“Why not? We’ve got two hundred cases with virtually no problems from therapeutic doses of the drug, one hundred and fifty of whom have been cured of a lethal disease. You’ve seen the patients. You’ve seen their results. And you heard Jodie Foster, M.D., up on the stage in the Hippodome saying how anxious the FDA was to get something, anything on Vasclear before it was released.”
“I don’t know, Phil.”
“Brian, I promise you. If we report these cases to anyone other than Jessup, Pickard, and Weber, and we get caught, or even if we go poking around and they get wind of it, we are finished. Here, there, and everywhere. Finished.”
Brian was still uncomfortable with letting the possibility of an unknown drug-toxicity just slip away. But everything—absolutely everything—Phil was saying made sense. Every single drug on the market had toxicities—many of them lethal. Risk-benefit ratio was the very backbone of clinical pharmacology.
Fatal aplastic anemia has been reported in less than one percent of patients taking drug A.… Hepatitis has occurred as a complication of therapy with drug B, liver-function tests should be monitored frequently throughout the course of therapy.… Cases of irreversible hearing impairment have been reported.… Drowsiness … Fever … Renal shutdown … Blindness … Convulsions … Encephalitis … Paralysis … Sudden death. The list of warnings and adverse reactions to FDA-approved medications filled much if not most of the three thousand or so pages in the Physicians’ Desk Reference.
So what if a small percentage of patients who received Vasclear developed a serious complication?
Risk-benefit ratio? No contest.
This was a case of miracle cure versus a couple of old men with commonplace symptoms that might or might not have had an uncommon cause. And, Brian reminded himself, Ford and Elovitz had received their Vasclear before the chemical-synthesis process had been modified. For the past two years, there had been no problems with Vasclear—none at all.
But still, he wanted to know more. He had chosen Vasclear as the linchpin of his father’s therapy, and now his father was dead. He needed to find out all he could about the drug. But at what cost?
“Look, Phil,” he said. “Supposing we poke around very quietly and see what we can learn about both Ford and Elovitz. If we don’t come up with anything more, we’ll just keep our mouths shut and let the chips fall where they may.”
“I don’t like it.”
“All right, all right. How about you just call up your man’s record and see if he had an elevated eo count? That can’t possibly hurt.”
Almost all White Memorial charts had been scanned into the record-room computers. Phil shrugged, turned to his terminal, and logged in. Brian came around the desk and stood behind his chair. It took less than a minute for the record to be electronically retrieved.
Two and a half years ago, when he was first seen at Boston Heart, Kenneth Ford was a sixty-nine-year-old black divorced laborer from the Dorchester section of the city. He was referred to one of the staff cardiologists for evaluation of chest pain, found to have moderately advanced coronary artery disease, and started on Vasclear as part of the Phase One study. He showed excellent early response to his treatment, but then began to experience increasing chest pain, shortness of breath, and ankle swelling.
They scanned the visits to doctors and to the Vasclear clinic.
“There,” Phil said, pointing at the screen. “There’s my dictation.”
Brian scanned the two pages, which were a near double for the ones he had done on Elovitz.
“There’s your plan,” he said. “Chest X ray, EKG, cardiac ultrasound, chems, CBC. Nice going. Find the CBC.”
Phil scrolled through the rest of the chart. There were plenty of lab tests, including some complete blood counts, but none at or after the date on which he had seen Kenneth Ford.
“Strange,” he said.
He returned to the clinic notes. Ford was seen one more time, by a resident who either had not reviewed the chart or hadn’t bothered to write down a summary of the case. There was no mention of Phil’s extensive note nor of the recent lab work. Congestive heart failure, the resident concluded, making what was obviously a rubber-stamp diagnosis. Cause: arteriosclerotic cardiovascular disease.
