On this first chapter of a brand new five-part season of Misplaced Girls of Science, we meet Frances Oldham Kelsey, a doctor and pharmacologist who joined the U.S. Meals and Drug Administration as a medical reviewer in 1960. Earlier than the yr was out, Kelsey discovered herself standing as much as massive pharma.
It’s September 1960, and a thick new drug software lands on Kelsey’s desk. The drug has already been available on the market in Europe for 3 years, and her supervisors anticipate her to rubber-stamp the applying. The drug is named Kevadon. Its energetic ingredient is thalidomide. And to Kelsey’s eager eye, one thing seems to be off.
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Katie Hafner: In 1962, Sherri Chessen’s life was all about children, around the clock. She was “Miss Sherri” the host of a children’ TV present in Arizona. It was a neighborhood version of “Romper Room,” a massively fashionable present in these years.
Sherri Chessen: I’ve at all times labored with youngsters. I used to be a camp counselor. I used to be a swimming acounselor. I might, I staged performs with them. I do not know. I simply have an affinity for youngsters. All the time have, at all times did.
Katie Hafner: So work for Sherri meant singing songs to children, studying them tales. At house, Sherri additionally had 4 children of her personal, all underneath the age of 8. And in the summertime of 1962, she was two months pregnant along with her fifth. And she or he was excited.
Sherri Chessen: Yeah, I imply I used to be excited. I wasn’t excited concerning the morning illness.
Katie Hafner: Sherri had handled morning illness with all her pregnancies. However this time it was particularly dangerous. So when she bought a uncommon second of peace and quiet, she savored it.
Sherri Chessen: I used to be sitting on my, my couch one afternoon, simply chugging by the paper, and I noticed an article.
Katie Hafner: It was a front-page story about 1000’s of infants being born in Germany with lacking arms or legs, typically with no limbs in any respect. And it was due to a drug their moms had taken after they have been pregnant. It was known as thalidomide. Happily, in accordance with the article, the drug was by no means bought within the US, because of an FDA worker who had stalled its approval.
Nonetheless, Sherri began to fret. Months earlier, her husband had introduced a drug again from England. It was a sleeping tablet, however Sherri thought it would assist her with abdomen upset too, and began taking it. However what precisely was in it?
Sherri Chessen: Nicely, I known as my physician and he says, ah,it is in all probability not, however deliver it in.
Katie Hafner: So she did. And a few days later, the physician known as again. He mentioned she and her husband had higher are available in once more.
Katie Hafner: I’m Katie Hafner and that is Misplaced Girls of Science. Within the Fifties and 60s, a drug developed in Germany was bought all over the world. It was billed as a marvel drug. It was thalidomide. Thalidomide precipitated 1000’s of infants to be born with shortened or lacking limbs or no ears, broken hearts… many died.
Katie Hafner: However in america, the drug was by no means accepted, because of a medical officer working behind the scenes on the Meals and Drug Administration. Her title was Frances Oldham Kelsey.
In the present day, the primary a part of our particular sequence, The Satan within the Particulars: The Physician Who Mentioned No to Thalidomide.
Katie Hafner: August 1, 1960 was Frances Kelsey’s first day of labor on the Meals and Drug Administration. It was usually for Washington D.C. in the summertime, sizzling and humid as she walked into the momentary, prefab constructing the place she’d begin her new job.
It wasn’t glamorous, but it surely was a brand new begin and a welcome change for Dr. Kelsey.
She wasn’t new simply to the FDA, she was new to D.C., too. Frances and her household had moved there that summer season, after she and her husband each took jobs in DC. They usually have been relieved to be again in an enormous metropolis after a number of years in Vermillion, South Dakota, the place they only did not slot in. Many of the different moms of their previous neighborhood stayed house with their children. Frances was an expert by and thru, completely engrossed by science. Her husband, Ellis, was the identical.
Christine Kelsey: Yeah, she and pop would discuss on a regular basis by dinner about their analysis or about their jobs or no matter.
Katie Hafner: Their youthful daughter, Christine Kelsey, remembers listening to all about her dad and mom’ science when she was a child. She additionally remembers how unbelievably boring it was.
Christine Kelsey: Sue and I might simply tune out. Oh, speaking about isotopes once more, isotopes, at all times isotopes. Yawn.
