| General Fiction posted September 17, 2024 | Chapters: |
...37 38 -39- 40... 
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Animal trials and a visit from Fran and Mike
A chapter in the book DUEL with the DEVIL
DUEL with the DEVIL - Chapter 39
by Jim Wile
| Background A brilliant young chemist creates a new painkilling drug with unknown benefits and pitfalls. |
Recap of Chapter 38: Brian has created and equipped his lab at huge expense with Julia’s full support. The science behind Brian’s new drug is explained in some detail. It will work using the same mechanism as the dentist’s lidocaine, which is completely different from the way opioids work. It can target the area of pain by the use of nanoparticles, and it causes the sodium channels in nerves to swell shut, blocking the pain pathway to the brain. Brian names the drug Dipraxa for the two practices involved.
Because of Covid, Julia is no longer touring, and she helps Brian in the lab. After initial success on individual cells, he is now ready for animal trials, and he files a patent application at the same time.
Chapter 39
Before I could hope to get the Food and Drug Administration (FDA) approval to run clinical trials of a new drug on humans, I had to demonstrate its efficacy and safety via animal testing. It’s important to see how a new drug interacts with an entire living organism rather than just individual cells.
I used white rats for the experiments. Taking care of the rats’ physical needs, like feeding and watering, was something Julia volunteered to do. In some of the experiments, I unfortunately had to subject them to pain, but I followed well-established protocols from NC State’s Institutional Animal Care and Use Committee, who also carefully reviewed my study design.
It took surprisingly few animal trials to verify the results I had seen with my other testing methods, and I was relieved about that. No one, save maybe a psychopath, likes to torture animals. There is an ethical dilemma with animal testing, and you have to constantly keep in mind the human goal. Even so, it’s a difficult thing to have to do. Fortunately, it was a very short phase of the drug’s overall testing because the drug’s theory was sound.
Throughout the entire development process, I invited my old professor and boss, Paul Rieke, several times to my lab to view the results. It was wonderful to have a sounding board like him to review my work and to suggest further tests I could use.
Fran and her husband Mike also made numerous visits during this time. They married eight years ago and also lived in Charlotte.
When Fran first met Mike on the ship during Fran’s cruise 10 years ago, he had claimed he was a lineman for Duke Energy. This was a cover story because he was actually a Department of Homeland Security agent involved with covert ops. He eventually revealed this to Fran.
During the past 10 years, Fran had moved on from being a sheriff’s deputy and later a detective to becoming an FBI field agent who now worked out of the field office in Charlotte. What exactly she did there, she wouldn’t tell me.
Fran and Mike visited us one weekend afternoon in early September, 2021. I took Fran upstairs to the lab to show her around, and we got into a discussion about our jobs.
“So, Fran, is the FBI trying to figure out if the Covid virus was purposefully spread to this country?”
“You know, little brother, if I told you that, I’d have to kill you. I can’t tell you what the agency is working on or what I’m personally doing either. I can only comment on what the agency has made public.”
“Well, can you tell me if you, personally, aren’t working on that?”
“No, I can’t even do that. I’m bound by confidentiality not to discuss anything that isn’t publicly known, even with family members. Spouses aren’t exempt either. Mike and I don’t discuss specifics of what we’re involved in at work.”
“C’mon, really?”
“Yes.”
“How about with another FBI agent?”
“Can’t even do that unless they’re directly involved with the same mission. Confidentiality is taken very seriously there.”
“Ya think?”
She chuckled. “Why do you care so much?”
“I don’t know. You’re my sister. You know everything about what I’m working on here. I just wanted to know what you were working on. Must be a drag not being able to talk to anyone about your work.”
“In a sense, yes. It's challenging to avoid discussing it with Mike, but it's a necessity when working for the FBI. It’s pretty clear why.”
“I suppose.”
“So, how has your back pain been lately, Brian?”
“The spinal cord stimulator is still working, but as I’ve aged, the analgesic effect has diminished some. I’ve had the leads adjusted a few times, but I’d say my pain level has slowly grown from about a 2-3 when I first started using it, to a 4-5 now. That’s one of the reasons I’m trying to fast-track this drug.”
“How would you say it’s going?”
“Jules was helping me do animal testing, and we just finished up last week. It went surprisingly well.”
“So, what’s left to do?”
“Human trials.”
“How do you go about getting test subjects?”
“To be honest with you, Fran, I’m going to experiment on myself first before I submit an Investigational New Drug application, called an IND, to the FDA. Don’t you just love all these TLAs?”
“TLAs?”
“Three-letter abbreviations. But I imagine you’re used to them, working in one of the alphabet soup agencies.”
“Oh yeah.”
“So, yep, I’m going to test it on myself first.”
“Does Jules know you plan to do that?”
“Of course. I would never hide something like that from her.”
“That’s good. Is it even legal or ethical, though, to test it on yourself?”
“Yes, but there are a few caveats. You’ve got to be careful of confirmational bias when testing it on yourself. You really want the drug to work, so you’re likely to discount any data that doesn’t support your beliefs and favor results that match them. But in this case, there will be no question about whether or not it works, because I won’t consider it a success unless my pain level gets down to a 1, and that’s a hell of a big difference from my current level of 4-5.
“Another thing is that even though it’s just on me, I will still have to give informed consent as a test subject. Everything has to be done legally and aboveboard. Of course, I'll share the results with the FDA when applying for the IND, and I'll still have to conduct the rigorous schedule of testing phases required for a new drug to be approved. Phase 1 will require a test group of between 20 and 100 volunteers, and further phases go up from there.”
“Sounds pretty involved.”
“Yeah, it is. I don’t expect it to be fast-tracked the way the Covid vaccines were, though.”
“Yeah, I can see that. That’s life and death. Yours is just pain.”
