Disciplinary Actions against Bradford Weeks, M.D.

Stephen Barrett, M.D.


In 2007. the Washington Medical Quality Assurance Commission (MQAC) charged Bradford S. Weeks, M.D. with unprofessional conduct for inappropriately prescribing a narcolepsy drug (Xyrem) to eight patients, five of whom he had never seen or examined. In 2008, he signed an agreed order under which he was fined $5,000, prohibited from prescribing Xyrem, required to take an ethics course, and placed on probation for five years.

In 2012, Weeks was charged again in connection with his management of four patients. The amended statement of charges, shown below, stated:

In 2013, Weeks was fined $5,000 and his license was suspended for at least three years. After that he is eligible to seek reinstatement provided he has completed a full year of postgraduate retraining approved in advance by the Commission.

Weeks petitioned the Superior Court to stay the Commission's order until the Court could fully consider his case. The Commission opposed this request, arguing out that without retraining, he represented a danger to the public. The court denied Weeks's petition, and there is no reason to believe that his

Weeks is also trying to organize political opposition to the MQAC, which he says is "not competent to evaluate innovative physicians." In 2008, he registered a nonprofit organization called the Corrective Health Institute. The Institute's Web site describes a Washington Corrective Medical Association, a political action group called Washington Citizens for Healthy Options and Clinical Excellence (WA CHOICE) and a 21-member "Corrective Health Institute Quality Assurance Commission" ("CHIQAC"), which it says "regulates approximately 200 holistic MDs and PAs."


STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION

In the Matter of the License to Practice
as a Physician and Surgeon of:

BRADFORD S. WEEKS, MD
License No. MD00030856

Respondent.

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No. M2011-839

AMENDED STATEMENT OF CHARGES

The Disciplinary Manager of the Medical Quality Assurance Commission (Commission) is authorized to make the allegations below, which are supported by the evidence contained in file number 2009-140473. The patients referred to in this Amended Statement of Charges are identified to the best of the Commission's ability in the attached Confidential Schedule.

1. ALLEGED FACTS

1.1 On May 20, 1993, the state of Washington issued Respondent a license to practice as a physician and surgeon. Respondent's license is currently active.

1.2 During a time frame that included September 23, 2009, Respondent offered to consumers via the internet the use of human growth hormone in oral spray form as an anti-aging remedy. Respondent claimed he prescribed growth hormone to patients to correct "adult growth hormone deficiency syndrome", but this so-called "syndrome" was not consistent with abnormally deficient hormonal levels in the patients. Since 1988 Federal law specifically bans the use of growth hormone as an "anti-aging" therapy or for any use other than the treatment of a disease. Since 1990 Federal law further limited the use of growth hormone therapy to those medical conditions specifically authorized by the Secretary of Human services. Since 1989 Washington State law prohibits the use of growth hormone to manipulate hormones to increase muscle mass, strength or weight or to enhance athletic ability. The only legitimate use of growth hormone prescriptions for adults is treatment of the disease of adult growth hormone deficiency, Acquired Immune Deficiency Syndrome (AIDS) wasting and short bowel syndrome.

1.3 The standard of care for diagnosing adult growth hormone deficiency requires:

1.3.1 The physician must have a high index of suspicion that the patient has growth hormone deficiency. Consideration for growth hormone deficiency in adults is indicated in patients with pituitary or brain disease, tumors or irradiation; patients who have suffered traumatic brain injury; patients with AIDS wasting syndrome Or rare patients with short bowel syndrome. In addition, adults who had childhood onset growth hormone deficiency should be considered for continued growth hormone therapy as adults.

1.3.2 The diagnosis of growth hormone deficiency must be achieved by obtaining an insulin-like growth factor (IGF-1) level and then performing a provocative (or stimulation) test. The stimulation test is required unless the patient has deficiencies in at least three other hormone levels or the patient has a history of childhood growth hormone deficiency. A simple measurement of IGF-1 level is not sufficient to make the diagnosis, except in patients also diagnosed with panhypopituitarism.

1.3.3 If growth hormone deficiency is determine by this standard, then the physician must look for the underlying cause.

1.4 Respondent treated Patient A, born in 1945, during a time. frame from January 3, 2007 through August 8, 2010. Respondent prescribed growth hormone for patient A during this time frame, with a hiatus between September 10, 2007 and October 8, 2007. Respondent described in a form template presented to Patient A on October 8, 2007 that growth hormone would be prescribed as part of "replacement therapy of hormones which are deficient because of normal aging." Although titled "Informed Consent", this form did not adequately inform Patient A of the known risks of growth hormone therapy. Patient A did not meet diagnostic criteria for hypothalamic disease. Respondent failed to conduct growth hormone stimulation testing for Patient A and failed to document regular monitoring of Patient A's hormonal levels. Respondent's initiation of and maintenance of growth hormone therapy regimen for Patient A was below the standard of care and created a unreasonable risk of harm to Patient A. Respondent stopped prescribing growth hormone for Patient A on March 9, 2010, citing "state policy ambiguity" .

