Q: Would You Please Give Us a Brief Introduction to Your Personal Knowledge Regarding

May 17, 2008

Patient F Q: Would you please give us a brief introduction to your personal knowledge regarding Patient F? A: Patient F is a 26-year-old, mother of two children who suffers from rheumatoid arthritis, colitis, and psoriasis. She has multiple allergies including intolerances to NSAIDs (aggravates her colitis), and a speech impediment, which she has had since childhood. She complains that she has had pain in her joints since childhood and “could not run and jump with her friends on the playgrounds because it hurt”. At age 15 she suffered a back injury during an altercation with another student at school who drove a knee into her spine. This resulted in a collapsed intervertebral disc at L4/L5 and L5/S1. That incident led to two spinal surgeries with discotomies and she now has chronic low back pain (see CT image of L-spine dated July 21, 2005). I wonder if this attempt to cure her pain by surgery involved a traumatized “rheumatoid joint”. She also suffers from insomnia, food intolerances, colitis-related chronic nausea, and unwanted weight loss. She is chronically malnourished and cachectic.

Patient F is a kindhearted individual who struggled to complete her high school education. She relies on DSHS (State welfare) for health care, food stamps, assistance with rent, and other necessities. On most days, she is optimistic, and hopeful about the future, unaware that her day-to-day struggle for survival is not shared to the severity that she experiences by most other people in the community. She has very limited family support. She describes her mother as an alcoholic and has little recollection of, or association with, her father whom she describes as the person who abandoned her at a young age in favor of a long-term relationship with heroin. From a young age, she has had to forge for herself in a leaderless home. 2

Q: When did she first come to your clinic? A: On April 16, 2004, she came to my clinic in Maple Valley for help with chronic low back pain. She was referred by another patient. She brought x-rays and minimal medical records supporting her prior diagnoses. She showed me her surgical scars and told me her story. She described her pain and life struggles in a manner that was very sincere and honest. Her history included a prior diagnosis of rheumatoid arthritis from a prominent rheumatologist. He had prescribed Enbrel for the purpose of reducing her risk to long-term joint destruction from that disease. I discovered that day that she was self- injecting the drug into her muscle, rather than under her skin (subcutaneously). The injection of Enbrel into a muscle creates permanent muscle necrosis, scarring, and reduces muscle contractility. It is unlikely that the rheumatologist provided her with these erroneous instructions. It is more likely that spotty follow up caused by lengthy gaps in her insurance coverage, resulted in her misunderstanding of the correct procedure.

Q: Did you notice any other conditions Patient F had early in your treatment of her? A: Shortly after her first visit to my clinic in April of 2004, I witnessed the worst outbreak of psoriasis in a young lady in my entire medical career. Huge, ugly psoriatic patches the size of my hands covered her knees, thighs, lower abdomen, legs, arms, and portions of her face and neck. These dramatic, unsightly lesions during her childhood and adolescent years had a significant impact on her social interactions with others, and her emotional development in general. She has coped remarkably well. The telltale signs of psoriatic arthritis (a brand of rheumatoid arthritis that coexists with psoriasis) were unmistakable, and I updated her diagnosis to psoriatic (rheumatoid) arthritis.

Treatment of the whole person (consistent with the osteopathic philosophy) necessitated addressing pain from rheumatoid joints as well as post-surgical pain from her lower back. It became obvious quickly that chronic pain was a major limiting factor in her life. She was started appropriately on opioid pain medications at conservative doses on her initial visit, pending the customary 3

urine drug screen (Exhibit No. F0371). She was asked to discontinue all NSAIDs as I considered them contraindicated for her colitis condition. She had also been receiving methotrexate prescriptions from her rheumatologist. The methotrexate did help suppress her psoriasis outbreaks, but the long- term use of that drug was causing blood dyscrasias including anemia and leukocytopenia, which left her prone to infections.

Q: How did you address her self-injection technique? A: I switched her from Enbrel to Humira, which was better tolerated and required fewer self-injections. I had taken care to demonstrate and observe her performing a subcutaneous injection, rather than an intramuscular injection for these medications. Humira helped to stabilize her rheumatoid arthritis as well as significantly suppressing her psoriasis outbreaks without having to use methotrexate as frequently. Humira (a tumor necrosis factor and IL-6 blocking drug) worked by suppressing her abnormal immune response, sparing the synovial lining of her joints from its destructive effects. In some patients a similar autoimmune pathology also occurs in the skin, resulting in the unsightly and painful eruptions known as psoriasis. These two diseases (RA and psoriasis) are linked by similar genetic alleles (HLA DRB 1 0401 and 0404). These genetic links explain why there is a response to both conditions using TNF drugs.

The long-term effects of rheumatoid disease carry significant risks of physical disabilities and disfigurement. The objective of current medical management is early diagnosis of rheumatoid disease so that the earliest possible intervention can be effected, sparing the likelihood of structural damage to synovial linings and joint surfaces.

Q: How did emotional stress affect this patient? A: Her stress level was high. Emotional stress is also well known to depress immune function, so it contributed to her long history of frequent colds and recurrent infections. She reports that she was considered a “sickly child” as she was growing up. 4

Q: Generally, what was the nature of her medical treatment history when she presented at your clinic? A: Patient F has multiple complex diseases and one of the biggest threats to her stability is not having the continuity of close, attentive medical care. She has always been dependent upon State administered health care services for her and her children. Unfortunately, a shortage of contracted DSHS specialists and primary care providers has resulted in long lapses in medical treatments and diagnostic work. Each year there are automatic cancellations, unreasonable spend-down requirements, or her failure to meet strict criteria, which have all placed her continuity of care at a significant disadvantage.