Katie Hafner: However science had introduced their dad and mom collectively to start with. Frances and Ellis first met as labmates on the College of Chicago in 1940, the place they have been each researchers within the pharmacology division.
And by 1960, they’d spent twenty years supporting one another’s careers, usually working and publishing collectively. They made positive to carve out time wherever potential, in order that each of them might work. Christine says her dad and mom by no means watched TV (apart from the information). They employed another person to do home tasks. Dinners have been deliberate upfront, and so they have been very simple.
Christine Kelsey: Each meal was a meat of some kind and a boiled potato and a salad and a vegetable.
Katie Hafner: After dinner, Frances and Ellis would sit in the lounge and browse medical magazines collectively. How romantic.
Christine Kelsey: Which, mm, I suppose technically was working additional time, however that was their curiosity.
Katie Hafner: And when Christine thinks again on how she was raised and the values her dad and mom instilled in her, one factor stands out:
Christine Kelsey: , simply query every part. That was at all times a, nearly a household motto, you realize, do not imagine it till you possibly can take a look at it, or till you realize it is true.
Katie Hafner: And that may transform key in Frances Kelsey’s new job on the FDA.
Katie Hafner: When she joined in August, 1960, Frances was one in all a few dozen medical reviewers who assessed the scientific trials submitted with new drug functions. Their job was to verify there was ample proof truly exhibiting that these medication have been protected for people.
This was not a job lots of people needed. I imply little children didn’t say “Oh I wish to be an FDA medical reviewer once I develop up.” The primary requirement was a medical diploma, however medical doctors, they weren’t silly, they knew they might earn much more in personal follow. So when Frances joined, quite a lot of the reviewers have been contemporary out of their residencies, working half time whereas they arrange their very own practices.
Katie Hafner: Frances Kelsey, she was totally different. She was 46 by then with the expertise to match. She had the required medical diploma in fact, PLUS a PhD in pharmacology… Oh, and he or she’d had years of expertise reviewing papers for JAMA, the Journal of the American Medical Affiliation. Which is all simply to say: Frances Kelsey knew good science when she noticed it. And dangerous science? That too.
So doing her new job on the FDA ought to have been a minimize and dried kinda factor for Frances.
However there was one little factor that occurred simply a few months earlier than her first day on the job. That summer season, Congress held hearings wanting into worth fixing within the drug trade. And at these hearings, a former medical reviewer on the FDA named Barbara Moulton testified.
Jennifer Vanderbes: So Barbara Moulton mainly has Kelsey’s job on the FDA earlier than Frances will get there.
Katie Hafner: That’s Jennifer Vanderbes, creator of the ebook Marvel Drug concerning the historical past within the U.S.
Jennifer Vanderbes: She is there as a doctor. She’s extremely educated. She is the primary one that begins selecting up on this form of corrupt tradition on the FDA the place the drug corporations are just too pleasant with the medical reviewers. She notices medication that shouldn’t be cleared going onto the market.
Katie Hafner: Moulton had pushed again towards overly cozy relations with the drug trade. Her bosses dismissed her complaints and reprimanded her, and he or she give up. However not the standard means. She didn’t simply inform her boss she’s leaving. That wasn’t Barbara Moulton’s model.
Nope, as an alternative, she took her story to a Congresswoman named Leonor Sullivan, who’d been advocating for client security. Sullivan despatched Moulton over to a senator named Estes Kefauver. He’s the one who’d been main the congressional cost towards pharmaceutical firms, and he invited her to testify in entrance of the committee. Now, be aware, at this level, Moulton nonetheless hadn’t turned in her official resignation letter.
Jennifer Vanderbes: She doesn’t undergo the FDA. She reads this dramatically as her congressional testimony.I imply, she form of lays out all the issues with the FDA drug approval and massive pharma in a means that nobody within the nation was speaking about. She basically, in, in additional refined phrases calls, the commissioner of the FDA, a little bit of an fool, successfully that every one these guys listed here are identical to buddies with pharma. They do not know what they’re doing. Um, harmful medication are being put available on the market shortly.
Katie Hafner: However even that did not appear to make a dent on the FDA.
Jennifer Vanderbes: She was, I feel, to a point dismissed as a loud, troublemaking lady in that period.
Katie Hafner: Had that whistleblower been a person, the response may simply have been much less dismissive. However I digress.
