Sinaiko Reconsideration Hearing
Oral Argument, November 6, 1998
Stephen Barrett, M.D.
In September 1999, the Medical Board of California concluded that Robert Sinaiko, M.D., had "departed from the prevailing standard of practice of medicine" by using antifungal drugs and other questionable methods to treat three adults and a nine-year-old child for nonexistent "Candida" problems. Sinaiko was assessed $49,472.79 for administrative costs and placed on five years' probation with stringent supervisory conditions. During the proceedings, after the board reached an initial decision, Sinaiko petitioned for reconsideration and a hearing was held on November 6, 1998. The transcript of that hearing is reproduced below. In it, Sinaiko's attorney tries to portray him as "a caring and competent physician in the process, a physician who has used a treatment which is medically and scientifically sound, which is medically and scientifically proven." But the prosecutor (Assistant Attorney General Alfredo Terrazas) replied:
This is not about the legitimate off-label use of medications previously approved as drugs or biologics, and it is not about merely representing a dispute between two legitimate mainstream schools of thought. Counsel refers to that in his argument as a battleground for medical turfs by competing factions.
Let me talk to you about what this case truthfully is about. This is about whether or not Dr. Sinaiko possesses the requisite medical ethics and medical judgment to practice safely with his patients. That's all that this is about before you today. I submit to you that the evidence in this case before Administrative Law Judge Astle has clearly and convincingly demonstrated that he possesses neither and that his very dogmatic and reductionistic view of human disease makes him an accident just waiting to happen.
Terrazas also disputed the widely circulated false claim that no patients had complained about Sinaiko's care.
Sinaiko appealed the medical board's decision. In September 2004, a California appeals court concluded that the board should have admitted testimony from Sinaiko's expert witnesses and returned the case to the board for further consideration. By that time, Sinaiko had been out of practice for more than five years; the composition of the medical board had changed; California had a new law relating to the practice of "alternative medicine"; and the board apparently became concerned that if it pursued the case and was not successful, Sinaiko might sue to recover his legal expenses. In 2005, Sinaiko and the board entered a settlement agreement under which Sinaiko agreed not to sue and the board (a) withdrew the original accusations, (b) vacated its previous decision, and (c) restored Sinaiko's medical license to "good standing." The following documents provide further insight into what happened.
- California Medical Board Decision, September 3, 1999
- California Court of Appeals Decision (2004)
- Settlement Agreement (2005)
- San Francisco Examiner archives (Select "Chron and Exam" in "Paper to Search," chose the year, and enter "Sinaiko" in the "Keywords to Search" box)
BEFORE THE DIVISION OF MEDICAL QUALITY
MEDICAL BOARD OF CALIFORNIA
STATE OF CALIFORNIA
ROBERT J. SINAIKO, M.D,
OAH No. N 9611106
November 6, 1998 8:00 A.M.
701 A Street San Diego, California
CATHERINE A-M GAUTEREAUX
CSR No. 3122 Our File No. 2-50815
JOYCE A. WHARTON: Administrative Law Judge
FOR THE RESPONDENT:
STATE OF CALIFORNIA DEPARTMENT OF JUSTICE
Attorney General's Office
BY: ALFREDO TERRAZAS
1515 Clay Street, 21st Floor
Oakland, California 94612
FOR THE PETITIONER:
LAW OFFICES OF RICHARD K. TURNER
BY: RICHARD K. TURNER
555 Capitol Mall, Suite 1440
Sacramento, California 95814
BY: NANCY E. CAHILL
10205 Westfield Boulevard Indianapolis, Indiana 46280
THE COURT: We are on the record now in the matter of the oral argument in the matter of the accusation against Dr. Robert Sinaiko. This is being heard before Panel B. The members present today are Dr. Anabel Anderson-Imbert, Ms. Karen Elliott, Mr. Philip Pace, Dr. Alan Shoemaker, Dr. Carol Hurvitz, and Dr. Ret. I'm Joyce A. Wharton, administrative Law Judge of the Office of Administrative Hearings, and I will preside over the panel today.
May I have the appearances today, starting with the agency, please.
MR. TERRAZAZ: Yes. Good morning, Judge. I represent the Division. My name is Alfredo Terrazas. I'm Deputy Attorney General and in this particular case I represent the respondent, the medical board.
THE COURT: Thank you.
MR. TURNER: I'm Richard Turner. I represent Dr. Sinaiko.
THE COURT: Gentlemen, I remind you of the schedule today. Each side will have 40 minutes for their opening and responsive arguments and then five minutes each for closing argument, and we will begin the opening argument by respondent. That's what's on here, but I think we should probably begin the opening argument with Dr. Sinaiko; is that correct.
MR. TURNER: I would hope so.
THE COURT: Okay. Fine.
MR. TURNER: Members of the panel, Judge Wharton, always nice to see you in San Diego. Mr. Terrazas, it's nice to see you again over the years, and members of the public, concerned patients and physicians, my name is Richard turner. I do represent Dr. Sinaiko. It's a pleasure to be here today. Thank you for letting us appear here today and address you on what I think is the most significant and serious national issue which is being presented here and using this case as a vehicle, if you will. We thank you for your interest in this case, and good morning.
And it is a good morning when we have the chance to shine a little light on a government decision that limits indeed patient choice and destroys a physician, a caring and competent physician in the process, a physician who has used a treatment which is medically and scientifically sound, which is medically and scientifically proven, which is medically and scientifically discussed in the peer review medical journals which are on the record but which you unfortunately do not have in front of you. You do not have that information in front of you unless you choose to read the record.
I want to begin with some very simple propositions which I think we can all understand from our daily life and, because I don't see too well, I have some charts here for us and I'd like to put them up for all to see.
First proposition is a simple one. We learn this in Civics 101; and that is that every person accused of violating the law, including doctors, have the right to be heard by those who decide. Obviously, if you are in a jury trial and one side presents its case and the jury then says, "We are through. We are going to decide the case," you might feel uneasy about that. You might feel you hadn't had your day in court.
We have a basic principle in the country that those who decide the cases have to hear the cases. In order to hear the cases, what does that mean in the context of this particular case? We don't have secret trials in this country. What we have are trials where both sides have a chance to be heard, and that is particularly true in the medical board context.
This is simple proposition No. 2, we'll call it, and that's—this is just my personal opinion, but I suspect it's shared by others—and that's that the medical board has a public responsibility, being a public agency, to hear both sides in a medical and scientific controversy. And that's what we have here. This isn't a case of substance abuse or sexual abuse or thievery or Medicare fraud. This is a case involving quality care issues. It involves a serious, legitimate, nationwide medical and scientific controversy.
Now, in order for both sides to be heard, in order for everybody to feel—both the Attorney General and Dr. Sinaiko, to feel like they've had a fair shake, both sides have to be heard. How does that happen? It only happens by information that is available to the people who decide the case. Those people are you in this instance, in this case.
Let's take this chart here. Information needed for the medical board to make an informed decision: The ideal disclosure of facts and opinions for you people to make an intelligent, informed decision. You have information from the prosecutor, Mr. Terrazas, and his staff. You also have information from the doctor. In this case you only have information from Mr. Terrazas because in the ALJ's decision and disclosure of facts you have a lot of information about the prosecutor's case but you have hardly any information about the doctor's case. The only information, really, you have about the doctor's case is the ALJ's comment that 12 responsible nationally-renowned physicians are of questionable credibility. That's what you have in the ALJ's decision as far as the defense case is concerned.
Left out of the ALJ's decision and unavailable to you in making a decision of national import are any of the studies that prove the scientific basis of what Dr. Sinaiko's did, are any of the medical literature and peer review medical journals, are any references whatsoever to the testimony of any of his defense witnesses except that these prominent doctors, including Dr. Lee, who is here today with us, are of questionable credibility.
What do we have from the Deputy Attorney General in this case, my good colleague Mr. Terrazas, is disclosure of facts and opinions by the Attorney General. Well, I am giving him some demerits here because what you have in the presentation he's made to you are, frankly—and I hate to say this, frankly—serious misrepresentations. I counted 23 misrepresentations in the court record in the first three pages of his brief to you in this matter.
