Disciplinary Action Withdrawn
against Robert Sinaiko, M.D.
Stephen Barrett, M.D.
In September 1999, as shown below, the Medical Board of California concluded that Robert Sinaiko, M.D., had "departed from the prevailing standard of practice of medicine" by using antifungal drugs and other questionable methods to treat three adults and a nine-year-old child for nonexistent "Candida" problems. Sinaiko was assessed $49,472.79 for administrative costs and placed on five years' probation with stringent supervisory conditions. On November 5, 1999, the San Francisco Examiner reported that Sinaiko had "permanently" closed his office. However, in September 2004, a California appeals court concluded that the medical board should have admitted testimony from Sinaiko's expert witnesses, and it returned the case to the board for further consideration. By that time, Sinaiko had been out of practice for more than five years; the composition of the medical board had changed; California had a new law relating to the practice of "alternative medicine"; and the board apparently became concerned that if it pursued the case and was not successful, Sinaiko might sue to recover his legal expenses. In 2005, Sinaiko and the board entered a settlement agreement under which Sinaiko agreed not to sue and the board (a) withdrew the original accusations, (b) vacated its previous decision, and (c) restored Sinaiko's medical license to "good standing." The following documents provide further insight into what happened.
- Transcript of oral arguments that the board considered in 1998
- California Court of Appeals decision (2004)
- Settlement Agreement (2005)
- San Francisco Examiner archives (Select "Chron and Exam" in "Paper to Search," chose the year, and enter "Sinaiko" in the "Keywords to Search" box)
DIVISION OF MEDICAL QUALITY
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA
In the Matter of the Accusation Against:
ROBERT SINAIKO, M.D.
Physician's and Surgeon's
No. 13 93 28495
OAH No. N 9611106
DECISION AFTER RECONSIDERATION
This matter came on regularly for hearing before Ruth S. Astle, Administrative Law Judge of the Office of Administrative Hearings, at Oakland, California on January 5, 6, 7, 8, 9, 12, 13, 14, 15, 26, 27, 29, 30, February 2, 3, 4, 5, 10, 11, 13, 17, 18, 19, 20, 24, and 25, 1998. Complainant [The MBC] was represented by Alfredo Terrazas, Deputy Attorney General. Nancy Cahill represented respondent for part of the proceedings, and respondent represented himself for part of the proceedings. Oral and documentary evidence was presented and the record was closed and the matter was submitted on May 14, 1998.
On July 15, 1998, the Administrative Law Judge submitted her proposed decision. Thereafter, the Division of Medical Quality, Medical Board of California (hereafter "division") adopted said proposed decision on August 4, 1998, with an effective date of September 3, 1998. A petition for Reconsideration under Government Code Section 11521 was filed in a timely manner by respondent and the effective date of the decision was stayed until September 14, 1998. On September 11, 1998, the division issued an Order Granting Reconsideration as to the issue of penalty. On October 13, 1998, the division issued a Notice of Time for Oral Argument. On November 6, 1998, the division considered oral and written argument as to its September 11, 1998, Order Granting Reconsideration. On November 9, 1998, the division issued an Order Modifying Reconsideration and subsequently issued Order Fixing Date for Submission of Written Argument. On June 30, 1999, the division issued a Notice of Hearing for Oral Argument. On July 30, 1999, both parties presented oral and written argument before the division. The time for filing written argument in this matter having passed, written and oral argument having been presented by both parties, the entire record having been read and considered, the division, pursuant to Government Code ßß11517 and 11521, and Business and Professions Code ß2335, hereby makes the following decision and order:
FINDINGS OF FACT
- Complainant Ron Joseph filed the accusation in his official capacity as Executive Director of the Medical Board of California (Board) and not otherwise.
- On March 26, 1973, the Board issued Physician's and Surgeon's Certificate No. G 24199 to respondent Robert Sinaiko. As of the date of the filing of the Accusation, this certificate was current.
(a) AMPHOTERICIN B (trade name Fungizone) is a polyene macrolide anti- fungal, antibiotic derived form [sic] Streptomyces nodosus, a soil actinomycete. Amphotericin B is not active against bacteria, rickettsiae, or viruses. The intravenous form is specifically intended to treat potentially life-threatening fungal infections which, prior to the availability of this drug, were almost always fatal.
At the time of the prescriptions related to this matter, the drug had been approved in intravenous and topical form (cream, lotion, and ointment containing 3% of Amphotericin B), but was not approved in any oral form by the Federal Food and Drug Administration. Amphotericin B, in the oral form, was not on the Approved Drug Products with Therapeutic Equivalence Evaluations which identifies drug products on the basis of safety and effectiveness by the Food and Drug Administration under the law.
The Physicians Desk Reference (PDR) 1996 Edition, Supplement A/1996, for the first time advertised the availability of Fungizone (trade name Bristol-Myers Squibb for Amphotericin B oral suspension), a "swish and swallow" medication, indicated for the treatment of oral candidiasis.
(b) BETA-GLUCURONIDASE - derived from abalone digestive hump, is a glucuronidide-splitting enzyme found in liver, spleen, and certain tissues of the endocrine and reproductive systems. It is found in fish liver, snails, mollusks, and some insects. Neither CDER (Center for Drug Evaluation and Research) nor CBER (Center for Biologics Evaluation and Research) has received an application for approval for the use of this enzyme in a human drug or biological product.
ENZYME POTENTIATED DESENSITIZATION (EPD)
(c) EPD is an experimental immunotherapy treatment "vaccine" based on the theory that using Beta-Glucuronidase as a biological response modifier alters the immunological response to antigen(s) in man and four species of animals (mouse, rat, guinea pig and dog), and that ultra-low (homeopathic) doses, via intradermal injection, of activator (Beta-Glucuronidase) and antigen(s) (allergens) can be used for multiple conditions involving allergy and immune dysfunction.
MINOR PATIENT L.T.S.
- L.T.S. was a male patient born May 15, 1984. He was first seen as a patient of family practitioner Gloria Vreeland, M.D. on June 28, 1991. He was seven years old at the time and was seen for a complaint of a rash on the buttocks and upper thighs. Patches of dry skin were observed, diagnosed as probable eczema and the use of Hydrocortisone lotion/cream was recommended for this condition. Respondent uses this diagnosis to support his belief that the patient had a history of allergies.
- On April 28, 1993 L.T.S. was taken to a child testing and counseling center, (Lifeline Testing and Counseling Services), where he underwent multiple tests administered by Lisa I. Zottnick, M.S., CET (Certified Educational Therapist). [Now known as Lisa Van Allen]. The tests administered were standard developmental and behavioral tests commonly performed in the evaluation of children for behavioral and learning disabilities. The patient was taken to the testing service by his father. As a result of these tests and other diagnostic procedures the patient was diagnosed with Attention Deficit Hyperactivity Disorder (ADHD).
- On April 29, 1993 the minor patient was prescribed a low dose of Ritalin for ADHD by an associate of Dr. Vreeland substituting for her while she was out on maternity leave.
- On May 12, 1993, L.T.S. was taken by his mother to see respondent. Respondent is an internist/allergist. The patient was almost 9 years old. Respondent was told that the patient had been prescribed Ritalin, 5 mg, twice a day for ADHD. Respondent was also advised by the child's mother, that the patient was "jittery" on Ritalin. Additionally, respondent was advised that while school problems continued to exist for L.T.S., the mother reported that "they weren't severe to begin with." Further, respondent charted that the child's emotional problems were now due to a custodial battle between the parents. Following a physical examination, respondent noted his impression of L.T.S. to be "ADDH-Mild" (circled) (sic) with a notation to "R/O allergy process." Respondent's plan, therefore, was for the child to undergo an "IgG Food & Mold MAST," to "continue Ritalin for now at present dose" and to return for a follow-up appointment in 2 to 3 weeks.
