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.
In three weeks, the Klander Group had pored over all the clinical data that Rene 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.
It was also understood that Nick’s rejection of the Klander Report could mean the end of Nick’s participation in the trials, his funding, the support for the MRI lab—a financial and image loss to the hospital. But institutional politics and fiduciary health was not what this was all about. “With all due respect, I think the Klander Report is bullshit.”
“Then you’re all alone, Nick,” Dr. Rubell said.
For the first time that night Jordan Carr raised his hand. “Look, Nick, we’ve worked together on this for a long time. And for the most part we shared the analysis and interpretation of the data. But I’ve studied the Klander Report, and I must say that I am comfortable with its conclusions. We’ve treated hundreds of people with dementing conditions, and most have been brought back from inevitable oblivion. That’s confirmation enough for me.”
“Hear, hear.”
“More than that, behavioral anomalies are to be expected in such a wide-ranging population.” Then Jordan thumbed through the report to its core argument. “It’s a proven fact that during the deterioration of the brain, connections are repatterned, while good ones become dominant. Which is why AD patients sometimes have sudden recall and forgotten talents—like sitting at the piano and playing the
And he continued in his smooth high-reasoned tone as he quoted statistics. When Carr finished, the others applauded. And Jordan flashed Nick a smile that could barely disguise the “gotcha” glow. Rene was right about him: He was a self-serving chameleon who said all the right things if it advanced his cause.
“If I may quote Mark Twain,” Nick said when the place quieted down, “‘There are three kinds of lies: lies, damned lies, and statistics.’ What we did was hire the Klander Group to give us what we wanted to hear: That Memorine is a miracle cure with no side effects. Period. Frankly it’s disingenuous of us to claim that this report offers a fair and neutral evaluation of our data. And I won’t be part of it.”
“I don’t like what you’re suggesting.”
“What, that money talks? Well, that’s what’s happened. And I cannot live with myself were I to vote to accept this report and, thus, make what I assume will be a unanimous endorsement of our application.”
“Nick, we’ve got spectacular results, and you’re harping on some minor problems. Just what do you propose?”
“That we request an extension of up to two years before approaching the FDA.”
“But we have a deadline,” someone shouted over the protests.
“Yes,” Nick said, “a deadline of GEM Tech’s marketing department, but not the health needs of people suffering from Alzheimer’s disease.
“Let’s say we accept the report and Memorine hits the market. What happens if we get another suicide or murder? Remember the multimillion-dollar settlement against GlaxoSmithKline after a man shot his wife, daughter, and granddaughter? The jury decided there was enough scientific evidence that it was the Paxil he was on. Do we want GEM taken over by the courts?
“What happens when caregiver complaints over flashbacks force the FDA to put a hold on distribution? And while we scramble to figure out what to do, millions of victims begin to slip away again. Meanwhile lawsuits fall from the sky like hail, and GEM Tech stocks won’t be worth the paper they’re printed on.
“And what happens when outside medical studies conclude that GEM Tech clinicians cut corners and pulled strings to get FDA approval? GEM Tech and every one of us in this room would be litigational toast. And the only ones celebrating would be the lawyers and the competition.”
Jordan spoke up again. “Nick, for the sake of argument, let’s say that some of these flashbacks are the direct result of the drug. So what? The alternative is dementia and death. But if the flashbacks don’t intrude, don’t threaten anyone, why not live with them? Look at Louis Martinetti—his Mini-Mentals are over seventy percent. That to me is a miracle.”
More chants of “Hear, hear.”
“I say we vote to accept this report while initiating an aggressive demographic profiling of patients who may have such seizures. This way we determine susceptible target groups.”
“You mean we conduct a demographic screening after approval?” Nick asked.
“Yes,” Jordan said. “And that population with a propensity for flashback problems would be warned to avoid the drug, and at the same time GEM could offer a free test to screen for it.”
“But that’s putting the cart before the horse,” Nick said. “I think it makes better sense to make those determinations
“The other option is a black box,” Paul Nadeau threw out.
Nick chuckled. A black box was the warning that the Food and Drug Administration required in a drug’s labeling—nothing a pharmaceutical company welcomed. “Sure: ‘If you don’t want your elderly patients to play Ding Dong School all day or attack the postman because he took your marbles, then this drug may not be for your dementia patient.’”
Nobody else found that amusing.
“What you are asking, Nick,” said Rubell, “is that we tell millions of people out there that they’ll have to let the fog close over them while we work out these little details. In my book there’s no crueler punishment—show