Q: Are you a DSHS provider, and if not, why did she come to see you with her limited resources? A: No I am not, and I have never been. She was referred by another patient and was prepared to pay for her visits. However, it was clear very early on that she had very limited resources. My wife Betty and I run our medical business in rural Maple Valley with a strong appreciation for the history of rural medicine in America. Osteopathic medicine has its roots firmly planted in rural America. In the early days before insurance, osteopathic doctors were trained to look after all patients in their community, regardless of means. Following in this philosophy, usually in late December of each year, we select two patients from our practice who are without medical care, whose cases are complicated, and who, through no fault of their own, lack the resources necessary to secure medical care. Patient F was a complicated medical case that met these simple criteria.

Q: Did she continue to pay for her visits? A: In January of 2005, Patient F was offered primary and specialty medical care services within the scope of my practice for that year. A contract was made between Patient F for payment of $100 per month for her medical services. In some cases, she was able to make the payment monthly, but for many months, she was not. When insurance was in place – for example, motor vehicle accidents or work-related accidents – these third parties were billed 5

for her medical services, but she would not be billed for any unpaid balance. Treatments for motor vehicle accidents, of which there were two, were documented in separate charts. Her general medical care, the largest component by far, was not covered by any insurance, and it was donated to her on a “pay if you can” basis. She was never denied medical care, or coordination of care with other physicians, nor was she ever billed for any outstanding balance. She was treated the same as any patient with full coverage of the best insurance coverage that was available. On one occasion, when her prolactin level on a hormone screen was found to be extraordinarily high, we sent her for an MRI of the brain to Valley Hospital rule out pituitary adenoma, and paid for the services on her behalf.

Q: Were you aware of conflicts she had with other doctors, especially an alleged incident regarding a conflict with another doctor? A: During February 2005, Patient F suffered a recurrence of a chronic infection in her left ear, which quickly developed into cellulitis. She had had prior episodes of this in her history. This time, however, it occurred at a time when I was attending a CME out of State (in Hawaii) so she turned to Highline Community Hospital in Burien for help. She was admitted through the emergency room and the attending M.D. called for an ENT consult. The ENT consult recommended hospitalization and aggressive treatment with IV antibiotics for the ear infection. Unfortunately, when she was established in her room on the hospital floor, she had a disagreement with her assigned attending doctor, Cynthia Taylor, M.D. Dr. Cynthia Taylor refused to provide the continuity of her routine pain medications while she was in hospital. I recall, on March 10, 2005, standing in the lobby of my hotel in Honolulu (where I was attending the annual KCOM family practice review CME) receiving a call on my cell phone from Patient F’s friend who was in a panic because Patient F was being evicted from her hospital room. Patient F’s friend told me that there had been a confrontation between Dr. Taylor and Patient F, and her fiancé, Patient G, who was there as well. She said that security had been called and they were being asked to leave the hospital. I could hear yelling and commotion in the background. I was able to talk briefly to Patient F who was upset because, she claimed, Dr. Taylor had made some 6 uncomplimentary remarks concerning her treating doctor (myself) with reference to the amount of pain medications that I had her taking. Dr. Taylor was refusing to provide continuity of her pain medications while Patient F was in hospital. Dr. Taylor, she reported, had left and security was there. I asked Patient F to give my cell number to Dr. Taylor and asked her to have Dr. Taylor call me. I waited for several hours with my phone on at the hotel and never did receive a call from Dr. Cynthia Taylor. At this point, based on information I had over the phone, it was my opinion that Patient F still had a dangerous infection and was at risk for developing MRSA (methicillin resistant Staph aureus), meningitis, or possibly even death, if she departed the hospital without treatment on 03/10/2005. Later in that day, I received another call from Patient F after she had returned home. She stated that she was still experiencing fevers, rigors and chills, and that the swelling on the side of her face and throat was worsening. She also told me that after she returned home, she received a phone call from someone (it was not Dr. Cynthia Taylor) from the hospital who apologized for what had happened at the hospital and asked her to return for treatment. I presume this may have been prompted by Patient F’s threats of a lawsuit as she was angrily departing the hospital. I encouraged Patient F to return to the hospital and follow through with the treatment that had been outlined by the ENT specialist in the emergency room earlier that day. On March 11, 2005, Patient F returned to the Highline Hospital for treatment. The ER doctor’s admit note on March 11, 2005 indicates that “he had no idea why” Patient F had returned to the hospital for readmission on the 11th, after having been admitted the previous day, March 10th. I do.

Patient F did complete a four-day course of IV antibiotics in the Highline Hospital and did receive pain control although it was a different type than what she had been prescribed as an outpatient at my clinic. It was Dilaudid and a PCP pump. The discharge records report that she was “improved” upon discharge from the hospital and was directed to follow up with the ENT doctor a week later. She also received, on discharge, a letter from Dr. Cynthia Taylor firing her as a patient. After returning from my out-of-State trip I saw Patient F at my clinic and followed up blood cultures to monitor the success of 7

her treatment. Through blood cultures I discovered that her blood was positive for Staph so I initiated outpatient treatment using IV Rocephin until the infection resolved. I did this only because Patient F steadfastly refused to return to Highline or any other hospital to follow up with her ENT specialist. I then referred her to Nancy Becker, D.O., an ENT specialist physician in Auburn, and was able to convince her to have the treatment we had completed in the clinic confirmed and possibly identify an underlying cause of the recurrent infections in her left ear and face that had been waxing and waning over a long period of time. Patient F got along well with Dr. Becker and that was a great relief. Her infection resolved.