- As a result of respondent's instructions, the minor L.T.S. had an IgG-Specific MAST Panel performed on May 18, 1993.
- On May 24, 1993 during an office visit L.T.S.'s father advised the child's physician, Dr. Vreeland, that the "Ritalin is helping...Thinks that school might verify that it has been helpful." On the same day, Dr. Vreeland also discussed the patient's medication progress with the mother and advised her to continue the Ritalin at the prescribed dosage and "report progress." The examination of the child was charted by Dr. Vreeland to be completely normal on this date.
- Minor patient L.T.S. was next seen by respondent on June 1, 1993. The patient was taken to see respondent by his mother and her husband, Bryce (the boy's stepfather).
- Close to the time of the June 1, 1993 visit, respondent reviewed the allergy testing results from the IgG-Specific MAST Panel performed on May 18, 1993 and respondent began a course of treatment for minor patient L.T.S. which included an elimination (replacement) diet and an oral antifungal medication, Amphotericin B. Respondent prescribed 250 mg capsules, number 100. There is no notation in the records as to what decision was made, if any, regarding the Ritalin prescribed by the patient's physician. The child's mother used the summer vacation to provide L.T.S. with a "medication holiday."
- Amphotericin B was not then a drug approved for oral administration in a solid pill, capsule or tablet form by the Federal Food and Drug Administration (FDA), for any medical purpose, and is a dangerous drug as defined by law.
- On June 8, 1993 the patient's family practitioner, Dr. Vreeland, discussed the patient with his school teacher. The child was described as different on the Ritalin, more lethargic, whereas previously he had been "active, impulsive, (a) temper problem" and the teacher's "most difficult student - discipline problem." He was also described as not eating lunch lately; yet, his medical records from Dr. Vreeland's office indicate that he had gained about 4 pounds in the three weeks previous to June 11, 1993.
- On June 11, 1993, the patient's physician, Dr. Vreeland, consulted with the minor patient's father. The patient's father advised Dr. Vreeland about his concerns regarding the "herbal" medicines and syrup ("Calm Child Herbal Syrup") given to his son by the child's mother. On this same date Dr. Vreeland prepared a letter, addressed "To Whom It May Concern," wherein she expressed her concerns regarding the prescribing of Amphotericin B to the minor patient. In her letter, Dr. Vreeland references Goodman and Gillman, a standard pharmacological text, and describes that in over 80% of persons prescribed the intravenous version of this drug decreased renal function and abnormal urine sediment developed. Further, she indicated that the literature described many other serious complications as possible with the taking of the medication. Dr. Vreeland then quoted from the text stating:
"All patients requiring Amphotericin B (injectable) must be hospitalized, at least for the initiation of therapy, and they must be under close observation through a course of systemic administration of the drug." It should be noted that respondent was not using the injectable form of Amphotericin B, but an oral form which Goodman and Gillman indicates is not well absorbed by the intestines. Dr. Vreeland concludes by opining that respondent's form of therapy could be considered child endangerment and urges the discontinuance of the medication.
- Sometime after June 15, 1993, the patient's medication regimen was changed from oral Amphotericin B to oral Nystatin, as the antifungal medication. The patient's father had obtained a court order to stop the Amphotericin B prescribed by respondent.
- On June 15, 1993 Dr. Vreeland ordered a Complete Blood Count (CBC) and a serum IgE (an indicator of systemic allergy) for the minor patient L.T.S. The patient was also referred to a Board Certified allergist for an evaluation by Dr. Vreeland.
- On June 16, 1993 the CBC and IgE testing reported, in relevant part, normal values.
- On June 29, 1993 respondent again saw minor patient L.T.S. in his office. Respondent noted that the patient had been off Ritalin for three weeks and that he "seemed better off Ritalin." The chart does not note the source of the medication history, any attempts by respondent to independently verify the information or who ordered that the Ritalin be stopped. Respondent noted that the patient was taking Nystatin, two capsules three times a day, and that the Amphotericin B was stopped due to "some family concern about non-FDA formulation." Respondent's noted impression again was one of ADDH (sic) with "? (sic) allergic basis-molds? foods?" per the medical records. Due to nausea and gastric upset, respondent decreased the Nystatin to one capsule three times daily with foods.
- On July 15, 1993 the minor patient was seen by Nathan Schultz, M.D. at the Allergy & Asthma Medical Group of Diablo Valley. He was seen as a result of the referral of Dr. Vreeland for an allergy evaluation.
- On July 19, 1993 Dr. Schultz noted in his written report to Dr. Vreeland, that the patient was brought to the appointment by his father and that the father brought with him a report from Lifeline Testing and Counseling Services completed by Lisa Zottnick, M.S., C.E.T. Dr. Schultz noted Lisa Zottnick's impression that the patient met the criteria for ADHD. The patient's father also reported to Dr. Schultz that for this diagnosis or the diagnosis of learning disabilities, the minor was first treated with Amphotericin B and then with Nystatin. In addition, Dr. Schultz also noted that following food testing (IgG MAST test), a specific food elimination diet was recommended. The expert testimony established that the IgG MAST test was not accepted as a valid diagnostic test for a minor patient with a diagnosis of ADHD. The IgG MAST test is for serious allergic conditions such as serum sickness and certain forms of hypersensitivity pneumonitis. Following a family history and physical examination, Dr. Schultz stated his impression that the minor patient showed no evidence of allergic disease, advised that the patient could discontinue the use of Nystatin and further instructed the father to liberalize the patient's diet. Dr. Schultz concluded that he did not think that any further allergy evaluation of the patient was necessary.
- On August 26, 1993 minor patient L.T.S. was seen, together with his mother, by Michael Levin, M.D., Behavioral and Developmental Pediatrics, for an evaluation. On August 31, 1993 Dr. Levin also met with the patient's biological father who provided some additional information about his son. The evaluation consisted of a semi-structured psychiatric interview with the patient and his family which covered past medical, psychological, and family histories; a structured clinical child interview and physical and neurological exams concluding with a presentation of clinical impression and recommendations. Dr. Levin's impression was that he felt that the patient met the criteria for Undifferentiated Attention-Deficit Disorder (UADD) and Oppositional and Defiant Disorder (mild to moderate). Dr. Levin described the UADD as follows:
"Under the old DSM-III classification this condition was identified as Attention-deficit Disorder without Hyperactivity. For this condition the over-focusing might be the characteristic feature and these children tend to have difficulties shifting attention in contrast with hyperactive children who tend to under-focus and have difficulties sustaining attention."Among the recommendations made by Dr. Levin was that the patient stop Nystatin "as this medication has no documented effect on attention or behavior" and that a four week placebo controlled study be initiated concerning the Ritalin "in order to obtain unbiased information about the cognitive and behavioral effects of Ritalin and any possible side effects." He also recommended, among other things, that the parents undergo parental training on the principles and techniques of behavior modification and individual psychotherapy for the minor.
- In diagnosing, caring for and treating minor patient L.T.S., respondent is subject to disciplinary action in that respondent did so in a repeatedly negligent manner. It was established by clear and convincing evidence that the use of IgG Food and Mold MAST testing ordered by respondent during the initial office visit is an inappropriate test for minor patients with a diagnosis of ADHD and does not meet the standard of care for diagnosis and treatment of the minor patient L.T.S.
- The use of any antifungal medication based on the diagnosis of ADHD and/or the history and physical examination of this patient was a departure from the standard of practice. * [Footnote: The asterisks (*) in this document denote matters which are negligent, do not meet the standard of practice and are aggregated together as repeated negligent acts which constitutes unprofessional conduct under 2234(c) of the Business and Professions Code.]
