After the Fall (15 page)

“Don't worry, Susan, I'm not taking time off. I need to work to take my mind off poor Karolee. Every time I think about that monster who took her life, I just fall apart. No, I want to be here.”

Susan relaxed, took a seat at the table, reached for Jake's information packet.

Karl released his grip, and Jake took the seat at the table across from Susan, leaving to Karl the chair by the second stack of papers. “By the way, thank you again, both of you, for coming to her service. It meant a lot to me.”

Both reviewers nodded politely, eyeing the stack of papers in front of them.

“I asked for this meeting first thing when I got back,” Jake said, “because I'm worried. Worried about the Immunone safety report. Something doesn't seem quite right.”

Two sets of quizzical eyebrows rose, and Jake continued, “I kept thinking about the deaths that occurred in the trials. Yes, we had a write-up on each, but something's nagging at me: where was the supporting information? The company is obliged to send the source documents, the actual hospital reports—”

“Come on, Jake,” Susan said, “Karl reviewed all that. Right, Karl?”

“Yeah, sure. Where are you going with this, Jake?”

“You know it's my job to make sure all the data is compiled properly.”

“Yes, but—” Susan started to push back her chair.

“In front of you, you have the adverse reactions tabulations. Overall AR Report, the Serious AR Report, and the Death Reconciliation Report. I am concerned there are discrepancies as well as missing data from the latter.”

“Something missing in the Death Report?” Susan asked, tossing her pageboy-styled hair. “Impossible.”

Here's where Jake had to tread carefully. He needed these two reviewers on his side. He could not afford to challenge their competency. He had to make them believe there was foul play that did not involve them. That they were the innocent, hoodwinked victims.

“When I went to collate the deaths, I found the individual reports, but the support documents were missing.”

“I've been a medical reviewer for twenty-seven years,” Susan said. “I go back to the Middle Ages when we didn't collect support data. So what's the big deal? We've got the reports. They look good. Active drug outperforms placebo in safety. What more do you want?”

Jake gulped. He wasn't expecting his point to be simply brushed aside.

Then Karl spoke. “Susan, source documents are critical to quality control. Before we had them, clinical investigators could simply make up data so they'd get paid by the drug companies. Blatant fraud. I've seen the case studies.”

“Bullshit,” Susan said. “You reviewed that data, Karl. You signed off. You'd never sign off without crossing all the i's and dotting all the t's.”

“That'd be dotting the i's and crossing the t's. Never mind.” Karl frowned at Jake. “Susan's right. I did check the backup. I reviewed the hospital reports. The works. Everything was in place.”

“Let's just get this damn Immunone approved so we'll be out of the spotlight,” Susan said, looking ready to get up and walk out. “We've got a backlog of drugs that have a lot of legitimate concerns waiting for review.”

“Look, you two, I'm just doing my job. There's nobody who wants to get Immunone behind us as much as I do.” Jake knew he had to kiss up to Susan while he kept Karl on his side. Susan and Karl were medical doctors, and when it came to drug approvals, they called the shots. Yay or nay. He was a project manager, a paper pusher. He facilitated, he didn't decide. “Our backlog is crushing, so I agree with Susan, but I couldn't live with myself if I failed to bring this strange, even suspicious, finding to your attention.”

“For God's sake, Jake, you're that concerned?” Susan flipped through the pages of the document.

“Not wanting to waste your time, I put this information package together.” Jake gestured to the stacks and turned on the overhead projector.

“Shit, Jake, your wife was just murdered and you went to all this trouble?” Karl glanced at Susan. “Of course, we'll go through this with you.”

Jake dimmed the lights and proceeded with his presentation.

Susan and Karl's eyes glazed over when he presented the adverse reaction charts. Again. The data were tabulated according
to the systems in the body. Jake had highlighted several line items in the cardiovascular category: arrhythmias, tachycardia, long QT syndrome, nonspecific ECG changes, high serum potassium level, low serum potassium.

“We've reviewed all this how many times?” Susan said. “The Immunone group is no worse than placebo.”

“I know. I'm underscoring these values for perspective. Setting the stage.”

Susan flipped to the next page. The severe reactions—those causing hospitalization or permanent injury. Again, Jake had highlighted the cardiovascular system. Again, there was no difference between the active drug, Immunone, and placebo. Jake pointed it out to preempt another Susan outburst. “Turn to the Deaths,” he said, when she tossed her head again.

“Okay,” Karl said, “but I can probably recite these details in my sleep. Phase Two, one death on Immunone, two on placebo. Phase Three, three on Immunone, seven on placebo. Pretty powerful evidence that the drug needs to be approved. The sooner the better. More transplants every day. Imagine how many lives will be saved once Keystone Pharma moves into kidney and liver transplants.”

“Their strategy to go with lung transplants rather than kidneys has always baffled me,” Susan said. “Like, why go for the smaller market, not the much larger one?”

“They figured we'd approve a drug for the lower incidence procedure with limited data,” Jake said. “Now, let me point out the problem here. Take a look at the four deaths in the active treatment group.” He flipped from the tabulated death report to individual narratives summarizing the circumstances of each patient death. One page per patient who died during the clinical trial.

“Yes?” Susan asked. “I've seen these. Karl wrote them.”

“The source documents are missing,” Jake said. “The hospital records surrounding the time of death.”

“Can't be,” Karl said, riffling through the pack. “Compliance always checks on them. They have their checklists.”

“I can't find them. I wanted to double-check the blood chemistries. Especially potassium, as we have an arrhythmia and an ischemic stroke. I was looking for long QT syndrome.”

“What are you saying, Jake?” Susan said, head bent, scanning the reports.

“Long QT syndrome?” Karl asked. “You're not a physician. What do you know about prolonged QT?”

You're not a physician
. How many times over his career had Jake heard this demeaning line? Second-class citizen. That's all he'd ever been. Little jerks like Karl lording it over him. It'd be fun causing him to squirm when the integrity of his report was brought into question.

“Look, I've been to enough advisory committee meetings, heard enough cardiology consultants, to know potassium plays a role in fatal arrhythmias. Torsades de pointes is a known side effect for several drugs. I want to be sure we had the potassium levels at the time of death. And the actual electrocardiograms.”

“You sure went out of your way, Jake,” Susan said. “Unusual for you.”

“Only curiosity at first. It wasn't until I couldn't find them that I became alarmed. I didn't want you to make an approval decision without knowing this.”

“Shit,” Susan said, “I don't need this grief. This is a hell of a good drug.”

“Just give me some time to track down the documents. Keystone Pharma must have duplicates. Then we'll know for sure the fatal event had nothing to do with torsades. If there's a connection, we can still approve the drug, just put in a warning for long QT.” Jake would take his time contacting the company. And with their key scientist dead, the company in disarray—Yes, it will take some time. As much time as Jake needed it to take.

“Susan,” Karl said, “Jake may have something here. I mean, better we identify this now. Get the warning on the package
insert and not have to endure the criticism that we missed something. Right?”

“Shit,” she said, glaring at Jake. “You're a pain in the ass.” She flung the package of papers onto the table, got up, and stalked out of the conference room.

“Karl,” Jake said. “I'll work to get the documents.”

Karl stood, neatly stacking Jake's reports and tucking them into his folder. “Let's just hope those documents support my summaries,” he said. “If we have to go back to an advisory committee, it's my head on the chopping block.”

“I think they'll do the job, Karl—unless—” he shook his head in frustration, “there's something more sinister going on.”

F
RIDAY
, F
EBRUARY
28

Laura had stopped taking narcotic analgesics, unwilling to surrender to their mind-addling effects, and was paying the price. Excruciating pain, radiating from her hand all the way up her arm to her shoulder. She'd given lectures on pain management, about all the different nerve tracks and where they ended up in the brain. About how to describe pain: crushing, throbbing, stabbing, lancinating, searing, burning. Right now, she could claim all of the above.

She'd just finished a torturous hydrotherapy session in a private treatment room on the premises of Keystone Pharma headquarters. Her young male therapist had recommended acupuncture, and she had agreed to a session before her scheduled therapy on Monday.

Waiting alone in the treatment room for the worst of the painful impulses to abate, she thought about the rest of her day and the approaching weekend. The chairman, Paul Parnell, was to officially introduce her to the rest of the board of directors at an informal, after-work cocktail party in the boardroom. At just the thought that Tim would escort her, Laura felt a smile break through her grimace.

During the last two weeks, as she'd struggled with her crushing injury, totally changed career paths, and began a new job, Tim had become her rock. She wondered how she could have survived without him, aware and amazed that he pervaded
her every thought. Even as she sat here, waiting for the pain to diminish to a tolerable level, she could feel his presence, always at one with her. Laura treasured her independence, would never sacrifice it, but this sense of interdependency just felt natural. She didn't remember ever feeling this with Steve. Maybe in the beginning, but she didn't think so. What she had with Tim, she knew she would treasure forever.

On her way to her office—a work in progress while the decorator and his assistants swarmed the space, clearly delighted to depart from manly office furnishings as they envisioned a rose-and-peach-colored décor—Laura stopped for a word with her new secretary. The woman had been devoted to Dr. Minn, and Laura hoped she could eventually fill his shoes. Back in Tampa, her secretary for fifteen years knew all her idiosyncrasies, knew all her kids, knew most of her secrets—but not all.

The thought of Tampa reminded her of Lonnie Greenwood, who'd called her at Keystone yesterday. Again, leaving a message. Said he was back in Detroit. Needed to talk to her urgently. Wanted to remind her that he was a friend of the Jones family.
What will the Joneses do if they find out I killed one of their own? Would it matter if they knew Johnny raped me at knifepoint, threatened my life?

“Dr. Abdul called you again.” Back in the moment, Laura, listened. “Was very insistent you call her back. The one from Replica, the company that discovered Immunone. Dr. Minn thought very highly of her.”

“Yes, I know who she is,” said Laura. She caught the woman staring at her bandaged hand, still supported in a sling.

When would they stop gaping at her disabled hand?

Another annoyance. Everyone here assumed she knew nothing about Immunone. She'd been the lead clinical investigator, probably knew more than most in the building. “I'll call her back,” Laura said, moving toward her office.

“Dr. Abdul, this is Dr. Nelson.”

“Thanks for returning my call, Dr. Nelson. I hate to bother
you, but have you heard anything about Immunone's approval? I tried calling the FDA, but no one returned my call.”

“Dr. Abdul, I told you, they don't want industry calls.”

“But the FBI called me today. I got worried. Thought something was wrong.”

Laura thought she meant FDA, not FBI. Why would the FBI be involved? She said nothing, waited.

“I'm not an American citizen. Oh, I have a green card. Everything legal, but I don't understand. In your country, can the FDA and the FBI and the CIA work together? Anything to do with the DEA, even though Immunone is not a narcotic? Not even close in its pharmacology.”

“Whoa,” Laura said. “You have me confused. What did you say about the FBI?”

“Not really FBI, the police, but aren't they the same?”

Laura didn't intend to advise anyone on law enforcement. “It can be complicated,” she said.

“Dr. Nelson, I'm scared. I got a call from the police. They want to question me about the murder of Jake Harter's wife. You know who he is? He's the FDA man in charge of Immunone. I must know what is happening at the FDA. You speak to these people. You can find out.”

“But why do the police want to question you?” Laura asked, the pain in her hand diminished now to a level that allowed her to think. And the woman was wrong about Jake Harter; he was not in charge. He was the project manager, not a medical officer.

“I called his house,” the woman said. “I called his house the day his wife died. They must have traced my call. So they know.”

“They know what?” Laura asked, perplexed, getting annoyed.

“That he was…I can't tell you. Can you call him? Jake Harter?”

Jake? She called his home? Could this woman be having a relationship with Harter? A real no-no. A flagrant conflict of interest. As a foreigner, the woman may not know it, but Harter's job would be on the line.