“Well, yes and no. Did you know there are about 80,000 deaths a year in the US from opioid overdoses? You’ve seen it nearly happen to me twice. I was lucky both times that I didn’t become one of those fatalities.”
“That’s a good point. So, your drug will replace the need for opioids for pain management. Won’t people still be able to take them just to get high, though?”
“Yeah, if they can get their hands on them. Hopefully, they won’t be manufactured anymore after my drug is introduced. A lot of addicts begin using them because of pain, though, so if they never get started on them and become addicted, there should be fewer overdoses leading to death. If my drug had been available when I was 16, I never would have gotten involved with Oxy.”
“I’m really proud of you, little brother. This will be an amazing achievement that you accomplished virtually by yourself. I always knew you were smart.”
“Well, let’s see if it works first.”
We had talked for a good while, and there really wasn’t much to show her that was new up here, so I said, “Why don’t we go back down and see what Jules and Mike are up to?”
When we were downstairs again, I could hear bluegrass music playing. Julia was telling Mike how she had recently developed a liking for bluegrass and had begun buying a few recordings.
“Did you tell him the story of how that came about, Jules?” I asked her.
“Not yet. I wanted Fran to hear it too.”
“Now this sounds intriguing,” said Mike. “It’s a little surprising that a famous classical musician like yourself would have an interest in bluegrass music.”
“What’s so surprising?” she countered. “Music is music. If it’s pleasing to the ear and the soul, what difference does it make what kind it is?”
“But bluegrass? Isn’t that for hillbillies and hicks?” he asked.
“Maybe I’m a hillbilly at heart, but I like it.”
“Alright,” said Fran. Let’s hear the story.”
“Okay. Brian and I decided to go to The Mellow Roast coffee shop downtown a few months ago after it reopened from being shut down, and the afternoon we went, there was a bluegrass band performing outside on a little stage. This was a beautiful late spring afternoon. We were enjoying the coffee and the music and the crowd, but in the middle of the performance, the fiddle player appeared ill and had to leave suddenly. The band leader jokingly asked the crowd, ’Is there a fiddle player in the house who might want to join us?’
“People laughed, but Brian said to me, ‘Jules, I don’t think he’s really expecting anyone to come forward. Why don’t you go up there?’ So on a whim, I did. The band leader, whose name happens to be Willy Stubblefield, was surprised that he actually had a volunteer, so I picked up the fiddle that the stricken fiddler had left and started to play along with them. I didn’t know the song, but I just listened to a few bars first, got the feel for it, and just started playing. Everyone seemed to enjoy it.
“Willy asked me if I knew any songs of my own, and really, the only one that came close to bluegrass was the country song ‘The Devil Went Down to Georgia.’ So, we played that one, and he knew all the words and sang along. It got big applause, so Willy asked me in front of the crowd if I’d ever played professionally before.”
I cut her off then and said, “So in typical Julia understated fashion, she says she’s made one or two CDs. Then Willy asks her, ‘So what’s your name, darlin’?’ and Jules tells him, ‘It’s Julia Kendrick.’ Now, Willy is a wise old guy, and he’d recognized her from the start, so he says, ‘Wait a minute, you’re not that classical violinist who’s a virtuoso soloist who tours the world and plays with famous orchestras, are you?’ So, tell them what you said, Jules.”
“’Uh, maybe?’ And he says, ‘Do you think you could show these good folks how a real classical violinist plays, Julia?’ So, I said, ‘Sure,’ and I started to play about two minutes worth of Mozart’s Violin Concerto No. 5. The crowd loved it and gave me a standing O when I was done. Willy gives me a hug and says, ‘Darlin, you can come play with us anytime you want,’ and I said, ‘I just may take you up on that.’
“Right up on stage there, Willy hands me his business card, and I signaled Brian to fish one out of my wallet in my purse, which I’d left with him, and he brings it up and hands it to him. The audience loves this. After that, Willy says, ‘Let’s hear it for Julia Kendrick, folks!’ and the place erupts as I wave to the crowd and go back and sit down with Brian.”
“I’ll be damned,” said Mike. “That is some story, Jules. So, you going to play in his band now?”
“You never know. They’re called ‘The Clark Creek Drifters.’ They made the CD we’re listening to.”
“Amazing,” said Fran. “Here’s this world-class soloist playing fiddle in a dinky bluegrass band.”
“And the banjo.”
“You play the banjo now too?”
“Yep, just started.”
“You two never cease to amaze me,” Fran said, looking at the two of us and shaking her head.
“Alright, ye of many talents,” said Mike. “How are your cooking skills? I’m starving here.”
We all laughed, and Jules and I headed into the kitchen together to get the meal ready.
 Recognized |
Brian Kendrick: The narrator of the story. At the beginning of the story, he is 12 years old and in 6th grade in Kernersville, North Carolina. The story traces his life into his 30s.
Julia Kendrick: Brian's wife whom he met at rehab when they were 16. She becomes a premier violinist.
Francine (Fran) Kendrick: Brian's older sister. She is 18 at the beginning of the story and goes to junior college, where she studies law enforcement.
Rafael Ortiz (Raffi): Youth therapy group leader at the rehab facility.
Robert Entwistle: Julia's father.
Dr. Marie Schmidt: Julia's mother.
Mike Pekarsky: Fran's boyfriend who she met on her Caribbean cruise.
Daniel Molebatsi: Brian's undergrad college roommate. He is from Botswana and is a business major.
Dr. Paul Rieke: Brian's organic chemistry professor.
Kimiko Yamada (Kimi): Brian's organic chemistry lab partner. She is from Japan and also resides in his and Daniel's dorm.
Willy Stubblefield: The leader of the Clark Creek Drifters bluegrass band that Julia joins.
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