<figure id="attachment_366901" aria-describedby="caption-attachment-366901" style="width: 856px" class="wp-caption alignnone"><a href="#" data-ident_hash="5f762ac2"><img src="https://res.cloudinary.com/fridaydigital/image/private/t_article_image/wpmedia/2024/04/e783ddc1a77759d70faeb61949bc7ace.jpg" alt=""></a><figcaption id="caption-attachment-366901" class="wp-caption-text">Kobayashi Pharmaceutical President Akihiro Kobayashi (center) and other executives apologize at a press conference held in Osaka City on March 29.</figcaption></figure>
<h3> Sloppy Crisis Management Concerning Red Yeast Rice</h3>
<p> Kobayashi Pharmaceutical held a press conference in Osaka City on the afternoon of March 29 to apologize for a series of health problems caused by a supplement containing red yeast rice, including the deaths of five people. He revealed that there were 114 hospitalized patients believed to be related to the supplements, and 680 people who had visited or wished to visit the hospital due to health problems, and that the company would cover the cost of their treatment.</p>
<p> On March 27, Osaka City issued an administrative action ordering a recall of products such as &#8220;Red Yeast Choleste Help,&#8221; &#8220;Naishi Help + Cholesterol,&#8221; and &#8220;Nattokinase Sarasara Granules GOLD,&#8221; warning people not to eat them if they have them on hand. However, the recall is expected to take several months due to the large volume of products in circulation.</p>
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<p> As of March 31, the health hazard is believed to be acute renal failure (acute kidney injury from tubulointerstitial nephritis), and puberulic acid has reportedly been detected in a limited lot of red yeast rice. Some reports have pointed out that red yeast mold toxin has a strong nephrotoxic mold toxin called &#8220;citrinin. It should be identified in the future.</p>
<p> It was on January 15 of this year that Kobayashi Pharmaceutical received the first report from a doctor about a kidney disease caused by products containing red yeast rice. The damage increased, and a report was made to President Akihiro Kobayashi 22 days later, on February 6. The voluntary recall was announced on March 22. That was 67 days later. This is far too late. Moreover, the health department was notified just before the announcement. Kobayashi is responsible for not notifying the public health center even after the report was made to top management, thereby allowing the damage to continue to spread.</p>
<p> Kobayashi Pharmaceutical&#8217;s awareness of crisis management is extremely sloppy. A former MHLW medical officer revealed, &#8220;The supplement in question is not a new product.</p>
<p><span class="strongInContent"> The supplement in question is not a new product. We do not know the details of the first report, but it would have been difficult for Kobayashi Pharmaceutical to determine whether or not there was a causal relationship at the stage of the first case. But at the stage when similar reports came in for the second and third cases, the doubts must have turned into certainty.&#8221;</span></p>
<p> In terms of crisis management, it is necessary to address the second case as an &#8220;aberration. The most important aspect of crisis management is to minimize the risk of damage. Needless to say, the risk in this &#8220;red yeast rice supplement problem&#8221; is the health hazard to consumers. Did Kobayashi Pharmaceutical have this in mind?　Did they consider the damage to their own company as the biggest risk?</p>
<p> A nephrologist continues, &#8220;We should do what we can to reduce the risk to the victims.</p>
<p><span class="strongInContent"> What we had to do to reduce the risk to victims was to publicize the problem. The first priority is to publicize the problem with the supplement and prevent further doses. Yet, the report to top management was made 22 days later. There may be a variety of reasons for this, but I believe that what occurred here was a &#8220;normalization bias.</span></p>
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<p> What is &#8220;normalization bias&#8221;?</p>
<p> Normalization bias&#8221; is a preconceived notion that <span class="strongInContent">&#8220;even if something unexpected and abnormal happens,</span> it is impossible for it to happen,&#8221; and therefore, one tries to keep one&#8217;s mind calm, <span class="strongInContent">thinking, &#8220;This is within the normal range, so no more problems will occur</span>.</p>
<div data-friday-nextpage-lead=" Why was information not disclosed for more than two months?"></div>
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<figure id="attachment_366941" aria-describedby="caption-attachment-366941" style="width: 986px" class="wp-caption alignnone"><a href="#" data-ident_hash="7b2b3937"><img src="https://res.cloudinary.com/fridaydigital/image/private/t_article_image/wpmedia/2024/04/c4f3d765d4947f44d065374833373691.png" alt=""></a><figcaption id="caption-attachment-366941" class="wp-caption-text">Photo source from Da Cunha Marques J, Nogueira F, Pereira C, et al. (December 13, 2022) Mesalazine-induced interstitial nephritis in patients with ulcerative colitis. doi:10.7759/cureus.32488.</figcaption></figure>
<h3> Normalization Bias and Crisis Management</h3>
<p> Let us illustrate normalization bias with a simple example.</p>
<p> For example, reports of a disaster gradually increase the number of victims. We have never heard a news report that adds an estimated number of victims (several hundred or several thousand), when in fact there are only a few victims confirmed at present. In the tragic Noto Peninsula earthquake that occurred on New Year&#8217;s Day, images from fixed-point cameras in various areas were broadcasted from the beginning, but many people felt that it was nothing serious, did they not?　The images from the fixed-point cameras did not show any collapsed houses or tsunami.</p>
<p> In fact, however, there was tremendous damage in places that were not filmed. One corner of my mind is thinking, &#8220;This can&#8217;t be true, even though the earthquake was measuring 7 on the Japanese seismic intensity scale. However, I was taking it in stride, thinking that the damage was not as bad as I had expected. Even though we can expect great damage, the movement to &#8220;keep a calm mind&#8221; moves us to &#8220;avoid bad imaginations.</p>
<p> Kobayashi Pharmaceutical probably had a normalization bias, not wanting to admit the fact that they had sold a large number of red yeast rice malt products and that such a thing had never happened.</p>
