the antigens arc extracts of the actual substances specified in this paragraph.
3. Board staff asserts Respondent's treatment is unsupported by medical research and is non-therapeutic. In addition, Board Staff asserts there was a lack of proper informed consent for these treatments
4. Respondent asserts that his diagnosis, care, and treatment of the above patients was appropriate and in accordance with established principles of medicine and peer reviewed articles disclosed to the Board.
6. Respondent admitted his current Informed Consent documents did not disclose that his antigen injections, were not FDA approved, and did not disclose that the chemical antigens mentioned in paragraph "2" above contained only the "electromagnetic imprint" of the chemical.
In determining the appropriate sanctions in this matter, the Panel considered the following mitigating factors:
i. Respondent has cooperated in the investigation of the charges related to this Agreed Order. Respondent's cooperation, through consent to this Agreed Order, pursuant to the provisions of Section 164.002 the Act, will save money and resources for the State of Texas. To avoid further investigation. hearings. and the expense and inconvenience of litigation, Respondent agrees to the entry of this Agreed Order and to comply with its terms and conditions.
ii. There were no claims of patient harm.
iii. Respondent's patients continue to support him.
CONCLUSIONS OF LAW
Based on the above Findings, the Board concludes that:
1. The Board has jurisdiction over the subject matter and Respondent pursuant to the Act.
2. Section 164.051(aX6) of the Act, as defined by Board Rule §190.8(I), failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient's behalf before performing tests, treatments or procedures.
3. Section 164.001 of the Act authorizes the Board to impose a range of disciplinary actions against a person for violation of the Act or a Board rule.
4. Section 164.002(a) of the Act authorizes the Board to resolve and make a disposition of this matter through an Agreed Order.
5. Section 164.002(d) of the Act provides that this Agreed Order is a settlement agreement under the Texas Rules of Evidence for purposes of civil litigation.
Based on the above Findings and Conclusion! of Law, the Board ORDERS that Respondent shall be subject to the following terms and conditions:
I. Respondent shall present the approved revised Informed Consent Form attached to this Order, to each and every patient who is undergoing or will undergo antigen injections for chemical/environmental sensitivity ("Therapy"). Respondent shall include in the revised Informed Consent Form, written disclosures that explicitly state the following information:
a. notice that the Therapy being offered is not FDA approved, and that this Therapy is considered non·traditional medicine (this notice shall be written in bold. oversized print);
b. the effectiveness/therapeutic value of Therapy is disputed;
c. a disclaimer that formulations prescribed have never been tested by the FDA for determination of the actual contents or the medical effectiveness;
d. a written disclaimer that the .. therapeutic value" of the Therapy, if any, has not been established or proven and is subject of dispute.
e. The following Disclaimers shall be made in capital bold type:
i. "THE TREATMENT/ANTIGEN THERAPIES BEING UTILIZED AND DESCRIBED BY RESPONDENT IN THIS DISCLOSURE STATEMENT DOES NOT CONTAIN ANY OF THE ACTUAL ACTIVE AGENT LISTED, AND CONTAINS ONLY "ELECTROMAGNETIC IMPRINT" OF THE AGENT. THE PATIENT IS NOT BEING INJECTED WITH ACTUAL ACTIVE AGENTS LISTED ON THE ANTIGEN"
ii "THE TREATMENT/ANTIGEN THERAPY BEING UTILIZED AND DESCRIBED BY RESPONDENT IN THIS DISCLOSURE STATEMENT IS NOT ENDORSED, SANCI'IONED, OR SUPPORTED BY THE TEXAS MEDICAL BOARD."
2. Respondent shall be required to have each patient sign an acknowledgment. This acknowledgment is specifically applicable only to those patients receiving Therapy from Respondent and/or employees of his practice. The acknowledgement shall state that: on the initial and/or first visit, after the effective date of this Order, the patient received a written copy of the Informed Consent described in Ordering Paragraph No.1.
