“I wanted to thank you,” he says. “We expect your case to be the highlight of the session. I read your report. Your results have been very encouraging.”
“They’re still preliminary.”
“As you know, we want to proceed. You’ve seen the plan. We have to move forward. I’m a little concerned that we’re falling behind schedule.”
“I’ve got a few concerns of my own,” Munin says. “There have been a few developments that weren’t in my report.”
“Side effects?”
“Not in the usual sense,” Munin says. “Adverse events.”
A side effect is common enough; predictable at times, generally explainable. An adverse event is a researcher’s term for an unexpected occurrence during a clinical trial. It isn’t an adverse reaction: that implies cause and effect. Event is less judgmental. It doesn’t assume the product is directly toxic or interacts with other drugs, is given at too high a dose, is misprescribed, misused, or abused.
There is only the Event. Like a weather anomaly — a freak storm, a hurricane or tornado. Like an accident, a mistake, a sudden death. Call it bad luck, call it a bad beat. It may be a sign of something malign, or just a coincidence. It may have no significance, statistical or otherwise. All that can be said with certainty is that it occurs. There is no question of liability. It can’t be predicted. It is never the intent. It is random, it is fate. It is part of the design of the universe.
The Singing Caballeros are line-dancing with the guests; there’s a dealer giving blackjack lessons. Crowd visibly thinning now, getting on to eleven o’clock. Pharma reps still out in force, but they’re running out of audience, tag-teaming two to a doctor now. The late hour silly with cerveza, mostly one blue-suited soul telling jokes to another with a doctor — poor sod — caught in the middle. But the sales pros can see the mark is starting to drift — eyes glazing, feet shifting, it’s all that pinstripe, some kind of moiré effect — until mumbled good nights, long day, he’ll see them at the conference tomorrow.
The late-stayers are rewarded with tequila shots and C-note Macanudos, Cuban contraband from the Winnipeg rep who smuggled in the goods in his sample case. Room emptying fast, but the salespeople will be the last to leave. All according to plan, the industry makes a point of hiring only the outgoing, glad-handers, extroverts ... it’s there in their files, securely locked away, evidence from psych tests, mostly pop versions of the Myers-Briggs or MMPI used in the interview to identify the extraverts, screen out the wallflowers. Does not enjoy solitude. Prefers to be in the company of others. Tough shank of the evening for them working a near-empty gig. Normally, they would have to return to their room, a hotel suite where the outward gaze turns uncomfortably inward. But this is Vegas: free booze, nolimit tables, lounge acts, quiet bistros, off-Strip strip joints for a little G-string action, bottomless clubs for the hip-flask crowd. In this town you don’t have to be alone, not ever.
Soren shepherds Munin through the hotel to a retro ratpack lounge, fifties-chic mahogany and leather, like something he’s seen on SVT. They sink into leather armchairs, overstuffed as an exec’s wallet. Scotches all around. A Johnny Mercer tune playing overhead gives a vibe that’s supposed to be mellow, but it isn’t working. Soren’s keyed up, inhaling a swig of single malt as if it were air. “You understand —”
“Yes —”
“That this symposium is very important to us.”
Munin’s heard the sales reps chatting it up, thick as thieves at the baccarat table, the new indication in OCD. Not officially, of course. They can’t discuss any off-label uses; it’s mostly broad hints of the backslapping variety. The rules don’t apply to Munin, the administration of a drug — how much, to whom — is left to his discretion as a clinician. “I’ve heard talk of a large trial.”
“A major study,” Soren says. “We’re planning to announce it here, maybe recruit one or two investigators.” They’re hoping for a bandwagon effect. The reps are already lobbying to get one or two docs in their territory on the short list of investigators. All of them will be there on Thursday, honorarium in breast pocket, and that’s just the beginning ... Then the follow-up visit, the letter thanking them for attending, the invitation to participate in a new study that’s in the works ...
Munin is out of the loop, but he knows the switch has been thrown, the machine has started to hum ... they’re talking dates for an investigators’ meeting to iron out the details, they’re working up a draft protocol for a phase II/III study, data analysis by Christmas. Soren’s damn determined to get this thing back on the fast track for a Q3 launch next year.
Playing with his Scotch on the rocks, making hexagonal rings of condensation on the cerise tabletop, Munin says, “It’d be better if we had more time.” The water marks resemble the phenylpiperidine structure of Soren’s product, some sort of synchronicity at play here. If Soren notices, it’s strictly subliminal.
“Your report last fall, you said you had a dozen patients lined up.”
“I haven’t updated you on the numbers,” says Munin.
They screened how many to get a mere twelve souls to enroll? Janus insisted on drug-naive subjects, so it was a tough slog. Who wasn’t on some medication nowadays? Most didn’t make it past the screening. Then they had to run the gauntlet of entry criteria — not young or old, no coexisting medical condition, willingness to be a trial subject. Six months collecting names. He started them on the target dose, the full measure right from the start. No slow titration, another Janus requirement. Time was already a factor; in an eight-week study there’s a small window to show efficacy, what the number crunchers called separation from placebo. Of course, the subjects couldn’t tolerate the high dose; the first six patients complained of side effects and dropped out of the study. They ended up dosing it the way Munin had planned all along: ten milligrams to start and doubling the dose every two to four weeks until the target was reached.
Soren knew all about it — on the job just two weeks when Grant Hublis, one of the research associates, cornered him in the cafeteria to give him the heads-up. “Dose titration? What is he, some kind of homeopath, Sor? It’ll take him what, four months to get the blood levels we need?”
“He knows his business.” Soren figured he’d cut Munin some slack. After all, he was the man in the trenches.
“His business just buggered our timeline,” said Hublis, a bit idiomatic, but Soren got the idea.
The first six dropouts were just the beginning. Two more quit after a month on study, one of the senior nurses joining the general defection. One lost to follow-up, a couple of protocol violations, skipping doses, forgot to take the drug, that sort of thing ... well, any trial can expect a few of those.
“I count eleven,” says Soren.
“Not that unusual,” Munin says.
“Eleven out of twelve?”
Always obstacles, challenges. Getting people to join. Getting people to stay. The number of subjects like so many half-lives tapering off to extinction ... Munin perhaps a little negligent in that regard; it takes the talents of a motivational speaker to keep some people on drug, and Munin was, shall we say, distracted.
Ring structure more elaborate now, Soren cold sober enough to notice that it resembles a Schedule II controlled substance. “So you’re saying?”
“Just one. One completer. She’s the case I’ll be presenting on Thursday.”
It took a year of planning: correspondence to define the objectives, work out the study protocol, inclusion/exclusion criteria, primary and secondary endpoints. Munin was to complete the pilot, and they would then proceed to phase II. Medical Affairs had budgeted a million dollars for the trial,