Q: You mentioned a speech impediment she has – how did that affect her? A: Patient F’s longstanding speech impediment causes occasional problems with her pronunciation of words. During her childhood, she was able to access speech therapists through social services and receive treatment for this condition. As an adult, she manages quite well except when she is under stress or in pain. Then her speech deteriorates and she begins to slur certain words. She sounds as if she has been drinking, or is overmedicated, when in fact she is not. Physicians unfamiliar with her history tend to disbelieve her and assume that she is drug seeking or abusing drugs and for that reason she has sometimes been inappropriately managed or misdiagnosed by Urgent Care or emergency room doctors.

Q: In your opinion, what type of care is best for a patient of this complexity? A: Patient F does best when she is under the care of a single physician capable of coordinating care for as many of her medical problems as possible. Stress and complications of seeing multiple specialists on a less than timely basis in the past has been problematic.

Q: How did she – a young person with complex diseases, and a young family - manage day-to-day? A: Regarding her ability to function in society, Patient F represents a mountain of determination. She tends to be very stoic with regard to her pain level and 8

has learned to walk and talk so as to conceal her discomfort. Possibly the result of her tumultuous childhood, she has poorly developed skills for interacting and communicating with others, particularly those in positions of authority. She becomes frustrated easily when she cannot communicate and quickly becomes verbally combative. This behavior has resulted in the alienation of many professionals to whom she has turned for help.

Q: Were you aware of allegations of theft made against her? A: At one point, I received a call from a local pharmacy that Patient F had been caught stealing from the store and would not be allowed back for prescriptions or for any purpose. A pharmacy security person had apparently followed her out to her car and found her with items that she had not paid for. They were small items apparently – children’s toys, things of that nature, of not large dollar value. Through security cameras at our clinic, we had noticed similar behavior involving small items of small dollar value – particularly items of interest to children. When I discussed the issue of the thefts with Patient F, it was as if she had no recollection of the incidents and was unaware of what was happening. I realized this was not a criminal mind at work, but a behavioral disorder. My research led to C.A.S.A. (Cleptomaniacs and Shoplifters Anonymous). I then realized that what she had was a personality disorder – kleptomania. I referred her to an expert in that field, Terence Shulman, for treatment and provided her with access to his treatment program website and actually gave her a copy of his book on the subject “Something for Nothing” (see Exhibit: Hold up Book). She was eager to take his course, but the cost was in excess of $1,200. She may have read the book, but I am not sure that she followed through with the treatment because of the cost.

Q: How is it that some doctors could consider her a “drug seeker” and a “malingerer”? A: I am convinced, after listening and treating her for approximately two years that she does suffer considerably, emotionally and physically, and for the most part, does so in silence. In the morning after rising, her joint stiffness from rheumatoid disease is so severe that it requires the assistance of another person for over an hour to help stretch her extremities in order to get 9

them moving. This stiffness continues for almost two hours – the hallmark of rheumatoid arthritis. With two young, busy children she requires assistance often for daily living activities involving things that many of us take for granted – such as being able to sit down and rise up from a toilet each morning, or during the night, without the assistance of another person. She has done a remarkable job of being a mother of two active and demanding children with very minimal household help. She has good mothering skills and is admirably protective of her children. She is not always well enough to drive herself to appointments and often misses appointments, or is late particularly if they are scheduled early in the day, or her car breaks down.

Q: So how did things go for her when you started as her “volunteer” primary doctor? A: In January of 2005, when I agreed to become her primary care treating physician, things started looking better for Patient F. It appears that this is also approximately the time that Washington State (DSHS) contracted with Molina, a California-based HMO, to manage Medicaid patients in Washington State. Prior to that, Patient F was receiving her medications through scripts written by any willing provider, which were then covered by DSHS at the pharmacy. I am not, and have never been, a DSHS provider in Washington State. The reason for that is the reimbursement level that Medicaid offers doctors in the State of Washington is so low that the cost of billing for the service often exceeds the reimbursement amount. My business manager advised that a solo practitioner was better off to provide the services free to patients than add the additional costs of getting paid.

Q: What happened during 2005 to make it difficult for Patient F to get her medications covered? A: At the same time, DSHS administrators (a group called IAG – Inter Agency Group) were tightening their grip on chronic pain patients and their doctors, believing that doctors were prescribing too many opioids (see Seattle Times press release dated Saturday June 25, 2005 “State to curb excess pill use”). Under Molina, which now had access to her pharmacy records, Patient F’s relatively high pain medication numbers were red flags. In late June 2005, the 10

medical director of Molina, Dr. Daniel Kent, blocked her prescriptions for Oxycontin CR at the pharmacy. There was no forewarning of her prescription rejection until the day she went to the pharmacy and was refused a prescription to refill Oxycontin CR (in 20 mg doses). She was then taking a total of 80 mg of Oxycontin CR in divided 20 mg doses every 12 hours. This method caused minimal upset to her sensitive stomach and provided her with the smoothest possible and acceptable continuous pain relief without side effects. Patient F called me in panic from the pharmacy with the news that her prescription had been declined. I called Dr. Kent directly and was told that he believed she must be selling or abusing her medications in order to be consuming that much. I explained to Dr. Kent that I had the benefit of requiring Patient F at one point early in our professional relationship to witness her consumption of her medications over a 48 hour period in order to rule out abuse. I was able to verify with my own eyes that she was taking these medications as prescribed and they were not being diverted. I explained to him that I also observed her function to improve considerably without evidence of side effects as she achieved this therapeutic dose. My telephone call and pleadings to Dr. Kent were met with considerable suspicion and resistance, but he finally did relent when I advised him that she would undoubtedly, within the next hour or two, go into withdrawal if she did not have her medication. Instead, he approved a generic brand of Oxycontin 80 mg CR tablet that he said was designed to prevent abuse by crushing, but only provided her enough for ten days (20 pills). That, he said, would be enough to give her time to find another doctor.

