By Chuck and Gena Norris
A few days ago, the Wall Street Journal highlighted some critical health-care news every American needs to know in the article, “A question for anyone getting an MRI.”
The article reported: “Earlier this month an advisory committee to the U.S. Food and Drug Administration voted 13 to 1 in favor of adding a warning on labels that gadolinium [used in MRI ‘dye’] can be retained in some organs, including the brain, even in patients with healthy kidneys. … It also voted to request that manufacturers of GBCAs perform more studies to see if there is a need for additional regulatory actions, such as restricting their use in pregnant women and children.
“Some patients [like my wife, Gena] with healthy kidneys are reporting getting sick from the dye and are pressing for more research and warnings to the public. Doctors have for years cautioned patients with serious kidney problems about getting MRIs that use gadolinium because their kidneys can’t always fully flush out the metal toxins.
“Brent Wagner, a staff physician at the South Texas Veterans Health Care System in San Antonio and a nephrologist, says his laboratory studies have found that human cells exposed to gadolinium show signs of fibrosis, or scarring. He says the symptoms that patients with healthy kidneys have complained about are similar to the ones exhibited by kidney patients who develop nephrogenic systemic fibrosis (NSF) from gadolinium exposure, a rare disease that causes severe pain and scarring all over the body and in the internal organs.”
The Wall Street Journal’s Sumathi Reddy: “Robert McDonald, senior associate consultant of neuroradiology at the Mayo Clinic in Rochester, Minn., says studies he and others have done using animals and postmortem human tissue have shown that residual gadolinium is retained in tissues and organs. ‘We’re trying to understand to what extent it’s happening in the tissues of the body and also the clinical significance, if any,’ says Dr. McDonald who was at the FDA committee hearing after several manufacturers asked him to attend. General Electric Co., one of the manufacturers of GBCAs, paid for his travel expenses.”
By the way, it wasn’t that the one dissenting voice among the 13-1 FDA Medical Imaging Drug Advisory Committee vote was opposed to the label warning, but that it didn’t go far enough.
Last week, I discussed how the dissenting Harvard medical scholar and doctor actually became a FDA whistleblower. Dr. Alicia Y. Toledano, Sc.D., believes people and patients everywhere should be warned in ways far greater than labels about the potential dangers of gadolinium poisoning through Magnetic Resonance Imaging, or MRIs, which are performed on millions every year.
Dr. Toledano’s warning is a must-hear testimony for all Americans and can be heard here or read here in my last column, “Is the FDA ready to jump into the ring with me?” We had a friend present at the hearing who read the statement of my wife, Gena, and how three MRI injections in a single week of a gadolinium-based contrast agents, or GBCAs, nearly killed her.
Despite Dr. Toledano’s scholarly admonishment to the rest of the FDA’s Medical Imaging Drug Advisory Committee that they must sound the alarm to the public about GBCAs, the committee voted that a label warning (which the public would never see) was sufficient enough.
The Wall Street Journal article was right again: “Most patients getting an MRI don’t know to ask a critical question: Will the MRI use gadolinium or not?”
Dr. Toledano is not alone in her opposition. Many professional colleagues among the American College of Radiology concur with her conclusions.
According to Wikipedia, the American College of Radiology, founded in 1923, is a nonprofit professional medical association composed of diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians and medical physicists.
The members of ACR’s Committee on Drugs and Contrast Media are:
James H. Ellis, MD, FACR, chair
Matthew S. Davenport, MD
Jonathan R. Dillman, MD
Robert P. Hartman, MD
Brian R. Herts, MD
Syed Z. Jafri, MD, FACR
Amy B. Kolbe, MD
Archana Laroia, MD Richard H. Cohan, MD, FACR, former chair
Robert J. McDonald, MD, PhD
Laurence Needleman, MD, FACR
Jeffrey H. Newhouse, MD, FACR
Jay K. Pahade, MD
Claude B. Sirlin, MD
Carolyn L. Wang, MD
Neil Wasserman, MD, FACR
Jeffrey C. Weinreb, MD, FACR
In their most recent version of their ACR Manual on Contrast Media (10.3), published in June, they gave a plethora of citations to clinical tests and evidence warning about the potential adverse effects of GCBAs. Our good friend, Marcie Jacobs, who spearheads three great Facebook pages opposing gadolinium use in MRIs, gave us a copy of the manual, and its contents are very enlightening.
