Arthur Hailey - Strong Medicine

"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 officials 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.”

Oh 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 recognising 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 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.