China's gamma knife situation is difficult to gain industry recognition
Release date: 2009-07-02
"I never expected that we would face such difficulties in entering the Chinese market, even with an award certificate from Premier Wen Jiabao."
After experiencing great success, China's gamma knife manufacturing companies are now facing a challenging situation.
Hui Xiaobing, chairman of a leading gamma knife enterprise and president of the Shenzhen Gamma Knife Association, told the "Weiwang" News Weekly: "Currently, most gamma knife companies are on the brink of shutting down."
Three years ago, Hui Xiaobing was involved in the development of the "full-body gamma knife (OUR-QGD stereotactic gamma ray systemic treatment system)" which won the second prize of the 2005 National Science and Technology Progress Award, the highest honor for large medical equipment in China.
The full-body gamma knife is a domestically developed device with independent intellectual property rights, capable of treating tumors throughout the body.
"With over two million new cancer patients each year and the introduction of foreign radiotherapy equipment, if the gamma knife is used properly, it could give some patients a chance to survive," said Xia Tingyi, a member of the Chinese Medical Association's Radiation Oncology Branch and director of the radiotherapy department at the Air Force General Hospital.
However, due to some quick wins in the industry and the negative impact of improper use by certain hospitals, some scholars and officials have doubts about China's self-developed gamma knife, causing the domestic manufacturers to hold core technology but struggle to grow healthily.
"It's hard to die"
"The gamma knife has been misused in practice, and the Ministry of Health introduced policies to regulate and limit its use," said Li Yuxiong, chairman of the Radiation Oncology Branch of the Chinese Medical Association and director of the Department of Radiation Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences.
He explained that modern radiotherapy techniques include three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, image-guided radiotherapy, and stereotactic radiotherapy, which are rapidly developing. Gamma knife is a form of stereotactic radiotherapy, which is a type of radiation therapy. Its physical dosimetric characteristics mean that it has specific indications, and relaxing these can lead to unnecessary demand or even delay treatment.
In the late 1960s, Sweden introduced the world's first head gamma knife. This technology, integrating neurosurgery, radiology, radiation therapy, and computer science, was seen as a revolution in medical history because it could replace parts of craniotomy.
In 1993, China imported its first head gamma knife for treating brain diseases, costing more than $3 million per unit.
Within the next two years, China had 13 sets of gamma knives, accounting for 20% of the global total at the time. Two-thirds were installed in 1994, mainly in coastal areas and major cities.
Due to issues like limited applications, complicated operations, and high costs, the government deemed the gamma knife equipment "overheated." Medical accidents began to occur, prompting the Ministry of Health to issue a notice suspending the use of gamma knives and Aikes knives. This marked the first cold spell for gamma knives in China.
"This restriction on imported gamma knives created opportunities for domestic ones," said Hui Xiaobing. "Between 1995 and 2005, China imported very few gamma knives from Sweden, and they lost the Chinese market."
During this period, China's gamma knife industry struggled to move forward –
In 1996, China developed its first rotating head gamma knife;
In 1998, it creatively developed a body gamma knife, expanding the treatment range from brain diseases to major body tumors;
In 2003, it re-launched the head-body gamma knife, combining both brain and body treatments.
"The body gamma knife and the head gamma knife share the same principle and technology, representing high-end equipment developed through independent innovation in China," said Xia Tingyi.
Then came the storm.
In 2002, the Ministry of Health held a meeting to discuss whether to ban Chinese gamma knives.
Xia Tingyi recounted that some experts claimed the Chinese gamma knife was just a replica of a cobalt-60 radiotherapy machine, which had been used for decades and had little value. They also criticized the misuse of gamma knives in hospitals and recommended a ban.
"I attended the meeting and asked two questions: Has anyone here actually used this 'knife'? And how can we judge it’s not easy to use if we haven’t used it?" he said. "After presenting my results on treating lung, liver, and pancreatic cancers, the Ministry of Health did not ban the gamma knife."
Recalling the event, Xia Tingyi expressed frustration: "How can someone who doesn’t understand the advanced multi-source focusing principle of the gamma knife compare it to outdated cobalt-60 machines? Why would they want to ban innovative technology?"
He added that the Chinese gamma knife, despite being "hard to die," continues to struggle in a vicious cycle.
