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 opening the Chinese market, even with an award certificate issued by Premier Wen Jiabao."
After experiencing a period of great success, China's gamma knife industry is now encountering significant challenges.
Hui Xiaobing, chairman of a leading gamma knife enterprise and president of the Shenzhen Gamma Knife Association, told Weiwang News Weekly, "Currently, most gamma knife companies are on the brink of suspension."
Three years ago, Hui Xiaobing participated in the development of the "full-body gamma knife (OUR-QGD stereotactic gamma ray systemic treatment system)" which won the second prize for National Science and Technology Progress Award in 2005 — the highest honor for large medical equipment in China.
The full-body gamma knife, also known as the body gamma knife, is a domestically developed stereotactic radiotherapy device designed to treat tumors in various parts of the body.
"With over two million new cancer patients each year and the introduction of foreign radiotherapy equipment, if used properly, the gamma knife could offer some patients a chance at survival," said Xia Tingyi, a senior official at 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 successes in the industry and the negative impact of improper use in certain hospitals, some scholars and government officials have raised doubts about China's self-developed gamma knife, causing the enterprises that hold the core technology to struggle for healthy growth," Xia Tingyi added.
"It's hard to survive."
"The gamma knife has been misused in practice, prompting the Ministry of Health to introduce regulations to control its use," said Li Yuxiong, chairman of the Radiation Oncology Branch of the Chinese Medical Association and director of the Radiotherapy Department at the Cancer Hospital of the Chinese Academy of Medical Sciences.
He explained that modern radiotherapy techniques include three-dimensional conformal, intensity-modulated, image-guided, and stereotactic radiotherapy, which are rapidly evolving. The gamma knife, as a form of stereotactic radiotherapy, has specific indications. Expanding these could lead to unnecessary treatments or even worsen patient conditions.
In the late 1960s, Sweden introduced the world's first head gamma knife, a revolutionary technology that replaced part of craniotomy.
In 1993, China imported its first head gamma knife for treating brain diseases at a cost of over $3 million per unit.
Within two years, China had installed 13 units, accounting for 20% of the global total at the time. Most were purchased in 1994, concentrated in coastal areas and major cities.
Due to misuse and high costs, the Ministry of Health, along with other departments, issued a notice to suspend the use of gamma knives, marking the first major setback for the technology in China.
"This restriction on imported gamma knives created an opportunity for domestic manufacturers," said Hui Xiaobing. "From 1995 to 2005, China imported very few gamma knives from Sweden, effectively losing the market."
During this time, China's gamma knife industry made progress:
- In 1996, China developed its first rotating head gamma knife.
- In 1998, it created the first body gamma knife, expanding treatment beyond the brain.
- In 2003, it launched the head-body gamma knife, combining brain and body tumor treatments.
"Both the body and head gamma knives use the same principle and technology, representing high-end equipment developed through independent innovation," said Xia Tingyi.
However, challenges persisted.
In 2002, the Ministry of Health held a meeting to discuss whether to ban Chinese gamma knives. Some experts claimed they were just replicas of cobalt-60 machines, which are outdated. Others criticized the misuse of gamma knives in hospitals, urging a ban.
"I attended the meeting and asked two questions: Has anyone here actually used the 'knife'? And how can you judge it without using it?" Xia Tingyi recalled. "After presenting my results on treating lung, liver, and pancreatic cancers, the Ministry of Health decided not to ban it."
Despite this, the gamma knife continued to face skepticism.
"Domestically, the head gamma knife has received international recognition, including approval for use in the U.S. and EU. But the body gamma knife faces more hurdles," Xia Tingyi said.
According to data from the Ministry of Health, only 36 head gamma knives were approved nationwide in 2008.
The 2007 "National gamma ray head stereotactic radiosurgery treatment system configuration plan" limited the number of head gamma knives to 60 between 2007 and 2010.
The body gamma knife was not mentioned in any of the relevant documents or speeches.
Today, more than 200 gamma knives in Chinese hospitals are mostly approved by the Ministry of Health, but many remain outside its system.
"Some hospitals under the Ministry of Health are hesitant to use domestically developed gamma knives, despite their innovative value," said Xia Tingyi.
"There are relatively few radiotherapy facilities in smaller hospitals, and some medical professionals lack understanding of the technology. This, combined with economic interests, leads to misuse, further eroding trust in the gamma knife."
The debate surrounding the Chinese gamma knife continues: Is its value significant? Should regulation focus on licensing or standardization? Do people trust national brands or remain skeptical?
"In radiation therapy, there are many 'knives' like photon knife and jet knife, all referring to stereotactic radiotherapy," said Li Xiongxiong. "Gamma knives have specific applications, and while newer technologies have emerged, they still play a crucial role."
"The head gamma knife is widely recognized internationally because it allows precise targeting after head fixation. The body gamma knife, however, faces challenges due to organ movement during treatment," he added.
"Despite these challenges, research shows that the body gamma knife can be highly effective when used appropriately," said Li Xiongxiong.
Xia Tingyi’s clinical results show that the gamma knife has shown promising outcomes in treating lung, liver, and pancreatic cancers. In 2006, he published a study in the International Journal of Radiation Oncology and Physics, highlighting its effectiveness in non-surgical cases.
"Since 1999, our department has used both head and body gamma knives, strictly adhering to proper indications. Each year, we perform several hundred treatments, proving its clinical value," he said.
While some argue that the gamma knife's indications are narrow, others believe that economic interests may lead to overuse.
"Hospitals need a variety of equipment, and the gamma knife is ideal for certain cases," said Xia Tingyi. "Its dose-focusing advantage makes it more effective than the X-knife in some situations."
"Regulation should focus on standards, not just permits," said Hui Xiaobing. "Misusing the technology is different from regulating it."
"The government should manage the use of gamma knives, preventing abuse and ensuring safe application," said Li Shaoxiong.
"While there are gaps between Chinese gamma knife technology and foreign advancements, the principle of using multiple cobalt-60 sources for high-dose treatment is internationally recognized," said Xia Tingyi. "Critics who dismiss it as outdated fail to see its real value."
"Some people believe foreign technology is always better," said Hui Xiaobing. "But innovation comes from within."
"National brands do have issues, such as not investing enough in software upgrades or equipment improvements," said Xia Tingyi. "They often copy existing models instead of innovating."
"The gamma knife industry itself has problems," said Li Shaoxiong. "With too many companies producing similar products, public perception suffers."
"Radiotherapy still ranks second in cancer treatment," said Li. "Many people don’t fully understand its importance, viewing it as a secondary option rather than a primary one."
"Radiotherapy departments should be treated as clinical specialties, not just support units," said Xia Tingyi. "This misunderstanding limits their development."
"The status of radiotherapy in cancer treatment hasn't been given enough attention," said Hui Xiaobing. "Without proper education, it's hard to promote the use of gamma knife technology."
"Modern medicine relies on both talent and advanced equipment," said Li Shaoxiong. "Over-regulation can hinder progress."
"There is an irreconcilable contradiction between the industry's wishes and government oversight," said Mao Qun’an, a spokesperson for the Ministry of Health.
"We have repeatedly requested meetings with Ministry of Health leaders to discuss gamma knife issues, but no action has been taken," said Hui Xiaobing.
"I knew the policies before taking over the project, but I didn’t expect the difficulties in entering the Chinese market, even with an award from Premier Wen Jiabao," he lamented. "We must adjust our strategy and expand into foreign markets, even making our most advanced technology appear as 'Made in America.'" (Health News)
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