A tribute to Dr. Frances Oldham Kelsey: A woman who made a difference

I learned over the weekend that a historic figure in science-based medicine has died. If you know anything about the history of the Food and Drug Administration (FDA), you will know this woman's name, Frances O. Kelsey, MD, PhD. It turns out that Dr. Kelsey died on Friday at the age of 101. Somehow I missed the news on Friday, but once the story showed up in my news feeds over the weekend, I knew I had to make her today's topic. Here's the short version:

The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration in September 1960. The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.

But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the F.D.A. job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Company of Cincinnati, for more information.

Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.

It's important to understand the context. When Dr. Kelsey received the application for Kevadon, the laws governing drug approval and the power of the FDA were very different than today, and the FDA was a very different agency. Back then, all the FDA was charged with doing was to make sure that the drugs it approved were safe. It's worth reviewing the history of the FDA up to 1960, when that fateful application for approval from the Merrell Company first crossed the desk of a new medical officer, who also happened to be a woman in what was then most definitely a man's world in science.

Before 1906, there was no federal law protecting the public from dangerous drugs or food. The decades leading up to that year were a golden age of quackery, with all sorts of patent medicines being sold by wandering salespeople and Bayer sold Heroin as a non-addictive morphine substitute and cough suppressant. Pharmaceutical companies didn't have to demonstrate safety or efficacy of their drugs before marketing them. It is an age that quacks, understandably, pine for. In 1906, Congress passed and President Theodore Roosevelt signed the Pure Food and Drug Act of 1906. Then, as now, such regulation was not easy to pass. It took muckraking and exposes such as The Jungle by Upton Sinclair to rally support for such a law.

The original law was relatively modest, its main purpose being to ban the foreign and interstate traffic in adulterated and mislabeled food and drug products. It required that active ingredients be placed on the label of a drug’s packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary. Originally, the law was enforced by the Bureau of Chemistry in the Department of Agriculture, a bureau that didn't become the Food and Drug Administration until 1930. Originally, the law didn't require approval of drugs before they could be marketed, and the burden of proof was on the government to demonstrate that a food or drug was adulterated or unsafe.

Clearly, the law had relatively little in the way of teeth back then. For instance, in 1910 the government seized a large quantity of a product called Johnson's Mild Combination Treatment for Cancer, whose manufacturer falsely claimed it could cure cancer. In the legal action that followed the Supreme Court ruled that the false claims of effectiveness were not within the Pure Food and Drugs Act. To address this weakness, Congress enacted the Sherley Amendment in 1912, which prohibited labeling medicines with false therapeutic claims. Unfortunately, the burden of proof on the government under the Sherley Amendment was high:

"To establish fraud, the bureau had to show that the manufacturer knew the product was worthless, and this proved difficult in many cases," Swann says. For example, Lee Barlett, a former shirt salesman from Pittsburgh, promoted a medicine called Banbar as being effective for diabetes. Banbar was an extract of horsetail weed. The government took Barlett to court for selling a misbranded drug and even showed the death certificates of people with diabetes who had taken Banbar. But the jury ruled in Barlett's favor.

The next major change in the Pure Food and Drug Act came in the 1930s. By the early 1930s, it was widely recognized that the Pure Food and Drugs Act of 1906 was obsolete, but there was no agreement over how to modernize it. It took years to come up with a compromise, which did happen by 1937, but Congress was going nowhere in passing a new law. Then disaster struck, the 1937 Elixir Sulfanilamide Incident, which killed over 100 people in 15 states:

Sulfanilamide, a drug used to treat streptococcal infections, had been shown to have dramatic curative effects and had been used safely for some time in tablet and powder form. In June 1937, however, a salesman for the S.E. Massengill Co., in Bristol, Tenn., reported a demand in the southern states for the drug in liquid form. The company's chief chemist and pharmacist, Harold Cole Watkins, experimented and found that sulfanilamide would dissolve in diethylene glycol. The company control lab tested the mixture for flavor, appearance, and fragrance and found it satisfactory. Immediately, the company compounded a quantity of the elixir and sent shipments--633 of them--all over the country.

The new formulation had not been tested for toxicity. At the time the food and drugs law did not require that safety studies be done on new drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage a firm's reputation, but it was not illegal.

