Simple check:

• Were you informed that benzodiazepines are highly addictive and that they should in general not be prescribed for any more than 2~4 weeks?

• Were you informed about the nature of withdrawal symptoms and how these can develop during the treatment, even whilst still taking the prescribed drugs, due to the forming of tolerance?

• Were you told that it is very dangerous to stop taking the drugs suddenly and the reasons why?

• Were you given alternative treatment options based on a risk analysis?

• Were you given the opportunity that, despite all the risks, the benefits outweighed those risks and any possibility of relying on safer non-drug methods such as lifestyle changes, practical coping techniques etc?

Detailed descriptions of informed consent

中毒治療科第４報告書4.4項目では、ジャドスン医師（中毒性薬物専門医）は、処方、インフォームド・コンセント及びモニタリングに関する考察事項のリストを提供しています。これらの殆どはニュージーランドの法律を踏まえた例と世界保健機構による勧告に基づいているものですが、ご自分の場合、適切なインフォームド・コンセントまた適切な経過観察があったかどうかご参考になるかもしれません。

Simple check:

• Has your prescribing doctor been asking you questions to check for the potential forming of tolerance at each of your consultations?

• Has your prescribing doctor been asking you questions to check for the potential forming of withdrawal reactions / symptoms at each of your consultations?

• Has your prescribing doctor been asking you questions to check for the potential forming of adverse effects at each of your consultations?

• Has he been keeping record of monitoring for the forming of potential dependency and adverse effects in the patient file?

• If you have reported problems, has your prescribing doctor responded in an appropriate manner? (See below)

Detailed descriptions of monitoring

中毒治療科第４報告書4.4項目では、ジャドスン医師（中毒性薬物専門医）は、処方、インフォームド・コンセント及びモニタリングに関する考察事項のリストを提供しています。これらの殆どはニュージーランドの法律を踏まえた例と世界保健機構による勧告に基づいているものですが、ご自分の場合、適切なインフォームド・コンセントまた適切な経過観察があったかどうかご参考になるかもしれません。

Did your prescribing doctor provide you with proper informed consent? (See above)

If the answer is “no”, then it reasonable to have your doubts.

Has your prescribing doctor been carrying out proper monitoring for potential forming of dependency and other adverse effects? (See above)

If the answer is “no”, then it reasonable to have your doubts.

Does your prescribing doctor have knowledge of what signs to look out for? (See Could You or Someone You Know be Dependent?)

If the answer is “no”, then it reasonable to have your doubts.

Has your prescribing doctor showed an understanding of the risks regarding adverse effects when prescribing for more than the recommended 2~4 weeks? (See adverse effects)

If the answer is “no”, then it reasonable to have your doubts.

Has your prescribing doctor showed an understanding of the risks regarding socioeconomic costs when prescribing for more than the recommended 2~4 weeks? (See socioeconomic costs)

If the answer is “no”, then it reasonable to have your doubts.

Consider this

• I had the opportunity to quiz a group of doctors about benzodiazepines at a reputable hospital. They were unable to answer about 90% of my questions, and yet some of them were prescribing them. They also said that information on benzodiazepines did not form any part of their curriculum at med school (needless to say, the government is responsible for this).

• I had the opportunity to talk to a pharmacist during my court case. When I raised the issue about benzodiazepines, he said “Oh, benzodiazepines are not addictive” and yet they are one of the most addictive substances there are (See How Addictive are Benzodiazepines?).

Further Reference

In Section of Addiction Report Four, Dr. Judson (Specialist in Addictive Medicine) discussed prescribing issues in my own case which may act as a further point of reference.

The short answer is no. Needless to say, drug companies have their own agenda which is to sell drugs.

例えば、私に処方された薬剤の添付文書には下記の注意しかなかったのです。

• アルコール類は、薬の作用を強めることがありますので避けてください。
• 眠くなったり注意力が散漫になりがちですので、車の運転や危険な機械操作等には十分に気をつけてください。
• 他の医療機関で診療を受ける場合は、このお薬を飲んでいることを医師または薬剤師に必ず伝えてください。

Where it failed:

• There was no actual drug names, only the brand names
• There was absolutely no mention of the fact these drugs are only recommended in general for 2-4 weeks as dependency can rapidly form.
• There was no mention that benzodiazepines don’t mix well with other drugs and only one should be taken at a time.
• There was no mention of the many tens, if not hundreds, of adverse effects and withdrawal symptoms associated with long term use (more than 2~4 weeks).
• There was no warning at all stating that it is dangerous to stop taking these drugs suddenly or the reasons why.
• There was no advice given on how to withdraw from these drugs.
• There were no recommendations stating what signs to look out for and what to do when problems occur.
• The information was misleading with statements like: 「このお薬は、気分を安定させる薬です」、「このお薬は、心と体の調子を良くする薬です」、「このお薬は、いらいら、動悸、頭痛などの症状を改善します」。

(NB: I had no history of psychological complaints or palpitations but I got both these for the first time AFTER being wrongfully prescribed these drugs. Also, other people have complained of headaches AFTER being prescribed these drugs. By the time I had finished the course of so-called treatment, I was a total mental and physical wreck).

この添付文書の問題は私の裁判でも誤審を招くことになりました。

The courts willingness to base their decision on documentation from the pharmaceutical company was alarming when it is only common sense that their main priority is to protect and sell their product.

2012年3月13日付き、ジャパンタイムズの記事を引用します。

「裁判でもう一つの争点となったのは、ダグラスさんが処方されていたベンゾジアゼピンの一日分の用量が依存に陥るほどの高用量であったかどうかということである。最も驚いたことは、高裁が、中毒を引き起こすとみなされるベンゾジアゼピンの用量を決める際、製薬会社が作成した添付文書に信用を置いたことであった。」

「裁きは公正ですか？」もご参照ください。

Later it became apparent that the package insert referred to by the judge in the verdict was not the same as the description / explanation that was inserted into my medication package.

This begs the question “How can something be called a ‘package insert’ if it’s not actually inserted into the package?” Isn’t it meant to be information for the customer? Nevertheless, it later became apparent that the information contained in the so-called package insert was inadequate anyway as it too failed to address the above.

製薬会社に対して、彼らの製造する薬について公正な評価を期待することは、ビール会社にアルコール依存に関する教えを期待するのと同じようなものである。マーシャ・エンジェル医師、医学専門誌“The New England Journal of Medicine”元編集長