Strong Medicine (84 page)

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, bul 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 death&

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-

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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."

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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

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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 recommen-

dation 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;

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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 midNovember, 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

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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,