You raise a number of interesting points. I do not have any issues with the time it took the FDA to issue EUA’s. On the other hand, I am pretty miffed about the time taken to get from EUA to BLA and the fact that under-12’s are still in the lurch.
This is a challenging scenario for regulatory agencies because they did not evolve with pandemics in mind. Most of the applications they review are for indications where some therapy exists, and in those cases the potential consequences for approving something bad are lower than the consequences for slow waling something good. It is also challenging because the pharma industry went all hands on deck and immediately started looking at any- and everything that even might help fight covid. There still needs to be a strong gatekeeper, because we have enough problems with quack covid remedies without giving any of them a halo of official authorization.
The other challenge is that traditional vaccines take more time to manufacture than adenovirus- or mRNA based vaccines. Unfortunately, these technologies did not have a track record of use in humans to rely on, so there was still a strong need to try them in the clinic. Usually clinical trials progress in sequential phases (first phase 1 for safety, then phases 2 and 3 for efficacy and dosage), because it provides an opportunity to learn from the previous trial and avoid potential issues. For these vaccines, the trials were run in parallel to save time, which was tremendously risky.
The other process that was happening in parallel was the ramp-up in vaccine production. This is not usually a bottleneck because there is usually a period of years to sort this out while the clinical trials progress and there is no point ramping up something that crashes in phase 2 anyway. In this case, production was a bottleneck and the benefits of a faster approval would have been limited by supply constraints.
It is easy to say that they took too long now that we have effective vaccines in hand, but if we had cut too many corners we might be lamenting the loss of people from HCQ side effects. We could have gone through a phase where there were a number of available therapies with a muddy picture of which therapies actually worked and where it was difficult to sort out because of a shortage of clear clinical data.
I do not know what the right answer is, but I do think that lowering the bar too much is a moral hazard. I am not trying to strawman you, just pointing out that this is a Scylla and Charybdis situation. Also, please keep in mind that we had a pretty clear picture that masking + other measures to limit airborne spread are effective before we could have possibly delivered any vaccines in volume, so the situation was certainly dire but not completely unmitigated.
This delta spread, though. At this point they need to get off their asses and start vaccinating kids 2 months ago. THAT is where I think the FDA fucked up.
Agreed on it being important to have standards, and removing them all would be a bad idea. Which ones, and how stringent, is a very reasonable debate to have, and I’m not qualified to discuss the finer details. Still, I don’t think the FDA’s standards are anywhere close to optimal. I’ve read in a few places that they’re at least sometimes strict to the point that they claim there isn’t enough data to approve, while corporate and academic IRBs won’t approve new studies because they believe the evidence is so strong it would be unethical to withhold treatment from the control group.
But back on topic: keep in mind the reason the vaccine isn’t approved in kids is because it wasn’t tested in kids at first, because that would have slowed down testing further, and covid is not nearly as dangerous to kids as it is to adults, so we prioritized adult testing and waited on kids, so now kids are deemed vulnerable (but not allowed to protect themselves) even though they’re at less risk than a fully vaccinated senior citizen. This is a regulatory catch-22 we didn’t need to be in. Also, mRNA vaccines didn’t have a track record because no one had ever bothered to get one approved because the costs of navigating the bureaucracy didn’t justify it until covid. This is a regulatory catch-22 w didn’t need to be in. The lack of vaccine production capacity is a natural follow-on to that last one.
I agree any mistakes the FDA made in the past two years are mostly debatable. The unforgivable ones are the ones made over the course of decades that built the industry and regulatory culture that made it so hard to move as fast as we could have been able to, when needed.
Edit to add: me getting angry about this is not specific to the FDA, or to covid. It’s a fully general observation that almost no one with any kind of authority bothers to try to foresee the often-predictabe systemic effects of building certain kinds of institutions and not others. It’s the malice-free corollary to what John Oliver was pointing to when he said “If you want to do something evil, put it inside something boring.”
Demographically, and especially with gerrymandering, TX is still out of range even as a purple state. There is nothing Democrats can do with the Mess that is Texas.
Hell, Yes! Republicans (when they arent ritually using “Democrat Party” instead of “Democratic Party”) are constantly slurring them as literal Communist/Socialists and Fascist/National Socialists. Democrats never hit back. Democrats don’t project a “team mentality” that would attract wavering Republicans. The only good Democratic ads are made by independents: Meidas Touch and [Republican-backed] Lincoln Project.
My experience from having to deal with the UK Labour party (different country, same accusations and problems) is that it is actually the right wing who strive for purity. RW Democrats haven’t got to the point of purges yet but Labour are doing theirs right now.
The demographics are actually way blue in Texas. Gerrymandering is a big issue, but the biggest problem in Texas, as in Georgia, is organized and systematic voter suppression. That’s why the GOP is doubling down on it right now.
