Disciplinary Action against
Gerald Wendall Miller, M.D.

Stephen Barrett, M.D.


The Oregon Medical Board has reprimanded Gerald Miller, M.D. fined him $2,000, and limited how he could practice. Miller formerly practiced in Beaverton, Washington, where he represented himself as practicing "anti-aging" medicine and specializing in nutrition and dietary counseling. The board's action was based on his mismanagement of six patients. In five of the cases, he diagnosed "hypothyroidism" even though the patient's laboratory tests were normal, and in all six he prescribed toxic amounts of thyroid hormone. The board's order (show below) states:


BEFORE THE OREGON MEDICAL BOARD
STATE OF OREGON

In the Matter of

GERALD WENDALL MILLER, MD

LICENSE NO MD 16819

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STIPULATED ORDER


l.

The Oregon Medical Board (Board) is the state agency responsible for licensing, regulating and disciplining certain health care providers, including physicians, in the State of Oregon. Gerald Wendall Miller, MD (Licensee) is a licensed physician in the State of Oregon.

2.

In an Amended Complaint and Notice of Proposed Disciplinary Action dated January 27, 2012, the Board proposed taking disciplinary action pursuant to ORS 677.205 against Licensee for violations of the Medical Practice Act, to wit: ORS 677.190(13) gross or repeated acts of negligence.

3.

Licensee is a general practitioner and formerly practiced in Beaverton, Oregon, where he represented that he practiced "anti-aging" medicine and specialized in nutrition and dietary counseling. Licensee's acts and conduct that violated the Medical Practice Act follow:

3.1 The Board opened an investigation that included a review of Licensee's medical records for Patients A - G that revealed a pattern of minimal documentation, in which Licensee failed to record new patient historical data or patient examinations for most patient visits. The Board's review revealed that Licensee failed to document his medical decision-making, often merely providing a list of diagnoses and nurse obtained vital signs, but without supporting observations and findings. Licensee's diagnoses arc often non-specific, such as "adrenal fatigue" or "borderline low adrenal reserve," which lack a well recognized diagnostic criterion and provide little information to other clinicians. Licensee frequently ordered laboratory studies that are not commonly used in clinical practice, to include rT3, insulin levels, pregnenolene levels, and occasionally leptin and adiponectin levels. Licensee failed to address reported TSH levels, and often continued to prescribe thyroid medication in the face of lab studies and symptoms that indicated thyrotoxicosis. The Board's review revealed that Licensee failed to utilize appropriate endocrine testing to diagnose hypothyroidism and to monitor patient response to treatment. Licensee frequently subjected his patients to excessive thyroid hormone dosing despite the lack of any objective medical findings that would support a diagnosis of thyroid disease. Licensee's chart notes failed to explain his medical reasoning and failed to articulate the clinical basis for diagnosing and treating hypothyroidism. Licensee continued to prescribe thyroid hormone, often increasing the dosage, in the face of blood tests and patient responses that indicated excessive dosing.

3.2 Specific descriptions of Licensee's care and treatment of patients that constitutes gross or repeated acts of negligence follow:

a. Patient A, a 58 year old female, presented to Licensee on May 27, 2009 complaining of recent weight gain. Her history included bipolar disorder, hypertension, biliary cirrhosis and long term lithium treatment. The chart reflects Patient A's height as 63 inches, her weight 166 pounds, with a body mass index of 29.4, Licensee conducted various lab studies and hormone testing. Without setting forth the supporting medical indications in the chart, Licensee's diagnosed "borderline low adrenal reserve" and "hormone imbalance." A lab study that was collected on July 13, 2009, reflected a TSH1 of l.23 µIU/mL, a free T4 of 1.26 ng/dL, and a free T3 of 2.7pg/mL—values which were in the normal range.

1Thyroid Stimulating Hormone (TSH) assay is a widely used screening test for hyperthyroidism and hypothyroidism. The Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism, published by the American Association of Clinical Endocrinologists (AACE), 2006 amended version, p. 463, state that "[ajppropriate laboratory evaluation is critical to establish the diagnosis and cause of hypothyroidism in the most cost-effective way. The most valuable test is a sensitive measurement of TSH level." The Guidelines, at p. 465, state that "treatment is indicated in patients with TSH levels > 10 µIU/mL or in patients with TSH levels between 5 and 10 µIU/mL in conjunction with goiter 01' positive anti-thyroid peroxidase antibodies (or both)." "The target TSH level should he between 0.3 and 3.0 µIU/mL."

