China's gamma knife situation is difficult to gain industry recognition

Release date: 2009-07-02

"I did not expect that we took the award certificate issued by Premier Wen Jiabao and it is so difficult to open the Chinese market."

After experiencing tremendous glory, China's gamma knife (also known as gamma knife) production enterprises are facing a dilemma.

Hui Xiaobing, chairman of the Gamma Knife Leading Enterprise and president of the Shenzhen Gamma Knife Association, told the "Weiwang" News Weekly: "The current gamma knife enterprise is basically on the verge of suspension."

Three years ago, Hui Xiaobing participated in the research and development of the "full body gamma knife (OUR-QGD stereotactic gamma ray systemic treatment system)" won the second prize of the 2005 National Science and Technology Progress Award, which is the highest award for large medical equipment in China. .

The whole body gamma knife, also known as the body gamma knife, is a stereotactic radiotherapy device with independent intellectual property rights in China, which can be used for tumor treatment of main parts of the body.

"With the addition of more than 2 million cancer patients each year and the introduction of foreign radiotherapy equipment, if the gamma knife is applied properly, it will give some patients a chance to survive." Standing Committee and Secretary General of the Radiation Oncology Branch of the Chinese Medical Association, Xia Tingyi, director of the radiotherapy department of the Air Force General Hospital, told the "Weiwang" News Weekly.

"However, due to some quick successes in the industry and the negative impact of the non-standard use of some hospitals, and some scholars from the relevant government departments and academia have doubts about China's self-developed Gamma Knife, leading to the production of gamma knives in China. Enterprises hold the core technology, but they can't develop healthily." Xia Tingyi is worried. In the radiotherapy circle, he enjoys the reputation of "China's first gamma knife."

"Difficult to die"

"It should be that the gamma knife has been improperly applied in actual use. The Ministry of Health has introduced policies to regulate and limit it." Li Yuxiong, the chairman of the Radiation Oncology Branch of the Chinese Medical Association and director of the Department of Radiation Oncology, Cancer Hospital of the Chinese Academy of Medical Sciences The reporter said.

He said that modern radiotherapy techniques include three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, image-guided radiotherapy and stereotactic radiotherapy, which are “developing rapidly and changing with each passing day”. Gamma Knife is a kind of stereotactic radiotherapy, which is a kind of treatment for radiation therapy. Its physical dosimetric characteristics determine the gamma knife has certain indications, and relaxing its indications means inducing demand, and may even delay. The patient treats or aggravates the condition.

In the late 1960s, the world's first head gamma knife was introduced in Sweden. As a new treatment system integrating neurosurgery, radiology diagnosis, radiation therapy and computer technology, this technology is regarded as “a revolution in the history of medical treatment” because it can successfully replace a part of craniotomy. A milestone".

In 1993, China introduced the first head gamma knife for the treatment of brain diseases at a price of more than $3 million per unit.

In the next two years, China has used and is equipped with 13 sets of gamma knives, accounting for 20% of the total number of gamma knives in the world at the time. Two-thirds of the users were introduced and equipped in 1994, concentrated on the coast. Open areas and large cities in the Mainland.

In this regard, the relevant departments judged that “the γ-knife equipment has been overheated”, “not only has a narrow range of adaptation, complicated operation, but also very expensive prices.” In particular, there are problems in the use and management of gamma knives, and medical accidents began to emerge. In the year, the Ministry of Health, the Ministry of Finance, the Ministry of Labor, and the People's Bank of China Notice on Suspending the Equipment for Gamma Knife and Aikes Knife were issued. The Gamma Knife suffered a cold spell for the first time in China.

"This restriction on imported gamma knives has objectively created opportunities for domestic gamma knives." Hui Xiaobing said, "In the 10 years from 1995 to 2005, China imported very few gamma knives from Sweden. They almost lost the Chinese market."

At that time, China’s Gamma knife industry struggled to move forward –

In 1996, China developed its first rotary head gamma knife;

In 1998, China creatively developed a body gamma knife to extend the treatment range of gamma knife from craniocerebral diseases to tumors in major parts of the body;

In 2003, China re-launched the head-body gamma knife, taking into account brain diseases and body tumor treatment.

"The body gamma knife and the head gamma knife use the same principle and the same technology, and are high-end equipment for independent innovation in China's large medical equipment." Xia Tingyi said.

It was then that the storm came.

