INTRODUCTION ^[1]

This is an extraordinarily important case. The decision ^[2] by a panel of the Medical Board of California ("Board") to be reviewed by this Court on mandamus has essentially ended the twenty-five year career of a highly regarded physician practicing in the fields of internal medicine, immunology, and allergy. ^[3] The Board sanctioned Doctor Robert Sinaiko by holding him to a "standard of care" that has no precedent in the law. This newly minted standard threatens the ability of all California physicians to make informed and reasonable medical judgments in caring for their patients and, of perhaps far greater importance, will impede the ability of the medical community to utilize medical techniques that have proved effective in the clinical context.

A comprehensive review of published decisions in matters of Board discipline makes clear that until recently it has been the role of the Board to ensure a minimum standard of medical practice in this state. Doctors guilty of repeated or gross negligence have properly been sanctioned. Zabetian v. Medical Board of California (2000) 80 Cal.App.4th 462 (doctor placed on a two year probationary term after he left the area without securing physician coverage for a patient in intensive care and failed to diagnose the patient's peritonitis which resulted in a serious and permanent injury). In this case, however, unlike every doctor discipline opinion that has been published in the California case reporters, there is no allegation that Doctor Sinaiko's care resulted in any physical or psychological injury to any patient. ^[4]

To the contrary, the record in this case makes clear that Doctor Sinaiko is a superbly trained and conscientious physician who, as the Hippocratic oath demands, has done his patients no harm. Relying on his training and long clinical experience, the clinical experiences of his colleagues, and the relevant literature, Doctor Sinaiko employed diagnostic and treatment methods he determined were in the best interests of his patients. These included a form of immunotherapy called Enzyme Potentiated Desenstization ("EPD"), the prescription of three oral anti-fungal medications, Amphotericin-B, Nystatin, and Difulcan, and the use of the IgG Mast test for allergies. Sinaiko's techniques were demonstrably safe in every instance and effective in many. Sinaiko's patients testified that he is an unusually diligent and devoted doctor who, for many, was a last and best hope for relief from seemingly untreatable systemic immunologic problems.

A handful of expert witnesses presented by the Attorney General, however, concluded that Doctor Sinaiko's treatment strategies are unproductive and are not employed by the majority of doctors in his areas of practice in this state. Faced on the one hand with expert testimony challenging Doctor Sinaiko's practice and on the other with equally credible expert testimony and literature extolling its virtues, the Board chose sides and found Sinaiko guilty of multiple Medical Practice Act ("MPA") violations. In so doing, the Board strayed from its traditional role as guarantor of a minimum quality of medical care in California and improperly became a court of science.

The penalty imposed by the Board-a long period of highly-supervised probation- makes clear that in this case it functioned not to penalize, or protect the public from, a bad doctor, but rather to limit the range of reasonable treatment strategies open to practitioners in a given field. Although Sinaiko was cited for sixteen MPA violations-and could have been cited for hundreds more based upon the Board's view of his practice methods ^[5] -the Board did not revoke his license. Rather it found that he could continue to diagnose and treat patients so long as he did not employ the particular techniques rejected by the Board. The Board thereby sent an unmistakable message to California doctors: stay within the confines of majority practice, or risk career-ending sanction.

It will not be petitioner's argument here that, in confronting a division of opinion in the medical community over preferable practice strategies, the Board necessarily chose wrongly, but rather that as a disciplinary organ it had no business choosing at all. Under California law, Doctor Sinaiko could be disciplined only if he was repeatedly negligent or violated another provision of the MPA. In order to satisfy its burden the state had to show that Doctor Sinaiko's methods departed from the "standard of practice" or "standard of care" expected from a California doctor. And it could do that only by offering clear and convincing evidence that, in his diagnostic and treatment decisions, Doctor Sinaiko had no reasonable scientific basis for his conduct.

As will appear, the state did not even try to satisfy that burden below. Rather, because it learned at a very early stage of the administrative proceeding that Doctor Sinaiko's techniques are fairly commonplace and had support among a group of highly qualified doctors, the state offered a new and extraordinarily narrow definition of "standard of practice": the Attorney General proposed that use of a diagnostic or treatment approach which had not gained "widespread" or "general" acceptance among California doctors in the same specialty area-i.e., was not a majority practice-- constituted a departure from the relevant "standard of practice" or "standard of care amounting to negligence.

As to conduct by a doctor that results in no injury to a patient, the "standard of practice" or "standard of care" proposed by the Attorney General is simply wrong. Such a narrow definition of the range in which a California doctor may legally practice has no support in the case law, and if affirmed by this Court would amount to a dangerous brake on innovation in medicine and an unnecessary limitation on consumer choice. Indeed, Doctor Sinaiko's diagnostic and treatment methods are practice modalities preferred by at least a highly qualified minority of practitioners in his field. Like other approaches that once commanded only minority support-for example, using vitamin C to treat scurvy or penicillin to manage infection-Doctor Sinaiko's methods may one day reach preferred status if they are not hindered by unwarranted disciplinary action.

The relevant question in this case should have been whether, as to each of the sixteen diagnostic and treatment decisions that are the subject of discipline, there was a reasonable basis for the decision stemming from Doctor Sinaiko's own clinical experience, the experiences of his colleagues, or the relevant literature. Once Doctor Sinaiko established such reasonable grounds for his conduct, the Board's probe should have ended. If the Board had employed the proper standard, it could not have found by a preponderance, let alone by clear and convincing evidence, that Doctor Sinaiko was repeatedly negligent or violated any other provision of law. Its further inquiry-i.e., into which side of various ongoing medical debates should receive the Board's seal of approval-was improper.

Following a "Statement Of The Case" and a discussion of the standard of review governing mandamus, petitioner therefore will begin by addressing the pure question of law on which this case turns: is the California standard of care limited to diagnoses and therapies employed by a majority of doctors in a field-i.e., generally accepted practices-or does it extend to reasonable methods embraced by a minority within that field which cause no injury? Having demonstrated that the legal standard upon which the prosecution rested its case and the Board its discipline was erroneous, he will turn to the extensive factual record in this matter and examine the evidence as to each of the sixteen MPA violations found by the Board, demonstrating that in each and every instance Doctor Sinaiko acted reasonably in treating his patients. On that basis, this Court should grant the present writ petition and vacate the Board's order.

Doctor Robert Sinaiko is board certified in Internal Medicine, as well as Allergy and Clinical Immunology. He received his B.A. from Brandeis in 1966 and his M.D. from Loyola University Stritch School of Medicine in 1970. He completed a three year residency in internal medicine at the U.S. Public Health Service Hospital in San Francisco in 1973. Doctor Sinaiko completed a further residency in Allergy and Immunology at the Kaiser Foundation Hospital in San Francisco (1977-1979).

From 1979 to 1985, Doctor Sinaiko was an attending physician in the Department of Allergy at Kaiser, South San Francisco. Since 1985, he has been in private practice in the Bay Area, specializing in allergy and clinical immunology, and internal medicine.

He belongs to numerous professional societies and organizations, and was on the staff at Mount Zion Hospital Medical Center of the University of California at San Francisco, until its recent closing. Doctor Sinaiko holds an academic appointment as assistant clinical professor in the Department of Medicine, at the University of California School of Medicine, San Francisco.

On November 1, 1996, the Medical Board of California, Division of Medical Quality filed an accusation against petitioner Sinaiko, alleging that his treatment in 1993 of a minor patient, LTS,^[6] was negligent in that it departed from the relevant standard of practice. (P1 15-18) On February 26, 1997, the Board followed with an amended accusation, alleging a variety of negligent acts in his care of LTS and three additional patients, RS, JH, and SL, between 1986 and 1993. (P1)

From January 5 to February 25, 1998, an administrative law judge presided over a hearing at which expert witnesses from both sides appeared.^[7] At the administrative hearing, Doctor Sinaiko offered testimony by his patients which made clear that he has diligently and thoughtfully served his patients for more than twenty years. Perhaps most importantly, petitioner offered evidence that when his treatment approach was not effective, he acknowledged that fact. He was entirely open with his patients regarding the nature and effectiveness of his practice methods. (See 22 RT 9 et seq.; 22 RT 45 et seq.; 22 RT et seq. 77; 23 RT 16 et seq.; 23 RT 55 et seq.; 23 RT 65 et seq.; 24 RT 46 et seq.) The parties also offered voluminous documentary evidence.

Judge Ruth Astle issued a proposed decision revoking Sinaiko's medical license on July 15, 1998. (P3 26) The decision also ordered Sinaiko to pay the Board's "actual and reasonable costs of the investigation and enforcement of this matter in the amount of $98,945." (P3 26)

On August 25, 1998, Doctor Sinaiko sought reconsideration both of the disciplinary action and penalty. (P4, P6) The Board granted reconsideration (P7, P10) and after briefing (P11, P19) and argument (November 6, 1998), issued its final order. That order modified the disciplinary findings slightly, and reduced the penalty to revocation, suspended, with a five year period of closely-supervised probation. (P27 22) The Board reduced the judgment for costs of investigation to $49,472.79. Sinaiko filed a timely petition for administrative mandamus in this Court on October 29, 1999, and lodged transcripts and exhibits in support of that petition on April 3, 2001.

STANDARD OF REVIEW TO BE EMPLOYED ON MANDAMUS

In an administrative mandamus proceeding, the trial court exercises its independent judgment on the evidence before it. See, e.g., Franz v. Board of Medical Quality Assurance (1982) 31 Cal.3d 124, 135. "When ruling on a petition for mandate, the superior court must first determine, in the exercise of its independent judgment, whether the board's findings in the matter are 'supported by the weight of the evidence.'" Yellen v. Board of Medical Quality Assurance (1985) 174 Cal.App.3d 1040, 1057. To sustain a disciplinary order against a physician, the Attorney General must have established its case in the administrative proceeding by clear and convincing evidence. Ettinger v. Board of Medical Quality Assurance (1982) 135 Cal.App.3d 853, 857.

ARGUMENT

I.   UNDER THE "STANDARD OF PRACTICE" RULE IN A DISCIPLINARY PROCEEDING, THE BOARD CAN PUNISH ACTS AND OMISSIONS OF A PHYSICIAN WHICH ARE UNREASONABLE, BUT NOT THOSE WHICH ARE BASED ON A DOCTOR'S REASONED ACCEPTANCE OF A MINORITY APPROACH TO TREATMENT WHICH CAUSES NO INJURY TO THE PATIENT

A.    The Standard Of Practice Rule In Disciplinary Cases Mirrors The Negligence Standard Applied In Medical Malpractice Cases

Business and Professions Code § 2234 requires the Board to take disciplinary action against any doctor who is charged with unprofessional conduct, defined to mean, among other things, "repeated negligent acts." B&P § 2234(c). Although no case has analyzed the word "negligence" in the disciplinary as opposed to the medical malpractice context, it is clear that courts reviewing Board decisions have simply borrowed the notion of a "professional norm" or "standard of practice" from the tort cases.

It has long been the rule that a doctor is subject to tort liability for injurious conduct which is not that of the average, reasonable practitioner; that is, conduct which is not "customary and usual in the profession." W. Prosser, Torts 165 (4th ed. 1971), cited in Note, Restrictions on Unorthodox Health Treatment in California: A Legal and Economic Analysis, 1977 UCLA Law Review 647, 657. As the California Supreme Court has held, the notion that a doctor's duty of care is measured by reference to a "standard" of care or practice stems from the application of general negligence principles in the particular context of malpractice allegations:

[N]egligence is conduct which falls below the standard established by law for the protection of others against unreasonable risk of harm. Thus, as a general proposition one is required to exercise the care that a person of ordinary prudence would exercise under the circumstances. . . . Because application of this principle is inherently situational, the amount of care deemed reasonable in any particular case will vary, while at the same time the standard of conduct itself remains constant, i.e., due care commensurate with the risk posed by the conduct taking into consideration all relevant circumstances. . . . There are no "degrees" of care as a matter of law; there are only different amounts of care, as a matter of fact. . . . Persons dealing with dangerous instrumentalities involving great risk of harm must exercise a greater amount of care than persons acting in less responsible capacities, but the former are no more negligent than the latter for failing to exercise the required care. . . . With respect to professionals, their specialized education and training do not serve to impose an increased duty of care but rather are considered additional "circumstances" relevant to an overall assessment of what constitutes "ordinary prudence" in a particular situation. Thus, the standard for professionals is articulated in terms of exercising the knowledge, skill and care ordinarily possessed and employed by members of the profession in good standing.

Flowers v. Torrance Memorial Hospital Medical Center (1994) 8 Cal.4th 992, 997 (footnotes, citations, and internal quotations omitted)(emphasis added); see also Osborn v. Irwin Memorial Blood Bank (1992) 5 Cal.App.4th 234, 275?283 (professional standard of care is defined by custom and practice); Wilson v. Irwin Memorial Blood Bank (1993) 14 Cal.App.4th 1315, 1326 (same); Silver, One Hundred Years of Harmful Error: The Historical Jurisprudence of Medical Malpractice 1992 Wis.L.Rev. 1193, 1216?1219 ("professional custom" continues to dominate as standard required of medical practitioners).

That this same analysis applies in disciplinary cases is illustrated by Glover v. Board of Medical Quality Assurance (1991) 231 Cal.App.3d 203. In that case, a doctor was charged with gross negligence in his treatment of Larry Wood, "a patient with a history of alcohol addiction, hallucinations, violence, depression and numerous suicide attempts. Id. at 205. Doctor Glover first saw the patient in 1981 and treated him with a variety of medications. The patient returned to Doctor Glover in 1985. The doctor took no history and failed to obtain medical records for the intervening period. He then prescribed, over an extended period, a whole series of medications which, had he taken an adequate history, he would have known were almost certain to lead the patient to commit suicide. Indeed, he continued to prescribe the drugs after the patient again attempted to kill himself. Id. at 206.

The Court of Appeal affirmed a Board license revocation order in light of testimony by three experts who opined that "appellant's practice of repeatedly prescribing psychotropic medications in large doses to a patient, who, known to appellant, repeatedly attempted suicide using these medications was an extreme deviation from acceptable standards of practice." Id. at 207 (emphasis added). In essence, the Glover court held that because the doctor had failed to exercise reasonable care in the application of his professional skill-i.e., had failed to act within the professional norm or standard of practice-he was grossly negligent and thus subject to discipline. Significantly, Glover did not offer any testimony by experts or documentary evidence that his conduct had any reasonable scientific basis.

As in Glover, the published opinions in which doctors have been disciplined under Business and Professions Code § 2234 for gross or repeated negligence uniformly have involved physician malpractice-i.e., conduct by a doctor (a) which results in a cognizable injury or death, (b) which has no reasonable scientific basis and (c) which would be the appropriate subject of a civil suit for damages. See, e.g., Kearl v. Board of Medical Quality Assurance (1986) 189 Cal.App.3d 1040, 1043 (doctor was grossly negligent in his anesthesia of a female patient who died after he failed to record her vital signs at five minute intervals commencing with the start of anesthesia; he demonstrated incompetence in his anesthesia of another patient who suffered brain damage when he erred in his choice of anesthetic solution and the dosage of anesthetic); Yellen v. Board of Medical Quality Assurance (1985) 174 Cal.App.3d 1040, 1055 (the Board found grossly negligent a doctor who gave a dangerous combination of a large array of drugs without indication to 16 month old baby who later died); Pasha v. Board of Medical Quality Assurance (1985) 174 Cal.App.3d 439, 445 (Board finds doctor grossly negligent because (a) he botched plastic surgery on patient's nose and then failed to remain in contact with her post-surgery and (b) in another case, failed to remedy problems with a patient's breast surgery); Aengst v. Board of Medical Quality Assurance (1980) 110 Cal.App.3d 275 (Board found grossly negligent a doctor who operated on a four year old boy, then failed to provide adequate post operative care, including failing to direct mother to take the child to the emergency room after he had coughed up a bowl full of bright red blood and had turned white, and the patient died in the doctor's office the next morning).Thus, the "standard of practice" rule as applied in discipline cases mirrors the negligence standard developed in medical malpractice cases.^[8]

This, however, is not a "malpractice" case, as the state has essentially conceded throughout these proceedings. The state has not proffered an instance of patient injury, or a medical decision not made in good faith based on scientific grounds. No patient appeared at the administrative hearing to testify that he or she had suffered physical injury at Doctor Sinaiko's hands. No civil suits against Doctor Sinaiko have preceded this action and none are pending. Rather than a claim of traditional malpractice, the state prosecuted Doctor Sinaiko on the theory that his methods of diagnosis and treatment are invalid because they lack sufficient acceptance in the medical community. The important question then arises of what "negligence" and "standard of practice" mean in a discipline case of this kind?

B.   The Attorney General Proposed, And The Board Accepted, The Kelly-Frye Test As The Definition Of "Standard Of Practice "

The Attorney General, who well understood the importance of this issue from the start of these proceedings, sought to define "standard of practice" by reference to California and federal law governing the admission of new scientific tests in civil and criminal trials. During the cross-examination of his lead expert, the Attorney General objected on relevancy grounds to questions relating to one of Doctor Sinaiko's procedures. At that point the state suggested that the rule of People v. Kelly (1976) 17 Cal.3d 24 and United States v. Frye (D.C. Cir. 1923) 293 F. 1013, superceded by rule, as noted in Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579, has some bearing on the "standard of practice" question. (4 RT 168)

As this Court is aware

"Kelly-Frye" is the name given to a specific limitation upon the use of expert scientific testimony and evidence. The principle was first definitively set forth in Frye v. United States, supra, 293 F. 1013, 1014, and later adopted by the California Supreme Court in People v. Kelly, supra, 17 Cal.3d 24. The objective of the Kelly-Frye rule is to preclude the use of untested and developing scientific methods of fact determination. The proof of a fact in issue is not permitted by use of new or novel methods until it can be shown that the new procedure has achieved reliability. This determination is made not upon the basis of the trial judge's determination of scientific reliability, but upon the judge's discovery as to whether there is "substantial agreement and consensus in the scientific community" regarding the process's reliability. (People v. Kelly, supra, 17 Cal.3d at p. 31.)

People v. Cegers (1992) 7 Cal.App.4th 988, 995 (emphasis added).

Throughout the administrative hearing, the Attorney General and his witnesses employed the language of Kelly-Frye-i.e., whether something had become "widely accepted" or "generally recognized"-in discussing the question whether Doctor Sinaiko's methods of diagnosis and treatment comprised a departure from the "standard of practice." See 1 RT 47, 54 (Attorney General in opening argument); 4 RT 168 (Attorney General arguing objection); 5 RT 47 (Attorney General arguing objection); 5 RT 49 (same); 12 RT 97, 98 (same); 14 RT 88 (same); 16 RT 19 (same); 25 RT 28, 31 (same); 4 RT 26, 27, 28, 36, 37, 42; 5 RT 53 (Doctor Abba Terr); 6 RT 22 (Doctor Gloria Vreeland); 7 RT 41 (Doctor Nathan Schutz); 8 RT 23 (Doctor Michael Levin); 10 RT 12, 29 (Doctor Frank Miraglia); 11 RT 30, 39 (Doctor Lawrence Diller) 12 RT 21, 32, 33, 73, 84, 93, 94, 95 (Doctor Jonathan Tepper); 13 RT 13, 15, 16, 18, 25, 40, 70 (Doctor Mark Zlotlow).