We also have—and I very much regret to say this—name-calling. Name-calling by Mr. Terrazas. I have a handout here in which Mr. Terrazas makes this case a personal vendetta against Dr. Sinaiko by calling him various names: Practicing junk science, voodoo medicine, pseudo-science—that is to say chronic fatigue syndrome is voodoo science—selling a bogus treatment, aggressive, loose cannon. He diagnosed Dr. Sinaiko and says he suffers from delusions, paranoia, grandiosity, he has persecutory delusions; if we are not careful, he will mutate his present form of medicine in some other form of quackery. He endangers the public. He is insidious, he uses junk science. To top it all, he is jealous. So what we have for you to make an informed decision is one side of the story. All you have is the prosecutor's case referenced through the decision of the administrative law judge. Not a comforting thought.
Now, it seems to me—and I've been doing this for 35 years—I believe truly quality-of-care cases ought to be out of business. Controversies in medicine about diagnoses and treatment ought to be decided by doctors, not lawyers. What you've got here is a case presented by a lawyer. You have a case defended by a lawyer, I'll admit it, and you have an administrative law judge who is a lawyer. Where is the physician oversight? What you have is the medical board being run by lawyers, not doctors. It seems to me that who is competent to make decisions about medical controversies and debates? Clearly here we have a serious controversy. Who is competent to make the decisions concerning whether Dr. Sinaiko is right, whether Mr. Terrazas is right, whether there is something in between?
I tell you: Lawyers aren't competent to do that. I'll tell you one thing: We lawyers wouldn't let doctors start telling us how to practice law. We lawyers from the state bar—however I feel about the state bar—don't let doctors come in and tell us how to practice law, what we should and shouldn't do with respect to our clients.
One more point. But, before I make that, I want to tell you some truths. I call them my truths. The first truth is that here you have only one side of the story. I don't think that can truly be debated. You have one side of the story. Is the story that you've gotten from the ALJ accurate? You don't know. And you'll never know unless you read the record and find out. She, as I've said, ignores the medical journals studies. She calls the testimony of these prominent physicians of questionable credibility.
Do you have the accurate story from the prosecutor, Mr. Terrazas? He is an advocate. He advocates for his client. I say to you you do not have the accurate story from Mr. Terrazas. I have 133 misrepresentations that he's made in his papers to you, and I suggest to you that you are ill-informed by his presentation.
Can I give you the truth? Can you trust me to give you the truth? I am also an advocate and, frankly, I am incompetent at medicine. I am not qualified to talk to you about any of the medical controversies in this case because I am only a lawyer and I've had no training as a physician or in any way whatsoever in any medical controversies or debates. I am as unqualified as Mr. Terrazas and as unqualified as the administrative law judge to run the medical board and to tell this panel what you should do about scientific debates.
The second truth is: This case does indeed involve medical scientific controversies. I am not going to debate any of these controversies, but, just to mention them to you, the diagnosis of multiple chemical sensitivities, the diagnosis of chronic fatigue syndrome. A wealth of literature, a plethora of literature in the peer-reviewed medical journals on both of these diagnoses.
Would you know that from the administrative law judge's decision? No. It's not in the decision. The use of Ritalin, giving little kids speed who are ADHD, major controversy in the United States. Literature all over the place in the popular press and medically peer-reviewed medical journals. There are many treatments being suggested and tried in opposition to or in addition to the use of Ritalin and amphetamine, a Schedule 2 drug on little kids. It's a controversial subject.
Do you have any evidence in the ALJ's decision that there are any other treatments that responsible physicians use, that these other treatments are discussed in the medical journals? No, you do not. It's not in the decision. The use of Amphotericin-B, a substance which Mr. Terrazas would have you believe is no better than ant poison, this substance approved by the FDA since the seventies, in the P.D.R. since 1996, no toxicity when taken by mouth, do you have any of this evidence in the ALJ decision? Absolutely not. You wouldn't know anything, but this is a, quote, "dangerous drug" if you read the administrative law judge's decision.
There is another side to that story: The use of E.P.D. in allergy treatments is the treatment of choice in England. Hardly a third-world country. Regarding the use of E.P.D. in this country, check the New England Journal of Medicine for late 1996, and there is an article that claims it's safer than other drugs. I don't know whether it is or it isn't. I have no idea. All I know is, there is a nationwide controversy going on among physicians who use the traditional allergy treatment and physicians who are looking for something better.
There is no reason why this board ought to find itself on one side of that debate. At the very least, this board should investigate what that debate is all about, but you won't find a mention of it in the administrative law judge's decision, not one.
So my question to you, Ladies and Gentlemen, is this: How can this panel decide what penalty is appropriate here or, frankly, if any penalty is appropriate, because you don't have the basic facts, the basic opinions, and the basic information in front of you. You only have one side of the story.
You know, if you buy a hair dryer or if you buy a car or if you buy a washing machine or if you are going to take a trip, you investigate what it's all about You check out other hair driers, you read stuff about it. You go to the store, you look at other products. You spend a lot of time investigating whether or not this is something you want to buy, somewhere you want to go, a college you want to send your kids to, or whatever it is. You check out all sides of the story.
It seems to me, when we are dealing with a man's career, with his life, with his family's life, that the least we can do is to look at all sides of the story and to investigate, to at least investigate. What you have right before you or would have before you in the record of a 26-day hearing, I guarantee you, there is more in there than you've received from the ALJ or from Mr. Terrazas.
Now, my last little chart here. This is what this panel will go down in history as honoring and supporting. And this is the problem, Ladies and Gentlemen, in letting lawyers run the medical board, in letting lawyers make decisions about medical controversies, in letting lawyers decide what's good science and what's not, in letting lawyers decide what's good medical practice and what's not.
This is a quote from the ALJ's decision. Your decision, if you adopt it, if you can figure out what it means. She says, "The peer science parts of medicine is between 15 and 30 percent." Well, my basic subtraction means that, therefore, the art of medicine must be 85, 70 percent. A lot of it in any event. "The science of medicine is where there are"—we all know this—"the scientific method, controlled, double-blind, repeatable results that result in statistically different data, data that tells you something that we can rely upon and be certain about. The art part of medicine requires the use of educated judgment, the risk benefit analysis, something that you as physicians do every day in your daily practice. The physician analyzes the condition of the patient"—no big deal—"assesses the risk of any proposed treatment method while keeping in mind the chances of possible benefit"—nothing startling in that—"this in both the practice and the art of science. In medicine cause and effect is the key"—well, I guess that's okay—"along with the exercise of good judgment." Yes. "The medical hypothesis to be tested is often designed to answer a cause-and-effect question." So far, so good. "That's the definition of experimentation."
Now we'll get to the good point. "Respondent engaged in experimentation with his patients"—in other words, he did what she says a doctor does when he or she practices the art of medicine—"when he deliberately gave his patients a medicine, a medication or diet to see if it would do any good"—to see if it would do any good. Now, isn't that a startling way to practice medicine—"and then discontinued it"—challenge for those of you who might be allergists—"to see how that would affect the patient's symptoms."
And, Panel Members, for this he was revoked. He was revoked separately and collectively on every single count in the accusation by the administrative law judge for doing what doctors do every day in their daily practice. This man sitting right here, Dr. Sinaiko, this quack, this pseudo-scientist who practices voodoo medicine, that's what he does. Do any of you do that? I'll bet you do. For experimenting, for doing this his license was revoked and he now faces an $99,000—I'll call it a fine. The Attorney General will call it cost reimbursement. That's what the decision is. If you adopt it, that's what is going to happen nationwide, and you're going to have to honor and support that decision.
I think this makes my point, Ladies and Gentlemen, that there truly is no physician oversight in this case and that's really what is the evil here. I want doctors to make decisions about medical and scientific controversies, not Mr. Terrazas and not me and not lawyers. This stuff should be done by doctors collegially, not in the course of adversarial proceedings.
Now we are in the course of an adversarial process, so what do we do about it. What I'm saying is that we at least look at both sides of the story. Otherwise, what we are going to do, we are not only going to quash Dr. Sinaiko, we are not only going to destroy his family, but we are going to destroy legitimate medical, clinical trial and error in daily medical practice. Who is going to take the risk? They are going to end up revoked with a $99,000 fine and their life ruined by, quote, "experimenting" on their patients. And it seems to me, Ladies and Gentlemen, that what we are doing here that I don't think is exaggerated by the result of this decision is returning to the dark ages of medicine, when people were afraid to practice medicine in front of the crowd, you know, we still have blood letting. People didn't say, "Wait a minute. This doesn't work. Let's try something else." Guys didn't get revoked for doing that, thank God. But how history repeats itself. And it's repeating itself here today. But we have a chance to stop that.
