The mighty oak was once a little nut that stood its ground.
Biblical text: A man cannot be established through wickedness, but the righteous cannot be uprooted. Proverbs 12:3
In the 1960s, drug companies were presenting nearly 700 applications a year to the Federal Drug Administration for new medicines. The beleaguered New Drug Section only had sixty days to review each drug before giving approval or requesting more data.
A few months after Dr Frances Kelsey joined the FDA, an established pharmaceutical firm in Ohio applied for a license to market a new drug, Kevadon. In liquid form, the drug seemed to relieve nausea in early pregnancy. It was given to millions of expectant women, mostly in Europe, Asia, and Africa. Although scientific studies revealed harmful side effects, the pharmaceutical firm printed 66,957 leaflets declaring its safety. The company exerted great pressure on Dr. Kelsey to give permission for labels to be printed, in anticipation of the drug's approval.
Dr. Kelsey reviewed the data and said no. Through several rounds of applications she continued to find the data "unsatisfactory." After fourteen-month struggle, the company humbly withdrew its application. "Kevadon" was thalidomide, and by that time, the horror of thalidomide, deformities was becoming well publicized! One firm "no" decision by Dr. Kelsey spared untold agony in the United States.
Sometimes standing your ground on something may not seem that important but in time you may see the "big" picture.
Biblical text: A man cannot be established through wickedness, but the righteous cannot be uprooted. Proverbs 12:3
In the 1960s, drug companies were presenting nearly 700 applications a year to the Federal Drug Administration for new medicines. The beleaguered New Drug Section only had sixty days to review each drug before giving approval or requesting more data.
A few months after Dr Frances Kelsey joined the FDA, an established pharmaceutical firm in Ohio applied for a license to market a new drug, Kevadon. In liquid form, the drug seemed to relieve nausea in early pregnancy. It was given to millions of expectant women, mostly in Europe, Asia, and Africa. Although scientific studies revealed harmful side effects, the pharmaceutical firm printed 66,957 leaflets declaring its safety. The company exerted great pressure on Dr. Kelsey to give permission for labels to be printed, in anticipation of the drug's approval.
Dr. Kelsey reviewed the data and said no. Through several rounds of applications she continued to find the data "unsatisfactory." After fourteen-month struggle, the company humbly withdrew its application. "Kevadon" was thalidomide, and by that time, the horror of thalidomide, deformities was becoming well publicized! One firm "no" decision by Dr. Kelsey spared untold agony in the United States.
Sometimes standing your ground on something may not seem that important but in time you may see the "big" picture.
1 comment:
This is great info to know.
Post a Comment