Nevertheless, on August 11, 2009, Licensee diagnosed "sub-optimal B 12," "hypothyroidism," and "elevated blood sugar not specifically diabetic." Licensee did not set forth findings to support the diagnosis of hypothyroidism, but prescribed Synthroid (Levothyroxine) 50 mcg #30 tablets, 1 p.o. (by mouth) daily. A lab study that was collected on October 20, 2009, reflects a TSH level of 0.10, free T4 of 1.98, and free T3 of3.5. On January 25, 2010, Licensee increased Patient A's dosage on Levothyroxine to 75mcg per day, and added Cytomel (Liothyronine, 5 meg every other day) without explanation. On January 27, 2010, Patient A complained that she was not losing weight. Without a sound basis in medical science, Licensee advised her that this was due in part to her thyroid issues. On April 1, 2010, Licensee increased the dosage of Levothyroxine to 100 meg per day, despite lab studies indicating excessive dosing. On May 24, 2010, Patient A complained of a near syncopal event at home. Patient A came to Licensee's clinic where her blood sugar was tested and found to be elevated at 158. Based on a single elevated blood sugar test, Patient A was told that she had "at least insulin resistance if not diabetes" and was diagnosed with "diabetes mellifluous". Licensee failed to set forth the medical indications to support his diagnosis in the chart. Licensee examined Patient A on June 10, 2010, diagnosed hypothyroidism and abnormal weight gain, and ordered a lab study. That study reflected a TSH of < 0.01, free T3 of 5.2, and a free T4 of2.66. Although these values did not support his diagnosis and indicated possible hyperthyroidism, Licensee did not change Patient A's diagnosis or modify the dosage of thyroid medication. On June 14, 2010, Patient A presented to Providence Hospital with nausea and vomiting. After an initial assessment, she was admitted. Her calcium level was found to be elevated at 11.3. During her workup, she was found to be excessively hyperthyroid with a suppressed TSH that was less than .01. Her diagnosis was determined to include dehydration, hyperglycemia, and hyperthyroidism. Patient A was treated with IV fluid hydration and the thyroid medications that she had been taking (Levothyroxine and Cytornel) were withheld. Patient A's calcium level fell to 10.3, her free T4 dropped from 2.66 to 1.89 and her free T3 declined from 5.2 to 3.7. Patient A's symptoms of nausea and vomiting resolved. She was discharged from the hospital on June 16, 2010. Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient A with thyroid medication exposed her to the risk of harm.

b. Patient B, a 61 year old female and breast cancer survivor, initially presented to Licensee on February 7, 2008, with a history of osteoporosis and symptoms associated with menopause. On February 21, 2008, without medical justification, Licensee's diagnosis list included hypothyroidism. Licensee prescribed Armour Thyroid 60 mg b.i.d. 5 refills. On March 13, 2008, Licensee added SRT3, 20 meg, and SRT4, 80 meg, b.i.d., 5 refills. In subsequent clinical visits, Licensee continued to list hypothyroidism as a diagnosis and continued to prescribed SRT3 and SRT4 in varying dosages. Licensee did not conduct lab. studies to determine Patient B' s ISH level, either as a baseline or to follow Patient B' s response to his medication regimen; neither did he set forth clinical findings to support his diagnosis. On October 8, 2009, Patient B reported "moodiness and irritability (bitchy) and have wondered if there would be any possible adjustment to hormone cream." Licensee did not consider these symptoms as an indication of mismanagement of her thyroid medication and continued to diagnose and treat hypothyroidism. Throughout 2009 and 2010, Licensee continued to list a diagnosis of "hypothyroidism" or "acquired hypothyroidism" without reporting supporting ISH levels or clinical findings. Patient B went to st. Vincent hospital on October 3, 2010, where she complained of extremely poor balance, and reported that she feels like she was "losing it entirely and gets frustrated easily." Her TSH was tested and determined to be 0.01 µIU/mL. This test and her reported symptoms indicated possible iatrogenic thyrotoxicosis. On October 6, 2010, there is a chart note that acknowledges that Patient B went to the hospital "like you told her to . . . found out her thyroid levels are high." There is no indication in the chart that Licensee reevaluated or modified his diagnosis or treatment plan. Instead, on November 10, 2010, Licensee's chart note states that "she presented with hypothyroidism." Licensee did not address the reported high thyroid levels or even acknowledge her recent hospitalization, but instead, listed her vital signs and basal temperature, noted "acquired hypothyroidism" as a diagnosis, and prescribed SRI3, 18.5 meg, and SRI4, 13.5 meg, 60 tablets, b.i.d., 3 refills. Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient B with thyroid medication exposed her to the risk of harm.

