"Tumor treatment shady" punishment result is here! Where will cell therapy go?

June 03, 2021

On May 28, the official website of the Supervision Office of the Shanghai Municipal Health Commission announced the relevant punishment results of Lu Wei, the doctor involved in the "tumor treatment shady". The punishment information showed that Lu Wei was punished with a “warning, a fine of 30,000 yuan, and a six-month suspension of practice”. The reason for the punishment was "failure to fill in medical records as required, and fail to perform the obligation of notification as required in the course of providing medical and health services." Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine was punished with a “warning and a fine of RMB 400,000”. The reason for the punishment was that the medical quality management of the medical institution was not sound. In addition, Shanghai Jiakang Biological Engineering Co., Ltd. was punished with a penalty of “confiscation of illegal income of 150,000 yuan and a fine of RMB 1.5 million; a total of 1.65 million fines and confiscations” for “practising without obtaining a medical institution’s practice license”.

On the evening of April 18th, Zhang Yu, a doctor from Peking University Third Hospital, published an article on a platform entitled "To my beloved country and many cancer patients and their families-please join me in calling for the country to set up a medical red line as soon as possible , To curb bad medical behaviors in cancer treatment" tweets. The article pointed out that Lu Wei, a general surgeon in a tertiary hospital in Shanghai, deliberately induced treatment, causing the patient Ma Jincang to spend more than 10 times the funds of conventional treatment, including NGS gene sequencing, acceptance of "NK cell therapy", and misuse of adjuvant drugs. Money is empty. Regarding the results of this incident, although the doctors, hospitals, and companies involved have been punished, there are still many problems that have not been resolved. Is there any benefit transfer between the doctors and the cell company? Does the hospital know about these things? How did these confusions result? How to solve?

What exactly is cell therapy? Is it "harvesting patients" or "a silver lining"

Dr. Zhang Yu's post made cell therapy into the public's field of vision once again.

Cell therapy is a treatment method that uses the patient's own (or foreign) adult cells (or stem cells) to undergo bioengineering, transplantation or infusion into the patient's body, to repair tissues and organs. According to cell types, cell therapy can be divided into stem cell therapy and immune cell therapy. The former is widely used in the fields of blood diseases, organ transplantation, cardiovascular diseases, liver diseases, nervous system diseases, tissue trauma and other diseases. Cellular immunotherapy therapies include CAR-T cell therapy, CIK cell therapy, DC-CIK cell therapy, DC cell therapy, NKT cell therapy, ACTL cell therapy, etc. Among them, CAR-T cell therapy stands for chimeric antigen receptor T cell therapy, which is the most promising therapy in immune cell therapy to overcome tumors. At present, 5 CAR-T cell therapies have been approved by the FDA for marketing worldwide. The NK cell therapy mentioned by Dr. Zhang Yu refers to collecting blood, extracting immune cells from the patient's body, expanding in vitro, and then infusing it back into the patient's body to enhance the patient's immunity and kill tumor cells. However, the efficacy of this therapy has not been verified, and it is still in the clinical research stage. Before that, Wei Zexi received DC-CIK cell therapy during his lifetime, and he is still in the early stage of clinical research. Although NK therapy has not been approved for clinical use, many businessmen engaged in the NK cell therapy business have turned to the underground for profit, forming a huge gray industrial chain. The price of treatment is even more chaotic. The price of a needle ranges from tens of thousands to hundreds of thousands, and the cost of a course of treatment can reach millions of yuan. According to the big data monitoring system of Yaozhi Public Opinion, since Dr. Zhang Yu posted a post on April 18, the topic of "cell therapy" has shown a high degree of public opinion. Up to now, the total number of relevant data is 113,936, and the evolution of public opinion has the following characteristics:

