At present, the only cancer immunotherapy allowed by FDA in the United States is limited to advanced prostate cancer. The author believes that cancer immunotherapy is not helpful to cancer patients, and cancer immunotherapy on the Chinese market should be banned until the relevant departments approve it.
Recently, the media reported that cancer immunotherapy is being carried out like fire in many 3A hospitals in China. Advertisements for various types of cancer immunotherapy have been widely publicized through various channels, which shocked the author. As shown in Southern Weekend’s article “Cancer Immunotherapy: Prudence in Foreign Countries and Prevalence in Domestic Countries”, foreign countries do retain a cautious attitude towards the therapy. This article will try to start from the therapy itself and tell consumers the truth of the therapy.
What is cancer immunotherapy
Cancer immunotherapy in a broad sense refers to the technology and method developed by the body’s immune principles to treat cancer. Including three major contents, cell-based therapies, antibody therapies and cytokine therapies. Immunological methods have been used to treat cancer for more than 100 years. The first person to put forward this idea was an American surgeon named William Collet, but it was quickly overtaken by radiotherapy, which flourished in the early 20th century, and faded out of doctors’ view.
The narrow sense of cancer immunotherapy only refers to the first category. Some Chinese scholars call it cancer biotherapy, which usually involves separating immune cells (natural killer cells, cytotoxic T cells and dendritic cells) from patients’ blood or cancer tissues and transfusing them back to patients after in vitro stimulation and appreciation to achieve the purpose of anti-cancer. This is also the content discussed in this article.
The current situation of the U.S. Market
Due to the difficulty of cancer treatment, Since Dr. Collet realized that cancer might be treated immunologically, As long as there is a glimmer of hope, Scientists will try their best. On July 29, 2010, A phase III clinical trial led by Dr. Kantoff of Harvard Medical School was published in the New England Journal of Medicine. This is a strictly designed double-blind, A placebo-controlled, multi-hospital clinical trial was conducted in 512 patients with advanced prostate cancer who failed to receive hormone therapy. The average survival time of the patients in the experimental group was 25.8 months, while that in the placebo group was 21.7 months. The conclusion was that this therapy could increase the survival time of patients with advanced prostate cancer by 4.1 months. FDA approved the use of this therapy according to this study.
This is also the only cancer that is currently allowed to use cancer immunotherapy in the U.S. Market. The treatment method is simply put forward. It is to extract and separate immune cells from the patient’s blood, send them to a specific laboratory, and then infuse them back to the cancer patient in three times after being cultured with a prostate acid phosphatase at intervals of two weeks each time. This is the standard method stipulated by FDA.
Compared with drug chemotherapy, It is virtually non-toxic, But the common side effects are fever, chills, fatigue, back pain, arthralgia, headache and nausea. A few people will suffer from serious problems such as dyspnea and hypertension. Some doctors also disagree with this method. It is mainly believed that the effectiveness is not obvious and the cost is large, and the current market cost in the United States is 93,000 US dollars. The author believes that the physical strength of patients with advanced cancer is weak, and this medical treatment method is a challenge to the physical strength of patients, such as improper operation and potential risk of blood infection.
The Current Situation of China’s Market
The author left the Chinese medical profession in 1997, The current situation of cancer treatment in China’s medical field is not very clear. Recently, media reported that cancer immunotherapy is being carried out in many 3A hospitals in China. Advertising is rampant. What is shocking is that the author found that Guangming reporter Li Ran reported on September 4 through Internet search. The State Health and Planning Commission, Wei Zheng Shen Fu (2014), issued two documents 0657 and 0658. The Health and Planning Commission did not organize clinical trials related to autoimmune cell (T cell, NK cell) therapy technology, nor did it approve any medical institution to carry out autoimmune cell (T cell, NK cell) therapy.
It is reported that some hospitals use cancer immunotherapy very well, And there are [actual data]. According to FDA regulations, This treatment plan must be subject to clinical trials in cooperation with multiple hospitals on the basis of FDA approval. The clinical trials were divided into stages 0, 1, 2, 3 and 4, Most of them will have to be evaluated by FDA medical experts after the completion of phase 3 clinical trials. After being approved to enter the market, There will also be 4 phases to track long-term side effects and long-term survival rate. The important link in the middle is that Funders will hire private companies independent of companies, hospitals and governments to carry out inspections. This examination runs through the whole process of clinical trials to ensure the accuracy and fairness of experimental data. The FDA will also conduct a review at each stage. The author believes that cancer immunotherapy is not helpful to cancer patients, and cancer immunotherapy on the Chinese market should be banned until the China Food and Drug Administration and/or the Health and Planning Commission approve the effective results of multi-center clinical trials in line with international standards.
Consumers Should Know the Truth
1. Advanced prostate cancer is the only disease allowed to use cancer immunotherapy in the US market.
2. According to the above reports, the China Food and Drug Administration CFDA and the China Health Planning Commission have never been approved to carry out clinical trials of cancer immunotherapy, and the results of single-center clinical trials independently conducted by a few hospitals have never been approved.
3. China’s 3A hospitals are in [anarchy] in carrying out cancer immunotherapy (or cancer biotherapy).
4. The commercial publicity of cancer immunotherapy by any company or media in China is false and is not the fourth therapy after surgery, chemotherapy and radiotherapy.
The author calls on the China Food and Drug Administration and/or the Health and Planning Commission to intervene in cancer immunotherapy so as not to increase the economic burden on cancer patients and delay formal treatment.
Author: Tao Jeff