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FDA’s New Drug Approval Process Too Slow and Complex. Usually.
A friend of mine used to do research for a pharma company. He told me of the day they sent the official application for a new drug patent to the FDA for review. At this point, they’d been working on this new drug for nearly 15 years, doing multiple long-term studies involving tens of thousands of patients in research centers worldwide. The application was enormous — five semi-trucks filled with paper. When the semis pulled out of the parking lot to drive the application to DC, everyone lifted their champagne glasses and cheered. That was 20 years ago. The process is much more complex and time-intensive now. Usually.
A new COVID vaccine was released recently. The Moderna version is supported by a research study that involved 50 patients. The Pfizer version has no human data at all — their study involved 10 mice. Neither has any efficacy data or safety data. The FDA has approved both, the CDC recommends that everyone over six months old should get these new vaccines, and the US government has already paid billions of dollars to Moderna and Pfizer for millions of doses.
While COVID remains common, it has predictably become less deadly over time. We’ve been averaging less than 100 COVID deaths per day all summer. In a country of 350 million people.
Suppose the new vaccine reduces the risk of death by half (which, of course, we don’t know, because there is no data). So we hope to reduce those deaths from 100 to 50. But to do so, we’d have to administer vaccines to nearly 350 million people.
Well, ok. But if any of the 349.999 million people who don’t benefit from the vaccine have an adverse reaction, we could be creating more disease than we are preventing. Even if the vaccines are very effective, which they might be. But we don’t know, because there is no data.
Again, I have no idea if those numbers are even close to correct.
But neither does anybody else. So how did the FDA approve these vaccines so quickly? And why?
The CDC is publicly stating that these new COVID vaccines reduce the risk of hospitalizations, prevent long COVID, and reduce the risk of spreading the disease to others. There is no evidence to support any of these claims. If Moderna or Pfizer had made such claims, the FDA would fine them hundreds of millions of dollars — it is illegal for Pharma companies to make claims that are not supported by data.
It’s ok for the CDC to do that, apparently.
I don’t understand what’s going on here. Why are the FDA and CDC doing this? It makes no sense. They’ve never done anything like this before. Approving untested drugs, which the government then buys in bulk whether anyone wants them or not. What on earth? I’ve been in this business a long time, and I’ve never seen anything like this.
I miss the days when our government tried to hide corruption. That was better.
This is unbelievable.
At least, I wish it was unbelievable. Crap.
Published in General
This has to be the result of the special authorizations that were part of Operation Warp Speed.
It has reached the point that I no longer believe anything put out by the Government or by the main stream media without first doing a lot of personal research and giving it a lot of thought. In recent years, my first reaction is that what I’m seeing or hearing from the Establishment is false, and if it is coming from our president, it is definitely an outright lie.
My instinct as well. And, as has been pointed out before here on Ricochet, that will cause major problems in public health in the future, as even if the government puts out correct and useful information, people won’t believe it.
There are a lot of things the government does that if companies or individual citizens did, the companies and individual citizens would be subjected to lawsuits, criminal fines, jail, and possibly (in the case of companies) execution (accounting practices, market monopolization, making false statements to induce people to act in a particular way, etc.).
The State makes Big Pharma fabulously wealthy so they then can go out and support the Industrial News and Media complex , which in turn supports the Industrial Gov Complex.
Win , win , win !!!
“So how did the FDA approve these vaccines so quickly? And why?”
Sigh.
Money.
I’m really tired of my tax money being used to make these worthless vaccines.
It’ll be ok. If you get sick with the ‘vid, just take Sudafed with phenylephrine. FDA said it works.
In God we trust, all others must bring data.
Follow the money…
I think you mean the Military Industrial Media Academia Complex (MIMAC).
I think it’s more than just money. It’s the untoward results they are looking for.
I agree. There must be more to it than kickbacks.
This makes no sense. I don’t understand.
Hey , he belongs to R
funny that !
Having gotten hundreds of shots from the polio scare in the 50’s through the Navy experience and then got all my Covid shots and boosters for the first time think I might take a pass. Excuse will be wife cannot walk with a broken ankle and did not want to leave her alone. Assume CDC will not offer to come to my house to do their job in making money for Moderna.
Related article: The FDA Has Gone Rogue
It has a lot of details of how the FDA has used questionable tactics to stretch out its power to push this stuff on us.
I would argue that the FDA’s record is Metformin. It took the FDA 50 years to approve this for the US when it was available everywhere else in the world. It took the last 10 years of that half century for the top diabetologists in the nation (Gerald Reavan, Ralph DrFronzo, Alan Garber) to convince the FDA it should approve the drug. It happens to be one of the safest drugs known to man. Medieval apothecaries used it as an extract of French Lilac to treat diabetes patients. So until 1995, American physician lacked access to a medication that had been used for a thousand years.
