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ASSEMBLYMAN GOTTFRIED: If everyone can take their seats we will resume.

(Whereupon the State Assembly Hearing on Disciplinary Process of Physicians and Physicians Assistants was reconvened.)

ASSEMBLYMAN GOTTFRIED: Our next witness is Joanna Amato. The stenographer will swear you in.

MS. AMATO: The term due process can be simply summarized in one word, fairness. The function of due process is to protect individual rights and liberties. In regard to the physician disciplinary process by the OPMC, is the current system fair to the public or to the accused. Is there any truth to the proposed theory that certain classes of physicians are specifically being targeted, and is the entire investigative process as it currently stands too secretive to protect the public from possible harm? Where does fairness enter the equation when human life is at stake? The quality of a patient's medical care simply cannot be compromised in exchange for what a physician perceives as his reputation in the medical community.

As it currently stands I feel the OPMC investigative process is more favorable to the accused. The patient whose medical chart is pulled and reviewed had no knowledge that his or her doctor or former doctor is being questioned for something ranging from a minute infraction to something much more serious. Hearings are kept closed and confidential which obviously protects the physician more than the patient. Most patients never have the chance to speak on behalf of what is written in their medical chart. I have some personal experience with this matter that saved my life.

One afternoon six months after my mother Angela Amato senselessly and savagely died under the care of a physician who is currently under investigation I received a phone call from hi. He casually proceeded to tell me he had a little political issue that he wanted to discuss with me. As the conversation unfolded I learned that this political issue as he called it was that my medical chart was pulled by the OPMC to be used in a formal investigation against him. In the seven and half years my family was under his care there seemed too many things that did not make sense. We couldn't understand why for some reason this doctor chose not to take an active role in providing us with the help we needed.

Our health was deteriorating by the year under his care and for some unknown reason he chose not to put us in contact with reputable, competent doctors who could help us. Rather he fogged the issue of our poor health with smoke screens and lies. We had no idea this doctor had been targeted by the OPMC since 1993.

After I found out about this political issue I was sent a list of charges compiled by the OPMC pertaining to my medical chart. I was stunned and astonished over how accurate and truthful the list of charges was. I was finally awakened to the possibility that my doctor could have been incompetent and negligent in providing us with adequate medical care.

So when I did receive the phone call from him on that September afternoon over a year ago the pieces of the puzzle were suddenly being fitted together for the first time. This was a start of our road to recovery and the search for answers for which under his care we did not know existed.

My former doctor is as he calls it a LLMD, which means Lyme Literate medical doctor. He has a reputation of being an international expert on Lyme Disease and associated tick borne illnesses. Thus nicknaming himself Lyme Warrior. Doctors who do not happen to share his personal view on Lyme disease are relegated to being referred to as ducks as instead of docs.

I was first under this physician's care in 1993 and developed from extended antibiotic treatments and unnecessary medications many symptoms and complications that this doctor failed to address and treat properly. This doctor was my family's primary care doctor and my family had no idea that he was under investigation by the OPMC, nor that he was not board certified, a credential valued and expected by competent doctors in the medical community. Instead of sending us to specialists affiliated with major hospitals, we were shielded purposely from the competent medical care we were desperately seeking and instead received two referrals from him to physicians we had no idea were also being investigated and disciplined by the OPMC.

One of these referrals from my LLMD came in 1998 when I was sent to a doctor I had no idea wad being investigated by the OPMC. First I was intimidated into going to this physician, and then when I asked my LLMD what this doctor could do for me I received no answers. I was also told that I could not schedule another appointment until I saw this physician whom he recommended.

When I finally met with this physician I was shocked and in disbelief when he told me he wanted to give me intravenous hydrogen peroxide treatments without even a physical examination. He had no answers to my simple, straight forward questions about possible complications from his proposed treatments. I was shocked and could not figure out at the time why my LLMD would send me to someone whom I felt was a charlatan. At the time of my appointment with this doctor I had no idea this physician was being investigated, his license was suspended with monitoring conditions. He was also undergoing treatment for controlled substance use and made false statements on his medical license application.

The other referral that was recommended by my LLMD came in 1996 to a physician who runs her own centers for Integrative Medicine. This doctor claimed with a special microscope that she saw spirochetes in a single drop of my sister's blood. She became hostile and defensive when asked if she was affiliated with a hospital. She proposed treatments that are regarded as alternative in conventional medicine. Among the proposed therapies was intravenous vitamins. Given the fact my sister has severe allergies my sister thought it must be best to do this in a hospital setting. The doctor simply said if anything goes wrong when you get home to call and inform her staff. My sister felt this was not an acceptable approach to medicine and declined any treatment from her.

By chance five years later my family learned that his physician had been under investigation by the OPMV for fifteen years and that she had her license revoked in September 2001. The nature of her misconduct included negligence, incompetence, practicing fraudulently, failing to exercise appropriate supervision, improper delegation of professional responsibilities an abandoning a patient.

Because physicians do not have to disclose this information to their patients and if you should be unfortunate enough not to ask your physician if he or she has ever been disciplined the patient risks putting himself in a potentially dangerous situation without even realizing it.

I propose that physicians be required to inform their patients of any investigative process they might undergo by the OPMC, regardless of the outcome. Even if the physician is truly innocent the patient should have a right to know the circumstances behind the investigation beforehand, so that he or she may make an informed decision. For the patient finding out your doctor is under investigation after the fact is simply not protecting while under their care.

Also I propose patients whose medical charts are pulled and used in an investigation against a doctor be notified by the OPMC. I feel they should be allowed, if they choose, to have an active role in the hearing process thus creating an environment that more closely resembles a due process of a civil proceeding. It is only fair to both physician and patient when both parties are given equal opportunity to present testimony during the hearing process to ensure that true or accurate decision is made.

