Authors: Larry D. Thompson
As Samantha was leaving her English class, she paused at the bulletin board on the first floor where jobs were posted, bicycles were offered for sale, roommates were solicited, that kind of thing. She had seen most of the postings, but a new one caught her eye. It offered a hundred and fifty dollars to participate in a clinical trial for a new drug, promising a minimal time commitment and no risk of ill effects. Samantha noted the name of a Dr. Vijay Challa who officed just off campus. She could use the money to put toward a new leather motorcycle jacket she planned to buy her dad for his birthday, she thought.
Samantha retrieved her bike and rode to the edge of campus. She stopped at the light and looked across the street to a sleazy strip center with a sign that hung crooked from a post, advertising a liquor store, a convenience store, and Dr. Challa’s office. As she sized up the center, she started to turn around. Then the light changed and she found herself crossing the street. She parked in front of the clinic, chained her bike to a rusty bike rack, and entered the doctor’s office.
Nothing happened. She called out, then called out again. “Hello, is anyone here?”
She was about to leave when she heard a back door shut. A moment later a small, dark-skinned man came through a curtain. “My apologies, miss. I just got back from an errand to the post office. My receptionist is off for the afternoon,” Dr. Challa lied. “How may I be of assistance?”
Samantha looked around the shabby office and again started to turn and leave, only she didn’t. “I saw a notice on the bulletin board over at the English Building, something about a clinical trial. Are you still looking for people?”
“Yes, yes indeed.” Dr. Challa smiled, white teeth showing under his black mustache. “Please, have a seat.”
Samantha took a seat across from the doctor while he pulled some forms from a desk drawer. “Your name, please?”
“Samantha Vaughan.”
“Ms. Vaughan, this is a trial for a new antibiotic. I presume that you occasionally have some sinus drainage.”
“Not really, only during pollen season.”
“Well, I’m sure that is enough. If you’ll fill in your name, date of birth, address, and so forth, I’ll complete the rest of the form.” Dr. Challa handed the first page of the form to Samantha, and she wrote in the information and returned it. “Now, if you’ll just initial each of these pages and sign the last one.”
“Shouldn’t I read this first?”
“Certainly you’re welcome to do so, but this is a mere formality.”
Samantha shrugged her shoulders and did as she was asked.
“Now, let me go to the back and get you the pills and a check for one hundred and fifty dollars.”
When Dr. Challa returned, he said, “I almost forgot, but I do need to take your temperature and your blood pressure and draw a little blood.”
Samantha grimaced at the thought and then agreed. Dr. Challa found a vein at her elbow and inserted a needle. “Now, I’ll need you to come back once a week for me to draw more blood and check your vital signs. That’ll be for six weeks. Then there’ll be a last visit in ten weeks. If you miss a time or two, that won’t be a problem. Please take these pills, one in the morning and one at night for the next five days. If you have any problem, just give me a call.”
Samantha took the pills as directed and made it back to Dr. Challa’s office three times over the next six weeks. When she didn’t show up, he reviewed her chart and estimated what her vital signs would be and carefully whited out the date from her last blood work and inserted a new one. Once he ran it through the copy machine, no one could detect the change.
The data arrived in a minivan. The boxes were unloaded and piled around the walls of a storage area in the basement of the CDER building. A metal folding table and four chairs were in the center of the room. A smaller box, containing the same data on discs, was placed on the table.
Roger Boatwright called Ryan into his office. “The Exxacia clinical trial is complete,” he said, beaming. “Here’s a summary of the results prepared by Ceventa. I must say that the clinical trial proved what we all knew.”
“That is?”
“Exxacia is highly effective and absolutely safe. I’m convening the advisory committee in three weeks with a recommendation that the committee approve Exxacia.”
Ryan took the summary from Boatwright and skimmed through it. “Wait a minute, Dr. Boatwright. Sounds like you’re trying to bypass me and my team. We did some random inspections at a number of the sites. There were major issues with nearly every one of them. I need to see the raw data, not just a summary. Didn’t Ceventa deliver it?”
Boatwright threw him a disgusted look. “Are you suggesting a distinguished scientist like Alfred Kingsbury would twist the results?”
“Look, Dr. Boatwright, I’m not suggesting anything. You and Kingsbury already know what I think about Exxacia. You’ve seen my e-mails.”
“All right, Dr. Sinclair. The files are in storage room three in the basement. Do whatever you think best. You’ll find a box of computer discs that have the trial data there, too. The meeting will be in three weeks whether you’re ready or not.”
