The Trial (3 page)

6

Roger Boatwright smiled as he replaced the receiver. He pushed himself out of his chair, thinking he really had to get serious about losing that forty pounds, and walked to a coat rack where he kept a coat and tie for just such occasions. He tried to wipe the wrinkles from the front of his white dress shirt before donning the tie and jacket, then gave up and figured it would have to do. If he had known this morning that he was having lunch with Alfred Kingsbury, he would have put on a nice suit and tie along with a freshly ironed shirt. Unfortunately, it was only now, ten thirty on Thursday morning, that Kingsbury’s secretary called, asking if he could meet Dr. Kingsbury for lunch at his club at twelve thirty. Silly question. Of course he could. Still, he put the secretary on hold while he feigned checking with his assistant before confirming the lunch.

At a quarter to twelve Boatwright told his assistant that he had an unexpected meeting out of the office and would return by midafternoon. He retrieved his eight-year-old Toyota Corolla from the third floor of the garage and turned onto I-95 for the fifteen-minute drive to Kingsbury’s club. As he drove he surveyed his life. He was forty-eight. After getting a PhD from the University of Pennsylvania, he had joined the Food and Drug Administration, expecting to stay a few years and then be lured away by a huge salary to a major pharmaceutical company. It hadn’t happened. Not even a small pharmaceutical firm came calling. So he learned to play the game of politics in the FDA and eventually rose to be director of the Center for Drug Evaluation and Research, known as CDER in the industry. It was an important job with only moderate pay, certainly not what he expected as he entered middle age. Every new drug application had to cross his desk. If a drug wasn’t safe or wasn’t efficacious, a big word meaning the drug didn’t work, he could kill it with one signature. He rarely exercised his veto. In his mind the pharmaceutical companies were his clients. New drugs rarely proved to be unsafe, and effectiveness was in the eye of the beholder. Besides, he hadn’t given up the idea of moving into industry. Maybe that’s what Dr. Kingsbury was calling about.

Boatwright turned off the freeway and took the first right, a tree-lined lane that led to the country club entrance, where he stopped at the security gate.

“Can I help you, sir?” the guard asked.

“I’m Dr. Boatwright here to have lunch with Dr. Kingsbury.”

“Yes, sir.” The guard checked his clipboard. “You’re thirty minutes early. I’m sure that if you go to the bar, they’ll serve you a drink while you wait for Dr. Kingsbury. Please drive up to the porte cochere. They’ll valet your car.”

Boatwright glanced at the porte cochere and realized his vehicle didn’t fit with the other cars lining the driveway. Instead, he parked at the back of the parking lot and walked to the entrance, where he was greeted by two uniformed attendants.

“I’m here to meet Dr. Kingsbury.”

“Good afternoon, sir,” one said as they opened the double doors. “You must be Dr. Boatwright. You’re welcome to wait for Dr. Kingsbury in the foyer or the bar.”

Boatwright stepped into a living room right out of
Architectural Digest
. The arched ceiling towered thirty feet above him; a crystal chandelier dropped from its center. At the back of the room was a fireplace twelve feet tall, with a fire cracking and popping on a day when the outside temperature was seventy-five. Boatwright found a straight-backed chair against one wall, perched on the edge of the seat, and watched the front door.

The double doors opened, and a tall man in a three-piece suit was silhouetted in the doorway as he allowed his eyes to become accustomed to the change in light. When Roger Boatwright rose from his chair, Kingsbury spotted him.

“Roger, delighted that you could join me.”

“Thanks for inviting me, Dr. Kingsbury,” Boatwright replied as he took Kingsbury’s outstretched hand.

“Look, Roger, my name is Alfred. We should be on a first-name basis unless I’m sitting in on one of your committee meetings or we’re appearing before Congress. Agreed?”

“Sure, Alfred,” said the smaller man, who was pleased to be on a first-name basis with Kingsbury.

“Now, this way to the dining room. I’ve reserved a table overlooking the eighteenth green, best table in the house.”

The maître d’ seated them at a giant window overlooking the green expanse of the golf course.

“You a golfer?” Kingsbury asked.

“Yes, sir, I mean Alfred,” Boatwright replied, trying to hide his nervousness. “I play with a foursome most Saturdays. I’m usually happy to break ninety.”