Later, in its opposition to Doctor Sinaiko's motion for reconsideration, the Attorney General suggested that testimony by experts that Doctor Sinaiko's methods were valid was itself unreliable because of an absence of proof that these experts' views were widely held or generally accepted. (P5 17)

Finally, in its main brief on reconsideration before the Board, the Attorney General repeatedly and expressly proposed an equivalence between the "standard of practice" rule in administrative proceedings and the evidentiary rule governing the admission of scientific tests in civil and criminal trials in California. Specifically, the state argued again and again in its brief that Doctor Sinaiko's methods were negligent-i.e., sanctionable under Business & Professions Code § 2234(c)- because they had not been "widely accepted" or "generally recognized." See e.g., P19 28, 99 (multiple chemical sensitivity has not "gained general or widespread acceptance within the medical community"); 34 (Candida sensitivity syndrome has not "gained general or widespread acceptance within the medical community"); 48 (same as to EPD); 54, 78, 90, 101 (same as to allergic causes for child behavior problems); 57 (use of Zovirax was not within "prevailing standard of practice of medicine."); 75 (use of Nystatin has not gained "widespread acceptance" for treatment of Candida hypersensitivity); 100 (use of IgG MAST test not "generally accepted").

In its disciplinary order, the Board did not discuss the meaning of the statutory term "negligence," or the phrases "standard of practice" or "standard of care." Rather, the Board simply opined that as to a variety of specific conduct in the cases of four patients, Doctor Sinaiko was negligent in that he departed from the "standard of practice."

Sinaiko submits the Board clearly accepted the Attorney General's view that the Kelly-Frye "general acceptance" rule should apply in a discipline case. As is demonstrated below, as to every medical decision herein at issue, petitioner placed in the record expert and documentary evidence which made clear his decisions had a reasonable medical basis; indeed, the state and Board have long acknowledged as much. If the Board had accepted that doctors who act with a reasonable basis stay within the "standard of practice," it could not have rationally sanctioned Doctor Sinaiko. On the other hand, Doctor Sinaiko would agree that he employs certain therapies embraced by only a minority-albeit a well-regarded one-of the practitioners in his field. Only if the Board accepted the state's argument that "standard of practice" equates with the Kelly rule-a position expressly proffered by the Attorney General in every relevant context in the administrative proceeding-does the Board's ruling makes sense.

C.    The Proper Standard Of Practice Rule Is Reasonableness, Not Kelly-Frye

As noted, the Attorney General proposed and the Board employed the Kelly test: i.e., Doctor Sinaiko's techniques of diagnosis and treatment have not been generally accepted and are therefore negligent. As will appear, the Board's test has never been used by any court, is unfeasible in the physician discipline context, ignores the manner in which medicine is actually practiced in California, and would constitute a dangerous restraint on innovation and patient choice. The proper test, on the other hand, has long been used in both the discipline and malpractice contexts, protects the public from dangerous practices, can be applied with ease, accommodates the manner in which doctors actually treat patients, and allows for the desired evolution of medical practice. That standard is simply whether a doctor acted reasonably in the exercise of his professional skill so as to protect his patients from an "unreasonable risk of harm." Flowers v. Torrance Memorial Hospital Medical Center, 8 Cal.4th at 997. If a doctor has a reasonable medical and scientific basis for employing a given modality and, having assessed the risks and benefits of that approach, concludes in good faith that the approach is in the best interest of his patient, he has acted without negligence and within the "standard of practice."

1.    The Kelly Test, Which Would Limit Doctors To Majority Diagnoses And Treatments, Has No Role Whatsoever In The Medical Discipline Context

Petitioner has found no California discipline case which suggests an equivalence between the "standard of practice" and the Kelly rule. The state has never cited any such authority in its prior briefs or argument. Nor has state's new standard been used to assess whether a doctor departed from the relevant standard of care in any medical malpractice case, the source of the "standard of practice" test now used in the discipline arena. Rather, in malpractice cases, a doctor's duty is simply to

use the care and skill ordinarily exercised in like cases by reputable members of the profession practicing in the same or similar locality under similar circumstances, and to use reasonable diligence and his best judgment in the exercise of skill and application of learning, in an effort to accomplish the purpose for which the physician is employed.

BAJI 6.01.1; see also N.N.V. v. American Assn. of Blood Banks (1999) 75 Cal.App.4th 1358, 1384 (holding BAJI 6.01.1 is applicable standard).

In the malpractice context a doctor is by no means required to confine his practices to majority methods. To the contrary, BAJI No. 6.03 instructs the jury: "Where there is more than one recognized method of diagnosis or treatment, and no one of them is used exclusively and uniformly by all practitioners of good standing, a physician is not negligent if, in exercising his best judgment, he selects one of the approved methods, which later turns out to be a wrong selection, or one not favored by certain other practitioners." See N.N.V., 75 Cal.App.4th at 1384.

As California courts have held

BAJI 6.03 embodies the notion that different doctors may disagree in good faith upon what would encompass the proper treatment or diagnosis of a medical problem in a given situation. Medicine is not a field of absolutes. There is not ordinarily only one correct route to be followed at any given time. There is always the need for professional judgment as to what course of conduct would be most appropriate with regard to the patient's condition. Thus, BAJI 6.03 states the rule that where there are several methods of approved diagnosis or treatment, which could be made available to a patient, it is for the doctor to use his best judgment to pick the proper one.

Barton v. Owen (1977) 71 Cal.App.3d 484, 501-502. Where a doctor exercises judgment in the exercise of his skill, he cannot be said to have violated his duty of care, even if others in field would have approached a problem differently. See Adams v. Boyce (1940) 37 Cal.App.2d 541, 549 ("It is never enough to show that he has not treated his patient in that mode, nor used those measures, which in the opinion of others, even medical men, the case required, because such evidence tends to prove errors of judgment, for which the defendant is not responsible, as much as the want of reasonable care and skill, for which he may be responsible.")(internal citations omitted)(emphasis added).

2.    Because Of The Nature Of Medical Practice, The Kelly Evidentiary Rule Is Not Even Applied To The Introduction Of Medical Opinions In Criminal Or Civil Trials, And Thus Cannot Possibly Apply To A Physician's Diagnostic And Treatment Decisions

The Kelly test requires a court, when faced with a novel method of proof, to require a preliminary showing of general acceptance of the new technique in the relevant scientific community. See 17 Cal.3d at 29. The California Supreme Court made clear that the advantage of the test is that it errs on the side of exclusion:

The primary advantage . . . of the Frye test lies in its essentially conservative nature. For a variety of reasons, Frye was deliberately intended to interpose a substantial obstacle to the unrestrained admission of evidence based upon new scientific principles. There has always existed a considerable lag between advances and discoveries in scientific fields and their acceptance as evidence in a court proceeding. . . . Several reasons founded in logic and common sense support a posture of judicial caution in this area. Lay jurors tend to give considerable weight to 'scientific' evidence when presented by 'experts' with impressive credentials. We have acknowledged the existence of a . . . misleading aura of certainty which often envelops a new scientific process, obscuring its currently experimental nature. As stated in Addison,supra, in the course of rejecting the admissibility of voiceprint testimony, scientific proof may in some instances assume a posture of mystic infallibility in the eyes of a jury . . . .

Exercise of restraint is especially warranted when the identification technique is offered to identify the perpetrator of a crime. When identification is chiefly founded upon an opinion which is derived from utilization of an unproven process or technique, the court must be particularly careful to scrutinize the general acceptance of the technique. Moreover, once a trial court has admitted evidence based upon a new scientific technique, and that decision is affirmed on appeal by a published appellate decision, the precedent so established may control subsequent trials, at least until new evidence is presented reflecting a change in the attitude of the scientific community.

17 Cal.3d at 31-32 (internal quotations and citations omitted; emphasis added).

Because of the nature of this test, it is not applied to the introduction of opinions of medical experts, a fact apparently lost on the state in this case. The California Supreme Court long ago stated that "We have never applied the Kelly?Frye rule to expert medical testimony . . . ." People v. McDonald (1984) 37 Cal.3d 351, 372. That is, under California law,

An expert medical witness may give his opinion as to the means used to inflict a particular injury, based on his deduction from the appearance of the injury itself. [Citation.] A medical diagnosis based on probability??as is the case with the 'battered child syndrome' diagnosis??is admissible; the lack of scientific certainty does not deprive the medical opinion of its evidentiary value.

People v. Jackson (1971) 18 Cal.App.3d 504. Courts have held "that there is a distinct difference between the development of a new scientific technique, i.e., 'a novel method of proof' ( Kelly, supra, 17 Cal.3d 1293 at p. 30), and the development of a body of medical knowledge and expertise." People v. Mendibles (1988)199 Cal.App.3d 1277, 1292; see also People v. Luna (1988) 224 Cal.App.3d 726, 732 (medical testimony not subject to Kelly test).

If the Kelly test were applicable in the disciplinary context, a doctor could lose his license for using a particular medical technique, but his testimony as a medical expert as to the appropriateness of that test would be fully admissible to support a judgment in a civil malpractice case, where Kelly does not apply. Given that the narrow Kelly evidentiary rule is not even applicable to the admission of medical testimony in criminal and civil proceedings, it borders on preposterous to suggest that it can be used to govern the Board's review of physician practice decisions.

3.    Use Of The Kelly Rule In The Discipline Context Is Unfeasible

First, the test presumes that a doctor in a busy and complex therapeutic setting has the means to determine whether a given modality is "generally accepted." No "general acceptance" hotline exists. Under the Board's order against Doctor Sinaiko, a doctor who relies on the advice of his expert colleagues is nevertheless subject to sanction, so long as the advice he receives has not become majority practice. How is the doctor to determine whether those he consults are in the majority? If a doctor has no practical means of discovering whether a practice has become the majority's choice, he should not be sanctioned for failing to satisfy that standard.

Second, the test presumes the state's experts have some means of discovering whether a practice approach is generally accepted. Indeed, the state's experts in this case repeatedly testified that aspects of Doctor Sinaiko's practice failed to clear that hurdle. But, how can an expert suggest that a modality is or is not one accepted by the majority of doctors in a given specialty area without data to that effect. As one commentator has noted, "When an expert answers a question about a community standard it is extremely unlikely that he or she has any real data on actual practices. It is far more likely that what an expert believes is the practice in a community is what the expert personally believes should be the standard of care. In practice, questions to an expert about a community standard are really more like questions about a personal belief." David M. Eddy, The Use of Evidence and Cost Effectiveness By the Courts: How Can It Help Improve Health Care, Journal Of Health Politics, Policy, and Law, April 2001, at 396 (emphasis added).

Finally, the reason no expert can convincingly testify that a particular practice approach has been widely accepted is that, as to most practices, studies have quite clearly shown that (a) there probably is no such thing as a majority view and (b) if there is one, as to any given practice method, it may well be wrong:

[R]ates of procedures vary across communities by factors of two, five, ten and more, and when 10 percent, 20 percent, 50 percent, even 70 percent of practices are judged by peers and experts to be inappropriate or equivocal (providing no advantage of benefits over harms), it is impossible to believe that there is a single community practice out there that the majority of practitioners are following." Indeed, given the very high rates of inappropriate care that can prevail in communities, if we actually measured what practitioners were doing and used that to define the standard of care, we would run a high risk of installing an inappropriate practice as the standard of care. The well-documented overuses of hysterectomies, antibiotics, bypasses, and C-sections are examples. Nor can we continue to take the opinions of experts at face value. New studies continually reveal that practices that were once accepted without doubt can turn out to be worthless or even harmful. We were wrong about diethylstilbestrol, radical mastectomies, erythropoetin for anemia in end-stage renal disease, hyponatremic encephalopathy, treatment of ingested poisons, hormone replacement therapy for heart disease, and class I anti-arrhythmics for heart attacks. Experts from top universities with the most experience testified under oath that high-dose chemotherapy for late-stage breast cancer would produce 20 to 30 percent long-term cure rates. Randomized controlled trials later proved them wrong. This is not to say that all experts are always wrong. It is to say that we cannot assume they are right, and there is no easy way to tell when they are and when they are not from their credentials or enthusiasm.

The Use of Evidence, supra at 396-397.

It is therefore clear that, among other reasons, the definition of "standard of care" proposed by the Attorney General, relied upon by the state's experts, and employed by the Board, is entirely unworkable.

By contrast, the "reasonableness" standard the Board should have used suffers from none of these deficits. A doctor can easily assess whether a particular approach is "reasonable" by reference to his own clinical experiences, the experiences and advice of his expert colleagues, and discussions in the relevant literature. An expert witness, whether for the state or the disciplinee, can easily render judgment on the issue. The reasonableness standard accounts for the considerable variations that exist among qualified practitioners and allows for (a) the eventual rejection of majority approaches that turn out to be either unsafe or ineffective and (b) the development of useful new practice approaches. The reasonableness test honors the rule that "where there are several methods of approved diagnosis or treatment, which could be made available to a patient, it is for the doctor to use his best judgment to pick the proper one." Barton v. Owen (1977) 71 Cal.App.3d 484, 501-502.

4.    An Administrative Proceeding Before A Panel Of The Division Of Medical Quality of The Medical Board Of California Is Not A Forum Capable Of Functioning As A Court Of Science Applying The Kelly Test

The administrative proceedings in which doctors face discipline in California are ill-equipped to apply the Kelly test, thereby serving as a courts of science which determine which of competing diagnostic and therapeutic approaches will be permitted to be used by physicians in this state and which will not. All testimony in such proceedings is taken before an administrative law judge, who also renders the initial decision as to whether a doctor will be disciplined. As in this case, that judge has no medical training or expertise. Such a judge may be as well-qualified or better qualified than a doctor to decide whether a physician is engaging in substance abuse, or is sexually abusing patients, or is guilty of not performing a specific required procedure, but that judge has no ability to determine which of two forms of therapy, each of which has support in the medical community and its literature, should be the exclusive form of treatment to be permitted in the state.

It is true that there are doctors on the panel of Division of Medical Quality to which a doctor may appeal a punishment recommended by an administrative law judge. But such an appeal does not exist as a matter of right, and, when granted, does not permit the panel to question and evaluate witnesses. Furthermore, there is no requirement that the doctors who review the imposed discipline have any training or experience in the field in which the controversy over treatment has arisen. The Division of Medical Quality can fairly judge whether a doctor has acted unreasonably in his field, but it is not equipped to serve as a court of science in selecting one among a series of competing approaches to treatment, all of which have substantial support among experts and practitioners in the relevant field.

5.    The Use Of The Kelly Rule In The Disciplinary Context Would Have Extraordinarily Negative Consequences

Finally, and most importantly, before this Court accepts an altogether new test to determine whether petitioner here acted within the required "standard of practice," it should consider the important practical implications of such a ruling. If the Attorney General is right, a California doctor who engages in any diagnostic or treatment modality as to which there is not "substantial agreement and consensus in the scientific community" (17 Cal.3d at 31), is subject to discipline. As the California Supreme Court has defined the Kelly standard, "general acceptance" means that a given technique "is supported by a clear majority of the members of th[e relevant scientific] community." People v. Guerra (1984) 37 Cal.3d 385, 418 (emphasis added).

Under the Attorney General's measure, discipline is mandated by California law (see B&P § 2234), if a doctor employs practices accepted by forty-nine percent of doctors and/or which are the subject of an ongoing debate among equally respected experts. That is so even in a case in which a doctor has caused no physical harm to any patient, in which there is no allegation of bad faith or fraud, and in which a doctor has employed methods based on his own clinical experience, the clinical experience of reliable and qualified colleagues, and on the relevant literature. Such a view is neither practical-it ignores how medicine is actually practiced-nor preferable. Indeed, application of the Kelly test to discipline setting is dangerous because it acts as a brake on medical innovation and imposes unnecessary restrictions on patient choice.

a.    The New Test Ignores How Medicine Is Practiced In California And Would Subject Doctors To Discipline For Commonly-Employed Practice Methods

Because of the trust we place in our doctors and their importance to our well being, it is not surprising that misconceptions exist in the lay community regarding the manner in which diagnosis and treatment decisions are made in the United States every day, by thousands of highly qualified doctors. Most importantly, the commonly held notion that medical practice methods are based on undisputed scientific evidence of safety and efficacy is simply wrong. Rather, medicine is largely a process of trial and error, within the context of informed consent and ongoing risk-benefit analysis.

As studies have long shown, and as the Administrative Law Judge acknowledged in her opinion (P3 22), ^[9] only between 15 and 30 percent of current medical practices are evidence-based. As the state's lead expert acknowledged, diagnosis and treatment decisions in most cases rely not on proof of efficacy and safety in formal, placebo-controlled, double blind studies, but rather on effectiveness and safety in the clinical setting. (See 5 RT 54, 91; see also 14 RT 90-98; Exhibit A4) Doctors very commonly use drugs for purposes unaddressed in the FDA approval process simply because the drugs have been shown in the clinical setting to be both safe and effective. Such off-label use without formal clinical trials is extremely common (16 RT 26) and has been acknowledged and accepted by state and federal authorities for many years. (See Exhibit 9, AG Opinion CV 76-212/CV 76-236, May 2, 1978, at 192 et seq; 3 RT 65)

Also, therapeutic practice is often presumptive rather than test-based. Thus, for example, although a child with an ear-ache may or may not have an infection, pediatricians commonly provide antibiotics without undertaking an expensive and time-consuming culture, simply to rule out the possibility of a bacteriologic etiology. (16 RT 77)

None of this ought to come as a shock. Most doctors are not in the business of determining through carefully controlled studies the safety and efficacy of various diagnosis and treatment methods. Given scarce resources, doctors must focus on treating patients. This is not to suggest that physicians can ignore the risks and benefits of their methods, but rather that decisions are based on a variety of factors, including reference to their own clinical experiences, the experiences of their colleagues garnered through consultation, along with the literature. If a doctor, after engaging in a thoughtful risk-benefit analysis, has determined that a certain practice approach works, it is unreasonable to think that he will forego that method until it has been subjected to controlled study.

