Baird rubbed at the fatigue in his eyes and then watched enviously as two runners loped along the walkway to his left. It was generally agreed that he had done an excellent job of restoring some of the lost public and private confidence in his agency. Now, political pressure seemed poised to overwhelm the caution that had marked his first nine months as FDA commissioner. And the only weapons he had been able to muster to counter the surge were his own intuition and an unwavering respect for the scientific process.
“Deep thoughts?”
Stan Pomeroy had entered the grove through the trees behind Baird. He took a seat on the bench and extended his hand. Baird shook it warmly. Pomeroy was the first black White House chief of staff and was held in almost universal esteem in a town where true esteem wasn’t easily come by. When Baird had waffled on the idea of stepping into the FDA furnace, it was Pomeroy who had flown out to Missouri to convince him.
“Nothing that figuring out the secret of life won’t take care of,” Baird replied.
“I see. Well, in that case, take a little more time.”
“That’s all right. I’ll take the subject under advisement until tonight in the shower.”
“Thanks for meeting with me like this, Alex.”
“Did I have a choice?”
Pomeroy shrugged.
“You always have a choice. I told you that when we asked you to take over at the FDA. The President knew what a thankless, controversial job you were walking into. He meant it then and he means it now. You’re the boss.”
Except were talking about the President of the United States here, Baird was thinking. The man even the seven-hundred-pound gorillas step aside for.
“I appreciate that, Stan,” he said.
Pomeroy opened his briefcase and extracted a file stuffed with newspaper articles. A quick flip-through showed Baird that they were from all over the world.
“You’ve seen these?”
“Enough of them.”
“And?”
“Stan, all I can say is that even a cursory search of the lay press will produce dozens—God, hundreds—of articles extolling the latest potential breakthrough in the search for a cure for cancer or heart disease or Alzheimer’s or AIDS. The public is desperate for good news in all medical areas, but especially those. Leaking information through the press is the form of extortion that researchers use to push for more grant money, or drug companies use to influence public opinion. The problem is that most of the time there’s a reason the researchers and pharmaceutical people have chosen to take their cases to the lay public rather than to pass them through the scientific community first—and that reason is, their work won’t stand up to close scientific scrutiny.”
“And how is this drug standing up to your scrutiny, Alex?”
Baird fidgeted for a time and stared out across at the city before he replied.
“The truth,” he said at last, “is that the results—as far as they go—are pretty impressive. The Phase Two patients have been randomized into three treatment groups, each with about two hundred people, and it does seem that one treatment group is doing much better than the other two, and that one group is doing much worse.”
“Then what’s the problem?”
“I don’t know, Stan. It’s a sense I have—a tingle in the back of my neck. First of all, there’s Newbury Pharmaceuticals. They’ve come out of nowhere on this one. Up until Vasclear, all they’ve ever produced are vitamins and a few generic copies of drugs. Remember, the FDA doesn’t have the budget or the resources to do any scientific or clinical research ourselves. All we can do is evaluate the work the drug houses submit to us. The more familiar we are with the company and their methods, the easier it is to trust that what they’re telling us is all there is to tell. And then there’s the drug itself.”
“Go on.”
“Well, the drug is almost too good to be true. Maybe I’m just frightened at the incredible potential for healing that has been laid in our hands by these people—frightened that something will be wrong with it. To this point, what we have are spectacular results treating a devastating disease coupled with minimal, if any, side effects. Usually our statisticians are battling the manufacturers over risk-benefit ratios, trying to decide if the scattered treatment successes are worth chancing the terrible side effects of a drug. In the case of Vasclear—provided, as I said, that what we’ve been given is all there is to the story—it’s no contest. The only negative thing of note that I’ve seen surrounding this drug is that it apparently doesn’t work for everybody. About twenty-five percent of the beta treatment group—the group I assume is getting high-dose Vasclear—has had no benefit from the drug whatsoever. But still, a seventy-five percent success rate with minimal side effects would put any medication in the pharmaceutical hall of fame.”
“Then I ask you again, Alex, what’s the problem?”
Baird sighed and massaged his temples.
“Maybe nothing. But the data submitted to us reflect only two years of treatment involving six hundred patients. I guarantee you that within a few days of Vasclear’s approval, tens of thousands of people will be on it. Within a couple of months it will be hundreds of thousands. Millions, maybe. We’re not talking about an anti-itch cream here, Stan. This is a drug people have been waiting for—a drug that has the potential to change the civilized world, to add years, hell, decades of healthy living for many of us.”
“That’s the President’s point exactly.”
“But only six hundred cases.”
“Don’t you follow up new drugs for side effects?”
“Of course. But the reporting and follow-up programs are largely voluntary and badly flawed, and this drug is going to be a runaway train. Once it’s out there, once those delivery trucks get rolling, if there are long-range adverse effects we don’t know about right now, some big-league damage is going to be done before there is any recall.”
“But so far no big-league damage.”
“Nothing.”
“And the study’s been well conducted?”
“As far as we can tell. I have one of our best people coordinating the review of Newbury Pharmaceuticals’ data. Teri Sennstrom, you know who she is?”
