BLIND TRIAL Page 4

  Six

  TRUDY MAYR sucked on a Doral Ultra Lite and blew at her reflection in a mirror above the desk where she’d sat for fifteen minutes. Smoking was prohibited—this was a hotel room—but who gave a damn for one morning? In thirty minutes, she’d head out to find the troublesome Dr. Honda. Mr. Hoffman said Marcia “insisted.”

  The vaccine chief tapped ash into a saucer by her wrist, glanced at a taped-up smoke detector, and returned to a printed typescript.

  Prevention of HIV-1 infection with WernerVac

  A phase III double-blind placebo controlled trial

  Wilson et al. She knew it like her hands. The New England Journal of Medicine was pressing for delivery if they were to get it to the peer reviewers on time.

  Subjects (male n=17,254; female n=9,458) were assigned at random to receive either WernerVac 300 micrograms (n=13,308) or placebo (n=13,404) by intramuscular injection. An initial injection was boosted at six months.

  She lifted a red ballpoint and corrected the text in a painfully tiny scrawl. She struck out “assigned at random,” inserted “randomly assigned,” and set the pen down beside the saucer.

  The trial was unblinded at 102 weeks on the recommendation of an independent data safety monitoring board (DSMB) when a benchmark efficacy of >60% was demonstrated.

  She found writing so difficult. Even with her right hand. Yet her left bore the brunt of her affliction. When her left hand wasn’t shaking like a dog’s paw scratching, the thumb and index finger trembled. Her specialist in Atlanta called it a “resting tremor,” but there was hardly an hour when she wasn’t being troubled by some aspect of Parkinson’s Disease.

  That would do for now. She moved to the bed and looked at the back of her award.

  Farragut Frames

  $9.99

  Cheapskates. Every last one of them.

  The achiever’s award was a fiction. A sham. They’d printed it merely to parade her. They’d be running some scheme on the NASDAQ, no doubt. Today, they’d get the rumor going on Wall Street, most likely. On Monday they’d go short in pre-hours trading, before issuing a calming statement to the markets. “Speculation” about the vaccine was “premature,” they’d insist, and then they’d buy back their own stock.

  She turned the frame sideways and tried to prize it open but quit when her cellphone rang.

  “Ahh, Doctor Mayr, Doctor Mayr, Doctor Mayr.”

  Would Doctorjee never let that rest?

  His repetitions of her title were a childish amusement: his side of the antipathy between them. Ahead of her retirement in two weeks’ time, her office on the ninth floor of the BerneWerner Building had been stripped of seven honorary doctorates, twenty-two professional honors, the Lacey Prize for Science, and a letter from President Obama. In the Legal Department, on the sixteenth floor, the name “Gertrude Sharon Mayr” was filed on forty-one patents, including molecules, formulations, and adjuvants.

  But her best regular qualification was a master’s degree from the University of North Carolina, Chapel Hill.

  Viraj Grahacharya, MD Pune, PhD UC San Diego, never missed a chance to score that point.

  “Are you there, Doctor Mayr? You appear somewhat reticent.”

  “Good morning. And how are the stars?”

  “Most inauspicious, I’m afraid. Most inauspicious indeed. We are in need of your presence posthaste.”

  Her celestial reference was aimed at his parentage. The Grahacharyas were of an astrologer sub-caste. While Trudy’s father, John Mayr, labored as a ferryboat engineer, hauling back and forth between Bodie and Hatteras islands on North Carolina’s Outer Banks, Sandip Grahacharya gained media profile in 1969 for predicting “Mankind will never touch the Moon.”

  “What?”

  “What is we need you in the ballroom at once. Dr. Honda has already commenced.”

  “What do you mean, she’s already commenced? She’s commenced what exactly? More tomfoolery?”

  “She is, I regret to say, BerneWerner’s guest speaker at Sanomo’s sponsored session.”

  Trudy felt a surge of cortisol and epinephrine. “She’s speaking? That’s preposterous. She’s nobody.”

  “Indeed. But it transpires that your friend Hiroshi Murayama personally invited her to address the gathering on our behalf. A most extraordinary breach of protocol, I must say. I have remonstrated. But to no avail.”

