Strong Medicine
However, did Martin’s opinion of her really matter? The answer: no! One reason: there was still something of the child in Martin, even at thirty-two. Celia had once heard someone say of research scientists, “They spend so much of their lives becoming more and more educated that they have time for little else and, in some ways, stay children forever.” For sure, some of that seemed true of Martin. Celia knew that she was much more a person of the world than he.
What was important, then? Not Martin’s personal feelings, nor Celia’s either, but the outcome of today.
True? Yes, again.
As to that outcome—Celia sighed within her—she wasn’t optimistic. In fact, she almost certainly did, to use Sam’s phrase, “blow it by being crass.” The more she thought about that, the less she liked what she had done, the more the memories of the day depressed her. The downbeat mood persisted as far as the hotel.
In the lobby of the Berkeley she was greeted by a uniformed concierge. “Good evening, Mrs. Jordan. Did you have a pleasant day?”
“Yes, thank you.” In her mind she added: Just some parts of it.
In turning to reach for her key, the concierge gathered up several message forms which Celia accepted. She would read them later in her room.
Then, about to turn away, she heard, “And, oh yes, Mrs. Jordan. This one came in a few minutes ago. A gentleman phoned. I took it down myself. It doesn’t seem to make much sense, but he said you’d understand.”
Tired, and without interest, Celia glanced at the slip of paper. Then her eyes were riveted.
The message read:
TO EVERY THING THERE IS A SEASON INCLUDING CRASS AMERICANS BEARING GIFTS. THANK YOU.
I ACCEPT.
—MARTIN.
Unusually, and to the frowning disapproval of the concierge, the staid lobby of the Berkeley echoed to a loud and piercing cry from Celia.
“Yippee!”
11
A few days before Celia’s Sunday tour of Cambridge, Sam and Lilian Hawthorne had left Britain for a brief visit to Paris and from there had flown directly to New York on Saturday. Therefore it was not until Monday, at 3:30 P.M. London time, that Celia reached Sam by telephone in his office at Felding-Roth, New Jersey.
When she informed him of the news about Martin Peat-Smith, he reacted enthusiastically, telling her, “I’m delighted, though astounded. Celia, you’re incredible! How the devil did you do it?”
She had been expecting the question and said cautiously, “I’m not sure you’ll like this.” Then she reported her conversation with Martin about money, and how that, as much as anything else, had influenced his change of mind.
At the other end of the line, Sam moaned audibly. “Oh, shit!—if you’ll pardon me.” Then he said, “I was the one who warned you not to mention money, and how could I have been so wrong?”
“You couldn’t have known,” she assured him. “I just probed, and uncovered some of Martin’s problems. By the way, he called me ruthless for doing that.”
“Never mind! What you did produced the result we wanted. I should have done the same, but didn’t have your insight and persistence.”
Celia thought, You also didn’t have Andrew to advise you. Aloud, she said, “Sam, for goodness’ sake stop blaming yourself! It isn’t necessary.”
“All right, I will. But I’ll make you a little pledge.”
She asked, “What’s that?”
“If ever, someplace down the road, you and I differ on a matter of judgment that’s important, you have my permission to remind me of this incident, and that your judgment was right and mine wrong.”
“I hope it never happens,” Celia said.
Sam changed the subject. “You’re coming home this week, aren’t you?”
“The day after tomorrow. I love London, but I love Andrew and the children more.”
“Good! As soon as you’re home, you’d better take some days off to be with them. But then, in a few weeks, I’ll want you back in Britain again. There’ll be more things to do in setting up the institute; also we’ll need to hire an administrator. Martin’s research skills are too important to waste on organization and office work.”
“I agree,” Celia said, “and all of that sounds fine.”
“Something else that’s fine,” Sam said, “is that during the few days I had in Paris last week I acquired the American rights to a new French drug for Felding-Roth. It’s still experimental and won’t be ready for at least two years. But it looks extremely promising.”
“Congratulations! Does it have a name?”
“Yes,” Sam said. “It’s called Montayne. You’ll hear much more about it later.”
The remainder of 1972 and into ’73 was, for Celia, an exciting, stimulating time. She made five more trips to Britain, each of several weeks’ duration. On two of them, Andrew joined her for part of the time; on another, Lisa and Bruce flew over. While Andrew was in Britain he and Martin met; the two men liked each other and later Andrew told Celia, “The only thing Martin needs is a woman like you to share his life. I hope he finds one.”
While the children were visiting her, and during times when she was not working, Celia, Lisa and Bruce inspected the sights of London to—in Celia’s words—“exhaustion point.”
Bruce, now twelve, revealed himself as a history addict. As he explained it one Sunday morning while the three of them walked around the Tower of London, “It’s all there, Mom, for anybody to find out—what went right, and all the mistakes. You can learn so much from what’s already happened.”
“Yes, you can,” Celia said. “Unfortunately, most of us don’t.”
Bruce’s fascination with history continued during a second tour of Cambridge, conducted, this time for the children, by Martin Peat-Smith. Celia met regularly with Martin during her working trips to Britain, though their total time together was not great because each was busy in differing ways.
Martin, now that his decision to join Felding-Roth was made, showed himself very much in charge, and aware of his requirements of equipment and staff. He recruited another nucleic acid chemist, a young Pakistani, Dr. Rao Sastri, who would be second-in-command on the scientific side. There were specialist technicians, including a cell culture expert and another skilled in electrophoretic separation of proteins and nucleic acids. A woman animal care supervisor would safeguard the hundreds of rats and rabbits to be used in experiments.
During visits to Harlow, Martin discussed the location of laboratories, staff, and equipment in the building where conversion work was already under way. However, such visits were brief, and until the institute was ready Martin would continue research in his Cambridge lab. Apart from the necessary excursions to Harlow, Martin insisted that his time not be taken up by administrative matters which others could handle—a strategy already endorsed by Sam Hawthorne and implemented by Celia.
Celia hired an administrator whose name was Nigel Bentley. A smallish, confident, sparrowlike man in his mid-fifties, Bentley had recently retired from the Royal Air Force where, with the rank of squadron leader, he was in charge of the administrative side of a large RAF hospital. The ex-officer’s qualifications for the new post were excellent; he also understood what was expected of him.
In Celia’s presence, Bentley told Martin, “The less I bother you, sir—in fact, the less you see of me—the better I’ll be doing my job.” Celia liked the statement, also the “sir,” which was a gracious way of making clear that Bentley understood what the relationship between himself and the much younger scientist was expected to be.
In between trips to Britain, and while Celia was back in the United States, a personal milestone—at least, as she saw it—occurred in her life. That was in September 1972 when Lisa, at age fourteen, excitedly left home to enter boarding school. The school was Emma Willard in upstate New York, and the whole family accompanied Lisa on her odyssey. At home during dinner the night before, Celia asked Andrew nostalgically, “Where did all those years go?”
But it wa
s Lisa—ever practical—who answered. “They happened while you were getting all those promotions at work, Mommy. And I’ve figured out that I’ll just be graduating from college when you get to sit in Mr. Hawthorne’s chair.”
They all laughed at that, and the good time extended through the next day when they, with other parents, families and new girls, were initiated into the beauty, enlivening spirit, and traditions of Emma Willard School.
Two weeks later Celia returned once more to Britain. Sam Hawthorne, deeply involved with other requirements of the company presidency, was now leaving almost all details of the British scene to her.
Eventually, in February 1973, the Felding-Roth Research Institute (U.K.) Limited was officially opened. At the same time, Dr. Martin Peat-Smith’s research project into Alzheimer’s disease and the mental aging process was transferred from Cambridge to Harlow.
It had been decided, as a matter of company policy, that no other research would be embarked on in Britain for the time being. The reasoning, as Sam confided it to the board of directors at a meeting in New Jersey, was that “the project we now have is timely, damned exciting, and with big commercial possibilities; therefore we should concentrate on it.”
No public fanfare was made about the Harlow opening. “The time for fanfare,” declared Sam, who had flown over for the occasion, “is when we have something positive to show, and that isn’t yet.”
When would there be something positive?
“Allow me two years,” Martin told Sam and Celia during a relaxed private moment. “There ought to be some progress to report by then.”
After the institute’s opening, Celia’s visits to Britain became fewer and shorter. For a while she went, as Sam’s representative, to help smooth out initial working problems. But, mostly, Nigel Bentley seemed to be justifying the confidence placed in him by his appointment as administrator. From Martin, as months went by, there was no specific news except, via Bentley, that research was continuing.
At Felding-Roth’s New Jersey headquarters, Celia continued as special assistant to the president, working on other projects Sam gave her.
It was during this period that, on the national scene, the putrescent boil of Watergate burst. Celia and Andrew, like millions of others worldwide, watched the parade of events nightly on television and were caught up in the unfolding drama’s fascination. Celia reminisced about how, a year earlier when driving to Harlow with Sam, she had dismissed the first published report of a Watergate burglary as insignificant.
Near the end of April, while tension mounted, two haughty presidential aides—Haldeman and Ehrlichman—were thrown to the wolves by President Nixon in an attempt to save himself. Then, in October, adding to Nixon’s and the nation’s misery, Vice President Agnew was ejected from office for other corruption, unconnected with Watergate. Finally, ten months later, Nixon himself reluctantly became the first American President to resign. As Andrew remarked, “Whatever else history may say, at least he’ll be in The Guinness Book of Records.”
Nixon’s successor promptly granted his predecessor a pardon-in-advance against criminal prosecution and, when asked if it was all tit-for-tat politics, proclaimed, “There was no deal.”
Watching and hearing the statement on TV, Celia asked Andrew, “Do you believe that?”
“No.”
She said emphatically, “Nor do I.”
Around the same time—less significant on the larger scene, but important to the Jordan family—Bruce, too, left home to enter prep school—the Hill School, at Pottstown, Pennsylvania.
Through the entire period and into 1975 the fortunes of Felding-Roth, while not spectacular, maintained an even keel. They were helped by two products developed in the company’s own laboratories—an anti-inflammatory for rheumatoid arthritis and a beta-blocker called Staidpace, a medicine to slow heartbeat and reduce blood pressure. The arthritis drug was only moderately successful but Staidpace proved an excellent, lifesaving product which became widely used.
