Arthur Hailey - Strong Medicine

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.”

Sam weighed what had been said.”What do you mean by 'a failed doctor'?" The research director consulted notes.”Since getting his medical degree, Mace has worked in five diffierent cities where he was employed by other physicians. After that, he was in practice on his own. As far as I can learn from those who know him, all those arrangements broke down because Mace doesn't get along with people. He didn't like the other doctors and, about quitting private practice, he says frankly he didn't like his patients.”

"From the found of it," Sam said, "they probably didn't love him. Why was he hired at FDAT' "You know the FDA situation. They have trouble getting anybody.” Sam said, "Yes, I do.”

Medical-scientific recruiting at FDA was a problem of long standing. Government salaries were notoriously low, and an M.D. Employed by FDA received less than half of what he or she could earn in private practice. In the case of scientists, the gap between those employed at FDA and drug company scientists with similar qualifications was even wider. There were other factors. One was professional prestige. In medical-scientific circles, working for FDA was not regarded as impressive. An appointment to the government's National Institutes of Health, for example, was much more sought after. Something else affecting M.D.'s at FDA was the absence of what most working doctors enjoyed-direct, "hands on" contacts with patients. There was only-as Sam once heard it described-"the vicarious practice of medicine through reading other people's case reports.” Again remarkably, and despite those limitations, the agency's ranks contained many highly qualified, dedicated professionals. But inevitably there were others. The unsuccessful. The soured and alienated who preferred comparative solitude to meeting many people. The dedicated self-protectors, avoiding difficult decisions. Alcoholics. The unbalanced, Clearly, as Sam and Vince Lord saw it, Dr. Gideon Mace was one of these. Sam asked, "is there anything I can do? Like going to the commissioner?" Lord answered, "I don't advise it. FDA commissioners are political; they come and go. But bureaucrats stay, and have long memories.”

"What you're saying," Sam said, "is that we might win with Staidpace but lose out badly later on.”

"Exactly.”

"What about Mace's alcoholism?" Lord shrugged.”Heavy drinking broke up his marriages, I hear. But he copes. He comes to work. He functions. He may keep a bottle in his desk, but if he does, no one I've talked to has seen him dipping into it.”

"Is the moonlighting, working in a private practice, against regulations?" "Apparently not, if Mace confines it to his free time, even though he may be tired next day when he comes to work. Other doctors at FDA do the same thing.”

"Then there's no way we can touch Mace?" "Not now," Lord said.”But he still has all that alimony to pay, and money troubles make people do strange things. So I'm going to keep watching. Who knows, something may turn up.”

Sam regarded the research director thoughtfully.”You've become a good company man, Vince. Handling this, which isn't pleasant. Looking out for all our interests. I'd like you to know that I appreciate it.”