Behind the surface
"Domestic head gamma knives have received considerable recognition and have even gained access to the U.S. and EU markets, but the body gamma knife has faced more challenges," said Xia Tingyi candidly.
According to data from the Ministry of Health, 36 head gamma knives were approved nationwide in 2008.
The Ministry of Health's 2007 plan restricted the number of head gamma knives to 60 units from 2007 to 2010, with no mention of the body gamma knife.
Currently, over 200 gamma knives in Chinese hospitals are mostly approved by the Ministry of Health, outside of its direct system.
Xia Tingyi noted that hospitals under the Ministry of Health are the backbone of the medical profession, and some large hospitals are hesitant to use China's independently developed gamma knife, despite having the technology.
He sighed, "Many small and medium-sized hospitals with gamma knives lack proper radiotherapy conditions. Some medical staff don't fully understand the technology, and economic interests often lead to misuse, causing negative effects and further distrust."
There are always three main topics surrounding the Chinese gamma knife: Is its value significant? Should regulation focus on licensing or standardization? Do people trust national brands or remain skeptical?
Li Xiongxiong explained that there are many "knives" in tumor radiotherapy, such as "photon knife" and "jet knife," all of which are forms of stereotactic radiation therapy.
"In radiation therapy, gamma knives have specific indications. Some tumors can be treated with either gamma or X-knife, or newer techniques like intensity-modulated radiotherapy. This may explain why the academic community is less interested in gamma knives."
Li Shaoxiong noted that while the international community generally accepts the head gamma knife, applying it to the body requires improvements in implementation methods. It is a technology with independent intellectual property in China. However, compared to head and neck tumors, the movement of body organs during treatment affects the precision of the dose distribution, leading to some opposition.
"However, research on body gamma knife or stereotactic radiotherapy has been published in reputable foreign journals. For diseases with appropriate indications, the effect is better. As long as the indications are strictly managed, body gamma knives or X-knives can be widely used clinically," Li said.
Xia Tingyi's clinical results show that the gamma knife is effective in treating lung, liver, and pancreatic cancers. In September 2006, he published a study in the International Journal of Radiation Oncology and Physics, highlighting the positive outcomes of systemic gamma knife treatment for non-surgical early-stage lung cancer, which has been cited internationally.
Xia Tingyi stated that his department has used domestically produced head and body gamma knives since 1999, with strict indications. Each year, they perform around 400-500 gamma knife treatments. "This demonstrates the clinical value of the gamma knife and the need for more patients to benefit from it."
Professionals with differing opinions believe the gamma knife's indications are relatively narrow, especially for hospitals with fewer resources. Economic incentives might lead to relaxed usage, resulting in adverse consequences.
Xia Tingyi emphasized, "Military forces need both heavy and light weapons. A large radiotherapy center should have various equipment, choosing what is needed. For patients suitable for gamma knife treatment, it is the best option, offering a higher dose concentration than X-knives. This is why X-knives try to replace gamma knives."
"Quasi-birth certificate" and "hukou"
The debate over whether to regulate the gamma knife through "licensing" or "standardization" remains intense.
In 1995, the Ministry of Health issued a notice to suspend the use of gamma knives and axe knives, requiring approval from the Ministry of Health.
This evolved into a certification policy in 2004.
In late 2004, the Ministry of Health released the "Management Measures for the Configuration and Use of Large-scale Medical Equipment," dividing large medical equipment into two categories—A and B—and implementing a configuration planning and certificate system. Class A equipment, which involves high investment and complex use, is managed by the Ministry of Health.
Gamma knife is classified as Class A, meaning hospitals must apply for a configuration certificate to legally acquire one.
For manufacturers, obtaining production licenses from the China Food and Drug Administration typically takes years and millions of dollars, involving tests, clinical trials, and trial production licenses.
Generally, the production license is like a "birth certificate," and the configuration certificate is like a "hukou"—both essential.
Hui Xiaobing told this reporter that during the ten years from 1995 to 2005, the Ministry of Health did not release a configuration plan for the gamma knife. "I support regulation, but I question what the government should supervise," he said.
"In management, we shouldn’t confuse the technology with its misuse," Xia Tingyi said, comparing it to producing a BMW car. "If you drive it recklessly, the authorities might blame the manufacturer, which is not good for innovative technologies."
Li Shaoxiong advocates regulating the indications of gamma knife use and preventing abuse, which would help the industry develop healthily.
