2017 FDA Hearing - Gadolinium Retention
In 2017, multiple patients and doctors attended an FDA hearing on gadolinium retention.
To recap, here’s where the FDA hearing falls on the timeline from MriDye.com:
Source: https://www.mridye.com/fda.html & research done by LivingWithGadolinium.com
Read & download slides from the hearing:
What was the conclusion of the 2017 FDA Hearing?
According to the FDA, new warnings for GBCAs were put in place. Unfortunately, this change barely had an effect on patients since labels are only visible to medical care providers and not directly to patients. Despite the new warnings, 91% of the 228 gadolinium toxicity patients surveyed for the book, “Gadolinium Deposition and Toxicity,” reported never receiving informed consent about gadolinium or its retention, even after the warnings were issued in 2017.
Source: Lambert, Gadolinium Retention and Toxicity, Page 218
At the FDA hearing, patients sat and waited their turn to speak, while doctors and industry speakers discussed things like sales data, the benefits of gadolinium, and how there is “no evidence” to prove that patients got sick from a neurotoxic heavy metal being injected into their bodies. Out of the seventeen speakers at the 2017 FDA meeting, five were patients, each limited to five minutes of testimony. An analysis of the meeting transcript reveals that patients collectively spoke approximately 4,051 words—just 6.58% of the total ~61,551 words spoken during the day-long event. The meeting lasted around nine hours, yet patients were only allocated a total of 25 minutes, representing a mere 4.6% of the overall time.
One patient recounts that, at the end of the meeting, after sharing that her family’s life had been permanently upended by immediate disability following one MRI scan with gadolinium, she felt sick to her stomach and, “wanted to jump out of her seat,” when the FDA representative’s concluding statement was that more testing with gadolinium needed to be done on women and children (Gadolinium FDA Hearing Transcript, 2017).
First, why do they continually refer to systemic poisoning of the bloodstream as “exposure”? Second, why would anyone want to inject more of this in pregnant women and children when patients have already shown that their children’s teeth grow in decalcified when they received gadolinium based contrast agents while pregnant or breastfeeding?
In 2017, the FDA made a Facebook announcement regarding new GBCA warnings that came as a result of the hearing. Read the hundreds of comments on the post to see how the FDA’s responses indicate that the administration:
responds with canned, non-answers
delivers no consequences for any facility that fails to offer medication guides to patients, deeming the “informed consent” essentially optional, which was patients’ intent by attending the hearing
tells every single patient to call and email them, even though patients have already filled out reports, called, and emailed them without receiving any response
redirects patients to state medical boards to file reports when the medical facilities fail to give patients informed consent, even though the FDA is in charge of implementing informed consent
Are we surprised, though?
The man who advises the FDA on gadolinium received hundreds of thousands of dollars from contrast dye companies and laughed about heavy metals being toxic on his podcast, as if he doesn’t have the ability to take a public stance against its toxicity, when he absolutely does. No human has to be complicit in poisoning other humans. That is a completely optional stance to take. Yet, for years and years and years, the people in charge of the use of gadolinium claim they, “just don’t know [whether or not it’s toxic] yet.” Their eyes are closed.
But, wait, are their eyes closed?
All of a sudden, they are so excited about a new gadolinium product that uses half a dose of gadolinium! Why are they excited about that, if gadolinium is harmless? Is it perhaps because they know that gadolinium is toxic? For years, it was “unclear that gadolinium was toxic” (false), but the moment a new product comes out, they are so excited to have less gadolinium! Finally, these safety issues are being “addressed”! And the answer we’ve all been waiting for? More gadolinium based contrast agents!