An expert at the administrative hearing who addressed the question of the boundaries of physician decision-making in the therapeutic context-who is both an M.D. and a health law expert-made clear that the reasonableness formulation is proper. Doctor Paul Radensky testified that a doctor's obligation is simply to decide the question of benefit and risk. In making the benefit analysis a doctor may rely on a rational scientific theory, reported evidence of effectiveness, on the literature, or specific data from clinical trials. Significantly Doctor Radensky testified that benefit analysis may also be based upon a doctor's own clinical experience. (13 RT 91-92)

Similarly, Doctor Philip Lee, who served as Assistant Secretary of Health in the Johnson and Clinton administrations, testified that the standard of practice in California in 1993 for the treatment of patients was simply that a doctor must have had a rational scientific basis for a treatment modality. (16 RT 59) Such a rational basis could consist of clinical experience, advice from leading practitioners, research, or literature. (16 RT 75) Finally, Doctor Lee testified that a treatment modality that is rationally beneficial to a patient is within the standard of care even if it does not comport with what the majority of similarly situated doctors would do in the same situation. (16 RT 79)

Under the definition of "standard of practice" ^[10] proposed by the Attorney General, a significant portion of the approximately seventy to eighty-five percent of medical practices that have never been subjected to formal controlled study would fall outside the standard of practice. As an expert witness made clear in the administrative hearing, innovation typically occurs as a result of doctors using new approaches among small patient groups. (14 RT 94) Although these methods often spread and ultimately become majority practice, the state's position is that until the approach crosses the line from minority to majority practice, it is a proper ground for discipline. That narrow view of the "standard of care" ignores the manner in which medicine is actually practiced in this state.

b.    The Attorney General's Proposed Definition Of "Standard Of Practice" Would Act As A Dangerous Brake On Innovation In Medicine In California At A Time In Which Other States Are Moving To Expand Physician Autonomy In The Therapeutic Setting

Commentators have long argued that narrow rules for the exercise of physician judgment, beyond that of the reasonableness requirement inherent in the "due care" standard, make for bad medicine. See Greenbaum, Current Standards of Practice in Medicine: The Medical, Judicial, and Legislative Roles, 7 Western State University Law Review 3 (1979)(physician judgment must be exercised without fear of incurring both malpractice liability and professional sanction; doctors must focus on patient care, in light of reasonableness standard). If doctors are narrowly confined to majority methods, the practice of medicine in this state will be frozen in place, a result which makes no sense for patients.

Indeed, the question of the circumstances in which a doctor may depart from majority practice-i.e., to innovate-is the fundamental basis of disagreement between the parties in this case. The Attorney General has long taken the position that Doctor Sinaiko could not use a variety of methods because they are not commonly used or generally accepted by practitioners. It is Doctor Sinaiko's view that so long as he behaved with due care-that is, employed a particular diagnostic or treatment approach having (a) made a risk/benefit assessment in each case, (b) had a reasonable basis for his approach, and (c) relied upon his own clinical experiences, the experiences of his colleagues, as well as the literature-he should not be sanctioned.

Reference to recently passed statutes in other states makes clear that, in recognition of the importance of physician innovation, the strong trend is away from disciplining doctors for employing non-traditional techniques. So, for example, both Alaska and Washington have revised their statutes to require "demonstrable physical harm" to a patient in the use of "unconventional or experimental" therapies, before a doctor can be disciplined. See Alaska Statute § 08.64.326(a)(8)(A) (1998); Washington Revised Code Annotated § 18.130.180(4)(Supp. 1999). In North Carolina "[t]he Board shall not revoke [a doctor's license] solely because of that person's practice of a therapy that is experimental, nontraditional, or that departs from acceptable and prevailing medical practices unless, by competent evidence, the Board can establish that the treatment has a safety risk greater than the prevailing treatment or that the treatment is generally not effective." North Carolina Statute § 90-14(6).

The Florida Supreme Court took a similar approach in State Board of Medical Examiners of Florida v. Rogers (Fla. 1980) 387 So.2d 937. In that case, the Board of Medical Examiners sanctioned a doctor for using "chelation" therapy in the treatment of arteriosclerosis. The Board concluded that discipline was in order because "chelation therapy can best be classified as investigational, that it more likely can be classified as quackery, and that its use outside a controlled environment such as a research institute fails to conform to acceptable and prevailing medical practice." Id. at 938.

The state Supreme Court concluded that the Florida Board had acted unreasonably because no evidence existed that chelation therapy was harmful or hazardous to patients, that the physician had engaged in fraud or deception, or that the physician had not fully informed his patients of the nature of the treatment. Id. at 939. The court noted that "The Board's findings do not support a conclusion of quackery, and the state-imposed limitation on the administration of chelation treatment has not been shown by the evidence to have a reasonable relationship to the protection of the health and welfare of the state. Id.

Thus, while other states have loosened the reins on doctor judgment in the therapeutic setting, at least within the bounds of treatments which result in no "demonstrable physical harm," in this case the Board has employed a novel test with no basis in law which would dangerously limit physicians in the treatment of their patients.

It should be noted, moreover, that the Board would freeze into place the present majority- practice techniques without regard for the extent to which past minority practices have slipped into the mainstream. Discoverers of the circulation of blood, the germ theory of disease, vitamin C for prevention of scurvy, vitamin B for pellagra, smallpox vaccine, and penicillin, were either persecuted or ignored by orthodox practitioners of their day. See Stang, Laetrile-Freedom of Choice in Cancer Therapy, Cancer Control Journal, July/August 1974, at 9, 10-11, 14. Also, the Board ignores the fact some of today's orthodox practices will be tomorrow's barbarisms. See Unorthodox Health Treatments, supra, at 674 ("Blood-letting is an ancient example; a modern one is the tonsillectomy, which was performed routinely a generation ago but the need for which is now being questioned.")

Application of the Kelly rule to physician judgment in the clinical context makes no sense. While the Board can insist that a doctor conduct himself with due care, its attempt to limit doctors to methods adopted by the majority not only is impracticable, it would act as a dangerous and entirely unnecessary brake on advances in practice methods.

c.    Use Of The Kelly Test Would Place Unnecessary Restrictions On Consumer Choice

Recent studies of health consumer behavior make clear that Americans now seek non-traditional diagnosis and treatment in massive numbers. "Alternative medicine has been rapidly expanding as consumers drive the demand for more cost?effective, accessible and individualized healthcare. A commonly cited survey in the New England Journal of Medicine (NEJM) found that more Americans were consulting alternative care providers than allopathic/conventional physicians." Kristen J. Josefek, Alternative Medicine's Roadmap to Mainstream, American Journal of Law & Medicine, 26, no. 2 & 3 p. 295 (2000); see Exhibit A-14. A follow-up study in the Journal of the American Medical Association indicates that in 1997, forty-two percent of Americans consulted one of sixteen identified alternative therapies. See David M. Eisenberg et al., Trends in Alternative Medicine Use in the United States, 1990-1997, 280 JAMA 1569, 1575 (1998). "This explosion of alternative care in the United States has begun to force prominent medical schools across the country to offer courses in alternative medical techniques. Over seventy?five major medical schools have begun to teach courses in alternative modalities." Josefek, supra at 295-296. Moreover, contrary to the commonly-held notion that those who seek non-conventional care have been duped, commentators have indicated that "[p]atients who utilize complementary medicine are generally very educated consumers." Kathleen M. Boozang, Western Medicine Opens The Door to Alternative Medicine, American Journal of Law & Medicine, Vol. 24 No. 2&3 at p. 186 n.4 (1998).

Given the increasing frequency with which patients turn to doctors and other practitioners who do not practice majority diagnostic and treatment methods, the question of the right of a consumer to choose among treatment alternatives is implicated by the Board's new "standard of practice" definition. While the Board has a legitimate role in protecting patients from dangerous or fraudulent doctors, it has no cause to narrow consumer choice unless-as has been required in Washington Alaska, and North Carolina-there is proof the practice method will result in "demonstrable physical harm" or poses a significantly higher risk than conventional treatments. The kind of despotic oversight employed by the Board here would place unjustified strictures on consumers' ability to choose.

6.    Doctor Sinaiko's Conduct Must Now Be Assessed Under The "Reasonableness" Test

To sanction Doctor Sinaiko the Board had to find that his methods of diagnosis and treatment fell outside the applicable "standard of practice." That is not the same as proving that he practiced "non-standard" medicine. Sinaiko's techniques may not yet have received general or widespread acceptance, as the Attorney General's witnesses testified. There is no "substantial agreement and consensus in the scientific community" regarding Doctor Sinaiko's approach to complex immunologic and allergic diseases. Indeed, there is an ongoing and contentious debate among highly qualified doctors and other specialists regarding the modalities at issue here.

But that very debate, when viewed in light of a proper understanding of the meaning of "standard of practice" in a discipline case, makes clear why the Board's order cannot be sustained. The question the Attorney General's experts and the Board did not ask and certainly did not answer is this: did Doctor Sinaiko act reasonably in the exercise of his professional skill and did he protect his patients against unnecessary risk? Every day, doctors recommend to patients that they endure horribly uncomfortable drug regimes, such as chemotherapy, or undergo life-threatening surgery that other doctors might recommend foregoing as unduly dangerous or unlikely to produce results, yet the conduct of these doctors is viewed as reasonable and therefore within the standard of practice. If Doctor Sinaiko had a reasonable basis for employing a given practice method-based on his own clinical experience, the experiences of any reliable colleague, or the relevant literature-and, having assessed the risks and benefits of that approach, concluded in good faith that his method was in the best interest of his patient, he acted reasonably. If he acted reasonably, he was not negligent nor did he act outside the "standard of practice."

As will appear below, the Board failed to apply or satisfy that standard as to any of the sixteen findings that support its disciplinary order.

II.    DOCTOR SINAIKO'S DIAGNOSIS AND TREATMENT OF THE FOUR PATIENTS UPON WHICH THE BOARD'S DISCIPLINARY ORDER IS BASED WAS WELL WITHIN THE PROPERLY DEFINED "STANDARD OF PRACTICE "

As noted in the introduction, Doctor Sinaiko was disciplined based on a finding of sixteen violations in the course of his treatment of four patients. Those sixteen findings-thirteen alleged deviations from the "standard of practice" and three purported statutory violations-all centered on the use of a handful of drugs and medical procedures Doctor Sinaiko consistently employed in his practice to treat allergies and immunological disorders.

The Board's disciplinary order contains a section captioned "Findings of Fact." (P27 2) That section provides very brief descriptions of Doctor Sinaiko's treatment of these four patients extending over seven years and of the diagnosis and treatment techniques for which he has been sanctioned. For the purpose of this Court's review, a more comprehensive statement of the relevant facts follows.

Petitioner begins with a statement of facts concerning the procedures and medications which are the center of this controversy. He then turns to each of the four patients in question, providing a detailed description of his or her treatment history, followed by a discussion of the Board's findings of deviations from the standard of practice concerning that patient and the reasons why those findings cannot be sustained under the correct legal standard of review. Finally, petitioner will discuss the three allegations of statutory violations, none of which has merit.

A.     Statement of Facts Concerning The Techniques and Drugs At Issue

1.    Enzyme Potentiated Desensitization And The Use Of Amphotericin-B And Nystatin

In treating patients with diagnosed allergic disorders, Doctor Sinaiko employed a form of immunotherapy called Enzyme Potentiated Desensitization ("EPD"). (Exhibits A33, 50) Traditional immunotherapy seeks to desensitize the patient to his allergy by injecting relatively high quantities of antigens. Such high dose antigens have an attendant risk of anaphylaxis which kills a substantial number of patients every year. (Exhibit 50 at 37) Antigen doses in EPD are at much lower levels and therefore carry no risk of anaphylaxis. The low dose antigen in EPD is "potentiated"-i.e., assisted-by combination with a small quantity of highly purified beta glucuronidase, an enzyme which is present in every cell of the human body, is commercially available as a mollusc extract, and which is listed by the FDA as an approved nutritional supplement. (3 RT 58-59; Exhibit A33)

EPD typically involves nine injections over a 2-year period of desensitization, which results in superior safety, convenience, and patient acceptance profile than traditional allergy injections. At the administrative hearing Doctor Sinaiko offered a number of published double-blind, placebo controlled trials demonstrating the safety and efficacy of EPD for a variety of allergic conditions, as well as testimony on that subject by experts. (See P11 34 n.9, citing articles and studies; see also 4 RT 154; 18 RT 19; 19 RT 18 20 RT 129; 21 RT 25; 22 RT 60) Significantly, although there was considerable debate at the administrative hearing regarding the efficacy of EPD, the Board did not find that Doctor's Sinaiko's use of the technique was negligent.

Because EPD treatment relies on a very small and also very precisely determined amount of antigen being present at the injection site, extraneous allergen exposure at the time of the injection can render the treatment less effective. Also, any stimulus to the immune system during the several days following an EPD injection, such as exposure to food or microbial allergens or infectious agents which stimulates antibody production, may reduce the effectiveness of the treatment. For these reasons, EPD is most effective for mold-allergic patients when each injection is preceded by a ten-day course of anti-fungal medication, such as Amphotericin-B or Nystatin. (Exhibit 50)

A key element of the Board's disciplinary order was its view that Sinaiko erred in his use of these entirely safe and effective oral anti-fungal medications. The experts at the hearing below were in complete agreement that because these drugs cannot be absorbed from the gastro-intestinal tract ("GI"), they are essentially risk free when taken in an oral formulation. (See 4 RT 41; 18 RT 98; 19 RT 99; Exhibit E) Both drugs have long been approved for oral use by the FDA. (See P12 at A-6: FDA Information: oral Amphotericin approved in 1971)

Amphotericin-B and Nystatin are essentially the same drug. Both are "polyene antibiotics"- anti-fungal medications active against Candida (a class of yeasts) and a broad spectrum of other fungal organisms. Nystatin is a benign anti-fungal with some associated GI side effects. (Exhibit M, Physicians' Desk Reference, 47th ed. 1993, p. 1738) Amphotericin B is an anti-fungal active against most fungi and yeasts. (Exhibit M, British National Formulary) Amphotericin-B in an oral formulation has been approved for sale by the FDA continuously since 1971. (P12 at A-6: N Reinwald, FDA Center for Drug Evaluation & Research, Letter of July 2, 1999 & related documents)

2.    The IgG MAST Test

As will appear, another component of the Board's disciplinary order is its view that Sinaiko departed from the standard of practice by using IgG MAST testing on one patient.

Gell and Coombs, a standard text on immunology, classifies four types of immunopathology or allergy (See 19 RT 12 et seq): Type 1 immunopathology is also called "traditional allergy." ^[11] It is generally mediated by the IgE ( "immunoglobulin E") antibody system. Type 1 reactions include ordinary hay-fever and rash allergies, which can be diagnosed by serum IgE tests or by skin prick test favored by traditional allergists, particularly those with no immunology specialization. (19 RT 13) Type 3 immunopathology relates to immune reactions, generally mediated by IgG antibodies. IgG is the main class of antibody protecting against recurrent infections. In some cases IgG antibodies can be overproduced or may over-react, causing Type 3, immunologic hypersensitivity disease. The IgG MAST is a proprietary test for elevated levels of IgG antibodies in human blood.

IgG has been the subject of controversy in the fields of allergy and immunology. A state expert testified that IgG antibodies revealed in the MAST test are not diagnostic. (5 RT 85-86) Doctor Sinaiko's expert testified that elevated levels of IgG antibodies constitutes evidence indicating Type 3 sensitivity, even in cases where IgE antibodies remain at normal levels.

3.    The Use Of Anti-fungal Medications By The Immunologist-Allergist To Control Candida And For Other Purposes

Whether the presence in the human gastrointestinal tract of Candida, a fungus that sometimes produces yeast infections, can influence the activity of the immune system, has long been a subject of debate in the medical community. Studies that support the view that Candida plays such a role are partially summarized in Kurstak's 1989 textbook Immunology of Fungal Diseases. (Exhibit A28; see also Exhibits A68A and A74 for further discussion of the relevant mechanisms)

The cited texts state that anti-fungal medications are useful for eradicating or limiting fungal or yeast colonization of the GI tract. This helps normalize immune function and treat allergic and other immunologically mediated diseases. But anti-fungal medications also have other uses, making them an important tool for those allergists who have learned to use them. An explanation of some of these uses follows:

a.    Anti-fungals for Alimentary Allergy to Yeast and Fungi

It has long been known that Candida, in addition to exacerbating the immunologic effects of other allergens, may itself be an allergen. (Exhibit A68) Like any foodstuff, yeasts can produce allergic reactions in susceptible individuals who ingest them. Colonization can be prevented very safely with orally formulated polyene anti-fungals such as Nystatin and Amphotericin-B because, as noted, these drugs are not significantly absorbed across the intestinal mucosa. For that reason they can be used safely both in short-term diagnostic trials and, if indicated, in more prolonged courses of treatment of yeast or mold allergy.

b.   Anti-fungals for Allergic Sinus Disease

Invasive fungal infections of the sinuses are rare, except in immuno-compromised patients. Corey study (See Exhibit A69 (Morpeth study); A70 (Brummond study); A71 (Maning study); Exhibit A72 (Goldstein study); A73. Allergic fungal sinusitis ("AFS"), on the other hand, is common and, according to experts who have published articles on the subject in recent years, the disease is greatly underdiagnosed. (Id.; see also Exhibit H)

Because elevated levels of IgG against specific fungi indicate fungal exposure, the lack of IgG against fungi, measured by commercial in vitro specific IgG tests such as MAST (Exhibit A69; Exhibit A70) will tend to rule against a diagnosis of AFS or other conditions related to mold allergy. Oral, nonabsorbed anti-fungal medicines (Nystatin and Amphotericin-B) can reduce fungal-specific IgG production by reducing GI tract exposure to fungi, reducing the ongoing stimulus to fungal specific IgG production. Therefore, the allergic sinus inflammation of AFS may be reduced by reducing the body's excessive production of IgG directed towards fungal allergens. Thus, some experts advocate the routine use of anti-fungals for AFS. (25 RT 26; Exhibits A69, A70]

c.    Anti-fungals in ADHD

Studies published in the peer-reviewed medical literature have demonstrated that a diverse array of natural and synthetic components of foods can trigger adverse behavioral symptoms and learning disabilities in a susceptible subset of children. (See P11 82 n.142 discussing studies, including the following which were presented to the Board: P12 at A-4 (Jensen, et al., Psychoactive Medication Prescribing Practice for U.S. Children, Journal of American Child and Adolescent Psychiatry (May 1999)); P12 at A-5 (L.E. Arnold, Treatment Alternatives for Attention-Deficit Hyperactivity Disorder, Review Supported by NIH contract for Consensus Development Conference on ADHD (1998)); Exhibit A23 (Breaky: Review Article, The Role of Diet and Behaviour in Childhood, Journal of Pediatric and Child Health (1997)); Exhibit 20 (Rowe et al., Synthetic Food Coloring and Behavior: a Dose Response Effect in a Double-blind, Placebo Controlled, Repeated-measures Study, Journal of Pediatricts (1994)); Exhibit 20 (Borris, Foods and Additives Are Common Causes of the Attention Deficit Disorder in Children, Annals of Allergy, Volume 72); Exhibit 20 (Carter, Effects of a Few Food Diet in Attention Deficit Disorder, Archives of Disease in Childhood (Nov. 1993)); Exhibit 20 ( B. Kaplan, et al., Dietary Replacement in Preschool-Aged Hyperactive Boys, Pediatrics (1989)); Exhibit 20 (J.Egger et al., Controlled Trial of Oligoantigenic Treatment in the Hyperkinetic syndrome, The Lancet (March 1985)); Exhibit 20 (Egger, Controlled Trial of Hyposensitisation in Children with Food-induced Hyperkinetic Syndrome, Lancet (1992)); Exhibit 20 (J. Swanson & M. Kinsbourne, Food Dyes Impair Performance of Hyperactive Children on a Laboratory Learning Test, Science Magazine, (March 28, 1980)); Exhibit 20 (G. Augustine, H. Levitan, Neurotransmitter release from a Vertebrate Neuromuscular Synapse Affected by a Food Dye, Science Magazine (March 28, 1980)); Exhibit 20 (W.J. Logan & J.M. Swanson, Erythrosin B Inhibition of Neurotransmitter Accumulation by Rat Brain Homogenate, Science (1979)); Levitan, Food, Drug, Cosmetic Dyes: Biological Effects Related to Lipid Solubility, Proceedings of the National Academy of Sciences (1977))).

