According to the guidelines imposed by the Review Board, the Compound J team had to have a “hit”—a demonstrably positive result—within the first fifteen patients. That meant tumor mass had to be reduced by at least fifty percent.
It was a daunting task. Still, for days after the meeting, Logan was flying. Finally, he and the others had their opportunity—and if it came in a slightly revised package, this is what they’d bargained for all along: a shot at making the case that the drug was both active and relatively safe.
Already, they knew they were most vulnerable on the toxicity issue. If patients failed to respond to the drug, that would be taken as unfortunate, an unhappy outcome to a worthy effort. But if the drug made patients dramatically sicker, or, God forbid, started killing them, it would be a catastrophe—nearly as much for the doctors involved as for the patients. Since before Hippocrates, medical science has dictated that the life of a patient is a sacred trust. To be perceived as abusing that trust, even with the best of intentions, is to raise questions about one’s very fitness for the profession.
Going in, they were determined to take every possible precaution to avoid such a disaster.
That placed even greater than normal importance on their most immediate order of business, putting together a patient roster. “It’s easy,” as Shein pointed out, “to kill a good drug with a bad trial.” And the easiest way to screw up a trial is to stock it with patients whose chances of doing well are already compromised going in.
Unfortunately, almost every potential candidate for this protocol would likely fall into that category since, upon diagnosis, they’d have been treated by either chemotherapy or radiation; and it is a given that anyone who’s already proven resistant to one therapy is likely to be resistant to others.
Thus, the best they could reasonably hope to do was locate fifteen women whose exposure to such treatments had, for whatever reason, been minimal.
The process of accruing protocol candidates was made far more cumbersome by Larsen’s refusal to grant the Compound J team a private office. This meant they’d be unable to field incoming calls directly, having to rely on their beepers to stay abreast of those that held promise; and make outgoing calls from the phone bank in the communal room—half work-space, half lounge—they’d shared with other first-year fellows from the start.
But Larsen could not prevent those calls from coming. For he could not deny them access to the ACF’s Community Outreach System—its link to the world of oncology beyond its borders. Like every other protocol being conducted at the ACF, a summary of the Compound J test was duly recorded in the system, available in printout to any physician calling the Foundation hotline.
The description of the protocol was followed by an appeal for likely candidates. At the urging of Reston, the wordsmith among the trio, this last they made short and sweet: This test requires a small pool of women with metastatic breast cancer; minimum performance status of seventy percent; must have no history of bleeding disorder or heart attack. Contact: Dr. Daniel Logan, Dept. of Medicine, ACF. 1-800-555-2002.
“It’s a trick I learned writing personal ads,” explained Reston, smirking. “Trust me, the more exclusive you make yourself sound, the more bites you’ll get.”
In fact, they expected a rush of calls—and so were concerned when the first several days produced only one inquiry. Alerted to the call via his beeper while on his rounds, Logan managed to make it down to the junior associates’ room within ten minutes to return it.
He found himself talking to a physician named Gillette, in Brownsville, Texas. From the sound of his voice and his courtly manner, he seemed to be well up in years. Gillette’s patient was a Mrs. Mary Brady.
“She’s just a lovely lady,” he explained, in a gentle drawl, “it’s just a shame what’s happening to her.”
Never having fielded such a call before, Logan wasn’t quite sure of the etiquette. How hard to push for the vital information he needed? How encouraging to sound about the protocol itself? “I’m very sorry to hear that,” he said. “Can you tell me a little something about the case?”
“Well, she’s forty-eight years old. Got two teenage boys that play on the football team—nice boys, not the sort that cause anyone trouble. We just want to do whatever we can to help her.”
“Uh-huh.”
“And this morning I just happened to dial up the ACF and I noticed this new protocol you’ve got going.”
“Yes. I see.”
“Can you tell me a little something about it?”
How, Logan wondered, had he suddenly become the interviewee? “Uh, well, it involves a drug called Compound J. We have reason to hope it will show activity against metastatic breast cancer. But I must stress this is a highly experimental treatment. We’re actually just getting started.”
“Well, frankly, I’m at the end of my rope down here. We’ve been through just about everything with this woman. At this point I don’t know what to do with her.”
