Statement 4

November 8, 2010

Address: Fuyu, Taimusupesu, 268-20 Mukaihara, Nihonmatsu City, Fukushima, 964-0916

Signiture:                                (Seal)

Introduction

I, Wayne Michael Douglas, wish to submit this additional statement (4) because I feel concerned that, despite Dr. Judson’s warnings about diagnostic guidelines for benzodiazepine dependence, the case appears as if it is being more and more narrowed down to the dispute over the symptoms analysis alone (Dependence vs. Autonomic Nervous Disorder / Anxiety Disorder).

Subsequently, in this statement I wish to highlight the following facts which are based on medical expert opinions from both Dr. Judson in his reports and information supplied by Professor Ashton.

A. Summary of Diagnostic Considerations by Dr. Judson -

Dependence vs. Anxiety Disorder (Autonomic Nervous Disorder)

(TN: “Autonomic Nervous Disorder” is a diagnostic term commonly used in Japan to describe: (A) Psychosomatic symptoms caused by a variety of stress / anxiety conditions, or (B) Any other condition where the Autonomic Nervous System acts in a way that produces symptoms, especially in cases where they are not sure of the cause).

NB: According to addictive medicine specialist Dr. Judson’s expert medical opinion, the following facts must be considered when determining a diagnosis for benzodiazepine dependence:

(1)

The outcome of the debate regarding whether or not an “Anxiety Disorder (Autonomic Nervous Disorder)” existed does not alter the fact that benzodiazepine dependency existed (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3.22).

(2)

Anxiety disorders and benzodiazepine dependence can and do coexist in some cases, and to say that a patient was not dependent because they had an anxiety condition is unfounded (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3.23~24).

NB: Could it be then considered fair for the court to rule out our case for dependency if you judge that I had an anxiety disorder (Autonomic Nervous Disorder) - even though that was not the case?

Despite the fact that I clearly met 5 DSM-IV-TR criteria, if the court still feels the issue over whether or not I had an anxiety disorder (Autonomic Nervous Disorder) is so important within context of the overall clinical picture, they are welcome to take up my offer outlined in my third statement to undergo clinical testing at any hospital they may wish to appoint in order to dismiss any lingering doubts they may have.

As mentioned in my third statement, if I had a predisposition to an “Anxiety Disorder (Autonomic Nervous Disorder)” due to a culturally different environment and general life stresses, as suggested by Dr. M and as being claimed by the defense, one would expect my condition to be much worse now due to the fact that my claim for compensation and more recent progression to the High Court of Appeal places me under significantly more stress now than what I had back in 2000~2001, or ever before.

(3)

There is no question that symptoms of anxiety and depression existed in 2000 ~ 2001. The only question is: to what degree were these symptoms (anxiety / depression) patient related and to what degree were they caused by benzodiazepine dependency. (Evidence article Koh A39 – Dr. Judson’s Report 4, article 3.2.7).

(4)

Dependency can produce the very symptoms the drugs were designed to treat, i.e. anxiety symptoms (Autonomic Nervous Disorder), as noted by Professor Ashton based on clinical studies (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3.15).

(5)

Although there are ways of differentiating between symptoms of dependence and those of anxiety (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3), a dependence diagnosis cannot be made on a symptoms analysis alone, rather, symptoms should be considered within context of the overall clinical picture (including the application of the DSM-IV-TR). (Evidence article Koh A35 – Dr. Judson’s Report 3, article 1.2.4).

NB: Could it then be considered fair for the court to make a decision based on the symptoms issue alone without considering the overall clinical picture and the application of the DSM-IV-TR? (TN: 3 of the criteria I met are not related to symptoms)

(6)

When the symptom patterns are put into context of the overall clinical picture including prescription history, the inability to work following the treatment and then the ability to return to work following drug rehabilitation etc. and the application of the DSM-IV-TR, including the unsuccessful attempts at reduction etc, it becomes clear that the worsening of symptoms and development of new symptoms during the course of treatment were most likely caused by dependence (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3.21).

(7)

I was in a state of clinical dependence in accordance with the DSM-IV-TR (5 from 7 criteria were met, for which only 3 are required in order to determine clinical dependence). (Evidence article Koh A35 – Dr. Judson’s Report 3, section 2), (Evidence article Koh A39 – Dr. Judson’s Report 4, section 2). Further, the overall clinical picture supports the dependence diagnosis (See Dr. Judson’s Report 1, pages 11~12).

