Frederick T. Zugibe, M.S., M.D., Ph.D., FCAP,  FACC,  FAAFS


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Regarding Allegations Made by the New York State Commission on the Quality of Care for the Mentally Disabled

Protecting the mentally disabledAbstract: It is the responsibility of the Medical Examiner, as an official independent "watch dog", to objectively report its' findings as to causation so that needless deaths may be prevented. Unfortunately, relating the truth is not always an easy road to travel, as rudely discovered by the Rockland County Medical Examiner in July, 1978. The Medical Examiner's Office opined that based upon autopsy findings and a statistical review, it appeared that a contributing factor in a large percentage of aspiration deaths at the two state psychiatric facilities located in Rockland County was the use of psychotropic and/or sedative drugs. This opinion was met by relentless and inordinate political pressures resulting in a barrage of formal hearings, distortions, character assassination, credibility undermining, harassment, and false accusations.  Nevertheless, the Medical Examiner fervently stood by its findings and after nearly a year and a half, the Office was vindicated.

Now, 20 years later, and although the association between psychotropic drugs and aspiration deaths is universally accepted, the Commission persists in spreading its professionally discredited position...and thus the reason for this page.

PLEASE READ ON...

1. What allegations were made by the Office of the Medical Examiner, County of Rockland leading to a report issued by the N.Y. State Commission on the Quality of Care for the Mentally Disabled entitled, "The Case of Joel G."  followed by a second report entitled  "Allegations Without Substantiation"?

In response to queries made by a reporter regarding the Levitt report, the Chief Medical Examiner stated that the Medical Examiner's Office had observed over the preceding years that a contributing factor in an alarming number of deaths investigated at Letchworth Village Developmental Center and the Rockland Psychiatric Center was the use of tranquilizing and sedative drugs.  It was opined that this correlation was, perhaps, endemic to all mental institutions. These two psychiatric facilities located in Rockland County operate under the auspices of the New York State Office of Mental Retardation and Developmental Disabilities (OMRDD). A review of all data compiled during a specified time period revealed that 110 cases were accepted for autopsy from the Rockland Psychiatric Center and 93 cases from Letchworth Village. Of the 110 Letchworth Village cases, 33 cases or about 30% were aspiration deaths and of the 93 Rockland Psychiatric cases, 35 cases or about 38% were aspiration deaths. This was in striking contrast to aspiration deaths outside these institutions that constituted approximately 2% of Medical Examiner cases. 

Aspiration deaths result from the sucking of vomitus, food or foreign bodies into the airways causing suffocation. The only apparent common denominator in the institution cases was the use of psychotropic and sedative drugs.

2. What was the substance of the commission's first report entitled "In the Matter of Joel G., Deceased, A Resident of Rockland State Psychiatric Center"?

The Commission charged that:

(a)  an autopsy report was not provided to the Mental Hygiene Medical review Board until November of 1977 despite a Supreme Court Order. 
This was FALSE!
Nancy Roth, Esq., Office of Counsel, Department of Mental Hygiene, named in the petition, signed for and received a copy of the autopsy report on August 8, 1977, the same date of the court order.  

(b) the family of Joel G. was compelled to wait nearly 18 months to learn the cause of death. This was also FALSE!  The cause of death was known to the family on July 5, 1977, approximately one month and 9 days after the autopsy. At that time, the father's attorney personally signed for and received a copy of the autopsy report.  A copy of the signed receipt was provided to the Commission, yet, they, nevertheless, persisted in the dissemination of this knowingly false statement

(c) Dr. Zugibe, the Chief Medical Examiner signed the death certificate although Dr. So, a pathologist performed the autopsy.  Again, the allegation was patently FALSE!  Both the original and the amended death certificates were signed by Dr. So.   

(d) the family's request for a special autopsy to determine the organic nature, if any, of their son's disability was refused by an Assistant Medical Examiner. This was FALSE! No representative of the Medical Examiner's Office was ever even contacted. It was later learned that a request was made to personnel at Nyack Hospital who incorrectly informed them that such an autopsy would not be allowed.

Myriad other unfounded and insolent charges were made that were, likewise, proven to be specious. For instance, the commission challenged the cause of death attributing the death to an epileptic attack. The clinical findings prior to his demise was most consistent with iatrogenic ventricular fibrillation and subsequent aspiration of gastric contents and inconsistent with epileptic seizure. It was the conclusion of the Medical Examiner that the investigation into the death of Joel G. by the State Commission on the Quality of Care for the Mentally Disabled and the Mental Hygiene Medical Review Board was based on incorrect facts, blatant misinterpretation of data and unfounded allegations.

3. What was the substance of their second report entitled "Allegations Without Substantiation"?       

The Commission charged that the Medical Examiner's allegations regarding the correlation between the use of psychotropic drugs and the remarkably high incidence of aspiration deaths at state psychiatric facilities were without substantiation.

4.  Were the facts in the State's Report accurate?

The facts related in the State report were fraught with willful inaccuracies. This agency resorted to egregious political tactics based on erroneous facts,  distortion of critical data and groundless allegations.

5. Was there a formal reply to the State's Report?

Yes, a 75 page report entitled "Death is an Unacceptable Side Effect" was immediately issued by the Medical Examiner's Office answering each allegation and exposing the fallacy of the Commission's politically motivated allegations. Each answer was supported with official documents, scientific publications and the opinions of renowned scientists.

