Several months earlier in Celia’s office, during that sales planning meeting where afterward his words had been applauded, he had described the effect of Hexin W. “… stops free-radical production, so that leukocytes—white blood cells—are not attracted to a disease site … Result—no inflammation … pain disappears.”
All of that was true.
What was also becoming clear, by deduction and some hasty new experiments, was that banishment of leukocytes opened up a weakness, a vulnerability. In the ordinary way, leukocytes at a disease site killed off foreign material—bacteria. Thus leukocytes, though causing pain, were also a protection. But in their absence—an absence caused by the quenching of free radicals—bacteria and other organisms flourished, creating massive infections in various body locales.
And death.
Though it had yet to be proved, Vincent Lord was sure that Hexin W was, after all, the cause of at least a dozen deaths, perhaps more.
He also realized, too late to be of use, that there had been a weakness in the Hexin W clinical testing program. Most of the patients observed had been in hospitals under controlled conditions where infections were less apt to flourish. All of the deaths recorded in his folder had occurred away from hospitals, in homes or other noncontrolled environments where bacteria could live and breed …
Lord reached the conclusion—acknowledging his failure, shattering his dreams, reinforcing his present, desperate fears—only a few minutes before Celia arrived.
He knew now that Hexin W would have to be withdrawn. He knew, with despair, that he was guilty of concealment—a concealment causing deaths that could have been prevented. As a result he faced disgrace, prosecution, and perhaps imprisonment.
Strangely, his mind went back to twenty-seven years before … Champaign-Urbana, the University of Illinois, and the day in the dean’s office when he had asked for accelerated promotion, which had been refused.
He had sensed then that the dean believed he, Vincent Lord, was flawed by some defect of character. Now, for the first time, peeling the layers from his soul, Lord asked himself: Had the dean been right?
Walking unannounced into Lord’s office, closing the door behind her, Celia wasted no time.
“Why was I not told that Exeter & Stowe canceled their contract four days ago?”
Lord, startled by the sudden entry, said awkwardly, “I was going to tell you. I hadn’t got around to it.”
“How long would you have taken if I hadn’t asked?” Then, without waiting for an answer, “I had to learn from outside that there have been adverse reports about Hexin W. Why haven’t I heard of those either?”
Lord said lamely, “I’ve been studying … collating them.”
She ordered, “Let me see them. Every one. Now.”
Knowing that, at this point, nothing could be held back, Lord produced keys and opened a locked drawer of his desk.
Watching him, Celia remembered the occasion seven years ago when she had come here, wanting to see those early, dubious reports about Montayne. At that time, Lord had been reluctant to show them, but when she insisted, he had gone through the same procedure with the same locked drawer. She had been surprised even then to discover that the reports were not in the general office filing system where they would have been accessible to others.
The same process of concealment.
Celia thought bitterly, the earlier experience should have taught her something. Because it hadn’t, an organizational weakness had persisted in the company, a weakness for which, as president, she was responsible.
Doubly responsible—because she had known of Vincent Lord’s penchant for hiding bad news, concealing what he didn’t like, and she had done nothing to guard against it.
Lord handed her a bulging folder. Celia’s first impression was shock at how much it contained. Her second, as she turned pages and read while Lord watched silently, was horror. She counted groups of pages. Fifteen deaths. And all those who died had been taking Hexin W.
At the end, she asked the inevitable question, though knowing the answer in advance.
“Have we informed the FDA of any or all of these reports?”
Lord’s face muscles twitched as he answered, “No.”
“You’re aware, of course, of the law and the fifteen-day rule?”
Lord nodded slowly, without speaking.
“I asked you some time ago,” Celia said, “if there had been adverse reports on Hexin W. You told me there were none.”
Desperately trying to salvage something, Lord replied, “I didn’t say there were none. What I said was—there was nothing that concerned Hexin W directly.”