1.5 Respondent treated Patient B, born in 1948, from May 3, 2006 through August 4, 2009. Respondent prescribed growth hormone for Patient B from May 22, 2006 through October 10, 2007. Respondent described in an informed consent template presented to Patient B on May 22, 2006, that growth hormone would be prescribed as part of "replacement therapy of hormones which are deficient because of normal aging." This form did not adequately inform Patient B of the known risks of growth hormone. Respondent failed to conduct growth hormone stimulation testing on patient B. Respondent failed to document regular monitoring of Patient B's hormonal levels. Patient B did not meet diagnostic criteria for hypothalamic disease. Respondent's initiation of prescribing and maintenance of growth hormone therapy for Patient B was below the standard of care and created an unreasonable risk of harm to Patient B. Respondent cited cost as the rationale for stopping growth hormone therapy for this patient.

1.6 Respondent treated Patient C, born in 1935, between August, 2006 and June 22, 2010. Respondent prescribed human growth hormone for Patient C beginning July 10, 2007. Respondent described in an informed consent template presented to Patient C on July 20, 2007, that growth hormone would be prescribed as part of "replacement therapy of hormones which are deficient because of normal aging." This form did not adequately inform Patient C of the known risks of growth hormone therapy. Patient C did not meet diagnostic criteria for hypothalamic disease. Magnetic Resonance Imaging (MRI) of Patient C's brain in April 2006 showed no evidence of pituitary or hypothalamic disease. Respondent failed to conduct growth hormone stimulation testing for Patient C and failed to document regular monitoring of Patient C's hormonal levels. Respondent's initiation and maintenance of a growth hormone regimen for Patient C was below the standard of care and created a unreasonable risk of harm to Patient C.

1.7 Respondent- saw Patient D, born in 1963, from October 2007 through May 2009. Patient D had been taking a growth hormone product since 2006. Respondent prescribed growth hormone for Patient D without a work-up for growth hormone deficiency. Respondent provided Patient D with a written statement claiming that therapy with growth hormone did not require a diagnosis of disease, and describing the use of growth hormone as an anti-aging technique. Respondent's written consent form signed by Patient D did not adequately explain the risks of growth hormone therapy. Respondent's initiation and maintenance of a growth hormone regime for Patient D was below the standard of care and created an unreasonable risk of harm to Patient D.

1.8 Respondent failed to provide un-redacted medical records to the Commission upon request by the investigator for the Commission mailed to Respondent on July 21, 2010 and September 16, 2010.

1.9 Respondent attempted to circumvent his responsibility as a licensed physician to cooperate with the Commission's request for patient records by preparing for patients' signature a form that purports to prohibit Respondent's release of medical records to any person or agency absent a court order and unless a warrant for the release of these records is obtained.

1.10 Respondent attempted to circumvent patient rights by having patients sign a commitment not to submit any documents or claims to any governmental agency for purposes of investigation.

1.11 Respondent attempted to circumvent patient rights by requiring patients sign an agreement to hold Respondent harmless for any subsequent legal action related to their care, specifically referring to investigations by the Washington State Medical Quality Assurance Committee.

1.12 Respondent characterized his treatment of patients as "experimental", but did not obtain oversight or approval for experimentation on human subjects.

1.13 On February 28, 2008, Stipulated Findings of Fact, Conclusions of Law and Agreed Order (2008 Agreed Order) was entered In the Matter of Bradford Weeks Washington Medical Quality Assurance Commission No. 07-03-A-1080MD. Paragraph 4.3 of the 2008 Agreed Order provided: "Prior to treating or prescribing medication to a patient, Respondent will physically examine and take a history of the patient adequate to establish a diagnoses and to identify underlying conditions and contra-indications to the medication recommended." This provision is a term of Respondent's five-year probation under the 2008 Agreed Order which began in February of 2008 and has remained continuously in effect.

1.14 Respondent violated paragraph 4.3 of the 2008 Agreed Order by his prescribing of human growth hormone for Patients A, B, C, and D without a physical examination and history of the patients adequate to establish a diagnosis of adult growth hormone deficiency (or any other diagnosis justifying prescription of human growth hormone) and by his failure to identify underlying conditions and contra­indications to the medication recommended.

1.15 Respondent's conduct, described in the preceding paragraphs, violated paragraph 4.6 of the 2008 Agreed Order which states: "Respondent will obey all federal, state and local laws and all administrative rules governing the practice of the profession in Washington."

