godfather of surgery

Chapter 1292 International Perspective
Li Gaoyang's treatment has entered its third course, which is the final stage of the original treatment cycle. Song Ziming and Xu Zhiliang take turns monitoring various indicators.

Dr. Johannesson asked, "If the tumor hasn't been completely eliminated after several treatments, is it necessary to increase the dose of the K virus?"

Yang Ping shook his head: "No need. Increasing the dosage arbitrarily will cause a new immune storm, and sometimes an immune storm can be fatal."

"What should we do then?" Johannesson meant that if the tumor had not completely disappeared after three courses of treatment.

“We need to change our approach.” Yang Ping pulled up metabolic images of Li Gaoyang’s brain and circled the core area of ​​the tumor with his finger. “The traditional treatment concept is to eradicate the tumor completely, but in functional areas like the brainstem, it may be possible to slowly and gradually eradicate it or allow patients to live with the tumor, just like with hypertension or diabetes, controlling the tumor into a chronic disease. In traditional treatment, the idea is to eradicate the tumor completely, but in reality, it is impossible to eradicate it completely.”

Song Ziming looked up: "You mean to put the tumor into a dormant state?"

“Yes, if we can’t completely eliminate it, we’ll change its behavior pattern.” Yang Ping began drawing a diagram on the whiteboard. “Our viral vector carries not only the K factor but also gene-editing elements. If we adjust the editing target to make tumor cells highly express aging-related genes, causing them to enter irreversible growth arrest…”

“This requires… a redesign of the carrier,” Xu Zhiliang reminded.

“No need for redesign, just adjustment of the expression regulation sequence.” Yang Ping was already thinking about the technical details. “We can use ultrasound microbubble focusing technology to temporarily open the blood-brain barrier locally in the tumor, and then administer a small molecule inducer intravenously. This inducer itself is harmless, but when it encounters tumor cells that have been edited by our vector, it will trigger the aging program.”

Johannesson quickly took notes, but couldn't help asking, "Professor Yang, have you done similar experiments before?"

"We've done proof-of-concept work on animal models, but we've never tried it on humans," Yang Ping frankly admitted. "So we need Li Gaoyang's consent."

These words silenced everyone. The risks of switching to a new, unproven treatment plan midway through treatment were obvious.

After listening to the translation, Rolf turned pale and asked in a trembling voice, "Professor Yang, what is the success rate of the new plan?"

“Without data, we cannot make an assessment.” Yang Ping looked directly at him. “Continuing with the existing plan could involve increasing the number of treatments, which is one approach. However, if we cannot completely eradicate the disease, we will have to undergo repeated K therapy treatments in the future. The former approach, on the other hand, can solve the problem once and for all, without having to undergo K therapy repeatedly.”

Rolf closed his eyes, recalling the words Rikoyan had written on his tablet yesterday: "If my treatment can find a new path for those who follow, then it is worth trying."

"I need to confirm with him personally."

In the ward, Li Gaoyang was more conscious than a few days ago. The ventilator had been removed, and he was able to speak in a weak but clear voice.

After hearing Rolf's account, he remained silent for a long time.

He recalled the day he was diagnosed with a relapse, when the doctor calmly told him, "You have about six months left." At that time, he felt that six months was too short, not enough to make arrangements for his funeral, not enough to say goodbye to everyone he loved.

He has now lived two more months, witnessed sixty more sunrises and sunsets, listened to sixty more video calls with his children, and experienced sixty more days as a "living person."

“Professor Yang,” he finally spoke, his voice hoarse but firm, “if I fail, will my data be helpful to those who come after me?”

“It will be a huge help,” Yang Ping said. “Whether you succeed or not, you will be the first person to receive this combination therapy. Every data point you have will give the next patient a little more hope.”

Li Gaoyang nodded, then smiled. It was the first time he had truly smiled since he fell seriously ill. His wrinkles smoothed out on his pale face, making him look like a child.

“Then let’s do it,” he said. “Anyway, this is extra time.”

"There's one more thing I need to tell you: this therapy actually has a very high success rate in primate experiments, but you're the first clinical trial volunteer," Yang Ping told him.

……

Just as Li Gaoyang was preparing to accept the innovative treatment plan, Li Xiaoyun's standardized treatment had already begun.

Unlike Li Gaoyang's tumultuous journey, her treatment was remarkably smooth, almost monotonous. She received medication weekly, with monitoring of various data after each dose, followed by a wait for the next week. The tumor shrank at a visible rate, from an initial 5.8 cm to 3.2 cm, and now to 1.7 cm.