Because no pharmacological studies had been done on the new sulfanilamide preparation, Watkins failed to note one characteristic of the solution. Diethylene glycol, a chemical normally used as an antifreeze, is a deadly poison.

From the perspective of 2015, it's hard to believe that any chemist could do something so completely boneheaded. Even back then, it was known that diethylene glycol was toxic, as even just a review of the medical literature would have revealed. After all, the first case of fatality from diethylene glycol poisoning had only been reported in 1930, and the studies showing that it could cause kidney failure had been published. Even in the absence of a literature review, animal testing would have revealed the extreme toxicity, but, for whatever reason, S. E. Massengill Company didn't do a literature search or animal testing. It just marketed the its new formulation of its drug.

This incident is worth remembering 80 years later, because the claim that the free market will guarantee drug safety because companies cannot bear the hit to their reputations that selling unsafe drugs would cause has not died, even though an incident like the Elixir Sulfanilamide incident should have put a stake in its heart. Indeed, I've documented such claims right here on this very blog as representing magical thinking.

It is also worth remembering how the victims died:

Victims of Elixir Sulfanilamide poisoning--many of them children being treated for sore throats--were ill about 7 to 21 days. All exhibited similar symptoms, characteristic of kidney failure: stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions. They suffered intense and unrelenting pain. At the time there was no known antidote or treatment for diethylene glycol poisoning.

Nor was there dialysis or kidney transplantation. The first dialysis machine was not developed until 1943.

Spurred on by the outrage caused by the Sulfanilamide incident, Congress passed the Food, Drug, and Cosmetic (FD&C) Act of 1938. For the first time, drug manufacturers had to demonstrate that their drugs were safe before they could market them. Manufacturers had to submit an application to the FDA before marketing a drug, but if the FDA didn't act on it within a certain time period the drug would be automatically approved. Further amendments allowed for factory inspections and the designation of certain drugs to be designated for sale by prescription only. That was the state of regulation at the time Dr. Kelsey received that fateful application for thalidomide.

Then this is what happened:

The company made glowing claims for Kevadon’s safety and effectiveness. It had been developed in West Germany, and since 1957 had been widely sold in Europe and elsewhere as an excellent sedative, Merrell said, giving prompt, deep, natural sleep without hangovers. Moreover, doctors had recently been prescribing it to women to suppress nausea in pregnancy.

Laws governing new drugs had been on the books for decades but were not always rigorously enforced, and F.D.A. approval was often routine. But Dr. Kelsey, working with a chemist and a pharmacologist, found the evidence for Merrell’s claims about Kevadon to be insufficient. She withheld approval and asked Merrell for more data on toxicity, strength and purity.

Merrell stood to make millions and was anxious to get moving. It had tons of Kevadon in warehouses, ready for marketing, and 1,000 American doctors had already been given samples for “investigational” research. The company supplied more data, but also mounted a campaign to pressure Dr. Kelsey. Letters, calls and visits from Merrell executives ensued. She was called a fussy, stubborn, unreasonable bureaucrat.

It wasn't just her, either. Dr. Kelsey and the other two FDA officials responsible for reviewing the application quickly developed questions about the drug. For example, the pharmacologist, Oyam Jiro, questioned whether the company's toxicity tests were adequate, while the chemist, Lee Geismar, was skeptical about the company's manufacturing controls. Dr. Kelsey thought that the safety data were inconclusive.

In pushing for more data, Dr. Kelsey was also prescient, with a very keen eye for spotting bullshit. As a result, she was subjected to intense pressure from Merrell executives. As described by Dr. Kelsey in the August 10, 1962 issue of LIFE, they "came to Washington in droves." They wrote letters, and they called her superiors as often as three times a week. They complained bitterly that Dr. Kelsey was being "unreasonable and irresponsible." Dr. Kelsey noted that, "Most of the things the called me, you couldn't print." To his credit, Dr. Kelsey's division chief, Julius Hauser, decided to back his young pharmacologist, joking, "When they would get too thick around Dr. Kelsey, I would just come in with my little hatchet and clear them out."

