New Republic: "What the $%&! Is Going On at the FDA?"

[Yavin4]

I don't want to hear any more about the FDA's process when they just approved a speculative Alzheimer’s drug, but not the covid vaccines. Full FDA approval would go a long way towards mandates by businesses, schools, and our military.

Before anyone mandates that I wear a mask or quaratine myself in my house again, there better be full FDA approval of the vaccines and mandates for people to take it.

Experts want to know why the agency approved a questionable Alzheimer’s drug but has withheld full approval from Covid vaccines.

Gregg Gonsalves feels guilty. Now a professor at Yale’s School of Public Health, Dr. Gonsalves remembers standing with other AIDS activists outside the Food and Drug Administration headquarters in the 1980s, accusing the agency of murder for not approving medications that might save lives but hadn’t been proven effective in clinical trials yet. “People were dying. We didn’t know what to do,” Gonsalves told me.

The activists demanded an expedited approval process for medications that showed potential with improving immune system markers like CD4 cell levels, while studies on whether the drugs actually prolonged lives were still being conducted. Rapid approval, even before a drug was shown to help, could mean the difference between life and death, they argued.

In 1992, the FDA established precisely this kind of rapid approval process. Now the FDA has used it to approve a controversial drug for Alzheimer’s disease, even as the agency hasn’t fully approved Covid vaccines with far greater evidence of efficacy. Aduhelm, a drug produced by a company called Biogen, reduces a type of brain plaque that is associated with Alzheimer’s—but it’s not yet clear if the medication can help control or halt the disease itself. Thanks to the FDA’s accelerated approval in June, patients can start using the drug to see if it helps while trials continue.

Six months into Biden’s presidency, the FDA is in turmoil; the administration still hasn’t even named a commissioner to lead the agency. The hasty Aduhelm approval shocked observers, in part because the agency has yet to offer full approval to Covid-19 vaccines despite millions of successful and safe vaccinations.

https://newrepublic.com/article/162975/alzheimers-fda-covid-vaccines

[kimbutgar]

2. Holdovers from the TFG administration?

Possibility approved it rougely?

[GoCubsGo]

12. DeJoy can only be fired by the Postal Service board of directors.

It's still made up of mainly Trump loyalists, who are in the process of being removed. Things like this don't happen overnight. It has to go through Congress.

[dalton99a]

3. Kick

[Orrex]

5. FDA approval of a covid vaccine will do nothing to persuade the contrarians

They will simply (and immediately) claim that the approval was simply a political maneuver forced by Biden in order to inflict "dangerous" vaccines upon Real Americans.

I suspect that many of these fools also take non-FDA-approved supplements and vitamins on a daily basis.


Not sure I understand how your preemptive refusal to self-quarantine follows from the FDA's action or failure to act, though.

[uponit7771]

6. Not about persuading them only

[Yavin4]

7. It's not about persuading them. It's about mandates to take the vaccine.

Businesses, schools, our military and other organizations cannot mandate that people be vaccinated because the FDA has not given full approval which is bunk, as stated in the article.

[Orrex]

11. I get that

But I still don’t get your refusal to self-quarantine absent FDA approval of the vaccine. One would seem to have nothing to do with the other.

[Yavin4]

19. Before vaccinated people are forced to wear masks again and go back into quarantine...

every effort should be made to vaccinate the hesitant including mandates from businesses and other organizations.

[Laura PourMeADrink]

9. Hmmm. Saw headline that said millions waiting just

for that approval. Means a lot to some people.

[Orrex]

15. I'd like to see that article

Are the millions of vaccine holdouts saying “I’ll get the vaccine once the FDA approves it,” or are they saying “I’m not not getting the vaccine without FDA approval?”

Two very different statements: one a commitment to act; the other a vague assertion with lots of wiggle room to refuse action later.

The latter is much more in line with sentiments I hear in Ohio and western PA.

[Laura PourMeADrink]

20. Agree. Think it was former. Will look for it.

[Laura PourMeADrink]

21. Here's one link

https://www.google.com/amp/s/abcnews.go.com/amp/Health/full-fda-approval-drive-covid-19-vaccinations-experts/story%3fid=78048166

One-third of unvaccinated U.S. adults say they will only get in line for the COVID-19 jab once it's fully approved, but medical experts say it can also be risky to wait.

[Orrex]

22. Thank you, that's actually somewhat reassuring

I honestly wouldn’t have guessed the number to be so high, but I am glad to hear otherwise.

[Laura PourMeADrink]

23. Me either! But evidently it's a big deal for some. Who

would have thought they would care about what the establishment (FDA) says???!!!??

[dsc]

13. It would permit the vaccine to be required by schools

which for me would be a very big thing (at least in potential).

[Orrex]

17. Yes, I understand that

If the mandate allows for religious exemption, then a great many will suddenly declare their faith by refusing the vaccine for themselves and their children.

And if there is no exemption, they will sue to block the mandate from taking effect because of bullshit about “religious freedom.” A judge will issue a stay while the case is adjudicated then the claimants will slow-walk it through the courts for months or years.

Forgive my cynicism, but recent years have shown me beyond doubt that the selfish, ignorant assholes in this country will stop at nothing to preserve their selfish ignorance.

[dsc]

18. In my state I doubt it would even get that far

since the legislature not the governor gets to decide what is and isn't required. But sadly the but Jesus exemption is a huge problem.

[joetheman]

14. Point well taken!