Phil scrolled through the rest of the record and stopped at a letter written four months after he had seen Kenneth Ford in the Vasclear clinic. The letter was from a general practitioner in Dorchester to the cardiologist to whom Ford had been initially referred, sadly informing the specialist of the death of Mr. Kenneth Ford at Boston City Hospital. The cause of death was pulmonary edema—overwhelming congestive heart failure—secondary to arteriosclerotic cardiovascular disease.
“Damn, but I wish I knew if he had an elevated eo count or not,” Brian said.
“What difference does it make? That test’s totally nonspecific.”
“Come on, Phil. You know as well as I do that the test is abnormal in allergic reactions and normal in most cardiac conditions. It’s certainly not something you’d expect to find in run-of-the-mill congestive failure from arteriosclerosis.”
“I’m telling you, Brian, let it drop.”
Brian snatched up the phone and tried calling the record room at Boston City Hospital. As he had expected, there was no way anyone would speak with him without a signed release from Kenneth Ford or his legal representative.
“Damn,” he murmured, setting the receiver down. “Phil, any thoughts as to why the CBC you ordered isn’t in Ford’s chart?”
“None.”
“Do you, um, think you might call the hematology lab and see if they can come up with it?”
“Brian, you’re fucking around with our future, here. And for what?”
“I don’t know, Phil. I don’t know for what. Why is that test missing?”
Phil called the heme lab. No CBC on Kenneth Ford after Phil had seen him in the clinic.
“Shit,” he whispered. “Brian, I don’t know what in the hell is going on, but I think you’re blowing this whole thing way out of proportion. People with heart disease have congestive failure all the time. Lab reports don’t make it into charts every day. Patients are always having unexplained elevations in their eosinophil count from nothing more malevolent than a virus. And we are getting in over our heads.”
“I’m sorry,” Brian said, settling himself down with a bite of his machine-canteen pastry.
“Thanks, pal. Look, I don’t know the reason you’re acting like a terrier on a rat about all this. Maybe you’re just angrier than you realize at Vasclear because it didn’t work for your father. But I do know that you’re overthinking this whole business. Overanalyzing it.”
“Maybe.”
“Well, thank you, Jesus, for that ‘maybe.’ My pulse rate is beginning to recede.”
“So, what are we going to do?”
“Do? Why, nothing, Bri. That’s the point. We have nothing, we do nothing.”
“Maybe.”
“Amen to another ‘maybe’ from the lad. Please, let’s call it a day. My conscience is clear. Your conscience is clear. And we’re both still employed.”
“What do you want to bet Kenneth Ford had an eo count above ten percent?”
Gianatasio’s expression became an awkward, flushed mix of fear and anger.
“Enough, Brian, please,” he said. “I’m telling you, these are not people you want to cross—especially when you have absolutely nothing to gain.”
“How are they going to find out if I go over to Boston City and try to get hold of Ford’s labwork?”
“I don’t know. How did I hear from someone who heard from someone else that you nearly had a fistfight with that drunken cretin who runs the animal room?”
Brian stared at him.
“What? What did I say?” Phil asked.
“The animal room! Phil, the fight I got into with that jerk Earl was over a monkey—a chimp that I thought had massive fluid retention and some degree of pulmonary edema. I wanted to know what e
xperimental study he was part of, and that doofus nearly tore my head off.”
“Oh, come on. Don’t add a fucking monkey to the conspiracy theory.”
Brian fished a paper out of his wallet.
“Four-three-eight-six,” he said. “That’s the chimp’s number. Wanna really make yourself some money? I’m going to make it a three-horse parlay. If any one horse loses, they all lose.”
“I don’t get it.”
“First, Kenneth Ford’s going to have elevated eos. Second, monkey number four-three-eight-six is going to turn out to be part of the early Vasclear studies. And third, he’s got some monkey version of pulmonary hypertension.”
“If you decide to go after this,” Phil said, “just do me one favor.”
“Namely?”
“Save me a luxury low-mileage sedan, and don’t bother with the insurance waiver.”
