Nick had been working out here and on a home treadmill, so he cut up the trail like a mountain goat, Rene right behind him. “Any idea which CRO?”
“No. Some gerontology specialists.”
“And what about flashback cases?”
“We continue fine-tuning dosages and noting behavior changes. Any problems we continue to treat with antiseizure drugs, antipsychotics, sedatives.”
Two other clinical PIs had bowed out of the trials in disagreement with GEM Tech’s pressure tactics and had been replaced by GEM-approved physicians. And now Peter Habib was dead. “Are we the only ones who think they’re rushing a faulty drug to market?”
“I think Brian Rich and Paul Nadeau agree, and possibly Jordan Carr. He may be coming around. Unfortunately, that’s up against a powerful flood of appeals by AD groups to get it to market by Christmas, no matter what.”
“But a CRO review could take months.”
“If pushed, they could review the data in a week. They’ve also got to have it done for Utah. That’s seven weeks from now.”
“So there’s a deadline.”
“Absolutely. Meanwhile, we box up all case report forms, records, whatever, including all files on CDs, and continue the trials.”
They came to a clearing and climbed the granite boulders to the top, where they had a three-hundred-and- sixty-degree view. Nick sat down on a rock and took a deep breath.
“You okay?”
He smiled and let out his breath. “Just a little dizzy.”
Rene handed him a water bottle from her day pack. “How long have you been having these spells?”
“Since I’ve been thirty pounds overweight.” He guzzled some water and stood up. “I’m fine.”
Toward the east the skyline of Boston shimmered in the milky blue mist. Nick took his camera out of his backpack and snapped off a few shots—of the local rocks, the Boston skyline, and Rene.
“The Utah conference is just an hour’s drive from Bryce Canyon. Imagine the views.”
“I take it the FDA knows nothing about these flashback problems.”
“Not officially, even though that was what Peter was pushing for,” Nick said. He snapped another two shots. “Nor will they unless that’s in the report by the CRO.”
“And if the CRO concludes that the problem is drug-related?”
Nick shrugged. “Then we go back to the drawing boards—determine where the problem is—dosages, interactions with other medications or other diseases, population demographics—whatever it takes. We’ve done nothing about determining a correlation. Maybe Italian Americans or Eastern European Jews are susceptible to such seizures. Or people with a particular genetic signature. Or those patients with high blood pressure. We just don’t know why some have flashbacks and others don’t, but we’d better determine that before the stuff hits the market.”
“And if this CRO concludes that the flashbacks are not drug related?”
“It goes to market.”
What bothered Rene was how GEM Tech reps were categorically dismissing the flashbacks as anomalies unrelated to the drug. Even Mary Curley’s death was ruled an unintentional suicide as the result of advanced dementia. The same with a man from Connecticut named Rodney Blake who had cut off his own genitals.
“Meanwhile, we continue feeding hope to victims and caregivers.”
“And isn’t that a shame.”
59
“I DON’T WANT HIM HOME LIKE THIS. He’s not right yet, I’m telling you. He’s not right.”
Rene and Nick were back at Broadview with Marie Martinetti and her daughter, Christine. Louis was insisting on being released from the home and had called a lawyer.
“The tests say he’s improved nearly fifty percent,” Christine said.
“Yeah, but he’s worse.”
Mrs. Martinetti was in her seventies and ailing with arthritis, and Louis was still strong and more active than ever. And given his cognitive improvements, Louis had outgrown the nursing home. That fact made this a circumstance that nursing homes had never before had to confront—not since Memorine. And Rene could feel Nick struggle with the dilemma.
“Well, you’re free to sign a release for him if you choose to bring him home,” he explained.
“That’s what I’m saying. I can’t handle him the way he is.” Marie looked pleadingly at Rene. “It’s that Memorine. You gotta take him off it. It’s making him crazy.”
Christine’s face was drawn in dismay. “Mom,” she began.
“Mom, nothing. You don’t know the half of it. You got to take him off it.”
“Mrs. Martinetti, we really can’t do that,” Nick said woefully.
“What do you mean you can’t do that? Of course you can do that.”
“If we withdraw Louis from the drug the disease will come back.”
Mrs. Martinetti glared at Nick as if he had just spit something up. “What?”
“That’s the problem with this medication, I’m afraid.”
“What’s the problem? What are you saying?” She shot Rene a frantic look for an explanation she could accept.
But Christine cut in. “Mom, they’re saying that the plaque will grow back. That he’ll get Alzheimer’s again if he’s taken off it.”
“What?” Mrs. Martinetti looked back at Nick. “You didn’t know about this?”
“It never occurred in the early phases of the trials with lab animals. No reversal of any kind. Even in the second phase using humans we didn’t see any evidence of a reversal.”
Nick was correct. Rene had scanned some of the reports from GEM and outside protocol test labs, and nothing in the data had indicated that withdrawal from Memorine in any dosage caused animals or healthy non- demented humans to develop the amyloid plaque. Not until Clara Devine was returned from McLean’s.
“It was completely unforeseen,” Nick said. “I explained to Christine the other day. I’m very sorry.”
“Sorry? But they said this was a miracle cure.” Then the realization set in and her face crumbled. “Oh, my God.”
“But, Mom, he can still take it,” Christine began. “He’s still recovering.”
But Mrs. Martinetti disregarded her. “So, what does that mean? Louis will have these flashbacks the rest of his life—go back someplace in the junior high gym or in the army? Sweet Mother of God, what are you telling me?”
“Mom, please. It’s better than him just wasting away.”
Her head snapped at her daughter. “No, it
“Colonel Chop Chop?” Nick asked.
“Some North Korean commander,” Christine said. “Chop Yong Jin, or something like that. I think he was in charge when my dad was taken prisoner. That was his nickname, Colonel Chop Chop.” She explained that he was a high-ranking Korean officer who brought a Russian advisor on military campaigns—a guy they nicknamed Blackhawk, from an old military comic book character. In the book Chop Chop was his loyal sidekick. “Dad escaped, but he saw some bad stuff he never talked about.”
“No, he didn’t escape,” Marie Martinetti cried. “They still got him. He keeps reliving them. And he talks about it and he’s back again and again, but you’re not there. I am. I
“I don’t care if he has a couple of flashback things,” Christine continued. “Those were the best times of his life, when he was young and full of himself. And he’s fine in between, and he’s not hurting himself or anybody else. And maybe you can come up with something that keeps them under control.”
“But you don’t know what he’s reliving,” Marie protested. “I’ve seen him. I’m here almost every day and