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<p> Why did Kobayashi Pharmaceutical&#8217;s president also not disclose the problem for more than two months after learning of the situation?　The president was not properly aware of his responsibility to the victims and his prediction of what would happen afterwards. He failed to make a top-level decision to minimize the number of victims. If the company did not act immediately upon receiving the report, its credibility would be damaged.</p>
<p><span class="strongInContent">What did the president and other executives think? They probably thought, &#8216;If we make an announcement, there will surely be a big fuss, and our company&#8217;s image will be damaged. The company&#8217;s image would be damaged.</span> They probably <span class="strongInContent">thought only of avoiding responsibility and protecting themselves</span>.</p>
<p> Of course, there is no way to know the scale of the damage without an investigation. Kobayashi Pharmaceuticals has decided that it would be better to wait until the details are known and the causes are analyzed. This may be in preparation for their own response when the issue is pursued and questions are asked.</p>
<p> They did not have the courage to withstand the multitude of questions and bashing for saying &#8220;We don&#8217;t know&#8221; or &#8220;We are investigating&#8221; in the event of an early announcement. For example, the quality control department insisted, &#8220;We want to verify all lots. The development and research departments would say, &#8220;We need time to investigate the cause. The sales department says, &#8220;We need data to explain the reason to our customers. All of this is an attempt to evade responsibility, but it is believed that they lied to their own conscience and convinced themselves with the excuse that an announcement would stir up anxiety among consumers.</p>
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<div data-friday-nextpage-lead=" Critical Differences in &quot;Crisis Management&quot; and &quot;Crisis Awareness&quot; between Japan and the U.S."></div>
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<figure id="attachment_366902" aria-describedby="caption-attachment-366902" style="width: 1024px" class="wp-caption alignnone"><a href="#" data-ident_hash="b839b4cf"><img src="https://res.cloudinary.com/fridaydigital/image/private/t_article_image/wpmedia/2024/04/779f617dd87f035c3857295bef573d76.jpg" alt=""></a><figcaption id="caption-attachment-366902" class="wp-caption-text">Ministry of Health, Labor and Welfare officials on their way to a subsidiary plant of Kobayashi Pharmaceuticals in Kinokawa, Wakayama Prefecture, for an on-site inspection.</figcaption></figure>
<h3> The Difference between Japan&#8217;s Crisis Awareness and U.S. Crisis Management</h3>
<p> As a national defense journalist covering the Self-Defense Forces and security issues, the issue of &#8220;crisis management&#8221; always comes up.&#8217; At the time of the leak of information from the Maritime Self-Defense Force&#8217;s Aegis in 2007, there was a contrast in &#8220;crisis management&#8221; between Japan and the United States. At that time, the SDF side investigated from the viewpoint that &#8220;this information would not have been leaked, and this part of the information should be safe,&#8221; based on their own inferences from the department and rank of the leaked personnel. However, the U.S. military first responded on the assumption that all information had been leaked. Then, they gathered evidence one by one that the information had not been leaked, and identified the leaked information.</p>
<p> The Supreme Court found the US military guilty with a suspended sentence for violating the secrecy law in connection with the Japan-US Mutual Defense Assistance Agreement and other related agreements. While the U.S. military&#8217;s risk management was correct in assuming the worst when it detected an anomaly, it also highlighted the &#8220;laxity&#8221; of the Japanese government.</p>
<p> When a crisis occurs, it is essential to assume the worst and take immediate action. Even if nothing serious happens, it is &#8220;OK to strike out. In the case of a matter that needs to be widely known to the world, the company should promptly and sincerely announce and report it as soon as it becomes aware of the situation. In recent years, Toyota has not been bashed too much for the scandals that began with Daihatsu&#8217;s fraud, because the company tried to minimize the problem by immediately publicizing it. Depending on the subsequent response, the company&#8217;s good reputation may even increase in the opposite direction. A pinch is also an opportunity.</p>
<p> Kobayashi Pharmaceutical caused victims, including deaths that could have been prevented, with its own product, a red yeast rice malt supplement. This is the worst crisis management response caused by a lack of imagination and an avoidance of responsibility for the damage that could have been caused by not announcing the product.</p>
<h4> ◆Mechanism of mesalazine-induced interstitial nephritis in patients with ulcerative colitis</h4>
<p><a href="#" data-ident_hash="b01fc526"><img src="https://res.cloudinary.com/fridaydigital/image/private/t_article_image/wpmedia/2024/04/f668290441e748234e5f3be71ba48c4b.jpg" alt=""></a></p>


 Rie Ogasawara is a national defense journalist. After graduating from Kansai Gaidai University, she worked as a freelance writer focusing on the Self-Defense Forces and security issues, and is the author of "Self-Defense Forces Personnel Buy Toilet Paper at Bases with Their Own Money" (Fusosha Shinsho), published in 2007. He was awarded the Seishi Sanshuji Award in the 15th "True Modern History" Essay Contest sponsored by the APA Foundation for the Rebuilding of Japan. Columnist for Sankei Shimbun's "Shimbun ni Kakaku! columnist for the Sankei Shimbun's "Shimbun ni Kakuro!

 Rie Ogasawara

 The five deaths from health problems caused by Kobayashi Pharmaceutical's "Red Yeast Rice Malt Supplement" have brought to light the company's sloppy crisis management. Former Ministry of Health, Labor, and Welfare (MHLW) officials explain why it took two months from the time the company received a report from a doctor to the time it decided to voluntarily recall the product.

Kobayashi Pharmaceutical’s Sloppy Crisis Management after Red Yeast Rice Malt Supplement Caused a Series of Deaths

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