Is the FDA ready to jump in the ring with me?

Just over a week ago, while Hurricane Irma dominated the news, a special advisory committee within the U.S. Food and Drug Administration, or FDA, was meeting, and my wife, Gena, and I were at the heart of it. The agency thought I was a tough contender until they met my better half!

Let me summarize for those who haven't heard.

Gena and I have been in the news recently because of the gadolinium poisoning she received through her Magnetic Resonance Imaging, or MRI, "a diagnostic technique that uses magnetic fields and radio waves to produce a detailed image of the body's soft tissue and bones."

We're not overlooking the good MRIs can do. We're speaking out against the dangers of gadolinium use in MRIs.

Gadolinium-based contrast agents, or GBCAs, are injected in about a third of 60 million MRIs performed annually – 30 million in the U.S. alone (that's one in 10 Americans), including children.

Gadolinium is a heavy metal chemical agent that is injected to enhance the images of a MRI. It not naturally found in the human body. Its proponents say it is always expelled from the body, primarily through the kidneys. But studies have shown it can be retained in the brain, bones, skin and others parts of the body.

More and more doctors, scientists and other health care professionals are coming forward to discuss the dangers of GBCAs.

And the crazy thing about it is: The FDA has been wrestling with the adverse health effects of GBCAs for more than 10 years, but without specifically warning the public or MRI patients about them. So, we're blowing the whistle about them.

As "Full Measure" reported, internal scientific documents from the FDA that are over a decade old reveal the agency has known about the potential adverse affects of GBCAs for a long time, but it did nothing about it.

That data concluded that, starting in 2006, there was a "strong association between gadolinium contrast agents and NSF [Nephrogenic systemic fibrosis, a deadly man-made disease]."

In 2007, the FDA issued a "black box warning" to those with weak kidneys to avoid GBCAs at all costs.

In 2015, the FDA issued another warning that GBCAs could linger in the bodies of those without kidney problems, from their bones to other vital organs.

Then, in May of this year, after an additional two-year study, the FDA suddenly reported that it had "not found any evidence of adverse events from the brain's retention of gadolinium after MRI." Surprised? Still, the agency highly admonished clinicians to "limit use" of GBCAs. It also confessed that while the review did not "identify" adverse health events related to brain retention, it wasn't ruling them out. It said it "will continue the study the effects of GBCAs," especially concerning "chronic pain and various other systems." Yet, it's sadly doing so while millions and millions globally continue to be injected with their poisons.

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In the same month of May, the European Medicines Agency Committee, which is responsible for the scientific evaluation, supervision and safety monitoring of medicines of more than 500 million people in the European Union, made a striking recommendation: The committee recommended a ban suspending the use of Linear GBCAs, including the biggest sellers by General Electric and Bayer.

Over the summer, the outpouring against the FDA's "GBCA benign brain ruling" was so overwhelming that, just a little over a week ago, the FDA held an official public meeting to wrestle again with the resistance and evidence it is receiving from the medical communities and beyond. That included evidence presented from our Norris household about my beloved wife's medical case.

The FDA's Medical Imaging Drug Advisory Committee specifically met to discuss the adverse and dangerous effects of GBCAs. Here's the Advisory Committee Briefing Document, which also outlines some of the spurious history and use of GBCAs, and the FDA's roller-coaster response to them.

At one point in the committee's meeting, the question was posed to the board: Are label updates/changes enough to warn the public, patients and medical personnel injecting GBCAs?

As MedPage Today reported on Sept. 11: "An FDA advisory committee voted 13-1, with one abstention, to recommend a new warning for gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging on Friday.

"Specifically, the FDA's Medical Imaging Drugs Advisory Committee recommended that prescribing information should include 'a warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain,' and that 'risk minimization steps' be taken for certain patient populations."

That's a warning step in the right direction, but a label warning is far from enough, as the one dissenting voice and medical scholar concluded.

God bless, Dr. Alicia Y. Toledano, Sc.D., who was educated and has taught at Harvard University as well as other prestigious institutions and organizations, and has received many outstanding honors and awards in the areas of radiology imaging. She was willing to go against the tide and state some unparalleled wisdom on GBCA dangers and their forthcoming warning's implementation.

