Equally maddening was that several times when Mace imperiously demanded extra data, it developed that what was being sought was already in the original submission. Mace simply hadn't looked for it or even asked whether it was there, When the facts were pointed out, he took still more weeks to acknowledge them-and then did so ungraciously. After a good deal of this, Vincent Lord took over from his staff and began doing what he disliked most-going to the FDA himself. The agency headquarters was in an inconvenient location-on Fishers Lane in Maryland, some fifteen miles north of Washington, an hour's tedious drive from the White House or Capitol Hill. It was housed in a plain brick building, shaped like an "E" and built cheaply in the 1960s without benefit of architectural imagination. The offices, where seven thousand people worked, were mostly tiny and crowded. Many were windowless. Others had so many occupants and were filled with so much furniture, it was hard to move around. What little space remained was filled with paper. Paper was everywhere. Piles of it, reams of it, stacks of it, tons of it.
Paper beyond imagination. The mailroom was a paper nightmare, each day subjected to an avalanche of more, moving two ways, though outgoing paper seldom equaled the inward flow. In corridors, messengers pushed delivery trolleys loaded down with still more paper. Dr. Gideon Mace worked in a room, not much better than a cupboard, on the tenth floor. In his late fifties, Mace was lanky and long-necked; people made unkind remarks about giraffes. He was red-faced, with a heavily veined nose. He wore rimless glasses and squinted through them, suggesting that his prescription needed changing. His manner was brusque. In conversation he could be sarcastic, and acidity came to him easily. Dr. Mace usually wore an ancient gray suit which needed pressing, and a faded tic. When Vincent Lord went to see him, Mace had to clear papers from a chair before the Felding-Roth research director could sit down. "We seem to be having trouble over Staidpace," Lord said, making an effort to be friendly.”I've come to find out why.”
"Your NDA is sloppy and disorganized," Mace said.”Also, it doesn't tell me nearly enough that I need to know.”
"In what way is it disorganized?" Lord asked.”And what more do you need to know?" Mace ignored the first question and answered the second.”I haven't decided yet. But your people will hear.”
"When will we hear?" "When I'm ready to tell you.”
"It would be helpful and perhaps save time," Lord. said, managing to subdue his anger, but only just, "if you could give me some idea of where we both have problems.”
"I don't have problems," Gideon Mace said.”You do. I'm doubtful about the safety of your drug; it could be carcinogenic. As to saving time, I'm unconcerned about that. There's no hurry, We have lots of time.”
"You may have," Lord retorted.”But how about people with heart disease who'll be using Staidpace? Many heart patients need that drug now. It's already saving lives in Europe where we gained approval for it long ago. We'd like to have it do the same thing here.”
Mace smiled thinly.”And just by coincidence, make Felding-Roth a potful of money.”
Lord bridled.”That part never concerns me.”
“If you say so," Mace said skeptically.”But from where I'm sitting, you sound more like a salesman than a scientist.”
Still Vincent Lord contained himself.”You mentioned safety a moment ago. As you must know from our NDA, side effects have been minimal, none dangerous, and there has been no trace of carcinogens. So will you tell me the basis of your doubts?" "Not now," Mace said.”I'm still thinking about them.”
"And meanwhile making no decision.”
"That's right.”
"Under law," Lord reminded the FDA official, "you have a time limit of six months...”
"Don't lecture me on regulations," Mace said testily.”I know them. But if I turn down your NDA temporarily, and insist on more data, the calendar goes back to zero.”
And it was true. Such procedural delaying tactics were used at FDA--sometimes with good reason, Vincent Lord conceded mentally, but at other times on an official's whim or merely to postpone decisions. Having reached the outer limit, Lord said, "Not making decisions is always the safe route for a bureaucrat, isn't it?" Mace smiled but didn't answer. In the end, the meeting produced nothing but an increase of frustration for Vincent Lord. It did, however, cause him to make a decision: he would find out more-as much as he could-about Dr. Gideon R. Mace. Sometimes that kind of information could be useful. Over the next few months, Lord had reason to make several other visits to Washington and FDA headquarters. Each time, through casual questions put to Mace's colleagues in the agency and discreet research outside, he managed to learn a surprising amount. In the meantime, Mace had faulted one of Felding-Roth's studies concerning Staidpace-a series of field tests on patients with heart problems. Plainly relishing his power, Mace ruled that the entire test sequence should be done again. Lord could see no valid reason for repeating the work; it would take a year and be costly, and he could have objected. But he also realized that any such objection might be self-defeating, resulting either in the Staidpace NDA's being stalled indefinitely or in the drug's rejection. Therefore, reluctantly, Vincent Lord gave orders for the testing program to be done again.
Soon afterward he informed Sam Hawthorne of the decision, and reported what he had found out about Gideon Mace. The two were in Sam's office. "Mace is a failed doctor," the research director said.”He's also an alcoholic, he's in money trouble, partly because he's paying alimony to two wives, and he moonlights by working evenings and weekends, helping in a private medical practice.”