The Trial (6 page)

16

Ryan found himself, once again, standing in front of Boatwright’s desk as the director pretended he wasn’t there. Boatwright finished proofing a letter and finally looked up. “Dr. Sinclair, the Infectious Disease Advisory Committee convenes in three days. There are a few minor matters, mainly follow-ups from previous meetings, but the bulk of the meeting will be a discussion of Exxacia.”

Ryan nodded. “I’ve been working with my team, Dr. Boatwright. I’ll be prepared to present our recommendation.”

“That’s what I want to discuss. Why don’t you shut the door and have a seat?”

Ryan did as he was told. Boatwright leaned over his desk. “Dr. Sinclair, you and I disagree about this drug. I expect you to lay out your team’s findings in full. However, I would ask that you not recommend a complete rejection of the drug. These committee members use antibiotics every day in their practice. They can hear what you say and draw their own conclusions. If they choose to reject the drug, so be it.”

Anger welled up in Ryan. He took off his glasses, wiped them with his tie, satisfied himself that they were clean, and replaced them, all the while composing himself. “You want me to defer to the committee?”

“Precisely, Dr. Sinclair.”

“Why would I do that? I’m a medical reviewer. My job is to evaluate drugs and make recommendations, not to pass the buck, Dr. Boatwright.”

Boatwright rose from his chair and shook his finger at Ryan. “Your job is to do what I say. Otherwise, I’ll accept your resignation right now, Dr. Sinclair.”

Ryan wasn’t ready to resign. He believed in his work. Someone in the FDA had to be accountable to the public. There were too many Boatwrights in the agency. If he stayed longer, maybe he could lead a quiet revolution and change the system. Besides, he wasn’t quite ready to move to the CDC. He got out of his chair and replied, “I’ll think about it, Dr. Boatwright. No promises, you understand.”

*   *   *

The eleven members of the Infectious Disease Advisory Committee assembled from around the nation. Rarely could all attend; today nine were expected. Eight were medical doctors, and one was a scientist with a special interest in antibiotics. They had read a briefing paper prepared by Ryan’s team and expected to question the staff, but first there was lunch. They assembled in a conference room on the second floor of CDER; place cards identified their seats. Dr. Ramon Salazar from San Antonio was at the head of the table. Dr. Boatwright sat to his left. The lunch conversation was about families, changes in faculty appointments at medical schools around the country, and NFL football teams. After the table was cleared, Dr. Salazar called the meeting to order.

“We’re here today to discuss a new Ceventa antibiotic, Exxacia. I’m sure you’ve all had the opportunity to study the briefing paper. Dr. Boatwright, I understand Dr. Sinclair is available to discuss the drug with us.”

Ryan had been sitting in the hallway outside the door, arms folded, doing a slow burn since he knew that Boatwright had intentionally denied him a place at the luncheon table. Boatwright went to the door and summoned him to a small podium at the front of the room. Ryan placed a briefing book on the podium, opened it, and looked around.

“Dr. Sinclair, am I correct that you have headed up the team that has been evaluating Exxacia?”

“Yes, Dr. Salazar. My team has been focused on it for over six months. I’m comfortable that I can answer any questions your committee may have.”

“Very well, please proceed with your introductory remarks. We’ll chime in from time to time.”

Ryan paused for a sip of water. “We should start with the results of the drug in Europe and South America. Ceventa has marketed it overseas for nearly three years. As of the last available data several million prescriptions have been written, mainly for sinusitis, but also for bronchitis and pneumonia, with some doctors also using it for tonsillitis. Based on physician and patient surveys by Ceventa, the response has been very favorable.”

“If I may interrupt, Dr. Sinclair,” Dr. Anita Sebastian, an infectious disease specialist from Chicago, said, “one of your footnotes alludes to some problems with liver failure, both in after-market reports overseas and in Phase III clinical trials here.”

Boatwright’s glare at Sinclair conveyed a demand:
Don’t overdo this, Sinclair.
Ryan caught the look. “That’s true, Dr. Sebastian. There can be instances of toxicity to the liver.” Ryan glanced at Boatwright as he continued. “We all know that is a trade-off that must be made with any antibiotic.”

