Stash (18 page)

“Not anymore they’re not. I can’t continue in the face of this evidence.”

It wouldn’t be the worst thing if Marta bowed out of the seminars, or if the series were canceled altogether. During an earlier meeting with Jennifer and Stephen, they agreed the seminars were the riskiest of the marketing practices and needed to be toned down or turned off. Brian also had issued his final recommendation
that they should begin the application process with the FDA to seek approval for Zuprone. He’d hate to reverse himself on that, even though no paperwork had been filed yet.

“Did you contact Stephen?”

“Of course I called Stephen. I left him a voice mail and he never called back. I guess your medical director doesn’t seem to think there’s an issue. Have you had other physicians reporting problems?”

“We haven’t, no problems,” Brian told her. “As a matter of fact, we have several internally published studies that show no serious side effects from using Zuprone for weight loss. And these trials are scientifically based, not just anecdotal evidence.”

“Are you doubting what I’m personally witnessing in my patients?”

“No, no I’m not doubting it,” Brian said. “I’m just letting you know we have other studies. As you’re well aware, I cannot offer them to you unless you make a request.”

“I don’t want your studies; I know exactly what they’re for. What I want is for you to issue warnings about the dangers of prescribing Zuprone for weight loss,” Everson said. “I’m treating some very sick women here.” Even in her aggressive, demanding words, the throaty undertones flourished.

“I understand you’re upset, Marta, but I think you need to put this in a broader perspective. You’re talking about a universe of twelve patients …”

“Three of whom have developed anorexic symptoms. That’s twenty-five percent.”

“… and no control group to compare them against. And you’re dosing at 120 milligrams while our studies used 100.”

“I’m giving Caladon the benefit of the doubt here. I’m giving the company a chance to correct a major problem. It’s not like
I’m bringing this up for selfish reasons—I won’t have the income from the seminars any longer. And I called you because I thought Brian Raine of all people would appreciate the gravity of this situation.”

“I do appreciate it. I’m just as concerned as you are.”

“Drug companies must be more accountable for putting people at such great risk.”

“Marta, I’m sorry, we’re not the ones prescribing the medication for off-label uses. That’s at the discretion of physicians.”

Marta snorted. “Physicians have become dependent more on drug companies than their peers for information. You know that as well as I do. What do you think those seminars are about? Physicians believe what they hear in them.”

“That sounds more like an indictment of your profession than mine.”

“I regret signing a speaking contract with Caladon. It makes me feel like I’m hawking potions in traveling carnivals.”

You’re the one who’s hungry for the stage, Brian thought.

As if on cue to Brian’s thoughts, Marta added, “I could get a lot of media attention on this, you know.”

“I would caution you against that at this point.”

“Caution me? What’s that supposed to mean?”

He had to deflect her. “You’re a highly respected physician, Marta, and you have an excellent reputation among your colleagues and in the media—and with Caladon, who pays you generously for the seminars. Bringing up a study that is not really a study at all but just the isolated experience of a few patients … Well, that could harm everyone, including you and your reputation.”

Marta paused for a few seconds, then found her voice again. “Would it harm the untold number of people out there taking Zuprone for weight loss? What about them? Are you cautioning
them as well? Would it harm Caladon? How much has Caladon profited from this off-label use of Zuprone?”

How much have you? Brian wanted to shoot back. He was getting nowhere. He’d stuck to the company line as best he could, but one of the attorneys or Stephen should be handling this. He wished he hadn’t picked up his phone without looking at caller ID. He thought it would be Gwen calling, thanking him for lunch earlier that day, whispering something in his ear, a promise for later.

“Marta, I’ll have Stephen call you back as soon as possible. He should be the one to address this with you.”

“You want to abdicate, is that what you’re saying?”

“Stephen’s our medical director. I’m not abdicating, I’m escalating.” He had to control his voice better, but Everson was getting to him now. “Can you at least give him the opportunity to speak with you before you do anything else? Don’t you think that’s the right thing to do, especially considering your own association with Caladon and in particular Zuprone?”

Reluctantly, Dr. Everson agreed.