  Trudy grappled with a pair of flat canvas shoes. “I’m coming right away. I’m coming.”

  SANOMO’S SESSION was in progress in the Grand Ballroom, in the basement, through a long, narrow foyer and double doors. Trudy was greeted—“Ohayou gozaimasu”—by four Japanese women in sky-blue suits staffing tables loaded with soft toys and zip drives.

  She turned right, through the doors, into a windowless gloom, and paused while her eyes became accustomed. The layout today was in schoolroom style: perhaps one hundred padded chairs at white-clothed tables facing a podium, screen, and banner. This was Saturday morning, so most chairs were empty. The banner:

  VACCINES—STEP BY STEP

  Now she spotted her nemesis, Hiroshi Murayama, seated by the doors through which she entered. He was ludicrously young to head Sanomo’s molecular biology division: late thirties, with the face of a boy. Now lit by an exit sign, he looked even younger, in a black suit, white shirt, and red tie.

  At the front of the room, a speakers’ lectern was mounted: where a slim young woman lit by a low-power bulb resembled a kid playing ghost with a flashlight. Her neck, chin, and cheeks glowed bright in the darkened room, but her head appeared to have no top. A young Japanese woman with an American accent. That must be Dr. Honda.

  That was her.

  Trudy scurried to a chair—her flat shoes flapping on a jazzy mauve carpet—in a row behind Marcia’s entourage. A position had been reserved toward the front for the CEO, with company people strung to her left. Across an aisle sat Mr. Louviere, the young lawyer from marketing who’d reported Dr. Honda’s concerns.

  A keyboard in the lectern punched an image to the screen—a trio of green-on-yellow bullet points.

  * Partially effective vaccine soon may save more lives than superior product later

  * Factors for impact include duration of immunity & potential adverse events

  * Expectations of efficacy may increase risk-taking behavior

  Trudy relaxed. This looked safe enough: from marketing’s The Road to a Vaccine. If the speaker followed the script, she would start the next segment with, “Volunteers may need reassurance.”

  Dr. Honda raised an arm and shot a pointer at the screen, sending a red dot dancing across the bullets. Pencil-thin microphones attached to the lectern caught the jingle of bangles on her wrist.

  Marcia twisted and whispered across the table to Trudy, “Now you have bumped into her, haven’t you?”

  “Volunteers may need reassurance.”

  “For goodness sake, I didn’t know she was speaking. Why’s she speaking? What on earth’s going on?”

  The bangles jingled to herald the next slide. The microphones caught a click from the pointer. If Dr. Honda followed the script, the screen would turn blue with a survey of sexual behaviors.

  The screen turned white. The ballroom lightened. The slide was a tabulation, with black lettering. This wasn’t from marketing, or anywhere in the company. The CEO’s row leaned forward as one.

  “Maximizing volunteer retention can be a critical challenge for clinicians. As this slide illustrates here.”

  The red dot danced over columns of trial data. “Our clinic at San Francisco randomized 1,603 subjects, which is the largest recruitment of any of the ninety-five participating centers. But our retention figures weren’t so impressive. Which shows how there can be a variation in response to messaging.”

  Trudy’s mouth gaped. What right had this woman to say anything at all? She wasn’t even one of the authors.

  “Overall, trial centers are to be congratulated
for maintaining an excellent relationship with the real stars of this research, the volunteers.” The bangles jingled. “Which illustrates how different approaches by clinical staff can yield a variety of outcomes.”

  From the end of Marcia’s row came a bang and a grunt. Frank Wilson pulled an arm off his wheelchair.

  Seven

  A SOUTHEAST wind blew up during the night, bringing a welcome freshness to the capital. Atop the summer-scorched hill on the National Mall, the fifty Stars and Stripes circling the Washington Monument crackled like Samurai banners. Steel cables rattled on aluminum flagstaffs. Tap-tap, zing-zing-zing.

  Sumiko squatted and smoothed a red-and-yellow beach towel on a slope facing the Lincoln Memorial. She’d made up her mind: they would come to her—at a location of her choice, not theirs. She didn’t want to look like a snitch telling tales, or, worse, come over as obsessed.