CHAPTER TWENTY-TWO
WhiteLink Intrahospital Memo
From: Thomas Dubanowski, Chief, White Memorial Security
To: All White Memorial Faculty and Personnel
October 14
We have been informed by hospital administration that the President of the United States will be at White Memorial Hospital on Friday October 18 or Saturday October 19 to preside over a ceremony, which will be held in the Hippocrates Dome. Also present that day will be Dr. Alexander Baird, commissioner of the Food and Drug Administration, and Senator Walter Louderman. Because of limited seating, admission to the Dome will be by guest list only.
Security around the Pinkham Building will be tight. Only those with essential patient-care tasks will be permitted in the building. Those who do not receive a formal invitation to the ceremony from White Memorial administration, Boston Heart Institute, or Newbury Pharmaceuticals, may have the chance to meet the President in the hospital cafeteria.
Details of the President’s trip to Boston have not yet been made public, nor has the exact date and time of the ceremony at White Memorial. Thank you in advance for tolerating any inconvenience our increased security and crowd-control measures may cause you. Any questions may be directed to this office.
BRIAN SIGNED OUT AT FOUR O’CLOCK, CLAIMING EXHAUSTION and a headache, and battled rush-hour traffic through the Callahan Tunnel to Logan Airport. Teri was waiting for him in one corner of a small bar in the B terminal.
It had been less than twelve hours since they had last made love. But sitting there in her business suit and glasses, hair up, briefcase open, reading a document, she looked light-years from the woman who had straddled him in his bed, crying out softly as she had first one, then another orgasm.
For a few moments, he paused by the doorway of the bar, watching her, aware of the bewildering, paradoxical feelings of connection and detachment, of intimacy and distance. He had touched every millimeter of her body, shared incomparable feelings with her. Yet he did not even know what her apartment looked like. Was this the beginning for them? Were they destined to become the love of one another’s lives?
Thank God it’s a day at a time, he was thinking. Otherwise the twists and turns would simply be too tight to negotiate.
For Brian, the Vasclear situation was still very much up in the air. But Phil had placed himself unambiguously on the sidelines. The two of them had spoken by phone a few hours after their meeting in his office. Brian had made the call.
“Phil,” he said, “I just wanted you to know that I haven’t gone racing off half-cocked about this Vasclear thing. And I wanted to tell you how much I appreciated your trusting me and my judgment by sharing what you knew with me the way you did.”
“I’m glad you called to tell me that. The truth is, I’ve been nervous since we spoke, thinking that if I had just kept my mouth shut about the Ford case, you wouldn’t be in danger of upsetting the applecart around here and getting yourself canned. I really do enjoy having you around, pal.”
“Thanks. Believe me, I’m in no mood to be back working behind the counter of Speedy Rent-A-Car, either. But Phil, you shouldn’t feel any responsibility for me no matter what happens. I’ll admit I’m curious about these little chinks in the Vasclear armor, but I assure you I am not about to self-destruct over them. So, stop worrying about me.”
“Okay. Presto change-o. I’m not worried about you.”
“I’m serious. I mean, what do we know, anyway? There were how many cases that received Vasclear during Phase One trials, do you suppose?”
“I’m not certain, but I think I once heard eighteen humans plus the usual array of four-legged subjects.”
“Okay, eighteen. Two out of eighteen may or may not have developed PH. One of those maybes had a single elevated eosinophil count. That’s it. That’s all we know.”
“That’s it,” Phil underscored. “And besides, Weber’s people modified whatever was causing the rashes in patients anyway. If that part of the drug was causing PH as well, it’s been fixed.”
“Exactly.”
“So, you’re going to let things drop?”
Brian hesitated before saying, “Probably.”
“We don’t do probably here at Boston Heart,” Phil said. “I want definitely. Because Brian, I’m telling you, we’ve got nothing to gain and I really can’t chance losing everything. I just can’t.”
“Hey, I understand. That’s why I called just now, to tell you that I didn’t even want you doing anything about these PH cases. You’re right. There’s too much at stake.”
“Thank you. Now, I only hope you’re listening to what you’re saying.”
“I am, Phil. You take care, now.”
“I will. Listen, there is one thing. That monkey you mentioned—the chimp in the animal lab?”
“Four-three-eight-six? What about him?”
“He doesn’t exist.”
“What?”
“And as a matter of fact, that animal keeper, Earl, is gone, too.”
“Tell me.”
“There’s nothing to tell. I went down to tend to my hamsters, and there was a new guy down there. Andrei, I think his name is. Speaks with some kind of accent, Russian, maybe. I asked him about Earl, and he said he had no idea who he was or why he didn’t work there anymore. Then I sort of sauntered past where the primates are kept. There’s one chimp there, but his number’s not four-three-eight-six, and he sure doesn’t seem to have anything wrong with him that I could see. He was jumping all over a swinging tire, and making faces at me like Joanne used to.”
“Did you ask what happened to the other monkey?”
“Hell, no. I’m telling you, Brian, the walls have ears around here, and I am out of the loop.”
“Out of the loop,” Brian echoed.
Teri glanced up and spotted Brian as he approached. Her smile lit up the dim corner. They had agreed that she would have him paged at the hospital at noon, just to check in. By then, he had decided to share with her what he had learned about Bill Elovitz and Kenneth Ford. She promised to check with her office to review exactly what had been reported on the two Phase One patients, and to fill him in at the airport.
“Hi, there,” she said. “I was wondering if you were going to make it before my flight.”
She rose and kissed him on the mouth, adding that she had thoroughly surveyed the bar patrons and determined she could risk it.
“In that case, risk it again,” he said. “God, you smell good.”
“I smell like Newbury Pharmaceuticals because that’s where I’ve spent most of the day. Here, I ordered your usual. I’m doing chardonnay.”
“How goes everything?”
“Well, I think this is it, actually. I have amassed as much information as I could.”
“And?”
“And I think we’re a go for Saturday. Let the Vasclear games begin.”
“What about those two cases?”
“Well, I checked with my office. The patients from Phase One and Phase Two are identified by initials only. Patient K. F., who I assume was Kenneth Ford, was reported as having died of cong
estive heart failure. But there was also a note from the team at Boston Heart saying that he was being evaluated for pulmonary hypertension at the time of his death. My people didn’t think much of that one case, especially since there have not been any others.”
“Until now.”
“Without divulging your name, I actually mentioned your second man—the poor fellow who was killed in the holdup—to Dr. Baird. He thought your findings were as consistent with congestive heart failure as they were with pulmonary hypertension. And before he came to take over the FDA, he was a professor of medicine. But even if it was PH, there’s no easy way to connect it to Vasclear. Besides, these men were part of Phase One studies. The chemical process used to make the drug was modified before Phase Two. Since then, nothing. Dr. Baird doesn’t feel we have any cause for concern or alarm. And the truth is, neither do I.”
Brian shrugged and took her hand.
“Hey, fine with me,” he said. “I was just doing what I promised to do—keep my eyes and ears open and report to you.”
“And I hope you know how grateful I am. Brian, I’m finally excited about Vasclear. After all this work, I think this drug is the real deal. I think it’s going to save lives—many, many lives.”
Memories of his father made it hard for Brian to share her enthusiasm.
“In that case, I’m excited, too,” he said. “I’m also glad your part in this is coming to an end.”
“I guess in a way it is. But we have a very active postmarketing surveillance program. If any problems crop up with the drug, we’ll be on top of them. And one really good thing about Vasclear getting approved is that I’ll have more time free to spend with you. In fact, I have a couple of weeks of vacation coming to me. How about we go someplace?”
“Unfortunately, I’m a newcomer at BHI. I don’t get any vacation for six months, and by agreement with Dr. Pickard, I can’t be away from my periodic random drug tests for a year, which means no travel away from Boston.”
“So, I’ll come up. I’d love to meet your girls.”
“Now you’re talking.”
“Two weeks from now I should be able to get away. Maybe you could fly down for a weekend before that.”
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