ProfessorSS: Little Yun, we have an issue. Three of the patients from Chenchen University Hospital have filed a lawsuit against Shennong for increasing risks of cardiovascular events.
Li Yun sighed as he looked at Professor Shao Shan’s message. He was half expecting it. Ten hospitals participated in the Yunli's clinical trial, including Qinbei, Magic City University, and Binchu University Hospital. He had the most control over Qinbei and some oversight in MCU with Professor Shao Shan, but the other hospitals were mostly out of his control.
The problem was, other than Berne, there were other large pharmaceutical companies eying the development of Yunli. Most companies ignored Huifu when it entered phase III since TCM medicine was harder to market internationally. Yunli, however, had better long-term potential. It was the type of landmark formula that could replace much of the ibuprofen and even acetaminophen market in the future.
Many of the companies, including some from overseas, had requested to buy the patient and technology from Shennong. There was even an offer from one of the large pharma companies to buy the company as a whole for 500 million yuan ($78 million USD.) The amount was a lot for a company that started less than a year ago. After Shennong declined the majority of the offer, most companies gave up as there were other players in the market to focus on. However, there were some companies who saw big potential in Yunli, and used whatever means to lower the value of the company.
Li Yun’s patent was for twenty years, but the first few years were wasted on clinical trials. Considering there were all sorts of problems during clinical trials, some companies could spend a decade in clinical trials and dealing with lawsuits. If his competitors were sabotaging the experiment, the best way to do so was through lawsuits, which served to damage the reputation of the product and to stretch out the time in litigation.
LiYun: Anything specific about the cardiovascular events?
ProfessorSS: The patients are citing heart attack, but the medical reports simply say cardiovascular events and chest pains.
LiYun: What is Chenchen Hospital’s response?
ProfessorSS: They want to pull out of the Yunli trial, citing potential negative effects.
At Chenchen Hospital, there were three groups of 150 participants. Group A was prescribed with the leading brand name ibuprofen, Group B with Yunli and Group C with a placebo. However, it was a double-blind trial, and no one at the hospital should be aware of which group received what medicine. However, if someone tested the medicine, they would be able to figure out what was given, but it was a breach of protocol. Finding new patients with chronic pain and arthritis wasn’t difficult, but Yunli was on the 13th week of a 26-weeks phase III trial. He didn’t want to restart his study.
LiYun: What is our data showing regarding the results?
ProfessorSS: 30 events for yunli, 20 for ibuprofen, and 4 for the regular placebo, but they said although they are not aware of whether it is caused by Yunli, they would still like to pull out of the study.
If the data was like the other clinical locations, there should have been around 5-10 events for Yunli. It wasn’t difficult for hospitals to create a medical incident with the patient’s collaboration, but an additional twenty patients experiencing cardiovascular events was odd.
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LiYun: They switched out Yunli with a different medicine. Did they stop the clinical trial before everyone got the next refill?
ProfessorSS: Yes. If they switched it out, it would be difficult to find evidence.
Li Yun could confirm it if he met with the patients, but the problem would be evidence. The best way to prove it was to get a confession or find evidence of collusion.
LiYun: Are they testing Berne’s medicine? Or have any connections with Berne.
ProfessorSS: Not at the moment. There is a Berne representative around that area, but I do not know what sort of relationship they have with Chenchen.
Li Yun thanked the professor and tapped his fingers on the table while searching his computers for the files on Chenchen’s hospital. After his seminar in Magic City, there were quite a few hospitals interested in collaborating with the Yunli clinical trial. Li Yun had screened and interviewed potential collaborators, but just because they passed the initial screening process, it didn’t mean they would keep their word in the future.
An image of Dr. Xuan, the chair of the anesthesia department, and Dr. Ming, the chief surgeon, popped up on his screen. They were the two people Li Yun had assigned as project managers to lead the clinical trial. If they received kickbacks and bribery; he needed to find evidence. He took out another phone from inside his coat pocket.
“Lawyer Wing Bo, can you send someone to investigate Dr. Xuan and Dr. Ming from Chenchen?” Li Yun asked over the phone. “Find out if they had recent money issues. Also, from the 150 patients on the clinical trial, find people with the most debt.”
Li Yun hung up and looked at Ju De and Fatty Fang who had been listening in. They had been taking care of Shennong while Li Yun was aboard and seemed to have gotten used to their roles. Fatty Fang was especially thankful he didn't have to take care of his child all day.
“Are they going to halt the clinical trial?” Asked Fatty Fang, yawning a bit from his lack of sleep.
“The judge could request it,” said Li Yun.
“Will it affect the overall project?”
“Just a bit, there are still 3000 active participants, but I’m afraid they may try this with the other hospitals,” said Li Yun. “If someone is desperate enough, they will start sabotaging the data. Ju De, announce that we will be suing Chenchen for breach of contract and corporate espionage.”
“You really want to initiate a lawsuit?” asked Ju De.
“We are already dragged into one,” said Li Yun. “Might as well do some damage.”
“What if the hospital fires the doctor and claims no liability?” Fatty Fang asked.
“I’m sure there were others who got kickbacks aside from the project managers. If one tree burns, the rest of the forest will burn.”
Fatty Fang couldn't tell from Li Yun's relaxed expression if he was pissed or being strategic. “This is really an aggressive stance."
“I want to drag every bit of dirty laundry from Chenchen. Sure, there might be scant evidence, but how many sponsors are they going to lose? The more they drag this out, the more damage they will incur. Let's see who lasts longer. We need to make an example out of Chenchen Hospital, or else the other hospitals will join in.”
“All right, I’ll contact Lawyer Gong,” Ju De said. He had been wanting to get them involved for some time. “How much are you going to ask for?”
“The data is already contaminated, and we can’t use it for the study. Request 300 million of damage.”
300 million seemed like a lot, but the cost of funding the study was 95k per patient. Many were paid by government grants, but the majority was investment money from Shennong.
Huifu was steadily generating income. During the first 6 months, they had received 50 million worth of orders. However, the amount was tapering after the initial publicity from his seminar and in-flight surgery. The 50 million was enough to pay back the initial investment, but not for the returns he had promised. He still needed to pay back 75 million within the next 10 years, which wasn’t bad considering the amount both Huifu and Yunli could generate in the future. And with the marketing and distribution license recently approved for Huifu, there were more options available. Li Yun wasn’t planning to aggressively advertise it yet.