Even though there was no evidence that she was abusing her medications, and this medical director had never seen Patient F as a patient, and, to my knowledge, has had very limited experience in ambulatory pain management, he gave her no choice and was unreceptive to any further pleas by me, her treating doctor.

Q: To your knowledge, had Patient F ever had generic Oxycontin 80s previous to your becoming her physician? 11

A: I had not prescribed them because she had indicated that she had had a bad reaction to them before. When I offered that information to Dr. Kent, the medical director dismissed that suggestion as further evidence that she was probably abusing and selling her medications for money. He said if she ran into problems with her medications to “go to the ER”. Patient F had no choice but to fill her prescription approved by Dr. Kent at the pharmacy that day for the generic brand of Oxycontin 80 mg CR, or go into withdrawal. She took the medication and two hours later was on my doorstep suffering from a severe reaction. She deteriorated quickly with dehydration from continuous nausea and vomiting. We both knew that if she went to the emergency room at the hospital for treatment, she would be treated as a “drug addict”. How could I, an osteopathically trained physician, deeply committed to helping relieve suffering and treating the whole person, trained and skilled in the art of treating adverse drug reactions, withdrawal, and difficult pain syndromes, turn her away? I knew that she knew I was the best equipped to help her out of her emergency. By the second day, she had erupted in a generalized pruritic rash that covered her entire body, including her trunk, her legs, her arms, genitals, neck, face, breasts (see Exhibits Nos. F-rash #1, F-rash #2, F-rash #14 attached to chart note 06/19/2005 and chart note 06/21/2005). Following that, her skin started to slough and peel off in large patches (see photos). She was miserable. I ordered the medication stopped and treated her with IV Benadryl and copious fluids for three days. The long-acting medication took forever to get out of her system, continuing to trigger her body’s adverse reaction. To counter withdrawal symptoms, which were now occurring on top of her drug reaction, it was necessary to reinstate opioids. I used Fentanyl patches, starting with a 100micgm patch for three days, then tapered to a 50 mg patch in order to avoid the gastrointestinal route. Six days later, she was transferred back to Oxycontin CR (brand name) avoiding problems with withdrawal. The Oxy CR brand was paid for from a collection taken from friends, relatives, and even clinic staff. I witnessed her terrible suffering for three days, the result of a medical misadventure, which was completely preventable. It was the direct result of a managed care executive’s interference with the treating doctor’s medical decision-making, placing this patient in harm’s way. 12

Q: How do you respond to the assertion that she drug tested positive for marijuana? A: Patient F also had the autoimmune companion disease colitis. This condition is responsible for a long history of complaints of irritable bowel, obscure abdominal pains, anorexia, bouts of recurrent nausea and vomiting (often daily), and malnutrition. The Humira I prescribed for her was remarkably effective in suppressing the autoimmune nature of all three of her diseases (RA, colitis, and psoriasis). In addition, Marinol, a prescription drug derived from marijuana, was highly effective, together with occasional small doses of Diazepam to quiet the bowel. Marinol was extremely effective at controlling her chronic nausea and vomiting. It made a remarkable difference in her anorexia and unwanted weight loss. (Marinol is a drug that triggers a positive THC (marijuana) in a standard drug screen.)

Q: How did she respond to your treatment? A: It was gratifying to see her complexion change from hideous, repulsive- looking psoriatic patches to the soft, clear skin of a beautiful young lady. Adequate pain management, guided by functionality and close monitoring for safety, using the best medications available for this specific patient, rather than the arbitrary cap of the cheapest pain medication available, proved to enhance her quality of life considerably. There were periods of time during her treatment at my clinic that she became well enough to return to work – once in a school cafeteria as a food services worker, once in a meat (deli) business as a food helper, and even in our clinic as a part-time medical assistant trainee. Most of her job history was physically demanding. Medical assistant trainee involved mostly reception and telephone work at the front desk. It is not physically demanding. My clinic requires “the clean gene” which Patient F had. Patient F is an example of what can be done with a well- planned and closely supervised medical care program that is customized by her physician for her unique needs. Patient F did not have the opportunity to choose her genes. She suffers from multiple, complex, genetically driven diseases that are no fault of her own. She does not fit well into a managed care mold. 13

Q: What complications, if any, arose with your continued treatment of Patient F due to the intervention of the State DSHS? A: The continuity of Patient F’s care suffered another setback in the fall of 2005. In May 2005 I wrote a letter of complaint regarding the handling of Patient F’s medications by DSHS to the Governor. DSHS responded, in my opinion, to my defense of my patient and other matter it involved itself with regarding my practice by sending a letter (see also Px C) to all pharmacists in the State directing them not to fill my prescriptions. Now, Patient F had to deal with her prescriptions being denied at the pharmacy at a time when she finally enjoyed the most medical stability that she had seen for many years. Again, she relapsed when she was denied her stabilizing medications and suffered on many fronts.

