After the Fall (4 page)

The phone rang. And rang. Why wasn't she answering? By now she'd be off in the cab, her purse nearby. Tim hung up. Tried again. Same result.

How would Laura react to Fred Minn's death? She respected him, admired his scientific discipline, enjoyed working with him on the Immunone clinical trials, but she wouldn't consider him a personal friend, close enough to come back to Philly to attend his funeral.
How selfish can a guy get?
Tim chastised himself. Now that he'd finally declared his love for Laura, he wanted her beside him.
All the time
.

He tried calling her on her mobile phone again. Same results. Nothing.
She must not have charged the battery
, he thought, as he gulped the last of the tepid coffee and headed to the shower.

Then he heard someone pounding on his door.

Tim opened the door, at first not recognizing the man
whom he'd just seen leaving, toting Laura's suitcase. Gone was the friendly attitude, the easy smile. Replaced by a wild look of panic.

“Dr. Robinson, the woman who just left. She took a bad fall. I had my service call an ambulance. I left her out there. A neighbor's with her. Thought you should know. I gotta get back down.”

“Laura?” Tim asked, but the man was gone.

Tim bolted after him, but the elevator had already left. He took the five floors of stairs at a run, sprinting through the lobby toward the automated front door.

He dashed through the door the instant it opened and found himself facing a black town car surrounded by a small crowd. At first, he did not see Laura lying crumpled next to the passenger door near the rear wheel. Until a crimson red coat against the white snow caught his eye through the bent figures who'd gathered to observe a prone woman on the icy ground.

“Laura,” he called out. “Are you okay?”

A tall, middle-aged man in a sweat suit responded. “I stepped out of my building to check the weather, and I saw it happen. The woman reached for the back passenger door, and she went down. Hit really hard. I could hear the crack from over there.” He pointed to the door of the next building.

Tim knelt at Laura's side. She appeared to be curled up, asleep, on top of the two inches of fresh snow. Except for the rivulet of blood staining the snow beneath the right side of her head. When Tim looked closer, he could see that her right lower arm protruded at an awful angle. “Call an ambulance,” he shouted, forcing himself not to try to shake her awake. For a moment, even the trauma basics escaped him. The ABCs: airway, breathing, circulation.

“Dr. Robinson, I am so sorry.” The driver knelt beside Tim. “I told her I'd get the door, but I had to move some things around in the trunk, and she didn't wait for me. Dispatch has an ambulance on its way. Should be here right away.”

That was a good thing about living in Center City,
Philadelphia. The ERs of four teaching hospitals all within minutes away.

Tim heard a woman's voice call out, “I hear the sirens now. Thank God.”

So far, Tim had done nothing other than take Laura's pulse at the right carotid artery in her exposed neck. Normal breathing, normal pulse. He wanted to turn her over, but was afraid to move her. What if she had a neck fracture? He was a pediatric cardiologist. His trauma experience dated back to medical school. He called her name. Nothing. She was out cold. Blood seeping out from under her head was expanding the red stain, but not at an alarming rate. Blood loss he did know how to assess, and this was minor.

Tim, jacketless, was still kneeling beside her when the paramedics' van pulled up. The female driver stopped behind the town car. Two male paramedics jumped out, one almost slipping on black ice obscured by fresh snow. The driver stayed inside behind the wheel as the two men pulled a stretcher out of the back, adjusted the height, and wheeled it to Laura. Tim frowned. The ambulance was sent from Hahnemann University Hospital, not the University of Pennsylvania, which would have been his preference, where her daughters were residents. But Hahnemann was a fine hospital, and speed was of the essence.

“Sir, do you know the woman?” asked one of the paramedics, who now knelt beside Tim, assessing Laura's condition as he spoke.

“Yes. She's Dr. Laura Nelson. She was visiting me from Tampa. Was on her way home.”

The second attendant had joined them. “She's a doctor? Wow, she took a bad fall.”

Tim stood, his teeth chattering, trying not to shake with cold and concern as the two men worked wordlessly to secure Laura's neck in a cervical collar, then carefully unfolded her from her twisted shape on the ground.

