Vincent Lord suffered through an example of the drug lag during the attempt by Felding-Roth to gain approval for United States marketing of Staidpace, a heart and blood-pressure medicine already in use in Britain, France, West Germany and several other countries.
The FDA required that before Staidpace could go on American drugstore shelves and be prescribed by doctors, there must be additional, thorough, American testing of the product’s safety and efficacy. And it was a good requirement. Nobody argued against it, including Vincent Lord and others at Felding-Roth.
What they did protest—after all the required testing had been done successfully, and results submitted to the FDA—was two extra years of petty, indecisive quibbling by the government agency.
In 1972 Felding-Roth delivered its Staidpace NDA—new drug application—to FDA headquarters in a truck. The NDA consisted of 125,000 printed pages, contained in 307 volumes, enough to fill a small room. All this material was required by law and included information covering two years of U.S. testing on animals and humans.
Although the information supplied was as complete as anyone could make it, there was an unspoken awareness on both sides that no one at FDA could possibly read it all. Similar amounts of material were received, with great frequency, from other manufacturers seeking approval of other drugs.
From the FDA’s medical-scientific staff, a reviewer was selected to oversee and adjudicate the Staidpace submission. He was Gideon R. Mace, M.D., who had been with FDA a year.
Dr. Mace would be assisted by scientific specialists in the agency—that 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. 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 tie.
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 pr
ogram 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 different 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 sound of it,” Sam said, “they probably didn’t love him. Why was he hired at FDA?”
“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 both 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.”
“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 was directed toward his continuing research on the quenching of free radicals—whenever he could free himself from other responsibilities in the department. The answers Lord sought were still elusive. But he knew they were there. He would never, never give up.
And there was a new incentive to his research. That was the company’s institute in Britain where Peat-Smith, whom Vincent Lord had not yet met, was concentrating on the mental aging process. It was a competition. Who—Lord or Peat-Smith—would achieve a breakthrough first?
It had been a disappointment to Lord when he had not been given authority over Felding-Roth research in Britain as well as in the United States. But Sam Hawthorne had been adamant about that, insisting that “over there” be independent and operate on its own. Well, Lord reasoned, as things had turned out, perhaps that was best after all. From rumors seeping back from Britain, it seemed that Peat-Smith was getting nowhere, had come up against a scientific brick wall. If true, Lord was divorced from any responsibility.
Meanwhile, on the American pharmaceutical scene there was much to do.
As to Dr. Gideon Mace, the opportunity Vincent Lord had hoped for—to “get” Mace—did arrive eventually, though not soon enough to help Staidpace which, after more delays and quibbling, was at last approved and went on sale in 1974.
It was in January 1975, a day after he had returned from Washington, having been there to visit FDA about another matter, that Lord received an unusual telephone call. “There’s a man on the phone,” his secretary announced, “who won’t give his name. But he’s persistent and says you’ll be glad if you speak to him.”
“Tell him to go to—no, wait!” Curiosity was inbred in Lord. “Put him on.”
Into the phone he said curtly, “Whoever you are, say what you want quickly, or I’ll hang up.”
“You’ve been collecting information about Dr. Mace. I have some.” The male voice sounded young, also educated.
Lord was instantly curious. “What kind of information?”
“Mace has broken the law. With what I have, you could send him to jail.”
“What makes you think I’d want to?”
“Look,” the voice said; “you wanted me to be quick, but you’re the one who’s futzing around. Are you interested or not?”
Lord was cautious, remembering that telephone conversations could be taped. “How has Dr. Mace broken the law?”
“He used confidential FDA information to make a profit for himself on the stock market. Twice.”
“How can you prove that?”
“I have papers. But if you want them, Dr. Lord, I’ll expect to be paid. Two thousand dollars.”
“Doesn’t peddling that kind of information make you as bad as Mace?”
The voice said calmly, “Perhaps. But that isn’t the issue.”
Lord asked, “What’s your name?”
“I’ll tell you when we meet in Washington.”
2
The bar was in Georgetown. It was elegantly decorated in subtle shades of red, beige and brown, with handsome bronze accoutrements. It was also, plainly, a rendezvous for homosexuals. Several faces looked up interestedly as Vincent Lord came in; he sensed himself being appraised and it made him uncomfortable. But before the feeling could persist, a young man who had been seated alone in a booth got up and came toward him.
“Good evening, Dr. Lord. I’m Tony Redmond.” He smiled knowingly. “The voice on the telephone.”
Lord muttered an acknowledgment and allowed his hand to be shaken. He had instantly recognized Redmond as an FDA employee; Lord recalled having seen him several times during other trips to Washington, though could not remember precisely where. Redmond, in
his mid-twenties, had short, curly brown hair, baby-blue eyes with prominent lashes, and was in other ways good-looking.
He led the way back to the booth where they sat down, facing each other. Redmond already had a drink. Motioning, he asked, “Will you join me, Doctor?”
Lord said, “I’ll order myself.” He had no intention of making this a friendly occasion. The sooner he finished what he had come here to do, the better he would like it.
“I’m an FDA medical technician,” Redmond volunteered. “I’ve seen you come in and out of our department several times.”
Now Lord had the younger man pinpointed. He worked in the same general area as Gideon Mace. It would explain, in part, how he had come by the information he had been touting.
Since the original call from the person now revealed as Redmond, there had been two further phone conversations. In one they discussed money. Redmond had been firm in repeating his original demand for two thousand dollars in exchange for documents he claimed to have. During the last call they had arranged this meeting, Redmond choosing the place.
A few days before, at Felding-Roth headquarters, Lord had gone to see Sam Hawthorne in the president’s office. “I need two thousand dollars,” the research director had said, “and I don’t want to have to account for it.”
When Sam raised his eyebrows, Lord continued, “It’s for some information I believe the company should have. If you insist, I’ll give you details, but in my opinion you’re better off not knowing.”
“I don’t like this kind of thing,” Sam objected, then asked, “Is anything dishonest involved?”
Lord considered. “I suppose it’s unethical—a lawyer might say borderline-illegal. But I assure you we’re not stealing anything—like another company’s secrets.”
Sam still hesitated, and Lord reminded him, “I said I’d tell you if you wish.”
Sam shook his head. “Okay, you’ll have the money. I’ll authorize it.”
“When you do,” Lord said carefully, “it would be best if as few people as possible were involved. I was thinking that Mrs. Jordan doesn’t need to know.”