c. Patient C, a 57 year old male, initially presented to Licensee on March 24, 20 I 0 with a history of Hepatitis C. A lab study drawn on Aprill2, 2010, reflected a TSH of 1.30 µIU/mL, free T3 pglmL of3.8, and a free T4 of 0.7 ng/dl., values which were all in the normal range. On May 6, 2010, Licensee listed hypothyroidism among his various diagnoses without stating his clinical findings or discussing the previous lab study and prescribed Synthroid, 50 meg, 1 p.o. daily a.c. (before meals) with 2 refills. This medication was not medically indicated. On June 7, 2010, Licensee prescribed Levothyroxine, 50 meg #30 1 p.o. daily with 3 refills. On August 3, 2010, Licensee noted "acquired hypothyroidism" as a diagnosis and prescribed Levothyroxine 75 meg, 1 tablet p.o., daily 1 hr a.c., 30 days, 1 refill, for a total of 30, "start on November 26, 2010, and end on January 24, 2011." On September 8, 2010, Licensee continued to list "acquired hypothyroidism" as a diagnosis. A lab study collected on October 1, 2010, reflected a TSH of .08, free T3 of3.6, and a free T4 of 0..8. Once again, Licensee's chart notes do not address this study. Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient C with thyroid medication was unnecessary and exposed him to the risk of harm.

d. Patient D, a 51 year old woman, initially presented to Licensee in December 2008. A lab study dated December 9, 2008, reflected a TSH of 1.65 µTIJ/mL, free T3 of 2.9 pg/mL, and free T 4 of 0.7 ng/dL. All the values were within the normal range. Nevertheless, Licensee prescribed SRT3 and SRT4, 4/40 meg, 60 tablets, b.i.d., a.c., 5 refills. A lab study dated February 16, 2009, reflected a TSH of 0.24 µIU/mL, free T3 of 314 pg/dL, and free T 4 of 1.3 ng/dL. On March 2, 2009, Licensee increased the prescription to SRT3 and SRT4, 5/55 meg, 60 tablets, b.i.d., 4 refills, without explanation. A note dated June 10, 2010, lists "acquired hypothyroidism" as a diagnosis without explanation. A review of the chart revealed that Licensee ordered several successive thyroid studies in the months to come, and continued to prescribe thyroid medication that was not medically indicated. A lab study collected on September 7, 2010, reflected a TSH of 0.94 µIU/mL, free T3 of 268 pg/dL, and free T 4 of 1.0 ng/dl.. On September 21, 2010, Licensee prescribed SRT4 90 meg, 30 tablets, daily, 3 refills. Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient D with thyroid medication exposed her to the risk of harm.

e. Patient E, a 41 year old female, has been a patient of Licensee for more than ten years. A lab study collected on October 10, 2007, reflects a TSH of 1.56 µIU/mL, free T3 of3.2 pg/mL, a free T4 of l.0 ng/dl., all values in the normal range. On April 8, 2010, Licensee's chart note states that Patient E "notes some ongoing concerns of her weight management and is requesting to go on the HCG [Human Chorionic Gonadotropin] diet." At the time, Patient E was noted to weigh 199 pounds, was 58 inches tall, with a body mass index of39.7. On April 12, 2010, Licensee prescribed 1.25cc HCG 1000 IU/vial in 10cc of diluent, a non-FDA approved RCG protocol for weight loss. On April 29, 2010, Licensee noted that Patient E had received the RCG and that Licensee would show her "how to prepare her HCG for injection." Her recommended dosage was 0.125 cc daily IM (125 IU). On May 28, 2010, a lab study reflects a TSH of 1.13 µIU/mL, free T3 of 2.7 pg/mL, and a free T4 of 1.26 ng/dL, all values in the normal range. On July 4, 2010, without explanation or medical indication, Licensee prescribed Levoxy (Levothyroxine) 75 meg #30 tablets, daily, 3 refills. On July 14, 2010, Licensee's diagnosis list included "abnormal weight gain" and "acquired hypothyroidism." A lab study collected on September 2, 2010, reflected a TSH of .06 µIU/mL, free T3 of 2.8 pg/mL, and a free T4 of 1.45 ng/dL. On September 28, 2010, Licensee ignored the lab study that indicated iatrogenic thyrotoxicosis and Licensee prescribed Synthroid (Levothyroxine) 100 meg #30 tablets, 1 hr. a.c., daily, 2 refills, and listed in his chart note a diagnosis of "acquired hypothyroidism." Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient E with thyroid medication exposed her to the risk of harm.

