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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