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Authors: David Matthew Klein

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BOOK: Stash
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Then she thought of Jude. She had run into him over the winter when downtown with Brian and the kids for Winterfest. They had left the bonfire and jugglers at center square and were walking along Pearl Street toward the river to see the ice sculpting display when Nora announced she had to pee. When Nora needed to pee, you called all hands on deck; it was a state of emergency. A two-minute drill began to find a bathroom; otherwise she’d wet her pants. The nearest place with an open door was a restaurant called Gull, too elite-looking for family dining or kids, but they went in and three of them stood just inside the front door while Nora darted into the bathroom. Wait. Was that Jude Gates standing behind the bar? It was. The same Jude who managed the Patriot when Gwen had worked there, who hung out with her after hours, who shared his joints and poured free drinks. Jude who she had partied with and slept with and almost fell in love with, even though he had a wife in a rehab facility and a young daughter to care for. Long gone days. Young days. Days when she did not consider consequences.

Gwen checked on Nora in the restroom while the boys waited. She hadn’t thought about Jude in a long time. Should she say hello? Would he remember her? Nora finished in the stall; Gwen decided she needed to pee, too. When they came out of the restroom, Jude was looking their way. He walked over and hugged her and shook hands with each of her kids and Brian. I guess he remembered her. And sure, he remembered meeting Brian when Gwen worked at the Patriot. He’d no idea they’d gotten married, or that she still lived in the area. He insisted they stay for a drink. Nora and Nate experienced virgin piña coladas for the first time. Gwen and Brian drank a quick glass of wine. Jude invited them to
come back for dinner some night and try the menu of his new chef, Andrew Cole.

She and Brian never went back, but it was Jude she thought of when she wanted to find some weed.

Gwen lit the joint again and took a last hit, then snuffed it out against the table. She had enough time to walk the Indian Falls trail and still finish packing and have the car loaded and kids ready when Brian got home this afternoon.

Then her phone rang. It was Marlene.

“I’m stuck in the waiting room,” Marlene said. “I haven’t been in to see McGuire yet. I hate to do this, but I don’t think I’m going to be on time to pick up the kids. Can you do it and drop them off, then they can spend a few hours with me?”

“Oh, I thought your appointment was at ten.”

“I know, ninety minutes sitting here. It’s probably not worth it.”

“No, I can do it,” Gwen said. She checked her watch. She’d have to leave in a few minutes, first to get Nate, then the girls.

“Sorry to throw this back at you.”

“That’s okay,” Gwen said. “By the way, I got it.”

“You did? What was it like?”

“Pretty easy; he’s just an old friend who did me a favor.”

“You’re a lifesaver,” Marlene said.

“I mean, it wasn’t totally comfortable, but …”

“Roger and I don’t know anyone else. If it wasn’t for you, we wouldn’t know where to begin looking.”

“I won’t be able to ask him again, though.”

“Never mind, we’ll worry about that later. We’re flush now and I’m putting the kids to bed early tonight.”

“I’ll bring it by later when I see you.”

“Thanks again, Gwen, for everything. You’re a great friend.”

Gwen took a few breaths to clear her head and focus. She’d have to save the trail walk for another time. She wrapped the remains of the joint in a tissue and zipped the tissue and pack of matches inside an inner pocket in her purse. She put the bag back over her shoulder, returned to her car, checked her teeth in the mirror, and drove back along Route 157, the road a series of wide switchbacks on descent, the sun bright through her windshield. She kept two hands on the wheel and the stereo on scan, hoping for a good song. She rounded a curve and suddenly a car appeared right behind her. She heard the bass of its stereo blaring and the growl of its engine. The driver edged out across the double line as if to pass, then pulled back behind her bumper.

Her heart pushed against her throat, but she maintained course and speed, stayed calm, and held the wheel firmly. She’d been in this situation before, she could handle it.

When the road straightened, the other car pulled out again and accelerated, defying the double yellow line, flashing past, windows dark as night. It cut back into the right lane and braked into the next turn, a long arcing curve with a wide cinder shoulder and a rusted guardrail on the ridge side. She must have been looking far ahead along the curve, to where the car that passed hers had disappeared around the bend and into the shade cast by a stand of roadside trees. It must be going so fast to be gone from view already. And then a new movement in the sunlight brought her focus in closer and another car was there, a different one, oncoming, right in front of her—a heartbeat from head-on.

Gwen wrenched the wheel to the right. The other car struck her rear quarter panel with a shuddering bang, sending her car into a spin. Her body pitched but her seat belt held her in place. She stared out the windshield. She felt motionless, as if the road
and the shoulder and the road again and now the trees moved in a slow horizontal pan in front of her while she remained in place clenching a steering wheel that would not respond.

Then the view through the windshield became mottled shades of dark. A flash of sun, shade again. Then another loud bang—and this one hurt.

A Growing Market

John Wilcox, up from the mother ship in Jersey, watched Brian, not the slides. Ryan Garcia, the CFO, and Jennifer Stallworth, legal counsel, sat back in their chairs, nodding as Brian clicked through his presentation. Seated at the far end of the table, Teresa Mascetti kept watch on the reactions in the room. She’d helped Brian with the presentation and knew it as well as he did; the few times he veered from his prepared talking points he could see her inhale and get this stricken look on her face, as if he’d whispered something dirty in her ear.

Brian stood to the side in front of the room and clicked a remote to move through the slides.

“The target market is growing with no end in sight,” Brian said, as his next slide came up, a bar chart showing the increasing weight of American adults over the past ten years, with ten-year projections added on. In place of simple colored bars to show the data, Brian had found a graphic of a belt, with the buckle in the middle representing median weight and the length of the belt growing longer with each successive year as average weight increased.

Teresa drew a breath. Brian wondered if he’d offended her. He’d added that slide just this morning, although it wasn’t necessary. Everyone in the room knew the market situation.

“Looks like my belt,” Wilcox said, patting his waistline. He
was a thick, powerful man with a voice that carried like thunder over distance, a throwback sales executive who landed big contracts with hospitals and HMOs over golf, meals, and cigars. “What do you think, Jennifer? Will that belt graphic work for our revenue chart in the annual report?”

Everyone at the table chuckled.

Home run. After eliciting the reaction he had hoped for with the depiction of the belt, Brian moved quickly past the slide.

The purpose of his presentation was to promote and defend the business case for Caladon Pharmaceuticals to seek FDA approval for Zuprone as a weight-loss drug, a strategy Brian recommended and expected the executive team to support. Zuprone already was approved and marketed as an antianxiety drug, which in itself covered a broad and vague range of indications. The problem was that Zuprone had captured only a minor share in the crowded antianxiety market. There were lots of “me too” competitors, and Zuprone was one of them. Yet, even at the time of launch, evidence existed of the weight-loss benefits. Over the past three years, active off-label prescribing of Zuprone for weight loss had increased the drug’s sales and profitability, and over the past six months, since Wilcox came aboard via the acquisition and immediately assigned Brian the mission of educating more physicians about the weight-loss benefits of Zuprone, sales had soared.

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.

BOOK: Stash
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