Samantha bounded down from the second floor and ran for the door.
“Samantha, stop! Don’t open that door yet.”
Luke walked to the hallway and stared at the apparition that his daughter had become. “My God, Sam, what have you done to yourself? Halloween is over.”
“You like it, Father? It’s the new Samantha.”
Luke could hardly speak. Samantha was wearing black jeans, black boots, and a T-shirt with Marilyn Manson on the front. In addition to a pentagram necklace, she wore a giant bracelet on each wrist and a chain around her waist. That was bad enough, but the worst was that she had dyed her beautiful red hair black.
“Sam, what did you do to your hair?” Luke stuttered as he tried to control his voice. “You can’t go out like that.”
“Father, calm down. All my friends dress like this. Let me show you.”
She threw open the door to reveal a skinny kid, probably fifteen, with a pasty-white complexion. He was shorter than Samantha by two inches. His outfit was almost identical to Samantha’s. His hair was black and sprayed into a spike, and he had a stud lebret hanging from his bottom lip.
“Father, this is Jimmy. He’s been showing me how to be goth.”
Luke looked with astonishment from his daughter to Jimmy and back to Samantha. Then he walked to the edge of the porch, where he saw Jimmy’s mother sitting in the driver’s seat of a ten-year-old Chevrolet, window down, puffing on a cigarette as she waited. Marilyn Manson reverberated from the open window.
“Samantha, go back in the house. You’re not going anywhere like that.”
“Father,” Samantha yelled, “you promised. You didn’t tell me there was a dress code.”
Luke sized up the situation and debated what to do. Finally he said, “All right, Samantha. Take off that chain. You don’t need it to hold up those jeans anyway. Leave the bracelets here, and you can go. Don’t you dare be home one minute past ten thirty. Do I make myself clear?”
“Yes, Father,” Samantha fumed as she removed the chain and bracelets. She tried to toss them on a chair in the foyer and missed. “Sorry, Father. You can pick them up. We’re late. Let’s go, Jimmy.”
They ran down the stairs and jumped into the car. As he watched them drive away, he pulled his cell phone from his pocket.
“Sue Ellen, Luke here. Sorry to call you on short notice. I should be taking you out to dinner or something, only I need some advice. Can I come over? I’ll even bring a bottle of Scotch.”
Sue Ellen could hear concern in Luke’s voice. “Come on, Luke. Forget the Scotch. I’ve got plenty.”
Luke and Sue Ellen had been seeing each other on a semiregular basis for the past year. The potential for a romantic relationship, perhaps more, was there, but neither pushed it. They enjoyed each other’s company and commiserated about raising kids as single parents.
Luke climbed the steps to Sue Ellen’s house, but before he could knock, she opened the door, a Scotch and water in her hand. “About time you got here. Start with this one. Let’s sit in the living room. Josh is upstairs playing some video game.”
Luke sat in an easy chair across from the sofa, where Sue Ellen folded her legs under her and waited. He sipped his Scotch for a couple of minutes. “You know anything about goths?”
“I presume you don’t mean the old European Goths, but the modern ones. Yeah, I do. I’ve run across a bunch of teenagers who are into the movement in criminal court.”
“Oh, that’s just great,” Luke replied as he took another sip of his Scotch.
“It’s usually nothing serious. Some drinking, a little marijuana, loud music disturbing neighbors, occasionally a DUI. Actually, they get into trouble about the same way that other teenagers do. Samantha into it?”
Luke described what had happened that night. “I’m at a loss. What’s possessed Samantha? What happens from here?”
“Luke, Samantha’s fourteen and she’s rebelling, probably rebelling against you and certainly against society. Kids want to be part of a group. The outfit is part of how they identify who they are and what group they belong to. Sports teams have their uniforms. Gangs have their colors. Kickers identify each other by their boots and belt buckles. Goths are just a little more extreme.”
“Wait a minute. Why would Samantha rebel against me? I’ve done the best I can as her father.”
“I’m sure you have. At least from your perspective you have. May just be that Samantha sees the relationship differently.”
