338: Chapter 338 The Judgment of Life

Washington, D.C.

The FDA headquarters is located in Maryland, a gray concrete building that looks like a fortress.

The offices of the Center for Devices and Radiological Health are on the fourth floor, and from the window, one can see the spire of the Washington Monument.

Jeffrey Shuren sat behind his desk with three documents spread out in front of him.

The first was an emergency procurement request from the Mayo Clinic.

The second was an emergency procurement request from the Cleveland Clinic.

The third was the technical documentation for Huatuo II submitted by Xingchen Headquarters.

Fifty-five-year-old Shuren is an authority in the field of medical devices; he has worked at the FDA for twenty years, rising from a junior reviewer to center director.

He has seen countless innovative products, but this technical documentation made him uneasy.

It wasn't because the technology was flawed. It was because the technology was too effective.

He convened an internal video conference. On the screen, there were six grids and six faces.

"Both the Mayo Clinic and the Cleveland Clinic have applied to import Huatuo II. What are your thoughts?"

A younger reviewer raised their hand: "Technically speaking, it should be safe. The data submitted by Xingchen Headquarters is very complete, including animal experiments, human clinical trials, and third-party inspection reports."

Another said: "Regarding the haptic feedback system, we truly have no precedent. We might need more data."

Shuren was silent for three seconds. Then he said: "Use 'national security' as a pretext to drag it out for now. Just say we need to review 'data cross-border transfer risks'."

Someone was stunned: "Director, this is medical equipment, not a weapon..."

Shuren smiled bitterly: "I know. But the White House has given the word—we cannot let them enter the U.S. market easily."

Ottawa, Canada.

A completely different scene. The Minister of Health signed the approval document directly. The pen dropped without hesitation.

"Huatuo II meets Canada's medical device safety standards and can be imported and used starting today."

On the same day, the UK, Australia, and New Zealand approved it simultaneously.

The morning of September 3rd, Basel, Switzerland.

The rehabilitation area of the university hospital is in the east wing. There is an entire floor-to-ceiling window here, where sunlight streams in, illuminating the pristine white hospital beds.

Mark stood in front of the window, standing on his own. No wheelchair.

Twenty-eight-year-old Mark, who was sitting in a wheelchair a month ago telling Shen Mubai "I am waiting to die every day," was now standing, his back straight, like any healthy young man.

He was wearing a hospital gown, the blue and white striped fabric hanging loosely on his body. The Rhine River flowed quietly outside the window, with tour boats slowly passing by on the water; people on the boats waved at him. He waved back.

The door pushed open.

The attending physician, Hans, walked in—fifty years old, with graying hair and gold-rimmed glasses. He is the most authoritative genetic disease expert in Switzerland, having worked at the Basel University Hospital for twenty-five years.

He held an examination report in his hand, a smile on his face.

"Mark, your muscle tone has returned to normal. The muscle biopsy shows that the expression rate of functional dystrophin has reached eighty-two percent."

Mark was stunned: "What does this mean?"

Hans smiled, a smile filled with relief, pride, and a hint of letting go of a burden: "It means your Duchenne muscular dystrophy has been cured."

Tears welled up in Mark's eyes. He turned and looked out the window. The Rhine River flowed quietly, shimmering under the sunlight. In the distance, the spires of the Basel Minster were visible, and the bells were tolling ten o'clock.

He remembered a month ago, sitting in his wheelchair, looking at the same scenery, thinking: This is probably the last time. Now, he was standing.

In the hall of the rehabilitation area, the sunlight was even brighter. Seventeen patients stood in a row.

They had sickle cell anemia, thalassemia, Huntington's disease, hemophilia... Those names that were once death sentences, now written on medical records, no longer represented death.

A month ago, they were all still waiting. Waiting for death, or waiting for a miracle. Today, they were all cured.

Journalists were taking photos frantically. Flashes lit up, and the sound of shutters rang out in unison.