In any case, there was no less than one particular person paying shut consideration: Frances Kelsey. She later wrote that Barbara Moulton’s testimony made her query whether or not she needed to hitch the FDA in any respect. However whether or not it felt prefer it was too late to again out or she noticed the FDA as a problem price taking up, Frances confirmed up for work on August 1, 1960. Although she didn’t comprehend it then, the destiny of 1000’s of households trusted that call.
Katie Hafner: Frances Kelsey’s first month on the FDA was fairly quiet. Her schedule was filled with conferences and orientations that pulled her to totally different FDA buildings throughout the town. However after a number of weeks, her bosses put two new drug functions on her desk. One was for an enema product—she accepted it a number of weeks later. The second was for a drug known as Kevadon.
Katie Hafner: Kevadon was the American firm’s model title for a drug that had already been promoting like loopy for a number of years in Germany, the U.Okay., and different nations, underneath different names. Within the US, the applicant was an previous pharmaceutical agency based mostly in Cincinnati known as William S. Merrell. The corporate was billing Kevadon as an especially protected sedative. And other people wanted a protected sedative. For many years, barbiturates had been the sedatives of selection. Medicine like phenobarbital and secobarbital. However barbiturates, as we all know, might be addictive. And other people can overdose on them. Judy Garland and Marilyn Monroe each famously died of overdoses within the Nineteen Sixties.
This new drug, Kevadon, didn’t appear to have both of these issues. You possibly can take as a lot as you needed, get an excellent night time’s sleep, and nonetheless get up the subsequent day. The energetic ingredient was thalidomide.
Thalidomide had been developed in Germany and it was a BIG moneymaker there. Merrell needed in. So the corporate bought a license to make and promote it within the US, and on September 8, 1960, Merrell submitted it to the FDA for approval.
Cheryl Warsh: They usually thought as a result of it was so fashionable in Europe already for a number of years, it was a shoe-in and it was a extremely delicate sedative that, you realize, simply let the brand new lady rubber stamp it.
Katie Hafner: Cheryl Warsh is a professor of historical past at Vancouver Island College in British Columbia and the creator of a ebook about Frances Kelsey that was printed earlier this yr. And Cheryl says that when Frances joined the FDA, this was a time of nice optimism about medication.
Cheryl Warsh: After penicillin, there have been every kind of miracle medication, um, vaccines, and this was the excessive interval of medicine. Medicine have been going to save lots of the world. , higher dwelling by chemistry.
Katie Hafner: Nonetheless, there’d additionally been eye-opening screw-ups over the a long time. Most famously, a drug known as “elixir of sulfanilamide,” bought in 1937 for the remedy of strep infections. The elixir turned out to be a really poisonous cocktail of antibiotics, cherry taste, and diethylene glycol, which is chemically associated to antifreeze. It killed greater than 100 individuals, together with youngsters.
Now, by some cosmic coincidence, Frances Kelsey had had a entrance row seat to this catastrophe. She was doing her PhD on the time, and her advisor had been enlisted to assist work out what it was precisely on this Elixir that was killing individuals. And sure, it was the diethylene glycol. Frances watched lab rats who consumed diethylene glycol get purple urine and die. Little doubt this entire incident would have left an impression along with her concerning the significance of making certain drug security.
Katie Hafner: Though that is vital to notice, what occurred in 1937 wasn’t truly the FDA’s fault. On the time, the FDA’s job was simply to verify medication contained the components that the businesses promoting them claimed they contained. However after the elixir of sulfanilamide catastrophe, the FDA was required to do one thing most of us take with no consideration as of late: they’d to verify medication have been protected earlier than they have been bought to the general public.
So when Frances Kelsey joined the FDA, right here’s the way it labored. When a drug firm needed to take its product to market, it will submit what was known as a brand new drug software or NDA to the FDA.
Katie Hafner: An software was damaged up into three components. First, a chemistry part, explaining what the drug was product of and the way the corporate ensured the drug would at all times be produced in the identical means every time, freed from contaminants. Then, a pharmacology part, with animal research exhibiting that the drug didn’t have any poisonous results, and that it might safely be taken for an extended time period.
And at last, the scientific research. Stories from medical doctors who had examined the drug on their sufferers, made cautious observations, and reported any opposed reactions to the drug firm.