Now, I have some time left. I want you to know that this is the first time in history that I've ever allowed time to be left when I have an argument to make, and I only do it because I want to fill it up by asking permission for Dr. Sinaiko to make a brief statement. Dr. Sinaiko.
DR. SINAIKO: Well, I am thinking that perhaps the best thing for me to do, since Mr. Turner made his presentation and covered most of the points that I had intended to cover in my statement, if perhaps I just leave myself open to questions. I would truly enjoy entertaining questions from each of you if you have any questions.
THE COURT: Does the panel have any questions at this point? I know that the panel prefers to reserve questions until after hearing all of the oral argument. So, if they don't have anything at this point, Doctor, the panel may have questions at the conclusion of all of the arguments.
DR. SINAIKO: Well, if I could amplify one small thing that Richard did say, which is that there is—there are five controversies here.
And, Richard, you hit on most of them. There is, first of all, multiple chemical sensitivity. Is that a real disease or is it a figment of the imagination? Is it strictly a psychosomatic syndrome, is it strictly psychogenic or is there a physiologic base?
Attention deficit disorder, attention deficit hyperactivity disorder, ADHD, what is the fundamental nature of that condition? What's the cause? What's the treatment? Are there several treatments? Do they all work equally well? Are there some that work better? Are there some that are safer? These are questions that are addressed by people of national stature and articles and controversy about these subjects in the scientific literature is to be found in peer-reviewed medical journals and at national meetings throughout the country where people of the caliber of Dr. Lee normally do address these subjects.
Another question: What about fungi and candida in the intestine? Is that something that can influence immune function? Is that something that can perhaps contribute to disease processes? Well, that's just another controversy in medicine. Some say yes, it can. Others say no, it cannot, but people of great national prominence and in here, in the State of California, the chief of the Department of Allergies and Immunology, my field, in one of the medical schools of the University of California at UC Irvine has stated unequivocally—and allergists know this and I'm taking it as a matter of supposition that allergists know that—and he said that from national podia, saying that, yes, candida overgrowth in the intestine can cause this, this, and this, and this. This is not some prank theory. That came from a doctor who wrote a book in the 1980s called The Yeast Connection.
If we look at the things that we submitted into our evidence, articles from the scientific literature, it's clear from those, it's clear from that excellent research which is reported in the peer-reviewed literature—this is the gold standard that the judge alluded to—it's clear that there are significant and sometimes profound changes that happen in immune function, and the chief of allergy and immunology at UC Irvine says, yes, allergists will tell you. if a patient is allergic and has fungal overgrowth or candida overgrowth in the intestine and you reduce it or eradicate it, the allergy symptoms improve. Now, sometimes I wonder if what I am being accused of is listening to wrong experts. It's not that I don't listen. It's that I listen to the wrong ones, the ones that were not chosen to testify by our friend here.
So let's see. I think I've covered four of the court controversies. The fifth is the ongoing territorial war between the two established specialties whose claimed position is to have expertise in the treatment for allergic disease, and we are talking about the otolaryngologists on one side, the board certified allergists on the other side, but, frankly, as in most disputes, these guys have some of the truth and these have some of the truth and the true truth is somewhere in between. These disputes don't get us anywhere. We need to rise above them. The medical board needs to rise above all of these disputes, but it's very, very difficult to do that because of the position that you are placed in. I think that you've been unwittingly placed in the position of choosing sides in each of these controversies. But it's not the medical board's position to choose sides. That's not what you are supposed to be doing, so that's not what you do. What you do instead is you take these areas of uncertainty and cast them into something that you are intended to do in your deliberations to decide right and wrong. And that, to me, is the reason why there is an enormous challenge before the medical board today, and that challenge is to establish policies and procedures which allow the medical board to set thoughtfully and intelligently the dividing line, that bright line which doctors and your own enforcement decision can look at and say, yes, on this side of the line is quackery, dangerous, deceptive practice; on the other side of the line invasion, yes, but appropriate invasion.
But what we've done is we've taken that out, we've taken this choice out of the place where it belongs, which is between physicians making good-faith attempts to solve what are very, very difficult and complex, scientific issues. And so in deciding whether I would actually stand up here and talk to you, I did what doctors do every day in their practice, which is a risk benefit analysis and, frankly, I am standing here and the risk is enormous because you people have the choice, when you go into closed session today, of revoking my license or of otherwise ruining my life and ruining my family's life and ruining my ability to make a living at my profession which I have been doing for all of these decades. The risk is enormous.
Let's talk about the benefit, what's at stake. What's at stake is not just my career but the ability of physicians to take good care of their patients throughout this state, the ability of patients to choose, the ability of patients to receive good, thoughtful care. That's what's at stake here. And what's at stake also is the whole issue of whether we are going to be governed in California as physicians by a thoughtful, rational, and intelligent health policy. That can all go down the drain today, and it's really up to you.
So I stand here not really as a supplicant. I don't stand here saying, please, please reduce my penalty. What I am really saying to you is let me see if I can't invite you to join in an attempt and in an inquiry to develop some kind of policy and procedural way in which that line which divides quackery from appropriate invasion can be drawn in a way that will provide appropriate, safe, and understandable guidelines for people like me, because I don't like to break the law. I can't remember the last time I got a speeding ticket. That's not what I do. Tell me the rules. I'll follow the rules.
This man tells me, "Oh, he knew the rules." But I'll tell you I did not know the rules. Why did I not know the rules? I thought I did. Before I've done each of the things I've done in my practice, I've gone and I've researched them. You know, there is a section in the beginning of the drug evaluations of VAMA that says very clearly what doctors can do with medicines, with substances which are not defined as medicines. It's all there very clearly.
Did anybody see the letter that I wrote to the medical board? It was attached to something else that Richard submitted. Raise your hand if you read that. Okay. Nobody read that. Well, that to me is a little bit sad. I did try to express some of what I remembered to be the truths of this case and I find it rather unfortunate that nobody read it and it's too long to summarize here because I am already encroaching on the time, but I should say that, please, before you decide my case, read my letter. I probably have another copy of this in my briefcase.
THE COURT: We did read it, and it is here. It is the letter that was attached to the petition for consideration.
DR. SINAIKO: I'm very pleased. I don't break the law. I don't break the rules. I try to find them out and then I try to follow what I think is the basic rule, which is you take the best care of every single patient in your practice. If that means conservatism as opposed to orthodox, the two are not the same. That's what I do. Thank you.
MR. TURNER: Five minutes for Dr. Lee, please.
DR. LEE: Judge Wharton, Doctors and members of the board, I'm please to have this opportunity to discuss the penalty phase of this, as I understand, since we are restricted to that area, but because there are some issues that bear on that I'd like to discuss some broader issues that I think are relevant to your decision.
First of all, the significance of the issues which Mr. Turner described part of it which is contained in the discussions section of the administrative law judge's proposed decision, in that section this description is included, as are others, and particularly with respect to the issue of what I would call irrational prescribing. Is this irrational prescribing? And, rightfully, that is an area that I've been involved in studying since the 1960s, first as chairman of the prescription drug task force in the Department of Health, Education and Welfare, then as co-author of a book, Pills, Profit and Politics with pharmacology Dr. Silverman which dealt with that issue in detail; late in 1988 with a colleague, Dr. Lipthorn [phonetic], a sociologist, again discussing those issues; and most recently in 1995 and '96 in discussions with physicians throughout the country, with people in the Food and Drug Administration, in the Department of the White House, members of Congress, including Dr. Frist, the Senator from Tennessee.
With respect to the off-label use of prescription drugs Congress made a decision in 1997 to permit pharmaceutical companies to send the physicians directly articles from the peer review literatures with respect to off-label use of prescription drugs, clearly in a sense legitimizing it more than it had been legitimized previously, because the FDA simply deals with the label, the prescribed label. They review that, but this is, I think, a recognition of what is of necessity a widespread practice.