Luke rose and turned to stare out the picture window into the darkness. “I’m sorry to say you’re probably right. Okay, you seem to understand this goth stuff better than I do. What do you suggest?”
Sue Ellen rose, stood beside Luke, and circled his waist with her arm. “Do nothing, Luke. The more you protest, the worse it will be. Let her be a rebellious teenager for a while.”
“Then what?”
“She’ll outgrow it. Probably when she goes to college she’ll mature out of the phase.”
“You’re telling me that I have to put up with this another three years,” Luke said as he turned to face Sue Ellen.
“That’s right, Luke. In the meantime, just love her,” Sue Ellen said as she put her arms around Luke’s neck and held him. Then she lifted her head and kissed him lightly. Luke responded by pulling her toward him and returning the kiss with one that was much more passionate and lingering.
Sue Ellen stepped back and looked into Luke’s eyes. “So, Mr. Vaughan, exactly where is this going?”
“I think we both know where we’re going. The only question is, when do we get there?” Luke smiled.
15
In the middle of Samantha’s junior year, Luke gave up trying to be a good father. In fact, he really gave up on being a father at all. It was not intentional, but he realized he had tried everything and was out of options.
It was a chilly Saturday night in February. Samantha was out with her friends. Luke was relaxed in his big easy chair in the upstairs living area with a John Grisham novel. Cocoa was curled up at his feet, snoring quietly in front of a roaring fire. His solitude was broken by the roar of heavy metal music coming from a car in the street. Cocoa barked and ran down the stairs. Sam’s home, he thought and then turned a page. Luke was resigned to Samantha’s goth friends. He didn’t like Sam’s outfits or the latest pink streak in her black hair. He only hoped that Sue Ellen’s advice that she would mature out of it proved to be correct.
Luke heard Samantha stumble over the front door threshold and trip as she made her way up the stairs. “Good evening, Father,” she slurred as she got to the second floor. “I’m going to my room. Come on, Cocoa.”
“No, you’re not, young lady. You’ll come right here,” Luke replied as he put his book on the ottoman. “How much have you had to drink?”
“Nothing, Father.”
“Sam, don’t lie to me. How much?”
“All right. We split a six-pack of beer in the parking lot at the mall.”
“Samantha, you are not to drink as long as you live under this roof.”
“Come on, Father, all my friends drink. Besides, what gives you the right to be so high and mighty? You drink every night. I never see you after five o’clock without a Scotch close by. Good night, Father.”
Samantha turned, motioned to Cocoa, and slammed the door to her room behind them.
Luke picked up his Scotch and started to drink it. Instead, he walked to the kitchen and poured the Scotch down the sink.
The next morning at nine, Luke pounded on Samantha’s door. “Sam, time to get up!”
“Father, it’s the middle of the night, for God’s sake.”
Luke opened the door and motioned to Cocoa, who was also just awakening. “Come on, Cocoa. Let’s go for a run. Sam, I expect you to be up when we get back.”
After the run he and Cocoa climbed the stairs and went into the kitchen, where he expected to find Samantha sitting at the breakfast table, probably reading the paper. He was wrong. Th
ere was no sound.
He walked to her door, threw it open, and commanded, “Samantha, get out of that bed right now. We need to talk.”
Samantha stirred and rolled over on her stomach, pulling her pillow over her head as she did so. Luke threw back the covers and tossed the pillow on the floor. “I mean now!”
“Okay, okay, Father, if it’s that important. Let me go to the bathroom first.”
Luke stomped out of the room, poured himself coffee, and sat at the kitchen table. Finally Samantha came from her room, wearing a robe and slippers. She slumped in a chair across from her father.
“You want something to eat?”
“No thanks. My stomach is feeling a little queasy. Look, I know this is about last night. I’m sorry, Father. It won’t happen again.”
Luke tried to modulate his voice. “Damn right it won’t. Until further notice you’re grounded.”
“Grounded! Father, what does that mean? I’m nearly seventeen.”
