Sara dropped her backpack by the door, kicked off her shoes, and collapsed into the one comfortable chair in her living room.
Automatically, her hand found the TV remote, but she let it fall onto the table with a clatter when she realized she didn't need background noise or diversion-she needed quiet and a chance to think. There was something about Jandramycin that wasn't right, something about the study and the people involved in it that set offalarm bells in her head. She had no proof, but her clinical intuition told her that the "wonder drug" had some late risks that had either been ignored or flagrantly hidden. Who would do it? Who could do it? Of course, this might have begun at the source with the people at Jandra Pharmaceuticals. She'd have to find out who had such access. She picked up a scratch pad from beside the phone, rummaged in the drawer of the small table until she found a pen, and made a note. "Jandra."
Beneath "Jandra," she wrote "Jack." Her ex-husband had control of the study, and its success or failure would have an enormous effect on his career. Then came "Resnick." She'd never liked the obsequious little doctor, and she could see him fiddling data and hiding information if it would benefit him. She tapped the pen against her teeth, fighting the urge to write the next name. No, he couldn't do such a thing. But he had almost as much access as Jack to the data. Finally, in handwriting that was uncharacteristically cramped, she scrawled,
"Rip." The ring of the telephone startled her. She dropped her pen, reached for it, and kicked it under the sofa. She'd get it later. Sara grabbed the phone just as her answering machine came to life. "Hi, this is-" She stabbed at the button to stop the message. "Hello.
Hello?" She could almost see Rip's frown from the tone of his voice.
"Sara, is this a bad time?" "No, I just dropped- Never mind. No, this is fine." "I missed connecting with you at the medical center, and I thought you'd want to know what I found out." Sara tucked her feet under her and rolled her shoulders to relieve some of the tension.
"Sure. Tell me about it." "I called everyone on the list of patients who received Jandramycin. Of the thirty-nine names I had, I was able to get information about thirty of them." "Pretty high rate of return for your calls. What did you find out?" "Interesting," Rip said. "Of the thirty, six have developed some sort of major medical problem."
"Such as?" "In addition to Chelsea, there's one other young man with Guillain-Barre syndrome. One woman has severe muscle pains and episodes of weakness, another has debilitating headaches and visual problems, a middle-aged man is being worked up for a bleeding disorder, and an older man looks like he's developing kidney failure."
Sara's mind was churning by now. Was there some kind of common link to these problems? And could she be sure they were all related to Jandramycin? "Still there?" Rip asked. "Yes. How much detail do you have on these patients?" "Not much, but I'm going to call their doctors tomorrow and see if I can't get more. Want to meet tomorrow about five to see if we can put this all together?" "Sure. Let's do it in my office. That way, we have my books and computer if we need to use them." They talked for a few more minutes before Rip rang off, pleading the same level of fatigue Sara felt herself. This had been quite a day for both of them. She no sooner put the phone down than it rang again. "What did you forget?" A voice she didn't immediately recognize said, "I forgot to ask you if you'd have dinner with me tomorrow night, but I thought I'd let you get home first." Sara smiled. "Mark, I'm sorry. I thought this was Rip calling back." "Nope, it's me. I really enjoyed our lunch together, even if it did turn into a game of 'What's wrong with this picture?' and I was wondering if you'd like to have dinner together tomorrow, just the two of us." Sara didn't know what to say. This was all moving much too fast for her, and the addition of another person to the mix was more than she could handle. "I appreciate the invitation, and I hope you'll ask me again, but right now I've got too much going on in my life." "So much that you don't take time to eat?" "No, but-" She could see how this man would be good in the courtroom. He obviously thought well on his feet.
"Listen, I already have something going on tomorrow afternoon, and I don't know how long it's going to take. Can we talk about this another day?" "Sure. And while I have you on the phone, have you discovered anything more about Jandramycin's side effects?" John Ramsey's words came back to her. "He's sharp, he's solid, and you can trust him."
Maybe three heads would be better than two. "Listen, are you free tomorrow afternoon?"