- Prescribing an oral formulation of Amphotericin B without a diagnosed indication was a departure from the standard of practice.*
- Respondent went outside of the prevailing medical standard of practice for the treatment of minor children with ADHD. According to the respondent he did not diagnose the ADHD although he did characterize it as mild without medical evidence for that characterization. Based on this, the history and physical exam that respondent recorded were within the standard of practice. While it may be acceptable to take another professional's diagnosis (in this case of ADHD) at face value and set a treatment plan based on that diagnosis, it is not within the standard of practice to then use unproven diagnostic methods to determine if an unproven fungal infection was the cause of the patient's behavioral problems. Respondent's claim that he was not treating the patient but attempting to diagnose him by using the Amphotericin B and then stopping it and then using it again to see if there is any pattern of change is a departure from the standard of practice* because there is no way that respondent can ever know if using an antifungal medication has any effect on the behavioral problems of a child diagnosed with ADHD who is also being treated with Ritalin
- Patient J.H., a then 22 year old male, was first seen by respondent on April 3, 1986 for a number of complaints. On April 4, 1986 the patient was seen by respondent for the remainder of his work-up. The initial diagnoses of respondent were, among other things: right maxillary sinusitis; seborrheic dermatitis, related to fungal allergy; mild seasonal allergic rhinitis; mild allergy causing "sinus blockage"; and flu-like symptoms and rash secondary to "candida colonization of [the) gut; allergic dietary yeast; and Eustachian Dysfunction." For the diagnosis of "increased" Candida colonization of the intestinal tract the patient was placed on a special diet and various forms of Nystatin; nose spray and oral.
- On April 18, 1986 the patient was next seen by respondent who continued the patient on a "candida control diet" and noted that the patient's chest rash was completely gone and that he was off of milk products. He was continued on oral Nystatin by respondent and it was noted that the patient was without "ill-effects" from Nystatin nose spray. Patient J.H. next saw respondent on June 10, 1986 when he was placed on immunotherapy for dust. Included in the diagnostic evaluation was testing with materials such as auto exhaust and newsprint. On August 18, 1986 the patient called and stated that he was not doing well on Nystatin so the patient, himself, doubled the dose, as he had previously been instructed by respondent, also without much improvement. Patient J.H. was continued on oral Nystatin powder, with dose variations, from his first appointment of April 4, 1986 to his appointment of October 7, 1986, when, after noting that the patient's tongue had been coated for 2 to 3 days, Candida testing was added. The patient saw respondent for appointments on October 13 and 22, 1986. It was during the October 22, 1986 office visit that the Candida testing was administered via injection. The patient called respondent on October 30, 1986. On November 6, 1986 patient J.H. next saw respondent and stated that he had no symptoms on the weekly Candida immunotherapy and the dosage was increased to two times per week. On December 4, 1986 patient J.H. was continued on twice weekly Candida immunotherapy, without a planned dose chance at that time, and on March 16, 1987 his Nystatin was refilled. On December 7, 1987 he was switched from 1/4 teaspoon of Nystatin powder to Nystatin tablets, #280 "prn" (take as needed). On January 25, 1988 patient J.H. was still on Candida and dust immunotherapy and on February 5, 1988 a new prescription for Nystatin tablets #500, was provided for him. On August 8 and 15, 1988 the patient complained that he felt very tired and "spacey" after immunotherapy. Dosage adjustments were made. On November 21, 1988 the patient reported a history of coryza (acute catarrhal inflammation of the nasal mucous membrane accompanied by profuse nasal discharge) and post-nasal drip for two weeks. Respondent attributed these symptoms to increased fungal sensitivity and ordered a MAST test. The patient also reported that his tongue has been severely coated but it is better on acidophilus. On examination the tongue was noted to be coated with a cream-colored material that was easily scraped off. On December 5, 1988 the patient's tongue was noted to be clearer. On examination there was a very minimum white exudate on the posterior 1/3 of the tongue. Respondent attributes the problem initially to a dose of systemic steroid given to the patient in the back, by way of a block, by another physician.
- On May 10, 1990 and again on July 20, 1990 the patient had his prescription for the antifungal, Nystatin, refilled. On February 12, 1992 patient J.H. was noted to have become "very chemically sensitive." There was also a comment on his osteoporosis. He was noted to have some constipation and stools that float. Respondent noted in the chart that the patient's "candida" symptoms were better on a combination of diet, pancreatic extract and continued Nystatin. The patient according to the note complained of headache, "sinus blockage" and the gradual onset of "debilitative" fatigue. The patient noted an increase in his symptoms provoked by various odors. On examination the patient was noted to look "worn out." Respondent noted that "he came in and went immediately to an open window, put his face to the fresh air." The physical examination was unremarkable and the impression was "r/o malabsorption secondary to hypersensitivity disease of the gut." Among the tests ordered was a stool for ova and parasites.
- On March 4, 1992 patient J.H. returned and the positive stool culture for Blastocystis hominis was noted. The patient was started on Flagyl for 10 days. He was given Tigan to use "prn" for nausea. The dosage of Nystatin was also increased.
- On March 18, 1992 the patient called and reported "increased sensitivity problems" and was prescribed Diflucan, an anti-fungal agent. One week later, March 25, 1992, the patient reported increased problems on Flagyl and he had been off it for 11 days. On examination he appeared "worn out" but breathing room air without problems. It was noted that he would be starting EPD in April. On June 10, 1992 it was noted that the patient would receive his third EPD injection.
- On August 18, 1992, the patient complained of labored breathing with air pollution. It was noted that he was seen in the emergency room and given a shot of steroids. Pulmonary function tests this date were normal.
- September 16, 1992 it was reported that he became short of breath and diaphoretic in response to something that the family put in the back yard to keep cats out. Respondent also noted that the patient reported that he was no longer experiencing night sweats and that his "bowels move normally now." It was also noted that on this date he received his third EPD injection. Respondent's treatment plan was noted to be to "Continue EPD and to return in 3 months."
- On December 16, 1992 it was noted that while he was in the office for his fourth EPD injection, there was no improvement with the third dose of EPD. He was noted to be doing well with homeopathic treatment by another practitioner and that he has not made an appointment with Dr. Al Levin, although Dr. Levin's specialty was not mentioned. Respondent's treatment plan was noted to be to "continue EPD and to return in 6 months." On March 15, 1993 the patient reported that he was doing much better, a fifth EPD injection was administered and the chart concluded with the notation that the fourth EPD injection was helpful. On March 25, 1993 the patient called respondent's office and reported that he was better and he was told to continue "nutribiotic" at 1 daily and to build to 1 "tid." On April 1, 1993 a final telephone call from the patient was recorded indicating that he was not doing well, has not tried "nutribiotic" and has had diarrhea the entire week. He was noted to be on Nystatin, vitamins and Benadryl to sleep and that he was now sensitive to the foam pad on which he sleeps. The entry concluded with the notation that the patient "try off the Nystatin" (sic) and on the "nutribiotic" and that "if the symptoms persist, consider a change to oral Amphotericin B." Shortly thereafter the patient moved from California to the Tucson, Arizona area.
