Home » Advocacy (Page 3)
Category Archives: Advocacy
Full-disclosure, we are reporting on our own retention paper.
Today we have released our fourth research paper on gadolinium retention from Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. The paper is titled “Gadolinium Retention from Contrast MRIs in 70 Cases with Normal Renal Function – 24-hour Urine Test Results”.
Drawing on the contrast MRI history and 24-hour gadolinium urine testing results information that we have received from members of the MRI-Gadolinium-Toxicity Support Group, we reported retrospectively on 70 cases with 120 urine test results. We are thankful to the members of our support group for being willing to share their information with us. The participants all had normal kidney function and report having symptoms of gadolinium toxicity. We believe the results reported are dramatic.
About the Gadolinium Retention Study
The number of results presented is up significantly from our last paper in 2014 when we reported on 15 cases and 40 test results. The additional data points allowed us to look at gender as a possible differentiator, but the data showed nearly identical test results for males and females. With information about the number of contrast-enhanced MRIs for each case, we were able to analyze the results in three groups: cases with a single contrast MRI, cases with 2 to 4 contrast MRIs, and cases with 5 or more contrast MRIs. Readers of this site will not be surprised that the analysis showed that for these cases, there was a discernible difference in test results based on these groupings. The 2 to 4 contrast group generally had higher levels of gadolinium in their urine for a longer period of time than those with a single contrast. Likewise, the results for the 5 or more MRIs group were higher longer than the cases in the 2-4 contrast MRIs group. This is consistent with the cumulative effect of multiple contrast-enhanced MRIs that others have reported.
We also provided the raw test results data for each case, enabling other researchers as well as patients to look at the progression of test results over time. Averages for time blocks since the last contrast MRI are also shown to help in understanding the progression of gadolinium urine levels.
A few observations regarding the test results are revealing. 21 cases had urine tests performed in the first month with results that range from 507 mcg Gd/24hr urine specimen 4 days after the contrast MRI to results around 17 mcg Gd/24hr near the end of the first month. All of the results are enumerated in the report. 8 cases had urine test results more than 36 months after their contrast MRI with results as high as 0.6 mcg Gd/24hr more than 7 years after the individual’s last contrast-enhanced MRI. There is no broadly utilized acceptable range for gadolinium in a 24-hour urine collection. Mayo Clinic has established a reference range that was recently updated to be 0.0-0.6 mcg Gd/24-hour urine specimen collected more than 96 hours after administration of a GBCA. 40 cases had urine tests in the first 3 months after their contrast MRI, with the lowest result being 1.74 mcg Gd/24hr, well above the Mayo reference range that is applicable once four days have elapsed since the contrast MRI. Simply stated the results we observed are inconsistent with the clearance times indicated on GBCA product labeling and the understanding of most researchers and clinical practitioners.
To the best of our knowledge, this is the most comprehensive reporting of retained gadolinium as evidenced by urine testing that is available to the public. While the methods we used do not meet the rigor of a clinical trial, and we do not know if similar results would be seen universally, we believe the consistency of the results and the lack of outliers on the low side are justification for concern. We believe that further investigation by researchers, GBCA manufacturers, and licensing agencies is warranted.
This study does not stand alone, but confirms the many recently published research papers that reported unexpected retention of gadolinium from contrast MRIs by people with normal renal function. We encourage stronger action by the FDA and others to inform patients about possible gadolinium retention from contrast-enhanced MRIs and the potential for long-term side-effects.
We urge patients, clinicians, and researchers to read the entire report and share as appropriate with your families, care-givers, and colleagues. Read the Report.
Hubbs Grimm and Sharon Williams
A petition drive to Stop the Damage and Find a Cure for Victims of MRI Contrast Toxicity has been started at change.org. The toxicity comes from the gadolinium that is retained from Gadolinium-Based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. We hope all of our readers will sign the petition and then tell all their friends who will sign it and then tell all of their friends. With today’s social media, we have a chance to get the attention of the FDA and other decision makers around the world.
The petition was started by MedInsight Research Institute. https://medinsight.org/ and specifically by Moshe Rogosnitzky, the co-founder and Executive Director. He is an established research scientist and medical innovator whose pioneering work has resulted in the development of new treatments for various types of cancer and auto-immune diseases. We have been in touch with Moshe since late 2015 when he first contacted us about gadolinium toxicity issues.
His blog post announcing the petition drive “What price will we pay for the FDA’s faith in Gd?” lays out his case for why various actions regarding the use of Gadolinium-Based Contrast Agents are needed now. He covers many of the points we have raised and brings new insight as to why the FDA, NIH, WHO, and other organizations worldwide must Stop the Damage and Find a Cure for Victims of MRI Contrast Toxicity, the headline for the petition.
Please take action now and show your support by signing this petition at Change.org.
On October 23, 2012, I sent a detailed letter to the FDA which expressed my concerns about gadolinium toxicity caused by retained gadolinium from Gadolinium-based Contrast Agents (GBCAs). Because of the many recently published studies about gadolinium deposition in the brain and bones of patients with normal renal function, I decided that it was the right time to make my letter available to the public. While some progress has been made, four years have passed since I wrote that letter and I am concerned that the full scope of the problem still might not be addressed.
While I believe that the FDA took my concerns about gadolinium retention seriously, things are moving much too slowly. By making my letter public, I hope it will stimulate more interest in the issue of gadolinium retention and the plight of the many patients who have been adversely affected by its toxic effects.
You can download a copy of my 2012 Letter to the FDA in the Advocacy section. Please share it with your doctors and other affected patients.
To the medical professionals that follow us, I hope you will take time to read my entire letter. I am not a trained medical professional or scientist. However, I believe you will find my comments well-reasoned and fact-based.
On May 5, 2015, Health Imaging published “Q&A: Gadolinium update with leading MRI safety expert Emanuel Kanal, MD”. That same day, an editorial authored by Emanuel Kanal, MD, Director of MR Services at the University of Pittsburgh Medical Center, and Michael F. Tweedle, PhD, Professor and Stefanie Spielman Chair in Cancer Imaging at The Ohio State University Medical School, was published online in Radiology. Their editorial, “Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients”, addresses the issue of gadolinium retention in patients with normal renal function. The Q&A is a follow-up to that editorial.
For those who may not be familiar with Dr. ‘Manny’ Kanal, he is a nationally recognized radiologist and a leader in the area of MRI safety. He is the Chair of the founding Board of Directors of the American Board of Magnetic Resonance Safety (ABMRS). Dr. Kanal spoke with Health Imaging for an exclusive interview regarding the new evidence of gadolinium retention and its potential impact on diagnostic imaging and patient safety.
I will not go into all the details of the Q&A here, but there are several interesting comments that Dr. Kanal made that I want to mention.
Regarding the effects of retained gadolinium, Dr. Kanal questioned a comment in an article on Mayo Clinic News Network that was made by one of the authors of the recently published Mayo Clinic study. He said something to the effect of ‘Well, no one has ever shown that this is harmful.’ Dr. Kanal, acknowledged that is true, but, he said, “At the same time, no one has ever studied it to date, so how could they show whether it’s harmful or not?”
When asked how many of the patients who received one or more of the estimated 10 million contrast injections in the U.S. each year could have retained gadolinium in their bodies, Dr. Kanal said, “There is the potential for some level of gadolinium retention for essentially 100 percent of those patients who receive contrast for an MR examination”. (more…)