5 ms·
So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? I don
by ipspam 5y ago
So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories?
I don't think you have thought this through. I don't think you read the part where the FDA has 18,000 employees.
The FDA should be above politics.
Isn't it suspicious that the FDA is doing this, and that the public have a right to know and see the underlying documents within 90 days of drug approval? Isn't is Phizers responsibility to submit the documents in a way that protects privacy?
All the norms are lost here. You couldn't find a better way to destroy the credibility of the FDA than to "never" have meaningful transparency on the fastest, most hastily produced, many corners cut drug.
Quite frankly, the FDA would rubber stamp a pile of cow poop if it were politically expedient.
The only way to win back trust is to hold them accountable, for better or for worse, even if it feeds vaccine conspiracies.
It can't be done in my generation, but maybe in the next when this COVID saga is largely memory holed
- dopylitty 5y agoNo, none of it is suspicious, unless you're a person who is trying to cast doubt on vaccines by claiming that vaccines on platforms that have been under development for two decades and went through enormous trials were 'hastily produced' with 'corners cut'
- keneda7 5y agoAre you referring to the mRNA vaccine platform? Could you point me to the mRNA vaccine application that was approved before covid? When I looked into it all, of them had been denied until covid and I did not hear of any breakthrough in mRNA technology that suddenly fixed the issues the previous ones (I found 8) had been denied for.
- jaywalk 5y agoIt's just a coincidence that these companies that have been working for years on this stuff failed every single time in the past, but then within a few weeks in early 2020 they suddenly figured everything out.
- ceejayoz 5y agoNot a coincidence, no. Just a very different cost/benefit analysis on "do all the steps we can in parallel to speed things up" during a pandemic.
- jaywalk 5y agoIf only Moderna had realized in that they could "do all the steps [they] can in parallel to speed things up" 8 years ago! They managed to accomplish what had eluded them for 8 years in a matter of weeks. Astounding stuff.
- ceejayoz 5y agoAgain, it's a cost/benefit analysis. The benefit went up. The acceptable costs of parallelization similarly went up. (Some steps got easier, too, for the same "everyone really wants a solution yesterday" reasons, like recruiting trial volunteers. For example: https://www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed https://www.sciencenews.org/article/covid-coronavirus-vaccin...) > For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. Based on this comparison, that’s roughly 730 days — nearly two years — saved in recruiting alone. The same article cites precisely one of those parallelization steps I'm talking about: > In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. Once the companies had emergency use authorization in hand, they were ready to ship doses immediately.
- jaywalk 5y agoSure, you're explaining why and how testing went faster. I totally understand that, but it's not at all what I'm talking about. All of the previous mRNA drugs failed testing due to safety concerns. But we're expected to believe that those safety concerns were resolved in a matter of weeks.
- hotz 5y agoIt boggles my mind that anyone can oppose transparency. Why do some people view these vaccines/pharma companies as something sacred, not to be questioned.
- Clubber 5y ago
- allturtles 5y agoWho is against transparency? Has anyone argued that this information shouldn't be released? AFAICT the court battle is just about speed, and whether the FDA should go out of its way to satisfy this particular FOIA request more quickly.
- lalaland1125 5y agoThere is a difference between normal transparency and demanding the release of 450,000 pages of patient data.
- steelstraw 5y agoIt's about being suspicious of the pharmaceutical industry and the FDA, which has a revolving door that has been abused. The FDA has never been held to account for its improper handling of the opioid crisis. But the FDA’s conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers. For example, the 2 principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency. Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers. Last January, the head of the FDA’s analgesic division retired from the FDA to start her own consulting business, which promises drug makers “help” to “successfully and efficiently bring your products to market” with “more than 30 years of experience at the FDA.” To be clear, the revolving door between the FDA and the pharmaceutical industry is not limited to opioids. A 2018 study found that 11 of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated. Without appropriate limits on employment after leaving the FDA, staff might be tempted to put the interests of future employers, whose favor they wish to gain, ahead of public health. https://journalofethics.ama-assn.org/article/how-fda-failures-contributed-opioid-crisis/2020-08 https://journalofethics.ama-assn.org/article/how-fda-failure...
- avs733 5y agoDo you have any evidence to support that accusation in the last paragraph or is it just a hypothesis that you linked to minimally related other facts?
- ghufran_syed 5y agoyou mean prove that conflict of interest is real? Isn’t that something that any experience with human behavior would confirm quite easily? Do we need to prove that judges should not receive money from one of the parties in a lawsuit they are presiding over?
- avs733 5y ago> So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? If the FDA screws up in their now legally compelled rush to produce these documents what happens? Pfizer could have their trade secret info leaked (like it or not that shouldn't happen) Participants in vaccine trials could have their private health information leaked (or have their identity stolen) The FDA is responsible and liable FOIA abuse is a thing, just like DMCA abuse is a thing. People abusing the FOIA process are the ones who are likely to lead to its power being destroyed, not the government here. It isn't suspicious...this group is intentionally misinterpreting things in bad faith under the guise of accountability. It's classic bad faith, and I'm deeply saddened at how easily this country falls for it.
- daveevad 5y agoI'd like to add that the situation is so severe we should prioritize a solution to COVID at the expense of individual privacy. This is the biggest problem we've ever needed to solve as a society. Release the documents and we'll find the bugs.