The Trial

by Larry D. Thompson

  “Perfectly secure, Roger. You can relax. I’ll see you at the committee hearing.”

  * * *

  Sara poured Ryan coffee and sat beside him at the kitchen table. “Ryan, quit the FDA. We don’t need this in our lives, and we don’t need the money. Look at me. I’m pregnant with our first child. Little Max needs a father,” she pleaded as her eyes filled with tears.

  Ryan stirred his coffee as he thought. “I’m not a hero, Sara, but I’m not a quitter either. You know that. I still intend to derail this drug. It’s going to kill people. I’m just not sure how or when. Meantime, I want you to move in with my dad and mom.”

  Sara took both of Ryan’s hands in hers and looked into his eyes. “Let it go for now. Pick another day for your fight. Boatwright is going to push it through committee anyway. Maybe you ought to go to Senator Grassley. He’s on the Senate drug oversight committee. Once you’ve gone public and have Grassley behind you, Kingsbury will back off.”

  “I’ll think about it. There’ll be a way,” Ryan said. Then he kissed his wife and led her to bed.

  40

  In San Marcos, Luke’s phone rang. “Mr. Vaughan? I mean Luke. This is Brad. Can I drop by for a few minutes this morning?”

  “Sure, Brad. Come on over. I’ll put on another pot of coffee.”

  Ten minutes later Luke saw Brad climb out of his pickup, dressed in a T-shirt, jeans, and boots, and stride up the sidewalk. Luke met him at the top of the steps.

  “Morning, Brad. What brings you over? You get a speeding ticket?”

  “No, sir. Got my last one four years ago. Can we go into your office?”

  Luke nodded, noting Brad’s solemn manner, and opened the door. When they were seated at the coffee table by the fireplace, Luke tried again. “Brad, I can tell you’ve got some problem. Spill it.”

  “Sir, it’s not about me. It’s Samantha. She’s started going to bed around eight, and even after twelve hours’ sleep, she’s sleeping through her first class. I’m worried about her.”

  Luke squeezed his hands together as he thought. “Now that you mention it, lately, when she comes over here to work, she’s not as efficient as she was. In fact, she’s almost listless. She claims she’s just been up studying.”

  “I’m sure that’s true, sir, but I think there’s something else going on. I’ve tried to get her to talk, and she just says she’s got some bug and she’ll get over it. Only it’s been going on for three or four weeks.”

  Luke frowned. “Thanks, Brad. I’ll talk to her this afternoon. I appreciate your concern.”

  41

  Dr. Kingsbury and two of his associates were already in the conference room when Dr. Boatwright entered. “Good morning, Dr. Boatwright. Beautiful morning, isn’t it? These are my colleagues Dr. Allen and Dr. Escamilla. They did some of the research on Exxacia.”

  “Good morning, Dr. Kingsbury,” Boatwright said. “May I have a word in private?”

  Kingsbury nodded and followed Boatwright into an adjoining room. Boatwright shut the door. His hands were shaking. He had also developed a nervous twitch in his right eye. He didn’t appear to have slept in days. “Alfred, judging from what happened at Sinclair’s house, it appears the price of poker is going up.”

  A look of horror came across Kingsbury’s face. “Surely you don’t still think I had anything to do with that. I was at home with Suzanne. No one else thinks I’m a suspect. Why should you? Maybe you’re the one who did it, Roger.”

  “Look, Alfred, I’m desperate. I’m on the Internet every night. I’ve called people all over the world, trying to find something to help Joanne. Finally I’ve located a scientist in Austria who has come up with an experimental treatment for ALS. It’s a two-year program that is going to run well into seven figures.” He paused, then blurted, “I need five million dollars. You get me the money. I’ll get your drug approved. If not, it won’t get past this committee today.”

  Kingsbury sized up the situation. He wasn’t sure that Boatwright wasn’t mentally unbalanced at this point. Still, the committee was assembling just outside the door. It was now or never. He would deal with Boatwright another day. “All right, Roger. We’ve got a deal. Payment to be made once the drug is approved and on the market.”

