Miracle Cure (8 page)

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, and 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?”

“If you can be patient just a bit longer, Mr. Weisman, I think you will have your answer. Now, Doctor, can you give us the same sort of capsule summary about AZT that you did for lovastatin?”

Baird searched for a trap behind the question, but could find none.

“AZT is an antiviral agent developed by Burroughs-Wellcome and Company, now Glaxo Wellcome, and has been a valuable treatment against the virus that causes AIDS.”

“And when were clinical studies begun on
that
drug?”

“I’m not sure. Sometime in the mid-eighties.”

“Actually, Doctor, Phase One trials of AZT began in
June of nineteen eighty-five. Phase Two began seven months later. The human testing was terminated in September, nineteen eighty-six, just eight months after Phase Two studies were begun. There never were any Phase Three studies.”

Baird was aware of his bladder now and silently cursed himself for not addressing that situation during the break. Just the same, whether out of fatigue, irritation, anxiety, or some combination of the three, he took several swallows of the ice water Teri had poured for him, and then motioned for her to respond to the statement.

“We’re not certain we follow you, Senator,” she said. “The FDA is certainly proud of the speed with which we got both lovastatin and AZT approved for public use.”

“And well you should be, Doctor Sennstrom. Because both those drugs had huge lifesaving potential for a large number of people.…”

Louderman paused, looked up at the bank of cameras, then once again shuffled the papers in front of him.

Here it comes
, Weisman wrote, filling the O in with a frowning face.

“…  Dr. Baird and Dr. Sennstrom,” Louderman said finally, “are you aware of a drug named Vasclear currently under Phase Two clinical studies?”

“We are aware of the drug, yes,” Baird responded.

“Could you tell us all what the drug does?”

“I can tell you what it’s
purported
to do. It is being investigated for properties it
may
have that reportedly enable it to dissolve arteriosclerosis.”

“Dissolve arteriosclerosis.… Do you mean it can cure hardening of the arteries?”

At that moment, Baird remembered that Newbury Pharmaceuticals, the small drug firm developing Vasclear, was based in Boston, Louderman’s home turf. Suddenly,
he understood the why and wherefore of the entire session. An ambush, indeed. He covered the microphone.

“Barry,” he whispered, “we know where Louderman’s going now. If we feel he’s squeezing us too tightly on this, I want you to go out in the hall, see if you can reach the President, and have him put a stop to it.”

He turned back to Louderman.

“From what I know of the drug, Senator, and I admit that is not a great deal at this point, curing hardening of the arteries is a possibility. I would caution you and everyone watching this hearing that research on Vasclear is quite preliminary.”

“A drug that cures hardening of the arteries and you don’t know a great deal about it?”

“A drug that
may
cure hardening of the arteries, Senator. We have literally hundreds of investigational new drugs we are currently following. And as I said, research on Vasclear is quite preliminary.”

“I beg your pardon, sir,” Louderman countered, “but the research on this medication is actually quite far along, and the American people should know that the results to date have been astounding. I know for a fact that the scientists of Newbury Pharmaceuticals have twice submitted a new-drug application to
your agency
requesting the same sort of consideration that was given to
that AIDS drug
, and twice they have been turned down by
your people.”

Go!
Baird wrote on the legal pad. Barry Weisman took the cellular phone from his briefcase, slipped it into his jacket pocket, and hurried from the hearing room. Baird stalled with another sip of water. From what he knew, the Vasclear research did hold great promise. But he also knew that Louderman’s staff had been pressuring the team assigned to evaluate Newbury Pharmaceuticals Company’s clinical data.

The income from a drug that could eliminate arteriosclerosis would be staggering. Louderman was angling toward the Republican presidential nomination. His early public support of the drug would be a huge political coup, and somehow, profits from the drug were sure to find their way into his campaign coffers.

However, from what Baird had been told by his staff, as remarkable as the early Phase Two data on Vasclear was, more study on humans needed to be done.

“Excuse me, Doctor,” Louderman was saying, “but would you please answer my question?”

“I … um … I’m afraid I’ll have to ask you to repeat it, Senator.”