Children may react behaviorally, as with other allergens, to natural microbial products of Candida and other fungi colonizing the intestine. In order to diagnose these sensitivities, doctors exclude the suspected offending substances, and then observe for symptomatic improvements. The use of safe, nonabsorbed anti-fungal medicines in this context is an essential part of the diagnostic process-i.e., offending GI allergens are negated and the child is observed for otherwise unexplained behavioral improvement.

B.    Doctor Sinaiko's Treatment of LTS Was Entirely Within The Applicable Standard Of Care

1.    The Treatment Of LTS ^[12]

This case began many years ago with Sinaiko's treatment of a young boy whose parents, then involved in a heated custody battle, differed over the proper response to a diagnosis of Attention Deficit and Hyperactivity Disorder ("ADHD"). The details of that treatment follow.

On 4/28/93 LTS was taken by his father to LifeLine Testing and Counseling Services, where after various tests he was found to meet the criteria for a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The next day LTS's father, Ray, took the boy to Doctor Gloria Vreeland, a family practitioner, who had seen him once two years previously for a rash on his buttocks and thighs. At that time she diagnosed the rash as chronic eczema. Doctor Vreeland was on maternity leave, so LTS was seen by an associate who diagnosed the child as having ADHD and prescribed Ritalin.(Exhibit 6) Ray apparently filled the prescription and began administering Ritalin to LTS during the remainder of this Easter holiday visitation.

The mother, Kelly, took LTS to Doctor Sinaiko on 5/12/93. She told him that in the few days he had been on Ritalin, her son was more "jittery." As was Doctor Sinaiko's practice, Kelly filled out an extensive New Patient Form, which requested both general and allergy history for the child, as well as allergy history for other family members. Kelly indicated that the main reason for the visit was ADHD and dry skin (previously diagnosed as chronic eczema). (P14 C-1)

Kelly asked Doctor Sinaiko to discontinue the Ritalin. Doctor Sinaiko refused to do so, making clear "he could not go against what another doctor had already prescribed." (15 RT 65) Kelly testified that LTS's side effects on Ritalin included stomachaches, headaches, loss of appetite, and being "so zombied out that you just couldn't get him to do anything without just prodding him along." (15 RT 62-63) Moreover, he was having episodes of violence and "really severe outbreaks with his sister," as well as "unusual falls."(15 RT 62-63) She had called Doctor Vreeland to complain of these side effects. Doctor Vreeland told her that they had to keep experimenting with the dosages. (15 RT 63-64)

At the first office visit, Doctor Sinaiko took a complete history and performed a comprehensive physical examination. Kelly said he was thorough, took a long time, answered all her questions and explained what he was doing at each step. (15 RT 61; P14 C1-C7) Doctor Sinaiko charted his impression of LTS to be "ADDH-mild" and indicated on the chart an intent to rule out allergic process. While not discontinuing Doctor Vreeland's prescription of Ritalin, his plan was to rule out allergy, starting with an IgG Food & Mold MAST Panel. LTS was to return in 2 to 3 weeks. (P14 C2)

On 5/18/93 Doctor Sinaiko received the results of LTS's LifeLine Testing. Also on that day the results of the IgG Food & Mold MAST Panel were evaluated by the laboratory. (Exhibit 7) The results were high positive for cladosprium and penicillium and positive for aspergillus, cheese, egg yolk, milk and onion mix.

On 5/24/93 LTS's father took him to Doctor Vreeland who charted that the exam was "normal" despite the child having lost five pounds over the past month while on Ritilan. No examination details were recorded at all. LTS's parents reported contrary observations: the father said "The medication is helping." The mother wrote the boy's "behavior was worse." Doctor Vreeland spoke with the mother on the phone, advising her to continue the Ritalin. (Exhibit 6)

On 6/01/93, Doctor Sinaiko met with the mother and stepfather. Kelly reported that LTS's behavior was worse on Ritalin, that there was physical aggression at home directed against her and her other children. She also reported that LTS was clumsy on Ritalin, that he fell a lot. Doctor Sinaiko called Doctor Vreeland to discuss the side effects of the Ritalin. (Exhibit 7) Doctor Sinaiko suggested eliminating milk and eggs from LTS's diet as part of his diagnostic procedure, and to take Amphotericin B capsules by oral administration, again as part of his diagnostic protocol, both based on the results of the IgG MAST test. The mother's goal in seeing Doctor Sinaiko was to rule out an allergic process contributing to her son's ADHD. (15 RT 93)

On 6/08/93 Doctor Vreeland discussed LTS with his school teacher. LTS was described as different on Ritalin, more lethargic, "like spark has gone out." His grades had fallen a little and he was not eating lunch. The mother wrote to Doctor Vreeland at that time, that his teacher said his behavior was worse on Ritalin. (Exhibit 6)

On 6/10/93 LTS's father informed Doctor Sinaiko by phone that LTS was "off Ritalin now per Doctor Vreeland." (Exhibit 7) On 6/11/93 LTS's father consulted with Doctor Vreeland who then, at the behest of the father, wrote a "To Whom It May Concern" letter expressing concern that LTS had been placed on Amphotericin-B by Doctor Sinaiko. In doing so, as her testimony at the administrative hearing makes clear, she confused the orally formulated Amphotericin B with the intravenous form. Indeed, her letter cited a portion of the preeminent text, Goodman and Gilman, describing the dangers of the drug when given intravenously. (See Vreeland testimony, 6 RT 51-52;15 RT 31-32; Exhibit 6) She did not consult with Doctor Sinaiko on his reasons for using the drug. LTS's father sought and received an order from the family court overseeing the ongoing custody battle which, based on Doctor Vreeland's letter, barred LTS's continued use of Amphotericin-B.

LTS's father, clearly alarmed by Doctor Vreeland's letter, approached an office of the Federal Food & Drug Administration, which advised him that Amphotericin-B is available in an oral formulation in other countries, especially in France, England, and some South American countries, that no patent exists on the drug, and that they had referred his inquiry to the California Medical Board. (Exhibit 4C)

On 6/15/93 Doctor Vreeland referred LTS to an allergist and changed his medication to Nystatin "for yeast." (Exhibit 6) The same day, Doctor Vreeland also ordered a complete blood count (CBC) and a serum IgE for LTS. The testing showed, systemically, that LTS was "equivocal for atopic allergy" with a note that adult reference ranges were used because Doctor Vreeland had neglected to record the age of the child on the laboratory form. (Exhibit 6) Although Doctor Vreeland interpreted the IgE test result as "normal" (exhibit 6), Doctor Vincent Marinkovich testified at the administrative hearing that in general IgE levels rise with age, and thus the levels reported that LTS had IgE antibodies sufficient to cause allergic disease. (19 RT 25)

On 6/18/93 Doctor Sinaiko had a phone conference (Exhibit 7) with LTS's father and stepmother, in which he asked for the school reports and any other documentation, and told them that if they were not happy with his care of their son, he would discontinue it. The father assured him that he was satisfied with the care his son was receiving, and that same day Ray forwarded to Doctor Sinaiko the requested documentation as well as a letter expressing willingness to cooperate with anything Doctor Sinaiko's treatment approach should suggest. (Exhibit 71)

On 6/29/93 Doctor Sinaiko saw LTS, who had now been off Ritalin for 3 weeks according to his mother. Doctor Sinaiko noted that LTS was taking Nystatin, that the Amphotericin B had been stopped due to "family concern about non-FDA formulation," and he reduced the Nystatin to 1 capsule three times daily due to nausea caused by the higher dose. He again noted his impression as: "ADDH- ?allergic basis - molds? Foods?" (Exhibit 7) This impression was part of an ongoing diagnostic process which involved ruling out various allergic/immunologic conditions as a contributing cause of LTS's behavior problems. This is the last time Doctor Sinaiko saw LTS. On 7/8/93 Ray reported by phone that there was no change on Nystatin and diet. (Exhibit 7) On 7/22/93, LTS's mother reported by phone that LTS was doing "great" except after visiting his dad. Doctor Sinaiko stressed to her that "there is still the need to make the allergic diagnosis, and that this will be made to everyone's satisfaction only after school starts and objective observers can compare" LTS on and off the diet and medication. (Exhibit 7)

Kelly testified that she gave up both diet and Nystatin because the father would not cooperate and actively appeared to undermine her efforts. (15 RT 72)

On 7/15/93 LTS's father took him to Nathan Schultz, M.D., an allergist. Doctor Schultz, eschewing any "review of systems" and not completing his own form for environmental exposure or family/personal allergy history, or performing any tests, concluded that LTS had "no evidence of allergic disease." (Exhibit 5) On 8/26/93 LTS's mother took him to Michael Levin, M.D., a psychiatrist. Doctor Levin concluded that LTS suffered from Undifferentiated Attention Deficit Disorder"and Oppositional Defiant Disorder, and again prescribed Ritalin. He wanted to do a four-week placebo controlled study to see how the Ritalin worked and to stop the Nystatin. (Exhibit 8) Kelly testified that the Ritalin was stopped, however, because LTS developed facial tics. When an abnormal EKG for LTS excluded the proposed substitute use of Imipramine, ^[13] Doctor Levin dismissed himself from the case. (15 RT 105-106)

2.    Disciplinary Findings Regarding Patient LTS

a.    The board erred in finding that "use of IgG Food and Mold MAST test 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 LTS" (P27 6)

Although there was disagreement in the administrative proceedings regarding whether the IgG MAST test can ever provide useful data to an allergist/immunologist (compare 4 RT 36, 6 RT 23, 11 RT 36 with 18 RT 85, 19 RT 61), the Board did not sanction Doctor Sinaiko because he used what is a per se unreliable or ineffectual diagnostic tool. Indeed, The Board could hardly do so given that in 1993 the IgG MAST test was being ordered 50,000 times per month by physicians. (19 RT 85) Rather, the Board found that the test was inappropriate for a patient who comes to a board certified allergist/immunologist with an existing diagnosis of ADHD.

As Doctor Sinaiko has described, LTS's mother came to petitioner for the purpose of learning whether her son's behavioral problems might be caused, in part, by an allergic condition. (15 RT 93) She informed him of the prior ADHD diagnosis and Doctor Sinaiko thereafter obtained the results of LTS's behavioral testing shortly after his first meeting with the boy.

The prior diagnosis of ADHD served as a basis for Doctor Sinaiko reasonably to believe that LTS was suffering from some behavioral problems. Because he is not a behavioral specialist, he could not provide comprehensive treatment of LTS's problems. Doctor Sinaiko made that perfectly clear to LTS's mother when he refused to remove the child from the Ritalin that had earlier been prescribed for him by Doctor Vreeland. What he could reasonably do was to exclude the possibility that LTS's behavior problems stemmed in part from allergic or immunologic problems. It is entirely true that the IgG MAST test cannot determine whether a child has ADHD-that question is answered, following testing, by a child behavior expert. What the test can do, and what it did in LTS's case, was to point to the possibility of Type 3 hypersensitivity.

It will be the state's position, as it was below (see e.g., 4 RT 31), that behavior problems in children can never stem from allergic processes. The published scientific literature, and qualified expert testimony, are to the contrary. (See supra section II(A)(3)(c); P11 82 n.142, discussing cited studies; see also expert testimony sustaining Doctor Sinaiko's views: 18 RT 65-67; 20 RT 147; 21 RT 18, 38; 23 RT 22; 23 RT 30; 23 RT 65; 24 RT 46; 24 RT 12 et seq.; 25 RT 15; Exhibit 9: Doctor Marinkovich letter, December 10, 1993; Exhibits, A22, A23, A24; A25)

Even the state's experts admitted that the research in this area has been conflicting (4 RT 48, 12 RT 73) which amounts to a concession that Doctor Sinaiko could quite reasonably believe that some behavior problems result from food or mold allergies and therefore could reasonably test for such allergies using IgG MAST. Indeed, even one state expert made clear that Doctor Sinaiko's use of the IgG MAST test in this case was entirely reasonable: Doctor Jonathan Tepper wrote that IgG MAST testing has support in a number of major medical schools and is supported by a large number of studies. (Exhibit 16 at 5)

In 1979, no one in the medical community could have imagined that the occurrence of Kaposi's sarcoma, a skin disease, could be related to the sexual transmission of a virus. The hypothesis that it was so related was a proposition that was advanced by a minority of the medical community well before it was accepted by the majority. See, e.g., Nuland, How We Die, Chap. 8, A Story Of Aids. There is at the very least a highly qualified minority opinion that supports Doctor Sinaiko's view that approaching behavioral issues from the perspective of an allergist makes sense. For that reason, his decision to use the IgG MAST test to aid him in determining what, if any, influence allergic disease had on LTS was entirely reasonable.

Petitioner's practice decisions here were more than reasonable, and the state utterly failed to prove by clear and convincing evidence that he engaged in negligent conduct.

b.    The Board erred in finding that "use of any anti-fungal 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." (P27 6) (5)

c.    The Board erred in finding that Doctor Sinaiko's use of Amphotericin B to diagnosis allergic disease was a departure from the standard of practice (P27 7)

d.    The Board erred in finding that "prescribing an oral formulation of Amphotericin B without a diagnosed indication was a departure from the standard of practice" (P27 7)

The Board has found that Doctor Sinaiko, in LTS's case, prescribed Amphotericin-B, an anti-fungal, in a manner not generally accepted in the relevant community of allergists. But the relevant question, as petitioner has argued, is simply whether, given the risks and benefits associated with his approach, he behaved reasonably. He most assuredly did so.

LTS's mother brought the child to Doctor Sinaiko because she was unsatisfied with a treatment plan that included Ritalin. It is worth noting that there is considerable debate in the expert scientific community whether Ritalin is always an appropriate treatment for child behavioral problems. One expert testified below, for example, that no research has established that the drug has long-term benefit for children with ADHD. (21 RT 77) LTS's mother had earlier become aware of the views of some doctors and researchers that allergies can play a role in behavioral problems. Armed with this knowledge, she sought Doctor Sinaiko's expert opinion regarding whether LTS was suffering from such an allergic condition. Doctor Sinaiko's comprehensive history and physical provided more than sufficient grounds for him to explore the possibility of allergic or immunologic illness-LTS had a history of dry skin, eczema, and a family history of allergies to pollen, animals, and bee stings.

The IgG MAST test registered "high positive" for antibodies to two molds (cladosprium and penicillium) and "positive" for antibodies to another mold and a variety of foods (aspergillus, cheese, egg yolk, milk, and onion). These readings did not positively identify fungal infection, but rather revealed that LTS has a significant immune response to the named molds. The test simply raised the possibility that LTS had some ongoing immunologic problems which, as petitioner has noted, have been connected in the literature with behavioral problems in some children.

Armed with the results of the IgG test, the strong family history of allergies, and clear indications that LTS had suffered from allergies in the past, Doctor Sinaiko sought to do exactly as he had charted at LTS's first visit: to "rule out" the possibility of an allergic etiology for LTS's behavioral issues. The first steps in that process were (a) encouraging LTS's mother to eliminate the offending foods (milk, cheese, eggs, and onions, per the IgG test) from her child's diet and (b) starting LTS on a course of anti-fungal medication, in this case the entirely benign oral form of Amphotericin-B. Doctor Sinaiko was unable to make any final conclusion regarding the effect of any allergy on LTS's behavior because the child was removed from his care after only a few visits.

Doctor Sinaiko's practices in his short involvement in LTS's case were entirely reasonable. Highly qualified experts testified at the administrative hearing as follows: adverse behavioral symptoms may have allergic etiology; in many cases a child appears to have ADHD and if the underlying allergic etiology is managed, the symptoms disappear. (18 R 65; 20 RT 147; 21 RT 64; 21 RT 95) It is entirely appropriate to undertake a trial of oral anti-fungals as part of a diagnostic workup of a child formerly diagnosed as meeting ADHD criteria. (18 RT 39-40; 18 RT 65; 19 RT 37) Doctor Vreeland, LTS's family physician, testified that she often explains to parents that an initial diagnosis may be proven by reference to a patient's response to medication. (6 RT 37) An expert witness testified that based on symptoms physicians very commonly treat presumptively, rather than by concrete disease diagnosis. (20 RT 167)

Oral anti-fungals can be highly effective in treating children with behavioral problems. (18 RT 61) Given LTS's history and the IgG test results, presumptive use of oral anti-fungal was clearly indicated, and certainly was not unreasonable. (18 RT 97; 19 RT 27-28) The fact that LTS was diagnosed as having had eczema two years before seeing Doctor Sinaiko was a perfectly valid basis for petitioner to conclude that allergy could be a factor in LTS's behavioral problems. (19 RT 23) Use of anti-fungals was appropriate because in a significant portion of the population, reduction of fungal colonization of the GI tract mitigates allergic symptoms. (See e.g, Exhibit FF; A68A) An expert testified that she has seen significant behavioral improvements with the use of anti-fungals. She regularly refers patients to Doctor Sinaiko based on his past successes with those drugs and food elimination diets. (24 RT 12 et seq.) Finally, Doctor Sinaiko testified that since his residency he has treated many children with anti-fungals and has seen dramatic improvements in about half. (25 RT 15)

There was also a volume of testimony by experts and the parents of Doctor Sinaiko's minor patients that Doctor Sinaiko's approach to behavioral problems works. As petitioner has argued here, he could reasonably rely on his own clinical experiences to make diagnostic and treatment decisions in LTS's case. (21 RT 18, 38; 22 RT 9; 23 RT 22; 23 RT 22; 23 RT 65; 24 RT 46) In one case an expert witness testified that she had undertaken a study of children with behavioral problems treated by an allergist. She reported that allergy treatments dramatically improved behavioral problems. (23 RT 30)

The Board's disciplinary findings are consistent with a "general acceptance" definition of the "standard of practice." As one of the state's experts opined, "I will maintain my position that many of [Doctor Sinaiko's] practices for the treatment of behavioral and performance issues of children are not consistent with 'standard medical care' . . . ." (Exhibit 14 at 1-2 (emphasis added); see also P19 54, 78, 90, 101 (Attorney General argues in brief on reconsideration that there is no "general acceptance" of notion that behavioral problems can have allergic component))

Doctor Sinaiko does not claim that his approach to the issues presented by LTS's case represents the majority practice, if indeed such a concept can be meaningfully measured. But it cannot seriously be contended that his methods were unreasonable. He undertook a perfectly adequate physical and history, as the Board found. (P27 7) He used a test to measure IgG antibodies which during the same time period was performed for doctors 50,000 times per month, and which was clearly the choice of a group of doctors who treat a wide variety of allergic and immunologic problems. He then began a presumptive trial of a medicine which posed no risk and caused no physical harm whatsoever to his patient. And he did all this in an effort to rule out a relationship between LTS's behavioral problems and possible allergic disease. This potential connection, although rejected in theory by many doctors, was confirmed by various experts below and has been confirmed by numerous well-controlled studies published in the medical literature.

Having assessed the risks and benefits of his approach, and having in mind his own experiences, the experiences of his colleagues, and relevant literature, Doctor Sinaiko attempted to determine whether LTS could be helped by an allergist. He never discovered an answer to that question because the child was removed from his care. But there is not a shred of evidence Doctor Sinaiko operated without a valid and reasonable basis for his conduct. The state failed to prove a single instance in which petitioner operated outside the properly defined standard of practice in treating LTS.

