Miracle Cure
Page 6
His feet ached by the time he reached his building. All he could think of was getting his shoes and socks off and getting into the recliner. The last obstacle between him, a glass of milk, some cookies, and the ball game was a single flight of stairs. He unlocked the front door and the inside security door. Clutching the plastic bag of groceries with one hand and the banister with the other, he ascended step by step.
Finally, at the second landing, he leaned against his apartment door, gulping air as he fumbled with the key. The apartment, as always, was pitch black. Not once that he was aware of had he left a light burning unnecessarily. As he stepped inside, he became aware of the distinct odor of gas. The pilot in the stove must have gone out, he thought as he closed the door behind him. He’d get a window open right away and then fix the damn thing. He threw the living-room light switch by the door, but he would never see the spark that resulted from the slightly widened gap in the contacts.
The gas-laden atmosphere instantly turned the neat apartment into an inferno. Mac MacLanahan’s eardrums imploded moments before his eyes melted and his clothes burned away. By the time his body slammed into the wall by the door, his skin and the lining of his lungs were charred. And by the time the wall began burning on its own, the last of his consciousness had begun to fade.
Brian left the hospital at five and walked to the Methodist church in the South End. When he had first returned from the Fairweather Treatment Center in Greenville, North Carolina, fifteen months ago, he had been too self-conscious to go to NA or AA meetings anyplace where he was likely to run into an ex-patient. He preferred the anonymity of Boston.
During a coffee break at his third or fourth meeting, this one in the Methodist church basement, a slightly built black man had approached him. He wore tortoiseshell spectacles with tinted lenses, and would have looked professorial except for the letter F in thick scar tissue over his wiry deltoid, and homemade blue tattoos on the bases of his fingers that read HARD LUCK when he balled his hands into fists.
“You know,” Freeman Sharpe said that night, in his mellow baritone, “this isn’t Acne Anonymous. This disease we’re doing battle with is lethal. It’s cunning, powerful, and above all, patient. You persist in sitting on your hands in the last row and keeping to yourself at the break, and sooner or later, probably sooner, you’re gonna crash.”
It was then Sharpe had volunteered to be Brian’s sponsor, helping him to meet people and guiding him through the ins and outs, the dos and don’ts of recovery. Even now they still spoke on the phone nearly every day. Whatever Brian’s problem, Freeman had a reasonable solution. Whatever his question, there was an answer.
Tonight, though, Brian felt his question was perplexing enough to test even Sharpe.
He had no more Aphrodite, no more Speedy Rent-A-Car, no more Darryl, decent money about to come in, and he was three days from being back taking care of patients. It was all there—all of it. Why, then, was he feeling so ill at ease?
Brian’s inexplicable apprehension began to lift as soon as he set foot in the grungy church basement. Although most of the support groups he attended were Narcotics Anonymous, he had no problems going to AA meetings, either. A drug is a drug, he had been taught at Fairweather, and the decision to stay away from mood-altering substances had to include alcohol.
Freeman Sharpe waved to him from across the room and greeted him with a handshake, a hug, and the appraising eye Brian had come to expect.
“Pardon me for saying it, young Holbrook,” Freeman said, “but you don’t look like a man who’s just had the weight of the world lifted from his shoulders.”
“That obvious, huh?”
“That obvious.”
“I think I’m frightened.”
“Of what?”
“I don’t know.”
“I don’t believe that. Why don’t you take a stab at it?”
“Well, Boston Heart Institute is like the top of the line.”
“So?”
“With my history, people will be watching me very closely.”
“So?”
“I … I don’t want to screw up.”
Freeman cleaned his glasses with a tissue, then tightened his fists and stared down at his HARD LUCK tattoos.
“I see,” he said.
People were settling in for the start of the Friday meeting, so Freeman led Brian outside into the cool late-summer air. Brian’s misgivings about starting at BHI had to connect with an important lesson for Sharpe to insist that he miss part of a meeting.
“Okay,” Freeman said, leaning against the building and crossing his arms, but never taking his eyes from Brian’s, “you’re afraid of screwing up at mighty Boston Heart Institute. Tell me, exactly who was it that hired you for this job?”
“Pickard. Ernest Pickard. He’s the director.”
Brian already sensed what was coming, but he was grateful that Freeman was going to lead him there.
“The director … and he hired you.”
“Right.”
“He went over your papers, your resumé, and your test scores and such?”
“Yes.”
“And he checked your references?”
“He did.”
“And he still decided to hire you?”
“He did.”
“Is he an intelligent man?”
“Very.”
“So, the way I see it—correct me if I’m wrong—is that you’re not the one responsible for bringing you on board at the hospital. A very intelligent man, who knows what the job’s all about, and who knows how to evaluate medical talent, and who went over all your stuff, determined you could do the job.”
“I guess so.”
“So, what’m I driving at?”
Sharpe, arms still folded, peered up at him. The man was a master at knowing when it was time for an answer and when it was time for a question.
“My only job is to do my best,” Brian responded, not daring to allow a singsong, this-is-child’s-stuff insinuation into his tone.