"Dr. Ramsey, are you ready to start seeing patients?" John wanted to tell Verna that he wasn't ready, might never be ready again. You work for forty years and never have a complaint lodged against you, much less a malpractice suit filed, and then one day, Bam! You're sued for trying to save the life of a woman experiencing a non-survivable event. He was ready to walk out of the clinic, go home, forget about practicing medicine. Instead, John did what he'd been doing for years, rain or shine, good mood or bad. He followed his calling. "Sure. Who's first?" Somehow John made it through the morning, pleased to find that he was still able to compartmentalize, putting his personal worries into quarantine while his professional self handled problem after problem. "That's it. You had one more patient, but he was a no-show."
"Thanks, Verna. I'm going to return these phone messages, then I'll get some lunch." John sighed when he saw the pink slips Verna had left in his dictation cubicle, held down by a paperweight advertising the latest wonder drug from some pharmaceutical company or other. But first things first. He dialed the number for Mark's office. After four rings, he heard the rhythm of the rings change and realized the call was rolling over to an answering service or voicemail. Oh, it's lunchtime. He hung up without leaving a message and dialed Mark's cell phone. John let it ring until he heard, "This is Mark Wilcox. Please leave a message." "Mark, this is John Ramsey. I've been… I've been served. I guess we need to talk. Are you available this evening?
Call my cell and leave a message." John had hardly hung up when his cell phone vibrated in his pocket. Was Mark getting back to him already? "Dr. Ramsey." "Doctor, this is Bill Alexander." He'd almost forgotten about his earlier call to his malpractice insurance carrier.
Maybe his coverage extended to the incident at the medical school.
Maybe things were going to work out. A spark of hope flared. "Yes.
Thanks for getting back to me." "You won't thank me after you hear what I've found out." The spark flickered and died, leaving nothing in John's heart but a chill that no sun could warm. "Let me guess. I'm not covered." The conversation lasted another five minutes, but the upshot was what John originally feared. His malpractice coverage was not in force for new events. And it was the opinion of the company's lawyers that it was unlikely the medical center would cover the actions of an employee who hadn't even officially gone to work yet. In other words, John was on his own. He thanked Alexander and hung up. He wondered what would happen if he just walked out, packed a suitcase, and took off for parts unknown. "John, God's in control. Hang on."
Beth's words were as real as though she were in the room with him.
Those words seemed to be her solution for everything bad that happened in their lives: an employee who embezzled a huge chunk of money from his practice, the sudden deaths of his parents in a terrible accident, the news that John's brother had terminal cancer. All these were times when he wanted to walk away from it all. And Beth always reminded him-God's in control. So he'd hung on. And sure enough, things worked out. Maybe they would this time, as well. He squared his shoulders and began to work his way through the message slips. He was wrapping up a conversation with an insurance claims representative, trying to keep his temper in check while convincing her that the presence of asthma in childhood didn't constitute a pre-existing condition in the case of a patient with pneumonia, when Verna appeared outside his door. He held up one finger in a "just a minute" gesture and ended the conversation, gratified that he'd been able to convince the sentry on the other end of the phone to let his patient pass into the realm of the insured. "What's up?" he asked. "That no-show is here. I'm not sure how he got into the general internal medicine clinic, though.
He's got an infected wound on his arm that looks pretty bad. Probably needs debridement and some antibiotics. Want me to send him to general surgery?" John was already on his feet. "No, he's here. I'll take care of it. In forty years of practice, I've seen my share of infected wounds." The patient was a middle-aged man, lean and tough as a buggy whip. He wore a flannel shirt with the sleeves rolled past the elbows.
A folded baseball cap peeked out of the hip pocket of his jeans.
"Sorry I was late, Doc. Had trouble with those valet parkers out there." He pronounced the word valett. "Told 'em I was gonna have to pay to see you, pay for my medicine, and I wasn't about to pay for some guy to park my pickup when I could do it myself." John smothered a smile. He'd had the same thought a number of times. "No problem.
You're here now. Let's see that arm. What happened?" While the patient related a story of coming out second best in a fight with a piece of rusty machinery at his auto repair shop the preceding week, John slipped on a pair of gloves and examined the man's left arm. It was swollen, hot to the touch, red from the elbow to the wrist. A weeping crust covered a six-inch gash on the side of the forearm. "Thought it would be okay if I kept a bandage on it and used some of that antee-beeotic ointment. Looks like I was wrong." "I'm going to clean that up and get you on some pills to fight the infection," John said.
