Earlier, Lilian had confided her concern that Juliet, who was twenty, should be marrying so young and abandoning college after only two years. But on the day of the wedding Sam and Lilian seemed so radiantly happy that such thoughts had clearly been put away—with good reason, Celia thought. Watching Juliet and Dwight, an intelligent and talented, yet modest, unaffected couple, she was impressed with them and had a conviction that theirs was a marriage which would work.
In May of that year, something of special interest to Celia was the publication of The Drugging of the Americas.
It was a book which attracted wide attention and cataloged the shameful failure of American and other pharmaceutical firms doing business in Latin America to supply warnings about adverse side effects of their prescription drugs—warnings required by law in more sophisticated countries. Described and documented were the practices which Celia, during her years in international sales, had observed personally and had criticized at Felding-Roth.
What made the book different from routine, acerbic attacks on the industry was the scholarly thoroughness of its author, Dr. Milton Silverman, a pharmacologist and faculty member of the University of California at San Francisco. Dr. Silverman had also testified a short time earlier before a congressional committee which listened to him with respect. In Celia’s view it was one more warning that the pharmaceutical business should accept moral obligations as well as legal ones.
She bought a half-dozen copies of the book and sent them to company executives who responded predictably. Typical was Sam Hawthorne who scribbled a memo:
Basically I share Silverman’s views and yours. However, if changes are made there will have to be all-around agreement. No one company can afford to put itself at a disadvantage to all other competitors—especially ourselves at the moment because of our delicate financial condition.
To Celia, Sam’s seemed a specious argument, though she did not contest it further, knowing she would not win.
A considerable surprise was the response of Vincent Lord, who sent a friendly note.
Thanks for the book. I agree there should be changes, but predict our masters will kick and scream against them until forced at pistol point to mend their ways. But keep trying. I’ll help when I can.
Increasingly of late, the director of research seemed to have mellowed, Celia thought. She remembered sending him, thirteen years before, a copy of The Feminine Mystique which he returned with a curt remark about “rubbish.” Or was it, she wondered, because Vince Lord had decided she was now high enough in the company to be useful to him as an ally?
During April, Lisa telephoned home to report excitedly that she would be heading for California in the fall. She had been accepted at Stanford University. Then, in June, Lisa graduated from Emma Willard in a gracious outdoor ceremony which Andrew, Celia and Bruce attended. Over a family dinner in Albany that night Andrew observed, “Today’s a high point, but otherwise I predict, worldwide, a dull year.”
Almost at once he was proved wrong by a daring Israeli airborne commando raid on Entebbe Airport, Uganda, where more than a hundred hostages were held captive, having been seized by Arab terrorists aided by the treacherous Uganda President Idi Amin. As the free world cheered, delighted to share some upbeat, inspirational news for a change, the Israelis freed the hostages and flew them back to safety.
The dullness did return, however—as Andrew was quick to point out—when, at the Democratic national convention in New York, an obscure Georgia populist, leaning heavily on being a “born-again” Southern Baptist, secured the nomination for President.
Despite the American public’s disenchantment, first with Nixon, now with Ford, it seemed unlikely the newcomer could win. In the Felding-Roth cafeteria Celia heard someone ask, “Is it conceivable that the highest office in this world could be held by someone who calls himself Jimmy?”
Yet, at the Morristown corporate headquarters there was little time for thoughts of politics. Most attention was focused on the exciting new drug soon to be released—Montayne.
It was almost two years since Celia had expressed to Sam her doubts and unease about Montayne but, at Sam’s urging, had agreed to keep an open mind while studying research and testing data.
In the meantime there had been voluminous material, most of which Celia read. As she did, her conviction grew that Sam was right: pharmaceutical science had made amazing advances in fifteen years, and pregnant women should not be denied a beneficial drug simply because another drug, long ago, had proven harmful.
Equally significant: the testing of Montayne—first in France, subsequently in Denmark, Britain, Spain, Australia, and now in the United States—had clearly been as cautious and complete as human care could make it. Thus, because of authenticated results and her own reading, Celia was not only convinced of the safety of Montayne, but enthusiastic about its usefulness and commercial possibilities.
At home, on several occasions, she attempted to share her knowledge with Andrew, seeking to convert him to her changed opinions. But, uncharacteristically, Andrew appeared to have a closed mind. He always managed to turn their conversation to other matters, making it clear that while wishing to avoid an argument, Montayne was a subject he preferred to hold at arm’s length.
In the end Celia gave up, in Andrew’s presence keeping her enthusiasm to herself. There would be, she knew, many other outlets for it once Felding-Roth’s sales campaign began in earnest.
8
“The important thing all of us in sales must remember and emphasize about Montayne,” Celia said into the podium microphone, “is that it is a completely safe drug for pregnant women. More than that, it is a joyous drug! Montayne is something which women—plagued by nausea and sickness during pregnancies—have needed, longed for, and deserved for centuries. Now, at last, we of Felding-Roth have become emancipators, freeing American women from their ancient yoke, making each day of pregnancy better, brighter, happier! The drug to end ‘morning sickness’ forever is here! We have it!”
There was a spirited burst of handclapping from the audience.
It was October 1976. Celia was in San Francisco at a Felding-Roth regional sales meeting, attended by the company’s detail men and women, sales supervisors and regional managers from nine western states, including Alaska and Hawaii. The three-day session was at the Fairmont Hotel on Nob Hill. Celia and several other senior officers of the company were staying at the elegant Stanford Court across the street. Among them was Bill Ingram, once Celia’s junior at O-T-C and now, as deputy director of pharmaceutical sales, her principal assistant.
Marketing plans for Montayne were in high gear, and Felding-Roth hoped to have the product on the market by February, now only four months away. Meanwhile it was necessary that those who would be selling Montayne know as much about the drug as possible.
Among the sales force, enthusiasm about the prospects for Montayne was running high, and someone at head office had composed a song to be sung to the tune of “America the Beautiful.”
O beautiful for carefree days,
For dreams of motherhood,
For now in safe and simple ways,
All mornings can be good!
Montayne, Montayne!
Montayne, Montayne!
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 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 recognizing 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 welcomed at Felding-Roth.
The other 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 knowing 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 defects.
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 Thalidomide 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 belief—Thalidomide was never intended, or used specifically, as a drug for women. It was a general sedative, a sleeping pill.
“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, experiments 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.”
“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 shru
gged.
“But would you prescribe it for 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 …?”
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 Felding-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 Fairmont session returned. “The presentations have gone smoothly. Everyone in the field is keen, and anxious to begin selling Montayne.”
Strong Medicine Page 29