Simply because my family was not aware of the fact our former doctor was under investigation we suffered a senseless and needless tragedy that no one should have to endure. As it was becoming more and more blatant that our mother needed medical intervention this doctor refused to intervene. At the time this was happening we were frantically seeking help and it seemed incomprehensible as to why he did not take an active role. Looking back unfortunately it made perfect sense and tragically cost our mother her life. This travesty of justice was by no means fair morally or ethically and that is why the present system in New York State is no adequate and needs revision. If by sharing my family's experience with this something good can come out of this tragedy then we have made a small step towards progress.

Thank you.

ASSEMBLYMAN MILLER: If you wouldn't mind could you give us the names of these physicians so that we can check in fact that one of them has been investigated for fifteen years and the other one for how ever many years. The other question is and this is obviously a tragic thing for a family to undergo. What prevented anyone in the family from just simply going to a hospital, a hospital emergency room or asking a friend gee what doctor do you use and using that type of referral to get the medical care from some other practitioner?

MS. AMATO: My mother had said to her doctor, Dr. Burrascano, she said out of desperation what if I just go to a major teaching hospital? He said if you go, he said they wouldn't believe you anyway. What happened was tragic.

She, my sister and I believed that we had Lyme disease. We thought that if we had Lyme disease then if anyone knew Lyme disease it would be this doctor. Unfortunately my sister and I never had positive tests. We had laboratory tests that were not FDA approved. All of these tests seemed to come back positive but they weren't mainstream Lyme tests. I was told that I had stealth virus and other tick borne illnesses. We were under the assumption that if we were dealing with Lyme disease that this was who you were going to see. We did go to other physicians who were also Lyme literate. It was the same story.

What happened with us it wasn't the Lyme disease at all. We had severe yeast overgrowths from the antibiotic therapy. If a doctor is going to give you antibiotic therapy then he should know what can happen.

ASSEMBLYMAN MILLER: You mentioned that in Albany when we had these hearings. I know I myself have had patients with significant yeast infections and frankly it is not a difficult diagnosis to make. It amazes me. Do you have the name of the person that was going to give you IV hydrogen peroxide treatments?

MS. AMATO: Yes. That was Jeffrey Coppelson. He's in Brewster.

ASSEMBLYMAN MILLER: This was an MD that was going to give --

MS. AMATO: I don't know if he is an MD now but at the time he was an MD.

ASSEMBLYMAN MILLER: And the woman who ran her own institution or institute and she was under investigation fro fifteen years?

MS. AMATO: Right. That would be Serafina Corsello. My sister went to her.

ASSEMBLYMAN GOTTFRIED: Thank you very much. Next is Lia McCabe.

MS. McCABE: I would like to thank the assembly for giving me an opportunity to share my story and my thoughts regarding the OPMC. I am encouraged to see the effort and time you have taken towards Lyme disease issues.

Before I got sick I was working for an investment banking company in New York City and was taking classes for my MBA and was married. In 1992 I realized that something was wrong. I was 25 years old. I was having difficulty with memory, confusion, extreme exhaustion, stumbling, migraines, joint aches, and ringing in my ears to name a few.

I saw at least fifteen doctors and specialists who misdiagnosed me with things such as MS and Chronic Fatigue. Finally in 1993 a doctor tested me for Lyme disease. It was positive. What a relief a diagnosis. I could get on with my life. Oral antibiotics provided some improvement but not enough so my doctor recommended IV antibiotics which was unfortunately denied by my insurance company. My symptoms progressively got worse. I went into work one day and did not know where my desk was and did not recognize my co-workers. This was one of the scariest days of my life. I went out on disability. My husband had to carry me up and down the stairs because of my pain and weakness.

In 1994 I was hospitalized for a workup. Lyme Disease was the only thing that came up positive. Once again the insurance company denied the IV treatment that might offer me some hope. I had already lost my career, my ability to walk and care for myself. It all seemed unreal and I could not comprehend the hospital administrator's words, "you have to decide what nursing home you want to go to." I was in shock thinking I am only 27, this can't be happening to me.

My incredible parents moved me in with them. When I was at my worst, my Mom came into my room to check on me. I was in pain and wanted to scream out to her for help but I couldn't physically speak or move. She thought I was sleeping and left. I was terrified. I felt like I was in a coffin and couldn't get out.

My parents started to pay for IV antibiotics. Although still very disabled I show much physical and cognitive improvement. I was strong enough to use a wheelchair independently and to participate in physical therapy at Helen Hayes. My need for sleep decreased to 15 hours a day.

Over the next few years after the IV was discontinued I notice my symptoms increasing and my quality of life decreasing. Testing by my doctor confirmed central nervous system Lyme with encephalitis. He recommended another course of IV antibiotics and suggested I see a doctor closer to home.

In January of 1999 the new doctor tested me for co-infections and found that I was also positive for Babesiosis. I could not express my emotions of surprise then joy when I awoke one morning after a month of treatment for Babesiosis and felt the remote control under my leg. It was the first time I had feelings in my legs in years. My drenching night sweats disappeared. My need for sleep decreased and my energy level improved. I began IV and oral antibiotic for Lyme. Within the first month, my family, my physical therapists and I all noticed significant improvements.

Today I am down to twelve hours of sleep. My strength and energy continue to improve. I can wiggle my toes. My memory and confusion have improved. I have packed my wheelchair away and removed the ramp. I'm living a life I didn't think was possible.

My medical care prior to my current doctor cost hundreds of thousands of dollars. Could you imagine what it would have cost if I had to spend my life in a nursing home?

Most of you have probably heard about the NIH so called long term antibiotic study reported in June. This study used only three months of antibiotics to treat chronic Lyme patients and called that long term treatment. If I had participated in that study I would still be in a wheelchair. Instead I am here before you walking.

The assembly hearings in November helped me to better understand the science of why diagnosis and treatment for Lyme Disease can be complicated and why there is not concrete standard. Well the science may be important what matters is what worked for me.

I firmly believe medical treatment should be decided between an informed patient and their doctor not the OPMC and the insurance companies. In addition I am horrified that my medical records can be used against my doctor without my knowledge.

I am grateful for this hearing and truly hope changes will be made to protect my access to the medical care that has helped me.

A friend who was on disability was treated with long term antibiotics and is now off disability back at work at her previous positions as an RN and social worker. I have submitted her testimony along with mine.

I am terrified that my doctor won't be there to help me and others get to that point. I still have my hoes and dreams to have a family, a house and a career.

I consider myself very lucky. I had medical benefits from my job, a supportive family and dedicated compassionate doctors who have risked everything to care for people as ill as I. I am getting my life back again. What happens to all the people who aren't as fortunate as I am?

The OPMC shouldn't be used as a tool by the insurance companies to deny us treatment. They shouldn't be taking sides in a medical debate that is unsettled.

Please consider there I would have been without the medical care I've received and how much that would have cost society.

Thank you. Questions?

ASSEMBLYMAN GOTTFRIED: Thank you very much. Questions? Okay. Thank you.

MR. ROSENTHAL: As you can tell I am a little out of it. I have Lyme and it's quite late for me. In the words of the great American philosopher Yogi Bearer this is dejavu all over again. Most of what I am going to say would have been appropriate a few hours ago. Issues I would have raised which have been addressed in the meanwhile and mostly by the attorneys that are here. I am very happy to see that tat has happened. I am just going to read it very quickly. I think it's the best thing I can do because I am kind of fuzzy right now.

For those of you who aren't aware advanced Lyme Disease patients are occasionally subject to unpredictable periods of memory loss so I have written down what even what might otherwise seem to be off the cuff comments. My testimony today will be a dissection resection of my previous testimony on November 27 therefore much of it will already have been by some of the panel, all of the panel and will be completely novel to all those who were not in attendance. I have removed the scientific, medical and some of the political content and at the same time I have added what I hope will be enhancements. This will also differ form my November 27th presentation and that I will often use the first person as the actions of the OPMC that have affected me in a personal deleterious fashion. I have attached my November 27th testimony for whoever else was here.

I am Norm Rosenthal. I am a Lyme Disease activist and support group leader from Queens, New York. I reside in the 27th Assembly District. I want to say I am also a member of the Long Island Lyme Association and there are three people left here from that so I applaud them for staying here with me. I began the journey down the path which lead me here today with three political goals.

First. To impress upon the State legislature that there is a legitimate medial controversy regarding the treatment and even the existence of advanced, persistent, chronic Lyme Disease. That there are major public health consequences surrounding this issue.

Second. To impress upon State legislature that there are difficulties in obtaining reimbursement from the insurance industry for the treatment of advanced, persistent, and chronic Lyme Disease. That a legislative solution may be necessary to compel such reimbursement.

Third. To impress upon the legislature that as a consequence of the environment described in my first two goals, there has been politicization of the OPMC to the serious detriment of the health of thousands of New Yorkers. And, that there must be immediate intervention and remediation by the legislature through the exercise of its oversight function. That due process protections in OPMC proceedings need to be strengthened by way of legislation.

Evidence that we are making progress towards the first two goals is found in a December 17, 2001 letter written to me by Chairman Gottfried. I consider this letter to be addressed to the entire Lyme community especially as others have received similar, but individualized letters.

Dear Mr. Rosenthal. Thank you very much for testifying at the Assembly Health Committee's public hearing on Lyme Disease on November 27th. The hearing was highly informative for me and my colleagues. Your expertise and experience on this issue was an asset to the hearing and was greatly appreciated.

It is not my job to make clinical judgments. But it is clear to me from this hearing and other information I have received that there is a substantial body of highly qualified medical support for the proposition that Lyme Disease can persist as a chronic condition and that long term antibiotic treatment can be appropriate. Health insurance companies should not be refusing out of hand to cover that treatment.

The response to the hearing has been enormous. I have received an extraordinarily number of e-mails, letters and faxes on the issue. I appreciate the input of practitioners, researchers, patients and their families in learning more about Lyme Disease, its impact and treatment.

In 2002 the Health Committee will be holding a hearing on problems with the State's system for policing physician misconduct.

Please do not hesitate to contact me on any matter that concerns you. Very truly yours, Richard Gottfried, Chairman.

So here we are today in 2002 addressing my third goal as Chairman Gottfried puts it, problems with the State's system for policing physician misconduct. As you can see understanding the first two goals provides a context for describing the Lyme Community's problems with the OPMC.

The Lyme Disease controversy has become so acrimonious that physicians on both sides of the issue have developed personal animosities towards each other. Not only has this hindered the development of more effective treatment, but it has resulted in some physicians instigating OPMC investigations against our physicians and testifying against our physicians. There has been a pervasive patter of persistent persecution of Lyme Disease treating physicians.

Looming in the background are the Managed Care and insurance companies who as everyone knows like to minimize their expenses. And Lyme Disease is an expensive disease if not caught early. It can cost thousands of dollars a month to treat. However, the point that seems to be lost by the insurance companies is that the longer that treatment is put off the more expensive it will be. We speculate that the motives of the insurance companies are augmented by the concept that unlike AIDS patients, we do not have the grace to die. However, there have been deaths from Lyme Disease and we have documentation. I have given you all death certificates. I have them with me. I don't think you need to see them. As an aside I would like to note that last year more people died form complications of Lyme Disease than Anthrax and West Nile Virus combined.

Due to the animosity in the medical community, and the influence of the insurance companies Lyme physicians have been targeted for prosecution by the OPMC well out of proportion to their numbers. This has had a chilling effect on the Lyme Disease treating doctors who have not yet been under investigation as well as on other doctors in the greater medical community who are intimidated from treating Lyme Disease in this climate. While this is happening, more and more people are getting sicker and sicker and therefore harder to treat.

This disproportionate prosecution of Lyme doctors in New York is in an environment in which it is publicly known that doctors guilty of gross malpractice including maiming patients are not prosecuted or suffer minimal penalties. Therefore any OPMC panel seeing a Lyme doctor standing before it will think that this person must really be guilty.

It is recognized that the medical profession is a licensed profession and that as such in order to protect the public good is a privilege not a right to practice medicine. Therefore all aspects of due process available to the general public are not available to defendants in OPMC investigations and prosecutions. However, even with this in mind there are certain aspects of due process considerations which are considerably lacking in OPMC investigations and prosecutions.

An anonymous complaint valid or not can start an investigation of an MD which can last for years and be financially ruinous. The original reason for the ability to file anonymous complaints was to protect individuals who could be intimidated by physicians. However, change should be made by which complaints that are initiated or instigated by insurance companies, managed care companies or other institutions be revealed as to source.

More ominously these investigations have become fishing expeditions. Anonymous complaints have lead to repeated pulling of a given doctor's records in order to find anything that may be perceived as wrongdoing. These wrongdoings real or imagined may or may not have anything to do with the original complaint. One result of all this is that the doctor is ultimately accused of poor record keeping, an accusation easy to make after hundreds of hours of perusing records. A statutory provision for determination of probable cause would counter this abuse. I just want to add here obviously the lawyers all said the same thing. Not being a lawyer I am glad they agree with me. I don't know how we could address the probable cause issue and I am hoping that someone is going to figure that out quite frankly.

We had a case where a physician witness who was personally biased against a physician defendant testified that various patients of that physician did not have Lyme Disease although that witness never examined the patients in question. Furthermore, he based his conclusion on what he saw in the patients' charts while at the same time testifying that the charts were inadequate to draw any conclusions.

This is where I divert from the November 27th. Defendant in this case, Dr. Perry Orens a prominent Lyme Disease treating physician had his medical license revoked. After a costly 1 year battle, Dr. Orens' medical license was fully restored in a unanimous decision by a five judge panel of the Appellate Division Third Department and the record was expunged.

After Dr. Orens lost his license inquiries were made by Lyme activists and members of the state legislature of the New York State Department of Health. The consistent response from the DOH was that the case had nothing to do with Lyme Disease. To support this response the DOH sent transcripts to those making inquiries. In actuality the approximately sixty pages of paperwork sent was a Statement of Charges and Determination and Order. By their nature these documents could only reflect the position of the OPMC. I have with me today the actual 1000 plus page transcript of the proceedings. It is hard to find a place where Lyme Disease is not discussed. Those of you who have seen me before today know that I am very well versed in many aspects of Lyme Disease and this is the largest document I have ever seen on the subject. That may change when the Burrascano thing come out. All this paperwork can be readily obtained from the clerk of the Appellate Division in the Justice Building across from the Empire State Plaza from the LOB.

On November 27tn in response to a question by Assemblywoman O'Connell I revealed that the sole witness against Dr. Orens was Raymond Dattwyler. Dr. Dattwyler has had FDA and CDC roles and participated in the process which lead to the approval of the disastrous Lymerix vaccine. I find it particularly disturbing that the state's sole witness is an employee of the state and is a recipient of government funds that seeded the development of a Lyme Disease test in which he has a financial interest. This is a test which to my knowledge is used by none of the physicians who treat advanced Lyme Disease. I know in the past I have sent that information to Joel by way of someone else. And Nettie Mayersohn has it obviously.

This case affected me personally as I was a patient of Dr, Orens when he lost his license on Thanksgiving of 1999. I was left with a Hickman catheter in my chest which ran to my heart. As the loss of Dr, Orens' license had put chill in the medical community and as I was now considered medical damaged goods it took quite some time to find a new doctor.

Getting back on topic. This is exactly what someone said earlier. Physicians are at once accused of over-testing, under-testing, over-treating,

under-treating, over-diagnosis, under-diagnosis. Differences in medical opinion are not grounds for discipline under New York State law nor should they be.

Furthermore, patients whose charts are used in the prosecution of a physician should be notified. They should be allowed to testify at an OPMC hearing at the consent of the patient and the physician.

Having said all this I must point out that Lyme Disease patients know better than anyone else that there are a lot of people out there in white coats masquerading as doctors. We do not want to throw out the baby in the bathwater. While many of us are quite concerned about the politicization of the OPMC and while we are strongly in favor of strengthening due process protections in OPMC proceedings, a number of us do not support some of the proposed reforms. As we find them too lenient, and too vague. Unfortunately to date I have not been successful in finding someone who is both willing and qualified to write legislation which would be acceptable to the various disaffected parties. I remain in hope that the legal talent that was assembled here today can come up with a solution.

Legislation leading to reform of the OPMC is essential to the residents of New York State. I am saying this from the perspective of patients whose physicians practice traditional medicine not alternative medicine. Many of these physicians have been intimidated by the current climate making them less enthusiastic about treating Lyme Disease. This not only includes physicians specializing in Lyme Disease but general practitioners and practitioners of all types.

Now I am dead.

ASSEMBLYMAN MILLER: I commend your stamina.

ASSEMBLYMAN GOTTFRIED: Thank you.

ASSEMBLYMAN MILLER: (Inaudible) and I certainly thank you for reading that quickly.

MR. ROSENTHAL: I wanted to mention that Pat Smith was not the only with a huge book.

ASSEMBLYMAN GOTTFRIED: Robert Giordano is not here. Marcus Cohen.

MR. COHEN: I am Marcus Cohen. I am a health care consultant specializing in government and the media. My primary allegiance is to patients deprived of necessary care because of medical politics.