During the period Patient F received medical care at my clinic in Maple Valley, she, like others, was always treated with respect and compassion (see Exhibit No. F0598). She received effective treatment for rheumatoid arthritis, psoriasis, irritable bowel, colitis, depression, anxiety, complex pain syndromes, behavioral disorders, insomnia, food sensitivities, malnutrition, malabsorption syndromes, and counseling for inappropriate social behaviors. Her pain was managed using a multidisciplinary approach in accordance with the guidelines of the Chronic Pain Network, in addition to meeting all of the guidelines adopted by the Osteopathic Board of Health for Washington State. She was closely monitored for safety without regard for her ability to pay for services. Supporting Patient F’s claim for the need for pain management, her medical record contains copious imaging studies, leaving no question of painful, degenerative spinal conditions, evidence of rheumatoid arthritis in multiple joints that justified her need for pain relief. It is also noted that her spinal condition, based on objective findings and limitations in her range of motion, in accordance with the AMA’s Guidelines for Impairment (5th edition) and the Washington State L&I Guidelines WAC296-27-280 qualified her for a category 4 permanent impairment rating for her spine in an application that she submitted for SSI disability with a request for open medical coverage (Exhibit No. F0537). As a result of the difficulties stemming from activities of 14

various government agencies and Molina, Patient F’s continuity of care with my clinic eventually came to an end in early 2006. I was able to fulfill my commitment to her of a year of my time and service – but with great difficulty.

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.13 that you: “Failed to seek or document consults with specialists”. How do you answer this Charge? A: This is simply not true as numerous referrals were in fact made regarding Patient F. See attached summary of referrals found within this patient’s chart involving consults with approximately 30 other specialists. One such referral was made by me to the Department’s (expert) in this case. (Exhibit No. F0077 and Exhibit No. F0484). In addition, Molina program coordinators had approved referrals of Patient F to me for the purpose of pain management services, including the preapproval of medications for Patient F which exceeded Molina guidelines (Exhibit No. F0556, Exhibit F0584).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.19 that you: “Diagnosed and prescribed for rheumatoid arthritis without consult with a rheumatologist and despite normal lab”. How do you answer this Charge? A: I deny that such is true. This patient came to my clinic with a prior diagnosis of rheumatoid arthritis from a rheumatologist (Exhibit No. F0370/71). Her prior treating rheumatologist had placed her on Enbrel (self-injection) (Exhibit No. F0364). Note that Patient F was found by me to be self-injecting Enbrel intramuscular contrary to recommended practice (Exhibit No. F0360). I corrected her practice of self-injection and continued to treat and improve on the treatment for not only rheumatoid arthritis, but also the companion conditions psoriasis and colitis by switching her to Humira. The patient enjoyed significant improvement. Patient F did not have normal labs. Review of her lab results both from her EMR records as well as the summary provided by exhibit from Dynacare Labs, indicated her RF (rheumatoid factor), sed rate, CBC (MCV, MHV, and iron levels) were frequently abnormal, consistent with a diagnosis of rheumatoid arthritis (Exhibit No. F0443 and Exhibit No. F0447). She was monitored for signs of joint destruction from rheumatoid arthritis 15

periodically through the use of x-ray and other imaging joint surveys (Exhibit No. F0331 and Exhibit No. F0676) and by CT (Exhibit No. F0195, Exhibit No. F0714, and Exhibit F0710). She was also followed for changes in serum chemistry for progress of treatment and side effects from medications (Exhibit No. F0340). These lab results were performed as often as possible, not as often as desired, due to the patient’s inability to pay and frequent interruptions in insurances coverage. The use of the above lab results are well documented in the literature as providing reliable indicators of progression of rheumatoid disease, when interpreted along with clinical findings (Reference: The Journal of Musculoskeletal Medicine, March 2008, Freeston, Jane, et al, page 110, “Spotting Early Warning Signs of Aggressive RA”).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.3 that your treatment of her fell below the “Standard of Care for managing chronic pain patients”. How do you answer this Charge? A: I absolutely deny such Charge. Patient F was managed following the guidelines used by the Chronic Pain Network (see package) which complemented the guidelines of the Washington Osteopathic Board of Health. All patients in my practice, including Patient F, were required to sign pain contracts prior to receiving opioid medications, then were regularly evaluated using quality of life index questionnaires (Ferrans and Powers) (Exhibit No. F0497 through F0500) in addition to pain intensity evaluations on every visit using the standard pain analog scale 0 to 10. All chronic pain patients in my practice, including Patient F, were monitored regularly – every two weeks on average – and some times more frequently if conditions were changing or the patient showed signs of being unstable (Exhibit No. F0042, and Exhibit No. F0308). When Patient F was ill with vomiting, dehydration and stomach upset from her colitis, I used Buprenorphine (injectable) to prevent withdrawal and treated the underlying cause of nausea and vomiting very aggressively in order to get it under control quickly (Exhibit No. F0327). When patients are vomiting up their pain medications, it is often necessary to adjust medications and numbers to make up for lost pills in order to prevent withdrawal symptoms. Periodic urine drug testing was performed (unannounced and 16

supervised by a female staff member) to confirm appropriate drug usage and levels, but mainly to rule out illicit street drugs (Exhibit Nos. F0554, F0555, F0561, F0575, F0586, F0587, F0534, F0535, F0514, F0510, F0482, F0481, and F0480). Monitoring for medication side effects was also performed routinely using Dynacare Labs to monitor kidney and liver function, CBC, and other parameters of anemia that she suffered from chronically (Exhibit No. F0338). Pain management contracts were updated any time there was a significant change in the medications and/or a change in the location of the pharmacy (Exhibit Nos. F0588, F0548, F0512). Dialogue and coordination with pharmacists regarding pain medication dosages and related pharmaceutical history and clarification was frequently performed (Exhibit Nos. F0531, F0532, F0533). For Patient F there were numerous telephone calls with pharmacists, many of which were lengthy due to the complexity of her case and the frequency of medication changes. Close manual and electronic pill counting was performed for Patient F’s medications with special attention being performed when the doctor planned to be away from his office (Exhibit No. F0477).