That final part—the human scientific trials—was the half Frances was in command of reviewing.
Cheryl Warsh: The way in which it will work is that they’d take the file and they’d divide it up into the three components, and the three teams would go off to their very own workplaces and their very own buildings and look over the report. If one in all them who was wanting on the medical half discovered that there was some unusual medical response that may occur when individuals took the drug, then the pharmacologist would see if the identical response was occurring or has been proven to occur within the studies with animals.
Katie Hafner: It was quite a lot of paperwork, a whole bunch of pages. Frances later described the Kevadon software as concerning the measurement of 4 telephone books sure collectively.
She and her colleagues—a pharmacologist and a chemist—got down to assessment the entire software. In the event that they discovered something indicating the drug was unsafe, they might reject it. However right here’s the catch: irrespective of how massive the applying, even when the applying was the dimensions of EIGHT telephone books, the FDA workforce had solely 60 days to reply.
Cheryl Warsh: In any other case it mechanically bought put available on the market. And you’ll see the issues with that, proper?
Katie Hafner: Frances’s superiors had good motive to anticipate this software to be a straightforward one. William S. Merrell was an previous and revered American drug firm. Its dad or mum firm, then known as the Vick Chemical Firm, was the maker of acquainted manufacturers like Vicks Vaporub. And Kevadon, the drug they have been proposing in 1960, had already been available on the market for a number of years in nations like Germany, England, Spain and Japan.
However it didn’t take Frances and her colleagues sixty days to comprehend one thing was off with this software. Let’s begin with the chemistry part. A number of the paperwork concerning the precise composition of the drug, and manufacturing course of… was in German. That’s in fact as a result of the drug had been developed in Germany, and marketed there for a number of years earlier than it was submitted for approval within the U.S.
However the FDA chemist reviewing that paperwork occurred to be fluent in German. And she or he observed that the unique German studies didn’t completely match the English translations Merrell had supplied to the FDA workforce. The errors weren’t essentially big ones, but it surely was sufficient to kinda make Frances and her colleagues cock their heads a little bit bit.
Katie Hafner: In order that was the chemistry part. Subsequent, pharmacology. Now, the pharmacologist truly thought the animal research appeared fairly good on the entire, however there was one thing curious. The drug was presupposed to be non-toxic, however… this drug was nearly too non-toxic. Often a drug that has some helpful impact additionally has negative effects, and at a excessive sufficient dose, it kills take a look at animals.
However in its software to the FDA, Merrell reported that no deadly dose may very well be present in animal checks. Even at very excessive doses, the animals at all times survived. And counterintuitive although it sounds, Frances was bothered by that. This drug was a sedative, and a really efficient one in people, but it surely didn’t appear to knock out animals. So what was occurring right here? Had been take a look at animals even absorbing this drug? And in the event that they weren’t, properly, then in fact it wasn’t poisonous to them! However it may nonetheless be to people.
And that’s why testing medication in animals alone isn’t sufficient. Right here’s the hero of our season, Frances Kelsey herself, a few years later, in an interview with NBC’s In the present day Present:
Interviewer: In testing any new drug, drug, do not we ultimately get to the purpose the place we have now to attempt it out in human beings?
Frances Kelsey: Uh, actually that’s the solely means in which you’ll, uh, discover out their, uh, limitations, uh, and their good results, too, in people. As a result of, uh, though animals gives you an amazing quantity of knowledge, the final evaluation, the human is the person who we’re involved with, and typically the human might deal with a drug otherwise from the standard laboratory animals.
Katie Hafner: The voice you simply heard is traditional Frances Kelsey. Matter-of-fact. Monotonic. Simply this aspect of bland. She may very well be remarking on a shift within the climate or she may very well be in a heated debate, and he or she would sound the identical. Cool {and professional}. You in all probability have individuals like this in your life. Even while you’re getting all labored up, they continue to be infuriatingly unflappable. And right here’s what’s much more annoying: they’re proper. A minimum of quite a lot of the time.
And within the fall of 1960, Frances Kelsey was proper when she flagged the unusual non-reaction animals appeared to need to Kevadon. However her job was to learn how people reacted to it, based mostly on the proof that Merrell had submitted to the FDA. As a result of as she identified, in her affect-free Frances means, people do not at all times deal with a drug in the identical means that animals do.