“Can you tell me how long ago she was diagnosed?”
“Certainly … I’ve got the records right here in front of me.” He paused. “Mary first found the lump fourteen years ago—that would make her thirty-four. I recall it was during her second pregnancy.”
“Uh-huh.”
“So we waited. But after the birth, she had a modified radical. She got an axillary lymph node dissection at the same time.”
“But it recurred …?”
“I’m afraid so—five years ago. Since then we’ve been trying to handle it with standard chemotherapeutic agents. But, as I say, things are looking pretty desperate now.”
Logan had already heard more than he needed. Still, he didn’t quite know how to break the bad news to the man on the other end. “I presume the tumor is estrogen-receptor negative,” he pressed on, hoping the other would pick up the hint. The absence of the protein necessary to bind estrogen to cells is a devastating prognostic factor in such cases.
“Yes, I’m afraid so.” Dr. Gillette paused. “We even tried giving her taxol, that stuff from Pacific yew tree bark. Her family insisted, after the newspapers made such a fuss over it and all. But it didn’t do a bit of good.”
“I’m sorry. That’s unfortunate.”
“So, Dr. Logan, what’s the next step? Would you like me to send you her records?”
Logan hesitated. “Listen, Dr. Gillette, I’m afraid the truth is we’re not going to be able to help her.” He explained about the need for patients with a comparatively clear treatment history.
“Please, Doctor,” came the reply, now almost a plea, “I’m not going to tell you how to run your business. But I’m sure there’s more you can do for her up there than we can here. You have fourteen other spots, what would you have to lose? What would she have to lose?”
“I’m truly sorry” was all he could say. “Please understand that we must include only patients who fit the profile. To begin doing otherwise would put the entire test at risk.”
The call put Logan in a funk for the rest of the day. This was one of the aspects of the process to which he’d frankly given almost no thought: the degree of ruthlessness the accrual process demanded of him. Almost as bad, he’d be regularly reminded of the fact by other doctors, decent men and women, earnest and uncomprehending, pleading on their patients’ behalf.
Over the next few weeks, as the calls slowly began to pick up, Logan noted a strikingly high percentage of those doctors making referrals to the protocol turned out to be in their sixties and seventies; people whose sense of values seemed rooted in a time as alien to most at the ACF as the nineteenth century.
Because, finally, for a doctor to refer a patient to a trial such as this was not merely a leap of faith—an acknowledgment that an untested treatment was likely of more value than anything he could offer—but an act of self-denial. It meant punting away easy money—in those cases where the patient was still in the relatively early stages of the disease, potentially a very great deal of it.
As the days passed, promising candidates got no easier to come by. Three weeks into the process, only a handful of women were being closely considered, their written records, X rays, and pathology slides having arrived for study; but not a single one had yet been accepted into the protocol.
The ice was finally broken late one Friday afternoon. Sabrina was preparing to head home when a nurse gave her word that Rachel Meigs, on duty in the Screening Clinic, needed to see her immediately. Meigs was one of their few peers who seemed sincerely interested in the success of the protocol.
Pragmatic as she was by nature, Sabrina allowed herself some hope as she made her way to the clinic.
“I think I’ve got a live one for you,” confirmed Meigs. She nodded toward the waiting room. “I finished the exam about half an hour ago.”
Sabrina looked through the glass partition. Except for a young woman, evidently very pregnant, the room was empty.
“That one?” she asked, incredulous. What was this? Did Meigs imagine a pregnant woman could even be considered for the program? Or was she merely having a joke at her expense?
Meigs nodded. “That one. I think you’ll like her.”
Entering the room, Sabrina extended her hand. “Hello, I am Dr. Como.”
The woman struggled to her feet. “Hi. I’m Judy Novick.”
Only now was it apparent: Aside from her bloated midsection, the woman was emaciated; instead of a robust pink, her skin was sallow.
She wasn’t pregnant at all, her abdomen was full of tumor!
It took just a moment to compute. Of course, a week or so earlier Sabrina had studied this woman’s X rays and the slides indicating a breast tumor that had metastasized to the liver. Novick was among those she and her colleagues had okayed for further investigation. It crossed Sabrina’s mind as she looked at her that once, not long ago, this woman had been very pretty.