Startled, Celia remembered. That was exactly what he had said. It had been a weasely answer, typical of Lord, whose ways she had known for twenty-seven years.
Armed with that knowledge, she should have recognized the answer for what it was—evasive—and persisted in her questioning. If she had, the adverse reports would have been out in the open months ago. And there would have been fewer of them than now—fewer deaths—because the FDA would have taken action, warnings would have issued …
But no! Instead, she had been caught up in euphoria, enamored of a second huge success … Peptide 7, then Hexin W … She had thought that nothing could go wrong. But it had, and now, while Vincent Lord’s world was crashing down about him, so was hers.
Not expecting any reasonable reply, she asked, “Why did you do it?”
Lord began, “I believed in Hexin W …”
She waved away the answer. “Never mind.”
Returning the papers to the folder, Celia said, “I’m taking these. Copies will be sent to Washington—the FDA—today, marked urgent, and by special messenger. I intend to telephone the commissioner to ensure they have proper attention.”
She added grimly, mostly to herself, “I imagine we’ll hear something back quite soon.”
20
The FDA reacted quickly, almost certainly because of Celia’s decision to involve the commissioner directly. An order for temporary withdrawal of Hexin W was issued, the “temporary” leaving open a possibility that the drug might be reintroduced later with more restrictive labeling. But even if that happened, it was clear: The highflying days of Hexin W were over.
“Which is a damn shame,” Alex Stowe said in a conversation with Celia soon afterward. “It’s still a fine drug, and a scientific achievement quite apart from the way Vince messed up personally.” He added dourly, “The trouble in our society is that everyone wants drugs that are free from risk and, as you and I both know, they don’t exist and never will.”
Since their recent joint experience Celia had fallen into a habit of talking regularly with Stowe, who was proving a wise friend and confidante.
“You will see Hexin W back,” he insisted, “maybe with greater safeguards, or after more development. There’s a need for the quenching of free radicals, even at some risk, and it’s a technique that’s spreading medically. In the next few years we’ll be reading more and more about it. When that happens, Celia, you can take heart that Felding-Roth was in there, pioneering.”
“Thank you, Alex,” she said. “Around here, right now, any cheerful thought is welcome.”
Despite the melancholy surrounding Hexin W’s withdrawal, the process itself went smoothly. Celia, anticipating it, had ordered preparations made in advance of the FDA order. Thus, when it came, a “Dear Doctor” letter immediately went out to all physicians advising them that the drug should no longer be prescribed. Within two weeks following that, the product was off drugstore shelves. Celia had attempted to have the Hexin W removal listed as voluntary, but the FDA demurred, choosing to exercise its authority. Because of the overhanging problem of the late reporting, Celia was advised by lawyers not to argue.
As to that problem, nothing was heard immediately, but a few weeks later the “Pink Sheet”—a weekly review of pharmaceutical affairs, published in Washington—stated:
In the matter of Felding-Rot
h and Hexin W, the FDA has referred its investigation of alleged adverse report violations to the Justice Department, though it is understood no recommendation has been made as to whether a grand jury should be empaneled.
“The way I hear it, confidentially,” Childers Quentin told Celia during a telephone conference call which included Bill Ingram and an in-house company lawyer, “is that you’re between two factions pulling different ways inside the FDA.”
At Celia’s request, Quentin, through his many contacts in the capital, had put out feelers to discover what was happening. Periodically the Washington lawyer relayed what he learned, and the Pink Sheet’s comment had prompted his latest call.
Quentin continued, “One faction includes the commissioner and some others who are inclined to go slow, knowing that grand juries and indictments are tricky and can bounce back on the FDA’s own people if their involvement was neglectful too. Another thing—the commissioner was impressed, Celia, when you were honest with him about those delayed reports.” Quentin paused. “However, there’s a second FDA contingent led by an associate commissioner; he has power, is a permanent bureaucrat, and will be around long after the commissioner has gone. The associate commissioner is in the corner of an FDA doctor named Gideon Mace, and it’s Mace who’s screaming for strong action. You may remember him. We were all on Capitol Hill together.”
