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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
I think the author of this article is suggesting that the safety of COVID vaccines is similar to, and as well established as, that of flu shots.
That’s bonkers. Flu shots use an old technology that has been widely used in other vaccines for several decades.
COVID vaccines use a novel technology and have been out for a few years now. Their safety is still being debated, as you might expect for something so new.
Perhaps we should continue to scrutinize such new players in this space.
In the case of the GLP-1 agonists(ozempic, Wegovy, etc) Novonordisk can sell all they want to people who can buy them at full value, without insurance coverage. Most of my patients cannot afford to do so, and since their insurance doesn’t cover the drugs, they are left out in the cold. The drug company makes more money selling at retail than through discounted insurance coverage. Regarding PBM’s I recommend the book “drugs, money, and secret handshakes” that begins to shed light on that shadowy world. It is complicated.
I’d be surprised if they can make more from the few people who can afford full price, than they could from insurance.
VERY surprised.
And, why not do BOTH?
It is also true that in addition to people who are affluent enough to not need to worry about if their insurer will or won’t give them the drug they want, there are huge numbers of people who cough up money when insurers decline this or that item because the alternative is not pretty. A diabetic does not want to have blood sugar levels at 300 plus..
If only there was a vaccine for that governmental tendency. Then the public could mandate the behavior away!
Also, flu vaccines are for known flu strains.
It is unfortunate that even sceptics have accepted calling a flu shot a vaccine. Just as illegal aliens have now become undocumented immigrants, those seeking to change the language are sadly succeeding.
A flu shot is a vaccine. I have an old–pre-politicization of pandemic–slip from CVS from the 2010-2011 vaccine year, and it was called the “Inactivated Influenza Vaccine.” I’m looking right at it. :) :)
To me, the really interesting thing about the flu vaccine is that it was not developed until 1931, well after the Spanish flu of 1918, and even then it wasn’t used widely until the 1940s.
The Spanish flu died out on its own. By itself, it did not actually kill that many people. It weakened them, and a pneumonia bacterial infection that seemed to travel along with the flu was the actual cause of death for most victims. To some extent that is still true today of the flu, especially in the pediatric group.
The Spanish flu died out by mid-1920, before a vaccine became available. There are many theories as to why that occurred, but most likely it attenuated (weakened), and people gained immunity to it from something they believed to be a mild cold.
At least some people have a theoretical option. The Xeljanz that I take would be like $8,000/month I’m told.
“COVID vaccines use a novel technology” — Only some do. The rest use old technologies. N.B.: The fact that old and new have very similar results tends to corroborate the theories behind the new ones. (Of course, the Flat Earth wing of the anti-vaxx movement would claim the similarly is that neither new nor old work.)
Also, COVID vaccines are for known COVID strains.
There is no excuse for clinging to antiquated viewpoints regarding the COVID vaccines.
Don’t believe me, I don’t care.
But given the status, the integrity and devotion to actual science that Dr Peter McCullough holds, there is no excuse to not step to the plate and look at what the top independent people across the globe understand about the COVID vaccines because of this man’s efforts.
It is a horrifying portrayal of a vaccine that in his words “uses the worst delivery mechanism possible” by which to supposedly bring humanity immunity from The SARS COV 2 virus. Having the vaccine set up to deliver a dangerous element, the spike proteins, into the vaccine recipient’s body makes no sense.
Given that we now know the vaccine has a ridiculous risk to benefit rating, due to its low efficacy, its risk rating stands at a “ban this item today” level.
It is now known that the vax material itself does not stay in the arm near the injection site. The spike proteins have an affinity to travel to those areas of the body where inflammation and/or blood flow are at the highest levels.
This relatively short video summarized the many details McCullough has found out about the COV vaccine over the past few years: https://twitter.com/i/status/1703544992243781880
Peter McCullough is a cardiologist, not any kind of expert on vaccines.
Maybe a cariologist is better at understanding the effects of a vaccine on the cardiovascular system, than a vaccine “expert?”
Unfortunately he doesn’t limit himself to that question, toward which he does have expertise.
Maybe he’s consulting with other experts, something the vaccine “experts” should have done already.
That’s really hard. Money goes all over the place. Some goes here, some goes there. How does one follow it all, especially when I don’t have access to complete information about everyone’s financial transactions?