One other area that I think bears on the case is the question of medical uncertainty. And, since the work of Gelson and Jack Weinberg [phonetic] in the early seventies and their study on small area variation, we've been aware that one of the major factors in physician decision making is the uncertainty that we face when we see patients every day, whether that's diagnostic procedures, treatments, surgical procedures, as well as outcomes of care.
Then, the issue of the process the board has followed. It's my understanding in 1986 the board read the decision with respect to Level 3 actions, actions where there is no harm to a patient. It's my understanding that the procedure, that procedure, has not been followed in this case. There the physician would be called before the board and a cease-and-desist order might be issued but not a revocation of license. And so I think that's a question.
The other was the judge's description of the witnesses, the four doctors, including myself, as being of questionable credibility, and I would just like to say, with respect to chronic fatigue syndrome, I've been involved in seeing patients since the early 1980s, My first patient I saw with chronic fatigue, I learned a great deal from that patient. I chaired a national meeting in 1989 that was co-sponsored by the San Francisco Department of Health. Later I chaired the department's task force on chronic fatigue. This is the committee which is mandated by Congress. The assistant to the secretary of health chaired the committee because of the concerns of Congress with respect to the issues. Representatives from the Center for Disease Control, the Food and Drug Administration and other agencies sat on that committee. I participated after I left in a national video conference sponsored by CDC. I wrote the foreword for an American Journal of Medicine article. I made a journal issue on the subject of chronic fatigue. This was the research symposium. And most recently I received the highest award, actually, of the American Society, the American Associates for Chronic Fatigue Syndrome for my contributions in this area. Hardly a non-credible witness, at least as far as the profession is concerned, with respect to this. And I would raise some doubts in your minds, perhaps, about the administrative law judge's objectivity with respect to such a judgment and with respect to her knowledge of medicine and science.
Then, I think that the fact that you all have not been able to receive the amicus brief submitted by the California Medical Association and by the Center for Public Interest Law of the University of San Diego State raises some further questions, and I'd like to suggest an approach that was suggested in an amicus brief, and I'd like to quote from him as suggesting an alternative procedure with respect to penalty: "Accordingly, CPIL believes that there is a proper case for suspension of proceedings which is until rules can be adopted as to two questions: One, the propriety of the off-label use of drugs and all forms of Amphotericin-B in particular; and, two, the status of MCS"—that's multiple chemical sensitivities—"and the several therapies addressing it to which some practitioners object. Once such rulings are established with opportunity for experts from all sides to be heard, this respondent shall be specifically ordered to comply. If he fails to do so, he risks new charges and the reinstatement of these charges under stipulated suspension which would waive the Statute of Limitations. Such a penalty, recognizing the obligation of the regulator to set predictable and ascertainable standards where possible according to regulatory purposes, such a harsh penalty is justified because a practitioner needs to be removed from further opportunity to harm patients and achieve a deterrent impact."
It is unclear why either of those rationales applies here. The correction of the issue, I think, for the board is, I think, to focus on the policy, the rule-making, which there wasn't a clear standard, there weren't a clear set of rules by which the administrative law judge could gather the facts and then make a judgment, including off-label use of prescription drugs and the administrative law judge's definition of experimentation and of fringe practice.
THE COURT: Dr. Lee, you have four more minutes.
DR. LEE: Thank you, Your Honor. I'm going to finish up in a few minutes. Administrative law judges are not qualified for such a policy role, and I think that belongs to the medical board.
In closing I would urge you very strongly to accept these amicus briefs, to review them, and then to follow the recommendations of the CPIL. Thank you.
THE COURT: Thank you, Dr. Lee. Mr. Turner.
MR. TURNER: I'll yield to my colleague.
THE COURT: Thank you very much.
MR. TERRAZAZ: Thank you. Good morning, Judge Wharton, members of the panel. I represented the medical board in administrative hearing 26 days earlier this year in this matter, and there is an axiom used by attorneys: When you don't have the facts in your favor, first, you attack the process, as you've just witnessed here. Then, you attack the presenter, as you've just witnessed here.
I would like to deviate for a moment and discuss the subject of penalty and cost reimbursement, because there are a couple of things I think you need to know so you have a clear mind with regard to this particular case.
First of all, I want to address for a moment credibility of witnesses. If His Eminence the Pope took the witness stand today in an accident reconstruction case, whether or not somebody ran a red light, his credibility of telling the truth and his capacity for telling the truth would not be an issue for me, but I would certainly want to know—if he wears glasses, I would certainly want to know if he had them on when he witnessed the accident.
With all due respect to Dr. Lee here, when he testified in this case, I asked him specifically, "Have you reviewed the medical records of the four patients in question here?" And he said he had not. So, again, I have no reason to question his capacity for truthfulness. Like the judge said, however, I do have reason to question his capacity for relevant testimony regarding the issues in this case.
First of all, let me clear up something. There have been contentions all along that not a single patient complained about Dr. Sinaiko's care. This is not true. Your Honor, with your permission, I didn't have the opportunity to do blowups as counsel did, but I do have copies of exhibits that were introduced into evidence at the hearing that I would like to use to demonstrate my point in these areas.
THE COURT: Fine.
MR. TERRAZAZ: I agree with counsel --
THE COURT: Does Mr. Turner know what's in those binders?
MR. TERRAZAZ: He should have copies, but I'd be delighted to provide him an extra one.
THE COURT: Thank you.
MR. TERRAZAZ: You should be swayed only by what the evidence in this case actually shows, not what counsel represent it to be. And I point that out because it's important. Mr. Turner wasn't present, not present during a single minute of a single day of a 26-day administrative hearing. So all he can tell you is what he has been told happened at that hearing.
Addressing the issue of whether or not patients complained, the father of the minor boy alleged in the accusation he filed a written complaint to the Food and Drug Administration. That complaint was forwarded to the medical board, and that was introduced into evidence as Exhibit 3. It's in the binder before you.
In addition to the complaint of the father of the eight-year-old boy, the record contains the written complaint to the medical board of another of the remaining three patients. That was Exhibit 36. That was introduced into evidence. That's a letter from patient Settlemeyer which lists his problems with the care and treatment provided by Dr. Sinaiko. Exhibit 36 is attached. Moreover, a typed 11-page letter to the San Francisco Department of Public Health from Samantha Simon, a pseudonym, forwarded and received by the medical board, also clearly complains about many of Dr. Sinaiko's practices, especially enzyme potentiated desensitization, E.P.D. We'll get to that in a few moments.
Finally, the record contains the to-whom-it-may-concern letter written by the family practitioner of the eight-year-old boy who felt so strongly about Dr. Sinaiko's prescriptions and, if I remember testimony about that, she felt obligated to write such a letter indicating that, quote, "this form of therapy could be considered child endangerment," end quote. That was marked as Exhibit 6, and a copy of Exhibit 6 also is in the documents before you.
A lot of argument has been made about the fact that not a single patient testified against Dr. Sinaiko at this hearing. That also is a very misleading statement. The father of the eight-year-old-boy appeared and provided testimony critical of Dr. Sinaiko's care and treatment for his son. The brother of the deceased patient who committed suicide because he was allergic to everything, patient James Hawkins, similarly appeared and provided testimony complaining about Dr. Sinaiko's care and treatment for his brother.
Moreover, it is interesting to note, in opposition to the argument that the patients did not testify against Dr. Sinaiko, when one of the two remaining patients did not appear and provide testimony, because Dr. Sinaiko's agents did everything they could to intimidate and dissuade the testimony of the female patient, Susan Lasly, who resides out of state in Charlotte, North Carolina. Dr. Sinaiko's investigator contacted this person, compelling the patient to respond in writing. In response the patient instructed Dr. Sinaiko's then-attorney and his agents to cease all their attempts to further contact her, asking that they not call her again, quote, "even to apologize for their previous attempts," unquote, to harass her. This written communication from the patient to Dr. Sinaiko and his agents was introduced as Exhibit 33 into evidence. That also is in the binder before you.
Now, you should also know that the fact the patients do not appear in medical board matters is not uncommon. In fact, it is quite common that they not appear. Remember, damages are not an issue in medical board proceedings since we do not represent purely private civil litigants. Thus, cases involving strictly medical issues as opposed to what happened, for example, in the examination room, those are usually not dependent on patient testimony. Some patients are dead, some are incapacitated, they are unavailable. Do not make anything important with regard to whether or not there is patient testimony. The medical records of the patients, which is the best evidence of what happened, were all introduced into evidence in this particular case.