  Ben called after breakfast to say he’d fixed a meeting, and she’d tried to give the impression of not caring. But now, as she saw them approaching in the distance, she felt energized in more ways than one. She felt angry and hopeful; implacable and reasonable; suspicious and desiring. Conflicted.

  She watched them climb from Constitution Avenue: Dr. Gertrude Mayr, leaning forward, arms trailing, as if battling a ferocious gale; Ben Louviere, glancing sideways, looking ready to leap and catch her if she stumbled on a patch of rough grass.

  Sumiko dug her fingers into a Macy’s paper shopping bag and pulled out a tube of Factor 30. She shrugged-off a red-check halter neck blouse—revealing a purple animal print bikini underneath—tugged up a black leather belted miniskirt and massaged the fruity sunscreen into her skin. Then she lowered a pair of Ray Bans from a red silk headband and sank back to face a hazy sky.

  “Dr. Honda, I presume.” The voice from the Montreal Room. He stood close enough to feel his shadow.

  Her eyelids opened to a pair of hairy legs rising into baggy blue surf shorts. Trudy Mayr stood beside them in white bowling shoes, a crumpled beige dress, and straw hat.

  “Good to meet you Dr. Honda.” The vaccine chief maneuvered herself onto hands and knees, then winced as she dropped beside the towel. “Mr. Louviere here’s told me all about your good work for us. Nice for us to get a chance to talk.”

  Sumiko pivoted and re-shouldered her blouse as a Boeing 737 sloped toward National airport. Ben sank cross-legged, knees pointing in her direction. Without shades, his blue eyes assumed a squint.

  Trudy Mayr removed the hat. “Get right to the point here, why don’t we? Ben here says you feel Frank’s been, maybe in some way, shall we say, less than a hundred percent professional.”

  “Less than professional? A hundred percent less than ethical. Dr. Mayr, the place is a shambles.”

  “‘Trudy’s’ fine.”

  Ben rubbed his fingers around his cruciate ligaments. “Guess it’s tough for the guy, what with his wheelchair and everything.”

  “That’s right.” Trudy Mayr flapped the hat. “Had things tough since his accident, you know. But he’s got a solid reputation. Three hundred-fifty peer reviewed papers and book chapters. And the trial data’s come through to us in very acceptable form.”

  “Oh, his accident, his accident. That was years ago. Years. Millions of people use wheelchairs and they don’t behave the way he does. And, of course, the data look acceptable. He goes in and changes them. That’s why.”

  The hat stopped flapping. “Well, those hints you were dropping this morning. If that’s what you’re getting at, they don’t mean a wet wind in April. When you drill down to individual sites, you do get these anomalies. Other studies have worse, believe me.”

  “Wilson’s the anomaly.”

  “You know, maybe what it sounds to me here is it’s a personality-clash type of thing you got going. Plain don’t get along with the fella. Personal chemistry. I can understand that. Lot of folks don’t get along with me.”

  Sumiko eyed Ben, who’d rolled onto his back and lay with his hands behind his head. He’d spread his legs wide—left knee to the sky; right knee pointing her way—in a V. Above his shorts, he wore a crew-necked white cotton T-shirt, lettered across the chest: DePaul & Furbeck. Between the shorts and the shirt, she saw a gap of hairy skin. His left knee rocked back and forth.

  “Did Ben tell you the things he says?”

  “Sure. Frank can be mean, I’ll give you that.”

  “And that doesn’t trouble you?”

  “Of course it troubles me. Been troubling me for years.”

  “You know what he said to a Latina volunteer? He was actually in reception, right in front of Ardelia? Do you?”

  “I’ve been a little busy.”

  “He said… And Ardelia heard this too. She’ll tell you. He said to the volunteer, ‘See you in three months, if you haven’t been deported.’”

  “Good grief. And you heard that?”

  “‘See you in three months, if you haven’t been deported.’”

  “Well then, I can see there would be a personality clash. Yes, that’s awful.”

  “Dr. Mayr, one thing this is not is a personality clash. It’s a professional concern, I assure you. He told Pearl Aderonke—she’s one of our research nurses—about an IV drug user, right there in the room. Now let me get this right for you. He said to Pearl, ‘Can you take her bloods, if she’s got any left?’ Right there in the room she was.”

