After the Fall

by Patricia Gussin

  “Addie, are you okay?” They all seemed genuinely concerned.

  “What did you say about Jake Harter’s wife?”

  “Let me take that mug. You’d better put ice on your hand.” The woman closest to Addie reached out to steady her and to take the cup out of her hand.

  “I’m okay,” Addie said.

  A young male technician turned to scrutinize her. “Guess you don’t read the papers, Boss. Mrs. Harter was out of town, and when she arrived home, she walked into a robbery. Whoever was in there must have shot her. They say she was dead when Jake Harter found her.”

  “Jake found her?” Addie echoed, immediately hoping “Jake” didn’t sound too familiar.

  “Yeah, but she’d been dead—what’d it say, a couple of hours by then?”

  So that’s why he hadn’t shown up. He’d been at his house with the police. When she remembered she had called his house, her knees started to buckle. The woman who’d answered must not have been Jake’s wife.

  Her colleagues started to dissipate, returning to their respective labs, but when Addie lingered, the young tech beside her asked, “Did you know Mrs. Harter?”

  “I never met her,” Addie said. “Of course, I know Jake Harter from the FDA.”

  “Oh,” said the tech, as they headed for the lab. “I thought you may have had a social relationship with the Harters.”

  “Why would you think that?” she said, afraid to ask, but needing to know if someone knew about her and Jake.

  “No reason,” he said, “just thought I may have seen—”

  “His position at the FDA,” she interrupted. “You know how important he is to Immunone’s approval, and how crucial that approval is to Replica. That’s all I think about, getting that drug approved.”

  “I can attest to that, Dr. Abdul. Nobody works harder than you do. The rumor mill says your share will be a whole lot of money. No wonder you’re so worried about the Harter murder. You know, they always look at the husband. What do you think?”

  “What I think is, let’s get to work.”

  From then on, Addie had refused to be drawn in to any speculation about what happened to Jake Harter’s wife. She’d been tempted to go to the funeral, to stay in the background, just to make eye contact with Jake, to signal that she needed to talk to him. But she couldn’t risk a public encounter. Surely, there’d be police lurking around. Would they be looking for her? Because of that phone call? Could they track the number to her apartment?

  Addie had made one other desperate attempt to find out what was happening with Immunone. On Monday, she’d called Tampa City Hospital to talk to that nice woman doctor she’d seen at the Advisory Committee meeting, Dr. Laura Nelson. But to her great surprise, she’d been told Dr. Nelson now worked at Keystone Pharma. Since the only phone number she had for Keystone was Dr. Minn’s, she tried it. A voice answered, “Dr. Nelson’s office.” Addie identified herself and asked to speak to Dr. Nelson and was told to hold. While she waited for Dr. Nelson to pick up, she felt a pang of sadness. Poor Dr. Minn. Two deaths in her world in one week, unpleasant coincidence since both related to Immunone and, worse yet, each potentially could slow down the approval: Minn, a key player, dead; Jake, distracted because of his wife’s death. Even though, Addie had to conclude, he wasn’t close to Mrs. Harter.

  Dr. Nelson had been cordial on the phone; pointed out this was her first day on the job at Keystone; she knew Addie was the inventor of the drug; respected her; appreciated her. Bottom line for Addie: nothing.

  Badur/Dru had insisted that Addie determine the probable date of Immunone’s approval. He’d demanded the legal papers pertaining to the payout she’d get from Replica once they got the funds from Keystone Pharma, and she’d given him a copy of the contract. Dru was a finance man, and she hoped he’d be ready to facilitate the transfer process to get the money into her hands. Only it would never get to her hands if Immunone’s approval was delayed and her father summoned her.

  After Dru left her a week ago, she’d slept little, trying in vain to account for his sudden intrusion. How had he known about her and Jake? How could she keep him and Jake from crossing paths? Addie considered her reality if she returned to Baghdad. Did she have the faith to go back and live in a place where an Islamic woman’s status was as low as that of animals in the field?

  What if she married Jake? His wife was dead, so no waiting for a divorce. If he embraced Islam, would her father approve? After so-called Desert Storm, Iraqi and American relations kept deteriorating. Ten waves of the invasive IAEA inspections. The harder they look, the more they come up with nothing, but George W. Bush’s obsession about nuclear weapons in her country made him seem determined to bring Iraq to its knees. As an Iraqi—especially one whose family has ties to Saddam—she could lose her green card and be sent home. Marriage to a US citizen could keep her here for as long as she cared to stay.

  Addie couldn’t get much accomplished that day, and she sensed her co-workers’ concern, overhearing, “What’s the matter with Addie?”

  Her technician again asked her if she was okay.

  CHAPTER TWENTY-SIX

  THURSDAY, FEBRUARY 27

  For Jake, Thursday morning couldn’t come soon enough. He’d set up a meeting on Immunone at 11:00. He’d asked the two medical officers responsible for the drug’s review to attend: Dr. Karl Hayes, the young Turk who’d done most of the actual review; Dr. Susan Ridley, the senior reviewer who’d been around the block a few times, a lazy woman who would take the easy way out rather than make the effort to determine the real deal.

  To set the stage for the meeting, Jake had dropped by his office late Tuesday after the meeting with Karolee’s attorney to issue a brief memo to Karl and Susan. In it, he expressed his concerns about missing laboratory data. He wanted to plant the seed, even though he wouldn’t return full force to the FDA until Thursday.

  To play the proper grieving husband, he stayed home Wednesday. All day long he paced, anxious to get back to work, anxious to be with Addie, but needing to play it safe. The cops might stop by for more of their endless questions. Prior to the funeral, he’d had two lengthy sessions with the Rockville detectives in their office. He was convinced he’d done a decent job playing the distraught, traumatized husband. Married thirty-one years. Now desolate. “At least I have my work,” he kept telling them. “My important work at the FDA has meaning. It’s what will get me through this tragedy.”

  Now, preparing for his meeting with the medical officers, Jake laid out on the small conference table two copies of a PowerPoint presentation. The top page showed a tabulation of Immunone adverse reactions. Next, a compilation of the most serious adverse reactions, displayed according to body system. Each report had three columns: active drug, placebo, and statistical difference. Under these reports was a tabulation of all deaths; beneath that, a one-page report on each of the thirteen deaths that had occurred in the clinical trial.

  Karl was the first to arrive, rushing toward Jake, flinging his arm around his shoulder. “Jake, we didn’t expect you in this week. I told Susan I’d cover for you. Help put together reports, that kind of thing.”

  When Jake tried to pull away, Karl gripped his arm and squeezed. “I’m so sorry, man, about your wife. Who could have done such a thing? Any leads on—”

  “No, nothing. I can tell you that it’s very frustrating—”

  “Jake.” They were interrupted by a tall, sturdy woman, with frosted gray hair hanging in an old-fashioned pageboy. “You sure you should be in? I mean, there must be so many things to take care of, I can’t imagine.” She paused. “Or did you come in to say you needed some time off? I could understand, but we’d be shorthanded at a critical time. We’re sitting on the imminent approval of Immunone, and I don’t need to tell you, the role of the project manager is key.”

  “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 someth
ing. 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.”

  CHAPTER TWENTY-SEVEN

  FRIDAY, FEBRUARY 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.