Finally, there are cases, this being one of those, where testimonial or happy patient testimonials are more prejudicial than they are probative of the facts that you need to know. This is particularly true in cases where there are hot emotional issues involved as in this case, as witnessed here this morning.
Counsel has also contended that the issue that no patient was harmed is something you should be considering. Please understand again, as I've indicated, that administrative actions are not civil actions. The objective is not to compensate a victim for injury caused by a physician. In fact, actual injury is not required in order to sustain a cause for discipline. In fact, it is the medical board's duty to prevent harm before it happens. And there is ample case law that sets forth this legal doctrine. In the most prominent one the judge said, quote, "There is no other profession is which one passes so completely within the power and control of another as does the medical patient." So, while actual harm is not required to prove the case, in this particular case there were numerous occasions of repeated negligence and grossly negligent conduct found by the administrative law judge. Those were the issues that she was deciding.
Also, please remember that harm can occur in many ways, including preventing a patient from seeking appropriate care and treatment for the condition from which they actually suffer. The failure to adequately diagnose and refer the patient James Hawkins, who committed suicide by shooting himself for what was clearly a psychiatric disorder which Dr. Sinaiko was treating as an allergic reaction, in itself delayed necessary care for a recognizable and clearly apparent mental disorder, in this particular case with great consequences.
During the testimony of the brother of that particular patient he introduced photographs depicting his brother's state of health before Dr. Sinaiko's treatment, during Dr. Sinaiko's treatment, and after Dr. Sinaiko's treatment. Those photos are in your binder. Those were introduced as Exhibit 73 and they depict a robust rodeo competitor before treatment by Dr. Sinaiko to someone basically living and sleeping in a sleeping bag on his brother's back porch because he was allergic to everything in the house.
During the day that patient would drive from the central valley to the San Francisco beach so that he could breathe the fresh air and get the positive ions from the ocean. Now, all of this while he was under the care of Dr. Sinaiko. He then moved to the Arizona desert, where his parents gutted an aluminum Airstream trailer so that he wouldn't become allergic to it, moved it to the desert. And he became allergic to that, finally moving into a three-sided lean-to. You've seen the photographs. He became allergic to that before he ended his life. Now, that's important to know in this particular case because that's the consequence that happens where harm actually occurs when you prevent the actual necessary needed medical care from being provided.
The problem is that we really don't know how many others of Dr. Sinaiko's patients may fall into that category even as we speak. And his attempt to provide care and treatment for the behavioral and developmental disorder, the hyperactivity disorder suffered by the eight-year-old when he has no training to make that diagnosis and, by his own admissions, had never made the diagnosis, ever, in his career, exposed that patient to considerable harm as well. The exposure is what I am telling you in my opinion is significant for the medical board to consider.
The Amphotericin-B, the antifungal medication that we discussed that he prescribed, is so toxic, the expert testimony was all clear on this. And when I get to my discussion with regard to off-label use of medications, I will tell you why that is really not an issue in this case. The reason it's not an issue in this case is because I would point out off-label use of a medication presupposes that the medication has been approved for the treatment of some medical condition and that it is recognized within the relevant practitioner's practice as having some demonstrated safe and affective treatment for a known condition.
Okay. We have four patients in this case, each one having to do with the Amphotericin-B prescribed in the capsule form that was prescribed and filled by a pharmacy in Oregon and mailed down to the mother. That is, a superior court judge in Contra Costa signed an order ordering the mother to cease and desist. And then three patients—well, two of the three underwent enzyme potentiated desensitization. In the case of that, please be aware that that which Dr. Sinaiko calls his vaccine uses a material which has a biology which is not approved in any form for any reason, and then he uses that as part of his vaccine. That is not the off-label use of the medication, I would submit to you. That does not constitute off-label use.
And, if counsel wishes to categorize the use of Amphotericin-B in the solid capsule form for attention deficit hyperactivity disorder and the use of it off-label as the cause for the administrative law judge to issue her decision disciplining him for that, then, he really misses the point, because that medication was originally approved and then withdrawn by the FDA because it didn't meet the safe and effective requirement for the medication. It was approved in 1996, three years after Dr. Sinaiko prescribed it in the capsule form for this particular boy. It was approved in 1996 in an oral swish and swallow or in a swish and expectorant form for a single life-threatening condition, oral candidiasis flush usually for severely immune compromised patients, AIDS patients, leukemia patients, chemotherapy patients, severe burn patients. That's why it was approved. This eight-year-old boy didn't have oral candidiasis. He didn't have a fungal infestation or an infection of the gut, G.I. tract, as Dr. Sinaiko likes to call it. There is no such evidence in the record whatsoever to establish that fact. And what makes this particularly glaring is that there were other available over-the-counter as well as prescription antifungal medications available had he truthfully believed that this was a fungal infestation of the G.I. tract.
Now, there was a glaring mistake that I will attribute to Dr. Sinaiko's counsel not having been at the hearing, but there is a glaring mistake in these briefs that indicates that this treatment protocol was approved by another physician, Dr. Jessop, a full-time faculty member who consulted on the patient. That is simply, unequivocally, not true. Dr. Jessop never saw that patient. She never discussed that patient with Dr. Sinaiko. Counsel is confusing this case with another case having to do with Susan Lasly. Moreover, she is not a full-time faculty member at UCSF.
Off-label, again, as I indicated, presupposes some reasonable and scientific basis for believing that the medication which has been approved for one condition can be safe and effective for the treatment of a condition that a clinician sees before him. This case is not about trying to limit a physician performing his duties and obligations as a clinician and using his clinical skills gained over years in observing the patient, making a clinical diagnosis, employing a risk-benefit ratio with regards to the treatment plan and the treatment that he employs with the patient. That's not what this case is about, because that didn't happen in this particular case.
Dr. Sinaiko decided to go off on his own, not tell his patient, with regard to the required informed consent, what he was doing, represented to them it was safe and effective for a million of different treatments and conditions that he was treating them for enzyme potentiated desensitization. But don't take me at my word. As attachments to my briefs I have submitted to you his own representations of all the myriad of different diseases that he finds E.P.D. to be safe and effective for. Read that for yourselves and then conclude to yourselves whether or not that isn't experimentation on patients.
The critical point offered here is that no study is offered. That was no gold-standard, peer-controlled, placebo-controlled and peer-review study that says E.P.D. works for any of those conditions. You'll find in the materials that he uses that he makes representations that it is safe and effective to his patients.
I apologize for the diversion from the issues that you presently have before you, but I needed to make sure that you were clear on these views before making your decision. I find that the campaign of disposition and intimidation, including the posting on the Internet of names, addresses, telephone numbers, fax numbers and, in some instances, even the home addresses of members of the division to be unconscionable. What we have here and what we have seen is that this case is not about the medical board advocating Ritalin over some other treatment modality for attention deficit hyperactivity disorder. This is not about the legitimate off-label use of medications previously approved as drugs or biologics and it is not about merely representing a dispute between two legitimate mainstream schools of thought. Counsel refers to that in his argument as a battleground for medical turfs by competing factions.
Let me talk to you about what this case truthfully is about. This is about whether or not Dr. Sinaiko possesses the requisite medical ethics and medical judgment to practice safely with his patients. That's all that this is about before you today. I submit to you that the evidence in this case before Administrative Law Judge Astle has clearly and convincingly demonstrated that he possesses neither and that his very dogmatic and reductionistic view of human disease makes him an accident just waiting to happen.
I would like to show the members of Panel B, to truly and better understand the nature of Dr. Sinaiko's practice, including his patient population, before proceeding any further I would like to show had you a videotape of a program that aired on QQED, the public broadcasting station in San Francisco area, in which Dr. Sinaiko appears himself and where some of the experts, some of the experts who appeared on behalf of the medical board, also appeared.
THE COURT: Is this on the record?
MR. TURNER: Well, there is so many things that he's talked about that are off the record, I'm having trouble getting them all, Counsel.
THE COURT: Has this been made an exhibit in the hearing?