- The standard of care for a Board-certified allergist/immunologist is to have knowledge of microbiological agents that cause immunological disease. In this instance, it is the standard of practice to know which agents have not been demonstrated, through adequate scientific investigation, to cause immunological disease. Among the patient's initial diagnosis is respondent's finding of "flu-like illness and rash secondary to candida colonization of gut." The rash is later diagnosed as seborrheic dermatitis. Respondent's determination of the etiology of the rash, i.e., that the presence of fungus, Candida, in the intestinal tract can cause the symptoms noted constitutes a departure from the standard of practice of medicine in California.*
- Respondent's diagnosis that there was a "colonization" of the intestinal tract of the patient, without objective data to support that conclusion, particularly when Candida is normally found in the intestinal tract and in the noted usual numbers without causing human disease constitutes a departure from the standard of practice of medicine in California.*
- Despite the lack of objective medical data that this patient, in fact, had a Candida "colonization of the gut" or that this was the source of the rash or seborrheic dermatitis (or any other symptom for that matter) diagnosed by respondent, and based on no other appropriate physical or diagnostic examination, respondent nonetheless diagnosed the patient as requiring an oral anti-fungal agent, Nystatin. Further, respondent prescribed the medication over an uncertain but very long period of time which, without clear indication and without significant information regarding the efficacy of it for the clinical situation of a "rash," constitutes clearly excessive prescribing. It is also a departure from the prevailing standard of practice of medicine among, the community of California licensed physicians and surgeons.*
PATIENT S. L.
- Respondent first saw female patient S.L., d.o.b. December 15, 1956, on March 28, 1986. The patient reported that after a laparoscopy in July of 1985 she developed hallucinations and a severe confusional state while working in a sealed office with many smokers. Since that time she reported persistent symptoms of nausea, depression, short term memory deficit, fatigue, and tingling and numbness in her right arm. However, further in the history, the patient attributes the onset of her symptoms to a flu-like illness contracted while she was a student at Michigan State University in 1977. On March 28, 1986 a number of tests were ordered by respondent including, thyroid function tests and titers for Epstein-Barr Virus (EBV). At the conclusion of this appointment, respondent placed the patient on a "Candida control diet." A physical examination was performed on April 30, 1986 and abnormal antithyroid microsomal antibody tests were noted. The diagnosis listed by respondent were: 1. Auto-immune thyroiditis; 2. Chronic G.I. Candidiasis; and 3. Food and Chemical Symptoms by history and work-up of Theron Randolph, M.D.; and 4. Chemical sensitivities secondary to numbers 1 and 2, above.
- The patient was next seen on June 3, 1986. It was noted by respondent that she had been seen by a neurologist who phoned for the results of respondent's laboratory tests. Respondent noted in the patient's chart that she was "now on Nystatin 1/4 tsp. b.i.d." Respondent further noted that there was no "die-off' reaction with starting Nystatin and that there was no improvement with Nystatin. Therefore, respondent notes that the patient is unlikely to have "chr. NIFE 2 degree candida." Respondent's diagnosis now was: 1. Auto-Immune thyroiditis; and 2. Food and Chemical sensitivity secondary to diagnosis #1. A thyroid scan was ordered at the conclusion of the appointment. Subsequently, when an abnormal thyroid function result was obtained, the patient was started by respondent on thyroid medication, Synthroid, for two weeks beginning on July 10, 1986.
- On a subsequent return visit on July 18, 1986 the dosage of thyroid was increased as there was no change in symptoms. Respondent noted continued "GI upset." The symptoms which were listed were weakness, diarrhea, headache, hot flashes, diaphoreses, tremor and dizziness. Respondent also noted that the Nystatin was helpful and the patient seemed less depressed. Respondent now listed "G.I. Candidiasis," in addition to "Hashimoto's Thyroiditis" as his diagnoses, with food and chemical sensitivity secondary to both of the others. The record failed to document the reason for the differences in his opinion of June 3, 1986 with the opinion of this date.
- As the result of what was described as a "situational depression" the patient was referred by respondent to a psychiatrist, Dr. Gladys Bennett, on September 2, 1986. On September 15, 1986 the thyroid (Synthroid) dosage was reduced when the patient complained of heart palpitations. On November 3, 1986 there was a note that the patient remained depressed and that the psychiatrist had placed the patient on Sinequan (a brand name for doxepin HCl; it is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents recommended for the treatment of patients with depression and/or anxiety) and Moban (a brand name for molindone hydrochloride, indicated for the management of the manifestations of psychotic disorders).
- The patient was next seen on January 23, 1987. On this visit she was still feeling depressed and was switched by the Santa Clara County Mental Health Department to a different anti-depressant, Desipramine, after weight gain on Sinequan. On this date the patient was noted to be very fatigued and was noted to have bilateral non-tender lymphadenoathy. A diagnosis of "probable chronic mononucleosis-like syndrome" was made and the patient was started on Zovirax (a trade name for Acyclovir, an antiviral drug; indicated in the treatment of initial episodes and the management of recurrent episodes of genital herpes, acute treatment of herpes zoster (shingles) and chicken pox (varicella)). It should be noted that titers for EB virus were done in March of 1986 and were negative. The patient was started on Zovirax, 200 mg, 1 cap, 5 times per day.
- On April 13, 1987 the patient has "PFC's (sic) (Premature Ventricular Contractions) with pulse testing to Glutamine, Coumadin, Gallic acid (sic) and Rutin." On April 19, 1987 it was noted that the patient has been using Rutin for a week and there was no longer wheat craving. By June 3, 1987 the wheat craving was relieved.
- On February 22, 1988 Zovirax was discontinued by the patient because of the cost. There was a note that there were no increased symptoms after cessation of the drug. Also on this date, the patient complained of nausea and emesis. An upper GI x-ray was ordered, and when it returned negative a CAT scan of the abdomen was ordered.
- On April 6, 1988 the patient reported that the Gastrointestinal symptoms disappeared on a trip to Charlotte, North Carolina and returned promptly upon returning to the Bay Area. Respondent's notes recorded that the patient was still on Nystatin. According to the record the patient was started on Nystatin on July 8, 1986 and the record contained no note indicating it was ever discontinued.
- In diagnosing, caring for and treating patient S.L., respondent was repeatedly negligent in that it is the standard of care for a Board-certified allergist/immunologist to have knowledge of microbiological agents that cause immunological disease. In this instance, it is the standard of practice to know which agents have not been demonstrated through adequate scientific investigation to cause immunological disease. There is no scientific evidence that the existence of variable levels of Candida in the gastrointestinal tract can cause such a wide variety of somatic and psychological symptoms as noted for patient S.L. It is the standard of care to establish, based on objective data or a significant clinical pattern, that a particular disease exists. Respondent's diagnosis and treatment of a non-existent disease and conclusion that the presence of the fungus, Candida, in the intestinal tract can cause the symptoms noted in patient S.L. constitutes a departure from the prevailing standard of practice expected among the community of California licensed physicians.* Also, at the time of treatment of this patient, and subsequently, there have been no well controlled clinical studies to document this clinical entity or belief. Any reports that this condition exists have been anecdotal at best. This is particularly true in the case of chronic infection. Respondent's diagnosis and treatment of a non-existent disease and that the presence of the fungus, Candida, in the intestinal tract can cause the symptoms noted in patient S.L. demonstrate a fundamental lack of knowledge or skill by respondent in performing his professional medical obligations and also constitute a departure from the prevailing standard of practice expected among the community of California licensed physicians.*
- Despite the lack of objective data that the patient, in fact, had a Candida "colonization in the gut" or that this was the source of her constellation of symptoms, and based on no other appropriate physical or diagnostic examination/information, respondent diagnosed the patient as requiring an oral anti-fungal agent, Nystatin. Further, respondent prescribed the medication over an uncertain but very long period of time beginning on June 3, 1986 and going until April 6, 1988 which, without clear indication and without significant information regarding the efficacy of this drug for the clinical situation constitutes both clearly excessive prescribing and negligence. It is a departure from the prevailing standard of practice of medicine in California.*
- When respondent initially saw patient S.L., on March 28, 1986, he ordered an Epstein-Barr Virus titer, which was performed and resulted in a negative finding. This virus causes mononucleosis. Beginning as early as September 2, 1986, respondent records a diagnosis that the patient was situationally depressed, patient had phoned the suicide crisis center on two occasions within the previous week. Yet, on January 23, 1987, without any other indication or corroborating laboratory data to indicate a change of clinical status, respondent placed the patient on an anti-viral drug, Zovirax, and continued the medication until December 14, 1987. The use of this anti-viral drug for 11 months without clear clinical indication and demonstrated efficacy in treating mononucleosis or any other disease caused by Epstein-Barr Virus with Zovirax constitutes a departure from the prevailing standard of practice of medicine* and also constitutes clearly excessive prescribing. It appears from the record that the only reason the Zovirax was discontinued was because the patient could no longer afford it.