“That means that you’re not going out with your goth buddies anymore until I say so. You want to have your friends over here, that’s fine, even those weirdos. Tell you what I’ll do. I’ll even provide a couple of six-packs of beer, provided it’s drunk here and I can monitor the consumption of your friends. I’ll probably even have a couple myself. How’s that?”
“Oh, great. So I tell my friends to come over and drink with my old man. That’ll go over like a pregnant elephant. No thanks. I’ll serve my penance by myself. If you want to have me do a few Hail Marys, just say the word. Now can I be excused?”
Samantha knocked over the chair as she rose, didn’t bother to pick it up, and stormed to her room.
16
Ryan found himself, once again, standing in front of Boatwright’s desk as the director pretended he wasn’t there. Boatwright finished proofing a letter and finally looked up. “Dr. Sinclair, the Infectious Disease Advisory Committee convenes in three days. There are a few minor matters, mainly follow-ups from previous meetings, but the bulk of the meeting will be a discussion of Exxacia.”
Ryan nodded. “I’ve been working with my team, Dr. Boatwright. I’ll be prepared to present our recommendation.”
“That’s what I want to discuss. Why don’t you shut the door and have a seat?”
Ryan did as he was told. Boatwright leaned over his desk. “Dr. Sinclair, you and I disagree about this drug. I expect you to lay out your team’s findings in full. However, I would ask that you not recommend a complete rejection of the drug. These committee members use antibiotics every day in their practice. They can hear what you say and draw their own conclusions. If they choose to reject the drug, so be it.”
Anger welled up in Ryan. He took off his glasses, wiped them with his tie, satisfied himself that they were clean, and replaced them, all the while composing himself. “You want me to defer to the committee?”
“Precisely, Dr. Sinclair.”
“Why would I do that? I’m a medical reviewer. My job is to evaluate drugs and make recommendations, not to pass the buck, Dr. Boatwright.”
Boatwright rose from his chair and shook his finger at Ryan. “Your job is to do what I say. Otherwise, I’ll accept your resignation right now, Dr. Sinclair.”
Ryan wasn’t ready to resign. He believed in his work. Someone in the FDA had to be accountable to the public. There were too many Boatwrights in the agency. If he stayed longer, maybe he could lead a quiet revolution and change the system. Besides, he wasn’t quite ready to move to the CDC. He got out of his chair and replied, “I’ll think about it, Dr. Boatwright. No promises, you understand.”
* * *
The eleven members of the Infectious Disease Advisory Committee assembled from around the nation. Rarely could all attend; today nine were expected. Eight were medical doctors, and one was a scientist with a special interest in antibiotics. They had read a briefing paper prepared by Ryan’s team and expected to question the staff, but first there was lunch. They assembled in a conference room on the second floor of CDER; place cards identified their seats. Dr. Ramon Salazar from San Antonio was at the head of the table. Dr. Boatwright sat to his left. The lunch conversation was about families, changes in faculty appointments at medical schools around the country, and NFL football teams. After the table was cleared, Dr. Salazar called the meeting to order.
“We’re here today to discuss a new Ceventa antibiotic, Exxacia. I’m sure you’ve all had the opportunity to study the briefing paper. Dr. Boatwright, I understand Dr. Sinclair is available to discuss the drug with us.”
Ryan had been sitting in the hallway outside the door, arms folded, doing a slow burn since he knew that Boatwright had intentionally denied him a place at the luncheon table. Boatwright went to the door and summoned him to a small podium at the front of the room. Ryan placed a briefing book on the podium, opened it, and looked around.
“Dr. Sinclair, am I correct that you have headed up the team that has been evaluating Exxacia?”
“Yes, Dr. Salazar. My team has been focused on it for over six months. I’m comfortable that I can answer any questions your committee may have.”
“Very well, please proceed with your introductory remarks. We’ll chime in from time to time.”
Ryan paused for a sip of water. “We should start with the results of the drug in Europe and South America. Ceventa has marketed it overseas for nearly three years. As of the last available data several million prescriptions have been written, mainly for sinusitis, but also for bronchitis and pneumonia, with some doctors also using it for tonsillitis. Based on physician and patient surveys by Ceventa, the response has been very favorable.”
“If I may interrupt, Dr. Sinclair,” Dr. Anita Sebastian, an infectious disease specialist from Chicago, said, “one of your footnotes alludes to some problems with liver failure, both in after-market reports overseas and in Phase III clinical trials here.”
Boatwright’s glare at Sinclair conveyed a demand: Don’t overdo this, Sinclair. Ryan caught the look. “That’s true, Dr. Sebastian. There can be instances of toxicity to the liver.” Ryan glanced at Boatwright as he continued. “We all know that is a trade-off that must be made with any antibiotic.”
“If I may be heard.” Dr. Holloway, a physician affiliated with Emory University, interrupted. “I don’t see anything here that alarms me.”
“Just a minute, young man,” Dr. Rogers from Palo Alto said. “It looks to me like the reports of adverse events are much more frequent than with some of our more common antibiotics. We rarely see liver problems with ampicillin, for example, and it works quite well for bacterial sinus infections and even pneumonia. Plus, it’s now been around long enough that it’s a generic and a whole lot cheaper than whatever Ceventa will charge for this new one.”
Dr. Craig from Miami popped up. “And what about those reports of cardiac irregularities? I don’t like those one bit.”
“Dr. Sinclair, you and your team have been living with this drug, as you say, for six months now. What’s your recommendation?” Dr. Salazar asked.
Not liking the way the wind was blowing, Boatwright rose to his feet and interrupted before Ryan could answer. “Members of the committee, may I make a suggestion? From what I can determine, Exxacia has marvelous potential, particularly since our population is aging and, frankly, older antibiotics are just not as effective. Why don’t we mandate that Ceventa conduct a large, randomized prospective clinical trial with patients throughout the country? I would suggest that we require an approval letter be subject to Exxacia passing such a trial with flying colors. If they don’t want to spend the money for it, or if the trial doesn’t produce satisfactory results, then we can reject Exxacia. And there’s another benefit. By the time the trial is complete, we’ll have much more data from other countries.”
“I don’t have any problem with that,” Dr. Salazar said. “Certainly, more data can only help our decision. Everyone in agreement?”
Heads nodded around the table. Ryan had backed away from th
e podium and leaned against the wall, his arms folded. He didn’t see the benefit of a trial. He was satisfied that Exxacia had far too many problems. Still, he was literally boxed into a corner. At least, he thought, it’ll take a year or more to do a study, and he could always hope that more problems would surface.
17
Alfred Kingsbury directed his driver to park in a handicap space at the front entrance of the CDER complex. He pushed out the back door before Mario could get to it and burst through the front door to the security desk. “I’m here to see Dr. Roger Boatwright, young man,” he bellowed.
“Is he expecting you, sir?”
“No, he’s not, but he ought to be. You call up there and tell him Dr. Kingsbury is here to see him—immediately, you understand?”
“Yes, Dr. Kingsbury. Give me a moment.” The guard dialed a number, and after a brief conversation, he handed a visitor badge to Kingsbury. “Please sign here. Someone will greet you on the fourth floor.”
Kingsbury scribbled his name and marched to the elevator, where he punched the button three times before one arrived. On the second floor two young women entered, chatting about their children, and punched the third-floor button. Kingsbury continued to fume as they exited and he repeatedly pushed the button to close the door without success. Finally it slid shut, then opened on the fourth floor, where Roger Boatwright, thankful he’d had time to put on his coat and tie, awaited him.
“Afternoon, Alfred.”
“Today it’s Dr. Kingsbury to you. Where’s your office?”
“Right this way, Dr. Kingsbury. Can I get you coffee?”
“No, Dr. Boatwright. This is not a social visit.”
Boatwright told his assistant that he was not to be disturbed. He closed his door and was about to take his seat when he realized that Kingsbury remained standing.
“Look, Dr. Kingsbury, I know why you’re here. You got the letter this morning.”
The Trial Page 5