  “An IV drug user?”

  “And African American.”

  “Did the volunteer say anything?”

  “She did. She said, ‘Screw you asshole’ and walked out the center. Took us two emails and a phone call from me to persuade her to come back.”

  “Awful. All this may well be medical board material, I can see that. And you need to write a report for our HR folks, if you would. But we have other things to think about right now, you know.”

  “He comes in late, leaves volunteers getting mad in the waiting area. You should hear it from my room. If he doesn’t approve of clinical data, he changes them. Everyone knows that. Never bothers checking on why clients don’t come back. This isn’t all in my head.”

  Dr. Mayr shook a solitary Doral from her purse and made repeated feeble efforts to light it. She tore three cardboard matches before Ben sat up to help, now exposing the back of his shirt. It was printed between his scapulae “The Law in the Loop.” Cotton strained on the trapezius of a pony.

  Sumiko had known it was pointless complaining. The company was sure to close ranks. “And of course, with all those lost to follow-ups, the trial’s efficacy data may be compromised.”

  “Compromised?” The vaccine chief sighed and looked to the sky. “Dr. Honda, the trial’s randomized. How could Frank’s interpersonal conduct compromise the data?”

  “We don’t know, do we?”

  “Nonsense. How? It’s double blind. He doesn’t know, and they don’t know, who’s getting placebo. At least he can’t discriminate over that.”

  Sumiko had expected a wall of denial. “For one thing, if he’s insulting differentially some certain kinds of volunteers and not others, that would make his consultations an uncontrolled variable, wouldn’t it?”

  “Excuse me?”

  “It’s true. Given the very small numbers of seroconversions from which our efficacy figures are actually derived, he might have preferentially driven away volunteers with particular characteristics.”

  “Absurd.”

  “More prone to at-risk behavior, for instance. And that might actually slant the efficacy data to appear more favorable to the vaccine.”

  Trudy Mayr sighed again, and recommenced flapping. “That would be vanishingly improbable. And have you ever heard of a trial controlling for the offensiveness of clinicians? It’s simply not credible. How would you do it? If what you say’s right, his behavior’s appalling, I agree. But it can’t affect our results.”

  “It is right. And those two deaths as well should have been identi
fied properly and recorded in the appropriate manner. The protocol states clearly that all events…”

  “Damn it Sumiko, I wrote the protocol. People do die on trials, you know. They drown, they get heart disease, they get burnt up in hijacks. They just die. Perhaps they died after we locked the data.”

  “They didn’t.”

  “Well, you know they don’t make a spit in a twister’s difference. You’re not saying they were anything to do with the vaccine? You’ve not joined the QAnon crazies?”

  “Of course not.”

  “Well then.”

  Ben sank back and lay silent on the grass. Back and forth went his knee. Back and forth, showing skin. Left knee to the sky; right knee pointing her way. Black hair below his navel. Back and forth.

  She watched him through the Ray Bans, while not being seen watching. How much would she have wished to lie beside him? What would Wilson matter, or a few lost to follow-ups, against a sunny afternoon in this man’s arms? “With respect, Dr. Mayr, Trudy, we have no protection against the potential impact of his behavior. We simply don’t know, do we?”

  “For goodness sake, we’ve got nearly twenty-seven thousand subjects.”

  “So? From how many of those is the vaccine’s efficacy actually derived? Only the seroconversions.”

  “Alright, I’m hearing what you say. And I’m taking it seriously.” Cigarette smoke gusted in the breeze. “I’ll speak with Frank, Monday. I’ll call him at the center and see what he’s got to say about all this. But you must understand, all big trials have their ups and downs.”

  “A chimpanzee could run it better than him.”

  The knee rocked back and forth.

  Dr. Mayr plucked at a ribbon around the hat. “What I’m suggesting is you recognize that fretting about Frank’s personality and trying to second guess data on the basis of vanishingly improbable speculations isn’t how you run a clinical trial.”

  “I think what I’m saying may be relevant.”

  “Then you should have raised your concerns months ago, if you had to. Of course, we’ll look into what you’re saying. Give us a report. That’ll help us mightily. We can learn from this. You’ve done us a service.”