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This is a very dangerous argument.

Decisions to approve or ban medications are difficult because they're about probabilities, and whichever decision you make, there is an expected body count attached to it.

The "but Thalidomide!" argument only considers one side: If you approve a medication that ends up hurting/killing people. That is bad, and everybody understands that.

The other side is that if you delay the approval of a life saving drug, that also kills a lot of people who die while you wait. That is bad, and very few understand that.

The same people who died before, keep dying today. This does not make news, no one has to resign, and as a result regulators become very prone to err on the side on delaying approvals.

How many Americans have died from this bias since Thalidomide is unknowable, but it's definitely in 6 figures, maybe more.

It's been over 50 years since the thalidomide tragedy. Do you still let plane crashes of last century direct your choice of transportation?

Plane crashes of the last century deeply inform regulation of planes this century. It's why we have so few plane crashes despite massive increases in passenger-miles flown.

I strongly doubt the planes of today present the vulnerabilities of last century. Those lessons were leant and applied. Today's airplanes have different issues and policy should better be about the current issues (and crashes) otherwise it would be outdated and obsolete.

But my analogy was about recommending flying or not flying: you should base that recommendation on the safety of today's airplanes, not on the crashes of the past (even if those crashes enabled the current safety level).

His point was the regulation of planes, not the planes themselves. Which is effectively what forms the "safety of today's planes" that you are looking for.

The point is the USA was right when everyone else was wrong and didn't bow to public pressure, and so I trust them a bit more when they are conservative with approvals.

Yes it was right in that case, but blindly letting a single tragedy direct policy without taking into consideration current factors is extremely dangerous.

People are dying of COVID right now. If fear of another thalidomide incident delays a saving vaccine we may end up losing more lives than potentially saving.

It's not blindly letting a single tragedy set policy. It's one example of many that the FDA has used to build up trust in their process over the last eight decades.

And it's not like the AZ vax is the only option out there. The lives will still be saved with the other vaccines.

I don't know any of the other "many examples", the only one I keep hearing about is the thalidomide incident.

Kind of like when people opposing nuclear power keep bringing up Chernobyl and Fukushima while ignoring their relative tiny victim count compared to the millions of people killed by our fossil energy production.

https://en.wikipedia.org/wiki/Lumiracoxib -- Approved in Europe, not the USA. Withdrawn from sales due to side effects.

https://en.wikipedia.org/wiki/Zimelidine -- Same.

https://en.wikipedia.org/wiki/Tolrestat -- Approved in Europe, failed stage 3 clinical in the USA

https://en.wikipedia.org/wiki/Rimonabant -- Approved in Europe, failed in the USA, withdrawn worldwide because the side effects were so bad.

Thalidomide is just the most famous because it was the most disastrous, but there are plenty of others. Like I said, the FDA has a strong many decades track record.

This is nothing like opposing nuclear plants.

OK, but if any of those was actually saving lives I'd argue it should've been approved, side effects be damned.

Last time I looked, thousands of people were dying every day of Covid. Ignoring those just in case a vaccine is harmful is, IMHO, a bad tradeoff and I don't trust the people making it in my name. I prefer, in life-or-death situations, making my own (informed) decisions.

If the AZ drug were the only COVID vax available, I might agree with you. But there are already two others and a third on a the way, all of which are more effective than the AZ drug. And the USA has already negotiated to get more of the approved ones than the UK is getting on a per capita basis.

Allowing a drug you know doesn't work well is a great way to break the public trust, especially when there are plenty of alternatives.

You'd be quite right if we had plenty of mRNA vaccines available, but, if I'm not mistaken, we are supply constrained and we'll be for at least a couple more months. Months in which people are dying, people who could be saved by the AZ vaccine, of course at some risk - but which is very much preferable to death, I'd say.

The AZ vaccine still needs to be produced, it isn't sitting in a warehouse somewhere. The amount of time it would take to make AZ vaccine is the same as making the other Pfizer/Moderna vaccines. It's unlikely it would increase supply at all.

I disagree, 3 vaccine sources should be better than 2.

Now, if the US hasn't contracted any AZ vaccine, then you're right and the whole discussion is moot.

AZ has been withdrawn in South Africa because it doesn't work well against the South Africa variant, which is also now known to be experiencing community spread in several parts of the US. So, whether the US (which wasn't alone in not approving it) was right to reject it based on information available in the past, it doesn't seem like it's something we want to try to gear up for now.

https://www.bloomberg.com/graphics/covid-vaccine-tracker-glo...

According to bloomberg the US has purchased 300M doses each of Moderna, Pfizer and AZ. That doesn't mean they actually have production capacity though.

"Side effects be damned" makes no sense.

Thalidomide is authorised for use in many countries today. It's just that the prescriber has to consider whether their patient could be or become pregnant, and ensure that if the patient could become pregnant they understand that this would be extremely bad.

For its original intended purpose this makes it useless, nobody feeling a bit nauseous wants a medical exam plus an hour lecture about contraceptives, but if you have leprosy and other drugs aren't working, Thalidomide might make a real difference to your life despite the scary contra-indications.

Completely factual post (with sources) downvoted to oblivion.

Well done HN.