I am going to skip my personal relationships with Assemblyman Gottfried and Sullivan and other areas and go right in to today's testimony.

My testimony today focuses on question eight, I don't think the due process questions under consideration at this hearing will lead to lasting OPMC reform. They are important to address and correct if necessary but not central.

I've been publishing an article on the OPMC in the Townsend Letter for Doctors and Patients a national monthly read mostly by people supporting alternative to mainstream medicine. Establishment figures occasionally contribute articles on medical politics in 1992 Bill Clinton published a letter printed on the cover which informed potential voters that he favored relaxed FDA regulation of nutritional supplements.

Two installments of my article are out. The first documents problems arising from OPMC prosecution of mainstream physicians. The second documents and analyzes this agency's proceedings against providers of complimentary and alternative medicine, CAM. I would waste time here summarizing the ground covered in these installments.

I'll note in passing however that most criticism of the OPMC involves disciplinary recommendations for mainstream physicians. That the problems in the agency's performance cropped up soon after the legislature vested the disciplinary function in the Health Department. That the criticism has come from various government officials, professional bodies and medical sources and that the reforms legislated usually broaden the OPMC's reach without eliminating its shortcomings or improving its performance.

Now on to question eight. Installment one of my article suggests that the OPMC continues to move further away from the job I am presuming you legislators intended this office to do when you created it in 1975. Weed out doctors who butcher surgeries, bungle diagnostic tests, botch drug prescriptions, abuse patients sexually, bill and put in claims for services never rendered, or habitually show up for work soused or spaced out.

Instead the OPMC has stepped more and more into determinations of "appropriate" treatment traditionally the province of the evaluative clinical sciences i.e. peer review. Lately judging from its prosecution of Lyme Disease specialist Dr. Joseph Burrascano for improper antibiotic use, the OPMC appears to have trained its sights on physicians who offer mainstream therapy but not according to the protocols that most of their colleagues follow.

Part one of my article features Burrascano's case where I term his protocol a minority treatment, question the basis for prosecuting him in the first place, stress that patients unable to benefit from the standard protocol have gained relief under his care and are willing to assume the potential risk of long term antibiotic therapy and that peer review has customarily determined the appropriateness of such minority approaches.

I have heard by the way that he hearing panel in Burrascano's case has agreed with me that his treatment is basically a matter for peer review to resolve. I hope to confirm that as soon as I get my hands on the panel's report. New York law incidentally allows the respondent physician to make these reports public during the appellate process.

Part two of my article features the case of Dr. Serafina Corsello setting it in the context of OPMC prosecution of CSM physicians since the late 1970's,

I want to depart for one second from the testimony that I prepared because of the remarks by Ms. Amato about Dr. Corsello. I am not defending Dr. Corsello when I make his statement. I am just talking about a problem of due process which as been the subject of most of today's meeting.

In the third installment which is about to be published in February I have written the following and these two small paragraphs of what I am going to read into the record now. Note that Corsello case has never gone to trial. When her attorney filed an answer late the administrative law judge declared her in default which moved the proceeding into the penalty phase. Her attorney is arguing that he law does not mandate a default for lateness. It leaves the ALJ the power to weight the circumstances and waive the default. Meanwhile the OPMC gives out to anyone protesting or merely inquiring that it found Dr. Corsello guilty of providing inappropriate and illegitimate tests and studies. Guilty in effect of fraud. While she has been willing and eager to defend her practice the OPMC is holding fast to the technicality it seized on to dispense with an evidentiary hearing. A right that the law affords respondents in all administrative proceedings. I thank you for giving me that little aside.

In prosecuting CAM physicians the OPMC regularly appears to engage in what I call de facto evaluations of minority approaches, regarding the not so much as departures from community practice but as challenges to standard care.

In this forum I have tome only to five the gist of Dr. Evelleen Richard's conclusions about mainstream evaluations of alternative approaches to account for the OPMC's behavior.

According to Richards a social scientist from Australia, purely objective evaluations of contentious therapies are a myth. The evaluators be they academic researchers or members of OPMC hearing panels, are inescapably partisan, defenders in effect of the medical status quo.

Part three of my article due out in February more fully explains Richards view and the implication it has for effective reform of the OPMC particularly the political implications. Effective reform I should add would discourage this agency from making de facto evaluations of CAM and mainstream minority approaches.

If you do decide it's a good idea to restrain the OPMC from further incursions into peer review territory you are going to set up markers that tell them they are stepping out of bonus. They seem not to know or concern themselves about this anymore.

I have two suggestions on workable limits. They will go into the draft of part four of my article which I've yet to write. Nevertheless I have thought enough about them to offer the preliminary prepublication versions.

The first would allow patients expressly to assume the risk of treatment that departs from community standards. This inherently a contractual arrangement requiring informed consent by the patient though not necessarily in writing, There're precedent in the courts, chiefly from two federal appellate opinions in malpractice cases against Dr. Revici. One in the late 1980's. The other in the early 1990's.

For your information the ripple effect of this precedent spread quickly to Congress where a bill based on it was introduced in both houses in 1994 sponsored by leaders in both parties,

There's also precedent of sorts in recent loosening of FDA criteria for approval of new drugs for diseases such as cancer and AIDS. These changes recognize that in dread diseases lacking broadly effective treatment patients are willing to risk therapies not conclusively proven to be both safe and beneficial.

Modern outcomes researchers who make it an ethical point to let patients choose the risks and benefits they want for treatment tend to support express assumption of risk too,

In the courts the precedent discourages contingency malpractice suits because it bears recovery of money damages if a defendant doctor proves that the patient suing expressly assumed the risk of nonstandard therapy.

My second suggestion was inspired to speak by the U.S. Senate's report on the 1962 amendments to the Food Drug and Cosmetic Act which authorized the FDA to consider efficacy as well as safety in approving nee drugs.

