“Ah … yes … hi,” Brian said, quickly regaining his composure. “It’s Brian.”
“Art. Art Weber.”
His pronunciation of the w was a cross between w and v.
“I know,” Brian replied. “I just finished watching you on the Vasclear video.”
“And what was your impression?”
“Excellent. Just great. If Vasclear performs the way you say, cardiac medicine as we know it is about to change forever.”
“There is no if.”
Brian stepped out of the med room and closed the door behind him.
“Well, Mrs. Nellie Hennessey is certainly testimony to that,” Brian said cheerfully, trying to deflect some of the man’s intensity. “I assisted at her cath this morning.”
“Carolyn told me what you did today.”
“I was lucky. The catheter fragment was in just the perfect position for the BIPAL forceps.”
“No, I mean sending in a defective-product report to the FDA.”
Brian groaned silently.
“I understand now that my doing so went against institute policy. I told Dr. Jessup it wouldn’t happen again.”
“Good. The same goes for Vasclear. We have encountered no significant problems, but if any do arise with any aspect of our program, I would expect you to report it to Dr. Jessup.”
“No problem there.”
“That includes our patients and our research animals.”
Earl. Brian quickly decided not to pick up the gauntlet. The animal keeper clearly wasn’t bluffing about having connections in high places.
“I understand completely,” Brian said.
He sensed the moment he had been waiting for was at hand.
“Excellent,” Weber said. “Excellent. We’re getting closer and closer to being allowed by our statisticians to break the code of our double-blind study. From that point, we hope it will only be a short while before the FDA approves Vasclear for general sale.”
“That would be wonderful.”
“Yes, it would. And needless to say, to get a bureaucracy like the FDA to shortcut their prolonged evaluation process requires impeccable data and an impressive, irrefutable risk-benefit ratio.”
“Which you have.”
“Which we have,” Weber echoed. “So, from now on, all reports of any problems go through us, yes?”
“Yes,” Brian said, forcing himself to maintain eye contact.
“Now, I understand from Carolyn that you have expressed the desire to have your father included in the Vasclear study.”
“Yes.”
“She has gone over his history with me, including her recommendation that he undergo repeat bypass surgery.”
“He had a terrible time with the first procedure. He’s willing to endure almost anything not to have another.”
“Well, he may want to reconsider, Brian. I felt deeply sorry for your father and his problem, and I did all that I could. I asked the statistician in charge of our double-blind study to randomize him into it, and this is the result.”
He reached into his jacket pocket and extracted a small card, about three-by-five. Computer-printed on the card were Jack’s name, birth date, sex, cardiologist’s name, and a number, seven, reflecting the severity of his coronary disease. Below that information, in capital letters, was a single word: ALPHA.
Alpha. Almost certainly the placebo group. Brian felt himself sag.
“There’s no way he can be put into the beta group?” he asked.
Weber shook his head.
“I’m afraid not,” he said. “I know it sounds absurd, but until we are statistically allowed to break the code identifying the doses received by alpha, beta, and gamma patients, we must behave as if we don’t yet know which of the groups is which. At this point, with our results so striking, it seems like a charade. But we just don’t have a large enough number of patients in our three groups to terminate our study unless we get FDA approval.”
“Do you have any idea how long it will be before you break the code?”
“Soon. Maybe just a couple of weeks. The FDA is sending one of their people up to meet with me, Dr. Jessup, and our statisticians.”
“Is there any sense in Jack participating in the study even in the alpha group? I mean, will that help your statistics?”
“The truth is, probably not. By the time his addition would matter, the study should be over. My suggestion is that you follow Dr. Jessup’s recommendation and get your father in for surgery.” Weber read Brian’s disappointment and added, “I’m sorry. I truly am.”
“Thanks,” Brian said.
But the Vasclear project director had already turned and started off. Brian glanced back at the refrigerator, then checked the time and hurried to the phone in the dictation carrel. He had five minutes before the next wave of Vasclear patients, and he wanted to talk with Freeman Sharpe.
It took five rings before Sharpe came on the line. As always, his smooth baritone had an immediate calming effect.
“Freeman, it’s Brian.”
“Hey, my man. Is there a doctor in the house?”
“Oh, yes. The doctor is in. Got a minute?”
“You taking care of yourself?”
“Of course.”
“Then I got a minute.”
“They admitted Jack into the Vasclear study, Freeman, but he got randomized into the group I’m sure is getting the placebo.”
“Too bad. Any chance they’ll just change their minds and put him on the good stuff?”
“I don’t think so, no. They want Jack to have the repeat bypass.”
“And you think he should get the drug.”
“This morning I helped do a cath study on a woman who’s about five years older than Jack. She had coronary disease at least as bad as his, even though she never had a heart attack or bypass. She got randomized into the maximum-dose group, and now she’s got arteries like a forty-year-old, and no symptoms.”
Sharpe whistled softly.
“So we’re thinking about what, stealing the drug?”
“I can’t get it any other way.”
“Can you get enough of it?”