By February 1961, reports of thalidomide toxicity were filtering in from Europe, in particular a report in the British Medical Journal linking thalidomide to peripheral neuropathy. More cases were reported, and there were indications that the drug could cause numbness, shaking, and tingling of the hands and other disturbances. These reports lead Dr. Kelsey to wonder whether thalidomide could damage nerves in a developing fetus. By November 1961, the first report of phocomela linked to thalidomide was reported. Phocomelia is a severe birth defect in which the fetal limbs are horrendously malformed resulting from use of thalidomide in the first trimester, when the fetal limb buds are forming. Further clinical development of thalidomide ceased, at least until it was found to be effective against multiple myeloma decades later.

Dr. Frances Kelsey: Drug Detective Dr. Frances Kelsey: Drug Detective

Alternative medicine quacks often like to attack the FDA by pointing out the thalidomide tragedy. Most of them seem not to know that thalidomide was never approved for use in the US, and that was almost entirely due to the vigilance and, yes, outright stubbornness of one brave woman, who could sniff out spin and misinformation in a drug company application and would not be swayed by unrelenting pressure. Thankfully, her superiors backed her up, something that wouldn't have happened if the FDA regime at the time didn't take drug safety seriously.

Dr. Kelsey's battle was unknown to the public until Washington Post reporter Morton Mintz broke the story in July 1962. The story led to public pressure for Congress to do something. As a result, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety, as had been the case prior to the amendments, before their drugs could be FDA-approved, but also to provide substantial evidence of effectiveness for the product's intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications. In 1962, President John F. Kennedy awarded Dr. Kelsey the Distinguished Civilian Service Medal, the nation’s highest federal civilian service award, saying she had “prevented a major tragedy of birth deformities, which she undoubtedly had.

That is the legacy of this remarkable woman, who will long be remembered for her achievement, as well as her decades of service to the FDA. Indeed, she didn't retire until 2005, and in 2010 the FDA she was the first recipient of an FDA award named after her and continues to be awarded annually.

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Indeed, she didn’t retire until 2005

I think Frances retiired at the usual age but couldn't stay away from working, hence the second retirement when she was 90.

By herr doktor bimler (not verified) on 09 Aug 2015 #permalink

A useful reminder that drug safety laws exist for a reason--and unfortunately, that reason is because people die unnecessarily early deaths under looser regulatory regimes. (A phenomenon which is hardly related to pharmaceuticals, more's the pity.)

I can understand why homeopaths would want to go back to the pre-FDA regulatory regime. In a world where you cannot trust medicines to be safe, they have the competitive advantage of not causing immediate harm, which is a rational consideration. That plus the placebo effect is how homeopathy managed to acquire any following at all. Compare with the present world, where the homeopaths have to compete against remedies that are both safe and effective, and can only do so by carving out regulatory exceptions on their behalf (which they have done).

By Eric Lund (not verified) on 10 Aug 2015 #permalink

She was a spectacular lady. She was actually involved in the follow up of the sulfanilamide disaster in University of Chicago:

http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/OralHistories/Se…

Further postgraduate work looked at the effects of quinine on pregnant rabbits. This experience was evident years later when she asked Merrell if thalidomide could cross the placenta and about the company's experience with thalidomide in pregnancy. She asked these questions before Lenz and McBride reported their suspicions.

Subsequently she was painted as a bureaucrat who got lucky, but she asked the right questions at the right time and protected countless children from a catastrophic outcome.

By Brian Cleary (not verified) on 10 Aug 2015 #permalink

At the very least, I'd like to see a Frances Kelsey postage stamp.

I've run across numerous forum postings by alties sneering at the FDA and citing the thalidomide case as an FDA failure. When I pointed out to them that the FDA (thanks to Kelsey et al) actually prevented a Europe-style thalidomide tragedy in the U.S., the response was sullen silence.

Truth can be very hard to handle.

By Dangerous Bacon (not verified) on 10 Aug 2015 #permalink

Clearly, the law had relatively little in the way of teeth back then. For instance, in 1910 the government seized a large quantity of a product called Johnson’s Mild Combination Treatment for Cancer, whose manufacturer falsely claimed it could cure cancer. In the legal action that followed the Supreme Court ruled that the false claims of effectiveness were not within the Pure Food and Drugs Act. To address this weakness, Congress enacted the Sherley Amendment in 1912, which prohibited labeling medicines with false therapeutic claims. Unfortunately, the burden of proof on the government under the Sherley Amendment was high:

One need look no further than Jim Humble,Kerri Rivera,and all the other dangerous "cures" for autism and cancer to see how little really has changed in the century or more since. :(

By Roger Kulp (not verified) on 10 Aug 2015 #permalink

It was on some science forum (maybe even here) that I was led to a collection of quack advertising in the 1900s.