After Ryan was gone, Boatwright called Kingsbury. Fifteen minutes later he pulled into the visitor lot at Ceventa, checked his tie in the rearview mirror, spat on his hand and wiped down the few loose strands of hair on his head, and hurried toward the building. When he got to the penthouse, he introduced himself to the receptionist.
“Yes, Dr. Boatwright, Dr. Kingsbury is expecting you. Please go through his office to the spa. The door will be to your right when you enter.”
Boatwright walked toward the double doors, and as he approached, a buzzer sounded to unlock them. He entered an office that dwarfed his. It had to be thirty feet wide and sixty feet long. The desk in front of the windows at the far end was almost as large as his entire office. A Persian carpet that probably cost more than Boatwright made in an entire year covered the floor in front of the desk. There was a sitting area with an antique sofa and Queen Anne chairs arranged to face a fireplace with a mantle that appeared to have come from an Austrian castle. On the wall to the right were photos of Kingsbury with presidents, heads of state, and a variety of movie stars. There was even one with the queen of England smiling at his side. A door was in the center of the wall.
Boatwright opened it. “Come in, Roger. I’ll only be a few more minutes, but we can talk while I finish my workout.”
Boatwright found Kingsbury on an elliptical exercise machine, dressed in shorts and a T-shirt with the Ceventa logo on it, a towel draped over his shoulder. A wide-screen television was tuned to a financial channel. As Boatwright entered, Kingsbury reached for the towel and wiped sweat from his face.
“Roger, old boy, you ought to put one of these in your office. Help you take off those extra pounds around your waistline. Now, what’s this about? I’m sure you’ve read our summary by now. Splendid result, if I do say so myself.”
Not knowing what else to do, Boatwright stood in front of Kingsbury. “Yes, sir. It’s excellent. Only there’s a problem.”
Kingsbury stopped the machine and clicked off the television. He walked over to a refrigerator and extracted two bottles of cold water. “Here, have a drink.”
He sat on a bench and motioned Boatwright to sit beside him. “Let me guess. It’s probably that damned Sinclair again, isn’t it?”
Boatwright sat on the end of the bench. “I’m afraid so, Alfred. He and his team won’t accept your summary. They’re going through the data.”
“Hellfire, Roger. There are twenty-five thousand patient charts. No way they can get those done. All they’ll find is a few adverse events and some problems with the sites.”
“I know, Alfred. That’s what I’m worried about. Sinclair has already requested a criminal investigation on several of the sites, just based on some of the preliminary data. He even e-mailed me a few weeks ago, demanding that I stop the clinical trial.”
“Yes, I heard about the site investigations. Fortunately, you didn’t stop the trial.” Kingsbury finished his water, wiped his face, and abruptly stood, stretched, and walked to the window overlooking the park. He was silent long enough that Boatwright wondered if he should leave. “Roger, you and I have gotten to be friends. I know you’ve got three daughters who are approaching college age. The cost of a four-year degree these days is outrageous, not even to mention graduate school or medical school.”
“Tell me about it. My oldest is applying to several Ivy League schools.”
“I want to help. I’ll wire five hundred thousand dollars to a Swiss bank account in your name today. Consider it a loan. You can pay it back whenever you can. That ought to be enough to get all three of the girls into the Ivy League.”
Boatwright continued to sit on the bench, his arms on his knees, staring at the floor. He would never have been so brazen as to ask for a bribe. Finally he decided that if he was going to take one and risk his career, he might as well go for broke.
“What’s the matter, Roger? I thought you’d be ecstatic. I mean, I just made your life a lot easier.”
Boatwright looked at Kingsbury. “I do appreciate it, Alfred, only I’ve got bigger problems than putting kids through college.” Boatwright paused, wiped one eye, and continued. “Joanne, my wife, has ALS.”
“You mean Lou Gehrig’s disease? Roger, I’m so sorry. When was it diagnosed?”
“Just last week, sir. The girls and I are devastated, and Joanne is giving up. I’m so depressed that I’m starting Prozac.”
Kingsbury shook his head. “I don’t know what to say. Ceventa is part of a consortium of drug companies that are studying ALS. Right now, no cure seems to be in sight. How long does she have?”
“The doctors don’t have any idea yet. Maybe months, maybe a year or two. She’s determined to see our youngest graduate from high school.” Boatwright stared at the wall and thought. Then he rose to face Kingsbury. “Look, Alfred, with all I’ve got to deal with, five hundred thousand dollars isn’t enough. Even with insurance, the cost to keep Joanne alive is going to bankrupt me. I need a million.”
This time Kingsbury rose. “Roger, I said I’m sorry about your wife, but don’t get greedy. It’s five hundred thousand. You can spend it however you see fit.”
