The Trial (19 page)

66

Luke was up with the sun on Saturday. He wanted to go for a run, but had given it up because he thought it would not be fair to Samantha for him to run when she couldn’t. He showered, shaved, and put on a pair of jeans and a blue golf shirt, then stepped out into the living area. He found Mary Sanchez seated in the dining area, reading the
Daily Record.

“Morning, Mary. How’s Sam?”

“About the same, Mr. Vaughan. I got her up to go to the bathroom. Then she insisted on putting on makeup because she thinks that Brad may be here today. That wore her out, and I put her back to bed. She was watching television when I came back up here.”

Luke walked quietly down the stairs so as not to disturb Samantha if she was sleeping. He peeked around the corner to find her staring at him.

“Dad, you don’t have to tiptoe. When I’m sleeping, I’m out of it. I doubt that a firecracker in the street would bother me.”

Luke walked over and kissed her on the forehead. “You’re looking good this morning. Already got your makeup on.”

Samantha clicked off the television. “Well, I hear we’re going to have a houseful of people. So I wanted to look my best. I’ve even changed into sweatpants and a T-shirt.” She glanced out the window. “Oh, there’s Brad’s pickup. You sure I’m looking all right? Help me get into my wheelchair.”

Luke did as he was told, and Samantha was waiting beside her bed for Brad when he knocked on the front door. Luke let him in and led him into Sam’s room.

“Hi, Sam. Looks to me like you’re making some progress. Nice looking shirt.”

Samantha managed a slight smile. “Shirt’s okay. Can’t say the same for this wheelchair.”

Luke excused himself, saying that Brad could bring Sam up to date on what was happening on campus and with their friends. Within half an hour Whizmo and Sue Ellen arrived. Whizmo had a smile on his face. “We’re good to go. Everyone fire up their computers. Sam, you can help Brad.”

Samantha shook her head. “Nope, I’m still a part of this team. I’ll work on my own computer until I need to take a break.”

“Okay, then everyone to the conference table. I’ve got a program on a disc for each of you. Load it onto your computers. When you’re ready, I’ll give each of you a disc from Ceventa with some of their data.”

Luke gave a list to each member of the team, outlining what they would be looking for. Sue Ellen passed out yellow legal pads and pens to make notes “the old-fashioned way,” as she put it. Silence prevailed as they pulled data from the Ceventa discs and made notes. At one time Luke said, “I can’t believe this crap.”

Later Sue Ellen said, “Do they think they’re dealing with fools?”

Whiz merely shook his head from time to time and let out a low whistle.

After two hours Sam retired to her room for a nap. Another hour went by, and Sue Ellen went upstairs to make sandwiches. When she announced that lunch was ready, Luke, Whizmo, and Brad joined her on the second floor. Between bites they discussed what they were finding.

“To start,” Brad said, “I’m finding a bunch of sites that are completely missing, gone, vanished. Not hard to figure out. The sites are numbered and my disc starts with 102 and goes through 198. I’m missing six.”

“I’ve got the same thing,” Luke replied. “I must have the first disc since mine has sites from 001 to 101. Eight of my sites have disappeared.”

“I’m missing twelve,” Sue Ellen said as she sipped a Coke.

“Then I must win the prize,” Whizmo said. “There are twenty-two missing from my group.”

“Correct me if I’m wrong, Professor Whizmo,” Luke said with astonishment showing in his face, “but that’s forty-eight sites gone up in smoke.”

“You’d make a good math teacher, Luke, and that doesn’t count what Sam might have found. Here’s another statistic that I did while I was working on this last night. There are twenty-one thousand four hundred and fifty-three subjects in the trial. Ceventa reported twenty-five thousand. I think we know what happened to those missing patients. We just don’t know why.”

“Next on the list is vital signs,” Luke said. “What are we finding there?”

“I’ll go first again,” Brad replied. “I haven’t counted them yet, but I’m finding some patients with the same vital signs on every visit at some sites, and at some of those sites several of the patients all have identical vital signs.”

“Same here,” Sue Ellen replied as Whizmo nodded with her.