MR. TERRAZAZ: In fact, the copy that is in the video player has the administrative law judge's stamp. It is the original of Exhibit 17 introduced into evidence:
MS CAHILL: I am Nancy Cahill. I was the attorney working with Dr. Sinaiko at the hearing. There were two versions of the tape. One was sent to KQED and it was then corrected before it went to McNeil-Lehrer. Do we have the inflammatory version or the corrected version of the producers, Your Honor?
MR. TERRAZAZ: I have the version that was aired on P.D.S. that was introduced into evidence.
MS CAHILL: Before the producers made the 0040 corrections?
MR. TERRAZAZ: I have no idea what corrections the producers made.
THE COURT: Is there some way to determine whether this videotape is the actual exhibit that was admitted into evidence in the hearing?
MR. TERRAZAZ: Yes. It has the administrative law judge's stamp for exhibit purposes.
THE COURT: Well, I need to know from the attorney. If you were the attorney at the hearing --
MS CAHILL: Yes.
THE COURT: What was the exhibit number?
MR. TERRAZAZ: 17.
THE COURT: And Exhibit 17 was admitted?
MS CAHILL: Yes, but there was also a subsequent corrected production version admitted as a much later exhibit for respondent.
THE COURT: And what exhibit number was that?
MS CAHILL: I would have to double-check that. I am sorry, I don't have that at hand.
THE COURT: Do we have the exhibit list? Does the panel have the exhibit list?
MR. TURNER: Well, I didn't know we were going to retry the case.
THE COURT: Well, whatever evidence is in the record, although at this point is there any reference in the proposed decision to this video?
MS CAHILL: None.
MR. TERRAZAZ: No.
MR. TURNER: He is just selecting stuff out of the record. We'll be here for two weeks.
MR. TERRAZAZ: Your Honor, I was allowed 40 minutes for purposes of my presentation. I purposely kept my oral presentation short because I wanted the panel members to see firsthand in Dr. Sinaiko's own word the patient population that he treats with these exotic treatments for these exotic diseases.
THE COURT: The concern is, I do not know whether that—if it was not mentioned as a piece of evidence or information that was relied upon by the administrative law judge in making the findings, we do not know whether this was totally discounted or how it was valued by the administrative law judge as supporting the facts. Just as there was apparently, you know, other evidence presented that was discounted by the administrative law judge in making decisions, so—Is there an objection to the video or not?
MR. TURNER: Absolutely. I have a strong objection to it. I have no objection to the entire record being made available, including this video, to this panel, the entire video. If we are going to pick and choose, let's put the entire record in front of this panel. That's the basis of my argument. This panel ought to see both sides of the story, 100 percent.
MR. TERRAZAZ: If I may be heard, counsel picked and chose his witnesses as Dr. Lee came forward to make his presentation to this panel. Why not object to that. I feel that for purposes of disposition, for disposition and what penalty, if any, this panel is going to recommend and adopt in this particular case, that it would be best demonstrative of the facts that the duties and functions and responsibilities of the panel and of the medical board acting as a whole is to protect the public. It needs to have an opportunity to see the public depicted in this particular video.
THE COURT: Mr. Turner?
MR. TURNER: Well, I don't know what he is talking about.
THE COURT: Are you planning to show the entire video?
MR. TERRAZAZ: No. I was going to shut it off when I concluded my 40-minute allotment.
MR. TURNER: I don't know why who he treats makes any difference. Are they poor people, street people, rich people? What relevance does it have?
MR. TERRAZAZ: I would like to remind the panel that he talked about patient population in his opening argument.
THE COURT: I am concerned about taking a piece of evidence without the full evidence being in front of the panel. If you want the panel to at some point review both videos that are there so that both videos are fully reviewed and it's not a misrepresentation of a video or an unfair excerpt of a video, then, the panel can do that if these exhibits have been admitted into evidence and the panel will be able to look a that. The panel, in making its decision, will be able to look at the administrative law judge's decision and perhaps the evidence—the exhibits which have been admitted into evidence, but at this point my concern is that it would be too misleading to take out a small portion of any specific exhibit without making the entire thing viewable and available.
MR. TERRAZAZ: My suggestion is that we start the video, which was my intention, and run it for as long as time permits without interruption and without editing or to its conclusion, although it's a 40-some-odd-minute tape. My intention was to run it continuously for as long as my time allowed.
MR. TURNER: Well, Your Honor, I really have to interpose a strenuous objection. If we are going to pick and choose evidence that we are going to put in front of this panel, then, I think the entire record ought to be made available to this panel, not bits and pieces. Perhaps, after viewing the video, which I've never seen, I'll want to introduce Exhibit 22 or 103. I don't know.
THE COURT: I'm going to sustain your objection to the viewing at this point of the video.
MR. TERRAZAZ: I would respectfully request that the panel review both videos. Counsel say that there is a corrected version. If there is, make that available to the panel.
My point is merely this: That counsel has made the argument that this is a decision to be made by doctors. I agree. On the video you will see the doctors both for and against Dr. Sinaiko's treatment modalities, including some who testified at the administrative hearing. Dr. Sinaiko and Dr. Robert, who all the people have indicated is the evil personified with regards to the opinions that he holds, they both appear on the tape. Those would be appropriate, I believe, for the decision from the panel for purposes of deciding what penalty would be appropriate in this case. I have no objection to both videos being viewed. I am very confident with regard to what is depicted there and the interpretation given by the panel members to what is depicted there. That's the only reason I wanted to show it, Your Honor.
MR. TURNER: It has to be in the context of the entire hearing.
THE COURT: The objection is sustained.
MR. TERRAZAZ: If there is an opportunity for the panel to review the entirety of this video and the other one, the corrected version counsel was referring to, I will make this representation, that what Ms. Cahill is referring to was a correction that was made regarding the description of Dr. Sinaiko. The original broadcast had him as a clinical oncologist, and the corrected version does not. Is that correct?
MS CAHILL: I won't get into the details.
MR. TERRAZAZ: That's my understanding.
THE COURT: This will be for the panel to decide what it may or may not want to look at.
MR. TERRAZAZ: Very well. I will leave the tape with you.
THE COURT: Well, I assume that the tape is in the record, is that correct, in the record exhibits that are here?
MS CAHILL: Yes, it is. It was in the record.
MR. TERRAZAZ: And that's the original that I brought. It has Judge Astle's stamp on it.
MR. TURNER: I understand the objection has been sustained and that's the end of it.
THE COURT: That's correct. I just want to make sure that they are in the actual record exhibits and not an attorney's version or an attorney's copy of an exhibit.
PANEL MEMBER: Exactly.
THE COURT: That's fine.
MR. TERRAZAZ: If you view the video firsthand for yourselves, you will see what this case is all about, but I'd like to also point out some similarities between the patients depicted in the video, if you see it, and two of the patients in this particular case. In the video you will find an individual who has a syndrome described as sick building syndrome. That sick building syndrome is very similar to the diagnosis of the little female patient in the accusation filed against Dr. Sinaiko. That is crucial because it shows you firsthand what happens to these patients in real life. They begin to live absolute nightmares where they have to spend most of their time outdoors. In fact, the woman in the video, in fact, is a human Geiger counter for purposes of sick building syndrome. She goes in and as she begins the experiments dysfunctions physically to the point where she can determine the level of toxic chemicals that are in the adhesive in the carpet and the veneer in the table in the room that is causing her to have these reactions.
In the medical records for Susan Lasly you will find that Dr. Sinaiko described an almost identical situation for the female patient there. In addition, you will also find that in this particular case, with regard to the patients in the accusation you see the investigational tests that Dr. Sinaiko relies on in reaching his diagnoses for these patients are themselves tests that are questionable and dubious in nature. You have in front of you part of either Exhibit 38, which is this IGG mold allergy test which says on its face that it's for investigational use only and that the actual prescription that was filled for purposes of Dr. Sinaiko using that test in determining that this boy had a fungal infestation or infection of the gut, that prescription had to be filled, as I indicated earlier, in a pharmacy in Oregon that formulated and compounded it and sent it down to the person—the mother of the child.
The other thing that you should be aware of that is in Exhibit 25 is that, in regards to the patient who did commit suicide, that the letterhead for the informed consent for the evaluation for allergy is actually on the letterhead of Joseph McGovern, Jr. That's the same clinical oncologist that is also mentioned in the video, Your Honor, and that patient never saw Dr. govern. He had already surrendered his license before that patient became a patient of Dr. Sinaiko's.