“I’ll get in touch with him right away,” Brian said. “I’m sure you’ll hear back from him within a day.”

After getting Marta Everson off the phone, Brian called Stephen Jeffries’s office. He had moved to the New Jersey headquarters after the acquisition of Pherogenix; he also kept an office upstate and traveled often. He got Stephen’s voice mail and was routed to his assistant. When Gina answered, Brian told her he had to speak with Stephen as soon as possible.

“He’s in San Jose at Pacik Labs,” Gina said. “Do you have his new mobile number?”

“Could you give it to me?”

He wrote down the number.

“It’s noon on the West Coast, this might be a good time to catch him,” Gina said. “He’s probably on his lunch run.”

Stephen ran every day at noon, wearing a headset to take and make calls.

He answered his phone panting.

“I’m running through downtown San Jose, the fucking sky is brown from smog. Imagine what I’m embedding in my lungs now.”

“The benefits of running outweigh it,” Brian said.

“Let’s hope so. What’s on your mind?”

Brian explained his call with Marta Everson. Her alleged study of patients on Zuprone—all twelve of them. The symptoms of anorexia. Her demand that Caladon do something about it.

“Jesus, Hurricane Marta,” Stephen said. “She left me a voice mail, I didn’t pay much attention.”

“Sounds like it could be a problem.”

“It
isn’t a problem—
she’s
a fucking problem. I’ve never met anyone so desperate for publicity. We never should have hired her for the seminars. Whose decision was that, yours?”

Brian didn’t answer, and Stephen continued. “What do you think we should do?” He cleared his throat, and Brian heard a series of short gasps.

“Have you heard of anyone else reporting these side effects?” Brian asked.

“A handful of incidents, yes, but there are many causes of anorexia and someone with a weight problem is already predisposed to weight-related illnesses, including anorexia and bulimia. I don’t think it’s an issue, Brian. And I don’t think it’s related to Zuprone. Do you know how many prescriptions were written for Zuprone for weight loss last year?”

“One-point-two million,” Brian stated.

“That’s right. And next year it will be, what—double that?
Didn’t you just present some figures on that to Wilcox and Garcia?”

“Of the one-point-two million prescriptions, the majority were written in the past six months,” Brian said. “It may be too early for the problems Everson reported to start showing up in any significance.”

“Oh, shit, I think I was supposed to turn there. You think I should try to run across the freeway?”

“Everson said she might publish her findings.”

Stephen laughed. “Twelve patients? No, I can run up this ramp and avoid it. I’d never get past all those cars. Did you tell her about our own studies? You and Teresa compiled a whole library, didn’t you? That was good work, really helpful for the reps.”

“She’s seen the reps carrying them around at the seminars. She knows what they are and doesn’t want them.”

“We can get her back on our side,” Stephen said. “I know everybody is supercautious and our industry has a target on its backside for anyone with ammunition these days, but we can handle this correctly and it will blow over.”

“I told Marta you’d get in touch with her as soon as possible, within a day. I had to tell her something.”

“That’s okay, I’ll take care of it. Consider it off your plate. Shit, Brian, it’s hard to breathe out here.”

Later, getting coffee in the cafeteria, Brian saw Teresa at the vending machine. She hadn’t noticed him come in and he watched her put coins into the slot and bend to retrieve her diet soda. Here was a woman whose ass had steadily diminished over the past six months, requiring several wardrobe overhauls. Lots of new clothes on that body, each change more tailored, more fitted, than the
last. Brian noticed. Everyone had. There had been an increasing volume of banter and cracks among the guys about Teresa behind her back. That was one of them: “I’d like to get her from behind her back.”

While her body underwent rapid transformation, her demeanor held steady. Teresa had always been outgoing and chatty, friendly to everyone at the office—both women and men, no enemies. A personality that might have been a defense mechanism for an overweight woman became offense for a slimmer one. Now men interpreted her sweetness as flirting, her chitchatting as interest. Yet Brian doubted she was seeing anyone right now, and on those weekends when she went back to New Jersey she talked about visiting her parents and brother, nothing about a boyfriend.