But today, a routine inspection uncovered an unexpected situation.

"A new enhancing lesion has appeared in the left temporal lobe." The radiologist pointed to the MRI image. "It is about 0.8 cm in size and its shape does not resemble a typical tumor recurrence, but we need to be vigilant."

When her husband, Wang Jianjun, heard the news, his legs went weak: "Wasn't...wasn't the treatment supposed to be effective? Wasn't the tumor supposed to keep shrinking?"

Yang Ping personally reviewed the images and then asked Li Xiaoyun, "Teacher Li, have you recently experienced headaches, blurred vision, or memory loss?"

"I have a slight headache... but it's not very serious," Li Xiaoyun replied weakly. "I just feel a bit foggy, like my head is covered in a layer of mist."

Has a cognitive function assessment been conducted?

Song Ziming pulled out the assessment report: "It has decreased by 12% compared to last week, mainly affecting short-term memory and attention."

Yang Ping pondered for a moment: "It might be a false breakthrough."

"False progress?" Wang Jianjun didn't understand.

“This is a phenomenon that can theoretically be encountered with K treatment,” Yang Ping explained. “Sometimes the K virus attacks the tumor and causes a local inflammatory response, which looks like a new lesion on imaging. In fact, it is a sign that the treatment is effective. But we need to rule out true tumor progression.”

How do we eliminate possibilities?

“We’ll do a PET-CT scan to check metabolic activity. If it’s pseudoprogression, the metabolic activity won’t be very high; if it’s true progression…” Yang Ping didn’t finish his sentence.

Wang Jianjun's face turned pale, after all, there was a 50% chance that it was a new lesion.

Looking at the despair in the couple's eyes, Yang Ping suddenly said, "There is another simple way to quickly identify it: cerebrospinal fluid biopsy."

"Cerebrospinal fluid?"

“Yes, we take a small amount of cerebrospinal fluid through lumbar puncture to test for tumor-related gene mutations and immune markers,” Yang Ping said. “If it is pseudoprogression, there will be a large number of immune cell activation signals in the cerebrospinal fluid; if it is true progression, there will be tumor-related mutations.”

"Then...when can it be done?"

"It can be done now." An hour later, Li Xiaoyun was wheeled into the operating room. Lumbar puncture is a minor procedure, but it was still a torment for the weak patient. As the pale yellow cerebrospinal fluid slowly flowed into the test tube, Wang Jianjun paced back and forth outside the door.

The samples were urgently sent to the gene sequencing laboratory. Normally, results would take three days. However, Yang Ping granted expedited processing, providing preliminary results within six hours.

The six hours of waiting felt like six years.

Li Xiaoyun lay in the hospital bed, holding her husband's hand: "Jianjun, if it really is a new lesion..."

"Don't talk nonsense."

“I mean, if,” Li Xiaoyun said calmly. “We’ve done our best. At least I spent three more months with you and the children. Those months were worth it more than anything else.”

Wang Jianjun buried his face in his wife's hands, his shoulders trembling slightly.

The results came out at 4 PM.

Song Ziming rushed into the ward with the report in hand, a relieved smile on his face: "False progression! A large amount of gamma interferon and interleukin-2 were detected in the cerebrospinal fluid, which are typical immune activation signals! The concentration of the tumor mutation gene has actually dropped to the detection limit!"

Wang Jianjun was stunned for two seconds, then hugged his wife and burst into tears. This time, it was tears of joy.

Li Xiaoyun gently patted her husband's back, tears streaming down her face, but the corners of her mouth were turned up in a smile.

“However,” Song Ziming added, “the immune response is indeed very strong, and we may need to undergo another short-term intensification of anti-inflammatory treatment to control the symptoms.”

“No problem! Anything is fine as long as it can be cured!” Wang Jianjun said, wiping away his tears.

This incident was documented in its entirety by reporters, and the narration in the report that evening described it as follows.

"Under the halo of cutting-edge medical care, the actual treatment process is full of uncertainty and anxiety. The significance of universal access lies not only in enabling ordinary people to have access to treatment, but also in allowing them to maintain dignity and hope amidst the uncertainty of illness."

The video, featuring Li Xiaoyun's calm expression and Wang Jianjun's tears of joy, touched countless viewers. Within 24 hours, the global K-therapy patient application platform received 30,000 new applications.

……

Just as everyone was focused on the fate of the two patients, an explosive piece of news came from Brussels.