"I may have to snip away some dead tissue, but I don't think it will hurt enough to need a local anesthetic. Think you can take it?" "I've had worse," the man said. While Verna cleansed the wound with peroxide and painted it with antiseptic, John took the dirty bandage from the treatment table and looked around for a spot to dispose of it. Blood, tissue, pus, and similar material were to be placed in a special container, one that was lined with a red plastic bag prominently labeled "biohazard." "Over in the corner," Verna said, nodding in that direction. "Thanks." John opened the container to drop in the bandage, but it hung on the rim. He swatted the dirty gauze into the almost overflowing bag, but when he did he felt a sharp pain in his hand.
"Ow!" "What happened?" Verna asked. John took a pair of forceps from the treatment table and stirred the top layer of debris in the biohazard bag. His throat tightened when he saw the glint of a syringe and needle peeking out of the container. He tried to keep his voice calm. "Verna, I'm going to need to talk with someone in Infectious Disease. Could you page them while I finish cleaning up this wound?"
"Sure. Is it about the antibiotic for this wound?" "No, it's about our needle-stick protocol. It's for me."
"Jandra Pharmaceuticals, how may I direct your call?" The voice was cheery, but the inflection told Sara that this was a message the woman repeated a hundred times a day. "This is a doctor in Dallas, calling about one of your new drugs. Is there someone there who can give me some details about Jandramycin?" There was a moment's silence.
"I'm sorry. I don't believe we have a drug by that name. Are you sure?" Sara shrugged to relieve the tension that had become a permanent fixture in her shoulder muscles. "I'm sure. Jandra Pharmaceuticals, Jandramycin. Think about it." She decided on a different tack. "Who's your public relations manager?" "That would be Mr. Olson, but he's on vacation." Sara waited, but apparently that was as much help as she was going to get. "Okay, your director of research?" "That would be Dr. Wolfe. Would you like me to ring him?"
"Please." If she says, "Have a good day," I'll scream. Just before the telltale buzz of a phone ringing, Sara heard "Have a good-" and gritted her teeth. It apparently wasn't going to take much to get on her nerves today. But if she wanted to coax any information out of this Wolfe guy, she'd better be on her best behavior. "Bob Wolfe." The voice was a deep baritone, the accent definitely East Coast. "Mr.
Wolfe, this is-" "Dr. Wolfe. I'm a Pharm D." "I'm terribly sorry. Yes, the operator did give me your title. I apologize." "No problem. Who's this?" "This is Dr. Sara Miles. I'm on the internal medicine faculty of the Southwestern Medical Center in Dallas. I have a question about Jandramycin." This time the pause was long enough that Sara thought she'd been disconnected. Finally, Wolfe said, "If you're at Southwestern, I'd suggest you talk with our principal investigator, Dr. Ingersoll. He's on the faculty there, too. Would you like his number?" I've got his number. I know more about him than you ever will, you self-important-" I know Dr. Ingersoll, and one of my patients is in his study. That's why I'm calling. She's developed what I believe is a late complication from Jandramycin, but Jack… Dr.
Ingersoll won't accept that possibility. I need to know if there's anything in the basic research that would suggest an association with-" "Stop. I don't want to hear about this. Dr. Ingersoll is in charge of the project, and if he doesn't think your patient's problem is related to Jandramycin, the matter's closed." "You mean-" "Listen, Dr. Miles, if that's really your name. How do I know you're not from one of our rival companies, sniffing around for dirt so you can sabotage our new drug application? What you're asking for is proprietary information. And you're not going to get it." There was a loud click. Why that self-important, self-centered, pompous- Sara took a deep breath and blew it out slowly through pursed lips. Who says Lamaze training can't be useful except in labor? The phone in her hand came to life, and she heard a familiar female voice. "Jandra Pharmaceuticals. How may I direct your call?" "I think I was disconnected." "To whom were you speaking? I'll be glad to ring them back." "Never mind. This time, would you ring your CEO or COO or whoever's in charge there?" "That would be Dr. Patel. I'll ring his office. Please hold." This time Sara said it before the operator could get it out. "Thanks. And have a nice day."
