Dr. Frances Kelsey and Thalidomide

On this August 7^th, back in 1962, Frances Oldham Kelsey, a Canadian-American physician/pharmacologist (who hailed from bucolic and beautiful Cobble Hill, on Vancouver Island, in which area I have spent some very pleasant time amongst friends) was awarded the President’s Award for Distinguished Civilian Service by John F. Kennedy.

For what, you ask? Working for the Food and Drug Administration – one of the first women to do so – she refused to authorize the drug Thalidomide, touted as a cure-all for morning sickness. Dr. Kinsey had concerns the drug had not been tested properly, and posed a possible hazard, suspecting that it could cross the placental barrier. Most of her fellow physicians, and all the drug executives, pooh-poohed her concerns, but she persisted.

I need hardly point out how right she was, but the evidence took years to unfold, a posteriori, with tragic birth defects manifesting in thousands of children, born without arms and legs. This was the generation of ‘Thalidomide babies’, whose mothers unwittingly took the drug at the advice of their doctors. There were anywhere from ten to twenty thousand victims, all of whom are now in later middle age, before the sage and prescient advice of Dr. Kelsey was followed. We’ll never know how much good that did, and FDA policies were made far more strict until, mysteriously, recently.

Hmm. Presidential medals for those who buck the consensus, and follow true science. We should always proceed cautiously, with some level of doubt and uncertainty.

Here is the chemical formula for Thalidomide. No one – even the most expert – could predict a priori from this assemblage of elements what it might do to humans. They could make a guess, a hypothesis, based on similar molecules, but that’s all it would be. Even the making of perfumes is a crapshoot, depending far more upon human noses than the mixture of chemicals themselves.

For all its harm to unborn children, Thalidomide is still much used in medicine, having been found to be quite effective in treating leprosy and certain forms of cancer, such as myeloma.

This is cyanide, which on paper, and even in appearance, would seem rather innocuous. They know now that this particular assemblage of carbon, hydrogen and nitrogen will kill you in minutes, but didn’t, until someone tried it out, and lived not to tell the tale. It’s like mushrooms in the forest; don’t eat them, unless you know that someone else did. But if we change that chemical formula ever so slightly, we again wouldn’t have much of a clue. A priori predictions in science are replete with uncertainty, and added risk in the case of administered drugs, which is why we have to experiment and test, rigorously and repeatedly.

Pharmacology, virology – indeed any science – works almost exclusively, a posteriori, ‘after the fact’, from the evidence itself. Once enough of these effects pile up, we can say with some degree of certainty that a given chemical – drug, hormone, therapy of any sort – will be safe, beneficial, or hazardous – even deadly.

The truth always wins out in the end. But, alas, in our stubbornness, ignorance, even our malice, often not without some collateral damage along the way.

This could be minimized by, as they say, following the science, which means the evidence of our senses and empirical research. We need not elaborate upon the analogy between Thalidomide and the current medical regime enforcing an experimental mRNA technology, the deleterious side-effects of which are now beyond reasonable denial.

Dr. Kelsey stopped an unfolding tragedy, but not before there were some twenty thousand victims. That’s going to seem an awfully small number if what is now transpiring before us is what it seems shaping up to be, perhaps a far more tragic version of Thalidomide.

Dr. Kelsey worked for the FDA until her 90th year, and died in 2015 at her daughter’s home in London, Ontario, also on August 7th, at the age of 101, just one day after receiving the Order of Canada, ironically for her role in warning of the dangers of not-fully-tested drugs recklessly administered in the face of contrary evidence. At the very least, mothers should have been warned of what might happen to their children. I’m sure all of them would have chosen another remedy for their morning sickness. Prudence and proportion are requisite in medicine.

We need a few more good women, and men, with Kelsey’s courage and counsel.

 

A postscript:

I once heard, and met, Tony Meléndez a Thalidomide ‘baby’, who had been born without arms, but who learned to play the guitar like a maestro with his feet, a lot better than I could with my hands. Tony performed beautifully for Pope John Paul II, on his 1987 visit to the United States, to international acclaim, and still tours with his aptly-named ‘Tony Meléndez and the Toe Jam Band’. God can always bring much good from what may seem a near-unmitigated tragedy.

Here is Tony, back in 1987: