It ’s official : As of Aug. 23 , theFood and Drug Administration(FDA ) give itsseal of approval to Pfizer ’s COVID-19 vaccinum . This is a landmark step in the fight against the novel coronavirus , and one that many the great unwashed ( vaccine hesitantor otherwise ) were waiting for .
FDA approval of any drug is no small matter . The process is rigorous and often lengthy — and that ’s by invention . But it was n’t always that way . Back in the day , " drugs were not develop on target , " says Katherine Donovan , a older scientist at theDana - Farber Cancer Institutein Boston , Massachusetts , " it was more like trial and error . "
So what change ? Today ’s FDA drug approving standards , modernize 60 years ago , were largely the product of a single drug and a woman who refused to give it FDA authorization .
The Hero of the FDA
We ’re talking about Frances O. Kelsey . She wasborn Frances Oldhamon Vancouver Island , British Columbia , in 1914 . She developed an interest in science betimes in life story . She earned a passkey ’s degree from McGill University in Montreal at age 20 , and would go on to fill out both an M.D. and Ph.D. in materia medica at the University of Chicago .
Like many women in science at the prison term , Kelsey faced opposition from the overwhelmingly manful scientific establishment . In fact , she suspected that her gender - neutral first namehelped launch her calling : The missive of acceptance for her Ph.D. program was even address to ' Mr. Oldham . '
" I do it that military personnel were the preferred commodity in those days,“she by and by wrote , " I do not know if my name had been Elizabeth or Mary Jane , whether I would have gotten that first big pace up . "
Nevertheless , Kelsey eventually joined the University of Chicago as a full - fledged faculty member in 1942 . It was there that she met and matrimonial fellow staff extremity Dr. Fremont Kelsey . In 1960 , the match moved with their two daughters to Washington , D.C. , where Francesaccepted a stead as a drug reviewer for the FDA . minuscule did she know , she was about to alter the course of history .
Dodging a Bullet
Just as Frances Kelsey was step into her new role at the FDA , a young drug was making the round in Europe , Africa and Asia .
Known asthalidomide , the drug was earlier uprise in the early 1950s as a sedative . " Back then , it was post - wartime and things were a trivial flake softheaded , " says Donovan , " so the world was in penury of a enough sedative to help people sleep . "
affected role taking thalidomide for anxiety quickly realized that it also worked wonders on an upturned tum , and it soon caught on as a remedy formorning sickness . A few people reported tingling in their hands and foot — also called neuropathy — after prolonged thalidomide use . However , these electronegative effect wear off as before long as they stop taking it , and so the drug was generally considered good . By 1957 , it wasapproved for over - the - counter sale in Germany , and uncommitted by prescription in XII of other countries .
The FDA diligence for thalidomide crossed Kelsey ’s desk in September 1960 , just seven month after she begin go there . At the time , theFDA ’s approval processfor new drug lasted just 60 days , during which the reviewer would wade through a hodgepodge of assorted black eye trial data and other material submitted by the applicant . Given thalidomide ’s popularity , it seemed destined to voyage through with ease .
But Kelsey had some concerns . An English study , which include some reports of neuropathy and standardized heart - related symptoms , pay her pause . She was also wary of the deficiency of data regarding the drug ’s core on pregnancy . Without further research , she decline to approve the drug .
It was a bold move . " There was a caboodle of pressure level from around the world to approve it , " Donovan says . Still , Kelsey stay put firm . One year later , her caution was vindicated .
The Rise and Fall of Thalidomide
Around the same clip thalidomide was under scrutiny for approval in the United States , Dr. William McBrideof Australia and Dr. Widukund Lenzof Germany both notice a strange normal : an strange number of children bear with strikingly like innate limb anomalies , all within a relatively small geographical area . The vulgar denominator , they discovered , was that their mothers hadall taken thalidomide for morning sicknessearly in their pregnancy .
McBride prove the alarm with abombshell piecepublished in the Lancet in 1961 , sending stupor wave through the aesculapian community . Thalidomide was pulled from shelf in Germany almost straightaway ; other countries followed suit briefly thereafter .
Kelsey ’s contribution in keep thalidomide largely out of U.S. drugstore might have gone unnoticed by the populace if not for a Washington Postarticle published in 1962 . That same year , PresidentJohn F. Kennedyawarded Kelsey the President ’s Award for Distinguished Federal Civilian Service and signed theKefauver - Harris amendmentsinto jurisprudence . This primal bit of lawmaking is the reason that drug in the U.S. must encounter rigid clinical trial criterion in ordering to be approved by the FDA .
Kelsey would go on to dish up the FDA for 45 years , helping hone the organization ’s drug commendation physical process all the while .
Curiously , that ’s not wherethe story of thalidomideends . In the backwash of its disastrous bequest , scientist began looking deeply into the mechanism of the drug itself to detect why it caused such unexpected side effect . They find that , unlike most drug , which simply bind to one receptor in the dead body , thalidomide " in reality raise other thing to bind . And that chair to those proteins being removed from the organic structure completely , " Donovan says . This can be either good or very bad , depending on which protein get hit . But by fine - tuning thalidomide ’s molecular structure , research worker believed it might be potential to target specific " bad " proteins for removal .
In 2006 , this enquiry revealed the drug ’s potential fortreating leprosyand plasm cell myeloma , an rare type of bone marrow Crab . Since then , two different drug based on the structure of thalidomidehave been approvedfor cancer treatment by the FDA .
