To be absolutely sure, Lord selected fifteen other patient names and made a similar review of blood studies. Again identical figures repeated with unnatural frequency.
There was no need to go further. Any medical investigator would accept the pattern already uncovered as evidence of falsification—in this instance, criminal fraud.
With silent, seething anger, Lord cursed Dr. Yaminer.
The overall report presented by Yaminer made Hexin W look extremely good. But it was unnecessary. The drug would have looked good anyway, as was demonstrated by every other report which Lord had read.
Lord knew what he ought to do.
He should immediately inform the FDA, laying everything before them. After which Dr. Yaminer would be officially investigated and almost certainly prosecuted. It had happened to other doctors before, and some had gone to prison. If Yaminer was found guilty he could go there too and also, perhaps, lose his license to practice medicine.
But there was something else which Lord knew.
If the FDA became involved, with Yaminer’s work thrown out, all of it would have to be done again. And allowing for new arrangements that would have to be made, it would take a year and would delay Hexin W’s introduction by the same amount of time.
Again Lord cursed Yaminer for his stupidity and the dilemma now created.
What to do?
If it had happened in connection with a drug about which there were doubts, Lord told himself, he wouldn’t have hesitated. He would have thrown Yaminer to the FDA wolves and offered to give evidence at Yaminer’s trial.
But there wasn’t any doubt about Hexin W. With or without the false report, it was going to be a beneficial, successful medication.
So why not let the fake study go in with the other genuine ones? It was a safe bet that no one at FDA would notice; the sheer volume of an NDA made that unlikely. And if Yaminer’s papers were looked over by an FDA examiner, there was no reason to suppose the deception would be seen. Not everyone was as quick to notice things as Vincent Lord.
Lord would have preferred to omit the study altogether, but knew he couldn’t. Yaminer’s name was listed in other material already sent to FDA.
He also hated the idea of letting Yaminer get away with what he had done, but there seemed no other way.
So … all right. Let it go. Lord initialed the Yaminer study and placed it on a pile of others previously reviewed.
He would make sure though, Lord vowed, that the bastard never worked for Felding-Roth again. There was a departmental file for Yaminer. Lord found it and stuffed his own rough work sheets in, the pages he had used to figure out the fakery. If he ever needed them, he would know exactly where they were.
Lord’s assessment of the situation proved to be correct.
The NDA was submitted and, in a satisfyingly short time, approved.
Only one thing briefly troubled Vincent Lord, making him nervous. In FDA’s National Center for Drugs and Biologics at Washington, D.C.—formerly the Bureau of Drugs—Dr. Gideon Mace was now a deputy director. Compared with earlier days, Mace was a changed and better person, a strict teetotaler, at last with a good marriage, and respected at his work. His bad experience at the Senate hearing appeared to have done him no harm. In fact, soon afterward he had been promoted.
Word reached Lord that Mace, while not directly involved with the Hexin W application, had taken an interest in it, as apparently he did with anything coming into the agency from Felding-Roth. Almost certainly, Mace still bore the company a grudge and hoped one day to get even.
But nothing happened as a result of Mace’s interest, and when FDA approval to market Hexin W was given, Lord’s nervousness evaporated.
As with Peptide 7, it was decided that the developmental name of Hexin W would be its product name also.
“It comes easily off the tongue and will look good on packaging,” Celia declared when it was time for the matter to be decided.
Bill Ingram agreed, adding, “Let’s hope it brings us the same kind of luck we had before.”
Whether luck helped or not, Hexin W was an immediate success. Physicians, including some in prestigious teaching hospitals, hailed it as an important medical advance which opened up new therapies for treating seriously ill patients. Medical journals praised both the drug and Vincent Lord.
Many doctors in private practice began prescribing Hexin W, including Andrew, who reported to Celia, “It looks as if you have a live one there. It’s as much a breakthrough, I think, as Lotromycin in its time.”
As more and more doctors discussed the drug with each other, and patients expressed gratitude for the relief it brought them, Hexin W’s use expanded and sales zoomed.
Other pharmaceutical companies, some of which had been wary at first, began using Hexin W under license, incorporating it in their own products to improve their safety. A few drugs that had been developed years before but were never marketed because of high toxicity were brought down from the shelf and subjected to experiments with Hexin W added.
One such was an anti-arthritic drug named Arthrigo. The patent owner was Exeter & Stowe Laboratories of Cleveland, whose president, Alexander W. Stowe, was well known to Celia. A former research chemist, Stowe and a partner had formed their company a decade earlier. Since then, while the firm remained small, it had achieved a merited reputation for high-quality prescription products.
After a licensing deal was negotiated, Stowe came personally to Felding-Roth headquarters. In his fifties, he was a genial figure who wore rumpled suits, had shaggy hair, and looked absentminded, which he wasn’t. During a meeting with Celia and Vincent Lord he told them, “Our company has FDA permission to use a combination of Arthrigo and Hexin W experimentally. Since both drugs have anti-arthritic properties, we’ve high hopes for the outcome. Of course, we’ll keep you informed as results come in.”
That was six months after Hexin W’s introduction.