A New York Times reporter crouched down and asked one of the fifteen-year-old boys. The boy used to be a hemophilia patient, unable to exercise, unable to bump into anything, not even able to attend physical education classes.

"What do you want to do the most right now?" The boy smiled. It was the smile a fifteen-year-old should have—sunny, bright, and without shadows.

"I want to play basketball. I never dared to before."

On the same day, Washington, D.C. In the Capitol Hill hearing hall, there was not a single empty seat. All one hundred seats in the gallery were filled, and dozens of people were standing in the aisles. Journalists squeezed into a designated area, their cameras pointed at the witness stand.

The title of the hearing read: "Why Can't American Patients Get Life-Saving Drugs?"

FDA Commissioner Stephen Hahn sat on the witness stand, his expression grim. His tie was neatly knotted, and his suit was crisp, but the fine beads of sweat on his forehead betrayed his nervousness.

Senator Bernie Sanders sat on the podium, holding up a photograph. In the photo was the silhouette of Mark standing in front of the window at Basel University Hospital. Sunlight shone on his face, and there was a smile on his lips.

"This young man, a Duchenne muscular dystrophy patient, was told in the United States that there was 'no cure.' He went to Europe and received Nuwa CRISPR-3 Gene Therapy. Now he is standing up."

Sanders stared at Hahn, his gaze burning: "Tell me, why do American patients have to go to Europe to survive?"

Hahn wiped his sweat: "Mr. Senator, we need time to review the data. We are currently evaluating the materials submitted by Xingchen Headquarters..."

Sanders interrupted him: "Review? Xingchen Headquarters' data is all public! Three thousand two hundred patients, one thousand eight hundred patients, seventeen types of genetic diseases! The Lancet says this is the 'SpaceX moment of surgery'! What are you still reviewing?"

The entire room erupted in applause. In the gallery, someone stood up to clap. One by one, eventually everyone stood up.

Hahn's expression grew even grimmer.

Outside the FDA headquarters, the same scene unfolded. Thousands of patients' families surrounded the building again. But this time, they weren't holding placards; they were holding photos. Recovered children, young people who could stand, elderly people who could speak again.

Under every photo was written: "The FDA can't save us, Xingchen Headquarters can."

"Let Huatuo II in!"

"Approve Nuwa CRISPR-3 Gene Therapy!"

A middle-aged woman stood at the front, holding a photo of her daughter. In the photo was a little girl around ten years old, smiling brightly. Below it was a line of text: "She was cured of leukemia in Europe. Why can't she come home?"

The morning of September 4th, Shenzhen.

On the top floor of Xingchen Headquarters, in Su Chen's office, the view outside the floor-to-ceiling window was of Shenzhen Bay. The seawater shimmered under the sunlight, and the skyline of Hong Kong was faintly visible in the distance.

Lin Wan stood behind him, holding a tablet, reporting the latest data: "European medical tourism is booming, with flight bookings increasing by three hundred percent. Swiss International Air Lines has specifically launched a direct flight route between Zurich and Shenzhen, with three flights per week."

"Canada, the UK, and Australia have already approved Huatuo II. The Mayo Clinic has offered three times the price to purchase it."

"The FDA is still dragging its feet."

Su Chen did not turn around. He looked out the window, silent for a moment.

"How is the production capacity?"

Lin Wan turned to the next page: "The annual production capacity for Huatuo II is fifty units, and domestic orders are already backed up until next year. The treatment capacity for Nuwa CRISPR-3 Gene Therapy is currently about two thousand people per year. We are expanding production, and it is expected to reach five thousand people next year."

Su Chen nodded: "Then let them wait in line. Tell the Mayo Clinic that they can buy it, but they must follow the order. The United States is behind Canada."

He paused: "As for the FDA—let them keep dragging it out. For every day they delay, more American patients will see the photos of those recovered in Europe. They will force the government to change in their own way."

Outside the window, the lights of Shenzhen Bay began to twinkle. In the distance, an airplane was landing, leaving a long contrail. It was a flight from Europe, carrying another batch of patients seeking treatment.