“Hurry,” Tim heard himself say. “Get her to the hospital.”

“Gotta splint the arm. And the hand looks deformed.” When Tim followed the younger paramedic's gaze, his heart fell, almost stopped beating. Laura was right-handed; her right hand was her livelihood. His clinical impression: that hand was beyond repair.

“Lift,” the paramedic said, kicking aside the plastic cover of Laura's coffee container. They placed her on the stretcher and steered toward the ambulance in a jerky motion as they navigated the snow and ice. “You going with us, sir?”

“Yes,” Tim said. He started to shake, violently now, and the limo driver took off his coat and placed it over Tim's shoulders.

“No,” Tim started to say.

“Least I can do, Dr. Robinson,” the driver said, his arm around Tim as he climbed into the ambulance behind the stretcher. “Godspeed.”

M
ONDAY
, F
EBRUARY
17

The Monday morning media had been glowing in their praise of government and industry working together for the common good, blah, blah. Jake headed to his windowless office at the behemoth FDA Parklawn Building on Fisher's Lane in Rockville, Maryland. He was prepared to block, in any way he could, the wave of enthusiasm he knew would overrun his department following the Immunone Advisory Committee meeting. The FDA likes to look good and they did when their medical officers and Keystone Pharma's doctors and consultants all went for fast-track approval on this lifesaving drug for organ transplant recipients.

Addie did not subscribe to newspapers so Jake had to wait until he got to work for a chance to check the
Washington Post
. He wanted to see the headlines about Dr. Fred Minn's fate—whatever the outcome. With Keystone Pharma now about to launch a blockbuster drug, for sure, the Minn incident would get much more media attention than it would have only a week ago.

Jake grabbed a coffee and a paper as he passed through the Office of New Drugs staff lounge. You weren't supposed to remove the newspapers from the break area, but he needed privacy. Reaching his office, he closed the door and spread the paper out on his cluttered desk. Second page: “Keystone Pharma Scientist Struck Down in Philadelphia: Doctor Fred Minn Victim of Hit and Run.” Minn had been pronounced dead on arrival at
Jefferson Hospital emergency room. So he
had
killed the old man. The article went on to expound on Minn, his career, Immunone's likely approval. Paul Parnell, Keystone's chairman of the board and former CEO, was “shocked and saddened.” As well he should be.

Working for the FDA is what you make of it, Jake knew. The vast majority of his coworkers put in their time. Show up. Stay eight hours. Take long breaks. Drink free coffee. Eat out of brown paper bags, skip the government cafeteria food. Go home. What happens in between, no big deal. Plug in the numbers. Give your bigwig bureaucrats what they seem to want. Come back the next day. Collect paycheck. Get pension.

But for a few, the job was about power, or perceived power. Everybody thinks the bigwigs make the decisions at the FDA. Not true. Any lowly reviewer in the trenches could throw a monkey wrench in a drug approval, or could raise a fuss about a food substance, or could initiate a hygiene concern. Pretty much at will. If they were so inclined. Which most weren't. Most just showed up, followed standard operating procedures, and went home.

Until now, Jake had been with the majority. Do the job. Go home. But today, he would join the small percentage who got off on using their FDA power to manipulate the outside world. And the outside world under the FDA's economic influence was vast. The FDA regulates 25 percent of all consumer expenditures in the United States. That's a lot of money, and that's a lot of influence for one individual—a seemingly lowly bureaucrat—to parlay.

Jake would not be using his position to exercise any measure of global power, but only as a means to keep Addie in the United States. Despite pressure from her father, she was determined to stay employed at Replica until she came into that Immunone windfall. Jake would have made her an honest woman by then. The Muslim religion had no problem with divorced men, but they wanted their woman pure and untouched until they were properly married. At least that was Jake's understanding. He was no expert on Islam, but he supposed he would become one
once he and Addie were joined in marriage. Would he still be considered an infidel? Even if he converted?

