Chapter 153: Ministry of Food and Drug Safety (8)

The president of the Womens Association of the apartment?[1]

Young-Joon tilted his head in confusion. Song Jong-Ho scoffed.

Shes probably telling us to leave.

Do they come and pressure you like this?

Of course. My family used to be well off, Song Jong-Ho said to Young-Joon. We used to live in a house, but things became difficult after I was diagnosed with this condition because of how expensive medication was and how our neighbors kept coming to see us.

...

Song Ji-Hyun sighed as she listened to them. She opened the door. The president bit her lip when she saw Song Ji-Hyuns face.

Are you the older sister of the son who lives here?

Thats right.

Your brother

I know. Youre telling us to leave, right? Song Ji-Hyun said quietly. Talk quietly since my brother could hear us.

Oh

And were going to leave soon. We cant take the hospital fees and the price of medication. Were going to take out our deposit and switch to a month-to-month basis.[2]

... Its not that

The president trailed off. She looked like she was in a bind.

Pardon?

Oh? Werent you on television before? the president said with wide eyes.

...

Um, youre the person who studies under Doctor Ryu Young-Joon.

I work with him. We work at different companies.

Then, youll know a lot about medicine. Even better.

What do you mean?

Thats Actually

The president of the Womens Association could not speak up easily. After some time, she finally said, My daughter isnt doing well

Shes not doing well?

The hospital said that it could be schizophrenia. They said it looks like schizophrenia from the questionnaire, but they need to do a blood test or something like that to see how much dopamine she has.

...

Was your brother like this? I was wondering what medication he is on right now and what family members should do. Were neighbors and were both in a tough situation, so I thought we could share some information. I came here because I was so anxious and frustrated.

Then, the president handed Song Ji-Hyun a plastic bag.

Oh, take this. I brought it for you and your brother.

It was some oranges.

Song Ji-Hyun was flabbergasted. The president of the Womens Association was the one who put the survey on the elevator. She was the person who had been harassing her parents so much until Song Ji-Hyun came home. It was so bad that her parents, who had a lot of pride, swallowed it and asked for her help. But now the president was here, asking her for help because her daughter had schizophrenia. Did she have no shame?

Song Ji-Hyun frowned. The president flinched, then dropped her head.

Um I made it difficult for you guys, right? I know, but there was nothing I could do. The Womens Association was putting pressure on me. I was only their puppet. Im sorry.

Song Ji-Hyun stared at her. She was so hypocritical, but Song Ji-Hyun didnt even have the energy to get angry at her. The president of the Womens Association was a middle-aged woman in her fifties who must have worked hard to get here. Like most ordinary people, this house that she owned with a mortgage was probably her only asset. Schizophrenia usually developed in adolescence, so her daughter was probably in middle or high school, just like Song Jong-Ho.

Phew

Song Ji-Hyun covered her eyes with her hand. Patients with schizophrenia and regular people who were afraid of them were all normal members of society. There were some misconceptions and prejudices mixed in, but in the end, the real evil was the disease itself.

I have to take care of my brother right now. We can talk when my parents come home later. I will tell you what you know.

Oh, thank you Thank you so much. And Im sorry.

Song Ji-Hyun, who came back inside, handed Young-Joon an orange.

Have one.

What did she say? Young-Joon asked like he knew nothing.

Young-Joon knew what they said because Rosaline went outside and heard everything they said.

The president said that her daughter also has schizophrenia, Song Ji-Hyun said.

Really?

Song Jong-Hos head shot up. Then, he bursted into laughter.

Hahaha. Good. Serves them right.

Dont be like that. The daughter didnt do anything wrong.

Song Ji-Hyun sat down on the sofa.

There are a lot of patients with schizophrenia, Young-Joon said.

Well, theres one in a hundred people. Its just a matter of the severity. Some people can control it with medication and have a normal social life.

...

But as you saw earlier, we need a drug that can cure it for sure.

Alright.

Is there anything I can help with? Song Ji-Hyun asked.

Its alright. Developing the drug isnt very difficult; the problem is whether the Ministry of Food and Drug Safety will approve it, Young-Joon said.

* * *

It wont be approved.

Oh Hyun-Dong, a member of the IRB at the Ministry of Food and Drug Safety said to Young-Joon.

Young-Joon, who received the call in his office at A-Bio, frowned.

It wont be approved?

Yes. I am telling you the truth because I really like you, DOctor Ryu. That was the decision we came to at the discussion.

But what I dont understand is that isnt it normal to ask for experiments to show that it is safe? What do you mean you wont give me approval when I havent even produced any data yet?

They wont approve it no matter what animal experiments you do. They are going to make all kinds of excuses and stop it. I tried my best to convince them, but it didnt work. They were shouting at me about whether I would take responsibility for it if there was an accident.

...

Doctor Ryu.

Oh Hyun-Dong said.

The MFDS[3] isnt as progressive and ambitious as you think. We are the most conservative out of the conservatives.

You guys just dont want to take responsibility.

I wont deny it. But that treatment method is too new. Nothing even similar to that has been done in clinical trials, has it?

...

You probably dont know this, but do you know how your pancreatic cancer treatment that used live viruses was approved for clinical trials?

How?

Originally, we werent going to approve it because the members were strongly against it. They were talking about how it was a genetically modified virus that hadnt been administered to a human body before, so we couldnt predict what kind of diseases it might cause. They also talked about who would be responsible for it

But?

But you did the clinical trial for the pancreatic cancer treatment in the United States as an international clinical trial. Since the FDA got involved, the members had something to say.

Ha, Young-Joon scoffed like it was ridiculous. So youre saying that you need something to deflect the blame?

To be honest, yes. But Doctor Ryu, you need to understand our perspective, too.

Oh Hyun-Dong said.

Were civil servants, not scientists. You are probably confident because you created the technology, but we are the ones who have to doubt it as much as possible when we apply it to patients. Thats our job.

I agree with that, Young-Joon said. But what you are trying to do right now isnt doubting it, but covering it up and denying it.

... Well, if you put it like that, theres nothing I can say.

Oh Hyun-Dong said.

But Doctor Ryu, Im not in a position to do anything about it. Most of the members were shocked when they heard about this.

...

This is exactly what the judges said. If the drug uses an innovative method like this, it must be first approved by a big and famous organization overseas, such as the FDA or the EMA.

What are you talking about?

They said that if a drug like that comes out and gets approved in the United States first, they can give you approval for a copy drug after you do the bioequivalence testing

That is a copy drug! Young-Joon shouted out of frustration. I developed this drug in Korea, but youre telling me I have to register it in the United States first and make a replica drug in Korea?

...

This is why pharmaceuticals in Korea cannot progress. We cant do our own research and establish a new market. This is why all we can do is ride on the coattails of developed countries.

Sigh

, I think so as well, but I cant do anything because everyone is so adamant.

... There are five hundred thousand patients with schizophrenia in Korea.

Yes

I was talking about this with a scientist I know personally, and I found out that they have a family member with schizophrenia. Do you know what that patient said? They asked to be part of the clinical trial, even though I had barely started mouse experiments and he doesnt know anything about it.

...

That is how desperate patients are, but you wont give me approval because theres no precedent for this treatment in developed countries?

Um Let me try to convince them one more time.

Oh Hyun-Dong said to Young-Joon in a quiet voice.

... Its not your fault. But please let me know if you cant convince them because I will have to try something else.

W-What are you going to do?

Oh Hyun-Dong asked in surprise as he knew what Young-Joon had done in the past year.

Its nothing. Do you think Im going to attack the MFDS? Im just saying that you shouldnt unconditionally oppose and ban it. Thats not how science works.

* * *

It was not easy to recreate mental health disorders in animal models. How could they know that a nonverbal animal was having auditory or visual hallucinations? How could humans confirm that they were having vicious delusions? There was no way. As such, animal models of schizophrenia were evaluated based on their behavior. For example, catatonic schizophrenia was characterized by motoric immobility, extreme negativism, echopraxia, hyperactivity, and stereotypic movement. Then, they would measure expression levels of neurotransmitters like dopamine in the animal model to determine if it has a disorder similar to human schizophrenia.

The mouse experiment was a success. Schizophrenia symptoms were greatly reduced in thirty mice with schizophrenia.

But this isnt enough, Young-Joon said.

𝕗𝐫𝐞𝕖𝕨𝐞𝗯𝚗𝕠𝘃𝐞𝚕.𝐜𝗼𝚖

What more do you need?

I only did the mouse experiment to generate baseline data, and I knew the MFDS was going to be that conservative. We need strong evidence to break through that.

What would that be? A brain organoid?

An organoid that can model schizophrenia would basically be an artificial organ. If we make a brain with that, I dont think I can handle the ethical issues they would create.

Then lets go with primates.

Rosaline said.

Apes?

Use bonobos. Bonobos are the most similar to humans, and most of all, they have a similar psyche to us. They have all the higher intellectual abilities that humans believe are exclusive to humans: empathy, patience, altruism, compassion, sensitivity, and more.

Uh I dont know. It makes me a little uncomfortable.

Young-Joon scratched his head.

Why?

Like you said, bonobos are too similar to humans, so they are being used less in animal testing.

Thats funny. Who decides what animals are fine and what animals arent?

Thats why there are a lot of scientists who are against it. But it is a little uncomfortable because they are really similar to humans. Even chimpanzees are being used less.

Thats a shame because developing this drug could help bonobos, too.

What?

Young-Joon was shocked.

Why?

What are you talking about? Bonobos can suffer from schizophrenia?

Well, they have a psyche similar to humans. Bonobos that live in urbanized zoos probably have schizophrenia.

Wait, then that changes everything, Young-Joon said. I can do the testing on those bonobos. Those animals havent been genetically engineered to produce more dopamine, they just have natural cases of schizophrenia, just like humans.

1. Apartments in Korea can have a Womens Association in the apartment to promote friendship and respond to matters of their apartment or community.

2. Korea has something called jeonse, which is a long-term deposit rental system. They typically put down a large deposit for two years and live there without paying rent. Then, the tenant would get the deposit back at the end of the contract.

3. Ministry of Food and Drug Safety