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 on Yahoo, 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.
The two of us, Sharon Williams and Hubbs Grimm, have been working together on gadolinium toxicity related issues since 2012 and this website since 2014. Since it affects us and our many new friends personally, coming to agreement on our “message” has not always been easy but we have done it.
Recently, out of frustration with lack of progress on matters related to gadolinium toxicity from MRI contrast agents, we wanted to do a post that was both reflective of where the medical community has been on this issue and where we believe it ought to go. While we had similar ideas, we differed in how we wanted to convey the message. So, we each worked on our own editorial and then we helped each other with the final copy as we have done many times in the past.
Tomorrow we will be posting two editorials about Gadolinium Toxicity. While our approaches are different, this is not a dispute between us or an attempt to decide which is right and which is wrong. Instead, it is two people, working together with great respect for each other, expressing their thoughts in an important discussion about something that affects countless other people. We invite industry representatives to contribute to this discussion.
We hope you will read both editorials and take time to consider the important points we make.
Sharon’s editorial is titled, “Gadolinium Toxicity: If not NSF, then what is it?”
Hubbs’ editorial is titled, “Gadolinium Toxicity – Let’s not make the same mistake again”
Sharon Williams and Hubbs Grimm
Coauthors of The Lighthouse Project
Coauthors of The Lighthouse Project provide facts about Gadolinium Toxicity to FDA Advisory Committee
As coauthors of The Lighthouse Project, we have provided written comments about the toxic effects of gadolinium and gadolinium retention in patients with normal renal function to the FDA’s Medical Imaging Drugs Advisory Committee in advance of its September 8, 2017 meeting. We will be making a brief oral presentation during the Open Public Hearing portion of the meeting which will be held at the FDA’s White Oak Campus in Silver Spring, Maryland.
Our comments are built around the following 6 major points that we cover in making the case that the FDA needs to take action regarding the use of Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs.
1. Medical literature documents toxicity of gadolinium and systemic implications.
2. The Risk Factors for adverse results are many.
3. NSF-Like Symptoms in patients with normal renal function.
4. Gadolinium from GBCAs does not clear the body in a few days, or even in a few months, allowing plenty of time for the Gd ion to dissociate from the chelate.
5. Underreported Symptoms from Contrast MRIs is a serious problem.
6. There is evidence of clinical implications of gadolinium deposition.
Our detailed comments can be found here: Comments-from-Lighthouse-Project-FDA-2017-N-1957 . We also included the following supporting materials:
- Sharon’s 2012 Letter to the FDA (SWilliams-2012FDALetter-FDA-2017-N-1957)
- Our Symptom Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs (Lighthouse Symptom Survey copy for Docket FDA-2017-N-1957), and
- Our most recent report, Gadolinium Retention from Contrast MRIs in 70 Cases with Normal Renal Function – 24-hour Urine Test Results (Lighthouse 70 Case Retention Study copy for Docket FDA-2017-N-1957)
We will report back later about our experience at the FDA Advisory Committee Meeting.
Sharon Williams and Hubbs Grimm