After the Fall (20 page)

“Let's just all read the fax,” Louis suggested. As they did so, lots of sighing.

Does this type of thing happen frequently?
Laura wondered, having read the accusation that Keystone had not provided accurate supporting clinical data about the patients who had died in the clinical trial.
Or was this unusual?
She scanned the team's faces: expressions of disbelief all around. She was way out of her experience zone. Was this a mere hiccup in the drug approval process, or was this the kiss of death? She knew the clinical data cold. But she did not know the inner operations of the FDA. She'd have to rely on Louis, and he appeared devastated—not a good sign.
Why hadn't she paid more attention when Fred Minn had tried to explain how the FDA worked?

The FDA Advisory Committee had gone so well, but now
as she reread the fax, the FDA claimed Keystone Pharma had held back key information. The tone was accusatory, like they'd presented fraudulent data, tried to mislead the FDA and the committee.

“This is bullshit!” Win's voice ricocheted off the paneled conference room walls. “How dare they insinuate we held back data. We gave them more backup than they required, more than they asked for. I'm going to call that son-of-a-bitch Harter. Demand to speak to the medical reviewers, tell them to get their heads out of their asses. Come on, Louis. Now. We call them now. Goddamned Susan Ridley and Karl Hayes. They've seen that data. They have to be out of their minds…”

Oh, yeah, this is what her predecessor meant when he said Win White had a temper and had to be insulated from any situation requiring diplomacy. A brilliant clinical scientist and strategist, Win was not one to put on public display. Fred Minn himself had played the public persona of the medical department, but now he was dead, and she had to figure out how to handle this explosive situation.

Paul Parnell had explained that the market had already factored in the imminent approval of Immunone, had calculated the financial upside of such an important drug. Now, even the hint of a problem with the approval would send Keystone's stock plummeting.
Holy shit
, and she had planned to take the company plane and fly to Tampa to get her affairs in order there. Now she was in the midst of a disaster. First, the medical director had to be tamed, but her head of regulatory affairs couldn't control his colleague's outbursts. Nor did any of her staff members make a move to intervene. Mel Greenberg did try, but Win hammered him. “Hey, it was your people who put all those charts and graphs together, did all the fucking statistics. You know goddamned well I'm right, Mel. Come on, back me up here.”

Laura flashed on years of testosterone-driven tirades from prima donna surgeons. “Win, will you sit down? Please. We need to work this out. Who are the key players?” She looked around,
and pointed her finger to three of them while answering her own question. “Win, medical; Louis, regulatory affairs; and Mel, information management. First, as you know, we need to keep this FDA communication strictly need-to-know. We will analyze it, decide what to do, and get this handled. We're going to crisis management mode.”

Her staff looked at her quizzically. Like, what would she know about crisis management? Well, she managed one hell of a crisis seven years ago—a life and death biological threat. Watch her deal with a mere administrative crisis. “Mel, Win, Louis, set up your operation in this conference room. Mel, get in the necessary communication devices. I'll operate out of here too. We share all information. All communications come from this room. No lone rangers. No loose ends. All decisions are made by me, once we as a group consider the options. Everything coordinated in this room as of this instant. The rest of you, business as usual for your departments, but stay on call twenty-four hours a day. The issue is confined to medical right now, but be ready in case we need you.”

Stunned faces confronted her, but chairs pushed back, papers were gathered.

“Before you go, I want you to know that I, personally, know this medical data. I've reviewed it meticulously. Personally talked to each principal investigator who reported a death.”

Laura nodded to Win, “You're right to be angry. I am too. I don't know what's behind this accusation, but we have to take it seriously. We will methodically refute it. Point by point.” Laura looked at Mel. “Your people compiled and audited all the source documents. We presented a comprehensive package.” She watched tension drain from Win's and Mel's faces, and the panic in Louis' eyes turn to determination. A manager supports her people. Surely, that had been Fred Minn's practice too.

“If the FDA is picking an area to criticize, at least it's one I know well. Thank goodness they didn't attack toxicology or chemistry; there, I'd be at a loss. So let's go forward.” She
announced that she needed to brief CEO Paul Parnell, that she'd be back shortly. “In the meantime, Louis, please draft a response that says we're addressing all the FDA's concerns. Tone should be polite, conciliatory—right?” She and Louis exchanged knowing looks.

On her way to the CEO's suite, Laura couldn't help but think of Patrick and how he was doing. Her motto—compartmentalize—worked most of the time, but before diving headlong into the machinations of the drug approval process, she had to call Lonnie Greenwood in Detroit.

T
UESDAY
, M
ARCH
3

“Jake Harter.”

“Sid Casey for you. Please hold.” Casey was acting director of Drug Evaluation and Research, one of the six major branches of the FDA.

Jake tensed for two long minutes, waiting until the man himself came on. He'd never had a call from anyone this high up.

“Jake, I have a press conference in Manhattan today. The usual: what's the FDA doing about getting lifesaving drugs approved faster? I'd like to use Immunone as a positive example. Can I say the approval is imminent? Will you have it signed off by the end of the week? I'm calling you directly since you control the process flow.”

So the higher-ups don't have a clue. Yet. This morning, Jake had dropped off a copy of Friday's fax to Susan and Karl. He'd not marked the fax urgent, hoping for low-priority treatment and delayed progress up the chain of command. Apparently, the ploy worked. Jake would have to break the news now.

“Dr. Casey, I need to inform you of something that may—”

“I'm in a hurry, Jake. Will the approval clear by the end of the week or not? I want to use Immunone as a promising example of how we are all working together toward a common goal. You know the rhetoric.”

“I found that some clinical data is missing, sir. I sent a fax to
the company asking for clarification. There's no way this can be cleared up this week.”

“You can't be serious? A problem with the approval? Why wasn't I informed? Our public relations people are working with Keystone on press releases. I don't have to tell you that this is a high-profile case. Press coverage of the Advisory Committee, an all-time high; our reviewers had no reservations; the committee gave the green light. What are you trying to tell me?”

“I just discovered missing medical backup in the death cases.” Jake knew that the word
death
would give this man pause. He put it out there and waited.

“I want to see you and the medical reviewers first thing tomorrow morning. I want to be briefed on every detail. This puts my press conference in shambles. First thing in the morning. In my office. All of you.”

Jake had waited until late on Friday to fax Keystone the document advising them that key documents were missing from their Immunone submission. The report referenced complicated statistical analysis that would take time for their statisticians to decipher.

He'd sent the fax on his own initiative, not bothering to check with the medical reviewers. Karl Hayes had taken a vacation day and Susan Ridley had indicated no interest when he'd brought the matter to their attention. He'd taken that for a green light to make demands—bordering on veiled accusations—of Keystone Pharma. Whatever it took to slow things down. Win White, their medical director, had an anger management problem. Maybe he'd blow his stack. Cause a major diversion by challenging the FDA. Something that would piss off Susan and make Karl go all self-righteous. Jake would take a back seat, support his medical reviewers, deny having seen the records in question, delay resolution long enough to keep Addie in the country.

Today, Jake reclined in his office chair, sipping coffee, waiting for the first salvo from Keystone Pharma. He'd waited all day
yesterday, anticipating that he'd be getting a call Monday morning as soon as they ripped the fax off the machine. Win White would go into a rage, and Jake would be on the receiving end of his fiery temper. But nothing.

Jake set down his coffee mug when his desk phone rang. An inside line. Had Keystone's CEO gone directly to the commissioner? He wouldn't put it past Paul Parnell. Why did big drug companies refuse to believe that calling the commissioner is the kiss of death? Nothing pisses off an FDA reviewer more than a company going over their head. The FDA is not like private industry, where the power resides at the top. No, here at the agency, the power emanates from the lowly medical reviewers—Susan and Karl in this case. A supervisor's attempt to overrule a medical reviewer would set up a liability risk that even the FDA commissioner found unacceptable. No one tampers with the lowly reviewer.

T
UESDAY
, M
ARCH
3

Jake had called Addie last night to tell her he was bringing Indian food take-out. He didn't stay long—just long enough for food and sex. He'd explained to Addie they had to be careful. Only twelve days after his wife had been murdered. The police were snooping around their relationship. He had to be home at night—alone—in case he was under surveillance.

“Surveillance?” The word alarmed her. In Iraq, men under surveillance disappeared. She'd known of many. Scientists who had worked with her father, friends of her family. Though her parents gave her little information about what was happening at home after the Gulf War, she learned about conditions from her sister, Farrah, on the rare occasions she received a letter. Addie hadn't seen Farrah since her last visit home four years ago. If only she could sit with her, tell her about Jake and his marriage proposal. Farrah may be younger, but she was married and a mother. She would tell her honestly whether Jake would be accepted in Iraq, even if he did convert to Islam. Or whether they'd always be outcasts.

Jake had tried to reassure her, explaining that husbands always are suspect after a wife's murder. Addie shuddered whenever she thought about Karolee's violent death. Shot in her own home. She'd considered America safe—compared to Iraq—but her confidence had suffered. Who had killed Karolee? And
why? A robber, according to Jake. But something about the way he'd said it caused her doubt.

And now, as she sat at her desk, trying to concentrate on yesterday's research results, she again puzzled over why, when she had asked Jake—multiple times—about Immunone, he kept evading her? Each time she implored him to tell her what was happening at the FDA, and explained how urgently she needed to know, he'd repeated, “It's in the approval process.” What does that mean? she wanted to scream. What was Jake not telling her?

Something was wrong and Jake didn't trust her. Why were Americans in business so obsessed by confidentiality and conflict of interest?

And the implications of Jake not trusting the woman he wanted to marry? Does he love me? Do I love him? Should I marry him?

She was interrupted by a phone call. “Dr. Abdul,” she answered, hoping it was Jake calling to say he'd stop by again tonight.

“Adawia, it's Dru. I have to see you.”

“I'll get out of work at five,” she said. “Want to meet for a drink somewhere near my office?” She didn't want him at her apartment. Didn't want a Dru-Jake scene. Dru knew about Jake, and she'd told Jake about Dru. Still…

“Now. This is important. Your place. Come home immediately. I'm there now.”

“I can't leave work. The Immunone approval will come any day now—”

“No.” Dru's tone sounded threatening. She'd known Dru for twelve years. He'd always been polite and easygoing.

“Now.”

When the line went dead, Addie grabbed her purse and the uneaten half of her sandwich. She'd finish it in the car on the way home; she'd stay just long enough to hear Dru out so she could be back for a three o'clock meeting. But on her way to the door, she turned back to her desk. Dru would want an update
on Immunone. Since Jake refused to tell her anything, she'd call Dr. Nelson. She didn't want to bug her, but she'd been so nice before, and Dru's tone of voice sounded dire.

Parking spots were hard to come by, and Addie parked on the street, two blocks away from home. As she approached on foot, she saw Dru pacing back and forth in front of her building.

“Dru,” she said, walking up to him from behind, touching his arm. He appeared bedraggled, not his usual, buttoned-up businessman look.

Addie almost lost her balance as he pivoted toward her, both arms extended as if he intended to strangle her.

“What's the matter with you?” She took two steps backward.

“Let's go inside.”

Dru said nothing on the ride up the elevator to her floor. Once inside her door, he announced, “We have to talk.”

“Okay.” She led him to two chairs, an end table between them. “Have you had lunch? You caught me during mine. I finished it in the car, but I'd be happy—”

“No. Let me get to the point. Tell you what you need to do.”

Addie bristled. This was the United States. Men didn't tell women what to do.

“I was summoned to Iraq last week. To the Presidential Palace.”