- Respondent's diagnosis that there was a fungal Candida "colonization" of the intestinal tract of the patient and that she also required the sustained use of both an anti-fungal medication (Nystatin) as well as an antiviral medication (Zovirax), without objective data to support his conclusions, a departure from the prevailing standard of practice of medicine expected among the community of California licensed physicians and surgeons.*
- Male patient R.S., 24 years old at the time, was first seen by respondent on September 26, 1990, complaining of sinus pressure since age 10 or 12, and over the past 2 or 3 years, a sensation of sinus blockage and postnasal drip. After a history and physical examination were performed, respondent's impressions were: 1. "Chronic Sinus Blockage; 2. Monilial Enteritis; 3. Noradrenergic depletion, due to chronic infection (monilial enteritis), with fatigue, cognitive symptoms, and failure of the sympathetic innervation of the upper respiratory tract; and 4. Milk Allergy (leading to upper respiratory hypersecretion) by history." For these disorders respondent prescribed a rapidly-tapered dose of Prednisone; Diflucan, 100 mg daily for 30 days, and Nystatin, 2 tablets, 3 times a day. In a letter to the referring physician five days later, October 1, 1990, respondent summarized the symptoms as "sinus" blockage, postnasal drip, "dull" occipito-frontal headaches, sore throat when tired, and sporadic bouts of inappropriate fatigue. Under the "Discussion" portion of his letter, respondent stated: "I do not think the majority of R.'s allergic-like symptoms are due to common inhalant sensitivity. The refractoriness to common treatments (and some not-so-common ones) is more in favor of abnormal sensitivity to something he is in contact with through his alimentary tract. The abdominal tenderness supports this impression, and suggests there is an ongoing inflammatory process in the gut. That this is more likely infectious than strictly allergic is supported by the significant tenderness and by the low grade fever (though it is hard to know what to make of such a minor temperature elevation found on an isolated occasion). The use of tetracycline for acne in his teens, and more recent use of Flagyl for Giardia, favor Candida as the infectious agent. To the pharyngeal sensitivity to environmental molds (increased symptoms when he used a humidifier in boulder (sic) -- those things really put out a lot of mold spores), his symptoms can be explained on the basis of sensitization, by monilial enteritis, of his Mucosal-Associated Lymphoid Tissue (MALT), to mold antigens." The patient had reported to respondent the use of two courses of Flagyl that he received in November of 1986 and again a few months later, in early 1987 (four years prior to treatment by respondent), for a Giardia infection. This past medical history, according to respondent, favored a gastrointestinal infection with Candida as the present infectious agent. On several dates in October the patient called respondent for further Prednisone.
- The patient was next seen on October 24, 1990. At that time respondent recorded that the headaches and nasal symptoms had improved as well as the fatigue. There is also no diarrhea and rectal itch. The patient still complained of feeling bloated. On examination, the abdomen was diffusely tender. On this basis, respondent suspected the presence of chronic amebic disease or persistent parasite. Respondent prescribed Atabrine (indicated for the treatment of Giardiasis and Cestodiasis; i.e., tapeworm), 100 mg t.i.d. for one week with specific warning, of possible CNS (Central Nervous System) side effects; Yodoxin (used in the treatment of intestinal amebiasis), 650 mg. t.i.d. for 20 days and the continuation of Diflucan and Nystatin.
- On November 5, 1990 there was a note that the Atabrine was finished and Yodoxin was discontinued two days ago. Specifically, there was no mention of hallucinations or other CNS side effects. Respondent charted that after drinking alcohol, while also taking Atabrine the patient reported that he "felt strange." The patient was encouraged to resume the Yodoxin and to avoid alcohol. Two weeks later, on November 19, 1990, the patient states "I'm definitely better." At this time he was on Prednisone every other day. He was told to finish the Yodoxin and Diflucan. He was once again started on Nystatin and placed on Flagyl for ten days.
- On December 7, 1990 the patient calls stating that he has finished his medications except for Nystatin and Prednisone and his "sinus" problems had returned. His Nystatin was continued and his Prednisone increased.
- Patient R.S. returned on January 16, 1991 and reported that his "stomach and sinus" problems were improved and that, among other things, he has discontinued the Nystatin. On examination there is slight abdominal tenderness noted and the patient is placed back on Nystatin.
- On February 6, 1991 patient R.S. was started on sublingual drops for house dust mite sensitivity. On the next visit of April 1, 1991, the patient was noted to be off Nystatin for two weeks and that it was "never of benefit." He also complains of "dull burning sensation" in his lower abdomen for the past two weeks. The examination reveals slight abdominal tenderness and a boggy nasal mucosa. Respondent's impression was that of a "low grade fungal sinusitis" for which respondent prescribed the treatment of "back on" Nystatin, Diflucan, a tapering dose of Prednisone and Klonopin (formerly known as Clonopin, a trade name for Clonazepam, an anticonvulsant of the benzodiazepine class of drugs).
- On June 3, 1991, patient R.S. reported that his nasal, gastrointestinal and headache symptoms persist. Respondent recorded that the patient "hallucinated, nervous on Atabrine." There was no recent prescription for Atabrine other than the prescription of October 24, 1990. Respondent suspected "parasite enteritis" and ordered a stool sample. He continued the Nystatin and Diflucan. He added "BiSS", Bismuth sub-salicylate, (Pepto-Bismol). Respondent ordered stool testing from the Great Smokies Diagnostic Laboratory for the patient and his girl friend.
- On July 2, 1991 the patient reported occasional loose stools and has slight abdominal tenderness on physical examination. Respondent noted that the stool examination, showed some unidentifiable bodies, (described as UFO'S or "Unidentified Fecal Objects" by the laboratory) and a slight amount of Candida which was reported as normal by the laboratory. At this time respondent's impression was "persisting terminal ileal inflammation" with questions regarding possible "early Crohn's?," "Candidiasis?" and "Food allergy?" In addition to continuing on the Diflucan and Nystatin the patient was given gamma globulin, vitamin B12 and magnesium sulfate.
- On July 23, 1991 patient R.S. was reported to be feeling worse and complaining of fatigue and achiness. Respondent's impression at this time was "Fibromyalgia picture" and Elavil (a trade name for Amitriptyline, a tricyclic anti-depressant) was added to the pharmaceutical therapy.
- Patient R.S. returned three months later, on October 25, 1991 and was reported to be less achy and sleeping better on the gamma globulin. Respondent again noted his impression as Fibromyalgia. The Elavil was continued, the patient was placed back on Nystatin and gamma globulin for an additional eight weeks and respondent also noted "EPD in November."
- During the office visit of January 17, 1992 patient R.S. was reported to have had his first EPD injection in November and "will have his second EPD injection during this appointment." It was now reported that his gastrointestinal symptoms increase when the patient was off Nystatin. He was continued on the EPD injections.
- Patient R.S. was next seen on April 9, 1992 when it was noted that he was feeling better since the second EPD injection. Once again he was placed on Flagyl by respondent and scheduled for an additional EPD injection in July.
- Patient R.S. was next seen on September 2, 1992 when respondent noted that the patient was doing well and charted the impression of "Food Allergy." Respondent's plan was to continue with the EPD injections.
