Medical Renaissance54. Japan is 20 years behind the United States - The Beni-Koji (red yeast rice) issue is a good opportunity to think about the state of Japanese society.

Masahiro Kami, M.D., Ph.D. President, Medical Governance Research Institute, Tokyo, Japan

Anything made by humans cannot eliminate the risk of contamination - The key is how much risk you are willing to accept.

The KOBAYASHI Pharmaceutical Beni-Koji (red yeast rice) issue has sparked discussions about the safety of health foods. There are strong calls for the government to strengthen regulations.

Many people who have used Beni-Koji have suffered ill health. Some people have passed away. I would like to express my sincere condolences. However, can we really expect effectiveness from such claims made under the guise of normative theory? I feel uncomfortable. That's because they don't seem to be learning from world history.

Health foods have a long history. Honey is said to be one of the oldest health foods in the world. It is a natural sweetener and has antibacterial and antioxidant properties, so it was used extensively as a health food.

However, honey also depends on how you use it. Excessive consumption can lead to obesity and diabetes, and can also cause dental caries. Giving honey to infants can also cause food poisoning called infant botulism. It is now recommended to avoid honey for babies under one year of age.

This Beni-Koji issue is essentially the same as the health hazards caused by honey. Anything made by humans cannot eliminate the risk of contamination to zero. It is a matter of how much risk you are willing to accept. Some have called for regulations to be applied to the same extent as pharmaceuticals, but considering the costs, this is not realistic.

If the government provides guarantees in a half-hearted way, there is a possibility that the people will suffer.

The difference between honey and Beni-Koji is whether it is guaranteed by the government or not. Government guarantees provide peace of mind to the public and support to businesses. If the government provides guarantees in a half-hearted way, there is a possibility that the people will suffer.

This has already become a social issue in the U.S. Dr. Mutsuko Ohnishi, who lives in Boston, says, "Japan is 20 years behind the U.S." What she finds noteworthy is that the functional food labeling system introduced in April 2015 is modeled after the Dietary Supplement Health and Education Act (DSHEA), which was enacted in the United States in 1994.

Under the DSHEA law, companies selling supplements can freely describe their safety and effectiveness simply by filing a notice with a government agency. As a result, Americans have no choice but to believe the claims made by manufacturers. Since then, health damage caused by supplements has rapidly increased.

This has become an important research topic, and numerous papers have been published. The most famous one was published in the New England Journal of Medicine (NEJM) in October 2015 by a research team from the Food and Drug Administration (FDA) and others, which found that in the U.S., there are 23,000 emergency visits due to the health effects of supplements annually, which required 2,150 hospitalizations.

The government is attempting to strengthen regulations on health foods, but it is likely to end up with the same results as in the U. S.

Various complications have been reported, but the most common are those caused by diet and sexual enhancement supplements, which have caused symptoms such as palpitations and arrhythmia. In some cases, these products contained ingredients that were originally prohibited.

New England Journal of Medicine (NEJM) is one of the world's most prestigious medical journals. This study was reported by various media outlets. Naturally, in the U.S., there was a lot of discussion about strengthening regulations, but this has not been realized due to lobbying by the rapidly growing supplement industry. For example, in 2022, a bipartisan group of senators submitted a supplement regulation bill to Congress, but ``the lawmakers who received donations from the supplement industry opposed it, so it was not passed.'' (Dr. Ohnishi)

The government is attempting to strengthen regulations on health foods, but it is likely to end up with the same result. In Japan, the regulation of functional food labeling is split between the Consumer Affairs Agency, which oversees the Food Labeling Law, and the Ministry of Health, Labor and Welfare, which manages the Food Sanitation Law.

The Consumer Affairs Agency is positive about strengthening regulations, but discussions on regulations under the Food Sanitation Law have not progressed. Most of the health food industry is made up of small and medium-sized enterprises. Large companies can handle it, but small and medium-sized enterprises struggle to gather safety date.

It is understandable that politicians representing these industries and influenced Ministry of Health, Labor and Welfare are reluctant revise the Food Sanitation Law.

In the U. S., the legal and medical communities guarantee “The Safety of Supplements.”

So, who is ensuring the safety of supplements in the U.S.? The answer is the legal and medical communities. The former is self-evident. Numerous lawsuits have been filed.

The medical community has also made a major contribution. Top academic journals in the U. S. are full of papers on the efficacy and safety of supplements. JAMA, published by the American Medical Association, lists 16 papers with the word "Dietary Supplements" in their titles. Of these, 13 were published after DSHEA was enacted. NEJM has also published 16 papers.

On the other hand, there are no voices from the Japan Medical Association or the medical community complaining about the damage caused by health foods. This difference is interesting.

Why does this difference occur? I think it originates from the history of Japan and the West. In the West, doctors are considered to be classical professionals along with lawyers, clergy, etc. Occupational norms were established before the establishment of modern states.

They use their skills for the benefit of their clients in exchange for compensation. They receive compensation from their clients. Because there is an information asymmetry between them and their patients, self-regulation is important. For this reason, unique professional norms exist. In the case of doctors, this is the Hippocratic Oath.

Why so many physicians in the U. S. write papers on supplements and publish them in prestigious journals like JAMA

Classical professionals must earn the trust of their customers to survive. It is in their own interest to provide accurate information about the health risks of supplements and to state that there is no conflict of interest with the industry. This is why so many physicians in the U. S. write papers on supplement issues and why prestigious journals such as JAMA publish them.

Why doesn't this happen in Japan? This has a lot to do with Japanese history. It was the Meiji government that created the model for Japanese medical community. The Meiji government, which was in a rush to modernize, established the Tokyo Imperial University to cultivate talented individuals who would be valuable to the nation, and thus to the government. The Faculty of Law and the Faculty of Medicine played a central role, as in the West universities, but the foundation of this education was not classical professionalism.

The chronic problem of the Japanese medical community is that traditional professionals are subservient to the state and become cogs in the machine of the organization. The conflict between organizations and classical professionals has been repeatedly debated in society, both in the East and the West, throughout the ages. A typical example is the death penalty and execution of Nazi military doctors who conducted human experiments at the Nuremberg Trials. Such debates have helped establish professional norms for physicians globally. In Japan, discussions on this topic are insufficient. The Beni-Koji issue is a good opportunity to think about the state of Japanese society.

Originally published in the July 2024 issue (Vol. 54) of Lifeline 21 Advanced Cancer Treatment in Japanese.