Gadolinium Toxicity

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Gadolinium in Ovaries 9.5 Years after GBCA Administration

Editorial by Sharon Williams
May 2020

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.

Sharon Williams

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References
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

7/27/15 FDA Safety Announcement – https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-evaluating-risk-brain-deposits-repeated-use-gadolinium-based

5/22/2017 FDA Safety Communication –  https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-identifies-no-harmful-effects-date-brain-retention-gadolinium

12/19/2017 & 5/16/2018 FDA Safety Announcements can be found here:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body

 

New White Paper about Health Risks of MRI Contrast Agents

The National Center for Health Research (NCHR) recently published a new white paper on its website about gadolinium-based contrast agents (GBCAs).   The title of the paper is “The Health Risks of Gadolinium-Based Contrast Agents used in MRIs” and the authors are Stephanie Fox-Rawlings, PhD, and Diana Zuckerman, PhD.  The paper provides a detailed history of GBCAs from regulation, to gadolinium toxicity and its clinical effects, possible treatments, and environmental exposure.

While there is much that we know about gadolinium and GBCAs, the authors acknowledge that there are still uncertainties, but that “the research thus far suggests that some people with healthy kidney function have been harmed by gadolinium.  This conclusion is based on the clear evidence of its accumulation and studies correlating its presence with symptoms”.

The authors pose several major questions concerning GBCAs and potential long-term harm.  They also describe the difficulties involved with designing studies to answer those questions.  However, they make it clear that new studies with carefully selected populations and study designs are needed.

Hopefully NCHR’s white paper about GBCAs will generate more research and interest in the potentially serious health risks associated with gadolinium retention and its long-term toxic effects.

About NCHR –
NCHR is a nonprofit, nonpartisan think tank that is focused on research that can improve the health of adults and children.  They do not accept funding from companies that make medical treatments.

According to its website, NCHR focuses on the programs and policies that they believe can most benefit from the research-based information that they can provide and the attention that they can generate.

You can read the article and learn more about NCHR here –
http://www.center4research.org/health-risks-of-gbcas/

Sharon Williams

Gadolinium Toxicity – Let’s not make the same mistake again

An Editorial by Hubbs Grimm
August 2018

(A pdf of this Editorial is available for download)

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.

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Gadolinium Toxicity: If not NSF, then what is it?

Editorial by Sharon Williams
August 2018

(A pdf of this Editorial is available for download)

What difference does a name make?  Evidently, when you are naming a disease it can make a huge difference.  The name can limit the scope of medical research, and when it comes to gadolinium, it has the potential to exclude other patient populations who have been exposed to the same toxic metal.

In 1997, when a group of patients on dialysis developed what appeared to be a new skin disorder, it was called Nephrogenic Fibrosing Dermopathy (NFD).  When researchers later learned that the problem went well beyond the patients’ skin and caused a systemic disease process, the name was changed to Nephrogenic Systemic Fibrosis (NSF).  The word “nephrogenic” in the name caused doctors and researchers to focus on people with severe renal disease.  At the beginning, that made sense since the problem only had been seen in patients with end-stage renal disease (ESRD).  Later we learned more about the cause.

In 2006, nine years after NSF/NFD was first diagnosed, the connection was made between NSF and gadolinium-based contrast agents (GBCAs) administered for MRIs.  Even though impaired kidney function did not cause NSF, the focus remained on the “N” or nephrogenic part of NSF.  Patients with normal kidney function were being overlooked; however, they were not unaffected by retained gadolinium from GBCAs.

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