f. Patient F, a 33 year old female, presented as a new patient on September 14, 2010, with a reported history of hypothyroidism. A lab study collected on September 17, 2010, reflected a TSH of2.33 µIU/mL, free T3 of2.3 pg/mL, and a free T4 of 1.43 ng/dL (all in the normal range). Licensee accepted the diagnosis of hypothyroidism, noted patient complaints of "existing problems with hypothyroidism" and continued Patient F on Synthroid, 75 meg daily. On November 1, 2010, Licensee prescribed Synthroid 88 meg, 1 tablet, p.o., daily 1 hr. a.c., 90 days, 3 refills, for a total of 90, "start on November 04, 2010 and end on October 29, 2011." A lab study collected on December 20, 2010, reflected a TSH of 0.298 µIU/mL and a free T4 of 1.20 ng/dL. Licensee did not address these findings or modify the treatment regimen. In a letter dated January 3, 2011, Patient F informed Licensee that she had repeatedly called his office to complain of problems that she was having with her thyroid medication, to include palpitations, "runs of tachycardia," and severe itching episodes, but his office had failed to respond. Licensee responded to her inquiry on January 6, 2011. Licensee's decision to accept the diagnosis and treat hypothyroidism was not medically indicated and his ongoing treatment of Patient F with thyroid medication exposed her to the risk of harm.

g. Patient G, a 51 year old adult female, initially presented to Licensee on October 6, 2003 "with some hormone questions." On March 15, 2006, Licensee diagnosed "hypothyroidism" without explanation or supporting clinical fmdings. Licensee charted: "I have recommended that she double her dose of Liquid Iodine to get 300 meg of Iodine per day for the time being and will also assigned (sic) a prescription currently SRT 20 meg, we will change this to 25 mcg (60) 1 p.o. b.i.d. 1 hour a.c.".2 A lab study collected on February 21, 2006 reflected a TSH of 1.65 µIU/mL, free T3 of 262 pg/dl., and a free T4 of 0.8 ng/dL. All of these values were within the normal range and did not support a diagnosis of hypothyroidism. Licensee increased the dosage of SRT3 to 25 meg 1 p.o. b.i.d, on April 17, 2006. Licensee failed to address a lab study collected on May 22, 2006, which reflected a TSH of 0.02 µIU/mL (subnormal), free 1'3 of 6.9 pg/mL, and a free T4 of 0.8 ng/dL. Rather than address the issue of possible hyperthyroidism, Licensee continued to prescribe thyroid medication for Patient G over the following years without clinical justification, and failed to address successive lab reports with TSH levels that indicated subclinical hyperthyroidism. A lab study collected on April 28, 2011, reflected a TSH < 0.01 µIU/mL, free T3 of 4.2 pg/mL, and a free 1'4 of 1.5 ng/dl., Licensee also failed to address the. possible connection between the abnormal TSH lab reports and Patient G's complaints of various symptoms that suggested possible hyperthyroidism, to include a complaint of tachycardia on March 5, 2007, excessive hair loss on June 7, 2007, reported difficulty walking up stairs and drooling while talking on March 31, 2008, and reports of tremors and swelling on April 9, 2008. Licensee charted on April 17, 2008, that he instructed Patient G to stop taking thyroid medications for several weeks, and she reported feeling better. A lab study collected on April 9, 2008, reflected a TSH of 0.02 µIU/mL(depressed), free T3 of 18.6 pg/mL, and a free T4 of 5.8 ng/dL. Nevertheless, on May 27, 2008, Licensee had Patient G resume taking SRT3/SRT4 5/65 meg one p.o.b.i.d. On July 24, 2008, Patient G reported hot flashes and a three inch loss of height since her youth. Throughout the course of her treatment, Licensee did not order a bone density study or discuss with Patient G the risk factor of osteoporosis that is associated with subclinical hyperthyroidism (which is characterized by a serum TSH level < 0.1 µIU/mL and normal free T4 and T3 estimates.) A lab study collected on July 30, 2008, reflected a TSH of 0.02 µIU/mL, free T3 of 3.7 pg/mL, and a free T4 of 1.78 ng/dL. A lab study collected on July 28, 2009, reflected a TSH of 0.01 µIU/mL, free T3 of 3.0 pg/mL, and a free T4 of 1.2 ng/dL. A lab study collected on January 19, 2010, reflected a TSH of < 0.01 µW/mL, free T3 of 4.1 pg/mL, and a free T4 of 1.19 ng/dl., On May 23, 2011, Patient G presented at the Urgent Care Center at Providence Tanasbourne with complaints of "fast and flipping" heart rate, rapid breathing, difficulty concentrating, swelling, and the inability to put words together. Her whole body was twitching. A lab study collected that day reflected a TSH < 0.01 µIU/mL, T3 > 800 ng/dL, and a free T4 > 12.0 ng/dL. The diagnosis was iatrogenic hyperthyroidism. Licensee's diagnosis and treatment of hypothyroidism was not medically indicated and his ongoing treatment of Patient G with thyroid medication exposed her to the risk of harm.

