今を生きる

2009年の春ごろにある先輩が進行癌であることの知らせを聞いて書いた記事。

海外から一時帰国の日が決まって、その先輩に連絡して見舞いに行こうと思ったときに亡くなられたとの連絡を受けた。生きるということは、必ず死ぬという終わりがあるからこそ美しい。限られた生きる時間を、後悔なく過ごしていく重要性を常に感じながら、今の瞬間を大事にしていきたい。

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先日、人づてにある先輩が胃癌の腹膜播種で治療中と連絡があった。あまりに身近な先輩で、なんとも言えない悲しい知らせである。今まで多くの癌の患者さんに接していても、同業の医師で身近な先輩となると感情が移入してしまう。その先輩が何か悪いことをした訳でもない、なんという皮肉な運命のイタズラなんだろう。
同期・後輩に伝えると皆言葉が出ない。皆医師として病状を客観的に評価することに慣れていても、あまりの身近な人のことで、あまりに厳しい病状で口に出せない。何も言わなくても胃癌の腹膜播種だと聞けば医師であれば予後が解る。

私自身、海外赴任中で見舞いにも行けず。連絡先を聞いたものの、電話するにも何て声を掛ければ良いのだろうと悩んだ。お互いに予後が分かっているのに、白々しく治療頑張って下さいなんて言えないし、かといって残りの人生楽しみましょうとも言えない。そうやって思い悩みながら、生きている間に話がしたいと思い自己満足のために電話を掛けた。

学生時代からサバサバといつも落ち着いた先輩である。電話越しでもいつもと変わらない調子だった。まるで他人事かのようにご自身の状態を話してくれる。暇にしてるのでまた気軽に連絡をしてねとまで言ってくれた。今までは医師としてろくに家族の時間も取れなかったが、今は家族とゆっくり過ごせると皮肉な話である。また、私は電話させて下さいと話して電話を切った。

感情的にはこの夏を無事過ごして欲しいと切に願うが、医学の常識を考えるとその可能性は決して高くはないという冷酷な現実である。そんな運命を落ち着いて受け入れている先輩を思えば、自分の日々のストレス・挑戦なんてささいな問題である。何気ない生活を送っていると、3ヵ月先もいつもと変わらず生きているものだと思いがちだ。自分の人生は限られている、それが3ヵ月なのか、6ヵ月なのか、10年なのか、もっと長いのかなんて誰にも分からない。そんな当然のことを改めて思い出し、「今を生きる」大切さを思い出させてもらった。

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夢のデータベースの資金源

前述の夢のデータベースを支える資金源ですが,診察券を兼ね備えたクレジットカードを発行し,病院での決済業務により賄います.

クレジットカード決済により医療費自己負担の数%の手数料を頂きます.ただ単なる既存のクレジットカード決済では利用増加はあまり見込めません.普通のクレジットカードは海外旅行損害保険が付帯されますが,それを医療過誤無過失保障保険を付帯することで医療機関へ普及を促します.額は小額ながら,医療過誤に対して無過失保障を行います.そうすることで,不要な医療訴訟の削減を狙ってます(無過失保障の制度は何度も議論が出ているようですが財源問題で頓挫してます.全国的な産科医療崩壊の激しさから産科のみやっと保障制度がスタートする予定です)

クレジットカード会社さんの方で,保険種別・有効期間を管理し病院側の請求業務の軽減を図ります.医療費の踏み倒しが問題になるなかで,信用調査・債務回収のプロのクレジットカード会社さんの必要性も増していると思います.又,クレジットカードから後から医療費を引き落とすという取り決めにして,患者さんは診察後に薬の受け取りのみで帰宅できるようにします.患者さんにとっては受診時間の短縮,医療機関ではクレジットカード決済の患者さんのレセプトは後からゆっくり処理できるので,請求漏れ・昼間の外来業務の効率化を図れると思われます.

受診患者の受診日・地域・年齢データ統計などを医療機関に提供し,医療機関の経営戦略を立てる参考(利用者サービスの向上)にしてもらいます.

会員データを使って,製薬企業さんに治験患者の收集サービスを提供することも資金源とします.上記のwebデータベースのアクセスにも会員費を徴収することでも資金源とします.

要は,既存のクレジットカード決済に無過失医療保険を付帯したものが基本の特殊な診察券です.

提携している医療機関の検査データは引き継げるような,全国共通の診察券といった便利さを目指します.