I had a ptient and her husband ask me yesterday how many Covid boosters I have had. I told them none. I had the first two shots (Moderna) then I got COVID, and haven’t had any more shots. I pointed out to the patient some of the points Dr. Gastiat makes above, particularly the lack of human trials. They had intended to get eht new booster. I think they changed their minds
Ralph DeFronzo is a friend of mine. He has some hilarious stories about that whole fiasco.
As the good Dr Campbell points out, the maths don’t math.
I don’t know what’s going on, but I know it’s not good.
I’ve got two pregnant daughters-in-law, and four toddler granddaughters. That these shots are being recommended for anyone six months + AND pregnant women??
You might be confused, Doc. I’m appalled and furious (and relieved that the women in my family are smarter than the FDA and CDC combined)
Every mom on the planet knows more than the CDC idiots.
In the law we have the concept of rebuttable presumption. I apply it to everything the government tells me.
I presume that everything the government tells me is false. It is false (to me) until it is proven to be true. And I need what we call clear and convincing evidence of the truth. That is more persuasive evidence than merely “probably true.”
How do you know these are useless? There is precious little data? I thought the point was that assertions about efficacy shouldn’t be made without some evidence. No?
Because they don’t prevent one from getting Covid. There is plenty of evidence of that. But, knock yourself out, get your 5th booster and continue to cower in fear of a cold virus.
It’s touted for mild cases of Covid because of its decongestive properties. However, you’d better get it while you can!
FDA Panel Declares Decongestant Phenylephrine ineffective.
The wheels on the bus go round and round…
It’s not about money.
It’s not about power.
It’s not even about the vast Davos conspiracy to make us bug eating serfs.
It’s about fear.
The fear something bad will happen and the politicians will be blamed. They might lose their phoney baloney jobs.
(1) How do you know that? I thought all government data was a lie? All except those, I guess. The data you like are pure as driven snow.
(2) The data on previous vaccines is abundant and clear. The most thoroughly vaccinated countries (or at a more granular level in the US, States) have the lowest levels of excess deaths. The vaccines are especially effective at preventing deaths among those aver 50 and those with at risk health issues. Every data set shows this. I know, I know. All these data sets are lies, right?
I think the early vaccines may have helped. I don’t see the data as clearly as you do. The evidence of benefit is not overwhelming. But I think they may have helped some. I took them myself.
But that’s not my point in this post.
The recently released vaccines have nearly no research behind them – certainly no safety data or efficacy data. The CDC is recommending that we vaccinate hundreds of millions of Americans for a disease which is killing less than 100 people per day. The math on that just doesn’t make any sense.
How safe is COVID now? Much safer – generally just a bad cold now.
How safe are these new vaccines? No idea.
So let’s give these vaccines to hundreds of millions of Americans. Right.
Man, I don’t know. I lack your certainty on all this. These new vaccines may turn out to be a good idea I guess.
But man, I don’t know…
We must curtail finding and using reliable fossil fuels and instead fund solar panels and windmills even though we know that policy has great costs and minimal benefits while not even effectively addressing the (grossly exaggerated) problem of CO2 emissions.
We must fund and submit to DEI nonsense to solve the non-existent problem of rampant white supremacy.
We must submit to vaccines, mask mandates and additionally futile, gratuitous policies to address the now increasingly minimal threat of an illness that is just another endemic respiratory flu virus. But the vaccine approval on an groundless emergency basis serves the narrative.
Because it simultaneously serves the need to continue the pretense that government is fighting a great threat while also creating a huge profit opportunity for the future employers of FDA officials, those vaccines will be imposed on the USA unless and until bodies pile up from immune system damage or some other cumulative adverse effects.
If the FDA/Big Pharma get their way, a child born this year will have 100-250 mandatory vaccines/boosters during a lifetime. And then of course, there will be a huge market for the drugs to restore immune health or fix other adverse effects from all those vaccine shots…
You ought to go reread your Ayn Rand quote. It actually seems to make sense with regard to the Covid mRNA vaccines.
I’m sure you’ve got your talking points to refute this 4 tweet thread from Alex Berenson but this assures me that my decision to not get jabbed was spot on. And as I said, knock yourself out and keep getting jabbed. Good luck with that.
TEAMWORK!!
The government makes claims that would be flatly illegal if the “private” sector issued them. The “private” sector will censor and suppress factual criticisms, which censorship would be illegal if the government did it. The government will issue complete and utter bulls##t to craft “guidelines” such that “private”and public entities can impose otherwise unlawful and dubious requirements on the basis of The Science(TM), rejection of which which is socially and legally impermissible. TEAMWORK!!
It is all pretty simple. Cui bono! essentially, follow the money.