“Hey you,” Teresa said, turning around with her can of soda. “You look a little dazed.”

“A lot going on.”

“Tell me about it. Are we still meeting later to put together the Zuprone training for the new reps?”

“I have to postpone,” Brian said.

He debated whether to tell her about his conversations with Marta Everson and Stephen Jeffries. He didn’t want to be the information source regarding serious accusations and problems about Zuprone. The upheaval in the company would be felt like an earthquake; Caladon would find itself in crisis management mode because of something Brian brought to attention.

Hopefully, Jeffries could talk Everson down from her frenzy and the situation would settle quietly.

“Have you heard any of the rumors that Zuprone can cause anorexia in those using it for weight loss?” Brian asked.

“You mean on top of the nausea, abdominal pain, diminished sex drive, and paresthesia we already know about?”

Brian smiled.

Teresa popped the tab on her can of soda. “I haven’t heard.”

She looked at him in a way he had not seen before and smiled just enough to show a hint of teeth, as if they shared a secret. He shifted his weight to his heels.

“Do I look anorexic to you?”

“I thought you might be taking it.”

“So you’ve noticed a change in me?”

“Of course.”

“I’ve seen you looking. But I don’t mind; in fact, that’s the whole idea in a way. Well, not the whole idea—I have health reasons to consider—but you know what I mean.”

Two women came into the room and Brian stepped aside so they could get at the coffee. He started walking out and Teresa kept up beside him. They went down the hall toward Brian’s office.

“I’ve lost twenty-five pounds in six months. That’s a pound a week,” Teresa said. “And I run two miles every morning before work. I think Zuprone is a miracle drug.”

“What happens when you stop taking it?”

“I’m not stopping. I’m not finished losing.”

“What if you can’t stop when you’re finished?”

“Anorexia is about having a pathological problem dealing with body image, not about taking control of your life to lose weight.”

“But the drug can change components of your physiology.”

“I’m not worried about it.”

“You don’t have any side effects?”

“I didn’t say that, but I’m not anorexic. I eat healthy, I’m losing at an aggressive but not unsafe rate.”

“Can I ask what dosage you’re taking?”

“One twenty.”

Same as what Everson prescribed her patients. “That’s what your physician prescribed?”

Teresa made a face, as if Brian had said something lame.

He decided to tell her about the call from Marta Everson and her patients on Zuprone who’d developed anorexia. After recounting the story, he registered her hesitation—Teresa didn’t know what to say.

“You know who Dr. Everson is, don’t you?”

“Who doesn’t? But I thought she was hosting some of our seminars on the West Coast.”

“She is—or was.”

“You said we contracted with her to make sure she was on board. Isn’t she like the worst possible person to be bringing this up?”

“I passed her off to Stephen Jeffries. He said he would deal with her.”

“But what do you think? Is there validity to her claims?” Teresa asked.

“I don’t know. I do think we should be running more clinical trials, whether we apply for FDA approval or not.”

The other thing Brian knew was that Stephen was right when he said pharmaceutical companies were targets for anyone or any group that had a gripe—legitimate or not. And with Zuprone, Caladon was coming awfully close to stepping into the sights of the FDA, consumer watch groups, and now even physicians. The off-label prescribing of Zuprone for weight loss was not in itself a problem, since doctors were free to use their medical judgment to prescribe any FDA drug for any indication, but Brian believed Caladon’s marketing practices for Zuprone—many of which he implemented under direction from Wilcox—to be right on the crumbly edge, although the company’s squad of lawyers rubber-stamped most activities. Such as the unpublished internal studies that the reps could let physicians know existed in case anyone wanted to request a copy. Such as dividing physicians into deciles
based on their prescription history and focusing rep visits on the top tiers that would deliver the greatest results. Or hosting consumer weight-loss blogs and websites underwritten by the company. Or bundling Zuprone with Caladon’s more mainstream drugs into the take-it-or-leave-it formularies offered to health plans. And, most of all, the “independent” educational seminars hosted by doctors paid by Caladon.

All standard pharmaceutical loophole practices, just legitimate enough to keep whistle-blowers doubtful and regulators at bay.