Senin, 09 Mei 2011

Frances Oldham Kesley (eng ver)

Now, let's talk a bit about pharmacy history, still in the Q-A form

Q : Who is Frances Odham Kesley?

A : She's a pharmacolist, born 24 July in Canada. Famous as a FDA reviewer that refused t approve Thalidomide being marketed in USA because she had concern about it's safety.

Q : Why is it important?

A : Because at that time, the regulation about drugs are not as strong as now. You don't have to prove your drug is safe or have an effect to be marketed. the Dosage could also be made up by yourselves. This Event is a important milestone for safer, better and proven effective drugs.

Q : How about the event?

A : Dr, Kesley joined FDA in 1960 as one of the scientist group that fight so that drugs have to proven effective to be approved. There were only 11 drug reviewers at that time.

There, Richardson Merrell sent an application for thalidomide to be marketed in USA, with the trade name "Kevadon", a drug that has been widely marketed in Europe and Canada for pregnant mother's "Morning Sickness".

But, even it has been approved in many places elsewhere, Kesley refused it, and demand a further study about the safety of this drug. She kept refusing although there was a huge pressure from pharmacy industries, and the drug has been marketed worldwide.

But, history has shown that she was right. The news from europe supported her. Researches show that Thalidomide can penetrate the plasenta barrier and can cause malformation of babies. Kesley prevented that to happen in USA.

Q : Is there anymore unique things about her?

A : Although a woman, her parents sent her to a private school for boys because that's where she can get good education.

there was also this case where she was thought to be a men by Dr. Geiling, the professor that hired her for a Pharmacology work. Kesley then asked her mentor about wheteher she should take the work or not.

"Don't be silly." the mentor said. "Accept the job, write your name and the (miss) afterwards."

Kesley accepted the job without clarifying that she's a women first.

With Dr. Geiling, she finished the case about the Sulfanilamide Elixir poisoning, that was caused by the use of diethylene glycol as the solvent. Her work with Dr. Geiling got credit in teratogenik.

So, for the pharmacists/apothecary out there, please remember we are the one who guarantee the drug safety and efficacy for the patient.



from :

http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey
http://www.jimplagakis.com/?s=thalidomide&x=0&y=0

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