Dr. Sinaiko similarly uses the services of The Great Smokies Diagnostic Laboratory which is in Ashville, North Carolina, for parapsychology tests. That is also in the three-ring binder before you. That was for patient B. Reed Settlemeyer. That was Exhibit 25. The fact that I wanted to point out to you in Exhibit 25 is that that state lab reported a first for me, a UFO found in the patient's stool sample. The lab reported the UFO as being unidentified fecal object and transmitted the copy of what that object looked like back to Dr. Sinaiko in the medical records, and you should have a copy of that in your binder. So he provides his patients instructions as seen in the video, advising them about them avoiding excessive overloads regarding toxic chemicals in the atmosphere all around us that can cause the symptoms in them, including things such as fragrance in his office and, if people wear perfume in his office, they will be sent home. You'll see that as part of Exhibit 25 in the three-ring binder before you as well.
So counsel tries to bring the issue as one of power in his written arguments, except that, contrary to his assertions, this is not about power at all. It's about four specific cases that were placed before Judge Astle where the evidence was introduced. And here is the interesting thing: The medical board called a number of medical experts to testify in this case, five in total, for the purposes of them reviewing the medical records and then expressing an opinion, whatever that opinion might be, for purposes of the issues that they saw in the care and treatment of those patients.
But in this particular case we also called to testify the physicians who were actually the treating physicians for the eight-year-old minor boy. And those physicians, by the way, themselves were preeminent physicians and they came in and testified. Remember, they were not medical board experts, they were not paid by the medical board, and they were not told what to say. They came in and testified with regard to their own opinions that the opinions expressed by the medical board's experts were right on, that they were absolutely correct and in agreement with. So the administrative law judge in the particular case, contrary to counsel's assertions, did an outstanding job and the criticism with regard to her written opinion—when you read it, her written opinion reads very well. It's very clear. It tells you exactly what her thought processes were regarding the evidence that was presented before her.
Now, the last issue I want to talk to you about is the slew of expert testimony. That is crucial. Dr. Lee brought it up and I want to address it because it's important that you know something. You all know that before scientific evidence is introduced into a court of law, that it must meet a minimum threshold of reliability, that methodology for purposes of everything be reviewed for purposes of its reliability to prove or disprove something that it advocates against or for. Now, there are legal tests for that to be done. For example, for many years DNA evidence wasn't allowed to be introduced in a court of law because it had not reached the level of scientific reliability to be more probative than not for purposes of whatever its proponents claimed. It's like fingerprinting: Scientific evidence.
Well, in medical cases, there is a standard which must be met that's been articulated in federal cases, Daubert versus Dow Chemical being the preeminent case. In that case which is being applied across this country using the criteria set forth in Douber, a district court may admit expert scientific opinion if it qualifies as scientific knowledge; that is if it has a grounding in the methods of and procedures of science and is more than subjective belief or unsupported speculation.
Now, why is that important? It's important for this reason: Across this country, where proponents have tried to introduce testimony by experts on these issues, multiple chemical sensitivity, for example, the law, as applied by federal district courts across this country, has kept out that sort of testimony. It has not been allowed in because it hasn't reached that reliability.
Now, that is positive for you to know because Judge Astle did not do that. Despite counsel's criticism of the process, the judge asked—she allowed in every witness who wanted to testify on behalf of Dr. Sinaiko as an expert witness and even as testimonial witnesses people who wanted to talk about his credibility and his credentials. She allowed all of that evidence in. Counsel now is taking the position that, because she did not rely on that evidence in making her decision, that, therefore, she must in some way be wrong.
Now, that isn't what happened. What happened is that evidence did not reach the threshold of reliability for her to make a finding on. With all due respect to Dr. Lee, whom I admire for his courage and credibility, he simply doesn't have the expertise for the subject matter areas that were introduced into evidence at the administrative hearing here, and he certainly did not review a single page out of the thousands of pages of the patients' medical records that were introduced into evidence. And it's important for you to understand that because there is a legal axiom that you don't allow that kind of evidence if it can be excluded. She allowed his testimony. She allowed every opportunity for every witness that Dr. Sinaiko wished to call to present him or herself be subjected to cross-examination, and then she weighed their credibility and assigned it the weight that she was appropriate. For them to criticize her now for having gone through that process when she could have just as easily excluded that testimony is unconscionable in this case.
I have attached to your binder—I didn't want to bring in all the C.V.'s and all the written reports. Remember that the medical experts who reviewed this case on behalf of the medical board were told, please review this and prepare a written report expressing your opinions, thoughts about this case. That they did. There wasn't a single written report evaluating the care and treatment provided these patients by any expert proffered by Dr. Sinaiko. You have before you a summary of the credentials of those experts as well as the pertinent and salient information in the summary of what is actually in their written reports. Don't believe he. Take counsel at his word. Don't believe me and don't believe him. Believe the doctors who have credibility before Judge Astle who had subject matter expertise and who testified and particularly who had the authority and the courage to put their thoughts and impressions down in writing and were subjected to cross-examination on this issue. There has been no transcript prepared for you here that you can rely on for purposes of what they said and what somebody else may have said, but you do have copies of the written expert-opinion reports. Take advantage of that. Rely on those.
With regard to this issue presented now about the weight of expert witness testimony, don't take my word for it. Don't take counsel's word for it. Ask Judge Wharton to explain the legal theories in your deliberations and you will see that it is important, not just because somebody has initials affixed to their name, that it is medically relevant evidence of a scientific nature that is going to shed light on the issues before the administrative law judge. I am going to conclude this portion of my presentation, Your Honor.
THE COURT: Thank you very much, Mr. Terrazas. You are two minutes early.
MR. TURNER: Well, I thank Mr. Terrazas for his sterling presentation, because it illustrates to this panel exactly why lawyers should not be deciding issues of medical and scientific controversy. I mean, I don't have enough time to go over, in my opinion, the misrepresentations that he's making to this panel about what happened at this trial. Sure, I wasn't there. That doesn't mean I don't get to argue the case. Lawyers argue cases in court all the time. I've done it for 35 years. Sometimes I am not in 26 days of trial, but I still get to show up and argue on behalf of my client.
Now, let's assume that everything he says is true. Take it at face value: Every single thing he says is true. I say to you, Panel Members, there is another side to the story and all you have to do to find out what that is to order up the record. Let's take a look at this video. Let's take a look at all these expert reports. Let's take a look at the three-ring binder. More like a three-ring circus. If you only read what's in the binder—I don't know. Exhibit 28, Exhibit 72. Let's look at all the exhibits. I urge you to order up this transcript and read what everybody said. Look at all the exhibits.
Maybe, after looking at all the exhibits, you'll find Dr. Sinaiko is simply a junk science, voodoo medicine doctor, but maybe you won't. Maybe you'll be educated about the legitimate breadth of opinion on the scientific controversies that are before you and not simply take the word of Mr. Terrazas or take the words of me.
Now, specialty by specialty during the defense of this case experts were put on to read the records who reviewed the records and who testified as to Dr. Sinaiko's treatment of these patients. It's not like Mr. Terrazas is trying to present to you that doctors came in there and never read the records. Dr. Lee didn't. He wasn't called as an expert who read the records. He was called as an expert in chronic fatigue syndrome, on the general issues which this case has spawned not just in California but nationwide.
He throws out Dr. McGovern. This is a guy that Dr. Sinaiko bought the chairs and tables from. He didn't assume the mantle of Dr. McGovern, whoever it is and whatever it is he did. He only bought the papers and the pencils and the paperclips from this guy.
The E.P.D. studies didn't cheat? Absolutely false. Read the record. It's right in there. You deserve to have those studies in front of you before you make a decision that this says this man is competent, because he does what a substantial portion of physicians in this country do.
Read the informed consent of Dr. Sinaiko in the record. Investigational tests. You know what? This test wasn't investigational. It was on the form and error, the word "investigational." This was part of the testimony at the hearing, I do know that, and the guy that prepared this form came in and—who does the test came in and said this is on the form and error. Mr. Terrazas knows that.
There is a lot of stuff here that's been talked about that was excluded from the record in this matter.
