Dr. Kelsey, while working for the FDA, blocked the sale of thalidomide in the US, saving many people from serious birth defects. She withstood pressure from the drug manufacturer, and complaints that she was a petty bureaucrat delaying the sales, while demanding additional information about the safety of the drug. She had learned that some drugs cross the placental barrier while she was working on anti-malarials.
Dr. Kelsey died yesterday at the age of 101.
She was born in Canada, and died in London, Ontario, where she was living with one of her daughters.
Indeed, a hero and an inspiration! Thank you for taking a moment to inform us of her passing and remind us of her work.
Certainly her remembrance should have a few moments of attention amidst all the circus currently occupying the news feed.
I was just reading up about her…truly an inspiration. And a reminder of how why sometimes regulation, when based on solid information, or when questioning bad information, is a good thing…
I’d never heard about who was responsible for thalidomide not getting into this country. When we lived in Germany we regularly saw people who had been affected by it.
I saw a boy at the beach last week who looked like a Thalidomide child. At age 10 or so, he couldn’t be, could he?
Perhaps he had a congenital issue that resulted in something similar. Still, he walked around, played in the sand, and swam with a vest on and seemed happy.
I work in the biotech industry. One of the compounds our team created is in the advanced stages of clinical trials. What are your credentials?
When you post blanket statements like the one you made, implying that the FDA is incompetent, and the industry’s only goal is to poison the population, you offend the honest, diligent folks who sacrifice a lot for the betterment of human health. The drug approval process became even more stringent, thanks to the folks like Dr. Kelsey. Paradoxically, the “evil” pharmaceutical industry employees will most likely agree that the FDA should have even more power than it was given. The quackery the supplement and cosmetics industries can get away with is mind boggling.
I just wanted to add a chemical sideline to this story, because I think it is a useful information item for parents of pre-medical students to pass along (or for the students to read themselves, if they are looking at this).
From what I have heard, in terms of its chemical structure, thalidomide has two mirror-image forms, called racemers. They do not superimpose on each other, because the molecule is not symmetric enough to permit that. The therapeutically beneficial form of thalidomide is the mirror image of the harmful form. If the racemic mixture is extremely well-separated into molecules of one form and (separately) the mirror image molecules, the harmful form would be removed from the therapeutically beneficial form, to a large extent. This tends not to be an easy separation, though.
In this context, Dr. Kelsey’s insistence on more information on the purity of the drug (as reported by the New York Times) becomes even more poignantly on-target. Her background would have made her well aware of the existence of racemers.
BunsenBurner can undoubtedly confirm what I’ve heard, or correct it.
Mostly correct, QuantMech! The two “versions” of the thalidomide molecule are called R and S forms- the mirror images of each other. (Think of your hands: they look identical, but you cannot superimpose them.) They are mirror images of each other. One is believed to be the active molecule, and the other is believed to be the problem molecule. Unfortunately, there are some reports that the two forms can interconvert in vivo (quite believable given the chemical structure).
So, the thalidomide lessons were: (1) always check for possible side effects on the unborn child and (2) if the drug is a mixture of 2 mirror images, study each separately (usually one turns out to be the active form, and the other is just a useless ballast).
This link has a good review of thalidomide’s biological activity:
The more the scientists learn about human metabolism, the stricter the FDA approval becomes. Sadly, some of these discoveries come to light only after bad stuff happens. For example, a deadly side effect called mitochondrial toxicity was not known until some people died from taking an experimental antiviral drug.
A good friend of mine was born with defects caused by this horrible drug. Her father was a civil servant stationed in Germany and her mom was given the drug while pregnant. While we need new drugs, there must be stringent processes in place before being released on the public. And yes, @BunsenBurner those supplement and cosmetic companies should be ashamed of themselves and the public should be demanding more stringent policies for their release too.
As I understand it, VeryHappy, that is true now, but it was not true in 1960. The uses then were as a sleep aid and as a drug against morning sickness. BunsenBurner could again add to this.
Just wanted to add: The possibility of introversion of forms in vivo is something else that future physicians and researchers in the pharmaceutical industry should be made aware of.
@greenwitch , there are other medical conditions that can result in a child being born with limb differences (often called “congenital amputation,” though “congenital limb difference” is more accepted and probably more accurate, as amputation implies removal of a limb).