Kobayashi Pharmaceutical’s red yeast rice response. Recordings stopped, and no minutes kept

On February 1, Medical Doctor B reported three cases and asked whether the company had any information concerning tubulointerstitial nephritis. After an internal check, the Customer Relations Office responded that there had been no reports of side effects of acute kidney failure to date.

But on January 15, the office had already received a report from Medical Doctor A that a patient who had taken the Product had acute kidney failure. That information had been entered into FastHelp, the company’s information-management system, and separately shared by email within the Pharmacovigilance Group.

The earlier acute-kidney-failure report was not communicated to Medical Doctor B.

The Committee said that, had the doctor been told, the doctor might have raised even more serious issues, and it identified a problem with information sharing in the Customer Relations Office.

Kobayashi Pharmaceutical had adopted an interpretation that, when health damage occurred to someone who had taken a Food with Function Claims product, reporting to governmental authorities was required only when the causal relationship was clear.

The Committee found no statement in the administrative documents it reviewed that directly supported that interpretation. The Pharmacovigilance Department also had not consulted governmental authorities or attorneys when adopting it.

The “only when the causal relationship is clear” interpretation had been used internally as a reporting criterion since around 2020.

The Group Operation Meeting (GOM), an executive forum for important business matters, was normally held four times a month. The same interpretation appeared in the February 13 GOM materials and became a premise for later decisions.

According to the Committee’s reconstruction, at the February 20 GOM the Senior General Manager of the Pharmacovigilance & Consumer Relations Division proposed that video recordings no longer be made. The stated purpose was to let people at different levels of the hierarchy express opinions freely when discussing sensitive matters such as whether to collect the Product. No particular objections were raised.

For the GOM meetings handling this issue from February 20 onward, there were neither video recordings nor minutes.

The Committee therefore had no objective record of the deliberations and had to reconstruct them from meeting materials and participant interviews.

On February 14, the Senior General Manager of the Pharmacovigilance & Consumer Relations Division emailed the January monthly report to the Chairman & CEO. It included, as risk information, the series of hospitalizations for kidney problems and the February 13 GOM deliberations.

The Chairman’s usual practice, however, was to review monthly reports after his secretary delivered printed copies to his house.

In this case he reviewed the report on February 20, a few days after the printed copy arrived.

After reading it, he asked through his secretary for a more detailed report on the issue.

From the February 26 GOM materials onward, the factors listed for considering whether government reporting was necessary went beyond medical and pharmacological examination of causality and seriousness.

The materials also said to make the decision while “taking into account the reputational risk and impact on the business.”

The Committee did not find that the GOM had discussed disregarding food safety in order to maintain the red yeast rice business. It nevertheless concluded from the materials that the company responded to the issue with a certain degree of awareness of maintaining that business.

At the March 4 TEAM-F meeting, a monthly meeting of the President, Senior Executive Director and full-time Audit and Supervisory Board members, Full-time Audit and Supervisory Board Member Kawanishi proposed sharing important management matters and potential serious risks with Outside Directors. He cited this issue as one example.

Senior Executive Director Yamane then instructed the Management Planning Department’s General Manager to share risk information. At a subsequent general manager meeting, a policy was agreed for the Monthly Risk Committee to select important matters for the Outside Directors, but sharing this issue itself was not specifically discussed.

Even after the issue was used as an example of risk information that should reach Outside Directors, it was not formally shared with them until the evening of March 20.

The Committee said that more timely sharing might have brought useful views from people outside the group handling the matter, and that the timing was difficult to regard as appropriate.

The issue was treated as a “Discussion Item” at the GOM. Related materials were generally sent immediately before the meeting, and in some cases attendees first saw them when they were projected on the screen during the GOM.

Until Peak X was detected, the scheduled discussion time for this issue was generally 15 to 20 minutes. In addition, there were at least four and as many as fourteen other items for deliberation and reporting.

For a serious health-damage issue, attendees could have little opportunity to read the materials beforehand, while the scheduled discussion itself was generally 15–20 minutes.

The Committee said that this made it difficult to discuss and examine the issue in depth with sufficient time.

Kobayashi Pharmaceutical’s Crisis Management Regulations provided for a Crisis Management Headquarters when a serious product accident or large-scale collection was expected. The President & COO would lead it, and its duties and chain of command would take precedence over ordinary work. It would have the authority needed to carry out its roles and functions within a reasonable and appropriate scope.

Before the announcement, however, the company primarily handled the matter through a GOM meeting about once a week and did not get as far as specifically considering a special response under the Crisis Management Headquarters.

The Committee said that intensive crisis management under the President’s direct leadership would have been a better organizational choice than handling the matter through a weekly GOM.

A headquarters — called the Task Force by the company — was established after the March 22 announcement, and then discussed the response intensively on consecutive days.

The company had a Reporting Flowchart covering the process from collecting health-damage information to implementing measures for Foods with Function Claims. One of its decision points contained an explicit parenthetical phrase.

The flowchart referred to an adverse event caused by the company’s product “including when the causal relationship is unclear.”

The “implementation of measures” under that flow included providing information to consumers and promptly reporting to authorities. The Committee said that, if the flowchart were followed, prompt reporting would be required even when causality was unclear. It obtained no reasonable explanation for how this fitted with the separate interpretation that reporting was required only when causality was clear.

At the Osaka Plant, about five to six employees worked on the red yeast rice raw-ingredient production line, while the work including quality control was almost entirely entrusted to a person in the Quality Management Group. The report says the same arrangement continued after the line moved to the Kinokawa Plant, and staff shortages had become routine.

In interviews, people described a dryer breaking during manufacture of a relevant raw-material lot, blue mold adhering to the inside of a culture-tank cover, and a deeply clogged exhaust duct discovered when the line was transferred.

The Committee expressly said it was unclear whether these events caused the issue; it also found that, before the March 22 announcement, the company made no proactive attempt to ask manufacturing personnel directly about problems in the manufacturing process.

The plant observations are therefore presented here as interview accounts recorded by the Committee, not as an established scientific cause of the health damage.

In its final conclusion, the Committee said that, by early February at the latest, the company should have treated the situation as an emergency requiring a company-wide response with consumer safety as the highest priority.

It acknowledged that investigating cause and causality was important, but warned that too much focus on those questions in a food accident can delay appropriate and prompt information to consumers.

The official English translation concludes that, unless consumer safety is instilled as the highest value and embodied in day-to-day operations, preventive measures are unlikely to be effective.

The Japanese original uses the expression 「画餅に帰す」 for this final warning. The English wording above follows Kobayashi Pharmaceutical’s official translation rather than translating that phrase independently.