“If I may be heard.” Dr. Holloway, a physician affiliated with Emory University, interrupted. “I don’t see anything here that alarms me.”

“Just a minute, young man,” Dr. Rogers from Palo Alto said. “It looks to me like the reports of adverse events are much more frequent than with some of our more common antibiotics. We rarely see liver problems with ampicillin, for example, and it works quite well for bacterial sinus infections and even pneumonia. Plus, it’s now been around long enough that it’s a generic and a whole lot cheaper than whatever Ceventa will charge for this new one.”

Dr. Craig from Miami popped up. “And what about those reports of cardiac irregularities? I don’t like those one bit.”

“Dr. Sinclair, you and your team have been living with this drug, as you say, for six months now. What’s your recommendation?” Dr. Salazar asked.

Not liking the way the wind was blowing, Boatwright rose to his feet and interrupted before Ryan could answer. “Members of the committee, may I make a suggestion? From what I can determine, Exxacia has marvelous potential, particularly since our population is aging and, frankly, older antibiotics are just not as effective. Why don’t we mandate that Ceventa conduct a large, randomized prospective clinical trial with patients throughout the country? I would suggest that we require an approval letter be subject to Exxacia passing such a trial with flying colors. If they don’t want to spend the money for it, or if the trial doesn’t produce satisfactory results, then we can reject Exxacia. And there’s another benefit. By the time the trial is complete, we’ll have much more data from other countries.”

“I don’t have any problem with that,” Dr. Salazar said. “Certainly, more data can only help our decision. Everyone in agreement?”

Heads nodded around the table. Ryan had backed away from the podium and leaned against the wall, his arms folded. He didn’t see the benefit of a trial. He was satisfied that Exxacia had far too many problems. Still, he was literally boxed into a corner.
At least,
he thought,
it’ll take a year or more to do a study,
and he could always hope that more problems would surface.

17

Alfred Kingsbury directed his driver to park in a handicap space at the front entrance of the CDER complex. He pushed out the back door before Mario could get to it and burst through the front door to the security desk. “I’m here to see Dr. Roger Boatwright, young man,” he bellowed.

“Is he expecting you, sir?”

“No, he’s not, but he ought to be. You call up there and tell him Dr. Kingsbury is here to see him—immediately, you understand?”

“Yes, Dr. Kingsbury. Give me a moment.” The guard dialed a number, and after a brief conversation, he handed a visitor badge to Kingsbury. “Please sign here. Someone will greet you on the fourth floor.”

Kingsbury scribbled his name and marched to the elevator, where he punched the button three times before one arrived. On the second floor two young women entered, chatting about their children, and punched the third-floor button. Kingsbury continued to fume as they exited and he repeatedly pushed the button to close the door without success. Finally it slid shut, then opened on the fourth floor, where Roger Boatwright, thankful he’d had time to put on his coat and tie, awaited him.

“Afternoon, Alfred.”

“Today it’s Dr. Kingsbury to you. Where’s your office?”

“Right this way, Dr. Kingsbury. Can I get you coffee?”

“No, Dr. Boatwright. This is not a social visit.”

Boatwright told his assistant that he was not to be disturbed. He closed his door and was about to take his seat when he realized that Kingsbury remained standing.

“Look, Dr. Kingsbury, I know why you’re here. You got the letter this morning.”

“You’re damn right that’s why I’m here.” Kingsbury stuck his finger in Boatwright’s face. “I depended on you to get my drug through. My company and I have a lot invested in Exxacia. Aren’t you the man in charge?”

Boatwright retreated behind his desk. “I am the director of CDER, but if I overrule one of my medical review officers, it raises red flags all the way to the top. Believe me, I want Exxacia approved, and I wish it could be today. The way things were going in that committee room, if I hadn’t suggested the clinical trial, there was a likelihood they were going to vote down the drug.”

