Janet Vondran, M.D., Ordered to Stop
Prescribing Growth Hormone
Stephen Barrett, M.D.
In 2012, Janet Vondran, M.D., a board-certified psychiatrist who practiced in Bremerton, Washington, was charged with unprofessional conduct for inappropriately diagnosing and treating three adult patients with human growth hormone. The statement of charges (shown below) said that she had also advertised hormone replenishment as as anti-aging therapy. In 2013, the charges were settled with an agreed order under which she was (a) fined $3,000, (b) prohibited from advertising or prescribing hormone supplementation, and (c) placed on probation for at least 2 years during which she was required to submit to semi-annual practice reviews.
STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
In the Matter of the License to Practice
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 2009-140487. The patients referred to in this Statement of Charges are identified in the attached Confidential Schedule.
1. ALLEGED FACTS
1.1 On Fe1.1 On September 15, 1995, the state of Washington issued Respondent a license to practice as a physician and surgeon. Respondent is Board certified in Psychiatry with a Geriatric Psychiatry sub-specialty certificate. Respondent's license is currently active.
1.2 Between approximately November 2006 and January 2008, Respondent treated adult patients with Norditropin, a brand name for injectable somatropin, a human growth hormone (growth hormone) classified as a Schedule III controlled substance. During a time frame that included December 2009, Respondent advertised hormone replenishment as an anti-aging therapy to consumers via internet. In her response to inquiry by the Commission, Respondent endorsed the use of growth hormone as an anti-aging therapy. Federal and State law specifically bans the use of growth hormone as an "anti-aging" therapy or as an anabolic agent for sports. Its only legitimate use in adults is treatment of adult growth hormone deficiency, Acquired Immune Deficiency Syndrome (AIDS) wasting and short bowel syndrome. The use of growth hormone is particularly contra-indicated in patients with an active malignancy because it may accelerate the growth of cancer cells. The use of growth hormone may be causative or contributory to carpal tunnel 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 the 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 pan hypopituitarism.
1.3.3 If growth hormone deficiency is determine by this standard, then the physician must look for the underlying cause.
1.4 Respondent prescribed growth hormone for Patient A, a fifty-five-year old adult, from approximately November 2006 until March 2009. This prescribing began on the basis of a single low serum IGF-1 level test result. There is no notation that Patient A had a condition that would indicate a work-up for growth hormone deficiency. 'Respondent failed to conduct growth hormone stimulation testing for Patient A and failed to conduct sufficient regular monitoring of Patient A's hormonal. Respondent warned Patient A of risks associated with low growth hormone, but did not advise of the standard of care for prescribing human growth hormone nor of the risks of human growth hormone supplementation. Human growth hormone supplementation can cause or exacerbate carpal tunnel syndrome. Patient A developed bilateral carpal tunnel syndrome requiring surgery on both wrists in April 2008, while still taking growth hormone. There is no indication Respondent made any connection between the human growth hormone therapy and the development of carpal tunnel syndrome. When symptoms of carpal tunnel syndrome occur while a patient is taking growth hormone therapy, the dose of growth hormone should be decreased or the drug discontinued. Respondent did not discontinue growth hormone therapy for Patient A until March 18, 2009. Respondent's initiation and maintenance of growth hormone therapy for Patient A was below the standard of care and created an unreasonable risk of harm to Patient A.
1.5 Respondent treated Patient B, a forty-nine-year old adult, from approximately August 20, 2007 to November 2007. Patient B described a history of removal of a cancerous legion on her nose, but Respondent did not document the date of this surgery. There was no notation that Patient B had any condition that would indicate a work-up for growth hormone deficiency. Respondent initiated growth hormone therapy for Patient B on September 14, 2007 after a single low serum IGF-1 level was obtained. Respondent did not document informing Patient B of the risks of growth hormone therapy, which include stimulation of the growth of cancer cells. Respondent did not document Patient B's informed consent to HGH therapy. Respondent discontinued the growth hormone therapy on January 9, 2008 after the IGF-1 level rose. Respondent's initiation 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.
1.6 Respondent began treating Patient C, a sixty-year old adult, approximately September 26, 2007. Respondent did not document any history of pituitary or brain disease in Patient C. Patient C disclosed a history of removal of a malignant melanoma, but Respondent did not document whether this was cured or when the surgery was performed. Respondent began prescribing a growth hormone for patient C on October 5, 2007 after a single low serum IGF-1 level was obtained. Respondent's initiation of a growth hormone regime for Patient C was below the standard of care and created an unreasonable risk of harm to Patient C. Respondent documented that she advised Patient C that her low growth hormone production may be associated with premature aging, chronic illness, heart disease and/or insulin resistance, poor memory and low stamina. Respondent did not document telling Patient C of the risks of growth hormone therapy, which include stimulation of the growth of cancer cells. Respondent did not document Patient C's informed consent to growth hormone therapy. Respondent's initiation and maintenance of growth hormone treatment for Patient C was below the standard of care and created an unreasonable risk of harm to Patient C.
1.7 Respondent's record keeping for Patients A, B, C is inadequate. For each of these patients, Respondent failed to establish a basis for a diagnosis to justify prescribing and maintaining a growth hormone regime. Respondent failed to document appropriate monitoring of the patients receiving growth hormone. Respondent failed to document informed consent by these patients for the growth hormone treatment she provided.
2. ALLEGED VIOLATIONS
2.1 Based on the Alleged Facts, Respondent has committed unprofessional conduct in violation of RCW 18.130.180 (4), (7); RCW 69.41.320, WAC 246-919-610, 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;
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.
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).
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 18, 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. § 853].
(4) As used in this subsection the term "human growth hormone" means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection
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
KRISTIN G. BREWER WSBA#38494
ASSISTANT ATTORNEY GENERAL
This page was posted on February 23, 2015.