Strong Medicine (83 page)

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 Wwas directly

responsible, there are still unanswered questions. We're

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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 P'

"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

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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 FeldingRoth 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 antiarthritic drug, died from

a massive liver infection. This was confinned 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 after 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 over-

whelming 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

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clearly not responsible in either case? Just the same, the accumulaing

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 bad 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 11-amed 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.

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

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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."

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