C.    Doctor Sinaiko's Treatment of RS Was Entirely Within The Applicable Standard Of Care

1.    Doctor Sinaiko's Treatment Of RS^[14]

RS was 24 years old when he first appeared in Doctor Sinaiko's office on 9/26/90 complaining of long standing nasal and sinus problems. He blew his nose constantly, without much discharge. Prolonged episodes of sinus headaches as long as a week were occurring intermittently and he complained of chronic fatigue, and memory and cognitive impairments. He had been treated in the past for Giardia with Flagyl and again had diarrhea and rectal itching. He had abdominal bloat after meals. Allergy medications were not very helpful and their side effects were troublesome. "Sudafed unclogs me but makes my throat dry." Seldane was not very effective. In college, dry air bothered him; he used a humidifier which seemed to give him "colds." He noted significant increase in upper respiratory secretions when he would ingest chocolate, milk, beer, peanuts, and sometimes bread. He craved chocolate and sugar.

Doctor Sinaiko took a complete history including family, environmental, and occupational histories, review of systems, past medical history, and surgical history, all of which were non-contributory. RS denied adverse reactions to medications.

Physical examination revealed a low grade fever, a boggy, hyperemic [inflamed] nasal mucosa, succulent [appearing liquid-filled] uvula, and tenderness of both malar [cheekbone] areas. The thyroid gland was lumpy and tender, the abdomen was diffusely tender, and the remainder of the physical examination was unremarkable.

RS's history included 2 years of Tetracycline as a teen for acne, and subsequent treatments for sinus infections and Giardia after visits to India.

Doctor Sinaiko noted chronic sinus blockage, possible gastrointestinal infection [possibly with yeast-also called monilial enteritis-due to previous antibiotics] and possible food allergies. Doctor Sinaiko placed the patient on a brief tapered course of prednisone to clear the sinuses, as well as Diflucan and Nystatin because of the likelihood of fungal involvement in both the sinuses and gastrointestinal tract. He was placed on a diet to avoid sweets and juices to allow the anti-fungal medications to work more effectively and to avoid dairy products, to which he had reported allergic symptoms. He was asked to return in three weeks.

On 10/5/90 RS called and reported major relief on the brief course of prednisone, but that his headache had returned when it was discontinued. Another course of prednisone, now at the very low dosage of five mg per day for five days followed by five mg every other day for two weeks, was prescribed.

On 10/9/90 RS reported that he had taken more prednisone than had been advised in the previous four days and that "I can't live without prednisone now."

On 10/10/90 RS reported that his nose became blocked with even two days off of prednisone, and his GI symptoms were improved on the anti-fungal medication. 7.5 mg of prednisone were prescribed for three days, then to taper over the next six days.

At a 10/24/90 visit he was doing well on five mg of prednisone a day, though occasionally when his sinus headaches would worsen, he would take 10 mg. without Doctor Sinaiko's approval. Hoarseness would recur whenever he decreased the prednisone. He reported a decrease in his fatigue, with less afternoon tiredness and said "I'm not that tired at night." His diarrhea had resolved completely as had his rectal itching. He said "that's totally gone away." However, he still had bloating and gas.

On physical examination his abdomen remained diffusely tender. Doctor Sinaiko prescribed Atabrine, clearly warning RS of its possible side effects, and Yodoxin. Nystatin and Diflucan were continued.

On 11/5/90 RS telephoned. He had finished Atabrine and he had discontinued Yodoxin. He reported his "head felt strange" after drinking alcohol while taking the Atabrine. He was told to finish the course of Yodoxin and avoid alcohol completely.

On 11/19/90 RS returned, saying "I am definitely better." The abdomen was less tender on exam and he was given a ten day course of Flagyl. The patient was continued on Nystatin.

On 12/7/90 RS telephoned reporting that his sinuses were worse again. Doctor Sinaiko prescribed a further tapered course of prednisone and said to phone in three days if the sinus problems were not clear.

On 1/16/91 RS returned. His sinus headaches were reported improved. He reported he was completely off alcohol per Doctor Sinaiko's recommendation and that he was trying to avoid milk. He reported that milk would result in increased nasal congestion. The diagnostic impression was allergic rhinitis, milk allergy and some inflammatory condition of the terminal ileum, the part of the intestine corresponding to the area of tenderness. Doctor Sinaiko continued the patient on oral Nystatin and off sugar and dairy products. Allergy skin testing was positive for house dust mite and negative for feathers. RS was begun on allergy immunotherapy for house dust mite.

On 2/6/91 RS telephoned to report that he was going on a ski trip to the Rocky Mountains for three to four weeks, and said he had sinus pressure for the past 2 days. He was given a six-day tapered course of Prednisone and told to return in March.

On 4/1/91 RS returned to the office still reporting clogged sinuses almost all the time and that while prednisone is "a miracle," his symptoms return promptly within two days of discontinuing it. He also reported disturbed sleep. On physical examination, the nasal mucosa was boggy. The patient's abdomen was normal on physical examination except for very minimal periumbilical [around the navel] tenderness, a marked improvement. RS had been off Nystatin for the previous two weeks, claiming that it was "never of benefit." At the same time, he reported that the "dull burning sensation" which had resolved on Nystatin, had returned. The diagnosis was low grade chronic fungal sinusitis and the patient was given Nystatin, Diflucan and another tapered course of Prednisone. A brief course of Klonopin in low dosage after dinner was prescribed for sleep. He was to avoid alcohol and return in two months.

On 6/3/91 RS returned, still with nasal blockage and intestinal symptoms including diarrhea, bloating, soreness and gas. He said he has felt better on fluconazole [Diflucan]. He was having sinus headaches. He reported that his 24-yr-old girlfriend also was feeling tired. She had recently been to India. Under further questioning, he now reported that he had felt nervous and had hallucinated on the previous course of Atabrine. He had been told when Atabrine was prescribed to telephone immediately in case of such symptoms, but he had not telephoned to report any such symptoms, reporting instead, two days after completing the medicine, that his head had "felt strange" while taking it and drinking alcohol.

On 7/2/91 RS returned, reporting diarrhea which improved with Pepto Bismol, headaches every day, nasal blockage, nasal congestion, bloating and gas, and fatigue. He felt achy and sore. The stool test showed 1+ Candida. Although such a result would be interpreted as normal under other circumstances, its persistence during Nystatin treatment suggests a very heavy colonization which has only been partly controlled with Nystatin. If not for a heavy colonization, Nystatin would have rendered the stool completely negative for Candida. The stool test also showed elevated numbers of unidentified fecal objects ("UFO"). On the back of the laboratory report, is a list of symptoms experienced by people found to have such an elevated report, which included all of RS's symptoms: diarrhea, bloating, gas, abdominal pain, fatigue, recurrent yeast, aches. In 1991 the laboratory's recommendation was to consider UFO's in the category of the pathogen blastocystis hominis, which should be treated if it resulted in the above-listed symptoms.

RS's stool test was negative for parasites. Physical examination revealed abdominal tenderness corresponding to the region of the terminal ileum, leading to the impression of terminal ileal inflammation, possibly early Crohn's Disease, Candida enteritis, or food allergy. The patient began an eight-week trial of weekly gamma globulin injections and weekly injections of vitamin B12 and magnesium sulfate.^[15]

On 7/23/91RS continued to feel ill, and his muscle aches suggested a diagnosis of fibromyalgia. Accordingly, Doctor Sinaiko prescribed Elavil 25 mg. Three months later, on 10/25/91 RS was less achy, sleeping better, but continued to have sinus symptoms and felt bloated after dinner. He had discontinued Elavil because it made him sluggish but was continuing to receive magnesium sulfate, B12 and gamma globulin.

On physical examination, again, there was abdominal tenderness and he was begun on a lower dose of Elavil for his fibromyalgia, and Nystatin for the returning intestinal symptoms. Weekly gamma globulin was continued and Doctor Sinaiko discussed with RS the possibility of beginning EPD for his sinus allergies.

On 11/20/91 RS had his first EPD treatment. Pre-treatment for EPD injections usually consisted of oral Nystatin for 2 weeks. When he began EPD injections, his pattern of anti-fungal medication use changed, so that he used Nystatin only as pre-treatment for two weeks before each injection.

On 1/17/92 RS received his second EPD injection, reporting that with the first, there was significant relief of sinus headaches and relief of muscle aches. He had stopped taking Elavil for fibromyalgia because even a 5 mg dose at bedtime left him drowsy in the morning. As before, RS reported increased GI symptoms each time he stopped Nystatin.

On physical examination there was moderate diffuse tenderness of the abdomen. Because of the worsening GI symptoms whenever discontinuing Nystatin, he was changed again to continuous Nystatin treatment.

On 4/9/92 RS received his third EPD injection. He reported very significant relief of his sinus symptoms, with no headaches after his second EPD treatment. Following a trip to Lake Tahoe, he had increased GI symptoms and the pattern of abdominal tenderness had changed, with tenderness now only on the left side. Suspecting reinfection with Giardia, he was again treated with one week of Flagyl. On 7/14/92 RS received his 4th EPD injection. Continuing EPD injections every three months, RS was doing well. There was only slight abdominal tenderness. He was on a milk-free diet, off ETOH, chocolate, sugars and fermented foods.

On 4/26/93 after being well for a whole year, RS reported periumbilical pain on the left which was worse after meals. He complained of nasal and throat congestion. He had been off Nystatin. On physical examination there was left-sided abdominal tenderness. He was given a course of Clindamycin [antibiotic] for 10 days as pre-treatment for the next EPD shot, and put back on Nystatin. An IgG food and mold MAST test was ordered and this showed abnormally high antibody levels against Candida, certain other fungi, and certain foods including milk, egg, and corn.

On 5/11/93 RS received his seventh EPD injection, and reported that the congestion and GI symptoms had cleared on Clindamycin, suggesting that he had been suffering from a bacterial infection which was cleared by this antibiotic. Because of the positive MAST test, he was told to avoid egg, milk and corn for two to three weeks after each EPD injection.

On 7/27/93 RS had his final EPD injection. No further contact with the patient was recorded thereafter.

2.    Disciplinary Findings Regarding Patient RS

a.    The Board erred in finding that Doctor Sinaiko's treatment of Candida without objective measure that Candida was present and his conclusion that Candida can cause symptoms noted in the patient comprised a departure from the standard of practice. (P27 16)

As will appear, if Doctor Sinaiko's approach to this issue is measured by reference to a "reasonableness" standard, there is no evidence he departed from the standard of practice. Indeed, the Board's handling of the Candida question represents perhaps the clearest example of its refusal to acknowledge opinion and findings in the expert community which support a minority view: i.e., that Candida does influence immune functioning and that the particular "objective measure" (i.e., cultures for the presence of Candida in the stool) called for by the Board is inappropriate.

When Doctor Sinaiko first examined RS in 1990, the patient had a variety of allergic symptoms: severe sinus problems, food intolerance, chronic fatigue, GI complaints, memory and cognitive impairments. RS reported a history of Giardia. Standard allergy treatments had proven to be ineffective. As a result of these findings, along with a comprehensive history and physical, Doctor Sinaiko determined that RS was suffering from Monilial Enteritis or Candida sensitivity.

The Board's view is that Candida, in quantities that are typically found in human adults, cannot play an exacerbating role in systemic immunologic or allergic malfunctioning. But there is a volume of peer-reviewed literature to the contrary. (See A68A 868, the Brostoff & Challacombe text on Food Allergy and Intolerance, which lists 103 references on the subject of chronic candidiasis and allergy).

The Brostoff text, which was published in 1987, makes clear that RS's history and symptoms fell neatly within the group of patients who have chronic sensitivity to Candida. RS had long used antibiotics and prednisone (Exhibit A68A 860), and he had a variety of physical symptoms which are associated with Candida problems: chronic fatigue, bowel disturbances, food intolerances, chemical sensitivity, food cravings, and mold sensitivity. (Exhibit A68A 855, 857)

The Brostoff text, too, makes clear that the Board's finding of negligence vis a vis Doctor Sinaiko's diagnosis of Candida sensitivity without "objective measures" is baseless. The diagnosis section of that text starts by indicating that "[t]here is no single diagnostically specific test for [Candida sensitivity]." (Exhibit A68 857) Doctor Sinaiko utilized the indicated diagnostic factors in determining how to treat RS: there was suggestive history and RS responded favorably to a trial period of anti-fungal therapy. (Exhibit A68 857) Brostoff makes clear that stool culturing in a case of suspected Candida sensitivity is "inherently limit[ed]" because it "tells us nothing about the host response and sensitization." (Exhibit A68A 858) An expert testified in this proceeding that during the relevant time period there was no good test for Candida colonization. (20 RT 152) Another expert made clear that it was entirely within the standard of practice during the relevant time period for a physician to make a diagnosis and treat Candida sensitivity by reference to empirical observations as opposed to a laboratory test. (20 RT 173, 184)

In RS's case, as the detailed description above makes clear, Doctor Sinaiko followed the lessons of the Brostoff text impeccably: he believed that RS's multiple symptoms were likely the result of Candida sensitivity, both in the GI tract and in his sinuses. That diagnosis was based, as Brostoff recommends, on a complete history and physical and a trial period of entirely benign anti-fungals. Neither the Board nor the Attorney General has ever argued that a doctor may not reasonably rely on the Brostoff text, which can be found in medical school libraries throughout the United States, or that the text itself is in any way lacking in authority.

Thus, the Board would have been wrong to hold that Doctor Sinaiko acted unreasonably in believing Candida could play a role in RS's problems or in diagnosing and treating for Candida sensitivity without an objective measure-i.e., cultured stool sample. It is true that the state's expert witnesses testified that there is no general acceptance of the notion that Candida sensitivity can result in immunologic problems. (See 4 RT 108; 13 RT 15) Doctor Sinaiko presented witnesses who took an opposing view. (16 RT 31 et seq.; 17 RT 22; 16 RT 100) "[W]here there are several methods of approved diagnosis or treatment, which could be made available to a patient, it is for the doctor to use his best judgment to pick the proper one." Barton v. Owen (1977) 71 Cal.App.3d 484, 501-502. Only by using a flawed "general acceptance" calculus to define negligence and the standard of practice could the Board sanction Doctor Sinaiko for his reliance on Brostoff and his use of methods therein.

b.    The Board erred in finding that Doctor Sinaiko's use of Nystatin and Diflucan to treat Candida without clear indication and without regard for efficacy of these drugs in the particular clinical situation amounted to a departure from the standard of practice and excessive prescribing. (P27 16)

As noted, a leading clinical text recommends long term and recurring use of anti-fungals in the treatment of Candida sensitivity. There can be no serious doubt that Doctor Sinaiko carefully diagnosed this serious immunologic disease in accordance with that text. It is difficult to understand, therefore, how he can have departed from the standard of practice by closely following Brostoff's recommendations. Doctor Sinaiko relied not only on the literature, but on his own clinical experiences and the expertise of his colleagues. As to his use of both Nystatin and Diflucan, petitioner had more than a reasonable basis for approaching RS's treatment as he did; he had overwhelming evidentiary basis. Most importantly, RS benefitted from Doctor Sinaiko's methods.

The Board faults Doctor Sinaiko first for his long term use of Nystatin, the drug preferred by Brostoff. (A68A 866) Reference to RS's history makes clear that his condition improved when he was on Nystatin and declined when he went off it, often against Doctor Sinaiko's advice. Brostoff notes that "Clinically, anti-fungal treatment of patients with [Candida sensitivity] may result in dramatic improvement in otherwise untreated mold, food and chemical intolerances . . . ." The text recommends long term treatment of four to sixth months, with recurring use of anti-fungals (preferably Nystatin or Amphotericin-B) if symptoms reappear. (Exhibit A68A 863, 866) Brostoff also recommends immunotherapy which Doctor Sinaiko later used successfully in RS's treatment. (Exhibit A68A 867) An expert at the administrative hearing who was familiar with the literature in this area testified that it was within the standard of practice to use anti-fungals over a long period for fungal colonization of the gut. (20 RT 108, 117)

Doctor Sinaiko later used Nystatin as a pretreatment for EPD on RS. Although, as will appear, the Board has sanctioned Doctor Sinaiko for certain aspects of his use of this long-established form of immunotherapy, it has neither doubted the efficacy of the technique nor questioned any aspect of its use, including the employment of a dose of anti-fungals for several days preceding each treatment. The use of anti-fungals in this manner was confirmed by EPD experts below. (18 RT 20, 84)

The Board also faulted petitioner for using another anti-fungal, Diflucan. As can be seen in the statement of RS's treatment history, he came to Doctor Sinaiko with a long-standing diagnosis of chronic sinusitis. (25 RT 118; 4 RT 111) Given RS's other symptoms, and Doctor Sinaiko's diagnosis of Candida in the GI tract, petitioner reasonably identified mold allergy as the source of RS's sinus problem-i.e., Allergic Fungal sinusitis ("AFS"). (25 RT 103; see A69, A70, A71, A72 and A73 (literature detailing AFS)) AFS is a reaction to various, non-invasive molds. (5 RT 103) Specifically, an allergic patient-as RS clearly was-breathes in and has an allergic reaction to airborne fungi which colonize the sinuses, causing an allergic reaction which closes off sinus openings. In RS's case, Doctor Sinaiko used Diflucan to address the AFS, as well as Nystatin; the latter drug helped the sinus condition by clearing the GI tract of fungi, reducing the IgG response. (25 RT 106; see A68A 853)

Just as with his use of Nystatin, it is hard to understand how Doctor Sinaiko's use of Diflucan was unreasonable. The literature makes clear Diflucan is indicated for AFS. (See e.g., A73 92) RS used the drug and his symptoms improved. Diflucan, like Nystatin, similarly was used as a pre-treatment for EPD. Unlike Nystatin, Diflucan is highly effective in reducing fungal colonization of the sinuses. Indeed, although Doctor Sinaiko is accused of having used Diflucan excessively, in truth he used it only for a few weeks at a time to address RS's recurring AFS. (P11 133) The Physician's Desk Reference specifically recommends that patients be treated with Diflucan "for a minimum of three weeks" and for two weeks following resolution of symptoms. The standard manual for the use of prescription drugs further indicates that an "inadequate period of treatment may lead to recurrence of active infection." (See P11 138 n.208) The Board's finding that Doctor Sinaiko departed from the standard of practice in his use of these drugs to treat RS is unsupportable.

The Board also found Doctor Sinaiko guilty of "repeated acts of clearly excessive prescribing" in his use of Nystatin and Diflucan in RS's treatment, pursuant to California Business & Professions Code § 725. That statute equates such "excessive prescribing" with the unprofessional conduct which is the hallmark of a § 2334 disciplinary proceeding. Charges under § 725 almost uniformly arise in cases in which a doctor is accused of providing narcotics to patients without indication. See e.g. Leslie v. Board of Medical Quality Assurance (1991) 234 Cal.App.3d 117.

