a bureaucracy seeking to protect itself is the enemy of science and of liberty

how to fix the american drug regulatory system

bureaucrats and politicians always want more power and less accountability. it’s just in their nature. it’s like saying water always seeks to flow downhill. it’s just a simple, observable, property of the world.

and when you get power without accountability, the key losers are science and liberty. always.

people continue to marvel at politicians and experts moving goalposts, manipulating data, and masking facts to suit narrative.

but what would truly be a marvel is if they didn’t. it’s what they always do. it’s what they always have. it’s just that this time, the stakes are really high and far more of us are paying attention.

what did you think they were going to do? say “oopsie” we sure got this wrong and ran the global economy into a ditch and injected a billion people with a vaccine that turns out not to stop the spread of covid and may even be making it worse?

no way. they will double and triple down, hide the risks, overstate the benefits, prevent real risk benefit analysis, move the goals once again, and claim we must do more of whatever they claimed so they can grab more power and remove any accountability.

2 weeks to flatten the curve becomes two years of flattening the world.

and then they blame you for not complying when it doesn’t work.

these are not people who change their minds when the data changes. that’s political and career suicide. these are people who change the data so they can keep their narratives.

so expecting them to accept a little thing like an FDA advisory panel advising against approving pfizer boosters for non-immunocompromised under 65’s was always a bit silly, wasn’t it?

they’re going to play politics and the NIH will either get what they want (and watch the last remnants of the once respected FDA’s credibility burn while gaining stature themselves) or they will not and then get to play heckler from the balcony and blame anything bad that happens on the FDA not listening.

win/win. (and a great reason to resign from the FDA if you have a shred of integrity)

this is the worst kind of crap science.

but it’s great politics.

you don’t get to run the NIH by accident…

let’s be very clear what we’re seeing here:

• this is the NIH saying that the vaccines they pushed are rapidly failing and demanding more vaccines despite the FDA expert panel saying it’s a bad idea.

• this is a desperate double down because a thing they did not predict (but that many others did), rapid drops in efficacy, is happening and so they want more of a vaccine that does not stop the spread of covid because we need to stop the spread of covid.

and if they think the israel data supports this, i’d love to see which data they are looking at. because what i see is THIS and it looks like boosters are a disaster.

this is going to take us into a truly dangerous set of political outcomes and this is ALL the fault of bad incentive structures.

all of it.

we’ve all seen a reckless gambler on tilt desperately betting the whole ranch on a clearly losing hand in hopes of getting back his kid’s college fund.

do you think politicians are any different?

imagine you're a health agency leader or an expert or a politician.

imagine you just pushed out a literally unprecedented in human history vaccine type at an uptake rate 100’s of times any before it.

you put this into a billion people.

imagine you told everyone it would create herd immunity and stop spread and end the pandemic.

now imagine it's not sterilizing at all, might be actually causing more cases, cannot generate ANY herd immunity, and may actually be accelerating/rekindling the pandemic.

how you feeling? ready to just say "oops" and light your career on fire and accept that you caused this?

COULD you even accept that?

would your mind even let you or would you bury it under 27 layers of cognitive dissonance, lie, cheat, hide and manipulate data, and double and triple down just like you did on masks and lockdowns because even letting you think the truth would flat out break your brain?

i am sure that some of these people know they blew it. pfizer does not make mistakes like rigging a trial. they are too good at what they do. pfizer makes choices and pushes the envelope. it is (allegedly) the job of the regulators to push back.

but what if they have been completely politically captured and are just a rubber stamp cum cheerleader?

where are we then?

they are not detectives seeking datacrime, they are accomplices seeking to feather future nests and please politicians. and it’s not like the politicians have any idea what the science is. so they swallow the claims uncritically because they suit the narrative.

it’s nastily circular and bends science to suit story and the story politicians always want to tell in a crisis is “me hero! me save you! give me more power!” so they gin up a compelling tale:

this is the grand undertaking of our time.

it’s the manhattan project of vaccines.

the '“trump fraud” becomes the “fauci ouchie” and everyone has gotta get one because this is “doing something” and this is “saving you.”

