by Stash (v5)
Seeking FDA approval for a second therapeutic indication could be cost prohibitive. Zuprone had already been through years of development and clinical trials for its original intent; repeating the process for weight loss would add significant costs to the drug’s balance sheet. But Brian’s projections pointed to increased profit because the second indication—obesity—was a growing market with no end in sight, as his clever belt slide indicated. Caladon could use the same manufacturing process and facility, and simply package, name, and market the drug differently for weight loss—once the application was submitted, clinical trials conducted, and FDA approval granted.
“The anecdotal evidence looks good in terms of number of prescriptions already written,” Garcia said. “But two things: One, we can’t go back and track these patients and call that a clinical study. And two, how much is our marketing responsible for the bump in number of prescriptions for obesity?”
“What about the research at UCSF, that guy McLellan?” Wilcox said. “We’ve been hosting a seminar that references his study.”
“It’s not the same thing,” said Jennifer Stallworth. “Research studies are not controlled clinical trials. They’re simply data points to help make our own decision whether to move forward or not. The patients who’ve been prescribed off-label have had none of the usual safeguards or controls in place. Though there is a chance some of the prescription history data can be transferred to trials.”
“I don’t want to be accused of human experimentation if we try to co-opt the existing data,” Garcia said.
“I wouldn’t worry about that,” Stallworth said. “Richardson v. Miller set precedents there. As long as the physician was seeking optimal treatment and the drug use was customary—even if off-label—it wouldn’t be considered experimentation.”
“If we start using anecdotal data about all this off-label prescribing, someone at the FDA might start wondering about the volume and how we built momentum,” Garcia said.
Brian stepped in to regain control. “Regardless of anecdotal data, we have to conduct every stage of trial for FDA approval. And I’ve projected the costs of clinical trials …” He quickly forwarded a few slides to a table of data.
Wilcox grunted. Everyone turned to look at him.
“When is Stephen coming?” Wilcox said. Stephen Jeffries was the medical director of Pherogenix. He’d been a founder of the company now owned by Caladon.
“He’s out this week,” Teresa said. “On vacation.”
Brian winced; Wilcox shook his head. Vacation was a sensitive topic with Wilcox, anyone’s vacation; he didn’t believe in them. And it was a particularly sensitive subject today. Wilcox had wanted to postpone today’s meeting until Monday, but Brian stated he’d be unavailable because he was taking a long-planned, although short, vacation.
Surprisingly, Wilcox had shrugged off the scheduling conflict during a phone call with Brian. “You probably deserve it,” he said. “We’ll come up as planned on Friday.”
You bet he deserved the vacation. Although sometimes Brian wondered what was the point. In the end you didn’t work any less or reduce your stress. He’d put in almost double time trying to pull this presentation together the last few weeks, missing dinner with his family almost every night and weekend outings to the pool. And when he got back from vacation, even if he stayed in touch through e-mail and voice mail while gone, he’d be in deep weeds again.
But in this case the vacation days would be worth the price he’d pay at work. If ever he needed time with Gwen, he needed it now. With the hours he’d been working, it was like he and Gwen were living in separate, parallel worlds, catching glimpses of each other but rarely connecting. He understood now the old phrase about two ships passing in the night. This would be Brian’s first time off in over a year and also the first time they’d spend more than a weekend at the lake house. They’d hardly gotten to enjoy it: a fully furnished custom house with a wraparound porch on Tear Lake, close to the road on one side, but with 150 feet of lakefront and a dock on the other. It was a luxurious second home with tall tinted windows and a view of America’s wilderness. The crazy thing is that between the stock and the bonus, paying for it wasn’t that much of a stretch. What a windfall the acquisition had been, with Brian the first to admit that luck, and not just ambition and hard work, had played a big role in his financial situation today.
