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Editorial by Sharon Williams
While being in the middle of the COVID-19 pandemic might not seem like the best time to write an editorial about long-term gadolinium retention, waiting longer was not a good option for me. I believe that the information I want to share with patients, doctors, and gadolinium researchers needs to be in the public domain.
Anyone who follows our posts knows that none have been made since mid-2019. I will not go into all the reasons for that, but one of the issues resulted in the removal of my ovaries late last year. Thankfully, no cancer was found, but something else that should not have been there was – gadolinium. Testing performed by Doctor’s Data determined that there was gadolinium in both of my ovaries which were removed more than 9.5 years after my last dose of a gadolinium-based contrast agent (GBCA). I must admit that I was not surprised, since gadolinium was also found in my thyroid tissue that was removed in 2014.
At the time of all my MRIs, I had what the NSF literature refers to as “normal” renal function, meaning an eGFR greater than 60. I have had 5 MRIs with a linear GBCA that is no longer on the market, and my last dose was 10 years ago in March of 2010. I have no history of brain tumors or cancer anywhere in my body. Based on what patients like me have been told, I should not have retained gadolinium from the contrast agent, but I did, and I have proof of long-term gadolinium deposition in my organs. While I understand that deposition alone does not prove causation, I believe it raises serious questions about the long-term effects of gadolinium retention that need to be answered.
You might be wondering if I made the FDA or anyone else aware of the fact that gadolinium was found in my ovarian tissue 9.5+ years after my last dose of a GBCA, and the answer is, yes, I did. I sent the FDA and more than 20 other doctors and scientists a copy of a document that contained details of my GBCA history and results of testing my blood, urine, and thyroid and ovarian tissue for gadolinium. While I heard back from the FDA and a few doctors, nothing else has come from it at this time.
Whether the gadolinium level in my tissue was high or not is not the issue since gadolinium should not remain in the body many years after MRIs with a GBCA. As the FDA noted on page 16 of its Briefing Document for the September 8, 2017, MIDAC public meeting about Gadolinium Retention, “detection of gadolinium weeks or months following GBCA administration is considered abnormal as gadolinium is a trace element and not involved in any physiologic processes.” Sherry et al. (2009) reported that gadolinium is toxic in biological systems that require calcium for proper function due to the very similar radius of the Gd3+ and Ca2+ ions. Surely, based on what we have learned about gadolinium (Gd) and Nephrogenic Systemic Fibrosis (NSF), no one can honestly think that patients who retain toxic gadolinium for many months or years will not be harmed by it in some way at some point in time.
Until mid-2015, the FDA had not recognized that patients with normal renal function were retaining gadolinium from GBCAs administered for MRIs. While the FDA and Radiology community now acknowledge that everyone who has an MRI with a GBCA likely retains gadolinium from each dose of contrast they receive, so far, they continue to say that they have seen no evidence that retained gadolinium causes harm. I find that statement hard to reconcile with what we know already from the published facts about NSF, GBCAs, and the toxic effects of gadolinium.
While some may think the long-term effects of gadolinium retention are still unknown, I cannot believe it is a benign substance since I continue to experience symptoms of gadolinium toxicity more than 10 years later. It seems clear that a gadolinium study to evaluate patients like me is urgently needed. In my opinion, the issue is not about the toxic effects of gadolinium when it is retained in the human body since the NSF-related literature already informed us about that. The problem is no one understands what it is doing to patients with normal renal function when less gadolinium may have been retained.
As we have said many times before, Gadolinium Toxicity is a “Disease of Degrees” with NSF being the worst manifestation of it when large amounts of gadolinium are retained. However, based on the published facts about gadolinium and GBCAs, we see no reason to think that retained gadolinium will cause full-blown NSF or nothing at all.
It is my belief that the medical community will not fully-appreciate the scope of the problems related to gadolinium retention until symptomatic patients with normal renal function are interviewed, examined, and tested. If all patients retain some gadolinium from every dose of contrast that they receive, why is it that only a small percentage of people report having symptoms of toxicity? Could asymptomatic patients who have retained Gd go on to develop gadolinium-induced health issues later? Why are patients who have received macrocyclic agents for their MRIs experiencing intense symptoms; could they be retaining the intact macrocyclic GBCA?
There are many unanswered questions about the long-term effects of gadolinium retention, and I believe patients who have been affected by the toxic effects of gadolinium are key to finding some of those answers. What you learn from patients like me might help guide new research.
