The Trial (8 page)
Authors: Larry D. Thompson
Ryan Sinclair watched as his dad sank a fifteen-foot putt. Ryan tapped his in from four feet away, and they walked to their cart.
“I’ve got a problem, Dad.”
Maxwell Sinclair looked at his son with concern. “At home or work?”
“Not at home. Couldn’t be going better with me and Sara. It’s work. Your friend Alfred Kingsbury and his company have submitted a new antibiotic that I think is a bad drug.”
Maxwell Sinclair got in the passenger seat, and Ryan drove to the next tee. “I thought you would be in a position to stop something like that.”
“So did I, only Boatwright has taken a personal interest. I intended to block it at the advisory committee, but Boatwright wouldn’t let me give them my recommendation. He pushed for a clinical trial instead. So now Ceventa has come up with a protocol that wouldn’t get third place in a high school science fair. On top of that, I’ve been looking at the list of clinical investigators. I wouldn’t let most of them touch my dog.”
Ryan approached the tee, placed his ball, sized up the fairway, and let loose a drive that came close to three hundred yards.
“Well,” Maxwell said, “I’m certainly glad those golf lessons I paid for when you were ten turned out to be worth the money.”
“It’s all your fault, Dad. If you had only started me when I was six, I’d be on the pro tour instead of having to deal with the FDA and drug companies who don’t give a damn about anything but their bottom line. I feel like I wimped out at the advisory committee. I had been asked my opinion about the damn drug, but before I could say anything, Boatwright jumped in the middle of it. I deferred to him since he’s head of the whole damn division. Bottom line is I didn’t do my job.”
“This is that new antibiotic, isn’t it? What’s the name again?”
“Exxacia.”
“Yeah, I remember now. Kingsbury told me about it, bragged about how much money it was going to make for Ceventa. Told me if I bought their stock now, I’d triple my money in two years.”
“Not if I have anything to do with it, and I will. Fortunately the clinical trial stands between Ceventa and approval. I’ll have another chance to kill it, and I won’t be so timid next time.”
“It really is that bad, is it?”
“Damn right. The number of cases of liver failure and death is ten times higher in Europe than with any other antibiotic.”
Maxwell lined up his tee shot, took a couple of practice swings, and hit one right down the middle, where it stopped at the 250 yard marker. After his shot, Maxwell walked up to his son and tapped the handle of his driver into Ryan’s chest as he spoke. “Son, you watch your backside on this one. Something tells me the stakes are high.”
Crowley, Louisiana, is in the heart of Cajun Creole country. There are still families there that speak only a French dialect, and gumbo is considered a staple. In fact, folks there take such pride in their family gumbo recipes that they are handed down from generation to generation and only by word of mouth. To put such a treasure in writing could mean it might be stolen and turn up on a neighbor’s table. One of the best of the gumbo chefs was John Paul Batiste, DO, an osteopathic physician who officed in a small house on the highway leading to Baton Rouge.
Under six feet tall, he weighed three hundred pounds. In spite of his weight, he had a sign in front of his office that touted his specialty in weight-loss medicine. His size didn’t bother his patients, mostly women. When they entered his office, the smell of gumbo drifted from the kitchen in back to fill the entire office. After he examined his patients, he took them to the kitchen, where he dished them up a bowl, whispering to them that while the pills he gave them would take off some weight, the secret ingredients in his gumbo would do more to help them shed pounds than any pill.
It was three o’clock one afternoon, and, as was his custom, Dr. Batiste took a bottle of vodka from the credenza behind his desk. He went to the kitchen and returned with a tea glass full of ice and poured the vodka up to the rim. He then leaned back with the glass in one hand and a magazine called
Louisiana Medicine
in the other. He flipped through the magazine until he ran across an ad from Ceventa, seeking clinical investigators for a new antibiotic. A smile crossed his face. He had been such an investigator too many times to count, enough times that he had learned how to manipulate the system to minimize his efforts and still fatten his pocketbook. He kicked his feet off his desk and turned to his computer to log on to the Ceventa Web site. In ten minutes he completed the application, and the message said to expect a packet of materials and drugs by FedEx within two days. Now he just had to start lining up subjects for the study, who were supposed to have one of the bacterial infections that the drug was developed to combat. Then he smiled as he thought that all of his plump patients almost certainly had the sniffles that could be caused by sinusitis. Certainly that would be his diagnosis.
Rudy Kowalski, Ceventa’s officer in charge of the Exxacia clinical trial, was the first to notice. Ceventa had enrolled several hundred doctors, and they were approaching twenty thousand subjects. Kowalski was pleased at how smoothly the trial was progressing. He thought they should easily meet their deadlines as mandated by Dr. Kingsbury. He printed off an Excel spreadsheet to get an idea of the sites and physicians involved. As he studied the list, he was sipping a cup of coffee. Then he spotted a problem, not just one problem, but a lot of them. He put his cup down so hard that some of the coffee spilled onto the desk. He grabbed some Kleenex and wiped off the spreadsheet and then studied it some more.
The protocol called for no more than fifty subjects to be evaluated by any one investigator. He started talking to himself as he evaluated the information. “Here’s one with seventy. More than approved, but not too bad. Here’s one with a hundred and twenty-five. And, crap, here’s some doctor named Batiste in Louisiana who’s got four hundred and forty-three.” He started writing down the names of the investigators who had more than fifty subjects and the numbers of patients. Finally he turned to the phone.
“Dr. Kingsbury, please. Rudy Kowalski calling. I only need about a minute of his time.”
“What’s up, Kowalksi? Make it fast,” Kingsbury said.
“Sir, I’m a little alarmed by our study. We’ve got eighty-three doctors who have anywhere from seventy to over four hundred subjects enrolled in the Exxacia trial.”
“How the hell did that happen, Kowalski? That’s eighty-three red flags for the FDA. Why didn’t you have someone monitoring this kind of thing?”
“I did, sir. She’ll be looking for another job this afternoon.”
Kingsbury thought for a few seconds. “Well, hopefully there’s no problem we can’t handle. We damn sure aren’t going to start this study over. Get someone to do a site inspection on that doctor with four hundred patients. We’ll start there and do random checks of others, depending on what you find.”
The car was loaded. Samantha hugged Cocoa good-bye and climbed into the passenger seat. She was ready for college. She was also ready to get out from under Luke’s thumb. After all, she was now a woman.
Luke got into the driver’s seat, and after he buckled his seat belt, he handed Samantha a piece of paper with numbered paragraphs. “Here, Sam. I’ve drafted ten rules for succeeding at A&M. Take a look at them and we can talk as we drive to College Station.” Samantha took the list and skimmed down the page before wadding it up and sticking it in her purse. Instead of having a discussion, they again drove in silence.
Once they arrived, they joined other parents and students who were unloading vehicles and carting the contents to dorm rooms. After the Sequoia was unloaded, Luke and Samantha stood awkwardly at the door to the dorm. Neither knew what to say. Then, much to Luke’s surprise, Samantha stepped forward and gave him a hug. In return he kissed her on the cheek.
“Do good, Samantha.”
“I will, Father.”
Luke smiled and turned to walk to the car.
When he returned to San Marcos, Luke checked his e-mail and phone messages. Finding nothing that wouldn’t wait until the next day, he went upstairs to change clothes, then came down again. Whistling as he went out the back door, he got what he now called his Harley and rode to pick up Sue Ellen. She was waiting on the porch.
“Hi, handsome. I haven’t been on one of those since college. You sure you know how to ride it?”
“Had the best teacher in town, Whizmo’s Riding Academy. Put this helmet on, and I’ll take you out in the hills to a biker bar Whizmo showed me. Best cheeseburgers in the Hill Country.”
It was Luke’s first time to have a passenger, so he took it easy.
Keep it under the speed limit,
he thought,
and watch for gravel on the curves
. They got to the edge of town, went down a hill, crossed a low water crossing, and were on their way. The sun was slowly disappearing, mixing shadows with beams of light as they climbed a hill and cruised down the other side. The road followed the curve of a river as it wound through the hills, and finally they came to a bridge over the river with a ramshackle house and a parking lot full of motorcycles on the far side.
As they went around the house to the back porch, Luke said, “Just so you’ll know. There are a few of the old bikers that hang out here, but most of the customers are modern-day professionals just trying to relive their youth.”
When they stepped onto the porch, the bartender hollered, “Hey, Luke, who’s your old lady and where’s Whizmo?”
“Whiz is in San Antonio seeing his grandkids. This is Sue Ellen. Give us a couple of cheeseburger baskets and Bud Lights.”
Luke and Sue Ellen settled into chairs at a table overlooking the river and watched the sun disappear behind the hills as Christmas lights that were strung from tree to tree were flicked on by the bartender.
“So, Luke, how’s it feel—I mean, to be an empty-nester?”
The bartender brought their beers.
“Little too early to tell. I’m just glad I got her out of high school and into college. Hopefully she does well, and hopefully not living under the same roof will make it better for both of us.” Luke reached across the table and took Sue Ellen’s hands in his as he gazed into her eyes. “And it means I’ll have more time for the second love of my life. Well, maybe the third if we count Cocoa.”
The comment drew a poke in the arm from Sue Ellen. “I’ll be willing to fight Cocoa for that number two spot. May the best girl win,” she teased. “Actually, I’ll be facing the same thing you are in a couple of years. Josh is determined to go to Texas and start at quarterback. I’ve told him that the Longhorns get their pick of the best prospects in the country. He just says, ‘Bring ’em on.’ He’s a good kid. Maybe not as smart as Sam, but he makes up for it by busting his butt in everything he does.”
A waitress dropped off two cheeseburger baskets.
“You eating onions?” Sue Ellen asked.
“You bet. You better, too, for self-defense if nothing else.”
Sue Ellen nodded and loaded her cheeseburger, topping it off with mustard and ketchup. When she took a bite, she chewed with a smile on her face. “You’re right. Best damn cheeseburger around. Promise to bring me back?”
“Not before tomorrow night, anyway.”
Sue Ellen nodded her agreement. When they finished the burgers, they grabbed two more beers and walked along the river as the moon peeked over the hills to the east. Pausing on a boulder that jutted out into the river, they turned and wrapped their arms around each other. The kiss was long and passionate. When they broke away, Luke said, “See, we couldn’t even taste the onions.”
Sally Witherspoon marched into Rudy Kowalski’s office, pitched her report onto his desk, and eased down into a chair. “We’ve got a mess on our hands down in Louisiana.”
Kowalski leaned forward. “I’ll read your report this afternoon, but give me the executive summary.”
“This Dr. Batiste knows how to play the system. It’s not bad enough that he has nearly nine times the maximum approved number of subjects enrolled. That alone will throw up a big red flag to CDER. He enrolled his entire family in the study, including cousins. Claims they’re all subject to sinus problems. His main practice is pushing a bunch of pills to fat women for weight loss. From what I saw, he should have had them out walking around the parking lot instead. There’s one batch with all the same blood work. Then there’s another group that have the exact same vital signs on every visit. How likely is it that two women are each going to have identical blood pressure of 139 over 83 on repeated visits? How about twenty with that same pressure? Also, if the charts are to be believed, he signed up forty-three subjects all between seven and eight one evening. You think he had a Tupperware party or something?”
Kowalski buried his face in his hands. “Anything else?”
“Probably half of the consent forms are forged. The initials on each page look like they were made by the same person with the same pen. There’s plenty more. It’s all in that report.”
“So what you’re saying,” Rudy sighed, “is that we paid the good Dr. Batiste a couple of hundred thousand dollars for crap.”
“If that’s a scientific term, Rudy, the answer is yes,” Witherspoon said, nodding. “Oh, and I might add that there was not one adverse reaction to the drug out of all of his patients. You and I both know that’s impossible. Surely some had liver enzymes climb enough to be reported.”
“Okay, Sally. For now let’s keep this just between us. I’ve got to figure out what to do before I break the news to Kingsbury.”