After the Fall (22 page)

“Oh, hi,” Tim said, “No, we're up. She's right here.” He gave back the phone to Laura, mouthing, “Mike.”

“Hello?” Over the years, Laura had trained her kids to wait until mid-morning to call her—just in case she was having one of those rare opportunities to sleep in.

“Hi, Mom.”

“Everything okay?” Laura asked.

“Hope so,” Mike said. “Patrick stayed over Sunday and Monday night. Came from Tim's—I mean—your place Sunday. He was pretty shook up. He left early this morning for New York.”

Had Patrick told Mike? Hadn't they left it that they would jointly tell the other kids?

Mike paused. When Laura said nothing, he continued, “When I asked what was going on, he just said, ‘Ask Mom.' So I'm asking you, what's up?”

“Oh, Mike,” Laura said, giving a sidewise glance to Tim, now pouring his cereal from box to bowl. “I had a talk with Patrick, a long overdue discussion. I'm afraid what we talked about upset him.”

“Go on,” Mike said when Laura stopped.

“I'd rather tell you in person,” she said.

“Can you just tell me what it's about? Patrick did say to ask you. That's all he said. Even when Nicole came over yesterday, that's all he said. Now you have the whole family's attention. You know what a big-mouth Nicole is. Both Natalie and Kevin called me last night. I couldn't say much because Patrick was still here.”

Laura wondered why they hadn't called her.

Mike said, “All three of them are afraid to call you. They think that you must have diagnosed him with some terrible disease—Natalie even mentioned AIDS, but that's—”

“No,” Laura said, firmly. “Nothing like that, Mike.”

“Mom, I'm Patrick's big brother, and I'm trying to figure this out. Just be honest, does it have to do with Dad?”

“Mike, you and the family need to know what this is about. But I need to work this out with Patrick. When he's ready—”

“Then call him. He knows we're all speculating. Think about it; I'm old enough to know what this is about. I was fourteen when Dad was shot; right after he refused to go with Patrick for the emergency surgery. Mom, I know you know that I know. So it's up to you to clear this up with all of us. I don't know the details, but I do know Patrick is not Dad's son. I've never discussed this with Kevin or the girls, but I've known since the year Dad died, and I think it's time for you to be honest with us all.”

“Okay, Mike. And thank you,” she managed to say, in a voice that shook.

She related her conversation to Tim and promised she'd call Patrick that day. Tim suggested they all get together for the weekend. He would attempt another home-cooked dinner. Laura nodded her assent. She packed up her briefcase, kissed Tim goodbye, and headed to the waiting limo. She skipped her morning slice of toast.

Laura's commute from Center City, Philadelphia, to Keystone's offices in Montgomery County took forty minutes, enough time for her to organize her day. First on her agenda would be a call to the FDA project manager in charge of Immunone. In fact, not wanting to risk her staff telling her that the drug company vice president calling FDA staff was not kosher, there were protocols for such communications, she placed the call from the limo phone.

“Drug Evaluation. Immunology. Jake Harter.” Good, Laura thought. No need for phone tag.

“This is Dr. Nelson. Keystone Pharma.”

“Yes?”

A note of wariness in Harter's tone reminded her that the
man's wife had been murdered since she'd last seen him at the advisory meeting. “I want to offer my condolences on the loss of your wife.” How many times had she delivered a version of this message over her career as a thoracic surgeon? Too many. The throb of pain in her right hand reminded her that future occasions would be limited. She was a paper pusher now, not a surgeon.

“Thank you, Dr. Nelson. And let me tell you how sorry I am about your injury. I know you are at Keystone Pharma now. That must be quite a change from the operating room and research labs. The pharmaceutical industry is a far cry from academia. Right?”

“I have lots to learn, that's for sure, but I have a great staff. I must admit, though, filling Dr. Minn's shoes is not going to be easy. He was beloved by his Keystone colleagues.”

“A great loss, indeed,” agreed Harter. “He seemed to be the pivotal force in R&D at Keystone. I assume Dr. Win White will be taking over Immunone. I haven't had much experience with Dr. White, as Dr. Minn usually attended the FDA meetings in person.”

Laura cringed at the thought of Win White, with his volatile temper, interacting with the FDA. A surefire formula for disaster, despite the man's clinical and strategic brilliance. “No, Mr. Harter, I will be handling Immunone. And that's why I'm calling, to respond to the fax you sent. About your problems locating the source documents related to the deaths in the clinical trials.”

Laura heard a sharp intake of breath. “But you just started.”

“True, but I know the data. I've personally reviewed each case. I have seen the reports that contain the specific information you list as missing.”

“Look here, Dr. Nelson. I have been in this project management job for twenty-five years. You have been in your job for what—a few days? When I say we do not have the data to adequately assess the safety of a new drug, I think I know what I'm talking about.”

Definitely off on the wrong foot, Laura wished she'd waited longer for the missing records to be documented so she'd have them in front of her now as she laid down this challenge. Now she'd jumped the gun, assuming this would be an easy call to clarify a misunderstanding.

“Mr. Harter, I was not implying anything controversial, just that the information you need does indeed exist. It's all been submitted to you, but in case you are having difficulty locating it, Keystone is pulling it together. And once we have it, we'll send it by express directly to your attention at the Parklawn Building in Rockville. Right?”

“If Keystone plans to send me any documents, Dr. Nelson, I suggest you go through Dr. Louis Sigmund. He's the head of regulatory affairs at your company. He's the proper person in your organization to call me. Don't bother with a carrier. It'll only get lost. Louis knows that. He knows the proper way to deliver documents to us.”