  When Kingsbury and Boatwright reentered the conference room, the committee members were starting to drift in from the hall. Kingsbury had studied them on the Internet and knew enough about their backgrounds to comment about each of them or their institution or compliment them on something about their work. Drs. Allen and Escamilla handed each member a packet of journal articles on Exxacia, now showing the lead author of each as a prominent member of the infectious disease community. Each article also had a label, indicating in what distinguished journal they might expect to see it published in the next few months. No one mentioned that the articles had been written by scientists on the Ceventa payroll.

  When eight of the eleven members were present, Dr. Salazar, the chairman, asked them to take their seats. The last person to enter the room was Ryan Sinclair, who chose to sit by himself along the wall. As he looked around, he saw the empty chairs at the oval table and studied the members in attendance. He concluded that no one in the room was seriously opposed to approval. Whatever he said was going to fall on deaf ears, particularly since Boatwright would be advocating strongly for the drug—and somewhere in the back of his mind he saw his burning Corvette and the note. As much as he hated to do so, he decided this was not the day to draw a line in the sand.

  “Ladies and gentlemen,” Dr. Salazar began, “we last met on this drug a little over a year ago and took Dr. Boatwright’s recommendation to request a large clinical trial. Ceventa agreed to it. You received the summary results last week, and Dr. Kingsbury has been kind enough to join us. Dr. Kingsbury?”

  Kingsbury stood at his place. “Thank you, Dr. Salazar. I’m pleased to advise that the clinical trial, one of the largest ever conducted by a pharmaceutical company, has proved just what we anticipated. Exxacia has a remarkable impact on sinusitis, bronchitis, pneumonia, and tonsillitis. It holds distinct promise for a number of other bacterial infections, but we are not seeking approval for those at this time.”

  “If I may interrupt, Dr. Kingsbury,” Dr. Rogers from Palo Alto said, “I’ve studied your data very carefully. I can go along with your recommendations on the three respiratory illnesses, but I’ll have to see more trials before I can approve Exxacia for tonsillitis.”

  Several other committee members nodded in agreement.

  “Dr. Kingsbury,” Dr. Sebastian from Chicago asked, “what about the issues we raised at our last meeting about Exxacia causing problems with the liver and heart?”

  Dr. Kingsbury smiled. “I’m glad you asked. There were a few isolated events, but nothing more than with any other antibiotic, right, Dr. Boatwright?”

  Boatwright, now calm and professional after taking a Prozac, stood beside Kingsbury and chimed in. “He’s correct, Dr. Sebastian. CDER is prepared to give Exxacia its highest recommendation, and if this committee agrees, an approval letter will go out immediately.”

  “I might also add,” Dr. Kingsbury continued, “your notebooks contain postmarket results from a number of countries in Europe and South America.” He neglected to mention that they had omitted such results from a number of other countries where the reports of adverse events were considerably higher.

  “I see Dr. Sinclair sitting over there.” Dr. Craig nodded in Ryan’s direction. “I understand he was the review officer in charge of this drug. Do you have anything to add, Dr. Sinclair?”

  Ryan remained seated and folded his arms. “No, sir. Dr. Boatwright is in charge of this meeting. I’m just here as an observer.”

  “Just a minute, Dr. Sinclair. You’ve lived with this drug for over a year and you’re telling us you have nothing to say. I find that hard to accept.”

  “Sorry, Dr. Craig, but Dr. Boatwright is speaking for CDER and the agency.”

  Dr. Craig was puzzled
about Ryan’s refusal to comment but said nothing further.

  “Well, then, Dr. Kingsbury,” Dr. Salazar said, “if you and your assistants will leave the room along with Dr. Boatwright and Dr. Sinclair, the committee will go into executive session.”

  The next morning Roger Boatwright posted a letter on the FDA Web site approving Exxacia for sinusitis, bronchitis, and pneumonia. Then he e-mailed Kingsbury and told him he would continue to push for approval for tonsillitis, but that approval would have to wait for another day.

  42

  Samantha pedaled from her last class to the house. She had to stop three times to get her breath and was sweating when she got home. She entered the front door and heard Luke on the phone talking to a client, so she went into her office and started opening the mail. Luke ended his call, crossed the hall, and took a seat.