“Dammit! It’s impossible for one patient to show up two days in a row and have exactly the same temperature, blood pressure, pulse, and oxygen saturation. Hell, usually if a physician takes a patient’s blood pressure twice in fifteen minutes it won’t be the same.”

“Luke, we’re making progress here. We can spend the rest of the week pulling up these statistics. Trouble is I can’t come up with a program that will identify forged signatures, initials, and so forth. So while you’re in Maryland, we’re going to have to take a look at every one of these charts and hunt for problems.”

67

“Michael, find David, and both of you get in here in five minutes!” Audrey Metcalf demanded and then slammed the phone down.

“Morning, boss,” the two younger lawyers said, almost in unison, when they appeared in answer to her summons. Michael took a handful of pink jelly beans from the jar on the front of the desk.

“Sit down,” Metcalf ordered as she plopped down in her executive chair. “By the way; don’t forget to pay for those on the way out. Now, we’ve got a problem to deal with in the Vaughan case.”

Both men focused their attention on her, with pens poised to write on yellow legal pads.

“The plaintiffs have issued a notice to take the deposition of Roger Boatwright at the FDA next week, and they’re subpoenaing the entire FDA file on the clinical trial.”

“That’s preposterous!” David St. James exclaimed.

“I’ll get right to work on a motion to quash it,” Michael Forsythe added. We can’t let that file see the light of day.”

“Forget it, guys. Nimitz isn’t going to quash anything. I’ll have Kingsbury deal with Boatwright and the FDA documents. I want you to get to Silver Spring and start preparing Boatwright. No, on second thought, I don’t want him to have to testify that he met with us to prepare for his deposition. I want him to appear to be the objective government servant. Call the FDA in-house lawyers and work through them. I’ll call Kingsbury to get their cooperation. Michael, you come up with questions that Luke Vaughan will ask and figure out the best possible answers. David, you’re to work with the FDA lawyers. They can spoon-feed the questions and answers to Boatwright. No one will ever know that we were the ones that prepared him for deposition. Call me if you run into a problem.”

In the Ceventa penthouse Kingsbury picked up a private line and called Boatwright’s cell phone. “Roger, can you talk?”

“Just a minute. Let me shut the door.” Kingsbury heard the sound of footsteps and the door closing. “Now it’s okay.”

“Roger, when Vaughan takes your deposition, he wants you to bring discs with the entire clinical trial on them. You and I both know that there are certain parts of that file that we can’t let him have. It would be bad enough for the lawsuit, but if word leaked out on the Hill, you and I both would be subpoenaed to the Senate oversight committee. You know what to do, don’t you?”

Boatwright hesitated and then said, “What’s the status of my five million dollars? Joanne’s deteriorating daily. Now you’re asking me to lie under oath.”

Kingsbury knew he had to keep Boatwright under control. “I’m sorry about Joanne. I really am. Understand me. It’s not easy just to juggle the books and send five million overseas without it getting some attention. I’ve got a few hundred thousand being wired today. More shortly. It’ll take a little while.”

“We may not have a little while,” Boatwright replied, his voice quivering.

68

Luke entered the CDER headquarters at nine forty-five for the ten o’clock deposition and announced himself to a guard behind the desk. He took a seat and stared at the clock above the elevator. At ten he watched the elevator bank, but no one exited to approach him. He picked up a copy of the
Washington Post
that a previous visitor had left behind and thumbed through the paper, his mind not really focused on what he was seeing. At ten fifteen he looked at his watch. At ten thirty he was ready to leave and fly back to San Marcos, where he would move for sanctions against Boatwright for failing to honor a subpoena. Then the elevator opened, and Michael Forsythe stepped out.

“Sorry to keep you waiting, Mr. Vaughan. Mr. Boatwright had some problem with his car this morning and just now got here. We met him for the first time five minutes ago.” Forsythe smiled, trying to convey the message that they certainly had not worked with this witness to prepare him for his deposition.