2 This indicates that Licensee was already treating Patient G with thyroid medication prior to diagnosing her with hypothyroidism.

4.

Licensee and the Board desire to settle this matter by entry of this Stipulated Order. Licensee understands that he has the right to a contested case healing under the Administrative Procedures Act (chapter 183), Oregon Revised Statutes. Licensee understands that all open Board investigations into his conduct will be closed with the signing of this Order by the Board Chair. Licensee fully and finally waives the right to a contested case hearing and any appeal therefrom by the signing of and entry of this Order in the Board's records. Licensee admits that he engaged in the conduct described in paragraph 3, and that this conduct violated: ORS 677 .190(13) gross or repeated acts of negligence. Licensee understands that this Order is a public record and is a disciplinary action that is reportable to the NatlonallJam trans, dUU LlJ.'-' Federation of State Medical Boards.

5.

Licensee and the Board agree to resolve this matter by the entry of this Stipulated Order subject to the following sanctions and terms and conditions:

5.1 Licensee must pay a civil penalty of $2,000, payable in two equal installments of $1,000, within 90 days and 180 days from the signing of this Order by the Board Chair.

5.2 Licensee may only work as a physician at a practice setting that is approved in advance by the Board's Medical Director. Licensee must submit any practice setting to the Board's Medical Director for review and approval prior to beginning work as a physician at the proposed position.

5.3 Licensee must not practice "anti-aging" medicine or endocrinology. This limitation on the license of Licensee prohibits Licensee from treating or diagnosing endocrine disorders, to include diabetes, in all of its forms, and the diseases of thyroid, parathyroid, adrenal glands, pituitary and gonads. Licensee must make arrangements to provide coverage and referrals for endocrine disorder patients. This limitation on license prohibits Licensee from treating any patient with thyroid medication, human growth hormones or testosterone.

5.4 Licensee is reprimanded.

5.5 Licensee's Interim Stipulated Order of August 13, 2011 is terminated.

5.6 Licensee stipulates and agrees that this Order becomes effective the date it is signed by the Board Chair.

5.7 Licensee must obey all federal and Oregon State laws and regulations pertaining to the practice of medicine.

5.8 Licensee stipulates and agrees that any violation of the terms of this Order constitutes grounds for further disciplinary action under ORS 677.190(17).

IT IS SO STIPULATED THIS 27th day of Sept, 2012.

_____________________________________
GERALD WENDAL MILLbR, MD

IT IS SO ORDERED THIS 24th day of October, 2012.

OREGON MEDICAL BOARD
State of Orevnn

_____________________________________
W. KENT WILLIAMSON, MD
BOARD CHAIR

This page was posted on October 3, 2013.

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