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-failure...
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.
Just a very different cost/benefit analysis on "do all the steps we can in parallel to speed things up" during a pandemic.
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-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.
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.
Sure, and all the planes leading up to the Wright Flyer failed.
https://www.nature.com/articles/d41586-021-02483-w has a great timeline graphic of the various advances and breakthroughs required to get to this point, including the first drug using the lipid nanoparticles - key to fixing the safety concerns! - approved in 2018.
If it's any old cave, you might just explore one at a time.
If you're pretty sure the Holy Grail is somewhere in it, you might hire six explorers, at higher initial expense.
Pick one. You can't have both.
Obviously they didn't start from zero. But it wasn't like they had something from, say, 2018 that was looking promising but just hadn't made it all the way through trials yet. They had nothing but failures.
Their 10-K from the end of 2019: https://www.sec.gov/Archives/edgar/data/1682852/000168285220...
> We have a diverse pipeline of 24 development candidates, 12 of which are currently in clinical trials, and many of which have the potential to be first-in-class or best-in-class medicines.
All of this is a bit academic, anyways. We've plenty of evidence the Moderna vaccine works. You can quibble over the exact rate of rare side effects a little, but it's abundantly clear it's good at reducing deaths and severe disease in the vaccinated population.
The point discussed is not whether it works or not, but what are the actual safety parameters.
That's not a "Pfizer's is slightly safer in 30+ males and should be used preferentially in that population if both are available" safety quibble.
The expected vaccine sales were high enough to justify spending resources initiating developement on lots of candidate mRNA vaccines in parallel, and spending the money testing more of the potentially viable ones at a time than would otherwise have been the case. When you throw a lot more against the wall, you find something that sticks a lot faster.
https://www.statnews.com/2017/01/10/moderna-trouble-mrna/
> But the Crigler-Najjar treatment has been indefinitely delayed, an Alexion spokeswoman told STAT. It never proved safe enough to test in humans, according to several former Moderna employees and collaborators who worked closely on the project. Unable to press forward with that technology, Moderna has had to focus instead on developing a handful of vaccines, turning to a less lucrative field that might not justify the company’s nearly $5 billion valuation.
Of course, as the apocryphal Edison quote goes, "I haven't failed, I've found 10,000 ways that don't work."
The reason why they are getting the endless pages of patient data is because the plaintiffs are asking for it.
Some people with certain medical conditions are vaccine-hesitant because of their health condition. If this data can prove that people with certain health conditions aren't at any increased risk from the vaccine, it could mean more people get vaccinated.
In order to make the report in the first place, Pfizer had to preprocess the data to intermediate, tabulated formats. However, this data is their secret IP, which in and of itself is absolutely insane, given that we're moving in the direction of mandates.
I don't get how one of the most foul industries – by public track record — suddenly get a carte blanche from otherwise sane and critical people. There are so many scandals in Pharma, and suddenly overnight you're a conspiracy theorist if you want independent scientists to double check the biggest public health mandate in history.
Transparency doesn't work in isolation. If there's a problem where the release of 450,000 pages of patient information is so difficult that it can't be done, then there's a fundamental process fuckup that should be corrected. For example, if everything's on paper, then the process failure is in a lack of transcription. If it's because private information is typed in a form, that form should be broken up in a way so that the important private information is typed into another field. Generally there are ways to make sure these issues don't happen -- from the beginning. Keep in mind, these people are aware of the existence of FOIA and the possibility that these records would be subject to FOIA. These processes should be built with that in-mind, especially considering the importance of the information.
It's such a big deal that in states like Illinois, the law disallows the use of the unduly burdensome exemption if the gov agency doesn't respond within the time limits of the statute. Takes 10k hours? Big deal, shoulda responded in time.
A lot of these issues stem from the fact that in so many cases, the agency's estimates are either beyond any possible worst case scenario (ie, unrealistic), or an intentionally naive estimate in order to urge the requester to go away. If we take these public agencies at face value that something would take forever without litigation, then they can easily just make it a routine process to call something unduly burdensome, so it's important to call them out on their shit. See: https://mchap.io/that-time-the-city-of-seattle-accidentally-...
It sucks, but the alternative is much worse.