He had started his career at Pherogenix, a start-up drug company that had been fishing medical schools to fill positions and found Brian in his fourth year. Stephen Jeffries recruited hard, offering to help pay down his school loans as a kind of signing bonus. At first Brian resisted; he had visions of becoming an MD and working a few years in war and poverty zones, making a difference for the underprivileged before settling into private practice. He’d scratched and clawed his way through four years of medical school—if he gave it up and joined Pherogenix he’d not complete his residency and never get licensed.
Then everything changed. Gwen got pregnant and Brian realized the difference he wanted to make in people’s lives was actually in one life: Gwen’s. He accepted a good salary and what he considered a boatload of stock from Pherogenix to help coordinate clinical trials for their new antianxiety drug, Zuprone. He was too busy to think about medical school again, and he never looked back. Seven years later, Caladon Pharmaceuticals grabbed Pherogenix when Zuprone showed potential. Since then Brian had been tracking data and surveying physicians who prescribed Zuprone. He’d been the first to notice the trend in off-label prescribing for weight loss. And while it was illegal for a manufacturer to promote a drug for off-label use, Wilcox jumped on the market opportunity and recruited Brian to educate more physicians and Caladon’s sales reps about the latest in obesity treatments, including Zuprone and its full range of therapeutic benefits.
Business case aside, Brian’s role in the advancement of Zuprone was a key reason he favored the FDA application. The focus would turn to new clinical trials and the drug approval process while taking any attention away from Caladon’s marketing practices on behalf of Zuprone. Brian executed that marketing under the watchful eye of the company’s attorneys, but pharmaceutical promotion had more gray than a stormy sky. Plus you never knew which overseeing agency or righteous physician or disgruntled employee might start making a fuss, and with Brian on the front lines of marketing and business development, he could quickly become a target if the finger-pointing started.
“Since Stephen’s not here let’s just move on,” Wilcox said. “You were going to tell us about the competition.”
In fact, Brian hadn’t been about to address the competition, but he now flicked forward another half-dozen slides and began speaking.
“There’s Orlistat, now available over the counter …”
“The oily discharge drug,” Wilcox interjected. “Talk about shooting yourself in the foot—or the ass.”
Another round of obligatory chuckles.
“Yet a projected $1.5 billion in annual sales, despite the side effects,” Brian added. “And Rimonabant, which blocks CB1 receptors, suppressing appetite.”
“It’s sold as Accomplia in Europe, rejected by the FDA here,” Teresa said. “Linked to an increased risk for suicide.”
“And Meridia is still out there,” said Brian.
“But none of these drugs have met expectations, with sales flattening after an initial market surge,” the CFO, Ryan Garcia, pointed out.
“Zuprone works differently,” Brian said. “Because it’s primarily an anxiety drug, it doesn’t have the same side effects, although at the higher doses generally prescribed for weight loss …”
“Let’s see the market data for the others,” Wilcox cut in.
It was Brian’s experience that Wilcox didn’t care much about competitive sales figures. Give him and his team a few talking points about competitive drugs and they were set to go. Of course, competitive research was part of any business case, and in this case it was the weak part of Brian’s presentation. He had
n’t the time to dig into the reams of research Teresa had gathered for him, instead taking a calculated risk that what mattered to his audience and to Caladon overall was what Zuprone could do in the market moving forward, not what older drugs had already done.
“We’re still compiling some of the data,” Brian said.
“I’m more concerned about drawing the FDA’s attention to Zuprone’s marketing efforts,” Jennifer said. “And that’s the first thing Stephen’s going to ask about.”
Brian was about to respond to Jennifer when Shelly Pearson, the receptionist, knocked at the conference room door and leaned in.
“Pardon me—I’m sorry. A call came through the switchboard for Brian.” She spoke to the room in general, then turned her attention to Brian. You could see the anxious look in her eyes. “It’s your wife, she said it’s an emergency.”
Brian blinked, vaguely aware that everyone had turned to look at him, but their faces became blurry and far away, part of the background.
