The golden triad of drug products
Quality, safety, and efficacy
Ask a group of people who their favourite live action1 movie Batman is and it will reveal some personal traits.
Here’s an insight into some of my inner monologue if I were to be having this conversation with someone. In doing so, please recognise that it’s not a slight on your personal character that I’m making here (I’m friendly judging, not mean judging).
If you’re choosing George Clooney, I’m assuming you aren’t really into Batman. I mean, it’s got to be all about the lust factor here, am I wrong? There’s really no other reason for that choice. Batman & Robin was a fun movie, not a serious film. His costume had nipples on it for god’s sake!2
If Val Kilmer’s your guy, then I’m putting you a similar category as the George lovers. But why go for Val when you can choose George? My guess is, if Val Kilmer is your choice you’re in a very specific age bracket...and I’m not entirely sure when that was. But I’m thinking one of his prior movies must’ve caught you in a very impressionable coming of age moment that you never quite outgrew3. Maybe it was a hangover from seeing him as Ice Man or Jim Morrison? Definitely not Tombstone. No one could’ve found him appealing as Doc Holliday, surely.
Ben Affleck - hmmm, ok. You must’ve come to the Batman movies via a path that already enjoyed Ben Affleck movies. Or perhaps you’re a Zac Snyder devotee? Maybe someone who’s really into the Batman vs Superman comics. Probably not a J Lo fan given how that turned out. Look, I don’t think it’s a shallow choice like George or Val - at least he’s broody rather than comical. I can buy him as an obnoxious rich guy who’s had enough with being a superhero, for sure. But it’s an interesting choice, nonetheless.
We’re now down to Robert Pattinson, Christian Bale, and the OG Michael Keaton.
My sense is that if Robert Pattinson’s your bat guy there’s a very strong lust factor here as well. Again, I’m not judgemental of that. On paper, the pairing of Pattinson with Zoe Kravitz should result in said paper self-combusting! Alas, you’d have to stay awake for long enough to bear witness to any chemistry. The Batman is so painfully slow that surely only the truest of Pattinson or fans actually persisted with watching the whole movie4. If that’s you, I’m quite confident, you’ve also seen the entire Twilight series and read all the books.
So that leaves Michael Keaton and Christian Bale. People who choose Michael Keaton root for the underdog, I think. He proves you don’t have to be the alpha to dominate the screen. And I like that, I do. His version of Batman was also a bit unhinged, adding some depth beyond the Clooney-esque comic variety but not all mopey and washed up like Ben. I’m quite confident lust has nothing to do with this choice.
And those who chose Christian Bale? Well, that’s me, so clearly I think they’re super insightful and cool.
Bale is the ‘whole package’ Batman choice. He’s attractive enough to pull off a believable playboy character5. He’s dark and broody, like only a super rich orphan can be. But, importantly, he plays the anti-hero perfectly6. He has the golden triad of ideal Batman characteristics. It also helps that he’s in Christopher Nolan films, and the supporting cast including Joseph Gordon Levitt (sigh)7.
I’ve illustrated this in the Venn diagram below, because the graphs in How to Disappear Completely were such a hit!
Where the hell are you going with this Lauren? This is a newsletter about drugs.
Yes, it is.
We’re going to talk about the golden triad of drug characteristics - safety, quality, and efficacy. And how understanding this can help you make better choices when self-selecting products.
The golden triad for drugs - safety, quality and efficacy
If you’re using a drug, it’s worth taking a moment to assess if it’s likely to be safe in your body, if the product is going to be of sufficient quality, and if it’s going to produce the effect you want it to (efficacy).
When it comes to medicines that are sold in reputable storefronts, this is where the regulations come in to play. It sounds a bit boring right? That’s why I started out with Batman.
I appreciate this is an international audience, and acknowledge that the specifics will differ for each jurisdiction. But most countries set things up roughly the same way, so I’m going to talk in generalities, with just a touch of Australiana.
Each jurisdiction will have a regulatory body responsible for registering and listing medicines and therapeutic goods8. In Australia, this is the Therapeutic Goods Association (TGA) and they maintain the Australian Register of Therapeutic Goods (ARTG).
To get listed on the ARTG, drug companies must provide the TGA with evidence regarding the product’s safety, quality, and efficacy. This is the evidence that is developed through the drug development process, including pre-clinical and clinical trials. We’ll save that for another time, but for now it’s enough to understand that the type of listing a product receives depends on the extent of evidence provided.
In the next few paragraphs, we’ll talk through the differences between these products, which will help you the next time you find yourself faced with a wall of supplements and not knowing which one to choose.
Registered medicines - the Christian Bale of the drug world
As I’ve already stressed, Christian Bale is the full golden-triad Batman. Within the drug world, these are the products that have been guaranteed to meet the full triad of efficacy, quality and safety. This includes all prescribed medicines, most over the counter products from pharmacies, and a few complementary and alternative medicines.
