I learned of this story from a FB friend. She sent me a wonderful article about a quiet hero that really made me think about the way we use drugs in pregnancy today.
There was a time, not too long ago when there were almost no regulations for bringing new drugs to the market. New medicines were sent to doctors to try out. Pharmaceutical agencies applied for a permit, and within 60 days the drug was on the market untested and often with unknown risks.
That was the way until Dr. Frances Kelsey worked for the FDA in 1960 and got intimately involved in the application process of a new drug. The William S. Merrell Company of Cincinnati wanted to sell a drug under the trade name Kevadon. At the time, the drug was very popular in Europe as a cure for morning sickness. The more common name for Kevadon: Thalidomide, today a CLEAR Pregnancy Category X medication.
While it was never approved for sale, Thalidomide made it into the US population as samples, for “experimental use only.” Unfortunately the number of doctors with the medication, and the number of women who took it where far greater than initially believed. As a result, THOUSANDS of infants were severely affected.
Times Magazine 1962: “All this added up to the greatest prescription disaster in medical history. Thanks to the intuition of the Food and Drug Administration’s Dr. Frances Kelsey,* the U.S. has got off lightly because the drug was never licensed for general use… the drug was obtained from abroad… Even so, the testing and marketing of new drugs in the U.S. are now almost certain to get close federal regulation.”
Fifty years later, Dr. Kelsey is being honored for her work. In the current NY Times article about her recognition, they report that Dr. Kelsey had a feeling something was not right. Things did not add up and she continued to research until she found the truth.
“Dr. Kelsey demanded better tests for thalidomide. She also distrusted Merrell, a company that had a history of confrontations with the F.D.A. … “I had the feeling throughout the day,” she wrote after a meeting with company executives, “that they were at no time being wholly frank with me and that this attitude was obtained in all our conferences, etc., regarding this drug.” (for a little more about her investigation read the 1962 article here)
While many safeguards where put in place after the Thalidomide incident, in recent years we have seen the FDA move to faster approval of drugs. This has created increasing debate as drugs are approved today, only to be found to have deadly side effects and be removed from the market a year or two later.
“The inauguration of the Kelsey award may also be a telling sign of where Dr. Hamburg stands in a series of internal agency struggles. For much of the past two decades, the F.D.A. has emphasized speed over certainty in its decisions — an industry-friendly stance that plays down safety concerns in favor of getting potential cures to the market as swiftly as possible.
But a series of drug, medical-device and food-safety controversies have led some agency medical officers to insist on better information before approving products and to lobby internally for risky products to be pulled from the market, putting the speed-oriented old guard on the defensive. A celebration of Dr. Kelsey, the patron saint of the agency’s safety-first faction, is bound to cheer those calling for greater caution. “
I hope that this does jog the memory of officials in office and reminder them of the dangers of what can happen when we use and approve too many medications, too often, too fast especially in pregnancy. Interesting note: When Dr. Kelsey was hired, they thought she was a man because of her first name. As history has shown, men have not routinely fought very hard for female issues. I wonder how many babies would have been affected if SHE had been a he.
In Birth and Love