For my wife, Vicki,
who encouraged me to become a writer and inspired me to succeed
Author’s Note
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs.
—Mission Statement,
United States Food and Drug Administration
Contents
Title Page
Dedication
Author’s Note
Prologue
Chapter 1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
Chapter 6
Chapter 7
Chapter 8
Chapter 9
Chapter 10
Chapter 11
Chapter 12
Chapter 13
Chapter 14
Chapter 15
Chapter 16
Chapter 17
Chapter 18
Chapter 19
Chapter 20
Chapter 21
Chapter 22
Chapter 23
Chapter 24
Chapter 25
Chapter 26
Chapter 27
Chapter 28
Chapter 29
Chapter 30
Chapter 31
Chapter 32
Chapter 33
Chapter 34
Chapter 35
Chapter 36
Chapter 37
Chapter 38
Chapter 39
Chapter 40
Chapter 41
Chapter 42
Chapter 43
Chapter 44
Chapter 45
Chapter 46
Chapter 47
Chapter 48
Chapter 49
Chapter 50
Chapter 51
Chapter 52
Chapter 53
Chapter 54
Chapter 55
Chapter 56
Chapter 57
Chapter 58
Chapter 59
Chapter 60
Chapter 61
Chapter 62
Chapter 63
Chapter 64
Chapter 65
Chapter 66
Chapter 67
Chapter 68
Chapter 69
Chapter 70
Chapter 71
Chapter 72
Chapter 73
Chapter 74
Chapter 75
Chapter 76
Chapter 77
Chapter 78
Chapter 79
Chapter 80
Chapter 81
Chapter 82
Chapter 83
Chapter 84
Chapter 85
Chapter 86
Chapter 87
Chapter 88
Chapter 89
Chapter 90
Chapter 91
Chapter 92
Chapter 93
Chapter 94
Chapter 95
Chapter 96
Chapter 97
Chapter 98
Chapter 99
Chapter 100
Chapter 101
Chapter 102
Chapter 103
Chapter 104
Chapter 105
Chapter 106
Chapter 107
Chapter 108
Chapter 109
Chapter 110
Chapter 111
Chapter 112
Chapter 113
Chapter 114
Chapter 115
Chapter 116
Chapter 117
Chapter 118
Chapter 119
Chapter 120
Also by Larry D. Thompson
Copyright
Prologue
Luke got the bad news on a Friday. On Monday he and Samantha drove to San Antonio to see Dr. Shepherd Stevens. They worked their way through the maze of buildings at the UT Health Science Center to the hepatology department and signed in. When they were escorted to the treatment area, they were met by a distinguished-looking physician with a calm, gentle demeanor. He invited them to take a seat.
“I’m pleased that you could come on such short notice. I’ve been following your case and advising Dr. Hartman as necessary. After looking at your last blood work, I thought it was time for a full workup.”
“I don’t understand, sir,” Samantha replied, her voice cracking with alarm.
“Samantha, your liver is still failing, even with the interferon. We’ve been following the results of your blood work. Now it’s time to do more testing.”
“Doctor, I’m only nineteen. Am I going to die before I’m twenty?” Samantha asked.
* * *
It was dusk when the red sports car turned into the upscale suburban neighborhood. In the driveway, the driver killed the engine and rested his head on his hands, which were clenching the steering wheel. His mind drifted back through the disturbing events of the past few months.
When the young executive finally entered the house, he kissed his pregnant wife and talked briefly with her before he excused himself and headed to their bedroom. He sat at a small desk and extracted several computer discs from his briefcase, the same ones he had been studying all afternoon. Absentmindedly flipping through them, he continued to mull over seemingly random events from the recent past. Finally, he picked up the phone and placed a call. After a brief discussion he confirmed an appointment for the next morning and walked back to the kitchen to tell his wife that he would be out of town on business for a couple of days. Before she could ask where he was going, his cell phone rang. He glanced at the caller ID and excused himself. This time he shut the door to the bedroom. He listened to the caller, nodded his head several times, and clicked off the phone.
He replaced the discs in his briefcase and was about to close it when he suddenly changed his mind. Instead he turned to his computer and burned a duplicate of each of the discs. When he had a complete second set, he put both in his briefcase and grabbed his coat. Leaving the house, he called to his wife that he had forgotten a business appointment and would be back in about two hours.
He drove slowly from the neighborhood, then turned into a small shopping center, where he parked and took his briefcase into a store. Five minutes later he was back in his car, heading down the freeway toward Rock Creek Park, where he stopped in a lot that only a couple of hours earlier had been full of cars, trucks, and SUVs. Now there were only two vehicles, both empty. He had waited ten minutes before a dark, nondescript sedan parked beside him. Taking his cue, he got out and stood beside the car. A large man dressed in black jeans and a black T-shirt came around the back of the sedan. The young executive looked around nervously. This was not who he was supposed to meet. He’d never seen the guy in his life. He was about to run when he was met by a second man who stepped from the shadows and quietly stood behind him, his hand gripping a syringe. Before the startled executive could react, the second man drove a small 22 gauge needle into his neck, expertly piercing the left jugular. He slumped into unconsciousness when the man pushed the plunger with his thumb and Versed was forced into the vein.
