“Even more remarkable, her cognitive test scores were double what she got before she was institutionalized and two to three times that of the placebo group—not to mention a five times response rate and enhanced ability to perform her activities of daily living. Six months before she took the drug, she could not dress herself or go to the bathroom alone. Now she’s undergone a clinical regeneration in twenty-four weeks at two ten-milligram dosages daily.”
“I’d very much like to see those results.”
“Of course.” Carr’s eyes beamed like a child sharing a secret.
“She was forgetting things from one moment to the next. It was like watching
her being peeled away like an onion.”
Cassandra Gould’s words buzzed in René’s brain.
And cutting across those her father’s plea:
“Promise me … I don’t want to end up just some gaga thing attached to a diaper.”
Maybe Clara Devine was just some extraordinary anomaly. “Are there other test subjects?”
“Of course.”
“So why all the secrecy if it’s such a miracle drug?”
“It’s a blinded study to keep people unbiased.”
Clinical trials were blinded so that the people responsible for patients wouldn’t attribute any and every change to the drug being tested. And while in such studies the caregivers may not know which patients receive the active drug and which patients receive a placebo, they are made aware that patients are enrolled in a clinical study. “But why wasn’t I or my pharmacy informed?”
“Because technically the trial compound is not among the active meds supplied by CommCare, your pharmacy. The Memorine tablets came from GEM.”
“But these patients were on other meds that CommCare supplies.”
“Look, their medical charts were meticulously kept by the nursing staff.”
“You mean a separate and hidden set.”
“Yes, but the trial data wasn’t kept from those who need to know at the FDA.”
“That still doesn’t explain why there are no nurses’ reports of the trials in my records or the alleged improvement of patients’ behavior and functionality. Or why I wasn’t told.” Because her job centered mostly on paperwork, she had only minimal contact with nursing home residents—something she hoped to change as time passed. Therefore, she could not personally have witnessed any actual improvements in the behavior of these trial subjects. Nonetheless, nurses and other staffers at her homes often talked about patients’ health, behavior, affect, the funny things they may have said. Yet, remarkably, nobody had uttered a word about the extraordinary changes in Clara Devine or any other patients in these trials.
“Well, I’m telling you now.”
“But only because Clara Devine eloped and murdered someone.”
His face darkened. “That was unfortunate.”
“Doctor Carr, this isn’t a blinded study, it’s a
concealed
one.”
He stared at her for a moment, then shrugged. “If you wish.”
He was trying to disarm her with a concession because he knew that she
could report him. As an employee of CommCare, she was an outsider to the nursing home and bound by state and FDA regulations. And they both knew that she could lose her job were she not to report a secret clinical trial. “Doctor, you’re not answering my question: Why was I kept in the dark?”
“It was nothing personal. Even the nursing staff didn’t know what the subjects were on, though they were aware they’d been enrolled in trial of a dementia drug.”
“That still doesn’t answer my question.”
He drained his wineglass. “Because GEM Tech did not want to risk the competition getting wind of what we have. Period.”
The
we
floated like a lazy feather in the air. “They’re really worried some other drug company’s going to whip up a me-too compound?”
“In a word, yes. They don’t want somebody else beating them to the market. You know what a rat race the pharmaceutical industry is. Somebody invents a Ford, and a Chevy is right on its bumper.” He lowered his voice to a conspiratorial whisper. “René, we’re talking about a supreme blockbuster drug here—a fifty-
billion
-dollar pill.”
The waiter arrived to clear their dishes. When he left, Carr said, “I know it’s premature, but the FDA is very excited about this,
very.
And I won’t be surprised if they fast-track its approval.”
That still didn’t justify burying data. But the more he talked about the miraculous results, the more she became self-conscious about raising niggling issues of policy regulations. Here was a celebrated senior neurologist sharing with her what might be the greatest breakthrough in medicine since penicillin, and two months on the job and little Polly Protocol was souring the air with fumes. “I can imagine.”
“In four months we’ll be submitting trial reports to the Institutional Review Board—all the data and documentation thus far, everything with all the
Ts
crossed and Is dotted as required by the FDA, to be followed by the necessary publications, which will no doubt make the press. This is going to be huge.”
“You’re talking as if you’re the principal investigator.”
“Actually, I’m one of them. A chief has yet to be named.”
The chief principal investigator on any clinical trial occupied a post heavy with responsibility and prestige, especially if the compound tested showed promise. That Jordan Carr was a prime candidate was evident. So was his yearning.
“So, what about Clara killing a man? How is that being explained?”
“That was unexpected, of course. And we’ll have to make the best of it. Thankfully, patient confidentiality protects us. Meanwhile, she’s at McLean for observation.”
She remembered Officier Menard’s question:
Was she on any antipsychotic medication or other stuff that might have caused her violence?
“So, what do we tell the police?”
“That there was a security breach and that it won’t happen again because new safeguards are in place.”
“I mean the murder.” He kept avoiding that fact.
“Simply that she was a woman suffering from dementia, that she just went berserk. And that’s not so far-fetched. These
are
crazy people, after all.”
René could hear her father’s voice.
“Honey, I can feel it. I can feel the holes.”
The chilly touch of his words bothered her. “So you’re saying that Memoring—”
“Memorine,”
he said, pronouncing it like a talisman. “
Memorine
—and file that away because it’s going to rock the world.”
“So you’re saying that Memorine did not cause her to attack the man.”
