FDA responses to FOIA requests on COVID vaccines – not a conspiracy

FDA FOIA

This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).

In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically. 

The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.

These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.

FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release. 

To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.

This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.

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Anti-vaccine activists generate and spread misinformation again

anti vaccine misinformation

This article about anti-vaccine misinformation tactics is based on a series of Twitter posts by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

This article are quoted verbatim, except for minor editing changes. We both felt a broader audience for this anti-vaccine tactic to spread misinformation will be useful to understand. In essence, an anti-vaccine group asked the CDC for a single patient record, something the CDC doesn’t keep, and then imply something nefarious is happening because the CDC couldn’t provide that information.

Below, Professor Reiss reviews how this is a cynical tactic to make it appear something is going on with vaccines, when it isn’t.

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Bad for science and academic freedom: harassing Kevin Folta

If you don’t know about the case of anti-GMO activists harassing Dr. Kevin Folta, Professor and Chairman in the Department of Horticultural Sciences at the University of Florida, I’ve written about it extensively over the past few months.

Dr. Folta  is considered to be an expert in plant genetics including genetic modification of plants. He has been studying this field for nearly three decades, published extensively in real peer-reviewed journals, and has trained legions of graduate students. He should be considered a real authority figure in GMO research.

In 2012, Dr. Folta was “targeted” by a Freedom of Information Act (FOIA) request from an activist to get all of Dr. Folta’s emails about GMOs. If you are unfamiliar with this particular tactic, it is used frequently by climate change deniers to harass and bully climate change scientists.

This will be a repeating theme of this article – the science deniers who are harassing Kevin Folta are almost exactly the same as the science deniers who attack climate change scientists. They must be proud of this.

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Anti-GMO activists and climate change deniers – no science

There is an evolving feeling that anti-GMO activists and climate change deniers are nearly the same. They both rely upon  denialism (also known as pseudoskepticism), which is the culture of denying the established scientific consensus despite overwhelming evidence.

Admittedly, some of the denialism is based on political expediency. Climate change denialism is a fundamental aspect of many politically conservative voters across the world, but especially in the United States, where Republican legislatures in the United States have passed anti-anthropogenic global warming legislation. 

But not to be outdone, the left-wing parties across the world have their own particular brand of science denialism–GMOs. Some may argue that vaccine denialism has a political component which is supported by some liberals, there’s also a lot of evidence that Republicans in the US have the same anti-vaccine belief. Setting aside the politically nuanced anti-vaccine groups, GMOs are the left’s version of climate change denial.

Anti-GMO activists and climate change deniers share some of the same tactics and strategies, even if they are, for all intents and purposes, at the opposite ends of the political spectrum.

They both tend to reject science. They both use the same character attacks on supporters. And they both are awfully good at cherry-picking data that buttresses their a priori conclusions. In other words, they look for the data to support their beliefs, rather than the scientific method which is to find what conclusions can be supported by the evidence.

Let’s look at something that just happened which should remove any doubt that anti-science believers use the same tactics, probably because they lack any evidence. It’s apparent that they all meet at some anti-science convention to receive training on how to do this best.

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