Downright scary and it causes me to wonder why we are regressing.

"Truth can be very hard to handle.

Indeed it is. Harder still when the lie got to them first, repeatedly.

Frances O. Kelsey, MD/PhD, may you rest in Peace.

By Not a Troll (not verified) on 10 Aug 2015 #permalink

For me, this kind of story sheds a harsh light on the sophomoric vacuity of free-market fundamentalism.

It's also nice to see that the good don't always die young.

By palindrom (not verified) on 10 Aug 2015 #permalink

Great woman. My friend at Sunday school in Scotland had thalidomide damage. She had tiny arms.

If only Europe/Britain had had a Frances Kelsey.

the sophomoric vacuity of free-market fundamentalism

@palindrom: You're not being fair to college sophomores here.

One need look no further than Jim Humble,Kerri Rivera,and all the other dangerous “cures” for autism and cancer to see how little really has changed in the century or more since.

Orac posted an article earlier this year about an MMS pusher who was busted. Not for selling bleach as a medical product with certain falsely claimed curative properties, but because he was importing the precursor product and lying on the customs forms about its intended use. Which, as I noted at the time, is like convicting Al Capone of income tax evasion. True, he violated a specific law in a technical fashion, as opposed to the other laws he broke in a not-so-technical fashion (but it would have been harder to prove the case). But at least he's off the streets, for now.

By Eric Lund (not verified) on 10 Aug 2015 #permalink

Dr. Kelsey is one of my heroes. Thalidomide is a close topic personally too. My mom is from Canada (where it was legal) and the doctor's had wanted to prescribe it to my grandma while she was pregnant with my mom. Luckily they didn't, can't remember why though.

NYT's Retro Report did a great documentary on Thalidomide called The Shadow of Thalidomide. There's a lot about Dr. Kelsey in there and it's only 12 minutes. I highly recommend it if you have a few minutes to spare.

By capnkrunch (not verified) on 10 Aug 2015 #permalink

What a great story. May she rest in peace.

"For me, this kind of story sheds a harsh light on the sophomoric vacuity of free-market fundamentalism."

But, but, but you could just sue after the fact and that makes everything right as rain! Darn rules and regulations...

But....but...you're ignoring the effect of "the invisible hand."

Francis Kelsey's passing was covered a few days ago in Canada by the CBC. The Governor General's office noted that "Throughout her career, Kelsey helped to improve pharmaceutical oversight procedures in the U.S."

She was originally from the Cobble Hill district of Victoria, British Columbia. Canada, unfortunately, was not spared from the drug; presently, there are nearly 100 Canadian thalidomide survivors remaining. On a brighter note, in the spring of this year, she received the Order of Canada medal in recognition of her outstanding work.

By Lighthorse (not verified) on 10 Aug 2015 #permalink

As near as I can tell, the invisible hand in these situations does nothing but make rude gestures.

I'll have to keep in mind the Elixir Sulfanilamide incident as well the the FDA stalling out the sale of thalidomide then next time someone like Delysid comes up and says we should abolish the FDA.

By Gray Falcon (not verified) on 10 Aug 2015 #permalink

"As near as I can tell, the invisible hand in these situations does nothing but make rude gestures."

I'm stealing that one. Well done...

If the invisible hand makes rude gestures, at least no one can see 'em.

But it's definitely a phrase worth stealing.

Of course, one of the other limitations of the invsible hand is that it does not apply a price signal to "the commons", so there's no direct economic reason for any individual industry to, say, avoid polluting the environment.

By palindrom (not verified) on 10 Aug 2015 #permalink

Thanks to Kelsey, HREF="http://www.cbc.ca/news/health/frances-oldham-kelsey-canadian-doctor-and…;"Only 17 children were born in the U.S. with thalidomide problems.".