Laura had not expected this dressing down. She was the head of research at the third largest pharmaceutical company in the world. And an FDA project manager had just told her to fuck off. Yes, there was a lot about working with the FDA that she didn't understand.
You should have followed protocol, Laura
.

“I see,” she said, not wanting to capitulate, not wanting to burn any bridges, just wanting to get that data into the FDA and put this whole mess to bed.

“I expect it will take some time—if you have the data—to pull it together and get it back to us. Then, of course, we'll have to review it, verify it. That all takes time, Dr. Nelson.”

When Laura had presented at the FDA Advisory Committee, Mr. Harter had seemed pleasant enough as he flitted about distributing reports, seeing to the needs of the FDA medical staff, the committee members, and the presenters from Keystone Pharma, herself included. So why was he now coming off as such a self-righteous, negativist jerk? At the conclusion of the meeting, the FDA reviewers, the committee members,
and the various spectators—including the media—had been upbeat and optimistic. Laura especially remembered the exotic young woman from Replica, the scientist who had discovered Immunone's drug category and who had called her yesterday trying to get information on the drug's approval. Hadn't she seen her deep in conversation with Jake Harter in an alcove off the meeting room?

“Thanks for your time, Mr. Harter,” Laura said. “Just so you know, I personally went over the data you're looking for with your department's medical reviewer, Dr. Hayes.”

“He's the junior reviewer here,” Harter said. “I hope he didn't misplace it if he did have it in his possession.”

“Tell him not to worry, Mr. Harter. I have replicate copies of everything in my office in Tampa should Keystone have any difficulty locating the data, which I'm sure they won't.”

Silence met this statement, and Laura said a simple good-bye. She could have heard a mumbled “shit” on the other end, but it could as well have been her own expletive as she slammed down the phone.

She had to tell Louis Sigmund about her unorthodox call, and as soon as she arrived at Keystone, she headed straight to his office. His secretary informed her that he was in a meeting with his staff, going over budgets. “I need to see him now,” she said. “My office.”

The elderly woman peered up over her half glasses. “Now,” she repeated. “You want me to interrupt his meeting?”

“Now,” Laura confirmed, heading back to her office. She guessed that the gentlemanly Dr. Minn did not make such demands. And normally, neither did she, but she'd just dug herself into a hole with the FDA. Wait until Paul Parnell found out his new hire had doomed the gazillion-dollar Immunone approval.

Louis arrived momentarily, toting a monogrammed leather binder. “Laura. Is something wrong?”

She figured anxiety must be written all over her face. One thing she was not: a good poker player.

“Yes, Louis. Let me tell you what just happened. Please, sit down.”

They sat across from each other at her conference table. He opened the binder to a lined yellow note pad, but didn't pull out a pen.

“Immunone?” he guessed. “I've been waiting all day for information from Science Information. Impossible that we never submitted the data. Nothing like this has ever happened. I can't—”

“Yes, Louis, I need to talk about Immunone. I haven't heard whether Medical and Information Management have what we need or not. We can head to Mel Greenberg's office after this.”

“Good idea,” Louis jumped up, hesitating when Laura remained seated.

“I called the FDA,” Laura said.

Louis reseated himself with a thud, as incredulity crossed his face. “You did?”

“I spoke to Jake Harter. The project manager.”

Louis nodded. “Not a bad guy,” he said, “as project managers in the agency go.”

“He was quite hostile,” Laura knew she had to be honest. Sugarcoating wouldn't help.

“I'm not understanding,” Louis said.

“I called to tell him that I'd personally reviewed the death cases. That I reviewed them all with Dr. Hayes.” Louis' expression was skeptical. “Karl Hayes, one of Immunone's medical reviewers.”

“Yes. Of course I know him,” Louis said. “He's the junior reviewer under Susan Ridley. They had to have reviewed the death cases.”

“He was most unreceptive. Defensive, I guess. Told me all communications needed to come from you. Pretty much put me in my place. Then I told him that I have replicate reports in my Tampa office—former Tampa office.”

“Laura, I know you meant well, but the FDA has certain expectations. Communications have to go through channels. Regulatory affairs manages document transmission and advises
on all FDA matters. Otherwise, things get out of control, and these one-on-one interactions cause misunderstandings. That's what happened here. I'll give him a call. Smooth things over. Depending on when we have a data package ready, I can hand deliver it. I work with these project managers all the time. It'll be fine.”

“I'm not sure, Louis. He seemed belligerent. Maybe he just doesn't like me. He said he assumed Win White would be taking over Immunone.”

“Trust me, Laura, Jake Harter detests our medical director. They're like oil and water. He did, however, seem to respect Fred Minn. Maybe it's just you taking his place—”

“Perhaps, but I'm not backing down for the time being. Keep me posted. Today's Tuesday. If Mel has any trouble finding what we need, I'll fly to Tampa.”

“Let's go check Mel's progress in locating that missing data. Better that it come officially from Keystone than from your Tampa office.”

But Laura would go to Tampa. Tonight. She had to arrange for Johnny Greenwood's lung transplant.

T
UESDAY
, M
ARCH
3

Addie called the department secretary at Replica, told her she'd left early, she was ill. And she was ill. After Dru left she'd vomited the contents of her stomach, then dry retched over and over. Now she sat with a cup of tea, and her stomach so far had not revolted.

How to deal with Dru's message? She'd known the day may come, but so abruptly? Give up forever the independence she'd come to take for granted?

What were her options? Did she have any? Or did she have to submit—as Muslim women had done over the centuries?

Addie didn't waste time on that question. The answer: submission.

All that was left to her now were the logistics.