“Then I must get you out here some weekend, maybe when the club has a member-guest tournament. Now, take a look at the menu, and I’ll order us a glass of my favorite wine. I recommend the lamb special. Best thing the chef cooks.”

The men made small talk as they ordered and waited for their meal. They talked about Tiger Woods, the upcoming election year, major league baseball, and families. Kingsbury knew Roger’s wife’s name and that he had three daughters. Roger was impressed that Kingsbury had taken the time to research his background. Kingsbury took great delight in talking about his daughter and three grandchildren, particularly when he pulled photos from his wallet that showed them playing in the sand at the beach. Roger commented that the kids looked like their grandfather. Kingsbury beamed his agreement.

After they finished lunch, Kingsbury got to the reason for the meeting.

“Roger, my company has an annual seminar for our managers. We try to combine some business with pleasure. This year it’s being held at the Ritz-Carlton in Montego Bay, Jamaica. We’ve invited three congressmen, key committee members, of course, to provide legislative updates. We’d like you to speak on the first day on a topic of your choosing, perhaps something about a current overview of the FDA, policies and procedures and maybe pitfalls to avoid in new drug applications.”

Roger was disappointed that there wasn’t a job offer on the table, but he figured one might come if he made a good impression at the seminar. “I’ll have to check my calendar when you give me the date, but I’m flattered that you would ask.”

“You’ll need to check your calendar for six days. We have other speakers for about three hours every morning, and then we hit the golf course. You’ll want to bring your clubs and your A game. And we want your better half to join us. She can go to the spa or go shopping with the other wives while we’re on the course. We’ll cover expenses for both of you.”

“Maybe I ought to pay for my wife, Alfred.”

“Nonsense, my boy. It’s all completely on the up-and-up. You’re our featured speaker and will be attending other lectures throughout the week, and spouses are expected. I promise there won’t be an eyebrow raised. I’ll e-mail you the details. Now, if you have five more minutes, let me tell you about a new antibiotic you’ll be seeing a new drug application on shortly. It’s called Exxacia, and it’s going to revolutionize how we treat infections.”

After Boatwright left, Kingsbury stepped outside to the edge of the golf course and called his home office in Copenhagen. With confidence in his voice he reported that he had just met with Boatwright and was certain that he could get the FDA on board with their new antibiotic. He was convinced that Exxacia was going to turn their company around in North America, probably tripling their earnings in two years. He also had a plan in the works that would more than triple his own net worth. That it involved insider trading was of no concern to Kingsbury.
My plan is foolproof
, he thought as he returned to the clubhouse with a spring in his step.

7

Kingsbury touched his sleeping wife lightly on the shoulder and said, “Suzanne, I have to go into town for a few hours. Should be back early afternoon. I’ll pick up some souvenirs for my grandkids while I’m out.”

Suzanne murmured something in reply and then settled back into her slumber. They had been married for five years, and it had not been easy. She was thirty-five, twenty years his junior, a former lawyer, and she had a wandering eye. Still, she served her purpose. Once made up, she could have passed for Princess Diana and was always ready to play the role of a loving and caring wife. Whatever she did when Kingsbury wasn’t around was of no interest to him as long as she was at his side when the lights went up and it was time for her performance.

Kingsbury stepped to the phone in the living room of the suite they occupied at the Montego Bay Ritz-Carlton and called Mario, one of his two driver-bodyguards, to tell him to bring his rented limousine to the front. Kingsbury rarely went anywhere without Mario and Ralph, who both looked like they had played on the defensive line for the Baltimore Ravens in prior lives. When Kingsbury exited the elevator on the first floor, he paused to visit with several of his managers, explaining that he couldn’t make the morning session because of a prior commitment. He saw Roger Boatwright and his wife in the dining room and made it a point to stop at their table to confirm that everything about the meeting was to their satisfaction. He promised to visit with them more that evening at the cocktail party.

The limo was waiting for him when he left the hotel. Ralph had the back door open. “Good morning, Dr. Kingsbury. Your Starbucks is in the drink holder, and the
New York Times
is on the seat.”