A few weeks later, Celia and Andrew gave a Saturday evening party at their Morristown house in honor of Vincent Lord. Lisa and Bruce came home for the occasion.
It was high time, Celia reasoned, that she did something personal for Lord, if only to make clear her recognition of his outstanding contribution to the company and to signal that any antagonism between them was now over, or should be.
The party was a success, Lord more relaxed and happy than Celia had ever seen him. His thin, scholarly face became flushed with pleasure as compliments were heaped upon him. He smiled continuously and mingled easily with the guests who included Felding-Roth executives, prominent citizens of Morristown, others who had come specially from New York, and Martin Peat-Smith whom Celia had asked to fly from Britain for the occasion.
The last gesture especially pleased Lord, as did Martin’s toast, proposed at Celia’s request.
“The life of a research scientist,” Martin declared while the other guests fell silent, “offers challenges and excitement. But also there are wearying years of failure, long hours of despair, and often loneliness. Only someone who has known those black occasions can understand what Vincent endured during his quest for Hexin W. Yet, his genius and dedication rose above them, leading to this celebration in which I humbly join, saluting—with you—a major scientific achievement of our time.”
“Very gracious,” Lisa commented later, when guests had gone and the Jordan family was alone. “And if all tonight’s company success talk gets out, it should send Felding-Roth stock up another point or two.”
Lisa, nearing her twenty-sixth birthday and four years out of Stanford, was a financial analyst, working for a Wall Street investment banking firm. In the fall, though, she would leave the money milieu to enter Wharton School of Business and study for an M.B.A. degree.
“What you should do,” Bruce advised his sister, “is on Monday suggest your clients buy Felding-Roth, then on Tuesday leak to the wire services that Dr. Peat-Smith, inventor of Peptide 7, is bullish on Hexin W.”
She retorted, “It would be unethic
al. Or don’t publishers worry about such things?”
Bruce, for the past two years since graduation from Williams, had been working for a New York textbook publisher where he was an editor in the history department. He, too, had plans for the future, which involved a move to Paris and studies at the Sorbonne.
“We’re concerned with ethics all the time,” he said. “Which is why publishers make less money than investment bankers.”
“It’s nice to have you both home,” Celia said, “and to know that nothing’s changed.”
Being president of a highly successful, wealthy company, Celia found, did not eliminate top management problems. Compared with when the company had been poor, there were just as many, sometimes more. However, their nature differed. Also, nowadays there was an exhilaration, a heady excitement lacking in the older times, on which Celia thrived.
Immediately following the social tribute to Vincent Lord, she was exceptionally busy with financial and organizational matters, all requiring travel. Consequently, nearly three months went by before she spoke to Lord again concerning the Hexin W licensing contract with Exeter & Stowe. He had come to her office about something else and she inquired, “What word is there from Alex Stowe on their Arthrigo and Hexin W?”
He answered, “Their clinical trials seem to be working well. Everything looks positive.”
“How about adverse reports on Hexin W generally? I haven’t seen any cross my desk.”
“I haven’t sent you any,” Lord said, “because there’s been nothing of importance. Nothing, that is, that concerns Hexin W directly.”
Celia’s mind, so accustomed nowadays to a diet of good news, had already moved on quickly to something else; therefore the wriggling proviso in Lord’s last remark escaped her. Later, she would remember it with regret, and blame herself for missing it.
For Lord, as had been his way for many years, going back to a time long before Celia had known him, had not delivered all the truth.
19
The news, when it broke, came quietly. Deceptively casual, even then it did not reveal itself entirely, and afterward it seemed to Celia as if fate had tiptoed in, at first unheeded and wearing a prosaic scabbard from which, later, emerged a fiery sword.
It began with a telephone call when Celia was away from her office. When she returned, a message—one of several—informed her that Mr. Alexander Stowe, of Exeter & Stowe Laboratories, had phoned and would like her to call him. There was nothing to indicate the request was urgent, and she dealt with several other matters first.
An hour or so later, Celia asked for a call to be placed to Stowe, and soon after was informed by a secretary that he was on the line.
She pressed a button and said into a speakerphone, “Hello, Alex. I was thinking about you this morning, wondering how your Arthrigo-Hexin W program is going.”
There was a moment’s silence, then a surprised voice, “We canceled our contract with you four days ago, Celia. Didn’t you know?”
Now the surprise was hers. “No, I didn’t. If you told someone at your place to cancel, are you sure they followed through?”
“I handled it myself,” Stowe said, obviously still puzzled. “I talked directly with Vince Lord. Then today, realizing I hadn’t spoken with you, thought I should, as a courtesy. It’s why I called.”
Annoyed at being told something she should have known sooner, Celia answered, “I’ll have something to say to Vince.” She stopped. “What was your reason for canceling?”
“Well … frankly, we’re worried about those deaths from infections. We’ve had two ourselves in patients we were monitoring, and while it doesn’t look as if either drug—Arthrigo or Hexin W—was directly responsible, there are still unanswered questions. We’re uneasy about them, so we decided not to go on, particularly in view of those other deaths elsewhere.”
