Fentanyl is placed under comprehensive control: China’s traditional analgesic drugs usher in new opportunities.

Release time:

2019-05-08 15:52

　　Starting May 1, China began placing all types of fentanyl-related substances under comprehensive control. This announcement was jointly issued one month ago by the Ministry of Public Security, the National Health Commission, and the National Medical Products Administration.

　　The inclusion of an entire class of substances means that all variants related to fentanyl will be subject to strict control. Aside from legitimate uses in medical, industrial, and scientific research, the illegal trafficking of fentanyl will be met with the harshest penalties under Chinese law.

　　Why is it necessary to place fentanyl under comprehensive control? To understand this, we first need to explore the story behind fentanyl’s invention and its misuse.

　　Abuse turns a potent painkiller into a drug.

　　In medicine, fentanyl is an effective analgesic commonly used for surgical anesthesia, postoperative pain relief, and chronic pain caused by cancer. Its common dosage forms are injectables and transdermal patches.

　　The scientist who first synthesized fentanyl was named Paul Janssen, a Belgian who devoted his entire life to developing potent painkillers. Eight years after fentanyl was successfully synthesized—in 1968— it was approved by the United States for medical use. In other words, fentanyl has been used in medicine for more than half a century now.

　　As for evaluating the half-century-long use of fentanyl, one can only say that its impact has been “a mix of merits and demerits.”

　　Because fentanyl, which takes effect rapidly but has an extremely short duration of action, is an opioid—a class of drugs that are highly addictive. In fact, “opioid” is merely an “academic nickname”; its Chinese name is “ya pian.” Well-known substances such as heroin, morphine, and pethidine are all refined from ya pian.

　　However, fentanyl is not derived from “extracting plant essences”; rather, it is synthesized in a laboratory. The analgesic effect of this synthetic drug is 50 to 100 times stronger than that of morphine or heroin. Its derivatives—such as sufentanil and carfentanil—can have analgesic potency thousands of times greater than morphine.

　　It’s obvious that the “power” of fentanyl cannot be underestimated—especially when it’s abused.

　　In 2017, the Trump administration released a report stating that 142 people across the U.S. died each day from opioid overdoses—a figure the media dubbed “a 911 call every three weeks.” Shortly thereafter, Trump declared that the United States had entered a “national public health emergency.”

　　Declaring a national public health emergency is no “child’s play” decision by Trump. Statistics show that the United States alone consumes 80% of the world’s opioid medications—medications that, in many cases, are not prescribed to meet patients’ pain-relief needs but rather to satisfy the cravings of drug users.

　　In fact, besides the United States, Europe also faces a problem of fentanyl abuse.

　　On August 1, 2017, the British newspaper The Guardian, citing data from the UK’s National Crime Agency, reported that in the past six months, 60 deaths had been confirmed due to poisoning from the abuse of fentanyl (and carfentanil), while another 70 drug users were suspected of having died from the abuse of fentanyl-related substances.

　　In contrast, China has always maintained strict controls over the use of fentanyl, and there has been absolutely no evidence of its abuse. In medical practice, fentanyl is classified as a “red prescription” drug and is subject to the “Five Specials” management system—namely, dedicated personnel responsibility, locked special cabinets, specialized ledgers, special prescriptions, and dedicated registration records. Even transdermal patches, once used, must be collected by hospitals afterward.

　　However, in order to ensure the more rational use of fentanyl-related substances, our country has made a commitment to place fentanyl under control.

　　Ethnic analgesics can partially replace opioid drugs.

　　The abuse of opioid analgesics has nearly turned the United States into a “country crippled by drugs.” Against this backdrop, the issue of alternatives to opioid analgesics has become one of the key topics discussed at medical and academic forums in Europe and the United States in recent years. Meanwhile, at numerous international academic forums, Qizheng Tibetan Medicine—a representative of China’s ethnic pharmaceutical companies—has begun to gain prominence.

　　In China, many people have heard of “Qizheng Pain-Relieving Plaster,” which is produced by Qizheng Tibetan Medicine.

　　“The Pain-Relieving Patch originates from a classic Tibetan medicinal formula, but it incorporates technological innovations based on that original formula. The first innovation lies in the dosage form. Traditionally, this medicine was prepared as a mixture of herbs combined with butter and applied externally—a format that was inconvenient to carry and use. However, Qizheng Tibetan Medicine has employed ultra-low-temperature vacuum freeze-drying technology to transform it into a unique wet-application patch. This innovative dosage-form improvement has overcome two major challenges faced by traditional formulations: short shelf life of active ingredients and insufficient efficacy. Moreover, the wet-application patch is convenient to carry and use, which has enabled this medicine to expand from the Tibetan regions to the entire country and even the global market.” Lei Jufang, a member of the 12th National Committee of the Chinese People's Political Consultative Conference and Chairperson of Qizheng Tibetan Medicine, told reporters that as the first Tibetan medicine product in China to receive an international invention patent and the National Science and Technology Progress Award, the successful development of Qizheng’s Pain-Relieving Patch has also provided new insights into the modern application of ethnic medicines.