“For two weeks, three at the very outside. But that may be all I need. I think the FDA’s going to approve the drug soon. If it works on him even slowly, Jack could probably make it.”
“If it doesn’t?”
“According to the results they’ve gotten so far, he’s got a seventy-five percent chance that it will. He likes those odds. So do I.”
“You can do this without getting caught?”
“Probably.”
“And without hurting anyone?”
“I think so.”
“This is an old tape for you, I’m sure you know, rippin’ off drugs from the hospital. Can you keep from dancing to it?”
“With your help.”
“God’s help, my man. Asking me is smart, but you’d best have a quiet chat with your higher power, too.”
“I’ll do that. Thanks, Freeman. You take care, now.”
“You know what you’re going to do?” Sharpe asked.
“I know,” Brian replied.
Brian set the Receiver down and made his way back to the med room. It took only a couple of minutes to empty two beta Vasclear vials into 10-cc syringes, make tiny marks on the vials, and refill them with saline. He then tucked the filled syringes into his clinic coat pocket and headed back to see more patients. An hour later, having put the syringes and an IV infusion set into his briefcase, he called home.
“Jack, how’re you holding up?”
“Same old, same old.”
“Well, I’ve got good news. You’re going to start on high-dose Vasclear tonight.”
“Hey, great. Dr. Jessup did that?”
“No. Another doctor. Actually, you’ve got to promise not to say anything to Dr. Jessup about it.”
There was a prolonged pause.
“Whatever you say,” Jack said finally.
“Perfect.
I’ll be home in a couple of hours. And Jack?”
“Yes?”
“I owe you ten bucks.”
“For what?”
“I had a save today—two of them, actually.”
CHAPTER THIRTEEN
BRIAN ADJUSTED THE MAKESHIFT IV POLE NEXT TO Jack’s chair, took a syringe full of Vasclear, and shot it into a 250-cc bag of dextrose and water.
“Ready for another jolt of joy juice?” he asked.
Jack laughed sardonically.
“Some joy juice,” he said. “It’s not working, is it?”
“Hey, come on, Pop. At this point we shouldn’t be forming any conclusions at all. Just don’t get discouraged. You’ve only had six treatments. From what I’ve been able to learn, with most people, it’s taken quite a bit longer than that for their symptoms to begin to improve. In fact, some people have continued to have symptoms for months even though their stress tests have returned almost to normal.”
“Eight to five says I’m not going to make it.”
“Dammit, Jack, stop talking like that. Your attitude has a lot to do with whether you make it or not.”
“I’m tired, Brian. I’m tired of being sick.”
“One more week, Coach. One more week and I’ll bet you see definite improvement.”
“And if I don’t?”
“If you don’t, we go see Randa.” Seeing the bleak look on Jack’s face, he added, “But I think this week it’s going to start working.”
For the past week, Brian had encountered no difficulties in manipulating the reserve supply of beta Vasclear in the clinic refrigerator. In addition, he had exchanged saline for Vasclear once with each of two patients. Both were well into their second year of treatment. It seemed impossible that there could have been any harm done to either of them. Still, doing such a thing at all went against every instinct.
He held on to the hope that if he could just buy a little time, the need for deception would soon be over. At noon tomorrow, White Memorial grand rounds was scheduled to be a Vasclear presentation by Art Weber and others, coupled with a response from a representative of the FDA. Brian anticipated getting some indication as to how soon Jack might legitimately go on full-dose Vasclear, provided, of course, the current treatment showed promise.
At work, his tumultuous first two days had mellowed into a comfortable, if busy, routine. He enjoyed managing the clinical ward and was regaining confidence in himself as a doctor with each new patient workup he completed and each crisis he dealt with. Phil Gianatasio was a huge help, and always seemed to show up just as a situation was getting tense. He was a bear of a worker, and had a tremendous attitude that included seeing the humor in almost any circumstance. He was also as cool and unflappable in a crunch as anyone Brian had ever worked with.
“Jack, any pain where that stuff is running in?”
“Nope.”
Brian checked his father’s blood pressure, which remained on the low side, and his pulse, which was fine. He had placed a thin catheter in a vein in Jack’s forearm, capped it, and kept it open with anticoagulant between treatments. Although Jack kept maintaining he was feeling no better, Brian did notice that he might be using fewer nitroglycerins. In addition, he had gone out in the yard once with his granddaughters and once on his own.
Although these were encouraging signs, Brian knew that he should not make too much of them. Part of the problem with clinical medication research was the well-documented placebo effect. The more that patients, their loved ones, and treaters wanted a given therapy to work, the more the subject’s symptoms suggested that it was working—at least up to a point.
Brian longed to discuss his father’s case with Carolyn Jessup—to check on whether Jack’s response to the drug was similar to that of other patients. But disclosing to her that he was stealing beta Vasclear would teleport him immediately back to No Job, No License-land. So, in terms of experience with the drug, he would simply have to fly blind. Soon, he kept telling himself. Soon, either through improvement in Jack’s symptoms and the legalization of Vasclear, or through surgery, the secrets would end. Soon.