“I do remember,” Celia said. “Dr. Mace seems to hold a grudge against Felding-Roth, though I’ve no idea why.”
Bill Ingram asked, “Is there anything we can do about what’s happening, or might happen, over at Justice?”
“Yes,” Quentin said. “Just sit, wait, and hope. There are things you can meddle with in Washington and sometimes get away with doing it, but a grand jury proceeding—if it comes to that—isn’t one of them.”
So that was how they left it, and the waiting was unnerving.
Even more unnerving was the appearance of federal marshals at Felding-Roth headquarters with a search warrant. The warrant had been issued by the U.S. Federal Court at Newark, the nearest federal court to Boonton.
Hexin W had been withdrawn during early October. In mid-November, the U.S. Attorney for the District of New Jersey, acting on instructions from the Justice Department, sought permission before a federal magistrate to “search for and seize all memoranda, correspondence and other documents relating to the pharmaceutical product known as Hexin W.”
It was an ex parte proceeding of which Felding-Roth had no advance knowledge; therefore the company was unrepresented when the search warrant was applied for and issued.
The search-and-seizure move was a shock to Celia and others, as was the presence of the marshals who remained for several days, finally taking away a dozen cartons of papers in a truck. Among them were contents of filing cabinets in the research department, including one in Vincent Lord’s office.
Lord tried to protest the intrusion into his office, but was shown the search warrant and ordered to stand aside.
Since the day when, in Lord’s office, Celia had discovered the illegally withheld adverse reports, the research director had avoided, as much as possible, contact with other senior people in the company, especially Celia. It was clear to all concerned that Lord’s days at Felding-Roth were numbered. Equally clear was that until the Hexin W adverse reports matter was resolved, the company, which included Lord, had no choice but to present a united front. The seizure of papers made this even clearer, therefore an uneasy truce prevailed.
While Lord was keeping his distance, Celia was formulating a plan to restructure the research organization, with a divisional president in overall charge and, reporting to him, vice presidents who would head specialist sections, including the new genetic engineering facility. She had some ideas about who the head of genetics might be.
After the mid-November activity, nothing more was heard on that subject through the remainder of the year. Shortly before Christmas, Childers Quentin reported, “Officially there’s still an investigation in progress, but they’ve a lot of other things going on at Justice, and Hexin W isn’t on their front burner.”
Bill Ingram, who again listened to the report with Celia, said, “I suppose the longer that action is delayed, the less chance there is of anything serious happening.”
“It’s been known to work out that way,” Quentin said. “Just the same, don’t count on it.”
The first day of the new year brought an item of happy news. The rumored knighthood for Martin Peat-Smith became reality with the appearance of Martin’s name on the Queen’s Honors List. The Times of London reported that the award was for “outstanding service to humanity and science.”
The official investiture of Sir Martin Peat-Smith by Her Majesty would be at Buckingham Palace in the first week of February. Celia, learning of this during a congratulatory telephone call to Martin, said, “Andrew and I will come over the week before, and after you’ve been to the Palace we’ll have a party for you and Yvonne.”
Thus, near the end of January, Celia and Andrew were in London, accompanied by Lilian Hawthorne whom Celia had persuaded to join them. In the seven and a half years since Sam’s death, Lilian had grown accustomed to living alone and seldom traveled. But Celia pointed out that the occasion was, in a way, a memorial to Sam since the Harlow institute had been his idea, and Martin, Sam’s choice to head it.
Celia, Andrew and Lilian were staying at the latest “in” place for affluent travelers—Fortyseven Park Street in Mayfair, where hotel convenience was combined with private luxury apartments.