“I think so. Young, sort of blondish hair, kind of pretty?”
“That’s Teri, although I think you’d get an argument from a lot of men about the ‘kind of’ part. She’s also extremely bright and very thorough.”
“Has she been up to Boston to observe the study firsthand and to meet with the people who are conducting it?”
“Once, but that was a while ago.”
“How about sending her up again? Or better still, go yourself if you think it would help you get more comfortable with your decision.”
“You mean, with my decision to approve the drug.”
Pomeroy immediately sensed Baird’s irritation. He turned, resting the side of his knee on the bench so he could face the FDA chief more directly. The intensity in his eyes mirrored his words.
“Alex, if it wasn’t important to us, damn important, I wouldn’t be here.”
“When I agreed to take this job, you promised me total latitude in running the agency.”
“And you still have it.”
“I do? Then why do I feel like I’m being bounced on the nose of the presidential seal?”
Pomeroy grinned at the image, then tightened the hold his eyes had on Baird’s.
“Tell me something, Alex,” he said. “The truth. If you were having chest pain right now, which would you choose, Vasclear or bypass surgery? With what you know right now—”
The question was hypothetical and not at all fair, and Pomeroy’s expression said that he knew it. The real question was, when was any amount of research on a drug, any amount of data, enough? In skilled hands, statistics were as malleable as Play-Doh.
“Give me the numbers,” one of the more brilliant statisticians at the FDA had once told him, “and I’ll give you whatever results you want without cheatin
g in any way. It just depends on what statistical tests one chooses to use, as well as which tests one chooses not to use.” Baird stared off at the city.
“With the data and reports I have now,” he said finally, accepting that he was about to capitulate, “and knowing no more than that, I would take the drug.”
Pomeroy exhaled his relief.
“Thank you, Alex. Thank you for your honesty. That being the case, you and Dr. Sennstrom have three weeks. At that time the President would like to be standing beside you when you sign the new-drug application and he announces that research partially funded by his administration is about to take a giant step toward curing cardiovascular disease. If, in the meantime, you find any tangible reason why we should put off approving the drug, just show us what it is and you can have all the additional time you need.… Alex, I know you’re thinking about resigning over this. All I can do is beg you not to.”
Baird absently twisted his wedding band.
“Okay, Stan,” he suddenly heard himself saying, as if through a distant tunnel, “three weeks it is.”
CHAPTER TWELVE
BRIAN MADE SIGN-OUT ROUNDS ON THE SEVENTEEN REMAINING patients on the clinical ward and headed for the Vasclear clinic. Carolyn Jessup had yet to call him with the results of her meeting with Art Weber, but she had promised he would hear from her before he left the clinic for home. Jack had spent a reasonably comfortable night, but at his best he was still living the life of an invalid. And he knew it. After helping Jack to his room, Brian had sat on the edge of his bed and once again talked with him about surgery and Vasclear.
“I want to die,” Jack said. “Look at me. What do I have to look forward to? Christ, I can’t even go to the movies, let alone a ball game.”
“But don’t you see, Pop, you’re feeling hopeless because you’re sick. You forget about being Gramps to the girls, and seeing me get back on my feet, and maybe meeting someone yourself, taking some trips, doing some Little League coaching. I mean, you’re only sixty-three. You have what all the rest of us have, today—no more, no less. I’m telling you, Jack, whether it’s Vasclear or surgery, when your body is better, your head will get better, too. You’ve just got to hang in there.”
“I just can’t face having my chest cut open again, Brian. All those tubes. I just can’t.”
Brian took some lanolin-with-vitamin-E lotion and massaged the dry, scaly skin on his father’s feet. Jack’s pajama shirt was unbuttoned, exposing the huge sternotomy scar, as well as the numerous “dimples,” each representing a drainage tube of one kind or another.
“I’m trying to get you the Vasclear, Pop. I really am. But if I can’t get you put on the beta strength of the drug, you’ve got to let me set you up with Dr. Randa. You had a bad time of it with your bypass. I know that. But a lot of people sail through the procedure and are out of the hospital in just four or five days. I agree that Randa may be a jerk, but he’s a world-class surgeon.”
“No, Brian. Get me put on the drug. I like those odds.”
Lucy Kendall had been taken by surprise by Brian’s first visit to the clinic. Today she was ready. She wore tight-fitting slacks and a sweater that couldn’t help but test the cardiac fitness of her male patients. Complaining about the heat in the seventy-degree clinic, she shimmied out of her lab coat and draped it over the back of a chair. Then several times, while showing Brian those parts of the facility he had missed on his first tour, she made a point of pressing one of her ample breasts against his arm.
“So, how many patients do we have scheduled tonight?” he asked, not at all in the mood for her sledgehammer-subtle flirting, but determined to use it to learn what he needed to know.
“Five an hour for four hours. That’s about average. You said you lived in Reading. Do you live alone?”
“No, with my dad. So, is their medicine brought over each day?”
“Who?”
“The Vasclear patients.”