In this case, if, as Doctor Sinaiko has argued, he was reasonable in his use of Nystatin and Diflucan in his treatment of RS, there is no logical argument he engaged in excessive prescribing. The charges fall together.^[16]

c.    The Board erred in finding that Doctor Sinaiko's use of Atabrine for an "undocumented infection" without indication or diagnostic test that would have confirmed need for the drug comprised a departure from the standard of care. (P27 16)

The Board and the state's experts faulted Doctor Sinaiko for using Atabrine to treat RS's recurrent GI problems. (4 RT 112, 13 RT 53) Again, the question is whether presumptive use of a drug clearly indicated for Giardia^[17] was unreasonable. It was not.

RS had history of Giardia infection, a tender abdomen, and chronic bowel symptoms-all clear indications of Giardia. (25 RT 120) Although Doctor Sinaiko suggested to his patient that his problem could be confirmed by use of a stool test, RS declined because of the significant expense. After being fully informed regarding the risks and benefits of the drug, RS decided to begin a course.

Neither the state nor the Board has suggested that Doctor Sinaiko undertook a dangerous treatment course without indication. Rather, petitioner was confronted with a patient who had serious GI problems, clear physical indications, a clear history of under-treated Giardia infection, and who declined testing. Moreover, Doctor Sinaiko was aware, as most infectious disease specialists are, that stool tests for Giardia and other bacteriologic agents are very commonly falsely negative. (25 RT 120) Given these circumstances, it cannot seriously be argued that his use of this appropriate and safe drug was unreasonable.

Such presumptive prescription is a mainstay of modern medicine. In many cases, as in this one, the resources are unavailable to support objective testing. No witness at the administrative hearing testified that such presumptive prescribing is either uncommon, or unreasonable. A patient who appears with a productive cough commonly receives a prescription for an antibiotic aimed at clearing bronchitis. A child with an earache and other symptoms is given an antibiotic for an ear infection. In neither case must a doctor require the patient, who may be experiencing serious discomfort and/or loss of income, to wait until a costly and time-consuming culture is prepared and analyzed. The drugs, which are safe, are provided presumptively-i.e., based on a reasonable supposition that they will work. If they do not, infection is ruled out.

Given that the treatment method was all but risk free, it was not unreasonable for Doctor Sinaiko to undertake a trial course and use his clinical observations to support a future treatment plan. There was no substantial evidence of any negligence in Doctor Sinaiko's treatment of RS.

D.    Doctor Sinaiko's Treatement of JH Was Entirely Within The Applicable Standard Of Care

1.    Doctor Sinaiko's Treatment Of JH^[18]

Past medical and surgical history revealed frequent sore throats and a lumbar laminectomy [operation on a ruptured disk] in 1981. Environmental exposure history did not reveal any allergenic exposures [no pets, etc.]. Adverse reactions to foods included sinus blockage following ingestion of milk products.

On review of systems, JH admitted to depression and fatigue and the physical examination revealed inflamed swollen nasal mucosa with erythema [redness] and edema [swelling] to the left of the nasal bridge and tenderness of the right malar [cheekbone] area.

Doctor Sinaiko's initial impression included allergic problems with milk, dietary yeast, possibly candida, and possible inhalant allergens inducing his rhinitis, eustacian dysfunction, and right maxillary sinusitis, which Doctor Sinaiko treated with prednisone and amoxicillin, and Nystatin nose spray. JH was told to return the following day.

On 4/04/86 JH reported that the prescribed treatment had already afforded him very significant relief. Because of his clear history of allergy to yeast, JH was placed on oral Nystatin. Doctor Sinaiko used this second visit to elaborate on JH's history. At that time the patient reported that his headaches occurred only when nasal and sinus symptoms were present. He reported that these symptoms became worse with browsing in old book stores and exposure to newsprint. His weight was stable at around 160, but he would occasionally gain to 170 pounds. He noted occasional swollen lymph nodes in the neck at those times when his sinuses were blocked. JH described back pain and pinched nerves in the neck which he dated back to previous injuries as a rodeo rider before his lumbar laminectomy in 1981.

Further allergy history revealed that the following factors would trigger his sinus symptoms: tobacco smoke, fresh newsprint, old books*, milk ingestion, synthetic clothing, wool clothing, and being outdoors in pollen season. JH's family history was positive for asthma and allergic rhinitis. Repeat physical examination on this date revealed swollen red nasal mucosa and redness of the throat without pus. Subtle nodularity was found on examination of the thyroid gland, which was not tender. Examination of the skin revealed a well-circumscribed irregularly shaped quarter-sized very hyperemic [red] patch just to the left of the midline of the anterior chest. JH was put on a Candida control diet, to maximize effectiveness of the Nystatin, told to avoid milk, and asked to come back in 2 weeks.

On 4/18/86 JH's sinuses continued to improve on treatment, his ears now remaining clear, and the rash on his chest was completely gone. He had no achiness and reported less reaction to cigarette smoke. He reported some problems with Nystatin powder and was therefore switched to Nystatin nasal spray which he tolerated well. Doctor Sinaiko also recommended a diet excluding sugars and dairy products. The impression on 4/18/86 was "resolved sinusitis" and JH was instructed to return for allergy testing. Over the next two months he underwent various tests which showed allergy to house dust and began immunotherapy.

On 6/10/86 JH returned reporting that the allergy immunotherapy which had been prescribed based on testing was well tolerated and that he was having no nasal problems except for awakening a "little stuffy" in the morning. He reported achiness in the right ear for one day. Physical examination revealed a coated tongue and a swollen inflamed nasal mucosa with green discharge. The right tympanic membrane was slightly bulging. The impression was right eustacian tube dysfunction, and he was treated with oral "swish and swallow" Nystatin [for oral thrush]. He was given Antivert [antihistamine], and his allergy immunotherapy dose was adjusted.

On 8/18/86 JH obtained a new bottle of Nystatin powder and reported not doing very well and discussed alterations in the dose with Doctor Sinaiko. In a later phone conversation the same day, JH reported the symptoms were well controlled with the new dose.

On 10/07/86 JH reported that he had felt well for four months with allergy immunotherapy and that his sinuses were generally much better. The antigen dose was regulated. He had discovered that his rash on his chest was triggered by ingesting mixed nuts and flour tortillas. Also ingestion of these foods triggered sinus blockage, and he found that when he discontinued ingesting nuts and tortillas both his rash and his sinus blockage cleared. He reported his tongue was again coated for 2 or 3 days.

Physical examination revealed that the white coating on his tongue had returned, and the nasal mucosa was red and swollen. The impression was allergy to yeast and to dust. The plan was to test him for allergy to candida and possible immunotherapy.

On 10/13/86 JH reported increased sinus congestion after acidophilus, probably due to allergy to the cow's milk protein in that product. Hypersensitivity skin tests on 10/22/86 revealed allergy to candida.

On 10/30/86 JH reported by phone that the first half of each bottle of immunotherapy caused muscle weakness which disappeared after the half-way mark. Doctor Sinaiko discussed a possible solution to the problem.

On 11/06/86 after having been treated with immunotherapy for candida, JH reported he was having no symptoms. Each of his previous symptoms were absent-except for a fluctuating rash on the chest, for which Doctor Sinaiko prescribed Selsun Lotion.

For the next year, JH did well. He called in December and March to discuss his immunotherapy. A note appears in the chart on 11/04/87 that he had not been seen in over a year and should return for a routine checkup.

On 12/07/87 JH returned, reporting several weeks of increasing seborrheic dermatitis [rash] on the chest as before, and morning nasal stuffiness which cleared for the rest of the day by taking a warm shower. Lotrimin cream and hydrocortisone cream were prescribed for areas of dermatitis, and oral Nystatin was continued. He returned on Jan. 4, 1988 for further skin testing.

On 1/25/88 in accordance with the skin test results, JH began further antigen immunotherapy with molds, including Epidermophyton and Candida, and his house dust immunotherapy was continued. On 2/05/88 JH called for a Nystatin tablet prescription.

On 6/3/88 JH called and reported having the flu. Doctor Sinaiko prescribed rest and fluids.

On 8/08/88 JH called, reporting that he felt "spacey" but felt better when he took a double dose (0.10 cc) of the immunotherapy. He was worried about having skipped a day of the immunotherapy. He was advised that skipping a day should not make any difference, and to stay on 0.10 cc unless a reaction develops.

On 8/15/88 JH called to report that he had needed to increase the dosage to 0.15 cc and then to 0.20 cc. He was advised that he would receive a new bottle, to see whether it makes any difference; if not, the patient should call or come in. In September, JH called to ask about some amino acid tests, but Doctor Sinaiko told him that he did not think it was necessary.

Having done well under Doctor Sinaiko's care for nearly a year, on 11/21/88 JH returned with nasal symptoms including postnasal drip and coryza with clear watery discharge since a one day sore throat 2 weeks ago. He would awaken with a stuffy head, but no particular headache. The sebhorreic dermatitis rash/acneform, over the sternum had returned for several days.

On 10/25/88 JH reported that another doctor had injected his back with steroid for pain. For a week after that injection, JH felt more fatigued. The back pain seemed to have diminished with this treatment. His tongue was severely coated. On physical examination the nasal mucosa was hyperemic and boggy [inflamed and swollen], and the tongue was heavily coated with flocculent [flaky] cream colored material that was easily scraped off [with a tongue depressor]. Sebhorreic dermatitis was noted on the chest; the diagnostic impression was thrush and possible mold allergy. An SMAC 25 (master chem) test was ordered. Paracan for thrush was recommended.

On 12/05/88 JH's tongue was clearer, following the use of a health food store remedy [Paracan] for thrush. Nasal allergy symptoms were well controlled and the physical examination was unremarkable except for minimal exudate [coating] on the tongue and minimal sebhorreic dermatitis on the chest. The diagnostic impression was that his recent increase in symptoms had been due to thrush, possibly caused by a cortisone injection from another physician.

On 4/10/89 JH called. He was on daily antigen, "feeling great" and adding foods back. Doctor Sinaiko recommended decreasing immunotherapy to twice a week.

On 9/28/89 JH called. Doctor Sinaiko recommended decreasing immunotherapy. On 5/10/90 JH's Nystatin was refilled for 2 weeks. On 7/20/90 the Nystatin prescription was again refilled, but the chart indicates "no more refill." More than a year later, on 9/21/90, Doctor Sinaiko did refill the Nystatin prescription after speaking with JH.

JH was not seen by Sinaiko for more than three years thereafter. At the time of his next appointment, he had been bed-ridden for many months with severe back injury. He had been diagnosed by another physician as being chemically sensitive. On 2/12/92 JH reported that he had been diagnosed with severe osteoporosis, and had been treated with calcitonin and testosterone injections and oral calcium by Doctor Felix Kolb, a specialist in metabolic bone disease. He felt ill after each calcitonin injection.

JH reported pulmonary symptoms when exposed to Pine-Sol. A special diet which he referred to as a "food-combining" diet, and a digestive enzyme supplement which he called "Zypan" were helpful with what he referred to as his "Candida symptoms." He was taking 2 Nystatin tablets twice a day and flax seed oil and reported that for the 2 months he had been taking these, he had improved, finding that he was able to gain weight and had better energy and less back problems. He reported the pain of his low-back problem radiated in the left sciatic distribution and that he had been diagnosed with micro-fractures of the spine. He was taking large amounts of Motrin, and this was helpful with the very troublesome side effects of calcitonin.

Twenty two days earlier, on the advice of another physician, he had moved into a special building which had been built in Mill Valley specifically to accommodate environmentally sensitive tenants. He reported that he was sensitive to a wide variety of common chemical exposures such as carpet, tile grout, particle-board shelves, and others. The reported symptoms upon exposure to such things included burning face, a hot feeling in the lungs, and a "chemical" taste in the mouth. He reported that it would take him hours to recover from the symptoms precipitated by sustained chemical exposure.

JH complained of daily headache with sinus blockage while living in his current "environmentally safe" apartment. He reported the gradual onset of severe and debilitating fatigue. His fiancee had left him a year ago - "she couldn't handle my health." He reported substernal pain, worse with deep breaths, in no relation to meals. He felt better after eating and worse in some stores. He was attending physical therapy sessions in a warm pool (a special facility for the handicapped) which is a frequent source of parasitic infection.

On physical examination, the patient looked generally worn out, came in and went immediately to an open window and put his face to the fresh air. Vital signs were normal, as was the examination of the lungs, heart and abdomen. Doctor Sinaiko's impression was to rule out malabsorption syndrome due to some condition of the intestine, such as infection or hypersensivity. Also included in his impression to be ruled out: "recent onset of chemical sensitivity."

Laboratory tests ordered included serum albumin, serum carotene, CBC and differential, stool for ova and parasites, and for fecal fat, and the continuation of the current medications and environmental controls that he had found helpful.

On 3/04/92 JH's stool was positive for Blastocystis hominis. JH was given the standard treatment for this parasite: Flagyl. In addition, Doctor Sinaiko increased JH's Nystatin dosage and told him to continue acidophilus, in keeping with the recommendation in the PDR that candicidal treatment be incorporated with Flagyl.^[19] He prescribed Tigan suppositories to take as needed for nausea. He was told to return in 3 weeks.

On 3/18/92 JH called, reporting increased allergy symptoms and, in view of the Flagyl and the above cited risk, Diflucan 100 mg #15, half-tablet daily was prescribed.

On 3/25/92 JH reported that symptoms had been worse on Flagyl but were now improving on Diflucan. He was taking Benadryl at bedtime and sleeping well. Physical examination revealed that the patient appeared worn out but was breathing room air without problems. His abdomen was nontender. The plan was to finish Diflucan and continue Nystatin. Desensitization options were discussed, and based on this discussion, the patient decided to begin EPD injections in April.

On 4/08/92 JH received his first EPD treatment. A second treatment occurred on 6/10/92. JH reported that by receiving an injection of Vitamin B12 from Doctor Kolb, along with his Calcimar [synthetic salmon calcitonin] from Doctor Kolb, he experienced less side effects due to Calcimar. He complained of night sweats and that he still had not quite bounced back from the Flagyl. He was sleeping on the back porch of his apartment, because he felt the air quality was better for him there. On physical examination he looked well.

On 8/18/92 JH reported that he had labored breathing at times when air pollution was present. He had gone to another physician, Doctor Alan Levin, and received an injection of Solumedrol in the emergency room which helped. He drove to the Sierra and felt better at 6,000 feet. He reported drenching night sweats and no cough. A chest X-ray and blood count had been normal 8 days earlier. He remained sensitive to air pollutants. On physical examination, the chest was clear.

Spirometry revealed a normal flow volume loop. Doctor Sinaiko's impression, in the absence of pulmonary irregularities was air-pollution-triggered laryngospasm (spasm of the larynx). The plan was to continue Nystatin, Benadryl for sleep, and EPD.

On 9/16/92 JH had his third EPD treatment. He noted that if he ingested fermented, moldy, or sugary foods, his achiness would increase. He was on a limited diet of grains, legumes, meat, fish, poultry and vegetables. His night sweats were no longer occurring, and his bowels were normal. He continued to feel less well, but attributed this to an increase of air pollution. He reported becoming short of breath and diaphoretic [sweaty] with exposure to some chemical that the family had put in the back yard to keep cats out. The plan was to continue EPD and he was referred to another board-certified allergist, Doctor Alan Levin, for a second opinion.

On 12/16/92 JH received his fourth EPD treatment. He reported he had not yet made an appointment with Doctor Levin, and he was strictly avoiding foods which had increased his symptoms. He was doing well generally though reported no perceived improvement following his third EPD injection. He was receiving homeopathic treatment from another practitioner and continued to report chemical sensitivity with increased symptoms upon exposure to wood smoke. He reported regularly sleeping outdoors under stacks of wool blankets.

On 3/15/93 JH received his fifth EPD treatment. This was the patient's final office visit before leaving California. He reported that he was doing much better and that the 4th EPD injection had been helpful. On 3/25/93 JH called from outside California to report that he was taking a health food store remedy, "Nutribiotic" [which is used for parasites]. Because of the possibility of persistent of B. hominis, Doctor Sinaiko recommended that he continue this, and consult the current treating physician.

On 4/01/93 JH called again. He had not resumed "Nutribiotic" and had diarrhea. He reported he had become sensitive to the foam pad on which he was sleeping. Doctor Sinaiko recommended covering the pad with cloth. This was the last time that Doctor Sinaiko was involved in any treatment decision. On 6/02/93 Doctor Sinaiko provided JH received a letter of referral to Doctor William Shrader, requesting that JH be allowed to continue to receive EPD.

An undated letter from JH referring to the "present" as June 94, indicates that JH had not yet seen Doctor Shrader and had not continued the EPD treatments, although it was then a year and 3 months after he had left the Bay Area. More than two years later Doctor Sinaiko learned of this patient's tragic suicide.

2.    Disciplinary Findings Regarding Patient JH

a.    The Board erred in finding that Doctor Sinaiko's "determination of the etiology of [JH's reported] 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 . . . ." (P27 10)

b.   The Board erred in finding that Doctor Sinaiko'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 . . . ." (P27 10)

c.    The Board erred in finding that Doctor Sinaiko's use of Nystatin in light of above two factors over long period of time without basis for believing efficacy for rash was both excessive prescribing and a departure from the standard of practice. (P27 10)

The Board's findings in this case are indistinguishable from the findings as to patient RS: Doctor Sinaiko improperly diagnosed Candida sensitivity as the cause of JH's illness, he did so without employing "objective" test for diagnosing the disease, and he prescribed Nystatin. (See 13 RT 28; 13 RT 30 (state experts support findings)) Petitioner's response is the same: the patient's symptoms strongly indicated Candida sensitivity, pursuant to a leading text on the subject. (Exhibit A68A) The "objective" measure the Board faults Doctor Sinaiko for not using-i.e., stool testing-was inappropriate for detecting Candida sensitivity. The Brostoff text makes absolutely clear that the proper way to diagnose Candida sensitivity is by empirical analysis: the doctor must consider the patient's symptoms and employ a trial of anti-fungals. Doctor Sinaiko did both. He also completed skin-testing which indicated Candida allergy. Finally, Brostoff specifically calls for prolonged treatment with Nystatin. Petitioner was not unreasonable in his treatment of JH.

When Doctor Sinaiko first saw JH, he had a history of severe sinus blockage and related headaches. The patient reported a rash on his chest after taking yeast as a nutritional supplement along with a perirectal rash and rectal itching. He had used antibiotics on many occasions for upper respiratory infections and sinusitis. He had ongoing flu-like symptoms. He reported muscle aches, joint pain, adverse reaction to milk, and fatigue. His history revealed sensitivity to various environmental factors.

As with patient RS, Doctor Sinaiko's impression was that JH had allergic fungal sinusitis and, particularly given the reaction to nutritional yeast, Candida sensitivity. The symptoms fit neatly within those discussed by Brostoff. (Exhibit A68A 855-857) As with RS, in this case Doctor Sinaiko used Nystatin (both in nasal spray and oral forms), per Brostoff, as well as Diflucan for AFS. JH was also placed on a Candida control diet to maximize the effectiveness of the anti-fungals. Following allergy testing, JH began immunotherapy. He was skin-tested (on October 22, 1986) and the result was allergy to Candida. As a result of these steps, JH's health improved significantly. (See Patient History, April 1986 to December 1987; see also 2 RT 37: testimony of JH's brother who recalled that JH reported his health improving with Nystatin)

Nearly a year later, in November of 1988, JH's health began to decline again. As a result of ongoing back problems another doctor had injected his back with steroids, which resulted in the return of various adverse symptoms. The patient was fatigued, his rash returned, his tongue was coated. These symptoms are consistent with Brostoff's discussion of the reaction of persons with Candida sensitivity to steroid use; thus, petitioner's diagnosis was reconfirmed. (A68A 856) Doctor Sinaiko continued to treat for Candida sensitivity until September of 1990. At that point, he did not have any contact with JH for one and a half years.

