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

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.

Read More »FDA responses to FOIA requests on COVID vaccines – not a conspiracy
HPV vaccine systematic review

HPV vaccine systematic review – anti-vaxxers and Cochrane

Back in May 2018, I wrote an analysis of a new HPV vaccine systematic review that clearly showed that not only was the HPV vaccine very safe, but it was also effective in significantly reducing the risks of cervical cancer. This was powerful and robust evidence that the HPV vaccine is one of the best tools in reducing HPV-related cancers. And that the vaccine is extremely safe, possibly the safest of all the very safe vaccines on the market.

For those who aren’t science nerds like me, you should know systematic reviews are at the pinnacle of the hierarchy of biomedical research. These type of reviews are one of the foundations of science-based medicine (SBM).

The idea of SBM is …to answer the question “what works?” we must give more importance to our cumulative scientific knowledge from all relevant disciplines.

Now I’ve said that systematic reviews are not perfect. For example, the Cochrane Database is considered one of the premier organizations that perform systematic and meta-reviews in the biomedical sciences. If I am looking to determine if there is evidence supporting a medical claim, I look there first. As a scientist, I don’t take their conclusions at face value – for example, they have made egregious errors in systematic reviews of acupuncture quackery in the past. Like all scientific literature, one must examine a systematic review (whether published in Cochrane or any other journal) with a critical eye. Is there bias in including or excluding data? Do they overstate the conclusion? Do they rely upon unusual or bad statistical analyses?

Recently, one Cochrane group has attacked the aforementioned HPV vaccine systematic review, written by another Cochrane group. Time to take a look at that.Read More »HPV vaccine systematic review – anti-vaxxers and Cochrane

Del Bigtree

Del Bigtree compares anti-vaccine cult to Founding Fathers

Vaxxed promoter and producer Del Bigtree has decided to take his ignorant anti-vaccine beliefs to whole new level – he compares himself and the anti-vaccine movement to America’s Founding Fathers‘ fighting against the tyranny of the British. You read that right. Del Bigtree thinks he’s a modern day Thomas Jefferson and John Adams. And he’s leading the charge against the tyranny of mandatory vaccinations.

I know, many of you are laughing so hard, it may not be possible to read the rest of the article. Don’t worry, it’ll be here after you catch your breath.

I was thinking maybe Bigtree has watched Hamilton too many times.

Now, part of the reason Bigtree conflates the anti-vaccine movement with the Founding Fathers is that many of these activists are Donald Trump type Republicans. He’s pandering to the anti-government and anti-science beliefs of these people. To be fair, a lot of the anti-vaccine gang are crunchy liberals, but they have their own special type of arrogance about science.

If Del Bigtree is going to compare himself to Adams or Jefferson, then let’s see how that works out. Warning – snark infested verbiage ahead.

Read More »Del Bigtree compares anti-vaccine cult to Founding Fathers