　　Rigorous, scientifically grounded clinical evidence and mechanistic studies represent a significant gap in the modernization of traditional ethnic medicines. However, for Qizheng Tibetan Medicine, this is precisely one of its strengths. A multi-center, large-sample, randomized, parallel-group, evidence-based study involving more than 50 authoritative hospitals nationwide and over 3,000 cases has confirmed the potent analgesic effects of Xiao Tong Tie Gao (Pain-Relieving Plaster). Articles published in specialized journals such as "Pain Medicine" have highlighted its unique analgesic mechanism, setting Xiao Tong Tie Gao markedly apart from currently common topical pain-relief medications.

　　“For example, its multi-target anti-inflammatory and analgesic mechanism allows it to be used both for acute pain relief and chronic pain management. Moreover, it takes effect quickly and provides longer-lasting pain relief. Even more noteworthy is that, being derived from natural Tibetan herbal medicines, Qizheng Xiaotong Plaster not only delivers remarkable pain-relieving effects but also poses no risk of addiction, making it a viable alternative to opioid medications to some extent,” explained Lei Jufang.

　　It is precisely because of their remarkable analgesic effects and unique mechanisms of action that several traditional ethnic pain-relief medications—such as Qizheng Xiaotong Paste—have gained favor among medical experts both domestically and internationally. Moreover, in recent years, Qizheng Tibetan Medicine has begun to attract increasing attention at several international academic conferences dedicated to pain management.

　　Faced with global challenges, national pain-relief medications are ushering in new opportunities.

　　In fact, in the field of medical services, pain is an issue that no department or disease type can avoid. Most patients seek medical care precisely because they are experiencing pain. Although from a medical perspective, every disease generally has more profound solutions at a deeper level, pain remains the primary issue that must be addressed first. As for addressing pain, traditional medicine—both in theory and practice—is far older and far more profound than modern medicine.

　　“For example, Qizheng Xiaotong Paste does not use commonly prescribed, high-value medicinal ingredients such as musk or tiger bone; instead, it relies on common Tibetan herbal medicines like Duyiwei and turmeric. Yet, research data show that Qizheng Xiaotong Paste—a formulation composed of these familiar herbs—can deliver pain-relief effects comparable to those of morphine-based drugs within half an hour of topical application. Moreover, after two or three hours of use, its efficacy becomes even more pronounced than that of morphine-based medications. This represents an important exploration in the modern application of our traditional medicine,” said Lei Jufang.

　　In addition to Qizheng Xiaotong Paste, several other pain-relief products from Qizheng have become “star” products in China’s pain-relief drug market. For example, in 2017, an article on Honghua Ruyi Wan—a Qizheng product used to treat gynecological inflammation—was published in the journal Biomedical Research. This marked a breakthrough for Chinese Tibetan medicine gynecological treatments in terms of publication in overseas SCI journals, and also signified that the clinical research on Honghua Ruyi Wan’s efficacy in treating gynecological pelvic pain has gained international recognition.

　　“Faced with the international challenges in the field of pain relief medications, our traditional medicine industry should also take collective action—working together to validate some of the advantageous categories within traditional medicine and jointly providing better solutions for people in China and around the world in alleviating pain caused by illness.” In Lei Jufang’s view, when European and American countries resolved to wage a modern “Opium War,” the Chinese government’s commitment to placing all fentanyl-related substances under strict control not only reflects China’s responsibility as a major global player but also represents a step forward in advancing and putting into practice the Healthy China national strategy.

　　Because enabling people both in our own country and around the world to live longer, healthier lives is not only the fundamental challenge that medicine must address, but also a shared goal pursued by nations worldwide. After all, pain relief solutions with fewer side effects represent a common need—and a shared challenge—for people across the globe.

　　“Yet, difficulties also present opportunities. Under the dual goals, traditional ethnic pain-relief remedies are now poised for new growth opportunities,” Lei Jufang told reporters with deep meaning. She expressed her hope that China’s traditional medicine industry would join forces to explore and validate more ethnic pain-relief remedies, thereby making every possible contribution to a healthy China and a healthy global community.