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 ofmillions 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