by Gary Braver
“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.
14
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.”
15
“DID YOU KNOW ABOUT THESE MEMORINE trials?”
Nick looked over his glasses at her. “Yes.”
“It seems as if everybody does but me.” She could barely disguise the emotion crackling in her words.
“Then someone should have told you, of course.”
“Dr. Carr was going on as if it was the medical breakthrough of the millennium.”
“From what I understand, the results are quite promising, but it’s too early to call a press conference.”
She nodded, feeling a swirl of hot emotions.
It was Thursday afternoon and they were sitting in the control room of the new MRI imaging suite at MGH. Glass windows separated the bank of computers from the huge scanner, the ring-shaped apparatus with an attached patient table, in the next room. Behind them were three technicians working at their own monitors. Nick was a regular here because he had helped pioneer new imaging techniques for studying Alzheimer’s—techniques that aimed at detecting the disease in the presymptomatic phase and diagnosing its progress.
“So, you had a pleasant evening with him?”
“It was interesting.” She knew how evasive that sounded.
“He’s a very bright and capable physician.”
“And very charming, and I’m not interested.” There was an awkward silence. Her relationship with Nick was warm and mutually gratifying. He was the older mentor-cum-father-figure and she the pretty former student who made him feel young and charming. She had always sensed that he regarded her with an admiration that exceeded the professor-and-student relationship. It was evident in the way he lit up when he looked upon her, or touched her arm when he was explaining something. He was also intent on seeing her find a boyfriend.
“Okay,” he said. “Did he show you the Palm Pilot images of Clara Devine’s tests? It’s all right, I’ve seen them. All these years and all the research, and this is the first time that anything out of a lab is showing promise of a cure. Quite remarkable, wouldn’t you say?”
“If it is, I was three years too late.” Tears filled her eyes.
Nick looked at her, and in a moment realization clicked in his eyes. “Ahh. You mean your father.” He took her hand. “Good God, woman, there was no way for you to know. How could you? Besides, he could not have lasted this long.”
“He was still strong.”
“Maybe physically, but there was nothing left of him inside, and you know that. I would have done the same thing if it were Thalia. I would have wanted the same thing if it were me.” He squeezed her hand with assurance.
“I did it for me.”
“No! You did it for him. It’s what he wanted.”
But if I had only waited …
“Listen to me. The first dementia patients were not enrolled in these trials until eight or nine months ago. That’s two and a half years after he died. You know as well as I what could have happened in that time. He would have continued to waste away, kept alive by machines and tubes and IV drips. Was that something you’d want? Of course not, and neither did he. And who’s to say this stuff would have worked for him? Or if he would have lived so long even full-coded. No, you did the right thing. So put it away for good.”
She nodded and gave Nick a hug. He was also the one person for whom she had unguarded respect and not a little affection. If it weren’t for him, she would have dropped out of pharmacy school and would probably be wiping counters at Starbucks. It was also Nick who had held her hand during her father’s demise.
Nick got up and poured her a cup of coffee from the small machine sitting on a back table. René took a few sips and let his consolation take effect.
“So, back to reality. You’re having some problems with administrative procedures, right?”
“I think I’ll feel better when I see Clara Devine’s records.”
“Dreadful story. I read the paper.”
“Nick, she was sexually abused as a young girl by some creep neighbor.” And she told him what Cassie Gould had said.
Nick’s face clouded over. “So, what are you saying?”
“I’m saying that in her head, Clara Devine may have been defending herself against the guy who raped her seventy years ago.”
“A flashback seizure.”
Flashback. The term lit up in her mind as if it were an established syndrome. “Yeah, exactly. A flashback.”
“It’s a Peter Habib term,” Nick said. “I guess it’s possible. We’re talking about axon connections rethreading the hippocampus. What does Dr. Carr say?”
“He says it’s the dementia, not an adverse drug reaction.”