補助的にクレジットカードによく会員特典サービスが付いていますが,それを検便・血糖値などの簡易な検査を無料もしくは格安で提供し,データベース構築の一助にもできます.又,これから財政破綻して行く地方自治体の既存の健診を代替えしていくことを目指します.

上記のシステムをいかに最小資金で構築するかについては,次回以降の記事の予定です.

僕自身は,僕の構想に共鳴していただいて実行して頂ける方を探しています.この構想を独り占めして儲けようとは毛頭思いませんし,的確な経営手腕を持った人がやっていくべきと思っています.人脈・資力・遂行力を持った方・会社で,僕の話を聞いていただける方がいれば,僕の知っている知識を全てお話したいと思っています.それぞれの得られるメリットは,取り組んでもらえる会社・人には莫大な(?)金銭的利益です.僕には,子供たちを守るための社会を残し,僕の仕事場である医療がよりやりがいのあるものとなります.これで互いのwin-winが実現できます.興味のある事業者の方は御連絡ください.又,共鳴してもらえる友達・知り合いがいればこんな馬鹿な夢を語っている奴がいると僕のブログを紹介してください.いつかこれを実行してもらえる事業者につながるはずです.

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古風な上司

先週は日本の上司が訪問してきていた。
いつもながらに、昔ながらのウェットな日本式対応を求められた。

1. 引っ越しに伴う物品管理
つい先日、オフィスの引越があった。出張時に使う上司の部屋に、私物(書類・電源コードetc)があったそうだが、今回の引越した先の上司の部屋にその私物が見当たらない。→気を利かせて管理しておくべきだったと注意あり。→それなら指示を出しておいてくれーー :-)

2. 会議の設定
ホテルに迎えに行き、何気なく「○×の件で15:00ぐらいに会議をする予定だ。」と言われた。その後に、「私に会議出席者を集めさせることをせず、気を利かせて出席者を集めておくもんだ」と注意あり。→自分が出席するのかどうかも聞いてないし、会議を設定する指示ももらってないぞーー :-)  (しかも会議の予定はしょっちゅう変更になる)

日本人部下にはかなりウェットな日本式対応を求められるのだが、欧米人にはいつもニコニコとfriendlyに対応する。完全に欧米人は「外」の人間、日本人は「内」という考えである。
古風な日本的managementスタイルで、ガイジンをうまくまとめられない。

いろいろ話していると非常に優秀な人には違いない、ただ、何でも自分で理解しているつもりになっていて自分の解釈が正しいと思い込んでいる。私がわかる範囲では、臨床試験データの解釈・統計解析法については、話しているとほとんど素人というか、中途半端な知識を持っているために、素人以上に悪影響である。私には非現実的にしか思えないデータ解釈を元に事業計画が組まれて、どうなることやら。。。私なりのコメントをしているのだが、結局は怒り出してしまうので話にならない。。。

ついつい愚痴が出てしまうが、この上司から学ぶことも多いので、ウェットな日本式待遇を学んでいくしかない。。。

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New Job

Dear My Friends,

I am sorry for my late update about my next challenge.
From this May, I am working as a kind of a public servant at Kasumigaseki.
You can check the title and the organization at the Linkedin. Please search my profile by my name.

warm regards,
Dreamer K

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Time has passed very quickly

It had been 3 years since I visited my hometown in Japan last time. And I hadn't seen Japanese TV programs for over 10 years. Now I feel like a 'Urashima-Taro', who is the main character in a very famous Japanese old folk tale and came back to his hometown after very long absence.
I realized that both of my parents are over 60 year old now, though I still feel they are in middle ages and I am their young son. While I am watching TV, I saw many unknown celebrities and some familiar ones. The familiar celebrities looks very old, comparing with my old memories.
Even though I feel still young, the time has surely passed. I recognize again that every moments are unique and just once in the continuum of my whole life.
Focusing on what I want to do and what I need to do, I will never waste my life. There is no eternity, life is limited. Let's appreciate every moments of now.

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Going back to Japan!!

Recently, my life is hectic. And this is the excuse why I didn't post any article on this blog. :-)
Why am I so busy now? The reason is that my current employer is nearly in bankruptcy!!! Ooh, scary!! :-)
Currently, my salary hasn't been paid since this February. And I can now realize the feeling of unemployed people. :-)
But this situation is what I could anticipated before I took this job. And I shouldn't complain about this and should focus on finding another position in this industry.

Accordingly, I am going back to Japan in this March. I hope I can meet with my friends in Japan. If you are willing to chat with me in person in Japan, please feel free to contact me!