Xia Tingyi said that although there is still a gap between China's gamma knife technology and foreign advanced radiotherapy equipment, the principle of using dozens of cobalt-60 sources to create a high-dose platform for treating tumors is a leading international technology. "Some people look down on China's gamma knife, claiming it's outdated. But if there is no such thing abroad, then what about innovation?"
"There are always people who think foreign moons are brighter," Hui Xiaobing said. "This is a matter of perception."
"In today's environment, national brands do have their problems," Xia Tingyi also pointed out. "They don’t focus on upgrading software or improving equipment, just on making money. After copying, they create different models. Whether the new model is better is unclear."
Li Shaoxiong believes the gamma knife industry itself has issues. "From one to nine companies in a few years, the products are similar. These problems affect public recognition. Whether to admire foreigners or not, the state awarded the second prize for Science and Technology Progress. That's clear enough."
"Second-line" position of radiotherapy
According to a 2004 report by Professor Yang Gonghuan's team at Peking Union Medical College, tumor deaths increased significantly from the 1950s to the 2000s in both men and women, urban and rural areas.
In response to cancer as a major killer, the medical profession has formed three main treatment methods: surgery, radiotherapy, and chemotherapy. However, in the battle against cancer, radiotherapy still ranks second.
"Many people know radiotherapy through the promotion of the gamma knife, but the public's understanding of it is still poor, often viewing it as a supplementary therapy to surgery and chemotherapy. In reality, it should play a bigger role," said Li.
Xia Tingyi said that in cancer treatment, it's important to understand the effectiveness and limitations of various treatments to choose the most effective options. However, doctors and the public lack knowledge about modern radiotherapy, missing many optimal treatment times, so the value of radiotherapy isn't fully realized. Additionally, "radiotherapy departments should be clinical subjects with beds, but they're often designated as medical technology departments in general hospitals. This subject positioning error hasn't been corrected in many hospitals."
The status and value of radiotherapy in cancer treatment aren't adequately recognized, naturally limiting the marketing and technical level of Chinese gamma knives.
"I didn't know medicine before. I didn't realize that very few medical schools in China offer radiotherapy specialists. There are very few doctors who understand this technology, making it difficult to talk about our equipment," Hui Xiaobing said.
Li Shaoxiong said that when he was in college, the primary treatment for tumors was surgery, with limited access to radiotherapy equipment. These shortcomings caused doctors to have insufficient understanding of radiotherapy and not view it as a radical treatment.
Xia Tingyi said, "Surgery isn't designed for cancer, but often dominates the comprehensive treatment of cancer. However, the invasiveness and metastasis of cancer make it hard for surgery to play its role. Radiotherapy, on the other hand, is the birth of cancer treatment. After nearly a century of development, it can treat some tumors where surgery cannot, and even do better with less trauma."
Therefore, he called for a multi-disciplinary comprehensive treatment model with modern radiotherapy as the main approach, creating a new era of non-invasive radiosurgery and clarifying the establishment of clinical departments for radiotherapy, allowing it to play a more important role in cancer treatment.
"Inconsistent contradiction"
"Modern medicine's competition isn't just about talent, but also equipment and technology. Radiotherapy relies on advanced equipment, and it can be said that a doctor's level is determined by the equipment available," said Li Shaoxiong. He believes the Ministry of Health should manage large-scale medical equipment, but attention should be paid to the scale of supervision. "If managed too much, it will hinder the development of the discipline."
Journalists learned from various channels that the Ministry of Health has not yet accepted interview requests from some Chinese media regarding the configuration of gamma knives and large medical equipment. In response to a journalist's question, Mao Qun'an, a spokesperson for the Ministry of Health, said: "There is an irreconcilable contradiction between the industry's wishes and the government's supervision."
Hui Xiaobing said he has repeatedly asked relevant leaders of the Ministry of Health to convene meetings to hear reports from industry and clinicians on issues related to Chinese gamma knives. "They always listen quietly and never refute me. But they never take action."
"I knew the Ministry of Health's policies when I took over the project, but I didn't expect that we would face such difficulty opening the Chinese market with an award certificate from Premier Wen Jiabao," Hui Xiaobing lamented. "We can only adjust our plans. 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 'MADE IN AMERICA' (Made in the USA)." (Health News)
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