this was a buffet of political opportunity and a demagogue’s dream.

of course they all went for it.

but then if it fails and you’re wearing this millstone around your neck instead of laurels upon your brow.

what wouldn’t a politician do to make it appear otherwise? because no one wants to own this.

keep an eye out guys, this is where it can really get nasty. the data going bad on them is not going to drive re-assessment, it’s going to drive the most mendacious sort of bigger hammer theory and anyone opposing it is gonna look an awful lot like a nail.

they will try to bully a win and play for time and they’ll do it by blaming you.

it’s long past time we separated these people from their power and their credibility.

if we don’t, believe me they are going to separate us from our lives and livelihoods and liberties.

between the narratives of the flailing experts and the freedom of we the people, the choice is obvious.

so let’s get on it.

it’s time for real, open source science and drug development. all these problems exist only because we have granted the government the power to decide which drugs we can take, which we cannot, and most perniciously, which we MUST take.

not a single one of these is justified in this day and age and not a single one of these problems would exist without these grants or power.

the free market can and will outperform all of this.

you saw what just happened here: vaccines that were barely even characterized, much less tested were approved, pushed, and mandated by a political body who ignored much of the science and clearly got quite a lot of it wrong.

meanwhile, the companies making $10’s of billions on it did so without ANY liability for their products. none. it was written into the laws and contracts like a biotechnological game of “punch no punchbacks.”

how can a system like this possibly be expected to produce sound outcomes?

(it can’t.)

there is a better way.

• how about manufacturers and developers DO face strict liability for their products?

• and how about THEY then get to decide when to sell them. they set their label and show effects and risks.

• the trials they perform to establish this are up to them.

• third parties and doctors track pharmaceuticals in use and track bad results in open source, public databases.

• if they diverge materially (more than 5% or so) from claims, companies have to pay for any damage they do or net efficacy they fail to provide.

this aligns ALL the incentives and takes politics out of it. if you’re injured by a drug, you (or your loved one) have every incentive to report it. because if you do you may get paid for it.

and people have incentives to keep good databases and make them easy to use, because they will share in your gains (or pay restitution/legal if they make false accusations).

and if you want to market a drug, you have all the incentives to avoid being sued for misrepresentation, so you’ll take due care to be sure the label carries claims you can defend.

the drug companies know better than anyone what to test for and the risks of their own products. all we have to do is make them liable if they make claims and don’t deliver.

and we the patients and our physicians would get access to an unparalleled wealth of data on how drugs are doing in the real world and how they compare to one another. private companies would compete to give us the best, most complete, and most accurate data and for our trust and our money.

it would be a new golden age for evidence based medicine.

you don’t need the department of dishwashers to make sure your dishwasher works well and does not explode. you don’t even need car safety agencies. manufacturers are selling products WAY safer than the minimum requirements. because that’s what you want.

all we need is liability and accountability and we’ll get a market clearing solution and great products that find a real trade off between speed and safety, price and performance.

and yet these are exactly the two things the current system is set up to completely avoid.

this is just plain wrong. sure, maybe in the 1930’s we could not have managed a system like this, but today it would be trivial and companies and ecosystems would arise and compete to monitor drug outcomes as well and precisely as possible for some share of the rewards when drugs go wrong (and constrained by facing liability and losing reputation if they make a false claim) and for fees from doctors that want access to the best data on best practices.

yet instead we let politicians do this.

we let them push scientists and data aside. we let the government run databases and set up all the incentives to hide data, protect careers, and serve partisan ends when what we need are incentives to get it right.

and that takes a market.

if you want an FDA, you can keep it. but it must be voluntary accreditation and not a monopoly. if you only want to use the dugs it says are ok, fine. pay more and wait longer while they decide. but leave the rest of us out of it.

this monopoly is long past being helpful and WAY into causing dire net harm.

the government has no place limiting medical treatment or setting drug standards. it has neither the competence nor the incentive to do it properly.

and it’s time we left it behind and made our own way.

because no public agency can keep the promises that were made to us.

we’re going to need to achieve that promise for ourselves.