That would be wrong.
A true free market economy would provide its own checks and balances against such things.
Let me know when you find one.
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Okay, why do you say itâs an unknowable process? I mean, the criteria are public knowledge. To the best of my knowledge, the process is pretty transparent. Itâs complicated and difficult - at least one board member actually used to be entirely employed handling FDA paperwork - but itâs not secret. Iâm not sure offhand how much of any specific submission is made public knowledge, but I know the criteria and process are certainly public knowledge. So Iâm kind of getting the feeling that âtotally unknowable processâ really means âtoo complicated to readily understandâ, which is I think inevitable; medicine is complicated, you know? Add in a need for public commentary, checks to prove that they arenât biased (yes, I know these checks arenât perfect), etc⌠yes, itâs going to take a long time. Alternatives involve things like âbelieve everything the drug company saysâ, âno, the public doesnât get to know anythingâ, and âsure, you can pay extra to skip that step.â
Is âfirst do no harmâ a bad thing? Hell, theyâre not even testing to make sure the drugs work as claimed. Should they abandon that criterion altogether? Iâm pretty sure youâre not suggesting that.
So, yes, theyâre going to be a bottleneck at the end of the cycle, because they have to be at the end of the cycle (and if somehow they were at another point, thereâd be complaint about that, too.)
Now, I canât explain everything with the FDA. I have no idea why theyâve made some particular decisions; Iâm not privy to those conversations, nor do I have the expertise to follow them even were I a fly on the wall. What I suspect, though, is that there are some unrealistic expectations for the FDA. I donât dispute that they could be made faster and more efficient, but it seems to me theyâre being used as a whipping boy based on the perception that theyâre just bureaucracy. I donât think they could possibly do their job and meet these expectations; when it comes down to it Iâd rather they do what theyâre supposed to do, and if pharma finds the FDA inconvenient, I shanât shed a tear.
Okay, why do you say itâs an unknowable process?
You canât know 10 years ahead of time what the regulations are doing. You also canât tell how politically popular your drug is going to be at the time.
The FDA can look at your drug, look at your tests, look at your data, and still decide the cost is not worth the benefit, based on opinion. âIt may cure herpes, but it kills one of every 10,000 peopleâ is a value judgement. They can also throw you back to the drawing board and delay your release by another x months/years asking for more long term testing.
Not saying itâs all bad, but itâs less predictable than you make it seem.
No, itâs not totally a bad thing, but it puts the focus on stasis. The biggest advances in the world come from risks, taking only the smallest risks means only the smallest increases most of the time. Do I think we need to just randomly test drugs on people at the bus stations, no, but this philosophy is a downer to advancement. Not a killer, but a brake, and I think right now we are resting our foot on that brake. I also think most of the low hanging fruit has been picked, the pendulum should swing a little the other way now.
Another agency that needs to spend more time doing one of itâs main functions and less time and money arresting people for privately selling raw milk. Or making food pyramids that suggest we eat a loaf of bread a day.
I donât think the FDA is the root of all evil, and is generally one of the more useful agencies, but they still have grown too big and have had quite a bit of mission creep.
Iâll be blunt - to me, the complaints Iâm seeing about the FDA seem like the same complaints about government regulation in every sphere. Companies never want to bother with regulatory compliance. They never want to spend that money. Itâs always too difficult, it always cuts into profit too much, it always slows things down. And yes, itâs always possible to find some way it could be made faster, and some decision that you disagree with.
I can certainly accept that the FDAâs drug approval process is flawed. I believe itâs flawed, too. And on the one hand, I believe those flaws can and should be fixed - but on the other hand, I recognize that there are people and companies who work very hard to find and exploit flaws in the system, so I donât think the process can ever be truly fixed because there are forces that are opposed to having the process exist at all.
And yet, on the gripping hand, we need that process. Weâve had a world without the FDA, and it kinda sucked. And if you think folks in West Africa distrust Western doctors now, just wait until theyâre being given experimental ebola drugs that kill them faster than the ebola.
Woodman, you think theyâve had too much mission creep. ClockWorkXon wants them to evaluate more things. Some parts of the industry want them to take over things from the USDA, other parts want to get rid of them. They need to be faster, but cheaper and more accurate with fewer people and less paperwork.