- On April 26, 1993 patient R.S. complained of periumbilical pain and a tender abdomen on physical examination. Respondent's impression was "Possible allergic sensitivity to bacterial flora of bowel." The patient was started back on Nystatin and the EPD injections were continued. The patient was also started on Clindamycin (which is a semisynthetic antibiotic indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and which also carries the warning that the therapy with this drug has been associated with severe colitis which may end fatally).
- The last recorded chart entry was for May 11, 1993 when respondent noted that the patient's nasal and intestinal symptoms had cleared on Clindamycin and the patient was once again being placed back on Nystatin.
- In diagnosing, caring for and treating patient R.S., respondent diagnosed Candida Albicans in the intestinal tract of this patient with no well controlled studies to demonstrate this. In this particular case there was a stool sample that showed normal levels of Candida in the stools. Further, at various times during the course of treatment, the patient was off the oral anti-fungal medication, Nystatin, and during those times showed no significant changes while off the medication. The patient was also placed on another anti-fungal drug, Diflucan, for prolonged periods of time. Respondent's diagnosis and treatment of a non-existent disease or that the presence of the fungus, Candida, in the intestinal tract can cause the symptoms noted in patient R.S. constitute a departure from the prevailing standard of practice expected among the community of California licensed physicians.*
- Despite the lack of objective data that this patient, in fact, had a Candida infection or that this was the source of his symptomology, and despite diagnostic laboratory information to the contrary, respondent nonetheless diagnosed the patient as requiring oral anti-fungal agents, Nystatin and Diflucan. Further, respondent, as in the cases of patients J.H. and S.L., prescribed the medications, over a long period of time which, without clear indication and without significant information regarding the efficacy of them for the clinical situation, constitutes both clearly excessive prescribing and negligence which is a departure from the prevailing standard of practice of medicine among the community of California licensed physicians and surgeons.*
- Respondent unnecessarily prescribed Atabrine, a drug which can cause transitory psychosis and which caused documented central nervous system side effects in this case, for an undocumented infection. The patient's only documented acute infection occurred approximately four years before beginning treatment with respondent. Respondent performed no objective diagnostic test which might have confirmed that the patient had an infection for which the drug would have been medically indicated. As in the case with patients J.H. and S.L., there was no objective evidence of existing infection or amebiasis or other significant clinical information to make such a presumptive diagnosis. Respondent has departed from the prevailing standard of practice of medicine in making such a diagnosis and treatment without the necessary diagnostic and clinical information in the record.*
ENZYME POTENTIATED DESENSITIZATION
- Between January 17, 1991 and July 27, 1993 for patient R.S. and between April 8, 1992 and March 15, 1993 for patient J.H. respondent administered eight and five [intradermal ] injections of Beta-Glucuronidase (respectively), an experimental and non-FDA approved drug (see Meza v. Southern California Physicians Insurance Exchange (March 26, 1998), 98 Daily Journal D.A.R. 3039 to what is considered a drug). Respondent administered the Beta-Glucuronidase without the required written list of "experimental subject's bill of rights" and informed consent in violation of California law. Respondent administered the Beta-Glucuronidase in an adulterated manner in violation of California Law.
- While the complainant has the right to charge the respondent with violations of the California Medical Practice Act based on violations of the Federal Drug laws including those laws that regulate experimental and investigational drug applications (this is not an attempt to enforce the FDCA), there is a requirement that the drug in question meet the jurisdictional requirements of Federal law. In this case there was no substantial evidence that the drug, as used by respondent, was in interstate commerce after it was in the possession of respondent. The drug was in interstate commerce prior to receipt and use by respondent. Therefore respondent was required to be a member of the Institutional Review Board (IRB) to use the drug on his patients, but he was not required to have his own new drug application.
INSTITUTIONAL REVIEW BOARD
- On September 21, 1996 respondent was approved by Great Lakes College of Clinical Medicine, Institutional Review Board, as a co-investigator on EPD and Beta-Glucuronidase. At no time has any sponsor or investigator, however, sought and secured an investigational new drug application for Beta-Glucuronidase from the FDA to begin clinical trials in humans for the experimental treatment protocol involving EPD or for the unapproved drug Beta-Glucuronidase.
- Beginning prior to September 21, 1996 and involving an uncertain number of minor patients, possibly as many as 200, respondent has engaged in human clinical trials employing EPD and the unapproved drug Beta-Glucuronidase for a number of various diagnoses including, but not limited to, Attention Deficit Hyperactivity Disorder, Multiple Chemical and/or Food Allergies and Candidiasis Hypersensitivity.
- a. Prior to September 21, 1996 respondent administered Beta-Glucuronidase without the required IRB approval.
b. Prior to September 21, 1996 respondent administered Beta-Glucuronidase without the required written informed consent in violation of California Law.
c. Prior to September 21, 1996 and continuing to the present time respondent administered Beta-glucuronidase in an adulterated manner in violation of California law.
- It was not established that respondent administered Beta-glucuronidase in a misbranded manner.
- The complainant requests $82,188.00 as cost recovery for the Department of Justice and $16,757.57 for the cost of investigation and enforcement including the cost of experts ($5,250.00 which is included). This amount is reasonable.
- The defense of laches fails in this case. Respondent asserts the affirmative defense of laches to all of the allegations contained in the accusation. While the defense of laches is available in administrative proceedings (Shea v. City of Los Angeles, (1948) 31 Cal.2d 542), the defense requires unreasonable delay plus either acquiescence in the act or prejudice to respondent resulting from the delay (Conti v. Board of Civil Service Commissioners (1969) 1 Cal.3d 35 1). Delay alone is insufficient. There must be prejudice such as lost evidence, faded memories or disappeared witnesses (Brown v. State Personnel Board (1985) 166 Cal.App.3d 1151). The time of the delay begins when the Board learns about the violation. The respondent has not met his burden of proving that there was an unreasonable delay on the part of the Board. There was also no significant prejudice to respondent as required by Fahmy v. Medical Board of California (1995) 38 Cal.App.4th 810. He continued to practice during the time that this matter was pending. The respondent's records were available as well as almost all of the patients' records from other treating physicians. Both parties had the opportunity to review these records before testifying. The only witness to testify that she did not have access to her records was Dr. Carol Jessop who testified that she remembered the facts and was sure of her testimony on behalf of respondent. The Board's action in bringing cases of violations of the medical practice act even after a lengthy period of time is supported by the strong public policy adopted by the legislature for the protection of the public (Business and Professions Code section 2229(a)).
- Any defense of entrapment was not established by respondent. Respondent was not enticed to use any of the treatments he employed for the four patients who are the subject of this decision. Nor was the defense of discriminatory enforcement established. There was no competent evidence presented to show that this prosecution was motivated by invidious discrimination or improper motive.
- The Board's expert witnesses, Jonathan Tepper, M.D., Mark Zlotlow, M.D., Lawrence Diller, M.D. and Frank Muraglia, M.D. all with sterling qualifications in their fields established that respondent failed to meet the standard of care for physicians in the state of California. They established that he engaged in unprofessional conduct in that respondent committed repeated negligent acts and clearly excessive prescribing. This was supported by a number of treating physicians including Nathan Schultz, M.D., Gloria Vreeland, M.D. and Michael Levin, M.D. These physicians were disinterested third parties with no economic conflict of interest. The expert witness Abba Terr, M.D. was shown to have some conflict of interest in this matter since he may draw from the same pool of patients as respondent. However, Dr. Terr is a distinguished member of the medical community with an impressive Curriculum Vitae. His opinions concerning the efficacy and propriety of the methods used by respondent were clearly formed independently of the case brought against the respondent by the Board. His testimony was credible.
- The experts who testified on behalf of the respondent concerning such medical diagnoses as Multiple Chemical Sensitivity, Environmental Illness, Chronic Fatigue Syndrome and Candida Hypersensitivity and that Candida Hypersensitivity causes symptoms and diseases such as Attention Deficit Hyperactivity Disorder, Autism or other behavioral disorders, while credible in their field, were not qualified to provide expert testimony as to the matters at issue.
