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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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