The video presentation ended with a slick promotional on the healing power of the drug—elderly patients having fun moments with younger family members, concluding with a voiceover pronouncement: “The Memorine Solution.”
Gavin Moy concluded with the reminder that they were at a turning point in medical and social history. “The world is waiting, and it is morally imperative that we respond accordingly and in a timely manner.”
A standing ovation exploded. The pep rally had come to a conclusion.
73
THERE WAS A HALF-HOUR BREAK AS people stretched and mingled, some execs and invited guests retiring to one of the bars. Then the twenty-three PIs moved to the Mountain Lion Room for the closed-door strategy meeting.
At the center of the room sat a large oval table with twenty-three chairs, each with place cards—nineteen men and four women. Although Nick thought it rather excessive, each clinician had been sworn to secrecy, their signatures appearing on a confidentiality document drawn up by GEM’s legal department.
Nick took his seat. He looked over at Paul Nadeau and Brian Rich. They nodded. From the other side of the table Jordan flashed Nick a thumbs-up. His backers—renegades in dissent, as René called them. (He would telephone her and, of course, Thalia when it was over.)
Nick called the meeting to order and offered sincere appreciation for the arduous work by the researchers and their various staff members. “I share with my colleagues the high enthusiasm over the successes of Memorine and the hopes that it can eventually live up to expectations. I need not remind anyone of the global impact of this meeting and the decisions we make. But I’d like to say that our purpose here is to evaluate the accuracy and legitimacy of our application report to the FDA and not to agree on strategies that would ensure smooth sailing through that process.”
An uneasy rustling circled the table.
Nick then asked for each doctor’s comments on the collective findings of the trials. And one after another the comments were expectedly praiseful. Some spoke of how exciting it had been to work on such a miraculous compound, others saying how personally gratifying it was to witness such positive results. Murmurs of “Hear, hear,” arose from others.
When it was Jordan Carr’s turn, he shot Nick a nervous glance and said he had nothing else to add but high expectations. Nick felt confused. It was agreed that Jordan would initiate the concern about the flashbacks and begin to quote troublesome data. But he just looked away.
When it came to Paul Nadeau and Brian Rich, they also concurred with the others’ praise and expectations, although Nadeau did mention a few cases of regressive delusional behaviors that were correctable by standard antipsychotic medications.
Nick was beginning to read the portents. “Thank you for your comments,” he said. “And while I appreciate your enthusiasm, I heard only passing reference to what I believe are serious adverse reactions as manifested in over thirty percent of the trial subjects—namely, the flashback seizures. And if we are to offer a balanced report of our findings, it is incumbent upon us to highlight those problems which have resulted in a number of deaths, including one murder and three suicides, several injuries, and some arrests, not to mention the effect on family members and caregivers.”
“I beg to differ,” said Harvey Schultz, a PI from Trenton. “I’m not sure where you’re getting your figures, Nick, but I have not experienced such adversities. And frankly I thought we had clarified this problem—namely, that these alleged flashbacks are delusions stemming from structural changes from AD and not the application of Memorine.”
Nick was ready for that. “We have not clarified the problem but buried it.”
A grumble arose. Jordan looked at Nick, his face reddening.
“A significant number of patients are receding into hallucinatory delusions of past-time-even early childhood—experiences. And many are very traumatic, locking patients into flashbacks. We’ve documented several cases of residents becoming highly agitated, including Louis Martinetti, from the video earlier, who out of the blue is back in a Korean POW camp. Another keeps getting stuck in a house fire that she was in when she was ten years old. Another relives the discovery of his father’s suicide by hanging. These are terribly traumatic flashbacks that they just can’t seem to escape.
“Furthermore, these episodes have not only created great difficulties for nursing home staffers, but, as you can imagine, they have had devastating effects on family members.”
Then he read a few sample letters from caregivers. “‘You have made my husband into a guinea pig and into someone I don’t know. His behavior is erratic. One minute he’s himself, the next he’s talking crazy things to people who died years ago. At least when he was demented, we knew what to expect. Now he’s like a lost child who cannot come out of his trances.’
“Another writes: ‘I don’t like what this has done to my father. It’s frightening and painful for our family to see him reliving painful experiences once forgotten. Our only option is to fill him up with tranquilizers and other drugs that send him into a stupor. You’ve created for us a horrible emotional seesaw. At least with the Alzheimer’s we knew what to expect and learned to deal with it. But this is awful.’
“Another says of his eighty-two-year-old wife who plays with toy animals all day: ‘I spent fifty-four years growing old with Helen, but I’m not sure I can grow young with her.’”
Silence filled the room.
Then Brian Rich spoke up. “As you know, Nick, I’ve scrutinized the data and given this a lot of thought over the last few weeks. But with all due respect, I’ve decided that our job is to cure diseases, not the social consequences of our successes. What we should be discussing is how best to make our deadline with this report. The world is waiting.”
And from around the table voices made a spontaneous chorus: “Hear, hear!”
“Can you demonstrate that once a patient is off the drug the flashbacks subside?” asked another physician.
They all knew the answer. “No, since we can’t take anyone off the drugs without bringing back the plaque. And that constitutes a double punishment by limiting our treatment of the flashbacks.”
“Then where’s the evidence that Memorine causes flashbacks if you cannot demonstrate the inverse?” Josh Rubell from Pittsburgh asked.
“Because in most cases the subjects experienced no sustained delusional activities prior to the trials.”
Rubell jabbed a long yellow pencil at Nick. “Those complaints wouldn’t have arisen had you not alleged that these flashbacks were the result of Memorine. You and you alone have poisoned the well, Nick, and I resent that.”
The place hushed. And Nick felt his face burn.
Another added, “Frankly, I’m getting tired of all this talk of flashbacks and adverse drug reactions. We hired an independent outside CRO to review all the data and make a determination. We have the Klander Report, and I’m going with that.”
Agreement passed around the table. Nick looked to Paul Nadeau and Brian Rich, who had shared Nick’s decision to seek an extension on the application. They were both nodding and muttering, “Hear, hear.” Across the table from them sat Jordan Carr, who was also nodding, his eyes steadfastly avoiding contact with Nick’s.
Et tu, you son of a bitch, Nick thought.
In three weeks, the Klander Group had pored over all the clinical data that René Ballard and others had helped amass—med schedules, behavior reports, charts, clinical observations, progress reports, test scores, and any alerts raised by Nick and others. But it was a foregone conclusion that the Klander Report would dismiss the flashbacks as a consequence of the disease.