- Respondent contends that disability standards established by Governmental entities should set the standard of practice for the practice of medicine. However, the standards for determining what will be considered a disability by a city, state or federal governmental entity can be much different than what is required by physicians to meet the standard of care. Public policy may require that those suffering from symptoms that make them disabled be granted financial aid and entitlement without scientifically determining what is actually causing the symptoms or disease. It is a practical way of dealing with reality rather than a scientific way. The reality is that some people are disabled by symptoms that do not have a known cause. The cause may be mental or physical or a combination of both. However, the reason for the disability is less important than the fact that these people need aid.
- Respondent engaged in repeated negligent acts. His treatment of all four patients in this matter involved both negligent and grossly negligent acts. The negligent acts were repeated with each separate patient as well as from time to time with the individual patient.
- While harm is not required for a finding that the Medical Practice Act has been violated and/or that the respondent has engaged in unprofessional conduct, harm can come in many forms. There can be economic harm as in the case of S.L. who paid for a drug with no proven efficacy which she could not afford; or paying for unproven treatments when the money would be better spent on counseling as in the case of L.T.S.
- Any affirmative defense raised by the respondent which is not specifically decided herein has not been established.
- Respondent, Robert Sinaiko, was educated at Brandeis University and graduated in 1966. He got his medical degree at Loyola University Stritch School of Medicine in Chicago, Illinois. He did his internship at the U.S. Public Health Service Hospital in San Francisco from 1970-71. He did his residency in internal medicine there from 1971-73 and Allergy and Clinical Immunology training at Kaiser Foundation Hospital in San Francisco from 1977 to 1979. From 1973-76 respondent did his military service with the U.S. Public Health Service. He was Board Certified in 1979 in Internal Medicine and he was Board Certified in Internal Medicine and Clinical Immunology In 1985. He is certified by the American College of Occupational and Environmental Medicine. He has an unpaid assistant clinical professorship in the Department of Medicine at UCSF School of Medicine. During his training at Kaiser San Francisco he trained under Benjamin Feingold, M.D. the Chief of Allergy. From 1979 to 1985 respondent remained at Kaiser Foundation Hospital at their South San Francisco clinic. In 1985 respondent left Kaiser Foundation and went into solo practice in Oakland, California. He transferred his private practice to San Francisco in 1988.
- Respondent has clearly demonstrated that he does not understand the serious nature of his violations of the Medical Practice Act. Respondent was described as "intelligent," "a good communicator" and "a nice/kind person." None of these characteristics constitutes mitigation or extenuation. No evidence of rehabilitation was presented.
- Any allegations in the Accusation based on Federal or State law and/or regulation not specifically set forth in the Findings herein have not been established by clear and convincing evidence and are therefore not a basis for the Determinations in this matter.
Respondent departed from the prevailing standard of practice of medicine among the community of physicians in California when he deliberately gave his patients a medication or diet to see if it would do any good and the discontinued without proper evaluation and documentation of how that would affect the patients' symptoms. In the case of EPD, respondent even submitted data on his patients to an IRB with the expectation that they would include his data in their study prior to his having any formal relationship with the IRB.
Experimentation without objectively evaluating and documenting results and a patient's individual response to the treatment is not within the standard of practice for physicians in California. This is true regardless of any "practice of medicine" exemption under Federal Law.
DETERMINATION OF ISSUES
- By reason of the matters set forth in Findings 3a, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25, cause for disciplinary action exists pursuant to Business and Professions Code (B&P) section 2234(c) (unprofessional conduct due to repeated negligent acts involving the same patient).
- By reason of the matters set forth in Findings 3b and c, 26 through 36, cause for disciplinary action exist pursuant to B & P Code section 2234(c) (unprofessional conduct based on repeated negligent acts involving the same patient).
- By reason of the matters set forth in Findings 3b and c, 26 through 36, cause for disciplinary action exists pursuant to B & P Code section 725 (unprofessional conduct based on clearly excessive prescribing).
- By reason of the matters set forth in Findings 37 through 44, 46 and 47, cause for disciplinary action exists pursuant to B & P Code section 725 (unprofessional conduct based on clearly excessive prescribing).
- By reason of the matters set forth in Findings 37 through 48, cause for disciplinary action exists pursuant to section 2234(c) (unprofessional conduct based on repeated negligent acts involving the same patient).
- By reason of the matters set forth in Findings 3b and c, 49 through 66, cause for disciplinary action exists pursuant to B & P Code section 2234(c) (unprofessional conduct based on repeated negligent acts involving the same patient).
- By reason of the matters set forth in Findings 3b and c, 49 through 63 and 65, cause for disciplinary action exists pursuant to B & P Code section 725 (unprofessional conduct based on clearly excessive prescribing).
ENZYME POTENTIATED DESENSITIZATION
- By reason of the matters set forth in Findings 3b and c, 67 and 68, cause for disciplinary action exists pursuant to Health and Safety Code (H & S Code) sections 24171, 24172, 24173, 109925, 109980, 111290, 111300, 111550, 111515, and 111520 (unlawful adulteration, unlawful use of new and experimental drug, failure to comply with list requirement of experimental subject's bill of rights, and informed consent).
- By reason of the matters set forth in Findings 3b and c and 68, cause for disciplinary action does not exist pursuant to 21 USCA 355(a), (b) and (c) and 21 CFR 312.1, 312.2, and 312.40 (respondent did not introduce EPD into interstate commerce).
INSTITUTIONAL REVIEW BOARD
- By reason of the matters set forth in Findings 69, 70 and 71(a), cause for disciplinary action exists pursuant to 21 CFR 56.101, 56.102, 56.109 and 56.111 (failure to obtain required IRB approval).
- By reason of the matters set forth in Findings 69, 70 and 71(b), cause for disciplinary action exists pursuant to H & S Code section 24172 (failure to obtain required informed consent).
- By reason of the matters set forth in Findings 69, 70 and 71(c), cause for disciplinary action exists pursuant to H & S Code section 111290 and 111300 (adulterated drug).
- By reason of the matters set forth in Finding 72, cause for disciplinary action does not exist pursuant to H & S Code sections 11375, 111430, 111440, 111450, 21 USCA 355(a),(b),(i) and 21 CFR 312.1, 312.2, 312.40 (not misbranded).
- By reason of the matters set forth in Finding 73, cost recovery was established in the amount of $98,945.57 pursuant to B & P Code section 125.3.
- By reason of the matters set forth in Findings 74, 75, and 79, the affirmative defense of laches, entrapment and lack of harm were not established.
- By reason of the matters set forth in Finding 80, any other affirmative defenses raised by respondent were not established.
- By reason of the matters set forth in Findings 24, 25, 35, 36, 45, 46. 47. 48. 64. 65. 66. and 78, cause for disciplinary action exists pursuant to section 2234(c) (repeated negligent acts involving all four patients).
- The matters set forth in Findings 76, 77, 81, and 82 have been considered in making the following order.
- By reason of the matters set forth in Finding 83, cause for disciplinary action does not exist pursuant to any law, rules or regulations not specifically set forth in these determinations.
- All other allegations set forth in the accusation are dismissed pursuant to Determinations 9, 13 and 19.
- The Physician's and Surgeon's Certificate No. G 24199 issued to Robert Sinaiko, M.D. is hereby revoked pursuant to Determinations 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 17, 18, and 23, separately and jointly.