Information source trend chart

Keyword Cloud

In addition to industry personnel and investors in related industries, patients with intractable diseases such as tumors and their families are more concerned about the topic of "cell therapy". Some illegal sellers of cell products are advocating the effects of cell therapy in various communities, making some cancer patients or their families believe that cell therapy is an opportunity to "give it a go." By guiding them in private transactions and buying their products heavily, the patient may eventually get a certain therapeutic effect, but it is more likely that people and money are empty. Although CAR-T, NK cell therapy and other therapies are currently hotspots of research and development, no cellular immunotherapy has been approved for marketing in China. The domestic product with the fastest progress is the Akilunza injection of Fosun Kate, a joint venture established by Shanghai Fosun Pharma and Kite Pharma, a subsidiary of Gilead, USA. Its listing application has entered the administrative approval stage in January this year, but it has not yet been approved. Approved. The cell products of the underground industry cannot guarantee curative effects at all. For patients who are eager to seek medical treatment, they can pay attention to regular clinical trials, and those who meet the requirements for entry can apply for trial drugs.

What is the cause of the chaos in cell therapy?

Liu Shuangsheng, President of Yiming Cell Quality, believes that “the lack of supervision by the Health Commission is the main cause of the chaos. The problem of illegal somatic clinical drug use is not unique to Shanghai, and it also exists in other regions. Attending physician, Department of Oncology and Chemotherapy, Peking University Third Hospital Mr. Zhang Yu is a whistleblower who warns of such violations. "In recent years, new technologies such as cells/genes have developed very fast, and new laws and regulations are needed to support them. Since the Ministry of Health included gene therapy in the third category of medical technology catalogue in 2009, the lack of supervision by the Ministry of Health has caused gene and cell therapy products to enter a state of chaos. The Wei Zexi incident put an end to this chaos and caused the development of cell therapy to fall into a sluggish state. In 2017, Novartis' CAR-T products were approved for listing, which re-attracted the attention of practitioners and regulatory agencies. The intervention of CDE has led to the orderly development of the regulation of gene and immune cell therapy products. However, the two documents issued by the Health Commission are "Management Conditions for the Clinical Application of New Biomedical Technologies (Draft for Comment" and "Management Measures for Clinical Research and Transformation Application of Somatic Cell Therapy (Trial) (Draft for Comment)" (Draft for Comment) It also gives hope to some companies that are unwilling to follow the path of the National Food and Drug Administration. Liu Shuangsheng believes that although the Health Commission’s idea is good, he wants cell therapy technology to enter the clinic quickly to benefit patients. However, the Health Commission cannot be like a medicine. The State Administration of Supervision has a complete review mechanism and on-site verification mechanism, and cannot strictly supervise like the FDA, which makes it difficult to implement the recommendations made by the Health Commission. Based on the uncertainty and unimplementability of the two drafts for comments, the current Looking at these two documents, it is likely that they have been shelved. It is not realistic for cell therapy products to take the third type of medical technology. However, the country may open individual holes, such as rare diseases in children. However, they will still require compliance. GMP principles. The main contradiction in the development of China's cell therapy industry is that the construction of the regulatory system lags behind the speed of industrial development. The country is increasing its support for the development of the cell therapy industry. At present, the relevant guidance documents in the research and development stage have basically been implemented, but there is a lack of guidance for NDA listing The policy implementation documents of the verification standards are also expected to be implemented soon.

Conclusion

Regarding the results of the incident, Dr. Zhang Yu issued a document at noon on May 28, stating that he felt that the above-mentioned administrative penalty decision was "mixed and difficult to evaluate". He wrote, "My wish is simple: I hope that people can get standardized medical treatment, and that bad medical behaviors become less and less. And many of my colleagues, those doctors who steadily work hard for the health of patients, can earn a reward." Cell therapy has shown good application prospects in the fields of tumors, immune diseases, nervous system diseases, chronic diseases and rare diseases, and is one of the most popular tracks for biomedicine research and development. On the one hand, cell therapy has brought hope for the cure of diseases, on the other hand, driven by interests, the industry has become chaotic. Those who illegally use cell products disrupted the market and undermined the confidence of normal research applicants. Only by improving the regulatory mechanism and regulating the research, clinical trials and commercialization of cell therapy products can patients truly benefit.

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