So, how many dietary supplements (DS) are on the market without established safety, efficacy or both based on well controlled clinical trials? Plenty. Some DS have only meager data to show relative safety in laboratory animals or in vitro. By one anecdotal estimate, if they were required to undergo approval for safety and efficacy by the FDA before they were allowed to enter the market, 80% would be removed from U.S. commerce. As it stands, the onus is on the manufacturer or supplier to establish efficacy and safety, but with the exception of New Dietary Ingredients (NDIs), they are not required to submit their data to the FDA. When you consider the number of job losses that would undoubtedly result, economic reasons may underlie the reasons that such a change in regulations may never come about.

By Lighthorse (not verified) on 10 Aug 2015 #permalink

Oops. Sorry about the sloppy post.

By Lighthorse (not verified) on 10 Aug 2015 #permalink

Subsequently she was painted as a bureaucrat who got lucky

According to Megan McArdle, for instance, the FDA was wrong to have withheld approval:

when pointless foot-dragging on the approval accidentally protected American mothers from limbless babies.

Sometimes the Invisible Hand of the market puts its fist up inside glibertarian apologists and wears them as skin-puppets.

By herr doktor bimler (not verified) on 10 Aug 2015 #permalink

@herr doktor bimler #21

Interesting; the same writer suggests that we would be better off if the FDA conducted all the necessary clinical trials, rather than to leave them to drug developers.

I can already hear the extremists clamoring that the FDA is socialism and should be privatized. Well, IMO, so are stop signs.

By Lighthorse (not verified) on 10 Aug 2015 #permalink

Interesting; the same writer suggests that we would be better off if the FDA conducted all the necessary clinical trials, rather than to leave them to drug developers.

Her modest proposal also includes the idea that

FDA should put much less energy into preventing drugs from reaching the market, and vastly more energy into assessing them after they have.

If we’ve learned one thing from the Vioxx saga and similar cases, it’s that it’s easier to withdraw a noxious drug from the market — once the doctors are receiving their honoraria for prescribing it, and the production has been scaled up, and the astroturf groups of patients have been funded to publicise their own good experiences with the drug and to decry any thought of replacing it with something else — than it would have been to test its side-effects in the first place.

By herr doktor bimler (not verified) on 10 Aug 2015 #permalink

As I've pointed out before, if fear of retribution were sufficient to prevent wrongdoing, we wouldn't have crime.

By Gray Falcon (not verified) on 10 Aug 2015 #permalink

Lighthorse: "She was originally from the Cobble Hill district of Victoria, British Columbia. Canada, unfortunately, was not spared from the drug; presently, there are nearly 100 Canadian thalidomide survivors remaining. On a brighter note, in the spring of this year, she received the Order of Canada medal in recognition of her outstanding work."

I am so glad she is recognized by her birth (and now death) country.

A few years ago we visited Victoria, BC and took a bus tour to Butchart Gardens. As we were filing back into the bus to go back to the hotel the driver was entertaining the passengers on notable Canadians (from an article he printed out). When he was done I noticed Dr. Kelsey was missing from that list. He did not know who she was, and that she was an "island girl" (a term he used a couple of times in his spiel). He did promise to look her up.

Mr. Clearly: "Subsequently she was painted as a bureaucrat who got lucky."

Thanks for the reminder on her rabbit research in Chicago. I knew I had read somewhere that they noticed that some drugs affected fetal rabbits, and she saw this type of data was missing from Merrill.

if fear of retribution were sufficient to prevent wrongdoing, we wouldn’t have crime.

Well, yes, but if succinct logic were enough to convince people out of emotionally-held positions, then we wouldn't have stupid arguments.

By herr doktor bimler (not verified) on 10 Aug 2015 #permalink

@Chris #25

But he didn't forget Pamela Anderson or Diana Krall (both "Island girls"), right? Sheesh.

By Lighthorse (not verified) on 10 Aug 2015 #permalink

It's a shame they didn't include her Ph.D. on that Civil Service poster. According to Wikipedia she did her PhD first and then her MD. That makes her even more of a role model for back then (and now, as well).

By Chris Hickie (not verified) on 10 Aug 2015 #permalink

shay, the invisible hand of the marketplace often turns out to be the invisible thumb on the scale.
Something the "strict liability" crowd never point out is that if Jane Doe from Third Rail, Ohio, takes SuperMegaUltraCorp to court is that she is going to walk into the courtroom with her pro bono lawyer to face fifty corporate lawyers, another fifty outside attorneys on hire, and a swarm of hot and cold running paralegals providing every kind of service their bosses could possibly require.