What kind of emergency? The kids. Was it Nate or Nora? Or both.
He reached for his phone on the side table where he had placed it with his notebook. He had turned off the ringer for the meeting; there were three new messages on it.
“She said to call her cell phone,” Shelly added.
“Excuse me,” he said. He started for the door. Someone stood up. Wilcox or Garcia. Brian couldn’t focus. He walked past Shelly into the hallway, hitting the speed dial for Gwen. He took a deep breath.
She answered on the second ring.
“What happened?”
Static messed the connection. Gwen said something.
“What?”
“I was in a car accident; I’m at St. Mary’s. I’m not hurt—I’m a little …” The phone signal cleared. He heard fear in her voice.
“How are the kids?”
“They weren’t with me—I was on my way to pick them up. I’m cut; they said I need stitches.”
“Where?”
“St. Mary’s.”
“No, where are you cut?”
“Above my eyebrow. I hit my face. I mean the air bag hit me. It’s not that bad, but there was a lot of blood and it was scary. It was so loud, it was terrifying.”
His heart stopped thumping. “Where are the kids now?”
“They had to wait for Marlene to pick them up. But she has them now.”
She coughed, then started to cry. “Brian …”
“I’m on my way.”
“Please hurry. Please.”
Teresa stood behind him now, and Wilcox. Brian turned and explained that everything was okay—mostly okay, his voice cracking. Gwen had been in a car accident and was at the hospital and he needed to leave.
“Of course,” Wilcox said, creasing his brow in concern. “Is there anything we can do? How’s your wife?”
“A little banged up,” Brian said.
He looked at Teresa. She put a hand on his forearm. “Let us know.”
Among the Cupcake Wrappers
Her face pulsed, swollen and hot, like a bad sunburn. Nose and cheeks tender. Dried blood clogged her nostrils, forcing her to breathe through her mouth. More blood stained her shirt. After the nurse had cleaned her up, Gwen asked for a mirror. A red gash capped her eyebrow.
Now she lay back on the gurney, curtains on either side dividing the treatment bays in the ER. The resident, Dr. Su, stuck the side of her temple with anesthetic before starting with the sewing kit. She heard voices and noises from behind other curtains and in the hallway, someone moaning like a cow, a steady background murmur, the hum and click of machines. Overhead lights hurt her eyes.
“Air bags can deliver a tremendous punch,” Dr. Su was saying. He fingered the wound. “I’ve seen broken noses and missing teeth. Even a dislocated jaw. But it’s better than swallowing the steering wheel, no?”
He looked like a teen refugee from a third world country, not a whisker on his face, his frame thin as a coat hanger. Gwen could see, even through the gloves, he had the long and slender hands of a model. His fingers moved with precision.
Dr. Su told her he was a resident in reconstructive plastic surgery; he’d make her look perfect again. His voice was soft, but he spoke with authority. “It will be easier if you close your eyes,” he said. “That way you won’t move so much.”
Gwen closed her eyes. She started crying a little, tears leaking out the sides of her shut lids, crying not from the pain of the sutures along her eyebrow—although each one stung like a bee, despite the anesthetic—but because she was scared. Her legs trembled, she couldn’t steady her knees. She’d never been in an accident, not even a small one. Never backed into the garage door or bumped fenders with another car in a parking lot. It had been so loud; she hadn’t expected that. Like a steel door slamming in her face and reverberating through her body. Like the lid of a Dumpster crashing down. Bang! The entire event lasted only a few seconds, yet so much had happened. She remembered the view out her windshield when her car went sideways, how the landscape moved across her field of vision, but slowly, like a camera panning. She’d been so out of control, unable to influence any of it. She spun onto the cinder shoulder and struck the tree and that’s when the air bag deployed, like a gunshot, slapping her face and collarbone, then just as quickly deflating. She sat dazed, not sure how badly she’d been hurt; she could be seconds from death or simply shaking off a slap. She didn’t know—she’d never been struck in the face. Then she unbuckled her seat belt and turned off the engine. She opened her door and looked back down the road for the other car, but it wasn’t there. Only a smattering of broken glass remained on the roadway. Had the other car struck her and kept going?
