"Tumor treatment shady" punishment result is here!

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"
.

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 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
.

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
.

Immunotherapy therapy comprises the treatment of CAR-T cells, CIK cell therapy, DC-CIK cell therapy, DC cell therapy, NKT cell therapy, ACTL cell therapy
.

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
.

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
.

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:

       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"
.

       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 cell products of the underground industry cannot guarantee curative effects at all
.

       What is the cause of the chaos in cell therapy?

       Liu Shuangsheng, President of Yiming Cell Quality, believes that “the current lack of supervision by the Health Commission is the main cause of the chaotic situation
.
The problem of illegal clinical use of somatic cells is not unique to Shanghai, and it also exists in other regions
.
Attending physician, Department of Cancer 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 require new regulatory support
.
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, there are two documents issued by the Health Commission, "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 who are unwilling to follow the path of the Food and Drug Administration
.

       Liu Shuangsheng believes that although the Health Commission’s idea is good, he wants cell therapy technology to quickly enter the clinic and benefit patients
.
However, the National Health Commission cannot have a complete review mechanism and on-site verification mechanism like the Food and Drug Administration, and cannot strictly supervise it like the Food and Drug Administration, which makes it difficult to implement the recommendations made by the National Health Commission
.

       Based on the uncertainty and unimplementability of the two drafts for comments, it seems that these two documents may have been shelved.
It is not realistic for cell therapy products to take the third type of medical technology, but the country may Will make individual openings, such as for rare diseases in children
.
However, compliance with GMP principles will still be required
.

       The main contradiction in the development of the cell therapy industry in China is that the construction of the regulatory system lags behind the speed of industrial development, and 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 policy implementation documents to guide the NDA listing verification standards, and it is expected that they will be implemented soon
.

       Concluding remarks

       Regarding the results of the incident, Dr.
Zhang Yu issued a document at noon on May 28, stating that he felt "mixed and difficult to evaluate" about the above-mentioned administrative penalty decision
.
He wrote, "My wish is very 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 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
.

       Editor in charge: Liuli