Wednesday 11 March 2015

I assumed she was a man

For three hours a week at The Institute, I teach human physiology to our first year Pharmacy Technician students, more than half of them are mature students already working in Ireland's pharmacies and more than 90% of them are women. As I explain to them, I find Human Physiology fascinating because I have a body and, by implication, they should at least be vaguely interested for the same reason.  It's quite academic, however, and a substantial minority of the students struggle with the course so I try to drop in the names, effects and contra-indications of some named drugs used to treat, for example, hypertension. Every year I start the course with a torch-carrying lecture about people who have been alert in the community and noticed an odd connexion between drug and side-effect.  The best examples of this are Widukind Lenz and William McBride who independently noticed the spike in children born with grossly under-developed limbs after the introduction of the sedative and morning-sickness pill Thalidomide. The drug was developed by the German pharmaceutical giant Grünenthal and marketed aggressively there and also in the UK, Canada, Australia and New Zealand under license to The Distillers Company. Distillers claimed "Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child...Outstandingly safe Distaval has been prescribed for nearly three years in this country." and watched revenue go up and off the graph. It was on sale over-the-counter between October 1957 and November 1961 and in that time, something in excess of 10,000 children were born with birth defects, half in Bundesrepublik Deutschland while several thousand died. In the Deutsche Demokratische Republik, officialdom was less susceptible to bullying gab from Big Pharma and the drug was refused a license im Osten.

The drug was also refused a licence in the USA because a remarkably well qualified physician working for the Food and Drug Administration required further testing because she read the literature which revealed a small UK study indicating neurological side-effects associated with Thalidomide.  Her name was Frances Kelsey and there is a generation of Americans whose mothers just had to suffer the morning sickness but gave birth to children who could run, jump, clap and scratch their own noses. Canada has 30 million citizens and 95 thalidomide survivors, so you'd expect ~950 in the USA because the population is 10x greater.  Because of Dr Kelsey and the FDA, their are only 9 survivors: 1% of the expectation. She was awarded President's Award for Distinguished Federal Civilian Service by JFK in 1962 whose sound-byte has come down as “We have to concern ourselves about the appreciation of Dr. Kelsey, who spared us this terrible human tragedy…and to provide administrative and legislative safeguards to less the chance of such action coming in this country,”.  ?"to less the chance of"? don't write English like this at home, folks.

Frances was born 24 July 1914 into the Oldham family near Victoria, British Columbia.  She graduated from high school at the age of 15 and obtained her BSc and MSc degrees from McGill U. in Montreal. She earned her PhD in Pharmacology and an MD at the University of Chicago.  She applied to Chicago because she wanted to work with Eugene Geiling who was setting up a new Department of Pharmacology. He replied positively to her application, starting with "Dear Mr. Oldham . . .": the name Frances is gender-ambiguous. One of the first tasks she had as Geiling's Research Assistant was to analyse the data on a number of deaths attributed to the new anti-bacterial drug Sulphanilamide. They were able to prove that the damage was done not by the drug itself but the solvent diethylene glycol that was used to deliver it.  You may suppose that this study helped give Frances the knowledge, background and backbone to face-down Big Pharma 20 years later over Thalidomide. She married another member of the U. Chicago Faculty, Ellis Kelsey, in 1943 and in 1947 they wrote The Textbook "Essentials of pharmacology. By Frances K. Oldham, F. E. Kelsey, and E. M. K. Geiling".  Notice how the publisher flags up the female name but give initials to the men?  A friend of mine, Geraldine Butler, got fed up with having her papers rejected or put through the wringer by dense and pedantic peer-reviewers.  She found much less flak when she submitted work as G. Butler and has since made this her standard practice. Misogyny doesn't have to be conscious to effectively demoralise and disempower women in science.

Mais revenons nous a nos teratogens! The children who were dosed with thalidomide before they were born are now in their late 50s and after a life-time of amazing resilience, adaptability and courage are now running out of steam. One example is mostly armless Irish woman and Irish artist Mary Duffy, whom I met when I worked in the Dublin Food Coop on Saturday mornings 20 years ago. Mary was a regular customer and I was in awe of her as she stood on one leg and riffled through her purse with the other foot to pay for her bags of rice and lentils. She had an exhibition at the time called Vital Signs in which she took off her kit and posed in conscious echo of the Venus de Milo.  Now that takes balls!

Thalidomide is in the news because Canada, country of  Frances Oldham Kelsey's birth, has been moved to offer some compo for the results of the legislative and regulatory failure w.r.t. thalidomide more than 50 years ago.  Canada has been the laggard in the compensation stakes, preferring to talk about the present rigorous regulatory environment than address the sins of long retired or dead administrators.  Their latest offer announced by Health Minister Rona Ambrose at the end of last week amounts to $125,000 [CAD!  $100K US or €90K] as a once off payment. Which seems like a very disappointing too little too late to the 95 survivors of the debacle and their families. The maths says $12million for that direct-and-immediate pay out, but the minister has also allocated a further $168million for demonstrable need.  I think this paternalistic arrangement (The Man will hold the purse-strings and tell you when money needs to be spent on your disability) is particularly galling to thalidomide survivors who have shown such frightening levels of capability for nearly sixty years.

Amazingly, Frances Kelsey, born as the World tumbled into the armageddon of WWI, is still with us honoured in all sorts of ways: awards honorary degrees, an asteroid, prize funds.
Bonnets indeed off from The Blob too!

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