“Not to be the best. By now, I hope you’ve realized that all that be-the-best shit has to go. ’Cause if screwin’ up on this job is the best you can do, that’s not your problem, my man, it’s Ernest Pickard’s. He picked you.”
CHAPTER FIVE
DR. ALEXANDER BAIRD GLANCED OVER HIS SHOULDER AT the cameramen and reporters crowding the press section of the hearing room. Immediately, two flashbulbs popped off. Then another. The Senate Committee for Government Affairs’ Subcommittee for Oversight of Government Management was in a five-minute recess. Baird, the Food and Drug Administration commissioner, was wishing he had emptied his bladder before entering the hall. The notion of plowing back through the milling crowd to the men’s room held absolutely no appeal.
It was the oversight subcommittee’s mandate to determine that the FDA was carrying out its functions in a proper fashion. Of course, “proper” had a distinctly political flavor. Over the two or three days before he was to appear at this gathering, Baird had heard rumblings from his staff that there was more than the usual amount of interest in the session. No one seemed to know why. Now, after three-quarters of an hour of fielding softball questions on a variety of subjects, Baird still had no explanation for the inordinate amount of media attention and observers.
“Teri, I can’t shake the feeling they all know something I don’t,” he whispered, glancing up at the paneled dais that enabled the subcommittee members to loom above the witnesses.
Dr. Teri Sennstrom, group leader for cardiovascular drugs, poured a glass of ice water, which her boss declined.
“That makes two of us,” she said. “The Little Bighorn’s mighty pretty this time of year, don’t you think, General Custer?”
“Very funny.”
“Very serious. I smell an ambush, but I just can’t figure out where it’s going to be coming from.”
Over the ten months that he had been FDA commissioner, Baird had come to rely heavily on Teri’s opinion. She was thirty-six, th
e same age as his daughter. But unlike Margaret, who had bounced through graduate schools in education and business and still didn’t know what she wanted to do with her life, Teri, who had already been with the agency three years when Baird took over, was as focused and resourceful as she was loyal. Deputy director positions in the FDA didn’t open up that often, but when the next one did, Teri Sennstrom would be high on his list of candidates. Today, she sat at Baird’s right hand as his clinical adviser. To his left was the FDA attorney, a hawk-nosed veteran of the political wars named Barry Weisman.
The subcommittee meeting, chaired by the powerful Republican senator from Massachusetts, Walter Louderman, was the second one before which Baird had appeared as head of the Food and Drug Administration. His first appearance, just after his appointment, had turned out to be little more than shadowboxing—a get-acquainted session in which a constantly smiling Louderman skillfully let Baird know that even though Baird was the President’s man, liberal through and through, Congress and all the committees that mattered were controlled by the GOP. This time Louderman, a moderate Republican with undisguised national aspirations, had yet to say a word.
Originally a small-town family practitioner, Baird was a professor at the Medical College of Missouri when he was summoned by the President to Washington to straighten out the FDA. The agency had been badly mismanaged throughout the last administration and had been rocked by a number of scandals, including one ugly episode involving payoffs to cover up the fraudulent labeling of baby food. Blunt and outspoken on social issues ranging from smoking to gun control, Baird was already being criticized for lacking the social grace, political savvy, and even physical stamina to survive long in his office.
He leaned over to Teri and shielded his mouth from the microphone.
“What on earth do you think Harvey Wiley would say if he witnessed this circus?” he asked.
Wiley, a turn-of-the-century chemist and consumer-rights advocate, had led the legislative battle to pass the Pure Food and Drug Act of 1906, and was generally regarded as the father of the FDA.
Teri smiled at Baird’s image.
“Wiley was a politician,” she said. “He’d understand this show perfectly. And from what I’ve read, he was also a bare-knuckles fighter when he had to be. But one slight correction, Dr. Baird. Circuses have a stated purpose to thrill and entertain. I prefer to think of these oversight subcommittee hearings as theater—theater of the absurd.” She motioned up at the senators returning to their seats and automatically reached up to smooth her pale hair. “Act Two,” she said.
Barry Weisman flipped off his and Baird’s microphones.
“Well, Alex,” he said, “here we go again. I’m right here beside you. Even if all you need is a break in tempo, feel free to put your hand over the mike and whisper something in my ear. It looks great on TV, too. And just remember, no matter how many compliments they shower down on you, no matter how many pearly whites they flash you, don’t let your guard down. Not for a moment.”
“Not for a moment,” Baird echoed.
“One other thing. The more you can get the camera on Dr. Sennstrom’s face, the better the agency looks.”
“Do I detect reverse discrimination?” Teri asked.
Weisman grinned. He had been a close friend of Teri’s for several years, since the day he had finally accepted that she had no interest in dating him.
“Just a biological truism,” he said.
“Okay, then, Dr. Baird,” Louderman began, “suppose we get on with our business. My esteemed colleague from Texas, Senator Harrington, has a few questions for you regarding some of the recent situations your agency has encountered.”
Teri covered the mike and whispered, “You know about this guy, yes?”
