Judge orders FDA to hasten FOIA release of Pfizer vaccine docs

There's very little reason to believe that the reassignment will actually come from teams working on either of those two problems. This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) - picking out a highly specific and avoidable method of executing the FOIA to attack the idea of doing the FOIA at all is...questionable, to say the least.

Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966)

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

>I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted)

see page 3, paragraph 11: https://www.courtlistener.com/docket/60390195/1/public-healt...

> The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork

I'm puzzled why they didn't make the document FOIA friendly in the first place. It was pretty obvious that it was going to be requested as it is of extreme public interest.

I'm wondering if this "burden" wasn't intentionally planned. But there's no reason to do so: after all, the FDA should be working in the public's interests, and they have nothing to hide.

Do you think that argument could delay an IRS audit for 55 years?

I’m ok with this. More transparency

How many people produce this many pages?

It seems if they kept data like this in digital format with meta data, production could be much easier.

I do similar work, but for non-gov. It is a challenge.

"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)."

So 50 people on a normal (40 hour work week) could do this in a month. The FDA has 18 000 employees. I think the answer is clear.

If you've ever dealt with public departments, you'd know that the vast majority of those they employ would be pencil pushers and meetware.

If it's helpful, Alex Jones seems to love 'citing' (meaning lying about) the documents they have produced so far.

Looks pretty good I’d say.

After giving a rat a 50ug dose (a single dose for a human is 30ug), the % of administered dose in the brain was .009, eyes .003, and heart .030. Comparatively, the injection site was 24.6 and liver 16.2.

Also, some of these rats were given some big ol’ doses. 1 mg RNA / kg.

What are you looking to compare? Conventional inactivated or attenuated pathogen vaccines don't use lipid nanoparticles at all, so the number will be 0 (barring some kind of contamination or measurement error).

Also, are people unaware that pfizer had to pay a $2.3b settlement in 2009 for fraud? It was the largest health care fraud settlement ever at the time.

https://www.justice.gov/opa/pr/justice-department-announces-...

It's so odd to me that the whole "trust the science" mantra of this entire pandemic is thrown out the window when we ask to actually see the science for ourselves.

Vioxx gets complicated; other NSAIDs, including non-selective ones, turn out to have a pretty nasty cardiac risk profile too, and the withdrawal harmed a lot of patients who relied on it.

https://pharmaceutical-journal.com/article/feature/still-fee...

> After Vioxx was withdrawn, there were numerous papers and discussion on the increased risk of cardiovascular events with all NSAIDS and labelling changes were made. However, Silman argues that it has still not been proven in observational studies that Vioxx’s cardiovascular events were any higher than, for instance, diclofenac, a popular non-selective NSAID.

> It proved to be complex: not all COX-2 inhibitors have the same cardiovascular risks and not all non-selective NSAIDs have the same cardiovascular risks. “If the VIGOR study had been comparing Vioxx against diclofenac, it is entirely plausible that it would have shown no difference in cardiovascular events,” Silman points out.

> ...

> If MSD had not withdrawn the drug, perhaps regulators would have deemed that it not be used in patients with pre-existing heart conditions and the elderly, Silman ponders. “It was not necessarily a given that Vioxx should have been withdrawn completely. For instance, diclofenac has not been withdrawn and is still on the market but with advice to use with caution,” he says.

> Neither does Silman think Vioxx should have been withdrawn, since it proved to be a very effective anti-inflammatory drug. “The joke at the time of its withdrawal was that every rheumatologist was stockpiling Vioxx because of its efficacy.” The Vioxx story is not so simple and it was not about “Vioxx being the bad guy”, he says.

And accountability. I understand the need for urgency and the use of emergency orders, but once these are gone these companies will still be unaccountable and will still be getting paid even if their promise of efficacy are not held.

Transparency is necessary but there's no evidence that Merck hid Vioxx clinical trials data from the FDA.

https://www.fda.gov/drugs/postmarket-drug-safety-information...

"increased risk of heart attack and stroke associated with long-term, high-dosage use" with benefit of the doubt, I'd imagine that people are quite interested in arthritis treatment alternatives, and it seems hard to determine the problems with trials? Apparently the drug did find a niche for "hemophilic arthropathy" per wikipedia post recall, so it seems far from an unmitigated disaster

Vaccines are brilliant but I don't like the idea that a company manipulates data and put people's lives at risk for profit. It's clearly criminal activity.

Anti-vaxxers are already using released technical documents to support their ideas using out-of-context or misinterpreted snippets of information. I don't think it's going to affect them much either way.

The FDA generally would only review the summaries, not the full patient information.

A lot of those 450,000 pages are careful patient documentation that simply isn't necessary when you already have the total side effect counts.

At most the FDA might review the clinical history of the patients with severe side effects. They aren't going to be reading the notes about every Bob Smith reporting fatigue after getting a COVID-19 vaccine.

Pessimist opinion? They didn't. The FDA has people move to private enterprise (https://www.cnbc.com/2019/06/27/former-fda-commissioner-scot...) and vise versa (I don't have sources, but I would be shocked if it didn't happen).

To that end, my (pessimist) opinion is that there were likely some financial incentives for the FDA to uh...gloss over 60% of that 450,000.

Pfizer financed an accelerated reading program for them

and docket: https://www.courtlistener.com/docket/60390195/public-health-...

There’s a conflict of interest. If I’m prepping a document to be filed with the government I can’t redact in accordance with the government’s interests under FOIA and redact it in the best interest of my client.

Or, to put it another way, would you want Monsanto or Philip Morris or Purdue Pharmaceuticals to “helpfully” redact documents on behalf of the government? It would largely defeat the purpose of FOIA.

Because then, when they got a FOIA request, the party submitting the request would inevitably challenge the redacted versions as over redacted. It isn't red light green light on words...your asking the judge to literally do the job that each department's FOIA folks are trained to do.

Sounds like an extreme amount of red tape, the same type of red tape that cost us hundreds of thousands of lives early in the pandemic.

How many do you think are appropriate? Add too many and people will be complaining about bureaucratic bloat. Besides, the number of civil servants doesn't mean they can't hire contractors to help, but putting those contracts out for bid is not an instantaneous effort.

It's a Titanic problem - too many people, not enough boats. Except here, it's too many projects, not enough funding.

Sure, this sucks right now but who's to say that we wouldn't be on board with the tradeoff if we knew what otherwise wouldn't have received funding?