The two men, both wearing latex gloves, glanced around the parking lot. Satisfied they were alone, they picked up the victim and carried him along the jogging path that ran beside the creek. When they arrived at a small clearing, one of the men pulled a .22 revolver from his back pocket. He placed it in the executive’s right hand and put the gun to his temple. Using the victim’s forefinger, he fired the weapon once. The victim jerked and then was quiet. The two men arranged the body beside the path, gun in hand, and retraced their steps. When they got to the victim’s car, they opened the driver’s door, grabbed the briefcase, and, afte
r taking one last look around the parking lot, slowly drove the dark sedan back to the freeway.
1
The elevator doors opened at the penthouse level of Ceventa Pharmaceutical’s headquarters just outside Washington, D.C., and a group of executives from the lower floors stepped into the executive suite. They talked among themselves as they waited for the CEO’s assistant to end a phone call. When the blond assistant hung up, one young man grinned. “Hey, beautiful, what’s going on? Why the command performance with only fifteen minutes notice?”
“You’ll have to ask Dr. Kingsbury,” she replied. “Please join the others in the boardroom. Coffee and sodas are on the credenza.”
The penthouse housed Dr. Kingsbury’s office along with a private health club, a gigantic boardroom, and the reception area. The reception area was thirty feet by twenty. At one end was the assistant’s desk guarding the door to Kingsbury’s inner sanctum. The remainder of the area was covered with antique chairs and sofas from the eighteenth century, part of Kingsbury’s private collection. The burnt gold carpet was thick enough to absorb all but the loudest voice. At the end opposite the assistant’s desk were two double doors with ornate brass handles.
The group walked to the double doors and opened them to find the boardroom full of other Ceventa executives. Some were seated in the twenty-four leather chairs around the long oval conference table. Others stood behind the chairs, drinking coffee from porcelain cups, also burnt gold in color. The room was filled with an expectant buzz of conversation and questions. Several managers speculated on why they were summoned to the penthouse. A few merely drank their coffee and waited quietly as they gazed out the windows on the panoramic view of green Maryland hills and the Washington Monument in the distance. All conversation stopped when both doors flew open and the man himself entered, trailed by three assistants.
Dr. Alfred Kingsbury was an imposing figure. Six feet six inches tall, he had long gray hair that he parted in the middle and combed back above his ears. A Vandyke beard gave him a decidedly European look. In fact, he was originally from England, where he had graduated thirty-odd years before with two degrees, one in medicine along with a PhD in pharmacology. Shortly thereafter he joined Ceventa and rose through the ranks to become CEO of the North American subsidiary. His next step to the top of the ladder would be at Ceventa’s global headquarters in Copenhagen, where he expected to be placed in charge of the one-hundred-billion-dollar pharmaceutical giant. With no apology for the delay, he stood at the front of the room, unbuttoned the jacket of his Armani three-piece suit, and spoke in a clipped British accent.
“Good morning. We have some exciting news. James, please lower the screen and start the PowerPoint.”
The screen dropped silently from the ceiling at the opposite end of the boardroom. The projector came into focus with the company logo, a blue and green globe showing CEVENTA in burnt gold script looping around the earth.
The logo disappeared and was replaced by EXXACIA.
“Most of you are familiar with Exxacia. It’s an antibiotic proven efficacious for pneumonia, bronchitis, sinusitis, tonsillitis, and several other infectious diseases. We developed Exxacia at our research and development facility in Copenhagen. It took ten years and nearly a billion dollars before we were ready to take it to market.”
As Kingsbury spoke he walked around the table to stand beside the screen, motioning James to bring up slides designed to emphasize the points Kingsbury was making.
“We launched Exxacia in South America originally, and with some carefully crafted promotion, it soon was bringing in over a billion dollars a year on that continent alone. Next we took it to Europe, and combined sales approached five billion.”
A self-satisfied grin crossed Kingsbury’s face as he extended his arms, palms up. “Now, my dear colleagues, it’s 2007 and we are ready to market in the United States. We will be—”
Kingsbury was interrupted by a young researcher who had been standing, arms crossed and leaning against the side wall. He dropped his arms as he spoke. “Dr. Kingsbury, haven’t we had some significant problems with that drug in other countries? I’ve read some of our internal reports that describe liver failure, heart problems, and even death following use of Exxacia. Don’t we need to be studying this drug, maybe halt sales in Europe and South America until we figure out what’s causing these problems?”
“What’s your name, young man?”
“Kinney, sir, Ralph Kinney. I’m a statistician on the third floor.”