“Damn it, Boatwright, that will cost my company a year and hundreds of millions in profit,” Kingsbury fumed. “And think what it will do to our stock. Once the word gets out, our stock will drop twenty or thirty percent when it should have doubled just with an approval letter.”

“Calm down, Dr. Kingsbury. Think long term. Another year or so and then you’ll be producing that hundreds of millions of profits every year.”

Kingsbury finally took a seat. “All right, Roger. Sorry I got so pissed off. What do you want in that study?”

“Your call, Alfred. I suggest that you design a trial that will put Exxacia in the best possible light. I’ll approve whatever you submit.”

“I’ve got it, Boatwright,” Kingsbury said with a smile. “We’ll design a trial that will have twenty-five thousand patients, maybe one of the largest you’ve ever seen by a pharmaceutical company. We’ll put it on a fast track, maybe less than a year, and then dump that data on Dr. Sinclair and his team. I’ll depend on you to push them to make a quick decision. No way they’ll be able to do a critical analysis of our data in a few weeks, right, Boatwright?”

Boatwright nodded his head in agreement. “You get us the data, and I’ll set the time limit to either accept or reject the drug. You can count on me.”

Kingsbury moved into action. First he assembled his marketing team and ordered them to run small classified ads in every medical trade journal in the country. He knew it wouldn’t take much to attract physicians to apply to be clinical investigators. After all, the family practitioners and internists were among the lowest-paid physicians in the country. To participate in a clinical study was not only good money, it was easy. Really all the physician had to do was follow the protocol, monitor the patients, and report the results. On top of that, these were not really sick patients, particularly the ones with sinus infections and bronchitis. It wasn’t like they were testing a new drug to treat heart failure or cancer. So the ad ran:

NEW DRUG APPLICATION

Major international pharmaceutical company seeks qualified physicians to investigate a revolutionary new antibiotic for treatment of sinusitis and similar respiratory infections. Contact us at Exxacia.com for further details.

As soon as the ads hit physician offices in November, the Exxacia team was overrun with e-mails. After minor screenings they selected nearly all of the family physicians, a few internists, and none of the infectious disease specialists. The team recognized that too much knowledge could be dangerous to the approval of their drug.

18

Luke heard the sound of a motorcycle on the street in front of the house. It stopped, and someone turned off the engine. He rose and looked out the window to see a Harley-Davidson in mint condition at the curb. Chrome reflected the afternoon sun; the saddlebags were a deep maroon; the body was a luxurious red.
My God,
Luke thought,
it’s Morgan Freeman coming to my office.
Then he looked more carefully and realized that the rider merely looked like the actor. The slender, middle-aged man strapped his helmet to the handlebars, glanced at the house, and started up the sidewalk. Curious, Luke opened the door and met him on the porch.

“Afternoon, sir.” The visitor spoke as he extended his hand. “Name’s Wilson Moore. I’m a history professor over at Texas State. You got a few minutes?”

Luke took an instant liking to him. “Sure, you want to come in or sit out here on the porch?”

“Out here’s fine with me. Too nice a day to be inside.”

“Have a seat. Let me holler at my assistant to get us some iced tea.”

While Luke went inside, Cocoa nosed her way through the screen door and sidled up to the stranger on her porch. Finding him to her liking, she permitted him to scratch her back until Luke returned with a tray complete with two tall glasses of tea and various sweeteners. “Now, what can I do for you, Professor Moore? You need a good lawyer?”

Professor Moore added Splenda to his tea, stirred it, and spoke. “First, just call me Whizmo.”

“Kinda strange name. Where’d that come from?”

“High school buddies. Somehow they shortened Wilson Moore to Whizmo, and I’ve been stuck with it ever since. Even my students call me Whizmo—Professor Whizmo when the dean’s around. Don’t need a lawyer. I’m looking for a place to live, and I’ve been noticing that you have an apartment over your garage. Is it for rent?”

“Well, it’s empty and has been since we remodeled this place. I’ve thought from time to time about renting it out. Just never got around to advertising it. I’ve got a daughter to put through college before long and could use the extra money. Don’t you have a place to live?”