B. Summary of DSM-IV-TR Criteria

Based on Evidence and Dr. Judson's Reports

(8)

Based on the evidence and Dr. Judson’s findings, I was in a state of clinical dependence in accordance with the DSM-IV-TR.

(9)

According to Dr. Judson, each of the DSM-IV-TR criteria needs to be looked at in a way that considers their relationship to one another (not individually) within context of the overall clinical picture (Evidence article Koh A35 – Dr. Judson’s Report 3, article 1.2.2).

(10)

Below is a summary of the 5 DSM-IV-TR criteria that I met based on the evidence and Dr. Judson’s reports.

(I) Tolerance

• Tolerance is supported by the fact that a state of withdrawal existed, because if a patient does not have tolerance, then there is no neuro-adaptation, and thus no withdrawals will occur (Evidence Koh A35 – Dr. Judson’s Report 3, article 2.1).

• “Tolerance and dependence can develop if benzodiazepines are used regularly for longer than 2-4 weeks.  There is no minimum dose, for example tolerance and dependence have been observed after the regular use of 2.5-5mg of diazepam.” (Evidence article Koh A35 – Dr. Judson’s Report 3, article 2.1 – Information supplied by Professor Ashton – world leading expert).

• Showed symptom patterns consistent with tolerance (Evidence article Koh A35 – Dr. Judson’s Report 3, article 2.1), (Evidence article Otsu A1 – Dr. X’s Patient File), (Evidence article Koh A39 – Dr. Judson’s Report 4, article 2.3.1), (Evidence article Koh A36-1 – Mental Health & Addiction Services Patient File, Pg. 9),  (Evidence article Koh A12-1 – My handwritten note to Dr. X).

(II) Withdrawal

• Developed withdrawal symptoms (including totally new symptoms) during treatment (My handwritten note filed with Evidence article Koh A6 – O Medical Centre Patient File).

• Was suffering from withdrawal following reduction attempt after returning to New Zealand (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File, Pg 3).

• Developed withdrawal symptoms (including totally new symptoms) during formal reduction program (Evidence article Koh A36-1 – Mental Health & Addiction Services Patient File), (Evidence article Koh A35 – Dr. Judson’s Report 3, articles 2.2.9~22).

(III) Loss of Control

• A series of unsuccessful attempts at reduction were made (Evidence article Koh A6 – O Medical Centre Patient File, Pgs 10~11), (Evidence article Koh A39 – Dr. Judson’s Report 4, article 1.5).

• Dr. Whitwell was having difficulty controlling my reduction in the same way as Dr. M above (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File, Pg 3), (Evidence article Koh A39 – Dr. Judson’s Report 4, article 2.3.6).

(IV) Impact on Life

• I was so unwell following the drug treatment that I could not work until the end of my contract with the Saitama International Association (March 31) and ended up having to leave my job one week early (March 25). (Evidence article Koh? – Employment Contract), (Evidence article Koh? – Return air-ticket).

• Ended up in a state where I was unable to work for more than a year following the drug treatment (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File), (Evidence article Koh? – Work & Income New Zealand – Sickness Benefit Certificate)

• Other facts based on evidence outlined in Dr. Judson’s third report (article 2.4).

(TN: The reason why there are no evidence article numbers above is because I did not have the evidence reference sheets with me at the time of writing)

(V) Continued Use Despite Knowledge of Harm

• I returned to the STRC Hospital Neurology Department seeking a re-referral to another hospital in the quest for alternative treatment. The timeframe of this re-referral request (Dec 13, 2000) coincided with my first attempt at reduction (late November) and my handwritten note of new symptoms (Dec 18, 2000) which all occurred within about 3 weeks of one another. (Evidence article Koh A24-2 – STRC Hospital Neurology Department Patient File, Pg 9), (Evidence article Koh A39 – Dr. Judson’s Report 4, article 1.5), (My handwritten note filed with Evidence article Koh A6 – O　Medical Centre Patient File).

• I had a desire to reduce but continued to use (Evidence article Koh A6 – O Medical Centre Patient File, Pgs 10~11).