The European Medicines Agency (EMA) has suddenly released a 50-page "technical position paper" raising seven "major concerns" about K therapy. The core issue is data security: "Patient genomic data, immune system data, and brain function imaging data generated during treatment will all be stored on servers located in China, which could lead to the leakage of the most sensitive health information of European citizens, violating the General Data Protection Regulation (GDPR)."

The document recommends: "Suspend all approval processes for K-therapy in Europe until the data sovereignty issue is resolved."

The news caused a global uproar.

At Ruixing headquarters, Huang Jiacai convened a crisis response meeting overnight.

"This is a blatant technological barrier," the legal counsel said angrily. "They didn't mention the data issue at all before, but now that they see the treatment is effective, they suddenly bring it up—it's clearly a delaying tactic!"

"Who's behind this?" Huang Jiacai asked.

The assistant pulled up an intelligence briefing: "According to our information, the French and Germans have been lobbying extensively within the European Parliament and the EMA. They are trying to push for an amendment requiring all medical technologies used in Europe to store patient data on servers located within the EU."

“These are specific provisions targeting us,” Huang Jiacai sneered. “But on the surface, they can occupy the moral high ground under the banner of ‘protecting the data security of European citizens.’”

“What’s more troublesome,” the Director of International Affairs added, “is that if the EMA really suspends approvals, our European partners with whom we are negotiating will immediately back down, and the implementation of the Inclusive Finance Framework in Europe may be delayed by more than a year, which will not be conducive to our rapid internationalization.”

“We need to respond,” Huang Jiacai said, “but not with emotional rebuttals. We will immediately draft a three-point statement: First, we respect European data protection regulations; second, Ruixing is willing to cooperate with the EMA to design a data management solution that complies with GDPR; and third, we recommend the establishment of a data security oversight committee composed of Chinese and European experts to ensure transparency.”

“This isn’t tough enough,” some objected.

Huang Jiacai said, "This is a game of rules. We need to show flexibility while adhering to our bottom line. Our bottom line is that the data must be accessible to the treatment team in real time, because treatment decisions need to be based on real-time data. However, we can accept the data being mirrored within the EU and subject to joint supervision. While adhering to our principles, we need to show appropriate flexibility and be familiar with the rules of our target markets. However, being tough won't solve all problems."

He paused, his voice turning cold: "But one thing must be clear: if the EMA insists on completely localized data storage, leading to delays in treatment decisions and impacting patient safety, we will have to reconsider our priorities for the European market. After all, it's not just Europe that needs this technology. So, while dealing with the regulations, we also need to stir up public opinion."

This is a subtle threat, suggesting that priority may be given to markets in Asia, Africa, and Latin America that are more open to data flows.

Two hours after the statement was issued, Huang Jiacai received a call from Schneider Electric.

“Mr. Huang, I regret that things have come to this point.” Schneider’s voice sounded very sincere. “EMA’s position does not represent our position. We still hope to cooperate with Ruixing.”

“But you are one of the main forces driving this issue forward,” Huang Jiacai said bluntly.

There was a pause on the other end of the phone: "We did raise our concerns, but we didn't expect the EMA to be so firm. However, this also gives us an opportunity. If Ruixing can work with us to design a data solution that meets regulatory requirements without affecting treatment, we can prove to the EMA that cooperation is feasible."

"So this is a game of 'creating problems and then solving them'?"

“That’s just how the business world is sometimes,” Schneider didn’t deny. “But I can assure you that as long as Ruixing demonstrates flexibility, we will do everything we can to push the proposal through. Our influence within the EMA is greater than you think.”

After hanging up the phone, Huang Jiacai fell into deep thought.

Schneider's words were half true and half false, but one thing is certain: European giants do have the ability to influence regulation, to make things worse or better, depending on the price.

He turned on his computer and began drafting a new proposal: "A Joint Initiative on Establishing a China-EU Framework for Mutual Trust in Medical Data Security." The core content includes: establishing a European data center for K-therapy in Frankfurt, serving as a mirror image of the main data center in China; setting up an independent oversight committee composed of five experts from each side to be responsible for data access audits; and granting patients the right to choose whether or not to use anonymized data for scientific research.

This proposal satisfies the requirement for local data storage, guarantees the treatment team's data access rights, and empowers patients with choices. More importantly, it transforms the data issue from a "China-EU confrontation" into a "technological solution."

Huang Jiacai sent the proposal to Schneider Electric with a message: "If you can get the EMA to accept this framework within a week, you will receive extra points in the European partner evaluation."

Expanding into international markets cannot rely on force and enthusiasm alone; it requires strategy and an international perspective.