A frown crossed Whizmo’s face as he fumbled for words. “Luke, I’ve been a history professor here for twenty years. I’ve even got a distinguished chair that pays me an extra forty thousand a year. I also teach a graduate seminar in computer science. There wasn’t a degree in it when I was in school, so I’m self-taught but pretty damn good, if I say so myself. I’ve got a big old house on the west side of town. My wife and I raised two kids there. They’re both out on their own now. One lives in Houston and the other in San Antonio.” Whizmo paused and summoned the strength to go on. “I lost my wife to cancer last year.”

“I’m sorry, Whizmo,” Luke said, finding it easier to say the strange name.

“No need, Luke, only I’ve been rattling around in that house with memories everywhere I turn. I finally decided I needed to put it on the market and move somewhere else. I’m not sure where I’ll end up, but your garage apartment looks like a good interim stop. It’s close to campus. I can walk some days and other days ride my Harley.”

“Don’t you own a car?” Luke asked with some amazement.

“Got an old pickup out at the place. Don’t use it except to haul wood and stuff. I’ve been riding Harleys since I was a kid. Second nature to me.”

“How long do you want to rent the place?”

“I’ll sign for a year and then evaluate my situation. Mind if I have a look?”

Luke rose and beckoned Whizmo to follow him around to the back. “I’ve got to warn you that it may be a little dusty. I’ll get a maid to clean up if you decide you want it.”

Luke opened the door and let Whizmo step in. The transformation from three years before was remarkable. Recessed lighting cast a pleasant glow throughout the living area and kitchen. Stainless steel appliances glistened from behind the kitchen bar. A fireplace occupied one wall. Two bedrooms shared an adjoining bathroom. The old windows had been replaced by modern picture windows with miniblinds to provide privacy.

Whizmo let out a low whistle. “Wow, this is more than I imagined. Frankly, I figured it would be your average run-down garage apartment. What do you want for this?”

Luke scratched his head. “You know, Whizmo, I don’t have a clue. You tell me?”

“How about fifteen hundred a month? And if you’ll let me have one of the garages I’ll throw in another hundred.”

“Done.” Luke smiled. “Why a whole garage?”

“Oh, I’ve got another Harley. It was my wife’s. It’s the one thing that I just can’t get rid of. Not yet, anyway. We had too many great rides and great memories to part with that, at least for now. Then, I’m into woodworking and I’ve got a few power tools. You need any furniture, I’m your man.”

“Deal, Whizmo. No lease necessary. If I’ve got to have someone sign a lease for my garage apartment, I don’t want that person living behind me. Now, let’s go back to the porch and seal this with a beer.”

Over the next several weeks Whizmo hauled furniture, all handmade, to the apartment. Luke volunteered to help with the heavy stuff. Then came the woodworking tools, along with a lathe, table saw, drill press, jointer, hand planes, and a large table, old and scarred. There was just enough room left for two motorcycles.

One Saturday Luke heard a low rumble and glanced out to see Whizmo turning into the driveway on a different Harley. He parked it in the backyard and proceeded to wipe it down with loving care. Luke wandered out to admire it with Samantha not far behind.

“She’s a beaut, Whizmo,” Luke said. “That one your wife’s?”

“Yep, she put sixty thousand miles on it before she died. We knew every road in the Hill Country. Hell, we even made Sturgis a couple of times when we were younger. This your daughter?”

“Samantha, this is Professor Moore. He teaches history and computers over at the university. Samantha’s a junior. She’ll be heading to college in another year.”

“My pleasure, Samantha. Just call me Whizmo like everyone else does. You ever been on a motorcycle?”

“No, sir, I mean Whizmo. I’m scared of those things. A friend of mine has a Kawasaki and shattered his leg. I’ll stick to cars. I’ll be getting my license soon, right, Father?”

“Probably about the time you go to college will be soon enough.”

Samantha glared at him and, without another word, walked back to the house.

Whizmo stood and wiped off his hands. “Strikes me that you and Samantha have a few issues.”

“More than just a few, Whizmo.”