Anyway, the life is thrilling! See you in Japan!!

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Different surname between husband and wife

In Japan, there has been a discussion on whether different surname between husband and wife should be allowed or not.
The main opposition to this different surname appears to attribute to a fear that it will challenge social order, because they think the core idea of family will be damaged.
The Japanese society still has paternalism in which father is the chief of the family.
I understand the concern of the opposing people, but I think what Japanese society need now is the capability to accommodate diversified people. The country will not survive in long term with such a inflexible society. In other words, monolithic idea just expels many diversified people including talented ones. It is about time for the society to be tolerable to diversified ideas.
We should be aware of a very simple scientific principle; most diversified species has the most highest likelihood to survive in long term. Monolithic species is fated to become extinct someday in the future. The circumstances cannot be unchanged in long term, monolithic species cannot catch up the change.

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Let's walk alone

As long as we follow the crowd, we will not reach further than the crowd. If we want to see something which nobody has ever reached, we need to walk alone. Don't be afraid that we are not in the crowd. Try to be a exceptional person and pioneer a new path to find something which nobody has ever faced. Conquering our own anxiety of the uncertainty, we need to move on.
Stay hungry, stay foolish.

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Look at myself objectively

As long as a person is a human, the person must have anything flawed somewhere.
If there is somebody perfect in this world, it should be the god. In this context, we don't need to be scared of not being perfect. We must admit there is something flawed in ourselves and look at the fact objectively. Once we could be aware of what disadvantage we have, we should sincerely admit the fact and think about what we should do to cover the disadvantage. In this way, we can minimize our inherent disadvantage and maximize our limited internal resource in ourselves.

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Off-label use

In connection with drug lag problem (there is substantial delay in marketing approval of new drugs in Japan, comparing with FDA, EMEA), off-label use of already approved drugs has been raised as a problem in Japan. In order to solve this problem, it has been thought that concerned MAHs (marketing authorization holders) need to apply for label extension to PMDA (Japanese authority), after appropriate clinical trials could be conducted. But I think this is ineffective solution and practically impossible.
The said solution has originated from an unspoken assumption; all reimbursement of drug costs should be made based solely on what was written in package insert (approved indication). But it has been legally allowed to deviate from the written indication by a ministry ordinance called 'Showa 55 notification'. So even though it is legally allowed to deviate from the written indication, why can the off-label use problem exist in Japan? Firstly because many HCPs (healthcare providers) aren't aware of the 'Showa 55 notice'. Secondly because there is some uncertainty whether the drug cost can be surely reimbursed by the payer. In Japanese system, the eligibility of reimbursement is decided by a reviewer of health insurer, and their decision can differ by each prefecture. Eventually, the description in the package insert has been regarded as solely justification in the reimbursement. And the revision of the labeling (package insert) has been thought as the solution.
Separately, even though the labeling could be revised, its revision cannot catch up with medical advance. The actual dosage and usage of drugs may change in real medical practice, having a new knowledge in medical community. In very advanced field, this tendency of evolving change is significant.
Given above, my practical solution for this off-label use is to make the health insurer have their own formulary which should be the basis of reimbursement decision. The root problem is the 'package insert' has been considered as the sole document for indications.

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元気出して行こう

新年明けましておめでとうございます.
横着して今年は年賀状も新年挨拶メールも出せていません.
いろんな方の御蔭で後悔無く毎日を送らせてもらっています.
末永く今年も宜しくお願いいたします.

2009年1月

p.s. こんなビデオを見かけました.何か壁にぶち当たった時に元気がでるかと期待しています.Nothing is impossibleと思って,小さな努力を重ねて行きたいと思います.
自閉症の高校生の話です.

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Get out of my comfort zone

This article will be the last one of this year 2009.
Taking this opportunity, I would like to sincerely appreciate all people around me.
I have tried to get out of my comfort zone all the time. Accordingly, I have made my family to be a kind of gypsy, crossing several countries. Though my financially and physically unstable life seems to have made a lot of stress especially to my wife, my whole family have been healthy and adapted themselves to a new environments. This simple reality makes me appreciate the luck of this year too.
Let's  "get out of our comfort zone" next year 2010!!

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Challenge in new therapeutic area

This is my own memo to check before challenging myself to a new therapeutic area in Medical Affairs task.

1. It will need about 3 months for me to thoroughly capture the necessary medical knowledge in a new therapeutic area.

2. It will need about another 3 months for me to figure out the market of the new therapeutic area.
What is the positioning of the product? Is the positioning for local only or globally applicable? How is the market share?
What are competing products? What is the positioning of the competitors?

3. KOL activity
Are national or regional thought leaders already specified? How is the relationship with them? Very cooperative or hostile?
Is the relation with international thought leaders well established at global team?

4. Publication activity
How flexibly can the global team cooperate with local needs?

5. Funding for investigator studies
Can we make a direct contract with investigators to fund their clinical study?
Are there any regulatory restriction to fund their studies?

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Weird Discussion about H1N1 vaccine in Japan

In Japan, there is a weird belief about H1N1 vaccine. It is said that a vaccine of foreign manufacturer is dangerous.
This belief may originally have several assumptions; 1) a foreign vaccine would not be tested for Japanese population, 2) foreign vaccines will have some adjuvants which aren't introduced into Japan yet.
In either reasoning, it doesn't seem to be fully justifiable. Though the belief might have been established by authority in order to protect domestic manufacturers, Japanese people prefer to use a domestic product based on the brand belief in 'made in Japan'.
To my knowledge, I haven't ever heard that Japanese have different immunity to influenza vaccine (safety and efficacy). And there are many H1N1 vaccines internationally commercially available, which are tested for larger population than Japanese domestic vaccines. Even in US, the H1N1 vaccines are mainly produced by foreign manufacturers; Novartis (Switzerland), CSL (Australia), MedImmune (originally US, but now subsidiary of AstraZenecca [UK]), and Sanofi Pasteur (France).
It is difficult for me to figure out justifiable reason why Japanese need to stick to domestic vaccines.

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Consolidate medical institutions in Japan

In connection with JAL's financial crisis, the necessity of many airports has been questioned in Japan. Basically, there is at least one airport in a prefecture in Japan. Most of the usage of the airports are commercial flights by air carrier (mainly JAL and ANA). It has been financial burden for local governments to sustain the airports.
On the other hand, the sustainability of many public hospitals has been also questioned. Especially, the hospitals managed by local governments are greatly challenged from financial standpoint. But almost all community residents want to keep the hospitals as it is, in other words, they want to have fully-equipped medical facility at hand. Though relatively fortunate medical accessibility in Japan has contributed to raise the level of public health to the first class in the world, it has caused to scatter the medical resource and patients. Consequently, the medical level couldn't reach the state-of-art level, because of the lack of sufficient patient number at each hospital.
Considering these two different problem together, I would like to propose 1) renovate prefectural airport into a fully-equipped medical facility with vast heliports, 2) downgrade local hospitals into clinics with heliport.
This will be seemingly stupid idea. But the airports will already have convenient access of public transportation to the site and vast facility of aviation. In this way, severely-diseased patients would be promptly transferred to advanced medical facility by helicopters, minimally sacrificing medical access. Rather it might be able to guarantee the state-of-art medicine to the community residents. I hope the financial burden of local governments could be collectively within almost same level, except for the initial reorganization cost.

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It is easy to blame, but hard to accommodate.

When we face something or someone unpleasant beyond our understanding.
We tend to blame it or the person. But this blaming makes matters worse and just ends up with spoiling the relationship with the person. What we need to do is to accommodate the person. In other words, showing our compassion, we should try to understand the person.
After the listening and learning attitude, we may make the person realize something to do it better. But even at this stage, we should never try to change the person to do something specific. What we can do is just to make the person realize what we should have done and should do hereafter.
This process takes long time and a kind of hassle. In many cases, we tend to take a shortcut to say something unilaterally without appropriate interaction.
The perseverance will be an essential attribute to accommodate someone else outside ourselves.