Of the 19 major chapters in the ACR Manual on Contrast Media (10.3), six are devoted to adverse to severe reactions and health consequences of GBCAs:
- Allergic-like and physiologic reactions to intravascular iodinated contrast media
- Contrast media warming
- Post-contrast acute kidney injury and contrast-induced nephropathy in adults
- Adverse reactions to gadolinium-based contrast media
- Nephrogenic systemic fibrosis
- Treatment of contrast reactions
Negative reactions to GBCAs are not restricted to those chapters, but they weave in and out of nearly the whole manual.
In chapter 13, “ACR–ASNR Position Statement on the Use of Gadolinium Contrast Agents,” the majority of what the committee states is a warning about their use, not their benefit:
“GBCAs increase the conspicuity of diseased tissues. … Recently, residual gadolinium has been found within the brain tissue of patients who received multiple doses of GBCAs over their lifetimes. For reasons that remain unclear, gadolinium deposition appears to occur preferentially in certain specific areas of the brain, even in the absence of clinically evident disease and in the setting of an intact blood brain barrier. Such deposition is not expected, and led the FDA to publish a Safety Alert in July of 2015 indicating that they were actively investigating the risk and clinical significance of these gadolinium deposits. …
“Gadolinium deposition in the brain may be dose dependent and can occur in patients with no clinical evidence of kidney or liver disease … additional research is warranted to elucidate the mechanisms of [brain] deposition, the chelation state of these deposits, the relationship to GBCA stability and binding affinity, and theoretical toxic potential, which may be different for different GBCAs. Until we fully understand the mechanisms involved and their clinical consequences, the safety and tissue deposition potential of all GBCAs must be carefully evaluated.
“Particular attention should be paid to pediatric and other patients who may receive many GBCA-enhanced MRI studies over the course of their lifetimes. If the decision for an individual patient is made to use a GBCA for an MRI study, multiple factors need to be considered when selecting a GBCA, including diagnostic efficacy, relaxivity, rate of adverse reactions, dosing/concentration, and propensity to deposit in more sensitive organs such as the brain. As this gadolinium deposition phenomenon remains a relatively undefined clinical phenomenon.”
With the ACR committee’s warning against those who have “received multiple doses of GBCAs over their lifetimes,” can you imagine how you’d feel if a loved one of yours like my Gena were subjected to three gadolinium-based MRIs in a single week without any warnings from the medical community?
If the FDA won’t listen to medical scientists, scholars and doctors or the Wall Street Journal, maybe late-night comedian Jimmy Kimmel, who seems to have become an unofficial national spokesman for health-care issues, should highlight the MRI gadolinium warning. (Jimmy shares something in common with us: We both have loved ones who have been gravely affected by a crippled health-care system, and we’re not going to take it anymore!)
I’ll say it again: If the FDA isn’t going to warn the public, we all must sound the alarm to our friends, neighbors and co-workers about the dangers of GBCAs. 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, postage-paid FDA form 3500, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
As Gena wrote in her statement to the FDA, we will continue to use our voice and now knowledge by experience to help others that are suffering from the same gadolinium poisoning that she did. We will continue to use our platform to raise awareness of the dangers of GBCAs until all Americans and other patients around the world do not have to risk their lives and limbs at the same time that they are simply seeking medical help.
FDA, here’s another warning label from me: Better inform the American public about gadolinium poisoning, or else Gena and my next step might be to go on “Jimmy Kimmel Live” and share this gadolinium news!