“Oh.… No, no. Each week. I send an appointment list over to Newbury each week, and they send over the appropriate vials of Vasclear. So, would you like to stop off somewhere for a drink after the clinic?”
“Thanks, I’d like to, but I’ve got to get home to my pop. He’s recovering from a coronary. Don’t you have little ones at home?”
“I’ve got an au pair to take care of them. I purposely picked a nineteen-year-old beauty queen from Sweden so that Jerry could have something to fantasize about besides me.”
“What if someone’s a no-show at the clinic? What do you do about their meds?”
“There aren’t many of those, but sometimes people can’t make it. I just keep their Vasclear locked up. Then, every few weeks, I catalog what’s left over and discard it. You like to dance?”
“Sure. I don’t get to do it much, and I’m not too graceful, but I like it. Is there a key for the fridge where the Vasclear’s kept?”
“Eight-four-nine-oh.”
“Pardon?”
“The code for the keypad on the refrigerator. Eight-four-nine-oh. You know, I should have one of those keypads put on the refrigerator at home. Maybe Jerry would take the hint and realize that a forty-inch waist just isn’t going to do it. You’re a thirty-six, right?”
“Good guess. Let me go over the administration of the drug again. Five times a week for two weeks, then three times a week for two months, then once a week?”
“Correct. Thirty-six waist, thirty”—she stepped back and appraised him expertly—“four leg, right?”
“Right again. That’s very impressive. I wonder who came up with that schedule, and how closely it has to be followed.”
“There’re missed-treatment days built in, I know that much. The clinic’s closed some holidays, and no one at Newbury seems to care if a patient misses one visit. We report it on a special form if someone misses two appointments in one week, or two weeks in any two-month period when they’re on a weekly dose regimen. That’s all. You’re very nice to talk to, do you know that?”
“Thanks. So are you.”
“You sure about that drink tonight?”
“Another time would be great. Don’t you think we ought to get started? There’re a couple of people in the waiting room.”
Brian began seeing patients and setting them up for their Vasclear administration. The work was more demanding than he had anticipated. Many of them were quite ill from their coronary artery disease. All of the sick ones, he noted, were in the alpha or gamma groups. As he waited for the call from Jessup, it was all he could do to keep his focus on the business at hand.
But there was another reason he was having trouble concentrating. He had all but made the decision. If Jack was refused admission to the Vasclear study, or was randomized into any group other than beta, he was going to steal the first dose of beta tonight, and use various methods to continue to obtain beta doses until the code was broken, the tightly controlled study was ended, and the drug was released for general use.
It was, without a doubt, the most frightening, wrenching choice he had made since the onset of his recovery. But what options did he have?
There was, he knew, one other decision he had to make. For more than a year, Freeman Sharpe had been there for him—first as a guide along the often poorly marked path of recovery, and then as a friend.
“All I ask,” Sharpe had said over and over, “is that before you drink, before you use, you call me.”
Unspoken was the additional plea that until Brian’s recovery was much farther along, he consult with Sharpe before doing anything emotionally risky. Would Freeman Sharpe try and talk him out of stealing the drug? Brian wondered. Was it worth putting the man in such a spot? At the moment, there was a thirty-three percent chance that Jack would be placed in the beta group and those questions would never have to be answered.
The first wave of patients were settled in and receiving their half-hour infusions. Brian took the opportunity to go over his plan one last time. There were two places the beta Vasclear for Jack coul
d come from: the reserve supply and the doses set aside for IV infusion in the patients. As far as he could tell, the reserve supply wasn’t counted, but it was disposed of frequently. If Lucy Kendall suspected medication was disappearing, controls would surely be tightened. He had decided that every third day, at least for the first two weeks, he would substitute normal saline for Vasclear for one of the beta infusions, rather than take a vial from the reserve. Lucy Kendall had made it clear that a missed-treatment factor had been built into the entire program. One missed dose was not harmful. No problem there.
God, but he hoped this whole exercise in deception-planning would be moot.
He wandered past the active-treatment rooms to make certain there were no problems, then slipped into the med room to try the keypad lock and count the number of beta vials on hand. The doorway was glass, so there was no reason to close it. Once inside the room, he glanced out at the corridor as he made a pretext of inspecting the shelves of various cardiac medications and the crash cart. He hated sneaking around like this.
“Eight, four, nine, oh.”
Brian knelt by the small refrigerator and whispered the numbers as he punched them in. The door released instantly. There were three low cardboard boxes—two on the middle shelf and one on the bottom, each labeled with a Greek letter. The beta box had four vials in it, not as many as Brian had hoped. Still, if he juggled things around, he would be able to make it through the first five days. After that, he would—
“Dr. Holbrook?”
The man’s greeting, from behind him, would have startled a weaker heart to an immediate standstill. Brian leaped and turned, closing the refrigerator door with the same movement. Dr. Art Weber stood just outside the doorway, smiling. He was in his early forties, and not as tall as Brian had thought from the video. But he was solidly built and undeniably good-looking, with sharp features and startling blue-gray eyes.
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