Leaf Baxter was born with optic nerve hypoplasia (ONH), a condition that renders infants effectively blind. For his parents, John and Stephanie Baxter, there were limited options. The most promising current treatment for Leaf’s condition involves using umbilical stem cells, but the method has not yet been approved in North America and Western Europe. John and Stephanie, desperate, turned to China’s Beike Biotechnology Company, which is pioneering a stem cell therapy for ONH in China.
"It’s simply the best medical option we had," Stephanie Baxter said. "We could try Beike’s treatment and hope that it helped Leaf’s vision, or we could stay home and do nothing outside of what standard US practice offered, which wasn’t very promising."
ONH therapy is available elsewhere, but the Chinese option was still the most attractive. "In Mexico," Stephanie said, "Leaf would be getting maybe 30,000 cells. In China, he is getting approximately 90 million."
Gene Liau, a director at Novartis, notes that China’s regulatory weakness is not without its advantages for firms like Beike. "Firms in China are able to move faster and more cheaply to get results," he said.
Jon Hakim, Beike director of international business, admits that providing the ONH therapy before it has been fully proven makes the treatment "controversial" but he says it is safe.
Regardless, the sector is undergoing rapid growth. At present there are 300 hospitals in China treating patients with stem cells for some 70 diseases. Beike itself started out with one patient in Shenzhen in 2005, but has worked with 4000 patients and 25 hospitals since then.
"We’re growing in terms of numbers of patients, probably by 100% a year," said Hakim. "We’re profitable but we’re reinvesting most of the money on research."
Most patients are Chinese, but Beike sees an average of 30 to 40 foreign patients a month.
"For foreign patients, the most important thing is a clean hospital where the doctors can speak English," Hakim said. "The Chinese, on the other hand, don’t mind being crowded, and in fact some of the most skilled doctors are in the less-renovated hospitals."
An early scare
The Baxters opted for the reasonably Xiao Shan hospital in Hangzhou. According to Hakin, it is not the best hospital in Zhejiang province, but by no means the worst. However, they still had a rough landing. On their first night there, Leaf’s blood sugar dropped to dangerous levels. All the translators, unfortunately, had gone home.
"The young doctor spoke no English and no one had given him Leaf’s medical history," Stephanie said. "I had a serious, life-threatening situation. I was beyond frightened. I was ready to turn around and go home the next morning."
The hospital quickly adapted its policy and put translators on call around the clock. Other adjustments have been made as well. Leaf is frightened by crowds, so staff have learned to talk quietly and not crowd into his room all at once.
For therapies not yet approved for use in Western countries, the lack of official certification and the cultural-linguistic barriers are offset by the desperation of the patients. As these treatments are formally approved (or denied) by Western medical authorities, the number of foreign patients may drop off. On the other hand, further improvements to China’s hospital facilities (and increasing number of multilingual staff) should improve the country’s traction.
There will still be opportunities for companies developing and implementing controversial therapies in China. The risks of such therapies must be born by consenting patients, of course, but for families who do not have the time to wait, it’s worth it.