Q: Concerning Allegation 1.16: What did you do to ensure Patient F’s medications were secure and not subject to diversion or sharing? A: Patient F was required to have a safe place for medications (Exhibit No. F0253). When there was repeated evidence of non-compliance, I threatened to discharge the patient (Exhibit No. F0478). Note references in the chart: “Monitor for medication overuse” (04/20/2005, Exhibit No. F0298). These, among others, are indications of close monitoring for patient compliance. Whenever there was an indication of laxity in compliance or insecurity of the patient’s medications, action was taken (Exhibit No. F0308). Note chart note reference 10/01/2004 “her mother dipping into her medications when she was moving”. See Exhibit No. F0347. Note that when Patient F, through domicile relocations, or having overnight houseguests, was required to bring her medications to the clinic for safe storage in the clinic safe. Her medications under these circumstances were dispensed to her on a weekly basis in a weekly-compartmentalized pill dispenser that she was to carry on her person and secure at all times (Exhibit No. F0101 and Exhibit No. F0102). The 17

dispensing of medications at the clinic under these circumstances was always supervised by a minimum of two persons. See patient’s personal medication dispensing case and diary from the clinic safe (Exhibit No. F0513, and Exhibit No. F0515). She was also provided with a lockable body fanny pack when she needed to carry her medications with her during the day.

Q: What alternative therapies did you implement to reduce her pain? A: She was treated with biomechanical corrective devices designed to decrease low back pain and reduce vibration to sensitive joints in the lower extremities, pelvis and spine using orthotics (Exhibit No. F0594). (See sample orthotics order form.)

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.5 that: “Opioids and benzodiazepines used in combination without a compatible diagnosis and without attempting non-narcotic or less potent narcotics and without documented efficacy”. How do you answer this Charge? A: I deny this Charge. Patient F had rheumatoid disease affecting all traditional rheumatoid joints, in addition to two failed back surgeries, one involving a rheumatoid joint (L5/S1). This history was abundantly evident from her first visit. It was also evident that she suffered from the companion autoimmune disease colitis and had known allergies to NSAIDs and multiple other medications. There was no merit, given the convincing evidence of her pain syndromes, that she would tolerate further courses or trials with non-steroidal anti-inflammatory drugs. There was no reason to withhold or delay what was obviously the most suitable drug to treat her joint pain – non-morphine, synthetic opioid-based medications (Oxycontin).

Benzodiazepines were provided, as needed, for the specific purpose of quieting her irritable bowel symptoms which would wax and wane with the companion condition “colitis”. She was provided with occasional benzodiazepines for that use. Diazepam injectable was also used during IV treatments to reduce her risk of seizures during high risk IV infusions. They were also occasionally selected and used during periods of high stress and 18

emotional meltdowns, which were particularly prevalent during the period May through July 2005 when she was under attack by DSHS and Molina.

She responded favorably to these treatments as evidenced by mention in the charts of her increased function and decreased pain (Exhibit No. F0353 and F0346). Patient F had multiple allergies and pharmaceutical sensitivities. See the allergy list in the patient’s history cited and reviewed on multiple patient encounters (Exhibit No. F0599, F0189, and F0485). Many intolerances to medications including non-steroidal anti-inflammatories, and other narcotics including Demerol, Fentanyl patch (the adhesive), generic “Oxycontin CR 80 mg tablet”, and morphine sulfate are also noted. These intolerances restricted choices for pain control agents for this patient.

Non-narcotic methods of pain control including osteopathic manipulation, trigger point injections, occasional trials of Cox2 anti-inflammatories, counseling, use of Lidoderm patches, exercise and stretching prescriptions, and counseling for anger management, lifestyle changes, parenting skills, and issues related to marital discord were also used frequently and are seen throughout this patient’s entire chart. References to using Lidoderm patches and Enbrel are (Exhibit No. F0364). See reference to “reevaluate with x-rays and OMT” (Exhibit No. F0363). See reference referring to “counseling”, “needs OMT”. See chart note 07/13/2004 including reference to OMT (Exhibit No. F0358). See reference “needs (short leg study) and “OMT beneficial” – see chart note 08/31/2004 (Exhibit No. F0354). See reference in chart note 08/20/2004 “taking Enbrel, blood draw and Lidoderm patch” (Exhibit No. F0356).

Q: The Statement of charges alleges with respect to Patient F in paragraph 1.20 that you: “Did not refer to hospital or ENT during course of treatment for cellulitis/facial abscess ultimately requiring hospitalization, IV antibiotics and ENT [and that you] Failed to follow up with ENT despite hospital recommendations”. How do you answer this Charge? 19

A: I deny this Charge. This patient visited Highline Hospital seeking emergency treatment for facial abscess and cellulitis during a period that I was out of State on a Family Practice Update CME (March 5-19, 2005). She was admitted March 10, 2005 via the ER. Her ER doctor ordered an ENT consult for her ear infection, and the ENT specialist ordered her admitted to the hospital for IV antibiotic treatments. During the hospitalization, Patient F encountered Dr. Cynthia Taylor who was her assigned doctor in the hospital. Dr. Cynthia Taylor refused to provide continuity of her current pain management therapy while in the hospital under treatment for facial cellulitis. Dr. Taylor also failed to provide the patient with a pain management consult while in the hospital. Dr. Taylor also failed to contact me as Patient F’s primary treating doctor to coordinate care while in the hospital. A confrontation occurred in the hospital on the day of admission, which resulted in Patient F leaving the hospital abruptly under security escort without getting treatment for her infection. (See the ER admitting doctor’s note dated 03/11/2005, (Exhibit No. F0568). In my opinion, this action by Dr. Taylor put this patient in harm’s way. According to Patient F, a hospital administrator later contacted her at home on 03/10/2005, apologized, and requested that she return to the hospital for treatment. During a long distance telephone call with Patient F shortly after, I encouraged her to return to the hospital for treatment for her infection, and she did. On 03/11/2005, the ER doctor’s records confirm she was readmitted the following day for the treatment recommended by the hospital ENT specialist (Dr. Maurice) (Exhibit No. F0568). In spite of my calls to the hospital on 03/10/2005 attempting to talk to Dr. Cynthia Taylor, Dr. Cynthia Taylor failed to return my calls. Nevertheless, Patient F did complete her stay at the hospital, complete the treatment as recommended by the ENT specialist, and was provided pain management during her stay. Upon discharge from the hospital four days later Patient F was presented with a letter from Dr. Cynthia Taylor firing her as a patient. Upon my return from Hawaii a few days later, I followed up with blood cultures, which were positive for Staphylococcus aureus. I treated her on an outpatient basis using IV Rocephin (Exhibit No. F0284, F0285, F0286 and Exhibit No. F0603). The positive blood culture I obtained was recorded 05/13/2005 (Exhibit No. F0602 and F0603). Following stabilization of Patient 20

