The Difference Between Japanese and American Physicians Felt Through the Kobayashi Pharmaceutical Issue: The Critical Background of the Medical Community's Silence on Health Food Damages

Masahiro Kami, M.D., Ph.D.

President, Medical Governance Research Institute, Tokyo, Japan

The Kobayashi Pharmaceutical red yeast rice issue has sparked discussions about the safety of health foods, highlighting that Japan is following a trend already established in the U.S. two decades ago. Part of Abenomics, the functional food labeling system initiated in April 2015, was modeled after the U.S.'s Dietary Supplement Health and Education Act (DSHEA) established in 1994. This act allows supplements to be sold without prior FDA approval, leaving consumers to rely solely on manufacturers' claims about their products' safety and efficacy. Since then, the U.S. has seen a surge in health-related incidents from supplements, a trend supported by various studies. One significant study reported by the FDA in October 2015 in the New England Journal of Medicine (NEJM) cited that there were 23,000 emergency visits and 2,150 hospitalizations annually related to supplements. As reports of health damages emerged, the debate over stricter regulations heated up in the U.S., but no substantial regulations have been implemented due to the supplement industry's rapid growth and lobbying efforts. The government is currently attempting to strengthen regulations on health foods, but it is likely to end in 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, Labour and Welfare, which manages the Food Sanitation Law. While the Consumer Affairs Agency is favorable towards stricter regulations, discussions on food sanitation laws have stalled. Most of the health food industry comprises small to medium-sized enterprises, which struggle to gather safety data. It is understandable that politicians representing these industries and the influenced Ministry of Health are reluctant to revise the Food Sanitation Law, a situation similar to that in the U.S.

In terms of oversight, in the U.S., it is the legal and medical fields that ensure the safety of supplements. According to Dr. Mutsumi Onishi, a physician residing in the U.S., law firm advertisements like “If you have suffered health issues from supplements, contact us,” are widespread. The number of supplement-related lawsuits stood at 65 in 2019 and 45 in 2020, with settlements rarely being disclosed, indicating these numbers are just the tip of the iceberg.

The medical community's contributions are also substantial. Top U.S. academic journals are filled with articles on the efficacy and safety of supplements. For example, the Journal of the American Medical Association (JAMA) has published 16 papers that include the term 'Dietary Supplements,' with 13 of those published after the enactment of DSHEA in 1994. Similarly, NEJM has also published 16 reports, underscoring a stark contrast in the attention given to supplement safety between the UK and the U.S. medical communities.

What draws my attention is the silence from the Japan Medical Association and the University of Tokyo on the issue of health food damage. This difference is noteworthy.

I believe this discrepancy stems from historical differences between Japan and Western countries. In the West, physicians are considered classical professionals, like lawyers and clergy, who offer their skills in exchange for compensation, received directly from their clients. Due to the asymmetry of information between patients and physicians, self-regulation is highly valued, and independent professional ethics, such as the Hippocratic Oath, are established.

Classical professionals, with a history dating back to Greek and Roman times, operate in a partnership model where senior members participate equitably in management and act independently. Marvin Bower of McKinsey & Company famously built this consultancy based on the professional standards of classical professionals.

For classical professionals to thrive, they must gain their clients' trust. For supplement health damages, providing scientifically accurate information and ensuring there are no conflicts of interest with the industry are aligned with their own interests. This explains why many U.S. physicians are writing papers and publishing them in prestigious journals like JAMA.

Why doesn’t this happen in Japan? The historical context of Japan plays a significant role. The Meiji government, eager to modernize, established Tokyo Imperial University to cultivate talented individuals who would serve the state. Just like in the West, the law and medical faculties were central, but classical professionalism was not the foundation of their education.

This "tradition" continues to this day. Graduates from the University of Tokyo's Law Faculty often aim to become government officials rather than protect individual citizens' rights. Many medical graduates prefer to achieve in medical research and advance within the academic industry rather than focusing on treating patients.

Whether they are university faculty or practicing doctors, their status as employees means that even if they lose their patients' trust, their income does not decrease, nor does their organizational evaluation change. Since salaries are fixed, engaging in lectures and supervisions for pharmaceutical companies and health food manufacturers only increases their income without reducing their base salary. In this environment, it is natural for doctors to prioritize side jobs over their main responsibilities.

The problem in Japan is that medical leaders live this way. The Medical Governance Research Institute's "Pharmaceutical Money Database YEN FOR DOCS" reports that Takashi Kadokawa, head of Toranomon Hospital and president of the Japan Medical Association, received approximately 74.95 million yen from pharmaceutical companies between 2016 and 2021.

Despite being an opportunity for the Japan Medical Association, there is no indication of proactive action. The Japan Medical Association publishes the "JMA Journal," yet it has not tackled the issue of health foods.

As an aside, the issue of pharmaceutical money is similar.

The Medical Governance Research Institute has addressed the issue of pharmaceutical money in Japan more than any other media, including "JAMA" and the "British Medical Journal" (BMJ) and its sister publications, contrasting sharply with the Japan Medical Association.

The chronic issue within Japan's medical community is that classical professionals are subordinated to the state and become cogs in the organizational machine. The Ministry of Health's medical officers frequently use a quote from Chen Yanji's book from China's Six Dynasties period, "The superior doctor treats the state, the average doctor treats people, and the inferior doctor treats diseases." Doctors who treat diseases and politicians who treat the state should be separate professionals. Although medical officers say this, they do not see it as problematic, losing sound judgment over time.

The conflict between organizations and classical professionals has been debated repeatedly across cultures and eras. For example, Nazi doctors involved in human experiments were sentenced to death at the Nuremberg Trials, a stark example of this issue. Such debates have helped establish professional norms for physicians globally, which have become a protective force for public health against supplement damages in Western societies.

Japan lacks sufficient discussion in this area. From a historical and broad perspective, Japan needs to reconsider its approach to professional ethics and public health protection.

This article was originally published in Japanese in Iyakukeizai (Pharmaceuticals and Economics) on May 1, 2024.