• A reduction plan was negotiated with Dr. M to reduce (because I felt the drugs were causing me harm) but I was unable to do so, and had to continue taking them 3 times a day (Evidence article Koh A6 – O Medical Centre Patient File, Pgs 10~11).

C. Summary of Overall Clinical Picture

Based on Evidence and Dr. Judson's Reports

NB: According to addictive medicine specialist Dr. Judson’s expert medical opinion, the overall clinical picture supports the dependence diagnosis as follows:

(I)

It is recommended that benzodiazepines should not be prescribed for any longer than 2 ~ 4 weeks as dependence can be rapidly formed. (Evidence article Koh A29-1 – Benzodiazepines: How They Work and How to Withdraw. Prof. C. H. Ashton – Chapter 2, Pg 3), (Evidence article Koh A39 – Dr. Judson’s Report 4, article 4.1.8).

(II)

I had been prescribed benzodiazepines for more than 40 weeks by the time I presented to Dr. Judson at Mental Health & Addiction Services (Evidence article Otsu A1 – Dr. X’s Patient File), (Evidence article Koh A6 – O Medical Centre Patient File).

(III)

It can be determined that there was at least a 50~100% chance of dependency simply based on the prescription duration and dosages alone (Evidence article Koh A35 – Dr. Judson’s Report 3, article 1.3.2), (Evidence article Koh B6 – Literature submitted by my legal representative, Mr. A).

(IV)

I had no prior history of neurological or psychological complaints (Evidence article Koh A42-1 – Dr. ter Haar’s Patient File), (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File).

(V)

I was still able to work in Japan, albeit on light duties, before the treatment began but struggled to carry out my normal duties during the contract. I eventually ended up not being able to work to the end of the contract maturity date of March 30, and subsequently, I ended up having to cut my contract short by just one week and return to my home country on March 25. (Evidence article Koh? – Saitama International Association Employment Contract), (Evidence article Koh? – Return Air-ticket to New Zealand).

(VI)

I then ended up in a state where I was unable to work at all again for over one year (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File, Pg 3), (Evidence article Koh? – Work & Income New Zealand – Sickness Benefit Certificate). (TN: The reason why there are no evidence article numbers above is because I did not have the evidence reference sheets with me at the time of writing)

(VII)

My condition started to improve for the first time after stopping benzodiazepines (Evidence article Koh A41-1 – Dr. Whitwell’s Patient File, Pgs 11~12), (Evidence article Koh A36-1 – Mental Health & Addiction Services Patient File, Pgs 19~20), (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.1).

(VIII)

I have been able to make a return to living and working in Japan, and despite being under considerable more stress on this occasion with my ongoing case for compensation, I continue to maintain a much better state of health.

(IX)

Other facts based on evidence outlined in Dr. Judson’s Report 1, article 2.2.

D. Definition of Autonomic Nervous Disorder

(I)

Dr. M (the person who gave the Autonomic Nervous Disorder diagnosis) describes “Autonomic Nervous Disorder (Anxiety Disorder)” as a condition where psychosomatic symptoms are brought about by day to day stress.

(II)

Dr. M (the person who gave the Autonomic Nervous Disorder diagnosis) said that I had “Autonomic Nervous Disorder (Anxiety Disorder)” caused by “culturally different environment and general life stresses” (See Patient Referral Form to T Physiotherapy Clinic).

(III)

Dr. Judson acknowledges Dr. M’s definition of “Autonomic Nervous Disorder” as a term used for psychosomatic symptoms brought about by day to day stress (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3.1).

(IV)

Dr. Judson considered this definition when he made his differential diagnosis (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.3).

NB 1: Could it then be considered fair for the court to rule out our case for dependency, if you judge that Dr. Judson’s definition of “Autonomic Nervous Disorder (Anxiety Disorder)” was different from that of Dr. M’s?

NB 2: Dr. X did not diagnose me as having “Autonomic Nervous Disorder (Anxiety Disorder)” during the time of his consultations. This diagnosis was only made by Dr. M after I had become benzodiazepine dependent under Dr. X.

Dr. M mistook my dependency for an anxiety disorder because benzodiazepines can produce the very symptoms the drugs are designed to treat which ended up leading to a misdiagnosis.

Contrary to his accounts during consultation, Dr. X only began claiming that I had an anxiety disorder after court proceedings began as a means to avoid accountability and to protect his own pride.

E. Reason for Request to Submit Report 5 from Dr. Judson

(I)

Reason One: According to addictive medicine specialist Dr. Judson’s expert medical opinion, when making a diagnosis for dependence all of the facts must be considered within context of the overall clinical picture including the application of the DSM-IV-TR.

However, key witness Dr. Judson has not yet had the opportunity to view any English translations of the SWRC Hospital patient files or to extend his professional opinion on their content.

Subsequently, Report 5 (based on the SWRC Hospital patient files) is needed to complete the evidence, so that my previous dependency can be proved beyond doubt.

(II)

Reason Two: The Tokyo District Court dismissed the “Long Term Suffering” part of our claim for the reason that no such diagnosis had been submitted (See Verdict - Pg 58). According to Dr. Judson, it is necessary to submit Report 5 together with a diagnosis.

As Dr. Judson has already explained, the “Long Term Suffering” aspect needs to be analyzed taking into consideration (1) Protracted withdrawal, (2) The trauma of the dependence experience, (3) The additional pressures of the subsequent case for compensation (Evidence article Koh A35 – Dr. Judson’s Report 3, article 3.1.2). At this present stage, we have not yet been given the opportunity to submit documentation regarding issues (1) ~ (3) above.

(III)

Subsequently, it would be appreciated if we could be given the opportunity to submit Report 5 based on the patient files, just as Report 3 was based on the patient files, and just as Report 4 was based on the patient files, so that the entire picture in this case (proving benzodiazepine dependency) can be clarified beyond any reasonable doubt.

With help from Dr. Judson and my lawyer, Mr. A, I have sacrificed the last 8 years (best years) of my life and spent a great deal of money in order to try and bring the dangers of benzodiazepines, and dependency in my case, to the attention of the court, so that others may better avoid becoming dependent and suffering as I did.

As a victim, I have given this much effort and sacrifice to the cause, so I would be grateful if the court would allow us just another 2½ months (during end of year holidays), so that we can submit Report 5 to complete the entire picture in this case and to make it clear beyond any reasonable doubt.

NB: Could it then be considered fair for the court to dismiss our case for any reason pertaining to the SWRC Hospital patient files, if in the case you do not provide Dr. Judson with the opportunity to consider their content by way of viewing the English translations and by way of responding to them through the submission of Report 5?

In Closing

(11)

It is understandable that at the beginning of proceedings this case was viewed from a wider perspective, and then as the case preceded, it was divided up into smaller more specific issues which have since been covered in detail. Also, I understand that in most cases, the courts usually endeavour to round the incident down to a single determining factor.

(12)

However, according to Dr. Judson’s expert medical opinion, determining a diagnosis for benzodiazepine dependency is completely different, as there is no single determining factor (I feel this is possibly where Dr. Judson’s specialist medical views and the court’s legal views are clashing).

According to Dr. Judson, after all of the finer details of specific issues have been analyzed individually, it is then important to join all of these specific issues back together again, so that the case can be viewed taking the overall clinical picture into consideration including the application of the DSM-IV-TR.

Further, each of the DSM-IV-TR criteria needs to be looked at in a way that considers their relationship to one another (not individually) within context of the overall clinical picture which requires some judgment from an expert in addictive medicine such as Dr. Judson.

“When making a diagnosis of substance dependence there is no specific test that gives us a clear defined result. Rather sensible use of diagnostic criteria requires some interpolation and judgment, taking into consideration the overall problem, as highlighted by Wesson, DR, Smith, DE. & Ling, W. in their discussion on benzodiazepine and other sedative hypnotic addiction in (Principles of addiction medicine third edition)”. For this reason we have guidelines which assist us in determining a dependence diagnosis. (Evidence article Koh A23 – Dr. Judson’s Report 1, article 2.1.1)

The court needs to realize this if a fair decision is to be reached.

(13)

The DSM-IV-TR is the internationally recognized standard used for diagnosing clinical dependence. I clearly met 5 out of the 7 criteria, for which only 3 are needed to determine a diagnosis for clinical dependency.

(14)

Finally, I would like to take this opportunity to pose the following question: “Why do you honestly think I ended up in a drug rehabilitation centre following 9 months of highly addictive benzodiazepine prescriptions?”