> The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials”
Wouldn't this separation be designed into the process for data management during the clinical trial?
Almost all content is managed by computer systems that are designed to protect PII and intellectual property, with managed restriction or redaction for external distribution. If it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary, why would it take decades to move from government->citizens?
If necessary, the reports can be re-exported from the corporate systems used for clinical trial data management, with additional computer-enforced redaction of sensitive data. There is also AI-assisted software used in legal discovery, which can quickly parse a large document corpus, to flag material for human review.
The FDA is required by the CFR to redact certain things from the publicly available file.
The privately available file (IE what they get) is not redacted.
You are correct that there are complex data management systems managing the trial, but i don't think they can quite meet all the CFR requirements in practice. At least, they couldn't when i used to know a lot more about this.
Neither side is right - the plaintiffs are playing language games in a lot of places to make it seem like this is easy. Even with the management systems, it's not.
Th FDA is playing games in saying thy need to review 330,000 pages (like, tons of them are just trial data and chart results. They are standardized page formats, etc. There will be no additional text or names.)
They should have redacted the info when they had advisory Committee's review it to recommend boosters and vaccines for kids. Usually when govt has personal identification, they use numeric identifiers in documents as HIPPA is very strict with personal identification. Proprietary data should be concentrated in specific documents and easily redacted. There is no excuse for what they are doing. I have worked with MEDI-CALand Sicial Security information on several occasions as an auditor and a fraud investigator. They have the resources and much of the proprietary and personal information is already coded in a manner that an outsider would not be able to decipher. 500 pages a month is ludicrous.
These companies were also granted liability waivers for these vaccines (and are making record profits from them). They should not get to preserve any "trade secrets."
Tell us about that time you and your neighbors called your representative and somehow "pressured" him to break against party, donors, and every other force acting in the opposite direction. Did you succeed because you and your neighbors made persuasive arguments, or were you important donors, or did you merely receive an equivocal response? Or was the matter a triviality with no important competing interests?
The real means of pressuring legislators (that is to say, how it is routinely done) is via regulatory capture. To have any influence you need to somehow bring more pressure to bear on your legislator than the current forces which determine your legislator's incentives. Let the legislator weigh in one hand angry constituent phone calls to his staff, and in the other, important donors, access to funding organizations, post-public sector job opportunities, etc. etc. Which hand is more weighed down?
When someone points out the depth of corruption and dysfunction and this elicits the response "just call your legislator", it strikes me as either patronizing or merely naive.
There are literally tens of billions of dollars at work trying to block this release. The harder they try, the more that tells you something is up. Time and resources are not the reason they won't release the info. Unfortunately, the legislators are compromised because Pfizer is making huge contributions to each party's Political Action Committee's. There is an incestuous relationship between industy and politics. Trial Lawyers, Unions and Pharma are the biggest influence buyers.
Man, if that were true it would be great. It would show that we could reward providing society with enormous benefts with enormous awards. If only that were true.
Moderna and BioNTech both made around $7 billion profit each, not revenue, just last year. Because of this, their share price is also up 11x since IPO 3 years ago, and 16x since IPO 2 years ago, respectively.
Damn, imagine making a world changing product used by close to half of the world's population to overcome a global crisis... and making less profit than a company that sells highly marked up leather bags.
Kind of a depressing thought the extent to which we prioritize things.
> These companies were also granted liability waivers for these vaccines (and are making record profits from them). They should not get to preserve any "trade secrets."
You are welcome to convince Congress to retroactively change the rules based on which the firms invested in the research (and then to have the government try to convince the Courts that that change is not a taking under the 5th Amendment), but FDA has to comply with the law as it exists, not your fantasy of what the law should be.
Yet Pfizer et al got their fantasy and nobody blinks an eye?
Pfizer, Moderna, and Biontech were recently reported as making $1000 per second from the vaccines. Fuck their "trade secrets." Protect the privacy of individuals, but these companies were not given special exemptions so they could make bank, and should not expect business as usual.
These vaccines are the product of tax dollars and abeyance of the laws, every cent of profit in excess of time and material should be going back to the US government. Pandemics shouldn't be winning lottery tickets - that's an obscene incentive for an industry already known for its blackhearted exploitation of human misery. "But muh rules" is already out the window. These companies already have the means to create pandemics, let's not set the precedent that worldwide plagues are great for the bottom line.
If you want solutions, and you have capitalism, there isn't much choice. I’m perfectly fine with dismantling capitalism, but that's not really the role of the court adjudicating an FOIA case.
> "But muh rules" is already out the window.
No, the rule of law and Constitutional guarantees against arbitrary deprivation of liberty and property are not out the window.
I get that some people in this thread desperately want them to be, though.
> Wouldn't this separation be designed into the process for data management during the clinical trial?
No.
> Almost all content is managed by computer systems that are designed to protect PII and intellectual property
Having worked in public sector entities dealing with masses of private data that deals with public records requests against that data for decades, no, its almost certainly mostly not,
> If it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary, why would it take decades to move from government->citizens?
Because the first transition basically requires the confidential data, and even where it doesn't strictly require it, it is low legal risk in the event of error because the government is bound not to release it.
> If necessary, the reports can be re-exported from the corporate systems
No, even if that was useful, they legally can't, because only the records actually held by the government are subject to FOIA. The material held in corporate systems from which reports were made to the federal government is not subject to FOIA.
Yeah, with 18,000 employees and a $6 Billion annual budget, the FDA clearly has sufficient resources to process the data. All personal information would be already be coded or assigned a numeric ID that would make it impossible to identify specific participants without the master key. To represent that this project would require additional resources via congressional action is complete nonsense. Redactions should have already been performed as most of this information has been reviewed during the FDA approval processes. I expect the judge will find that the March 2022 date requested by FOIA will be seriously considered by the Judge on December 14th, as people are being fired for not complying with vaccine mandates and this would merit an urgent matter. I can't believe they tried to release only 500 pages per month in thos polarized environment we live in.
> it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary
Do companies redact patient data before submitting it to the FDA? Are they even allowed to? That sounds like the sort of information that the FDA should have access to.
> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor
PII is not just name and SSN. Using all the demographic information recorded for each participant and open-source intelligence, you should be able to uniquely identify them.
Wouldn't this separation be designed into the process for data management during the clinical trial?
Almost all content is managed by computer systems that are designed to protect PII and intellectual property, with managed restriction or redaction for external distribution. If it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary, why would it take decades to move from government->citizens?
If necessary, the reports can be re-exported from the corporate systems used for clinical trial data management, with additional computer-enforced redaction of sensitive data. There is also AI-assisted software used in legal discovery, which can quickly parse a large document corpus, to flag material for human review.