Kingsbury nodded to him and got in the car. He greeted Mario, the driver, as Ralph took the front passenger seat. As they drove along the main highway leading into Montego Bay, Kingsbury reflected on the past three days. It couldn’t have gone better. Of course, he wanted his managers and spouses to enjoy themselves. More importantly, he had played golf with Boatwright all three days and continued to bring up Exxacia, taking every opportunity to convince him it was a miracle drug that was destined to revolutionize treatment of bacterial infections. He was satisfied that he had Boatwright in his back pocket and FDA approval was close to being a mission accomplished.

The limousine stopped in front of a three-story building with a sign that announced it was the St. James Parish National Bank. Kingsbury entered the lobby to be greeted by a distinguished, gray-haired Jamaican and a younger man, bald but handsome.

“Dr. Kingsbury, I’m Christopher Cornelius, president of the bank. This is Kevron Tillman, senior partner in our bank’s law firm.”

They shook hands, and Cornelius led them to his corner office on the first floor. After coffee was served and the president’s secretary had shut the office door, Kingsbury took over the meeting. “Gentlemen, as you know, I’m CEO of the North American subsidiary of Ceventa, but I’m here on personal business, not company business. Mr. Tillman, I want to establish eight offshore corporations. You can decide whether they are all to be in Jamaica or if some should be domiciled on other islands.”

“My firm can handle that, Dr. Kingsbury,” Tillman interrupted. “We have offices in several other places in the Caribbean. I will need to have some idea of the purpose of the corporations.”

Kingsbury studied the two men. “Both of you must understand that what I am about to tell you is highly confidential. If word leaks out, we will all be in trouble. On the other hand, there is the opportunity for significant profit.”

Mr. Cornelius put down his coffee cup and responded, “You can be assured that we are in the business of maintaining our clients’ confidences at all costs.”

Kingsbury nodded and continued. “The corporations will be used to invest in Ceventa. I expect our stock to skyrocket over the next two years. I am in the process of liquidating nearly all of my assets and will be wiring one hundred million dollars to this bank. Once received, Mr. Cornelius, you will be directed to divide those funds and wire them to the eight corporations established by Mr. Tillman. Mr. Tillman will be directed to buy Ceventa stock at market in lots of a size that will not attract the attention of authorities. The stock is the lowest it’s been in ten years. That’s about to change.”

Tillman rubbed his hands together, and greed appeared in his eyes. “That can be accomplished with no problem, Dr. Kingsbury. Might I inquire why you think your stock is going to perform so well?”

Kingsbury rose to leave. “One word, Mr. Tillman, Exxacia. It will make us all rich. If you choose to buy in, please be discreet. You will be receiving further direction next week. Good day, gentlemen.”

Kingsbury returned to the limo, satisfied that his plan was being properly launched. As Mario opened his door, he said, “On the way back, we’ve got to find a store. My grandkids will be disappointed if their grandpa doesn’t return with something from Jamaica.”

“Boss, I saw a store selling seashells just up the way a few blocks.”

“Perfect! Let’s get some big ones for my grandson and look for some small, pretty ones for my granddaughters,” Kingsbury replied.

8

Ryan Sinclair parked his red Corvette convertible in the garage behind the FDA’s Center for Drug Evaluation and Research. He unfolded his six-foot frame from the car, brushed a mop of blond hair from his eyes, and put on wireless glasses that he wore to create the studious image he sought. While most of his co-workers dressed business casual, he always wore an expensive suit and tie to the office. He would hang the coat on a coat rack inside his office until he left at the end of the day. While it wasn’t necessary, he thought it was the right way to dress. Probably it came from his physician father who never failed to wear a suit and tie. Or maybe it came from his grandfather who made his money on Wall Street and left all of his grandchildren multimillion-dollar trust funds they inherited when they turned twenty-five.

Entering the building, Ryan reminded himself that this was only a stepping-stone to his ultimate career. His goal was the Centers for Disease Control, where he hoped to assist in conquering some of the most virulent infectious diseases that plague the poor of the world. He’d chosen to start at the FDA to learn the regulatory side of drugs. Another two years and he would be ready to move on.

Once inside, he stopped to talk Ravens football with the burly guard at the security desk and then joined others crowding into an elevator. He exited on the fourth floor and was walking past the corner office occupied by Roger Boatwright when he heard Boatwright’s voice. “Hey there, Dr. Sinclair, come in here a minute.”