  “How was school today, Sam?”

  “About the same, Dad. I may make a B in French, though.”

  “Don’t worry about it. I know you’re pushing yourself. Brad dropped by this morning.”

  “Brad? Why?”

  “He’s worried about you, Sam. He says that you’ve been sleeping through classes.”

  “Brad ought to be minding his own business,” Samantha said.

  “Sam, he’s concerned. He’s just trying to do what’s best for you. Is he right?”

  Tears filled Samantha’s eyes. “Yes, sir. Dad, I don’t know what’s going on. I’m sleeping all the time. I’m not eating much either because I’m too nauseated.”

  “Sam, I don’t quite know how to ask this but directly. Are you pregnant?”

  “Dad, of course not. Brad and I aren’t even sexually active.”

  Luke nodded his head and looked at his daughter as he thought. “Your face is looking sweaty.”

  “Yeah, I just rode home, and it’s pretty warm out there today.”

  Luke stepped around the desk and looked more carefully at his daughter. “Sam, I want you to come out in the front yard so I can get a better look at you.”

  “Why, Dad? What if the neighbors see us?”

  “Just for a minute. Come on.”

  Reluctantly, Sam followed Luke down the steps and into the sunlight. Luke took her hands and turned them over so that the underside of her forearms caught the sun.

  “Sam, your skin is yellow. Look up at me. I want to see your eyes.” She did as he asked. “The whites are yellowish. How long has that been going on?”

  “I don’t know, Dad. A few days, I guess.”

  “Okay, come back in the house. I’ve got another question.”

  When they were seated in Luke’s office, he asked, “Sam, I may be getting too personal. Forgive me. When you go to the bathroom, what color is your urine?”

  “It’s pretty dark.” Sam sighed as she slumped in her chair again.

  “I’m taking you to see Clyde Hartman in the morning. He’s the best internist in town, maybe one of the best in this part of the country. And you’re spending the night here, not back at your apartment.”

  “Dad, I’ve got homework to do and classes tomorrow.”

  “Sam, this is more important. Stay here a minute while I call Clyde. Then you can go up for a nap.”

  Cocoa had been listening intently to the conversation. While Luke turned to the phone, she went over to Samantha, whined quietly, and lay down at her feet.

  “Yes, ma’am. This is Luke Vaughan. Is Dr. Hartman around?”

  Clyde Hartman picked up the phone. “Afternoon, Luke. As far as I know, I’m not getting sued for malpractice. So what can I do for you?”

  “Clyde, Sam’s jaundiced. I don’t know if it’s her liver or something else. Can you see her tomorrow?”

  “You bet. Don’t worry about an appointment. Just come on over. I’ll work her in.”

  Luke thanked the doctor and told Samantha to take a nap. Sam and Cocoa climbed the stairs. It was the next morning before she woke.

  43

  The campaign was launched within twenty-four hours. Drug representatives had already been supplied with free samples and started leaving them with physicians all over the country. In turn, the physicians gave them to patients in place of other antibiotics.

  Network medical editors were provided with briefing books and summaries of the studies. Always looking for ways to get more face time in front of the cameras, they were eager to talk about the new wonder drug.

  A reader couldn’t open Time, Newsweek, Sports Illustrated, or a major newspaper without being confronted with a full-page, multicolor ad with bold print touting the benefits of Exxacia. Six-point type at the bottom of the page that would require a magnifying glass outlined warnings of potential adverse consequences.

  Ceventa bought time on all the major networks and cable outlets to run a commercial that featured an actor who had played a successful doctor on a long-running hospital drama. He was shown standing by a patient’s bed, stethoscope around his neck. As the camera zoomed in, he turned and said, “As you know, I’m not a real doctor. If I were, I know exactly the drug I would be recommending to my patients with certain bacterial infections. It’s Exxacia. The next time you have a sinus problem, bronchitis, or even pneumonia, ask your doctor about Exxacia. You won’t be disappointed.” The camera then backed away as the actor turned to place his stethoscope on the chest of the make-believe patient.

