“Wins milestone lawsuit” is so fucking disingenuous, but what else to expect from anti-vaxxers?
On August 25, 2017, the stipulation tells us that the anti-vaccine ICAN submitted an FOIA request for any reports submitted. After not getting a quick enough answer, they filed a complaint with a federal district court under the Freedom of Information Act provisions (on April 12, 2018). On June 27, 2018, the HHS sent them a message saying that “the [Department]’s searches for records did not locate any records responsive to your request,” and detailing how they searched. The parties filed the stipulation attached, which acknowledges that the response fills the FOIA request.
What it likely means is that HHS did not file the reports it was supposed to file with Congress. If the anti-vaccine ICAN wants to lobby for filing such reports, more power to them. These reports should be filed.
What this does not mean
The stipulation does not mean that HHS did not work on vaccines safety, or that there is not abundant research on the topic.
Multiple Institute of Medicine
reports – now the National Academy of Science – looked at vaccines. These detailed reports summarize a large body of studies and draw conclusions based on this ongoing data. HHS commissions these reports. In July 2014, a
large report on vaccine safety commissioned by HHS was also completed.
Four
different federal committees within HHS look at vaccine safety from different directions.
All of these committees have independent experts and slots for consumer representatives among their members. To give one example of their work, the NVAC creates
standards for best practices related to vaccines. These include a requirement to check indications and report adverse events. The American Academy of Pediatrics
endorses these standards, shares them, and offers guidance on implementation.
Four monitoring system – one passive, three active, oversee vaccine safety:
- VAERS – the Vaccine Adverse Events Reporting System – is a passive reporting system designed to catch safety signals, where anyone can submit a report with no verification needed.
- The Vaccine Safety Datalink, a collaboration of the CDC and large healthcare organizations, allows for active monitoring and studies of over 9 million people.
- PRISM, a collaboration between FDA and provider organizations, also allows for active monitoring and studies.
- The CDC’s Clinical Immunization Safety Assessment (CISA) project allows for studies of especially vulnerable populations, and for consultation with individual providers facing adverse events or potentially at-risk patients.
All these HHS units are actively engaged in working on vaccines safety.
In a letter
responding to a previous set of claims from the anti-vaccine ICAN, Dr. Melinda Wharton from HHS corrected many of the organization’s misunderstandings on vaccines safety studies.
In short, while the HHS should have submitted the required reports, it has done and continued to do abundant work related to vaccines safety. Anyone claiming based on the stipulation that HHS is not working to assure and improve vaccines safety or that there are no studies either misunderstands or lacks knowledge about what HHS is doing, or is being dishonest.