F’s condition using outpatient IV therapy, I referred Patient F for a second opinion to Dr. Nancy Becker, an osteopathic ENT specialist at Auburn Regional Medical Center (Exhibit No. F0122).

Highline Hospital records containing details of the confrontation, which occurred between Patient F, her friends, and Dr. Taylor on 03/10/2005, including my calls to the hospital, are conspicuous by their absence. Hospital records list Dr. Cynthia Taylor, a doctor Patient F had never seen prior to her admittance to Highline Hospital, as Patient F’s PCP. All concerned were quite aware that Patient F was vocally declaring me as her primary care physician (Exhibit No. F0566). Cynthia Taylor, M.D. remedies this on Patient F’s discharge, 03/17/2005, with a letter firing her as a patient (Exhibit No. F0574).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.21 that you gave her a: “Steroid injection given at the same time as treatment with IV antibiotic”. How do you answer this Charge? A: I deny this Charge. The patient was treated with IV antibiotics periodically for recurrent cellulitis and infections. Occasionally, during these treatments or between, the patient would have flares of joint pain – in particular, upper pole sacroiliac joint inflammatory pain. Under sterile technique, these painful, difficult to treat, conditions were sometimes treated using IV Lidocaine injections into the inflamed joint space. The injection material was principally Lidocaine with a very small amount of Celestone added as an anti- inflammatory. The total amount used was a fraction of the amount that would normally be used in a major joint injection (Exhibit No. F0203). The combination of Lidocaine (the primary component) significantly reduced the acute pain for a number of hours. A small amount of Celestone contained in the joint capsule (non-systemic) would suppress inflammation over a period of several days and sometimes several weeks. These injections were very accurately placed within the joint capsule and would not have an opportunity to have any significant systemic effect. These injections provided significant relief from joint pain without having to increase her opioid regime (Exhibit No. 21

F0201). These non-systemic injections did not significantly put her at risk for infections, nor have I ever had an infection result from one of my injections.

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.22 that you made: “Joint and soft tissue injections in wrist of recently operated wrist without notifying orthopedic surgeon”. How do you answer this Charge? A: I deny this Charge. This is another complete error and misrepresentation or interpretation of this patient’s medical records. There is absolutely no history of any surgical operation on the wrists of Patient F nor does she have any record in her medical history or records of joint or soft tissue injections to the wrist. There is no factual evidence supporting this allegation.

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.8 that there was: “Another pain program terminated for opioid and staff abuse”. How do you answer this Charge? A: I deny this Charge. This allegation apparently stems from the incident in Highline Hospital referred to above where the patient had gone for emergency treatment for a potentially life-threatening facial abscess/infection. My testimony and evidence addressing this circumstance has been previously presented in detail. What is documented in the record can hardly be interpreted as a “pain program terminated for opioid and staff abuse”.

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.8 that you: “Failed to take action following urinalysis positive for cannaboids”. How do you answer this Charge? A: I deny this Charge. Patient F suffered from colitis, anorexia, chronic nausea with vomiting, dehydration, and abdominal pain (Exhibit F0201, Exhibit F0210). A prescription for Marinol to prevent anorexia and life-threatening weight loss as well as dehydration from vomiting was appropriate and indicated. It was ordered and used during periods in which her colitis flares were at their worst – July, August, and October of 2005. See EMR Med History. The patient benefitted from these treatments (Exhibit No. F0210). Molina approved the use of Marinol for Patient F for a period of time (Exhibit 22

No. F0528). This medication, derived from marijuana and chemically identical, triggers a positive THC (metabolite) on urine drug screens (personal communication with Dynacare Toxicology Lab). The use of Marinol prescriptions for this patient was outlined in my letter of referral for a consult to Dr. Hillyer’s pain clinic (Exhibit F0491). See Reference to “Allergies” and Patient History. This information was apparently not considered in their evaluation of Patient F. (Letter Exhibit F0484-F0488). Further, Patient F, during periods when her medication benefits were being disrupted by the actions of Molina and DSHS, was forced to go without Marinol because of its high cost when her prescriptions were not covered by DSHS. Under these circumstances, she may have turned to the use of marijuana for medical relief, but there was never any encouragement by me for her to do so. To the contrary, she was reminded during multiple counseling sessions that to use street acquired marijuana is illegal and dangerous (Exhibit No. F0319 and Exhibit No. F0320).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.6 that you: “Prescribed benzodiazepines and opioids together which depresses respiration and antagonizes pain”. How do you answer this Charge? A: I deny this Charge. The infrequent use of benzodiazepines in low doses for the purpose of treating irritable bowel flares and quieting abdominal pain primarily during daytime hours was appropriate and effective. Opioids were used for the treatment of severe joint pain. The benzodiazepines, used in low doses, make no impact on respiration and minimal risk of interactions with other medications. To the contrary, they provided enhanced relief of pain through reducing anxiety and significant relief from abdominal pain due to colitis (Exhibit No. F0273, and Exhibit No. F0274. “Patient doing better”. Then on 05/25/2005, patient says “doing better” only to be set back by the actions of Molina (Exhibit No. F0265, and Exhibit No. F0266).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.7 that you: “Prescribed in a manner to create high risk for misuse”. How do you answer this Charge? 23

