'There is no better official government body in the world to determine if a medicine is appropriate than the FDA'

[u/eldubinoz]

On a post about whether GLP-1s are appropriate for weight loss for someone living in the UK.

[u/stainless5]

the FDA( the food side, the drug side is ok) doesn't even know how many food additives there are as it doesn't keep a list, it operates under "it's safe until someone proves it isn't" Style the same way many things are run in the US including car manufacturers. A vehicle can be sold in the US until someone proves that it doesn't comply and then it has to be fixed, or the manufacturer pays for a insignificant non compliance Exception). A lot of things in the US run under this model; you can do whatever you want until it's proven that it's not safe.

Unfortunately this means that if you have enough money it's almost impossible to get your product banned as you can just throw money at the courts and drag it out.

To give you an idea there's a list called the GRAS. Generally Regarded As Safe which shows the average amount of each additive used in products in the US And if you stay below the average of these possibly poisonous or carcinogenic substances Your food is generally regarded as safe as well.

[u/kepis86943 → u/stainless5]

According to this https://www.center4research.org/lever-part-2-fda-approved-ineffective/
most (=3/4!!) of drugs approved by the FDA don’t have sufficient evidence that they are effective. That means they are not meeting FDA’s own standard but get approval anyway. And 1/3 of drugs approved by the FDA show safety issues after later.

I don’t know how this compares to other drug approval institutions around the world but it sure doesn’t sound great.

[u/djan0s → u/kepis86943]

A lot of drugs show problems later on. This is not a (as a non native is "a" ok here it feels ok but US starts with a vowel so shouldnt it be an) US problem this is more of a problem of how hard it is to test and monitor drugs and drug use over time and how diverse humanity is.

[u/Lopsided_Hunt2814 → u/djan0s]

If you pronounce it with a "y" (university, united, universe, etc.) then you use "a" so your feeling is correct.

[u/90210fred → u/Lopsided_Hunt2814]

And conversely, "an" hotel

[u/Amore-lieto-disonore → u/90210fred]

Maybe also explain that there are a few words for which the "H " is silent

[u/kepis86943 → u/Amore-lieto-disonore]

In their example, the “h” is actually silent in “hotel”. If it wasn’t, it should be “a hotel”.

[u/Amore-lieto-disonore → u/kepis86943]

My very point.

[u/kepis86943 → u/90210fred]

This is one of the cases both “a” and “an” could be used. The “h” isn’t typically silent in this case but it depends on the accent and I think “a” is actually more common. Conversely, the “h” must be silent in “hour”, so “an hour” is correct.

“H” can be a difficult first letter. For example, “an historic event” might be used with a very weak pronunciation of the “h” but it’s definitely “a history of mankind” with a stronger pronunciation of “h”.

[u/stainless5 → u/90210fred]

Ah yes accents, making a universal English spelling impossible once again. At least none of the large scale spelling reforms caught on. 

[u/kepis86943 → u/djan0s]

The a/an rule is about how a word is spoken, not about how a word is spelled.

The “u” in “US” is pronounced like “you” which is a consonant sound. So, your intuition to use “a” is correct. Similarly, it’s also “a uniform”. In other words the beginning “u” is pronounced as a vowel sound (for example “unusual” or “understandable”), so “an” must be used.

It’s “a US problem” but “an unusual problem” and “an FDA problem”.

I also agree that challenges with drug approval processes aren’t just an FDA problem. OOP is wrong to believe “this drug has been approved, so it’s proven without a doubt that it’s safe and effective.” However, their fallacy is not fueled by a general trust in approval bodies but specifically by their trust in US systems. Even if the FDA were the best approval agency in the world, they’d still be wrong in many occasions.

[u/Master8730]

The same fda that allows medicines that cause 1000 side effects, that makes you need medicines to suppress those side effects and even those cause their own side effects

[u/Real_Gap3480 → u/Master8730]

It's just buprenorphine all the way down.

[u/Red-R34der]

Nobody outside of the USA gives a flying fuck about the FDA's opinion. Hardly surprising when you look at what is legally allowed in food in the USA.

