The Supplement Maze | Hiroyuki Ishida, Dean of the Graduate School of Health Management
2024.06.18
It has been some time since health problems believed to be caused by supplements containing "beni-koji" (red yeast rice) ingredients from a certain pharmaceutical company were reported, yet I hear the investigation into the cause is still ongoing. It seems that accidental contamination by unexpected mold during the manufacturing process and the resulting nephrotoxic puberulic acid produced by that mold are suspected as the cause, but there has been no explicit official announcement about the truth. Regardless of the cause, I cannot hide my surprise that supplements containing beni-koji ingredients are still being sold online even under these circumstances. While it is likely true that there were issues with quality control in the manufacturing process, as a humble member of the medical community, my perspective is slightly different. I feel that there are more fundamental systemic flaws that lie upstream of this incident.
A long time ago, I trained to become an internist. From my time as a resident, it was drilled into me that "the lifeline of an internist is diagnostics and the selection of appropriate treatment (medication) based on it." Therefore, prescribing medicine is an important part of my job. However, recently, perhaps due to the impact of adverse events associated with the COVID-19 vaccine, I get the impression that apprehensive questions like, "Does this medicine have any side effects?" have become more common. While this is a very valid concern, I have always felt that people should view supplements with a more critical eye as well. Is there a stereotype that prescription drugs are dangerous while supplements are safe? I often wonder about people's tolerance for supplements, health foods, and alternative medicine. In particular, products that claim to be anti-aging or to lower or improve "XX" seem to have many devotees, aided by advertising across various media. As I personally pay no mind to supplements, this was the first time I realized just how widely beni-koji products are distributed. There have been fatalities, and I feel truly sorry for the victims. However, I believe the health problems caused by beni-koji supplements serve as a wake-up call regarding information literacy about supplements, and I would like to take this opportunity to share my personal views.
This may get a bit technical, but the first of the cholesterol-lowering drugs named "XX-statin," which many people take, was pravastatin, launched in Japan in 1989 by Sankyo Co., Ltd. (at the time). Just as the antibiotic penicillin was discovered from blue mold, there are many cases where substances produced by mold have become the origin of new drugs. Compactin, the precursor to the "XX-statin" (chemical name) drugs that are now standard for lowering cholesterol, was also discovered from blue mold—and surprisingly, it was discovered by a Japanese scientist, Dr. Akira Endo. The contribution of Dr. Endo's discovery to global medicine is immeasurable, and I personally consider it an achievement worthy of a Nobel Prize, though unfortunately, it is not widely known. Following compactin, Dr. Endo also discovered a substance called monacolin K from red yeast rice mold. This monacolin K is none other than the ingredient in lovastatin (marketed in Japan as "Crestor"), which competes for top share in the global statin market. Amazingly, beni-koji supplements contain this lovastatin—a bona fide "medicine." So, my view is, of course it's effective.
By the way, if you look up "supplement" in an English dictionary, the first definitions you will find are "addition" or "something that completes or enhances something else." That's right—the original purpose of (dietary) supplements is to "supplement" specific nutrients when they cannot be obtained from one's diet for various reasons. However, this has recently evolved, and products claiming specific "functions"—that is, to lower or improve "XX"—have appeared, which is where the public's confusion began. The Ministry of Health, Labour and Welfare has also played a part in this confusion by establishing systems such as "Foods for Specified Health Uses (FOSHU)" and "Foods with Function Claims," approving labels that can be interpreted as a government seal of approval. The beni-koji supplements in question fall into the latter category. As has been reported in the media, the review process for Foods with Function Claims is simpler than for FOSHU, and the reporting of adverse events and manufacturing process control standards are left to the manufacturers' discretion. This is likely one reason why the response to this incident has been so reactive. It should be noted that this May, the government (hastily) issued a notice mandating the reporting of adverse events and adherence to GMP (Good Manufacturing Practice) in the manufacturing process.
I want you to think carefully. Whether you take a supplement, a FOSHU product, or a Food with Function Claims, if it has a clear effect (if it "functions"), it means some ingredient has acted on your body. In most cases, that ingredient has already been purified and marketed as a "medicine." In other words, if a supplement is effective, it is a medicine. It is common knowledge that medicines have a certain probability of side effects. We who prescribe them in hospitals pay close attention to these side effects and drug interactions, and we make it a habit to warn our patients. Nevertheless, the system that allows supplements containing the same ingredients to be obtained with almost no safeguards, and the fact that this risk is not widely known to consumers, is a grave situation. I believe this is the most fundamental problem highlighted by the beni-koji supplement issue (and that mandating quality control or adverse event reporting is not the core of the problem). Of course, I am not denying self-medication. However, such products should be sold on the condition that they are treated as "medicines requiring guidance"—like the visceral fat-reducing drug "Alli" from Taisho Pharmaceutical, which, although available at pharmacies, requires regular checks by a pharmacist. Effective supplements sell well. But if it's effective, isn't it a medicine? It must have side effects, too. Yet, supplements are classified as food... I just can't seem to resolve this matrix in my mind.