2. ALLEGED VIOLATIONS

2.1 Based on the Alleged Facts, Respondent has committed unprofessional conduct in violation of RCW 18.130.180 (4), (7), (8)(a), (9); RCW 69.41.320 with definitions at RCW 69.41.300, WAC 246-919-610, WAC 246-919-620, and 21 U.S.C.A. § 333 (e) which provide:

RCW 18.130.180 Unprofessional conduct. The following conduct, acts, or conditions constitute unprofessional conduct for any license holder or applicant under the jurisdiction of this chapter:

(4) Incompetence, negligence, or malpractice which results in injury to a patient or which creates an unreasonable risk that a patient may be harmed. The use of a nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does not result in injury to a patient or create an unreasonable risk that a patient may be harmed;

(7) Violation of any state or federal statute or administrative rule regulating the profession in question, including any statute or rule defining or establishing standards of patient care or professional conduct or practice;

(8) Failure to cooperate with the disciplining authority by: (a) Not furnishing any papers, documents, records, or other items;

(9) Failure to comply with an order issued by the disciplining authority or a stipulation for informal disposition entered' into with the disciplining authority;

RCW 69.41.320 Practitioners-Restricted use-Medical records. (1)(a) A practitioner shall not prescribe, administer, or dispense steroids, as defined in RCW 69.41.300, or any form of autotransfusion for the purpose of manipulating hormones to increase muscle mass, strength, or weight, or for the purpose of enhancing athletic ability, without a medical necessity to do so.

(b) A person violating this subsection is guilty of a gross misdemeanor and is subject to disciplinary action under RCW 18.130.180.

(2) A practitioner shall complete and maintain patient medical records which accurately reflect the prescribing, administering, or dispensing of any substance or drug described in this section or any form of autotransfusion. Patient medical records shall indicate the diagnosis and purpose for which the substance, drug, or autotransfusion is prescribed, administered, or dispensed and any additional information upon which the diagnosis is based.

RCW 69.41.300 Definitions. For the purposes of RCW 69.41,300 through 69.41.350, "steroids" shall include the following: . . . (3) "Human growth hormones" means growth hormones, or a derivative, isomer, ester, or salt that act in the same manner on the human body.

WAC 246-919-610 Use of drugs or autotransfusion to enhance athletic ability. (1) A physician shall not prescribe, administer or dispense anabolic steroids, growth hormones, testosterone or its analogs, human chorionic gonadotropin (HCG), other hormones, or any form of autotransfusion for the purpose of enhancing athletic ability.

(2) A physician shall complete and maintain patient medical records which accurately reflect the prescribing, administering or dispensing of any substance or drug described in this rule or any form of autotransfusion. Patient medical records shall indicate the diagnosis and purpose for which the substance, drug or autotransfusion is prescribed, administered or dispensed and any additional information upon which the diagnosis is based.

(3) A violation of any provision of this rule shall constitute grounds for disciplinary action under RCW 18.130.180(7). A violation of subsection (1) of this section shall also constitute grounds for disciplinary action under RCW 18.130.180(6). .

246-919-620 Cooperation with investigation.
(1) A licensee must comply with a request, under RCW 70.02.050, for health care records or documents from an investigator who is acting on behalf of the disciplining authority pursuant to RCW 18.130.050(2) by submitting the requested items within fourteen calendar days of receipt of the request by the licensee or the licensee's attorney, whichever is first. If the licensee fails to comply with the request within fourteen calendar days, the investigator shall contact the licensee or the licensee's attorney by letter as a reminder.

(a) Investigators may extend the time for response if the licensee requests an extension for a period not to exceed seven calendar days. Other requests for extension may be granted by the commission chair or the commission's designee.

(b) If the licensee fails to comply with the request within three business days after the receipt of the written reminder, a statement of charges shall be issued' pursuant to RCW 18.130.180(8) and, if there is sufficient evidence to support additional charges, those charges may be included in the statement of charges.

21 U.S.C.A. § 333 (e) Prohibited distribution of human growth hormone (1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, or both.

(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by Title 1 B, or both.

(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C.A. § 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C.A. § 8531.

2.2 The above violations provide grounds for imposing sanctions under RCW 18.130.160.

3. NOTICE TO RESPONDENT

The charges in this document affect the public health, safety and welfare. The Disciplinary Manager of the Commission directs that a notice be issued and served on Respondent as provided by law, giving Respondent the opportunity to defend against these charges. If Respondent fails to defend against these charges, Respondent shall be subject to discipline and the imposition of sanctions under Chapter 18.130 RCW.

DATED: March 13, 2012.

STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION

_____________________________
DANI NEWMAN
DISCIPLINARY MANAGER

_____________________________
KRISTIN G. BREWER WSBA#38494
ASSISTANT ATTORNEY GENERAL

This page was revised on March 17, 2015.

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