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Peter Gøtzsche


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
Cochrane Nordic

Cochrane Nordic kerfuffle – HPV vaccine is still safe and effective

If you’ve been following the old dinosaur’s articles over the past few weeks,  you’d know the ongoing kerfuffle between the anti-vaccine group located within Cochrane Nordic and the parent Cochrane Collaboration. Cochrane Nordic attacked a well done systematic review, published by Cochrane, of safety and effectiveness of the HPV vaccine without merit.

In case you are unfamiliar with the organization, the Cochrane Collaboration is a critically important source of evidence-based medicine and a useful tool in providing analytical evidence that can debunk pseudoscientific beliefs. Cochrane’s goal is to organize research data and publications in a logical way that helps physicians and researchers make appropriate decisions about a proposed new therapy, medication or clinical idea.

According to Cochrane, their mission is:

…to provide accessible, credible information to support informed decision-making has never been more important or useful for improving global health. In the Internet age, people have much greater access to health information, but little way of knowing whether that information is accurate and unbiased. We do not accept commercial or conflicted funding. This is vital for us to generate authoritative and reliable information, working freely, unconstrained by commercial and financial interests.

Mostly, Cochrane produces systematic reviews, which utilizes systematic methods to collect published data, critically analyze research studies, and then synthesize data from numerous published studies in an attempt to eliminate bias and increase the power of the data that includes a larger number of patients than one study alone.

In the hierarchy of biomedical research, systematic reviews rank at the very top. They are, without a doubt, the most powerful pieces of scientific research available in medicine. To be fair, Cochrane is not perfect. 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.

So this whole Cochrane Nordic kerfuffle may seem like an internecine feud of no importance to the world of science. And it would have been, except it has evolved into one of those tropes that the anti-vaccine religion uses to attack the cancer-preventing HPV vaccine.

Let me end this introduction with a simple statement backed by a mountain of science – the HPV vaccine is demonstrably safe and demonstrably effective.

Let’s take a look at this whole Cochrane Nordic nonsense.Read More »Cochrane Nordic kerfuffle – HPV vaccine is still safe and effective