Rip Pearson knew this was one of the most-feared situations faced by health care professionals, and he worked hard to keep his voice low and his manner calm. "John, this isn't the end of the world. I've seen this scenario dozens of times, and the odds are so overwhelmingly against your getting infected in any way-" "I know, I know." John Ramsey squirmed on the edge of the treatment table. "But it makes me so angry that someone, a health care professional, could dispose of a needle and syringe in such an unsafe manner. Besides, it's not even one of the safety units they're supposed to use, the ones you can recap with one hand after using them." "What makes you think it was one of the staffthat did this? You said yourself this wasn't one of the safety syringes we use here. If it were, we wouldn't be having this conversation. This was most likely a patient, probably a drug user. They had the syringe in their purse or their pocket and saw a chance to get rid of it. The cap came offwhen they dumped it, and it sat there just waiting to bite you." "Okay. I'll stop fuming over something I can't change. Now what do I do?" "Have you had hepatitis immunizations?" "Aren't we going to talk about HIV exposure?" Rip made a calming gesture. "We'll get to that, but your chances of getting HIV from a needle stick like this are less than 1 percent. What we worry about most is hepatitis, especially Hep B. Have you been immunized?"
"Yeah, the full series." "Tetanus?" "Current on that, too." "There's the possibility of bacterial infection at the wound site, but we don't usually give prophylactic antibiotics for that. We'll just watch."
John leaned forward a bit. "And last, but certainly not least?" "As I said, HIV isn't much of a risk. As you know, we can't do any kind of meaningful test on the needle or syringe, and we can't HIV test the person who used them last. I'd call this a class 2 or 3 exposure.
We'll draw a baseline blood test and retest you periodically. You'll need to be on the standard twodrug regimen for at least a month. The odds are overwhelming that you'll be fine." John didn't seem to relax despite the reassurance. That would probably take a while. He struggled with what was probably meant to be a smile. "Thanks for coming over so quickly, Rip. I appreciate it." "Glad to do it. I'm sorry that Dr. Ingersoll wasn't available. We generally like for a senior faculty member to take care of situations like this that involve our staff." "Actually, I'm glad it's you. I trust you. I'm not sure I can say the same about Jack Ingersoll."
He'd wondered how long it would take for questions to arise.
Nothing is perfect, certainly not in medicine. He'd heard it all his life. "When something's too good to be true, it isn't." There wasn't a drug in the world that worked all the time with no potential for side effects. Penicillin had been a fantastic leap forward after Fleming made the accidental discovery in 1928. But now 2 percent of the people in the U.S. were allergic to this wonder drug, risking reactions that ranged from an uncomfortable rash to a violent death. Aspirin had been in use for over one hundred years, providing relief of mild to moderate pain. But over 5 percent of the population couldn't take it because of sensitivity or ill effects that ranged from minor to fatal.
Nothing, however benign it might appear, was perfect. The same was true for Jandramycin. What he'd told the board of Darlington was true-sort of. Jandramycin had problems, and when they came out, Jandra Pharmaceuticals would go in the tank. But he'd known all along it wouldn't be necessary for him to leak the information. The questions would be asked, and someone would eventually ferret out the truth. Of course, if that didn't happen, he was still sitting pretty on the inside of a multi-billion-dollar enterprise with four million untraceable dollars. If it did, that amount swelled to ten million.
Not just a golden parachute-more like platinum or diamond. Enough to let him live for the rest of his life in comfort in a place he'd already picked out. For now, all he had to do was sit back and let matters take their course. And he was prepared to do just that.
John couldn't hear the ring of his cell phone over the buzz of conversation and clatter of trays in the medical center's food court, but the vibration finally caught his attention. "Dr. Ramsey." "This is Mark. What's up?" John Ramsey picked up his venti mocha in his free hand and said, "Let me move outside. I can't hear myself think in here." He walked quickly into the hallway and from there outside into the courtyard. He settled onto an unoccupied bench in a quiet corner.