Lilian, who would be sixty at her next birthday, was still a strikingly handsome woman, and during a visit by the trio to the Harlow institute Rao Sastri was obviously attracted to her, despite the twenty-year difference in their ages. Sastri conducted a special tour of the labs for Lilian and afterward the two of them took off for lunch. Celia was amused to learn that they had arranged an evening in London—dinner and a theater—for the following week.
On Monday, two days before the investiture, Celia received a transatlantic call from Bill Ingram. “I’m sorry to burden you with bad news,” the executive vice president began, “but Childers Quentin just called. It seems that in Washington all hell just broke loose.”
The news, he explained, concerned the FDA, Dr. Gideon Mace, the Department of Justice, Senator Dennis Donahue and Hexin W.
“The way Quentin tells it,” Ingram said, “is that Mace got tired of what he saw as inaction at the Justice Department. So on his own, unofficially, he took all the Hexin W papers over to Capitol Hill to one of Donahue’s aides. The aide showed them to Donahue, who grabbed the whole schmear as if it were a Christmas present. According to Quentin’s informant, the senator’s words were, ‘I’ve been waiting for something like this.’”
“Yes,” Celia said, “I can imagine.”
“The next thing,” Ingram continued, “is that Donahue called the Attorney General and demanded action. Since then—again as Quentin tells it—Donahue’s been calling the A.G. every hour on the hour.”
Celia sighed. “That’s a lot of bad news at once. Is there anything else?”
“Unfortunately, quite a bit more. First, it’s now definite that a grand jury will be empaneled to look into the Hexin W delayed reports, plus something else that’s come out. And the Attorney General, who’s taking a personal interest because of Donahue, is sure he can get indictments.”
“Against whom?”
“Vince Lord, of course. But also, I’m sorry to tell you, Celia, against you. They’re going to argue that you were responsible—and that’s on Donahue’s urging. According to Quentin, Donahue wants your scalp.”
Celia knew why. She remembered the Washington lawyer’s warning after the Senate hearings. “You made him look a fool … If, any time in the future, he can do harm to Felding-Roth or to you … he’ll do it and enjoy it.”
Then she recalled some words of Ingram’s spoken moments earlier and asked, “Bill, you said there was ‘something else th
at’s come out.’ What?”
This time Ingram sighed. Then he said, “This gets complicated, though I’ll try to put it simply.
“When the clinical testing data on Hexin W was submitted to Washington with our NDA, it contained the usual gamut of medical studies, including one by a Dr. Yaminer of Phoenix. It now turns out that Yaminer’s study was a fake. He listed patients he didn’t have. Much of his data was fraudulent.”
“I’m sorry to hear that,” Celia said, “though it happens occasionally. Other companies have had the same problem. But when you find out about the faking—if you do—you tell the FDA and they go after the doctor.”
“Right,” Ingram agreed. “What you’re not supposed to do, though, is include the data in an NDA after discovering it to be false.”
“Of course not.”
“Vince did. He initialed Yaminer’s report and let it go.”
Celia asked, “But how does anyone know that Vince was aware—”
“I’m coming to that.”
She said wearily, “Go on.”
“When those federal marshals were with us, doing their search and seizure, they took away files from Vince’s department. Among them was one for Dr. Yaminer. In that file were some rough notes in Vince’s handwriting, showing he’d discovered Yaminer’s report to be false before he let it go to FDA. The Justice Department now has the original report and Vince’s notes.”
Celia was silent. What was there to say? She wondered: was there any end to infamy?
“And I guess that’s all,” Ingram said. “Except …”
“Except what?”
“Well … it’s about Dr. Mace, and the way he seems antagonistic to us. I remember you saying once that you had no idea why.”
“I still haven’t.”
“I think Vince knows why,” Ingram said. “I have an instinct. I’ve watched Vince too. He seems scared stiff any time Mace’s name comes up.”
Celia weighed what she had just heard. Then suddenly, in her mind, Ingram’s words linked up with a conversation she had had with Lord at the time of the Senate hearings. She had accused him then of lying on the witness stand and …
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