When he returned, in February 1992, JH had been diagnosed by another doctor as having sensitivity to multiple chemicals. Doctor Sinaiko began JH on a course of EPD with Nystatin as a pretreatment medication. Following his fourth (December 1992) and fifth (March 1993) EPD treatments, JH reported that the EPD seemed to be helping. JH then left the Bay Area and did not continue the EPD treatments, although he was referred for such treatment to another doctor outside California.

Doctor Sinaiko's handling of this difficult case was entirely reasonable. Contrary to the Board's finding, based on his clinical experience and the literature, Doctor Sinaiko could quite reasonably believe that Candida sensitivity illness exists. Given JH's symptoms, per Brostoff, Doctor Sinaiko could quite reasonably believe JH had that illness. Petitioner could reasonably use Nystatin to treat the illness because it is an entirely safe drug that was the preferred response, per Brostoff, to Candida sensitivity. And, finally, Doctor Sinaiko was not obligated to use an "objective" measure because the literature makes abundantly clear that a stool test is of little value in these cases: "There are inherent limitations to the use of Candida cultures in the diagnosis of [Candida sensitivity]." (Exhibit A68A 858) Petitioner used the diagnostic tools Brostoff recommends: analysis of symptoms and therapeutic trial of Nystatin.

The Board's findings as to JH are insupportable.

E.    Doctor Sinaiko's Treatment of SL Was Entirely Within The Applicable Standard Of Care

1.    Doctor Sinaiko's Treatment Of SL ^[20]

On 3/29/86 SL, a 29 year old female, first came to Doctor Sinaiko. She became ill in July of 1985 when working in a sealed office with many smokers. She had pelvic pain which had become worse and persisted. After a laparoscopy by another doctor which resulted in what the patient reported as "another round of antibiotics," she had hallucinations, and was unable to carry on mental processes. Doctor Sinaiko received a report from another allergist that SL was allergic to "inhalants and some foods, and was hypersensitive to environmental chemical pollutants, including tobacco smoke, auto exhaust, synthetic solvents, chlorine, and formaldehyde."

SL's prior doctor had placed her on Nystatin. She was doing well living in a beach area where the air was relatively unpolluted, until she was unable to continue Nystatin and immunotherapy, because of the loss of her disability benefits. At that point, she became much worse, and suffered from severe depression among other symptoms.

At her first appointment with Doctor Sinaiko, SL reported severe confusion, severe arthralgia, and episodes of suicidal depression, which became worse any time the Nystatin was discontinued. She suffered from recurrent fevers, dizziness, sore throat, headache, vomiting, and bilateral knee pain. Other persistent symptoms included short term memory deficit, weakness, mild to severe nausea, parasthesias of the right upper extremity, chronic diarrhea, abnormal food cravings, and difficulty concentrating. Cognitive symptoms were worst in sealed offices with inadequate air quality or the presence of smokers, newsprint, duplicating papers, and volatile components of certain inks. She had difficulty with handwriting because of her right arm weakness, and at times had difficulty in speaking, chest tightness, swollen glands in the neck, and mouth sores followed by chills and fever. She furthermore had intermittent rashes on the hands, face, back, abdomen, scalp, chest, thighs, and extremities. She had delayed-onset urticaria (hives) from dish and laundry detergent, and shampoos.

SL's complex medical history included a clear report from a prior doctor that the patient had severe symptoms which were dramatically relieved in the past by oral Nystatin. Doctor Sinaiko had the patient resume Nystatin again with marked symptomatic relief. Laboratory data at the beginning of her treatment showed that SL had an Epstein-Barr virus antibody panel that suggested past infection with this agent. The various thyroid tests were consistent with a diagnosis of active Hashimoto's thyroiditis. She was treated with synthroid, and was continued on oral Nystatin.

On 6/3/86, as on most of her follow-up visits during this first year, SL had a low grade fever, a chronic sore throat, fatigue and depression. Sores continued to occur in her mouth, but no longer led to a febrile flu-like syndrome each time. The number of "good days" had been increasing from month to month, and chronic nausea improved markedly when she discontinued using a stool softener.

Doctor Sinaiko also referred SL for psychiatric evaluation to Doctor Gladys Bennett, who placed her on medication. SL continued to receive psychiatric follow-up with the Santa Clara County Department of Mental Health. During periods of non-compliance with a dietary regimen, she had increased symptoms.

During the first year of Doctor Sinaiko's care of SL, he presented the case informally to Doctor Carol Jessop. Among the full time faculty members at UCSF School of Medicine, Doctor Jessop was at that time the acknowledged expert on chronic fatigue syndrome/chronic Epstein Barr Virus disease. Doctor Jessop recommended the continuation of Nystatin and the introduction of another medication, Acyclovir, which she had frequently used with other patients exhibiting this syndrome. Doctor Jessop also suggested to Doctor Sinaiko that he send SL to her for a formal consultation, which he did on April 13, 1987. In the course of that consultation, Doctor Jessop outlined to Doctor Sinaiko a treatment plan including a higher dose of acyclovir and continuation of Nystatin and the other treatments which Doctor Sinaiko had found helpful in this case.

On 1/23/87 SL began a course of Zovirax (Acyclovir). The Epstein-Barr Virus test done almost a year earlier was consistent with "previous infection." (Exhibit 34) On 3/17/87 Doctor Sinaiko reported that SL's clinical response to Zovirax was dramatic and that the patient's mouth sores and recurring viral-like illness had improved to the point where the patient enrolled herself in a State Department of Rehabilitation program.

SL reported her menses were now regular since the start of her use of Zovirax/acyclovir with "only mild" dysmenorrhea. Before December, the dysmenorrhea had been characterized as severe. In her most recent menses, she "only had to take a single Advil for the entire period" She had no sores in her mouth or recurrent febrile viral-like symptoms, except for a sore of a single day's duration. SL's headaches were much better and her nausea had disappeared. SL's depression had improved and she spoke of rehabilitation, reporting that she would become involved with a program of the Department of Rehabilitation starting April 1.

On 4/13/87 SL reported feeling much better with Zovirax. She reported exercising, reading, and looking for a new apartment. On 6/03/87 the following symptoms were improved: no more wheat craving, no severe PMS. She no longer felt sweaty and hot. Her perception of temperature had improved and she was "delighted" she could now wear sleeveless blouses. Her short term memory was good now; she did not need lists for everything. But she still got confused around fumes and with stress. Due to such an episode, she missed her appointment with Doctor Jessop at the end of May and planned to see her on June 9. She could now use dishwasher liquid without a rash, and she used "Carress" soap without problems.

On 8/03/87 SL reported that she had seen Doctor Jessop 6 days before at Healthworks for Women. Doctor Jessop had diagnosed SL as having Chronic Fatigue Syndrome. The patient continued to improve. On that date, following Doctor Jessop's advice, Doctor Sinaiko increased SL's Zovirax dosage.

On 9/29/87 SL reported that the increased dose of acyclovir was successful in controlling the following symptoms: recurring high fever, sore throat, sore lymph glands in the neck, symptoms of stomach flu, vomiting, nausea, diarrhea, muscle aches.

On 10/27/87 SL reported only continued nasal blockage, which improved with antihistamine (Benadryl), and some residual fatigue. On that date SL reported that the following symptoms were improved: chronic fatigue, and Plummer's Nails (a symptom of thyroid disease for which Doctor Sinaiko had been treating SL).

On 12/14/87 SL was still on Tagamet, Zovirax, Nystatin, and Synthroid. The following symptoms are still well controlled on Zovirax: fevers, sore throats. Her fatigue was "still bad, although not as bad as before." SL reported that her days now consisted of reading, vocational rehab support group. She reported that she had been working out mildly in a health club. She reported believing that her nasal blockage had improved with use of Nystatin nasal spray.

On 2/22/88 SL reported that she had discontinued Zovirax in January-she ran out of money to pay for it. She claimed no increase of symptoms off Zovirax at that time. She then complained of nausea and vomiting, which "occurs out of nowhere" three or four times a week. Nausea interfered with her daily activities. The nausea usually occurred immediately after eating, but was not related to specific foods, stress, odors or exposure. It was not related to milk. She tried discontinuing Nystatin, but had no improvement off it. She thought it may be an old ulcer coming back. The symptoms were reminiscent of symptoms from before Zovirax, except that the myalgias, fevers, and sore throats had not returned. She was still able to go to the health club and ride the stationary bike. Her nasal blockage was not "too bad" but she said when she lay down on her back "it feels like my throat is collapsing." The sensation would wake her up. This seemed to be getting worse. A repeat thyroid scan was ordered as was an upper GI series which revealed no problem.

On 3/23/88 SL reported that she was engaged to be married in June. She continued to have nausea and vomiting, only slightly helped by Maalox. She had lost weight. She reported the Tagamet had been somewhat helpful. There was sweating with these attacks, but no diarrhea or flushing or burning of skin. Her white blood count was low and her anti-thyroid antibodies, while improved from previous levels in 1986 and 1987, continued to be significantly elevated.

On physical examination the thyroid gland was slightly tender and Doctor Sinaiko ordered a serum gastrin test because of the clinical indications suggesting possible gastrinoma. Also, to rule out a neoplastic [tumor] diagnosis, Doctor Sinaiko ordered a C-T scan of the abdomen.

On 4/06/88 Doctor Sinaiko had his last contact with this patient. The diagnostic evaluation for gastrinoma and/or other neoplasm was negative. The GI symptoms present since December went away in Charlotte, NC where she spent a week. She only had some mild hay fever there. She said there was no change in diet, sleep pattern or stress level. GI symptoms returned one day after returning home from Charlotte. Upon questioning, it was revealed that her home had been painted a month ago. Doctor Sinaiko recommended avoidance of exposures to volatile organic compounds by opening the windows to air out her home. Tagamet was continued, as were Synthroid and Nystatin.

2.    Disciplinary Findings Regarding Patient SL

a.    The Board erred in finding that Doctor Sinaiko's "diagnosis and treatment of a non-existent disease [i.e., Candida] and conclusion that the presence of the fungus, Candida, in the intestinal tract can cause the symptoms noted in patient SL - constitutes a departure from the prevailing standard of practice . . . ." (P27 12)

b.    The Board erred in finding that Doctor Sinaiko's use of Nystatin for extended period without evidence of Candida colonization or that this was the source of her symptoms comprised both excessive prescribing and a departure from the standard of practice. (P27 12)

As with patients RS and JH, the Board and its experts faulted Doctor Sinaiko for (a) finding that Candida sensitivity is a disease, (b) finding the existence of the disease without "objective measure" and (c) treating it with Nystatin. Based on the sources cited previously, it is clear that petitioner was reasonable to treat SL with Nystatin-the preferred drug for treating Candida illness-if she presented with the indicative symptoms. As will appear, it is obvious that SL, like RS and JH, was suffering at least in part from Candida sensitivity.

Also, in this case, because he was not satisfied with SL's improvement, Doctor Sinaiko consulted an national expert on the treatment of systemic immunologic illness at UCSF. That expert specifically recommended that he continue SL on Nystatin, a recommendation that makes his conduct unquestionably reasonable. Most important, the record is also quite clear that SL benefitted enormously from extended use of Nystatin.

Before first seeing Doctor Sinaiko SL had experienced a host of physical problems and had been prescribed Nystatin by another physician. It was reported that she had done very well on the drug but was forced to stop using it when her disability benefits terminated. Her health worsened thereafter.

When she first saw Doctor Sinaiko in 1986, she had a variety of symptoms that were consistent with Candida sensitivity: prolonged use of antibiotics, increased chemical and environmental intolerance, abnormal food cravings, nausea, diarrhea, flu symptoms, and joint pain, chest pain, and urticaria. (A68A 855-857) Believing that SL was suffering from Candida sensitivity, he prescribed Nystatin, the drug Brostoff favors. And as a result, SL's condition improved, although the patient continued to have serious problems.

As a result, Doctor Sinaiko took two appropriate steps. Fearing that a part of SL's problems could be due to psychiatric illness, he referred her to a psychiatrist. He also consulted with Doctor Carol Jessop, a professor at University of California San Francisco medical school, and an expert on Chronic Fatigue Syndrome ("CFS").

Doctor Jessop recommended that Doctor Sinaiko continue to use the Nystatin. She testified at the administrative hearing that she had begun prescribing Nystatin to patients in the mid-1980s for recurring vaginal yeast infections. (20 RT 112) Some patients reported that the drug cured not only the yeast problems, but also dramatically reduced headaches, fatigue, and nausea. (20 RT 112) The reports of improvement of CFS symptoms were so common that she undertook a clinical study, which involved prescription of anti-fungals for more than 1100 patients over three years. (20 RT 113) She reported these findings at a conference at UCSF in 1989. (Exhibit A59) She found that eighty-four percent of patients with CFS improved on anti-fungals.(20 RT 115)

When Doctor Sinaiko reported to Doctor Jessop that SL had been intermittently non-responsive to the Nystatin, Doctor Jessop recommended that SL begin a course of an anti-viral drug, Zovirax. She testified that there was evidence CFS was triggered by a virus and that she and other doctors had found dramatic improvements from the use of anti-viral drugs in a small percentage of patients. (20 RT 121-123) Doctor Jessop later saw SL for a consult and determined that the patient was suffering from CFS. Doctor Sinaiko thereafter carefully followed Doctor Jessop's advice regarding SL's treatment and her condition improved dramatically, although there was serious recurrence later in his treatment of the patient who, for financial reasons, was forced to discontinue using the anti-viral drug. (See Patient history, supra, January 1987-April 1988)

Doctor Sinaiko was not unreasonable, based on his clinical experience and the literature reviewed above, to find that SL had Candida sensitivity. Indeed, her symptoms fit perfectly into the Brostoff discussion of the topic. He was not unreasonable to use Nystatin to treat that illness: (a) because Brostoff specifically recommends that drug, (b) a prior doctor had prescribed the drug and SL reported that it had helped and (c) Doctor Jessop recommended that Doctor Sinaiko continue using the drug.

This finding well illustrates the danger, even absurdity, of a Board disciplinary proceeding serving as a court of science in taking sides on medical controversies in a given field. The course of treatment herein at issue was recommended by an national expert on the treatment of systemic immunologic illness at UCSF. That course of treatment was found to be negligent by an administrative law judge who has no training or expertise on treating systemic immunological illnesses. It was affirmed on appeal, probably largely for reasons of internal institutional politics, by a panel none of whom had anything like the expertise of Doctor Jessop on the question at hand. The Board's findings are unsupportable.

c.    The Board erred in finding that Doctor Sinaiko's extended use of Zovirax, an anti-viral drug, despite negative finding on Epstein-Barr test amounted to a departure from the standard of practice and excessive prescribing. (P27 12 )

The Board and the state's experts also faulted Doctor Sinaiko for treating SL with Zovirax, an anti-viral medication. Three responses are in order. First, as described above, Doctor Sinaiko at first reasonably diagnosed Candida sensitivity and treated SL with Nystatin. Unsatisfied with the results, he consulted Doctor Jessop, an expert in CFS at UCSF, who recommended that he continue SL on Nystatin and that he use the anti-viral drug Zovirax. Doctor Sinaiko also insisted that the patient see Doctor Jessop for a consult, after which the consulting doctor found that SL had CFS. Thereafter Doctor Sinaiko treated SL in accordance with Doctor Jessop's directions, including continued use of Nystatin and Zovirax. It is simply impossible to argue that Doctor Sinaiko could not reasonably rely on Doctor Jessop's advice, given her status and experience, and the fact that she had treated hundreds of patients in precisely the manner petitioner treated SL.

Second, along with her other symptoms, SL had recurring herpes-type mouth sores. Even if Doctor Sinaiko could not reasonably rely on Doctor Jessop's expert advice, he was justified in prescribing Zovirax because the drug was commonly used for herpes-type sores. (Physician's Desk Reference, p.825)

Finally, and of great importance, the drugs prescribed for SL, including Zovirax, worked. SL's health and well being dramatically improved on the anti-viral medication, and when she was forced to stop using the drug for financial reasons, a variety of prior symptoms returned. (See Patient history, supra, January 1987-April 1988)

Given these factors, the Board's finding of a violation regarding Doctor Sinaiko's use of Zovirax with SL is unsupportable.

F.    Disciplinary Findings Regarding Doctor Sinaiko's Use Of EPD

As petitioner has discussed, EPD is a form of immunotherapy long used in Europe and imported by American doctors in the early 1990's. (See section II(A)(1), supra) In traditional immuno-densensitization a relatively large quantity of antigen is injected into the skin of an allergic person in an effort to reduce allergic reaction. The process is repeated over an extended period, and is quite dangerous due to the risk of anaphylaxis from the large antigen dose. EPD employs a minuscule quantity of antigen (precisely the same antigen that would be used in a larger dose in traditional immunotherapy) and small quantity of an assistive enzyme (or potentiator) called Beta-Glucuronidase.("BG"). BG, which is present in every human cell, is extracted from molluscs and is available commercially. The state offered no evidence that BG is an illegal substance. Indeed, its FDA witness testified that BG is listed by the FDA as a nutritional supplement. (3 RT 58-59)

There was considerable debate in the administrative hearing regarding Doctor Sinaiko's use of EPD. The state's experts testified that EPD does not work (4 RT 39) and that its use amounts to a departure from the standard of practice. (4 RT 114) Doctor Sinaiko's experts and his patients testified that it works wonderfully (18 RT 19-25; 22 RT 60; Exhibit 41, enclosing supportive literature), and that its use was and is within the standard of practice. (18 RT 45)

In one sense, the Board handled the expert debate on the efficacy of EPD in precisely the manner it should have responded to the conflicts over Doctor Sinaiko's treatment of LTS, RS, JH and SL. It refused to comment on a long-established but minority medical practice without some showing that Doctor Sinaiko had behaved unreasonably in treating his patients. There was, of course, no indication that any patient was ever injured by Doctor Sinaiko's years of employing EPD, and considerable evidence of an enormous benefit to patients, including the four named in the state's accusation. In refusing to pass on the propriety of the technique, the Board correctly left that debate to be continued and ultimately resolved in the medical community.

But the Board chose to enter the fray through a back door: it determined that EPD is "experimental," and that Doctor Sinaiko used an experimental technique in his treatment of patients RS and JH ^[21] in a manner that amounted to unprofessional conduct. The Board's findings are contrary not only to law, but to logic. As will appear, under federal and state law Doctor Sinaiko was perfectly entitled to use EPD in a clinical setting without reference to laws written to protect persons who are the subject of formal human subject experimentation. Those laws make clear that a process or drug is experimental only if it is employed experimentally: i.e., with the sole purpose of answering a question raised in formal medical research. A drug or treatment process is not covered by those laws if it is used in a therapeutic setting for the sole purpose of treating patients.

