Frances Oldham Kelsey And Helen Brooke Taussig – Two Advocates For Drug Safety
September 29, 2019 at 11:11 p.m.
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While more than 8,000 children worldwide were born with such deformities as flipper like arms and legs, the United States escaped practically unscathed due to the diligence of an FDA medical reviewer, Frances Kelsey, and a physician, Helen Taussig. Because of their work, thalidomide was not approved for mass American distribution.
Dr. Kelsey
Dr. Frances Kathleen Oldham Kelsey worked at the Food and Administration for years, retired at age 90 in 2005, and died in London, Ontario, on Aug. 7, 2015, at age 101. Kelsey was a pharmacologist from the agency who helped save the United States from the thalidomide disaster, but also prompted widespread and justifiable concern about the inadequacy of drug regulations in the 1960s.
Kelsey's efforts in premarket review are part of the fascinating history of food and drug law and the effect individuals can have in changing it.
Dr. Taussig
Not as well known perhaps was the work done by Dr. Helen Taussig. When in 1962 she heard about the tragedy unfolding in Europe due to thalidomide, she traveled there to examine affected babies and learn about their medical history. Having confirmed that thalidomide was the cause, she returned to the United States, testified, lectured and wrote in opposition to the pharmaceutical industry until the FDA refused to approve the drug. Without the indefatigable work done by Kelsey and Taussig, thalidomide would have been approved here in the early 1960s.
Taussig was one of the few women to apply and graduate from Johns Hopkins University Medical School, and she obtained her degree there in 1927. Her work in pediatric cardiac surgery was instrumental in her appointment as chief of the department, a position she held until her retirement in 1963. Many of the procedures she helped develop are still in use today. She died in 1986.
About Thalidomide
Thalidomide was synthesized in West Germany in 1953 and, because it had no pharmacological effect in laboratory animals, the original company working with the drug discarded it. Subsequently, the West German firm Chemie Grunenthal undertook development of the compound, but once again thalidomide showed no effects in animals and appeared to be nontoxic. (It seemed impossible to find a dose high enough to kill a rat.) The structure of the molecule suggested it could be effective as a sedative acting promptly to provide a deep, all-night sleep without a hangover. Given the trade name Contergan in 1960, it became the most commonly used sleeping remedy in West Germany, available without a prescription. It was thought to be as safe for humans as for animals.
By the early 1960s, pharmaceutical companies in countries other than West Germany began to market the drug. At the height of its demand, thalidomide was being produced by 14 firms under 15 different trade names.
On Sept. 8, 1960, the Canadian branch of William S. Merrell Company of Cincinnati, Ohio, applied to the Food and Drug Administration for approval to sell their version of thalidomide, Kevadon, in the United States.
The review was passed on to Dr. Kelsey, a new medical officer. Because the drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed to be routine, it appeared to be readily approvable. Existing laws at that time held that after an application had been submitted, the agency had 60 days in which to decide that the drug was safe for the proposed use; if the FDA did not respond, the drug was automatically approved. But some of the data on drug safety troubled Kelsey and she asked Merrell management for more information.
The application for thalidomide landed on her desk on Sept. 12, 1960, one week after she reported to work. She was concerned that no lethal dose for rats could be found as it suggested that the rats were simply not absorbing the drug. Then there was a question as to why thalidomide was an hypnotic in humans and not able to induce sleep in animals. Kelsey waited until the 58th day after her review before declaring the application incomplete, and thus ineligible for submission. This meant that a new application had to be filed which provided more time for Kelsey to ponder and reject it.
Congress, in light of the thalidomide tragedy, reexamined the new drug approval process and promulgated the Drug Amendments of 1962. The amendments were the most comprehensive revision of the drug regulatory law since passage of the 1938 Act.
Final Thoughts
Thalidomide is also newsworthy and is currently being used for a number of indications with a host of safeguards. It was initially approved on July 16, 1998, to treat a clinical form of leprosy and later for multiple myeloma.
Max Sherman is a medical writer and pharmacist retired from the medical device industry. He has taught college courses on regulatory and compliance issues at Ivy Tech, Grace College and Butler University. Sherman has an unquenchable thirst for knowledge on all levels. Eclectic Science, the title of his column, touches on famed doctors and scientists, human senses, aging, various diseases, and little-known facts about many species, including their contributions to scientific research. He can be reached by email at [email protected].