So Frances’s job was to fastidiously have a look at the proof Merrell had submitted about Kevadon’s results in people. Based on Merrell, a number of dozen medical doctors helped run the corporate’s scientific trials, and 1,589 sufferers participated. And about the identical quantity participated in research in different nations. However as Frances leafed by a whole bunch of pages of the corporate’s so-called proof, she grew annoyed.
Katie Hafner: To a much less skilled, much less skeptical reviewer, possibly this may have appeared like an excellent software.
There have been medical doctors who’d submitted kinds or letters indicating they have been attempting out the drug and the outcomes to date appeared “extremely encouraging.” There have been summaries of research. However the place have been the detailed studies? Merrell ought to have submitted details about each affected person who obtained the drug: their age, their intercourse, what they have been being handled for, the dosages they got, how lengthy they bought the drug, an outline of any opposed results…. , what you would want to know in an effort to decide whether or not the drug was protected! The info wasn’t there.
Like, one physician wrote up a abstract of his checks with 30 sufferers who have been affected by insomnia and 15 extra hospitalized for psychiatric situations. And he mentions rashes, vomiting, convulsions in a number of sufferers. However what doses have been these sufferers given? And for the way lengthy? There was no placebo management within the examine, so it’s arduous to say whether or not it was the drug or possibly current situations. It’s simply arduous to attract any conclusions from this sort of information.
Right here’s Frances herself in an interview a few years later.
Frances Kelsey: “Right here was a drug that appeared prefer it must be no drawback, however on the identical time there was only a feeling that there was one thing within the information or the absence of information that was a reason for concern.”
Katie Hafner: Reason behind concern. You’ll be able to say that once more. In different phrases, Frances was underwhelmed.
Jennifer Vanderbes: She was the worst particular person so far as Merrell might think about to have all this paperwork land as a result of she might perceive all of it.
Katie Hafner: That’s Jennifer Vanderbes once more.
Jennifer Vanderbes: Frances was terribly overqualified for this explicit job that she had. She had a really world overview of the mess that they’d submitted to her and was very assured in the truth that what she’d been handed was actually dodgy.
Katie Hafner: Frances knew there was no means she might approve this drug, not with out extra data. However she additionally didn’t have what she wanted to reject it outright: a smoking gun within the software, information provingthat the drug wasn’t protected. And within the fall of 1960, whereas she pored over the applying, studying and re-reading the research and the medical doctors’ testimonials… Merrell turned up the warmth.
Jennifer Vanderbes: Merrell’s FDA liaison says, you realize, we actually wish to get this available on the market for Christmas. They’re- they’re satisfied this drug goes to be a blockbuster for the vacations. And I feel this, as a pharmacologist and doctor, I feel this in all probability simply, made her head explode [laughs] with outrage.
Katie Hafner: Merrell already had brochures printed, and sufficient uncooked materials to make 15 million tablets. That’s quite a lot of tablets.
They usually had each motive to be assured. Their software to Canadian authorities was chugging alongside properly and would in actual fact be accepted in late November, lower than three months after they’d submitted it.
However this FDA newcomer, Frances Kelsey, was proving to be an actual ache within the butt, asking questions, dragging her toes. And actually, there was nothing she might level to that was unsuitable with thalidomide precisely. She simply couldn’t say for positive it was protected. She needed extra information, extra proof.
If Merrell had been proper, if thalidomide was as protected as the corporate promised, this entire incident might need gone down in historical past or simply been forgotten as one very nitpicky bureaucrat tying up a improbable new drug in purple tape. Because it turned out, Merrell was dangerously unsuitable. And boy, did we get fortunate that Frances Kelsey was in that job at that exact second in time.
Katie Hafner: As a result of within the fall of 1960, as Frances and Merrell jostled backwards and forwards about information and documentation, what neither of them knew was that throughout the Atlantic, medical doctors have been simply beginning to take discover of a mysterious epidemic in infants. Often affecting their arms or legs, typically their intestines or their hearts. The record of accidents went on. It was only a few infants at first, not sufficient to boost an alarm. Then extra, and extra, till it couldn’t be denied. One thing unusual was occurring in Europe. One thing was hurting these infants. However nobody had any concept what it was.
