Strong Medicine (49 page)

Prescribed for pregnancy;

Let's sell it strong, proclaim its joys,

Its riskless potency!

The words had been sung cheerfully and loudly this morning by the

assembled sales people, and would be repeated often over the next two

days. Celia, personally, had reservations about the song, but others in

sales had argued in its favor, so she agreed to its use, not wanting to

dampen buoyant spirits.

As to United States testing programs for the drug, these had been

conducted over the preceding year and a half-on animals and five hundred

humans-with only the mildest and occasional side effects, none medically

significant. The good results were similar to those in other countries

where Montayne was already on sale, enormously popular and being praised

by prescribing physicians and their women patients.

Following the United States tests, the usual voluminous new drug

application had been submitted to FDA's Washington headquarters, with the

hope of fast approval.

Unfortunately, that hope had proved in vain. So far, FDA permission to

sell the drug as a prescription product had not been given, and this was

one of two small clouds now hovering over Felding-Roth's elaborate

marketing scheme.

At company headquarters, however, it was considered impossible to halt

all preparations until approval was granted; otherwise six months or more

of selling and important revenue would be lost. So the decision was made

to proceed with manufacturing, preparation of advertising, and warm-up

sessions like this one, on the assumption that the FDA green light would

be given before the critical deadline.

Sam Hawthorne, Vincent Lord, and others were confident the needed FDA

approval would be forthcoming soon. They also noted

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that one factor working in Felding-Roth's favor was media publicity.

Because of the progress and popularity of Montayne overseas, questions

now being asked publicly were: Why was FDA taking so long to decide? Why

was American womanhood being denied this beneficial medication when other

women elsewhere were using it successfully and safely? The phrase

"American drug lag" was once more being bandied around critically, the

blame for it directed at the FDA.

One of the pointed questioners was Senator Dennis Donahue,

normally a critic of the pharmaceutical industry but now recogniz

ing which side of an issue was the popular one. In response to a

reporter's query, he described the FDA's indecision over Montayne

as "clearly ridiculous in the circumstances." Donahue's comment

Was Weleorn, - rd at Felding-Roth.

The othe- small cloud was created by Maud Stavely, M.D., chairperson of

the New York-based consumer group, Citizens for Safer Medicine.

Dr. Stavely and her CSM were aggressively opposed to American approval

of Montayne, arguing that the drug might be unsafe and should be given

more prolonged testing. All who would listen were bombarded with this

view, which received considerable media coverage.

The basis of the Stavely argument was a civil lawsuit which had been

argued several months earlier in the courts of Australia.

A twenty-three-year-old woman living in the Australian Outback near Alice

Springs had given birth to a female child. The mother, during pregnancy,

had been one of the early users of Montayne. Later, tests showed the baby

girl to be mentally deficient, her mind described by doctors as "a

blank." Also, the child was unable to make any but the feeblest physical

movements, even a year after birth. Examining physicians agreed the child

would forever remain a vegetable and would never walk or sit up unaided.

A lawyer hearing of the case persuaded the mother to sue the Australian

company that distributed Montayne. The suit went to court and was

dismissed. That judgment was appealed to a higher court, which ruled

against the plaintiff, upholding the lower-court decision.

During both-legal proceedings the evidence seemed overwhelming that

Montayne was not responsible for the child's condition. The mother, a

person of poor reputation who admitted not know-

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ing who the baby's father was, had been taking other drugs throughout her

pregnancy-methaqualone (Quaalude), diazepam (Valium), and several others.

She was also a near-alcoholic, a chain smoker and a user of marijuana. An

expert medical witness at the jury trial described her body as "a horrible

cauldron of antagonistic chemicals from which anything could happen." He and

other medical witnesses absolved Montayne from linkage with the baby's de-

fects.

Only an Outback "flying doctor" who had treated the woman during pregnancy

and delivered the child at birth testified on the mother's behalf and

blamed Montayne, which he himself had prescribed. However, under

cross-examination the doctor admitted having no evidence to back his claim,

only what he described as "a bloody strong hunch." In light of other,

expert testimony, his views were not taken seriously.

Subsequently, an Australian government-sponsored inquiry, where medical and

scientific experts again testified, reached the same conclusion as the

courts, confirming Montayne to be a safe drug.

The American, Dr. Stavely, a notorious publicity seeker, had no other

evidence to support her opposition to Montayne.

Thus, though the Maud Stavely-CSM campaign was regarded at Felding-Roth as

a nuisance, it did not represent a major problem.