In 2002, the Ministry of Health held an expert discussion meeting to study whether to ban Chinese gamma knives.

Xia Tingyi told this reporter that the reason was that some experts wrote to the Ministry of Health that the Chinese gamma knife is actually a replica of the cobalt-60 radiotherapy machine, and the cobalt-60 radiotherapy machine has been used for decades, and it is of little value. The value of the gamma knife itself is not large. In addition, some hospitals abuse gamma knife treatment, which has adverse effects in society. It is recommended that the Ministry of Health ban.

"I have the honor to attend the meeting. After everyone's views, I asked two questions. First, has anyone in the room used this 'knife'? Second, since it has not been used, how can we judge that this 'knife' is not easy to use? I can't use it. Then, I reported the results of my treatment of lung cancer, lung metastases, liver cancer, liver metastases, and pancreatic cancer for more than two years. After the meeting, the Ministry of Health did not issue a document to ban the gamma knife."

Recalling this past, Xia Tingyi could not restrain his inner anger: "I am very surprised, how can a person who is unclear about the gamma knife technology's advanced multi-source focusing principle and the backward cobalt-60 radiotherapy machine? What is the demand for innovative technology to ban?"

He is even more distressed that the Chinese gamma knife, which is "difficult to die", is still struggling in a vicious circle.

Behind the floating

"The domestic head gamma knife has received quite a lot of recognition, and it has also obtained permission for access to the United States, the European Union, etc., and the body gamma knife is not so smooth." Xia Tingyi said frankly.

According to the data provided by Chen Xiaohong, deputy minister of the Ministry of Health, in the “National Health System Infrastructure and Equipment Management Work Conference” in 2008, 36 head gamma knives were approved nationwide.

According to the "National gamma ray head stereotactic radiosurgery treatment system configuration plan" issued by the Ministry of Health in 2007, the total amount of national head gamma knife configuration should be controlled within 60 units from 2007 to 2010, among which, 2007-2008 The annual control is within 50 units.

In the relevant documents and leadership speeches of the Ministry of Health, the body gamma knife and the head body gamma knife were not mentioned.

At present, more than 200 gamma knives equipped by Chinese medical institutions are mostly approved by the Ministry of Health, which is independent of the Ministry of Health system.

Xia Tingyi said that the medical institutions of the Ministry of Health are the main force in the Chinese medical profession. Some of the large hospitals under their jurisdiction have doubts about China's independent innovation of the gamma knife and are reluctant to use it. Some want to use it but have not been configured. license.

He sighed, "There are relatively few radiotherapy conditions in small and medium-sized hospitals with gamma knives. Some medical technicians know less about radiotherapy technology, and even don't understand the characteristics and indications of gamma knife technology, plus market operation and economy. The impact of interests, the abuse of Gamma Knife has occurred from time to time, causing a lot of negative effects, and this adverse effect has further aggravated the distrust of the gamma knife.

There are always three major topics surrounding the Chinese Gamma Knife: Is its application value large or small? Does the regulatory measure focus on “licensing” or “normative”? Is “national trust” or “suspiciousness” for national brands?

Li Xiongxiong said that there are many "knife" in tumor radiotherapy, such as "photon knife" and "jet knife". In fact, these "knife" are a kind of treatment for radiation therapy, and their professional names are "stereotactic". Radiation Therapy".

"In the technical means of radiation therapy, gamma knives have certain indications. Some tumors can be treated with gamma knife and X knife, or new radiotherapy techniques such as intensity-modulated radiotherapy and image-guided radiotherapy. It has also been widely used in the last ten years. This may be one of the reasons why the academic community is less interested in Gamma Knife."

Li Shaoxiong explained that the international general recognition of the head gamma knife, because physically, after the head is fixed, the respiratory movement and organ movement have little effect on the treatment, and the positioning effect is better (the error caused by the position is relatively small). It is an improvement to apply this kind of equipment to the body and improve the implementation method in China. It is also a technology with independent intellectual property rights in China. However, compared with head and neck tumors, the organ movement and respiratory movement of the fixed body tumor have a relatively large effect on the treatment, which means that the tumor will also move in the treatment. In contrast to larger tumors, the scanning pattern makes the dose distribution uneven, so a small number of people oppose the body gamma knife.

"However, the research results of body gamma knife or body stereotactic radiotherapy have been published in very good foreign journals. It should be said that for diseases with gamma knife indications, the curative effect is better. Therefore, as long as strict Master the indications, body gamma knife or X knife can be widely used in clinical." Li Xiongxiong said.