Celia was startled. For the first time since the conversation began, a shiver of chill ran through her. She had a sudden premonition there was more to come and she would not like hearing it.
“What other deaths?”
This time the silence was longer. “You mean you don’t know about those either?”
She said impatiently, “If I did, Alex, I wouldn’t be asking.”
“There are four we actually know about here, though without details, except that all the deceased were taking Hexin W and died from differing types of infection.” Stowe stopped, and when he resumed his voice was measured and serious. “Celia, I’m going to make a suggestion, and please don’t think this presumptuous since it concerns your own company. But I think you need to have a talk with Dr. Lord.”
“Yes,” Celia agreed. “So do I.”
“Vince knows about the deaths—the other ones and ours—because we discussed them. Also, he’ll have had details, so as to inform the FDA.” Another hesitation. “I truly hope, for everyone’s sake in your shop, that FDA has been informed.”
“Alex,” Celia said, “there appear to be some gaps in my knowledge and I intend to fill them right away. I’m obliged to you for what you’ve told me. Meanwhile, there doesn’t seem much point in our continuing this conversation.”
“I agree with you,” Stowe said. “But do please call me if there’s any other information you need, or any way I can be of service. Oh, and the real purpose of my calling was to say I’m genuinely sorry we had to cancel. I hope, some other time, we can work together.”
Celia answered automatically, her mind already on what must be done next. “Thank you, Alex. I hope so too.”
She terminated the call by touching a button. She was about to press another which would have connected her with Vincent Lord, then changed her mind. She would go to see him personally. Now.
The first report of death where a patient had been taking Hexin W arrived at Felding-Roth headquarters two months after the drug’s introduction. It had come, as was usual, to Dr. Lord. Moments after reading it, he dismissed it entirely.
The report was from a physician in Tampa, Florida. It revealed that while the deceased had been taking Hexin W in conjunction with another drug, the cause of death was a fever and infection. Lord reasoned that the death could have had no relation to Hexin W, therefore he tossed the report aside. However, later that day, instead of sending it for routine filing, he placed the report in a folder in a locked drawer of his desk.
The second report came two weeks later. It was from a Felding-Roth detail man and was mailed after a conversation with a doctor in Southfield, Michigan. The salesman had been conscientious in recording all the information he could find.
Reports about side effects of drugs, including adverse effects, came to pharmaceutical companies from several sources. Sometimes physicians wrote directly. At other times, hospitals did so as routine procedure. Responsible pharmacists passed on what they learned. Occasionally, word came from patients themselves. As well, the companies’ detail men and women had instructions to report anything they were told about a product’s effect, no matter how trivial it seemed.
Within any pharmaceutical company, reports of side effects of drugs were accumulated and, in quarterly reports, passed to the FDA. That was required by law.
Also required by law was that any serious reaction, particularly with a new drug, must be passed to FDA, and flagged as “urgent,” within fifteen days of the company’s learning of it. The rule applied whether the company believed its drug to be responsible or not.
The detail man’s report from Southfield, again read by Lord, revealed that the patient, while taking Hexin W and another anti-arthritic drug, died from a massive liver infection. This was confirmed at autopsy.
Again, Lord decided that Hexin W could not possibly have been the cause of death. He put the report in the folder with the first.
A month went by, then two reports came in, separately but at the same time. They recorded deaths of a man and a woman. In both cases they had been taking Hexin W with another drug. The woman, elderly, developed a serious bacterial infection of a foot a
fter it was cut in a home accident. As an emergency measure the foot was amputated, but the infection spread quickly, causing death. The man, who had been in poor health, died from an overwhelming infection of the brain.
Lord’s reaction was one of annoyance with the two dead people. Why had their damned diseases, from which they would have expired anyway, had to involve Hexin W, even though the drug was clearly not responsible in either case? Just the same, the accumulating reports were becoming an embarrassment. Also a worry.
By this time Lord was aware of his failure to comply with federal law by not reporting the earlier incidents immediately to FDA. Now, he was in an impossible position.
If he sent the latest reports to FDA, he could not omit the earlier ones. Yet those were long overdue under the fifteen-day reporting rule, and if he sent them, both Felding-Roth and he personally would be shown as guilty of a law violation. Anything could happen. He was uncomfortably conscious of Dr. Gideon Mace probably waiting at FDA to pounce on such an opportunity.
Lord put the two latest reports in his folder with the others. After all, he reminded himself, he was the only one with knowledge of the total number. Each had arrived separately. None of the individuals making a report was aware of the others.
By the time Alexander Stowe telephoned, canceling Exeter & Stowe’s contract for the use of Hexin W, Lord had accumulated twelve reports and was living in fear. He also learned—increasing his anxiety—that Stowe had somehow heard about four of those Hexin-W-related deaths. Lord did not tell Stowe that the actual number was twelve, plus the two Stowe knew about directly, which Lord learned of for the first time.
Since, legally, Lord could not ignore what Stowe had told him, the total of known deaths was now fourteen.
A fifteenth report came in on the day that Stowe telephoned Celia. By then, reluctantly but unable to avoid the scientific truth, Lord had gained an idea of what was causing the deaths—most of them, if not all.