A: I deny this Charge. Patient F was a complex case involving multiple, legitimate pain generators supported by objective findings (multiple imaging studies and range of motion deficits) and pain syndromes linked to known diseases. She was a high risk, complicated case, often in crisis, requiring intensive, complex management. For that reason, she was monitored closely using techniques and methodology consistent with the standard of care (Chronic Pain Network, and other recognized pain management associations) including those recommendations and policies of the Washington State Osteopathic Medical Board of Health. She was managed under a pain management contract from the first prescription of an opioid. Her pain contract was then modified and updated regularly, with her signature, every time there was a significant change in the medication, and/or location of her pharmacy. Copies of her pain contract were copied and sent to the pharmacy. Her pain management contract was a three-way agreement – her doctor, her pharmacist, and herself. There was constant and frequent communication between the doctor and the pharmacy. She was seen face to face at the clinic and reevaluated for pain at least every two weeks and sometimes more if there were reasons to change management program in concert with changing conditions or symptoms. She was required to keep her medications under lock and key (Exhibit No. F0253) and was provided with a special, lockable fanny pack device which she could carry on her person for medication security. There were times when she was also required by the doctor to keep her medication supplies (opioids) at the clinic in the safe when her home was deemed insecure (Exhibit No. F0515). She was monitored frequently when her conditions were worsening, for example, during June of 2005, and was reminded of the risks of overuse (Exhibit No. F0229). Multiple types of pain management techniques were used including non-narcotic Cox2 NSAIDs for short periods of time, homeopathics (Rhus toxicondrum 30X), osteopathic manipulation treatment (OMT), Lidoderm patches, hot packs, injection therapies, including muscle trigger point injections, joint injections, stretching, specialized exercises, pain management psychology counseling and others. 24

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.14 that you: “Failed to consider lab tests in treatment plans”. How do you answer this Charge? A: I deny this Charge. See multiple labs for this patient, which were considered on an ongoing basis for both short and long-term treatment plans (see Exhibits Nos. F0410 to F0490; F0373.1-F0373.31). These are all exhibits that are contained in the electronic medical record system. See also lab results summarized by Dynacare as a separate, all-inclusive report (Section). Patient F labs including screening for treatment efficacy, medication and treatment side effects, fluctuations in disease severity, and patient compliance (numerous unannounced urine drug screens), were used extensively for the purpose of planning and changing treatment plans on an ongoing basis. An example of how lab results were followed closely and used to direct treatment plans is contained in the chart note for the encounter 03/23/2005. This was following the patient’s departure from a hospital stay when a low potassium obtained during hospitalization was noted in the hospital discharge records. Upon presentation at the clinic, patient was evaluated again for possible hypokalemia on 03/23/2005 with a blood draw that also screened for adverse effects of multiple medications (CBC and the liver enzymes) in addition to urine bacteriology – culture and sensitivity, and an unannounced urine drug screen (Exhibit No. F0308 and F0306). On 05/09/2005, when Patient F showed signs of instability, blood work was used to evaluate the underlying cause (Exhibit No. F0288). On 05/10/2005, there is reference to using labs to confirm and treat UTI when labs indicated resistance. At that point, additional labs were ordered (Exhibit No. F0285) and action was taken based on lab culture results (Exhibit No. F0280).

Q: The Statement of Charges alleges with respect to Patient F in paragraph 1.16 that: “The patient was treated in a setting involving girlfriend/boyfriend relationship with no consideration to med sharing or diversion”. How do you answer this Charge? A: I deny this Charge. There is absolutely no evidence that I did not consider that situation. Patient F and Patient G were officially engaged and living together as husband and wife. There were financial/legal reasons why they 25

were not married. They were counseled regarding the security of their medications in the same manner as other patients in my practice who are husband and wife. They were required to maintain a secure place for their medications, which were not accessible to the spouse. They were required to be in a lockable safe to which the other party had no knowledge or access to the combination. At times when this couple was relocating, Patient F was required to maintain her medications in the clinic safe and these were dispensed into daily medication dispensers on a weekly basis for the purpose of increasing security (Exhibit No. F0101, F0102, and F0319). Within the practice, my patient records utilize sophisticated electronic medical technology capable of electronic pill counting accurately. Witnessed medication counts were used whenever medications were dispensed to Patient F in the clinic environment. Witnessed urine testing was used in the clinic, by clinic staff. All reasonable safeguards were taken. There was no evidence that Patient F ever abused or diverted her medications through her significant other. When there was evidence of her medications becoming insecure, action was promptly taken. When there was an indication she was sending someone else to the pharmacy to pick up medications I acted and ordered “only patient may sign to receive medications” (Exhibit No. F0290).

Their pain issues were managed in a manner that encouraged and promoted honesty and trust between them, individually and together, and me as their doctor.

Q. For each of the applicable Standards under which opioid usage is to be evaluated as set forth in the Board’s 2002 Guidelines for Management of Pain, do you have specific chart notes and Exhibits that you believe document your compliance with each such Standard for Patient F? (Yes)

Q: Would you please share with us that information. (Read summary table)