Staidpace would have contributed even more to Felding-Roth revenues had its United States approval not been delayed by the Food and Drug Administration for what seemed an unconscionable time—in the company’s view, two years longer than necessary.
At FDA’s Washington headquarters there seemed, in the frustrated words of Felding-Roth’s research director, Vincent Lord, “an infectious unwillingness to make a decision about anything.” The opinion was echoed by other drug firms. Reportedly, one senior FDA official exhibited proudly on his desk a plaque with the famed promise of France’s Marshal Pétain in World War I, “They shall not pass.” It appeared to sum up neatly the attitude of FDA’s staff to any new drug application.
It was about this time that the phrase “drug lag”—describing the non-availability in the United States of beneficial drugs in use elsewhere—began to be used and gain attention.
Yet, always, a routine reply to any plea for faster action on new drug approvals was: “Remember Thalidomide!”
Sam Hawthorne tackled this attitude head-on in a speech to an industry convention. “Strong safety standards,” he declared, “are necessary in the public interest, and not long ago, too few of them existed. But pendulums swing too far, and bureaucratic indecision has now become a national disservice. As to critics of our industry who point back to Thalidomide, I point forward to this: The number of Thalidomide-deformed babies is now exceeded by the number of those who have suffered or died because effective drugs, held back by American regulatory delays, are failing to reach them in their time of need.”
It was tough talk and the beginning of what would be a fiercely argued, pro-and-con debate extending over many years.
At Felding-Roth, one keenly anticipated project was now on “hold.”
The deal made by Sam for the American rights to a new French drug, Montayne, still had not reached a point where tests for safety and efficacy, as required by law, could begin in the United States. Thus there was a long way to go even before a new drug application could be made to FDA.
Montayne was a drug to combat morning sickness in pregnant women; it held great promise, especially for working women whom it would free from a burden that made life difficult and sometimes threatened their employment. The drug’s discoverers—Laboratoires Gironde-Chimie, a reputable house—were convinced they had something of highest quality and safety, as shown by unusually extensive tests on animals and volunteer humans. The tests, the Paris-based firm informed Felding-Roth, had so far produced excellent results and no adverse side effects. Still, as the head of Gironde-Chimie explained in a personal letter to Sam:
Because of past occurrences, and the nature fragile of this drug, we have need of being extremely prudent. Therefore we have decided to make a few more series of tests on different types of animals, and also more humans. This will take a little more of time.
In the climate of the times, Sam agreed, the additional precautions seemed wise. Meanwhile, Felding-Roth continued to wait for a green light from the French before beginning their own work on Montayne.
THREE
1975–1977
1
While Dr. Vincent Lord had some problems which were imaginary, he also had others that were real.
One was the FDA.
The Food and Drug Administration, with headquarters just outside Washington, D.C., represented a labyrinthine obstacle course which any new pharmaceutical drug and its sponsors had to run before the drug was approved for general use. Some drugs were never approved; they failed to complete the course. And since sponsors of drugs were almost always the companies which discovered, manufactured, and eventually sold them to the public, the big drug firms and FDA were, more often than not, locked in a combative state. That state ranged, according to the issue of the moment, from intellectual-scientific skirmishing to all-out war.
As far as Vince Lord was concerned, it was war.
Part of his job at Felding-Roth was to deal, or supervise dealings, with the FDA. He loathed it. He als
o disliked, and in some cases despised, the people who worked there. Adding to his problem was that, to achieve anything at all at FDA, he had either to subdue those feelings or keep them to himself. He found both things difficult, at times impossible.
Of course, Dr. Lord was prejudiced. So were others, from other drug firms, who dealt with FDA.
Sometimes that prejudice was justified. Sometimes not.
This was because laws and custom required the FDA to be several things at once.
It was a guardian of the public’s health, its duty to protect the innocent from excessive avarice, incompetence, indifference, or carelessness, all of which sins were at times committed by pharmaceutical companies whose bottom line was profit. The reverse of that was FDA’s function as a ministering angel: the covenant to make available, with utmost speed, those new and splendid drugs—from the same pharmaceutical companies—which lengthened life or shortened pain.
Another agency role was to be a whipping boy for critics—drug firms, consumer groups, journalists, authors, lawyers, lobbyists, other special interests—who accused FDA of being either too rigid or too lenient, depending on what camp the critics lived in. As well, the FDA was used regularly as a political platform by self-serving and self-righteous congressmen and senators who sought an easy way to get their names in print and on TV.
Coupled with all this, the FDA was a bureaucratic mess—overcrowded, in critical areas understaffed, its medical and scientific experts overworked and underpaid.
Yet the amazing thing was, amid all these roles, hindrances, and critics, the FDA did its job—on the whole—remarkably well.
But without question there were glitches, and the so-called drug lag was one of them.
Just how bad the drug lag was depended, like so much else surrounding the FDA, on your point of view. But that it existed, even the FDA itself conceded.