Boatwright considered his options. There would be another day. “Okay, okay. I’ll get your drug through the advisory committee,” he said as he started to leave.
“Wait a minute, Roger. You have to put a muzzle on Ryan Sinclair. Lock him in the closet on the day of the meeting if you have to. I don’t want his opinions polluting the committee.”
“Understood, Alfred. One more thing. I haven’t told anyone at the office about Joanne. I prefer to keep my personal problems to myself.” Boatwright walked out the door with his head down and shoulders slumped.
It was Sunday afternoon. Ryan and his colleagues pictured themselves as being trapped in a dungeon. Knowing there would be no air-conditioning, they sat around the basement table dressed in T-shirts, shorts, and flip-flops. They had two more days before the advisory committee met, and they were down to the last thousand charts.
“You know, guys,” Ryan said, “I think we’ve seen enough. There’s nothing in those last few boxes that’s going to change my mind.”
“I agree,” Robert replied as he wiped up a bead of sweat that had dripped onto the chart that was open in front of him.
“Same here” was the response from the other two.
“Let’s shut it down,” Ryan said.
“You don’t have to say that twice.” Henry rose and started replacing the boxes along the wall.
“You guys get out of here. I’m going up and send an e-mail to Boatwright. If you see smoke rising from the vicinity of his office when you get here in the morning, you’ll know who sparked the fire.”
Ryan rode the elevator to the fourth floor and walked through the deserted office. While he waited for his computer to wake up, he composed his e-mail to Boatwright.
October 4, 2009, 5:30
P.M.
To: Roger Boatwright
From: Ryan Sinclair
Subject: Exxacia
Our team has completed its analysis of the clinical trial charts. My report to the advisory committee will cover our findings and will also include concerns about numerous data integrity issues along with potential fraud that raises serious questions about the validity of the entire clinical trial. Further, as you already know, several of the sites are the subject of an agency criminal investigation. Additionally, we have uncovered a significant number of adverse events that are not mentioned in Ceventa’s report. The impact of Exxacia on a patient’s liver, heart, and vision continues to be a significant problem. Last, there are more reports from Europe of continuing adverse events, even deaths, that add more questions about the safety of the drug. We still refuse to recommend approval.
“Dr. Sinclair, please come to my office immediately!” Boatwright barked into the phone.
Ryan walked the few steps down the hall, thinking that he and the rest of his team were about to be fired. He closed Boatwright’s door without being asked.
“Dr. Sinclair, I’m only going to say this once. The advisory committee is not to be told about any allegations of fraud. There is nothing about fraud in any of the materials going to the committee. Those allegations are the subject of an agency criminal investigation, and we cannot compromise it.”
“That’s absurd, Boatwright, and you know it. We can have a closed-door session. We can go off the record if we need to. You can’t have the committee evaluate this drug on just the data Ceventa wants to show them! Are you going to put a pair of rose-colored glasses at each member’s place around the table?” Ryan asked, sarcasm dripping from his words.
“That’s enough, Sinclair! Further, I’m instructing you to soften your opinions about the safety issues so that I’ll have some wiggle room if I have to explain our decision somewhere down the line.”
“Wiggle room! So you’ve already made up your mind. We’re just going through the motions, is that it?”
“Not at all, Dr. Sinclair,” Boatwright said in a calmer voice. “In fact, I’ve instructed Ceventa to present postmarket data from other countries of their choosing. There’ll be more than enough justification for approval of the drug.”
Ryan stormed out of the office, slamming the door behind him. He went to the stairs and took them two and three at a time to the first floor. Once outside, he paced a walking path around the building four times while he thought about what had just occurred. Kingsbury and Boatwright were going to present clinical trial data that was carefully whitewashed, backed up with foreign postmarket data of Kingsbury’s choosing. He returned to the building and stopped at Henry’s office on the third floor.
Henry glanced up. “Is that smoke that I’m smelling from the floor above? I haven’t heard any fire alarms.”
Ryan stood in front of Henry’s desk, hands shoved in his pockets. A plaque on Henry’s wall caught his attention. It was recognition of distinguished service to the FDA for ten years. “I’ll never get one of those. I’m out of here.”
“Hold on, Ryan. Take a deep breath. Tell me what went on up there.”
Ryan outlined the discussion and concluded, “Now you can see why I’m so pissed.”
“Look, Ryan, stick it out for a while longer. If all of us who are trying to do the right thing leave, we might as well just hand the keys to the pharmaceutical companies. There’ll be no one looking out for the health and well-being of the good folks of this country.”
Ryan collapsed in a chair and stared at the ten-year plaque. “Okay, okay. A few more months, but I won’t promise anything beyond that.”