Jake stuffed the
Post
into his briefcase, opened his door, and gazed out into the hall. His coworkers were pouring in, and he wanted to pick up on the morning chatter: Friday's Advisory Committee and the Fred Minn hit and run last night. But two overarching problems needed his urgent attention. One, he'd get started today on undercutting Immunone. And two, Karolee. She'd surprised him by taking off from her big-money executive chef gig to go to Miami to visit their first grandchild, a two-week-old baby girl. Hard to imagine his haughty wife as a granny. Jake smirked at the thought. And how was Granny's visit going? Their son's wife couldn't stand Karolee, and the sentiment was mutual. Mark should have moved farther away than Miami.

Jake was still sitting at his desk when a colleague poked his head in the cubbyhole office and announced, “Jake, get your butt to the conference room. Meeting's starting now.”

Jake arranged his papers, grabbed a fresh, lined yellow pad, and made his way down the hall to join the rest of the team from the Office of Drug Evaluation III. He took the last vacant seat at the rectangular conference table as Agency Deputy Director Sid Casey began to address the attendees. His mood seemed even more jovial than usual. “Jake, my man,” he started, nodding his way, “great show last Friday. You guys pulled it off. Even the
New York Times
had kudos for the Agency. Now, how long has it been since that happened?”

“Forever,” a voice called out.

“So now we get down to the real work. Putting the approval package together. Jake, as project manager extraordinaire, you take the lead. That'll free up the medical reviewers and pharmacologists to finalize their sections. Work with Drug Safety to make sure the adverse event monitoring is tweaked to collect as much new data as possible.”

“Will do.” Jake already knew how he would quash all this optimism. Before coming in, he had requested all the data on the
deaths that had occurred during the Immunone trials. No matter how safe a drug is, patients always die on drug trials. Sometimes they get hit by a truck. Sometimes they take a stray bullet. Some accident occurs that's obviously not drug related. Other times they rupture an aorta, throw a blood clot, develop pneumonia, commit suicide. Who knows: drug related, or not? These cases are more difficult to decide. Did the drug increase the blood pressure, coagulate the blood, weaken immunity, cause depression? If one such incident occurs, it's considered an isolated incident. More than one triggers doubt, and doubt translates to delays.

The director continued, “…drug like Immunone is a tricky synthesis. Chemistry, Manufacturing and Controls—you CMC guys—gotta be all over this Immunone process. We're in the honeymoon period now, boys and girls. Any minute, doctors and patients are going to be clamoring for this drug, so make damn sure Keystone can make it in scaled-up quantities.” He pointed to Jake, now sitting at the far end of the table. “Those validation reports have to be letter-of-the-law. No cutting corners. No rest for the wicked. Jake, that's all on you to verify. Okay? Understood? Questions?”

Jake had planned to broach the subject of doubt. Doubt about the status of the death evaluations, but he thought better of it. So much attention had been directed his way, basically the entire coordination process. He'd have plenty of time to “stumble” onto the unfortunate “discovery” that critical data was missing relative to the thirteen deaths that had occurred during the clinical trials.

When the team was dismissed, Jake thanked the director for the confidence he'd placed in him. Then he went back to his office to call Addie. He'd tell her the meeting did not go well. There were complications. Serious problems with Immunone that were confidential and being kept out of the media.

M
ONDAY
, F
EBRUARY
17

A dull pounding reverberated in her head. Indiscernible voices drifted. And in the background, a beeping, like a heart monitor. A familiar, yet irritating odor. Starched stiffness covering her. Pulsating pain ran from her right shoulder all the way to her hand where it was even more intense. Laura tried to open her eyes, but the effort seemed too much. And when she tried to turn her head, the pounding in her head became a jackhammer. So she lay still, eyes closed. Where was she? How did she get there?

As Laura lay motionless, she heard her son Mike's voice, “Kevin's meeting Patrick at the train station and coming right here.” The reality of place began to register.

All three of my sons coming here?

“Mom should be at Penn.” Laura recognized the bossy voice of her daughter Nicole. “I say we move her.”

“She's got a concussion,” Natalie said. “We can't move her yet. Even though I think we should once she wakes up.”

All five of the kids
?

Mike's voice, “I know you're both med students at Penn, but Hahnemann is a great hospital. They had Mom's MRI results before I even got here.”