“Because post-traumatic stress hallucinations can plague dementia victims. I suppose that will have to be determined. In the meantime, what are you thinking of doing?”
“Nick, for nearly two months I’ve been up against some clinical code of omertà while secret trials were going on right under my nose.”
“So you’re thinking of filing a formal complaint against the record-taking procedures of a senior clinician working on a potential cure for Alzheimer’s disease.”
“Not when you put it that way.”
“Then let it go. You’ll get the charts. Look through them, check the nurses’ reports, and if anything looks irregular, then write your letters. In the meantime, visit some of the trial patients. I think you may be impressed with what’s happening.”
“And what’s that?”
“Maybe medical history.”
“Wait a second. Are you part of this?”
“GEM’s made some recent inquiries.”
“How long have you known about the stuff?”
Nick must have heard her words skid because he narrowed his eyes. “I’m telling you it was not an option for your father. They hadn’t even begun phase one trials on animals yet. Nobody had any idea if it would work with AD patients. And had I known, you would have been the first to hear.”
She nodded. “I know.” She had scoured the journals and the Internet looking for every experimental drug in clinical trials, and nothing had held any promise for her father’s condition. Memorine was still deep in GEM’s pipeline.
“And in case you’re wondering, I haven’t committed myself.”
“Maybe you should. Given how they’ve been operating, they could use some ethical standards.”
“That’s very kind, but what do you think that’d do to my retirement plans?”
“You’re still young and energetic.”
“Kinder still. But Thalia has got her health problems, and I have a new grandchild, number three.”
“Okay. When I asked him why I was kept in the dark, Dr. Carr said that GEM wanted to guard against the competition. That seems rather paranoid to me.”
“Might also be good business. First of all, clinical trials are almost never done with geriatrics in nursing homes, as you know. So they wanted to keep things quiet for as long as possible. Secondly, GEM’s a small, tight drug company and nervous about some Goliath out there stealing its hot molecule. It’s happened before. I suppose if this compound turns out to be the real thing, the benefits will more than make up for minor irregularities.”
He, too, was saying to look the other way. “And what about Dr. Carr? I’m sure he’s doing well by GEM.”
“There’s nothing unethical or illegal in a physician’s getting a fee for enrolling patients in trials. It’s how research progresses.”
“That’s the one gray area that frankly bothers me. Doctors get paid thousands of dollars for each patient they enroll in a trial, plus resear
ch grants, equipment upgrades, staff support, travel perks, plus stock options in the company. With all those incentives, it’s hard to write up a negative report to the FDA.”
“Except actual scientific results don’t lie. And from what I hear, this Memorine is looking remarkable.” Nick fixed his glasses and rolled his chair. “Now, come here and look at this.” He inserted a CD into the computer and ran his fingers across the keyboard. In a matter of moments multicolored images of a brain filled the screen. He moved the mouse around and clicked a couple of times, and the colors began to change, pulsing in yellows and reds. “Thanks to the genius of imaging physicists and computer technicians, we now have the first quantitative, dynamic visualization of the destruction of cortical brain regions in people with dementia. What you’re seeing is a 3-D sequencing movie of a seventy-five-year-old male’s brain under the siege of plaque formation and neuron tangles over a thirteen-month period.”
As best she could, she tried to dissociate herself from thoughts of her father. “What do the colors represent?”
“The base image of the brain is blue. And in red is the beta-amyloid plaque.”
“God, it looks like a blight spreading across the brain.”
“And of the worst sort. What makes this technology very special is that we can directly monitor both the progressive damage as well as any therapeutic responses from Aricept and other treatments.” Nick ran the serial scan images several times.
“It’s moving right across the parietal and temporal lobes.”
“Exactly, the areas controlling language and major cognitive functions.”
“And obliterating memories, personalities—everything that made them who they were,” she said.
“His name is Louis Martinetti. He’s at Broadview. Maybe you’ve met him.”
“Yes. The Korean war vet.”