3. Respondent must keep the signed acknowledgement in the medical record of each patient and an additional copy of each Informed Consent and signed acknowledgement in a separate file. This separate file shall be made available to the Compliance Division upon request to verify compliance with requirements of Ordering Paragraphs Nos. 1 and 3 above.
4. In addition, Respondent shall not start using any new Therapy, antigens, or other formulations that contain any amounts of the active ingredient of substances that are classified as hazardous substances and/or carcinogens by EPA, Agency for Toxic Substance Registration & Disease Registry (ATSDR), OSHA, or any other federal or state regulatory agency.
5. Respondent shall not change, modify. or alter his current antigen protocol as provided to Board Staff and described during his deposition on May 21, 2010.
6. Respondent shall comply with all the provisions of the Texas Medical Practice Act and all other state and federal statutes regulating the Respondent's practice.
7. Respondent shall fully cooperate with the Board and the Board staff, including Board attorneys, investigators, compliance officers, consultants, and other employees or agents of the Board in any way involved in investigation, review, or monitoring associated with Respondent's compliance with this Order. Failure to fully cooperate shall constitute a violation of this order and a basis for disciplinary action against Respondent pursuant to the Act. Cooperation within the meaning of this agreement shall include providing Board staff or designees with samples of the antigens to be tested.
8. Respondent shall inform the Board in writing of any change of Respondent's mailing or practice address within ten days of the address change. This information shall be submitted to the Permits Department and the Director of Compliance for the Board. Failure to provide such information in a timely manner shall constitute a basis for disciplinary action by the Board against Respondent pursuant to the Act.
9. Any violation of the terms, conditions, or requirements of this Order by Respondent shall constitute unprofessional conduct likely to deceive or defraud the public, and to injure the public, and shall constitute a basis for disciplinary action by the Board against Respondent pursuant to the Act. Respondent shall be provided 30-day notice of a Probationer Show Compliance Proceeding to address any allegation of noncompliance of this Agreed Order as required by the Medical Practice Act
10. The above-referenced conditions shall continue in full force and effect without opportunity for amendment. except for clear error in drafting. If, after the passage of the 12-month period, Respondent wishes to seek amendment or termination of these conditions, Respondent may petition the Board in writing. The Board may inquire into the request and may, in its sole discretion, grant or deny the petition without further appeal or review. Petitions for modifying or terminating may be filed only once a year thereafter.
11. This Order resolves in their entirety the following board matters concerning Respondent: SOAH Docket No. 503-07-4032, and Investigative Log or case Nos.10-48S7 and 08-1434. The Board shall take no further action against the respondent with respect to the three matters referenced above and the Board's files regarding these matters shall be closed.
RESPONDENT WAIVES ANY FURTHER HEARINGS OR APPEALS TO THE BOARD OR TO ANY COURT IN REGARD TO ALL TERMS AND CONDITIONS OF THIS AGREED ORDER. RESPONDENT AGREES THAT THIS IS A FINAL ORDER.
THIS ORDER IS A PUBLIC RECORD.
I, WILLIAM JAMES REA, M.D., HAVE READ AND UNDERSTAND THE FOREGOING AOREED ORDER. J UNDERSTAND. THAT BY SIGNING, J WAIVE CERTAIN RIGHTS. I SIGN IT VOLUNTARILY. I UNDERSTAND THIS AGREED ORDER CONTAINS THE ENTIRE AGREEMENT AND THERE IS NO OTHER AGREEMENT OF ANY KIND, VERBAL, WRITTEN OR OTHERWISE.
DATED: 6-29, 2010.
WILLIAM JAMES REA, M.D.
SIGNED AND ENTERED by the presiding officer of the Texas Medical Board on this 27 day of August, 2010.
Irvin Zeitler, Jr., D.O.
President, Texas Medical Board
EHC-D DALLAS INFORMED CONSENT REGARDING