Arthur Hailey - Strong Medicine

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.”

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 high-flying 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-Roth 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 empanelled. "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.”