If I were to obtain that information, though, I promise that I wouldn’t abuse my new powers!
How do you know that it’s booming?
McCullough is a far greater expert on COVID vaccines than anyone you can point to in any Fed government spot since the beginning of this crisis.
He has monitored the health status of a large group of cardiac-afflicted people, & knows how to decide thru specific testing if the heart damage was due to a COV infection & its spike proteins, or else a spike protein-containing injection.
He also collates info in scientific reports from trusted sources. He interacts face to face with 100s of other doctors, scientists & researchers.
The people you rely on have been lying to us ever since the words “2 weeks to flatten the curve” first ejected themselves from Lizard Person Anthony Fauci’s lips.
Those same “experts” of yours ignored the antibody dependent enhancement reality first mentioned by world’s top vaccinologist Gert Vanden Bossche in Spring 2020. This reality is why we continue to have the vaxxed people end up in hospitals & morgues from new COV strains.
Or maybe the ghost of Edward Jenner is whispering in his ear, if we’re going to speculate without evidence.
I think I’ve had that just over a month ago. I’m not worried about it. The testing on the original vaccine suffices as far as I’m concerned. But I’m not going to say it should suffice for you or anyone else. It’s a bad habit for the FDA and Pfizer to start releasing these new versions of the vaccine without human testing, and then for the CDC to recommend them for all ages, and for the government to pay for it all, and to try to mandate them for anyone. Nothing good is going to come from those precedents.
(When I went to Rite-Aid to get my vaccine booster, I was glad to see they offered the Pfizer version. The web site had said they only offered Moderna. I told the pharmacist that I favored the one with the lower dose, and he understood completely.)
??? They are guesses about what strains may be coming.
Better.
Karen.
There are only four or five in circulation. They match our vaccine formulas to whatever strains are circulating in South and Central America during their winter and our summer.
That usually works, but not always. Once in a while, it doesn’t work, and the flu vaccine doesn’t match the strain making the rounds that year.
Tony “I Am The Science” Fauci is an allergist, not any kind of expert on vaccines.
The reason I started getting the flu vaccines is that I saw indications that close enough is good enough in preventing (decreasing the probability of) serious disease or death. I haven’t paid more than passing attention to the issue, though. I never got around to getting the vaccine the past two winters, but will plan to get one this year.
Unless you’ve gotten the flu when you didn’t get the shot, why would you resume getting them?
I haven’t gotten the flu since I stopped getting the shots.
No, he’s an immunologist, so he has some claim to expertise in vaccines. On the other hand, he is not an epidemiologist, so he was off base, trying to suppress the Great Barrington Declaration, by people who are experts in that area.
@carol not easy to kill — “world’s top vaccinologist Gert Vanden Bossche”:
On March 6, 2021, a Belgian veterinarian named Geert Vanden Bossche published an open letter “to all authorities, scientists and experts around the world” asserting that, in his expert analysis, the current global COVID-19 vaccination program will “wipe out large parts of our human population.” The way to avoid this purported calamity, Vanden Bossche asserts, is for scientists to pay more attention to his own invention — a “universal vaccine” that uses the body’s innate immune system to kill SARS-CoV-2. — snopes.com
Sounds like a crackpot to me. I don’t know if he is still waiting for “large parts of our human population” to be killed. Certainly, we’re no closer than we ever were to a universal vaccine.
Read more carefully, please. Getting the flu vs getting seriously sick or dead from the flu. Two different things. I can deal with getting the flu, and getting a manageable case of flu also gives me some immunity against a seriously bad case of the flu. I would prefer not to get the flu at all, of course.
One difficulty in having discussions about biological functions around here is that people tend to be too binary in their thinking, as if there are only two states, for example, getting covid and not getting covid. But in real life and real biology, there are all sorts of gradations from not getting covid to getting mild covid to getting seriously dead covid, and many points in between. They also think of immunity as only one thing: an immunity that completely stops a virus before it does anything to you. There IS such a thing. It’s called sterilizing immunity. But that’s not the only kind of immunity. Your immune system is not a quitter such that if it doesn’t succeed at first, it just quits goes home. It keeps working and building up its forces for the long haul. Conflicts in real life and real biology are like that. Life is not a digital, binary computer.