Then she saw the gap in the guardrail where a chunk of steel had been ripped away, the remaining edges sharp and rusted.
“Oh no, oh my God,” she spluttered. Blood smeared her vision in one eye; more dribbled from her nose. She licked at it with her tongue, a metallic taste flooded her mouth.
She felt dizzy, foggy. But she had to do something, Gwen realized. What did she have to do? Yes. Help, call for help. She was still wearing the purse around her shoulder and she reached into it for her phone. She dialed 911 and told the operator there had been an accident, she was on Route 157, yes people were injured, she was one of them—she didn’t know how badly. When she hung up, nausea surged up her throat.
She should find the other car. It had gone over the edge of the ravine.
She tried to take a step in that direction but her legs quit and she collapsed to the ground with her back against the front wheel of her van. The sunlight blinked in and out from behind the canopy of leaves waving in the trees above her.
Dr. Su said, “Try to hold still, please. Almost done.”
“I am trying.” Then she added, “My husband is coming. He’ll be here soon.” Brian would hold her hand. It was an accident, that’s all. Not her fault. She needed a few stitches. She would be fine.
“Just one more to go.”
Gwen opened her eyes and the doctor’s fingers were dancing right over her face, tying thread. “Six altogether. Luck to have an even number.”
“What?”
“That’s what I say. It’s good luck to have an even number of sutures. I always try to do that.”
“Oh, thank you,” Gwen said, unsure how grateful she should be.
The nurse who had cleaned her up was back now, peering over Dr. Su’s shoulder at Gwen’s face. “You look good, hon. Dr. Su is very talented.”
“No scar,” Dr. Su said. “You’ll still have exquisite eyebrows.”
Other drivers had stopped across the road. One approached Gwen seated on the ground against her car and asked if she could stand. Gwen said, “Nate, I have to get Nate.”
“Who’s Nate? Is someone still in the car?”
She heard sirens in the distance, from the direction of town, coming up the hill. She had her phone, although there was blood on the screen and keypad. She pressed Brian’s number and his vo
ice mail picked up immediately. Next she tried Marlene and got through. Before Gwen could say a word, Marlene told her she was just walking out of the doctor’s office and could pick up the kids after all.
Gwen sobbed into the phone.
The commotion increased around her. First a police cruiser arrived, then the fire rescue, a daytime disco of lights swirling around her.
A paramedic squatted next to her. Gwen was aware of activity in the distance. One of the police officers had set up flares and was directing traffic through the one open lane. Another had disappeared over the edge of the ravine where several bystanders now stood on top.
The paramedic asked her questions. Was her vision blurry? Could she turn her head from side to side? Was she injured anywhere else? Could she move her arms and legs? As he spoke he wiped away the blood near her eye and around her mouth. Gwen smelled the antiseptic on the wipe. Was she having any trouble breathing? He shone a light in her eyes.
She answered none of his questions.
When Gwen saw the stretcher being wheeled over, she got to her feet and said, “I don’t need that.”
“You need medical care and we need to transport you.”
Gwen looked at her car. The front end was crumpled against a tree, the side near the rear caved in.
“Please, can you hold this?” The paramedic had pressed a gauze against her forehead. Gwen held it in place as she allowed herself to be helped onto the stretcher.
“I want to sit up.”
The paramedic angled the stretcher into a sitting position.
“Ma’am, I’m Officer Hendricks. What’s your name, please?” It was a policewoman now, uniform, pad in hand. No hat, blond hair in a ponytail. Something familiar about her.
“Gwen Raine.”
“Can you tell us what happened, Ms. Raine? How the accident occurred?”