The Senate committee wanted new drugs to become available if the evidence for effectiveness rested on "a responsible body of opinion and scientific fact. They termed this threshold "substantial evidence" and asked the FDA to permit medical claims "even though there may be preponderant evidence to the contrary based upon equally reliable studies."

Substantial evidence as defined in that report is worth thinking about in connection with the OPMC's actions against CAM and mainstream minority treatments. As you know the standard used by the OPMC is preponderant evidence.

The FDA by the way was unable to abide the legislative intent in passing the 1962 amendments. They changed the standard to conclusive evidence, a higher one than the OPMC's and prevailed in several Supreme Court challenges in the 1960's.

My present thinking is that by making the OPMC look for substantial evidence by requiring it to see whether there is a responsible body of opinion and scientific fact supporting the effectiveness of CAM and other minority approaches, there would be fewer CAM and minority approach prosecutions and those investigations that proceeded to trail would be fairer to doctors following these approaches.

It should be understood that I am speaking here chiefly about CAM and minority mainstream treatments that help patients unable to respond to standard care.

And, I have in mind and you legislators should bear in mind too that possibly as much as 80% of treatments in community practice are not evidence based. They are untested theories of treatment and some of those that have been tested have turned out harmful. In effect, the OPMC is using double standard when it decided that a CAM or minority approach is of dubious effectiveness judging it against the presumed efficacy of community practice.

This is as far as I dare to go today. I have a suggestion for a third reform which would enforce the limits I've broached above. It comes from a member of the White House Commission on CAM Policy during a meeting of the Commission in New York City last February. He raised the prospect of some degree of penalty for malicious prosecution, citing a California provision. Malicious prosecution is very difficult to prove so I am considering a lower threshold wrongful prosecution.

In the fourth installment of my article anyone interested in my suggestions for OPMC reform will find them in a more developed form.

Thank you for inviting me to testify. I also thank your committees' staff for quickly attending to my pre-hearing inquiries. If you have questions, shoot.

ASSEMBLYMAN GOTTFRIED: I would appreciate seeing the fourth installment of your article when the draft is ready. Mark Barnes.

MR. BARNES: Good evening. I am Mark Barnes. I am a partner at Ropes and Gray in the New York office. I practice Health Care law. I represent a number of academic medical centers and physician groups in New York. I occasionally practice before OPMC but that's not (inaudible) the majority of my practice. I am joined by Lynn Stansel who is the associate general counsel of Montefiore Medical Center. I am the chair of the New York State Bar Association committee on health care providers. Lynn is the chair of the in-house counsel committee, the hospital in house counsel committee also of the State Bar Association. We are tonight representing the health law section of the New York State Bar Association which has debated and has considered the issues regarding OPMC and potential reforms to the OPMC process.

We have written testimony which has actually has been gone over a great deal by members of the bar. It represents I think its safe to say a kind of compromised position about issues of OPMC reform. We contain in it about seven very specific suggestions, major suggestions for reform of OPMC procedures.

The State Bar's Health Law section has a number of different competing interests one might say because we are composed of OPMC judges, are included in our membership. OPMC prosecutors are included in our membership and a number of attorneys who represent the accused physicians before OPMC and many like Ms. Stansel and myself who come into contact with OPMC occasionally but not all the time and have some experience. Not only as counseling people who might be defendants but also counseling people who are witnesses in the OPMC process. We believe that our association and what we try to do it really does represent a broad cross section of interests. We tried in these recommendations to come with things. That perhaps did not satisfy everyone in the Health law section but did satisfy the broad middle range of concerns.

Certainly the Health Law section understands that to OPMC prosecutors and staff have in some cases a thankless job. It's a job of prosecuting bad doctors and getting them out of practice which is something that is necessary and actually has a ultimately salutary public purposes, public health and safety purpose. At the same time it's obviously a serious task and its replete with we think with some really quite serious procedural problems.

Most of our recommendations really pertain to opening the process. What I mean by opening the process is not opening it to the public in terms of attendance but instead clarifying rules and procedures that according to our membership who are all over the state of New York really do vary between the Albany office, the western New York office and the New York office and the New Rochelle office of OPMC.

Procedures differ from place to place. They markedly differ and standards differ we find from investigator to investigator, attorney to attorney, panel member to panel member. Many of these things are simply because there are no standards except perhaps internal standards issued through internal memoranda within OPMC. They govern things like the production of exculpatory evidence that really are quite important standards that ought really to be adhered to in any kind of process that could be construed as fair and impartial.

We believe that a fair and impartial process sis important not simply as a matter of due process to physicians but also because a fair process ultimately will lead to better results in terms of routing out physicians who really are bad as opposed to those who are not. If you simply had one or two instances of perhaps making bad judgments or rendering bad care.

Let me just describe them briefly. I know the hour is late and if you have any questions about it Lynn and I are happy to answer them.

We do that the existing process rally does, it has a huge hole in it which is that it really doesn't give physicians in all cases or perhaps in a majority of cases fair notice of charges against them. There are few kind of subheadings under that.

One is that the physicians in many cases don't get the expert reports of the OPMC experts until the actual day of the hearing or a couple of days before the hearing long after the real opportunity has passed for a careful analysis of what that expert opinion contains and a presentation of a counter bailing view or an opposing view or a different view to the investigator and to the medical coordinator within OPMC who is the physician who coordinates the work of both the investigator and also the expert. We think that's a bad thing. It's something that actually having a greater clarity in the process in terms of the OPMC being forthcoming with the expert opinion really doesn't hurt anyone. It will only provide for a grater ability to debate the evidence and talk about it before our case actually proceeded to hearing.