The Board has not said Doctor Sinaiko's use of EPD for RS and JH was unreasonable. Rather, it has sanctioned him for failing to comply with laws which were entirely inapplicable to his handling of those cases and, most extraordinarily, for failing to join a study of EPD that did not exist during the period he is accused of improperly using the technique (January 17, 1991, to March 15, 1993). The Board's findings regarding petitioner's use of EPD are insupportable.

1.    The Board erred in finding that because Beta-Glucuronidase is an experimental and non-FDA approved drug, Doctor Sinaiko was required to have IRB approval for his use of the drug in a therapeutic setting (P27 17)

Peter Dubinsky, a state witness, is the Director of Compliance at the Center for Biologic Evaluation and Research, United States Food and Drug Administration. That organization is responsible for reviewing applications to sell new biologic products in interstate commerce. (3 RT 10) As Dubinsky explained, under federal law, a drug manufacturer that wants to sell a new product in interstate commerce is required to demonstrate the drugs's safety and effectiveness in human beings. (3 RT 13) To make such a showing it must undertake human subject experimentation. (3 RT 13) Such experimentation depends on approval by the FDA of an Investigational New Drug ("IND") application. As part of an approved IND, the applicant must be supervised by an Institutional Review Board ("IRB"), a neutral panel that oversees human subject experimentation. (3 RT 15; see also 21 C.F.R. 561.101 et seq., governing IRB composition and operation) Among other things, the IRB monitors the provision of informed consent to the individuals participating in the human subject experimentation. (3 RT 18-19)

Mr. Dubinsky further testified that the IND application process applies exclusively to products sold in interstate commerce. (3 RT 30) He made clear that the IND process has no application to a doctor who uses a legal substance "in [his] own practice, with no commercial intent . . . ." (3 RT 56) Doctor Paul Radensky, a health law expert, confirmed that under federal law a doctor can use a "product obtained lawfully . . . in patient care, without subjecting the product to investigational new drug application requirements . . . ." (14 RT 46-47)

The rule exempting doctors from FDA oversight in the use of legal substances in their practices has long been the rule in California. In a detailed opinion letter issued in 1978, the California Attorney General began by stating

A physician may prescribe new drugs and a pharmacist dispense such drugs, pursuant to the physician's prescription, so long as the component elements of such drugs in any combination or single have not been banned by state or federal law or regulation.

[T]he FDA does not have jurisdiction to regulate the administration of a drug by a physician. In order to invoke the jurisdiction of the FDA, 21 U.S.C. Sec. 355(a), requires a person to: " . . . introduce or deliver . . . into interstate commerce any new drug."

[T]he California physician in his private treatment of a California patient [with a new drug] is engaging in a manifestly different quantitative and qualitative act than introducing or delivering for introduction into interstate commerce. The FDA interpretation of the 1938 Act and its 1962 Amendments does not treat the use of [a new drug] by a treating and prescribing physician as being in interstate commerce.

(Opinion Letter, quoting Federal Trade Commission v. Simeon Management Corp. (N.D. Ca.1975) 391 F.Supp. 697, 706-707 , aff'd 532 F.2d 708 (9th Cir. 1996))

The Opinion Letter concludes:

If we were to reach a contrary conclusion a most unrealistic result would ensue. To apply Section 26670 [the former new drug provision of California's Health and Safety Code] to the healing arts practitioner would mean that every time a patient was being treated with what may be technically a new drug, the treating practitioner would have to comply with the new drug provisions of the Health and Safety Code. These sections create mechanisms which simply do not fit the reality of the clinical situation. For example, they speak of new drug applications seeking approval of a new drug . . . ; of six month waiting periods on applications . . . ; of hearings . . . ; of submitting reports of investigation and testing . . . of proposed labeling and advertisement . . . ; of manufacturing methods facilities and controls . . . ; of maintaining clinical records pending approval . . . ; and of department orders withdrawing approval of applications . . . . Patently these provisions cannot be impressed upon the local healing arts practitioner treating an individual patient without creating havoc in California clinical practice. These provisions are designed, as is their federal model, to apply to commercial activities. [note omitted] Applied to those ventures they make sense; applied to the clinical situation they do not.

Section 26666 provides that a practitioner may personally furnish his own patients with such drugs as are necessary in the treatment of the condition for which he attends such patient. This section appears to underscore the right of the practitioner to exercise his professional discretion when providing drugs in a therapeutic setting.

(Opinion Letter at 209)(emphasis in original)

The Board faults Doctor Sinaiko for using a new drug without IRB approval. The Code of Federal Regulation sections it cites, beginning with 21 C.F.R. 561.101, are simply the "general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration."

But the law could not be clearer: when a doctor uses a non-banned substance in his medical practice for the purpose of treating a patient, and is not engaged in a formal investigative study, he is not covered by the IND rules set forth in federal law. If there is no human subject experimentation, there is no requirement for an investigational new drug application, and therefore no need for the formation of an IRB or for IRB approval. The Board is correct that Doctor Sinaiko used a new drug (i.e., BG), and used it extensively in his EPD practice. There is not a shred of evidence that during the period cited by the Board he was engaged in anything other than the therapeutic use of that technique, and for that reason the Board's finding is insupportable.

It is important to note, finally, that Doctor Sinaiko did become involved in a formal research study of EPD in 1994. When he joined the study, which was undertaken by Doctor W.A. Shrader in October of 1993, and overseen by the Institutional Review Board of the Great Lakes Medical Association, Doctor Sinaiko used the official IRB consent form, in addition to his own long-standing comprehensive informed consent process. (22 RT 90) That document was drafted by the Great Lakes IRB in an effort to comply with the stringent informed consent requirements required by state or federal law in the case of human subject experimentation. (Exhibit 50)

2.    The Board erred in finding that "Prior to September 21, 1996 respondent administered Beta-Glucuronidase without the required written informed consent in violation of California law" (P27 17), a violation of Health and Safety Code § 24172. (P27 21)

The board's second finding is entirely consistent with its invalid finding that because BG is experimental, Doctor Sinaiko could not use it without receiving IRB approval. The California statute to which the Board refers, Health and Safety Code § 24172 is the "Experimental Subject's Bill of Rights." That section, together with § 24173, requires that a physician or other scientist engaging in human subject experimentation must provide a host of information and warnings to their subjects.

Doctor Sinaiko did not violate § 24172 or 24173 because neither RS nor JH was at any time the subject of human subject experimentation. Doctor Sinaiko testified that he received fully informed consent from each of his patients before an EPD treatment and there was no evidence to the contrary. (25 RT 72; see also Exhibit Z: EPD Patient Information Update) Doctor Sinaiko did not employ forms specially drafted to comply with the relevant California and federal statutes. That is because he was engaging not in experimentation, but in treatment. When Doctor Sinaiko joined an ongoing research project in 1994, he began using the extensive informed consent packet provided by the study. (Exhibit 50) The board has ever suggested that document was inadequate in any way, nor has Doctor Sinaiko been sanctioned for failing to provide informed consent to patients after he joined the Great Lakes study.

The Board's finding that petitioner failed to obtain the required informed consent is unsupportable.

3.    "Prior to September 21, 1996 and continuing to the present time respondent administered Beta-Glucurondiase in an adulterated manner in violation of California law" (P27 17), a violation of Health and Safety Code §§ 111290, 111300. (P27 21)

The Board finally faults Doctor Sinaiko for using BG in an adulterated manner, in violation of Health and Safety Code §§ 111290, 111300. Those sections simply make it unlawful for a person to adulterate a drug. A drug is adulterated "if any substance has been mixed or packed with it so as to reduce its quality or strength or if any substance has been substituted, wholly or in part, for the drug . . . ." § 111290.

It is difficult to see how these laws apply to Doctor Sinaiko's use of BG. It is true, of course, that BG was mixed with infinitesimal quantities of antigens. The combination was used, very successfully, to treat systemic allergic and immunologic illness. The antigen cannot logically be said to have reduced the quality or strength of the BG, when in fact the substances were combined for the express purpose of enhancing the effect of the antigen. Similarly, it is illogical to suggest that the antigen in any way "substituted, wholly or in part, for the" BG: the potentiator was added to the antigen to assist its therapeutic effect. The adulteration sections are clearly inapplicable to the clinical use to which Doctor Sinaiko put these substances.

More importantly, of course, the evidence below was absolutely uniform that a doctor, in treating patients, may formulate drug compounds within the bounds of reasonableness. The state's FDA witness described the so-called "practice of medicine" exception to FDA regulation. Under that rule, which has existed at least since the early 1970's, the FDA has acknowledged that doctors very commonly compound substances for the treatment of patients. So long as there is no attempt to commercialize the compound, the FDA does not attempt oversight. (See 3 RT 31, 34, 43, 56)

Similarly, in its Opinion Letter issued in 1978, the California Attorney General made clear that a physician or pharmacist may compound drugs as part of the "practice of medicine,"-i.e., without placing the drug in interstate commerce-without risking violation of state laws. The Attorney General Opined that pursuant to the request of a physician, a pharmacist may "compound and dispense . . . materials for an individual patient's needs so long as the component elements of such materials in any combination or singly have not been banned by state or federal law or regulation . . . ." . (Exhibit 9, Opinion Letter at 192-193, see also Opinion Letter at 205 et seq.) The state's allergist experts made clear that an allergist could, within the standard of practice, compound substances into an injectable substance. (See 5 RT 75, 79; 13 RT 80-82) This is, of course, precisely what Doctor Sinaiko did in the EPD process: in his treatment of patients he combined substances in an immunotherapy formulation. Indeed, the combining ingredients for administration to patients of his own practice, for which Doctor Sinaiko has been sanctioned, is therefore entirely subsumed within the notion of entirely permissible physician compounding. It is simply beyond dispute that, within the bounds of reasonableness, Doctor Sinaiko was absolutely entitled to use BG in combination with allergens in the treatment of his patients.

The Board's finding in this regard is unsupportable.

III.    EVEN IF THIS COURT WERE TO FIND THE BOARD CORRECTLY USED THE KELLY TEST TO DEFINE "STANDARD OF PRACTICE" IN A DISCIPLINARY CASE, IT MUST NEVERTHELESS VACATE THE BOARD'S ORDER BECAUSE APPLICATION OF THE NEW TEST AGAINST DOCTOR SINAIKO WOULD DEPRIVE HIM OF DUE PROCESS OF LAW

Even if this Court were to find that the Kelly test should govern "standard of practice" review in disciplinary cases, it could not hold Doctor Sinaiko to that standard. That is so because the new, narrow test of physician conduct was advanced and applied for the first time in this case. The Attorney General will be able to point to no case in which a "general acceptance" test was used to measure the propriety of physician conduct in the past or to any statute that provided notice that such a standard governed medical practice in California. As Doctor Sinaiko has argued, the test heretofore used has been a far broader, reasonableness test. Doctor Sinaiko therefore was provided no notice that his reasonable conduct could serve as the basis for the sanctions that have been imposed by the Board because it did not conform to the majority view. Imposition of those sanctions in the absence of such notice amounts to a due process violation.

As the United States Supreme Court long ago made clear, "a statute which either forbids or requires the doing of an act in terms so vague that men of common intelligence must necessarily guess at its meaning and differ as to its application violates the first essential of due process of law." International Harvester Co. v. Kentucky (1914) 234 U.S. 216, 221; see also Lanzetta v. New Jersey (1939) 306 U.S. 451, 453 ("No one may be required at peril of life, liberty or property to speculate as to the meaning of penal statutes."); Connally v. General Construction Co. (1926) 269 U.S. 385, 391 (that a law must be "sufficiently explicit to inform those who are subject to it what conduct on their part will render them liable to its penalties, is a well-recognized requirement, consonant alike with ordinary notions of fair play and settled rules of law."); Keeler v. Superior Court (1970) 2 Cal.3d 619, 633-34 (murder statute prohibiting killing of human being could not be fairly applied to death of fetus).

This Court should reject the Kelly test for the reasons stated. If it determines that the Board may use that test in future cases, California physicians will be on notice of that fact. But Doctor Sinaiko cannot be held to answer under the new, strict standard, without depriving him of due process of law. He had insufficient notice that his conduct could lead to discipline.

That is particularly the case in light of an opinion of the Third District Court of Appeal issued March 9, 1987. See Seymour v. Board of Medical Quality Assurance (1987) 3 Civil C000268. (The opinion is reprinted at P15) That opinion was unpublished, and therefore cannot be relied upon by Dr. Sinaiko in support of his legal argument here. But petitioner could reasonably have relied upon Seymour in believing that he would not be sanctioned by the Board for practice methods that had not been accepted by a majority of the doctors in his fields. That is, Seymour weighs heavily in favor of a finding that Dr. Sinaiko had insufficient due process notice that his conduct could be the subject of Board discipline.

In Seymour, a doctor was disciplined for his handling of four cases. (P15 4-6) His license was suspended by the Board and that decision was affirmed on mandamus. The Court of Appeal reversed. It found that there had been substantial disagreement between experts presented by the two sides regarding the acceptableness of some of Doctor Seymour's conduct. (P15 20-22) Specifically, the Court found that both the Medical Board and "the trial court stepped beyond [their] bounds in deciding a disputed question of medical science . . . ." (P15 20) As to the specific practices at issue, the court held that they were "disputed question[s] of medical science." The court held that "[s]ince the Board has not prescribed a standard by which to measure incompetence, and the evidence merely shows that the treatment methodologies employed by plaintiff were disputed, we conclude the trial court erred in upholding the Board's finding of incompetence insofar as it related to plaintiff's care, diagnosis and treatment of patients." (P15 25) The court finally noted that the court below had "assumed the posture of a court of science, and improperly set the standard for the medical profession . . . ." (P15 24)

Doctor Sinaiko could reasonably rely on the Court of Appeal's view of the Board's proper role. Under Seymour, the Board would not be in the business of choosing between "disputed questions of medical science." Petitioner therefore not only had no notice of the strict new standard applied in his case, he was affirmatively on notice that the Board would be precluded from disciplining doctors who reasonably pursued minority or disputed practice methods.

The Board's disciplinary order should be vacated.

IV.   THE AWARD OF COSTS IN THIS CASE UNDER BUSINESS & PROFESSIONS CODE § 125.3 IS UNCONSTITUTIONAL

The Attorney General sought imposition upon Doctor Sinaiko of more than $98,000 as the costs of its investigation and enforcement, pursuant to Business and Professions Code § 125.3. Although the administrative law judge held no hearing on the sufficiency of the Attorney General's showing as to its fees, in its order the ALJ found that the costs were "reasonable." (P3 19) That finding apparently was based on two short declarations: one from a Board investigator, Renee Threadgill, who claimed to have run up costs of $16,757.57, which included payments to Board experts; and one from Deputy Attorney General Alfredo Terrazas, claiming billing of $82,188. (P8 at Exhibits F, G)

A.    BUSINESS & PROFESSIONS CODE § 125.3 IS FACIALLY INVALID

As Sinaiko argued in his brief on reconsideration (see P11 205-212), based on the California Supreme Court's recent decision in California Teacher's Association v. California (1999) 20 Cal.4th 327, § 125.3 is unconstitutional. In California Teachers, the Court invalidated a statute (Education Code § 44944) which requires a teacher to pay for half of the cost of a disciplinary hearing. The Court found the "[t]he state has no legitimate interest in discouraging a teacher from invoking the right to present, to an impartial adjudicator, evidence and nonfrivolous contentions that some or all of the district's charges are without merit, and that the teacher should not be dismissed or suspended." 20 Cal.4th 343. The Court went on to note that "The cost provision imposes a burden upon, and therefore a disincentive to, the exercise of" the teacher's due process right to a hearing on disciplinary charges. "The teacher's stake in the proceeding is the protected liberty and property interest the state is attempting to revoke." Id.

That ruling should apply with equal force to the statute employed here, B&P § 124.3. The provision permitting the Board to award costs of investigation and prosecution acts as a substantial and impermissible burden on a doctor's due process right to a hearing on the accusations against him. The statute is facially invalid.

B.    THE AWARD OF COSTS IN THIS CASE VIOLATED PETITIONER'S DUE PROCESS RIGHTS

Doctor Sinaiko sought and was granted reconsideration by the Board on the costs issue. In his briefing on reconsideration petitioner challenged the process by which costs had been awarded, arguing that he had never had an opportunity to litigate the question or test the assertions contained in the relevant declarations. Specifically, petitioner had summoned the Board's investigator to testify on the costs question on February 25, 1998, the final day of the administrative hearing. According to a declaration placed before the Board by Doctor Sinaiko's then lawyer, Nancy Cahill (P18 at Appendix H), there was insufficient time on that date for the investigator to testify. Ms. Cahill asked Judge Astle to bifurcate the costs question and the judge "responded in such a way that I was led to believe the [costs] issue would be taken up at a later date." (Id.) Instead, Judge Astle issued her opinion on both the discipline and costs questions without further input from the parties.

Although Doctor Sinaiko challenged the cost award on due process grounds (P11 201 et seq.), in its order on reconsideration the Board simply noted that the ALJ had found reasonable the cost figure of more than $98,000. The Board then halved the amount "in its discretion," awarding $49,4712.79, to the Division of Medical Quality for "its investigation and prosecution costs." (P27 24) The Board did not meaningfully respond to Doctor Sinaiko's due process argument.

The Board's order is as flawed as that of the ALJ. Under § 125.3(c), the certifications from the Board's investigator and Mr. Terrazas comprised "prima facie" evidence of the reasonableness of any award. But the disciplinee should have had an opportunity to rebut that evidence. Because Judge Astle never permitted Doctor Sinaiko to cross-examine Ms. Threadgill or Mr. Terrazas on their declarations, adequate due process was not afforded. There can be no question that Doctor Sinaiko was entitled to full due process rights in the administrative process. See Ettinger, 135 Cal.App.3d at 857; California Teacher, 20 Cal.4th at 337. The Board's decision to cut the cost award in half hardly cured the error. Petitioner should have been afforded an opportunity to challenge the figures proffered by the Board's investigator and its lawyer.

There are many reasons why such a hearing could have led to the setting of a lower cost figure by the Board or, more properly, an order than no costs be imposed. As noted in the preceding argument, Doctor Sinaiko had no notice that his conduct could be subjected to disciplinary sanction, as the decision in this case to punish reasonable, if minority, practice was unprecedented. That being so, even if the Board placed Sinaiko on probation, it should not have doubly penalized him for defending himself against a wholly novel form of disciplinary charge.

Furthermore, the fairness of some of the costs imposed on Doctor Sinaiko was highly questionable. The Board conceded that one expert proffered against him, Dr. Abba Terr, had an economic "conflict of interest in this matter since he may draw from the same pool of patients" as Doctor Sinaiko." (P27 18). A fair hearing could certainly have resulted in the conclusion that Doctor Sinaiko should not be burdened with the cost of paying an adverse expert who benefitted monetarily from driving his competitor out of practice.

The failure to permit Doctor Sinaiko any meaningful opportunity to respond to cost figures proffered by the Board or the Attorney General violated his due process, and certainly renders § 125.3 unconstitutional as applied in this case, even if this Court determines that the statute is facially valid.

For the reasons stated, this Court should vacate the Board's disciplinary order.

Dated: June 7, 2001


Respectfully submitted,






__________________________
BY: DENNIS P. RIORDAN
Counsel for Petitioner
ROBERT SINAIKO