Now, at the San Francisco sales meeting, after waiting for applause to

subside, Celia continued her address.

"Something you may encounter," she cautioned her listeners, "is anxiety

about our new drug, Montayne, from people with memories of an older drug,

Thalidomide, which had terrible effects on the fetuses of pregnant women,

causing them to give birth to deformed babies. I am mentioning this now,

bringing it out in the open, so it is a subject we are all prepared for."

There was silence in the hall as the men and women facing Celia listened

attentively.

"The differences between Montayne and Tbalidomide are many and

overwhelming.

"in the first place, Thalidomide was developed some twenty years ago at a

time when pharmaceutical research was not as thorough, or safety

regulations as informed and rigorous as they are today. Another thing-and

contrary to popular beliefThalidomide was never intended, or used

specifically, as a drug for women. It was a general sedative, a sleeping

pill.

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"And going back to the subject of research, Thalidomide was not tried

experimentally on a wide range of animals before it was put to human use.

After the banning of Thalidomide, for example, expenments with animals

showed that some breeds of rabbits produced the same deformed fetuses as

humans, demonstrating that if those full animal studies had been done,

the human tragedies would never have happened."

Celia paused, referring to her notes which she had prepared carefully for

this and later occasions.

Still with the same attention focused on her, she said, "Montayne, on the

other hand, has had the fullest possible range of tests-including tests

on various types of animals, as well as on human volunteers-in five

countries, all of which have strict laws affecting drug control.

Moreover, in most of those countries Montayne has been used by many

thousands of women for well over a year. Let me give you just one example

of how thoroughly this research and testing program has been carried

out."

Celia described the decision of Laboratoires Gironde-Chimie, the French

discoverers of Montayne, to do an additional year of medical testing over

and above that required by French law, to be certain of their product's

quality.

"Probably no drug ever introduced before," she added, "has been tested

more thoroughly for safety."

Following Celia's speech, scientific spokesmen from the company endorsed

her words and answered questions from the sales force.

"How did your sales presentation go?" Andrew asked an hour or so later

in the comfortable luxury of their suite at the Stanford 'Court. He had

taken a few days off from his practice to accompany Celia westward and,

at the same time, visit Lisa, now a freshman at Stanford and living on

campus.

"Well enough, I think." Celia kicked off her shoes, stretched tiredly,

and put her feet up on a sofa. "In some ways, regional sales meetings are

like a traveling road show, so we should get better with each

performance." She regarded her husband curiously. "Do you realize that

was the first time you've asked me a question about anything to do with

the progress of Montayne?"

"Is it?" He tried to sound surprised.

"You know it is. I'd like to know why."

"Maybe it's because you tell me everything, so I've never needed to ask."

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"That isn't true," Celia said. "The truth is, you still have reservations,

haven't you?"

"Look," Andrew objected, putting aside a newspaper he had been reading when

she came in, "I'm not qualified to make judgments about a drug I haven't

used. You've a host of scientific people, here and abroad, who know much

more than I do. They say Montayne is okay. So . . ." He shrugged.

"But would you prescribe it fbr a patient?"

"I don't have to. Fortunately I'm not an obstetrician or a gynecologist. "

"Fortunately?"

"A slip of the tongue." Andrew said impatiently, "Let's talk about

something else."

"No," Celia persisted; there was an edge to her voice. "I want to talk

about this because it's important to both of us. You always used to say no

woman should take any drug during pregnancy. Do you still believe that?"

"Since you ask-yes, I do."

"Isn't it possible," Celia said, "that while you were right once, that view

could now be out of date? After all, it's a long time since you began

practicing medicine-twenty years-and many things have changed." She

remembered something Sam had told her. "Weren't there doctors who opposed

anesthesia for pregnant women because they said . . . T'

Andrew was becoming angry. "I told you I don't want to talk about this."

She snapped back, "But I do!"

"Dammit, Celia! I'm not involved with your Montayne and don't intend to be.

I've already admitted I don't have the knowledge-"

"But at St. Bede's you have influence."

"Which I will not use-one way or the other-about Montayne."

They were glaring at each other when the telephone rang. Celia swung her

legs down and reached out to answer.

A woman's voice inquired, "Mrs. Jordan?"

"Yes.-

"This is Felditig-Roth, Boonton. Hold, please, for Mr. Hawthorne."

Sam came on the line. "Hi, Celia. How is everything going so far?"

"Very well." The positive mood in which she had left the Fair-

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mont session returned. "The presentations have gone smoothly, Everyone in

the field is keen, and anxious to begin selling Montayne."

"Greatl"