6.  Was there a statistical relationship between the use of these drugs and the deaths?

Yes, The Medical Examiner equated the link between these deaths and the psychotropic drugs to that of the scientific connection between cancer and cigarette smoking proclaimed by the U.S. Surgeon General's Office and numerous research studies. However, the Chairman of the Mental Hygiene Medical Review Board, Dr. Sheldon Sommers not only disputed the drug/aspiration relationship but also dismissed the tobacco/cancer connection which, as everyone knows, is currently accepted even by the tobacco companies themselves.  It should be noted that at the same time that Dr. Sommers Chaired the Medical Hygiene Medical Review Board, he was Chairman of the industry financed Scientific Advisory Committee of the Council for Tobacco Research, a defender of the tobacco industry against the government's efforts to prevent lung cancer by restricting smoking!

7.  How do you answer the Commission's accusation that not a single case was identified (as conceded by Dr. Zugibe) where it could be unequivocally concluded that the aspiration death was precipitated by the use of a psychotropic drug.

Their objection places environmental medicine on trial, in essence questioning the well known statistical relationships between estrogens and endometrial cancer, cigarettes and lung cancer, thalidomide and birth defects and so forth. Of course, no individual autopsy will reveal a definitive cause and effect relationship. The finding of lung cancer in a person smoking 5 packs of cigarettes daily for years in no way confirms that the cigarettes definitively caused the cancer in that individual since there is no analytical method that can demonstrate that cigarette smoking did, indeed, cause the cancer in any individual case. Moreover, the cause and effect relationships are clearly recognized by drug manufacturers in the Physicians Desk Reference and package inserts on the basis of experimental studies and clinical observations.

8. Did you present any of your findings before any credible scientific body?

Yes, the results of the Medical Examiner's investigation were presented by invitation before the Forensic Pathology Section of the American Academy of Forensic Sciences in Atlanta, Georgia and was attended by medical examiners from throughout the United States and Canada. The paper, entitled "Psychotropic and/or Sedative Drug Related Deaths" was well accepted.  This was followed by an invitation to write a definitive chapter for the book, Legal Medicine 1980 edited by Cyril Wecht (Appleton-Century-Crofts) entitled "Sudden Death Related to the Use of Psychotropic Drugs".

9.  In the State Report, was the Rockland County Legislature requested by the Commission on the Quality of Care to determine whether the Rockland County Medical Examiner's Office was being operated in a manner consistent with the public interest?

Yes, they formed a Special Committee that conducted months of hearings. This Special Legislative Committee embarked on a complete investigation into every aspect of the Medical Examiner's Office and concluded that the Office was operating in a manner consistent with the public interest. 

A report that had been conducted by the Rockland County Department of Audit and Control was introduced. This report stated: "Our study indicated the uniqueness of the Medical Examiner's Office. Due to the nature of the work, a special dedication and responsibility was particularly noted in the study. Standards were found in areas such as immediate response, timely work and high quality of work. To effectively meet these standards, it was found that the staff worked together closely in terms of 24-hour, 7 day availability with no compromises in work quality. To assist them, policies and procedures were finely organized in manuals, forms were clearly produced and outstanding files were maintained so that data is easily retrieved. The quality of management on the part of the medical examiner promoted a cooperative spirit on the part of the entire staff. The entire operation indicated effective organization and management to achieve objectives in an extremely sensitive area of work."

10. Was the Medical Examiner recognized for his efforts?

Yes, The Rockland County Legislature presented the Chief Medical Examiner, Dr. Zugibe with the County of Rockland Distinguished Service Award and declared by official proclamation the week of February 16-22, 1980 as Frederick T. Zugibe Week. A testimonial in honor of the Chief Medical Examiner was sponsored by the Police Chief's Association and attended by several hundred prominent citizens, government officials, politicians and friends. Dr. Zugibe was presented with numerous awards and commendations by the District Attorney, County Legislature, Governor, U.S. Senators and Congressmen, County officials, PBA, Fire Divisions, etc. Also, Phoenix Rising ( Montreal, Canada) awarded the prestigious Phoenix Pheather " for honesty and courage in speaking out against the numerous health risks in the face of severe criticism."

Interestingly, a publication entitled "Manual of Psychotherapeutic Drugs and Epileptic Drugs" was authored by the State of New York Office of Mental Retardation and Developmental Disabilities (OMRDD) in April, 1979 for the purpose of guiding physicians in "the very specialized use of psychotropic and epileptic drugs, as well as possible adverse reactions and undesirable interactions" by setting the "standard of prescribing behavior for medical staff caring for developmentally disabled persons of all ages".   The manual , thereafter, proceeds to warn and instruct that a "MAJOR ADVERSE EFFECT" of certain psychotherapeutic drugs  is, indeed, the "SUPPRESSION OF THE COUGH REFLEX".  Although the Medical Examiner's observations relative to the correlation between psychotropic drugs and aspiration deaths is now universally recognized by pathologists and mental health professionals, including the New York State OMRDD, the Commission persists in its politically expedient, yet professionally discredited position by the recent re-publication of their findings on the internet.

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