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FDA Ignores Validation Rules, Putting the Blood Supply at Risk

By Beaux Reliosis on March 20, 2018 • ( 0 )

What you tell the Feds who are responsible for protecting the blood supply and assume that their colleagues are honest humans who know how to do their job:

I wanted to make you aware of an issue that profoundly affects the diagnosis of Lyme disease in people, and presumably could impact efforts to ensure the safety of the blood supply as well.

Noel Gerald of the FDA–who is on the diagnostics subcommittee of the HHS Tick Borne Disease Working Group(TBDWG)–is supposed to be an expert in validations. His job is to ensure that diagnostic tests meet the FDA’s own rules for methods validation, meaning that they are sensitive, specific, rugged, etc., with the result being that they reliably detect the analyte in question as close as possible to 100% of the time.

As background, the two-tier testing that the CDC endorses for Lyme disease detects ONLY the HLA-linked hypersensitivity cases, and not the post-sepsis immune deficiency cases which account for about 85%.

In this transcript, Noel Gerald confirms Joe Breen’s assertion that new Lyme tests should be “validated” against this false two-tier method. https://www.cdc.gov/lyme/resources/webinar/09242012_diagnosticswebinartranscript.pdf

By the way, this false standard is the reason we even have the ridiculous dog-and-pony-show called a “working group.” Everyone knows the testing doesn’t work, but nobody wants the embarrassment of admitting that after all these years, millions of people are suffering with a B cell AIDS acquired from the fungal antigens transmitted through a tick bite. Not to mention the cost of legitimately treating all these very sick people.

So, here we have an FDA validations expert saying that the validity of new diagnostic tests should be measured against a fraudulent standard that was designed to detect a high antibody response, rather than the limit of detection for the pathogen in question.

This guy should be fired, but instead, he’s not only on a critical subcommittee for recommending Lyme disease policy, but apparently his day job is within the Division of Transfusion Transmitted Diseases at CBER.

Just thought you should know.