In early January, a federal court ruled that under the FOIA, the FDA must produce the Pfizer vaccine approval documents at a faster rate than their request of 500 pages a month. At that pace, it would have taken 55 years to produce the whole document and most of us would be dead. Maybe you all don’t want to read the vaccine approval documents, but you know that I do. Very badly.
Everything I’ve seen about the Pfizer trial to date is downright terrifying: from 21 people dying during the trial with the vaccine as compared to only 17 with the placebo, to causing a 500% increase in deaths due to heart attacks between the groups to offering all the placebo patients the vaccine 6 months into the trial so there would be no control group and finally calling the difference between 1 dying of COVID with the vaccine and 2 dying of COVID with the placebo out of 22,000 people in both groups a success, I have serious questions, but I digress. Whether you agree with my extreme cynicism or not, I know we can all agree that 500 pages a month pace is absolutely ludicrous given that the FDA was able to read through all 450,000 pages in the documents and approve the vaccine in 108 days. And after all, if this is about public health and we want to get the vaccine to the more than 3 billion people around the world who remain unvaccinated today, shouldn’t we want as much transparency to build trust as possible????
Surprise surprise. The FDA, and now with Pfizer as an intervening party, has indicated to the court that they can’t possibly produce 55,000 pages a month until at least March and have said so in a recent court filing. Moreover, they appear to be setting up a situation where they simply don’t comply with the court order. Red flags, anyone?
I have long said that I distrust pharma, the media, and the government. Even typing that makes me feel crazy although, in fairness, I’ve been called a lot worse for 2 years, so I’ll manage. But this blatant disregard for the rule of law from our government (CDC eviction moratorium, deemed illegal, and the OSHA vaccine mandate, deemed illegal) is downright terrifying.
But, there is reason for optimism. The courts. This brief from the plaintiffs against the FDA is brilliant. I encourage you to read it. Obviously the court will have to rule, but the argument is pretty incredible. As a preview, I’ll repost my favorite part. I’m a numbers guy, and I really really love proof. This just made me very happy. Long live the courts.
With just the 11 full time reviewers working 7.5 hours per day and reviewing 50 pages per hour (rather than the absurd claim of just 5 pages per hour), the FDA could review over 88,000 pages per month in February and in March 2022. That is more than sufficient to produce the 55,000 pages per month currently ordered by the Court for these two months, and 8 times greater than the 10,000 per month the FDA requests.
To further confirm these numbers, and the reasonableness of the Court’s existing Order, Plaintiff contacted a professional document review company, BIA, is a highly regarded and established document review company that has been performing document review services for law firms for over 17 years. (App000782.) Plaintiff provided BIA with copies of the 8,347 pages of sample CRF data the FDA already produced (after removing redactions and inserting made-up data). BIA estimated it could provide project management, and review and redact those documents for both trade secrets and PII within 50-70 hours, and for a budget of just $3,700. (Id.) That is a rate of between 119 and 166 pages per hour.
The FDA could easily retain BIA (or any similar company) for the entire portion of the production that only involves PII. In fact, as noted in Plaintiff’s prior papers, BIA estimated it could complete the whole review of all 450,000 pages for PII and trade secrets within 6-8 weeks with 10 reviewers and 1 team lead, for approximately $132,000 (Dkt. No. 31 p. 3)
Personally, I would love to see the FDA be found in contempt of court and see Janet Woodcock end up in jail. Many people have spent time in jail for a lot less.
Interesting how they want to postpone until at least March. Isn't March suppose to be the release of the new Omicron vaccine?? I mean definitely can't produce these documents until everyone has taken this new vaccine they are developing, likely under the same controls as the first batches.
A couple of things here. First, in reference to Pfizer testing it is import to remember when thing. When Pfizer was testing the vaccines they did not spend any time testing the high risk (over 65+ year old people). They tested the young, healthier, low risk people who weren't a big risk. Now that Pfizer is claiming they may intervene I smell a rat. They claim they will "help" do the work to review (black out) the documents. 46% of the FDA's budget comes from user fees. (From the people they are supposed to be policing). The whole thing stinks.