The elevator stopped on the sixth floor, where Forsythe led Luke to a small, windowless conference room already filled to capacity with the court reporter, a videographer, Audrey Metcalf, David St. James, two legal assistants, and, of course, Roger Boatwright. Someone had turned the thermostat up to eighty-five. Luke sized up the situation and understood the game they were playing. Fine with him. He intended to be gone before he broke a sweat. Two chairs remained, one for Luke and one for Forsythe. The videographer was set up along the back wall with a camera pointed at Boatwright. Metcalf remained in her seat and said icily, “This is Dr. Boatwright. You may begin when you choose.” Then she returned to doodling on her yellow pad.

Luke took his seat and nodded at the court reporter, who administered the oath. Metcalf noticed that Luke had nothing in front of him, no notes, no legal pad, not even a pen.

“You’re Roger Boatwright.”

“I am.”

“You’re the director of the Center for Drug Evaluation and Research.”

“Yes, sir,” Boatwright responded as beads of sweat broke out on his forehead even before there were any hard questions.

“Who have you talked to in preparation for this deposition?”

“Only the in-house lawyers for the FDA.”

“You were served with a subpoena to produce the entire Exxacia clinical trial maintained by the FDA. Have you complied?”

Boatwright broke out in a fit of coughing, got control of his voice, and pushed a box of discs toward Luke. “Here’s the complete clinical trial.”

“And you swear under penalty of perjury that there is nothing more, that this is complete, and by that I mean every scrap of paper, e-mails, memos, and patient charts, kept here at the FDA on Exxacia?”

Boatwright squirmed in his seat and finally said, “Yes, sir. I swear.”

“Madam Court Reporter, please mark these as Boatwright deposition exhibit one for the record,” Luke said, then turned his attention back to Boatwright. “As head of the division that is responsible for clinical trials, do you permit your clinical investigators to forge the signatures of patients?”

“Of course not,” Boatwright replied with poorly contrived astonishment.

“Do you allow your investigators to alter vital signs on patient charts?”

“Preposterous, Mr. Vaughan.”

“Do you know what blood splitting is, Dr. Boatwright?”

Boatwright reached into his back pocket and pulled out a handkerchief, which he used to wipe the sweat from his forehead. “Perhaps you should explain, Mr. Vaughan.”

“Blood splitting, Dr. Boatwright. Taking blood from one patient and using it to perform lab work for a number of other patients. Do you permit that in your clinical trials?”

“Absolutely not, Mr. Vaughan.”

“How about editing of patient charts after the study is over?”

“Ridiculous, sir!”

Metcalf had quit her doodling and now was paying attention. A frown briefly crossed her face.
Is he just fishing?
she thought.
Or does he know more than we think?

Luke stood at his place and placed his hands on the table, leaning into the witness. “You would agree, wouldn’t you, Dr. Boatwright, that those kinds of practices would call into question the integrity of the whole clinical trial, right, Doctor?”

“Sir, we oversee our trials to ensure that those kinds of events never occur.”

“Answer my question, Dr. Boatwright.”

Boatwright looked at Metcalf, who had returned to her doodling, her poker face back in place.

“You’re correct, Mr. Vaughan.”

Luke switched gears. “Have you or any of your staff, to your knowledge, had any contact with Ceventa employees outside of work being done for the FDA?”

Boatwright tried to sidestep the question. “Well, I, I’m not sure what you mean.”

“Not a very complicated question, Dr. Boatwright,” Luke pressed. “You know, golf, dinner, travel, entertainment, off-the-record discussions about Exxacia behind closed doors, that kind of thing?”

Boatwright knew he had to lie again, but he figured a small-town lawyer like Vaughan would never catch him at it. Besides, he’d made a deal with the devil and could hardly back out. He straightened his posture, looked directly into the camera, and replied, “Of course not, Mr. Vaughan. I would never do such a thing and would fire any of my employees who did.”

Luke hesitated as if he didn’t know quite what to ask next. “By the way, how well do you know Dr. Alfred Kingsbury?”

“Certainly I’ve seen him, but always in a strictly professional capacity.”

“You swear that there has been nothing improper about your contacts with Dr. Kingsbury, no lavish dinners, golf outings, corporate junkets, that kind of thing?”

“Absolutely, Mr. Vaughan, absolutely.”