Xia Tingyi's research and clinical results show that Gamma Knife has significant efficacy in the treatment of lung cancer, liver cancer, pancreatic cancer and other tumors. In September 2006, he published in the International Journal of Radiation Oncology and Physical Biology, "The exciting clinical results of systemic gamma knife treatment for early non-small cell lung cancer in the inoperable surgery", which has been repeatedly quoted by many scholars at home and abroad.

Xia Tingyi said that his radiotherapy department of the General Hospital of the Air Force had been equipped with domestically produced head and body gamma knives since 1999, and had strict indications for indications. Each year, there were four or five hundred gamma knife treatments. "This figure fully demonstrates the clinical application value of gamma knife and patients with more indications."

Professionals with different opinions believe that the indications of Gamma Knife are relatively narrow, especially for hospitals with fewer sources. Due to economic interests, it is likely to relax the indications of Gamma Knife and cause adverse consequences.

Xia Tingyi stressed that "the three armed forces need heavy weapons and light weapons. A large radiotherapy center should be equipped with a variety of radiotherapy equipment, what needs to be used, what can be used. For patients suitable for gamma knife treatment In other words, the gamma knife is the most suitable, and the gamma knife has a larger dose focusing advantage than the X knife. This is the main technical reason why the head X knife has been trying to replace the head gamma knife. ."

"Quasi-birth certificate" and "account"

The supervision of the gamma knife should focus on “permission” or “normative”, and the debate is more intense.

In 1995, the Ministry of Health, the Ministry of Finance, the Ministry of Labor, and the People's Bank of China Notice on Suspension of Equipment for Gamma Knife and Axe Knife, the Gamma Knife must be approved by the Ministry of Health and issued with a permit.

This requirement evolved into a certification policy in 2004.

At the end of 2004, the Ministry of Health promulgated the "Management Measures for the Configuration and Use of Large-scale Medical Equipment", which divided the management items of large-scale medical equipment into two categories, namely, A and B, and implemented a configuration planning and configuration certificate system. Among them, Class A equipment with large capital investment, high operating cost, complicated use technology and great impact on health expenditure growth is managed by the Ministry of Health.

Gamma Knife is a Class A device. This means that hospitals that want to introduce equipment need to apply for a configuration certificate from the Ministry of Health in order to legally equip the gamma knife.

In the case of gamma knife manufacturers, it often takes years and tens of millions of dollars to obtain the production of China Food and Drug Administration through various procedures such as formal tests, clinical trials, and trial production licenses. license.

Generally speaking, the production license is equivalent to the “birth certificate”, and the configuration certificate is equivalent to the “hukou”. Both are indispensable.

Hui Xiaobing told this reporter that during the ten years from 1995 to 2005, the Ministry of Health did not make a configuration plan for the gamma knife. He said: "I am in favor of regulation. The question is what the government department should supervise."

"In management, we can't confuse the gamma knife technology with the abuse of the gamma knife." Xia Tingyi made an analogy. "I have produced the BMW car. You have to drive the BMW out and hit the people. The relevant departments have hit the board." On the producer side of BMW, this is not conducive to the development of innovative technologies."

Li Shaoxiong advocated that the relevant departments regulate the indications of radiotherapy for gamma knives, manage their use, and prevent the abuse of gamma knives, which is more conducive to the healthy development of the gamma knife industry.

Xia Tingyi said that although there is still a gap between the Chinese gamma knife technology and the rapidly developing advanced radiotherapy equipment in foreign countries, the principle of using dozens of cobalt-60 radioactive sources to form a high-dose platform for treating tumors is a leading international technology. And the effect of treating tumors is obvious to all. "Some people look down on China's Gamma Knife and say it is old-fashioned. A common argument is that there is no such thing in foreign countries. It can be seen that this is chaos. Then, if there must be someone else we can have it, then what else? Innovation?"

“There are always people who think that the moon in foreign countries is better than China’s.” Hui Xiaobing said, “This is a matter of concept.”

"In the current social environment, national brands do have their problems." Xia Tingyi also pointed out that "they don't do the most things they should do, such as upgrading software and improving equipment, but just seeing that this device can make money." After separation, we will make a copy of the equipment and create some different models. As for the new model, it has more advantages than the old model. It is worth tossing, it is hard to say."