"Better. Can you hear me okay?" "Loud and clear," Mark said. John brought him up to date, feeling the lump in his throat grow larger as he worked through the details. His malpractice insurance was no longer in force. It was unlikely that the medical school would protect him from any suit. "And now I've been served with the papers. Can I get you to look at them? Maybe I can buy you dinner tonight?" "Um, well-"
Mark's hesitation told John all he needed to know. "That's okay.
Obviously you have something planned for tonight." "Actually, I have a meeting at the medical center at five, but I don't know how long it's going to last. Why don't I call you after that?" John finished his coffee and tossed the cup in a nearby waste container. "That's fine."
He rose and began to move slowly back toward the entrance. "What kind of a meeting do you have, if you don't mind my asking?" "It's about-"
John could almost see the gears turning in Mark's head. "You know, you might want to be there as well. Here's the deal."
Sara heard the tap on her office door but didn't look up from the journal she was reading. "It's open." "Am I early?" Rip said from the doorway. Sara looked at the clock on her desk. Five minutes to five.
"No, you're fashionably on time. Come in and sit down." Rip eased into a visitor's chair and put a worn leather portfolio on the corner of Sara's desk. "I have some pretty interesting information on the patients who've developed problems after receiving Jandramycin." "Uh, let's wait just a minute. I sort of invited Mark Wilcox to join us. I hope that's okay." It seemed to Sara that a frown flitted across Rip's face. "I guess not. And John did vouch for him." "Did I hear my name?"
Mark said. He ambled in, shook hands with Rip and Sara, and took the other visitor's chair. "Is it still okay that I'm participating in this get-together?" "I was telling Rip that I invited you. And of course it's okay. We can use all the help we can get." "Good," Mark said. "Because I've asked John Ramsey to join us." As though on cue, John stuck his head in the doorway. Seeing that the chairs were occupied, he disappeared and returned in a moment with the chair from the secretary's desk in the outer office. After more explanations and more assurances that everyone was welcome, Sara said, "I'll start, I guess. I decided to call Jandra to see if I could get any information on possible late complications from Jandramycin. I thought they might have seen something in the preliminary animal studies." "And?" Rip asked. "No dice. I spoke with their research director, a Pharm D named Wolfe, who stonewalled me. At first he said I should check with Jack, since we're at the same institution. When I kept asking questions, he clammed up. He claimed that what I wanted to know was proprietary information. He even insinuated that I might be a spy from another pharmaceutical company." "Not unusual. Paranoia is the norm in the pharm industry. They're always looking over their shoulder for a competitor sneaking up on them," Mark said. "Did you talk with anyone else there?" "I got as far as the secretary of somebody named Patel, who's the CEO or COO, not sure of his title. What I am sure of is that she referred me right back to Wolfe. Wouldn't even let me talk with Patel." She picked up a pen from the desk and began to twirl it between her fingers. "I think Jandra is a dead end." Mark raised a tentative hand like a fifth grader with the answer to a problem. "Why don't I see if we can get any information from the New Drug Application Jandra has filed?" "Are NDA's public record?" John asked.
"No. Remember what I said about drug companies being paranoid. Keeping an NDA secret is supposed to prevent competitors from stealing information." Mark grinned. "But in my legal practice I made some contacts in Washington. Maybe one of them has connections with the FDA. I'll see what I can get." "If we suspect that Jandramycin is causing problems, shouldn't we contact the FDA directly and ask them not to act on Jandra's application?" Sara asked. Rip shook his head.
"And tell them what? We have no proof. All the clinical data here is locked up tight in Ingersoll's lab, guarded by Resnick like a dog watching over a bone. The preclinical trials were done by Ingersoll when he was doing a research fellowship at Jandra, so if there's any useful data in those records we'll never see it. Whatever the FDA has is a sanitized version of the truth, and we have no facts to refute it." Conversation stopped when John Ramsey's watch beeped. He shrugged and said, "Sorry, got to take my medicine. My doctor tells me it's important that I don't miss a dose." He looked at Rip and managed a weak grin. "Be right back." He pulled two pill bottles from his pocket and ducked out of the room. As soon as John was back, Rip pulled a sheet of notes from his portfolio. "I've managed to contact most of the patients who received Jandramycin. Of the ones I've contacted, all but three got the drug more than six weeks ago. Out of that group, six have what I consider serious conditions." Sara rose. "Let's move to the conference room for this." An hour later, names, symptoms, and pertinent lab data covered the blackboard in the conference room. "To summarize," Mark said, "we have six patients. They've developed various complications: neurologic problems, kidney failure, muscle weakness, excessive bleeding, and headaches with vision loss. Is there the common denominator?" "Let's put specific diagnoses on the groups where we can," John suggested. "Start with the neurologic problems.
