Arthur Hailey - Strong Medicine

Developments started slowly, unnoticed except locally, and-in the minds of anyone involved at the beginning-unconnected with a drug. In West Germany, in April 1961, physicians were startled by an outbreak of phocomelia-a rare phenomenon in which babies are born tragically deformed, without arms or legs, instead having tiny, useless, seal-like flippers. The previous year two cases had been reported----even that an unprecedented number since, as one researcher put it, "'two-headed children have been more common.”

Now, suddenly, there were dozens of phocomelic babies. Some mothers, when shown the children to whom they had given birth, screamed in revulsion and despair. Others wept, knowing that, as one put it, "my son could never feed himself unaided, bathe himself, attend to basic sanitary requirements, open a door, hold a woman in his arms, or even write his name.”

Among the mothers, several committed suicide; far more required psychiatric help. A formerly devout father cursed God.”I spit and shit upon him!" Then he corrected himself.”There is no God. How could there be?" And still the cause of the phocomelia outbreak remained unknown. (The word, it was explained, is from the Greek-phoke meaning "seal"; melos is "limb.” ) One study suggested the cause might- be radioactive fallout from atom bombs. Another, that a virus was at work. Many of the babies had other defects as well as missing limbs. Ears were absent or deformed; hearts, bowels and other organs were incomplete or didn't function as they should. Some babies died-"the lucky ones," as one observer wrote. Then, in November 1961, two doctors working independently and unknown to each other-a pediatrician in Germany and an obstetrician in Australia-linked phocomelia to the drug Thalidomide. Soon afterward, it was established that the drug was indeed the cause of the defective births. Australian authorities, acting swiftly, ordered Thalidomide off the market during the same month the connection became known. West Germany and Britain withdrew the drug a month later, in December. But in the United States it was two months more until, in February 1962, the Thalidomide-Kevadon application was withdrawn from the FDA. Canada, inexplicably, left the drug on sale until March--four months later than the Australian withdrawal and time for many more individuals, including pregnant women, to take it. Celia and Andrew, who followed the grim story by reading scientific publications as well as the regular press, discussed it frequently. One night at dinner Celia said, "Oh, Andrew, how glad I am you wouldn't let me take any drugs during pregnancy!" A few minutes earlier she had looked with love and gratitude at their own two healthy, normal children.”I could have taken Thalidomide. I hear there are doctors' wives who did.”

Andrew said quietly, "I had some Kevadon myself " You did?" "I was given samples by a detail man.”

Jolted, Celia said, "But you didn't use them?" Andrew shook his head.”I'd like to say I had a suspicion about the drug, but it wouldn't be true. I simply forgot they were there.”

"Where are the samples now?" "Today I remembered them. I pulled them out. There were several hundred tablets. I read somewhere that more than two and a half million were distributed to American doctors. I've flushed mine down the toilet.”

"Thank God.”

"I'll second that.”

In the months that followed, more news about Thalidomide continued to flow in. It was estimated that twenty thousand deformed babies were born in twenty countries, though the exact number would never be known. In the United States the number of phocomelia births was Iowan estimated eighteen or nineteen-because the drug had never been approved for general use. Had it been approved, the number of armless and legless American babies would probably have reached ten thousand. "I guess we all owe a debt to that woman Kelsey," Andrew commented to Celia on a Sunday in July 1962. He was at home, relaxing, a newspaper spread out before him in the den they shared. "Kelsey" was Dr. Frances Kelsey, an FDA medical officer who, despite intense pressure from the drug firm which planned to market Thalidomide-Kevadon, used bureaucratic tactics to delay it. Now, declaring she'd had scientific reasons for doubting the drug's safety all along, Dr. Kelsey was a national heroine. President Kennedy had awarded her the President's Gold Medal for Distinguished Service, the country's highest civilian decoration. "As it turned out," Celia said, "what she did was right, and I agree about being grateful. But there are some who say she got the medal for doing nothing, just putting off making a decision, which is always the safe thing for a bureaucrat to do, and now she's claiming to have had more foresight than she really did. Also, it's feared that what Kennedy has done will mean that in the future, good drugs that are truly needed will be delayed by others at FDA who'd like a medal too.”

"What you have to understand," Andrew said, "is that all politicians are opportunists and Kennedy's no exception, nor is Kefauver. Both of them are using the pubhcity about Thalidomide for their own advantage. Just the same, we need some kind of new law because whatever else Thalidomide did, it sure as hell showed that your industry, Celia, can't regulate itself and that parts of it are rotten.”

The remark was prompted by revelations, following investigations into the drug firms responsible for Thalidomide, of duplicity, callousness, greed, cover-up and incompetence, revelations that seemed to surface almost daily. Celia acknowledged sadly, "I wish I could argue with you. But no one in their right mind could.”

Surprisingly, and despite the political maneuvering that preceded it, some good legislation did emerge and was signed into-law by President Kennedy in October 1962. While far from perfect, and with provisions which later would deny valuable new drugs to those in desperate need of them, the new law provided consumer safeguards that had not existed "B.T.”

which was how many in the drug industry would in future identify the era of "before Thalidomide.”

Also in October the news reached Celia that Eli Camperdown, president and CEO of Felding-Roth, who had been ill for several months, was dying. The cause was cancer. A few days after she heard, Sam Hawthorne summoned Celia to his office. "Eli has sent a message. He would like to see you, He's been taken home from the hospital and I've arranged for you to be driven there tomorrow.”

The house was five miles southwest of Morristown at Mount Kemble Lake. Located at the end of a long driveway and shielded from outside view by trees and heavy shrubbery, it was large and old, with a frontage of fieldstone which had weathered and taken on a green patina. From the outside the interior looked dark. Inside, it was. A stooped, elderly butler let Celia in. He led her to an ornate drawing room furnished with heavy period pieces and asked her to wait. The house was quiet, with no sounds of activity. Perhaps, Celia thought, it was because Eli Camperdown lived alone; she knew he had been a widower for many years. In a few minutes a uniformed nurse appeared. In contrast to the surroundings, she was young, pretty and brisk.”Will you please come with me, Mrs. Jordan. Mr. Camperdown is expecting you.”

As they climbed a wide, curving staircase with deep carpeting Celia asked, "How is he?" The nurse said matter-of-factly, "Very weak and in a good deal of pain, though we use sedation to help him with that. Not today, though. He said he wished to be alert.”

She looked at Celia curiously.”He's been looking forward to your coming.”

Near the head of the staircase the nurse opened a door and motioned Celia in. At first Celia had difficulty in recognizing the gaunt figure propped up by pillows in the large four-poster bed. Eli Camperdown, who not long since had seemed the embodiment of strength and power, was now emaciated, wan and fragile-a caricature of his former self. His eyes, sunk in their sockets, regarded Celia as his face twisted in an attempt to smile. When he spoke his voice was low and reedy.”I'm afraid advanced cancer isn't pretty, Mrs. Jordan. I hesitated about letting you see me like this, but there are things I wanted to say to you directly. I thank you for coming.” The nurse had brought a chair before leaving them alone and Celia sat in it beside the bed.”I was glad to come, Mr. Camperdown. I'm just sorry you are ill.”