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
Sharyl Attkisson, five-time Emmy Award winner, and recipient of the Edward R. Murrow investigative reporting award, featured Gadolinium Toxicity in her June 11 edition of Full Measure. Chuck Norris and his wife Gena Norris both talked about her struggle with her related symptoms that resulted in them spending over $1,000,000 on special care.
Our own Sharon Williams was also featured in the segment, both for her own symptoms and for her advocacy including letters to the FDA in starting in 2012 and the maintenance of this website..
Y0u can see a video of the program and read the dialogue here: