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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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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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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