“That’s exactly what I’m saying.”
“But how do you know that if the drug’s been in its final phase of study for only six months?”
A smile spread across his face like a rainbow. “René, we’ve been running trials at Broadview and testing efficacy and safety for months, and there’ve been no adverse reactions whatsoever. The Clara Devine incident is an unrelated anomaly. Period.”
“She was sexually abused as a child.”
“Beg pardon?”
René did not want to violate the woman’s privacy, nor did she want to betray Cassandra Gould, but this was vital information. “A neighbor next door did things to her.” And she explained what she knew.
“How unfortunate, but what does that have to do with anything?”
She wasn’t sure if he was playing coy again or drawing her out. “Doctor, I’m saying that Clara Devine attacked the man because in her mind she was seeing her abuser. I’m just wondering if it had anything to do with this Memorine.”
Carr laid down his fork with a definitive snap. “Well, it didn’t.”
“But how can one be certain if the stuff’s improving memory?”
“Because half the people in your nursing homes are seeing dead people all the time. Their husbands are their baby brothers, their sisters are their
kindergarten teachers. You spend your days on these wards, you should know that. Clara Devine was no different, except she’s had some kind of post-traumatic stress experience—which happens to people all the time. VA hospitals are full of them.”
“There’s also the matter of informed consent. Her sister had passed on power of attorney, which meant that Clara was a ward of the state. Essentially, nobody was watching out for her.”
Carr made another audible sigh. “And I suppose you’re going to quote the Nuremberg Code on the principles governing ethical experimentation on humans.”
“Actually, I was thinking of the Declaration of Helsinki.”
“Look, this is not some hideous conspiracy. We’re not conducting Josef Mengele experiments on the elderly, shooting them up with voodoo compounds. We’re bringing them back from a killer fog. You saw Clara Devine, and you’re going to see others in the next year. So, think of this as our apology for keeping you in the dark, as you said.”
She nodded, feeling as if she were being bought. “I’d like to know what other patients of mine are in these trials.”
“Of course, but you’ve got hundreds of patients, and I don’t know the overlap.”
“Dr. Carr, every clinical trial is bound by very detailed, very stringent protocols established well in advance. Were I to approach the Institutional Review Board and raise the question about their approval in advance of GEM Tech clinicians sequestering documentation of trial patients from the consulting pharmacist, what might be their reaction?”
For the first time that evening Jordan Carr’s face froze, his cheeks mottled with red as if he had been hit with a flash case of the hives. “Ms. Ballard, you’re very sharp and very responsible. I’ll make certain that you will have total access to all your patients enrolled, as soon as possible. But I ask that any indiscretion or irregularities you please overlook, okay? And I ask you because this is a turning point in the treatment of dementia, and any regulatory roadblock could be disastrous. Can’t you appreciate that?”
He was asking her to look the other way, and that made her very uncomfortable. And it wasn’t just being in complicity with regulatory violations. She didn’t like the power she suddenly possessed. One word from her and some very important people would end up on the proverbial red carpet and the trials of GEM Tech’s hot drug could be suspended. “Then I expect a full list of patients who are enrolled at Broadview and elsewhere.”
“Of course.”
“And full documentation of meds including Memorine, schedules, and nurses’ observations, et cetera.” If he proved as good as his word, she would not contact the IRB.
“Certainly. Absolutely.” The relief was clearly visible in his face.
The waiter came to clear the dishes. “Would you like to see the dessert tray?”
René shook her head.
Dr. Carr studied her face for a moment. “Irregularities aside, aren’t you impressed? A cure for Alzheimer’s?”
“If it’s the real thing, of course.” She could hear the forced brightness in her voice.
“Well, take my word for it, it’s the real thing.”
“And how long have these trials been going on?”
“The last phase for eight months. But we’ve known about the neurological benefits to dementia patients for years.”
She nodded, and felt something rip inside her heart.
JACK WAS AT THAT DOOR AGAIN.
The same brown stained wood-panel structure with the hanging herbs and tarnished brass knob. He had lost count how many times it had been. How many times he had grabbed the mouse and padded to the door through the sticky wet. Then how he had frozen again, knowing on some level that horrible things were happening out there, but also knowing he had to get out to Beth and the others.
Jack stared numbly at the doorknob as if something profound were about to occur. Then he heard a voice full of gravel: “Goddamn you, die.”
Then that horrible sound that pounded through his brain over and over again, every time he got here, every time he put his hand on the knob—a sound that set loose a flock of bats in his chest: The crack of iron against bonecap.
Somebody, please, I beg you. Make this stop.
He folded into the corner on the floor, still clutching the mouse, his eyes pressed shut, his own whimpers humming in his head.
“Jack, you’re having a dream. Can you open your eyes for me?”
He opened his eyes and the window at the top of the door flashed down at him with a blue-green light.
“He’s saying something.”
Safe. The thing with the big head has gone away.
Jack got up from the floor and put his hand on the doorknob. Cold metal. He turned it …
“Jack, wake up. Come on, you can do it. Just push.”
… and he pushed.
Instantly the wind sucked open the door with a bang. His heart nearly exploded. The thing with the pointy head stood before him, its arm raised, the shiny club glinting in the light.
“Close the goddamn door.”
He closed the door.
“What did he say? I didn’t catch it.”
“I think, ‘Nice Mookie’?”
“Who’s Mookie?”
“I haven’t got a clue.”