Sara tells me she thinks her patient has Landry's ascending paralysis- what you younger doctors would call GBS or Guillain-Barre syndrome."
Sara wrote "GBS" and underlined it. "Kidney failure can be due to lots of things, so let's put that one aside," John said. "The same with muscle weakness and bleeding disorders. But the visual loss and headaches, associated with an elevated sed rate and some response to steroids suggest-" "Temporal arteritis," Sara almost shouted.
"Everyone agree with that?" There were murmurs of assent, so she wrote "Temp art" and circled it. "Is there a common thread to those two disorders, one that could also apply to kidney failure, muscle weakness, and excessive bleeding?" John and Mark looked at each other, and Sara could tell the answer was forming in their minds almost simultaneously. "Autoimmune disorder," they said in unison. "If we accept that," Rip said, "then let's see if there's a link to the others. Muscle pain and weakness?" "Polymyositis," Mark said. "It's autoimmune, and it fits." Sara wrote "Polymyo." "How about bleeding?"
Sara thought for a moment. "Rip, did the patient with bleeding have any purpura?" she asked, referring to the red or purple spots sometimes seen on the skin of patients with blood disorders. Rip checked his notes. "Yes. And that leads us to-" "Idiopathic thrombocytopenic purpura," Sara said, scrawling "ITP" on the board.
"And that's autoimmune." "That leaves kidney failure. Which autoimmune disorder can cause that?" John asked. They kicked that around for a bit and finally settled on kidney failure with an immune cause:
IgA-mediated nephropathy. Sara added "Imm neph" to the board. She stepped back, nodded in satisfaction, and put down her chalk. The discussion continued for a few minutes, but soon it was evident that they were in agreement. The complications from Jandramycin were autoimmune-the patients had literally become allergic to their own tissue. The effects were just manifested in different organ systems.
"Okay," Sara said. "We're dealing with an autoimmune problem. We don't know why, and we need to look at how that happens. But more important, how can we treat it? Steroids can help, of course, but their effect is temporary. Is there something that will reverse the process?" Rip shook his head and yawned. "We've got more work to do." He looked around the room. "But we're all dog-tired. Let's get some rest and reconvene here tomorrow night." They straggled out of the building and walked in loose formation across the nearly silent plaza toward the parking garage. Mark moved beside Sara and said, "I was hoping to take you to dinner. Is that offthe table for tonight?" Sara had to smile at the way Mark phrased his invitation. "I'm afraid so. I'm exhausted, and I'll bet you are." She slowed and half-turned toward him. "As for another night, why don't you wait until things settle down a bit? Then call me." All three men insisted on seeing Sara safely to her car, and soon she was on her way home. A few blocks from the medical center, she remembered that she needed cereal and milk. Sara was a creature of habit, and cereal for breakfast was one of them. She scanned the businesses around her. She was almost past the grocery store when she spotted it on the right. Sara swerved into the parking lot with only a light touch on her brakes. The squealing of her tires almost covered the sound of breaking glass. She screeched to a stop in the parking lot, looked behind her, and saw the rear window was shattered. Glass shards covered the backseat. To her right, a jagged hole marred the front passenger window. It took a few seconds for the reality of the situation to set in, and when it did, Sara seemed to implode upon herself like a blown-up balloon that's lost its air. She was vaguely aware of a number of people in the parking lot pulling out cell phones. A few eased toward her car, apparently afraid to approach too near for fear the shooting wasn't over. One man, braver than the rest, shuffled forward and called, "Are you hurt?" She shook her head. She was still sobbing, gripping the steering wheel in a death grip, when she heard the sirens approaching.