This business about the Simon case, the business about child endangerment. Totally false. In fact, Dr. Jessop thought Dr. Sinaiko was talking about the injectable Amphotericin-B, not the oral form you take. And, of course, in the P.D.R. you will see it's a dangerous situation. You inject water in your veins, that can be dangerous too.
Mr. Terrazas says this was the evidence in this hearing. These mysterious agents that intimidated people, who are they? Is it in the record? No, it's not. The suicide he tries to play on and alleges in some ways that Dr. Sinaiko is responsible for some guy that goes to Arizona and commits suicide. This is the way this case was tried, by innuendo, by manipulation, by putting this—by diversion, "This happened over here, and it's all this guy's fault."
All he's tried to do is treat four patients by methods that are accepted throughout this country by thousands of other physicians. The ions in the ocean, where did that come from? Some guy comes back to San Francisco for ions in the ocean, that's Dr. Sinaiko's fault. He says necessary medical care was prevented. Where is that in the record? Whose care was prevented? What happened to these people? There is no evidence of any of that in the record. What's wrong with reading the record in this case and finding out what the rest of the story is?
Paul Harvey, the guy who invented the words "rest of the story," I think, a national broadcaster—I don't know if any of you listens to Paul Harvey—he said just three days ago, "If there is one irrefutable lesson to be learned from history, it is that excesses inevitably are their own undoing." Excesses are their own undoing.
Ladies and Gentlemen, that's what you have here: You have an excess. I defy you to find in the record any evidence of patient harm. I defy you to find in the evidence any indication that a patient came in and testified against Dr. Sinaiko. I don't have enough time here. It would take me two weeks to tell you, even as little as I know about this case, about all the misrepresentations that have been forced on this panel in the written material and in the; discussion here today. It's an excess to revoke this doctor's license for what he's done. It's an excess to require that henceforth any doctor who chooses an alternative to give children's speed for ADHD ought to have his license revoked. It's an excess to adopt the uninformed opinion of an administrative law judge—I am not taking her on personally. I would say the same thing if it were I that wrote the decision—an untrained person making untrained pronouncements about a medical controversy that are going to have impact in this country nationwide.
It's an excess to set medical policy in this state based upon only one side of the story: The misrepresentations that you are hearing from Mr. Terrazas. It's an excess to crucify this doctor, destroy him, destroy his family by calling him a quack when all he is is a caring, competent doctor doing what doctors do every day, trying things that hundreds and thousands of other doctors have tried to see if they work, to see if they make his patients feel better, to see if he can figure out what are these conditions, how can I treat them. He is a doctor's doctor. He gets referrals from other doctors. They've got patients with conditions they can't figure out.
But mark my words. If this decision is adopted and Dr. Sinaiko's license is revoked, the medical board comes after him and tries to get his house and take away his kids' educational fund to get the $98,000—where did we ever come up with a figure like that—mark my words: This excess will inevitably be this own board's undoing. And then you'll know the rest of the story. Too late.
THE COURT: Thank you, Mr. Turner.
MR. TERRAZAZ: Thank you, Your Honor. I agree with counsel, excess will be its own undoing. Don't trust me. Look at the exhibits that have been attached to the oppositions that I have filed in handwriting which depict what Dr. Sinaiko represents to his patients: The E.P.D. is ineffective as a treatment form. Read that. Make your own judgment. That was introduced into the record in this particular case.
The issue here with regard to Ritalin is really a misstatement and a deliberate misstatement because in this particular case that boy, that eight-year-old boy, had been administered every diagnostic test in agreement. Even Dr. Sinaiko diagnosed him as an attention deficit hyperactivity patient. The person who actually did the assessment visited his school, talked to his teacher, to his principal, administered the test. This is, in her words, "the most troublesome boy in the entire school," and his family practitioner, who came in, put him on a low dose of Ritalin, 5 milligrams twice a day, in a truly common modality that all the experts agreed was the way you treat ADHD.
Let's assume that what Dr. Lee had an—by the way, pharmacologically speaking, it doesn't work as speed, Ritalin, in a child of that age. The exact opposite, in fact—but let's agree that he had an opinion against the pharmacological intervention. The ironic part here: They advocated taking him out of Ritalin and then instituted another pharmacological intervention, which is the Amphotericin-B, which has been proven to be very toxic.
Please join Judge Astle and even Dr. Sinaiko himself in not considering the kind of procedure that's appropriate for purposes of probation. I've set forth all the reasons in my written argument for you as to why that would be something you should not do. He vows to continue his kind of practice despite all the scientific evidence that has been produced before him at the administrative hearing. And you should know that this vaccine shot series costs almost $2,500 for those people who receive it. So, while he is giving them the treatment that he believes is something that they need, he's allowed himself to make quite a profit with regard to every patient that he puts on E.P.D. He's asked that he not be placed on probation. Grant him that wish. I think he is an inappropriate candidate for probation.
The final thing I want to discuss is this cost recovery of $98,000. There were two declarations submitted by the medical board's investigator as well as myself weeks before the administrative hearing in this case. Not once either before the hearing and not once during the 26 days of the hearing was there any challenge whatsoever to the costs that were laid out in a very detailed fashion that had been incurred by the medical board totaling this $98,000 in the investigatory and prosecutory costs, but beyond all that, in the lawsuit that Dr. Sinaiko filed against Dr. [inaudible] for libel, he wrote a to-whom-it-may-concern letter in which he is asking her for $351,000 for his costs just representing his portion of the case before the medical board regarding the one patient, the eight-year-old boy. So for counsel, for Dr. Sinaiko to continue to detail these costs as being unreasonable and usurious simply is not true. There was nothing that prevented Dr. Sinaiko or his two attorneys at the hearing—he had two—from inquiring and asking any question about the costs incurred by the investigation and the prosecution in the case against him.
In summary, it is not enough that Dr. Sinaiko tells his patients that he has breakthrough knowledge that can help them. It is not enough that he thinks that he can help them. It is not even enough that he wants to help them. By perpetrating and perpetuating his patient's own belief that all that ails them is due to some exotic allergy that usually only he has been able to diagnose and treat, this doctor, who is supposed to keep his patients safe from harm, becomes the harm.
I want to thank you each and every one of you for your attention in this matter. That concludes my presentation. Thank you, Judge Wharton.
MR. TURNER: I'd like another hour to respond.
THE COURT: Thank you, Mr. Terrazas. Thank you, Mr. Turner.
At this time the board or the panel members will enter into closed session to deliberate. And thank you both for your very good presentations. I'm sorry. Excuse me.
Do the panel members have any questions at this time?
PANEL MEMBER: I am not sure if it's a question or a comment, but one of the issues appears to be that the physicians should decide and that the whole record should be—the whole case should be seen and heard by physicians. And I just would like, well, to know if it would satisfy you or at least to let you know that on the panel of the board that has to settle this case four of us are physicians. Some of us are very, very familiar with drugs like Amphotericin-B. Two of us are not physicians, but that will be the panel that has to make the decision.
MR. TURNER: And you need all the information in the evidence to make that decision, and you don't have it.
PANEL MEMBER: And the other thing that I would like to say, too. For instance, we've disciplined physicians for using ampicillin, which was the inappropriate thing to use at that time. So it's just not the nature of the drugs.
PANEL MEMBER: I have a question that I'd like to address to either Mr. Terrazas or Mr. Turner: Is Dr. Sinaiko currently practicing or is he under a ISO or a TRO?
MR. TURNER: He is currently practicing.
PANEL MEMBER: There are no restrictions on his practice; is that correct?
MR. TURNER: No, no.
PANEL MEMBER: No, there are no restrictions?
MR. TURNER: There are no restrictions and, of course, all the issues here regarding these patients arose six, seven, eight years ago. He's had a few patients in the meantime.
PANEL MEMBER: Thank you.
MR. TERRAZAZ: All I can respond is, I don't know what his current practice is. I do know that during the hearing, when he took the witness stand in February of this year—remembering now that the original accusation was filed in late '96 and the supplemental in '97—he indicated that, even as he testified, three different rounds of patients had come in in groups to receive E.P.D. even as the proceeding was going forward. That's all I know.
THE COURT: Any other questions? Thank you again very much for your presentations, and we will go into closed session at this time.
[Proceedings concluded at 12:30 p.m.]
This page was revised on March 28, 2005.