  At the end of the month Ceventa released data on the remarkable sales of Exxacia, which were far greater than predicted by analysts. Overnight Ceventa stock rose 10 percent.

  Kingsbury leaned back in his office chair and thumbed through the Wall Street Journal until he found the article. He read with satisfaction the analyst’s assessment of Ceventa and the impact Exxacia would have on its stock price over the next two years. Finally, he thought, after all of the obstacles he had to overcome, he was seeing the results of his plan. Not as soon as he had originally expected, but better late than never, he surmised.

  His eye caught the date of the newspaper, and he realized he had a minor problem. He turned to his computer contact information and pulled up the florist he used for special events. When a female voice answered, he said, “Morning. This is Alfred Kingsbury. I have a personal account with you.”

  “Yes, of course, Dr. Kingsbury. How can we be of assistance?”

  “I just realized that my granddaughter’s school play is in three days. I want to order two dozen Sterling Silver roses, you know, the light purple ones, delivered to her house day after tomorrow.”

  “We can certainly do that, Dr. Kingsbury,” the florist replied. “But, we don’t keep those in stock. They’ll probably have to be shipped from France. On short notice, that will be quite expensive. We’ve got some beautiful red roses in stock.”

  “Don’t worry about the expense,” Kingsbury said as he glanced at the headline in the paper. “I can afford them and the overnight charge. Put on the card, ‘To Kelley. Break a leg. Love, Grandpa.’”

  44

  Luke opened Samantha’s door to find her sleeping with all of her covers thrown off. Cocoa was beside her. He walked to her side and felt her forehead.

  Samantha stirred. “What is it, Dad?”

  “I think you’re running a little fever. It’s time to get up. I want to get you over to Dr. Hartman.”

  “Can’t I just sleep a little more?”

  “Sam, you’ve been asleep fifteen hours. You can go back to bed after you see the doctor.”

  Samantha slowly sat up, and Luke looked into her eyes. He didn’t say anything, but he didn’t like what he saw.

  They got in the car to make the five-minute drive to Dr. Hartman’s office. Samantha dozed off before they got there. Once inside, Luke told the receptionist that Dr. Hartman was expecting his daughter. In a few minutes the nurse led them back to a treatment room, where the doctor greeted them.

  Dr. Hartman was a large man with a mane of white hair complemented by a bushy white mustache. He had graduated from Baylor College of Medicine in Houston and probably
could have stayed as a faculty member. Instead, he moved to San Marcos. As he put it, he wanted to be in a town where he knew his patients and would see them at church or the grocery store, not just when they were sick.

  “Good morning, Luke. Sam, I hear you’re a little under the weather.”

  “I think I’ve just got the flu or something.”

  “Okay, let’s see. Put this thermometer in your mouth.” He took it out when it beeped and glanced at the reading. “You’ve got a little fever, about one hundred and one. Let me look in your eyes. Look at this light. Yep, your eyes are yellow.” Next he wrapped a cuff on her right arm and pumped it up, listening with his stethoscope. “Blood pressure is good. Lie back, please.” Dr. Hartman listened to Samantha’s heart and lungs. Then he pressed on her abdomen. Samantha grimaced when he did so. “That hurt a little?”

  “Yes, sir.”

  “Sam, I’m going to draw some blood from your arm. You’ll feel a little prick, that’s all. Then I want you to take this little cup and go to the restroom, where I want you to leave me a urine sample.”

  As Samantha left the room, Luke asked, “What’s happening, Clyde?”

  “Something’s going on with her liver. She ever had a problem with gallstones?”

  “Never.”

  “If she doesn’t have a stone in her common duct, she’s most likely got some form of hepatitis. I’ll get the blood and urine off to the lab this afternoon. I’m not sending her to the hospital for an ultrasound until we see those results. Bring her back day after tomorrow. I could talk to you on the phone, but I’d like to have another look at her.”

  Luke nodded.

  Two days later Luke and Samantha were seated across the desk from Dr. Hartman. “All the test results are back. As I suspected, the liver function tests are elevated. The tests for hepatitis A, B, and C are negative. That leaves us with a hepatitis that is probably drug induced.”