Researchers interested in conducting a study with me or other patients with normal renal function who have evidence of gadolinium retention and symptoms of gadolinium toxicity, should email me at Sharon@GadoliniumToxicity.com. I sincerely hope that researchers contact me since this problem is not going away.
9/8/2017 FDA Briefing Document for Medical Imaging Drugs Advisory Committee Meeting about Gadolinium Retention. https://www.fda.gov/media/107133/download
Sherry, A. D., Caravan, P., & Lenkinski, R. E. (2009). Primer on gadolinium chemistry. Journal of Magnetic Resonance Imaging : JMRI, 30(6), 1240–1248. Retrieved from http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2853020&tool=pmcentrez&rendertype=abstract
12/19/2017 & 5/16/2018 FDA Safety Announcements can be found here:
February 24, 2019 – Researchers from Finland, led by Dr. Aida Kiviniemi, found that gadolinium deposits can be detected in both enhancing and non-enhancing gliomas, adjacent normal brain tissue, and necrosis. The authors said that to their knowledge, “this is the first study to provide quantitative data of gadolinium retention in gliomas and neighboring normal brain with respect to tumor enhancement and type of GBCA used”. “The levels of gadolinium in the tumor and normal brain correlated suggesting a possible transit of gadolinium to the surroundings of the brain lesion. The most powerful predictor of gadolinium retention was the type of GBCA administered with significantly higher gadolinium accumulation detected with linear (gadodiamide and gadopentetate dimeglumine) relative to macrocyclic (gadoterate meglumine and gadobutrol) agents.” The study, Gadolinium retention in gliomas and adjacent normal brain tissue: association with tumor contrast enhancement and linear/macrocyclic agents, was recently published online in Neuroradiology. (more…)
Study Reports Gadolinium Clearance Times for 135 Contrast MRI Cases including Agent Administered for 63 Unconfounded Cases
On December 5, 2018, Hubbs Grimm and Sharon Williams, coauthors of GadoliniumToxicity.com, released their fifth research paper on gadolinium retention from Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. The paper is titled Gadolinium Clearance Times for 135 Contrast MRI Cases and includes the contrast agents for the unconfounded cases.
Drawing on the contrast MRI history and 24-hour gadolinium urine testing results that have been received from members of the MRI-Gadolinium-Toxicity Support Group, the study reports retrospectively on 135 cases with 218 urine test results, including 63 unconfounded cases with 81 test results. The participants all had normal kidney function and report having symptoms of gadolinium toxicity. The results reported are dramatic and involve all linear and macrocyclic GBCAs currently in use in the United States.
About the Gadolinium Clearance Time Report
In addition to reporting on additional cases received since our previous paper in 2017, we now report the contrast agents received with each unconfounded case. Analysis of the these cases produced trend lines over time that indicate typical gadolinium found in 24-hour urine testing for each of the agents including Dotarem, Gadavist, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The graphs and tables provide helpful information for both patients and medical practitioners trying to understand their test results. The analysis of clearance times for each agent is presented on a separate page.
The results show that all agents, both linear and macrocyclic, do not clear from the body in a few days as most patients are told. None of the test results in the first 2.5 months following a contrast-enhanced MRI was within the reference range used by Mayo Clinic Laboratories. It should be noted that the contrast agent and test result information presented is from people who believe they are suffering symptoms of gadolinium toxicity since their contrast-enhanced MRI. It is not known whether the clearance times presented would also apply to individuals who are not symptomatic.
The complete set of test results, without any data that would identify patients, is available to other researchers upon request.
With the evidence provided that clearance times are much longer for all of the agents than expected by medical practitioners, the authors present five recommendations for needed actions by medical professionals, other researchers, government agencies, and contrast agent manufacturers.
We want to thank members of the MRI-Gadolinium-Toxicity Support Group for their willingness to share their test results and other information with us. Our papers would not be possible without their continued support.
We urge patients, clinicians, and researchers to read the entire report and share as appropriate with your families, caregivers, and colleagues.
Hubbs Grimm and Sharon Williams
An Editorial by Hubbs Grimm
I want to talk about the unfortunate results of the early studies of gadolinium toxicity that defined NSF and the parallels I see today in the effort to define Gadolinium Deposition Disease (GDD). I will also propose an alternative view of how to describe gadolinium toxicity in a way that reflects what we currently know and do not know that will recognize all patients who have been affected by retained gadolinium.
Before I begin, I want to be clear that I believe all those who have contributed in the past and those who are contributing today are doing so with the best of intentions and working from the basis of their experience and perspective. But that does not mean that the result or proposals are necessarily best for meeting the needs of the people who are suffering from the toxic effects of gadolinium.