Dr. Toledano explained during her testimony a warning that every medical institution and health-care professional needs to hear and heed:

"People need to know [about the danger of GBCAs], not just the doctors, and I don't think this [label warning] plan is sufficient. It is hard to dismiss an anecdotal report when you are the anecdote. A life ruined is a life ruined. What does a patient do when doctors and everyone else she turns to for help poo-poos her concerns, and doesn't order a test, a simple urine test? When a patient is finally tested and is found to have gadolinium retention, when there's no FDA anecdote, what does that patient do? The disconnect noted in Gena Norris' statement is so true all across this country every single day.

"Who prescribes the gadolinium-based contrast agent? Who chooses the agent? Who sets the dose? Is it the oncologist or neurologist or whatever specialist that orders the imaging? That person may not be able to request a specific agent or specific dose. There are lots of MRIs that happen in places without choices of agents. Not every MRI happens within an inpatient context and a tertiary care hospital. Sometimes it's just whatever the facility has. 'This is what we do for all the patients,' and if you ask us if it's safe, we will tell you, 'Sure, just drink some water when you get home. You will be fine.' How often do patients see any labeling? Almost never. When do patients get the opportunity to ask those questions?

"When someone gets an order from their neurologist or oncologist to go to the hospital or the imaging facility to get an MRI, they show up. They are asked to sign a consent form. What happens if they say no? Where does that patient go? Who talks to that patient? I know these concerns.

"We do not have evidence on which populations we need to minimize risk. We do not have effective means, or maybe we do but we just haven't exercised them, to engage the public with communication. There's not a simple fact sheet. If a patient goes to get an MRI from Community Radiology Associates here in the DC/Metro area – and I'm not picking on them because they're necessarily different, just a big one – the person at the desk may not even be aware yet of these [FDA GBCA] safety warrants. The communication has to be the patient, and we need the active … vigilance. So, I voted no, because as beautiful as this wording is [on the label warning], I do not believe it is sufficient."

You can listen to all eight minutes of Dr. Toledano's testimony here:

Keep listening right after Dr. Toledano's conclusions to the chairman's response: "That's an important explanation." And then listen to another doctor on the committee, who chimed in and asked, "May I comment?" He then weighs in, and says, "I want to thank you [Dr. Toledano] for those comments." He then affirmed her statements, "I just want to comment for the record: "That the D chelation approach is [still] considered experimental." Dr. Toledano immediately then commented, "I agree! That's why I say: You don't know if there's an anecdote. It's still investigation."

My question is: Even if DTPA is experimental, then why in the world is it being used in MRI contrast?! We are making millions of patients guinea pigs every day without an anecdote!

In a world that is becoming more and more sensitive to environmental, organic and holistic issues and uses, does the public really want the medical community to continue to pump the poison of GBCAs into both our bodies and precious planet?

We must sound the alarm and voice our concerns today to the FDA, the World Health Organization and every medical community, including your local one. Please join our growing army, take the following steps and sign the petition here:

Share this column – and others I'll write on the issue – on your social media.
Encourage others to watch Gena and my "Full Measure" interview.
Warn physicians and patients about the risks of gadolinium. Make sure physicians are properly informing patients about its dangers.
Restrict GBCA to much smaller and infrequent doses and use only in cases where the benefits far outweigh the risks, like in matters of life and death or the most serious of health issues.
Invest in rapid development of safe gadolinium alternatives.
Sponsor large studies of gadolinium toxicity in patients who have undergone MRI scans.
Promote the development of effective treatments to remove toxic gadolinium from patients affected by it.

As Medscape.com recommends, report any problems with GBCAs by contacting MedWatch, the FDA's safety information and adverse event reporting program, via telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, with postage-paid FDA form 3500 or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

For the latest information about gadolinium toxicity, please visit the Facebook page MRI Gadolinium Toxicity Illnesses or The Light House Project.

I'll say it again. When it comes to issues like gadolinium poisoning, Edward Everett Hale (1822–1909) gave us all a worthy marching order: "I am only one; but still I am one. I cannot do everything; but still I can do something; and because I cannot do everything, I will not refuse to do the something that I can do."

Round 2 next week: Watch out for the roundhouse kick!