By Old Rockin' Dave (not verified) on 10 Aug 2015 #permalink

Something the “strict liability” crowd never point out

The glibertarian pundits who devote half their columns to calling for regulations to be abolished (so that lawsuits can punish the manufacturers of faulty products) seem to alternate those with columns calling for tort reform and the abolition of 'frivolous lawsuits'.

By herr doktor bimler (not verified) on 10 Aug 2015 #permalink

Call it skepticism or call it scientist's intuition, but Kelsey's persistent sense that "something isn't right" saved us from what could have been a horrendous tragedy.

Thirty plus years of beating up on government from the right, and the preceding twenty or so years of beating up on government from the left, have added up to funding cuts, demoralization, and a self-fulfilling spiral of decline. We have something precious that countless people have given their lives to defend, and we are taking it for granted.

Enough was enough long ago.

We need to inspire more Frances Kelseys, present and future, in all branches of government service. And we need to recognize all of their good works, whether humble or exalted.

Part of this is the moral value of respect for one's fellow humans. Part of it is the civic value of respect for the institutions of democracy. Part of it is the practical value that government provides services that the private sector can't or won't. And part of it is the irreducible value of civilization as compared to the lack thereof.

The burden of proof should be upon those who want to tear down a system rather than those who want to uphold and improve it.

By Gray Squirrel (not verified) on 10 Aug 2015 #permalink

GS: "Call it skepticism or call it scientist’s intuition, but Kelsey’s persistent sense that “something isn’t right” saved us from what could have been a horrendous tragedy."

Except was not "intuition", it was knowledge and personal experience. If you look above (see Brian Cleary's comment #4) she had seen damage in rabbit fetuses from some pharmaceuticals. She had a special interest in teratogens (things that cause damage to developing fetuses). It was logical for her to request similar testing for something being prescribed to pregnant women.

Also, why do so many people think it is remarkable that a woman from Vancouver Island who got both a PhD in the 1930s and an MD in 1950 would not have some kind of tenacity? Despite being "only" 45 kilometers from Victoria, it was mostly likely not a booming suburb in the 1920s and 1930s (it still has less than two thousand residents). She graduated from high school when she was fifteen years old!

Anyone who claimed she was just a foot dragging bureaucrat should should be ashamed of themselves. Especially if they are just a random blogger.

Dear hubby spent some formative time in a Vancouver Island town a bit further north after his father died (his mom moved near to her mother, where she grew up. Everyone was expected to graduate high school (which his mother did not do) and go work for the lumber company. Being someone who wanted to get an education and leave was very much out of the norm. (and yes, for his mom it was the same, which is why she first married someone who could get her out, and then did it a second time... and that included becoming a US citizen with her first husband just months before his tragic unexpected death).

Another random anecdote: by the way, my mother-in-law and both of her sisters are also very tenacious. Her 80+ year old sister still paints her little Victoria house by herself, and goes sailing and kayaking with her much younger boyfriend. They all tire out their baby boomer children.

Humor anecdote: I grew up camping as a kid. I did not realize until later I married one of the very few folks from Vancouver Island (he was born on the island, and lived there!) who refuse to camp. Even his cousins think this is weird. Though my brother forced him to when we visited his family while they were stationed in Germany, because it is both cheap and the European campgrounds, unlike hotels or inns, often have swimming pools to help tire out the kids (also they have washing machines and well stocked markets with fresh bread for breakfast). I loved it, hubby not so much. :-)

Its a pity that more countries did not have a person as tenacious and thorough as Dr Kelsey. Its a pity that there wasn't an equally talented person in Australia and Europe who could sort out the spin from the truth.
May Dr Kelsey be long remembered for her great work.

Chris @ 34: I think you misread the implication there. In no way was I intending to deprecate the degree of intelligence, education, and dogged determination that Kelsey had in going after thalidomide. When I use that word "intuition," I mean that someone has come to a conclusion or developed a hypothesis that is correct, based on something other than specific empirical data or direct logical inference. The inferential process involved, is indirect or implicit. (See also the "release-of-effort effect" with examples such as mathematicians solving difficult problems while taking a break from their deliberate efforts.)

As I read Orac's description of what happened, Kelsey did not at first have the hard data on teratogenic effects of thalidomide in Europe. She had other data that were suggestive but not conclusive, and from that starting point, she was able to ascertain the outlines of a potentially serious problem that was later confirmed.

I'm well aware of the unpleasant implications of the word "intuition," both in a sexist sense ("female intuition") and in the sense that riles up skeptics ("intuition" as blackbox for various forms of irrationalism and magic-infested thinking). For which reason I specifically said "scientist's intuition," intending to put those implications to rest. Apparently that didn't work. But hopefully it's clearer now, and we're on the same page.

By Gray Squirrel (not verified) on 10 Aug 2015 #permalink

I certainly hope when I go north of the border again, that both my cell phone works and someone there knows about Dr. Kelsey!

Some of Francie's relatives are still out on the Island; some have crossed the border and live down near Seattle.

Anyone who claimed she was just a foot dragging bureaucrat should should be ashamed of themselves. Especially if they are just a random blogger.

Megan McArdle is incapable of shame.

By herr doktor bimler (not verified) on 10 Aug 2015 #permalink

Old Rockin' Dave @32 -- I enjoyed the parts of that link that I skimmed.

Please join me in rebranding Libertarianism as "The New Irresponsibility".

By palindrom (not verified) on 11 Aug 2015 #permalink

If you look above (see Brian Cleary’s comment #4) she had seen damage in rabbit fetuses from some pharmaceuticals. She had a special interest in teratogens (things that cause damage to developing fetuses). It was logical for her to request similar testing for something being prescribed to pregnant women.

This gives the lie to the "animal rights" fanatics that the thalidomide disaster was due to a failure of animal testing.

There's a great story in today's Times-Colonist (the Victoria BC daily paper) about the decision to name the new Cowichan District (where she grew up) high school after Dr Kelsey. She replied to the superintendent who phoned for permission: "I don't believe I have ever been offered such a great honour"
She then asked if she could come to the opening ceremony, where the kids "treated her like a rock star". She continued to stay in touch with her school and was a great inspiration to the students.

hdb: "Some of Francie’s relatives are still out on the Island; some have crossed the border and live down near Seattle."

It is a fairly porous border. There are lots of families with relatives on both side. I am part of one of those families and have run across many many more. It is only recently that one needed an actual passport to cross that border.

It often depends on where there is a job. There are at least a couple Microsoft employees that go to our skeptic meetup that are from British Columbia.

TBruce: "This gives the lie to the “animal rights” fanatics that the thalidomide disaster was due to a failure of animal testing."

Exactly. It was a lack of adequate animal testing.

Thank you, TBruce for that link.

I love this quote from TBruce's link: "As she toured the school, walking with a slight limp because of a white-water rafting accident the day before, this 81-year-old scientist, by now being spoken of in the same terms as Sir Frederick Banting and Charles Best, chuckled with undisguised glee at the way labs had been set up and asked how many girls were considering a science career."

A few years ago, when I tried to find information on her work, one of the better ones was an essay from Frances Kelsey Secondary School. Being a student project, its life on the internet was brief.

But once a drug is approved, the FDA doesn't require follow-up studies.

I can't tell if Meagan's being ignorant here or willfully deceitful--post marketing surveilance, anyone?

palindrom, you really should read the whole thing, and then go to some of his other pages. Like I said, whether or not you agree with him on some particular point or not, reading Steve Dutch is always worth the time.
Next, move on to David Brin, again someone with a sidewise take on things, and always giving me something to think about, and sometimes to wish for.

By Old Rockin' Dave (not verified) on 11 Aug 2015 #permalink

I can’t tell if Meagan’s being ignorant here or willfully deceitful

She's a pundit; "willfully ignorant" is the term I would use. When your remuneration depends on promoting a particular political agenda, It is easy to remain oblivious - or to become oblivious - to incompatible facts .

By herr doktor bimler (not verified) on 11 Aug 2015 #permalink

Argh.
Of course the implied subject (and pronunciation) of "Read that" will be instantly obvious, preventing anyone from seeing it as an imperative. Right?

By Porlock Junior (not verified) on 16 Aug 2015 #permalink