Andrew D. Pauli, M.D., Charged with
Improperly Prescribing Growth Hormone
Stephen Barrett, M.D.
In 2012, psychiatrist Andrew Denzil Pauli, M.D., was charged with unprofessional conduct for diagnosing five patients with growth-hormone deficiency and prescribing growth hormone without doing appropriate diagnostic testing. The statement of charges (shown below) says that he had advertised growth hormone therapy as anti-aging treatment, a use that federal law prohibits. In 2013, Pauli signed an agreed order under which he was fined $8,000 and placed on probation for at least four years, during which he was required to take an ethics course and prohibited from advertising or prescribing hormone supplementation. The agreed order also noted that he no longer had an office in the State of Washington but if he resumed practice he would have to cooperate with practice audits. He now practices psychiatry in Alaska.
STATE OF WASHINGTON
DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
In the Matter of the License to Practice
ANDREW D. PAULI, MD
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 2009-140483. The patients referred to in this Statement of Charges are identified in the attached Confidential Schedule.
1. ALLEGED FACTS
1.1 On July 1, 1987, 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 October through December 2009, Respondent participated in an internet site advertising hormone replacement therapy as an anti-aging therapy to consumers.
1.3 The standard of care for diagnosing adult growth hormone deficiency in adults requires first, that the physician have a high index of suspicion that the patient has growth hormone deficiency. Consideration for growth hormone replacement therapy 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 have had childhood onset growth hormone deficiency should be considered for continued growth hormone therapy as adults. The diagnosis of growth hormone deficiency must be achieved by obtaining an insulin-like growth factor one (IGF-1) level and then perform the provocative (or stimulation) test. A simple measurement of serum IGF-I is not sufficient to make the diagnosis, except in patients who are also diagnosed as having panhypopituitarism. 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. If growth hormone deficiency is determined by this standard, then the physician must look for the underlying cause. The FDA specifically bans the use of growth hormone as an "anti-aging" therapy or as an anabolic agent for sports. The use of growth hormone is contra-indicated in patients with active malignancy.
1.4 Respondent treated Patient A during a time frame between October 2004 and June 15, 2005. Respondent recommended growth hormone replacement to Patient A in. December 2004 and Patient A began growth hormone replacement in January 2005. Patient A was a middle aged woman with weight gain and a host of minor complaints. Respondent purported to diagnose growth hormone deficiency based on a low serum IGF-1 level. There was no evidence of growth hormone stimulation testing. There was no notation that the patient had any condition that would indicate a work-up for growth hormone deficiency. The standard of care for initiating and maintaining growth hormone therapy was not met in this patient. Respondent's prescription of growth hormone for Patient A created an unreasonable risk of harm to Patient A. Respondent did not document telling Patient A of the risks of growth hormone therapy. Respondent did not document Patient A's informed consent to growth hormone therapy Patient A stopped taking growth hormone in approximately March 2005.
1.5 Respondent treated Patient B between December 8, 2006. and October 2007. Patient B was a post-menopausal woman with numerous mild medical problems. Respondent purported to diagnose growth hormone deficiency based on a low serum IGF-1 level. There was no evidence of growth hormone stimulation testing. There was no notation that the patient had any condition that would indicate a work-up for growth hormone deficiency. The standard of care for initiating and maintaining growth hormone therapy was not met in this patient Respondent's prescription of growth hormone for Patient B created an unreasonable risk of harm to Patient B. Respondent did not document telling Patient B of the risks of growth hormone therapy, Respondent did not document Patient 8's informed consent to growth hormone therapy.
1.6 Respondent treated Patient C between May 2003 and January 2008. Patient C was a middle-aged man with radiographic evidence of Coronary Artery Disease. During 2003, Patient C was taking testosterone. In 2001 the patient had a brain Magnetic Resonance Imaging that was normal, showing no pituitary pathology. There was no notation that the patient had any condition that would indicate a work-up for growth hormone deficiency, Despite the IGF-1 normal level, Respondent indicated growth hormone therapy might be useful. Respondent provided Patient C's records as those of patients for whom he prescribed and treated with human growth hormone. There is no notation that Patient C had a condition that would indicate a work-up for growth hormone deficiency. Respondent failed to conduct growth hormone stimulation testing for Patient C and failed to conduct sufficient regular monitoring of Patient C's hormonal levels, Respondent failed to record the dates and amounts of hormone therapy recommended, prescribed and/or taken by Patient C, Respondent's initiation of an HGH regime for Patient C and Respondent's maintenance of HGH therapy for Patient C was below the standard of care and created an unreasonable risk of harm to Patient C.
1.7 Respondent treated Patient D between February 2003 and October 2007. Patient D was a healthy man Respondent purported to diagnose with growth hormone deficiency based on a normal lGF-1 level of 162 on February 20, 2003, Growth hormone therapy was suggested and patient had already obtained it. The patient continued on growth hormone replacement therapy and Respondent included Nordipen, an injectable form of the human growth hormone somatropin, in Patient D's treatment plan as late as October 4, 2007. Respondent did not document any growth hormone stimulation testing. There was no notation that the patient had any condition that would indicate a work-up for growth hormone deficiency. Respondent's initiation and maintenance of human growth hormone therapy for Patient D was below the standard of care and created an unreasonable risk of harm to Patient D.
1.8 Respondent treated Patient E between September 2006 and October 2007. Patient E came to Respondent because he was interested in using growth hormone. Respondent prescribed growth hormone for Patient E based on a normal IGF- 1 levels. Respondent did not conduct growth stimulation testing of Patient E. There was no notation that Patient E had any condition that would indicate a work-up for growth hormone deficiency. Respondent's initiation and maintenance of human growth hormone therapy for Patient E was below the standard of care and created an unreasonable risk of harm to Patient E.
1.9 Respondent's record keeping for Patients A, B, C, D and E is inadequate for purposes of establishing the basis for a diagnosis, documenting prescriptions, justifying prescribing of and maintenance of human growth hormone replacement therapy, documenting explanation of the risks of human growth hormone replacement and documenting the patients' informed consent.
1.10 Respondent failed to cooperate by refusing to provide unredacted patient files to the Commission as specifically requested on March 15, 2011, Respondent's redactions were extensive and appear to include omissions beyond the name, date birth and contact information for Patient.
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); RCW 69.41.320, WAC 246-99- 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;
(8) Failure to cooperate with the disciplining authority by: (a) Not furnishing any papers, documents, records, or other items;
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 BREWER WSBA #38494
ASSISTANT ATTORNEY GENERAL
This information is confidential and is NOT to be released without the consent of the individual or individuals named below. RCW 220.127.116.11(1)
|Patient A||Middle-aged Female: Respondent refused to divulge identity or date of birth to the Commission|
|Patient B||Middle-aged Female: Respondent refused to divulge identity or date of birth to the Commission|
|Patient C||Middle-aged Male: Respondent refused to divulge identity or date of birth to the Commission|
|Patient D||Middle-aged Male: Respondent refused to divulge identity or date of birth to the Commission|
|Patient E||Middle-aged Male: Respondent refused to divulge identity or date of birth to the Commission|
This page was posted on February 17, 2015.