We have a problem with the interview process which you have heard I think from some of the respondent's counsel who testified tonight. In some cases the investigator are really quite good. They will explain in some detail what the charges are. In other cases you can walk into an interview and you can defend either a witness or a physician and you have no idea about whether you are going to be held for thirty minutes or six hours or even for three days in regards to questions. There can be medical records on one patient that really be six, seven, ten inches high and you have no idea exactly what was in that medical record your client or your witness is expected to talk about. We think there ought to be a procedure to make it clearer what people are being asked to come and give a statement about.

The charges when they are finally issued against an OPMC physician if it's going against a physician by OPMC, if its going through the whole process also are most often phrased in very vague terms without even the (inaudible) specificity and the charges as to exactly what the physician is charged with. Presumably that's a prosecutorial strategy so that if evidence comes up during the hearing that doesn't conform to the charges that they would still be included in the charges because the charges are broad and we think that rally is not the fairest way to go in terms of giving notice to the accused physician.

There is also a difference in practice in regard to what investigator will tell physicians when physicians ask them whether they need or would require an attorney for legal representation within the process. Some investigators will say it's a good idea to have an attorney. Others will say its not necessary many people go through this process without an attorney. Physicians will go trusting in the state to make a right decision and they are there in the middle of their statement being taken and questioned extensively when they realize they really should have had legal counsel.

Our suggestion there perhaps doesn't need a statutory form but it is that there be some kind of directive that when advising physicians about holding an interview that the investigator say very clear just the truth that OPMC is a disciplinary body. That it has the ability to discipline physicians for misconduct. That misconduct is a legal definition. That disciplinary action can include the loss of a medical license and fines and that physicians are permitted to have legal representation. We think that that kind of answer given really by all the investigators to those kinds of questions would eliminate much of the confusion that physicians have.

ASSEMBLYMAN GOTTFRIED: You may think that that wouldn't require legislation in order to make it happen. I can guarantee you it will never happen unless either the legislative or judicial branches of government order it.

MR. BARNES: That may be true Assemblyman Gottfried unfortunately.

ASSEMBLYMAN MILLER: Perfect example. We have a bill by Sam Coleman that wanted nothing more than to tell people who come before a grand jury that thy are to remind the grand jury members that they are not working for the district attorney but in fact they are an independent review but they refused to do that. So you know the district attorneys be swayed over grand jury's but we can't get that law passed.

MR. BARNES: Another example of where there is internal policy but I think it lacks clear application is in regard to exculpatory evidence. There had been rally some quite serious cases that have been brought to the attention of the bar association in which exculpatory evidence, that was rally directly exculpatory was not introduce. In 1999, in September of 1999 after one of these cases really came to a head with attention that went up to the State Commissioner of Health because of the withholding of directly exculpatory evidence throughout an entire hearing and the representation of OPMC of a medical record that was complete that in fact lacked the exculpatory pages, the crucial exculpatory pages, there was an internal memorandum issued by then General Counsel Greenburg directing people within OPMC to produce exculpatory evidence. It took a very horrible case and what I understand to be some serious cases that went before in order for an internal policy like that to be produce.

An internal policy can simply be revoked by the next internal policy. The bar association thinks there should be a very clear directive that exculpatory evidence should be produced soon after it is discovered by OPMC and after there is a reasonable apprehension that the evidence might be exculpatory. Which might not be exactly obvious at the time the evidence comes into OPMC's possession.

ASSEMBLYMAN GOTTFRIED: Do you have a copy of that memo?

MR. BARNES: Yes sir I do. I do actually in my briefcase. I would be happy to give it to you. It was only provided to me a couple of days ago by one of our section members who works for OPMC. He had first told me that it was a long standing policy. I said I wasn't real sure about that because I knew of cases that it had not been enforced.

ASSEMBLYMAN GOTTFRIED: If you could provide it to me afterwards I would appreciate it.

MR. BARNES: Yes sir. I would be happy to do that. I only have one copy of it. I will show it to you and then fax it to you if that's okay or maybe there's a Xerox machine still working around here. I will be happy to show it to you tonight.

Another problem is often times after the investigation process but before the actual hearing has begun there are settlement offers that are made by OPMC, by OPMC attorneys after the case has been referred over to the prosecutorial side of OPMC. Unfortunately the experience of many attorneys in the New York region but perhaps we have found a difference in terms of the way the Albany region of OPMC behaves. Almost every case seems to be accompanied, no matter how serious seems to be accompanied by exactly the same demand which is that the physician surrender his or her license. There seems not to be in terms of that first kind of demand any kind of calibration of the initial demand of the state to the seriousness of the charges or even the evidence.

This may not be a function of OPMC attorneys at all because in fact what I understand, what our section understands is that the charging committee, the internal charging committee that approves the charges against the physician is the one that sets the settlement parameters.

Having a situation, I am not sure exactly how, we don't have a good suggestion as to how to remedy because it really goes to attitude more tan anything else. We call it to your attention because having a situation like that where the initial demand is quite insistent and it is for surrender of license is not really a good way to run a railroad and it's particularly unfair to physicians and to their counsel who have had little experience with OPMC and don't understand that that is only a first offer and that after a few weeks or even months OPMC will generally back away from that. It's a very odd phenomenon and we do find that it occurs especially in the New York City region.

Another point that has been brought up by several of our members is that OPMC and because it is a reactive agency and because of the standards it enforces and the forty-five or forty-six different sub-definitions of professional misconduct in Section 6530 of the education law it often times it is complaint driven will accept a complaint and essentially will make, will break brand new law break ground and redefine what one of these standards in 6530 means in a brand new way which is not really given one would say perhaps fair notice or adequate notice to physicians of exactly what the standards are and how OPMC really interrupts 6530.

Some of the areas in which our members have suggested and our members are not just defense lawyers but actually a number of lawyers who used to be OPMC prosecutors and judges who made these comments. These are not all believe me from people who are on the respondent side only. Is that in certain areas like research misconduct, alternative medicine, inappropriate of third party payers or alleged inappropriate billing and physician advertising that the one or two unlucky physicians who get complained about in the first instance all of a sudden their cases are making new law but there has been really no adequate notice to them or to any of their colleagues about how these new interruptions are working.