“Mr. Kinney, your concerns are misplaced,” Kingsbury replied sternly. “We all know that any drug has side effects, complications. It’s true that some of the people who have taken Exxacia are very sick. Many are elderly, and in flu season no matter what the treatment the elderly will die from the flu.” Kingsbury’s eyes darted around the room to look for any disagreement with his comments. Blank stares were all he saw, except from Kinney.
“Do you really think we should be selling a drug that may cause liver failure and death just to cure a sinus infection?”
“Mr. Kinney, no one has proved with certainty that Exxacia causes liver problems. Undoubtedly, those who took the drug and died from liver failure had a compromised liver that would have failed in spite of any drug. We can expect to save hundreds of thousands of lives in the United States alone. And I should add that our financial people expect United States sales of between five billion and ten billion dollars three years after FDA approval. That process will start within three months. Our timetable calls for the drug to be approved in eighteen months. No more questions. This meeting is adjourned.”
Kingsbury left the boardroom. He stopped briefly at his assistant’s desk and in a low voice said, “Get me the personnel file on an employee named Kinney who works on the third floor. I want it this afternoon.”
As he turned to walk away his assistant said, “Oh, Dr. Kingsbury, don’t forget that tomorrow is Teddy’s sixth birthday.”
Kingsbury looked back. His scowl had turned to a smile. “Don’t worry. I never forget a grandchild’s birthday. I’ll stop at Toys ‘R’ Us on the way home this evening, and I’ll be leaving early tomorrow for Teddy’s party.”
2
Lucas Vaughan parked in an open lot across the street from the old Harris County courthouse in downtown Houston. As he came to a stop, he looked in the rearview mirror and studied his face. I don’t like what I’m seeing, he thought. It’s only 2004. I’ll be forty next month. My hair is turning gray, and I’ve got dark circles under my eyes. The lines on my face make me look fifty. No wonder. I was up half the night with stomach cramps. Maybe it’s time to be doing something else. Luke sighed at the mirror, reached for a bottle of Maalox in the cup holder of his Toyota Sequoia, and took a giant swig. As the Maalox settled into his stomach, a determined look crossed his face. Last day. It’s the biggest case of my career. Time to win it.
He grabbed his oversized briefcase from the back, tossed the Maalox in it, waved at the parking attendant, and waited at the corner for the light to change.
“Morning, Luke.” Another lawyer approached. “You in trial?”
“Hi, Jock. Yeah, I’m in the third week of a products case against Ford. My client’s husband was killed in a rollover.”
“I thought the tire manufacturers were responsible for all those SUV deaths. Who’s up today?”
“We settled the tire case for a large but confidential amount, enough to pay back six-figure expenses that I borrowed from the bank and put some money in my widow’s purse. Hopefully, today is my payday. My experts say that Ford has at least equal responsibility, maybe greater. I’m crossing the Ford design engineer this morning.”
Luke entered the courthouse, walked through a metal detector, and boarded the decrepit elevator that creaked and moaned its way to the sixth floor. When he stepped into the hall, he found it crowded with lawyers and clients. He smiled at two jurors and entered the courtroom.
Luke’s client was seated on the back row, obviously d
eep in thought. “Morning, Nancy,” he greeted her. “This should be the last witness. Good chance we can argue this afternoon.” Pain shot over Luke’s face, and he grabbed his stomach.
“Luke, you okay?”
“I’m fine. Just some indigestion. Happens a lot during trial. Let’s get seated.” Luke led the way to their counsel table.
“All rise.”
Judge Ruby O’Reilly came through the back door as the jurors entered from the side.
“Good morning, ladies and gentlemen. Mr. Vaughan, you may recall Mr. Alberson for cross-examination.”
A slender, graying gentleman who could have been a college professor rose in the first row of the audience and made his way to the witness stand. He had done an excellent job the day before, establishing that the plaintiff’s car had some risk of rolling over, but no more than any other SUV. He blamed the crash on a tire that had lost its tread after only twenty thousand miles. As to the roof design, which was a major issue in the case, it met every federal standard. Fred Ayers, Ford’s lead lawyer, knew that he had some problems in the case, but was satisfied that Alberson had managed to handle all of them quite nicely.
“Mr. Alberson, you would agree that Ford markets these cars as SUVs that are safe and passenger friendly?” Luke asked.
“Yes, sir. I certainly would.”
“You understand that we’re not here to talk about tires?”
“Sorry, Mr. Vaughan, but I disagree.” Alberson shook his head. “The jury has already heard that the accident was caused when the tire tread on the right front came completely off.”
Several jurors had puzzled expressions, wondering why the tire manufacturer was not in the case. Of course, they didn’t know that the Texas rules of evidence barred them from learning that the tire company had settled.
Luke put his hands in his pockets and walked away from the witness to stand at the rail behind his client. Switching gears to get away from a discussion about tires, he continued, “You know, don’t you, that my client’s husband died from a fractured skull, following the crash?”
“Mr. Vaughan, I’m very sorry for your client’s loss,” the professional witness said sympathetically.
The Trial Page 1
