FLASHBACK (39 page)
Authors: Gary Braver
TO CELEBRATE THE END OF THE trials, the GEM Tech clinical team and executive administrators met at the Red Canyon Resort Hotel, a rustic but grand hundred-year-old lodge located near Bryce Canyon and Capital Reef on Route 12. It had been selected for its privacy and because it was located within driving distance of the splendid canyon and Rocky Mountain scenery crisscrossed with endless hiking trails and whitewater rapids. It was also near Gavin Moy’s ski condo.
Although people had arrived on Friday, the official opening of the conference was Saturday at noon with a formal kickoff luncheon and talk, followed by the clinical investigators’ meeting behind closed doors for the FDA strategy session.
Nick’s overriding impression of the conference was the expense. Little had been spared. GEM had flown in sixty people from various parts of the country—execs, medical officers, marketing VPs, legal staffers, clinicians from outside the company, as well as the twenty-three clinical physicians who, for nearly two years, had headed up various trial sites. They had rented out half the lodge and the adjoining Mountain Lion Room, where later in the day the principal investigators would determine the final application report to the FDA. In the balance lay the hopes and fate of millions of Alzheimer patients, their families, and caregivers. Also billions of dollars.
The afternoon began with a five-course meal served in the elegantly appointed Ponderosa Room, where a SWAT team of waiters had assembled. Dinner consisted of leek and potato soup, carpaccio of tuna, salad greens, a choice of filet mignon, salmon, or lobster tail served in elegant presentations, assorted spring vegetables, and fancy Italian desserts. There were the finest wines from Napa Valley as well as endless bottles of Taittinger champagne. Table conversation sparkled with talk of skiing in Utah versus Gstaad and Chamonix, diving on the Great Barrier Reef, trekking in New Zealand’s Milford Sound, the comparative virtues of Mercedes and BMWs.
It was an afternoon of well-decorated egos assembled in celebration of scientific success, of historic possibilities, and, of course, high personal rewards.
While the setting and glittering promise were very alluring, Nick could almost hear folks calculating how many millions they were about to make in the next few years. If the projection of GEM’s bean counters was accurate, the value of Nick’s own shares would top ten million dollars in two years, maybe twice that when the European markets opened up. Then there was Asia, the Middle East, and the rest of the world.
While the setting and glittering promise were very alluring, Nick could almost hear folks calculating how many millions they were about to make in the next few years. If the projection of GEM’s bean counters was accurate, the value of Nick’s own shares would top ten million dollars in two years, maybe twice that when the European markets opened up. Then there was Asia, the Middle East, and the rest of the world.
What ate at him was how all the others would react once, with the backing of Brian Rich, Paul Nadeau, and Jordan Carr, he dropped a bomb.
AFTER LUNCH, MARK THOMPSON, GEM TECH medical director, introduced Gavin Moy, reminding the audience of his humble beginnings as a medical resident who decided to start his own lab in a cramped basement behind MIT.
“What separates Gavin Moy from the rest of us mere mortals is the genius to recognize possibilities. What to a lesser man would have been merely a happy accident was to Gavin a discovery humming with neuropharmacological benefits. And he was clever enough to get patents on a whole family of base compounds from the jellyfish toxin.
“Not only did he believe in himself, but he also had the courage and tenacity to pursue a dream that led to this very room. Yes, it took years of isolation and synthesis, research and development. But over those years Gavin raised enough capital to expand his labs and to create a certain esprit de corps, a palpable feeling of shared enthusiasm that may not be found in every such scientific enterprise. That energy and sheer pride is a reflection of the man who resides at the top.”
More applause and cheers filled the air.
“It has been nearly four decades since young Gavin Moy and a couple of local grad students first fired up their Bunsen burners in that small room below Junior Dee’s Auto Parts Store. Today we are at the culmination of that determination, vision, and genius as we are about to give to the world the fruits of such great labor and science—the world’s first cure for Alzheimer’s disease, a scourge of aging humanity for generations and generations. Ladies and gentleman, I am proud to introduce Gavin Moy.”
To a thunderous standing ovation Gavin Moy rose to the podium, looking elegant in his black pinstripe suit and tanned shiny head. Nick looked around the room. Brian Rich and Paul Nadeau shared a table with Jordan Carr, who had told Nick that he had reconsidered the data and was behind him in his recommendations for an extension.
Jordan caught Nick’s eyes and nodded. And Nick felt a warm rush of gratitude.
“For the first time in history,” Moy began, “we have demonstrated a plaque eradicator in the treatment of mild to severe Alzheimer’s disease, thus representing the world’s first treatment …”
And he cited impressive statistics on patient improvement while faces glowed with wine and expectation. “In one study alone, one hundred and sixty patients with moderate to severe dementia had experienced an average of seventy percent improvement in cognitive behavior as measured by various mini-mental and higher cognitive tests …”
Bolstering Moy’s claims was a video of AD patients moving about the wards of different nursing homes looking purposeful and alert. Other patients answered the questions of interviewers. Responses were sometimes halting but focused and generally lucid. In one sequence, subjects—including Louis Martinetti—happily explained how wonderful it was to regain their memory. But what the video did not show was that Louis, home on furlough, was having continuous and traumatic flashbacks to his POW days, and yet for some mysterious reason he resisted taking medications prescribed to control those flashbacks.
The video segued into testimonials by members of the Alzheimer’s Association who had witnessed miraculous improvements. Also tearful and touching reports of nurses, home staffers, and family members who expressed profound gratitude that their loved ones were improving. Heartfelt applause followed the testimonials.
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.
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.
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.’
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.
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.
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
Moonlight Sonata
when we thought there was little left inside. This is precisely what occurs with these flashback victims.”
Moonlight Sonata
when we thought there was little left inside. This is precisely what occurs with these flashback victims.”
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. René 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
before
we submit our application. Even if it takes a year or so, it’s to everybody’s advantage to determine which
patients might be susceptible to these flashbacks. The alternative is a dangerous rush to market that is unacceptable to me.”
before
we submit our application. Even if it takes a year or so, it’s to everybody’s advantage to determine which
patients might be susceptible to these flashbacks. The alternative is a dangerous rush to market that is unacceptable to me.”
“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 them the light, then blow it out. We are simply not going to stop this train.”
“I agree,” said Jordan.
“Well, then,” Nick concluded, “I have to say that I cannot in clear conscience vote to allow this report to go to the FDA without a disclaimer statement. It’s a whitewash job that feeds false hope to sufferers and caregivers. And I refuse to contribute to the perception that we researchers are so embedded with GEM investors that we have collectively voted to look the other way.”
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