Therefore one of the suggestions made by a member of our section who is a very prominent person who used to work for David Axelrod and the two of you I am sure know him. Is that in these kind of vague areas where the board, the State Board of Medical Conduct really thinks that there ought to be new standards in these areas like physician advertising, they should put out memorandum prospectively, the board should saying these are what we think the applicable standards are in regard to physician advertising and then publish those just like a Department of Health memorandum is published and give fair notice to the provider community as to what the standards are especially in these vague and kind of path breaking, ground breaking areas.

We also felt that the one fair person that I think both sides agree really is fair is that the administrative law judges tend to be pretty good with an OPMC. We actually as a section favor not diminishing their authority but strengthening their authority to compel both sides to produce evidence, to share evidence, to act appropriately, if strengthening their hand to restrain both OPMC counsel and respondent counsel both of whom in any particularly case like in any court case can kind of be all over the map. Our section was very supportive of the role, the strengthened role really of the ALJ's in the OPMC process.

There also in the seventh specific suggestion is that there really ought to be consideration given to having a statute of limitations in the OPMC process. Right now the statute of limitations there is none and even though medical record retention policies in almost every physician's office, hospital and licensed health care facility are six years or majority plus six years in the case of children. It seems really not fair for OPMC in terms of a prosecution to be able to dredge up things of which the physician has few records or no records and even less memory of the case. Certainly if there is a bad practicing physician one would think that the bad practice would have occurred within the previous six years.

One of our, many people expressed this point of view and one person in particular who has some deep experience with OPMC suggests, in fact he is an ALJ for, within OPMC suggested six years as an appropriate statue of limitations.

Some other areas that we heard comments on but which we don't have particular recommendations tonight would include the prevalence on panels of a core of members who and really there are not being adequate circulation of members or representation of additional members of the State Medical Board on the panels that their case is. The familiarity with which these core panel members greet and talk with OPMC attorneys. The fact that the administrative review board unlike most Appellate bodies will substitute its judgment of the facts for the trier of facts, judgment of the facts which seem to some to be unfair.

Finally there is statutorily requirement of the existing statute that OPMC give a post interview written notice of charges to the physician before the actual charges are issued. That apparently, according to no one that we could find, that statutory standard is not respected at all even though it actually is in the statute.

Finally I should say that the reason that we were in some sense prepared to give these comments and I know that the city bar was trying, the city bar health committee was trying to pull some comments together but the reason that we felt prepared to do it was about nine months ago between the Ms. Stansel's committee on in-house providers and my committee on health care providers we formed a working group actually to look at OPMC issues to consider all the different points of view in OPMC issues and try to come up with some suggestions for reforming the process that would allow OPMC to continue to be a robust and aggressive agency but still give a greater due process and make it a fairer kind of more even playing field and an open playing field so that everyone understands the rules. That committee has begun meetings, has not finished its work, hopefully will soon. But, in advance of that these are kind of the preliminary determinations that have been reached in the process.

With that I will stop.

ASSEMBLYMAN GOTTFRIED: Okay we look forward to your recommendations.

ASSEMBLYMAN MILLER: Let me just ask one question. Why two and a half years for malpractice and six years for OPMC? It seems to me that if you are doing one minor infraction every two and a half years it's not a big deal. If you do one major infraction they should be coming after you right away. It seems like six years is a very long time. You are giving the state which has basically unlimited resources and is supposed to know these things far more leeway than we should. It's the state's responsibility to do this. Clearly if it takes them six years to get around to it --

MS. STANSEL: I could see a position however that if there was some cumulative actions that were done with regard to a number of patients that there could be some argument made that perhaps a longer time is needed. However I agree with you that there should a reasonable time limit. You don't have that issue in malpractice where you are focusing on one particular series of events.

MR. BARNES: One of the problems that OPMC would bring up is that their backlog of prosecutions in terms of their length of time it takes for an investigation is quite lengthy and that the two and half years presumably could expire so that one would have to develop if one took that into consideration the length of time to reach a prosecutorial decision. One could perhaps have a kind of tolling event or something like that.

I think the reason that the ALJ suggested six years is increasing in health care six years is looked at as kind of the time, statute of limitations that we live with except in malpractice cases because the Federal Faults Claims Act which is the very act under which the federal prosecutors and in some cases state prosecutors go after health care providers for bad billing, for inappropriate billing practices to third party payers. That statute is essentially regarded as having a six year statute of limitations which is sort of what we for better or worse have become used to in the health care law profession. I think you are right even six years is a long time ago in regard to a particular kind of ambiguous, whether care given ambiguous or not. Whether a physical examination was complete or not. Those are things that are kind of illusive and six years can be a long time.

ASSEMBLYMAN MILLER: Again financial matters sure that's cumulative, you owe us $2 million not the $7 you stole last week. It comes from the state being incapable of doing it's job in a timely fashion. That should be the state's responsibility. I think we should encourage a little more efficiency.

ASSEMBLYMAN GOTTFRIED: Thank you. We are adjourned.

(Whereupon at 9:30 P.M. the State Assembly Hearing on Disciplinary Process of Physicians and Physicians Assistants was adjourned.)

C E R T I F I C A T I O N

I, FRANK GRAY, a Notary Public in and for the State of New York, do hereby state:

THAT I attended at the time and place above-mentioned and took stenographic record of the proceedings in the above-mentioned matter;

THAT the foregoing is a true and correct transcript of the same and the whole thereof, according to the best of my ability and belief.

IN WITNESS WHEREOF, I have hereunto set my hand this day of February, 2002.

 

 

_______________________

FRANK GRAY



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