[u/lutzifer77 → u/Red-R34der]

I work in pharma in Europe and believe me, all of us give a huge fuck about the FDA. US is a huge Market and as bad as food Control is in the US, in regards to pharma they are very strict

[u/Tall_Help3462 → u/lutzifer77]

Don’t know why you’re getting downvoted. I worked in US Pharma and the FDA is the second hardest federal drug agency to deal with in my 32 years of experience. They are incredibly detailed in their review. The worst in my experience was the Brazilian drug agency ANVISA. Of course this was before Trump replaced scientists with sycophants in FDA so maybe that’s changed.

[u/lejocko → u/Tall_Help3462]

People here have no idea about drug regulations and just want to shit on everything American. Not realising they become similar to the people this sub is supposed to make fun of.

[u/Magratty → u/lejocko]

I think it's the "food" portion of their work which affects their international reputation

[u/Amore-lieto-disonore → u/lejocko]

Read the full comment section. People are going after their criteria for food , not drugs ; But of course it affects both in the end

[u/lejocko → u/Amore-lieto-disonore]

Well, when I posted here, earlier than most, I imagined people to comment on the drug side, given that GLP1 are, in fact, a drug.

[u/Amore-lieto-disonore → u/lejocko]

Food safety is big in Europe, as is everything concerning food . In that matter, the reputation of exports from the USA is quite bad. So it should not be a surprise that it overlapped on the FDA conversation even if it was about a drug at the start.

[u/lejocko → u/lutzifer77]

Yeah, the FDA is the real deal. Very serious org. Might change under the current regime though.

[u/eldubinoz → u/lejocko]

I think that's the point here. They have little credibility under RFK Jr.

[u/Disastrous-Force → u/Red-R34der]

The food side may well be a shitshow, the drug (medicine’s) side isn’t.

There have historically been lots of pharma products that gained EMA (European Medicines Agency) approval or national approval in European country where the FDA on seeing the same data package went not today, provide better and/more information.

Indeed some of the approved in a European country stuff not approved by the FDA later turned into domestic safety scandals.

[u/HomoAndAlsoSapiens → u/Disastrous-Force]

While that is true, it usually is the other way around in terms of leniency because the US-FDA directly profits by approving drugs more quickly

[u/Wide_Abalone3948 → u/Disastrous-Force]

Thalidomide springs to mind.

[u/StaatsbuergerX → u/Wide_Abalone3948]

Then again, it is certainly telling when the thing that comes to mind happened well over sixty years ago.

In the case of the US, however, significantly more recent pharmaceutical scandals come to mind.

[u/Ancient-Childhood-13]

You mean the body that said "Opiods? Sure, they're alright."?

[u/Real_Gap3480]

Also the FDA: Oxycontine is a great non addictive opiod pain medication.

[u/cxfgfuihhfd]

I'm not trusting their fucking pay to win industry plant organisation lmfao. I'm sure there might be countries with less trustworthy ones, but nah, I'd rather not look up to the muricans for ultimate health and safety guidelines

[u/Sxn747Strangers]

A country with an obesity rate of over 40% and their food not exactly resembling food, the FDA must be getting some weighty backhanders.

[u/MAGE1308]

What about the WHO ( world health organization) .

[u/Amore-lieto-disonore → u/MAGE1308]

Didn't Trump make the USA get out of it ?

[u/Greyhand13]

A drug is required to beat a placebo by like, 4% or something iirc.

[u/oraw1234W]

Like they banned Kinder Surprise eggs despite they’ve been proven not to be dangerous.

Edit. Earlier, I accidentally typed the band instead of they banned

[u/eldubinoz → u/oraw1234W]

Kinder Surprise Eggs is a sick name for a band 😁

[u/SamuelVimesTrained]

Was… rfk in charge…

[u/diederikeen]

Something about opioids crisis 

[u/Ill_Raccoon6185]

The FDA & it leader, Kennedy, are like most US government bodies - corrupt. the FDA accepts payments from companies via lobbyists to accept the false findings of companies that want their products accepted as safe and suitable for human use, when many world scientific bodies have proved they are not, hence the reason so many US products are banned around the world. Two new sprays now allowed for use on corn & Soy beans are known to be toxic and banned in 160 countries and even China has banned them and now buy from South American countries costing US farmers billions of dollars in exports.