As good as the past week at the hospital had been, there was one unpleasant encounter. Brian had just set his tray on the conveyor belt to the dishwasher when he noticed Laj Randa approaching him, followed by his omnipresent pair of sycophant fellows. His turban this day was red, a color that seemed only to enhance his warrior’s visage.
“So, Holbrook, how is it with your father?” he asked.
“He’s home resting.”
“I know that. Was he put in the Vasclear study?”
“No,” Brian said, “but I’m hoping the drug will become generally available before too long.”
“Answer me something, Holbrook. Why do you think Weber and his drug company are pushing and lobbying so hard to speed this product into the marketplace?”
“I don’t know. Money?”
“No, not just money, my friend, a vast amount of money. A single dose of this medication is going to cost over one hundred dollars. That is one thousand dollars for the first two weeks per patient. A hundred thousand patients, a hundred million dollars. In two weeks. And a hundred thousand doesn’t begin to touch the numbers who will be taking this drug inside of just a few months.”
“So?”
“In their zeal to cash in on their product, Newbury Pharmaceuticals is making an all-out push to circumvent standard scientific practices. A limited double-blind study with no crossover at midpoint and no multi-institutional component. That’s all they have. There is always something wrong with cutting corners like that, Holbrook. Always. You took biostatistics in medical school. You know that there is a reason that a study is not statistically valid until n in the equations—number of cases—has exceeded a certain minimum.”
“Their results are very impressive.”
“Their results are meaningless until the appropriate mathematics say otherwise.”
Randa’s voice was raised now, enough to attract the attention of those around them.
“Dr. Randa,” Brian replied, “my father was in the hospital for nearly eight weeks after his last bypass. He was more dead than alive. And you know the numbers for repeat surgery as well as I do. The second time is more than twice as risky.”
“Not in my hands.”
“Tell me something,” Brian ventured. “Does your bias against Newbury Pharmaceuticals and their drug and their methods have anything to do with how much Vasclear will shift the treatment of coronary artery disease away from surgery?”
The Sikh looked at him disdainfully.
“You’re a fool, Holbrook,” he said. “Your father needs surgery. He’s not getting the operation he requires because of all the hype that has been generated over this drug. Until the scientific community gives the medication its blessing, it is only so much snake oil. You are making a mistake to wait for it to become available for him.”
Without waiting for a reply, he stalked away.
The Hippocrates Dome was perched atop the five-story Pinkham Building at White Memorial. It was an amphitheater, built on the site where one of the first operations was performed under general anesthesia, and had quickly become known as the Hippodome. The four hundred sharply banked seats, still wooden with peeling veneer, were set beneath a striking stained-glass canopy consisting of scenes depicting various significant moments in medical history. After more than a hundred years, the dome was being refurbished, with scaffolding inside and out and a huge crane hovering above it like a giant mantis.
At twenty of twelve, when Brian arrived on the sun-splashed terrace just outside Pinkham 1, Phil was waiting for him with two cups of coffee.
“Still black with an ice cube?”
“Absolutely.”
It was coffee resident-style, designed to be gulped on the way from one patient to another.
“I … um … didn’t think you’d want a cruller, so I didn’t get you one.”
“Good move,” Brian said, “as long as y
ou didn’t get me one before you decided I wouldn’t want it.”
“M’lord, thou cuttest me to the quick, wherever that is.”
“So, what’s your take on this dog and pony show?”
“I don’t know. A representative from the FDA appearing on the stage alongside Ernie Pickard and Art Weber has got to be good news for the ‘V’ team.”
“I certainly hope so. It’d be good news for my dad, too.”
“How’s he doing?”
Brian hesitated, uncomfortable at withholding the real story from an old friend. But in the end, it just wasn’t worth putting Phil on the spot by telling him Jack was secretly on beta Vasclear.
“The truth is,” Brian said, “he’s not doing that great.”
“Surgery?”
“The last time I mentioned it, he didn’t refuse outright the way he usually does. I guess it depends on whether we get any indication today of when the FDA intends to move on Vasclear. Tell me something, Phil. In your experience, how long has it taken for beta Vasclear patients to start showing an improvement in their symptoms?”
“It varies. Some just a couple of days. Most within two weeks. Some a couple of months. But remember, a quarter of the cases don’t get better at all. Most of those treatment failures have ended up in the OR. A few of them have ended up in the morgue.”
Brian nodded. Phil knew as well as he did that except for simple treatments like penicillin for strep throat, almost no medication could boast that sort of success rate. Certainly no cardiac med. Brian checked his watch.
“Let’s head up there, okay? I want to get good seats for this one.”
A crowd was milling in front of the two Pinkham elevators. Protesting nearly every step of the way, Phil followed Brian up the stairs. The seats in the Hippodome were already half-occupied, and the rest were filling rapidly. Brian wasn’t the least surprised. Vasclear coverage was now appearing in the Star and the National Enquirer, as well as on various evening newscasts. The drug was becoming a national celebrity.
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