The Trial
Authors: Larry D. Thompson
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
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, after taking one last look around the parking lot, slowly drove the dark sedan back to the freeway.
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.”