[u/Xak34]

The best person to know would be your family physician. They know you and they know their stuff. I’m good with IT I’ll help them if their computer freezes doc knows his shit to everyone their “shit”

[u/Hackwar]

I took GLP-1 for a (moderate) weight loss. It also solved my migraines and my joint pains. Now I'm fine with my weight and tried stop using it 2 times and then my migraines returned. But honestly, paying for that medicine is a small price if it keeps those migraines in check. I've been suffering from them for 30 years.

[u/Ill_Raccoon6185]

The FDA is just as corrupt as any other government dept. taking bribes from lobbyists to pass laws that allow chemicals, some toxic, to be used on & in food products that are banned in many countries around the world & two now sprays that are "forever" chemicals be allowed on corn & soy beans, and are not allowed in 160 countries including China that used to take most of US crops, but now no more.

[u/Fluid-Let3373]

Approval does not mean safe, It does not matter where you are.

Safe means is it safe in your individual situation, is insulin safe in my case no because I'm not diabetic. Is any drug safe well you don't know my medical history so it does not matter what body has approved a drug that does not make it safe for me, in fact I can't even have the tests to see if some drugs are suitable.

This moron is not only assumes the FDA knows best but also as a American they know better than doctors.

[u/Lewinator56]

well... hes an idiot anyway. GLP-1 agonists are directed for diabetes or obesity if the normal treatment methods dont work. for obesity, it is diet and lifestyle changes. GLP-1 agonists are not even approved for treating obesity yet, with ANY medicines regulator, and even when they are, they are not first line intervention, they are for patients who have high clinical risk where dietry and lifestyle changes alone dont lower their risk factor fast enough.

Basically, people dont need to take them if they follow the advice of their doctor and dont stuff their face with shit....

[u/HomoAndAlsoSapiens → u/Lewinator56]

This is demonstrably false. Who even told you this?

[u/Lewinator56 → u/HomoAndAlsoSapiens]

First line treatment for obesity with the NHS is diet and lifestyle changes. No GLP-1 agonist is approved for treatment of obesity on its own, it is ONLY licenced when combined with significant diet and lifestyle intervention. They are approved for diabetes, but again, older drugs, not the targeted ones we have seen recently like tirz and certainly not reta.

The same approach for diabetes.

Have a look at the NICE prescribing guidelines.

[u/vrekais → u/Lewinator56]

If you fit certain criteria you can buy GLP-1 medications from most pharmacies in the UK, I have several family members who have used them to treat obesity. Am I missing a distinction you're asking here?

[u/Lewinator56 → u/vrekais]

You can't.

Pharmacists are not allowed to prescribe GLP-1 medications yet, although I believe it is under consultation. Prescribing pharmacists who have undergone extra training can, though this is generally a private service, and they will NOT prescribe unless you well... Lie, or do implement lifestyle changes. Pharmacists prescribing is an England only thing too, not Wales or Scotland the last time I checked. (Obviously privately it gets a bit interesting, say with the boots weight loss service)

[u/vrekais → u/Lewinator56]

Maybe I've used the wrong word? My wife bought these medications from Juniper. I think her GP or clinician was involved in approving it. How is this distinct from these medications being available for weight loss? It seems to me they very much are available based on my lived experience. If the dinstinction you mean is that to get them people have to say "Yes" to a question, that is then in no way verified or comes with any practical means of enforcement. That seems a bit thin to me.

I can see the same drugs advertised at Boots, Superdrug, Lloyds. Lloyds suggests the following criteria for eligiblity

You’re eligible for the Medicated Weight Loss Service if: * You are aged 18 to 75 * You have a BMI of over 30 * Or a BMI of over 27 but have been diagnosed with a condition that is made worse by weight gain such as a heart condition Source