Luke put his hands in his pockets and stared at the ceiling. “One last question, Dr. Boatwright. You require drug sponsors like Ceventa to preserve all the data on every one of the clinical investigation sites, don’t you?”

“Certainly, Mr. Vaughan.”

“That’s all, Dr. Boatwright. I’m out of here. I’ve got a plane to catch.”

Luke turned and left a room full of surprised people who were expecting the questioning to go into the night.

The deposition of Roger Boatwright was supposed to be kept quiet, but such an event circulated on the CDER grapevine faster than an e-mail “reply to all.” Nearly everyone in the building knew the date and even the time of the deposition. At the end of the day Ryan Sinclair stationed himself on the first floor and waited for Boatwright to step from an elevator, then followed him outside.

“Hey there, Dr. Boatwright, hold up for a minute,” Ryan called as Boatwright circled the fountain between the building and the garage. Boatwright looked back, saw Sinclair, and quickened his pace.

Ryan caught up with Boatwright and grabbed his arm, forcing him to stop.

“Dr. Sinclair, please remove your hand from my arm. I’m late for an appointment.”

“This won’t take long. Just a question. I know you were required to bring all the Exxacia clinical trial data to your deposition today. I just want to know if you included the memos and e-mails from me and my team or not.”

Boatwright started to walk away again.

“Simple question, Dr. Boatwright. Did you or didn’t you?”

“That’s none of your business, Dr. Sinclair,” Boatwright said. “Now please get out of my way!”

“Look, Boatwright, I’m really pissed about how this whole Exxacia affair has come down. Let me make myself clear. I have a complete copy of the clinical trial on discs locked up at my house. If it comes out that you’ve provided something different, I’m going to be the first to accuse you of perjury, clear, Dr. Boatwright?”

Boatwright, trying to feign outrage to hide the fear that was inside, turned and marched to the garage. Once in his car, he called Kingsbury’s cell phone and reported what had just occurred.

The Southwest Airlines plane carrying Luke landed at Austin’s Bergstrom Airport at six in the evening. When he got in his Sequoia, he called home, and Mary answered, saying Samantha had already gone to bed. He was going to stop by Sue Ellen’s house before he got home, he told Mary; he wanted to discuss the deposition with her and talk about where they should go from here with their lawsuit. As he made the forty-five-minute drive to San Marcos, he worried about his daughter. By now she was sleeping twelve to fourteen hours at night with a three-hour nap in the afternoon. Would she make it until the trial was over? Was all of this effort to bring down a giant pharmaceutical company going to accomplish anything? Was it merely a pipe dream that he might somehow get some money out of Ceventa in time to get Samantha a new liver? Then he thought that he had no other choice. The trial was now only a few weeks away. He prayed that Samantha would hang on and somehow a miracle would occur.

Sue Ellen met him at the door with a glass of wine. Josh was watching a baseball game on television in the living room, so they sat at the kitchen table, where Luke described the day’s events.

“I’ll bet they were surprised when you finished the deposition in twenty minutes,” Sue Ellen said.

Luke shrugged his shoulders. “I got what I came for. Sometimes the best depositions are the shortest ones.”

Sue Ellen nodded her agreement as she rummaged around the kitchen and retrieved a brick of cheddar cheese and some crackers. “Now, let me tell you what we found while you were gone. First, most of the investigators did their jobs. Still, even setting aside the sites we’re missing, the only way to describe this study is shitty.” She handed Luke a manila folder containing several pages of computer notes. “Here, Whizmo prepared this summary. It’s all tied back into the database. Where do we go from here?”

Luke finished chewing his crackers and cheese and took a sip of wine before he spoke. “I was thinking about that on the way back from Maryland. Of course, we file a motion to compel the production of the charts and data from the fifty or so sites we’re missing. Then we include a motion to sanction Ceventa for hiding the data. I doubt if the judge will fine them enough to make a big company wince.”

“Yeah, Luke, you’re right. Chuck’s pretty conservative about things like that. Still, if we can catch them in more violations on down the line, the dollars will get bigger. I’ll draft the motion and have it ready for you by tomorrow afternoon. We can probably get a hearing early next week.”