While more than 8,000 children worldwide were born with such deformities as flipper like arms and legs, the United States escaped practically unscathed due to the diligence of an FDA medical reviewer, Frances Kelsey, and a physician, Helen Taussig. Because of their work, thalidomide was not approved for mass American distribution.
Dr. Kelsey
Dr. Frances Kathleen Oldham Kelsey worked at the Food and Administration for years, retired at age 90 in 2005, and died in London, Ontario, on Aug. 7, 2015, at age 101. Kelsey was a pharmacologist from the agency who helped save the United States from the thalidomide disaster, but also prompted widespread and justifiable concern about the inadequacy of drug regulations in the 1960s.
Kelsey's efforts in premarket review are part of the fascinating history of food and drug law and the effect individuals can have in changing it.
Dr. Taussig
Not as well known perhaps was the work done by Dr. Helen Taussig. When in 1962 she heard about the tragedy unfolding in Europe due to thalidomide, she traveled there to examine affected babies and learn about their medical history. Having confirmed that thalidomide was the cause, she returned to the United States, testified, lectured and wrote in opposition to the pharmaceutical industry until the FDA refused to approve the drug. Without the indefatigable work done by Kelsey and Taussig, thalidomide would have been approved here in the early 1960s.
Taussig was one of the few women to apply and graduate from Johns Hopkins University Medical School, and she obtained her degree there in 1927. Her work in pediatric cardiac surgery was instrumental in her appointment as chief of the department, a position she held until her retirement in 1963. Many of the procedures she helped develop are still in use today. She died in 1986.
About Thalidomide
Thalidomide was synthesized in West Germany in 1953 and, because it had no pharmacological effect in laboratory animals, the original company working with the drug discarded it. Subsequently, the West German firm Chemie Grunenthal undertook development of the compound, but once again thalidomide showed no effects in animals and appeared to be nontoxic. (It seemed impossible to find a dose high enough to kill a rat.) The structure of the molecule suggested it could be effective as a sedative acting promptly to provide a deep, all-night sleep without a hangover. Given the trade name Contergan in 1960, it became the most commonly used sleeping remedy in West Germany, available without a prescription. It was thought to be as safe for humans as for animals.
By the early 1960s, pharmaceutical companies in countries other than West Germany began to market the drug. At the height of its demand, thalidomide was being produced by 14 firms under 15 different trade names.
On Sept. 8, 1960, the Canadian branch of William S. Merrell Company of Cincinnati, Ohio, applied to the Food and Drug Administration for approval to sell their version of thalidomide, Kevadon, in the United States.
The review was passed on to Dr. Kelsey, a new medical officer. Because the drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed to be routine, it appeared to be readily approvable. Existing laws at that time held that after an application had been submitted, the agency had 60 days in which to decide that the drug was safe for the proposed use; if the FDA did not respond, the drug was automatically approved. But some of the data on drug safety troubled Kelsey and she asked Merrell management for more information.
The application for thalidomide landed on her desk on Sept. 12, 1960, one week after she reported to work. She was concerned that no lethal dose for rats could be found as it suggested that the rats were simply not absorbing the drug. Then there was a question as to why thalidomide was an hypnotic in humans and not able to induce sleep in animals. Kelsey waited until the 58th day after her review before declaring the application incomplete, and thus ineligible for submission. This meant that a new application had to be filed which provided more time for Kelsey to ponder and reject it.
Congress, in light of the thalidomide tragedy, reexamined the new drug approval process and promulgated the Drug Amendments of 1962. The amendments were the most comprehensive revision of the drug regulatory law since passage of the 1938 Act.
Final Thoughts
Thalidomide is also newsworthy and is currently being used for a number of indications with a host of safeguards. It was initially approved on July 16, 1998, to treat a clinical form of leprosy and later for multiple myeloma.
Max Sherman is a medical writer and pharmacist retired from the medical device industry. He has taught college courses on regulatory and compliance issues at Ivy Tech, Grace College and Butler University. Sherman has an unquenchable thirst for knowledge on all levels. Eclectic Science, the title of his column, touches on famed doctors and scientists, human senses, aging, various diseases, and little-known facts about many species, including their contributions to scientific research. He can be reached by email at [email protected].
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