Ryan stepped into his boss’s office. Boatwright was behind his desk, tie askew and white shirt already looking as if he had been wearing it all day. He let Sinclair stand in front of his desk for two full minutes while he read a three-page memorandum. The contrast between him and Sinclair could not have been more dramatic.

Finally, Boatwright glanced up. He didn’t like Sinclair. The young doctor was born with a silver spoon in his mouth—Harvard, then Johns Hopkins Medical School and internal medicine residency, followed by an infectious disease fellowship. He’d heard about Sinclair’s trust fund. Sinclair didn’t even have to work, but he’d chosen the FDA and was clearly the best medical review officer CDER had on infectious diseases, as well as the youngest. Sinclair was independent by nature, and Boatwright would have preferred to put him on agency scutwork. Still, if he didn’t put Sinclair on major projects, particularly involving infectious diseases, his boss would wonder why.

“Dr. Sinclair, I have a new assignment for you.”

“You know I always like a challenge, Dr. Boatwright. What is it?”

“Ceventa’s got a new antibiotic. It’s called Exxacia. Supposed to be revolutionary. According to Alfred Kingsbury of Ceventa, it wipes out bacteria causing community acquired pneumonia, bronchitis, sinusitis and tonsillitis.”

Sinclair nodded. “Sounds promising, if it works. And I know Dr. Kingsbury slightly. My dad golfs with him frequently. I joined them a couple of times back in my college days.”

Boatwright did a slow burn at the thought of his junior scientist golfing at Kingsbury’s club while he was out on the public links. “I have no doubt that it will do just what Kingsbury says. And, by the way, Ceventa has paid us the million dollars to put it on the fast track. That means that you and your team have six months to evaluate and approve the drug. That clear?”

“I’ll have my assistant print a copy of the new drug application this morning, and we’ll start this afternoon,” Sinclair answered. He walked to his office thinking that Boatwright was an ass, and only minimally competent to boot.

Sinclair’s assistant pushed a cart loaded with two large banker boxes into his office. “Where do you want these, Ryan? It’s that new Ceventa drug, Exxacia.”

“Two boxes, we’ll put them on the floor here by my desk. Here, let me help you.” Ryan rose and started around his desk.

“Not so fast, Ryan. Two boxes here and fourteen more in the copy room. You want them all?”

Ryan pulled the lid off one and found six three-inch binders labeled
EXXACIA NEW DRUG APPLICATION.
“Looks like these are the NDA. This other box contains exhibits. Probably that’s what’s in the other fourteen. Leave the application box and put the other fifteen in our file room. I’ll find them if and when I need them. Make three more copies of the application for the rest of the team. I’ll tell them where to find the exhibits.”

A new drug was routinely assigned to a medical review officer in CDER, Sinclair or one of his colleagues, who would call on a team of researchers and statisticians as needed. Exxacia was now Ryan’s drug, and he expected to spend the next several months learning everything he possibly could about it. He needed to understand its formulation and evaluate its efficacy and its safety. Did it really work in the ways that Ceventa’s scientists said? Were there any significant risks to patients? He took his job very seriously. Some of his peers were prone to rubber-stamping NDAs. They figured that the pharmaceutical companies knew what they were doing and wouldn’t submit an application until they were certain that it was a good and safe drug. Not Sinclair.

When it was all said and done, Ryan Sinclair was known to defer to no one. He could recommend approval of Exxacia and it would sail smoothly to market. On the other hand, if he found problems, he would certainly recommend that the application be rejected. He could be overruled by Boatwright or even someone higher up the food chain. So far, that hadn’t happened.

After his assistant had taken one of the boxes away, Ryan put the remaining one on his desk and pulled the first binder from it. He read through the executive summary, finding that Ceventa wanted to market the drug for various respiratory problems and tonsillitis initially, and then come back for approval for other bacteria-caused illnesses at a later date. That immediately struck him as a little strange. Most antibiotics that worked in the respiratory tract were not usually effective elsewhere. He immediately questioned its value in fighting tonsillitis. Next he noted that Exxacia was already being marketed overseas and took that as a positive since most countries in Europe and South America had drug regulations somewhat similar to those in the United States.

Four hours later his assistant stopped at his door to say that she was leaving and asked if he needed anything else. “Nothing more than another set of eyes and a couple dozen aspirin,” he replied. “Only kidding. I’m going to be here a while. Have a good evening.”