Li Shaoxiong also believes: "The gamma knife enterprise itself still has problems. It took only a few years to change from the original one to nine, and the products produced are similar. The problems of this enterprise will of course affect. The recognition of the common people. As for whether or not to worship foreigners, I believe that the state can award the second prize for its Science and Technology Progress Award. This is already very clear."

"second line" position of radiotherapy

According to the information released by the research team led by Professor Yang Gonghuan of Peking Union Medical College in 2004, from the 1950s to the 2000s, tumor deaths have shown a significant upward trend in both men and women, cities and rural areas.

In response to the important killer of cancer, the medical profession has basically formed three major treatment methods: surgery, radiotherapy and chemotherapy. However, in the battlefield of anti-cancer treatment, radiotherapy still ranks second.

"Many people know that there is a radiotherapy method through the promotion of Gamma Knife, but even now, the public's understanding of radiotherapy is not very good, and it is often used as a supplementary therapy for surgery and chemotherapy. Therapy, in fact, it should play a bigger role," Li said.

Xia Tingyi said that in cancer treatment, it is necessary to understand and understand the effectiveness and limitations of various treatments, and to choose the most effective treatments in order to obtain better results. However, doctors and the public do not understand the progress of modern radiotherapy technology, missed many of the best time to use radiotherapy, so the value of radiotherapy has not been fully reflected. Moreover, "the radiotherapy department should be a clinical subject, and there should be a bed preparation, but it is designated as a medical technology department in a general hospital. This kind of subject positioning error has not been corrected in many hospitals."

The status and value of radiotherapy in cancer treatment has not been paid enough attention, which naturally restricts its branch--the marketing and technical level of Chinese gamma knife.

"I didn't know medicine before. I didn't know that after I did this project, there are very few medical schools in China that offer radiotherapy specialists. There are very few doctors who know this professional technology, but we must be with people who are not particularly knowledgeable. It’s very difficult to talk about our equipment,” Hui Xiaobing said.

Li Shaoxiong said that when he was in college, the treatment of tumors was first of all surgery, plus equipment for radiotherapy, and there were few medical institutions with equipment. These kinds of defects caused doctors to have insufficient understanding of radiotherapy and did not treat radiotherapy as a tumor. Radical treatment.

Xia Tingyi said, "Surgery is not born for cancer, but often surgery is dominant in the comprehensive treatment of cancer. However, the invasiveness and metastasis of cancer make it difficult for surgery to play its role. Radiation therapy is cancer. Birth, after nearly a hundred years of development, currently in the treatment of some tumors, surgery can not do, radiotherapy can be done; surgery can do, radiotherapy can do better, less trauma."

Therefore, he called for the establishment of a multi-disciplinary comprehensive treatment model for cancer with modern radiotherapy as the main means, creating a new situation in the treatment of tumors by non-invasive radiosurgery, and clarifying the setting up of clinical departments for radiotherapy, allowing radiotherapy to play a more important role in cancer treatment. .

"Inconsistent contradiction"

"The competition of modern medicine is not only the talents, but also the equipment and equipment. The field of radiotherapy relies on the advanced nature of the equipment. It can be said that the level of a doctor is higher and there is no equipment." Li Shaoxiong believes that the Ministry of Health should manage large-scale medical equipment. However, we must pay attention to the scale of supervision. "If you manage too much, it will affect the development of the discipline."

The journalists learned from various channels that the Ministry of Health has not yet accepted the interview requirements of some Chinese media about the configuration of Chinese gamma knives and large medical equipment. In response to a question from the journalist, Mao Qun'an, a spokesperson for the Ministry of Health, said: "There is an irreconcilable contradiction between the wish of the industry and the supervision of the government."

Hui Xiaobing said that he has repeatedly asked the relevant leaders of the Ministry of Health to convene a meeting to hear reports from industry and clinicians and discuss issues related to the study of Chinese gamma knives. "They always listen to me quietly and never refute me. But always see no action."

"I already knew the policies of the Ministry of Health when I took over the project, but I did not expect that we would be so difficult to open the Chinese market with the award certificate issued by Premier Wen Jiabao." Hui Xiaobing lamented, "We can only adjust the plan." We will strive to expand the foreign market and even bring our most advanced technology to the United States, so that the equipment developed by the Chinese will be branded as 'MADEINAMERICA' (Made in the USA)." (Health News)

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