Baird nodded. Senator Bart Harrington was Louderman’s stooge, and sometimes his muscle. Whatever Harrington had to say had doubtless been fed to him by the committee chairman. Baird thought he knew what was coming. One of his first acts as FDA commissioner had been to pull Kinethane, a controversial weight-loss drug, off the market three years after it had been approved for general use. The product, which had made hundreds of millions of dollars for a Texas-based company, appeared to be causing an unusual, sometimes lethal, form of pancreatitis in a small but significant proportion of the many millions who were taking it.
Twenty-five deaths had been attributed to the product, and a class-action suit was in the works. The manufacturers had countered the charges with expert testimony from a team of highly paid hired-gun statisticians showing that, given the improved health accompanying even a modest decrease in obesity plus the “natural” occurrence of this form of pancreatitis, the benefits of Kinethane far outweighed its risks. But the FDA had statisticians of its own. And in the end, Baird had felt he had no choice but to pull the drug.
Baird knew that the most brutal oversight-subcommittee hearings often revolved around the agency’s approval of a drug later found to be harmful. He expected to have to answer questions about why it had taken the FDA so long to appreciate the Kinethane hazard and respond to it, so he was well prepared with data and with Teri Sennstrom. He pulled out the half-inch-thick file from the stack in front of him, in anticipation of an attack. But that attack never came.
“Dr. Baird,” Harrington began, “I want to congratulate you for the excellent job you are doing putting the FDA back on its feet.”
Baird glanced over at Barry Weisman, who merely rubbed at his chin and shrugged.
“Thank you, Senator,” Baird responded. “We’re certainly trying.”
“What I’m particularly interested in today, Dr. Baird, is having you share with us some of your data regarding investigational new drugs.”
“Such as?”
“Well, for instance, how long does it take for a new drug to make it to the public?”
“From animal testing?”
“Yes.”
“Well, of course that varies greatly depending on the drug, the thoroughness of the pharmaceutical company sponsoring it, and many other factors. But from beginning to end, the process can take from five to as long as ten years or even more, and cost upward of one hundred and twenty-five million dollars.”
“There are three phases of human testing in drug research, is that correct?”
Baird was startled by the specificity of the question, but answered it in tempo.
“Essentially, yes. Each of the three human-testing phases involves more patients than the previous one and usually more investigating institutions as well.”
“Do promising, life-saving drugs ever get approved for public use while the human research is still in Phase Two of the customary three phases?”
“Yes, Senator Harrington, there have been such occasions.”
Harrington, whose heavily veined face and W. C. Fields nose strongly suggested to Baird that he might have a drinking problem, consulted his notes then cleared his throat.
“Dr. Baird, could you tell us something about the drug lovastatin?”
“Such as?”
“Just a brief history of the drug from the FDA’s point of view.”
Teri covered the mike.
“Any idea where he’s headed?” she whispered.
Baird shook his head.
“In that case, tread lightly,” she warned.
“Lovastatin is a wonderful cholesterol-lowering agent developed by Merck and Company. It was approved for prescribing to the public in August of nineteen eighty-seven.”
“Approval of a new-drug application, also known as an NDA, is the last step before a medication is released for general use, yes?”
“That’s correct, Senator.”
“Well then, could you tell us, please, Doctor, how long after the lovastatin new-drug application was submitted was it approved?”
“Before answering,” Baird said, picking his way along as if he were in a pitch-black room, “I feel I must explain that a new-drug application is submitted to our agency only after Phases One, Two, an
d Three are—”
“Yes, yes, I understand, Doctor. Could you please answer my question?”
The interruption and the edge in Harrington’s tone immediately put Baird on red alert.
Easy does it, Weisman jotted on the legal pad set between them on the table.
“Nine months after the NDA for lovastatin was submitted,” Baird said, “it was approved. But the research on that drug was—”
“Thank you, Doctor.”
“No, Senator, if you please, I’d like to finish my sentence. The Merck company did meticulous clinical studies of their drug and submitted remarkably comprehensive data. Their work on lovastatin actually began in the late seventies.”
“Then tell us, if you will, precisely how much time elapsed from the beginning of Phase Two human trials until the NDA for lovastatin was approved?”
“I really don’t have that information at my fingertips. But I’d be happy to—”
“It was just three years, Dr. Baird. Just three years from the beginning of Phase Two human trials until approval of the drug.”
Harrington, his smug expression almost comical, turned to Walter Louderman and nodded that he was passing the baton. Louderman, a husky, graying Harvard Law grad, shuffled some papers. Then he took a slow drink of water and cleared his throat before fixing his pale blue eyes on Baird.
“Dr. Baird,” he said, “there’s another drug I’d like you to tell us about. Correct me, please, if my pronunciation is off. The drug is zidovudine.”
“Your pronunciation is perfect, Senator Louderman.” Why wouldn’t it be? You probably practiced saying the word a hundred times before you’d chance it in front of all these cameras. “The drug you ask about was originally and perhaps more commonly known as AZT.”
Barry Weisman motioned with his hand for Baird to hold up and turned the microphone toward himself.
“Senator Louderman,” he asked, “do you think we might be given some idea as to where this line of questioning is leading?”