Strong Medicine (40 page)

is, whenever they could spare time from work on other drugs.

Another part of the procedure was that, as FDA's examination proceeded,

scientists from Felding-Roth would be called in, perhaps to explain some

of the submitted material or to add even more. This was normal.

What proved to be less normal were the work habits and attitude of Dr.

Mace. His pace was snail-like-slow even for the FDA. He was also petty,

unreasonably querulous, and mean.

This was how the name of Gideon Mace came to be added to the list of

people at FDA whom Vincent Lord despised.

Lord had personally overseen the Staidpace application and believed it

to be as complete and thorough as any ever submitted by the company.

Therefore, as months went by with no decision made, Lord's frustration

grew. Then when Mace was finally heard from it was about trifling points,

and later-as one of Lord's assistants put it-"he seemed to query every

damn comma, sometimes having nothing to do with science." 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.

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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 FeldingRoth a potful

of money."

Lord bridled. "That part never concerns me."

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"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.

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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 iound 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,

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Clearly, as lx)th Sam and Vince Lord saw it, Dr. Gideon Mace was one of

theFe.

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 regu-

lations?"

"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."

"Well . . ." Lord looked surprised, though not displeased. "I hadn't

thought of it that way. All I've wanted is to nail that bastard, and have

Staidpace approved. But maybe you're right."

Vincent Lord, reflecting later, supposed that what Sam had said about his

being a company man was true. Lord was now in his eighteenth year at

Felding-Roth and, even if you didn't expect it to happen, in that length

of time certain loyalties built up. Also, nowadays, introspective

thoughts about whether he had been right or wrong in leaving academia for

industry occupied him less than they once had. Much more of his thinking