Over the subsequent 4 episodes of this sequence, you’ll hear about vanity and greed, about months and months of unconscionable inaction as tragedy was unfolding. And also you’ll hear about girls: girls’s healthcare, and the ladies who took motion to safeguard it.
In reality, girls are concerned in each facet of this story–Barbara Moulton, whom you’ve already met who blew the whistle on the FDA, Helen Taussig, one other scientist, who went abroad to research an alarming epidemic earlier than nearly anybody within the US caught wind of it. And naturally, Frances Kelsey, who took a stand in an period after we seldom if ever questioned our medical doctors or the drugs they gave us or the businesses that made and bought that drugs.
Katie Hafner: The story is sophisticated. It performed out all over the world over the course of years.
Many dangerous issues occurred throughout these years to many good individuals. What makes the story much more sophisticated is that various things have been occurring somewhere else on the identical time—finally, in all places, to tragic impact.
Time performs a central position within the story due to the maddeningly sluggish trickle of knowledge. And it wasn’t simply because the world didn’t have the Web again then; it was as a result of data that might have prevented catastrophe was withheld deliberately.
So within the fall of 1960, right here’s the place issues stood: In america, a questionable drug had been submitted for approval. And though the drug had been available on the market for 3 years elsewhere on the earth, a keen-eyed physician on the FDA had noticed issues within the software. And in concept, this might have been the top of our story. However it wasn’t as a result of every day—regardless of the warning indicators within the software, regardless of a string of unusual births in Europe—individuals all over the world stored taking this drug. And they’d achieve this for years to return.
The drug had many names. Contergan in Germany, Insonid in Spain, Talidomida in Brazil, and typically it was known as Distaval, just like the tablet {that a} man introduced again from England, a provide of which sat in a toilet cupboard for months and months till his pregnant spouse, the beloved youngsters’s TV host, Miss Sherri, began taking it in 1962.
Katie Hafner: Subsequent week on the Satan within the Particulars, a father in Germany decides to research what precipitated the accidents to his child.
Jennifer Vanderbes: So that they set out on like a highway journey in an previous VW Beetle, and so they go form of home to accommodate. They usually determine that what they should do is a few form of survey. They believe that some form of toxin has entered the system of those pregnant girls.
Credit
Katie Hafner: This episode was produced by Sarah Wyman with our senior producer Elah Feder and me, Katie Hafner. Our affiliate producer is Mila Rahim. Sophia Levin and Eva McCullough supplied analysis help.
Our music was composed by Lizzy Younan. We had truth checking assist from Lexi Atiya. Sophie McNulty and Alexa Lim did audio modifying and sound design. Hansdale Hsu mastered this episode. Lisk Feng created the artwork for this sequence.*
Thanks, as at all times, to my co-executive producer, Amy Scharf, and to Eowyn Burtner our program supervisor, and to Deborah Unger, our senior managing producer, in addition to to Jeff DelViscio at our publishing accomplice, Scientific American.
We’re funded partly by the Alfred P. Sloan Basis and the Anne Wojcicki Basis. We’re distributed by PRX.
When you’d wish to learn a transcript of this episode or to study extra about Frances Kelsey, please go to our web site, lostwomenofscience.org
See you subsequent week!
*We’d additionally wish to thank Lily Whear for artwork design.
HOST: Katie Hafner
Katie is the co-founder and co-executive producer of Misplaced Girls of Science. She is the creator of six non-fiction books and one novel, and was a longtime reporter for The New York Occasions.
PRODUCER: Sarah Wyman
Sarah is an audio reporter and narrative documentary producer. Her work has aired on the Atlas Obscura Podcast, 99% Invisible, The World from PRX, and Enterprise Insider’s Delivered to you by…
SENIOR PRODUCER: Elah Feder
Elah is a journalist, audio producer, and editor. Her work has appeared on Science Friday, Undiscovered, Science Diction, Planet Cash, and numerous Canadian Broadcasting Firm radio reveals.
GUESTS:
Sherri Chessen, former host of the Arizona version of Romper Room
Christine Kelsey, daughter of Frances Oldham Kelsey
Jennifer Vanderbes, journalist and novelist
Cheryl Krasnick Warsh, professor of historical past at Vancouver Island College
FURTHER READING:
Autobiographical Reflections. Frances Oldham Kelsey. U.S. Meals and Drug Administration