I just donât think the expectations are realistic. Honestly, when I look at what has been approved, my own opinion is that the regulation is rather too lax; I think we might disagree on that point.
But, regardless, the FDA is dealing with a lot of contradictory expectations, and if theyâre not doing the best possible job, I donât think theyâre doing all that horribly, either.
No, you are right, we could have people dying of cured diseases, or bad drugs so easily. Weâre not China where God knows what you are getting in either your food or your drugs.
And I recall the quickly-dismissed kerfluffle when it was discovered that expired medications or medications mis-labeled were being shipped to refugee camps in Africa and Asia.
The âfirst do no harmâ is part of the Hippocratic oath (which Pharma companies are not beholden to anyway). But the phrase refers to not making things worse. It is often quoted, but I see many areas where it has been largely ignored - but I can see areas where it is sometimes necessary in order to save the patient (the series House has provided examples - some of which are extremely questionable in the interest of making it more interesting).
The experiments of Mengele illustrate the dangers of allowing a so-called doctor to ignore the phrase, âin the interests of scienceâ (too bad he threw scientific standards out the window, eh?).
WELCOME BACK TO THE MADNESS, HASUFIN!! As you can see, we moved the furniture a bit, but things are basically the same 
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I should clarify: I donât see a need to evaluate more things. I just want them to either shut up about how unreliable studies on the subject is, or actually review the studies. Itâs their choice. Either would suit me just fine.
Remember the Cheerios scandal? Guess what, it wasnât what it was painted as. They didnât say the claims were false (like many assume), they said there was no proof. However, numerous experts had gone on the record prior to that, that a good source of fiber (like oat bran) improved health, including hearty problems due to cholesterol.
Like I said, they can stop shooting off their mouth about things they know diddly squat about, or they can educate themselves.
Interesting lesson to be learnt here.
If youâre the President (or government) of a country, do you prohibit public hospitals to release Ebola statistics, or do you allow them to?
Case in point - there is a rumoured Ebola case in Durban (South Africa, Kwazulu Natal), but we canât really say for sure as the news reports we got on these was confusing and conflicting. We also donât know what is going on since the hospitals have been told not to release any information.
FWIW I think Ebola can only thrive in its current location - darkest Africa - but when it is relocated (via a victim) to another country, then it loses its virulence.
I think I might require them to.
I tend to agree on Ebolaâs survival chance outside of a stone age culture. Which does include some areas in the US. Imagine Ebola hitting a small population in the Appalachian Mountains, or a set of projects in Detroit. High distrust of the government/hospitals and poor living conditions appear to be necessary for it to be as virulent as itâs been in some parts of Africa. Some parts of Central and South America as well, and it would tear through regions of China without notice until the dead started walking.
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Apologies for resuscitating this thread, but what with the latest Ebola outbreak in the Congo*, I want to add my own observations to this.
Absolutely. For some weird reason it remains locked in a geographical area, and does not spread far away from that area.
However, for the first time it surfaced in Uganda.
2019 is going to be an interesting year for Ebola. If not, 2020 will be.
Clearly you havenât watched enough TV thrillers. Why, Ebola can break out at any Emergency Dept at the drop of a hat!
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Aaaand⌠in other newsâŚ
I am not assured by the comments in the article above. âIt is just a simulationâ ââŚexcerciseâŚâ etc.
The real acid test will be when a live case happens, where you wonât expect it.
However, we will have to play the waiting game and see what happens. I have no faith in our DoH and Govt at this stage.
WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
12 November 2019
News release
The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
Prequalification means that the vaccine meets WHO standards for quality, safety and efficacy. United Nations agencies and Gavi, the Vaccine Alliance, can procure the vaccine for at-risk countries based on this WHO recommendation.
âThis is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. âFive years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.â
Iâm sceptical.
Nah, it will totally work. And the people in the countries most affected will fight over who gets it, some will say it causes AIDS, and the ones who do get it wonât do the full treatment creating super Ebola. The Congo will literally be on fire. Meanwhile Chinese knockoffs will be sold that donât do anything but cost land rights to âworthlessâ land which will be dug up for rare earth minerals.