“You must be tired, no?”
In fact, the procedures the patient had already undergone this afternoon hardly qualified as rigorous: a chest X ray, an EKG, drawing a little blood, some manual probing of the tumors. But her condition was such, Sabrina knew, she felt as if she’d just done a dozen rounds with the heavyweight champion. Rocking unsteadily on her feet, she appeared scarcely able to keep her balance.
“Actually, yes, I am. Very.” Judy Novick smiled gratefully. “It’s been a long day.”
“Come,” said Sabrina, leading her toward an examining room, “let’s go to a more comfortable place.”
The numbers in the patient’s paperwork confirmed the visual evidence: the cancer was laying waste to her body at an awful rate. Yet, at least from the perspective of the protocol, there was also some good news. To date, the only treatment Novick had undergone was a single course of adjuvant therapy. She’d been referred to the program after the most active drugs available had proven useless.
And she lived in Bedford, Pennsylvania, little more than two hours from the ACF.
“Now,” offered Sabrina, as the patient stretched out on an examining table, “I am sure you have some questions, no? And I have some questions for you also.”
“Well …” Novick began, then stopped. “I really don’t even know what all this involves. I’m only here because my doctor wanted me to come. And my family.”
Sabrina nodded, showing nothing. According to the guidelines, candidate selections could not be made on the basis of criteria as vague or subjective as “morale” or “attitude”; yet she knew that once a patient has given up, her chances of doing well decreased markedly.
“The first thing I will tell you,” replied Sabrina, “is that this is an outpatient trial. We might need you here in the hospital at the beginning, but afterward you would live at home.”
“But what does it do? What kind of—” She stopped in midsentence. “I don’t even know exactly what I’m asking—I was never any good at science.”
“What the trial will do?” Sabrina moved closer and made eye contact. Her tone was at once straightforward and sympathetic. “I can only tell you of our hopes. This is a new treatment—it is something some of us believe in very much. But I cannot say it will be easy.”
“What kind of success have you had with it so far?”
“I must tell you, this protocol is just now beginning. This is a very new idea.”
“How many patients has it been tried on?”
Sabrina hesitated. “You will be the first—number one.” She smiled. “This is kind of an honor, no?”
The woman looked away. “I don’t know whether to be flattered or horrified.”
Like Logan, Sabrina had never imagined this part of it would be so tricky. Suddenly she found herself having to sell the protocol—and to a patient she wasn’t even sure she wanted. “I understand,” she allowed. “I wish I could tell you for certain.…”
“What you’re telling me instead is this is the only chance I’ve got.”
That was something no reputable doctor would ever say to a patient, even if, as now, she believed it to be the case; playing God was not part of the job description. “You are possibly a good candidate for this treatment,” she offered simply. “And this is not a thing we can say to very many.”
For a long moment, Novick said nothing.
“Judy …? May I call you that?”
“I was just thinking. It’s not an easy decision.”
“I, too, would like to ask some things.”
“Okay.”
“You talk of your family. You are married?”
As Sabrina well knew, a strong family—a devoted spouse, or sister, or parents—could provide crucial support in such a situation, logistical as well as emotional. It had to be anticipated that there’d be times when a protocol patient would be unable to feed herself, let alone, if it came to that, make it on her own to the ACF emergency room.
“Yes, I’m married. He’s been wonderful.”
“Good, this is so important.”
“But I wouldn’t be doing this just for him,” she cut in, with sudden spirit. “I don’t want you to think that.”
“No. I do not think that.”
“I’m doing it because I think it’s the right thing.”
“Of course.”
Sabrina betrayed nothing; but the excitement was building within: hadn’t she just agreed to participate in the test?
“Because it really is my only shot, isn’t it? I’m not one of those people who lie to themselves.”
That put to rest Sabrina’s last lingering apprehension. Morale wouldn’t be a problem, after all.
“Still,” Sabrina said evenly, “before we agree, you must think about it a little. I want you to look carefully at the Informed Consent Document. And talk with your family and with your doctor. And I must talk with my colleagues.”
She nodded. “Fine. But if we’re doing this, I’d like to get started.” Perhaps unconsciously, she passed a hand over her distended belly. “The sooner the better.”