In order for a higher risk medicinal product to go on sale, the drug company has to provide evidence that the drug is effective for the conditions its being used to treat, the ingredients used are of adequate quality, and the product is safe to use in humans9.
In Australia, these medicines are called registered drugs. You can identify them by the AUST R on the label.
Listed medicines - the Michael Keaton’s, Robert Pattinson’s and Ben Affleck’s of the drug world
Michael Keaton, Robert Pattinson and Ben Affleck’s Batman’s all meet some of the more ‘serious’ elements of the golden Batman triad, but not to the same extent as Christian Bale. Within the drug world, these are the medicines that have some level of assurance but haven’t been fully evaluated against the full triad of efficacy, quality and safety. These are medicines that have a lower degree of risk associated with them and can be sold over the counter, in supermarkets, or health food shops.
In order to go on sale, the drug company still needs to provide some evidence, but it’s not at extensive. They might not provide evidence that the drug does what it says it will (efficacy). The ingredients need to be from an approved list, but aren’t assessed for quality like the registered drugs. The table below, from the TGA website, shows you the difference between the level of evidence that needs to be provided.
In Australia, these medicines are called listed and assessed listed drugs. You can identify them by the AUST L or AUST L (A) on the label.
Supplements - the George Clooney’s of the drug world
George Clooney’s Batman had a lot of charm and good looks, but he was not a serious Batman. Within the drug world, these are the products that don’t fit under the drug regulations, but the food standards - dietary supplements and food products. There are still quality and safety standards that need to be met, but there is no expectation that these products have any evidence of efficacy.
These products are sold over the counter in pharmacies, health food shops, supermarkets, online. Some countries, like Australia, still have labelling requirements for some drugs in this category like caffeine.
George Clooney is a pretty good reminder when it comes to these types of products, because they’re often marketed to look really attractive. But, if there’s an alternative that’s a listed or registered product, then you should probably consider it instead.
Street drugs - the Val Kilmer’s of the drug world
Look, I don’t even really know what was going on with Val Kilmer’s Batman. Which is kind of how it is if you buy a drug off the street, I guess.
Safety? Depends. Efficacy? Not sure. Quality? Hopefully!
And by ‘off the street’, I don’t mean a street corner. It could also apply to products that you directly import, or get from a less than reputable source. Buyer beware.
So what does this mean for you?
As I said before - anytime you put a substance into your body, it’s worth taking a moment to think about the safety, quality, and efficacy of the product.
Within most countries in the world, if you’re getting a prescribed medicine you can take it for granted that the product will be Christian Bale level.
If you’re buying something over the counter though - stop and assess your options before committing to a purchase. Find out what to look for on labels in your country and understand what it means. If you’re in Australia - an AUST-R option is best, followed by AUST-L(A), then AUST-L.
You tend to get what you pay for when it comes to this sort of stuff, so spend wisely.
Thanks so much for reading!
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This was edited to specify live action after my original post disappointed several readers for not including Lego Batman Will Arnett or Kevin Conroy.
Interestingly, Alicia Silverstone’s Batgirl costume seems to be without the nipples.
One of the reasons for my confusion here, is that there was a time in my innocent youth where I too was partial to a bit of Val Kilmer. But, it didn’t survive adulthood.
I really wanted to enjoy The Batman, I really did. I found the idea of Robert Pattinson as a Batman to be very appealing, as I’ve been crushing on him since he was Cedric Diggery. But its just. so. slow. And the emo eyeliner thing. I just wanted to wash his face and give him a hug. The tortured orphan vibe was really strong in this one.
Seeing American Psycho was enough to turn me off Christian Bale forever. However, I can appreciate that he is objectively a handsome man.
Apparently, one of the reasons Christian Bale’s Batman is favoured so much by movie lovers is because it embodies the classic personality features of the dark triad - narcissism, psychopathy, and Machiavellianism. I’m sure the proper fiction writers will know more about this than I do.
Of course, The Dark Knight also sees Christian Bale star alongside talented Australian actor Health Ledger, but his story still makes me sad. No one should die from the drugs they take - even famous people!
In Australia, this is the Therapeutic Goods Administration, in the US the Food and Drug Authority, in Europe it’s the European Medicines Agency, the UK is the Medicines & Healthcare products Regulatory Agency, Canada’s Drug Agency…you get the idea.
There are some limitations with the safety and efficacy data a drug company is able to produce from clinical trials. I think we’ll get into this next week.
This is some crazy shit but I love it.
First of all, I love this newsletter. I actually cover a lot of pharma and biotech stories, and when I bring this up to people, it becomes very clear very fast that there is so little knowledge of how medicines are developed and tested and scrutinized, how they work, and sometimes, why they exist at all. A lot of people here simply view pharmaceutical companies as the enemy—while also viewing them as the first stop to treat all of their problems. I’m not saying there aren’t major issues in the pharma industry, but that’s not all there is to know about it.
Secondly, and perhaps more importantly, my favorite Batman was not listed: Lego Batman. And I’ll not be told for one second that it’s not a serious Batman, because that movie is a masterpiece.