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Medical Affairs in Japan

Following the previous entry, I would like to explain the Medical Affairs situation in Japan.
This area isn't matured yet in Japan, though many foreign-capital pharmaceutical company so called GAISHI has been trying to expand Medical Affairs function to reach out practicing physicians. The biggest hurdle would be restriction on funding for investigator initiated study (IIS) by pharmaceutical industry. When investigators try to conduct a clinical study, they cannot have any direct support from pharmaceutical company.
This restriction has been originally based on anti-trust law. Following this law, each industry has own autonomous council which is acknowledged by Fair Trade Commission (FTC). In pharmaceutical industry, it is supposed to be the Fair Trade Council of the Ethical Drug Manufacturing Industry (FTC-EDMI: http://www.iyakuhin-koutorikyo.org/). The FTC-EDMI has issued the 'Code of Fair Competition' which restricts specific funding for investigator initiated study. This code wasn't issued by regulatory authority itself, but by autonomous council acknowledged by FTC (authority). Thus, this code has been regarded as a kind of a law itself by the industry.
In this way, even though many GCP studies have been conducted by pharmaceutical companies, almost none of IIS has been done as GCP study in Japan because of lack of funding. The investigators cannot have placebo supply, study drug supply, or statistical support from the pharmaceutical industry. This seems to be a factor of poor productivity of Japanese clinical study.
To circumvent the restriction of direct funding to any specific study (stipulated by the said code), the pharmaceutical companies have provided many contribution under the name of scholastic promotion. But actually most of the contribution were made for specific studies. As you might realize, this contribution is legally gray. And generally, the amount of the contributions end up with relatively small price (less than $1 million at very best case), because public company cannot pay legally questionable money with big price in order to be accountable to share holders. Considering strict implementation of compliance in global company, the sustainability of this contribution has been challenged.
It should be about time to change the code in Japan. But existing interested parties (pharmaceutical companies, and medical institution) are not willing to change the situation, because there are some risk for them to lose already established interests.
Recently JAPhMed released a proposal to change the situation as a first step (http://japhmed.jp/whats_new/post_18.html). Though they seem to have had some negative pressure from the industry, I wish their effort produce the initial momentum for the big change.

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Medical Affairs

In pharmaceutical industry, there is a field called 'Medical Affairs'. And this has been well established in western countries. The objective of this role is to support marketing team from scientific standpoint. Along with the expansion of pharmaceutical industry, this area has really expanded and made great influence on medical community.
In medical community, EBM (Evidence Based Medicine) has been a buzz word. Under the name of EBM, many guidelines has been made and those influenced on actual practices of physicians. Once a guideline was made, many physicians follow the guideline. And physicians have been eager to conduct studies to establish evidences for their practicing policy (guideline).
On the other hand, pharmaceutical company want physicians to prescribe their medicine as much as possible. Between the needs of pharmaceutical company and practicing physicians, Medical Affairs teams are supposed to connect them together. Pharmaceutical companies support practicing physician to conduct their studies by supplying study drugs or financial aids. In their supports, their company names have not been noticeable, because all studies have been conducted by practicing physicians under the name of scientific purpose. In this way, many studies have been conducted under strong interest of pharmaceutical companies, and the conclusions of the studies have been utilized in guidelines which practicing physicians follow. The problem of this scheme is that many practicing physicians aren't aware of the presence of pharmaceutical company and they tend to accept the study result without caution.
I don't think Medical Affairs is unfavorable entity, because they have supported to establish guidelines and made great contributions in clinical research. They are well mediating between practicing physicians and pharmaceutical companies.
Without big support from pharmaceutical industries, many of clinical studies couldn't be conducted. But the supports should have been more revealed and transparent. Practicing physicians should become aware that what we call EBM has been affected by the interest of pharmaceutical industry.
The situation in Japan is more complicated, I will take another chance to write about it later.

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Japanese Nationality

If I try to figure out characteristic of Japanese nationality with simple word, it will be well expressed in 'perfectionism'. Owing to this unparalleled perfectionism, the current financial power has been established by manufacturing perfect product. Once something was invented somewhere in the world, its improved product (better quality) could be made in Japan. In this way, this perfectionism has contributed the current prosperity.
On the other hand, this perfectionism has affected Japan negatively too. Japanese people are used to perfect service, and tend to blame imperfection materially and humanly. And they tend to blame themselves from time to time. Forgetting to appreciate others and every existence, they tend to accuse somebody and something.
But as we know, as long as we are human, there is no perfection. The perfect existence is only god. What we need to do is to accept ourselves as imperfect existence.
Admitting our own incompleteness, we should accept the incompleteness of others. Our environments were made by human, but the human is incomplete. How can we expect the environments is complete? Let's cease complaining our environments and others.
We need to appreciate the existing people and environments around us, instead of looking for perfect substitute of them.

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The first step to knowing

When people get to know something new, what we need to know is what we don't know.
Once we can realize what we still don't know, let's think about what is practically needed to eliminate that ignorance.
As long as we believe that we are knowledgeable, there is no possibility for us to progress further. In other words, our self-development will remain at current level.

If we want to develop ourselves further, proactively look for the ignorance of ourselves, not others.
Don't be too confident to change ourselves, don't be too ignorant to know ourselves.
Once you think I know all, it is the end of your progress.

We need to break through our own limitation which we created by ourselves.

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