Most analysts are thinking Texas is purple within the next two cycles. There’s a risk that the GOP will successfully break elections altogether, of course, but barring that, they lose over time.
Since schools already have a long list of mandatory vaccines that are required for admission, one wonders just why no one has filed suit demanding that those requirements be ‘optional’, as well…
That occupancy rate is merely an average. Some areas have no beds available.
FTFY.
Might as well call 'em what they have proven themselves to be. FDK.
Nothing ‘conservative’ about demanding behaviour that both worsens and prolongs disease amongst the populace.
It seems like they won’t, for whatever reason.
They sure do seem like they don’t comprehend they are dealing with psychopaths who have no intentions of ‘playing fair’ or ‘in good faith’.
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They really need to. I hope whoever runs hammers that stuff into the ground,
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Pretty sure that Beto would, if he decides to run.
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but I am not hopeful.
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I’m hopeful, but also not holding my breath.
It is a sweet and fitting thing to die for Trump?
Yeah, makes sense. Doesn’t apply to the ‘leaders’, of course…
That would be more like mere incompetence, whereas their actions are done with malice aforethought.
Mass murder would seem more appropriate.
Lather, Rinse, Repeat
It is less of a ‘party’ & more of a Cult.
A Klan, if you will… a Fascist Death Kult.
FDK!
They are mainly what would have been regarded as Moderate Republicans about 40 years ago.
EDIT: tyop
It would have to be of breaking an existing law that was certainly out of bounds of his job description. The only ones I could see would be “reckless endangerment”, “practicing medicine without a license.”
First, the last time Texas Dems left the legislature to block an issue was gerrymandering, and the move then, as now, accomplished almost nothing.
Second, Texas will backslide badly unless Dems turn out in HUGE numbers in the next election. Period. Most Dems think it’s hopeless after all the Republicans have managed to force feed the public over the past few years. The hispanic/latino vote is even more up in the air than it was in the presidential election. The most reasonable explanation I’ve heard for that is that latinos in Texas have little faith that Democrats could change much if given power, and that Republicans mostly ignore latino accomplishments at the local level, as long as they don’t get noticed trying to make things happen at the state level.
Texas Government was designed to be a strong Governor, an influential Lt. Governor and a weak Legislature. Right now, all have been securely in Republican hands for 20 years. Wasn’t until last election that ANY Democrat won a statewide position in two decades. The population is changing, but the political powers? not much.
BioNTech had one for SARS I believe but we dealt with that competently and didn’t need it. Vaccines are low profit so they aren’t in general sexy to the pharma world which prefers repackaging SSRIs for new purposes than actually preventing illness.
Which brings us to the real reason more great therapies aren’t developed: they prefer to spend their money on stock buybacks, reverse takeovers, and executive pay. Even their R&D budget, which may be a small fraction of their making the execs and shareholders rich budget, includes advertising.
Reform the SEC and you’ve a better chance of fixing this than the FDA.
It isn’t about sexy, it’s about how in the current system getting a drug to market costs about a billion dollars and takes over a decade from beginning to end. If you can’t sell at a high enough price, or to enough patients, to recoup that plus an acceptable profit (aka enough that investors don’t move their money elsewhere) in the 7-10 years been approval and losing patent protection, the drug won’t get developed.
Edit to add: as long as we rely on companies to develop medications, they’ll either generate a profit, or go out of business as investors move their money elsewhere. While I don’t agree with all the points in this article, I think it is significant that the IRR of pharma R&D has been falling steadily for at least 20 years, and was already below the cost of capital in 2017. This is happening despite steadily improving basic knowledge and research techniques and methods.
You make good points, especially about the Latino vote, but Texas has an intentionally weak governor system to limit the power of the appointed governor after the civil war. The Republicans have managed to overcome that, but it’s not how the office was designed:
However, things changed during the 21st Century with the long-time service of Governor Perry who demanded strict loyalty of his officers and due to his many re-elections, guaranteed he would appoint all state officers and be there when their terms expired. Yet, his successor, Governor Greg Abbott has imposed significant structural changes of questionable constitutionality that has caused his office to have new, significant powers not exercised by prior governors under our current constitution.
I’ll agree with your general sentiment that the GOP just seems to be better at this authoritarian stuff and the Democrats have been a disappointing opposition party at best.
I did mean the current operation, not the original plans. Originally, Judges had a lot more sway. Even the Governor’s wife had major influence for a while. Texas politics has a long history of reshaping itself in the mold of the loudest voice – It started long before Perry became Governor, but the gang that maneuvered Bush’s election cemented it. For a long time before that, the Lt. Governor practically ran the state.