The revocation is stayed and respondent is placed on probation for five (5) years upon the following terms and conditions:
- Respondent shall take and pass an oral clinical examination in Allergy and Immunology, with specific focus on the diseases which gave rise to the Accusation in this matter. The examination shall be designated and administered by the Division or its designees. This examination shall be taken within 90 days after the effective date of this decision. If respondent fails the first examination, respondent shall be allowed to take and pass a second examination which may consist of a written as well as an oral examination. The waiting period between the first and second examination shall be at least three months. If respondent fails to pass the first and second examination, respondent may take a third and final examination after waiting a period of one year. Failure to pass the oral clinical examination within 128 months after the effective date of this decision shall constitute a violation of probation. The respondent shall pay the costs of all examination.
- Within 60 days of the effective date of this decision, respondent shall enroll in a course in Ethics approved in advance by the Division or its designee, and shall successfully complete said course during the first year of probation.
- During probation, respondent is prohibited from employing or directing the use of the protocol known as Enzyme Potentiated Desensitization, (EPD) unless he seeks and obtains approval from a California medical school affiliated Institutional Review Board (IRB), including compliance with all applicable statements and disclosures required by 21 CFR Part 50 (Protection of Human Subjects and particularly Subpart B-Informed Consent of Human Subjects), 21 CFR Park 56 (Institutional Review Boards) and 21 CFR Part 312 (Investigational New Drug Applications). Respondent is specifically placed on notice that under no circumstances is he allowed to use EPD, and specifically Beta-Glucuronidase, either as a treatment protocol or clinical investigation and/or experimental protocol, unless and until he does so under the authority of both Institutional Review Board (IRB) and an Investigational New Drug Application (IND) or a New Drug Application (NDA). Further, during probation, respondent is prohibited from dispensing, prescribing or administering Amphotericin-B, in an oral form unless and until it is approved by the U.S. Food and Drug Administration for human use for the specific condition for which respondent desires to prescribe, dispense or administer said drug.
- Within 30 days of the effective date of this decision, respondent shall submit to the Division for its prior approval a plan of practice in which respondent's practice shall be monitored by another physician in respondent's field of practice, who shall provide monthly reports to the Division or its designee. The monitor must be board certified by the American Board of Internal Medicine with subspecialty certification in Allergy and Immunology. The Medical Board of California may, at its discretion, also consider a proposed monitor who has certification in the subspecialty of Infectious Disease.
The monitor shall meet, in person, with respondent a minimum of twice per month and the monitor shall be made specifically aware that he/she must, at a minimum, review the following aspects of respondent's care for and billing of patients:
- The level and adequacy of good faith prior physical and history examinations as medical indications for any and all diagnostic and treatment procedures;
- The medical indications for all diagnostic procedures and treatments;
- The interpretation of all diagnostic procedures performed on patients;
- The appropriateness of diagnosis and differential diagnosis;
- The appropriateness and level of competency displayed in diagnostic and treatment modalities;
- The appropriateness of medications and/or treatments, their use, length of their use, dosage and possible adverse effects;
- The appropriateness and adequacy of medical records created;
- The appropriateness and adequacy of medical records created;
- The level and adequacy of appropriate disclosures of alternative treatments as well as the risks and benefits of recommended treatments; and
- The adequacy and level of patient informed consent to diagnostic and treatment protocols.
The monitor shall have the discretion to review any and all of respondent's medical records as he/she deems necessary. The monitor and all costs associated with the monitor's duties, functions and responsibilities shall be paid by respondent. Respondent is specifically prohibited from entering into any bartering or other similar arrangement with the monitor (i.e., using the referral of patients to the monitor to offset the expenses incurred in satisfying this term of probation, etc.) so as not to compromise the ability of the monitor to render fair and unbiased reports to the Division. If the monitor quits, or is no longer available, respondent shall within 15 calendar days nominate a new monitor for approval by the Division.
- Within 60 days of the effective date of this decision, respondent shall enroll in a course in prescribing practices, approved in advance by the Division or its designee, and shall successfully complete the course during the first year of probation.
- Within 90 days of the effective date of this decision, and on an annual basis thereafter, respondent shall submit to the Division or its designee for its prior approval an educational program or course to be designated by the Division, which shall not be less than 40 hours per year, for each year of probation, This program shall be in addition to the Continuing Medical Education requirements for re-licensure. Following the completion of each course, the Division or its designee may administer an examination to test respondent's knowledge of the course. Respondent shall provide proof of attendance for 65 hours of continuing medical education of which 40 hours were in satisfaction of this condition and were approved in advance by the Division or its designee.
- The respondent is hereby ordered to reimburse the Division the amount of $49,472.79 within 90 days from the effective date of this decision for its investigative and prosecution costs. Although the administrative law judge found the amount of $98,945.57 to be reasonable, the Panel exercises its discretion to reduce that amount. Failure to reimburse the Division's cost of its investigation and prosecution shall constitute a violation of the probation order, unless the Division agrees in writing to payment by an installment plan because of financial hardship. The filing of bankruptcy by the respondent shall not relieve the respondent of his responsibility to reimburse the Division for its investigative and prosecution costs.
- All actual costs incurred for probation monitoring during the entire probation period shall be paid by the respondent. Such costs shall be payable to the Medical Board of California at the end of each fiscal year. Failure to pay such costs shall be considered a violation of probation.
- Respondent shall obey all federal, state and local laws, all rules governing the practice of medicine in California, and remain in full compliance with any court ordered criminal probation, payments and other orders.
- Respondent shall submit quarterly declarations under penalty of perjury on forms provided by the Division, stating whether there has been compliance with all the conditions of probation.
- Respondent shall comply with the Division's probation surveillance program. Respondent shall, at all times, keep the Division informed of his or her addresses of business and residence which shall both serve as addresses of record. Changes of such addresses shall be immediately communicated in writing to the Division. Under no circumstances shall a post office box serve as an address of record.
- Respondent shall also immediately inform the Division, in writing, of any travel to any areas outside the jurisdiction of California which lasts, or is contemplated to last, more than thirty (30) days.
- Respondent shall appear in person for interviews with the Division, its designee or its designated physician(s) upon request at various intervals and with reasonable notice.
- In the event respondent should leave California to reside or to practice outside the State or for any reason should respondent stop practicing medicine in California, respondent shall notify the Division or its designee in writing within ten days of the dates of departure and return or the dates of non-practice within California. Non-practice is defined as any period of time exceeding thirty days in which respondent is not engaging in any activities defined in Sections 2051 and 2052 of the Business and professions Code. All time spent in an intensive training program approved by the Division or its designee shall be considered as time spent in the practice of medicine. Periods of temporary or permanent residence or practice outside California or of non-practice within California, as defined in this condition, will not apply to the reduction of this probationary period.
- Upon successful completion of probation, respondent's certificate shall be fully restored.
- If respondent violates probation in any respect, the Division, after giving respondent notice and the opportunity to be heard, may revoke probation and carry out the disciplinary order that was stayed. If an accusation or petition to revoke probation is filed against respondent during probation, the Division shall have continuing jurisdiction until the matter is final, and the period of probation shall be extended until the matter is final.
- Following the effective date of this decision, if respondent ceases practicing due to retirement, health reasons or is otherwise unable to satisfy the terms and conditions of probation, respondent may voluntarily tender his certificate to the Board. The Division reserves the right to evaluate the respondent's request and to exercise its discretion whether to grant the request, or to take any other action deemed appropriate and reasonable under the circumstances. Upon formal acceptance of the tendered license, respondent will no longer be subject to the terms and conditions of probation.
Respondent is to pay the Division of Medical quality the actual and reasonable costs of the investigation and enforcement of this matter in the amount of $49,472.79
This Decision shall become effective at 5:00 p.m. on October 4, 1999.
IT IS SO ORDERED this 3rd day of September, 1999
ALAN E. SHUMACHER, M.D., Chair
Division of Medical Quality
Medical Board of California
This article was revised on March 28, 2005.